Abstract
Background/Objectives: Aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and imposes an increasing burden on aging populations. Although transcatheter aortic valve implantation (TAVI) has transformed the treatment of severe AS, current guidelines do not differentiate management based on gender. This study aimed to investigate gender-based differences in procedural complications and one-year clinical outcomes in patients treated with next-generation self-expandable TAVI devices. Methods: This retrospective, multicenter international registry included 3862 consecutive patients who received either the ACURATE neo or Evolut R/Pro valve. Patients were stratified by gender; propensity score matching (PSM) adjusted for baseline differences. The primary endpoint was a composite of all-cause mortality or stroke at one year. Secondary endpoints included major vascular complications, major or life-threatening bleeding and acute kidney injury (AKI). Results: Of 3353 patients included (64.5% female), women were older (82.3 ± 5.6 vs. 81.1 ± 6.2 years, p < 0.001) and had higher STS scores (5.2 ± 3.9 vs. 4.5 ± 3.4%, p < 0.001). In the unmatched population, major vascular complications occurred in 7.7% of females versus 4.1% of males (p < 0.001), life-threatening bleeding in 2.8% vs. 1.4% (p = 0.016) and AKI in 8.5% vs. 5.7% (p = 0.009). After PSM, the primary endpoint was more frequent in females (9.4% vs. 6.0%, p = 0.014), largely driven by stroke (2.8% vs. 1.2%, p = 0.024), while overall mortality was similar (11.3% vs. 9.5%, p = 0.264). Conclusions: Despite comparable long-term survival, female patients undergoing TAVI with self-expandable valves experience higher rates of procedural complications, notably stroke and major vascular events. These findings underscore the need for tailored procedural strategies to improve outcomes in female patients.
1. Introduction
Aortic stenosis (AS) is the most common form of valvular heart disease in developed countries, particularly affecting the elderly population [,]. Without valve replacement, symptomatic severe AS is associated with high mortality []. In recent years, transcatheter aortic valve implantation (TAVI) has transformed the treatment of AS, expanding from high-risk patients to those at intermediate and lower surgical risk [,,].
Despite the widespread adoption of TAVI, gender-based differences in clinical outcomes remain underexplored. Women undergoing TAVI often present distinct clinical and anatomical characteristics compared to men, including older age and smaller vascular dimensions, which may influence procedural risks and outcomes [,]. However, current clinical guidelines do not differentiate management based on gender, and existing evidence regarding gender-specific outcomes remains conflicting [,,].
Understanding these differences is crucial for optimizing procedural planning and improving outcomes. Recent studies have suggested higher rates of procedural complications such as major vascular events, bleeding and stroke in female patients, but data remain limited, particularly for next-generation self-expandable valves [,,,,,,,,].
This study aims to address this gap by evaluating gender-based differences in procedural complications and one-year clinical outcomes among patients treated with ACURATE neo or Evolut R/Pro valves. Using a large real-world registry and propensity score matching, we sought to isolate the effect of gender while adjusting for baseline characteristics, providing new insights to guide gender-specific strategies in TAVI.
2. Materials and Methods
2.1. Study Design and Population
This retrospective, multicenter, international registry analysis evaluated patients who underwent TAVI using two next-generation self-expandable bioprostheses, ACURATE neo and Evolut R/Pro valves. Data were collected from consecutive patients at European high-volume TAVI centers. The aim was to assess gender-based differences in clinical characteristics, procedural outcomes and one-year clinical endpoints. Initially, 3862 consecutive patients were included in the registry. For the purposes of this analysis, patients were divided into two cohorts based on gender (male and female). Exclusion criteria were limited to patients with incomplete follow-up data or missing key procedural or outcome parameters.
2.2. Propensity Score Matching
To account for differences in baseline characteristics and pre-procedural risk factors, a PSM analysis was performed. Propensity scores were generated using logistic regression that incorporated all relevant baseline covariates, including age, body mass index (BMI), comorbid conditions (e.g., diabetes, chronic obstructive pulmonary disease (COPD), peripheral arterial disease [PAD] and prior cardiac surgery) and echocardiographic parameters (e.g., valve area and left ventricular ejection fraction). A 1:1 matching without replacement was applied to pair male and female patients, ensuring that matched pairs had similar baseline characteristics and thereby enabling a more accurate comparison of outcomes between the two groups.
