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BACKGROUND: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV). METHODS: Electronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs). RESULTS: The meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV. CONCLUSION: In this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV.

The prevalence of coronary artery disease in patients undergoing transcatheter aortic valve replacement (TAVR) is high. Treatment of a coronary events (CE) after TAVR can be technically challenging. The authors sought to assess the incidence and prognostic impact of CE after TAVR. Patients undergoing TAVR for native aortic stenosis, with balloon-expandable valves (BEV) or self-expandable valves (SEV), included in the France-TAVI registry (Registry of Aortic Valve Bioprostheses Established by Catheter) were studied. The primary endpoint was the rate of first hospitalization for CE at maximal follow-up. The main secondary endpoint was the composite of all-cause mortality or hospitalization for heart failure following CE. Between 2013 and 2021, 64,660 patients were included (BEV 63.8%, SEV 36.2%). CE occurred in 11.6% of cases (1.5%/y). Previous coronary artery disease and known coronary artery stenosis >50% before TAVR were the main predictors of CE. After CE, the composite endpoint was lower in patients who underwent percutaneous coronary intervention (PCI) compared with those who had only coronary angiography or no intervention (79.6%, 85.2%, and 86.5%, respectively; P = 0.002) and higher in SEV than in BEV patients (85.8% vs 83.8%; P = 0.01). Patients admitted to a TAVR center were more likely to have PCI (OR: 1.20 [95% CI: 1.01-1.42]; P = 0.04), even more so if they had a BEV (OR: 1.42 [95% CI: 1.18-1.71]; P = 0.002). The yearly incidence of CE after TAVR is low. In the event of CE, patients who have not undergone PCI have a worse outcome. SEV patients have a higher rate of unfavorable outcomes and are less likely to undergo PCI, especially when admitted to non-TAVR centers. [Display omitted] [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) using a self-expandable valve (SEV) promotes better hemodynamics compared with a balloon-expandable valve (BEV) in a small aortic annulus (SAA). The authors sought to compare hemodynamic properties and clinical outcomes between the latest-generation BEV and SEV after TAVR for SAA. We retrospectively analyzed 1,227 patients undergoing TAVR for aortic stenosis with SAA, defined as an annulus area ≤430 mm2, using the BEV (SAPIEN3 Ultra RESILIA, Edwards Lifesciences) and SEV (Evolut FX, Medtronic). The impact of valve design on severe prosthesis–patient mismatch, aortic valve mean pressure gradient ≥20 mm Hg, paravalvular leakage (PVL) ≥ mild, new permanent pacemaker implantation (PMI), and modified VARC-3 device success at discharge was evaluated using logistic regression and propensity score analysis. Of 1,227 patients, 798 (65.0%) underwent TAVR with BEV implantation. TAVR using BEV had a relatively higher rate of severe prosthesis–patient mismatch (OR: 1.74; 95% CI: 0.54-5.62) and significantly higher incidence of mean pressure gradient ≥20 mm Hg (OR: 2.05; 95% CI: 0.91-4.62) than that using SEV. By contrast, the BEV showed significantly lower incidence of PVL ≥ mild (OR: 0.19; 95% CI: 0.14-0.26), and new PMI (OR: 0.53; 95% CI: 0.33-0.86). The rate of device success was comparable between the BEV and the SEV. These results were confirmed by propensity score analysis. In TAVR for SAA, SEV demonstrated better hemodynamics than the latest BEV, whereas the latest BEV had lower incidences of PVL ≥ mild and new PMI than the SEV. [Display omitted] [ABSTRACT FROM AUTHOR]

Transcatheter pulmonary valve implantation (TPVI) is the standard of care in patients with repaired tetralogy of Fallot (rTOF) presenting with right ventricular outflow tract (RVOT) dysfunction. However, the feasibility of TPVI is limited by the high cost and nonavailability of larger-sized valves for dilated native RVOT of rTOF patients. We report the first successful TPVI with a custom-made 35 mm balloon-expandable valve (Myval™) in a 30-year-old rTOF patient with severe pulmonary regurgitation and RV dysfunction.

