ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS Key Data … DS - MASTER DOCUMENT...43 ACCF/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral 44 Atherosclerotic

2010 PAVD Data Standards CONFIDENTIAL DRAFT August 24, 2010

© 2010 by the American College of Cardiology Foundation and the American Heart Association, Inc.

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ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS

Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

A Report of the American College of Cardiology/American Heart Association

Task Force on Clinical Data Standards

(Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic

Vascular Disease)

in collaboration with ACP/AACPR/AAN/ADA/NHLBI/SAI-P/SCCT/SCMR/VDF

WRITING COMMITTEE MEMBERS Mark A. Creager, MD, FACC, FAHA, Chair

Michael Belkin, MD* Emile R. Mohler, III, MD, FACC, FAHA‡‡ Edward I. Bluth, MD, FACR† Timothy Murphy, MD, FACR, FAHA, FSIR, FSVMB§§ Donald E. Casey, Jr, MD, MPH, MBA,FACP‡ Jeffrey W. Olin, DO, FACC, FAHA Seemant Chaturvedi, MD§ Judith G. Regensteiner, PhD, FAHA║║ Michael D. Dake, MD Robert H. Rosenwasser, MD, FACS, FAHA¶¶ Jerome L. Fleg, MD, FACC, FAHA║ Peter Sheehan, MD## Alan T. Hirsch, MD, FACC, FAHA Kerry J. Stewart, Ed.D., FAACVPR, FAHA, FACSM ** Michael R. Jaff, DO, FACC¶ Diane Treat-Jacobson, PhD, RN††† John A. Kern, MD# Gilbert R. Upchurch, Jr., MD, FACS, FAHA* David J. Malenka, MD, FACC, FAHA, FASE** Christopher J. White, MD, FACC‡‡‡

Edward T. Martin, MD, FACC, FACP, FAHA†† Jack A. Ziffer, MD, PhD, FACC§§§

*Society for Vascular Surgery Official Representative; †American College of Radiology Official Representative; ‡American College of Physicians Official Representative; §American Academy of Neurology Official Representative; ║National Heart, Lung, and Blood Institute Official Representative; ¶Vascular Disease Foundation Official Representative; #Society of Thoracic Surgeons Official Representative; **ACCF/AHA Task Force on Clinical Data Standards Liaison to the Writing Committee; ††Society for Cardiovascular Magnetic Resonance Official Representative; ‡‡Society for Atherosclerosis Imaging and Prevention Official Representative; §§Society of Interventional Radiology Official Representative; ║║ Society for Vascular Medicine and Biology Official Representative; ¶¶American Association of Neurological Surgeons Official Representative; ##American Diabetes Association Official Representative; *** American Association of Cardiovascular and Pulmonary Rehabilitation; †††Society for Vascular Nursing Official Representative; ‡‡‡Society for Cardiac Angiography and Interventions Official Representative; §§§ Society of Cardiovascular Computed Tomography

TASK FORCE MEMBERS

Véronique L. Roger, MD, MPH, FAHA, FACC, Chair Robert C. Hendel, MD, FACC, FASNC,FAHA, Vice-Chair Pamela N. Peterson, MD, FAHA Gregg C. Fonarow, MD, FACC, FAHA Eric E. Smith, MD, MPH, FRCPC, FAHA Jeffrey P. Jacobs, MD, FACS, FACC William S. Weintraub, MD, MPH, FACC



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This document was approved by the American College of Cardiology Foundation Board of Trustees in XXXX 2010, the 1 American Heart Association Science Advisory and Coordinating Committee in XXXX 2010, the American College of 2 Radiology Board** in XXXX 2010, the Society fir Cardiac Angiography and Interventions Board in XXXX 2010, the Society 3 of Interventional Radiology in XXXX 2010, Society for Vascular Medicine and Biology** in XXXX 2010, Society for Vascular 4 Nursing** in XXXX 2010, and the Society for Vascular Surgery** in XXXX 2010. 5

The American College of Cardiology Foundation requests that this document be cited as follows: Creager MA, Belkin M, 6 Bluth EI, Casey, DE Jr., Chaturvedi S, Dake MD, Fleg J, Hirsch AT, Jaff MR, Kern JA, Malenka DJ, Martin ET, Mohler, ER, 7 Murphy T, Olin JW, Regensteiner JG, Rosenwasser RH, Sheehan P, Stewart KJ, Treat-Jacobson D, Upchurch GR, White CJ, 8 Ziffer JA. 9

ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS Key Data Elements and Definitions for Peripheral 10 Atherosclerotic Vascular Disease. J Am Coll Cardiol 2010;XXX:XX-XX. 11

Copies: This document is available on the World Wide Web site of the American College of Cardiology (www.acc.org). For 12 copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail 13 [email protected]. 14

Permissions: Modification, alteration, enhancement, and/or distribution of this document are not permitted without the 15 express permission of the American College of Cardiology Foundation. Please contact [email protected]. 16



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Table of Contents 17

18 19

PREAMBLE..........................................................................................................................................4 20 I. INTRODUCTION .......................................................................................................................6 21 II. METHODOLOGY.......................................................................................................................7 22

A. Writing Committee Composition...................................................................................7 23 B. Relationships with Industry ...........................................................................................7 24 C. Review of Literature and Existing Data Definitions......................................................7 25 D. Defining Data Elements.................................................................................................8 26 E. Relation to Other Standards ...........................................................................................9 27 F. Consensus Development................................................................................................9 28 G. Peer Review, Public Review, and Board Approval .......................................................9 29 H. Considerations for Peripheral Atherosclerotic Vascular Disease Data Standards.......10 30

1. Clinical Programs................................................................................................10 31 2. Clinical Research.................................................................................................10 32 3. Quality Assessment/Performance Measurement..................................................10 33

III. PERIPHERAL ATHEROSCLEROTIC VASCULAR DISEASE CLINICAL DATA STANDARD 34 ELEMENTS AND DEFINITIONS ..........................................................................................................11 35

A. General Table of Data Elements ..................................................................................11 36 B. Lower Extremity Peripheral Artery Disease Table of Data Elements .........................23 37 C. Aorta Table of Data Elements......................................................................................39 38 D. Renal and Mesenteric Artery Disease Table of Data Elements ...................................54 39 E. Extracranial Carotid Artery Disease Table of Data Elements .....................................72 40

IV. APPENDICES .........................................................................................................................91 41 APPENDIX A: Author Relationships with Industry and Other Entities –42 ACCF/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral 43 Atherosclerotic Vascular Disease .........................................................................................................91 44 APPENDIX B: Peer Reviewer Relationships with Industry and Other Entities –45 ACC/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral 46 Atherosclerotic Vascular Disease .........................................................................................................96 47

References 48



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PREAMBLE 49

50 The American College of Cardiology Foundation (ACCF) and the American Heart Association 51 (AHA) support their members’ goal to improve the prevention and care of cardiovascular 52 diseases through professional education, research, development of guidelines and standards and 53 by fostering policy that supports optimal patient outcomes. The ACCF and AHA recognize the 54 importance of the use of clinical data standards for patient management, to assess outcomes, and 55 conduct research and the importance of defining the processes and outcomes of clinical care, 56 whether in randomized trials, observational studies, registries, or quality improvement initiatives. 57 58 Hence, clinical data standards strive to define and standardize data relevant to clinical topics in 59 cardiology, with the primary goal of assisting data collection by providing a platform of data 60 elements and definitions applicable to various conditions. Broad agreement on a common 61 vocabulary with reliable definitions used by all is vital to pool and/or compare data across 62 studies and assess the applicability of research to clinical practice. The growing adoption of 63 electronic medical records renders even more imperative and urgent the need for such definitions 64 and standards. Therefore, the ACCF and AHA have undertaken to define and disseminate 65 clinical data standards—sets of standardized data elements and corresponding definitions to 66 collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data 67 standards is to contribute to the infrastructure necessary for accomplishing the ACCF/AHA’s 68 mission of fostering optimal cardiovascular care and disease prevention. 69 70 The specific goals of clinical data standards are: 71 1. to facilitate the establishment of registries and quality improvement programs by providing a 72 list of major variables, outcomes, and definitions. 73 2. to optimize the comparison of results and outcomes across registries and studies 74 3. to become the basis for a standardized medical documentation process, essential for the 75 electronic medical record environment. 76 77 The key elements and definitions are a compilation of variables to measure patient management 78 and outcomes for clinical and research purposes as well as for quality improvement in order to 79 standardize the language used to describe cardiovascular diseases and procedures, enhance 80 consistency in cardiology, and increase opportunities for sharing data across data sources. The 81 ACCF/AHA Task Force on Clinical Data Standards selects cardiovascular conditions and 82 procedures that will benefit from creating a data standard set. Experts in the subject are selected 83 to examine/consider existing standards and develop a comprehensive, yet not exhaustive, data 84 standard set. When undertaking a data collection effort, only a subset of the elements contained 85 in a clinical data standards listing may be needed or, conversely, users may want to consider 86 whether it may be necessary to collect some elements not listed. For example, in the setting of a 87 randomized clinical trial of a new drug, additional information would likely be required 88 regarding study procedures and drug therapies. 89 90 The Health Insurance Portability and Accountability Act (HIPAA) privacy regulations, which 91 went into effect in April 2003, have heightened all practitioners’ awareness of our professional 92 commitment to safeguard our patients’ privacy. The HIPAA privacy regulations 93



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(http://www.hhs.gov/ocr/combinedregtext.pdf, page 31) specify which information elements are 94 considered “protected health information.” These elements may not be disclosed to third parties 95 (including registries and research studies) without the patient’s written permission. Protected 96 health information may be included in databases used for health care operations under a data use 97 agreement. Research studies using protected health information must be reviewed by an 98 institutional review board or a privacy board. 99 100 We have included identifying information in all clinical data standards to facilitate uniform 101 collection of these elements when appropriate. For example, a longitudinal clinic database may 102 contain these elements, since access is restricted to the patient’s caregivers. On the other hand, 103 registries may not contain protected health information unless specific permission is granted by 104 each patient. These fields are indicated as protected health information in the data standards. 105 106 The ACCF/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual 107 or potential conflicts of interest that may arise as a result of an outside relationship or a personal, 108 professional, or business interest of a member of the writing panel. Specifically, all members of 109 the writing group were required to submit a disclosure form showing all such relationships that 110 might be perceived as real or potential conflicts of interest. These statements are reviewed by the 111 ACCF/AHA Task Force on Clinical Data Standards, reported orally to all members of the 112 writing panel at the first meeting, and updated as changes occur. Writing Committee members’ 113 relationships with industry are listed in Appendix A. Relationships with industry for official peer 114 reviewers are listed in Appendix B. 115 116 In clinical care, caregivers communicate with each other through a common vocabulary. In an 117 analogous fashion, the integrity of clinical research depends on firm adherence to pre-specified 118 procedures for patient enrollment and follow-up; these procedures are guaranteed through careful 119 attention to definitions enumerated in the study design and case-report forms. When data 120 elements and definitions are standardized across studies, comparison, pooled analysis, and meta-121 analysis are enabled, thus deepening our understanding of individual studies. 122 123 The recent development of quality performance measurement initiatives, particularly those for 124 which comparison of providers is an implicit or explicit aim, has further raised awareness about 125 the importance of data standards. Indeed, a wide audience, including non-medical professionals 126 such as payers, regulators, and consumers, may draw conclusions about care and outcomes. To 127 understand and compare care patterns and outcomes, the data elements that characterize them 128 must be clearly defined, consistently used, and properly interpreted, now more than ever before. 129 130 131 132

Véronique L Roger, MD, MPH, FAHA, FACC 133 Chair, ACCF/AHA Task Force on Clinical Data Standards 134



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I. INTRODUCTION 135

136 Atherosclerotic vascular disease refers to disorders of arteries of caused by atherosclerosis (1). 137

This document provides clinical data standards for peripheral atherosclerotic vascular diseases 138

including lower extremity peripheral artery disease, abdominal aortic aneurysm, renal and 139

mesenteric artery disease, and extracranial carotid artery disease. It may serve as a companion to 140

the ACCF/AHA Guideline Statement of Peripheral Arterial Diseases(2) and the ACCF/AHA 141

Performance Measures for Peripheral Arterial Disease(3). Coronary artery disease is outside the 142

scope of this document. Multiple disciplines are engaged in the evaluation and management of 143

patients with peripheral atherosclerotic vascular diseases and developments in relevant research 144

and technology are emerging rapidly. Therefore, in order to ensure optimal documentation and 145

communication among health care providers, researchers, policy makers, payers, and industry, 146

the establishment of a uniform set of data elements and definitions for peripheral atherosclerotic 147

vascular diseases could not be more timely and compelling. 148

149

The data standards covered in this document are divided into six distinct tables. The first covers 150

general data elements that are common to all peripheral atherosclerotic vascular diseases. This 151

includes demographic information, atherosclerotic risk factors, concurrent atherosclerotic 152

diseases, comorbid conditions, medications, the cardiovascular examination, and relevant blood 153

chemistries and hematology. The remaining tables cover data standards that are specific for 154

lower extremity peripheral artery disease, abdominal aortic aneurysm, renal artery disease, 155

mesenteric artery disease, and extracranial carotid artery disease, respectively. Each of the 156

disease specific tables includes the following data elements: medical history; physical 157

examination; laboratory testing; diagnostic procedures; invasive therapeutic procedures (both 158

endovascular and open surgical); pharmacologic therapy; follow-up; and outcomes. 159

160



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II. METHODOLOGY 161

A. Writing Committee Composition 162

163 The ACCF/AHA Task Force on Clinical Data Standards selected members for the Writing 164

Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease 165

(Writing Committee). The Writing Committee consisted of 23 members who are well versed in 166

the epidemiology, clinical evaluation, medical management, invasive therapy, and/or outcome 167

assessment of patients with vascular disease and included individuals with expertise in patient 168

care, clinical investigation, and health services research and delivery. The Writing Committee 169

included representatives from a broad range of cardiovascular professional societies and 170

organizations, to ensure that the content of this document is widely applicable. All organizations 171

listed on the masthead and collaborating organizations nominated individuals to comprise the 172

makeup of the Writing Committee. 173

B. Relationships with Industry 174

175 The ACCF/AHA Task Force makes every effort to avoid any actual or potential conflicts of 176

interest that may arise as a result of an outside relationship or a personal, professional, or 177

business interest of a member of the writing panel. Specifically, all members of the writing group 178

were required to complete and submit a disclosure form showing all such relationships that might 179

be perceived as real or potential conflicts of interest. These statements are reviewed by the 180

ACCF/AHA Task Force on Clinical Data Standards and are updated when changes occur. Please 181

see Appendix A for the Writing Committee relationships with industry. 182

C. Review of Literature and Existing Data Definitions 183

184



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The PAVD Data Standards are intended to provide data elements that parallel and complement 185

existing data fields as previously reported in ACCF and AHA clinical data standards 186

documents(4-8), along with those used as fields within existing registries, such as those 187

developed by the ACC National Cardiovascular Data Registry (NCDR)(9). We also reviewed the 188

ACCF/AHA 2007 Methodology for Development of Clinical Data Standards(10), the Reporting 189

standards formulated by the Society for Vascular Surgery/International Society for 190

Cardiovascular Surgery, the National Heart Lung and Blood Institute (NHLBI) Claudication: 191

Exercise versus Endoluminal Revascularization (CLEVER)(11, 12) and Cardiovascular Outcome 192

in Renal Atherosclerotic Lesions (CORAL) trials(13, 14). 193

D. Defining Data Elements 194

195 The data elements were developed by the Writing Committee in a way that the definitions were 196

broad enough for use in various aspects of data collection, but specific enough to promote 197

uniform and simplified interpretation of data. Some elements will require an additional level of 198

specificity by the end-user for implementation which is beyond the scope of the Writing 199

Committee. Data definitions were linked whenever possible to the evidence-based national 200

guidelines. 201

To ensure consistency across ACCF/AHA clinical data standards, writers used an 202

existing ACCF/AHA definition. The Writing Committee chose not to develop an all-inclusive 203

list of every possible data element that may be used for all aspects of Peripheral Atherosclerotic 204

Vascular Disease. Rather, the Writing Committee focused its attention on common elements that 205

cross vascular specialty disciplinary boundaries. It is anticipated that some data definitions and 206

elements will need further delineation, likely by subspecialty society organizations and groups. 207



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The purpose of this document is to attempt to harmonize as many common data fields as 208

possible. 209

E. Relation to Other Standards 210

211 The Writing Committee reviewed other standards including those developed for heart failure, 212

atrial fibrillation, electrophysiology, acute coronary syndromes, and cardiac imaging, as 213

previously noted. It was felt that this Writing Committee possessed key levels of expertise 214

needed to address issues regarding Peripheral Atherosclerotic Vascular Disease in a consistent 215

fashion. 216

F. Consensus Development 217

218 These ACCF/AHA data standards, like others, are team-developed and written 219

documents and are based on the judgments of experts. The Writing Committee met more than 10 220

times, by telephone and in person, over the course of 3.5 years to define and refine the data 221

elements. Throughout the process, consensus was developed through extensive in-person 222

discussion, teleconferences, and e-mails. 223

G. Peer Review, Public Review, and Board Approval 224

225

The set of PAVD standards and definitions was independently reviewed by official appointees 226

from the ACC, AHA, ACR, SCAI, SIR, SVMB, SVN, ACCF/AHA Data Standards Task Force 227

as well as experts from collaborating organizations namely ACP, AACPR, AAN, ADA, NHLBI, 228

