Sex-Based Differences in Outcomes With Transcatheter Aortic Valve Therapy
Key result
Female sex is linked to ~27% lower 1-year mortality after TAVR despite higher vascular complications.
- HR 0.73
- 95% CI 0.63 to 0.85
- P<0.001
- n=23,652
Why the study?
A differential impact of sex had been observed in TAVR outcomes from small observational studies and subgroup analyses of randomized trials.
Do in-hospital and 1-year outcomes differ between female and male patients undergoing transcatheter aortic valve replacement?
Key Points
- To evaluate sex-specific in-hospital and 1-year clinical outcomes among patients undergoing transcatheter aortic valve replacement (TAVR).
- Analyzed national data from the STS/ACC Transcatheter Valve Therapy Registry linked to CMS records for 23,652 patients (11,808 women and 11,844 men) undergoing TAVR between 2011 and 2014.
- Applied multivariable logistic regression for in-hospital outcomes and Fine-Gray competing risk models for nonfatal 1-year outcomes.
- In-hospital vascular complications were significantly higher in women than in men (8.27% vs. 4.39%; adjusted HR: 1.70; 95% CI: 1.34–2.14; p < 0.001), alongside a trend toward increased bleeding (8.01% vs. 5.96%; adjusted HR: 1.19; 95% CI: 0.99–1.44; p = 0.06).
- One-year mortality was significantly lower in women compared to men (21.3% vs. 24.5%; adjusted HR: 0.73; 95% CI: 0.63–0.85; p < 0.001).
Study Design
Type
Observational (n=23,652)
Multicenter
Yes
Structured PICO
Do in-hospital and 1-year outcomes differ between female and male patients undergoing transcatheter aortic valve replacement?
P
Population
23,652 patients (49.9% female) undergoing TAVR from the U.S. nationwide registry between 2011 and 2014, evaluated for in-hospital and 1-year outcomes.
E
Exposure
Female sex (patients undergoing TAVR)
C
Comparator
Male sex (patients undergoing TAVR)
O
Outcome
In-hospital outcomes (vascular complications, bleeding) and 1-year mortalityhard clinical
Main Result
Hazard Ratio: 0.73 (95% CI 0.63–0.85)
Absolute Event Rate: 21.3% vs 24.5%
p-value: p=< 0.001
Female patients undergoing TAVR have a higher risk of in-hospital vascular complications but superior 1-year survival compared to male patients.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These studies can inform future quality improvement initiatives and point to potential adjunctive therapies or interventions that may be administered in a sex-specific manner but with the overall goal of improving quality of life and survival for both sexes.”
“Sex differences in outcomes after TAVR remain incompletely understood. Earlier studies described a 'sex paradox,' with women experiencing more procedural complications, but similar or superior survival compared with men. However, most data derive from earlier device generations, and contemporary evidence is limited.”
MSMolly SzerlipInterventional cardiologist, Heart Hospital Baylor Plano
“We thought that women had a survival advantage, [but] it may have been that men had a disadvantage and once we leveled the playing field it equalized.”
Implication
May support sex-specific TAVR risk discussions; hypothesis-generating and requires prospective validation before practice change.
Abstract
BACKGROUND: A differential impact of sex has been observed in transcatheter aortic valve replacement (TAVR) outcomes from small observational studies and subgroup analyses of randomized trials. OBJECTIVES: The goal of this study was to compare the in-hospital and 1-year outcomes in male and female subjects from the U.S. nationwide TAVR registry. METHODS: National data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Multivariable logistic regression adjustment was performed for in-hospital outcomes. Fine-Gray models were used for nonfatal 1-year outcomes to account for the competing risk of death. RESULTS: From 2011 to 2014, a total of 11,808 (49.9%) women and 11,844 (51.1%) men underwent TAVR. Compared with male patients, female patients were older, with a lower prevalence of coronary artery disease, atrial fibrillation, and diabetes but a higher rate of porcelain aorta, lower glomerular filtration rate, and higher mean Society of Thoracic Surgeons score (9.0% vs. 8.0%; all p < 0.001). Women were treated more often by using nontransfemoral access than men (45.0% vs. 34.0%). Despite using smaller device sizes, women achieved valve cover index ≥8% more often than men (66% vs. 54%). In-hospital vascular complications were higher in women (8.27% vs. 4.39%; adjusted hazard ratio [HR]: 1.70; 95% CI: 1.34 to 2.14; p < 0.001) and a trend toward higher bleeding (8.01% vs 5.96%; adjusted HR: 1.19; 95% CI: 0.99 to 1.44; p = 0.06) was observed; however, 1-year mortality was lower (21.3% vs. 24.5%; adjusted HR: 0.73; 95% CI: 0.63 to 0.85; p < 0.001) in women than in men. CONCLUSIONS: Female patients undergoing TAVR had a different risk profile compared with male patients. Notwithstanding a greater adjusted risk for in-hospital vascular complications, 1-year adjusted survival was superior in female patients.
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Cite This Study
Chandrasekhar et al. (2016) conducted an observational in Transcatheter aortic valve replacement (n=23,652). Female sex vs. Male sex was evaluated on 1-year mortality (HR 0.73, 95% CI 0.63 to 0.85, p=< 0.001). Female patients undergoing TAVR had lower 1-year mortality compared with male patients, despite higher vascular complications.