Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months

• Published in: JACC. Clinical electrophysiology 2016-04, Vol.2 (2), p.212-220
• Main Authors: Boriani, Giuseppe, MD, PhD, Connors, Sean, MD, PhD, Kalarus, Zbigniew, MD, Lemke, Bernd, MD, Mullens, Wilfried, MD, PhD, Osca Asensi, Joaquin, MD, PhD, Raatikainen, Pekka, MD, PhD, Gazzola, Carlo, BSc, Farazi, Taraneh G., PhD, Leclercq, Christophe, MD, PhD
• Format: Article
• Language: English
• Subjects: cardiac resynchronization therapy; Cardiovascular; left ventricular pacing; LV lead complications; phrenic nerve stimulation; quadripolar lead; randomized trial
• ISSN: 2405-500X; 2405-5018
• DOI: 10.1016/j.jacep.2015.10.004

Abstract Objectives The aim of this study was to test the hypothesis that a quadripolar left ventricular (LV) lead results in fewer LV lead–related events than a bipolar cardiac resynchronization therapy (CRT) system in a prospective randomized trial. Background Bipolar LV leads cannot be implanted at the optimal site in up to 10% of patients who need CRT, because of anatomic or technical challenges (pacing threshold, phrenic stimulation, or mechanical instability). Methods The MORE-CRT (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges) trial enrolled 1,078 patients. Patients with indications for CRT defibrillator therapy were randomized into 2 groups in a 1:2 ratio: a group with a bipolar CRT lead system (the BiP group; any manufacturer) and a group with a quadripolar CRT system (the Quad group; Quartet LV lead). The primary endpoint was freedom from a composite endpoint of intraoperative and post-operative LV lead–related events at 6 months. Results A total of 1,074 of 1,078 patients (99%) were randomized and contributed to the primary endpoint. Freedom from the composite endpoint was significantly greater in the Quad than the BiP group (83.0% vs. 74.4%, p = 0.0002). The intraoperative component of the endpoint was met less frequently by Quad group patients (6.26% Quad vs. 12.1% BiP), whereas there was no difference for the post-operative component (7.1% Quad vs. 7.6% BiP). Conclusions The Quartet LV system significantly reduced total LV lead–related events at 6 months after implantation compared with a bipolar CRT system. The reduction in events demonstrates the superiority of this quadripolar technology to effectively manage CRT patients. (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges [MORE-CRT]; NCT01510652 )