1-Year Outcomes of US TAVR Registry with 5th Generation Balloon Expandable Valves

The use of transcatheter aortic valve replacement (TAVR) has extended to younger patients with lower risk severe aortic stenosis (AS) and therefore the improvement of hemodynamic variables and valve durability have become key factors for valve selection decision making. There have recently been favorable reports of short term hemodynamic benefits with the balloon expandable SAPIEN 3 Ultra Resilia (S3UR). However, long term outcomes have not been reported. 

The aim of this study was to compare 1-year clinical and echocardiographic outcomes the S3UR vs SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the STS/ACC TAVR registry.

The primary end point included mortality, stroke and a composite of one-year mortality and stroke. The secondary end point consisted of echocardiographic and functional outcome analysis between groups.   

Results: 1-Year Outcomes of TAVR with SAPIEN 3 Ultra Resilia (S3UR) Valve in Patients with Aortic Stenosis

A total 4,598 patients treated with S3UR were propensity matched with 4.598 and 32.536 patients treated with S3 and S3U, respectively. Mean patient age was 76, and they were mostly men. Mean STS was 3.6. The 26 mm valve was most frequently implanted, followed by the 23 mm. According to the Heart Team, 30.4 % of S3UR patients and 32.8 % of S3 and S3U patients presented intermediate risk (P = 0.01). Approximately 37 % of patients were classified as low risk.

At discharge, the effective valve rea was larger among S3UR patients (P < 0.0001). Lower discharge mean gradient was maintained at 30 days and 12 months (P < 0.0001 for all cases).  

Read also: EuroSMR Registry: Edge-to-Edge Mitral Treatment with 5-Year Outcomes.

At 1 year, results were the following:

• All-cause mortality: 7.6 % of S3UR vs 9.7 % of S3 and S3U patients (HR: 0.8; 95 % CI: 0.67-0.93; P = 0.004).
• Mild or greater paravalvular leak (PVL): 15.6 % of S3UR vs 18.5 % of S3 and S3U patients (HR: 0.82; 95 % CI: 0.69-0.97; P = 0.02).
• Life threatening bleeding: 2.0 % of S3UR vs 2.7 % of S3 and S3U patients (HR: 0.7;  95 % CI: 0.54-0.94; P = 0.03).

In low risk patients, both the use of S3UR and the presence of mild or greater PVL were predictors of mortality at 1 year. 

Conclusion 

The use of S3UR in TAVR procedure was associated with superior clinical and echocardiographic outcomes at 1 year vs. S3 and S3U, especially in low risk patients. Also, there was a lower rate of PVL, larger effective valve area, lower echocardiographic gradient and lower reintervention incidence. Further studies with longer follow-up are needed to validate these findings.

Original Title: 1-YearReal-World Outcomes of TAVR with the Fifth-Generation Balloon-Expandable Valve in the United States.

Reference: AnnapoornaS.Kini,MD et al JACCCardiovasc Interv. 2024.