Candidates for transcatheter aortic valve replacement (TAVR) occasionally have a "borderline-size" aortic annulus between 2 transcatheter heart valve sizes, based on the manufacturer's sizing chart. Data on TAVR outcomes in such patients are limited. We retrospectively reviewed 1816 patients who underwent transfemoral-TAVR with balloon-expandable valve (BEV) at our institution between 2016 and 2020. We divided patients into borderline and non-borderline groups based on computed tomography-derived annular measurements and compared outcomes. Furthermore, we analyzed procedural characteristics and compared outcomes between the smaller- and larger-valve strategies in patients with borderline-size annulus. During a median follow-up of 23.3 months, there was no significant difference between the borderline (n = 310, 17.0 %) and non-borderline (n = 1506) groups in mortality (17.3 % vs. 19.5 %; hazard ratio [HR] = 0.86 [95% CI = 0.62–1.20], p = 0.39), major adverse cardiac/cerebrovascular events (MACCE: death/myocardial infarction/stroke, 21.2 % vs. 21.5 %; HR = 0.97 [0.71–1.32], p = 0.85), paravalvular leak (PVL: mild 21.8 % vs. 20.6 %, p = 0.81; moderate 0 % vs. 1.2 %; p = 0.37), or mean gradient (12.9 ± 5.8 vs. 12.6 ± 5.2 mmHg, p = 0.69) at 1 year. There was no significant difference between the larger-(n = 113) and smaller-valve(n = 197) subgroups in mortality (23.7 % vs. 15.2 %; HR = 1.57 [0.89–2.77], p = 0.12), MACCE (28.1 % vs. 18.4 %; HR = 1.52 [0.91–2.54], p = 0.11), mild PVL (13.3 % vs. 25.9 %; p = 0.12), or mean gradient (12.3 ± 4.5 vs. 13.6 ± 5.3 mmHg, p = 0.16); however, the rate of permanent pacemaker implantation (PPI) was higher in the larger-valve subgroup (15.9 % vs. 2.6 %, p < 0.001). Borderline-size annulus is not associated with higher risk of adverse outcomes after BEV-TAVR. However, the larger-valve strategy for borderline-size annulus is associated with higher PPI risk, suggesting a greater risk of injury to the conduction system. [Display omitted] • Patients undergoing TAVR may have an aortic annular size that falls in the grey zone between 2 prostheses sizes. • The presence of borderline-size annulus is not associated with worse outcomes after balloon-expandable TAVR. • In borderline annulus, valve size should be selected based on the individual anatomic patient characteristics. • Implantation of the larger THV in borderline annulus is associated with higher pacemaker risk. [ABSTRACT FROM AUTHOR]

Dialysis patients undergoing transcatheter aortic valve replacement (TAVR) face increased risk and have poorer outcomes than non-dialysis patients. Moreover, TAVR in dialysis patients using an alternative approach is considered extremely risky and little is known about the outcomes. We routinely perform minimum-incision transsubclavian TAVR (MITS-TAVR), which is contraindicated for transfemoral (TF) TAVR. This study aimed to evaluate the outcomes of MITS-TAVR compared with those of TF-TAVR in dialysis patients. This single-center, observational study included 79 consecutive dialysis patients who underwent MITS-TAVR (MITS group, n = 22) or TF-TAVR (TF group, n = 57) under regional anesthesia. The rates of peripheral artery disease (MITS vs. TF, 72.7 % vs. 26.3 %; p < 0.01), shaggy aortas (MITS vs. TF, 63.6 % vs. 5.26 %; p < 0.01), and tortuous aortas (MITS vs. TF, 13.6 % vs. 1.75 %; p = 0.031) were significantly higher in the MITS group. The 30-day mortality was 2.53 % and comparable between the two groups (MITS vs. TF, 4.54 % vs. 1.75 %; p = 0.479). In the MITS group, 14 patients had ipsilateral dialysis fistulas, and three patients had patent in situ ipsilateral internal thoracic artery grafts; however, no vascular complications were observed. Kaplan–Meier survival curves for the two groups showed no significant difference in the survival rate (at 2 years; MITS vs. TF, 77.3 % vs. 68.8 %; p = 0.840) and freedom from cardiovascular mortality (at 2 years; MITS vs. TF, 90.9 % vs. 96.5 %; p = 0.898). The multivariable Cox proportional hazard model also indicated that survival in the MITS group was not significantly different from that in the TF group (hazard ratio 1.48; 95 % confidence interval, 0.77–2.85, p = 0.244). The patency rate of ipsilateral dialysis fistula was 100 % during follow-up. The outcome of MITS-TAVR was comparable to that of TF-TAVR in dialysis patients, despite the higher risk of patient characteristics. [Display omitted] • Minimum-incision transsubclavian (MITS) group showed higher rates of peripheral artery disease, shaggy and tortuous aorta. • Early outcomes of MITS-transcatheter aortic valve replacement (TAVR) are comparable to those of transfemoral-TAVR. • No vascular complications and strokes were observed in patients undergoing MITS-TAVR. • The patency rate of ipsilateral dialysis fistula was 100 % during follow-up. [ABSTRACT FROM AUTHOR]

