Severe Aortic Valve Prosthesis-Patient Mismatch Higher in Women

Women and men with aortic stenosis and small annuli have a similar incidence of all-cause mortality in medium-term follow-up of transcatheter aortic valve implantation (TAVI). Incidence of severe prosthesis-patient mismatch predischarge is higher in women than men and incidence of all-cause mortality is higher in women with severe prosthesis-patient mismatch than those with less than severe prosthesis-patient mismatch, according to study findings published in the International Journal of Cardiology.

Investigators sought to evaluate transvalvular hemodynamics and clinical outcomes in patients with small aortic annuli receiving TAVI stratified by sex. The primary outcome was all-cause mortality. The secondary outcome was incidence of predischarge severe prosthesis-patient mismatch and its association with all-cause mortality.

They conducted the retrospective, observational TAVI-SMALL 2 international registry from June 2011 to April 2020. The registry included 1378 patients treated with transfemoral implantation of current-generation self-expanding (Portico, Abbott Vascular, Santa Clara, California; Acurate neo, Boston Scientific, Marlborough, Massachusetts; Evolut R and Evolut Pro, Medtronic, Minneapolis, Minnesota) and balloon-expandable valves (Sapien 3, Edwards Lifesciences, Irvine, California) for severe native aortic valve stenosis and small aortic annuli (annular perimeter <72 mm or area <400 mm²) at 16 high-volume centers. Patients with valve-in-valve procedures, TAVI for pure aortic regurgitation, or lack of preprocedural computed tomography data were excluded.

At baseline there were 1233 women (89.5%) and 145 men (10.5%) with aortic stenosis and small aortic annuli treated with transfemoral TAVI. Women compared with men were older (83.1 years vs 80.9 years; P <.001) and had lower height, weight, and body surface area (all P <.001). Hypertension was more common in women, but comorbidities of coronary artery disease, peripheral artery disease, chronic obstructive pulmonary disease, dyslipidemia, previous myocardial infarction, and percutaneous coronary intervention were more common among men. There were no significant between-group differences in atrial fibrillation, diabetes mellitus, or the Society of Thoracic Surgeons Predicted Risk of Mortality.

Propensity score-matching 1:1, women vs men, resulted in 99 pairs with no significant difference in any baseline characteristic.

At median follow-up of 377 days (IQR, 168-700 days), investigators found no difference between women vs men in incidence of all-cause mortality overall (10.3% vs 9.8%; P =.842) and in propensity score-matched populations (8.5% vs 10.9%; P =.586). They found no between-sex difference in cardiovascular mortality (P =.307), acute kidney injury (P =1.000), transient ischemic attack or stroke (P =.789), myocardial infarction (P =.375), or hospitalization for heart failure (P =.734).

There was no evidence of a difference in predischarge severe prosthesis-patient mismatch after propensity score matching (P =.275) though prosthesis-patient mismatch was numerically higher in women (10.2%) vs men (4.3%). Women in the overall population with severe prosthesis-patient mismatch suffered a higher incidence of all-cause mortality vs women with less-than-severe prosthesis-patient mismatch (log-rank P =.027) and less-than-moderate prosthesis-patient mismatch (log-rank P =.024). In the overall population and after propensity score matching, women were at increased risk for major vascular complications and major bleeding with borderline significance.

Significant study limitations include the possibility of selection or confounding bias, as well as the possibility of missing data. The sample size is also underpowered for men.

“No difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI,” the study authors wrote. “Incidence of predischarge severe PPM [prosthesis-patient mismatch] was numerically higher in women than men, and it was associated with increased all-cause mortality in women.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.