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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.
郭航远
绍兴市人民医院
1
2
Cleland JG, et al. N Engl J Med. 2005;352:1539-1549.
Cleland JG, et al. Eur Heart J. 2006;27:1928-1932.
3
Bristow MR, et al. J Card Fail. 2000;6:276-285.
Abraham WT, et al. N Engl J Med. 2002;346:1845-1853.
5 Young JB, et al. JAMA. 2003;289:2685-2694.
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1
CRT Is Highly Beneficial1-8
CRT is an effective treatment for heart failure patients with:
• systolic dysfunction
• ventricular electrical conduction delays
Mortality
HF or CV
Hospitalizations
Cardiac Function/
Structure
QoL 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
NA = Not powered, not collected, or not blinded for specific end point.
1
2
3
4
Cleland J, et al. N Engl J Med. 2005;352:1539-1549.
Cleland J, et al. Eur Heart J. 2006;27:1928-1932.
Bristow M, et al. J Card Fail. 2000;6:276-285.
Abraham W, et al. N Engl J Med. 2002;346:1845-1853.
* Post-hoc analysis.
5
Young J, et al. JAMA. 2003;289:2685-2694.
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.
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2
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
* 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"
1
2
Tracy CM, et al. Circulation. 2012;126:1784-1800.
Tang AS, et al. N Engl J Med. 2010;363:2385-2395.
3
Linde C, et al. J Am Coll Cardiol. 2008;52:1834-1843.
Epstein AE, et al. Circulation. 2008;117:e350-e408.
5 Fonarow GC, et al. Circ Heart Fail. 2008;1:98-106.
4
3
Current Challenges with CRT
Unpredictable CRT
Implant Times
CRT Challenges
Suboptimal CRT Response
4
Clinical & Economic Need:
CRT Implants Are Complex and
Time-Consuming
Initial CRT Device Implants (N=870)1
1
PPDA Q3FY12/Q4FY12/Q1FY13/Q2FY13 - (Waves 1-4): Economic Considerations for CRT Implants
5
Clinical & Economic Need:
Placing the LV Lead Is Time-Consuming
1
2
PPDA Q4FY12/Q1FY13 - (Waves 2 and 3): Economic Considerations for CRT Implants.
Bax JJ, et al. J Am Coll Cardiol. 2005;46:2168-2182.
6
Current Challenges with CRT
Unpredictable CRT
Implant Times
CRT Challenges
Suboptimal CRT Response
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Up to 1/3 of Patients Do Not
Experience the Full Benefits of CRT
100%
90%
% Improved
Clinical Composite Score
80%
70%
60%
67%
67%
69%
67%
58%
50%
52%
40%
30%
20%
10%
0%
MIRACLE1
MIRACLE
ICD2
MIRACLE II
ICD3
1
4
2
5
Abraham WT, et al. N Engl J Med. 2002;346:1845-1853.
Young JB, et al. JAMA. 2003;289:2685-2694.
3 Abraham WT, et al. Circulation 2004;110:2864-2868.
InSync III
Marquis4™*
PROSPECT 5
FREEDOM6
* AV optimized only
Chung ES, et al. Circulation. 2008;117:2608-2616.
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
Potential Reasons for Suboptimal CRT Response
Percentage of Nonresponder Patients
with These Findings
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Suboptimal
AV Timing
Arrhythmia
Anemia
Suboptimal
LV Lead
Position
< 90%
Suboptimal Persistent
Underlying
Biventricular
Medical
Mechanical
Narrow
Pacing
Therapy Dyssynchrony
QRS
Compliance Primary RV
Issues
Dysfunction
Mullens W, et al. JACC. 2009;53:765-773.
Achieving maximum CRT response requires a multi-disciplinary approach
1 Mullens
W, et al. J Am Coll Cardiol. 2009;53:765-773.
9
Economic Impact
Lab Capacity
Length of Stay1
Unpredictable
CRT
Implant Times
Staff Overtime
CRT Challenges
Suboptimal CRT
Response
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).
Supply Usage
HF Hospital
Admissions1
10
Real-Time Navigation for CRT Implants
The CardioGuide™ Implant System Provides a Solution
The 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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CardioGuide 3D System:
Optimize LV Lead Implant
Shoot 2+
venograms
Trace veins of interest
on both venograms
Obtain 3D model
automatically
 Understand and Examine Vein Anatomy
13
CardioGuide 3D System:
Optimize LV Lead Implant
Select preferred target site and choose LV lead
Navigate real-time in fluoro
 Obtain anatomical information about target & match best lead
 Detect where lead is & how far from target
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CardioGuide M-Map System:
Drive for Full Benefit of CRT
Obtain contraction timing
maps along veins
Select most appropriate delayed site
and choose LV lead
 Identify latest site(s) of mechanical activation
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Drive for Full Benefit of CRT
•
1
2
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
Giannola G, et al. Europace. 2011;13:244-250.
Khan FZ, et al. Europace. 2011;13:845-852.
3
4
Khan FZ, et al. J Am Coll Cardiol. 2012;59:1509-1518.
Prinzen FW, et al. J Cardiovasc Transl Res. 2012;5:188-195.
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Thank You
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