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8-16-2021

Hot topics in interventional cardiology: Proceedings from the Hot topics in interventional cardiology: Proceedings from the

society for cardiovascular angiography and interventions (SCAI) society for cardiovascular angiography and interventions (SCAI)

2021 think tank 2021 think tank

Srihari S. Naidu

Suzanne J. Baron

Marvin H. Eng

Shyam K. Sathanandam

David A. Zidar

See next page for additional authors

Follow this and additional works at: https://scholarlycommons.henryford.com/cardiology_articles

Authors Authors Srihari S. Naidu, Suzanne J. Baron, Marvin H. Eng, Shyam K. Sathanandam, David A. Zidar, Dmitriy N. Feldman, Frank F. Ing, Faisal Latif, Michael J. Lim, Timothy D. Henry, Sunil V. Rao, George D. Dangas, James B. Hermiller, Ramesh Daggubati, Binita Shah, Lawrence Ang, Herbert D. Aronow, Subhash Banerjee, Lyndon C. Box, Ronald P. Caputo, Mauricio G. Cohen, Megan Coylewright, Peter L. Duffy, Andrew M. Goldsweig, Donald J. Hagler, Beau M. Hawkins, Ziyad M. Hijazi, Sasanka Jayasuriya, Henri Justino, Andrew J. Klein, Chad Kliger, Jun Li, Ehtisham Mahmud, John C. Messenger, Brian H. Morray, Sahil A. Parikh, John Reilly, Eric Secemsky, Mehdi H. Shishehbor, Molly Szerlip, Steven J. Yakubov, Cindy L. Grines, Jennifer Alvarez-Breckenridge, Colleen Baird, David Baker, Charles Berry, Manisha Bhattacharya, Seth Bilazarian, Rosanne Bowen, Kevin Brounstein, Cole Cameron, Rafael Cavalcante, Casey Culbertson, Pedro Diaz, Susan Emanuele, Erin Evans, Rob Fletcher, Tina Fortune, Priya Gaiha, Devi Govender, Dan Gutfinger, Kurt Haggstrom, Andrea Herzog, Denise Hite, Bethany Kalich, Ann Kirkland, Toni Kohler, Holly Laurisden, Kevin Livolsi, Lois Lombardi, Sarah Lowe, Kevin Marhenke, Joie Meikle, Neil Moat, Megan Mueller, Roberto Patarca, Jeff Popma, Novena Rangwala, Chuck Simonton, Jerry Stokes, Margaret Taber, Christopher Tieche, John Venditto, Nick E.J. West, and Laurie Zinn

S C A I T H I N K T AN K P RO C E E D I N G

Hot topics in interventional cardiology: Proceedings fromthe society for cardiovascular angiography and interventions(SCAI) 2021 think tank

Srihari S. Naidu MD, FAHA, FSCAI1 | Suzanne J. Baron MD, FSCAI2 |

Marvin H. Eng MD, FSCAI3 | Shyam K. Sathanandam MD, FSCAI4 |

David A. Zidar MD, PhD, FSCAI5 | Dmitriy N. Feldman MD, FSCAI6 |

Frank F. Ing MD, MSCAI7 | Faisal Latif MD, FSCAI8 | Michael J. Lim MD, FSCAI9 |

Timothy D. Henry MD, MSCAI10 | Sunil V. Rao MD, FSCAI11 |

George D. Dangas MD, PHD, MSCAI12 | James B. Hermiller MD, MSCAI13 |

Ramesh Daggubati MD, FSCAI14 | Binita Shah MD, FSCAI15 |

Lawrence Ang MD, FSCAI16 | Herbert D. Aronow MD, FSCAI17 |

Subhash Banerjee MD, FSCAI18 | Lyndon C. Box MD, FSCAI19 |

Ronald P. Caputo MD, FSCAI20 | Mauricio G. Cohen MD, FSCAI21 |

Megan Coylewright MD, FSCAI22 | Peter L. Duffy MD, MMM, FSCAI23 |

Andrew M. Goldsweig MD, FSCAI24 | Donald J. Hagler MD, MSCAI25 |

Beau M. Hawkins MD, FSCAI8 | Ziyad M. Hijazi MD, MPH, MSCAI26,27 |

Sasanka Jayasuriya MD, FSCAI28 | Henri Justino MD, FSCAI29 |

Andrew J. Klein MD, FSCAI30 | Chad Kliger MD, FSCAI31 | Jun Li MD, FSCAI32 |

Ehtisham Mahmud MD, FSCAI33 | John C. Messenger MD, FSCAI34 |

Brian H. Morray MD35 | Sahil A. Parikh MD, FSCAI36 | John Reilly MD, FSCAI37 |

Eric Secemsky MD, FSCAI38 | Mehdi H. Shishehbor MD, FSCAI39 |

Molly Szerlip MD, FSCAI40 | Steven J. Yakubov MD, MSCAI41 |

Cindy L. Grines MD, MSCAI42 | And the members of the SCAI 2020 Think Tank

Consortium: Lindsay Ackman43 | Jennifer Alvarez-Breckenridge44 | Colleen Baird45 |

