216-40: Prospective Safety And Efficacy Evaluation of a Down-Sized Bradycardia Pacing Lead Designed for Use In MRI Environments. (10th June 2016)

• Record Type: Journal Article
• Authors: Cosedis, Jens; Love, Charles; Elke, Sommerijns; Wold, Nick; Hedrich, Olaf
• Is Part Of: Europace. Volume 18(2016)Supplement 1
• Page Start: i151
• Page End: i151
• Publication Date: 2016-06-10
• Subjects: Arrhythmia -- Treatment -- Periodicals; Cardiac pacing -- Periodicals; Catheter ablation -- Periodicals; Heart -- Physiology -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1093/europace/18.suppl_1.i151a
• Languages: English
• ISSNs: 1099-5129

Abstract

Abstract: Purpose: Down-sized leads have advantages during implantation and with regard to venous obstruction, but historically have resulted in increased complication rates. New requirements for MRI compatibility also have the potential to increase complication rates. A newly developed 6Fr bradycardia pacing lead designed for MRI compatibility was evaluated in a large prospective investigational device exemption clinical study. Method: The INGEVITY Trial is an ongoing, prospective, non-randomized, multi-center, study evaluating the safety, performance and effectiveness of the Active and Passive Fixation Leads implanted in patients who are care candidates for conventional cardiac pacing or cardiac resynchronization therapy. Study follow-up is 5 years for all patients; with predefined safety endpoints (Lead Related Complication (LRC) Free rate) at 3 and 12 months and pacing performance endpoints at 3 months. Summary of Results: A total of 1599 leads (79% active fixation, 65% right ventricular) were evaluated in 1036 patients in 77 centers in Europe, North America and Asia. Patient characteristics were 97% PM, 3% CRT-P, mean age = 74 ± 11 years, 55% male. Safety The LRC-Free Rate at 3 months was 98.4% (97.5% lower confidence limit of 97.7%). The LRC-Free Rate from 3 to 12 months was 99.7% (97.5% lower confidence limit of 99.4%). Lead dislodgements occurred in 8 of 563 (1.4%) RA and 12 of 1036 (1.2%) RV implants. Zero of 1599 leads resulted in perforation. Effectiveness The mean pacing threshold at 3 months was 0.67 V ± 0.33 V. The mean sensed amplitude at 3 months was 4.8 mV ± 2.6 mV in the right atrium and 16.5 mV ± 6.5 mV in the right ventricle. The mean pacing impedance was 773 Ω ±155 Ω. Conclusion: The INGEVITY active and passive fixation leads passed all of the electrical pacing endpoints (3 months) and safety endpoints (3 and 12 months). Lead related complications were rare on this downsized, MRI Compatible lead design.