Self-expanding Valve Research Articles

Comparable efficacy and safety for bicuspid aortic valve stenosis patients undergoing transcatheter aortic valve replacement with balloon-expandable or self-expanding valves using Wei's sizing method.

The present study aimed to investigate whether proper sizing can improve the procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) with new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs) for treating bicuspid aortic stenosis (BAS). We retrospectively evaluated consecutive patients who underwent TAVR with Sapien 3 valves (Edwards Lifesciences, Irvine, CA) or Evolut R/PRO valves (Medtronic, Minneapolis, MN) for severe BAS from 2017 to 2022. The primary endpoints were device success rate and major adverse cardiac and cerebral events (MACCEs), including mortality, non-fatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team employed a complementary approach of supra-annular sizing in addition to the conventional annular sizing method (Wei's method) to guide the TAVR procedures. We recruited a total of 75 consecutive patients, of whom 43 (57%) were treated with BEVs from October 2017 to June 2021, and 32 (43%) were treated with SEVs from July 2021 to December 2022. Device success was similar between the BEV and SEV groups (93% vs. 94%; p > 0.99), and no cases of annular rupture occurred in either group. Similar rates of moderate-to-severe paravalvular leak were observed in the BEV and SEV groups (5% vs. 6%, p > 0.99). At a median follow-up of 464 days, the MACCE rates were comparable between the two groups. In multivariate analysis, the presence of previous percutaneous coronary interventions (hazard ratio: 5.43; p = 0.039) and New York Heart Association functional class III/IV heart failure at 30 days of follow-up after TAVR (hazard ratio: 9.90; p = 0.037) were independently associated with long-term MACCEs. Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei's sizing method.

Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era.

Predictors of permanent pacemaker implantation (PPMI) after self-expanding transcatheter aortic valve implant (TAVI) were described. Is unknown if PPMI predictors remain in the era of high implants using the cusp overlap (COP). Single-center, prospective, consecutive case series of patients undergoing self-expanding TAVI with the COP approach. The status of PPMI and other clinical events were ascertained at 30 days. A total of 261 patients were included (84% with Evolut, n = 219). Implant depth >4 mm was infrequent (13.8%). TAVI depth (OR 1.259; p = 0.005), first or second-degree auriculo-ventricular block (OR 3.406; p = 0.033), right-bundle (OR 15.477; p < 0.0001), and incomplete left-bundle branch block (OR 7.964; p = 0.036) were found to be independent predictors of PPMI. The risk of PPMI with deep implant and no electrical disturbances was 3%, and 0% with high implant and no prior electrical disturbances. Those who received PPMI had no statistically significant increased risk of death, myocardial infarction, stroke, bleeding events, or vascular complications at 30 days, but longer hospital stay (mean difference 1.43 days more, p = 0.003). Implant depth and prior conduction abnormalities remain the main predictors of PPMI using self-expanding TAVI in the COP era. Patients with high implants and no prior conduction abnormalities may be candidates for early discharge after uneventful self-expanding TAVI, while the rest may need inpatient monitoring regardless of achieving a high implant. The need for PPMI was associated with longer hospital stays.

Transcatheter Aortic Valve Implantation in Japanese Patients With Large Annulus: The OCEAN-TAVI Registry

BackgroundEast Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve implantation (TAVI) outcomes in Asian patients with a large annulus. ObjectivesThis study aimed to compare the short- and long-term outcomes of TAVI using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. MethodsThe study retrospectively analyzed the data from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry. A large annulus was defined by an annular area ≥500 mm2 and an average diameter ≥25 mm as measured by computed tomography. The primary endpoint was 3-year all-cause mortality. Secondary endpoints were 3-year heart failure rehospitalization (HFR) after TAVI, short-term outcomes of TAVI, and changes in valve function 2 years after TAVI. ResultsAmong 773 patients, 671 underwent BEV TAVI. The SEV TAVI group showed a significantly higher incidence of greater than moderate paravalvular leakage (PVL) (P < 0.001), and an increased pacemaker implantation rate (P = 0.035). The incidence of prosthesis-patient mismatch did not differ between the 2 groups. The Kaplan-Meier curve showed no significant differences in 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and echocardiographic valve function at 2 years post-TAVI did not differ between the 2 groups. ConclusionsThe lack of differences in postoperative valve performance and long-term prognosis between BEV TAVI and SEV TAVI highlights the importance of selecting valves that can reduce the pacemaker implantation rate and PVL grade in the acute phase in patients with a large annulus. (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation [OCEAN-TAVI]; UMIN000020423)

