One‐year clinical and echocardiographic outcomes of transcatheter aortic valve replacement with SAPIEN 3 Ultra versus SAPIEN 3. Issue 2 (13th December 2022)

• Record Type: Journal Article
• Authors: Isogai, Toshiaki; Agrawal, Ankit; Shekhar, Shashank; Spilias, Nikolaos; Hodges, Kevin; Yun, James J.; Puri, Rishi; Reed, Grant W.; Krishnaswamy, Amar; Kapadia, Samir R.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 101:Issue 2(2023)
• Page Start: 417
• Page End: 430
• Publication Date: 2022-12-13
• Subjects: balloon‐expandable valve -- hemodynamics -- paravalvular leakage -- SAPIEN 3 Ultra -- transcatheter aortic valve replacement; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.30515
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: Background: The newest‐generation balloon‐expandable valve, SAPIEN 3 Ultra (S3U), is expected to function well with the enhanced sealing skirt compared with SAPIEN 3 (S3). However, current literature on the comparison between these two valves is limited to short‐term follow‐ups. Therefore, we aimed to evaluate the 1‐year outcomes and echocardiographic changes of S3U compared with S3. Methods: We retrospectively identified patients who underwent transfemoral‐transcatheter aortic valve replacement with S3U or S3 (20/23/26 mm) at our institution in 2018–2020. Outcomes were 1‐year clinical events and echocardiographic parameters, and were compared between S3U and S3 after adjustment with inverse probability of treatment weighting. Results: The S3U and S3 groups included 297 (25.7%) and 858 (74.3%) patients, respectively. There were no significant differences between the two groups in clinical events (death 5.8% vs. 5.5%, hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.81–1.90; death or heart failure hospitalization 10.3% vs. 10.1%, HR 1.04, 95% CI 0.67–1.62). The S3U group had a lower prevalence of mild paravalvular leakage (PVL) (13.7% vs. 22.3%, p = 0.044), with similar moderate PVL (0.7% vs. 1.2%, p > 0.99). No significant differences were observed in aortic valve mean gradient and Doppler velocity index at 1 year. However, the S3U group had a larger increase in mean gradient from implantation to 1 year (median +4.70 vs. +1.63 mmHg, p < 0.001). Conclusions: S3U and S3 carried similarly favorable clinical event risks. Nonetheless, S3U was associated with less frequent mild PVL but a larger increase in transprosthetic gradient. Further studies are needed to determine the prognostic impact of these hemodynamic differences.