David Baker46 | Charles Berry45 | Manisha Bhattacharya44 |

Seth Bilazarian MD47 | Rosanne Bowen48 | Kevin Brounstein49 |

Cole Cameron50 | Rafael Cavalcante48 | Casey Culbertson51 | Pedro Diaz44 |

Susan Emanuele46 | Erin Evans43 | Rob Fletcher49 | Tina Fortune45 |

Priya Gaiha MD52 | Devi Govender47 | Dan Gutfinger45 | Kurt Haggstrom44 |

Andrea Herzog44 | Denise Hite44 | Bethany Kalich53 | Ann Kirkland54 |

Toni Kohler50 | Holly Laurisden50 | Kevin Livolsi45 | Lois Lombardi51 |

Sarah Lowe54 | Kevin Marhenke53 | Joie Meikle55 | Neil Moat MD45 |

Megan Mueller54 | Roberto Patarca44 | Jeff Popma MD54 | Novena Rangwala51 |

Received: 28 July 2021 Accepted: 28 July 2021

DOI: 10.1002/ccd.29898

Catheter Cardiovasc Interv. 2021;1–10. wileyonlinelibrary.com/journal/ccd © 2021 Wiley Periodicals LLC. 1

Chuck Simonton MD47 | Jerry Stokes43 | Margaret Taber48 |

Christopher Tieche54 | John Venditto MD, MBA56 | Nick E. J. West MD45 |

Laurie Zinn44

1Department of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, New York, USA

2Division of Cardiology, Department of Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA

3Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan, USA

4Department of Cardiology, Le Bonheur Children's Hospital, Memphis, Tennessee, USA

5Department of Cardiology, UH Harrington Heart & Vascular Institute, Cleveland, Ohio, USA

6Department of Cardiology, Weill Cornell Medical Center, New York, USA

7Department of Cardiology, UC Davis Medical Center, Sacramento, California, USA

8Department of Cardiology, The University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, USA

9Department of Cardiology, St. Louis University School of Medicine, Saint Louis, Missouri, USA

10Department of Cardiology, The Christ Hospital Health Network, Cincinnati, Ohio, USA

11Department of Cardiology, Duke University Health System, Durham, North Carolina, USA

12The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, USA

13Department of Cardiology, Ascension St. Vincent Cardiovascular Research Institute, Carmel, Indiana, USA

14Department of Cardiology, The West Virginia University School of Medicine, Morgantown, West Virginia, USA

15Department of Cardiology, NYU Grossman School of Medicine, New York, USA

16Division of Cardiovascular Medicine, The University of California, San Diego, California, USA

17Department of Cardiology, Lifespan Cardiovascular Institute/Brown Medical School, Providence, Rhode Island, USA

18Department of Cardiology, Dallas Veterans Affairs Medical Center, Dallas, Texas, USA

19Department of Cardiology, West Valley Medical Center, Caldwell, Idaho, USA

20Department of Cardiology, Levine Heart and Wellness, Naples, Florida, USA

21Cardiac Catheterization Laboratory, University of Miami Miller School of Medicine, Miami, Florida, USA

22Department of Cardiology, Erlanger Health System, Chattanooga, Tennessee, USA

23Department of Cardiology, West Florida Hospital, Pensacola, Florida, USA

24Division of Cardiovascular Medicine, The University of Nebraska Medical Center, Omaha, Nebraska, USA

25Division of Pediatric Cardiology and Department of Cardiovascular Diseases, Mayo Clinic Health System, Rochester, Minnesota, USA

26Cardiology, Weill Cornell Medical College, New York, USA

27Sidra Medicine, Doha, Qatar

28Cardiology, Ascension Columbia St. Mary's Hospital Milwaukee, Milwaukee, Wisconsin, USA

29Division of Cardiology, Department of Pediatrics, Texas Children's Hospital, Houston, Texas, USA

30Department of Cardiology, Piedmont Heart Institute, Atlanta, Georgia, USA

31Department of Medicine, Division of Cardiovascular Medicine, Northwell Health Lenox Hill Hospital, New York, USA

32Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA

33Coronary Care Unit, University of California, San Diego, California, USA

34Department of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA

35Department of Cardiology, Seattle Children's Hospital, Seattle, Washington, USA

36Division of Cardiology and Center for Interventional Vascular Therapy, Columbia University Irving Medical Center, New York, USA

37Division of Cardiovascular Medicine, Department of Medicine, Stony Brook University Hospital, Stony Brook, New York, USA

38Department of Internal Medicine, Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA

39Harrington Heart & Vascular Institute, UH Harrington Heart & Vascular Institute, Cleveland, Ohio, USA

40Division of Cardiology, Baylor Scott & White The Heart Hospital – Plano, Plano, Texas, USA

41Department of Cardiology, OhioHealth Heart & Vascular Physicians, Columbus, Ohio, USA

42Department of Cardiology, Northside Hospital Cardiovascular Institute, Atlanta, Georgia, USA

43TandemLife, LivaNova, Pittsburgh, Pennsylvania, USA

44Cordis, Santa Clara, California, USA

2 NAIDU ET AL.

45Abbott, Santa Clara, California, USA

46Philips Healthcare, Cambridge, Massachusetts, USA

47ABIOMED, Danvers, Massachusetts, USA

48Boston Scientific, Marlborough, Massachusetts, USA

49Shockwave Medical, Santa Clara, California, USA

50W. L. Gore, Newark, Delaware, USA

51GE Healthcare, Chicago, Illinois, USA

52Siemens Medical Solutions USA, Malvern, Pennsylvania, USA

53Amgen, Thousand Oaks, California, USA

54Medtronic, Minneapolis, Minnesota, USA

55Getinge US, Wayne, New Jersey, USA

56AstraZeneca, Wilmington, Delaware, USA

Correspondence

Srihari S. Naidu, Westchester Medical Center,

100 Woods Road, Macy Pavilion Room 134,

Valhalla, NY, USA.

