Lead Extraction Should be Performed by EP with CT Surgical

Back-up

Jonathan P. Piccini, MD, MHS, FHRS

Associate Professor of Medicine

Duke University Medical Center

Disclosures

Grants for Clinical Research

• ARCA biopharma

• AHRQ

• Boston Scientific

• Gilead

• Johnson & Johnson

• ResMed

• St Jude Medical

Consulting/Honoraria

• Laguna Pharmaceuticals

• Glaxo Smith Kline

• Janssen Pharmaceuticals

• Medtronic

• Spectranetics

My Colleague and OpponentI will eat you

for lunch.

Why extract?

ICD and CRT-D Implantation Rates

Camm J. Europace 2011;13:448-448

Marked increase in cardiac device infections

Greenspon AJ. J Am Coll Cardiol. 2011;58:1011-6.

One-year survival device removal vs no removal during index hospitalization

Athan E. JAMA. 2012;307:1727-1735.

Δ 18.2%

Early and complete device removal is associated with improved survival

HR 30-day

mortality

HR 1-year

mortality

Antibiotics Only vs.

Complete Removal

6.97 (1.36–35.6) 1.61 (0.37–6.86)

Immediate Device Removal

vs Delayed Removal

0.76 (0.16–3.60) 0.35 (0.16–0.75)

Le KY. Heart Rhythm. 2011;8:1678-85

Why should EP physicians be the primary operator?

The Robert Fulghum Principle

CT surgeon2%

EP98%

Sohal et al. Europace 2013;15:865-870

Who is doing lead extraction?

CT surgeon

12%

EP88%

Bongiorni, MG. Europace. 2012;14:783-6.

Who is doing lead extraction?

Who is providing guidance?

Cardiothoracic Surgery Guidelines on Lead Management/Extraction

Professional Society Engagement?

2

2Message

from the

President

The Society of Thoracic Surgeons

STSNEWS

volu

me n

o. 15

issue 1 •

Win

ter 2

010

OUR MI SSI ON I S TO ENHANCE THE ABI LI TY OF CARDI OTHORACI C SURGEONS TO PROVI DE

THE HI GHEST QUALI TY PATI ENT CARE THROUGH EDUCATI ON, RESEARCH, AND ADVOCACY

(continued on page 3)

Plan to Attend STS 46th AnnualMeeting in Fort LauderdaleGreater Fort Lauderdale/Broward County Convention Center: Jan. 25-27, 2010

Tech-Con: Jan. 23-24, 2010 | STS University: Jan. 27, 2010

Astellar educational event awaits attendees of the upcoming STS 46th Annual

Meeting in Fort Lauderdale, Fla. With a wide range of educational formats presenting

the latest and the best information on new technologies and techniques in cardiotho-

racic surgery, the Annual Meeting will be the pre-eminent educational event for 2010. Noted

here are some associated highlights that shouldn’t be missed.

For those looking to remain on the cutting edge of cardiothoracic surgery, participation begins

with STS/AATS Tech-Con 2010. During this two-day program, Jan. 23-24, sessions will

explore the latest developments in valvular heart disease, aortic therapies, and heart failure. In

addition, there will be in-depth discussion of upcoming technology trends and a host of “How

I Do It” courses, all offering new insights into general thoracic surgery.

STS NationalDatabase PartnersWith ConsumerReports for DataDistributionAs the demand for transparency has con-

tinued to grow, STS leaders have articulat-

ed a belief that public reporting of out-

comes is in the best interests of patients

and the profession -- that the public has a

right to know and understand performance

at the hospital and group levels.

With that in mind, STS has been working

to develop a fair and meaningful report

structure – one that is based on audited

clinical data, not administrative claims data

which could be flawed and misleading.

The result is a viable reporting mechanism

that will allow STS Adult Cardiac Surgery

Database participants to voluntarily post

their CABG overall composite star ratings

and their component domains on a Web

site available to the public.

