Percutaneous left ventricular partitioning therapy in ischemic heart failure

Abstract

Aim: A novel Left Ventricular (LV) partitioning device (PARACHUTE™) has been developed to treat patients with apical dysfunction after post-anteroapical Myocardial Infarction (MI) and with Heart Failure (HF) symptoms. The goal of the LV partitioning is to partition dysfunctional myocardium and decrease LV size while improving the efficacy of LV mechanics, provide myocardial unloading and improve patient clinical status. Method: The PARACHUTE ™ device is implanted percutaneously under light sedation in a one-hour cath lab procedure. The LV volume and systolic function data were determined with standard echocardiographic techniques. Primary safety and efficacy end-point were device related MACE at 6 months post implant and change in systolic function. Data were analyzed in 8 patients treated with the PARACHUTE™ at the Cardiology Clinic, University Clinical Centre of Serbia. Results: In non-randomized clinical trial, the PARACHUTE™ was implanted in 8 patients. All patients were males, average age 59.7±7.8 years. Average time since MI to Parachute procedure was 63.7 months. We have found no device related MACE at 6 months post implant. Patients reported significant improvement in symptoms at 6 month follow-up compared to a pre-procedure baseline. NYHA Class improved from the mean of 2.4±0.5 to 1.7±0.8 (p<0.01). LV end-diastolic volume changed from 219±23ml at baseline to 177±21ml at 6 months; and LV end-systolic volume changed from 159±26 ml to 122±34ml (all p<0.05). Significant improvement was observed in EF from 27.4±8.7% at baseline to 33.7±11.5% at 6 months (p<0.05). No significant changes in cardiac output was observed at 6 months (4.1±0.9 vs 3.9±1.0L/min, p=ns). Conclusion: These preliminary results demonstrate the potential beneficial clinical effect of the PARACHUTE™ device, warranting further studies in a larger randomized controlled trial.