14ο Βορειοελλαδικό Καρδιολογικό Συνέδριο ΚΕΒΕ Βηματοδότηση: Νεότερες εξελίξεις Προοπτικές

Transcription

1 14ο Βορειοελλαδικό Καρδιολογικό Συνέδριο ΚΕΒΕ Βηματοδότηση: Νεότερες εξελίξεις Προοπτικές Α.Γ. Κατσίβας Συντονιστής Διευθυντής, Α Καρδιολογική Κλινική, ΓΝΑ «Κοργιαλένειο-Μπενάκειο Ε.Ε.Σ»

2 BRADY - ARRHYTHMIA

3 A history of pacing innovation First External Pacemaker Pediatric Asynchronous Pulse Generator Rate response Radically smaller size 1 st Micro- Full automaticity processor-based, Mode switching 1 st MRI- Conditional Transcatheter Pacing System First Implantable Pacemaker Chardack - Greatbatch Dual chamber rate response Rate response via activity Full & minute ventilation automaticity nd MRI- Conditional

4 The Need for MRI MRI is unmatched and irreplaceable for diagnosis of cancer and neurological disorders. For investigation of the brain and spinal cord, there is simply no suitable alternative in most cases. Torsten Sommer, MD, PhD Professor of Radiology Chief, Cardiovascular Imaging, University of Bonn CT CT MRI MRI

5 MRI technology evolution Non MRI Exclusion zones Full body scan

6 ESC EHRA Guidelines on scanning device patients

7 ESC EHRA Guidelines on scanning device patients

8 complications associated with traditional technology Pocket Related Complications! Infection! Hematoma! Erosion Lead Related Complications! Fractures! Insulation Breaches! Venous thrombosis and obstruction! Tricuspid regurgitation 8

9 Pacemaker complications

10 patient experience with current technology scar bump visible or physical reminder invasive procedure post-implant activity restrictions 10

11 Miniaturized Leadless Pacemaker

12 History of Leadless Pacing: Miniature Pacemaker Tested in 1991 a: Guiding catheter b: Pusher catheter c: Miniature pacemaker d: Steering arm

13 No scar, no bump, no wire. 13

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15 Publications to date 15

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19 HEART FAILURE

20 CRT Is Highly Beneficial 1-8 CRT is an effective treatment for heart failure patients with: systolic dysfunction ventricular electrical conduction delays Mortality HF or CV Hospitalisations Cardiac Function/ Structure QoL or NYHA CARE-HF 1, NA COMPANION NA NA MIRACLE 4 NA NA + + MIRACLE ICD 5 NA NA NA + REVERSE 6 NA +* + = RAFT NA NA MADIT CRT 8 +* + +* NA NA = Not powered, not collected, or not blinded for specific end point. * Post-hoc analysis. 1 Cleland J, et al. N Engl J Med. 2005;352: Cleland J, et al. Eur Heart J. 2006;27: Bristow M, et al. J Card Fail. 2000;6: Abraham W, et al. N Engl J Med. 2002;346: Young J, et al. JAMA. 2003;289: Linde C, et al. JACC. 2008;52: Tang A, et al. N Engl J Med. 2010;363: Moss A, et al. N Engl J Med. 2009;361:

21 Up to 1/3 of Patients Do Not Experience the Full Benefits of CRT 100% 90% 80% % Improved Clinical Composite Score 70% 60% 50% 40% 30% 67% 52% 58% 67% 69% 67% 20% 10% 0% MIRACLE 1 MIRACLE MIRACLE II InSync III PROSPECT 5 FREEDOM 6 ICD 2 ICD 3 Marquis 4 * 1 Abraham WT, et al. N Engl J Med. 2002;346: Abraham WT, et al. Heart Rhythm. 2005;2:S65. 2 Young JB, et al. JAMA. 2003;289: Chung ES, et al. Circulation. 2008;117: Abraham WT, et al. Circulation. 2004;110: van Gelder BM, et al. J Cardiovasc Electrophysiol. 2008;19:

22 There are Many Drivers for CRT Non-Response 50% Potential Reasons for Suboptimal CRT Response 1 45% Percentage of Nonresponder Patients with These Findings 40% 35% 30% 25% 20% 15% 10% 5% 0% Suboptimal AV Timing Arrhythmia Anemia Suboptimal LV Lead Position < 90% Biventricular Pacing Suboptimal Medical Therapy Persistent Mechanical Dyssynchrony Underlying Narrow QRS Compliance Issues Primary RV Dysfunction Achieving maximum CRT response requires a multi-disciplinary approach. 1 Mullens W, et al. JACC. 2009;53:

23 SmartDelay (EEHF+)! Programmer-initiated sequence to suggest AV delays based on: Measured As-Vs timing, measured Ap-Vs timing Measured or manually entered LV>RV timing! In office test takes up to 2,5 minutes

24 SMART-AV SmartDelay determined AV Optimization: A Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (SMART-AV)! Three-arm study, comparing SmartDelay every three months to empiric 120ms delay to iterative echo optimization! No difference in primary endpoint (LVESV change at 6 months)

25 QuickOpt! Programmer-initiated sequence to provide a suggested VV interval, SAV and PAV based on measured values! In office test takes 90 seconds