PAD SAI-P, SCCT, SCMR and VDF. To increase its applicability, this document was posted on 229

the ACC Website for a 30-day public comment period from September 1, 2010 through October 230

1, 2010. The document was then approved by all sponsoring organizations on __________. 231



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The Writing Committee anticipates these data standards will require review and updating, 232

just as with guidelines, performance measures and appropriateness criteria. At the anniversary of 233

the data standards publication, the Writing Committee will review the data standards to ascertain 234

whether or not modifications should be considered. 235

H. Considerations for Peripheral Atherosclerotic Vascular Disease Data Standards 236

237 The Writing Committee anticipates that the Peripheral Atherosclerotic Vascular Disease Data 238

Standards will prove useful in several settings: 239

1. Clinical Programs where providers and health plans work in concert to achieve 240

optimal utilization of procedures pertaining to PAVD. Data standards will assist 241

in the development of structured reporting systems, organizing and designing of 242

electronic medical information systems including clinical data-basing and 243

decision support tools. 244

2. Clinical Research including prospective registries and randomized controlled 245

trials. Meta-analyses will be particularly strengthened by the use of standardized 246

data for key variables. 247

3. Quality Assessment/Performance Measurement. Data standards will 248

especially facilitate interpretation for nonmedical users, including payers, 249

regulators, and consumers. 250



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III. PERIPHERAL ATHEROSCLEROTIC VASCULAR DISEASE CLINICAL DATA 251

STANDARD ELEMENTS AND DEFINITIONS 252

253

A. General Table of Data Elements 254

255 The general elements listed in table 1 are applicable to all of the peripheral atherosclerotic 256

vascular diseases included in this document. These include: demographic elements, such as 257

gender, age, race, ethnicity, and payor information; elements related to the patient’s presentation 258

such as the primary reason for the encounter and its location; risk factors for atherosclerosis, 259

such as hypertension, dyslipidemia, diabetes mellitus, and cigarette smoking; and evidence of 260

previously established atherosclerotic conditions, such as coronary artery disease, peripheral 261

artery disease, renal/mesenteric artery disease, abdominal aortic aneurysms, and cerebrovascular 262

disease; and co-morbid conditions, such as congestive heart failure, pulmonary insufficiency, and 263

chronic kidney disease. More detailed data elements for each peripheral atherosclerotic vascular 264

disease are provided in the subsequent tables. The general elements table also lists components 265

of the physical examination, such as height, weight, body mass index, vital signs, and aspects of 266

the cardiac and vascular examination. Detailed elements of the examination are provided in 267

subsequent tables as applicable to each peripheral atherosclerotic vascular disease. Also included 268

in the general elements table are common laboratory values, such as the complete blood count, 269

renal and hepatic function tests, lipids, cardiac enzymes, markers of inflammation, and tests for 270

inherited and acquired thrombophilias. Additional general elements include current 271

pharmacotherapy such as antiplatelet/anticoagulant drugs, medications to treat atherosclerotic 272

risk factors, and drugs for comorbid cardiovascular conditions. 273

274



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275

Table 1: General Elements

Element Name Definition Demographics

Gender Indicate the patient’s gender at birth. Choose one of the following:

• Male

• Female

Date of birth Patient date of birth (day, month, and year of patient’s birth).

Race Patient’s race as determined by the patient/family:

• American Indian or Alaska Native

• Asian

• Black or African American

• Native Hawaiian or other Pacific Islander

• White

• Other (specify)

Hispanic ethnicity Is this patient Spanish, Hispanic, or Latino? Choose one of the following:

• Yes

• No

Patient zip code Zip code of the residence where the patient typically resides.

Insurance payor Indicate the patient’s primary insurance payor for this admission. Choose one of the following:

• Government: Refers to patients who are covered by government-reimbursed care. In the U.S., this includes:

- Medicare - Medicaid (including all state or federal Medicaid-type

programs) - Veterans Health Administration - Department of Defense - Other federal group (specify)

• Commercial: refers to all indemnity (fee-for-service) carriers and preferred provider organizations (PPOs).

• HMO: refers to a health maintenance organization characterized by coverage that provides health care services for members on a pre-paid basis.

• None: refers to individuals with no or limited health insurance; thus, the individual is the payor regardless of ability to pay. Only mark “None” when “self” or “none” is denoted as the first insurance in the medical record.

Presentation to Health Care Facility

Presentation to healthcare facility

Indicate the date and time the patient presented to the healthcare facility.



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Element Name Definition Type of encounter • Emergency admission for stroke or TIA

• Emergency admission for limb ischemia

• Emergency admission for other cardiovascular (CV) problem

• Emergency admission for non-CV problem

• Planned admission for evaluation/treatment of carotid artery disease

• Planned admission for evaluation/treatment of peripheral artery disease

• Planned admission for evaluation/treatment of aortic aneurysm

• Planned admission for evaluation/treatment of renal/mesenteric artery disease

• Planned admission for other CV problem

• Planned admission for non-CV problem

• Regularly scheduled outpatient visit

• Urgent or other unscheduled outpatient visit

Primary reason for encounter

• Symptoms related to carotid artery disease

• Symptoms related to peripheral artery disease

• Symptoms related to aortic aneurysmal disease

• Symptoms related to renal artery disease

• Symptoms related to mesenteric artery disease

• Symptoms related to other CV disease

• Non-cardiovascular symptoms

Admission location • ICU / stroke unit

• Step-down unit

• Unmonitored hospital floor

• Observation / holding unit in emergency department

Means of transport • Self / family / friend / caregiver

• Ambulance

• Mobile ICU

• Air or ambulance transfer from another facility

Location of encounter • Acute care hospital

• Long-term care facility

• Urgent care clinic

• Caregiver office: primary care or specialist

Patient History

Atherosclerosis Risk Factors



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Element Name Definition Hypertension Indicate if the patient has hypertension as documented by:

• History of hypertension diagnosed and treated with medication, diet, and/or exercise

• Blood pressure ≥ 140 mm Hg systolic or 90 mm Hg diastolic on at least 2 occasions

• Blood pressure ≥ 130 mm Hg systolic or 80 mm Hg diastolic on at least 2 occasions for patients with diabetes or chronic kidney disease (25)

More than one of the above may apply. The year of onset (first diagnosis)

may be helpful.

Diabetes(15) History of diabetes diagnosed and/or treated by a physician. The American Diabetes Association criteria include documentation of the following:

• A1C >6.5%; or

• Fasting plasma glucose >126 mg/dl (7.0 mmol/l); or

• Two-hour plasma glucose >200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test; or

• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose >200 mg/dl (11.1 mmol/l).

The year of onset (first diagnosis) and whether type 1 or type 2 may be

helpful.

Dyslipidemia History of dyslipidemia diagnosed and/or treated by a physician. National Cholesterol Education Program criteria include documentation of the following: 1. Total cholesterol greater than 200 mg/dl (5.18 mmol/l); or 2. Low-density lipoprotein (LDL) ≥130 mg/dl (3.37 mmol/l) in patients with 2 or more risk factors, or ≥160 mg/dl in patients with 0-1 risk factor.; or 3. High-density lipoprotein (HDL) <40 mg/dl (1.04 mmol/l) in men and < 50mg/dl (1.30mmol/l) in women. 4. Fasting triglycerides >150 mg/dl(1.70mmol/l) Treatment is also initiated if LDL is >100 mg/dl (2.59 mmol/l) in patients with known coronary artery disease or CHD equivalent, and this would qualify as hypercholesterolemia.

History of smoking(16) History confirming cigarette smoking in the past. Choose from the following categories:

• current every day smoker

• current some day smoker

• former smoker

• never smoker

• smoker, current status unknown

• unknown if ever smoked. For current or former smokers, total pack years may be useful.



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Element Name Definition Alcohol consumption Specify alcohol consumption history. Choose from the following categories:

• None

• One or fewer alcoholic drinks per week

• 2 to 7 alcoholic drinks per week

• 8 to 13 alcoholic drinks per week

• 14 or more alcoholic drinks per week Specify alcohol dependency history. Choose all that apply:

• Documented alcohol dependency

• Medical sequelae of alcohol consumption (alcoholic hepatitis, cirrhosis, alcohol neuropathy, Wernicke-Korsakoff syndrome)

• Treatment for alcohol dependency

For dependent consumers of alcohol, note treatment for dependency,

cessation of use, or continued use.

Evidence of Atherosclerosis



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Element Name Definition History of MI Indicate if the patient has a history of MI. A myocardial infarction is

evidenced by any of the following:

• A rise and fall of cardiac biomarkers (preferably troponin) with at least one of the values in the abnormal range for that laboratory [typically above the 99th percentile of the upper reference limit (URL) for normal subjects] together with at least one of the following manifestations of myocardial ischemia: a. symptoms consistent with myocardial ischemia; b. ECG changes indicative of new ischemia (new ST-T changes, new

left bundle branch block, or loss of R- wave voltage), c. Development of pathological Q- waves in 2 or more contiguous

leads in the ECG (or equivalent findings for true posterior MI); d. Imaging evidence of new myocardial infarction or new regional

wall motion abnormality; e. Documentation in the medical record of the diagnosis of acute

myocardial infarction based on the cardiac biomarker pattern in the absence of any items enumerated in a-d due to conditions that may mask their appearance (e.g., peri-operative infarct when the patient cannot report ischemic symptoms; baseline left bundle branch block or ventricular pacing)

• ECG changes associated with prior myocardial infarction can include the following (with or without prior symptoms): a. Any Q-wave in leads V2-V3 >=0.02 seconds or QS complex in

leads V2 and V3. b. Q-wave >=0.03 seconds and >=0.1 mV deep or QS complex in

leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF).

c. R-wave >=0.04 seconds in V1-V2 and R/S >=1 with a concordant positive T-wave in the absence of a conduction defect.

• Imaging evidence of a region with new loss of viable myocardium at rest in the absence of a non-ischemic cause. This can be manifest as: a. Echocardiographic, CT, MR, ventriculographic or nuclear imaging

evidence of left ventricular thinning or scarring and failure to contract appropriately (i.e., hypokinesis, akinesis, or dyskinesis)

b. Fixed (non-reversible) perfusion defects on nuclear radioisotope imaging (e.g., MIBI, thallium)

• Medical record documentation of prior myocardial infarction.



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Element Name Definition MI within the past 6 weeks Indicate if the patient had a myocardial infraction (MI) within 6 weeks prior

to the index procedure as evidenced by the following: 1. Acute myocardial infarction (<=7 days) manifested as a rise and fall of cardiac biomarkers (preferable troponin) with at least one of the values above the range of normal for your laboratory [above the 99th percentile of the upper reference limit (URL)] together with evidence of myocardial ischemia with at least one of the following:

a. ischemic symptoms; b. ECG changes indicative of new ischemia (new ST-T and/or T

wave changes or new left bundle branch block), c. Development of pathological Q waves in the ECG; d. Imaging evidence of new loss of viable myocardium or new

regional wall motion abnormality. 2. Recent myocardial infarction (>7 days) manifested by:

a. A myocardial infarction meeting the criteria of an acute MI, as documented in the medical record, or

b. By either of the following: 1. Development of new pathological Q waves with or

without symptoms. 2. Imaging evidence of a region of loss of viable

myocardium that is thinned and fails to contract, 3. In the absence of a non-ischemic cause.

History of angina History of angina may include:

• Stable angina

• Unstable angina

• Remote myocardial infarction (more than 6 weeks previously)

Dates should be sought for the onset of either stable or unstable angina.

Previous Coronary Artery Bypass Graft Surgery (CABG)

Prior CABG surgery. Total number of CABG procedures and year of most recent may be helpful.

Previous Percutaneous Coronary Intervention ( PCI)

Prior PCI of any type (balloon angioplasty, atherectomy, stent, or other). Total number of PCI procedures and year of most recent may be helpful.

History of peripheral artery disease

Indicate if the patient has a history of lower extremity peripheral artery disease This can include:

• Asymptomatic (confirmed by non-invasive diagnostic test)

• Claudication

• Ischemic rest pain

• Tissue loss (including ischemic ulcer and/or gangrene)

• Amputation for critical limb ischemia

• Vascular reconstruction, bypass surgery, or percutaneous intervention to the extremities

• Abnormal noninvasive test (e.g., ankle brachial index =< 0.9, ultrasound, magnetic resonance or computed tomography imaging demonstrating > 50% diameter stenosis in any peripheral artery, i.e. aorta, iliac, femoral, popliteal, tibial, peroneal).



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Element Name Definition History of Aortic Aneurysm Indicate if the patient has a history of aortic aneurysm. This can include:

• Thoracic aneurysm

• Thoracoabdominal aneurysm

• Abdominal Aortic Aneurysm Confirmed by ultrasound and MR imaging

History of Renal or Mesenteric Artery Disease

Indicate if the patient has a history of renal or mesenteric artery disease. This can include abnormal imaging study such as magnetic resonance angiography, computed tomographic angiography, or catheter-based contrast angiography demonstrating >50% diameter stenosis in either renal artery, celiac trunk, superior mesenteric artery or inferior mesenteric artery

Transient Ischemic Attack (TIA)(17)

Documented history of TIA consisting of a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. Note the following:

• R retinal

• R hemispheric

• L retinal

• L hemispheric

• Vertebrobasilar

• Unknown distribution

Previous stroke Previous stroke defined as acute loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours, or symptoms <24 hours with evidence of acute infarction (for example, by CT or MRI) If present, record stroke type(18, 19):

• Ischemic stroke

• Intracerebral hemorrhage

• Subarachnoid hemorrhage

• Unknown type If ischemic, list the most likely etiology:

• Large artery atherosclerosis of the extracranial vessels (e.g. carotid)

• Large artery atherosclerosis of the intracranial vessels (e.g. middle cerebral artery stenosis)

• Cardioembolism

• Small vessel occlusion (lacunar)

• Ischemic stroke of other determined etiology (e.g. arterial dissection)

• Ischemic stroke of undetermined etiology

Congestive Heart Failure



19


Element Name Definition Congestive Heart Failure (CHF)

Indicate if there is a previous history CHF. This includes a previous hospital admission with principal diagnosis of CHF. CHF is defined as physician documentation or report of any two of the following Framingham major criteria of heart failure: orthopnea/paroxysmal nocturnal dyspnea; or the description of rales, jugular venous distension, hepatojugular reflux, s3 gallop, or pulmonary edema on chest x-ray, or one of the major plus two Framingham minor criteria including dyspnea on exertion, nocturnal cough, ankle edema, pleural effusion or tachycardia. A low ejection fraction without clinical evidence of heart failure does not qualify as heart failure.

New York Heart Association Functional Class

If heart failure, indicate NYHA Class. Choose one of the following:

• Class I: patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

• Class II: patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.

• Class III: patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

• Class IV: patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Symptoms are present even at rest or minimal exertion. If any physical activity is undertaken, discomfort is increased

Pulmonary insufficiency Indicate if there is a history of pulmonary insufficiency. Pulmonary insufficiency is defined as a PaO2 of less than 60 mm Hg while breathing air or PaCO2 of more than 50



20


Element Name Definition Chronic kidney disease(20) Current or previous history of chronic kidney disease, captured as current

status. Chronic kidney disease is defined as either kidney damage or GFR less than 60 ml/min/1.73 m2 for greater than or equal to 3 months. Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies. Indicate the patient’s stage of disease:

• Stage 0—No known kidney disease

• Stage 1—Kidney damage with normal or high—GFR greater than or equal to 90 ml/min/1.73 m2

• Stage 2—Kidney damage with mildly decreased—GFR 60 to 89 ml/min/1.73 m2

• Stage 3—Moderately decreased—GFR 30 to 59 ml/min/1.73 m2

• Stage 4—Severely decreased—GFR 15 to 29 ml/min/1.73 m2

• Stage 5—Kidney failure—GFR less than 15 ml/min/1.73 m2 or on dialysis

Note: GFR may be estimated using the serum creatinine–GFR 186 (PCr) 1.154 (age) 0.203 (0.742 if female) (1.210 if black) Year of onset (first diagnosis) may be helpful.

Patient Assessment – Physical Evaluation

Height Patient’s height in centimeters or inches. May be measured or reported by patient.

Weight Patient’s weight in kilograms or pounds. Must be measured during encounter. It is advisable to standardize clothing worn (i.e., whether shoes are worn).

BMI Calculated according to formula: patient’s weight in kilograms, divided by height in meters squared. Obesity is defined as BMI greater than or equal to 30 kilograms per meter squared.

