Background Contemporary self-expanding transcatheter heart valves (SEV) have incorporated design refinements to reduce paravalvular leak (PVL) and pacemaker implantation (PPI). We aimed to characterize clinical outcomes after transcatheter aortic valve replacement (TAVR) with contemporary SEVs in patients with severe aortic stenosis. Methods PubMed, EMBASE, and Scopus were searched through October 5, 2025, for studies reporting procedural, hemodynamic, and clinical outcomes for patients undergoing TAVR with the (1) Navitor or (2) Evolut PRO/ PRO+/ FX. Random-effects meta-analyses pooled single-arm event rates, stratified by SEV group, using the Freeman–Tukey double arcsine transformation. Between-platform differences were assessed using subgroup interaction testing. Results Fifty-two studies (n = 21,349; weighted mean age 82 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) 4.8%) were included. At 30 days, all-cause mortality was low among Evolut and Navitor cohorts (1.4% and 1.5%; p = 0.63), and device success was high for both platforms (92.1% and 93.0%; p = 0.73). Moderate or greater PVL occurred in 2.5% and 1.1% of Evolut and Navitor cohorts, respectively (p = 0.12), mild PVL occurred in 31.1% and 19.9% (p = 0.046), and new PPI occurred in 13.4% and 15.3%, respectively. Mean gradients remained low among Evolut and Navitor cohorts at 1 year (7.7 and 7.3 mmHg; p = 0.65), while effective orifice area was higher among Evolut cohorts at 1 year (2.1 and 1.8 cm2; p < 0.001) (p = p-interaction). Conclusions Navitor and Evolut PRO/PRO+/FX both demonstrated high device success, low mortality, favorable hemodynamic performance, and low rates of moderate or greater PVL at 1-year follow-up. Mild PVL and new PPI remained frequent. Observed comparative signals should be interpreted as indirect hypothesis-generating findings.
Background Comparative data among contemporary self-expanding transcatheter heart valve designs remain limited. We compared clinical and hemodynamic outcomes following transcatheter aortic valve replacement (TAVR) using two leading contemporary platforms. Methods This multicenter cohort study utilized the AMTRAC registry to evaluate consecutive patients treated with either Evolut PRO/PRO+/FX or Navitor. The primary analysis employed a 1:1 propensity score-matched (PSM) cohort, utilizing multilevel mixed-effects models to adjust for center-level clustering. The primary endpoint was 1-year all-cause mortality. Results Of 2,673 patients, PSM yielded a balanced cohort of 1,200 patients. At 1-year, all-cause mortality was similar between groups (Navitor: 7.1% vs. Evolut: 9.2%; HR 0.75; 95% CI: 0.47–1.21; p = 0.24). In-hospital mortality (0.8%), periprocedural stroke (2.3%), permanent pacemaker implantation (Navitor: 14.4% vs. Evolut: 15.9%; p = 0.554), and paravalvular leak (p = 0.221) were comparable. Initial differences showing lower vascular and bleeding events with Navitor were completely attenuated after accounting for center-level clustering (vascular: p = 0.838; bleeding: p = 0.745). Conversely, post-procedural mean transaortic gradient was lower with Evolut (7.3 ± 3.9 mmHg vs. 8.6 ± 4.1 mmHg; p < 0.001), a hemodynamic advantage that remained highly robust after center adjustment (OR 2.43; 95% CI: 1.66–3.58; p < 0.001). Sensitivity analyses yielded consistent results. Conclusions Contemporary self-expanding platforms demonstrate comparable 1-year mortality and stroke rates. Periprocedural vascular and bleeding safety profiles are strongly modulated by center-specific clustering and practice variations. Conversely, the superior hemodynamic performance of the Evolut platform remains independent of institutional factors. These findings support an anatomy-driven approach to valve selection integrating patient profiles with institutional practices.
Background Transcatheter aortic valve replacement (TAVR) has transformed the management of severe aortic stenosis, with expanding indications and progressive device refinements. Long-term outcomes with balloon-expandable valves across device generations remain incompletely characterized. Methods We analyzed 4,137 patients who underwent balloon-expandable TAVR at a high-volume tertiary center from 2006 to 2022. Patients were stratified by device generation (SAPIEN 9000TFX, SAPIEN XT, and SAPIEN 3). Procedural outcomes, survival, echocardiographic follow-up, and reintervention rates were assessed. Cox regression and competing-risk analyses were performed to evaluate associations with mortality, stroke, and myocardial infarction. Results The mean age of the cohort was 79 ± 9.6 years, and 60.5% were male. Transfemoral access increased significantly with newer devices (90% with S3 vs. 74% with SXT and 41% with S9000TFX). Periprocedural complications declined across generations, with the S3 valve demonstrating the lowest rates of in-hospital mortality (0.3%), tamponade (0.1%), stroke (0.5%), and acute kidney injury (0.2%). During follow-up, all-cause mortality was significantly higher with S9000TFX compared with S3 (HR 1.43, 95% CI 1.25–1.64; p < 0.001). Long-term echocardiography demonstrated stable aortic valve gradients (<20 mmHg) and minimal PVL, especially in the S3 group. Only 10 patients required TAV-in-TAV intervention, with a median interval of ∼6 years, most of whom underwent repeat implantation of a similar-sized S3 valve. Conclusions In this large single-center experience with balloon-expandable TAVR, the contemporary era of newer-generation devices was associated with lower procedural complication rates, improved survival, and stable valve hemodynamics during follow-up among patients with available imaging. These findings underscore the rapid maturation of TAVR as a therapeutic option complementing surgical treatment in expanding treatment options for a wider spectrum of patients. Improved long-term survival has enabled a more robust assessment of valve durability, and TAV-in-TAV remains a viable treatment strategy for structural valve degeneration.