After more than a year of negotiations,

STS has finalized an agreement with one

of the most widely recognized and credible

organizations in the consumer rating

industry, Consumers Union (CU),

publisher of Consumer Reports. CU,

a strong advocate of the STS quality

(continued on page 3)

14The

Annals

6STS

University

Courses

12Washington

Scene

15Stop

Smoking

Brochures

STS/AATS TECH-CON 2014

50th Annual Meeting Abstract Book 39

3:10 PM

IntroductionJames R. Edgerton, Dallas, TXCOMMERCIAL RELATIONSHIPS J. R. Edgerton: Speakers Bureau/Honoraria, AtriCure, Inc, Medtronic, Inc, St Jude Medical, Inc

3:12 PM

Surgeons and Lead Extraction: Collaboration and Maintaining SafetyRoger G. Carrillo, Miami, FLCOMMERCIAL RELATIONSHIPS R. G. Carrillo: Consultant/Advisory Board, BIOTRONIK SE & Co KG, Boston

Scienti c, M edtronic, Inc, Spectranetics, Tyco; Research Grant, SORIN GROUP, St Jude M edical, Inc

3:20 PM

Role of Left Atrial Appendage Closure in Preventing Stroke and the Emerging Service Line of LAA ClosureJames L. Cox, Denver, COCOMMERCIAL RELATIONSHIPS J. L. Cox: Consultant/Advisory Board, CoreMatrix Cardiovascular, Inc, SentreHEART,

Inc; Ownership Interest, CoreM atrix Cardiovascular, Inc, SentreHEART, Inc

REGULATORY DISCLOSURE is presentation will address the o -label use of a radiofrequency ablation device approved

for the treatment of persistent and long-standing persistent atrial brillation, but not for paroxysmal atrial brillation.

3:28 PM

Percutaneous Endoprosthesis Occlusive Devices (Watchman and Amplatzer)

3:36 PM

Percutaneous Endovascular and Epicardial Access Devices: Lariat SystemMiguel Valderrabano, Houston, TXCOMMERCIAL RELATIONSHIPS M. Valderrabano: Consultant/Advisory Board, Boston Scienti c, SentreH EART, Inc;

Research Grant, Medtronic, Inc, St Jude Medical, Inc

REGULATORY DISCLOSURE is presentation will address the Sentreheart Lariat device, which has an FDA status of

investigational.

3:44 PM

Thoracoscopic Clip Occlusive DevicesBasel Ramlawi, Houston, TXCOMMERCIAL RELATIONSHIPS B. Ramlawi: Consultant/Advisory Board, AtriCure Inc; Research Grant, Baxter; Other

Research Support, M edtronic, Inc; Ownership Interest, REPLICor Inc

REGULATORY DISCLOSURE is presentation will address the o -label use of AtriCure’s AtriClip.

3:52 PM

Economic Realities: The Dramatic Cost Di erences Between DevicesJack C. J. Sun, Seattle, WA

4:00 PM

Cross rePanelists

4:15 PM

Discussion

3:10 PM – 4:30 PM Crystal Ballroom H-Q

Adult Cardiac Track V: Emerging Service Lines—Left Atrial Appendage Closure, Lead Extraction, and the Role of the Cardiac Surgeon

Moderators: James R. Edgerton, Dallas, TX, and Mark La Meir, Maastricht, NetherlandsCOMMERCIAL RELATIONSHIPS J. R. Edgerton: Speakers Bureau/Honoraria, AtriCure, Inc, Medtronic, Inc, St Jude Medical,

Inc; M . La Meir: Consultant/Advisory Board, AtriCure, Inc

Audience Poll Ticketed Event

2:45 PM – 3:10 PM Crystal Ballroom Foyer

BREAK—Visit STS/AATS Tech-Con 2014 Exhibits

2010 2014

Who is leading research in lead management/extraction?

79

11 82

0

10

20

30

40

50

60

70

80

90

EP Surgery EP/Surgery Anesthesia

100 most recent publications on lead extraction. As per pubmed.gov on August 27

Publication Count

CT Surgeons Are Busy

Indications for Lead Extraction

9

HRS indications for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes. See HRS consensus document Class III indications for when lead removal is not recommended.

Expanded Indications from 14 to 3016

CATEGORY INDICATION CLASS

Infection Pocket infection I Occult gram-positive bacteremia I Occult gram-negative bacteremia IIa

Chronic Pain Severe chronic pain IIa

Occlusion Ipsilateral occlusion w/o contralateral contraindication IIa

Functional Lead

Due to design or failure, may pose immediate threat I Risk of interference with device operation IIb Due to design or failure poses potential future threat IIb Functional leads not being used (ICD upgrade) IIb To permit the implantation of an MRI conditional CIED system IIb Need MRI with no other imaging options for diagnosis IIb

Non Functional Lead

Implant would require > 4 leads on one side or >5 leads through SVC IIa Need MRI with no other imaging options for diagnosis IIa To permit the implantation of an MRI conditional CIED system IIb Non functional lead at device/lead procedure IIb

Growing Need for Lead Management

© 2015 The Spectranetics Corporation. All Rights Reserved. Approved for External Distribution D014953-06 032015

Wilkoff BL, et al. HeartRhythm. 2009;6:1085-1104.

