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Boston Scientific — Technical Presentation (October 2013)
15 slides from Boston Scientific's technical presentation, October 2013
Slide 1: Battery Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators
Battery Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators Samir Saba, MD, FACC, FHRS Director, Cardiac Electrophysiology University of Pittsburgh Medical Center CRM-192506-AA-Oct2013
Slide 2: Introduction
Introduction • Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) are indicated for the management of heart failure patients with severe left ventricular (LV) systolic dysfunction and a wide QRS complex • The benefit of CRT-ICDs depends upon achieving a high burde
Slide 3: Introduction
Introduction • Cardiac resynchronization therapy-ICD pulse generator replacement is an invasive procedure with the potential risks of infection, bleeding, and damage to the implanted leads • It is an expensive procedure, which along with the cost of a new device, contributes to rising healthcare cos
Slide 4: Rationale
Rationale We investigated the real-life battery longevity on CRT-D across different manufacturers, in a contemporary cohort of patients CRM-192506-AA-Oct2013
Slide 5: Method
Method • All patients implanted with CRT-ICDs from January 1, 2008 to December 31, 2010 at the hospitals of the University of Pittsburgh Medical Center were included in this analysis. • The primary endpoints of this analysis were the rate of battery depletion (reaching ERI) as well as the time from
Slide 6: Methods
Methods 746 Implanted 94 Excluded (32 BSC, 55 MDT, 7 STJ, 6 Bio) Follow-up clinic not UPMC, lost to follow-up 646 Included within 1 month. Equivalent proportions by Mfg to the overall cohort BSC 173 MDT 416 STJ 57 CRM-192506-AA-Oct2013
Slide 7: Baseline Characteristics
Baseline Characteristics Variable Overall Cohort Boston Medtronic St. Jude Scientific Medical N 646 173 416 57 Age (years) 69±13 70±12 69±13 70±13 Gender (female) 26% 20% 29% 21% Coronary Artery Disease * 64% 70% 62% 61% Diabetes Mellitus 34% 38% 33% 33% Hypertension * 66% 69% 65% 70% Left Ventricul
Slide 8: Devices reaching ERI
Devices reaching ERI Manufacturer (N) Device model (N) Devices reaching ERI (N) ERI N (%) Follow-up time (years) H220 LIVIAN (16) H225 LIVIAN (2) H225 LIVIAN (1) H227 LIVIAN HE (18) H227 LIVIAN HE (4) N118 COGNIS 100-D (22) Boston Scientific (173) 7 (4%) 2.5±1.6 N119 COGNIS 100-D (100) N119 COGNIS 1
Slide 9: Rate of Devices Reaching ERI by Manufacturer
Rate of Devices Reaching ERI by Manufacturer CRM-192506-AA-Oct2013
Slide 10: Battery Depletion in CRT Defibrillators by Vendor
Battery Depletion in CRT Defibrillators by Vendor BSC s ra 2 e pj 2) @ S _— io =] E | oO Unadjusted P<0.001 Adjusted P<0.001 2 3 Time to Battery Depletion (years) Boston Scientific 172 87 34 Medtronic 415 St. Jude Medical 56 CRM-192506-AA-Oct2013
Slide 11: Device Usage Data
Device Usage Data Variable Boston Scientific Medtronic St. Jude RA output (V) 2.6±0.7 2.6±0.9 2.6±0.6 RA Pulse width (ms) 0.49±0.04 0.49±0.11 0.50±0.14 RA Impedance (Ω) * 493±195 604±596 396±67 RA pacing burden (%) 21±33 25±34 20±29 RV output (V) 2.8±0.7 2.6±0.8 2.8±0.7 RV Pulse width (ms) 0.50±0.04
Slide 12: Independent Predictors of Battery Longevity
Independent Predictors of Battery Longevity Variable Group 1 Group 2 Odds Ratio ± 95% CI OR 95% CI P value Manufacturer MDT Other MFG 6.27 2.53-15.52 <0.001 RA impedance Higher Lower 1.00 1.00-1.00 0.762 RV impedance Higher Lower 1.00 0.99-1.00 0.786 LV Output Higher Lower 1.97 1.64-2.37 <0.001 LV I
Slide 13: Discussion
Discussion • First head-to-head comparison of CRT-D battery performance using the hard endpoint of device replacement • In contrast to earlier publications, includes only contemporary CRT-ICD models available in the USA and the rest of the world • Battery longevity has direct implications on patient
Slide 14: Conclusions
Conclusions • Our data demonstrate a large discrepancy in CRT-ICD battery longevity by device manufacturer in a contemporary cohort of patients with device models that are currently implanted in the USA and all over the world • These findings have important implications for patient care. Other large
Slide 15: Indications and Usage
Indications and Usage These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: • Moderate to severe h
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