Email: srihari.naidu@wmchealth.org

Abstract

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a

collaborative venture that brings together interventional cardiologists, administrative

partners, and select members of the cardiovascular industry community annually for

high-level field-wide discussions. The 2021 Think Tank was organized into four paral-

lel sessions reflective of the field of interventional cardiology: (a) coronary interven-

tion, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart

disease. Each session was moderated by a senior content expert and co-moderated

by a member of SCAI's Emerging Leader Mentorship program. This document pre-

sents the proceedings to the wider cardiovascular community in order to enhance

participation in this discussion, create additional dialog from a broader base, and

thereby aid SCAI, the industry community and external stakeholders in developing

specific action items to move these areas forward.

K E YWORD S

congenital heart disease, coronary artery disease, pediatrics, peripheral arterial disease,structural heart disease intervention

1 | INTRODUCTION

The annual Society for Cardiovascular Angiography and Interventions

(SCAI) Think Tank brings together content experts, SCAI leaders, and key

industry partners for a one-day session on timely topics within the four

pillars of interventional cardiology—coronary, peripheral, structural, and

congenital. The themes of this year centered on quality assurance of cor-

onary and peripheral procedures, either at ambulatory surgical centers or

in the hospital setting, the need to expand indications for minimally inva-

sive structural procedures to meet the needs of an aging cardiovascular

population, and the need to track implantable devices over time in our

pediatric patients with congenital heart disease (CHD) who have now

been able to achieve a longer life expectancy into young adulthood, mid-

dle age, and beyond. It is hoped that these discussions stimulate further

initiatives within SCAI, our members, and our industry colleagues to

meet these contemporary demands and help us achieve better outcomes

for our cardiovascular patients.

2 | CORONARY: PERCUTANEOUSCORONARY PROCEDURES IN THEAMBULATORY SURGERY CENTER—WHATDOES THIS MEAN TO THE PRACTICE,OVERSIGHT, VALUE, AND QUALITY OFPROCEDURAL AREAS?

Over the last 35 years, percutaneous coronary intervention (PCI) has

evolved considerably in terms of device technology, pharmacologic

options, and procedural techniques. In parallel with these scientific

advancements by our members and industry partners, the rates of

PCI-related complications have dropped precipitously despite the

increasing anatomic and clinical complexity seen more routinely now

in patients presenting with coronary artery disease.1,2 Accordingly,

same-day discharge after PCI has been increasingly adopted and PCI

has been expanded to centers without cardiothoracic surgical back

up.3,4 With these developments in care processes and improved

NAIDU ET AL. 3

outcomes, PCI is now in the early stages of being performed in non-

hospital outpatient facilities (e.g., ambulatory surgical centers [ASCs]).

While there are potential benefits to the performance of PCI in ASCs,

including cost-savings,5 wider access to care, a more gratifying patient

experience, and greater physician autonomy, there are no published

data on the safety of PCI performed in ASCs specifically. Hence, the

true risk of adverse clinical outcomes in this setting is unknown,

prompting concerns regarding quality and oversight.

As a national society comprising over 4000 members of the inter-

ventional cardiology community, SCAI is in a unique position to help

define the quality benchmarks for the evaluation of catheterization

laboratories and for the performance of PCI. In keeping with this role,

SCAI in 2020 proactively generated and published two complemen-

tary expert consensus statements detailing guidance for the optimal

performance of complex PCI as well as for the development of an

ASC-based PCI program.6,7 Notably, it was recommended that poten-

tially high-risk procedures, such as the treatment of unprotected left

main lesions, chronic total occlusions, and severely calcified lesions

be referred to a hospital-based setting.6 Nevertheless, with the

recent Centers for Medicare & Medicaid Services (CMS) decision all-

owing for the reimbursement of complex PCI procedures in ASCs, a

growing (albeit small) number of atherectomy procedures are now

being performed in these centers. As such, a group of key opinion

leaders from the interventional community, representing both physi-

cians and industry partners, convened at the 2021 SCAI Virtual

Think Tank to deliberate how PCI in ASCs should be performed,

especially when case selection falls outside of our initial recommen-

dations, and the role that SCAI should play in optimizing quality in

these settings.

During the discussion, the overarching theme was related to the

importance of ensuring optimal outcomes for patients undergoing PCI

at ASCs (Figure 1). In the spirit of patient transparency, there was a

strong sentiment that informed consent must include a clear acknowl-

edgement of the possible consequences of the absence of services

and equipment that are normally present in a hospital-based setting

(e.g., cardiac anesthesiology, mechanical circulatory support, and car-

diothoracic surgery) and that financial incentives (if any) for the physi-

cian to perform the procedure at the ASC should be made clear to the

patient. Additionally, while catastrophic complications are expected to

be rare if case selection is appropriate, transfer protocols in the event

of a major complication should be clearly communicated to the care

team and the potential need for emergency transfer made clear to the

patient prior to the procedure.

