Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions.

OBJECTIVES: Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.
METHODS: Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.
RESULTS: 21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.
CONCLUSIONS: Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.