Patients with small aortic annuli (SAAs) are predominantly women. We sought to compare gender-based and propensity-matched outcomes of index transcatheter aortic valve replacement (TAVR) in patients with SAAs. In this retrospective institutional analysis (2012 to 2023), primary stratification was by gender. SAA was defined as an aortic valve annulus diameter <23 mm and the 30-day and 1-year outcomes were compared between the groups. A total of 3,911 patients underwent TAVR. Of those, 661 patients had an SAA, of whom 23.8% were men and 76.2% were women. Propensity matching (1:1) identified 152 pairs. The mean age was 81 years. History of surgical or percutaneous coronary intervention was more prevalent in men (72.4% vs 48%, p <0.001). Men had a higher incidence of postoperative pacemaker implantation (8.6% vs 3.3%, p = 0.05), whereas only women had iliofemoral dissections (4.6% vs 0%, p = 0.007). The rates of moderate (23.0% vs 25.7%) and severe (2.6% vs 0.7%) prosthesis-patient mismatch was not statistically significantly different between the groups (p = 0.364). The 30-day mortality was 0%, whereas the 1-year mortality was 4.3%, with no difference between the groups. An increase in preoperative creatinine was associated with higher risk of death (hazard ratio 1.206, 95% confidence interval 1.025 to 1.418, p = 0.02), whereas gender was not. Kaplan–Meier survival estimates (Log rank, p = 0.768) and cumulative incidence of stroke readmission (p = 0.842) were similar in both groups. In conclusion, the outcomes of TAVR in SAAs do not differ by gender, with safety and efficacy evident in men and women.
Transcatheter aortic valve replacement (TAVR) has been a paradigm shift in the management of severe aortic stenosis (AS), with exponential growth in volume surpassing surgical aortic valve replacement (SAVR). Considerable attention has been given to gender-based outcomes in the TAVR landscape ; however, gender-based analysis of TAVR in small aortic annuli (SAAs) remains underexplored.
An SAA is defined as an aortic annulus diameter <23 mm , or an aortic valve annulus area <430 mm 2 as measured on computerized tomography. , The presence of an SAA increases the complexity of AS management and deserves special consideration because of the potentially higher risk of paravalvular leak (PVL) in TAVR and increased risk of prosthesis-patient mismatch (PPM) and adverse outcomes in SAVR. ,
Severe AS in the setting of an SAA is not an uncommon observation, especially in women, which is plausible given the relation of body surface area to aortic annular dimensions. In surgical reports, the prevalence of SAA is around 44%, whereas in the landmark intermediate- and low-risk clinical trials of the past decade comparing SAVR vs TAVR, patients with SAA comprised 21% to 36% of the patient populations. Existing evidence on outcomes in patients who underwent TAVR with SAA is conflicting, with some reports indicating marginally worse outcomes in these patients and other reports indicating comparable outcomes. , , The most implicated cause of these apparently worse outcomes includes increased risk of PPM with subsequent impact on survival.
Nevertheless, there is a paucity of data on the prognostic effect of gender on outcomes of TAVR in patients with SAAs, which is especially pertinent because women comprise most of the SAA population. Given this female predominance, we sought to compare gender-stratified clinical and hemodynamic outcomes of TAVR in patients with SAAs.
Methods
SAA was defined as an aortic annulus with maximum diameter of <23 mm on computed tomographic measurement. The following Valve Academic Research Consortium-3–defined outcomes were also analyzed: technical success defined as (1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomic location; and (4) freedom from device-related surgery or intervention (excluding permanent pacemaker) or a major vascular, access-related, or cardiac structural complication at exit from the procedure room.
Device success was defined as (1) technical success; (2) 30-day freedom from mortality; (3) 30-day freedom from device-related surgery or intervention (excluding permanent pacemaker) or a major vascular, access-related, or cardiac structural complication; and (4) intended performance of the valve (mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index >0.25, and less than moderate aortic regurgitation). Periprocedural death was defined as death occurring <30 days after the index procedure or >30 days but during the index hospitalization.
This study was an observational, retrospective analysis of institutional Transcatheter Valve Therapies database. Standard American College of Cardiology/Society of Thoracic Surgeons Transcatheter Valve Therapies registry definitions and terminologies were used in this study. All patients categorized as having an SAA who underwent index TAVR from 2013 to 2023 were included in this study. Patients who underwent valve-in-valve TAVR (any previous aortic valve intervention), patients aged <18 years, and those with no follow-up echocardiographic data were excluded. This study was approved by the institutional review board of the University of Pittsburgh (STUDY18120143).
