Abstract
Background
Transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs) may have different outcomes with supra-annular valves (SAVs) or intra-annular valves (IAVs) in patients with small aortic annuli (SAA), but this topic remains underexplored. We aimed to evaluate outcomes between different SEVs, namely SAVs (CoreValve/Evolut R/PRO/PRO+/FX) vs. IAVs (Portico/Navitor).
Methods
Single-center data with patients with SAA (maximum diameter <23 mm) who underwent TAVR from 2013 to 2023 with SEVs, followed by 1:1 propensity score matching (PSM).
Results
We obtained 86 PSM pairs with median age of 83.0 years (SAVs) and 82.0 years (IAVs), with women representing 77.6% of the PSM cohort. After TAVR, we did not find statistically significant differences for the following outcomes: Valve Academic Research Consortium-3 periprocedural mortality, technical success, device success, clinical efficacy, and rates of paravalvular leak were not statistically significantly different, but we found higher rates of permanent pacemaker implantation in the IAV group (1.2 vs. 8.1%; p = 0.029). Despite the larger indexed effective orifice area with SAVs (median 1.0 vs. 0.8 cm 2 /m 2 , p = 0.001), we did not find statistically significant differences between the groups in terms of residual mean gradients >20 mmHg (0.0 vs. 2.3%, p = 0.155), and severe prosthesis-patient mismatch (2.3 vs. 5.8%, p = 0.390). No statistically significant difference was observed in survival (log-rank p = 0.950) and stroke ( p = 0.6547) between patients who received SAVs and IAVs. For patients with SAA, TAVR with SEV devices is safe.
Conclusions
IAVs and SAVs are associated with comparable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.
Highlights
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Self-expanding valve (SEV) with supra-annular valve (SAV) or intra-annular valve (IAV) design in small aortic annulus remain underexplored.
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In 86 propensity score matching pairs, SAV and IAV did not present differences in Valve Academic Research Consortium-3 outcomes.
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Larger indexed effective orifice area with SAV, but no differences in residual mean gradients >20 mmHg.
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No differences in severe prosthesis-patient mismatch between SEV-SAV and SEV-IAV.
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No statistically significant difference in survival between stroke SAVs and IAVs.
Introduction
Transcatheter aortic valve replacement (TAVR) has become the most disruptive technology in the management of severe aortic stenosis (AS) over the last 20 years and has become the gold-standard treatment for patients at high, intermediate, and even low surgical risk. Although the CoreValve/Evolut (Medtronic, Dublin, Ireland) and SAPIEN (Edwards Lifesciences, Irvine, California) TAVR platforms are the most used commercial devices with their performance constantly put under the microscope, new platforms such as Portico/Navitor (Abbott Vascular, Chicago, Illinois) arose on the structural heart market.
The presence of a small aortic annulus (SAA) poses a considerable challenge in the management of patients with severe AS, especially in elderly women, in whom it is a very frequent finding and associated with increased risk of prosthesis-patient mismatch (PPM), which in turn is associated with an increased risk of overall mortality proportionally to its severity, suboptimal valve hemodynamics, and less left ventricular mass regression after both TAVR and surgical aortic valve replacement. ,
The hemodynamic performance of transcatheter heart valves (THVs) has been considered a reliable predictor of long-term clinical outcomes. , Within the SAA subgroup, evidence from observational registries indicates better hemodynamic performance for TAVR, with self-expanding valves (SEVs) outperforming balloon-expandable valves (BEVs). , Noteworthy, these studies , compare SEVs with a supra-annular design against BEVs, which have an intra-annular design. Therefore, behind the SEV-vs.-BEV comparison lies a comparison between supra-annular valves (SAVs) and intra-annular valves (IAVs). This is important because IAVs are associated with lower effective orifice area (EOA) and, thus, tend to present higher post-TAVR gradients and higher rates of PPM. In this scenario, a question remains underexplored: are there significant differences in the performance of SAVs and IAVs if both platforms are SEVs?
In this context, we aimed to compare the hemodynamic and clinical performance of 2 SEV platforms in contemporary TAVR practice: the Medtronic SAV (CoreValve, Evolut R, Evolut PRO/PRO+ and Evolut FX) vs. the Abbott Vascular IAV (Portico/Navitor) in patients with SAA.
Methods
Study Design
This study was an observational, retrospective analysis of the 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 with SAA who underwent transfemoral TAVR in a native aortic valve from 2013 to 2023 with SEVs were included in this analysis. Patients who underwent valve-in-valve TAVR (any previous aortic valve intervention), pure aortic regurgitation, patients <18 years of age, and those with no follow-up echocardiographic data were excluded.
