Late Clinical Outcomes of Balloon-Expandable Valves in Small Annuli: Results From the PARTNER Trials.

BACKGROUND

Short-term clinical outcomes after transcatheter aortic valve replacement (TAVR) are similar in individuals with small or large annuli. The longer term impact of prosthesis-patient mismatch (PPM) and mean gradient (MG) post-TAVR in these patients remains controversial.

OBJECTIVES

The aim of this study was to investigate 5-year outcomes in patients with small vs large annuli.

METHODS

Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 intermediate-risk registry and the PARTNER 3 low-risk randomized controlled trial were grouped according to small (≤430 mm2) or large (>430 mm2) annular size. The primary endpoint was a composite of all-cause death, disabling stroke, or heart failure hospitalization. In addition, the relationships between both PPM and post-TAVR MG and clinical outcomes were analyzed.

RESULTS

In total, 1,355 patients were included: 476 with small annuli (376.7 ± 41.9 mm2) and 879 with large annuli (518.3 ± 58.0 mm2). Patients with small annuli were older (age 79.6 ± 7.1 years vs 78.7 ± 7.8 years; P = 0.047), were more often female (75.0% vs 16.2%; P < 0.0001), had higher baseline Society of Thoracic Surgeons scores (4.3% ± 1.93% vs 4.0% ± 1.93%; P < 0.0001), and had higher left ventricular ejection fractions (66.3% ± 15.82% vs 59.7% ± 13.68%; P < 0.0001). Primary endpoint rates were similar at 1 year (7.8% vs 8.0%; P = 0.94) and 5 years (36.3% vs 35.8%; P = 0.83). Bioprosthetic valve failure was infrequent at 5 years in both groups (2.9% vs 2.1%; P = 0.46). Among female patients, outcomes were similar for small vs large annuli (primary endpoint; 33.6% vs 34.2%; P = 0.90). Among patients with small annuli, there was no association between 5-year outcomes and any severity of PPM (P = 0.22) or 30-day MG (P for nonlinearity = 0.96).

CONCLUSIONS

Five-year clinical outcomes were excellent and comparable between patients with small vs large aortic annuli. Outcomes in patients with small annuli were not affected by 30-day MG or PPM.