Early Commercial Experience with a Novel Balloon-Expandable Transcatheter Heart Valve: 30-Day Outcomes and Implications of Preprocedural Computed Tomography

 

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Objectives: Due to marked improvements of transcatheter heart valves (THV) and delivery systems, increased operators experience, and advances of imaging modalities, transcatheter aortic valve implantation (TAVI) has become a routine procedure for treatment of aortic valve stenosis. One of the most frequently used THV is the balloon-expandable (BE) Sapien 3 (Edwards Lifesciences Inc., Irvine, CA, US). The recently introduced successor, the Sapien 3 Ultra (S3U) THV system, consists of a larger outer skirt to improve protection against residual paravalvular leakage (PVL) and was initially launched with a preloaded valve delivery system and the novel Axela sheath. We herein report a single-center experience with the S3U balloon-expandable (BE) transcatheter aortic valve implantation (TAVI) system.

Methods: Between 03/2019 and 01/2020, a total of 79 consecutive patients (40.5% female, 79.8 ± 7.1 years, logEuroSCORE I 12.1 ± 8.8%) received transfemoral TAVI using the S3U device. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions. Detailed analysis of multislice computed tomography data (MSCT) data was conducted to identify potential predictors for permanent pacemaker (PPM) implantation and residual paravalvular leakage (PVL) post-TAVI.

Result: Device success and early safety were 97.5% (77/79) and 94.9% (75/79) with resulting transvalvular peak/mean pressure gradients of 21.1 ± 8.2/10.9 ± 4.4 and PVL > mild in 0/79 patients (0%). Mild PVL was seen in 18.9% (15/79) of cases. 30-day mortality was 2.5% (2/79). The VARC-2 adjudicated clinical endpoints disabling stroke, acute kidney injury and myocardial infarction occurred in 1.3% (1/79), 5.1% (4/79) and 0% (0/79) of patients. Postprocedural PPM implantation was necessary in 7.6% (6/79) of patients. MSCT analysis revealed significantly higher calcium amounts of the right coronary cusp in patients in need for postprocedural PPM implantation and a higher eccentricity index in patients with postinterventional mild PVL.

Conclusion: First experience with this novel BE-THV demonstrates excellent 30-day outcomes and hemodynamic results with low mortality, relatively low rates of PPM implantation and no residual PVL > mild. The herein presented MSCT values with an elevated risk for PPM implantation and residual mild PVL may help to further improve outcomes with this particular THV in TAVI procedures.

Publication History

Article published online:
19 February 2021

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