James H. Baker II, MD St. Thomas Heart Nashville, TN

Transcription

1 James H. Baker II, MD St. Thomas Heart Nashville, TN

2 Overview Non-responder rate with CRT remains 30-35% despite mature technology MIRACLE study (ACC 2001): 67% improved HF CCS

3 Overview Non-responder rate with CRT remains 30-35% despite mature technology MIRACLE study (ACC 2001): 67% improved HF CCS FREEDOM study (HRS 2010): 67.5%

4 Overview Non-responder rate with CRT remains 30-35% despite mature technology MIRACLE study (ACC 2001): 67% improved HF CCS FREEDOM study (HRS 2010): 67.5% Primary options for improving response rate include better patient selection, improved LV lead positioning, and optimization of timing intervals

5 Optimization of CRT Programming Timing interval optimization part of most multicenter CRT trials, although techniques used were varied Echocardiographic method Supported by American Society of Echocardiography

6 Optimization of CRT Programming Timing interval optimization part of most multicenter CRT trials, although techniques used were varied Echocardiographic method Supported by American Society of Echocardiography Acute hemodynamic and short-term clinical improvement documented in numerous small studies

7 Optimization of CRT Programming Timing interval optimization part of most multicenter CRT trials, although techniques used were varied Echocardiographic method Supported by American Society of Echocardiography Acute hemodynamic and short-term clinical improvement documented in numerous small studies Limited by cost, complexity, time demands

8 Optimization of CRT Programming Timing interval optimization part of most multicenter CRT trials, although techniques used were varied Echocardiographic method Supported by American Society of Echocardiography Acute hemodynamic and short-term clinical improvement documented in numerous small studies Limited by cost, complexity, time demands Nominal settings standard of care ACT Registry of >1000 CRT-D patients found < 10% received optimization of timing intervals (2006)

9 Intracardiac Electrogram (IEGM) Methods for CRT Optimization Review available techniques AV optimization VV optimization Discuss clinical studies Future applications

10 AV Optimization Goal maximize LV preload by allowing for the completion of the atrial contribution to diastolic filling before mitral valve closure Barold S S et al. Europace 2008;10:iii88-iii95

11 QuickOpt TM Method of AV Optimization Empirical method based on clinical observations and validated by echocardiographic studies Algorithm makes optimized AV delay calculations based on the duration of the intrinsic atrial IEGM Aims to ensure that ventricular pacing occurs after atrial depolarization and mechanical contraction are complete

12 AV Optimization - QuickOpt TM Offset factor: 30 ms if AV > ms if AV < 100

13 AV Optimization - SmartDelay TM Developed through intraoperative measurements and validated with invasively measured LV dp/dt Uses intrinsic AV intervals and the duration of native VV conduction time to calculate the optimal delay Adjusted for LV lead location Separate calculations for sensed and paced AV delays Truncates the AV delay to between 50 ms and 70% of the intrinsic AV interval

14 Optimal Balance of Intrinsic and Paced Wavefronts Better with more prolonged QRS interval

15 VV Optimization - QuickOpt TM Aims to ensure the paced LV and RV conduction wave fronts meet in the septum and coordinate LV and RV contraction to maximize resynchronization Measures both sensed and paced conduction delays between the LV and RV leads to calculate the optimal VV interval Correlates well with aortic VTI and 3D echo techniques

16 Long-term Clinical Studies of IEGM-Based Optimization FREEDOM study - investigated effect of frequent optimization of AV and VV intervals using QuickOpt on outcome of CRT in comparison to usual care SMART-AV trial compared the results of CRT using 3 different techniques for programming AV delays: fixed delay of 120 ms, echo-optimized delay and AV delay optimized with SmartDelay Adaptive CRT study Medtronic, results pending

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20 SMART-AV Trial Compared the effects of 3 techniques for AV delay programming for CRT Baseline Evaluation To document inclusion / exclusion criteria and establish baseline heart status* Randomization (1:1:1 SmartDelay: Echo: Fixed) 1 14 days post implant AV Delay Optimized Quarterly Using SmartDelay AV Delay Optimized Using Echo (Iterative Method) AV Delay Fixed at 120ms with 0 Offset Clinic Follow-up Visits 3 month and 6 months post implant

21 SMART-AV Results 6 month data* The change in LVESV for the SmartDelay arm was no different than echodetermined AV delay or fixed delay of 120 mg Ellenbogen et al Circulation 2010; 122:

22 SMART-AV Results 6 month data* The change in LVESV for the SmartDelay arm was no different than echodetermined AV delay or fixed delay of 120 mg The routine use of AV optimization techniques assessed in this trial is not warranted Ellenbogen et al Circulation 2010; 122:

23 Future of EGM-Based Algorithms Potential role in non-responders RESPONSE-HF trial (HRS 2010) Non-responders after 3 months of simultaneous VV pacing randomized to sequential vs. simultaneous pacing (primarily using QuickOpt) Higher percentage converted to responders with VV optimization: 76.9% vs. 48.4%

24 Future of EGM-Based Algorithms Potential role in non-responders RESPONSE-HF trial (HRS 2010) Non-responders after 3 months of simultaneous VV pacing randomized to sequential vs. simultaneous pacing (primarily using QuickOpt) Higher percentage converted to responders with VV optimization: 76.9% vs. 48.4% SMART-AV substudy QLV Subset of CRT patients may benefit from SmartDelay

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27 LVESV Response: SmartDelay vs. Fixed Multivariate Logistic Regression Results The LVESV response rate for SD vs. fixed increased as QLV prolonged. In the highest quartile of QLV, SD had a greater than 6 fold increase in odds ratio for a LVESV response vs. fixed. Gold MR et al. HRS 2012 Adjusted for baseline EF, LVESV, Etiology of HF, LBBB, Gender, NYHA, QRS and age