Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves

Abstract

BackgroundConduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve.MethodsWe included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge.ResultsNo significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer’s guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001).ConclusionNo significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Early clinical outcomes of Portico and Edwards Sapien 3 valve prosthesis in transcatheter aortic valve replacement: propensity-matched analysis

“…The 30-day mortality of 3.7% associated with Portico valve prostheses is comparable to earlier reported mortality rates in other trials ( 11 – 14 ). In contrast, the ES3 group showed a relatively low 30-day mortality rate of 0.9%, which aligns with previously reported data ( 15 , 16 ). Considering the preprocedural calculated EuroScore II for each group, the expected mortality rates were anticipated to be quite similar.…”

“…For instance, Murray et al reported a rate of 25.5% ( 18 ), followed by De-Torres et al reporting a rate of 19.1% in 2016 ( 19 ). Most recently, Monizzi et al described a substantially lower rate of 6.3% in 2022 ( 16 ). The rate of 13.1% of PPM implantation in ES3 in our study aligns with the decreasing trend reported in previous studies.…”