Two recent articles featured in JACC Cardiovascular Interventions showed that short term (at 30 days) outcomes of patients treated with the next-generation self-expanding Medtronic Evolut R valves could present several advantages compared to the original CoreValve, including recapturability. Both analyses reported similar rates of all-cause mortality and stroke.
The study carried out by Dr. Jeffrey Popma as main investigator reported outcomes for 241 patients who were not suitable candidates for surgery (but who could have undergone surgery nevertheless) and were included in the CoreValveEvolut R US Clinical Study registry. At 30 days, the rate of all-cause mortality was 2.5% and the rate of disabling stroke was 3.3%. Life-threatening or major bleeding occurred in 7.1% of patients.
In the other published study, Dr. Kalra analyzed 264 real-world consecutive patients participating in the UK and Ireland registry. As regards outcomes, the rate of all-cause mortality at 30 days was 2.3% and the rate of stroke was 3.8% (all non-disabling).
In the UK registry, the rate of pacemaker implantation was 14.7%, and the device was implanted a mean of 3 days after the procedure. In the US trial, the rate of pacemaker implantation was 16.4%.
The most notorious difference between these studies was related to the rates of paravalvular leak, for which one of the studies reported moderate or severe leak in 7.7% of patients and, in the other, the rate was lower (5.3%), all leaks were moderate, and no severe cases were reported.
The next-generation CoreValve device, called Evolut R, is a recapturable and repositionable valve implanted through a delivery system of only 14-F.
In the European registry, the average age of patients was 81 years old and the EuroSCORE was 19.9. Approximately 40% of patients received a valve without general anesthesia and only sedation. This is in agreement with the worldwide minimalistic trend in this regard.
Both studies reported a low rate of vascular complications (between 5% and 7%), as expected from a 14-F device.
The rate of pacemaker implantation with first-generation CoreValve devices of around 25% was clearly improved with Evolut R, bringing this valve much closer to results observed with the balloon-expandable valve.
While these outcomes for Evolut R have been recently published, a newer next-generation device, called Evolut R PRO, is already available in some places. This device features a porcine pericardial skirt aimed at reducing the rate of paravalvular leak.
Original title: Early Clinical Outcomes AfterTranscatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients with Severe Aortic Stenosis Who Are Suboptimal for Surgery.
Reference: PopmaJJ et al. J Am CardiolIntv 2017;10:268-275 y Kalra SS et al. J Am CardiolIntv 2017;10:276-282.
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