The primary outcomes were periprocedural mortality, technical success, device success as defined by Valve Academic Research Consortium-3 criteria, and stroke rates at 1 year.
The secondary outcomes were the following (at 30 days and/or 1 year): permanent pacemaker implantation (PPI), aortic valve area, major bleeding, moderate/severe PVL, residual mean gradient, indexed effective orifice area (iEOA), presence of PPM (according to in vivo iEOA), and Kansas City cardiomyopathy questionnaire (KCCQ)-12 score.
The primary stratification was by gender. Unmatched and propensity-matched baseline characteristics and clinical and echocardiographic outcomes were compared between the cohorts. Nearest neighbor (1:1) propensity score matching method was used to match patients on baseline characteristics. Continuous data are presented as mean ± SD for normally distributed data or median and interquartile range for non-normally distributed data and these were analyzed using Student’s t test (normally distributed) and Mann–Whitney U test (non-normally distributed). Categorical data are presented as frequency and percentage and compared by way of the chi-square or Fisher’s exact test, as appropriate. A Cox regression model for mortality and a cumulative incidence function for stroke readmission were created. The proportional hazards assumption was tested by Schoenfeld residuals. The residuals were independent of the time (log time, function of time), thus satisfying the assumption.
All tests were 2-sided, with an α level of 0.05 predetermined to indicate statistical significance. Unadjusted and propensity-matched survival estimates obtained through Kaplan–Meier analysis were compared using log-rank statistics. All statistical analyses were performed using SAS/STAT Version 15.2 (SAS Institute Inc., Cary, North Carolina).
Results
After applying the inclusion criteria, we identified 1,016 patients with SAAs, of whom 664 had echocardiographic assessments at 30 days and 1 year, who were included in this study. Propensity matching identified 152 pairs of men and women in the study cohort. The mean age in the matched population was 81 years. The majority of those were white (96.4%). The proportion of men with a history of coronary revascularization (PCI or coronary artery bypass grafting) was higher than women (72.4% vs 48%). Preoperative creatinine was also higher in the male population (1.3mg/dL vs 1.0mg/dL). The left ventricular ejection fraction (LVEF) in the male population was lower than that in the female population (55% vs 58.5%). Additional baseline characteristics are listed in Table 1 .
| Unmatched Population | Propensity-Matched Population | |||||
|---|---|---|---|---|---|---|
| Baseline characteristic | Men (n=157) | Women (n=504) | P-value | Men (n=152) | Women (n=152) | P-value |
| Age | 81.0 (76.0-86.0) | 82.0 (76.0-87.0) | 0.7824 | 82.0 (76.0-86.0) | 81.0 (75.0-86.5) | 0.5345 |
| Race | 0.0489 | 0.9033 | ||||
| White | 152 (96.8%) | 459 (91.1%) | 147 (96.7%) | 146 (96.1%) | ||
| Black | 2 (1.3%) | 10 (2.0%) | 2 (1.3%) | 3 (2.0%) | . | |
| Other | 3 (1.9%) | 35 (6.9%) | 3 (2.0%) | 3 (2.0%) | . | |
