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

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• 作者：Giuseppe Boriani ; MD ; PhD^a ; ^b ; ^{giuseppe.boriani@unimore.it" class="auth_mail" title="E-mail the corresponding author} ; Sean Connors ; MD ; PhD^c ; Zbigniew Kalarus ; MD^d ; Bernd Lemke ; MD^e ; Wilfried Mullens ; MD ; PhD^f ; Joaquin Osca Asensi ; MD ; PhD^g ; Pekka Raatikainen ; MD ; PhD^h ; Carlo Gazzola ; BScⁱ ; Taraneh G. Farazi ; PhD^j ; Christophe Leclercq ; MD ; PhD^k
• 关键词：cardiac resynchronization therapy ; left ventricular pacing ; LV lead complications ; phrenic nerve stimulation ; quadripolar lead ; randomized trial
• 刊名：JACC: Clinical Electrophysiology
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：2
• 期：2
• 页码：212-220
• 全文大小：782 K

文摘

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)