Response to the Center for Medicare & Medicaid Services coverage with evidence development request for primary prevention implantable cardioverter-defibrillators: Data from the OMNI study

Michael O. Sweeney, Scott Sakaguchi, Grant Simons, Christian Machado, John E. Connett, Fang Yang

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

BACKGROUND: The Center for Medicare & Medicaid Services expanded coverage for primary prevention (PP) implantable cardioverter-defibrillators (ICDs) included a request for outcome comparisons between 3 Group B subgroup patients (left ventricular ejection fraction [LVEF] 31%-35%, nonischemic dilated cardiomyopathy [NDCM] duration of <9 months, and New York Heart Association class IV heart failure (HF) treated with cardiac resynchronization therapy/defibrillator [CRT/D]) and non-Group B patients (LVEF ≤30%, NDCM duration of <9 months, and New York Heart Association class III HF treated with CRT/D) using real-world observational studies. OBJECTIVE: To compare outcomes in Center for Medicare & Medicaid Services Group B and non-Group B PP ICD patients. METHODS: OMNI was a 4-year prospective observational study that enrolled 1464 PP ICD patients with a mean LVEF of 25%; 72% were men, 78% had class II-IV HF, and 66% had coronary disease. A total of 795 (54.3%) received ICDs, and 669 (45.7%) received CRT/Ds. Ventricular tachyarrhythmia therapy rates and mortality were compared over 39 ± 18.4 months. RESULTS: Twenty-five percent received ventricular tachyarrhythmia therapies, and 21.2% died within 4 years. Patient-year therapy rates were not significantly different for LVEF of 31%-35% (0.36 per year) vs ≤30% (0.51/y) and CRT/D for class IV HF (0.21/y) vs class III HF (0.43 per year) but were lower for NDCM <9 months (0.3/y) vs <9 months (0.85/y; P = .02). Four-year mortality was similar for LVEF 30%-35% (22.6%) vs <30% (24.4%) and NDCM <9 months (14.2%) vs <9 months (12.3%) but was higher for CRT/D for class IV HF (48.6%) vs class III HF (27.4%) (P = .01). CONCLUSION: Patient-year ventricular tachyarrhythmia therapy rates did not differ between non-Group B and Group B PP ICD patients, though NDCM <9 months was significantly lower. Survival at 4 years was lowest in patients with New York Heart Association class IV HF treated with CRT/D and similar between all other non-Group B and Group B patients.

Original languageEnglish (US)
Pages (from-to)1058-1066
Number of pages9
JournalHeart Rhythm
Volume9
Issue number7
DOIs
StatePublished - Jul 2012

Bibliographical note

Funding Information:
The OMNI study was sponsored by Medtronic. Dr Sweeney worked as a paid consultant and received honoraria for speaking from Medtronic. Dr Simons received research grants and honoraria for speaking from Medtronic . Dr Connett received payment to perform statistical analyses. Dr Yang is an employee of Medtronic.

Keywords

  • Heart failure
  • Implantable cardioverter-defibrillator
  • Mortality

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