Potential Survival Benefit from Investigational Devices in Patients ≥65 Yrs: Lessons from the Implantable Cardioverter Defibrillator (ICD) Experience

Controversy regarding the issue of Medicare reimbursement for investigational devices led us to examine the medical implications of this debate. Pt survival was estimated in large ICD (“PCD”) clinical investigation spanning the transition from epicardial (Epi) systems to the less invasive nonthoracotomy lead (NTL) systems (5/89-1/93), period during which only Epi-type devices were FDA-approved. Among the 1471 Epi and 1356 NTL implantations, 1289 (46%) of system recipients were ≥65 yrs of age (“65+”) and the remainder were under age 65 (“0-64”). Cumulative survival at 1-yr was analyzed within age groups, controlling for clinical descriptors (where CAD = coronary artery disease; C = cardiac arrest; and NYH = NY Heart Association Functional Class): The improved observed survival with NTL vs. Epi ICDs was significant in both the 0-64 (p < 0.0001) and the 65+ (p = 0.001) age groups. Even after adjustment for differences in pt characteristics, and cardiovascular or arrhythmi descriptors, the risk of death was still lower in NTL pts for both 0-64 (p < 0.0001) and 65+ (p = 0.02). Conclusions: 1) Pts ≥ 65 yrs of age benefit as much as younger pts from NTL devices. 2) At time when only Epi-type ICD systems were FDA-approved, preventing access to investigational (and less invasive) NTL device systems would have denied older pts greater 1-yr survival compared to that achievable with an Epi ICD. 3) These results suggest that relevant medical dat should be available to policy makers and the public to facilitate informed decisions regarding third-party payment for investigational devices.