Browsing by Author "Nikolic, Serjan D. (57206463240)"

Background: The ventricular partitioning device (VPD) (Cardiokinetix Inc., Redwood City, Calif) is a novel device that is deployed percutaneously in the left ventricle in patients with anteroapical regional wall motion abnormalities after a myocardial infarction (MI) to partition the ventricle and segregate the dysfunctional region. In this case report we present the first implantation of the VPD in a human, with a 12-month efficacy and safety follow-up. Methods and Results: A 48-year-old man had an anterior MI in 2004. A coronary angiogram showed an occlusion of the proximal segment of the left anterior descending artery with no stenosis on other major epicardial vessels. Echocardiography revealed a dilated left ventricle (62 mm) with anteroapical wall motion abnormalities, no apical thrombus, a calculated ejection fraction of 26.8% (by Simpson biplane formula), and an end-systolic volume index (ESVi) of 76.8 mL/m2. The VPD implant was delivered percutaneously from the femoral artery by the standard techniques for left-sided heart catheterization. The postimplantation course was uneventful. Echocardiography on discharge showed the VPD implanted at the apex, with a left ventricular ejection fraction of 30.9% and an ESVi of 57.2 mL/m2. Left ventricular ejection fraction and ESVi remained improved during the 12-month follow-up. Conclusion: This case report demonstrates that VPD implantation in this particular patient was feasible and that it may provide a nonsurgical approach to prevent or reverse left ventricle remodeling. © 2007 Elsevier Inc. All rights reserved.

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.