As was clearly defined in SCAI's statement on ASC-based PCI

programs,6 certain standards for the facility itself, the equipment

available at the ASC facility, and the qualifications of all personnel

(e.g., nursing, technologist, and physician) practicing at the ASC were

felt to be of paramount importance. In particular, there was consider-

able discussion regarding the use of intravascular imaging and physio-

logic testing. Multiple studies have demonstrated improved outcomes

with the use of these strategies when compared with angiographically

guided PCI alone.8–12 The availability of these technologies is neces-

sary to determine the need for revascularization and optimize PCI out-

comes. Nevertheless, given the lack of CMS reimbursement for

intravascular ultrasound and optical coherence tomography, there

was concern that monetary considerations could limit the use of these

evidence-based tools in an ASC setting. As such, it was felt that SCAI

needs to continue to actively advocate for additional CMS reimburse-

ment for these adjunctive procedures, and assure their availability and

use in ASC facilities, in order to promote best practices and decrease

the potential for inappropriate PCI not only in ASCs, but in any PCI

center.

In order to ensure that ASCs performing PCI adhere to best prac-

tices, there was further consensus that some form of data monitoring

would be necessary for ongoing quality assurance. In fact, since it is

expected that the majority of PCIs performed at ASCs will and should

be lower risk, it was proposed that a higher benchmark for safety out-

comes should be considered. While existing national cardiovascular

registries, such as the NCDR CathPCI registry, do provide a wealth of

information regarding volumes, outcomes, and procedural appropri-

ateness in the hospital setting, currently there is no existing registry

that evaluates metrics specific to an ASC site of service. Since the pri-

mary focus for monitoring ASCs would be to assess safety

(as opposed to a repository of data for research), it was agreed that

the development of a scaled-back registry, focused only on the essen-

tial measures of quality (including appropriate PCI, complication rates

and discharge protocols based on best practices), is needed and that

participation in such a registry should be tied to reimbursement in

order to guarantee ASC site involvement. The Outpatient Endo-

vascular and Interventional Society (OEIS) is currently developing a

cardiac module within their national registry, specifically focused on

cardiac interventions performed at ASCs and outpatient interventional

suites and may provide an opportunity in the near future to imple-

ment a quality assessment program for ASCs performing PCIs. It was

recognized that the major barrier to implementing this process would

be the cost involved and the need for a clinical director (e.g., cath lab

director) to provide physician and data oversight at the ASC, and it is

recommended that payers and ASC facilities take this into

F IGURE 1 Key recommendations for high-quality ASC-based PCIprogram. ASC, ambulatory surgical centers; PCI, percutaneouscoronary intervention

4 NAIDU ET AL.

consideration when negotiating contracts and determining reimburse-

ment policies for procedures performed in an ASC setting.

In summary, there was a general consensus that SCAI should con-

tinue to advocate that ASCs abide by the expert recommendations laid

out in the recent position statement, supplemented by the updated

2021 Cath Lab Best Practices Consensus Document,13 on the perfor-

mance of PCI at an ASC.6 In order to preserve patient safety and ensure

high-quality outcomes, proper incentives to promote best practices (such

as the use of intravascular imaging or physiology-guided PCI) and

requirements to engage in the reporting of quality metrics are needed.

By working together with state and federal governing bodies and agen-

cies, SCAI has the opportunity to play a large and important role in the

evolving landscape of ASCs performing PCI.

3 | PERIPHERAL: UNDERSTANDING THEVALUE ASSESSMENT OF PERIPHERALTECHNOLOGIES IN ACUTE AND CHRONICINFRAINGUINAL INTERVENTIONS

The focus of the endovascular session was to discuss emerging issues

related to device selection for endovascular treatment of peripheral

artery disease, including critical limb ischemia. Stakeholders from the

interventional cardiology community, industry, and SCAI leadership

were in attendance. SCAI has a long history of prioritizing quality ini-

tiatives regarding best practices and the appropriate use criteria in

peripheral vascular interventions (PVI).14 The society has provided

several consensus guidelines (class of recommendation and level of

evidence) for device selection in specific clinical or anatomic subsets,

based on comparative device safety and effectiveness data.15,16 How-

ever, recent studies continue to show marked heterogeneity of treat-

ment practices in real world settings, both when performed in hospital

or at an ASC.17 The SCAI think tank provided a forum to discuss sev-

eral interrelated issues pertaining to SCAI's role in guiding hospitals

and clinicians regarding utilization of peripheral endovascular technol-

ogies. It is hoped that standardization aligned with best practices will

serve the wider community by minimizing disparities of care demo-

graphically and geographically.

There was uniform support for SCAI's role in monitoring practice

patterns, device utilization, and outcomes in PVI. Given SCAI's man-

date to promote and enhance quality care and physician education,

these activities were deemed to be consistent with the mission of the

society. In addition, given SCAI's prior quality initiatives in publishing

expert consensus statements and appropriateness criteria, there is

precedent and expertise for these initiatives within the SCAI member-

ship. Past lessons from highly publicized examples of rarely appropri-

ate PCIs highlight the legal exposure to physicians and health care

systems as well as the negative impact such cases can have on the

reputation of the interventional cardiology community. For these rea-

sons, it was agreed that SCAI, physician membership, and industry

partners should be aligned in fostering transparency regarding prac-

tice patterns with an eye toward understanding and disseminating

best practice guidance to the peripheral interventional community.

