Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

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).

The Future of Heart Failure Diagnosis, Therapy, and Management

“…Because most therapies which slow or reverse remodeling also favorably affect the natural history of the HFrEF syndrome, 35 substantial ongoing investigative efforts are examining whether various mechanical approaches to reshaping the ventricle may be a useful therapeutic strategy. Approaches include a percutaneously placed device that internally excludes akinetic or dyskinetic territories leading to less mechanical contractile inefficiency, 38 a hybrid interventional and minimally invasive surgical approach that involves placing anchors across scarred myocardium that are then cinched to exclude the scar and recreate a more normal LV shape, 39 and multiple injections of a biopolymer gel meant to reduce wall stress and prevent further remodeling. 40 These and other approaches have shown signs of efficacy in models or very early human trials, which are often unblinded however, by the nature of the intervention.…”

Percutaneous Left Ventricular Restoration In Chronic Ischemic Heart

“…Results are summarized in Table 3. [19] The cumulative incidence of HF hospitalization and death was 16.1%, 32.3% and 38.7% at 12, 24 and 36months respectively. The author concluded that PVR device is feasible and safe up to 3 years post implantation.…”

“…Thus out of 50 patients initially screened for PVR, only 8 patients were implanted with parachute device after proper screening with 2D-ECHO and cardiac CT [18] . Costa et al (2014) [19] reported 3 years outcome in 39 patients with ischemic heart failure, NYHA Class II-IV, EF 15-40% and dilated /akinetic anterior wall apex without the need of revascularization. PVR was successfully done in 31 out of 34 patients (success rate 91%).…”

Percutaneous Treatment of Adverse Left Ventricular Remodeling

“…This study demonstrated the potential for a percutaneous device to successfully reduce ventricular volumes in patients with adverse ventricular remodeling after acute infarction up to 3 years [ 18 ]. Of course, limited conclusions regarding clinical benefi t to VPD insertion can be drawn from this small, uncontrolled, initial registry.…”