Blood pressure (right and left arm)

Systolic and diastolic blood pressure (mm Hg) in both right and left arm, recorded closest to the time of presentation to the health care facility. Patient position (supine, sitting, other) may be noted.

Heart rate Heart rate (beats per minute) recorded closest to the time of presentation to the health care facility and/or on discharge (for inpatient). Specify whether heart rate is regular or irregular. Heart rate may be ascertained from electrocardiographic tracing or from record of physical examination.

Cardiac rhythm Indicate if the patient has any of the following:

• Normal sinus rhythm

• Atrial Fibrillation

• Other

Complete vascular examination

Carotid, upper, lower extremity pulses, auscultation of the neck for carotid bruits, auscultation of the abdomen and femoral arteries for bruits, palpation of the abdomen for aneurysm

Complete cardiac examination

Palpation and auscultation of the heart, assessing rate, rhythm, presence of murmur, presence of gallop (e.g. S3 suggesting left ventricular dysfunction; S4 suggesting non-compliant left ventricle); notation of location of point of maximal intensity



21


Element Name Definition Limb edema

Note presence/absence of lower extremity (less common upper extremity) edema, including location, extent, pitting vs non-pitting

Laboratory Testing

Complete blood count (CBC)

1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Hemoglobin 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Hematocrit 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Glucose 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Blood Urea Nitrogen (BUN) 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Creatinine 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Glomerular filtration rate (GFR)

Indicate estimated or actual glomerular filtration rate in ml/min/1.73 m2

Sodium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Potassium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Hemoglobin A1C 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Prothrombin time PT: Measured in seconds.; Report INR as ratio

Partial thromboplastin time Indicate whether activators used (aPTT) or not (PTT). Measured in seconds.

Total cholesterol 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Low-density lipoprotein cholesterol (LDL)


High-density lipoprotein cholesterol (HDL)


Triglycerides 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

High sensitivity C reactive protein (hs-CRP)


Erythrocyte sedimentation rate (ESR)


Calcium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Magnesium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Thyroid stimulating hormone (TSH)


B-type Natriuretic Peptide (BNP) or N-terminal BNP


Aspartate aminotransferase (AST)


Alanine aminotransferase (ALT)




22


Element Name Definition Creatine kinase (CK) The upper limit of normal of total CK as defined by individual hospital

laboratory standards. The units of the CK and type of units (e.g., IU, ng/dl, kCat/l) should be noted. All CK values during the hospitalization should be noted; include the units, date, and time

Troponin Indicate which type: T or I Indicate the upper limit of normal (usually the 99th percentile of a normal population) and the units (e.g., ng/dl) All troponin T or I values during the hospitalization should be noted; include units, date, and time

Homocysteine 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Vitamin B12 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Folate 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Prothrombin 20210 gene mutation


Protein C activity 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Protein S activity 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Antithrombin III 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Anticardiolipin antibody 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Lupus anticoagulant 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Venereal Disease Research Laboratory (VDRL)


Current Pharmacologic Therapy to Manage Cardiovascular Disease

Antiplatelet drugs Aspirin Note specific dose

Clopidogrel Note specific dose

Prasugrel Note specific dose

Other thienopyridine Note specific drug and dose

Dipyridamole Note specific dose

Others Note specific drug and dose

Anticoagulant drugs Unfractionated Heparin Note specific dose

Low molecular weight heparin

Note specific drug and dose

Fondaparinux Note specific dose

Direct thrombin inhibitor Note specific drug and dose

Warfarin Indicate whether this drug has been prescribed

Others Note specific drug and dose

Drugs to control CV Risk Factors

Antihypertensives Note the specific drug and dose.

Statins and lipid-control agents

Note the specific drug and dose.



23


Element Name Definition Hypoglycemic drugs in diabetics

Note the specific drug and dose

Drugs to aid in smoking cessation

Note the specific drug and dose

Drugs for Co-existing CV Conditions

Anti-arrhythmic drugs Note the specific drug and dose.

Heart failure medications Note the specific drug and dose

Drugs for symptoms of peripheral artery disease

Note the specific drug and dose.

Non-CV medications Note the specific drug and dose

Other elements related to pharmacologic therapy to manage CV disease Medication allergy Specify medication and type of reaction

Medication side effect Describe side effect and whether medication stopped

276

277

B. Lower Extremity Peripheral Artery Disease Table of Data Elements 278

279 280 Lower extremity peripheral artery disease (PAD) is defined as atherosclerotic disease that affects 281

the arteries supplying the legs(1). Affected blood vessels may include the aorta, iliac, femoral, 282

popliteal, tibial and peroneal arteries and their major branches. The data elements defined in 283

Table 2 enable detailed documentation of symptomatic status, the vascular examination, and the 284

severity of limb ischemia. The table includes data elements used in physiologic diagnostic tests, 285

such as the ankle brachial index, treadmill exercise test, limb segmental pressure measurements 286

and pulse volume recordings. It also provides detailed elements of imaging tests including 287

duplex ultrasonography, magnetic resonance angiography, computed tomographic angiography, 288

and catheter-based radiocontrast angiography, such as the artery imaged and the location and 289

severity of stenoses. Data elements relevant to treatment include pharmacotherapy and exercise 290

rehabilitation for claudication. Table 2 also includes detailed data elements for both 291

endovascular and open surgical revascularization such as the target vessel, the specific 292

procedure, outcomes and complications. 293

294 295 Table 2: Lower Extremity Peripheral Artery Disease Elements and Definitions

Element Name Definition Patient Assessment – Signs and Symptoms



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Table 2: Lower Extremity Peripheral Artery Disease Elements and Definitions

Element Name Definition Asymptomatic The patient has no symptoms of claudication, no symptoms of ischemic pain,

and no limitation in walking distance.

Claudication: Characteristics

Indicate claudication as determined by the discomfort being:

• Exertional

• Reproducible

• Resolves promptly with rest

Claudication: Description Indicate discomfort description. Choose all that apply:

• Cramping

• Aching

• Fatigue

• Other

Claudication: Location Indicate Limb (right leg, left leg, both) and location of discomfort. Choose all that apply:

• Buttock

• Thigh

• Calf

• Foot

Claudication: Walking Indicate the following descriptors for walking:

• Pain-free walking distance (in feet/blocks)

• Maximal walking distance (in feet/blocks)

• Typical walking speed - Slow - Normal - Fast

• Flat surface vs. incline

Claudication: Symptom Onset

Indicate the following:

• Date of onset

• Duration of symptoms

Claudication: Stability of symptoms

Indicate if symptoms:

• Improved

• Stabilized

• Worsened

Atypical Symptoms Describe atypical symptom characteristics



25


Element Name Definition Ischemic rest pain Indicate if pain and discomfort:

• Is characterized by aching or burning at rest or with elevation

• Is relieved by dependency

• Interferes with sleep Also indicate the following:

• Location (Indicate right or left leg or both legs) - Forefoot - Toes

• Date of onset

• Duration of symptoms

• Occurrence - Intermittent - Constant

Tissue loss Report of non-healing wound. Indicate the following:

• Location

• Onset/Duration

Acute Limb Ischemia

Characteristics Indicate if there is a sudden onset of:

• Pain

• Paresthesia

Location Indicate the specific location of pain

Symptom Onset Indicate the onset and duration of symptoms

Patient Assessment – Physical Evaluation

Pulses Indicate the characteristics of pulses in the following locations:

• Femoral

• Popliteal

• Dorsalis pedis

• Posterior tibial Indicate if pulses are:

• 0 – Absent

• 1 – Diminished

• 2 - Normal

• 3 – Bounding

Bruits Indicate the presence or absence of bruits on auscultation in the following:

• Carotid

• Abdominal

• Femoral

• Subclavian

Elevation Pallor Indicate the presence of pallor of forefoot after elevation of leg 60° for 1 minute

Reperfusion delay Reperfusion delay( > 40 seconds)



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Element Name Definition Dependent rubor Indicate if there is rubor of foot when held in dependence after elevation pallor

maneuver

Acute Limb ischemia Acute limb ischemia is characterized by:

• Pallor

• Pulselessness

• Poikilothermia (coolness)

• Paralysis - One of the following categories should be assigned:

o I. Viable – Limb is not immediately threatened; no sensory loss; no muscle weakness; audible arterial and venous Doppler

o II. Threatened – Mild to moderate sensory or motor loss. Inaudible arterial Doppler; audible venous Doppler.

Irreversible – Major tissue loss or permanent nerve damage inevitable; profound sensory loss, anesthetic; profound muscle weakness or paralysis (rigor); inaudible arterial and venous Doppler

Tissue loss (Ischemic Wound or Gangrene): Characteristics

Tissue loss is characterized by:

• Dryness

• Necrosis

• Granulation

Tissue loss (Ischemic Wound or Gangrene): Affected limb

Indicate the affected extremity/extremities. Choose one of the following:

• Left

• Right

• Bilateral

Tissue loss (Ischemic Wound or Gangrene): Onset

Indicate the onset and duration of tissue loss.

Tissue loss (Ischemic Wound or Gangrene): Location

Specify the location of tissue loss. Choose all that apply:

• Distal aspect of leg or foot

• Over bony prominence

• Toe

• Others

Tissue loss (Ischemic Wound or Gangrene): Wound area

Indicate the measured area of the wound in cm

Tissue loss (Ischemic Wound or Gangrene): Infection

Indicate the presence or absence of infection. Choose one of the following:

• Yes

• No

Tissue loss (Ischemic Wound or Gangrene): Type

Indicate the type of tissue loss. Choose one of the following:

• Minor – non-healing ulcer, focal gangrene with diffuse pedal ischemia.

• Major – extending above transmetatarsal (TM) level, functional foot no longer salvageable.



27


Element Name Definition Tissue loss (Ischemic Wound or Gangrene): Depth/Wagner Grade

Indicate the Wagner grade of the wound/gangrene. Choose one of the following:

• Grade 0 – pre or postulcerative lesion

• Grade 1 – partial /full thickness ulcer

• Grade 2 – probing to tendon or capsule

• Grade 3 – deep with osteitis

• Grade 4 – partial foot gangrene

• Grade 5 – whole foot gangrene

Diagnostic Testing – Non-invasive Procedures

Ankle Brachial Index/Toe Brachial Index

Date of Procedure Indicate the date the procedure was performed (Month/Day/Year)

ABI value Indicate the ABI value. Choose one of the following:

• Normal (ABI > 0.9 to ≤1.3)

• Abnormal (ABI < 0.9)

• Abnormal (ABI ≥1.3)

Ankle systolic pressure Indicate ankle systolic pressure of the right and left legs and whether it is recorded from the posterior tibial or dorsalis pedis arteries.

TBI value Indicate the TBI value. TBI value of < 0.7 is abnormal.

Exercise Testing – Treadmill Exercise

Date of Procedure Indicate the date exercise testing was performed (Month/Day/Year)

Protocol Specify the symptom-limited exercise protocol used. (constant load/graded)

Post-exercise ankle pressure and/or ABI

Indicate if immediate post-exercise ankle pressure and/or ABI measurement was performed. Choose one of the following:

• Yes. If so, indicate value

• No

Walking Time Indicate the following walking time in minutes:

• Pain-free walking time

• Maximal walking time

Distance Indicate the walking distance in meters:

• Pain free walking distance

• Maximal walking distance

Metabolic equivalents (METS)

One MET is defined as 3.5 ml O2·kg-1·min-1. Indicate METS at peak exercise.

Alternative methods If treadmill testing is not available, choose any of the following alternative methods:

• 6-minute walk – distance able to walk in 6 minutes on flat surface using standardized measurement procedures. Reported in feet or meters.

• Active pedal plantar flexion – Toes raised to maximal height and maximal speed for 5 minutes.

Segmental Pressure Examination

Date of Examination Indicate the date the segmental pressure examination was performed (Month/Day/Year)



28


Element Name Definition Segmental pressure measurements

• Right and left brachial pressures

• Right and left high thigh pressures

• Right and left low thigh pressures

• Right and left high calf pressures

• Right and left dorsalis pedis pressures

• Right and left tibial pressures Indicate if there is >20 mmHg drop between the contiguous segments of the same leg, which can be suggestive of the location of stenosis.

Pulse Volume Recording

Date of recording Indicate the date pulse volume recording was taken (Month/Day/Year)

Amplitude reduction Indicate the leg and location of the PVR. Right/Left high thigh Right/Left low thigh Right/Left calf Right/left ankle Right/Left metatarsal Choose one of the following to describe pulse wave amplitude:

• Normal

• Mild

• Moderate

• Severe

Duplex Ultrasound


Artery imaged Indicate the artery imaged. Choose all that apply:

• Right/Left Common femoral artery

• Right/Left Proximal profunda femoris artery

• Right/Left Superficial femoral artery

• Right/Left Popliteal artery

• Right/Left Tibioperoneal trunk

Peak systolic velocity Specify for:





• Right/Left Tibioperoneal trunk

Category of stenosis Specify for:





• Right/Left Tibioperoneal trunk Indicate the category of stenosis(21):

• Normal

• 1-49%

• 50-99%

• Occlusion



29


Element Name Definition Bypass graft Indicate location of proximal and distal anastomosis and type (e.g. in situ

saphenous vein, reverse saphenous vein, polytetraethylene, etc.)

Peak systolic velocity of bypass graft

Indicate peak systolic velocity at proximal anastomosis, along conduit, distal anastomosis

Ratio of peak systolic velocites of bypass graft

Indicate ratio of peak systolic velocity of two contiguous segments at proximal anastomosis, along conduit, and at distal anastomosis

Category of bypass graft stenosis

Bypass Graft Percent stenosis. Indicate location and choose one of the following:

• 0-49%

• 50-99%

• Occluded

Magnetic Resonance Angiography


Contrast use Indicate if Gadolinium was used. Choose one of the following:

• Yes

• No


• Abdominal aorta

• Right/Left iliac (common, internal, external) artery

• Right/Left femoral (common, superficial, deep) artery

• Right/Left popliteal (above knee, below knee, both) artery

• Right/Left tibial/peroneal (anterior tibial, posterior tibial peroneal) arteries

Lesion location Specify lesion location.

Artery stenosis Indicate severity of stenosis by quantitative analysis using the formula; 100 x (1 – minimum lumen diameter)/maximum diameter of reference segment

Reconstitution Indicate if reconstitution was done. Choose one of the following:

• Yes

• No

CT Angiography

Date of Procedure Indicate the date procedure was performed (Month/Day/Year)

Contrast used Indicate the type of contrast used. Choose one of the following:

• Ionic contrast

• Non-ionic contrast; specify: - Monomer - Dimer

Contrast volume Indicate the volume of contrast used in ml.

Slice thickness Indicate the slice thickness in mm

Format: Raw images Indicate if raw images were reviewed. Choose one of the following:

• Yes

• No



30


Element Name Definition Format: Reconstructed images

Indicate if reconstructed images were reviewed. Choose one of the following:

• Yes. If yes, specify: - Shaded surface images - Maximal int. project

• No


• Abdominal aorta


• Right/Left femoral (common, superficial, deep) artery

• Right/Left popliteal (above knee, below knee, both) artery

• Right/Left tibial/peroneal (anterior tibial,posterior tibial peroneal) arteries

Lesion location Specify lesion location.

Calcification Indicate if calcification is present. Choose one of the following:

• Yes - If calcification is present, specify location.

• No


Reconstitution Indicate if reconstitution was done. Choose one of the following:

• Yes

• No

Diagnostic Testing – Invasive Procedures

Catheter Angiography

Date of procedure Indicate the date the procedure was performed (Month/Day/Year)

Operator Name Last name, first, middle

Anesthesia Indicate the anesthesia used. Choose one of the following:

• General anesthesia (i.e. completion arteriogram post bypass)

• Local anesthesia - With sedation - Without sedation

• Other (regional) - With sedation - Without sedation

Vascular access site Specify the vascular access site.

Contrast agent Indicate the contrast agent used.

• Iodinated - Ionic - Non-ionic

� Monomer � Dimer

• Non-iodinated (CO2)

Field size Indicate the field size in centimeters or inches.

Frame rate Indicate the frame rate per second (FPS).



31


Element Name Definition Image type Indicate the image type. Choose one of the following:

• CINE

• Digital images

Digital subtraction Indicate if digital subtraction was done. Choose one of the following:

• Yes

• No

Fluoroscopy time Indicate total fluoroscopy time recorded to the nearest 0.1 minute. The time recorded should include the total time for the procedure.


• Abdominal aorta


• Right/Left femoral (common, deep, superficial) artery

• Right/Left popliteal (above knee, below knee, or both) artery

• Right/Left tibial/peroneal (anterior tibial, posterior tibial, peroneal) arteries

Lesion location Specify lesion location (ostial, proximal third, middle third, and distal third).

Calcification Indicate if calcification is present. If calcification is present, specify location. Choose one of the following:

• None

• Mild

• Moderate

• Severe


Reconstitution Indicate if artery is reconstituted by collaterals. Choose one of the following:

• Yes - If yes, indicate level.

