TCT-380 Hemodynamic Effects of a Catheter-Deployed Intra-Aortic Micro-Axial Entrainment Pump in a Porcine Acute HF Model

Abstract

Background: This study examined the hemodynamic effects of Procyrion's catheter-deployed, partial circulatory support device in a porcine acute heart failure (HF) model. Long-term circulatory support (LTCS) is currently limited to large devices with invasive and risky surgical implantations and therefore is restricted to NYHA Class IV HF patients. In contrast, Procyrion's device is an intra-aortic micro-axial entrainment pump implanted with cath-lab techniques and is intended for LTCS in earlier stage HF patients. Methods: The pump was deployed in the thoracic aorta and anchored using selfexpanding struts. Acute cardiac dysfunction was induced via continuous esmolol infusion until cardiac contractility was 50% of the pre-esmolol baseline. Hemodynamic effects were recorded using a pressure-volume catheter (left ventricle), a flow probe (renal artery) and pressure catheters (aorta and renal artery). Effects were evaluated from changes in hemodynamic parameters between baseline (device off) and device on. Results: The intra-aortic pump increased cardiac output, stroke volume, ejection fraction, and renal flow and pressure while decreasing cardiac stroke work, afterload and end-diastolic pressure.Conclusions: This study demonstrates that the catheter based intra-aortic fluid entrainment pump improves porcine acute HF hemodynamics. Additionally, improved renal perfusion may enhance HF treatment and disrupt cardiorenal syndrome. These results suggest the intra-aortic pump has the potential to improve HF outcomes and quality-of-life by resting the heart, promoting reverse remodeling and augmenting end-organ perfusion.Background: Left ventricle (LV) remodeling after anterior wall myocardial infarction (AWMI) leads to increased LV volumes, myocardial stress, and ultimately heart failure (HF). Treatment options are limited for these high-risk HF patients. Two prior first-in-man studies of PVR using the Parachute TM device support the safety and efficacy of this approach. An ongoing study (Cohort B) was designed to confirm these observations and to evaluate an extended range of 8 device sizes, prior to launching a U.S. pivotal randomized controlled trial. Methods: Aims: To confirm the acute safety and acute and long-term efficacy of PVR using an expanded range of Parachute TM device sizes in patients with ischemic HF with prior AWMI. Methods: Up to 60 patients with NYHA class II-IV HF secondary to AWMI, with akinetic or dyskinetic wall motion abnormality, LV ejection fraction Ͻ 40%, and have been fully revascularized are being enrolled into this non-randomized trial at 15 European sites. Major endpoints were death and repeat hospitalization.Results: As of June 1, 2012, 38 patients were treated. Parachute was implanted successfully in all patients. There were no procedural (nϭ38) or 30-day (nϭ34) stroke or death observed. Enrollment and 6 month FU on 30 patients will be completed by October 1, 2012. Results will be available for presentation. Conclusions: This ongoing trial of PVR using an expanded range of Parachute TM devi...