Highlights
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TAVR is technically feasible and safe in patients with large and extra-large aortic annuli.
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Balloon-expandable valves (BEVs) showed lower rates of moderate or greater paravalvular leak than self-expanding valves (SEVs).
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Paravalvular leak was particularly frequent in patients with extra-large annuli (perimeter >96 mm and an area >730 mm²) treated with SEVs.
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Careful imaging-based sizing and valve selection are key to optimizing outcomes in this challenging anatomy.
Patients with large or extra-large aortic annuli pose a particular challenge for Transcatheter aortic valve replacement (TAVR), as clinical outcomes are less favorable than in patients with smaller annuli. This study aimed to evaluate periprocedural and clinical outcomes in patients with large and extra-large annuli undergoing TAVR and to compare results between balloon-expandable (BEVs) and self-expanding valves (SEVs). This study included patients with severe aortic stenosis (AS) and extra-large annuli who underwent TAVR with either BEVs or SEVs. The primary endpoints were periprocedural and clinical outcomes, including device success, rates of moderate or greater paravalvular leak (PVL), permanent pacemaker (PPM) implantation, new Left bundle branch block (LBBB), stroke, and in-hospital and 1-year mortality. Secondary endpoints included safety outcomes and subgroup analyses comparing outcomes between patients with large (annular perimeter >90 mm and an area >660 mm²) and extra-large annuli (perimeter >96 mm and an area >730 mm²). A total of 237 patients underwent TAVR, including 160 with BEVs and 77 with SEVs. The mean annular area and perimeter were 737 ± 76 mm² and 96.1 ± 4.1 mm, respectively, with no significant differences between groups. Overall device success was high, though slightly lower in the SEV group (84% vs. 93%, p = 0.034), a difference that was no longer statistically significant after multivariate analysis (p = 0.234). Moderate or greater PVL occurred more frequently with SEVs (13% vs. 4%, p = 0.016), particularly in patients with extra-large annuli (26% vs. 4%, p = 0.012). One-year mortality was similar between groups (SEV 13% vs. BEV 12%, p = 0.807), and no significant differences were observed in PPM implantation, new LBBB, stroke, or major vascular and bleeding complications. TAVR is feasible and safe in patients with large and extra-large annuli, with higher rates of moderate or greater paravalvular leak observed in SEV patients with extra-large annuli.
Transcatheter aortic valve replacement (TAVR) has become a cornerstone intervention for the management of severe aortic stenosis (AS). ,,, Over the past decade, its use has expanded rapidly across the globe, fuelled by widening clinical indications and continuous improvements in device technology and procedural techniques. , Patients with large aortic annuli, Defined as annular perimeter >90 mm and an area >660 mm², represent a particularly challenging subgroup for TAVR. Recent studies have attempted to address this population, demonstrating that TAVR is technically feasible and safe with contemporary-generation valves. Nevertheless, outcomes remain less favorable compared with patients with smaller annuli, as reflected by lower device success rates and a higher frequency of complications, including moderate or greater paravalvular leak (PVL) and permanent pacemaker (PPM) implantation, especially in patients receiving self-expandable valves (SEVs). ,,, Despite these findings, evidence regarding TAVR in extra-large annuli remains limited. In particular, the impact of extreme annular dimensions on periprocedural safety, valve performance, and clinical outcomes has not been systematically investigated in a large real-world cohort. This study aimed to assess overall periprocedural and clinical outcomes in patients with extra-large annuli undergoing TAVR, and to compare results between balloon-expandable (BEVs) and SEVs.
Methods
Study population
This retrospective, single-center clinical registry was conducted at Clinique Pasteur (Toulouse, France). Data were collected from all patients undergoing TAVR for severe aortic stenosis using balloon (Edwards Sapien 3) or self-expandable (Medtronic Evolut R, Evolut Pro, Evolut Pro+ and ACURATE neo) valves between 2012 and 2024. For the present analysis, we included only patients with annuli with a perimeter >90 mm and an area >660 mm². During the study period, approximately 6,500 TAVR procedures were performed at our center, of which 237 (3.6%) involved patients with large or extra-large aortic annuli. Patient selection for TAVI followed the European Society of Cardiology guidelines for valvular heart disease and was determined by a multidisciplinary Heart Team. The study was approved by the local ethics committee.
The primary outcomes of the study were to evaluate overall and valve-specific (BEVs vs. SEVs) periprocedural and clinical outcomes. Periprocedural outcomes included rates of pre and postdilatation, need for a second valve, coronary obstruction, and conversion to surgery. Clinical outcomes included in-hospital and 1-year mortality, device success (Defined as absence of procedural mortality, correct position of a single prosthetic valve with a mean aortic gradient <20 mm Hg and no significant aortic regurgitation), moderate or greater PVL, PPM implantation, and stroke. The secondary outcomes included additional safety endpoints, including major vascular complications and life-threatening or major bleeding. Subgroup analyses were also performed to compare outcomes between patients with large (annular perimeter >90 mm and an area >660 mm²) versus extra-large annuli (perimeter >96 mm and an area >730 mm²).