The Think Tank group agreed that SCAI should be involved in the

study of practice variation and valuation of devices related to peripheral

endovascular procedures. There was less agreement about how best to

improve the quality of patient care and minimize costs. One barrier is the

identification of operators and institutions that are outliers, with respect

to quality and/or appropriateness of device utilization. It is not known

how much practice variation should be expected, however. There was

interest in joining resources with other physician groups and societies

(e.g. Society for Vascular Surgery) on policy statements to broaden global

impact of such initiatives. More generally, we should consider promoting

ethical business principles such as the value agenda, which in this con-

text might include evaluation of practices based on the following param-

eters: (1) improved organization and integration of care, (2) established

measures to evaluate outcomes and cost of care, (3) process for bundled

payments for patient care cycles, (4) integrated care delivery across sepa-

rate facilities within a health care system, (5) expand or build services

across a geographic region to improve access to care, (6) lifecycle man-

agement with emphasis on value-based care, and (7) appropriate

reimbursement.

One option to identify “at risk” operators or laboratories would

be to put quality assurance metrics in place, including peer review for

appropriateness of PVIs, review of device selection and utilization,

and review of adherence to guidelines and expert consensus docu-

ments. There was a debate about whether an outside review board

could assist with oversight and accountability for operators and insti-

tutions, and whether there should be reimbursement for such reviews.

There was moderate interest, but no consensus achieved, about how

this could be financed and whether a SCAI-led, industry-funded mech-

anism could be put in place.

Another option offered to address practice variation and under- or

overutilization of certain devices was organizing a peripheral laboratory

certification or accreditation process through SCAI, which could certify

or accredit laboratories after a comprehensive peer-based review. SCAI

would provide guidance and issue accreditation to programs meeting

specific requirements, such as a random peer case review program and

QA/QI process. Accreditation for ASCs should not be based purely on

adjusted complication rates, but also on short- and long-term outcomes,

as well as procedure and device appropriateness.

There was general agreement that there should be awareness

that proliferation of ASCs nationwide has occurred without proper

professional societal quality/utilization/appropriateness evaluations in

place. The office-based lab (OBL)/ASCs were not necessarily deemed

to be the problem, and in fact, many patients seem to prefer to

receive care in an OBL/ASC setting. However, the current financial

incentives of OBL/ASC physicians and lack of oversight regarding

appropriateness of procedures and device selection pose a potential

concern. One topic, which was debated, was whether OBL/ASCs per-

forming endovascular procedures should be required to be part of a

PVI registry. Physicians in attendance and stakeholders from industry

were keenly interested in a concept of a comprehensive registry that

would include data on costs, procedural complications/outcomes, and

patient reported short- and long-term outcomes. Mandatory participa-

tion would be necessary for full engagement, complete quality

NAIDU ET AL. 5

metrics, and accountability. However, the feasibility of such a registry

for ASCs might be limited since outpatient-based laboratories do not

generally have an infrastructure for data collection, as already dis-

cussed in the coronary section above. Whether self-reported patient

data would be accurate and impactful was also discussed.

Another central topic discussed was whether observational/regis-

try data would change physician practice patterns. There was moder-

ate pessimism that such data would impact practice patterns since, for

instance, even high-quality randomized controlled trials have not

resulted in large-scale utilization of drug-coated balloons. There was

consensus that given the strong influence of reimbursement on physi-

cian behavior, SCAI members and industry should strive to work with

payers to realign payment structure, with an emphasis on evidenced-

based outcomes-based metrics. There was a view that consensus doc-

uments may not help to change physician behavior unless they can be

enforced. Thus, linking registry participation to reimbursement by

payers was discussed.

In summary, there was general agreement that issues related to

PVI procedural appropriateness, heterogeneity in device selection,

variance in cost and practice patterns were all linked in complex ways

and are important priorities for SCAI to be engaged in (Table 1). The

expansion of OBL/ASCs was recognized as an opportunity to create

SCAI-led quality assurance metrics, such as peer review for appropri-

ateness of PVI and review of device selection/utilization. Several

options, such as development of a SCAI-led certification or accredita-

tion process for operators and laboratories and participation in PVI

registries were identified as discussed above. There was a consensus

that SCAI should advocate for realignment of financial incentives with

an emphasis on outcomes-based metrics.

4 | STRUCTURAL: ENHANCINGINNOVATION IN STRUCTURAL HEARTPROCEDURES—EMERGING INDICATIONSFOR VALVES, CLIPS, AND PLUGS

As more cardiovascular patients survive to an advanced age, with inher-

ent associated comorbidities including frailty, cardiac procedures will

need to continue to evolve to treat diseases via percutaneous (rather

than open surgical) methods. The current era of minimally invasive

devices for structural heart disease (SHD) interventions presents clini-

cians with a toolbox to develop creative solutions. As expected, these

solutions involve permutations of utilizing medical devices in methods

novel to their intended purpose, or in the United States device regula-

tory framework, outside of their approved “labeled” indication.For example, transcatheter valves are approved for transcatheter

aortic valve replacement (TAVR) in patients with severe aortic steno-

sis. However, there are complex patients for whom adjunctive proce-

dures have evolved to overcome challenges to successfully

performing TAVR that are not part of the food and drug administra-

tion (FDA) labeling for the procedure (e.g., BASILICA).18 Furthermore,

given that there are no similar valves approved for replacement of the

mitral valve, operators have utilized the available aortic valves to

perform transcatheter mitral valve replacement (TMVR). While such

“off-label” use of a product may gain traction within the interven-

tional cardiology community through podium presentations, case

reports, and social media,19 a presentation bias occurs as operators

are reluctant to share deaths or serious complications. Thus, quality

and safety remain a concern regarding appropriate case section, tech-

nical skillsets, complication management, and post-procedure care. In

addition, the medical device industry, charged with assuring proper

use of their products through operator training, support, and guid-

ance, are unable to assist to assure optimal procedural outcomes

when the devices are used off-label. While measurement and commu-

nication of quality within the interventional community and to the

public remains a challenge already for FDA-approved procedures, it is

exceedingly difficult for off-label device procedures.