Comparison of Two Generations of Self-Expandable Transcatheter Heart Valves in Nine Surgical Valves: An In Vitro Study.

(1) Background: This study aimed to analyse the hydrodynamic performance of two generations of self-expanding transcatheter heart valves (THV) as a valve-in-valve (ViV) in different surgical aortic valve (SAV) models under standardised conditions. The nitinol-based Evolut R valve is frequently used in ViV procedures. It is unclear whether its successor, the Evolut PRO, is superior in ViV procedures, particularly considering the previously implanted SAV model. (2) Methods: EvolutTM R 26 mm and EvolutTM PRO 26 mm prostheses were implanted in nine 21 mm labelled size SAV models (Hancock® II, Mosaic® UltraTM, EpicTM Supra, TrifectaTM GT, Perimount®, Perimount® Magna Ease, AvalusTM, IntuityTM, Freestyle®) to analyse their hydrodynamic performance under defined circulatory conditions in a pulse duplicator. (3) Results: Both THVs presented with the lowest effective orifice area (EOA) and highest mean pressure gradient (MPG) inside Hancock® II, whereas THVs in Intuity showed the highest EOA and lowest MPG. Evolut R and Evolut PRO showed significant hydrodynamic differences depending on the SAV. Both THVs performed similarly in porcine valves. Although the Evolut R performed better than Evolut PRO in stented bovine SAVs, the Evolut PRO was superior inside the Intuity. Further, the SAV model design markedly influenced the TAV's geometric orifice area and pin-wheeling index. (4) Conclusions: These findings show that the Evolut R and Evolut PRO perform differently depending on the previously implanted SAV model. THV selection for treatment of a specific SAV model should consider these results.

Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.

In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the firstFDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.

Transcatheter Valve-in-Valve Replacement With Balloon- Versus Self-Expanding Valves in Patients With Degenerated Stentless Aortic Bioprosthesis

Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been associated with favorable outcomes in patients with degenerated stentless bioprosthesis. However, whether the outcomes after ViV TAVR for failed stentless bioprosthesis differ between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) remains unknown. Therefore, we retrospectively analyzed 59 consecutive patients who underwent ViV TAVR for failed stentless bioprsothesis with BEVs (n = 42) versus SEVs (n = 17) in a single-health care system between 2013 and 2022. Overall, the mean age was 70.8 years and 74.6% were men. The mean transcatheter valve size was 26.3 ± 2.2 mm for BEVs and 26.4 ± 4 mm for SEVs (p = 0.93). The mean Society of Thoracic Surgeons score was 6.0 ± 3.6 for BEVs and 7.5 ± 5.5 for SEVs (p = 0.22). Compared with patients who received BEVs, those who received SEVs had higher rates of device malposition (2.4% vs 23.5%, p <0.01), postdeployment balloon dilation (11.9% vs 35.5%, p = 0.04) and need for a second transcatheter device (2.4% vs 35.5%, p <0.01). However, both groups showed similar improvement in aortic valve function at 30-day and 1-year follow-up (incidence of 1-year severe patient-prosthesis mismatch in BEVs: 17.6% vs 14.3% in SEVs, p = 0.78). The 1- and 3-year mortality did not differ between BEVs and SEVs (11.9% vs 11.8% and 25% vs 30%, respectively, Log rank p = 0.9). In conclusion, performing ViV TAVR for failed stentless bioprsothesis is technically challenging, especially when using SEVs; however, satisfactory positioning is possible in most cases, with excellent hemodynamic and clinical outcomes with BEVs and SEVs.