Background Comparative real-world data on newer balloon-expandable valve (BEV) platforms remain limited. We sought to compare clinical, procedural, and early hemodynamic outcomes following transcatheter aortic valve replacement (TAVR) using 2 contemporary balloon-expandable valves in a multicenter international registry. Methods Consecutive patients undergoing TAVR with Sapien 3/Ultra and MyVal from the AMTRAC multicenter registry were included. Propensity score matching (PSM) was used to generate a balanced 1:3 cohort. The primary endpoint was 2-year all-cause mortality. Secondary endpoints included in-hospital complications, defined according to Valve Academic Research Consortium–3 criteria. Results A total of 1903 patients undergoing TAVR with BEV were included (Sapien, n = 1676; MyVal, n = 227). Baseline clinical and echocardiographic characteristics were largely comparable between groups. In the propensity-matched cohort (n = 743), 2-year all-cause mortality did not differ between groups. In-hospital mortality and major procedural complications were similar across platforms. New permanent pacemaker implantation (PPI) occurred more frequently with MyVal compared with Sapien (26.6% vs.10.1%; p < 0.001).Postprocedural mean transvalvular gradients were comparable between valves, but a greater proportion of Sapien recipients had elevated mean gradients (>10mmHg), (44.0% vs.32.3%; p = 0.019). Paravalvular leak (PVL) distribution differed, with more-than-mild PVL observed more frequently in the MyVal group (9.8% vs.2.1%; p < 0.001). Conclusions In this analysis, both BEV platforms demonstrated comparable safety, mortality, and overall hemodynamic performance following TAVR. However, MyVal was associated with higher rates of PPI and PVL. These findings highlight important platform-specific differences that may inform valve selection and warrant further long-term evaluation.
Background Stroke remains a serious complication after transcatheter aortic valve replacement (TAVR), even with contemporary devices. Objectives To evaluate the incidence, predictors, and prognosis of in-hospital stroke in patients undergoing TAVR with contemporary valve platforms. Methods We analyzed 5,123 patients from the multicenter OCEAN-TAVI registry who underwent TAVR with Sapien 3 Ultra RESILIA, Evolut FX, or Navitor between May 2022 and December 2024. Stroke incidence across valve types was compared using inverse probability of treatment weighting (IPTW). Predictors were assessed using multivariable Firth penalized logistic regression. Results In-hospital stroke occurred in 2.5% of patients. After IPTW adjustment, stroke incidence differed among valve types: 1.7% of patients treated with Sapien 3 Ultra RESILIA, 4.5% with Evolut FX, and 2.4% with Navitor (p = 0.044). Disabling stroke was more frequent with Evolut FX (2.5%) compared with Sapien 3 Ultra RESILIA (0.4%) and Navitor (0.7%; p < 0.001). Self-expanding valve use (adjusted odds ratio [aOR] 2.64, 95% confidence interval [CI] 1.67–4.16 for Evolut FX; aOR 2.37, 95% CI 1.35–4.18 for Navitor; both vs. S3UR), prior stroke (aOR 1.83, 95% CI 1.19–2.73), reduced renal function, and nontransfemoral access (aOR 2.11, 95% CI 1.29–3.45) were independently associated with in-hospital stroke. One-year survival was significantly lower among patients with stroke than among those without stroke (73.0% vs. 90.3%; p < 0.001). Conclusions In-hospital stroke remains an important complication after contemporary TAVR and is associated with worse clinical outcomes. Differences in stroke incidence across valve types were observed, highlighting the need for improved risk assessment.
Historically, the complexity of patients being evaluated for mitral transcatheter edge-to-edge therapy (M-TEER) has been divided into three main categories: green zone: defined as cases where M-TEER is straightforward and not complex, yellow zone: cases with medium complexity where M-TEER is feasible but not entirely straightforward and the red zone: cases where you would not consider M-TEER as the first option and may be swayed towards consideration of other options like transcatheter mitral valve replacement (TMVR) or surgical management. However, the advancement in pre-procedural planning with precise anatomical definition by 3D imaging modalities has changed how we address complex mitral regurgitation cases. The expansion of available devices for management of mitral valve disease has changed the way we think about undertaking challenging M-TEER procedures. Management in the current era emphasizes meticulous preprocedural assessment of mitral regurgitation (MR) pathology, strategic planning for device implantation, judicious device choice, and early consideration of TMVR or other innovative transcatheter devices. This review article provides a comprehensive overview of the available data on M-TEER and outlines treatment strategies for complex cases within the context of contemporary transcatheter technologies.