2.3. Study Endpoints
The primary endpoint was a composite of all-cause mortality or stroke (disabling and non-disabling) at one year following TAVI. Secondary endpoints included the individual components of the primary endpoint (all-cause mortality and stroke) as well as other clinically significant procedural complications, including major vascular complications, major bleeding, life-threatening bleeding, cardiac tamponade, AKI, the need for blood transfusion, new permanent pacemaker implantation and hospital readmission for heart failure (HF).
2.4. Data Collection
All clinical, echocardiographic, procedural and outcome data were prospectively recorded at each participating center using a standardized format []. Baseline characteristics included demographic variables (e.g., age and sex), cardiovascular risk factors (e.g., hypertension, diabetes, dyslipidemia and smoking) and detailed procedural data (e.g., valve type, valve size, use of predilatation and post-dilatation and vascular access). Imaging data, including echocardiographic and computed tomography parameters, were assessed by local heart teams. Post-procedural clinical outcomes, including adverse events, were defined according to the Valve Academic Research Consortium (VARC) criteria []. Major vascular complications were defined as those resulting in death, major bleeding, visceral ischemia, or necessitating surgical intervention. Acute kidney injury was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) classification []. All endpoints were adjudicated by an independent clinical events committee.
2.5. Statistical Analysis
Categorical variables are expressed as counts and percentages, while continuous variables are presented as means ± standard deviations (SD) or medians with interquartile ranges (IQRs), as appropriate. Comparisons between male and female patients were performed using the chi-square test or Fisher’s exact test for categorical variables and the Student’s t-test or Mann–Whitney U test for continuous variables. To account for potential confounders in the unmatched cohort, multivariable logistic regression was performed to identify independent predictors of the primary composite outcome; odds ratios (OR) with 95% confidence intervals (CI) were calculated for each variable. In the PSM cohort, outcomes were compared between men and women using McNemar’s test for categorical variables and paired t-tests for continuous variables. Statistical significance was defined as a two-tailed p-value of less than 0.05. All statistical analyses were performed using SPSS v.22 (IBM® SPSS® Statistics, 1 New Orchard Road Armonk, New York, NY, USA).
2.6. Ethical Considerations
The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki [], and approval was obtained from the institutional review boards of all participating centers. Given the retrospective and observational nature of the study, the requirement for informed consent was waived at each institution; however, all patient data were anonymized to protect privacy.
3. Results
3.1. Baseline Characteristics (Pre-PSM)
A total of 3353 patients who underwent TAVI with either the ACURATE neo or Evolut R/Pro valves were included in the analysis. Of these, 2162 (64.5%) were female and 1191 (35.5%) were male. Female patients were, on average, older than male patients (82.3 ± 5.6 years vs. 81.1 ± 6.2 years, p < 0.001), had a higher BMI (27.7 ± 5.7 kg/m2 vs. 27.2 ± 4.5 kg/m2, p = 0.023) and exhibited a lower prevalence of dyslipidemia (50.2% vs. 54.7%, p = 0.037). Women also had lower rates of diabetes (26.8% vs. 33.7%, p < 0.001), smoking history (10.0% vs. 24.3%, p < 0.001), COPD (17.4% vs. 21.9%, p = 0.002) and prior cardiac surgery (8.6% vs. 18.8%, p < 0.001). The mean STS score was significantly higher in women (5.2 ± 3.9% vs. 4.5 ± 3.4%, p < 0.001). Imaging data revealed that women had smaller aortic valve areas (0.7 ± 0.2 cm2 vs. 0.9 ± 4.1 cm2, p = 0.037), higher mean valve gradients (45.4 ± 17.1 mmHg vs. 42.7 ± 14.7 mmHg, p < 0.001) and smaller annular perimeters (56.8 ± 23.0 mm vs. 62.0 ± 23.8 mm, p < 0.001). Full details of the baseline characteristics are presented in Table 1 and Table 2.
Table 1.
Baseline characteristics of the study population (pre-PSM).
Table 2.
Pre-procedural imaging parameters stratified by gender in the study population (pre-PSM).
3.2. Procedural Characteristics (Pre-PSM)
Procedural characteristics were stratified by gender. Transfemoral access was used more frequently in male patients (63.5% vs. 53.9%, p < 0.001), whereas women more often underwent procedures with the Evolut R valve (41.5% vs. 36.5%, p = 0.006). Post-dilatation was required more commonly in male patients (35.2% vs. 30.0%, p = 0.002), and the mean balloon size for post-dilatation was larger in males (16.3 ± 11.3 mm vs. 13.6 ± 11.2 mm, p < 0.001). Full procedural details are available in Table 3.
