Cardiac Resynchronization Therapy (CRT) Is an Effective Treatment for Heart Failure and Indications Are Expanding

Multiple trials have shown the clinical value of CRT: decreased mortality, improved quality of life, and reduced hospitalizations.1-5

Today, more patients than ever are available to receive a CRT device and benefit from this therapy.

1 Cleland JG, et al. N Engl J Med. 2005;352:1539-1549. 2 Cleland JG, et al. Eur Heart J. 2006;27:1928-1932.

3 Bristow MR, et al. J Card Fail. 2000;6:276-285.4 Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 5 Young JB, et al. JAMA. 2003;289:2685-2694. 1

郭航远绍兴市人民医院

MortalityHF or CV

HospitalizationsCardiac Function/

StructureQoL or NYHA

CARE-HF1,2 + + + NA

COMPANION3 + + NA NA

MIRACLE4 NA NA + +

MIRACLE ICD5 NA NA NA +

REVERSE6 NA +* + =

RAFT7 + + NA NA

MADIT CRT8 +* + +* NA

CRT Is Highly Beneficial1-8

CRT is an effective treatment for heart failure patients with:

• systolic dysfunction • ventricular electrical conduction delays

1 Cleland J, et al. N Engl J Med. 2005;352:1539-1549.2 Cleland J, et al. Eur Heart J. 2006;27:1928-1932.3 Bristow M, et al. J Card Fail. 2000;6:276-285.4 Abraham W, et al. N Engl J Med. 2002;346:1845-1853.

5 Young J, et al. JAMA. 2003;289:2685-2694.6 Linde C, et al. JACC. 2008;52:1834-1843. 7 Tang A, et al. N Engl J Med. 2010;363:2385-2395. 8 Moss A, et al. N Engl J Med. 2009;361:1329-1338.

NA = Not powered, not collected, or not blinded for specific end point. * Post-hoc analysis.

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Number of Patients Receiving CRT May Increase in Coming Years Due to:• Expansion of indications for CRT-D devices to NYHA Class II1-3*

• Under-penetration of current NYHA Class III/IV indications4,5

1 Tracy CM, et al. Circulation. 2012;126:1784-1800.2 Tang AS, et al. N Engl J Med. 2010;363:2385-2395.

* Indications for CRT-D devices include "Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II"

3 Linde C, et al. J Am Coll Cardiol. 2008;52:1834-1843.4 Epstein AE, et al. Circulation. 2008;117:e350-e408.5 Fonarow GC, et al. Circ Heart Fail. 2008;1:98-106. 3

Current Challenges with CRT

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Unpredictable CRTImplant Times

Unpredictable CRTImplant Times

CRT ChallengesCRT Challenges

Suboptimal CRT ResponseSuboptimal CRT Response

Clinical & Economic Need:CRT Implants Are Complex and Time-Consuming

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Initial CRT Device Implants (N=870)1

1 PPDA Q3FY12/Q4FY12/Q1FY13/Q2FY13 - (Waves 1-4): Economic Considerations for CRT Implants

Clinical & Economic Need:Placing the LV Lead Is Time-Consuming

1 PPDA Q4FY12/Q1FY13 - (Waves 2 and 3): Economic Considerations for CRT Implants.2 Bax JJ, et al. J Am Coll Cardiol. 2005;46:2168-2182. 6

Current Challenges with CRT

7

Unpredictable CRTImplant Times

Unpredictable CRTImplant Times

CRT ChallengesCRT Challenges

Suboptimal CRT ResponseSuboptimal CRT Response

Up to 1/3 of Patients Do Not Experience the Full Benefits of CRT

* AV optimized only

67%

58%

67%

MIRACLE1 MIRACLE MIRACLE II InSync III PROSPECT5 FREEDOM6

ICD2 ICD3 Marquis4™*

100%

67% 69%

52%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

% Im

pro

ved

Clin

ical

Co

mp

osi

te S

core

1 Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 2 Young JB, et al. JAMA. 2003;289:2685-2694.3 Abraham WT, et al. Circulation 2004;110:2864-2868.

4 Chung ES, et al. Circulation. 2008;117:2608-2616.5 van Gelder BM, et al. J Cardiovasc Electrophysiol. 2008;19:939-944.6 Abraham WT, et al. Late-Breaking Clinical Trials, HRS 2010. Denver, Colorado. 8

There Are Many Drivers for CRT Non-Response1

Achieving maximum CRT response requires a multi-disciplinary approach

Potential Reasons for Suboptimal CRT Response

Per

cent

age

of N

onre

spon

der

Pat

ient

s w

ith T

hese

Fin

ding

s

Mullens W, et al. JACC. 2009;53:765-773.

SuboptimalAV Timing

Arrhythmia Anemia SuboptimalLV LeadPosition

< 90%Biventricular

Pacing

SuboptimalMedicalTherapy

PersistentMechanical

Dyssynchrony

UnderlyingNarrowQRS

ComplianceIssues

Primary RVDysfunction

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

1 Mullens W, et al. J Am Coll Cardiol. 2009;53:765-773. 9

Economic Impact

1 Cost information from 2010 Premier hospital database analyzing 108,982 Inpatient Heart Failure Admissions (Abstract Submission to ISPOR and AHA QCOE, to be presented in July 2013).

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Unpredictable CRT

Implant Times

Unpredictable CRT

Implant Times

CRT ChallengesCRT Challenges

Suboptimal CRT Response

Suboptimal CRT Response

Real-Time Navigation for CRT Implants

The CardioGuide™ Implant System Provides a SolutionThe CardioGuide Implant System – the first real-time navigation system for CRT implants – uses computer technologies to guide implanters in optimal LV lead placement.

The system generates 3D images of coronary vessels to help clinicians:

• Find appropriate LV lead locations

• Identify proper lead delivery tools

• Confirm final lead position

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12

12

Obtain 3D model automatically

Shoot 2+ venograms

Trace veins of interest on both venograms

Understand and Examine Vein Anatomy

CardioGuide 3D System: Optimize LV Lead Implant

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Navigate real-time in fluoroSelect preferred target site and choose LV lead

Obtain anatomical information about target & match best lead Detect where lead is & how far from target

CardioGuide 3D System: Optimize LV Lead Implant

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CardioGuide M-Map System: Drive for Full Benefit of CRT

Identify latest site(s) of mechanical activation

Obtain contraction timing maps along veins

Select most appropriate delayed site and choose LV lead

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Drive for Full Benefit of CRT

• Helping clinicians choose the proper lead location and providing confirmation of final lead position may impact CRT procedure efficiency and the economic welfare of the hospital.1-4

1 Giannola G, et al. Europace. 2011;13:244-250.2 Khan FZ, et al. Europace. 2011;13:845-852.

3 Khan FZ, et al. J Am Coll Cardiol. 2012;59:1509-1518.4 Prinzen FW, et al. J Cardiovasc Transl Res. 2012;5:188-195. 16

Thank You

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