Cost-effectiveness analysis of leadless cardiac resynchronization therapy.

BACKGROUND: The Wireless Stimulation Endocardially for CRT (WiSE-CRT) system is a novel technology used to treat patients with dyssynchronous heart failure (HF) by providing leadless cardiac resynchronization therapy (CRT). Observational studies have demonstrated its safety and efficacy profile, however, the treatment cost-effectiveness has not previously been examined. METHODS: A cost-effectiveness evaluation of the WiSE-CRT System was performed using a cohort-based economic model adopting a "proportion in state" structure. In addition to the primary analysis, scenario analyses and sensitivity analyses were performed to test for uncertainty in input parameters. Outcomes were quantified in terms of quality-adjusted life year (QALY) differences. RESULTS: The primary analysis demonstrated that treatment with the WiSE-CRT system is likely to be cost-effective over a lifetime horizon at a QALY reimbursement threshold of £20 000, with a net monetary benefit (NMB) of £3781 per QALY. Cost-effectiveness declines at time horizons shorter than 10 years. Sensitivity analyses demonstrated that average system battery life had the largest impact on potential cost-effectiveness. CONCLUSION: Within the model limitations, these findings support the use of WiSE-CRT in indicated patients from an economic standpoint. However, improving battery technology should be prioritized to maximize cost-effectiveness in times when health services are under significant financial pressures.

Feasibility of leadless left ventricular septal pacing with the WiSE-CRT system to target the left bundle branch area: A porcine model and multicenter patient experience.

BACKGROUND: The WiSE-CRT system delivers leadless endocardial left ventricular (LV) pacing to achieve cardiac resynchronization therapy. The electrode is conventionally placed on the lateral wall, but implanting on the LV septum may have advantages, including capture of the left bundle branch, and improved battery longevity owing to reduced distance from the transmitter. OBJECTIVE: The purpose of this study was to assess the feasibility of leadless LV septal pacing via the WiSE-CRT system. METHODS: Two pigs underwent electrode implantation on the LV septum with subsequent anatomical and histological examination. Eight patients underwent implantation of the WiSE-CRT system with deployment of the electrode on the LV septum via an interatrial transseptal approach. RESULTS: Deployment of the electrode on the LV septum was successful in both animals. Histological examination demonstrated electrode tines in close proximity to Purkinje tissue. WiSE-CRT implantation with an LV septal electrode was successful in all patients. Biventricular capture was confirmed, with a significant reduction in QRS duration (187.1 ± 33.8 ms vs 149.5 ± 15.7 ms; P = .009). Temporary LV pacing achieved further QRS reduction (139.8 ± 12.4 ms), and in 4 patients the peak LV activation time in lead V5/V6 was <90 ms, suggesting left bundle branch capture. At early follow-up, the median LV pacing percentage was 98.5% and 5 patients (62.5%) improved symptomatically. The transmitter-to-electrode distance was lower than the distance to the lateral wall during acoustic window screening (8.8 ± 1.6 cm vs 11.9 ± 1.5 cm; P = .002). CONCLUSION: Leadless LV septal pacing with the WiSE-CRT system to target the left bundle branch appears feasible. Further study is required to assess the efficacy and safety of this technique.