Table 3.
Procedural characteristics of the study population (pre-PSM).
3.3. Procedural Complications and Secondary Outcomes (Pre-PSM)
The incidence of procedural complications varied significantly between genders. Female patients experienced higher rates of cardiac tamponade (1.5% vs. 0.4%, p = 0.008), major vascular complications (7.7% vs. 4.1%, p < 0.001), life-threatening bleeding (2.8% vs. 1.4%, p = 0.016) and major bleeding (5.1% vs. 2.9%, p = 0.004). Additionally, the need for blood transfusion was significantly higher in women (8.9% vs. 4.6%, p < 0.001), as was the incidence of acute kidney injury (AKI) (8.5% vs. 5.7%, p = 0.009). There was no significant difference in the incidence of annular rupture or aortic regurgitation between the groups. Detailed outcomes are presented in Table 4.
Table 4.
Procedural complications and secondary outcomes stratified by gender in the study population (pre-PSM).
3.4. Primary and Secondary Outcomes (Pre-PSM)
In the unmatched population, the primary endpoint, a composite of all-cause death or stroke at one year, occurred at similar rates in women and men (7.9% vs. 6.9%, p = 0.337). Likewise, there was no significant difference in all-cause mortality (5.9% vs. 5.6%, p = 0.786) or stroke rates (2.5% vs. 1.8%, p = 0.243). However, women exhibited higher in-hospital mortality compared to men (1.6% vs. 0.6%, p = 0.016). Full clinical outcome data are summarized in Table 5.
Table 5.
Clinical outcomes stratified by gender in the study population (pre-PSM).
3.5. Baseline Characteristics (Post-PSM)
After propensity score matching, 844 female patients were matched with 844 male patients, resulting in two cohorts with similar baseline characteristics. There were no significant differences in age, BMI, or the prevalence of cardiovascular risk factors—including diabetes, dyslipidemia and COPD. The matched cohorts also exhibited similar echocardiographic parameters, such as mean pressure gradients, ejection fraction and annular dimensions. Baseline characteristics and pre-procedural imaging parameters after PSM are detailed in Table 6 and Table 7, respectively.
Table 6.
Baseline characteristics of the study population (post-PSM).
Table 7.
Pre-procedural imaging parameters stratified by gender in the study population (post-PSM).
3.6. Procedural Characteristics (Post-PSM)
In the propensity-matched cohort, procedural characteristics remained balanced between the groups. The use of transfemoral access, predilatation, and post-dilatation was similar between men and women, although women more frequently received the Evolut R valve (44.8% vs. 35.0%, p < 0.001). The balloon size used for post-dilatation and the contrast volume administered were not significantly different between genders. Full procedural characteristics are provided in Table 8.
Table 8.
Procedural characteristics of the study population (post-PSM).
3.7. Procedural Complications and Secondary Outcomes (Post-PSM)
Despite matching for baseline characteristics, gender differences in procedural complications persisted. Women continued to experience higher rates of major vascular complications (6.8% vs. 4.1%, p = 0.024), the need for blood transfusion (9.1% vs. 4.6%, p < 0.001) and AKI (8.7% vs. 5.6%, p = 0.029). There was no significant difference in the rates of cardiac tamponade or emergency surgery between men and women. These findings are summarized in Table 9.
Table 9.
Procedural complications and secondary outcomes stratified by gender in the study population (post-PSM).
3.8. Primary and Secondary Outcomes (Post-PSM)
In the matched cohort, the primary endpoint of all-cause death or stroke at one year was significantly higher in women (9.4% vs. 6.0%, p = 0.014). Stroke was more prevalent among female patients (2.8% vs. 1.2%, p = 0.024), although there was no significant difference in all-cause mortality (11.3% for women vs. 9.5% for men, p = 0.264). Additionally, rates of major bleeding and life-threatening bleeding were higher in women, though these did not reach statistical significance. Full clinical outcome data after PSM are presented in Table 10.
Table 10.
Clinical outcomes stratified by gender in the study population (post-PSM).
