Preliminary Safety and Performance Results of a Two Lead Cardiac Resynchronization Therapy Device: Sub-analysis of the QP ExCELs Post-approval Study

Abstract

Background Re-intervention due to lead dislodgment and malfunctioning of conventional three lead cardiac resynchronization therapy defibrillator (CRT-D) devices can increase the risk of infection, hospitalization costs, and mortality. Two lead CRT-D (CRT-DX) devices are designed to eliminate the atrial lead while providing physicians with critical diagnostic information based on an atrial signal detected by a floating dipole on the right ventricular lead and can promote fewer lead complications, reduced mortality, reduced procedural complexity, and economic benefit. Objective This analysis evaluates a preliminary subset of patients that have been implanted with a two lead CRT-DX system in the QP ExCELs study. QP ExCELs is a multi-center, prospective, non-randomized post-approval study to confirm long-term safety and efficacy of the BIOTRONIK Sentus QP LV lead. Methods Patients with a standard CRT-D indication were enrolled from the investigators’ general population. Follow-up is scheduled at the pre-discharge/wound check, 3, 6, and 12 months post-implant then every 6 months through 5 years to assess for related adverse events (AEs) and LV lead performance. All lead/system related AEs were adjudicated by an independent clinical events committee. Results At the time of this interim analysis, 39 subjects in the QP ExCELs study had been successfully implanted with a BIOTRONIK Intica 7 HF-T QP CRT-DX (66.7% male, age 63.4 ± 11.9 yrs) at 15 U.S. investigational sites. For all subjects, there were no adverse events adjudicated as related or possibly related to the CRT-DX pulse generator or the DX lead. LV lead performance with the CRT-DX is compared to a conventional three lead system in Table 1 . Conclusion These preliminary results suggest two lead cardiac resynchronization therapy devices are safe, reliable and infrequently associated with AEs. Additional data will be collected and analyzed as subjects continue to be enrolled and followed through 5 years.