Percutaneous Ventricular Restoration using the Parachute® Device in Patients with Ischemic Heart Failure: Three-year Outcomes of the PARACHUTE First-in-Human Study
Background—Left ventricle (LV) remodeling after anterior wall myocardial infarction leads to increased LV 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 (PVR) therapy using the Parachute® device in subjects with HF due to a cardiac ischemic event.
Methods and Results—Thirty-nine subjects with New York Heart Association (NYHA) Class II-IV ischemic HF, ejection fraction (EF) between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized, were enrolled in a prospective, non-randomized, multi-center investigation testing PVR using the Parachute device. The safety primary endpoint was defined as successful procedure without device-related major adverse cardiac events (MACE) over 6-months. Clinical and echocardiographic outcomes were obtained at 6, 12, 24 and 36-months post treatment. Echocardiographic and endpoint 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. NYHA symptom class was improved or maintained in 85% of subjects. Left ventricle end-diastolic volume index (EDVi) and end-systolic volume index (ESVi) were reduced from 128•4±22•1 ml/m2 and 94•9±22•3 ml/m2 pre-implant to 115•2±23•1 ml/m2 and 87•3±18•7 ml/m2 at the 3-years follow-up (EDVi p=0•0056, ESVi, p=0•4719), respectively. The cumulative incidence of HF hospitalizations or death were 16•1%, 32•3% and 38•7% at 12, 24 and 36-months respectively. By 3-years follow-up, two (6•5%) of the 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 PVR using the Parachute device demonstrates feasibility and safety of the device up to 3-years post treatment.
- ischemic heart failure
- structural heart disease
- left ventricular remodeling
- myocardial infarction
- left ventricular wall motion
- Received January 22, 2014.
- Accepted July 7, 2014.