Long-Term Impact of Gender Differences After Transcatheter Aortic Valve Implantation

BackgroundThe short-term and midterm impact of gender differences on transcatheter aortic valve implantation (TAVI) has been studied. However, the impact on long-term clinical outcomes remains unclear. The objective of the study was to investigate the impact of gender differences after TAVI on long-term clinical outcomes and structural valve deterioration (SVD). MethodsOf the 672 consecutive patients who underwent TAVI, with balloon- or self-expandable valves, between 2013 and 2018, a total of 511 who underwent multidetector computed tomography analysis within 30 days after TAVI were included. Echocardiographic data were analyzed annually. ResultsThe number of women was 343 (67.2%), and 90.7% of them had a small annulus (< 430 mm2). The effective orifice area was significantly smaller in women compared with that in men, whereas no difference occurred in the incidence of prosthesis–patient mismatch. The incidence of leaflet thrombosis detected by multidetector computed tomography was similar for women vs men (15.2% vs 13.1%, respectively; P = 0.53). During the median follow-up of 1844 days (interquartile range: 1190-2311 days), women showed a significantly decreased incidence of all-cause mortality (hazard ratio, 0.69; 95% confidence interval, 0.54-0.90; P = 0.005). The development of SVD was comparable (hazard ratio, 0.99; 95% confidence interval, 0.78-1.25, P = 0.90). Severe frailty and the balloon-expandable valves were the independent risk factors for all-cause mortality and SVD in women, respectively. ConclusionsWomen had superior long-term clinical outcomes, compared with those of men, despite their having a small annulus. During long-term follow-up, the incidence of SVD in women was similar in the entire cohort, compared to that in men; however, balloon-expandable valves were possible risk factors for SVD in women.

Transcatheter pulmonary valve implantation: Initial experience with self-expandable valve in patients with congenital heart diseases and comparison with balloon-expandable valve

Transcatheter pulmonary valve implantation: Initial experience with self-expandable valve in patients with congenital heart diseases and comparison with balloon-expandable valve

Differences in Hemodynamic Performance and Modality Measurements Between Self-Expanding Versus Balloon-Expanding Valves in ViV-TAVI Patients with Failed Aortic Bioprosthesis (FAB-TAVI Study)

Differences in Hemodynamic Performance and Modality Measurements Between Self-Expanding Versus Balloon-Expanding Valves in ViV-TAVI Patients with Failed Aortic Bioprosthesis (FAB-TAVI Study)

Force Analysis Using Self-Expandable Valve Fluoroscopic Imaging: a way Through Artificial Intelligence.

This study aimed to develop a force analysis model correlating fluoroscopic images of self-expandable valves with stress distribution. For this purpose, a nonmetallic measuring device designed to apply diverse forces at specific positions on a valve stent while simultaneously measuring force magnitude was manufactured, obtaining 465 sets of fluorescent films under different force conditions, resulting in 5580 images and their corresponding force tables. Using the XrayGLM, a mechanical analysis model based on valve fluorescence images was trained. The accuracy of the image force analysis using this model was approximately 70% (50-88.3%), with a relative accuracy of 93.3% (75-100%). This confirms that fluoroscopic images of transcatheter aortic valve replacement (TAVR) valve stents contain a wealth of mechanical information, and machine learning can be used to train models to recognize the relationship between stent images and force distribution, enhancing the understanding of TAVR complications.