Statistical analysis
Categorical and dichotomous variables are presented as frequencies and percentages and were compared using Pearson’s chi-square or Fisher’s exact tests, as appropriate. The Kruskal–Wallis test was used to assess the distribution of continuous variables. Continuous variables with a normal distribution are reported as mean ± standard deviation and were compared using the unpaired, 2-sided Student’s t-test. Non-normally distributed variables are reported as median and interquartile range and were compared using the Mann-Whitney U test.
Univariate and multivariate logistic regression analyses were performed to identify factors associated with device success, using a backward stepwise method including variables with p < 0.20 in univariate analysis.
One-to-one propensity score matching was employed (for variables that were statistically different between the groups at baseline) to balance the comparison between the 2 groups and minimize potential bias due to baseline characteristics, namely age, sex, coronary artery disease (CAD), prior coronary artery bypass grafting (CABG), and Society of Thoracic Surgeons (STS) score.
Subgroup analyses were performed to assess whether the incidence of moderate or greater PVL differed between large and extra-large aortic annuli, stratified by valve type (BEVs vs. SEVs). All p-values were 2-sided, and values <0.05 were considered statistically significant. Analyses were conducted using SPSS version 31.0.0.0 (IBM Corp., Armonk, NY).
Results
A total of 237 patients were included in the study, comprising 160 who received BEVs and 77 who received SEVs. Baseline characteristics are summarized in Table 1 . The mean overall annular area was 737 ± 76 mm² and the mean perimeter was 96.1 ± 4.1 mm. In the BEV group, the mean area and perimeter were 732 ± 67 mm² and 95.8 ± 4.2 mm, respectively, while in the SEV group they were 748 ± 92 mm² and 96.7 ± 5.6 mm. These differences were not statistically significant (p = 0.179 for area and p = 0.185 for perimeter). The mean age of the cohort was 82 years. Patients in the BEV group were more frequently male compared with the SEV group (96% vs. 83%). Both groups had a high prevalence of cardiovascular risk factors, including hyperlipidemia, hypertension, and diabetes mellitus. Patients in the SEV group had a higher prevalence of CAD (60% vs. 41%, p = 0.006) and prior CABG (22% vs. 8%, p = 0.001), as well as a higher median surgical STS score (4.3 vs. 3.5, p = 0.002). Conversely, patients in the BEV group had a higher prevalence of bicuspid aortic valves (24% vs. 12%, p = 0.029).
Table 1
Baseline characteristics
| Characteristic | Overall | BEVs | SEVs | p-Value |
|---|---|---|---|---|
| n | 237 | 160 | 77 | |
| Age, y (mean ± SD) | 82 ± 6 | 82 ± 6 | 81 ± 7 | 0.585 |
| Gender, male n (%) | 218 (92%) | 154 (96%) | 64 (83%) | <0.001 |
| Cardiovascular comorbidities | ||||
| Dyslipidemia, n (%) | 109 (46%) | 78 (49%) | 31 (40%) | 0.219 |
| Hypertension, n (%) | 184 (78%) | 122 (76%) | 62 (80%) | 0.317 |
| Diabetes mellitus, n (%) | 54 (23%) | 41 (25%) | 13 (17%) | 0.133 |
| BMI (mean ± SD) | 27 ± 4 | 27 ± 4 | 26 ± 4 | 0.228 |
| BSA (mean ± SD) | 1.9 ± 0.2 | 1.9 ± 0.2 | 1.8 ± 0.2 | 0.057 |
| Coronary artery disease, n (%) | 112 (47%) | 66 (41%) | 46 (60%) | 0.006 |
| Prior PCI, n (%) | 74 (31%) | 48 (30%) | 26 (34%) | 0.558 |
| Prior CABG, n (%) | 29 (12%) | 12 (8%) | 17 (22%) | 0.001 |
| Atrial fibrillation, n (%) | 64 (27%) | 47 (29%) | 17 (22%) | 0.236 |
| Prior CVA/TIA, n (%) | 24 (10%) | 14 (9%) | 10 (13%) | 0.311 |
| PVD, n (%) | 35 (15%) | 24 (15%) | 11 (14%) | 0.885 |
| eGFR, ml/min (mean ± SD) | 55 ± 21 | 56 ± 20 | 52 ± 22 | 0.130 |
| Baseline CCT and TTE data | ||||
| Annulus diameter, mm (mean ± SD) | 30.6 ± 1.5 | 30.5 ± 1.3 | 30.8 ± 1.7 | 0.185 |
| Annulus Area, mm² (mean ± SD) | 737 ± 76 | 732 ± 67 | 748 ± 92 | 0.179 |
