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.
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.
Authors: Guilherme H Oliveira; Sadeer G Al-Kindi; Hiram G Bezerra; Marco A Costa Journal: J Cardiovasc Transl Res Date: 2014-02-27 Impact factor: 4.132
Authors: Lik Chuan Lee; Liang Ge; Zhihong Zhang; Matthew Pease; Serjan D Nikolic; Rakesh Mishra; Mark B Ratcliffe; Julius M Guccione Journal: Med Biol Eng Comput Date: 2014-05-03 Impact factor: 2.602
Authors: Martin Genet; Lik Chuan Lee; Rebecca Nguyen; Henrik Haraldsson; Gabriel Acevedo-Bolton; Zhihong Zhang; Liang Ge; Karen Ordovas; Sebastian Kozerke; Julius M Guccione Journal: J Appl Physiol (1985) Date: 2014-05-29
Authors: Stefan D Anker; Andrew J S Coats; Gabriel Cristian; Dinu Dragomir; Enrico Pusineri; Massimo Piredda; Luca Bettari; Robert Dowling; Maurizio Volterrani; Bridget-Anne Kirwan; Gerasimos Filippatos; Jean-Louis Mas; Nicolas Danchin; Scott D Solomon; Randall J Lee; Frank Ahmann; Andy Hinson; Hani N Sabbah; Douglas L Mann Journal: Eur Heart J Date: 2015-06-16 Impact factor: 29.983
Authors: Xu Wen Ng; Yingying Huang; Horng H Chen; John C Burnett; Freddy Y C Boey; Subbu S Venkatraman Journal: PLoS One Date: 2013-07-04 Impact factor: 3.240