• No

Trans-lesional pressure gradient

Indicate the pressure measured proximal to the stenosis minus pressure measured distal to stenosis. Also indicate the following:

• Baseline pressure gradient - Systolic - Mean - Diastolic

• Enhanced (hyperemic, post vasodilator) pressure gradient - Systolic - Mean - Diastolic

• Measurement timing - Simultaneous - Pullback

Pharmacologic Therapy for Symptoms of Claudication



32


Element Name Definition Cilostazol Indicate if the patient has been prescribed cilostazol. Choose one of the

following:

• Yes - If yes, indicate the following:

� Dose � Duration of treatment

• No

Pentoxifylline Indicate if the patient has been prescribed pentoxifylline. Choose one of the following:

• Yes - If yes, indicate the following:

� Dose � Duration of treatment

• No

Exercise Rehabilitation for Intermittent Claudication

Exercise Program Assessment

Functional ability Document functional ability at initiation and completion of exercise program based on the following:

• Pain-free walking distance

• Maximal walking distance

• METS achieved at peak exercise

• 6-minute walk test

• Questionnaires

Total exercise time Document the total exercise time during exercise session at initiation and completion of exercise program.

Total rest time Document the total rest time spent during the exercise session at initiation and completion of exercise program

Walking time Document the duration of walking time at initiation and completion of exercise program.

Exercise Prescription

Place Indicate the place where exercise is done. Choose one of the following:

• Supervised facility

• Home based

Mode of exercise Indicate the mode of exercise prescribed. Choose one of the following

• Treadmill - Indicate initial speed and grade - Indicate final speed and grade

• Track walking - Indicate initial speed - Indicate final speed

• Cycling - Indicate initial speed and grade/watts - Indicate final speed and grade/watts

Progression Indicate the recommendation for progression of exercise

Intensity level Indicate the recommended claudication pain intensity level before resting

Rating of perceived exertion (RPE)

Indicate the recommended range of rating of perceived exertion



33


Element Name Definition Duration of session Indicate the duration of exercise session in minutes.

Frequency of session Indicate the number of days of exercise session per week

Duration Indicate how long the exercise prescription should be performed in number of sessions or number of weeks

Intervention/Therapeutic Procedures – Revascularization

Endovascular

Date Indicate the date the procedure was performed

Operator name Last Name, First, Middle

Limb revascularized Indicate which limb was revascularized. Choose one of the following:

• Right

• Left

• Both

Procedure Indicate the procedure performed. Choose one of the following:

• Balloon angioplasty

• Cutting balloon

• Stent - Indicate if stent is drug eluting. Choose one of the following:

� Yes - If so, specify type of drug eluting stent

� No

• Stent graft

• Atherectomy

• Laser

• Cryoplasty

Vessel Indicate the target vessel for revascularization. Choose all that apply:

• Aorta

• Common iliac artery

• External iliac artery

• Internal iliac artery

• Common femoral artery

• Superficial femoral artery

• Deep femoral artery

• Popliteal (above the knee)

• Popliteal (below the knee)

• Anterior tibial artery

• Posterior tibial artery

• Peroneal Artery

• Pedal arteries

Manufacturer Indicate the manufacturer of the device

Model Indicate the model number of the device

Diameter Indicate the maximum diameter of the device in mm

Length Indicate the maximum length of the device in mm

Time arrived in catheterization lab

Indicate the time of patient arrival in the catheterization lab in hour:minute

Last catheter removed Indicate the date in month/day/year and time in hour:minute of last catheter removal.



34


Element Name Definition Thrombolytic Agent Indicate the thrombolytic agent used. Specify the following:

• Specific thrombolytic agent used

• Route of delivery

• Dosage

• Duration of infusion

Antithrombotic Agent Indicate the antithrombotic agent used. Specify the following:

• Specific antithrombotic agent used. Choose one of the following: - Unfractionated heparin - Low molecular weight heparin - Fondaparinux - Direct thrombin inhibitor

• Route of delivery

• Dosage

• Duration of infusion

Antiplatelet Agent Indicate the antiplatelet agent used. Specify the following:

• Dosage

Closure device Indicate if closure device was used. Choose one of the following:

• Yes. If yes, specify the following:

• Manufacturer of closure device

• Model of closure device

• No

Contrast Indicate type of contrast was used. Choose one of the following:

• Iodinated - Ionic - Non-ionic

o Monomer o Dimer

• Non-iodinated (CO2)

Device Utilization Indicate the device used for the procedure. Choose all that apply:

• Guidewires

• Guiding catheters

• Intravascular ultrasound

• Angioplasty balloons

• Cutting balloon

• Infusion catheter

• Laser catheter

• Thrombectomy device

• Atherectomy device

• Re-entry device

• Thermal balloon

• Embolus protection device

• Stent

• Drug eluting stent

• Stent graft



35


Element Name Definition Technical outcome Indicate the technical outcome of the procedure. Specify the following:

• Post procedure translesional gradient

• Residual % stenosis

Technical Complication Indicate any technical complications encountered during the procedure: Choose all that apply:

• Vessel perforation

• Embolization (loss of runoff vessel)

• Dissection

• Vasospasm

• Access site bleeding

Open Surgery


Operator name Last name, First Middle

Location Indicate which limb the procedure was done. Choose one of the following:

• Right

• Left

• Both

Procedure Type Indicate the type of procedure performed. Choose one of the following:

• Primary/Secondary

• Bypass - Inflow/Outflow - Anatomic/extra anatomic

• Endarterectomy

• Thrombectomy

• Graft revision

Proximal anastomotic site Indicate the proximal anastomotic site and side. Choose one of the following:

• Thoracic aorta

• Abdominal aorta




• Proximal superficial femoral artery

• Distal superficial femoral artery

• Profunda femoral artery

• Proximal popliteal artery

• Distal popliteal artery

• Tibioperoneal artery

• Proximal anterior tibial artery

• Distal anterior tibial artery

• Proximal posterior tibial artery

• Distal posterior tibial artery

• Proximal peroneal artery

• Distal peroneal artery

• Dorsalis pedis/tarsal artery



36


Element Name Definition Distal anastomotic site Indicate the distal anastomotic site. Choose one of the following:




• Proximal superficial femoral artery

• Distal superficial femoral artery

• Profunda femoral artery

• Proximal popliteal artery

• Distal popliteal artery

• Tibioperoneal artery

• Proximal anterior tibial artery

• Distal anterior tibial artery

• Proximal posterior tibial artery

• Distal posterior tibial artery

• Proximal peroneal artery

• Distal peroneal artery

• Dorsalis pedis/tarsal artery

Graft Material Indicate the type of graft material used for the procedure. Choose one of the following:

• Autogenous - Specify the harvest site. Choose one of the following:

� Left � Right

- Specify the vein used. Choose one of the following: � Saphenous vein, in situ � Saphenous vein, nonreversed � Arm vein � Lesser saphenous vein � Composite vein � Vein patch

• Autogenous-Prosthetic composite

• Prosthetic - Specify the type. Choose one of the following:

� PTFE � Heparin-coated PTFE � Dacron � Other; specify

Graft Diameter Specify the graft diameter

• Prosthetic

• Vein



37


Element Name Definition Anesthesia Indicate the type of anesthesia used. Choose one of the following:

• General

• Local - Indicate if sedation was used. Choose one of the following:

� Yes � No

• Regional - Epidural - Spinal - Indicate if sedation was used. Choose one of the following:

� Yes � No

Technical outcome Indicate the technical outcome of the procedure. Specify the following:

• Post procedure translesional gradient

• Residual % stenosis

Completion study:

Indicate the type of study performed after the procedure. Choose one of the following:

• Angiogram

• Duplex ultrasound

Estimated blood loss Indicate the estimated amount of blood loss in ml.

Transfused blood products Indicate the blood products transfused to the patient. Choose all that apply:

• Auto transfused blood (specify volume used)

• Packed red blood cells

• Fresh frozen plasma

• Platelets

• Other (specify)

Operative time Indicate the total time of the procedure in hours:minutes

Outcomes of Endovascular/Open Surgery Procedures

Time point Indicate the period at which outcome measures are assessed. Choose all that apply:

• Peri-procedure (24 hour)

• Procedure-related (30 days)

• 3 months

• 6 months

• 1 year

Serious adverse event Indicate major clinical complications arising from the management or treatment of the disease. Choose one of the following:

• Yes - Specify the serious adverse event. Choose all that apply:

� Hospitalization/prolonged hospitalization � Loss of limb or function of organ system � Persistent or significant disability or incapacity � Death

• No



38


Element Name Definition Complications of Endovascular Procedure

Indicate postoperative clinical events or conditions associated with the endovascular procedure. Choose all that apply:

• Pseudoaneurysm

• AV fistula

• Hematoma

• Dissection

• Vessel thrombosis


• Atheromatous embolization

• Contrast nephropathy

• Contrast hypersensitivity

• Requirement of intervention to prevent permanent impairment/damage

Complications of open surgery

Indicate the complications of open surgery. Choose all that apply:

• Minor complication

• Major complication; i.e. life-threatening

• Death

• Hospitalization including prolonged hospitalization

• Hemodynamic

• Infection

• Coagulopathy

• Thrombosis

• Systemic

• Graft

Clinical Outcomes

Limb-related outcomes


• 1 month

• 3 months

• 6 months

• 1 year

Limb-related outcomes: Symptoms

Claudication

• None

• Unchanged

• Improved

• Worsened Ischemic rest pain Ischemic tissue loss Amputation



39


Element Name Definition Limb Related Outcomes: Functional Capacity

Walking ability

• Pain-free walking distance

• Maximal walking distance Functional status/Quality of life

• Questionnaire assessment o Community-based walking (PAD Specific) – Walking

Impairment Questionnaire, others o Generic Health Status – SF-36; Nottingham Health Profile

EuroQol, Sickness Impact Profile, others o PAD Specific Quality of Life – VascuQOL, PADQOL, others

• Patient Anecdote

Noninvasive Assessment of Outcome

Limb perfusion pressure and/or ABI Graft scan Other imaging (CTA or MRA)

Procedure related outcomes Patency primary assisted secondary

Limb Related Outcomes: Wound Healing

Wound healing characteristics. Complete all that apply:

• Description of dressing

• 1 week change in area

• 4 week change in area

• Presence and amount of granulation tissue

• Presence of re-epithelialization

• Presence of fibrin slough

Cardiovascular Outcomes

Cardiovascular Outcomes New cardiovascular ischemic event

• Angina

• Myocardial Infarction

• Coronary artery revascularization

• TIA/Stroke

• Carotid artery revascularization

• Death

296

C. Aorta Table of Data Elements 297

298 Table 3 provides a list and definition of data elements that are relevant to abdominal aortic 299 aneurysms (AAA). Atherosclerosis is associated with the degenerative changes found in the 300 aortic wall of AAA, though it is not necessarily causal. For this reason, it is included in this 301 document as a peripheral atherosclerotic vascular disease, though there are other much less 302 common causes of AAA, such as aortitis, infection, aortic dissection, and inherited disorders of 303 connective tissue. The data elements defined in Table 3 enable documentation of symptoms, 304 relevant medical history, and the physical assessment of AAA. The table comprises detailed 305



40

elements of diagnostic imaging tests including ultrasonography, magnetic resonance imaging, 306 and computed tomography such as aneurysm type, size, location, and other characteristics. 307 Additional elements relate to endovascular and open surgical repair and include details of the 308 procedures, outcomes and complications. 309 310 Table 3: Abdominal Aortic Aneurysm Elements and Definitions

Element Name Definition History

History of Present Illness Indicate if the patient has been having any of the following symptoms. Specify duration. Choose all that apply:

• Abdominal pain

• Back pain

• Groin pain

• Leg pain

Past Medical History Indicate if the patient has any of the following past medical history. Choose all that apply:

• Aneurysms or dissection - indicate location/s and extent

• Prior aneurysm surgery

• Marfan Syndrome

• Ehlers-Danlos Syndrome

• Aortic surgery or endovascular repair - Indicate location/s, type and extent of repair

• Aortitis

• Other inflammatory or infectious disorders - Giant cell arteritis - Takayasu arteritis - Beçhet’ Syndrome - Infection

Family History Indicate if the patient has any of the following family history. Choose all that apply:

• Aneurysms or dissections - indicate location/s

• Marfan Syndrome

• Ehlers-Danlos Syndrome

Physical Assessment

Abdominal Aorta

Body Habitus Indicate the patient’s body habitus. Choose one of the following:

• Thin

• Normal

• Obese

Aortic Pulsations Indicate the presence or absence of palpable abdominal aortic pulsations. Choose one of the following:

• Absent

• Present



41

Table 3: Abdominal Aortic Aneurysm Elements and Definitions

Element Name Definition Aortic Pulsation Characteristics

Indicate the characteristics of aortic pulsation. Choose one of the following:

• Normal

• Expansile

Aortic diameter Estimate of AAA diameter by palpation in inches or centimeters

Abdominal Bruit Indicate the absence or presence of abdominal bruit. Choose one of the following:

• Absent

• Present

Abdominal Aortic Area tenderness

Indicate the absence or presence of tenderness in the abdominal aortic area. Choose one of the following:

• Absent

• Present

Abdominal Tenderness Indicate the absence or presence of abdominal tenderness in areas other than the abdominal aortic area. Choose one of the following:

• Absent

• Present

Abdominal tenderness location

Indicate the location of the abdominal tenderness.

Lumbar spinal tenderness Indicate the absence or presence of lumbar spinal tenderness. Choose one of the following:

• Absent

• Present

Pulses Indicate the characteristics of pulses in the following locations:

• Femoral

• Popliteal

• Dorsalis pedis

• Posterior tibial Indicate if pulses are:

• 0 – Absent

• 1 – Diminished

• 2 - Normal

• 3 – Bounding or Expansile

Diagnostic Procedures – Noninvasive

Ultrasonography


Aneurysm: Type Indicate the type of aneurysm. Choose one of the following:

• Fusiform

• Saccular

• Pseudoaneurysm

Aneurysm: Size Indicate the size of aneurysm in millimeters in AP, sagittal, and longitudinal dimensions

Aneurysm: Distance Indicate the distance from the most proximal portion of aneurysm to its most distal portion in millimeters.

Magnetic Resonance Imaging




42


Element Name Definition Method of MR angiography Indicate the method of MR angiography used. Choose one of the

following:

• Contrast enhanced MR angiography – defined as white blood angiogram obtained by lowering the T1 relaxation time of blood below the surrounding tissue

• Time-of-Flight MR angiography – defined as white blood angiogram generated by utilizing the in-flow effect

Contrast used Indicate if Gadolinium was used. Choose one of the following:

• Yes

• No

Aneurysm: Location Indicate the location of the aneurysm. Choose any of the following:

• Thoracoabdominal: - Type 1 - Type 2 - Type 3 - Type 4

• Abdominal - Indicate proximal extent aneurysm

� Suprarenal � Juxtarenal � Infrarenal

- Indicate whether distal extent of aneurysm is aorta or whether

it involves iliac arteries

� Aorta � Aorto-iliac

- Bi-iliac - Left iliac - Right iliac


• Fusiform

• Saccular

• Pseudoaneurysm

Aneurysm: Size Indicate the size of aneurysm in millimeters by recording the maximum axial dimension measured from outer margin to outer margin. The axial dimension should be perpendicular to blood flow.


Thrombus Indicate if there is thrombus present. Choose one of the following:

• No

• Yes

Dissection Indicate if there is dissection present. Choose one of the following:

• No

• Yes

Leak Indicate if there is leak present. Choose one of the following:

• No

• Yes



43


Element Name Definition Characteristics of other arteries

Indicate other arteries imaged and indicate patency or severity of stenosis. Choose all that apply:

• Celiac artery

• Superior mesenteric artery

• Inferior mesenteric femoral artery

• Right renal artery

• Left renal artery

• Right/left iliac artery

• Right/left femoral artery

Computed Tomography

CT Method Indicate method of CT. Choose one of the following:

• Standard CT

• Spiral (helical) CT

• Electron beam CT


Contrast used Indicate the type of contrast used. Choose one of the following:

• Ionic contrast

• Non-ionic contrast; specify: - Monomer - Dimer

Contrast volume Indicate the volume of contrast used in ml.

Slice thickness Indicate the slice thickness in mm

Format: Raw images Indicate if raw images were reviewed. Choose one of the following:

• Yes

• No

Format: Reconstructed images

Indicate if reconstructed images were reviewed. Choose one of the following:

• Yes. If yes, specify: - Shaded surface images - Maximal int. project

• No



44


Element Name Definition Aneurysm: Location Indicate the location of the aneurysm. Choose any of the following:









• Fusiform

• Saccular

• Pseudoaneurysm

Aneurysm: Size Indicate the size of aneurysm in millimeters by recording the maximum axial dimension from outer margin to outer margin. The axial dimension should be perpendicular to blood flow.