TABLE 1 Practice variation in device selection in PVI procedures

Practice variation in peripheral vascular interventions (PVI)

Lessons learned and emergingchallenges

Potential societal initiatives andsolutions

•PVI and device selection can

be affected by financial

incentives

•Expanded local and national

peer review board/system

•Financial incentives can lead

to:

•SCAI-led industry funded

peripheral laboratory

certification and/or

accreditation for OBL/ASCs.

•Unnecessary procedures,

adverse outcomes, and

harm to patients

•Establish a comprehensive

outpatient PVI registry, with

participation being linked to

reimbursement

•Healthcare disparities •Realignment of financial

incentives to emphasize

evidence-based and outcomes-

based metrics

•Additional expense to

payers and health care

systems

•Engagement with other

physician groups and vascular

societies

•Patient and societal mistrust

•Identifying “at risk” operators/outliers is challenging

•OBL/ASCs expansion is

occurring without a

mechanism to evaluate

appropriateness, quality, and

safety

•Consensus/guidelinedocuments are not being

followed and do not lead to

higher quality care

•Physician behavior is strongly

linked to reimbursement

•Reimbursement is not

necessarily linked to best PVI

practices

Abbreviations: ASC, ambulatory surgical centers; OBL, office-based lab;

SCAI, society for cardiovascular angiography and interventions.

6 NAIDU ET AL.

The specialty of interventional cardiology has historically been

at the forefront of innovation and improved patient care by generat-

ing the data to support novel procedures (e.g., randomized con-

trolled trials, well-conducted observational studies). Furthermore,

carefully designed registries are used to examine off-label device

use and supplements the research on approved products beyond the

randomized data.20,21 To date, these innovations have principally

been in the areas of coronary and peripheral vascular procedures,

however. Notably, and in contrast, the field of SHD has developed

with unique challenges that necessitate a different pathway for

meeting deficiencies in patient/procedural care. These include

(1) The mandate of the “Heart Team” approach with the physical

presence of both cardiac surgeons and interventional cardiologists

to evaluate and treat patients cooperatively; and (2) National Cover-

age Decisions that closely associate FDA labeling of devices, clinical

trial data, and reimbursement for structural heart procedures. In

essence, enhancing treatment for patients with SHD now involves

the complexity of the medical device industry, federal government,

cardiac surgery, and interventional cardiology. The mission of SCAI

is to lead the global interventional cardiology community in educa-

tion, advocacy, research, and quality of patient care. Clearly, to

achieve all of these aims, SCAI must endeavor to enhance and

improve the treatment of patients with SHD moving forward.

4.1 | Alignment of operators, industry, andregulators

To allow iterative expansion of labeled indications for devices

and/or procedures, SCAI has the unique ability to unite operators,

the medical device industry, and the FDA to devise acceptable next

steps to achieve this result (Figure 2). SCAI think tank consensus

was to consider single-arm studies and more specific device/proce-

dure registry data that could be utilized for this goal and SCAI could

be the organizing “sponsor” to facilitate the process. In this way,

multicenter industry sponsored studies would still be undertaken to

expand indications and procedures (e.g., TAVR in patients with mod-

erate aortic stenosis) as has been the current and accepted stan-

dard. However, leaflet altering procedures such as BASILICA

preceding TAVR would not require such randomized trial data to

become “on-label” for appropriate patients. Furthermore, single arm

studies and appropriate registry data would be large enough to

develop standards for patient outcomes that should be acceptable

for such procedures. Lastly, reimbursement for these procedures

continues to be an issue for operators, and SCAI would be appropri-

ately empowered with this type of data to pursue opportunities to

appropriately affect reimbursement and payment decisions.

4.2 | Organization of education and training

Education and training are ongoing needs with continued proce-

dural innovations and SCAI is ideally suited to fulfill this need. Pre-

viously, SCAI has developed position statements, training

requirement statements and supported e-book learning for inter-

ventional procedures. All of these avenues should be considered

for training in the structural heart arena with a focus on adapting

the best available media and computing resources to support train-

ing programs. Likewise, there is a need for “expert consultative”services in which “experts” in the field could be consulted for pro-

cedural advice prior to an operator taking on an advanced proce-

dure. These could be facilitated by SCAI by organizing and

publicizing an available “expert panel” of individuals agreeable to

providing such a service as well as by providing the optimal

method of communication between parties. The concept of “virtualproctoring” was also brought forward given the rapid development

in hardware and software (e.g., augmented reality and virtual real-

ity) to allow such interactions currently and in the near future,

although there are multiple potential liability concerns that would

have to be considered prior to implementation.