| BMI | 27.7 (24.3-31.1) | 28.8 (24.2-33.8) | 0.0764 | 27.6 (24.4-31.2) | 27.4 (23.6-31.8) | 0.6008 |
| BSA | 2.02 ± 0.25 | 1.79 ± 0.25 | <.001 | 2.03 ± 0.25 | 1.78 ± 0.25 | <.001 |
| NYHA class (2 weeks prior) | 0.002 | 0.7433 | ||||
| 2 | 17 (10.8%) | 103 (20.4%) | 17 (11.2%) | 19 (12.5%) | ||
| 3 | 86 (54.8%) | 280 (55.6%) | 86 (56.6%) | 90 (59.2%) | ||
| 4 | 54 (34.4%) | 114 (22.6%) | 49 (32.2%) | 43 (28.3%) | ||
| HTN | 150 (95.5%) | 468 (92.9%) | 0.2337 | 145 (95.4%) | 145 (95.4%) | 1 |
| Diabetes | 80 (51.0%) | 183 (36.3%) | 0.0011 | 77 (50.7%) | 75 (49.3%) | 0.8185 |
| COPD | 57 (36.3%) | 132 (26.2%) | 0.0143 | 54 (35.5%) | 55 (36.2%) | 0.9048 |
| Current Dialysis | 6 (3.8%) | 15 (3.0%) | 0.5979 | 6 (3.9%) | 5 (3.3%) | 0.7588 |
| Atrial Fibrillation | 3 (1.9%) | 27 (5.4%) | 0.0701 | 3 (2.0%) | 5 (3.3%) | 0.4736 |
| CVD | 2 (1.3%) | 32 (6.3%) | 0.0119 | 2 (1.3%) | 4 (2.6%) | 0.4096 |
| Prior PAD | 57 (36.3%) | 124 (24.6%) | 0.0035 | 54 (35.5%) | 44 (28.9%) | 0.2049 |
| Prior stroke | 29 (18.5%) | 63 (12.5%) | 0.0591 | 28 (18.4%) | 18 (11.8%) | 0.1095 |
| Previous ICD | 9 (5.7%) | 12 (2.4%) | 0.0365 | 9 (5.9%) | 5 (3.3%) | 0.2737 |
| Urgent/emergent | 11 (7.0%) | 14 (2.8%) | 0.0153 | 6 (3.9%) | 7 (4.6%) | 0.7768 |
| Prior MI | 71 (45.2%) | 139 (27.6%) | <.001 | 67 (44.1%) | 49 (32.2%) | 0.0336 |
| Prior CABG/PCI | 114 (72.6%) | 222 (44.0%) | <.001 | 110 (72.4%) | 73 (48.0%) | <.001 |
| Valve system | 0.0008 | 0.1196 | ||||
| Self-expanding | 26 (16.6%) | 152 (30.2%) | 26 (17.1%) | 37 (24.3%) | ||
| Balloon expandable | 131 (83.4%) | 352 (69.8%) | 126 (82.9%) | 115 (75.7%) | . | |
| Aortic insufficiency >mod | 39 (24.8%) | 91 (18.1%) | 0.0618 | 36 (23.7%) | 31 (20.4%) | 0.489 |
| Mitral insufficiency >mod | 51 (32.5%) | 105 (20.8%) | 0.0027 | 50 (32.9%) | 39 (25.7%) | 0.1656 |
| Tricuspid insufficiency >mod | 39 (24.8%) | 137 (27.2%) | 0.5621 | 35 (23.0%) | 38 (25.0%) | 0.6871 |
| LVEF | 55.0 (43.0-60.0) | 60.0 (55.0-63.0) | <.001 | 55.0 (44.0-60.0) | 58.5 (53.0-63.0) | 0.0011 |
| STS risk score | 5.0 (3.4- 9.4) | 6.0 (3.6- 9.0) | 0.8852 | 5.0 (3.3- 9.0) | 6.4 (3.7-10.8) | 0.2551 |
| Aortic valve annulus size | 22.0 (21.0-23.0) | 21.0 (20.0-22.0) | <.001 | 22.0 (21.0-23.0) | 22.0 (21.0-23.0) | 0.8538 |
| Smallest Aortic Valve Area | 0.7 (0.6- 0.8) | 0.7 (0.6- 0.8) | 0.0045 | 0.7 (0.6- 0.8) | 0.7 (0.5- 0.8) | 0.1008 |
| Aortic Gradient-Highest Mean | 43.0 (38.0-49.0) | 45.0 (39.5-54.0) | 0.0018 | 43.0 (37.5-49.5) | 45.0 (39.5-53.0) | 0.0202 |
| AV annulus area | 393 (372- 407) | 370 (349- 394) | 0.0388 | 393 (372- 407) | 390 (376- 400) | 0.6112 |
| Preprocedural Creatinine | 1.3 (1.0- 1.5) | 1.0 (0.8- 1.2) | <.001 | 1.3 (1.0- 1.6) | 1.0 (0.8- 1.2) | <.001 |
| Aortic prosthetic Implant Size | 26.0 (26.0-26.0) | 23.0 (23.0-26.0) | <.001 | 26.0 (26.0-26.0) | 23.0 (23.0-26.0) | <.001 |
| Overall KCCQ-12 | 43.8 (24.7-64.6) | 49.5 (28.1-68.8) | 0.1318 | 43.8 (27.1-65.6) | 47.0 (24.3-64.6) | 0.9584 |
| Bicuspid aortic valve | 2 (1.3%) | 11 (2.2%) | 0.474 | 2 (1.3%) | 4 (2.6%) | 0.4096 |
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