Symetis Acurate Neo transfemoral aortic bioprosthesis — initial Polish experience

Abstract

A b s t r a c tBackground and aim: Transcatheter aortic valve implantation (TAVI) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high-risk and surgically inoperable patients who suffer from severe symptomatic aortic stenosis. With the second generation of TAVI devices improvements in both handling and performance are highly demanded. This brief clinical communication reports the first Polish experience with the second generation of transfemoral TAVI device -Symetis Acurate Neo. Methods: From November 19th 2014 until February 18 th 2015 nine (n = 9) patients with severe symptomatic aortic stenosis have been operated on using the Symetis Acurate Neo. Patients were subject to seven-day evaluation and 30-day phone follow-up. Results:The procedure was safely and successfully performed in all patients. A SMALL (S) valve (21-23 mm equivalent) was used in two patients, MEDIUM valve (M; 23-25 mm equivalent) in five patients, and a LARGE valve (L; 25-26 mm equivalent) in two patients. In three cases post-release balloon dilatation was required. There were no intraoperative complications and no major adverse events (as per VARC classification) during initial hospitalisation, including conduction or rhythm disturbances. In all cases, the mean gradient on the prosthetic valves was 7.8 mm Hg (10.2 mm Hg on the "S" valves). Rapid improvement in patients' functional class was noted. Perivalvular leak was evaluated as "mild" in three cases, "trace" in one, and "not existing" in five.Conclusions: This initial experience with the Symetis Acurate Neo demonstrates its good safety profile and excellent haemodynamics. Low radial stress of the valve results in minimal incidence of atrioventricular rhythm disturbances, and a sealing crown for nearly non-existent paravalvular leak.

First North American experience with the transfemoral ACURATE‐neoTM self‐expanding transcatheter aortic bioprosthesis

“…In order to properly anchor the valve within the aortic annulus, the inflow (subannular) portion of the ACURATE‐ neo TM valve protrudes into the LVOT; but notably, the radial force of this device appears to be less than the CoreValve ® and thus, may account for the lower rate of heart‐bock. The present series shows a relatively low (5.3%) rate of PPI and is comparable to the results of Maeda et al 6.7%, Zembala et al , 0% using the ACURATE‐ neo TM and also compares favorable with the ACURATE‐TA TM registry reporting 10% rate or PPI .…”

“…Importantly, our initial experience using the transfemoral ACURATE‐ neo TM shows 100% procedural success as well as 0% mortality rate at 30 days and 9 months. These results are comparable to those of Maeda et al reporting a 30‐day and 6‐month mortality rate of 0 and 6.7%, respectively, and Zembala et al reporting 0% mortality at 30 days.…”

“…Prior studies reported a dramatic decrease in transvalvular gradients after ACURATE‐ neo TM implantation and there were no PVL greater than grade‐1 . These hemodynamic gradients are also in accordance to those obtained with the CoreValve ® Evolut ® R and SAPIEN‐3 devices and seem better than the findings with the Lotus ® valve reporting transvalvular gradients above the two‐digits (mean 12.4 mm Hg) .…”

Conduction disturbances after transcatheter aortic valve implantation procedures – predictors and management

“…These findings are consistent with our experiences, both with CV and Evolut R prostheses. Similar outcomes were reported in the case of the new Acurate valve generation, as was mentioned before [41]. Only in the case of the new ES prosthesis generation (Sapien 3, ES3) was a higher rate of postprocedural conduction abnormalities and PPM implantations reported when compared to the Sapien XT devices.…”

“…The new version of the Acurate device (Symetis Acurate Neo) implanted via the transfemoral route seems to be less harmful for the conduction system. In the published data the periprocedural PPM implantation rate was not higher than 9% [41–43]. …”