4. Discussion
This study represents one of the largest real-world analyses to date examining gender-based differences in patients undergoing TAVI with next-generation self-expandable bioprostheses. The findings from both the unmatched and PSM cohorts provide significant insights into how gender influences clinical outcomes and procedural characteristics, even after adjusting for baseline disparities.
4.1. Baseline Characteristics
Pre-PSM, our cohort revealed distinct differences between men and women, with female patients generally being older, having a higher BMI and presenting with lower rates of cardiovascular risk factors such as dyslipidemia, diabetes and smoking. These gender differences are consistent with previous studies, which have noted that women undergoing TAVI tend to present with fewer traditional cardiovascular risk factors but with more advanced age and greater frailty [,,,]. After PSM, the baseline characteristics were balanced, allowing for a more accurate assessment of gender-specific outcomes.
4.2. Procedural Characteristics and Complications
The higher frequency of transfemoral access and post-dilatation in male patients pre-PSM likely reflects anatomical differences, including larger body surface area and annular dimensions in men, as indicated by pre-procedural imaging parameters. After PSM, baseline profiles were balanced except for kidney function; female patients still exhibited lower eGFR values compared to males. This residual difference may have influenced post-procedural AKI rates and is a relevant limitation that should be considered when interpreting our findings. In fact, although the procedural differences were mitigated after PSM, women continued to experience higher rates of procedural complications, including major vascular events, the need for blood transfusion and AKI. Notably, even after matching, women exhibited significantly higher rates of AKI and major vascular complications, corroborating existing literature and underscoring the vulnerability of female patients to specific procedural risks [,,]. These findings reinforce the need for a sex-specific procedural strategy, including careful vascular access planning (adoption of lower-profile delivery systems and meticulous closure techniques) and low-contrast strategy, particularly in female patients.
4.3. Clinical Outcomes
The primary composite outcome of all-cause death or stroke at one year was significantly higher in women post-PSM, largely driven by an increased incidence of stroke. Interestingly, mortality rates between men and women remained similar both before and after PSM. The higher stroke risk in women is consistent with other studies and may reflect anatomical and physiological differences that predispose women to cerebrovascular events during TAVI [,,]. These findings are clinically significant, as they suggest that while female patients are not at a higher risk for mortality, they are more likely to experience stroke, which can profoundly affect post-procedural quality of life and long-term recovery. Greater attention to embolic protection strategies and procedural optimization may be warranted for female patients, particularly those with additional stroke risk factors [].
4.4. Vascular and Bleeding Complications
Women consistently had higher rates of major vascular complications and bleeding, even after adjusting for baseline differences. These observations align with existing data indicating that smaller vascular dimensions and greater vascular fragility in women contribute to an elevated risk of vascular injury during TAVI []. These results underscore the importance of tailored vascular strategies, including pre-procedural imaging, minimizing sheath-to-artery ratios and careful device selection to mitigate bleeding and vascular risks in female patients. Despite advances in valve technology and procedural techniques aimed at minimizing these complications, the higher rates of bleeding and transfusion in women highlight the need for further refinement of TAVI strategies in this patient population.
4.5. Acute Kidney Injury (AKI)
The higher incidence of AKI among women, observed both before and after propensity score matching, is a significant finding with important clinical ramifications. Although major baseline characteristics were balanced after matching, women still exhibited significantly lower eGFR values compared to men. This residual difference suggests that female patients may have entered the procedure with a higher degree of renal vulnerability, potentially predisposing them to post-procedural kidney injury. Moreover, the interplay between vascular complications, bleeding events and hemodynamic instability, all of which were more frequent among women, may have further contributed to renal insult in this population.
These findings highlight the need for proactive renal protection strategies in female patients undergoing TAVI. Measures such as minimizing contrast agent use, applying strict peri-procedural hydration protocols, avoiding nephrotoxic medications when possible and early identification of renal function deterioration should be prioritized. Moreover, individualized risk stratification for AKI should be integrated into the pre-procedural planning, especially in women with borderline renal function, to further optimize outcomes [].
4.6. Clinical Implications
The persistent gender differences in procedural complications and outcomes after PSM underscore the need for gender-specific strategies in TAVI. For female patients, special attention should be given to minimizing vascular and bleeding complications, as well as addressing the elevated risks of stroke and AKI. These findings suggest that tailored procedural planning, including the use of smaller vascular access devices, careful hemodynamic management and stroke-prevention strategies during the peri-procedural period, may benefit female patients. Moreover, the comparable long-term survival benefits of TAVI between men and women indicate that, despite higher procedural risks, women should not be denied access to TAVI.
