cardiac resynchronization therapy (crt) is an effective treatment for heart failure and indications...
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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
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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
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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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