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Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy
- Source :
- JACC: Clinical Electrophysiology. 3:1510-1518
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
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 MPP-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)
- Subjects :
- medicine.medical_specialty
Ventricular lead
business.industry
medicine.medical_treatment
Cardiac resynchronization therapy
030204 cardiovascular system & hematology
medicine.disease
law.invention
Surgery
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Heart failure
Cardiac resynchronization
Cardiology
Medicine
In patient
030212 general & internal medicine
Implant
business
Lead (electronics)
Subjects
Details
- ISSN :
- 2405500X
- Volume :
- 3
- Database :
- OpenAIRE
- Journal :
- JACC: Clinical Electrophysiology
- Accession number :
- edsair.doi...........c7d1003fc6293c1e023b34e0f8db17e3
- Full Text :
- https://doi.org/10.1016/j.jacep.2017.06.022