4.7. Study Strengths and Limitations
The strengths of this study include its large sample size and the use of propensity score matching to adjust for baseline differences between men and women. This approach allowed for a more accurate comparison of outcomes across genders and provided robust real-world data that complement findings from more selective clinical trials. Additionally, focusing on next-generation self-expandable valves reflects contemporary TAVI practice, making these findings highly relevant to current clinical decision-making. However, the retrospective nature of the registry introduces inherent biases, and despite PSM, unmeasured confounders may still influence the outcomes. Moreover, the study was unable to fully explore the pathophysiological mechanisms underlying the observed gender differences—particularly the higher stroke and AKI rates in women. Future studies incorporating detailed anatomical and hemodynamic assessments could help elucidate these mechanisms further.
5. Conclusions
In conclusion, this large real-world TAVI registry highlights significant gender differences in procedural complications and clinical outcomes. Female patients undergoing TAVI remain at higher risk for stroke, major vascular complications, bleeding and AKI, even after adjusting for baseline risk factors. These findings call for a more tailored approach to TAVI in women, with strategies aimed at minimizing procedural risks and improving post-procedural outcomes. Further research is needed to explore the underlying mechanisms driving these gender disparities and to develop targeted interventions that enhance the safety and efficacy of TAVI for all patients, regardless of gender.
Author Contributions
Conceptualization, A.S. and S.B.; methodology, A.S., S.B. and F.G. (Francesco Giannini); software, A.S. and S.B.; validation, A.S., W.-K.K., A.A.K., T.Z., S.T., R.G., F.D.M., A.M., D.R., B.R., L.N.-F., M.B., A.R., T.P., J.R.-C., I.P., A.C. and F.G. (Francesco Giannini); formal analysis, A.S., S.B., F.G. (Francesco Gallo), A.C. and F.G. (Francesco Giannini); investigation, A.S., W.-K.K., A.A.K., T.Z., S.T., R.G., F.D.M., A.M., D.R., B.R., L.N.-F., M.B., A.R., T.P., J.R.-C., I.P., A.C. and F.G. (Francesco Giannini); resources, A.S., W.-K.K., A.A.K., T.Z., S.T., R.G., F.D.M., A.M., D.R., B.R., L.N.-F., M.B., A.R., T.P., J.R.-C., I.P., A.C. and F.G. (Francesco Gallo); data curation, A.S., D.G. and F.G. (Francesco Gallo); writing—original draft preparation, A.S., D.G. and F.G. (Francesco Giannini); writing—review and editing, A.S., D.G., W.-K.K., A.A.K., T.Z., S.T., R.G., F.D.M., A.M., D.R., B.R., L.N.-F., M.B., A.R., T.P., J.R.-C., I.P., A.C. and F.G. (Francesco Giannini); visualization, A.S., S.B. and F.G. (Francesco Gallo); supervision, A.S., I.P., A.C. and F.G. (Francesco Giannini); project administration, A.S. and F.G. (Francesco Giannini). All authors have read and agreed to the published version of the manuscript.
Funding
This research received no external funding.
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and submitted as study communication to the Institutional Review Board of every participating center without a dedicated approval due to its retrospective character.
Informed Consent Statement
Patient consent was waived due to the retrospective and anonymized nature of the data.
Data Availability Statement
Data are unavailable due to privacy and ethical restrictions.
Conflicts of Interest
Won-keun Kim received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences and Shockwave Medical. Stefan Toggweiler serves as a consultant and/or proctor for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott Vascular, Biosensors, Shockwave, Teleflex, Medira, AtHeart Medical, VeoSource and Polares Medical, has received institutional research grants from Boston Scientific, Biosensors, Fumedica and Novartis and holds equity in Hi-D Imaging. The other authors have nothing to disclose.
Abbreviations
The following abbreviations are used in this manuscript:
| BSA | Body Surface Area |
| BMI | Body Mass Index |
| COPD | Chronic Obstructive Pulmonary Disease |
| ICD | Implantable Cardioverter Defibrillator |
| PCI | Percutaneous Coronary Intervention |
| eGFR | Estimated Glomerular Filtration Rate |
| NYHA | New York Heart Association |
| STS | Society of Thoracic Surgeons |
| LVOT | Left Ventricular Outflow Tract |
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