title: Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study.
abstract: BACKGROUND
  Left ventricle remodeling after anterior wall myocardial infarction leads to increased left ventricle volumes, myocardial stress, and ultimately heart failure (HF). Treatment options are limited for these high-risk HF patients. A study was conducted to assess safety and feasibility of a percutaneous ventricular restoration therapy using the Parachute device in subjects with HF because of a cardiac ischemic event.
  
  
  RESULTS
  Thirty-nine subjects with New York Heart Association class II to IV ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled in a prospective, nonrandomized, multicenter investigation testing percutaneous ventricular restoration using the Parachute device. The safety primary end point was defined as successful procedure without device-related major adverse cardiac events during 6 months. Clinical and echocardiographic outcomes were obtained at 6, 12, 24, and 36 months post-treatment. Echocardiographic and end point data were adjudicated independently. Of the 39 subjects enrolled, device implantation was attempted in 34 and successful in 31 patients. Twenty-three subjects reached 3 years post-treatment with the device implanted. New York Heart Association symptom class was improved or maintained in 85% of subjects. Left ventricle end-diastolic volume index and end-systolic volume index were reduced from 128.4±22.1 and 94.9±22.3 mL/m(2) preimplant to 115.2±23.1 and 87.3±18.7 mL/m(2) at 3-year follow-up (end-diastolic volume index, P=0.0056; end-systolic volume index, P=0.4719). The cumulative incidence of HF hospitalization or death was 16.1%, 32.3%, and 38.7% at 12, 24, and 36 months, respectively. By 3-year follow-up, 2 (6.5%) of 31 patients with successful implant had died from cardiac reasons, with no cardiac deaths occurring past 6 months post-treatment.
  
  
  CONCLUSIONS
  The first series of ischemic HF patients treated with percutaneous ventricular restoration using the Parachute device demonstrates feasibility and safety of the device ≤3 years post-treatment.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifiers: NCT00573560 (US patients) and NCT01286116 (EU patients).
authors.affiliation: From the Center for Research and Innovation Harrington Heart and Vascular Institute University Hospitals, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (M.A.C.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (E.L.M., W.T.A.); CardioVascular Center, Frankfurt, Germany (H.S.). Marco.Costa@UHhospitals.org.
authors.forename: Marco A
authors.initials: MA
authors.lastname: Costa
authors.affiliation: From the Center for Research and Innovation Harrington Heart and Vascular Institute University Hospitals, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (M.A.C.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (E.L.M., W.T.A.); CardioVascular Center, Frankfurt, Germany (H.S.).
authors.forename: Ernest L
authors.initials: EL
authors.lastname: Mazzaferri
authors.affiliation: From the Center for Research and Innovation Harrington Heart and Vascular Institute University Hospitals, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (M.A.C.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (E.L.M., W.T.A.); CardioVascular Center, Frankfurt, Germany (H.S.).
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: From the Center for Research and Innovation Harrington Heart and Vascular Institute University Hospitals, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (M.A.C.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (E.L.M., W.T.A.); CardioVascular Center, Frankfurt, Germany (H.S.).
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
mesh_terms: D006328:Cardiac Catheterization / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000379:methods*; D004452:Echocardiography; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006352:Heart Ventricles / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D013318:Stroke Volume; D016896:Treatment Outcome; D020257:Ventricular Remodeling
keywords: heart failure; myocardial infarction; ventricular remodeling