Overview
Transcatheter aortic valve implantation (TAVI), also called transcatheter aortic valve replacement (TAVR), has transformed the treatment of severe aortic stenosis, especially in older adults and patients at higher surgical risk. This nationwide Medicare study examined whether men and women differed in how often they received TAVI, the complications they experienced around the procedure, and their long-term outcomes over a 10-year period in the United States.
The findings highlight a persistent and evolving sex-based pattern. Women made up a smaller share of TAVI recipients over time, experienced more periprocedural complications, yet had slightly better long-term survival than men. These results underscore the importance of sex-specific evaluation and follow-up in structural heart disease.
Why sex differences matter in aortic valve disease
Aortic stenosis occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the body. Over time, this can cause chest pain, shortness of breath, fainting, heart failure, and death if untreated. Although the condition affects both sexes, women and men often differ in clinical presentation, anatomy, referral patterns, and outcomes.
Women with severe aortic stenosis may be older at the time of treatment, may have smaller blood vessels, and may present later in the disease course. Men, on the other hand, often have different patterns of heart remodeling and comorbid disease. These differences can influence candidacy for TAVI, procedural risk, and recovery.
Understanding sex-based outcomes is clinically important because it can help clinicians refine patient selection, counseling, procedural planning, and post-procedure surveillance.
Study design and population
This retrospective, population-based cohort study used US Medicare fee-for-service claims data. The investigators identified beneficiaries discharged after TAVI between January 1, 2013, and December 31, 2022. Patients with concomitant valve surgery, infective endocarditis, valve-in-valve TAVI, transapical TAVI, TAVI for pure aortic insufficiency, or later conversion to Medicare Advantage were excluded to keep the cohort clinically consistent.
In total, 314,123 patients were included, of whom 141,233 were women and 172,890 were men. The median follow-up time was 2.19 years, with an interquartile range of 0.94 to 3.79 years. Analyses were performed between October 1, 2024, and April 1, 2025.
This type of study does not prove cause and effect, but it provides a valuable real-world view of how TAVI has been used and how outcomes have differed by sex across a decade of practice.
Who underwent TAVI?
Women represented 45.0% of the study population, while men represented 55.0%. Women were slightly older than men at the time of treatment, with a mean age of 80.3 years compared with 79.4 years in men. Although the age difference was modest, it suggests that women may be referred for intervention later or may reach treatment with a different clinical profile.
One of the most notable findings was the changing sex distribution over time. The proportion of female patients undergoing TAVI declined from 47.6% in 2013 to 43.6% in 2022. This decline was statistically significant. In practical terms, the study suggests that women became a smaller share of TAVI recipients even as the procedure expanded nationally.
The reasons for this trend are not fully established. Possible contributors include differences in disease recognition, referral behavior, anatomic eligibility, comorbidity burden, and access to care. Further work is needed to determine whether women are being under-referred, whether competing clinical factors are limiting treatment, or whether broader changes in TAVI selection criteria have affected sex distribution.
Periprocedural outcomes: more complications in women
The study found that women had higher rates of several complications around the time of TAVI compared with men.
Periprocedural mortality was 2.5% in women versus 2.2% in men. After adjustment for measured differences between the groups, women had a 20% higher odds of periprocedural death.
Women also had more vascular complications, occurring in 5.8% of women compared with 3.6% of men. Their adjusted odds were 65% higher than those of men. This finding is clinically plausible because women often have smaller peripheral arteries, which can make catheter-based access more challenging and may increase the risk of bleeding or vessel injury.
Bleeding was also more common in women, affecting 10.4% of women compared with 6.8% of men. The adjusted odds of major or life-threatening bleeding were 67% higher in women.
These complications matter because they can prolong hospitalization, increase the need for transfusion or intervention, and negatively affect recovery. They also reinforce the need for careful vascular access planning, imaging review, and bleeding risk reduction strategies in women undergoing TAVI.
Lower pacemaker implantation rates in women
An interesting contrast was seen for permanent pacemaker implantation (PPI). Women had lower rates of pacemaker placement after TAVI than men: 16.9% versus 20.0%. After adjustment, women had an 19% lower odds of requiring PPI.