Aortic Neck Morphology Indicate each of the following:

• Presence or absence of calcification

• Presence or absence of thrombus within the neck

• Degree of angulation in the neck

• Diameter of the neck

• Length of the neck from the lowest renal artery to the origin of the aneurysm.


• No

• Yes

Dissection Indicate if there is dissection present. Choose one of the following:

• No

• Yes


• No

• Yes



45


Element Name Definition Characteristics of other arteries


• Celiac artery







Diagnostic Procedures – Invasive

Catheter angiography

Date of Procedure Month/Day/Year

Contrast Indicate the contrast used. Specify the following:

• Type

• Amount in ml

Fluoroscopy time Indicate total fluoroscopy time recorded to the nearest 0.1 minute. The time recorded should include the total time for the procedure.

Aneurysm: Location Indicate the location of the aneurysm. Choose any of the following:









• Fusiform

• Saccular

• Pseudoaneurysm

Aneurysm: Size Indicate the size of aneurysm in millimeters by recording the maximum axial dimension measured from the outer margin top the outer margin. The axial dimension should be perpendicular to blood flow.



• No

• Yes



46


Element Name Definition Dissection Indicate if there is dissection present. Choose one of the following:

• No

• Yes


• No

• Yes

Characteristics of other arteries


• Celiac artery







Treatment – Invasive Therapeutic Procedures

Open abdominal aortic aneurysm repair

Date of Procedure Indicate the date the procedure was performed.

Extent of Aneurysm Indicate the extent of aneurysm in the following areas: Thoracoabdominal:

• Type 1

• Type 2

• Type 3

• Type 4

• Associated Dissection - No - Yes

Infrarenal:

• Aortic

• Aorto-iliac - Bi-iliac - Left iliac - Right iliac

Clamping site: Proximal Specify the proximal clamping site (or proximal control). This may include: Thoracoabdominal:

• Above mesenterics

• Descending thoracic aorta

• Hypothermic circulatory arrest (no clamp)

• Distal to left subclavian

• Proximal to left subclavian Infrarenal:

• Infrarenal

• Supraceliac

• Suprarenal



47


Element Name Definition Clamp time Indicate the following:

• Proximal time

• Time to restoration of visceral flow

• Total clamp time

Clamping site: Distal Specify the distal clamping site. This may include: Thoracic:

• Clamp site

• Segmental clamping - No - Yes

Infrarenal:

• Aorta


• External and internal iliac artery

Neuroprotection technique (thoracoabdominal)

Indicate the neuroprotection techniques used. Choose all that apply:

• Clamp and sew (no protection)

• Preoperative imaging of spinal perfusion

• Retrograde perfusion - Atrial-femoral bypass - Axillo-femoral bypass - Femoro-femoral bypass - Shunt - Others: Specify

• Neurologic monitoring

• CSF drainage

• Systemic cooling

• Epidural cooling

• Reimplantation of intercostal arteries - Specify how many

Graft Indicate the type of graft used for the procedure. Choose one of the following:

• Polyester Woven

• Polyester Knitted

• PTFE Infrarenal:

• Tube graft

• Bifurcated graft

• Site of distal anastomosis (iliac or femoral arteries)



48


Element Name Definition Management of visceral segment for thoracoabdominal

Indicate how the visceral segment was managed. Choose one of the following:

• Visceral patch including celiac artery, superior mesenteric artery (SMA), right renal artery, and left renal artery.

• Visceral patch including celiac artery, SMA and right renal artery with left renal artery either bypassed or implanted into aortic graft separately

• Individual bypasses to visceral and renal arteries.

• Indicate if visceral organ protection was used - If so, specify type (perfusion, cold infusion)

Management of inferior mesenteric artery

Indicate how the inferior mesenteric artery was managed. Choose one of the following:

• Chronically occluded

• Oversewn

• Reimplanted

Intraoperative details for Open AAA repair

Additional procedures Indicate other procedures performed. Choose all that apply:

• Renal artery bypass/endarterectomy

• Visceral artery procedure (specify)

• Other (specify)

Intraoperative complications Indicate if there were any intraoperative complications. Choose one of the following:

• No

• Yes (specify)

Endovascular AAA Repair

Date of procedure Indicate the date the procedure was performed

Aortic and iliac diameters and lengths

Indicate aortic and iliac diameters and lengths

• Aortic diameter at lowest renal artery

• Aortic diameter 1.5 cm below lowest renal artery

• Aortic diameter at terminal aorta

• Maximum diameter of right common iliac artery

• Maximum diameter of left common iliac artery

• Minimum diameter of right external iliac artery

• Minimum diameter of left external iliac artery

• Length of aorta from lowest renal artery to aortic bifurcation

• Length from aortic bifurcation to right internal iliac artery

• Length from aortic bifurcation to left internal iliac artery

Graft Indicate the type of graft used. Choose one of the following:

• Fixation - Infrarenal - Suprarenal

• Unibody

• Bifurcated - Single docking limb - Two docking limbs



49


Element Name Definition Hypogastric arteries excluded Indicate the number of hypogastric arteries excluded. Choose one of the

following:

• 0

• 1

• 2

Management of inferior mesenteric artery

Indicate how the inferior mesenteric artery was managed. Choose one of the following:

• Chronically occluded/covered

• Coil occluded

Extension used Indicate the extension used. Choose one of the following:

• Distal - Number and size placed - Landing zone

� Common iliac artery � External iliac artery

• Proximal - Number and size placed

Adjunctive procedures Indicate the adjunctive procedures used. Choose one of the following:

• Adjunctive angioplasty or stent required. Specify the following: - Side – indicate left or right - Location – CIA, IIA, EIA - Indication

• Conduit used for insertion of endograft. Specify the following: - Side – indicate left or right - Size and type of graft material of conduit - Indication

• Accessory renal artery management. Specify the following: - Side – indicate left or right - Site of artery - Size of artery - Treatment: � Embolization � Coverage

• Iliac embolization. Specify the following: - Side – indicate left or right - Size: Balloon or stent - Indication

Endograft configuration Indicate the configuration of endograft

• Aortobi-iliac

• Aortouni-iliac graft with femoral artery to femoral artery bypass and iliac occlude

Aortic Neck Morphology Indicate each of the following:

• Presence or absence of calcification

• Presence or absence of thrombus within the neck

• Degree of angulation in the neck. Specify the C-arm correction angle in degrees.

• Diameter of the neck

• Length of the neck from the lowest renal artery to the origin of the aneurysm.



50


Element Name Definition Intraoperative details for Endovascular AAA Repair

Endoleak present Indicate the type of endoleak present at the end of the case. Choose one of the following:

• Type I

• Type II

• Type III

• Type IV

• Undetermined

Limb kinking If present, specify the following:

• Site

• Size

• How it was resolved

Patency of arteries Indicate the patency of the arteries. Specify the following: Renal arteries:

• Number Accessory renal arteries • Number • Side Iliac arteries:

• Side

Intraoperative complications Indicate if there were any intraoperative complications. Choose one of the following:

• No

• Yes. If yes, choose all that apply: - Arterial injury

� Indicate right or left side � Indicate the artery injured

- Embolization � Indicate site

- Inadvertant covering or artery � Indicate site

Invasive Therapeutic Procedures - Other Operative Details

Estimated blood loss Indicate the amount of total amount of blood loss in mls.

Transfused blood products Indicate the blood products transfused to the patient. Choose all that apply:

• Auto transfused blood (specify volume used)

• Packed red blood cells

• Fresh frozen plasma

• Platelets

• Other (specify)

Operative time Indicate the total time of the procedure in hours:minutes

Invasive Therapeutic Procedures- Post-procedure details

Time to extubation Indicate when the patient was extubated post procedure. Choose one of the following:

• Immediate

• Post operative day (indicate day number)

Oral intake Indicate the day of oral intake

Length of ICU stay Indicate the length of stay in the intensive care unit. Specify the number of days.



51


Element Name Definition Post-operative complications Indicate post-operative complications. Choose all that apply:

• Bleeding

• Cardiac

• Infectious

• Pulmonary

• Neurological - Paralysis - Paresis - Stroke

• Re-operation

• Other (specify)

Total length of stay Indicate the length of stay in the hospital. Specify the number of days.

Discharge status Indicate the patient’s discharge status. Choose one of the following:

• To home

• To standard rehabilitation facility

• To ventilator rehabilitation facility

Follow-Up

Open repair Documentation of follow-up evaluation of patient 2 to 4 weeks following discharge should include:

• Physical examination

• Duplex ultrasound to check integrity of repair CT scan of the chest, abdomen and pelvis should be considered within 5 years to evaluate for synchronous aneurysms.

Endovascular/Hybrid approach

Documentation of follow-up evaluation of patient 4 weeks following discharge should include:


• CT scan of the abdomen and pelvis

• Plain film of the abdomen to access stent integrity and migration

Outcomes of Open AAA and Endovascular Repair



• Procedure related (30 days)

• 3 months

• 6 months

• 1 year

• Other

Serious adverse event Indicate major clinical complications arising from the management or treatment of the disease. Choose one of the following:

• Yes - Specify the serious adverse event. Choose all that apply:

� Hospitalization/prolonged hospitalization � Loss of limb or function of organ system � Persistent or significant disability or incapacity � Death

• No



52


Element Name Definition Complications of Endovascular Repair


• Death




• Myocardial infarction (see cardiovascular complications below)

• Seroma

• Hematoma

• Dissection


• Vessel rupture

• Mesenteric ischemia

• Renal failure

• Pneumonia


• Deep venous thrombosis (DVT)




• Post-implant syndrome

Complications of Open Repair

Indicate the complications of open surgery. Choose all that apply:

• Death




• Myocardial infarction (see cardiovascular outcomes below)

• Mesenteric ischemia

• Renal failures

• Pneumonia

• Deep venous thrombosis (DVT)

• Graft limb or bypass thrombosis



Clinical Outcomes


• 1 month

• 3 months

• 6 months

• 1 year

Graft or endograft-related outcomes



53


Element Name Definition Graft or endograft-related outcomes

• Patency � Primary � Assisted � Secondary

• Ischemic rest pain

• Ischemic tissue loss

• Amputation

Cardiovascular Outcomes

Cardiovascular Outcomes New cardiovascular ischemic event

• Angina

• Myocardial Infarction

• Coronary Artery Revascularization

• TIA/Stroke

• Death

Outcomes Assessment

Noninvasive assessment of outcome

• Pulse exam

• ABI

Long-term Outcomes of Open AAA repair and Endovascular AAA repair

Open AAA Repair: Long-term Outcomes

• Infection

• Aortoenteric fistulae

• Second aneurysm formation (remote from open AAA repair)

• Paragraft aneurysm formation (close or near old aneurysm repair)

• Need for secondary procedure

Endovascular AAA repair: Long-term Outcomes

• Infection

• Aortoenteric fistulae

• Secondary aneurysm formation (remote from open AAA repair)

• Paragraft aneurysm formation (close or near old aneurysm repair)

• Endoleak

• Need for secondary procedure

311 312 313 314



54

D. Renal and Mesenteric Artery Disease Table of Data Elements 315

316 In the context of this document, renal artery disease is defined as atherosclerotic disease that 317

causes stenosis or occlusion of arteries supplying the kidneys(1). Other causes of renal artery 318

disease include thrombosis, embolism, and fibromuscular dysplasia. Mesenteric artery disease 319

refers to atherosclerotic stenosis or occlusion of the celiac trunk, superior mesenteric artery 320

and/or inferior mesenteric artery. Other causes include thrombosis, embolism, vasculitis and 321

extrinsic compression. The data elements defined in Table 4 include symptoms and clinical 322

findings that occur in patients with renal artery disease. Table 4 also provides detailed elements 323

of renal imaging tests including duplex ultrasonography, magnetic resonance angiography, 324

computed tomographic angiography, and catheter-based angiography, In addition, there are 325

detailed data elements for renal artery angioplasty and stenting including specific elements 326

concerning the procedure, target lesion location, results and complications, and similarly for 327

surgical revascularization of renal artery stenoses. In addition, data elements are defined for 328

clinical outcomes following medical and revascularization therapy. The data elements defined in 329

Table 5 include symptoms and clinical findings that occur in patients with mesenteric artery 330

disease. Table 5 also provides detailed elements of mesenteric artery imaging tests including 331

duplex ultrasonography, magnetic resonance angiography, computed tomographic angiography, 332

and catheter-based angiography, In addition, there are detailed data elements for mesenteric 333

artery angioplasty and stenting including specific elements concerning the procedure, target 334

lesion location, results and complications, and similarly for surgical revascularization of 335

mesenteric artery disease. In addition, data elements are defined for clinical outcomes following 336

medical and revascularization therapy. 337

338 339 340 Table 4: Renal Artery Disease Elements and Definitions

Element Name Definition History



55

Table 4: Renal Artery Disease Elements and Definitions

Element Name Definition Hypertension suggestive of renal artery disease

• New onset hypertension in those <30 or >55 yrs of age

• Accelerated hypertension

• Refractory hypertension

• Hypertension and concomitant atherosclerotic disease in other vascular territories

• Hypertension urgency/emergency

Cause of chronic kidney disease, if known

Chronic kidney disease that is not due to a clear cut cause such as:

• Glomerular disease

• Tubular/interstitial disease

• Obstructive uropathy

• Polycystic kidney disease

• Other (specify)

• Unknown

History of acute renal insufficiency

History of reduced renal function (see “History of chronic kidney disease insufficiency” element) for less than 3 months. Year of occurrence of and precipitant for acute renal insufficiency may be specified.

Chronic kidney disease Current or previous history of chronic kidney disease, captured as current status. Chronic kidney disease is defined as either kidney damage or GFR less than 60 ml/min/1.73 m2 for greater than or equal to 3 months. Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies. Indicate the patient’s stage of disease:

• Stage 0—No known kidney disease

• Stage 1—Kidney damage with normal or high—GFR greater than or equal to 90 ml/min/1.73 m2

• Stage 2—Kidney damage with mildly decreased—GFR 60 to 89 ml/min/1.73 m2

• Stage 3—Moderately decreased—GFR 30 to 59 ml/min/1.73 m2

• Stage 4—Severely decreased—GFR 15 to 29 ml/min/1.73 m2

• Stage 5—Kidney failure—GFR less than 15 ml/min/1.73 m2 or on dialysis

Note: GFR may be estimated using the serum creatinine–GFR 186 (PCr) 1.154 (age) 0.203 (0.742 if female) (1.210 if black) Year of onset (first diagnosis) may be helpful.

Recurrent “flash” pulmonary edema without coronary ischemia/left ventricular dysfunction

Episodes of heart failure or pulmonary edema in the absence of a clear cut cardiac cause such as:

• Active coronary ischemia

• Systolic dysfunction on echocardiography



56


Element Name Definition Other cardiovascular disease related to renal artery disease

Coronary artery disease, peripheral artery disease, carotid artery disease, abdominal aortic aneurysms

Non-invasive Diagnostic Procedures Duplex ultrasound

Date of procedure Indicate the date of the procedure (Month/Day/Year)

Artery imaged Indicate the artery imaged.



Peak systolic velocity Aorta Proximal, mid-, distal right renal artery Proximal, mid-, distal left renal artery

Ratio of renal to aortic peak systolic velocities

Record ratio for right and left renal arteries

Category of stenosis Specify for right and left renal arteries. Choose one of the following(22):

• 0-59%

• 60-99%

• Occluded

Location of stenosis Indicate the side (right or left) and location of stenosis. Choose all that apply:

• Proximal

• Mid

• Distal

Kidney size Indicate the maximum pole-to-pole renal length in cm

Resistive index [peak systolic velocity – end diastolic velocity] / peak systolic velocity

Assessment of aorta Identify atherosclerosis, stenosis, occlusion, and/or aneurysm of the abdominal aorta.

Magnetic Resonance Angiography (MRA)


Location of stenosis Indicate the side (right or left) and location of stenosis. Choose all that apply:

• Proximal

• Mid

• Distal

Location of stenosis: specific location in renal artery

Indicate the side (right or left) and location of stenosis. Choose all that apply:

• Main renal artery ostium

• Main renal artery post-ostium (>1 cm from ostium)

• Segmental renal artery

• Intrarenal renal artery

Artery stenosis

Indicate severity of stenosis by quantitative analysis using the formula; 100 x (1 – minimum lumen diameter)/maximum diameter of reference segment



57


Element Name Definition Aorta Identify atherosclerosis, stenosis, occlusion, and/or aneurysm of

the abdominal aorta

Kidney size Indicate the maximum pole-to-pole renal length in cm

Symmetry of renal perfusion Consistency and equality of renal blood flow in both kidneys

Symmetry of renal excretion Symmetry of rate of excretion of contrast agent from kidney

Renal artery morphology • Fibromuscular dysplasia (FMD)

• Atherosclerosis

Computed Tomographic Angiography

Date of procedure Indicate the date of the procedure







Artery stenosis


Aorta Identify atherosclerosis, stenosis, occlusion, and/or aneurysm of the abdominal aorta

Kidney size Indicate the maximum longitudinal renal length in cm

Symmetry of renal perfusion Consistency and equality of renal blood flow in both kidneys

Symmetry of renal excretion Symmetry of rate of excretion of contrast agent from kidney


• Atherosclerosis

Captopril Renography


Operator name Last name, First, Middle

Symmetry Equal uptake and excretion of radiotracer within kidneys

Renogram curve

Absolute time-activity curves pre- and post-captopril, including peak and time to half activity after peak Time activity curve consists of:

• Vascular phase

• Secretory or functional phase

• Excretory phase

Invasive Diagnostic Procedure Catheter-based angiography




58


Element Name Definition Catheter position • Selective

• Non-selective

Renal perfusion Were all renal arteries identified (i.e., are there unexplained perfusion defects in the nephrogram phase)?









