Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy: The MultiPoint Pacing Trial
Imran Niazi, James Baker 2nd, Raffaele Corbisiero, Charles Love, David Martin, Robert Sheppard, Seth J Worley, Niraj Varma, Kwangdeok Lee, Gery Tomassoni, MPP Investigators, Imran Niazi, James Baker 2nd, Raffaele Corbisiero, Charles Love, David Martin, Robert Sheppard, Seth J Worley, Niraj Varma, Kwangdeok Lee, Gery Tomassoni, MPP Investigators
Abstract
Objectives: The MultiPoint Pacing (MPP) trial assessed the safety and efficacy of pacing 2 left ventricular sites with a quadripolar lead in patients with heart failure indicated for a CRT-D device.
Background: Cardiac resynchronization therapy nonresponse is a complex problem where stimulation of multiple left ventricular sites may be a solution.
Methods: Enrolled patients were indicated for a CRT-D system. Bi-ventricular (Bi-V) pacing was activated at implant. Three months later, clinical response was assessed and the patient was randomized (1:1) to receive Bi-V pacing or MPP. Patients were followed for 6 months post-randomization and clinical response was again assessed.
Results: The CRT-D system was successfully implanted in 455 of 469 attempted implants (97%). A total of 381 patients were randomized to Bi-V or MPP at 3 months. The primary safety endpoint was met with freedom from system-related complications of 93.2%. The primary efficacy endpoint of the noninferiority comparison of nonresponder rates between the 2 arms was met. Patients randomized to MPP arm and programmed to pace from anatomically distant poles (MPP-AS) responded to therapy at significantly higher rates than MultiPoint pacing-other programmed settings (MPP-Other). Within this group, 87% were responders at 9 months, 100% designated as nonresponders at 3 months converted to responders at 9 months, and 54% experienced an incremental response compared to MPP-Other. Also within MPP-AS, 92% of patients with de novo CRT-D implant were classified as responders compared with patients with MPP-Other.
Conclusions: MPP is safe and effective for treating heart failure. The study met the pre-specified hypothesis that response to MPP is noninferior to Bi-V pacing with a quadripolar left ventricular lead. (MultiPoint Pacing IDE Study [MPP IDE]; NCT01786993).
Keywords: bi-ventricular pacing; cardiac resynchronization; heart failure; multipoint pacing; randomized controlled trial.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed