title: 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.
abstract: OBJECTIVE
  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.affiliation: Division of Cardiovascular Medicine, The Ohio State University Heart and Vascular Center, 473 West 12th Ave., Columbus, OH 43210-1252, USA. Ernest.Mazzaferri@osumc.edu
authors.forename: Ernest L
authors.initials: EL
authors.lastname: Mazzaferri
authors.forename: Sinisa
authors.initials: S
authors.lastname: Gradinac
authors.forename: Dragan
authors.initials: D
authors.lastname: Sagic
authors.forename: Petar
authors.initials: P
authors.lastname: Otasevic
authors.forename: Ayesha K
authors.initials: AK
authors.lastname: Hasan
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Goff
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Nina
authors.initials: N
authors.lastname: Wunderlich
authors.forename: Serjan D
authors.initials: SD
authors.lastname: Nikolic
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D011446:Prospective Studies; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013318:Stroke Volume; D016896:Treatment Outcome; D020257:Ventricular Remodeling / Q000502:physiology*