麻豆传媒

A self-expanding aortic bioprosthesis was tied to "very low" mortality and new pacemaker rates comparing favorably to those reported for other transcatheter aortic valve replacement (TAVR) devices, according to European post-market registry data.

Among 1,000 all-comer patients that got the Acurate neo device, just 8.0% died within a year, according to researchers led by Won-Keun Kim, MD, of Kerckhoff Heart Center in Bad Nauheim, Germany, reported in the July 23 issue of .

That rate stood out compared with the 11.8% death rate among Sapien 3 recipients in the SOURCE 3 registry, 16.0% among those getting the CoreValve prosthesis in ADVANCE, and 11.7% for Lotus patients in the RESPOND registry, the researchers suggested.

The 9.9% 1-year pacemaker rate observed in their SAVI-TF registry with Acurate neo was "similar to or better than the pacemaker rate reported in the SOURCE 3 registry (13.6%) using the balloon-expandable Sapien 3 prosthesis and is substantially lower than pacemaker rates reported with the CoreValve and Lotus prostheses," Kim and colleagues added.

Rates of disabling stroke and permanent pacemaker implantation were 2.3% and 9.9%, respectively, at 1 year. Through that first year, there were five reinterventions after TAVR: three valve-in-valve and two surgical aortic valve replacements in the group .

Moreover, 3.6% had more than mild paravalvular leakage and 87.0% were in New York Heart Association class I or II at 1 year. Patients also had a mean effective orifice area of 1.84 cm² and an average gradient of 7.3 mm Hg.

The study population was 81.1 years of age on average upon enrollment in the SAVI-TF registry in 2014-2016. These TAVR patients went into the procedure across 25 European centers with a logistic EuroSCORE of 18.1% and a 6.0% Society of Thoracic Surgeons score. Men made up 38.8% of the group.

The supra-annular Acurate neo has a self-expanding nitinol frame and is implanted in two steps with transfemoral access. It received the CE mark in 2014.

"The Acurate neo is not recapturable, has no external cuff or skirt, and is still implanted through a relatively large-profile (18-F compatible) delivery system. Looking at these characteristics, one may think that this device cannot even aim to compete with the latest self-expanding transcatheter heart valves currently available in clinical practice," noted an . "Here lies the paradox!"

Acurate neo's highly-controlled deployment might drive these "favorable results," wrote the editorialists, Marco Barbanti, MD, and Denise Todaro, MD, both of the University of Catania in Italy.

"[U]nlike other self-expanding devices, the Acurate neo is initially released from the aorta (arches) rather than from the left ventricle outflow tract, with subsequent deployment of the subannular portion (lower crown). This enables stability during valve positioning as well as minimizes hemodynamic compromise during deployment," they added.

"Indeed, the V-shape of the device with the upper crown and stabilizers opened avoids obstruction of antegrade blood flow during the positioning and self-deployment steps, thereby protecting against uncontrolled device movements and/or embolization," Barbanti and Todaro continued.

How the Acurate neo directly compares with the Sapien 3 and CoreValve Evolut lines remains unknown, since the SAVI-TF registry was limited by its single-arm nature and lack of independent event adjudication. Investigators are now enrolling patients in the SCOPE-I and SCOPE-II trials for head-to-head comparisons between the Acurate neo and these devices.