Transcatheter pulmonary valve implantation (TPVI) is the standard of care in patients with repaired tetralogy of Fallot (rTOF) presenting with right ventricular outflow tract (RVOT) dysfunction. However, the feasibility of TPVI is limited by the high cost and nonavailability of larger-sized valves for dilated native RVOT of rTOF patients. We report the first successful TPVI with a custom-made 35 mm balloon-expandable valve (Myval™) in a 30-year-old rTOF patient with severe pulmonary regurgitation and RV dysfunction. [ABSTRACT FROM AUTHOR]

Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL. [ABSTRACT FROM AUTHOR]

BACKGROUND: Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment. METHODS: Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-tosinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility. RESULTS: Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P<0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant (P<0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size. CONCLUSIONS: This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement in extra-large annulus is challenging because of the limited sizes and data of the current commercial prosthesis sizes available. We present a case of successful transcatheter aortic valve replacement with a new balloon-expandable SAPIEN 3 Ultra RESILIA valve for an aortic annulus area >1,000 mm2 on computed tomography.

IntroductionParavalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR.MethodsWe retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated.ResultsIn total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p

Objectives: Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is a novel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve. Methods: In this prospective single-centre study, 120 consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30 days and 6 months using Valve Academic Research Consortium‑2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for a permanent pacemaker implantation (PPI) were investigated. Results: At 6‑month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30 days. An intermediate valve size was selected in 51% of the patients. Conclusions: The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6‑month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve. [ABSTRACT FROM AUTHOR]

BACKGROUND: Coronary accessibility following redo--transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. [ABSTRACT FROM AUTHOR]

Background In transcatheter aortic valve implantation (TAVI) using a SAPIEN3 balloon-expandable valve (S3), wire withdrawal from the left ventricle (LV) during the procedure before deployment can induce vascular injury in the access site or require surgical treatment when an S3 removal is attempted. We present a successful case of bailout from this situation safely with a minimally invasive technique using a 6-F snare catheter (SC). Case summary An 86-year-old woman with severe aortic stenosis underwent trans-femoral TAVI using an S3 under conscious sedation. After a pre-shaped wire was inserted into the LV from the right femoral artery, the LV wire was accidentally withdrawn completely from the LV before deployment. Wire re-insertion using a soft straight wire through the tip lumen of the S3 was hindered because the wire orientation was uncontrollable. Hence, we used a 6-F SC to control the wire direction by changing the orientation of the S3. Catching the tip of the S3 with an SC at the ascending aorta enabled us to control the wire direction, and wire re-insertion in the LV with the soft wire was successful. Furthermore, the SC worked well in advancing the S3 through the aortic valve to enhance co-axiality without aortic root injury. The S3 was successfully advanced through the aortic valve and implanted at an optimal position without complications. Discussion Our simple technique using a 6-F SC is technically effective, feasible, and minimally invasive and can be an option for bailout from accidental LV wire withdrawal during balloon-expandable valve TAVI. [ABSTRACT FROM AUTHOR]

