Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial

Giuseppe Boriani; Sean Connors; Zbigniew Kalarus; Bernd Lemke; Wilfried Mullens; Joaquin Osca Asensi; Pekka Raatikainen; Carlo Gazzola; Taraneh G Farazi; Christophe Leclercq

doi:10.1016/j.jacep.2015.10.004

Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial

JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.

Authors

Affiliations

¹ Institute of Cardiology, DIMES Department, University of Bologna, Bologna, Italy; Cardiology Department, Modena University Hospital, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: giuseppe.boriani@unimore.it.
² Department of Cardiology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
³ Department of Cardiology, Silesian Center for Heart Diseases (SCHD), Zabrze, Poland.
⁴ Department of Cardiology, Hospital Lüdenscheid, Lüdenscheid, Germany.
⁵ Department of Cardiology, Hospital Oost-Limburg, Universiteit Hasselt, Genk, Belgium.
⁶ Department of Cardiology, University Hospital La Fe, Valencia, Spain.
⁷ Department of Cardiology, Central Finland Health Care District and University of Eastern Finland, Jyväskylä, Finland.
⁸ SJM Coordination Center BVBA, Zaventem, Belgium.
⁹ St. Jude Medical Inc., Sunnyvale, California, USA.
¹⁰ Hospital Pontchaillou, Rennes, France.

PMID: 29766873
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).

Keywords: LV lead complications; cardiac resynchronization therapy; left ventricular pacing; phrenic nerve stimulation; quadripolar lead; randomized trial.

Associated data

ClinicalTrials.gov/NCT01510652