Kidney size The maximum longitudinal renal length in cm

Symmetry of renal perfusion Assess the consistency and equality of renal blood flow in both kidneys.


• Atherosclerosis

Medical Therapies Antihypertensive therapy Indicate name, dose, frequency of specific antihypertensive

agent(s) used—address use of angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists

Antilipidemic therapy Indicate name, dose, frequency of specific lipid lowering agent(s) used

Antiplatelet therapy Indicate name, dose, frequency of specific antiplatelet agent(s) used

Invasive Therapeutic Procedures Renal Artery Angioplasty/Stenting


Angioplasty/stenting Choose one:

• Balloon angioplasty alone

• Stent

Balloon length Indicate the length of the balloon used in mm

Nominal balloon diameter Indicate the diameter of the balloon at initial inflation and final inflation in mm

Target renal artery Indicate whether the target vessel for the procedure is the right or left renal artery.



59


Element Name Definition Current procedure part of clinical trial

Indicate whether the procedure is part of a clinical trial. Choose one:

• No

• Yes If yes, indicate the trial type:

- IDE - Post-market approval - Other (specify)

Anesthesia Indicate if the patient received general anesthesia, conscious sedation, local anesthesia or no anesthesia during the current procedure

Procedure indications and anatomic variables

Clinical indication • Hypertension

• Renal insufficiency

• Congestive heart failure/pulmonary edema

• Angina pectoris

Re-stenosis in target vessel after prior renal stent

Note if the indication for the current procedure is restenosis in the target renal artery which was previously treated with an angioplasty and/or stent.

- Renal artery re-stenosis is defined as greater than 50%

diameter stenosis at or adjacent to the site previously treated

with balloon angioplasty or stent.

Contrast volume Indicate the volume of iodinated contrast injected during the procedure in milliliters (ml).

Fluoroscopy Time Indicate total fluoroscopy time recorded during the procedure visit to the nearest 0.1-minute. The time recorded should include the total time for the procedure.

Contralateral renal artery occlusion Indicate if there is known 100% occlusion of the patient’s contralateral renal artery.

Spontaneous aortic or renal artery dissection

Indicate if the patient has had a spontaneous renal artery dissection prior to the current procedure.

Procedure arterial access site Indicate the primary arterial access site utilized to perform the carotid artery stenting (CAS) procedure. Note location:

• Femoral

• Brachial

• Radial

• Axillary



60


Element Name Definition Arterial access closure method • List methods and devices in chronological order of

closure.

• Indicate the method used to achieve hemostasis. - Device - Nondevice (such as manual compression)

Lesions

Target lesion location List the following:

• Ostial

• Proximal

• Mid

• Distal

• Intrarenal

Visible thrombus present Indicate if the target lesion contains thrombus as assessed by baseline angiography and implied by presence of filling defect.


• None

• Mild

• Moderate

• Severe

Lesion length Indicate the length of the target lesion in millimeters (mm) as assessed by baseline angiography.

Minimal luminal diameter (MLD) Indicate the target lesion’s minimum luminal diameter in millimeters (mm) as assessed by baseline angiography. Minimal Luminal Diameter (MLD) is defined as the minimum

luminal diameter derived from the angiographic view that shows

the tightest point of the stenosis.

Diameter of distal renal artery Indicate the diameter of the non-tapering distal segment of renal artery measured at the intended landing zone of the distal edge of the stent

Pre-procedure % stenosis of renal artery




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Element Name Definition Lesion treatment incomplete or aborted

Indicate if the lesion treatment was incomplete or aborted. Choose one of the following:

• No

• Yes - If yes, note reasons:

� Failure to gain vascular access. � Failure to engage ostium with guide catheter � Unable to cross with guide wire. � Unable to deploy stent. � Failure to confirm significant stenosis. � Unable to cross balloon. � Cardiac ischemia � Unable to deploy device � Hypotension � Hypertension � Unable to deliver stent � Other

Embolic protection attempted Indicate if the operator attempted to use an embolic protection device (EPD). Choose one of the following:

• No

• Yes - If yes, indicate if pre-dilatation prior to balloon or stent

was performed or not. - If yes, list EPD in chronological order. Note if

successfully deployed.

Stent mal-position Indicate if the stent was deployed in a location or position other than for which it was intended.

Final minimal luminal diameter (MLD)

Indicate the final residual lumen diameter in millimeters (mm)

Final % stenosis of renal artery Indicate the percent stenosis post procedure by quantitative analysis using the formula; 100 x (1 – minimum lumen diameter)/maximum diameter of reference segment

Device

How many stents used (per artery)? • One

• More than one

Stent type Indicate the type of stent used. Choose all that apply:

• Balloon expandable

• Self-expanding


• Covered stent

Stent brand name Identify the brand name of the stent used

Stent model Indentify the model number of the stent used



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Element Name Definition Stent manufacturer Identify the manufacturer of the stent used

Stent length Indicate the length of the stent used in mm

Stent diameter Indicate the diameter of the stent used in mm

Renal Artery Surgical Revascularization


Indications for the procedure Consider indications for renal artery revascularization. Choose all that apply:

• Clinical indications - Hypertension - Renal insufficiency - Congestive heart failure/pulmonary edema - Angina pectoris

• Surgery specific indications - Repetitive failure of renal artery angioplasty/stent - Need for aortic surgery (i.e. abdominal aortic

aneurysm repair)

Surgical procedures Identify surgical revascularization procedure

• Renal artery endarterectomy

• Aortorenal bypass with either saphenous vein or synthetic material

• Extra-anatomic bypass: hepatorenal, splenorenal, ileorenal

Outcomes of endovascular/open surgical procedures Time points Indicate the period at which outcome measures are assessed.

Choose all that apply:


• Procedure-related (30 days)

• 3 months

• 6 months

• 1 year

Complications of Endovascular Procedure


• Pseudoaneurysm

• AV fistula

• Hematoma

• Dissection









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Element Name Definition Complications of open surgery Indicate the complications of open surgery. Choose all that apply:



• Death


• Hemodynamic

• Infection

• Coagulopathy

• Thrombosis

• Systemic

• Graft

Clinical Outcomes Time points Indicate the period at which outcome measures are assessed.


• 1 month

• 3 months

• 6 months

• 1 year

Blood pressure • Indicate systolic and diastolic blood pressure

• Categories of blood pressure

• Reduction in Systolic Blood Pressure by 20 mmHg;

• Reduction in Diastolic Blood Pressure by 10 mmHg.

• Normotensive vs. hypertensive

• Indicate changes in number of antihypertensive medications (specify medications)

Renal function

Monitor estimated calculated GFR :

• Improvement: change of at least one stage for the better i.e. going from stage 3 to stage 2

• Stable: No change in stage of kidney disease

• Decline: change for the worse of at least one stage, i.e. going from stage 3 to stage 4 .

Morbidity/mortality

• Myocardial infarction

• Congestive heart failure

• Stroke

• Other adverse cardiovascular event

• Hospitalization/prolonged hospitalization

• Loss of function of organ system

• Persistent or significant disability or incapacity

• Death (indicate causes) .

341 342



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Table 5: Chronic Mesenteric Artery Disease Elements and Definitions

Element Name Definition History Risk Factors

Atherosclerosis Known atherosclerosis in any vascular territory

Patient Assessment - Symptoms

Indicate if any of the symptoms listed below are present

Symptoms suggestive of mesenteric ischemia

Abdominal fullness, bloating, discomfort following eating that ultimately results in “fear of food”. Weight loss, anorexia, failure to thrive. All associated with presence of atherosclerosis in other vascular beds, or the presence of cardiac dysrhythmia (i.e. atrial fibrillation) or severe left ventricular dysfunction

Post-prandial abdominal pain Pain, bloating, early satiety following ingestion of food and/or liquids

Fear of eating Avoidance of eating due to predictable abdominal pain, often resulting in more frequent eating of small amounts of food

Weight loss Specify the amount of weight loss in pounds or kilograms

Malnutrition Due to inadequate caloric intake to meet metabolic demands, as well as dehydration, the patient manifests malnutrition.

Malabsorption/steatorrhea Diarrhea Oily stool Floating stool

Physical Examination Complete Abdominal Examination

Body Habitus Indicate the patient’s body habitus. Choose one of the following:

• Thin

• Normal

• Obese

Aortic diameter Estimate of abdominal aortic diameter by palpation in inches or centimeters

Abdominal Bruit Indicate the absence or presence of abdominal bruit. Choose one of the following:

• Absent

• Present

Rectal Exam

Digital rectal exam Examination of the lower rectum to check for abnormalities in the rectum and stool (Hemoccult).

Stool testing for occult blood Occult blood present or absent

Laboratory Testing Amylase, Lipase Indicate the following:

• Date of test

• Value

• Unit of measurement

• Normal range



65


Element Name Definition Stool fat content • Microscopic – indicate the number of stainable lipid

globules per high-powered microscope field

• Gravimetric – indicate the collection period (number of days), reference range and test result in grams of lipid per 24 hours

• Titrimetric

Fecal occult blood Occult blood present or absent

Non-invasive Diagnostic Procedures Mesenteric artery duplex ultrasound

Date of procedure Indicate the date of the procedure

Operator name Last name, First Middle

Peak systolic velocity measurements • Aorta

• Celiac artery


• Inferior mesenteric artery

Ratio of mesenteric artery to aorta peak systolic velocities

Record ratio for celiac, superior mesenteric, and inferior mesenteric arteries

Location of stenosis Indicate the location of stenosis. Choose all that apply:

• Celiac artery



Category of stenosis Specify for celiac, superior mesenteric, and inferior mesenteric arteries. Choose one of the following:

• 0-69%

• 70-99%

• Occlusion

Computed Tomographic Angiography



• Celiac artery



Location of stenosis Indicate the location of the stenosis

Artery stenosis


Aneurysm Dilation of a mesenteric artery to a diameter ≥ 1.5 times its nondilated diameter



66


Element Name Definition Small and large bowel Indicate if there is thickening of the small or large bowel wall.

Choose one of the following:

• No

• Yes

Free air in the abdomen Indicate the presence of free air in the abdomen. Choose one of the following:

• No

• Yes

Mesenteric venous thrombosis Patent venous opacification of the superior mesenteric vein and portal vein

Pneumatosis coli Indicate the presence of pneumatosis coli

• No

• Yes

Magnetic Resonance Angiography



• Celiac artery



Location of stenosis Indicate the location of the stenosis.

Artery stenosis



Small and large bowel Indicate if there is thickening of the small or large bowel wall. Choose one of the following:

• No

• Yes

Free air in the abdomen Indicate the presence of free air in the abdomen. Choose one of the following:

• No

• Yes

Mesenteric venous thrombosis Patent venous opacification of the superior mesenteric vein and portal vein

Pneumatosis coli Indicate the presence of pneumatosis coli

• No

• Yes

Diagnostic Procedure – Invasive Catheter-based angiography



67


Element Name Definition Date of procedure Indicate the date the procedure was performed (Month/Day/Year)


• Celiac artery





Diffuse vasospasm Indicate presence or absence of vasospasm consistent with non occlusive mesenteric ischemia

Mesenteric venous thrombosis Indicate whether the superior mesenteric vein and portal vein are patent or occluded by thrombus

Invasive Therapeutic Procedures – Catheter based Mesenteric Artery AngioplastyStenting


Angioplasty/stenting Choose one:

• Balloon angioplasty alone

• Stent

Balloon length Indicate the length of the balloon used in mm

Nominal balloon diameter Indicate the diameter of the balloon at initial inflation and final inflation in mm

Stent type Indicate the type of stent used. Choose all that apply:

• Balloon expandable

• Self-expanding


• Covered stent

Stent brand name Identify the brand name of the stent used

Stent model Indentify the model number of the stent used

Stent manufacturer Identify the manufacturer of the stent used

Stent length Indicate the length of the stent used in mm

Stent diameter Indicate the diameter of the stent used in mm



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Element Name Definition Target mesenteric artery Indicate whether the target vessel for the procedure is celiac,

superior mesenteric, and/or inferior mesenteric artery

Current procedure part of clinical trial

Indicate whether the procedure is part of a clinical trial. Choose one:

• No

• Yes If yes, indicate the trial type:

- IDE - Post-market approval - Other (specify)

Anesthesia Indicate if the patient received general anesthesia, conscious sedation, local anesthesia or no anesthesia during the current procedure

Procedure indications and anatomic variables

Clinical indication • Symptoms of mesenteric ischemia

• Weight loss

• Malnutrition

• Other

•

Re-stenosis in target vessel after prior renal stent

Note if the indication for the current procedure is restenosis in the target mesenteric artery which was previously treated with an angioplasty and/or stent.


Fluoroscopy Time Indicate total fluoroscopy time recorded during the procedure visit to the nearest 0.1-minute. The time recorded should include the total time for the procedure.


• Femoral

• Brachial

• Radial

• Axillary

Arterial access closure method • List methods and devices in chronological order of closure.

• Indicate the method used to achieve hemostasis. - Device - Nondevice (such as manual compression)

Lesions



69


Element Name Definition Target lesion location • Indicate location of target lesion


Calcification - Indicate if calcification is present. If calcification is present, specify location.

Choose one of the following:

• None

• Mild

• Moderate

• Severe


Minimal luminal diameter (MLD) Indicate the target lesion’s minimum luminal diameter in millimeters (mm) as assessed by baseline angiography.

Diameter of distal mesenteric artery Indicate the diameter of the non-tapering distal segment of mesenteric artery measurement at the intended landing zone of the distal edge of the stent

Pre-procedure % stenosis of mesenteric artery


Lesion treatment incomplete or aborted

Indicate if the lesion treatment was incomplete or aborted. Choose one of the following:

• No

• Yes - If yes, note reasons:

� Failure to gain vascular access. � Failure to engage ostium with guide catheter � Unable to cross with guide wire. � Unable to deploy stent. � Failure to confirm significant stenosis. � Unable to cross balloon. � Cardiac ischemia � Unable to deploy device � Hypotension � Hypertension � Unable to deliver stent � Other



70


Element Name Definition Embolic protection attempted Indicate if the operator attempted to use an embolic protection

device (EPD). Choose one of the following:

• No

• Yes - If yes, indicate if pre-dilatation prior to balloon or stent

was performed or not. - If yes, list EPD in chronological order. Note if

successfully deployed.

Stent mal-position Indicate if the stent was deployed in a location or position other than for which it was intended.


Indicate the final residual lumen diameter in millimeters (mm)

Final % stenosis of mesenteric artery Indicate severity of stenosis by quantitative analysis using the formula; 100 x (1 – minimum lumen diameter)/maximum diameter of reference segment

How many stents used (per artery)? • One More than one

Invasive Therapeutic Procedure – Surgical Revascularization Aortomesenteric bypass graft surgery


Proximal anastomosis Indicate location of proximal anastomosis location with graft (i.e. supraceliac aorta, iliac artery)

Distal anastomosis Indicate location of distal anastomosis location with graft (i.e. mid-celiac artery, mid-superior mesenteric artery)

Conduit Indicate type of graft material used for bypass (i.e. synthetic, autologous

Mesenteric Endarterectomy


Outcomes of Endovascular/Open Surgery Procedures

Time Points Indicate the period at which outcome measures are assessed. Choose all that apply:


• Procedure related (30-days)

• 3 months

• 6 months

• 1 year



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Element Name Definition Complications of endovascular procedure


• Pseudoaneurysm

• AV fistula

• Hematoma

• Dissection







Complications of Open surgery Indicate the complications of open surgery. Choose all that apply:



• Death


• Hemodynamic Infection

• Coagulopathy

• Thrombosis

• Systemic

• Graft

Clinical outcomes Time points Indicate the period at which outcome measures are assessed.