What about outcomes?

Incidence of Surgical Intervention in Lead Extraction

n=37 out of 2999 cases

1.2%

Data from 2-High Volume Centers

Sprint Fidelis (n = 360)

Riata/Riata ST (n = 102)

P value

Powered sheath use 237 (79.8) 75 (82.4) .847

Laser 170 (57.2) 64 (70.3) .028

Mechanical 68 (22.9) 11 (12.1) .036

Femoral approach 9 (3.0) 2 (2.2) 1.000

Clinical success 357 (99.4) 99 (97.1) .075

Procedural success 357 (99.4) 98 (96.1) .024

Major complications 4 (1.1) 2 (2.0) .618

Death 3 (0.8) 0 1.000

El-Chami MF. HeartRhythm. 2015;12:1216-20

Innominate/SVC tear

Pneumothorax

SVC/RA junction tear

SVC/RA junction

Unexplained PEA

______________________

1.1% with surgical intervention

Curtis J. JAMA. 2009;301:1661-1670.

111,293 ICD Implant Procedures:Physician Specialty & Outcomes

56 F with NICM, LVEF 20%, RV paced 79%, and worsening HF with dual chamber ICD

73 F with chronic AF & bradycardia

• RV lead associated severe TR

• RV distress

Cohen M, et al. Circulation. 2001;103:2585-2590

Epicardial leads have limitations

59 year old female with elevated shock impedance

• Nonischemic cardiomyopathy & LBBB

• BiV-ICD with 0185 RV implanted 8 yrs ago

• DFT with frequent drop out despite 0.2 mV

sensitivity

• Referred for lead extraction

Caveat emptor

• Lead extraction is not a one-man band*

• It is a collaborative, multispecialty procedure

• Participation & close collaboration between surgery and EP is mandatory for best practice and best outcomes

*Roger Carillo (next speaker) and others are exceptions.

Sohal M, et al. Europace 2013;15:865-870

Surgical Coverage & Location of Extraction Procedures

Don’t extract in the EP lab

Brunner MP. HeartRhythm. 2014;11:419–425.

“Of the 16 patients with SVC injury, 6 were too unstable to be

transferred from the EP lab to the OR.”

Duke Extraction Protocol

• Double consultation

– EP outpatient consultation

– CT surgery outpatient consultation

• Preprocedure CT

• Intraoperative TEE (CT anesthesia present)

• Operative plan briefing reviewed in room by the whole team

• Surgeon scrubbed /participates

Why EP should be the primary operator.

1. The person who put in the device should be able to fix it.2. EPs do the majority of lead extractions. 3. EP has professional society engagement.4. EP does the vast majority of research and innovation.5. Sometimes you don’t need to extract.6. Complications requiring surgical intervention are rare (<1.5%)7. Epicardial leads are limited8. Surgeons are too busy 9. The reimplanting physician often has the largest stake in the

game.10. The physicians following the patient, device, and leads are often in

the best position to help patients make decisions.

Summary

• The need for lead extraction is increasing substantially

• The primary operator should be a physician trained and dedicated to heart rhythm and device management

• In the vast majority of cases this should be and will be an EP

The Ultimate Back-Up

Jacob Schroder Jack Haney Mani Daneshmand Jeff Gaca

Don Glower Andy Lodge Carmelo Milano

Thank You

Duke Lead Management Program

Supplemental Slides

• VT with ICD placement through Glenn.

• 6949 Sprint Fidelis fracture– VF detected

– short VV intervals

– Pacing impedance > 3000 ohms.

• Lead adherence to Glenn but shunt patent

20 M with Epstein’s anomaly s/p RA reduction, TVR, bidirectional Glenn, RA maze

RV

RA

IVC

MPA

RPA LPA

SVC

RV

RA

IVC

MPA

RPA LPA

SVC