Author + information
- Received July 31, 2015
- Revision received September 14, 2015
- Accepted October 8, 2015
- Published online April 1, 2016.
- Giuseppe Boriani, MD, PhDa,b,∗ (, )
- Sean Connors, MD, PhDc,
- Zbigniew Kalarus, MDd,
- Bernd Lemke, MDe,
- Wilfried Mullens, MD, PhDf,
- Joaquin Osca Asensi, MD, PhDg,
- Pekka Raatikainen, MD, PhDh,
- Carlo Gazzola, BSci,
- Taraneh G. Farazi, PhDj and
- Christophe Leclercq, MD, PhDk
- aInstitute of Cardiology, DIMES Department, University of Bologna, Bologna, Italy
- bCardiology Department, Modena University Hospital, University of Modena and Reggio Emilia, Modena, Italy
- cDepartment of Cardiology, Memorial University of Newfoundland, St. John’s, Newfoundland, Canada
- dDepartment of Cardiology, Silesian Center for Heart Diseases (SCHD), Zabrze, Poland
- eDepartment of Cardiology, Hospital Lüdenscheid, Lüdenscheid, Germany
- fDepartment of Cardiology, Hospital Oost-Limburg, Universiteit Hasselt, Genk, Belgium
- gDepartment of Cardiology, University Hospital La Fe, Valencia, Spain
- hDepartment of Cardiology, Central Finland Health Care District and University of Eastern Finland, Jyväskylä, Finland
- iSJM Coordination Center BVBA, Zaventem, Belgium
- jSt. Jude Medical Inc., Sunnyvale, California
- kHospital Pontchaillou, Rennes, France
- ↵∗Reprint requests and correspondence:
Prof. Giuseppe Boriani, Cardiology Department, University of Modena and Reggio Emilia, Policlinico di Modena, Via del Pozzo, 71, 41124 Modena, Italy.
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)
- cardiac resynchronization therapy
- left ventricular pacing
- LV lead complications
- phrenic nerve stimulation
- quadripolar lead
- randomized trial
This study was sponsored by St. Jude Medical. Prof. Boriani has received speaking fees from Biotronik, Boston Scientific, Medtronic, and St. Jude Medical. Dr. Connors has received consulting fees from St. Jude Medical; and speaking fees from St. Jude Medical, Biosense Webster, Bristol-Myers Squibb, and Boehringer-Ingelheim. Prof. Kalarus has received speaking fees from Pfizer, Eli Lilly, Boehringer-Ingelheim, Abbott, Bayer, St. Jude Medical, and Adamed; and consulting fees from Boehringer Ingelheim, Amgen, and AstraZeneca. Prof. Lemke has received speaking fees from St. Jude Medical, Medtronic, Biotronik, and Impulse Dynamic. Dr. Osca-Asensi has received consulting fees from St. Jude Medical. Prof. Raatikainen has received consulting fees from Bayer and Bristol-Myers Squibb/Pfizer; speaking fees from Biosense Webster, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, and Cardiome; and research support from St. Jude Medical. Mr. Gazzola and Dr. Farazi are employees of St. Jude Medical. Prof. Leclercq has received consulting fees from St. Jude Medical, Medtronic, Sorin, Boston Scientific, and Biotronik. Dr. Leclerq has reported that he has no relationships relevant to the contents of this paper to disclose.
- Received July 31, 2015.
- Revision received September 14, 2015.
- Accepted October 8, 2015.
- 2016 American College of Cardiology Foundation