Introduction: Balloon-expandable (BE) and self-expandable (SE) prostheses are the main types of devices currently used in transcatheter aortic valve implantation (TAVI). Despite the different designs, clinical practice guidelines do not make any specific recommendation on the selection of one device over the other. Most operators are trained in using both BE and SE prostheses, but operator experience with each of the two designs might influence patient outcomes. The aim of this study was to compare the immediate and mid-term clinical outcomes during the learning curve in BE versus SE TAVI. Methods: The transfemoral TAVI procedures performed in a single center between July 2017 and March 2021 were grouped according to the type of implanted prosthesis. The procedures in each group were ordered according to the case sequence number. For each patient, a minimum follow-up time of 12 months was required for inclusion in the analysis. The outcomes of the BE TAVI procedures were compared with the outcomes of the SE TAVI procedures. Clinical endpoints were defined according to the Valve Academic Research Consortium 3 (VARC-3). Results: The median follow-up time was 28 months. Each device group included 128 patients. In the BE group, case sequence number predicted mid-term all-cause mortality at an optimal cutoff value ≤58 procedures (AUC 0.730; 95% CI: 0.644–0.805; p < 0.001), while in the SE group, the cutoff value was ≤85 procedures (AUC 0.625; 95% CI: 0.535–0.710; p = 0.04). A direct comparison of the AUC showed that case sequence number was equally adequate in predicting mid-term mortality, irrespective of prosthesis type (p = 0.11). A low case sequence number was associated with an increased rate of VARC-3 major cardiac and vascular complications (OR 0.98 95% CI: 0.96–0.99; p = 0.03) in the BE device group, and with an increased rate of post-TAVI aortic regurgitation ≥ grade II (OR 0.98; 95% CI: 0.97–0.99; p = 0.03) in the SE device group. Conclusions: In transfemoral TAVI, case sequence number influenced mid-term mortality irrespective of prosthesis type, but the learning curve was longer in the case of SE devices. [ABSTRACT FROM AUTHOR]

BackgroundData comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV.MethodsA total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV.ResultsA 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109).ConclusionsTreatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

The Evolut R/Pro and the Sapien 3 are the most commonly valve systems used today for transcatheter aortic valve implantation (TAVI). However, there is a still uncertainty regarding the efficacy and safety comparison of these two valves. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing the Evolut R/Pro versus the Sapien 3. The primary outcome was all-cause mortality (short and long-term). The secondary outcomes were stroke, bleeding, permanent pacemaker implantation (PPI), acute kidney injury (AKI), major vascular complication, device success, moderate- severe aortic regurgitation (AR), and pressure gradients. Twenty-one publications totaling 35,248 patients were included in the analysis. Evolut R/Pro was associated with higher risk of short-term all-cause mortality (OR = 1.31;95% CI 1.15–1.49, p < 0.001) and a trend of higher long-term mortality (OR = 1.07;95% CI 1.00–1.16, p = 0.06). The Evolut R/Pro was associated with higher risk of PPI and AR and lower risk for bleeding, major vascular complication, and pressure gradients. There was no significant difference between the groups regarding the risk of stroke, AKI and device success. The Evolut R/Pro valve system compared to the Sapien 3 is associated with higher risk of short-term mortality, significant AR and PPI while providing the advantage of lower risk of bleeding, major vascular complication, and lower residual transvalvular gradients. • Evolut R/Pro compared to Sapien 3 is associated with higher short-term death risk. • Evolut R/Pro is associated with higher risk of pacemaker implantation. • Evolut R/Pro is associated with higher rate of moderate + AR. • The Sapien 3 is related to higher risk for bleeding. • The Sapien 3 is associated with higher risk for major vascular complication. [ABSTRACT FROM AUTHOR]

