Marco A Costa1, Ernest L Mazzaferri2, Horst Sievert2, William T Abraham2. 1. 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. 2. 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.).
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. METHODS AND 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. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00573560 (US patients) and NCT01286116 (EU patients).
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. METHODS AND 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 HFpatients treated with percutaneous ventricular restoration using the Parachute device demonstrates feasibility and safety of the device ≤3 years post-treatment. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00573560 (US patients) and NCT01286116 (EU patients).
Authors: V J Nijenhuis; L Sanchis; J A S van der Heyden; P Klein; B J W M Rensing; A Latib; F Maisano; J M Ten Berg; P Agostoni; M J Swaans Journal: Neth Heart J Date: 2017-10 Impact factor: 2.380
Authors: Tom Hendriks; Remco A J Schurer; Lawien Al Ali; Ad F M van den Heuvel; Pim van der Harst Journal: Heart Fail Rev Date: 2018-11 Impact factor: 4.214