Original title: Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System. 30-Day Primary Endpoint Results From the REPRISE II Study. Reference: Ian T. Meredith AM et al. J Am Coll Cardiol 2014;64:1339–48.
Transcatheter aortic valve replacement (TAVR) showed results comparable to those of surgery in patients at high surgical risk, but complications can impact long term results. The Lotus valve (Boston Scientific Corporation, Marlborough, Massachusetts) has been designed to overcome first generation device shortcomings, it is completely repositionable and retrievable and has a unique seal to minimize regurgitation.
The REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) is a multicenter study that evaluated this new device to treat symptomatic severe aortic stenosis.
120 patients were included. Patients had an aortic annulus between 19 and 27 cm and were considered at high surgical risk by a multidisciplinary. Patients received the Lotus valve by femoral access. The primary end point was 30 day mortality and secondary end points were safety and efficacy according to VARC criteria. The valve was successfully implanted in all patients, there were no cases of embolization, ectopic valve deployment or need for a second valve. In 26 patients, the valve was repositioned and in 6 retrieved without complications. 34 patients (28.6%) required a permanent pacemaker.
The primary device performance endpoint was met: mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, mortality was 4.2%, and the rate of disabling stroke was 1.7%; only one patient (1%) had moderate regurgitation and none had severe regurgitation.
Conclusion
REPRISE II showed the safety and efficacy of the Lotus valve in patients with severe aortic stenosis at high surgical risk.
Editorial Comment
This new valve incorporates several improvements, one of them is that it starts working almost as soon as it is being opened, which minimizes hemodynamic compromise and allows a more controlled release. It can be fully assessed prior to releasing the delivery system and, in case it was not the correct one, it can be repositioned or recaptured.
Finally, the outer seal made of polyurethane and polycarbonate was designed to adapt to calcic nodule irregularities and minimize paravalvular regurgitation. Given these reasons, this new valve seems promising, though it still has to beat time and the great number of cases intervened with the two preferred valves.
SOLACI