Coronary Access and PCI after Transcatheter Aortic Valve Replacement With Different Self-Expanding Platforms in Failed Surgical Valves

BackgroundCoronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors, and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough, MA) and Evolut PRO+ (Medtronic, Minneapolis, MN). MethodsFifteen computed tomography (CT)-based patient-specific aortic models were 3-dimensionally (3D) printed and implanted with specific SAVs and with the 2 SS-TAVs with commissural alignment. Two operators attempted CA (n = 120) and PCI (n = 120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was used to assess procedures. CT of the models was obtained. ResultsACURATE neo2 showed significantly higher rates of successful CA (96.7% vs 75%, P = 0.001) and PCI (98.3% vs 85%, P = 0.008) and was associated with a shorter procedural time compared with Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3 mm vs 4.8 mm), facilitating more often an external cannulation approach for both CA (36.7% vs 15%, P < 0.001) and PCI (36.7% vs 21.7%, P = 0.013). ConclusionsThe rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 compared with Evolut PRO+. The differences in SS-TAVs design affected the cannulation approach and subsequent procedural outcomes.

Coronary angiography following transcatheter aortic valve replacement: Insights from the SWEDEHEART registry.

Transcatheter aortic valve replacement (TAVR) is the most common treatment in patients with symptomatic severe aortic stenosis (AS). As concomitant coronary artery disease is common in AS patients, access to the coronary arteries following TAVR is of increasing importance. This study evaluated the incidence and risk factors for unplanned coronary angiography following TAVR and, using fluoroscopic time as a surrogate, analyzed the complexity of coronary artery cannulation. All patients who underwent TAVR in Sweden between 2008 and 2022 were identified using the SWEDEHEART registry. The cumulative incidence of coronary angiography after TAVR was analyzed with mortality as a competing risk. Angiography and PCI complexity were analyzed using fluoroscopic time and compared across different transcatheter heart valve designs. Out of 9806 patients, 566 subsequently required coronary angiography. The incidence was highest for three-vessel and/or left main disease. Younger age, the extent of prior coronary artery disease, and peripheral vascular disease were associated with an increased risk of coronary angiography. Fluoroscopy time was increased in TAVR patients compared to the control group with the longest fluoroscopy times observed in cases involving supra-annular and self-expanding valves. The incidence of coronary angiography following TAVR is still low. Younger patients and patients with concomitant coronary artery disease have a higher risk. Procedural time is longer in patients with a previous THV replacement. As TAVR is emerging as the first-line treatment in patients with longer life expectancy, facilitating coronary access is an important factor when considering which THV device to implant.

Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve

Repositionable self-expanding valves allow for repositioning during deployment to achieve optimal valve placement. However, the risk of brain injury associated with repositioning, as detected by diffusion-weighted magnetic resonance imaging (DW-MRI), is unknown. Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with repositionable self-expanding valves and receiving DW-MRI before and within 7 days post-TAVR procedure were included. The primary outcomes were incidence, number, total volume, and volume per lesion of the cerebral ischemic lesion in DW-MRI after TAVR. Univariate and multivariate logistic regression assessed the association between repositioning and bigger total lesion volume (> 1 cm3 or > 0.5 cm3). Negative binomial regressions were performed to explore the association between repositioning and number of lesions. A propensity score matching was performed to adjust the potential confounders. Moreover, inverse probability of treatment weighted regression model with nonstabilized weights was used as sensitivity analysis. Among 243 included patients, repositioning was performed in 116 (47.7%) patients. The incidence of overt stroke (1.7% vs. 1.6%, p = 0.927) and silent stroke (86.2% vs. 85.8%, p = 0.932) were comparable between two groups. However, the number of new lesions (5.0 [2.0–9.0] vs. 3.0 [2.0–6.0], p = 0.048), and total lesion volume (275.0 [90.0–947.5] mm3 vs. 180.0 [50.0–440.0] mm3, p = 0.022) were significantly higher in the repositioned group. Moreover, the proportion of patients with lesion size greater than 0.5 cm3 was higher in the repositioned group (37.9% vs. 22.0%, p = 0.007). The similar results were observed after propensity score matching. In both multivariate regression model and sensitivity analysis, the repositioning was the independent predictor of number of lesions and bigger total lesion volume after TAVR. The utilization of the repositioning feature may increase the number and volume of silent brain infarcts in DW-MRI in patients who underwent TAVR. (Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population [TORCH]; NCT02803294)

Expanding Treatment Options: Successful UNICORN Procedure with Self-Expanding Valves in Complex Transcatheter Aortic Valve Replacements

Expanding Treatment Options: Successful UNICORN Procedure with Self-Expanding Valves in Complex Transcatheter Aortic Valve Replacements

Early clinical outcomes of Portico and Edwards Sapien 3 valve prosthesis in transcatheter aortic valve replacement: propensity-matched analysis.