Definitions
SAA was defined as an aortic annulus with a maximum diameter of <23 mm on computed tomographic measurement. Valve performance, procedural, and clinical outcomes were defined on the basis of the Valve Academic Research Consortium-3 (VARC-3) definitions. Bioprosthetic valve dysfunction was defined as hemodynamic structural valve dysfunction (HSVD) if the mean pressure gradient was ≥20 mmHg or nonstructural valve dysfunction (NSVD) if severe PPM or moderate/severe paravalvular leak (PVL) was present. Technical success was defined as follows: 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 anatomical location; and 4) freedom from surgery or intervention related to the device (excluding permanent pacemaker) or a major vascular, access-related, or cardiac structural complication at exit from the procedure room. Device success was defined as follows: 1) technical success; 2) 30-day freedom from mortality; 3) 30-day freedom from surgery or intervention related to the device (excluding permanent pacemaker) or a major vascular, access-related, or cardiac structural complication; and 4) intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index >0.25, and less than moderate aortic regurgitation). Periprocedural mortality was defined as death meeting one of the following criteria: occurring <30 days after the index procedure or >30 days but during the index hospitalization. Clinical efficacy (at 1 year and thereafter) was defined as: freedom from all-cause mortality; freedom from stroke; freedom from hospitalization for procedure- or valve-related causes; freedom from the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score <45 or decline from the baseline of >10 points.
Outcomes
The primary outcomes were periprocedural mortality, technical success, device success, clinical efficacy as defined by VARC-3 criteria, survival, and stroke rates at 2 years.
The secondary outcomes were the following (at 30 days and 1 year): permanent pacemaker implantation (PPI), moderate/severe PVL, residual mean gradient, dimensionless index, indexed EOA, presence of PPM, and KCCQ-12 score.
Statistical Analysis
Unmatched and propensity-matched baseline characteristics, clinical characteristics, and echocardiographic outcomes at 30 days as well as 1 year were compared between the cohorts. The nearest neighbor (1:1) propensity score matching (PSM) method was used to match patients on selected baseline characteristics. Continuous data are presented as mean ± standard deviation for normally distributed data or median and interquartile range (IQR) for non-normally distributed data. Categorical data are presented as frequency and percentage. Normally distributed continuous data were analyzed using Student’s t test, while non-normally distributed continuous data were analyzed with the Mann-Whitney U test. Categorical data were compared via the chi-square or Fisher’s exact test as appropriate. A univariable Cox regression model for mortality as well as a Fine and Grey competing risk model for stroke were created.
All tests were two-sided, with an alpha level of 0.05 set to indicate statistical significance. Unadjusted and propensity-matched survival estimates obtained through Kaplan-Meier analysis were compared using logrank statistics. All statistical analyses were performed using SAS/STAT Version 15.2 (SAS Institute Inc, Cary, NC, USA).
Results
Study Population
After applying the predefined exclusion criteria, we identified 583 patients with SAA who underwent TAVR with SEVs using either SAV (n = 477) or IAV (n = 106) between 2013 and 2023. PSM (accounting for demographic, clinical, and anatomical characteristics) resulted in 86 matched pairs of patients receiving either SAV or IAV platform. Baseline patient characteristics of the matched and unmatched cohorts are presented in Table 1 . The matched cohort was predominantly female (83.7 and 89.5%) and White (93.0 and 95.3%), with a median age of 83.0 and 82.0 years. The adjusted cohort was well balanced, except that we still observed a statistically significant difference in the median Society of Thoracic Surgeons mortality score, which was higher in the IAV group in comparison with the SAV group (median for SAV 3.2, IQR 2.3-5.3 vs. median for IAV 4.2, IQR 3.0-5.8, p = 0.005).
