Nationwide comparison of patients treated with self-expanding versus balloon-expandable valves for TAVI: insights from the netherlands heart registration

Background

As transcatheter aortic valve implantation (TAVI) expands towards younger patients, valve selection has become increasingly important for lifetime management and durability. Randomized trials demonstrated comparable mortality rates between balloon-expandable and self-expanding valves but differences in outcomes such as stroke and permanent pacemaker implantation. However, strict inclusion criteria limit their generalizability. Contemporary large-scale real-world data are therefore needed to assess patient selection and outcomes with different valve types in routine practice.

Purpose

The aim of this study was to characterize patients and compare clinical outcomes among those undergoing TAVI with balloon-expandable versus self-expanding valves in a large, nationwide, contemporary cohort.

Methods

Netherlands Heart Registration data identified patients undergoing TAVI between 2019 and 2024, excluding patients with an unknown implanted valve type and with prior aortic valve intervention. Time-to-event analysis for mortality was performed using Cox proportional hazards regression, adjusting for baseline characteristics and medical history variables associated with mortality in univariable analyses.

Results

A total of 6,922 patients underwent TAVI in the Netherlands between 2019 and 2024. Mean age was 79.9 ± 6.3 years, and 44.9% was female. Median Euroscore II was 3.07% (interquartile range 1.95%–4.87%). Of these, 3,522 (50.9%) patients received a self-expanding valve, while 3,400 (49.1%) received a balloon-expandable valve. Patients who received self-expanding valves were more often female, frail, and more frequently had poor mobility and dyspnea. In contrast, patients who received balloon-expandable valves more often had extracardiac arteriopathy and reduced left ventricular ejection fraction.

Patients receiving balloon-expandable valves experienced stroke with neurological dysfunction during hospitalization less often than those receiving self-expanding valves (1.5% vs. 2.5%; OR 0.60; 95%CI 0.42-0.85; p=0.004). Major vascular complications within 30 days after TAVI were more frequent in patients receiving balloon-expandable valves (2.4% vs. 1.7%; OR 1.45; 95%CI 1.01-2.08; p=0.04). Need for permanent implantation at 30 days was comparable between both groups (9.9% vs. 11.3%; OR 0.86; 95%CI 0.74-1.00; p=0.05). Adjusted mortality up to 4-year follow-up was comparable between patients receiving balloon-expandable and self-expanding valves (37.6% vs. 34.7%; HRadj 1.10; 95%CI 0.99-1.23; p=0.07; Fig. 1).

Conclusion

In this nationwide cohort, balloon-expandable valves were more often implanted in males and patients with extracardiac arteriopathy. Major vascular complications occured more often in patients receiving balloon-expandable valves. In contrast, strokes occurred more often in patients receiving self-expanding valves. The 4-year mortality rate and need for pacemaker implantation was comparable between both groups.Kaplan Meier plot for mortalityFor image description, please refer to the figure legend and surrounding text.