56-49: Manufacturer change at the time of ICD replacement: Italian survey and data from the DECODE study

Purpose of the study: Development and adoption of technical standards among ICD manufacturers is mandatory. Although the interchangeability of the ICD systems is ensured by established and codified specifications, some barriers seem to exist in changing ICD manufacturer at the time of device replacement. Method used: We analyzed 784 consecutive ICD/CRT-D replacement or upgrading procedures during a 1,5-year time frame in 36 Italian centers in order to evaluate potential factors associated with changing manufacturer. Subsequently, we compared these results with a survey administered to the implanting physicians at the end of the enrolling period. Summary of results: Devices in analysis were 211 single-chamber (SC), 210 dual-chamber ICDs (DC) and 363 CRT-D. A manufacturer change occurred in 191 cases (24%): 72 SC ICDs (34%), 52 DC ICDs (25%) and 67 CRT-D (18%, p < 0.001 vs SC). Replacement-only procedures were associated with a lower rate of manufacturer change than upgrading procedures (23% vs 32%, p = 0.02). In the SC/DC cohort, the reduction in generator volume (GV) was the only variable that favored the manufacturer change (OR, 2.7; 95%CI: 1.6–4.4; P = 0.001), while DC devices were associated with the maintenance of manufacturer (OR, 0.6; 95%CI: 0.4–0.9; P < 0.05). In the CRT-D group, service life below the median value (OR, 2.2; 95%CI: 1.1–4.2; p = 0.02), reduction in GV (OR, 15.3; 95%CI: 6.9–33.9; p < 0.0001) and change from a sharp- to a rounded-shape (OR, 4.7; 95%CI: 2.3–9.7; p < 0.0001) favored the manufacturer change. According to the survey, the reasons to change ICD manufacturer were: higher expected longevity of the new device 26%, remote monitoring 4%, physical characteristics 17%, algorithms/features 15%, administrative reasons in 27%, recall/advisory in 10% and other reasons in 1%. Conclusion: At the time of ICD replacement, manufacturer change occurs in 24% of patients, mainly when the new device presents a more physiological design or the replaced one exhibited a lower than expected longevity. Conversely, it is less likely to occur with CRT-D devices that are equipped with more specific technology and less frequently require addition of features. These findings agree with the physician's opinion captured by the survey.