4.3 | Partnership with congenital interventionalists

It was recognized that a great deal of symmetry exists between these

structural heart treatment issues proposed and those faced by our

colleagues in the CHD arena. Thus, moving forward, the proposed

efforts by SCAI should not occur specifically to the structural heart

arena or specific procedures, but rather be developed as more general

templates and pathways to allow for iterative expansion of

indications.

To summarize, clearly innovation and meeting the needs of an

aging population require that our tools and techniques expand signifi-

cantly in the structural heart space. Alignment of relevant stake-

holders and agreement on a process to facilitate appropriate FDA

approvals, potentially orchestrated by SCAI, together with organiza-

tion of novel educational and training initiatives, will all be pivotal to

expand treatment options in a safe and efficacious manner.

F IGURE 2 SCAI as the intermediary to align structural operators,the medical industry, and the food and drug administration. SCAI,society for cardiovascular angiography and interventions

NAIDU ET AL. 7

5 | CONGENITAL: HOW CAN THEPEDIATRIC INTERVENTIONAL COMMUNITYEFFECTIVELY TRACK IMPLANTABLEDEVICES FROM CHILDHOOD TOADULTHOOD?

At the CHD Think Tank discussion, members of the pediatric/

congenital interventional cardiology community met with corpo-

rate representatives of CHD device manufacturers and discussed

the current status of device-tracking from childhood into adult

life, identified gaps in this process, and offered possible strategies

and solutions to fill these gaps. The discussion revolved around

how SCAI can engage the various stakeholders including physi-

cians, industry, and patients together to establish an improved

system for device tracking.

Survival of children born with CHD into adulthood has steadily

improved over the past three decades.22 This has brought about sev-

eral new challenges in the management of adult survivors of CHD.

One of these involves tracking of devices implanted during infancy

and childhood into adult life. Tracking poses unique challenges, as

infants and children who are treated can now outlive the physicians

implanting the devices, device-tracking registries, the manufacturer,

and even currently available technology. Further, CHD patients often

require reoperations where devices may be explanted or modified.

Repeat interventions may also alter the original implanted device or

additional devices may be implanted superimposed onto previously

implanted devices. Clearly, then, details of the type, medical device

manufacturer, model, size, and number of devices implanted previ-

ously, along with the implant dates, procedure notes, and potential

procedural challenges encountered are vital for the proper transfer

and continued care of pediatric CHD patients transitioning to adult

care. However, this effort will require a standardized device tracking

mechanism, collaboration of all stakeholders, and addressing of con-

cerns over potential HIPAA violations to enable proper transfer of

information.

5.1 | Gaps in the current device-tracking practicesfor CHD patients

There are no standardized tracking systems currently available for

devices implanted to treat CHDs and the gaps are multifactorial

(Table 2). Industry tracks certain devices as mandated by the FDA,

which include devices that have the potential to result in a serious

adverse health consequence in the event of a device failure, are

implanted for more than one year, and whenever the device is

intended to be a life sustaining or life supporting device outside of a

hospital setting (e.g., implantable pacemakers).23,24 However, this pro-

cess is not universally applied to all permanently implantable medical

devices (e.g., vascular stents and plugs) and active surveillance in some

cases. In addition, when it does occur, the tracking process is typically

not beyond a few years post-implant. One of the pitfalls for industry

tracking devices is that the company can track only those devices that

are registered, and tracking is dependent on the operator to submit

the device registration information. Furthermore, industry has no

standardized methods of tracking of devices used off-label, which is a

common practice across the CHD interventional community. The FDA

also does not require all implantable devices to be registered. For

example, there is no requirement to register stents, which are often

used for treatment of vascular stenoses in CHD. Moreover, follow-up

for CHD patients is frequently not streamlined during the transition

to adult congenital cardiology care.

Most hospitals typically have an internal device-tracking system

for patients within the health care system. Currently, most electronic

medical records (EMR) are not built with any robust device-tracking

platform. In addition, the EMRs of distinct hospital systems most typi-

cally do not communicate with each other. Therefore, as pediatric

patients' age and move out of parental care and insurance, details of

their implanted devices are often lost. National registries such as the

NCDR (National Cardiovascular Data Registry), and the CCISC

(Congenital Cardiovascular Interventional Study Consortium) are nei-

ther built specifically for device-tracking, nor are they kept active or

updated regarding long-term device related issues such as late device

malfunction, device explantation, device reintervention, or change in

the patient's clinical situation.24–26

TABLE 2 Summary of tracking of implantable devices in CHD:gaps and strategies for improvement

Tracking of implantable devices from childhood to adulthood

GapsStrategies to streamline devicetracking

•No tracking system

currently available

•Prioritization of certain devices for

tracking throughout the lifetime of

CHD patients

•Industry tracks devices only

if FDA mandated

•Backfilling into currently available

registries and device-tracking

systems within industry

•Tracking can only occur if

device registration is

submitted

•Develop a system to track off-label

use of devices

•Lack of active surveillance •Establishment of a SCAI registry

specifically for device tracking for

CHD patients

•Off-label use of devices for

CHD prevents tracking

•Partnering with EMR systems to

develop electronic device

registration and tracking

algorithms

•Transition of care is not

streamlined into

adulthood

•Development of patient specific,

health passports

•Gaps in transfer of EMR

between hospital systems

•Regulatory agencies/insurance

carriers to mandate device

registration/tracking

•Complexities in allowing

patient access to medical

records

Abbreviations: CHD, congenital heart disease; EMR, electronic medical

records.

