Prosthesis‐patient mismatch after transcatheter implantation of contemporary balloon‐expandable and self‐expandable valves in small aortic annuli

Abstract

BackgroundEvidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted.AimsTo assess the clinical impact of prosthesis‐patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon‐expandable (BEV) and self‐expandable valves (SEV) in patients with small annuli.MethodsTAVI‐SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral TAVI at 16 high‐volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all‐cause mortality. Predictors of all‐cause mortality and PPM were investigated.ResultsAt a median follow‐up of 380 days (interquartile range: 210–709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all‐cause mortality when compared with less than moderate PPM (log‐rank p = 0.046). Severe PPM predicted all‐cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27–21.2) and intra‐annular valves (IAVs, HR: 4.23, 95% CI: 1.28–14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95–8.79). Supra‐annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13–0.83).ConclusionsPatients with small aortic annuli and severe PPM after TAVI have an increased risk of all‐cause mortality at early term follow‐up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.

Incidence, Implications, and Treatment of Patients With Severe Aortic Stenosis and Small Aortic Annulus

“…10 TAVR prostheses may have improved hemodynamic performance relative to comparably sized surgical prostheses, but there are important differences between approved devices. 11…”

Prosthesis-patient mismatch in transcatheter and surgical aortic valve replacement

“…Less PPM may be seen with oversizing the valve ( 28 ) and balloon post-dilation ( 31 ). Multiple studies show a significantly higher incidence of severe PPM with the balloon-expandable valve compared to the self-expandable valve ( 39 , 40 ). The TAVI-SMALL 2 registry enrolled 628 patients in an international retrospective registry, which included patients with severe AS and small annuli (annular perimeter <72 mm or area <400 mm 2 ); of note, the mean age—83 years and 89% were women ( 40 ).…”

“…Multiple studies show a significantly higher incidence of severe PPM with the balloon-expandable valve compared to the self-expandable valve ( 39 , 40 ). The TAVI-SMALL 2 registry enrolled 628 patients in an international retrospective registry, which included patients with severe AS and small annuli (annular perimeter <72 mm or area <400 mm 2 ); of note, the mean age—83 years and 89% were women ( 40 ). This study confirmed that balloon-expandable and intra-annular valves predicted the presence of severe PPM in small annuli.…”

Hemodynamics after TAVR matter

“…There was a greater impact of PPM on mortality in patients receiving intra-annular and balloon-expandable prostheses with a protective effect for supra-annular prostheses. 3 In addition to the observational design, limitations of this analysis include the mix of valve prostheses, the timing of assessment predischarge rather than at 30 days when flow becomes more normal, the inclusion of older generations of devices utilized from 2011 to 2020, and the absence of a core echocardiographic laboratory. Despite these limitations, the core concept that adverse hemodynamics after bioprosthetic aortic valve replacement affect outcomes is clear.…”