Giuseppe Boriani1, Sean Connors2, Zbigniew Kalarus3, Bernd Lemke4, Wilfried Mullens5, Joaquin Osca Asensi6, Pekka Raatikainen7, Carlo Gazzola8, Taraneh G Farazi9, Christophe Leclercq10. 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.
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).
RCT Entities:
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).
Authors: Hye Bin Gwag; June Soo Kim; Kyoung-Min Park; Young Keun On; Seung-Jung Park Journal: J Interv Card Electrophysiol Date: 2021-03-27 Impact factor: 1.900
Authors: Jonathan M Behar; Hui Men Selina Chin; Steve Fearn; Julian O M Ormerod; James Gamble; Paul W X Foley; Julian Bostock; Simon Claridge; Tom Jackson; Manav Sohal; Antonios P Antoniadis; Reza Razavi; Tim R Betts; Neil Herring; Christopher Aldo Rinaldi Journal: JACC Clin Electrophysiol Date: 2017-02