title: Response to the Center for Medicare & Medicaid Services coverage with evidence development request for primary prevention implantable cardioverter-defibrillators: data from the OMNI study.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardiac Pacing and Heart Failure Device Therapies, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115, USA. mosweeney@partners.org
authors.forename: Michael O
authors.initials: MO
authors.lastname: Sweeney
authors.forename: Scott
authors.initials: S
authors.lastname: Sakaguchi
authors.forename: Grant
authors.initials: G
authors.lastname: Simons
authors.forename: Christian
authors.initials: C
authors.lastname: Machado
authors.forename: John E
authors.initials: JE
authors.lastname: Connett
authors.forename: Fang
authors.initials: F
authors.lastname: Yang
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy; D014487:Centers for Medicare and Medicaid Services, U.S.; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006801:Humans; D019458:Insurance Coverage; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011322:Primary Prevention; D012042:Registries; D017180:Tachycardia, Ventricular / Q000401:mortality / Q000628:therapy*; D014481:United States