| Baseline characteristics | Unmatched population | Propensity-matched population | ||||
|---|---|---|---|---|---|---|
| Supra-annular (n = 477) | Intra-annular (n = 106) | P value | Supra-annular (n = 86) | Intra-annular (n = 86) | P value | |
| Age, years | 81.0 (76.0-86.0) | 82.0 (77.0-89.0) | 0.056 | 83.0 (76.0-87.0) | 82.0 (78.0-89.0) | 0.675 |
| Sex, female | 400 (83.6%) | 90 (90.6%) | 0.080 | 72 (83.7%) | 77 (89.5%) | 0.261 |
| Race | 0.081 | 0.778 | ||||
| White | 443 (92.9%) | 100 (94.3%) | 80 (93.0%) | 82 (95.3%) | ||
| Black | 11 (2.3%) | 5 (4.7%) | 4 (4.7%) | 3 (3.5%) | ||
| Other | 23 (4.8%) | 1 (0.9%) | 2 (2.3%) | 1 (1.2%) | ||
| BMI | 28.6 (24.2-33.6) | 28.5 (23.5-35.1) | 0.953 | 29.1 (25.5-34.4) | 29.2 (23.7-35.5) | 0.829 |
| BSA | 1.80 ± 0.23 | 1.79 ± 0.25 | 0.668 | 1.82 ± 0.21 | 1.80 ± 0.25 | 0.652 |
| NYHA class (2 wk pre-TAVR) | 0.734 | 0.207 | ||||
| I | 16 (3.4%) | 5 (4.7%) | 3 (3.5%) | 3 (3.5%) | ||
| II | 257 (53.9%) | 52 (49.1%) | 55 (64.0%) | 43 (50.0%) | ||
| III | 183 (38.4%) | 45 (42.5%) | 27 (31.4%) | 36 (41.9%) | ||
| IV | 21 (4.4%) | 4 (3.8%) | 1 (1.2%) | 4 (4.7%) | ||
| Hypertension | 437 (91.6%) | 101 (95.3%) | 0.200 | 78 (90.7%) | 83 (96.5%) | 0.119 |
| Diabetes | 147 (30.8%) | 30 (28.3%) | 0.610 | 24 (27.9%) | 27 (31.4%) | 0.616 |
| COPD | 119 (24.9%) | 32 (30.2%) | 0.265 | 28 (32.6%) | 26 (30.2%) | 0.742 |
| Current dialysis | 10 (2.1%) | 6 (5.7%) | 0.042 | 2 (2.3%) | 5 (5.8%) | 0.247 |
| Preprocedural creatine | 1.0 (0.8-1.2) | 1.0 (0.8-1.3) | 0.246 | 0.9 (0.8-1.1) | 1.0 (0.8-1.3) | 0.069 |
| Atrial fibrillation | 97 (20.3%) | 31 (29.2%) | 0.045 | 26 (30.2%) | 28 (32.6%) | 0.742 |
| Prior PAD | 61 (12.8%) | 11 (10.4%) | 0.490 | 11 (12.8%) | 8 (9.3%) | 0.465 |
| Prior stroke | 55 (11.5%) | 13 (12.3%) | 0.831 | 11 (12.8%) | 10 (11.6%) | 0.815 |
| Urgent/emergent TAVR | 3 (0.6%) | 3 (2.8%) | 0.042 | 1 (1.2%) | 2 (2.3%) | 0.560 |
| Prior CABG/PCI | 146 (30.6%) | 42 (39.6%) | 0.072 | 36 (41.9%) | 32 (37.2%) | 0.532 |
| Unable to walk | 21 (4.4%) | 11 (10.4%) | 0.014 | 6 (7.0%) | 10 (11.6%) | 0.293 |
| MR moderate | 10 (2.1%) | 0 (0.0%) | 0.132 | 0 (0.0%) | 0 (0.0%) | N/A |
| Previous RBBB/LBBB | 135 (28.3%) | 35 (33.0%) | 0.333 | 22 (25.8) | 32 (32.5%) | 0.313 |
| LVEF (%) | 63.0 (55.0-65.0) | 63.0 (58.0-63.0) | 0.203 | 63.0 (58.0-65.0) | 63.0 (58.0-63.0) | 0.203 |
| STS PROM (median) | 3.4 (2.3-5.6) | 4.2 (2.9-5.8) | 0.002 | 3.2 (2.3-5.3) | 4.2 (3.0-5.8) | 0.005 |
| AV area (cm 2 ) | 0.6 (0.5-0.7) | 0.7 (0.6-0.8) | 0.026 | 0.7 (0.6-0.8) | 0.7 (0.6-0.8) | 0.762 |
| AV mean gradient (mmHg) | 43.0 (39.0-52.0) | 45.0 (40.0-57.0) | 0.099 | 45.0 (40.0-53.0) | 44.5 (40.0-52.0) | 0.788 |
| AV annulus diameter (mm) | 21.7 (21.0-22.3) | 22.0 (21.2-22.5) | 0.011 | 22.3 (21.2-22.7) | 22.0 (21.2-22.4) | 0.091 |
| AV annulus area (mm 2 ) | 367.0 (344.0-389.0) | 371.0 (344.0-390.0) | 0.797 | 386 (347-399) | 370 (341-390) | 0.059 |
| AV annulus perimeter (mm) | 69.4 (67.0-71.0) | 70 (67.2-71.5) | 0.4161 | 70.6 (67.2-71.6) | 70.6 (67.4-71.5) | 0.352 |
| Bicuspid aortic valve | 7 (1.5%) | 0 (0.0%) | N/A | 1 (1.2%) | 0 (0.0%) | 0.315 |
| KCCQ-12 overall | 58.7 (37.0-80.0) | 51.5 (35.0-71.0) | 0.079 | 59.0 (36.0-82.0) | 50.5 (34.0-70.5) | 0.117 |
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