There is a lack of real-world data directly comparing different valve prostheses for transaortic valve replacement (TAVR). We aimed to compare early clinical outcomes at 30-days between the self-expandable Portico valve (Abbott) with the balloon-expandable Edwards Sapien 3 valve (Edwards Lifesciences) (ES3). Out of 1,901 patients undergoing TAVR between January 2018 and December 2021, all patients who received either Portico valve or ES3 valve via transfemoral TAVR were matched using nearest-neighbor (1:1) propensity scoring. Primary endpoints were single safety endpoints and early safety composite endpoints defined by Valve Academic Research Consortium-2 (VARC-2) criteria. The secondary endpoint was to analyze risk predictors for new permanent pacemaker (PPM) implantation in TAVR. Out of 661 complete cases, a total of 434 patients were successfully matched based on age, sex, Euro Score II and STS-score. In the matched cohort, 217 received either a Portico or valve and 217 received an ES3 valve. The VARC-2 early safety composite scores indicated a significantly greater overall 30-day safety risk in the Portico group at 9.2% (n = 20) compared to 3.7% (n = 8) in the ES3 group (p = 0.032). The requirement for new permanent pacemaker (PPM) implantation was also higher in the Portico group, at 21.2% (n = 46) vs. 13.4% (n = 29) in the ES3 group (p = 0.042). 30-day mortality was higher was 3.7% (n = 8) in Portico group compared to 0.9% in ES3 group (p = 0.11). Furthermore, implantation of the Portico valve was identified as a significant risk predictor for new PPM implantation, alongside higher age, preprocedural atrioventricular block (AVB) and longer total procedure duration. This study shows significantly higher rates of early clinical complications for Portico valve prostheses compared to ES3. These findings should be especially taken into consideration when selecting valve prosthesis for high-risk patients.

Early clinical and hemodynamic outcomes of balloon-expandable versus self-expanding transcatheter aortic valve replacement in patients with large aortic annulus: a study-level meta-analysis.

This study aimed to compare early clinical and hemodynamic outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis and large aortic annulus using either balloon-expandable valves (BEVs) or self-expanding valves (SEVs). A comprehensive search of PubMed, Scopus, and the Cochrane Central Register of Controlled Trials was conducted through September 10, 2023, to perform a meta-analysis comparing the clinical outcomes of BEV versus SEV for large aortic annulus (annulus perimeter ≥ 80mm). Seven studies (one propensity-matched study and six observational studies) met our eligibility criteria, including a total of 2167 patients (BEV, 1521; SEV, 646). The rates of procedural stroke (pooled odds ratio 0.55, 95% confidence interval 0.32-0.98), valve embolization (0.11, 0.05-0.24), need for second valve implantation (0.21, 0.17-0.26), permanent pacemaker implantation (0.43, 0.28-0.67), and aortic regurgitation ≥ moderate (0.23, 0.08-0.68) were significantly lower in the BEV group. Conversely, postoperative transvalvular gradient was significantly lower in the SEV group (pooled standard mean difference 0.55, 0.12-0.98). Subgroup analysis with newer-generation valves also showed significant differences in the need for second valve implantation and permanent pacemaker implantation, as well as aortic regurgitation ≥ moderate, favoring BEVs. BEV provides better early outcomes in TAVR for large aortic annulus in terms of lower rates of stroke, valve embolization, need for second valve, permanent pacemaker implantation, and aortic regurgitation ≥ moderate. Conversely, SEV provides a better transvalvular gradient in the early period after TAVR. The online version contains supplementary material available at 10.1007/s12055-024-01770-1.