26 FREEDOM Trial: Study Procedures and Follow- Up Enrollment (n=1647) 2 weeks post CRT-D implant 1:1 Randomization stratified by cardiomyopathy classification Treatment Group QuickOpt Control Group Standard of care AV/PV Optimization VV Optimization Empiric programming or One-time non-iegm optimization within first 4 weeks Follow-up (3,6, 9, 12 months) QuickOpt optimization Follow-up (3, 6, 9, 12 months)

27 FREEDOM Results

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29 Adaptive CRT

30 What Is Adaptive LV Pacing?! The timing of the LV pace is automatically adjusted based on the atrial to intrinsic QRS interval measurement (AV interval)! The LV pace will occur at about 70% of the intrinsic AV interval, but at least 40 ms prior to the intrinsic QRS! Intrinsic RV contraction completes biventricular activation

31 What Is Adaptive BiV Pacing?! The AV delays are updated every minute based on AV interval and P- wave width measurements! The AV delay is adjusted to pace about 30 ms after the end of the P- wave but at least 50 ms before the onset of the intrinsic QRS! The ventricular pacing configuration (RV->LV or LV->RV) and V-V pace delay are updated every minute based on AV interval and QRS width measurements

32 Adaptive CRT Trial 1 In the Adaptive CRT Trial there was a 44% reduction in RV pacing. 1 1 Martin, D.O., et. al. Heart Rhythm (2012), doi: /j.hrthm

33 AdaptivCRT Response Analysis 1 12% Absolute Higher Response Rate was Achieved with AdaptivCRT Compared to Historical CRT Trials. OBJECTIVE: Compare AdaptivCRT response rates to Historical trials 15% 52% 67% 69% OVER 1,300 CRT-D PATIENTS STUDIED: AdaptivCRT Cohort; n = 318 patients Historical Cohort; n = 1,003 patients COMPARISON METHOD: Propensity Score allows comparison with historically matched patients Compensates for differences in baseline patient characteristics across trials RESULTS: A 12% Higher Response Rate was achieved with AdaptivCRT Compared to Historical CRT Trials. % Response Improved as compared to Historical trials 11% 8% 4% 12% Note: Differences between the clinical composite scores of the Historical and AdaptivCRT cohorts were averaged across the subgroups. 0% [95% CI: 2.7% to 19.2%] 1 Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm compared with echo guided AV optimization: a propensity score analysis of multi-center trials. Presentation at European Society of Cardiology Congress August 2012.

34 AdaptivCRT Reduced AF Risk by 46% As compared to patients receiving echo optimized CRT % Patients with 48 Hours of AT/ AF 50% 0% p = 0.03 HR = 0.54 ( ) Months Since Randomization Echo acrt Number remaining % 8.8% Martin D, Lemke B, Aonuma K, et al. Clinical Outcomes with Adaptive Cardiac Resynchronization Therapy: Long-term Outcomes of the Adaptive CRT Trial. HFSA Late Breakers. September 23,

35 There are Many Drivers for CRT Non-Response 50% Potential Reasons for Suboptimal CRT Response 1 45% Percentage of Nonresponder Patients with These Findings 40% 35% 30% 25% 20% 15% 10% 5% 0% Suboptimal AV Timing Arrhythmia Anemia Suboptimal LV Lead Position < 90% Biventricular Pacing Suboptimal Medical Therapy Persistent Mechanical Dyssynchrony Underlying Narrow QRS Compliance Issues Primary RV Dysfunction Achieving maximum CRT response requires a multi-disciplinary approach. 1 Mullens W, et al. JACC. 2009;53:

36 Quadripolar LV leads

37 Compromise due to Phrenic Nerve Stimulation 1,2 1. Kirubakaran S, Rinaldi CA. Europace. 2012;14: Parahuleva MS, et al. Clin Med Insights Cardiol. 2011;5:45-47.

38 Automaticity Another useful feature is automatic measurement of thresholds to guide programming to reduce battery consumption. Quadripolar CRT-D systems are currently able to automatically perform thresholds from a variety of configurations and to indicate their impact on device longevity (taking into account the impedance measurements)

39 Automated Vector Optimisation Johnson B, et al, Accuracy of an Automated Pacing Capture Thresholds Algorithm for Quadripolar Left Ventricular Leads. HRS 2014, Poster presentation, PO04-185

40 Multi lead pacing

41 Multiple pacing vectors

42 Concept of Multipoint Pacing: Early Experimental Evidence Muscle bundle with horizontal fiber orientation 1 single point pacing nonuniform conduction, slow activation, delay of ± 15 ms between 1-4 uniform conduction, faster activation, virtually no delay between simultaneous multipoint pacing Spach MS, et al. Circ Res. 1982;50:

43 Multipoint pacing! Another alternative LV pacing strategy such as multisite ventricular stimulation has been proposed to improve the clinical and echocardiographic outcomes. In a small multicentre study, despite no differences in clinical outcome, triple-site stimulation further promoted a significantly higher increase in LVEF and reduction in LV end-systolic volume when compared with conventional strategy Gold MR, Birgersdotter-Green U, Singh JP, Ellenbogen KA, Yu Y, Meyer TE, et al. The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy. Eur Heart J2011;32:

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46 Results: II. Detection of SDB Utilizing the Respiratory Sensor: REST Respiratory Sensor for Pacer Rate Modulation

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48 Block HF study design

49 Block HF study results

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51 Back up