| Annulus perimeter, mm (mean ± SD) | 96.1 ± 4.7 | 95.8 ± 4.2 | 96.7 ± 5.6 | 0.185 |
| Bicuspid aortic valve, n (%) | 47 (20%) | 38 (24%) | 9 (12%) | 0.029 |
| LVEF%, (mean ± SD) | 50 ± 13 | 51 ± 13 | 50 ± 13 | 0.525 |
| NYHA Class III-IV, n (%) | 98 (41%) | 66 (41%) | 32 (41%) | 0.964 |
| AVA, cm² (mean ± SD) | 0.84 ± 0.22 | 0.83 ± 0.18 | 0.86 ± 0.29 | 0.390 |
| Mean Aortic gradient, mm Hg (mean ± SD) | 45 ± 13 | 45 ± 13 | 45 ± 13 | 0.137 |
| Surgical risk | ||||
| Euroscore II, median (Q1 ± Q3) | 4.15 (2.07 to 7.02) | 4.03 (2.01 to 6.62) | 4.37 (2.15 to 8.91) | 0.081 |
| STS Score, median (Q1 ± Q3) | 3.65 (2.22 to 6.41) | 3.50 (2.10 to 5.34) | 4.43 (2.69 to 10.03) | 0.002 |
AVA = Aortic valve area; BEV = Balloon-expandable valves; CABG = Coronary artery bypass graft; CCT = Cardiac computed tomography; CVA = Cerebrovascular accident; eGFR = estimated glomerular filtration rate; LVEF = Left ventricle ejection fraction; PCI = Percutaneous coronary intervention; PVD = Peripheral vascular disease; SEVs = Self-expandable valves; TIA = Transient ischemic attack; TTE = Transthoracic echocardiography.
Primary and secondary outcomes
Periprocedural data is summarized in Table 2 . Ninety-five percent (95%) of patients underwent TAVR via the transfemoral approach. Compared with the BEV group, the SEV group had longer procedure duration (62 ± 23 vs. 50 ± 23 minute, p < 0.001), longer fluoroscopy time (18 ± 8 vs. 14 ± 7 minute, p < 0.001), and greater contrast medium use (129 ± 66 vs. 86 ± 44 ml, p < 0.001). predilatation (48% vs. 24%, p < 0.001) and postdilatation (29% vs. 14%, p = 0.009) were also more frequent in the SEV group. There was no significant difference between groups in the need for a second valve (1.2% vs. 1.8%, p = 0.747). Clinical outcomes are summarized in Table 3 and Figure 1 . In-hospital mortality occurred in 1 patient in the BEV group and 3 patients in the SEV group (p = 0.102), with no statistically significant difference in 1-year mortality (SEV 13% vs. BEV 12%, p = 0.807). Device success was lower in the SEV group (84% vs. 93%, p = 0.034), driven primarily by a higher incidence of moderate or greater paravalvular leak (PVL) (13% vs. 4%, p = 0.016). However, after multivariate regression analysis (see Supplementary table S1 ), the difference in device success between groups was no longer statistically significant (p = 0.234). postprocedural mean gradient was lower in the SEV group (8.3 vs. 10.4 mm Hg, p < 0.001). The rate of permanent pacemaker implantation was higher in the SEV group (16% vs. 13%) but did not reach statistical significance (p = 0.609). No significant differences were observed in the incidence of new LBBB (SEV 12% vs. BEV 7%, p = 0.288) or stroke (SEV 1% vs. BEV 0.6%, p = 0.545). Major vascular complications occurred in 4 patients (1.6%), life-threatening bleeding in 5 patients (2%), and major bleeding in 10 patients (4%), with no statistically significant differences between the SEV and BEV groups.
Table 2
Peri-procedural data
| Characteristic | Overall | BEVs | SEVs | p-Value |
|---|---|---|---|---|
| n | 237 | 160 | 77 | |
| Transfemoral approach, n (%) | 225 (95%) | 151 (94%) | 74 (96%) | 0.570 |
| Procedure duration, min (mean ± SD) | 54 ± 23 | 50 ± 23 | 62 ± 23 | <0.001 |
| Fluoroscopy time, min (mean ± SD) | 15 ± 8 | 14 ± 7 | 18 ± 8 | <0.001 |
| Contrast medium, ml (mean ± SD) | 100 ± 56 | 86 ± 44 | 129 ± 66 | <0.001 |
| Predilatation, n (%) | 76 (32%) | 39 (24%) | 37 (48%) | <0.001 |
| Postdilatation, n (%) | 45 (19%) | 23 (14%) | 22 (29%) | 0.009 |
| Need for second valve, n (%) | 4 (1.6%) | 3 (1.8%) | 1 (1.2%) | 0.747 |
| Coronary obstruction, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | n/a |
| Conversion to surgery, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | n/a |
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