• 1 month

• 3 months

• 6 months

• 1 year

Patient assessment Assess recurrent signs and symptoms of mesenteric disease:

• Appetite

• Caloric intake

• Nutritional status

• Presence or absence of post-prandial abdominal pain

• Food avoidance/tolerance

• Weight loss/gain

Adverse events • Recurrent bowel ischemia/infarction

• Repeat revascularization

• Bowel resection

• Myocardial infraction

• Stroke

• Other adverse event

• Death



72

E. Extracranial Carotid Artery Disease Table of Data Elements 343

344 In the context of this document, extracranial carotid artery disease is defined as a cerebral artery 345

atherosclerotic disease that causes stenosis or occlusion of the cervical portion of the carotid 346

arteries(1). Other causes of carotid artery disease include fibromuscular dysplasia, arteritis, 347

radiation-induced arteriopathy, dissection and restenosis following carotid artery 348

revascularization procedures. Extracranial vertebral and intracranial cerebral artery diseases are 349

outside the scope of this document. The data elements defined in Table 6 include symptoms and 350

clinical findings related to ischemic strokes and transient ischemic attacks that occur in patients 351

with carotid artery disease. Also included are data elements which define anatomic high risk 352

conditions and comorbid cardiopulmonary conditions that are used to assess risk of carotid 353

revascularization procedures. Table 6 provides detailed elements of carotid artery imaging tests 354

including duplex ultrasonography, magnetic resonance angiography, computed tomographic 355

angiography, and catheter-based angiography, In addition, there are detailed data elements for 356

carotid artery stenting including specific elements concerning the procedure, target lesion 357

location, results and complications, and similarly for carotid endarterectomy. In addition, data 358

elements are defined for clinical outcomes following carotid revascularization. 359

360

Table 6: Extra Cranial Carotid Artery Disease Elements and Definitions

Element Name Definition Patient History

Asymptomatic Indicate if the patient is asymptomatic. No prior stoke or transient ischemic attack



73


Element Name Definition Previous stroke Previous stroke defined as acute loss of neurological function caused by an

ischemic or hemorrhagic event with residual symptoms at least 24 hours, or symptoms <24 hours with evidence of acute infarction (for example, by CT or MRI) If present, record stroke type:

• Ischemic stroke

• Intracerebral hemorrhage

• Subarachnoid hemorrhage

• Unknown type If ischemic, list the most likely etiology:

• Large artery atherosclerosis of the extracranial vessels (e.g. carotid)

• Large artery atherosclerosis of the intracranial vessels (e.g. middle cerebral artery stenosis)

• Cardioembolism

• Small vessel occlusion (lacunar)

• Ischemic stroke of other determined etiology (e.g. arterial dissection)

• Ischemic stroke of undetermined etiology

TIA Documented history of TIA consisting of a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. Note the following:

• R retinal

• R hemispheric

• L retinal

• L hemispheric

• Vertebrobasilar

• Unknown distribution Date of the first and most recent episode

Acute or evolving stroke Yes or no

ASA grade I, II, III, IV, V

History of dementia History of dementia, Alzheimer’s disease, chronic confusion (at least one month in duration), or senility. Year of onset (first diagnosis) may be helpful.

Seizures Indicate if the patient has a documented history of epilepsy

Hemorrhage Indicate if the patient has any hemorrhage. Choose all that apply:

• Intraparenchymal

• subarachnoid

• subdural



74


Element Name Definition Cause of carotid/veterbral stenosis

Select any of the following that apply

• Atherosclerosis

• Fibromuscular dysplasia

• Dissection

• Vasculitis (Takayasu or giant cell arteritis)

• Irradiation

• Restenosis following CEA

• Restenosis following CAS

Anatomic high risk conditions Previous neck radiation Indicate if the patient had previous radiation therapy to the neck prior to

the current admission or prior to the current procedure.

Previous neck surgery (other than CEA)

Indicate if the patient had a previous extensive (i.e., radical) neck dissection (other than carotid endarterectomy [CEA]) prior to the current admission or prior to the current procedure.

Previous carotid intervention Yes or no. If yes, within <30 days, 31-180 days, or >180 days? Note:

• R CEA

• R CAS

• L CEA

• L CAS

Previous vertebral intervention

Yes or no. If yes, within <30 days, 31-180 day, or > 180 days? Note:

• Left

• Right

• Proximal

• Distal

Previous ipsilateral CEA Yes or no.

Previous vertebral intervention

Yes or no. If yes, within <30 days, 31-180 days, or >180 days? Note:

• Right

• Left

• Proximal

• Distal

Tracheostomy present Indicate if the patient has an open tracheostomy, at the time of the current procedure.

Cranial nerve palsy(23, 24) Indicate if the patient has a history of cranial nerve palsy/palsies. Choose one of the following:

• Yes - If yes, indicate all nerves involved: � Recurrent laryngeal or its parent nerve, the vagus nerve � Hypoglossal � Facial � Other

• No

Comorbid cardiopulmonary conditions



75


Element Name Definition History of chronic lung disease

History of chronic lung disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis, emphysema, restrictive lung disease) or currently being chronically treated with inhaled or oral pharmacological therapy (e.g., beta-adrenergic agonist, anti-inflammatory agent, leukotriene receptor antagonist, or steroid). Year of onset (first diagnosis) may be helpful.

On home oxygen Indicate if, prior to the current procedure, the patient has been receiving home oxygen therapy for treatment of chronic lung disease.

NYHA class III or IV in last 6 weeks

Indicate if the patient's highest New York Heart Association (NYHA) cardiac functional class has been Class III or IV anytime within 6 weeks prior to the current procedure. Patients with NYHA Class III and Class IV have anginal or heart failure symptoms, at rest, and/or resulting in marked limitation of physical activity. Class III and Class IV are formally defined as: • Class III: Patient has cardiac disease resulting in marked limitation of physical activity. Patient is comfortable at rest. However, less than ordinary physical activity (e.g., walking one to two level blocks or climbing one flight of stairs) causes fatigue, palpitations, dyspnea, or anginal pain. • Class IV: Patient has dyspnea at rest that increases with any physical activity. Patient has cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms may be present even at rest. If any physical activity is undertaken, discomfort is increased. Note: for patients without cardiac disease or patients with NYHA Class I or II, code No.

Patient Assessment

Carotid bruits Indicate if carotid bruits are present. Choose one of the following:

• Yes - Left - Right - Bilateral

• No

• Not assessed

Supraclavicular bruits Indicate of supraclavicular bruits are present. Choose one of the following:

• Yes - Left - Right - Bilateral

• No

• Not assessed . .



76


Element Name Definition NIH Stroke Scale score Indicate if NIH Stroke Scale (NIHSS) was measured. Choose one of the

following:

• Yes - Indicate scores done pre-procedure, immediately after

procedure, prior to discharge, and other

• No

Modified Rankin stroke score Indicate the patient’s score:

Score Description

0 No symptoms at all

1 No significant disability despite symptoms; able to carry out all usual duties and activities

2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3 Moderate disability; requiring some help, but able to walk without assistance

4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6 Dead

Barthel Index Indicate if Barthel Index was measured. Choose one of the following:

• Yes - Indicate scores done pre-procedure, immediately after

procedure, prior to discharge, and other

• No



77


Element Name Definition Specific neurologic findings Indicate the presence or absence of the following:

• Hemi paresis

• UMN facial weakness

• LMN facial weakness

• Dysphasia

• Hemisensory loss

• Visuospatial neglect

• Branch retinal artery occlusion

• Central retinal artery occlusion

• Dysarthria

• Gait ataxia

• Dysconjugate gaze

• Tongue deviation

• Nystagmus

Diagnostic Procedures

Carotid Duplex Ultrasound Location of measurement Measure each of the following in the right common carotid artery, right

internal carotid artery, left common carotid artery, and left internal carotid artery

Plaque characteristics Indicate if any of the following is present:

• No plaque

• Homogeneous plaque (stable)

• Heterogeneous plaque (unstable)

• Surface irregularity

Intima media thickness Indicate the thickness of intima media in mm

CCA systolic velocity Measure velocity in centimeters/second

CCA diastolic velocity Measure velocity in centimeters/second

ICA systolic velocity Measure velocity in centimeters/second

ICA diastolic velocity Measure velocity in centimeters/second

Peak Systolic Velocity ratio Indicate systolic velocity radio measured in centimeters/second. Choose one of the following:

• <2.0

• 2.0-4.0

• >4.0

Degree of stenosis Indicate the range of the stenosis:

• Normal

• 0-49%

• 50-69%

• 70-99%

• Complete occlusion

Carotid stent occlusion Indicate the range of stenosis post carotid stenting:

• 0-49%

• 50-69%

• 70-99%

• Complete occlusion



78


Element Name Definition Carotid bifurcation location Indicate the location of carotid bifurcation. Choose one of the following:

• Normal

• High

Vertebral artery flow direction

Indicate the direction of the artery flow for the right and left vertebral artery. Choose one of the following:

• Forward

• Reversed

CT Angiography Date of Procedure Indicate the date the procedure was performed (Month/Day/Year)

Radiologist Last Name, First, Middle

Location of measurement Measure each of the following in the right common carotid artery, right internal carotid artery, left common carotid artery, and left internal carotid artery

CCA residual luminal diameter

Measure diameter in millimeters

ICA residual luminal diameter


Degree of stenosis Use NASCET method for measurement of stenosis defined by the formula: % stenosis = 100 x (1- minimum luminal diameter at the lesion site)/diameter of non-tapering segment of distal internal carotid artery

ICA non obstructed diameter Measure diameter in millimeters

Plaque Characteristics Indicate if any of the following is present:

• Calcifications

• Ulceration

• Tandem lesion

Intracranial Atherosclerotic Disease

Indicate if intracranial atherosclerotic disease ( > 50% stenosis) is present in the distribution in either the right and left internal carotid arteries: yes or no

Other Vascular Abnormality Indicate if another vascular abnormality is present including aneurysm, AVM, etc

MR Angiography Location of measurement Measure each of the following in the right common carotid artery, right

internal carotid artery, left common carotid artery, and left internal carotid artery

CCA residual diameter Measure diameter in millimeters

ICA residual diameter Measure diameter in millimeters

Degree of stenosis Use NASCET method for measurement of stenosis defined by the formula: % stenosis = 100 x (1- minimum luminal diameter at the lesion site)/diameter of non-tapering segment of distal internal carotid artery

ICA – non obstructed diameter




79


Element Name Definition Plaque Indicate if any of the following is present and describe:

• Fibrous cap thickness (in millimeters)

• Film cap disruption

• Intraplaque lipid content

• Intra plaque hemorrhage

Tandem lesion Indicate yes or no.

Other vascular abnormality Indicate if another vascular abnormality is present including aneurysm, AVM, etc

Intracranial atherosclerotic disease

Indicate if intracranial atherosclerotic disease ( > 50% stenosis) is present in the distribution of either the right or left internal carotid artery: yes or no

Invasive Therapeutic Procedures - Carotid and Vertebral Artery Stenting


Target carotid vessel Indicate whether the target vessel is the right or left carotid artery for the current procedure. Right or left

Target vertebral artery Indicate whether the target vessel is the right or left vertebral artery for the current procedure. Right or left

Current procedure part of clinical trial

Yes or no. If yes, note trial type:

• Post-market surveillance

• Pre-market approval

• IBE

• Other (specify)

Anesthesia Indicate if the patient received general anesthesia, local anesthesia, or no anesthesia during the current procedure. If more than one given, code General.

Procedure indications and anatomic variables Target lesion symptomatic within past six months

Indicate if the patient has had neurologic symptoms in the past six months related to the target lesion. Symptoms may include: vertigo, syncope, seizures, dementia, headaches, transient ischemic attacks, and stroke.

Re-stenosis in target vessel after prior CAS

Note if the indication for the current procedure is restenosis in the target carotid artery which was previously treated with an angioplasty and/or stent. Carotid artery restenosis is defined as greater than 50% diameter stenosis at or adjacent to the site previously treated with balloon angioplasty or stent.

Re-stenosis of the target vessel after prior CEA

Note if the indication for the current procedure is restenosis in the target carotid artery which was previously treated with a carotid artery endarterectomy. Restenosis is defined as renarrowing within or adjacent to a prior endarterectomy site, evidenced by greater than 50% diameter stenosis.



80


Element Name Definition Lesion difficult to access surgically

Indicate if the lesion is difficult to access surgically for CEA. Lesions that are difficult to access include those which are quite high in the neck (e.g. at or above the level of C2), and those that are within the proximal 1/2 or 1/3 of the common carotid artery, at or below the clavicle rendering endarterectomy either difficult or impossible.

Carotid lesion difficult to access surgically

Yes or no

Vertebral lesion difficult to access surgically

Yes or no

Aortic arch type Indicate the patient's aortic arch type configuration. The three types of aortic arch are based on the relationship of the innominate artery to the aortic arch. The more inferior the origin of the target artery (i.e., Type II or III aortic arch), the greater the difficulty in gaining access to the carotid artery. Category:

• Type 1

• Type 2

• Type 3


Fluoroscopy time Indicate total fluoroscopy time recorded during the procedure visit to the nearest 0.1-minute. The time recorded should include the total time for the procedure.

Contralateral carotid occlusion

Indicate if there is known 100% occlusion of the patient's contralateral carotid artery.

Contralateral vertebral occlusion

Indicate if there is known 100% occlusion of the patient's contralateral vertebral artery.

Bovine arch Indicate if the patient's aortic arch is bovine, in which the right brachiocephalic and left carotid arteries share a common trunk from the aortic arch.


• Femoral

• Direct carotid puncture

• Direct vertebral puncture

• Brachial

• Radial

• Axillary exposure

• Carotid cut down

• Vertebral cut down



81


Element Name Definition Arterial access closure method

List methods and devices in chronological order of closure. Indicate the method used to achieve hemostasis. Methods should include devices and non-device such as "Manual Compression".

Tandem lesions Indicate if there is evidence of tandem lesions. Choose one of the following:

• Yes - Specify location(s)

• No.

Intracranial stenosis Indicate if there is evidence of intracranial lesions. Choose one of the following:

• Yes - Specify location(s)

• No.

Other intracranial pathology Indicate if there is evidence of other intracranial pathology. Choose one of the following:

• Yes - Specify type

• No

Lesions and Devices Target lesion location List the following:

• Isolated common carotid artery

• Isolated internal carotid artery

• Bifurcation

• Vertebral ostia

• Vertebral artery ostia

• Mid-cervical vertebral


Ulceration Indicate if the target lesion is ulcerated as assessed by baseline angiography.


• None

• Mild

• Moderate

• Severe


Minimal luminal diameter Indicate the target lesion's minimum luminal diameter in millimeters (mm) as assessed by baseline angiography. The Minimal Luminal Diameter (MLD) is defined as the minimum luminal diameter derived from the angiographic view that shows the tightest point of the stenosis.



82


Element Name Definition Diameter of distal internal carotid artery

Indicate the diameter of the non-tapering distal segment of Internal Carotid Artery (ICA) for North American Symptomatic Carotid Endarterectomy Trial (NASCET) measurement at the intended landing zone of the distal edge of the stent (where the vessel is no longer tapered and the walls become parallel). Note: NASCET was a randomized clinical trial to compare the safety and efficacy of carotid endarterectomy versus medical therapy for the prevention of stroke in symptomatic patients.

Pre-procedure % stenosis of carotid artery

Indicate the percent stenosis pre-procedure, calculated as follows: 1. When the tightest stenosis is in the Internal Carotid Artery or at the carotid bifurcation, use NASCET methodology. Percent Diameter Stenosis is calculated as: 1- (minimum luminal diameter at the lesion site/diameter of non-tapering segment of distal ICA). "Non-tapering site" is where the walls of the ICA become parallel. 2. Do not use NASCET if the distal lumen collapses from a low-flow situation. In such cases, enter 99%, as the stenosis may be graded as a near occlusion. 3. For stenosis localized to the Common Carotid Artery, Percent Diameter Stenosis is calculated as: 1- (minimum luminal diameter/diameter of the adjacent normal segment of the Common Carotid artery).

Pre-procedure % stenosis of vertebral artery

Indicate the percent stenosis pre-procedure calculated as follows: When the tightest stenosis is in cervical vertebral artery (origin to dural entry), Percent diameter stenosis is calculated as: 1 – (minimum luminal diameter of non-tapering segment of the distal vertebral artery). “Non-tapering site” is where the walls of the vertebral become parallel

Lesion treatment incomplete or aborted

Indicate if the lesion treatment was incomplete or aborted. Yes or no. If yes, note reason(s):

• Failure to gain vascular access

• Unable to cross with guide wire

• Unable to deploy stent

• Arrhythmia

• Failure to confirm significant stenosis

• Unable to cross balloon

• Difficult to access due to tortuosity

• Cardiac ischemia

• Unable to deploy device

• Hypotension

• Hypertension

• Unable to deliver stent

• Other



83


Element Name Definition Embolic protection attempted Indicate if the operator attempted to use an embolic protection device

(EPD).

• Yes - Indicate if pre-dilatation was done prior to balloon or stent. - List EPT devices in chronological order - Note if successfully deployed

• No Yes or no. If yes, pre-dilatation prior to balloon or stent? Yes or no. If yes, list EPT devices in chronological order. Note if successfully deployed.

Pre-dilatation Indicate if pre-dilatation was performed prior to attempted stent implant or after embolic protection device Yes or no.

