Clinical data for CoreValve device shows significant improvement in QoL for aortic stenosis- Medtronic

Medtronic unveiled new clinical data that showed positive clinical outcomes at one year for the CoreValve System in new aortic stenosis patient populations with significant co-morbidities. New data on 109 patients with failed surgical valves in the Expanded Use Study showed a low rate of all-cause mortality (13.4%) and major stroke (3.1%) at one year. These rates included patients with small surgical valve sizes (17 mm inner diameter) who had not been previously studied. Importantly, all patients demonstrated a statistically significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an average improvement of 31.8 at one year (P<0.001) on the 100-point scale. Additionally, 93.6% of the initial 109 patients were in NYHA class III and IV at baseline, and in the surviving patients at one year, 73.2% were in NYHA Class I. Patients in the Valve-in-Valve study also experienced a low rate of moderate aortic regurgitation (6.4%) with no cases of severe regurgitation (0.0%), and benefited from strong haemodynamic performance with a mean gradient of 16.5 mmHg at one year despite placement within small surgical valves.

Findings from the low gradient aortic stenosis (LG-AS) patient population within the Expanded Use Study were also comparable to the CoreValve Extreme Risk Study. Patients with LG-AS treated with the self-expanding valve had a low rate of all-cause mortality or major stroke whether or not they had LG-AS with normal ejection fraction (26.0% for LG-NEF, n=113) or LG-AS with low ejection fraction (26.3% for LG-LEF, n=46). The KCCQ score confirmed the patients' improvement in quality of life at one year with average improvements of 25.8 (LG-NEF) and 30.5 (LG-LEF) points, respectively. Results from three patient populations evaluated within the CoreValve US Expanded Use Study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium.

Comment: Trans aortic valve replacement (TAVR) – artificial heart valves – are the leading cardiology advance since the introduction of cardiac drug-eluting stents. The TAVR valves allow a less invasive catheter-based implantation of the valve making the procedure possible for the elderly who are too frail for open heart surgery. TAVR is available in the US and EU and the first was produced by Edwards LifeSciences (Sapien), followed by Medtronic (CoreValve). The Lotus Heart Valve from Boston Scientific and the Portico Heart Valve from St Jude Medical have a CE Mark.