Background: The management of Transcatheter Aortic Valve Implantation (TAVI) patients with a small aortic annulus (SAA) postures a substantial challenge, increasing the risk of patient- prosthesis mismatch (PPM) and overall mortality., Aims: This study aimed to compare the hemodynamic and clinical outcomes of transcatheter balloon-expandable valve (BEV) versus transcatheter self-expandable valve (SEV) in SAA., Methods: We conducted propensity score matching (PSM) of severe AS patients with SAA who underwent trans-femoral TAVR and enrolled to the Israeli TAVR registry between the years 2008 and 2023. SAA was defined as an aortic-valve annulus area ≤ 430 mm 2 . Since the BEV used have a smaller size cut-off, an additional analysis on very small aortic annulus (vSAA) as defined as aortic-valve annulus area ≤ 345 mm 2 was performed., Results: The study included 1364 consecutive patients with SAA of (BEV n = 485; SEV n = 879) at a mean age of 82 ± 7 years, of whom the vast majority were female (83%). Propensity-matched groups comprised of 329 and 122 paired for the SAA and vSAA patients, respectively. As compared to BEV in the SAA and vSAA analyses, SEV showed lower rates of postprocedural of LBBB (32% vs. 22% and 41% vs. 22%; both p < 0.01, respectively), however, higher rates of major vascular complications (2% vs. 7% and 2% vs. 12%; both p < 0.01, respectively) and major or life-threatening bleeding but only in vSAA group (17% vs. 9.1%, p = 0.009). One-month mortality was higher in the SEV versus BEV in both SAA and vSAA comparisons (2% vs. 0.6%, p = 0.048 and 3% vs. 0%, p = 0.018; respectively). A nonsignificant trend of higher 5-year mortality was observed in univariate models, noted mainly in vSAA patients (22% vs. 19%, p = 0.385; 24% vs. 15%, p = 0.073)., Conclusions: The present analysis observed higher rates of major vascular complications and 1-month mortality in SAA and vSAA treated with SEV. A similar nonsignificant trend toward long-term mortality for the vSAA group was observed and should be evaluated in larger cohorts., (© 2024 Wiley Periodicals LLC.)

Transcatheter aortic valve replacement (TAVR) is a minimally invasive strategy for the treatment of aortic stenosis. The complex postoperative complications of TAVR were related to the type of implanted prosthetic valve, and the deep mechanism of this relationship may guide the clinical pre-operative planning. This technical brief developed a numerical method of TAVR to compare the outcome difference between balloon-expandable valve and self-expandable valve and predict the postoperative results. A complete patient-specific aortic model was reconstructed. Two prosthetic valves (balloon-expandable valve and self-expandable valve) were introduced to simulate the implantation procedure, and postprocedural function was studied with fluid-structure interaction method, respectively. Results showed similar stress distribution for two valves, but higher peak stress for balloon-expandable valve model. The balloon-expandable valve was associated with a better circular cross section and smaller paravalvular gaps area. Hemodynamic parameters like cardiac output, mean transvalvular pressure difference, and effective orifice area (EOA) of the balloon-expandable valve model were better than those of the self-expandable valve model. Significant outcome difference was found for two prosthetic valves. Balloon-expandable valve may effectively decrease the risk and degree of postoperative paravalvular leak, while self-expandable valve was conducive to lower stroke risk due to lower aortic stress. The numerical TAVR simulation process may become an assistant tool for prosthesis selection in pre-operative planning and postoperative prediction. [ABSTRACT FROM AUTHOR]

Current guidelines provide recommendation for transcatheter aortic-valve replacement (TAVR) in severe aortic stenosis without emphasis on valve systems. The comparative performances of balloon-expandable valves (BEV) and self-expanding valves (SEV) remain unclear. We aim to compare the early (30-day) and midterm (1-year) mortality and cardiovascular outcomes of BEV with SEV. PubMed, CENTRAL, and EMBASE were searched from inception to February 13, 2020 for randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Odds ratios (ORs) for binary outcomes and mean differences for continuous outcomes were pooled using random-effect models (DerSimonian–Laird method) with Hartung-Knapp-Sidik-Jonkman variance correction. Primary outcomes were early and midterm all-cause mortality. We included 3 RCTs (1418 patients) and 12 PSM studies (36,540 patients). Compared with SEV, BEV was associated with significantly lower mortality at 30 days (OR 0.76, 95% CI 0.67–0.85, p < 0.001, I2 = 0) and 1 year (OR 0.87, 95% CI 0.77–0.99, p = 0.04, I2 = 20.4%) in PSM studies, but not RCTs with insufficient power. Similar findings were found in subgroups analysis based on valve generations and SEV types. The 30-day and 1-year cardiovascular mortality, 30-day incidences of moderate to severe paravalvular leak, procedural contrast agent volume, and procedure time were lower, but transvalvular pressure gradient was higher in BEV than SEV in PSM studies. The 30-day incidences of permanent pacemaker implantation (PPI), acute kidney injury, stroke, major bleeding, major vascular complications, and rehospitalization were not statistically different between BEV and SEV. Early-generation SEV was associated with a higher 30-day PPI risk than corresponding BEV comparators. PPI risk was lower in ACURATE neo (Boston Scientific, Natick, MA) but higher in Evolut R SEV (Medtronic Inc., Minneapolis, MN), both compared with SAPIEN 3 BEV (Edwards Lifesciences, Irvine, CA). PSM studies suggest lower early and midterm mortality in BEV than SEV, but the contribution of unmeasured confounders cannot be excluded. Results from adequately powered RCTs with long-term follow-up are critically needed to confirm these findings. [Display omitted] • Balloon-expandable valve (BEV) transcatheter aortic-valve replacement might be associated with lower early and midterm total mortality than self-expanding valve (SEV) replacement. • Early moderate to severe paravalvular leak was lower with BEV than SEV. • Early incidence of stroke, permanent pacemaker implantation, acute kidney injury, and major bleeding were not different. [ABSTRACT FROM AUTHOR]