Stents implanted Yes or no. If yes, list stents in chronological order with the following information:

• Stent

• Brand

• Model

• Manufacturer

Stents tapered Yes or no.

Stent(s) diameter Indicate the diameter of the stent. If a tapered stent was used, indicate the smallest diameter of the tapered stent in millimeters (mm).

Stent(s) length Indicate the length of the stent in millimeters (mm).

Stent(s) mal-position Indicate if the stent was deployed in a location or position other than that for which it was intended. .

Post-dilatation performed Yes or no. If yes, note the following:

• Nominal balloon diameter in millimeters

• Maximum inflation pressure in atmospheres


Indicate the final residual lumen diameter in millimeters (mm).

Final % stenosis for carotid artery

Indicate the percent stenosis post-procedure, calculated as follows: 1. For Internal Carotid artery site, use NASCET methodology. Percent Diameter Stenosis is calculated as: 1- (minimum residual luminal diameter within the treated site/diameter of non-tapering segment of distal ICA). "Non-tapering site" is where the walls of the ICA become parallel. 2. For lesion and interventional site localized to the Common Carotid Artery, Percent Diameter Stenosis is calculated as: 1- (minimum residual luminal diameter/diameter of the adjacent normal segment of the Common Carotid Artery).

Final % stenosis for vertebral artery

Value is dependent on largest using essentially similar NASCET criteria for vertebral disease

Invasive Therapeutic Procedures - Carotid Endarterectomy


Operator identification Last Name, First, Middle



84


Element Name Definition Current procedure part of carotid trial

Yes or no. If yes, not type of trial:

• Post-market surveillance

• Pre-market approval

• IDE

• Other (specify)

Target carotid vessel Indicate whether the target vessel is the right or left carotid artery for the current procedure.

• Right

• Left

• Common

• Bifurcation

• Distal internal

Anesthesia Indicate if the patient received general anesthesia, local anesthesia, or no anesthesia during the current procedure. If more than one given, code General.

Endarterectomy technique Standard or Eversion

Procedure indications and anatomic variables Target lesion symptomatic within past six months

Indicate if the patient has had neurologic symptoms in the past six months related to the target lesion. Symptoms may include: vertigo, syncope, seizures, dementia, headaches, transient ischemic attacks, and stroke.

Target lesion symptomatic within past three months

Yes or no.

Target lesion symptomatic within past six weeks

Yes or no.

Re-stenosis in target vessel after prior carotid endarterectomy (CEA)

Note if the indication for the current procedure is restenosis in the target carotid artery which was previously treated with a carotid artery endarterectomy. Restenosis is defined as renarrowing within or adjacent to a prior endarterectomy site, evidenced by greater than 50% diameter stenosis.

Contralateral carotid artery occlusion

Indicate if there is known 100% occlusion of the patient's contralateral carotid artery.

Contralateral carotid artery stenosis

Yes or no. If yes, indicate

Spontaneous carotid artery dissection

Indicate if the patient has had a spontaneous carotid artery dissection prior to the current procedure. Yes or no. If yes, note location:

• Common carotid

• Carotid bifurcation

• Distal internal

Tandem lesions Yes or no. If yes, note location

Intracranial stenosis Yes or no. If yes, note location

Other intracranial pathology Yes or no. If yes, note type

Intra-procedural information Patch utilization If standard technique:

• Yes – Dacron, PTFE, Bovine pericardium, Vein

• No



85


Element Name Definition Thrombus present on direct visual inspection

Indicate if a thrombus (blood clot) was present on direct visual inspection interoperatively during the carotid endarterectomy (CEA) procedure.

Monitoring technique utilized Note the following:

• Awake monitoring

• Selective monitoring based on EEG, stump pressure, SSEP, motor evoked potential, anatomic or other factor (describe).

Shunting utilized Indicate if a shunt was used. If yes, note the following:

• Selective shunt based on EEG, stump pressure, SSEP, motor evoked potential, anatomic or other factor (describe).

• Was a shunt indicated but not technically possible?

Surgical procedure terminated

Indicate if the carotid endarterectomy procedure was terminated. Yes or no. If yes, note reason(s):

• Hypotension

• Hypertension

• Nerve compromise

• Excessive scar tissue

• Carotid artery thrombosis

• Difficulty with anesthesia

• Difficulty with suction

• Internal carotid artery string sign or atresia

• Cardiac instability

• Inability to implement shunting

• Excessive bleeding

• Inability to access lesion due to anatomical lesions

• Other (specify)

Intraoperative completion evaluation

Check all that apply:

• None

• Standard Doppler

• Arteriogram (include findings)

• Duplex scan (include findings)

Intraoperative complications Indicate any of the following:

• Re-opening of carotid artery (note indication and findings)

• Technical difficulties (describe)

Patient outcome • Normal Neurologic exam

• Deficit (describe)

Medications Antiplatelet therapy, aspirin, ASA

Yes or no. If yes, note type.

Contraindicated clopidogrel Yes or no.

Contraindicated ticlopidine Yes or no.

Contraindicated other Yes or no.

Intra-operative anticoagulation

Indicate the type of dosing used:

• Standard

• Units/kg

Procedural Outcomes



86


Element Name Definition Intraprocedural/Intraoperative Adverse Events

Indicate adverse event(s) which occurred during or following procedure. Specify time of occurrence relative to procedure:

• Abrupt closure

• Spasm requiring treatment

• Loss of external carotid

• Distal intracranial embolization

• Embolization (systemic)

• Embolization (carotid)

• Thrombosis

• Occlusive untreated dissection

• Arrhythmia requiring treatment

• Hypotension requiring treatment

• Stroke

• TIA

• Amaurosis fugax

• Seizure

• Puncture site complications

• Death (or Death in Lab)

• Intubation or resuscitation

• Stent malposition

• Embolic protection retrieval

• Intracranial hemorrhage

• Other (specify)

Results • Procedure technical failure – unable to deploy stent

• Procedure terminated for stenosis <70%

• Procedure terminated due to complication prior to deployment

• Procedure technical success without complications

• Procedure technical success with complications

Acute occlusion Indicate if there is acute occlusion <24 hours post procedure

Residual stenosis Note:

• Right

• Left

• Bilateral

Right side % stenosis Indicate right side % stenosis

Left side % stenosis Indicate left side % stenosis

Stent migration/deformation Stent located in planned landing zone with complete lesion coverage

Distal embolization Occlusion of cerebral arteries or periprocedural neurological deficit resulting from dislodgement of atheromatous debris or thrombus from the procedural site.



87


Element Name Definition Post-procedural complications in hospital

Indicate if any of the following occurred:

• None

• Arrhythmia requiring treatment

• Hypotension requiring treatment

• MI

• New unstable angina

• EKG changes

• Cardiac enzyme changes

• Pulmonary embolism

• Peri/post-procedural CVA/stroke

• Stroke (major or minor)

• Modified Rankin Scale

• TIA

• Amaurosis fugax or TMB

• Seizure

• Intracranial hemorrhage

• Hyperperfusion syndrome

• Other neurological complication (specify)

• Secondary carotid intervention (specify)

• Vessel thrombosis or ischemic of extremity

• Puncture site complications

• Pseudoaneurysm

• Pseudoaneurysm vascular repair

• Hematoma (local or retroperitoneal) or bleeding

• Hematoma (local or retroperitoneal) or bleeding requiring transfusion

• Access site infection

• Creatinine increase >1.0 mg/dl

• Hemodialysis

• Pneumonia

• Urinary tract infection

• Systemic sepsis

• Death

• Other (specify)

Patient Education/Counseling

Medication instruction

Verbal and written medication instructions provided to patient and/or family.

Recognition of new or worsening symptoms

Verbal and written instructions provided to patient and/or family (by physician or nurse) regarding new or worsening of symptoms and when to call the physician.

Diet counseling pertinent to lowering cardiovascular risk

Advice given or discussion carried out with the patient and/or family regarding diet counseling. May include:

• Sodium restriction

• Fluid restriction

• Other (specify)



88


Element Name Definition Referral to dietician for diet counseling

Referral to dietitian for weight management and/or advanced nutritional instruction.

Activity counseling

Advice given or discussion carried out with the patient and/or family regarding activity level and restrictions in activity, and/or exercise recommendations.

Smoking cessation counseling

Advice given or discussion carried out with the patient (by physician, nurse, or other personnel) regarding the importance of stopping smoking. May include:

• Counseling (may be basic or advanced)

• Written materials

• Referral to smoking cessation program

• Nicotine replacement therapy

Plan for follow-up care

Documentation of plan for follow-up care with physician and/or nurse. Should include date of follow up.

Patient referral

Patient referred to other care such as a neurology, neurosurgery, vascular surgery, cardiology clinic/office Transitional care (specify duration):

• Home health care

• Nurse case manager

• Hospice or palliative care

• Home telemonitoring

• Ambulatory cardiac telemetric monitoring (e.g., mobile cardiac outpatient telemetry)

Period of time enrolled in program and/or qualitative characterization of level of patient’s success/participation in the program(s) may be specified.

Discharge status

• Discharge NIHSS

• Discharge Modified Rankin Scale

• Discharge Barthel Index

• Cranial nerve injury

• Technical defects requiring revision

• Stroke (major or minor) – Note date

• TIA (single or multiple) – Note date

• Amaurosis fugax

• MI (Q wave or Non-Q wave) – Note date

Outcomes

Time Points Indicate the period at which outcome measures are assessed. Choose all that apply:

• 1 month

• 3 months

• 6 months

• 1 year



89


Element Name Definition Follow-up visit

Documentation of follow-up evaluation for patients with established carotid/vertebral arterial disease should include:

• Patient history

• Functional status


• Laboratory or other tests

Date of visit Indicate date of visit in mm/dd/yyyy

Follow-up NIHSS (see scale above)

Repeat duplex ultrasound performed

Indicate if repeat duplex ultrasound was performed in any of the following timeframes:

• Prior to discharge - Yes - No

• Three months - Yes - No

• Six months - Yes - No

• Annually - Yes - No



MRA or CTA angiogram performed

Indicate if MRA or CT angiogram was performed in any of the following timeframes:

• Prior to discharge - Yes - No

• Three months - Yes - No

• Six months - Yes - No

• Annually - Yes - No



Follow-up Modified Rankin Scale

(see scale above)

Follow-up Barthel Index (see scale above)

Reason for Termination Indicate the reason for termination



90


Element Name Definition Death Note the following:

• Date

• Cause

• Date of last visit patient was evaluated

• Death within 30 days of last visit

• Death 30 days after last visit

Repeat hospitalization Date of admission Indicate the date of admission in mm/dd/yyy

Primary reason for readmission

Stroke, TIA, MI, other

Repeat duplex ultrasound performed?

Yes/ no.


Left side % stenosis Left side % stenosis

Was repeated MRA, CTA or conventional angiogram performed?

Yes/no

Target lesion revascularization

Indicate whether CAS was performed

Target vessel revascularization

Indicate whether CEA or CAS was performed

Stent patency Indicate whether the stent is patent and if there is restenosis..

• Right side % stenosis

• Left side % stenosis

361 Staff 362

American College of Cardiology Foundation 363 John C. Lewin, MD, Chief Executive Officer 364 Charlene May, Senior Director, Science and Clinical Policy 365 Melanie Shahriary, RN, BSN, Associate Director, Performance Measures and Data Standards 366 Maria Lizza D. Isler, BSMT, Specialist, Clinical Data Standards 367 Erin A. Barrett, Senior Specialist, Science and Clinical Policy 368 369 American Heart Association 370 Nancy Brown, Chief Executive Officer 371 Rose Marie Robertson, MD, FACC, FAHA, Chief Science Officer 372 Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science 373 Operations 374 375

376

377


© 2010 by the American College of Cardiology Foundation and the American Heart Association, Inc. 91

IV. APPENDICES

APPENDIX A: Author Relationships with Industry and Other Entities –ACCF/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

Name Employment Consultant Speaker Ownership/

Partnership

/

Principal

Research Institutional,

Organizational

or

Other Financial

Benefit

Expert

Witness

Mark A. Creager

Brigham & Women’s Hospital

• Biomarin

• Genzyme

• Roche

• Schering Plough

• Vascutek

None None • Merck

• Sanofi Aventis

• American Board of Vascular Medicine

• Vascular Disease Foundation

None

Michael Belkin

Brigham & Women’s Hospital

None Medtronic None None None None

Edward I. Bluth

Ochsner Clinic Foundation

None None None None None None

Donald E. Casey, Jr.,

Atlantic Health None None None None None None

Seemant Chaturvedi

Harper University Hospital

Merck • Boehringer-Ingelheim

• Bristol Myers-Squibb/Sanofi Aventis Partnership

None None None None



Michael D. Dake

Stanford University School of Medicine

None • Abbott Vascular

• Angiodynamics

• Boehringer Ingelheim

• Cook, Inc.

• Cordis Endovascular

• ev3

• Medtronic

• W.L. Gore

None None None None

Jerome L. Fleg

NHLBI Division of Epidemiology and Clinical Applications

None None • Bristol Myers-Squibb

• General Electric

None None None

Alan T. Hirsch, M.D.

University of Minnesota Medical School

• ev3

• Cytokinetics, Inc

• Talecris

None None • Abbott Vascular*

• Bristol Myers Squibb/Sanofi Aventis Partnership*

• Sanofi Aventis*

• Summit Doppler

• AHA Council and Educational Committee Leadership Roles

• Vascular Disease Foundation

None



Michael R. Jaff

Harvard Medical School

• Abbott Vascular

• Access Closure

• Arsenal Medical

• Atheromed

• Baxter Cell Therapies

• Becker Venture Services Group*

• Boston Scientific

• Harvard Clinical Research Institute

• IC Sciences

• Medtronic Vascular

• Micell

• Nexeon Medical Systems

• Sadra Medical

• Vascular Therapies

None • Hotspur

• Icon Interventional

• Primacea

None VIVA Physician’s Group

2009 – Represented Defendant – Stroke and Carotid Artery Disease

John A. Kern

University of Virginia Health Systems


David J. Malenka

Darthmouth Hitchcock Medical Center Section of Cardiology

None None None • Abbott Vascular*

• St. Jude Medical Foundation*

None None

Edward T. Martin

Oklahoma Heart Institute

• Astellas

• Siemens

None None Siemens None None



Emile R. Mohler, III

University of PA Health System

• AMAG

• GSK

• Bristol Myers Squibb-Sanofi

• Merck

None • Bristol Myers Squibb-Sanofi*

• GSK*

NIH* None

Timothy Murphy

Rhode Island Hospital Department of Diagnostic Imaging

• Bristol Myers Squibb

• GSK

None None • Abbott Vascular*

• Boston Scientific*

• Cordis/J&J*

• Otsuka Pharmaceuticals*

None None

Jeffrey W. Olin

Mt. Sinai School of Medicine

• Fibromuscular Dysplasia Society of America

• Genzyme

None None • Merck

• Bristol Myers Squibb-Sanofi Aventis Partnership

Colorado Prevention Center

2009 – Represented Defendant – Pulmonary Embolism

Judith Regensteiner

University of Colorado – Denver

None Bristol Myers Squibb/Sanofi Aventis Partnership

None None None None

Robert H. Rosenwasser

Thomas Jefferson University – Jefferson Hospital for Neuroscience


Peter Sheehan, M.D.

Mount Sinai School of Medicine

None • Bristol Myers Squibb-Sanofi

• Edwards Lifesciences

• FoxHollow

None Genzyme None None



This table represents the relationships of committee members with industry and other entities that were reported by authors to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceeding definition. Relationships in this table are modest unless otherwise noted.

*Indicates significant relationship

Kerry J. Stewart

Johns Hopkins Bayview Medical Center

• Boston Scientific

• Medifast, Inc.

• Milner-Fenwick, Inc

None None NIH* None None

Diane Treat-Jacobson

University of Minnesota School of Nursing

None Bristol Myers Squibb-Sanofi Aventis Partnership

None NHLBI* None None

Gilbert R. Upchurch

University of Michigan Hospitals and Health Centers


Christopher J. White

Ochsner Clinic Foundation

Baxter

None None • Boston Scientific

• Neovasc

• St. Jude

• NCDR-CARE Registry

• SCAI

None

Jack A. Ziffer

Baptist Hospital of Miami

• Astellas

• Lantheus

• Rcadia

• Spectrum Dynamics

None None None None None



APPENDIX B: Peer Reviewer Relationships with Industry and Other Entities –ACC/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

Peer Reviewer Representation Consultant Speaker Ownership/

Partnership/

Principal

Research Institutional,

Organizational or

Other Financial

Benefit

Expert

Witness

This table represents the relationships of committee members with industry and other entities that were reported by authors to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceeding definition. Relationships in this table are modest unless otherwise noted.

*Indicates significant relationship



97

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Documents

ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS Key Data … DS - MASTER DOCUMENT...43 ACCF/AHA/ACR/SCAI/SIR/SVMB/SVN/SVS Key Data Elements and Definitions for Peripheral 44 Atherosclerotic