This result is consistent with prior observations that conduction disturbances after TAVI can differ by sex. The reasons are complex and may relate to valve anatomy, implantation depth, baseline conduction system vulnerability, and differences in procedural characteristics. While the exact mechanisms remain under study, the lower pacemaker rate in women is a reassuring finding in one aspect of the procedure, even though other complications were more common.
Long-term survival and late outcomes
Despite higher early procedural risk, women had better long-term survival after TAVI than men. The adjusted hazard ratio for all-cause mortality was 0.92, indicating an 8% lower hazard of death over follow-up in women.
This survival advantage is modest but consistent and clinically meaningful in a large cohort. It suggests that women who survive the early post-procedure period may do slightly better over time than men. The explanation is likely multifactorial and may reflect differences in baseline risk, myocardial adaptation, disease phenotype, or unmeasured social and clinical factors.
At the same time, women had higher risks of later hospitalization for heart failure, acute myocardial infarction, stroke, and bleeding. This combination is important: better overall survival does not mean lower morbidity. Women may live longer but still experience more cardiovascular events that require ongoing monitoring and treatment.
The pattern indicates that post-TAVI care should not stop after discharge. Instead, women may benefit from structured follow-up focused on blood pressure control, antithrombotic management, symptom surveillance, and early recognition of heart failure or cerebrovascular events.
What these findings may mean for clinical practice
This study supports several practical implications for clinicians and health systems.
First, sex should be considered more explicitly during referral and evaluation for TAVI. Women may be underrepresented relative to their disease burden, and a declining share over time raises the question of whether access or selection is fully equitable.
Second, procedural planning should account for anatomy and vascular risk. Pre-procedure CT assessment, access-site selection, sheath size optimization, and bleeding avoidance strategies may be especially important in women.
Third, because women had more late heart failure, stroke, and bleeding events, follow-up should be proactive rather than reactive. Medication reconciliation, rhythm monitoring when appropriate, and individualized antithrombotic therapy are likely important parts of care.
Fourth, the findings remind clinicians that early complications and long-term outcomes can point in different directions. A group with higher procedural risk may still show better survival later, so both phases of care need attention.
Possible reasons behind the sex-based patterns
The study does not prove why these differences exist, but several biologically and clinically plausible factors may contribute.
Women often have smaller iliofemoral vessels, which can increase the technical difficulty of transfemoral access and raise bleeding or vascular complication risk. They may also have more concentric left ventricular remodeling and different patterns of valve calcification, which can affect procedural planning.
Men may carry a higher burden of atherosclerotic disease or conduction abnormalities, potentially explaining some of the differences in late outcomes and pacemaker implantation. Social factors may also influence the timing of referral, symptom reporting, and follow-up care.
Importantly, many claims-based studies cannot fully measure valve anatomy, frailty, functional status, symptom severity, or operator technique. Therefore, some apparent sex differences may reflect factors that are not directly captured in administrative data.
Strengths and limitations
This study has several strengths. It includes a very large, nationwide Medicare cohort, offers a decade of real-world data, and captures both short-term and long-term outcomes. The large sample size provides strong statistical power to detect meaningful differences between women and men.
However, there are also important limitations. Because the study relied on claims data, it lacked detailed clinical information such as echocardiographic measurements, valve anatomy, frailty measures, and procedural specifics. Residual confounding is possible even after adjustment. The results apply primarily to older US adults covered by Medicare fee-for-service, so they may not generalize fully to younger patients or other health systems.
In addition, observational data can identify associations but cannot determine whether sex itself causes the observed differences. Some outcomes may be influenced by unmeasured differences in baseline risk, access to care, operator experience, or hospital practice patterns.
Bottom line
In this nationwide Medicare analysis, women accounted for a shrinking proportion of TAVI recipients over time, had higher rates of periprocedural mortality, vascular injury, and bleeding, but lower rates of pacemaker implantation and slightly better long-term survival than men.
The study highlights the need for more sex-aware approaches to patient selection, procedural planning, and post-TAVI follow-up. As TAVI continues to expand, understanding and addressing sex-based disparities will be essential to achieving the best outcomes for all patients.
