Authors
St. Jude Medical Inc.
Title
Summary of Safety and Effectiveness Data. Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. St. Jude Medical Epic HF System including the Epic HF Model V-338 cardiac resynchronization therapy defibrillator, the Aescula LV model 1055K lead, the QuickSite LV model 1056K lead, and the model 3307, v4.5m programmer software.
References
US Food and Drug Administration. Premarket Approval Application Number: P030054. Available at: accessdata.fda.gov
Background
None.
Purpose
To verify the safety and efficacy of the Epic HF ICD system in an ICD indicated patient population with advanced heart failure and prolonged QRS duration.
Design
Prospective, multicenter, randomized, double-blind controlled trial 182 patients enrolled Approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia Symptomatic, advanced heart failure (ischemic or non-ischemic) not due to reversible causes, diagnosed for at least 6 months NYHA III/IV despite a minimum of 90 days of appropriate pharmacological therapy (including ACE inhibitor and beta-blocker), which has been stable during 30 days prior to enrollment LVEF ≤ 35% QRS ≥ 150 ms
Exclusion Criteria
Standard bradycardic indication for pacing History of chronic atrial fibrillation (continuous AF lasting >1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month Ability to walk > 450 meters during the 6-minute walk test NYHA I/II Contraindication for an emergency thoracotomy Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 6 months Recent MI, unstable angina, or PTCA/CABG within 1 month of enrollment Recent CVA/TIA within 3 months of enrollment Severe musculoskeletal disorder Pregnant or planning for pregnancy within next 6 months Participating in, or has participated in, a clinical investigation within 30 days Life expectancy of less than 6 months Less than 18 years of age
Follow-Up
Average 12.1 ± 3.4 (range 0.3 – 20.3) months
Treatment Regimen
Implantation of ICD/CRT system Randomization in a 2:1 fashion to CRT-ON or CRT-OFF Evaluation at baseline, 1 months, 3 months, 6 months, and subsequently every 3 months to study completion Crossover permitted after completing 6 month visit
Results
Primary End Points: LV lead-related complications: 6-month survival of 92.8% (one-sided 95% lower confidence interval of 89.4%) Epic HF system-related complications: 6-month survival from system-related complications of 93.4% (one-sided 95% lower confidence interval of 90.6%) Defibrillation system effectiveness (VF detection/redetection times): one-sided 95% upper confidence interval of 3.11 seconds for mean detection time and 1.61 seconds for redetection time Change in peak oxygen consumption: CRT-ON group (+0.52 mL/kg/min) vs CRT-OFF group (- 1.41 mL/kg/min) (p = 0.001) Secondary End Points: Change in NYHA class at 6 months: CRT-ON group (- 0.48) vs CRT-OFF group (- 0.28) (p = 0.048) Change in Quality of Life (Minnesota questionnaire – higher score, worse QOL) at 6 months: CRT-ON group (- 7.8) vs CRT-OFF group (+3.4) (p = 0.009) Change in six-minute walk distance at 6 months: CRT-ON group (+ 13 m) vs CRT-OFF group (- 15 m) (p = 0.07) Aescula LV lead performance: 88.6% patients with a successful implant (one-sided 95% lower confidence interval of 83.8%) Aescula LV lead pacing capture threshold: Average pacing capture threshold of 2.2 ± 1.5 V (one-sided 95% upper confidence interval of 2.37 V)
Summary
CRT with the Epic HF ICD CRT system demonstrated an improvement in functional class and quality of life with an acceptable device safety profile.