CoreValve has advantages over cardiac surgery in Aortic Stenosis patients- Medtronic

Medtronic plc has revealed new one-year clinical data showing that transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve System offers advantages in survival and safety compared to surgical aortic valve replacement (SAVR) in high risk Aortic Stenosis patients who have previously undergone coronary artery bypass grafting (CABG) surgery. This is the first analysis to evaluate a self-expanding valve in prior-CABG patients within a trial of TAVR and SAVR.

Presented at the 2015 Annual Meeting of The Society of Thoracic Surgeons (STS), the post-hoc sub-analysis of the High Risk Study of the CoreValve U.S. Pivotal Trial included 226 prior-CABG patients who were either treated with TAVR (N=115) or SAVR (N=111). At one year, there was a significant difference favoring TAVR with CoreValve in the combined primary study endpoint of all-cause mortality or major stroke with an incidence of 11.4 percent in the TAVR group vs. 21.8 percent in the SAVR group (p=0.04). Additionally, there was a trend towards a survival advantage for patients who received TAVR with CoreValve compared to SAVR (90.4 percent vs. 81.9 percent, respectively; p=0.06) and lower rates of cardiovascular mortality (7.0 percent vs. 13.8 percent, respectively; p=0.10).

The analysis also showed reduced complications for patients receiving TAVR vs. SAVR at one year, including lower rates of acute kidney injury (5.3 percent vs. 16.3 percent; p=0.007), life threatening or disabling bleeding (14.0 percent vs. 43.5 percent; p<0.001), as well as lower macce with the tavr-treated patients 17.5 percent vs. 28.1 percent respectively p="0.05)." there was no difference in the overall rates of all stroke 10.6 percent vs. 14.3 percent p=""><0.40) or major stroke 8.8 percent vs. 6.6 percent p=""><0.54) between the two patient groups.>

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 valves are available in the US and EU and the first was produced by Edwards LifeSciences (Sapien), followed by Medtronic (Core Valve).The Lotus Heart Valve from Boston Scientific has a CE Mark and the Portico Heart Valve from St Jude Medical has its CE Mark temporarily suspended.