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis.

Aortic stenosis (AS) is a common heart condition categorized into congenital and acquired forms. Transcatheter aortic valve replacement (TAVR) is an innovative method for AS management, and two valve types, self-expanding valves (SEV) and balloon-expandable valves (BEV), are used in TAVR. The objective of this study is to compare the clinical outcomes associated with balloon-expandable and self-expandable valves in transcatheter aortic valve replacement. The researchers conducted a comprehensive meta-analysis following PRISMA guidelines and AMSTAR-2 tool. The methodology involved a systematic literature search, strict eligibility criteria, unbiased study selection, meticulous data extraction, quality assessment, and rigorous statistical analysis. Our analysis included twenty-six papers and 26553 patients. BEV exhibited significant advantages over SEV in overall mortality across 21 studies, particularly in perioperative and 30-day assessments. However, no substantial disparities emerged between the two valve types in stroke incidence. BEV demonstrated notable benefits in reducing hospitalization rates across 6 studies and significantly fewer instances of permanent pacemaker implantations across 19 studies, particularly evident in the perioperative setting. Other secondary outcomes like bleeding, acute kidney injury, and myocardial infarction showcased non-significant differences between BEV and SEV. The analysis indicates that BEV may offer benefits in specific aspects of TAVR outcomes, but further research is needed to fully understand the factors influencing patient outcomes and mortality in TAVR procedures.

Supra-Annular Versus Intra-Annular Self-Expanding Valves in Small Aortic Annulus: A Propensity Score-Matched Study

BackgroundTranscatheter 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). MethodsSingle-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). ResultsWe 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 cm2/m2, 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. ConclusionsIAVs 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.

Transcatheter aortic valve replacement in China - a review of the available evidence.

This paper discusses aortic stenosis (AS) in China, emphasising the role of transcatheter aortic valve replacement (TAVR) in treating AS in an ageing population. AS characteristics, its treatment and the clinical outcomes of transfemoral TAVR in Chinese patients are described via a systematic review. AS affects >1% of the Chinese population aged ≥65 years, with degenerative AS predominating over rheumatic AS among this age group. Chinese patients often have high aortic valve (AV) calcification with bicuspid AV morphology. In 2021, 38,000 surgical aortic valve replacements (SAVR) were reported in China, while the number of TAVR increased from 293 in 2017 to 7,357 in 2021. There are four self-expanding valves and one balloon-expandable SAPIEN 3 valve available in China. Among them, the Venus A-Valve is the most studied and widely used, whereas limited data are available for VitaFlow, TaurusOne, and SAPIEN 3. Notably, 10.0-16.5% of Venus A-Valve recipients and 0.2% of SAPIEN 3 recipients required multiple valve implantations. The rates of 30-day paravalvular leakage were 0-11.7%/0% for Venus A-Valve, 2.0%/0% for VitaFlow, and 0%/0% for SAPIEN 3, for moderate and severe leakage, respectively. Thirty-day all-cause mortality rates were 3.7-10.0% for Venus A-Valve, 0.9% for VitaFlow, and 0-3.2% for SAPIEN 3. One-year all-cause mortality rates were 5.9-13.6% for Venus A-Valve, 0-4.5% for VitaFlow, 6.7% for TaurusOne, and 6.2% for SAPIEN 3. The Venus A-Valve indicated lower 30-day permanent pacemaker implantation (PPI) rates (7.4-20.5%) than VitaFlow and TaurusOne. Outcomes for patients with bicuspid or tricuspid aortic valves were similar. AS is rising among the elderly Chinese population; SAVR is common, and TAVR is increasing. Limited device comparisons exist, but the Venus A-Valve seems to have lower PPI rates, and SAPIEN 3 has low 30-day mortality in China.

Accurate deployment of self-expanding transcatheter aortic valve implantation for permanent pacemaker reduction

Accurate deployment of self-expanding transcatheter aortic valve implantation for permanent pacemaker reduction