As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]). Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176). In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR. [Display omitted] [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis, providing a viable alternative to surgical aortic valve replacement (SAVR) for patients deemed to be at prohibitive surgical risk, but also for selected patients at intermediate or low surgical risk. Nonetheless, there still exist uncertainties regarding the optimal management of patients undergoing TAVR. The selection of the optimal bioprosthetic valve for each patient represents one of the most challenging dilemmas for clinicians, given the large number of currently available devices. Limited follow-up data from landmark clinical trials comparing TAVR with SAVR, coupled with the typically elderly and frail population of patients undergoing TAVR, has led to inconclusive data on valve durability. Recommendations about the use of one device over another in given each patient's clinical and procedural characteristics are largely based on expert consensus. This review aims to evaluate the available evidence on the performance of different devices in the presence of specific clinical and anatomic features, with a focus on patient, procedural, and device features that have demonstrated a relevant impact on the risk of poor hemodynamic valve performance and adverse clinical events. [ABSTRACT FROM AUTHOR]

Bicuspid aortic valve (BAV) remains challenging in transcatheter aortic valve replacement (TAVR) because of unfavorable anatomy. New-generation balloon-expandable valve (BEV) appears to be a valid alternative to surgery, especially in some Asian countries with a higher prevalence of BAV. This tutorial review summarizes current thinking about how to plan and implant BEV in BAVs using versatile techniques. First, the authors depict the main morphological characteristics of BAVs and their effects on the TAVR procedure. Next, the authors provide preprocedural analysis on sizing, obtaining the optimal deployment projection, and how to simplify valve-crossing. Finally, the authors provide step-by-step guidance on how to deploy the BEVs with evolved iterations in terms of specific anatomies, calcified annulus, and giant annulus.

Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [ P < 0.001] and 12.7% vs 10.0% [ P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [ P < 0.001] and 2.2% vs 1.4% [ P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [ P < 0.001] and 3.4% vs 3.7% [ P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [ P = 0.021] and 16.8% vs 16.5% [ P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274) [Display omitted] [ABSTRACT FROM AUTHOR]

BackgroundOur goal was to explore the role of 3-dimensional (3D) printing in facilitating the outcome of a mitral valve-in-valve (V-in-V) implant of a balloon-expandable valve.MethodsFrom November 2020 to April 2021, 6 patients with degenerated mitral valves were treated by a transcatheter mitral V-in-V implant of a balloon-expandable valve. 3D printed mitral valve pre- and post-procedure models were prepared to facilitate the process by making individualized plans and evaluating the outcomes.ResultsEach of the 6 patients was successfully implanted with a balloon-expandable valve. From post-procedural images and the 3D printed models, we could clearly observe the valve at the ideal position, with the proper shape and no regurgitation. 3D printed mitral valve models contributed to precise decisions, the avoidance of complications, and the valuation of outcomes.Conclusions3D printing plays an important role in guiding the transcatheter mitral V-in-V implant of a balloon-expandable valve.Clinical Trial RegistrationClinicalTrials.gov Protocol Registration System (NCT02917980).

