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Menlo Park, CA, United States

Mazzaferri Jr. E.L.,Ohio State University | Gradinac S.,University of Belgrade | Sagic D.,University of Belgrade | Otasevic P.,University of Belgrade | And 6 more authors.
American Heart Journal

Objectives: The aim of this study was to assess the feasibility, safety, and preliminary efficacy of a novel percutaneous left ventricular partitioning device (VPD) in patients with chronic heart failure (HF) and a prior anterior myocardial infarction. Background: Anterior myocardial infarction is frequently followed by left ventricular remodeling, HF, and increased long-term morbidity and mortality. Methods: Thirty-nine patients were enrolled in a multinational, nonrandomized, longitudinal investigation. The primary end point was an assessment of safety, defined as the successful delivery and deployment of the VPD and absence of device-related major adverse cardiac events over 6 months. Secondary (exploratory) efficacy end points included changes in hemodynamics and functional status and were assessed serially throughout the study. Results: Ventricular partitioning device placement was not attempted in 5 (13%) of 39 subjects. The device was safely and successfully implanted in 31 (91%) of the remaining 34 patients or 79% of all enrolled patients. The 6-month rate of device-related major adverse cardiac event occurred in 5 (13%) of 39 enrolled subjects and 5 (15%) of 34 treated subjects, with 1 additional event occurring between 6 and 12 months. For patients discharged with the device to 12 months (n = 28), New York Heart Association class (2.5 ± 0.6 to 1.3 ± 0.6, P <.001) and quality-of-life scores (38.6 ± 6.1 to 28.4 ± 4.4, P <.002) improved significantly; however, the 6-minute hall walk distance (358.5 ± 20.4 m to 374.7 ± 25.6 m, P nonsignificant) only trended toward improvement. Conclusions: The left VPD appears to be relatively safe and potentially effective in the treatment for patients with HF and a prior anterior myocardial infarction. However, these limited results suggest the need for further evaluation in a larger randomized controlled trial. © 2012 Mosby, Inc. Source

CardioKinetix | Date: 2006-05-31

Implantable medical devices, namely, implants consisting of artificial materials.

Silicon Valley Bank and CardioKinetix | Date: 2011-11-22

Medical implants composed of artificial materials.

CardioKinetix | Date: 2012-05-29

Medical implants composed of artificial materials.

CardioKinetix | Date: 2013-03-11

Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials; medial implants composed of artificial materials.

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