8 NAIDU ET AL.

There are two other gaps in the mechanisms for transfer of medi-

cal records—the patient having personal access to their medical

records in a passport-like file so that they can easily transmit it to a

new physician without requiring institution to institution transfer of

medical records, and a registry system to contain this passport. This is

much more complicated, obviously, and risks breaches in privacy.

5.2 | Strategies for SCAI to develop a streamlineddevice tracking process for CHD patients

There exists a great opportunity for SCAI to engage physicians, indus-

try partners, regulatory bodies, and insurance carriers to develop a

simple, easy to use, and streamlined device tracking system for

patients with CHD that can be updated periodically with follow-up

patient and device related data while ensuring that patient privacy is

protected. The following points were made during the group discus-

sion and summarized in (Table 2):

1. There is common agreement among the stakeholders of the impor-

tance of tracking devices used to treat CHD.

2. The CHD and industry representatives are enthusiastic to engage

and collaborate with SCAI in developing a process for device track-

ing throughout the lifetime of children born with CHDs.

3. Specific strategies for device tracking can include but are not lim-

ited to:

a. Prioritization of implantable devices for tracking throughout the

lifetime of the CHD patient, depending on long-term complica-

tions, impact on future surgeries or other medical care (i.e., MRI

compatibility of certain devices).

b. Backfilling of missing patient and device related information into

currently available registries and device-tracking systems within

the device industry.

c. Develop a system to track off-label use of devices.

d. Establishment of a national registry by SCAI specifically for CHD

device tracking which includes tracking of multiple device implants,

explants, and device reinterventions in a single patient.

e. Partnering with EMR systems to develop electronic device regis-

tration and tracking algorithms for implantable devices, which

allows sharing of HIPAA compliant device information among vari-

ous EMR platforms.

f. Development of a patient specific, health passport. With the wide-

spread use of smart phones throughout the United States and

around the world, these patient health passports can be created as

a cellphone/tablet application (Apps) that can be constantly

updated through the internet “cloud.” Voluntary patient participa-

tion and “opting-in” within these Health Passport Apps can obviate

health privacy concerns.

While there remain financial costs to developing such dependable

tracking systems, there are also potential financial benefits. For exam-

ple, tracking of off-label use of devices may provide important

retrospective data that can be used to gain eventual FDA approval for

the off-label indication to treat CHD as well as to develop proper CPT

codes and valuation for the procedure.

Compliance to register an implanted device can be a challenge.

However, strategies involving regulatory agencies and insurance car-

riers to mandate registration of implanted devices by the hospital or

implanter prior to reimbursement can improve compliance. Some of

these rules are already in practice for SHD. Alliance with insurance

carriers could also ensure reputation incentives for transparent, self-

reporting, and improved ratings for hospitals to participate in device

tracking registries.

In summary, the SCAI CHD Think Tank group of CHD physicians

and industry representatives had a very fruitful discussion regarding

tracking of devices throughout the lifetime of patients with CHD.

There was group consensus that there is a need for establishing a sim-

ple pathway for continuous tracking of these devices. There exists a

great opportunity for SCAI to engage physicians, industry partners,

regulatory bodies, and insurance carriers to develop a robust device-

tracking system not just for CHD, but for other types of interventional

cardiovascular procedures with permanent implants. SCAI has an

opportunity to play an important role and can have a significant

impact in the progress of interventional therapies by tracking of medi-

cal devices for patients with CHD.

6 | CONCLUSION

SCAI is committed to enhancing safety, quality, and efficacy of percuta-

neous procedures. The current topics highlight areas of growth within

our field, including the move to ambulatory surgical centers, providing

more uniformity and standardization of care across geographies and

demographics, following our pediatric congenital patients as they age

and move through life, and rapidly evolving technology and techniques

in the structural arena to meet the needs of a diverse, aging population.

Hopefully, this initial discussion fuels attempts at collaboration to meet

these challenges, and we welcome any further discussion from impor-

tant stakeholders and the wider cardiovascular community.

CONFLICTS OF INTEREST

No conflicts of interest.

ORCID

Suzanne J. Baron https://orcid.org/0000-0002-8319-5637

Marvin H. Eng https://orcid.org/0000-0002-0334-6504

Timothy D. Henry https://orcid.org/0000-0003-1123-0533

George D. Dangas https://orcid.org/0000-0001-7502-8049

Ramesh Daggubati https://orcid.org/0000-0002-2257-6997

Binita Shah https://orcid.org/0000-0001-8872-8001

Lawrence Ang https://orcid.org/0000-0002-3206-7432

Mauricio G. Cohen https://orcid.org/0000-0003-2038-6070

Andrew M. Goldsweig https://orcid.org/0000-0003-2952-7837

Donald J. Hagler https://orcid.org/0000-0002-0331-3294

Brian H. Morray https://orcid.org/0000-0001-7587-7518

NAIDU ET AL. 9

Sahil A. Parikh https://orcid.org/0000-0002-7740-1481

Mehdi H. Shishehbor https://orcid.org/0000-0002-4888-2431

Molly Szerlip https://orcid.org/0000-0002-4907-1825

Steven J. Yakubov https://orcid.org/0000-0002-0952-7509

Cindy L. Grines https://orcid.org/0000-0003-1653-6443

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