[Display omitted] [ABSTRACT FROM AUTHOR]

Abstract Objective Thrombocytopenia is common after transcatheter aortic valve implantation (TAVI) and is associated with mortality and major complications, although the underlying mechanisms are unclear. This retrospective single-center study aimed to identify factors associated with the decrease in platelet count (DPC) after TAVI in Japanese patients. Patients with severe aortic valve stenosis who underwent transfemoral TAVI between March 2014 and August 2019 were grouped according to DPC values of

Abstract Background Transaxillary access (TAx) has shown promise as an excellent alternative TAVR option, but data on the Edwards SAPIEN 3 in TAx-TAVR is limited. We sought to study the safety and efficacy of TAx-TAVR using this current-generation balloon-expandable valve. Methods A retrospective study of our first 24 TAx and 20 transthoracic (TT) TAVR patients treated with the SAPIEN 3 valve was performed, and the patients’ preoperative characteristics, procedural outcomes, and clinical outcomes were compared to our first 100 transfemoral (TF) patients using the SAPIEN 3 device. Results There were no statistical differences observed for outcomes between the TAx and TF groups, despite the TAx patients having more comorbidities (STS-PROM 11.3 ± 7.6 versus 7.3 ± 5.2, p = 0.042). In addition, no significant difference was found in the fluoroscopy time and contrast amount between the two groups. The patients’ baseline characteristics were similar between the TAx and TT groups. Their procedural and clinical outcomes were comparable, but there was a trend towards lower incidence of acute kidney injury (13.0% versus 23.5%), new-onset atrial fibrillation (5.6% versus 33.3%), shorter median length of stay postoperatively (4 versus 6 days), fewer discharges to rehabilitation (16.7% versus 35.0%), and a lower rate of readmission within 30-days (8.3% versus 35.0%), all favoring TAx access. Conclusions TAx-TAVR with the SAPIEN 3 valve is a safe alternative to TF access. It offers advantages of improved recovery over TT access, and appears to be a superior alternative-access option for TAVR. TAx access could be preferred when TF access is not feasible.

ObjectiveCurrent guidelines recommend that transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) with aortic stenosis (AS) should only be performed in selected patients. However, we consider it even more crucial to identify what the really important factors are while determining long-term outcomes in patients with BAV undergoing TAVR, which is precisely the aim of this study.MethodsWe retrospectively evaluated consecutive patients who underwent TAVR with balloon-expandable Sapien XT or Sapien 3 valves (Edwards Lifesciences, Irvine, CA) for the treatment of severe bicuspid AS. The primary end points were major adverse cardiac and cerebral events (MACCE), that is, mortality, non-fatal myocardial infarction (MI), disabling stroke, valve failure needing reintervention, or clinically relevant valve thrombosis during follow-up.ResultsA total of 56 patients who underwent TAVR with Sapien XT (n = 20) or Sapien 3 (n = 36) were included. The device and procedural success rates were similar between the two TAVR valves; however, the newer-generation Sapien 3 yielded a trend toward better long-term clinical outcomes than the early-generation Sapien XT did (MACCE rates 35 vs. 11%, p = 0.071). In the multivariate Cox proportional hazards analyses, the presence of calcified raphe > 4 mm was the only independent predictor of long-term MACCE (hazard ratio: 6.76; 95% confidence interval: 1.21–37.67, p = 0.029).ConclusionTAVR performed by a skilled heart team, while using newer-generation balloon-expandable Sapien 3 valve, may yield better long-term clinical outcomes compared to TAVR using early-generation Sapien XT valve. Moreover, the presence of calcified raphe >4 mm is an independent determinant of adverse clinical outcomes.

Background: Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion., Aims: To compare hemodynamics after TAVR with small BEV according to postdilation strategy., Methods: This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success., Results: Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001)., Conclusions: RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP., (© 2024 Wiley Periodicals LLC.)

An 83-year-old man with severe aortic stenosis underwent implantation of a 29-mm SAPIEN-3 (Edwards Lifesciences) transcatheter aortic valve (TAV) appropriately sized for an aortic annulus area of 543.6 mm2.

Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs. • Myval THV provides three intermediate-size THVs and two extra-large sizes in addition to the conventional sizing matrix. • Intermediate-size Myval THVs were implanted in 42.0% of patients worldwide. • Availability of the intermediate-size THVs could mitigate the hazardous selection of grossly undersized or oversized valve. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs). AA ≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs. A retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death). AA ≥48° did not influence outcomes in patients with BE THVs. Additionally, AA ≥48° did not influence procedural success (99.1% vs. 99.1%; p = 0.980), number of THVs used (1.02 vs. 1.04; p = 0.484), rates of more than mild PVL (0.4% vs. 0%; p = 0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p = 0.178), in-hospital stroke (3.9% vs. 1.8%; p = 0.298), or in-hospital death (0.4% vs. 0.9%; p = 0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs. AA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA ≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection. [Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality. Background: Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking. Methods: The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure. Results: Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05–1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45–37.06, p < 0.0001) were confirmed as independent predictors of high gradient. Conclusion: HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV’s analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

[Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data.Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes.Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively.Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users. [ABSTRACT FROM AUTHOR]

Introduction: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce., Methods: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate., Results: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242)., Conclusions: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV., (© 2024 Wiley Periodicals LLC.)

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloonexpandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons. [ABSTRACT FROM AUTHOR]

Introduction: Transfemoral access (TF) is the preferred access for transcatheter aortic valve implantation (TAVI). Transcarotid TAVI (TC-TAVI) is an alternative for patients in whom TF-TAVI is impossible. Two types of valves - balloon-expandable (BE) and self-expandable (SE) -- can be used in TC-TAVI procedures. Aim: Comparison of the short-term results of patients treated with TC-TAVI using BE and SE valves. Material and methods: The retrospective registry included 39 patients in whom the TC-TAVI procedure was performed between 2017 and 2020 (BE-TAVI; n = 10, SE-TAVI; n = 29). Preoperative characteristics, operative and postoperative results, and 30-days mortality were compared. Results: Patients from the BE-TAVI group had higher surgical risk (EuroSCORE) (10.8% (6.2-14.0) vs. 5.5% (4.3-8.7); p = 0.027). The incidence of chronic obstructive pulmonary disease (COPD) was higher in the SE-TAVI group (34.5% vs. 0%; p = 0.040). In terms of other comorbidities, demographics, preprocedural laboratory results, transthoracic echocardiography (TTE), and multislice computed tomography (MSCT), the two groups were comparable. In both groups, we observed 100% procedural success. The median valve size was larger in the SE-TAVI group (29.0 (26.0-29.0) vs. 26.0 (23.0-26.0); p < 0.001). The hospitalization time was shorter in the BE-TAVI group vs. SE-TAVI (5.8 ±0.6 vs. 6.4 ±0.9; p = 0.043). We did not observe statistically significant differences between BE-TAVI and SE-TAVI in periprocedural and 30-day mortality, or the number of strokes/TIA. Also TTE parameters and NYHA class showed similar improvement at 30 days in both groups. Conclusions: TC-TAVI using balloon-expandable and self-expandable valves showed similar safety and efficacy in 30 days follow-up. [ABSTRACT FROM AUTHOR]

Aims: Heart failure (HF) hospitalization prior to transcatheter aortic valve replacement (TAVR) is associated with increased post-procedural mortality. We sought to assess the association between recent (≤6 months) HF hospitalization and long-term adverse outcomes in patients with symptomatic, severe aortic stenosis, undergoing TAVR in the PARTNER 2 trial and registries.Methods and Results: Intermediate to high or even prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries were included in the analysis. Clinical outcomes at 30 days and 2 years were compared between patients according to whether they were recently hospitalized for HF, using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. A sensitivity analysis was conducted using propensity score matching. Of 3988 patients (99.8%) with available information on recent HF hospitalization, 1622 patients (40.7%) were hospitalized for HF symptoms during the 6 months prior to TAVR. After multivariable adjustments, recent HF hospitalization was associated with increased all-cause mortality at 30 days [adjusted hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.07-2.48, P = 0.02] and 2 years (adjusted HR 1.30, 95% CI 1.13-1.49, P = 0.0003), which was driven by increased cardiovascular mortality. Infective endocarditis rate at 2 years was also higher in patients with recent HF hospitalization (adjusted HR 2.35, 95% CI 1.38-4.01, P = 0.002). These results remained consistent when propensity score matching was used.Conclusion: In a large cohort of patients with severe symptomatic aortic stenosis from the PARTNER 2 trial and registries, all-cause and cardiovascular mortality as well as infective endocarditis rates at 2 years were higher in patients with recent HF hospitalization. [ABSTRACT FROM AUTHOR]