Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: Results of the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts Trial

• Published in: The American heart journal 2012-05, Vol.163 (5), p.812-820.e1
• Main Authors: Mazzaferri, Ernest L., MD, Gradinac, Sinisa, MD, Sagic, Dragan, MD, Otasevic, Petar, MD, Hasan, Ayesha K., MD, Goff, Thomas L., MD, Sievert, Horst, MD, Wunderlich, Nina, MD, Nikolic, Serjan D., PhD, Abraham, William T., MD
• Format: Article
• Language: English
• Subjects: Adult; Aged; Analysis of Variance; Biological and medical sciences; Cardiac Catheterization - instrumentation; Cardiac Catheterization - methods; Cardiology. Vascular system; Cardiovascular; Cardiovascular disease; Catheters; Coronary Angiography; Coronary heart disease; Coronary vessels; Equipment Safety; Family medical history; Feasibility Studies; Female; Follow-Up Studies; Heart; Heart attacks; Heart failure; Heart Failure - complications; Heart Failure - diagnosis; Heart Failure - therapy; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - complications; Myocardial Infarction - diagnostic imaging; Myocardial Infarction - therapy; Myocarditis. Cardiomyopathies; Prospective Studies; Prostheses and Implants; Prosthesis Design; Prosthesis Implantation - methods; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Stroke; Stroke Volume; Transplants & implants; Treatment Outcome; Ventricular Remodeling - physiology
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2012.02.013

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.