Mid-Term Outcomes of Balloon-Expandable Aortic Valve-in-Valve Replacement in the United States.

BACKGROUND

Aortic valve-in-valve (AViV) replacement for is approved for patients with degenerated surgical valves at high or prohibitive surgical risk, mostly on the basis of small series with short-term follow-up.

OBJECTIVES

The aim of this study was to analyze the outcomes of AViV therapy using contemporary balloon-expandable valves (BEVs) in a large series with mid-term outcomes.

METHODS

BEV AViV patients (June 2015 to December 2023) in the Society for Thoracic Surgeons (STS)/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were propensity matched to native transcatheter aortic valve replacement (TAVR) patients. Primary analysis included death and stroke at 5 years. Comparisons were also made on the basis of STS score, BEV subtype, and stented vs stentless index surgical valve type.

RESULTS

In total, 14,474 AViV patients were matched to 385,556 TAVR patients (13,638 pairs). The mean age was 74 years, and the mean STS Predicted Risk of Mortality was 6.1%. Emergency cardiac surgery (0.2%) and bioprosthetic valve fracture (22%) were infrequent. Death (43.1% vs 55.2%; P < 0.001), stroke (10.5% vs 11.8%; P < 0.001), and their composite were lower for AViV compared with TAVR at 5 years with similar findings at each STS tertile. The SAPIEN 3 Ultra RESILIA device demonstrated lower discharge echo gradients for all sizes (20 mm, 19.4 mm Hg vs 23.8 mm Hg; 23 mm, 15.1 mm Hg vs 19.2 mm Hg; 26 mm, 12.1 mm Hg vs 15.1 mm Hg; and 29 mm, 8.6 mm Hg vs 12.1 mm Hg). There was no difference in death or stroke at 5 years for stentless vs stented surgical valves (42.9% vs 46.0%; P = 0.12).

CONCLUSIONS

This large, real-world analysis confirms the safety and durability of AViV compared with TAVR at all surgical risk levels at mid-term follow-up. Consideration may be given to broadening the indication for AViV.