Abstract 4734: Percutaneous Therapy for Ischemic Heart Failure: Long Term Safety and Efficacy in 33 Patients
A novel left ventricular (LV) partitioning device (PARACHUTE™) has been developed to treat patients with a post-MI regional wall motion abnormality and heart failure (HF) symptoms. The PARACHUTE ™ device is implanted percutaneously in a one-hour cath lab procedure without excising myocardium. The goal of the LV partitioning is to decrease LV size while improving the efficacy of LV mechanics, provide myocardial unloading and improve patient clinical status. In a phase I, non-randomized clinical trial, the PARACHUTE™ was implanted in 33 patients in 12 centers in US and EU. Cumulative survival is 462 months (38 years), with the longest of 43 months (3.5 years). There was one early and three late deaths and total of 10 serious adverse events occurring in 5 patients. Presently we are reporting 6 month follow-up data in 22 patients. Patients reported significant changes in symptoms at 6 month follow-up compared to a pre-procedure baseline. NYHA Class improved from the mean of 2.5±0.6 to 1.3±0.6 (p<0.001); MLHF Questionnaire score improved from 33.1±26.7 to 21.7±21.6 (p<0.01). Exercise capacity measured by the 6 minute hall walk improved from 366±109 meters to 394±120 meters (p<0.02). The hemodynamic data are summarized in the table⇓ below.
Conclusions: These preliminary results demonstrate the potential beneficial effect of the PARACHUTE™ device, warranting further studies in a larger randomized controlled trial.