Self-expanding Evolut Research Articles

Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.

There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs). We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series. The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%. The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32). The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days. ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.

Correlation of prosthesis position on mid-term pacing burden in patients with new permanent pacemaker after TAVI

Abstract Background Prior studies suggest a strong correlation of the final prosthesis position on the occurrence of new conduction disturbances resulting in permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI). A high burden right ventricular pacing (PPM stimulation rate of &amp;gt; 20 %) is associated with poor long-term outcomes. So far, data about predictors influencing the PPM stimulation rate after TAVI are scarce. Purpose Thus, the purpose of this study was to evaluate the influence of the three-dimensional transcatheter heart valve (THV) position, as well as device landing zone characteristics or peri-/post-procedural factors on the stimulation rate in patients with new implanted PPM as TAVI complication. Materials: We evaluated the final THV position of 387 patients (106 with self-expanding Evolut R THV, 281 with balloon-expandable Sapien 3 THV) using fusion imaging of pre- and post-TAVI computed tomography angiography (CTA) to obtain a three-dimensional reconstruction of the THV within the native annulus region. The length of the THV above and below the native annulus was measured within the fused images to assess the implantation depth. PPM stimulation rates were examined pre-discharge and after 3 months. Patient’s clinical long-term outcome was evaluated over 5 years via standardized questionnaire as well as contacting general practitioners. Results Out of the 387 patients 112 (29%) received a new PPM pre-discharge after TAVI between 2014 and 2022. They were grouped into patients with stimulations rate below and above 20%. A stimulation rate &amp;gt; 20% in the PPM control before discharge and after three months was detected in 69 % and 67 % of them, respectively. Using uni- and multivariate logistic regression analysis, only new occurred third degree atrioventricular blocks (p=0.007) was identified as predictor for high burden right ventricular pacing after PPM-implantation as well as after 3 months. The implantation depth of the THV showed no influence on the PPM stimulation rate – neither the mean value nor the exact implantation depth adjacent the left, right and non-coronary cusp (P=0.455, P=0.108 and P=0.932, respectively). There were no significant differences regarding MACE between both groups during long-term follow-up; only the degree of dyspnea 5 years after TAVI was significantly higher in patients with a stimulation rate &amp;gt; 20% (p=0.01). Conclusion We detected no correlation of the exact three-dimensional THV position on mid-term pacing burden in 112 patients implanted with a new PPM after TAVI using CTA fusion imaging. Only a new occurred third degree atrioventricular block was a predictor for a high burden right ventricular pacing (stimulation rate &amp;gt;20%). These results provide important insights into which patients actually require PPM implantation after TAVI.

Thrombus attenuation predicts natural history of hypo-attenuating leaflet thickening after transcatheter aortic valve replacement

Abstract Background Hypo-attenuating leaflet thickening (HALT) after transcatheter aortic valve replacement (TAVR) occurs in up to 25% of patients and is characterized by diverse temporal dynamics. Several studies investigated the natural history of HALT in transcatheter and surgical cohorts, but little is known about the imaging features of persistent thrombus. Purpose To examine the association of quantitative HALT volume and attenuation from computed tomography angiography (CTA) with its natural history. Methods We prospectively examined patients with HALT present on CTA at 30 days after TAVR and who underwent a follow-up CTA at one year. Hypoattenuation affecting motion (HAM) was defined as the presence of HALT with at least moderately reduced (&amp;gt;50%) leaflet motion. HALT was quantified by segmenting the inner volume of the bioprosthetic frame at the level of the leaflets and extracting voxels between a threshold of -200 to 200 HU. Thrombus volume, mean thrombus attenuation and thrombus heterogeneity measured with standard deviation of attenuation were automatically calculated (Figure 1). Results A total of 37 patients (70% men, 71±7 years old) undergoing TAVR with balloon-expandable SAPIEN3 (86%) and self-expanding EVOLUT (14%) valves were evaluated. Hypoattenuation affecting motion (HAM) at 30 days after TAVR was present in 29 (74%) patients. Patients with HAM had higher thrombus volume than patients without reduced leaflet motion (0.40cm3 [IQR 0.16 – 0.61cm3] vs 0.14 [IQR 0.06 – 0.19 cm3], p=0.009) but comparable mean attenuation values (145HU [IQR 141-151HU] vs 123 [IQR 114 – 141HU], p=0.079). Only 3 patients were switched to oral anticoagulation following HALT detection. At one year, HALT resolution was observed in 18/37 (48%) and HAM resolution in 19/29 (65%). No difference in quantitative thrombus features was noted between patients with persistent and resolved HALT. Notably, patients with persistent HAM had higher mean thrombus attenuation (141HU [IQR 123-156HU] vs 123HU [IQR 110 – 138 HU), p=0.045; Figure 2) and thrombus heterogeneity (58HU [IQR 51-63HU] vs 48HU [IQR 41- 54HU], p=0.021) than resolved HAM. Mean thrombus attenuation (area under the curve of 0.732, p=0.044) and thrombus heterogeneity (area under the curve of 0.763, p=0.022) were predictive of HAM resolution at one year. The optimal cutoff values as determined by Youden index was 140HU for mean attenuation and 52HU for heterogeneity. There was an increase in the mean transvalvular gradients between measurements at 30 days and one year in patients with persistent HAM as compared to patients with HAM resolution (Δ3mmHg [IQR -3 – 11mmHg] vs Δ-1mmHg [IQR -4 – 0mmHg], p=0.049). The volume of thrombus at one year was associated with the magnitude of change in transvalvular gradients (β = 10.3, 95% CI 1.6- 19.0, p=0.025). Conclusion Quantitative evaluation of HALT by CTA may aid the identification of patients at risk of persistent thrombus.

Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement with Evolut FX up until October 2023. Patients who underwent transcatheter aortic valve replacement with Evolut EPO between 2018 and 2020 (n = 1,128), and those with Evolut EPO+ between 2020 and 2023 (n = 1,696) served as the control groups. The exclusion criteria comprised patients on dialysis with a history of infective endocarditis or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs 5.2% vs 4.5%, respectively, p <0.01) and new pacemaker implantation rates (11.2% vs 6.1% vs 7.7%, respectively, p <0.01) differed significantly. In the propensity score-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), whereas all vascular complications (4.6% vs 4.6%, respectively, p = 1.00) and new pacemaker implantation (5.9% vs 7.6%, respectively, p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs 1.9%, p = 0.095), without statistical significance. In conclusion, compared with the Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce the incidence of in-hospital stroke.

800.01 - Redo-TAVR With the Supra-Annular, Self-Expanding Evolut Platform: Insights from a Multi-Center Real-World Registry

800.01 - Redo-TAVR With the Supra-Annular, Self-Expanding Evolut Platform: Insights from a Multi-Center Real-World Registry

Temporal Trends, Outcomes, and Predictors of Next-Day Discharge and Readmission Following Uncomplicated Evolut Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Analysis.

Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut. Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD). Propensity score matching was used to compare risk adjusted 30-day readmission rates and 1-year outcomes in NDD versus non-NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well-matched NDD and non-NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30-day readmission rates (6.3% versus 8.4%; P<0.001) and 1-year adverse outcomes (death, 7.0% versus 9.3%; life threatening/major bleeding, 1.6% versus 3.4%; new permanent pacemaker implantation/implantable cardioverter-defibrillator, 3.6 versus 11.0%; [all P<0.001]). Predictors of NDD included non-Hispanic ethnicity, preexisting permanent pacemaker implantation/implantable cardioverter-defibrillator, and previous surgical aortic valve replacement. Most patients undergoing uncomplicated self-expanding Evolut transcatheter aortic valve replacement are discharged the next day. This study found that NDD can be predicted from baseline patient characteristics and was associated with favorable 30-day and 1-year outcomes, including low rates of permanent pacemaker implantation and readmission.

Optimal oversizing in transcatheter aortic valve replacement with the self-expanding Evolut valve system.

Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

Impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation using a self-expandable Evolut R valve

BackgroundTranscatheter Aortic Valve Implantation (TAVI) has a growing target population after being indicated even in low-surgical-risk patients with severe symptomatic aortic stenosis. However, postoperative outcomes can be compromised due to para-valvular leakage (PVL). A lot of procedural steps have been investigated to decrease this partially avoidable operational hazard. Oversizing is a main technique to decrease the PVL, despite being itself a risky step. Many studies have been conducted to identify the optimum degree of oversizing. However, studies about oversizing by more than 20% are scarce. We aimed to evaluate the safety and efficacy of oversizing equal to or more than 20%.Results209 patients who underwent TAVI using the self-expandable valve Evolut R were initially included. 66 patients were excluded because of the baseline conduction disturbance and lack of sufficient data, so 143 patients, 60 females and 83 males, were enrolled in our study as two groups based on the degree of oversizing: Group A included 97 patients with an oversizing index (OI) of less than 20%, and Group B included 46 patients with an OI of 20% or more. We conducted a new technique for more accurate measuring of the OI in the context of the implantation depth, and our patients were categorized using this technique. Our findings have met our primary end point in terms of the safety and efficacy of oversizing by 20% or more. There was no significant difference between both groups in terms of new-onset conduction disturbance (NOCD), with zero cases of annular rupture or coronary encroachment. In terms of efficacy, The incidence of significant PVL (grade 2 or more) in group B was less than in group A (P value 0.007). The ROC curve found that the minimum depth of implantation-derived oversizing (DIDO) to predict no significant PVL was less than 17%.ConclusionProsthesis oversizing by 20% using the self-expandable Evolut R valve is safe and effective, with no significant effect on the conduction system, coronary encroachment, or annular injury, and warrants a greater reduction in the incidence of significant PVL.

Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis

BackgroundThe new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. MethodsThe EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. ResultsAt 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2–5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. ConclusionsBoth THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Assessing Potential Risks of Future Redo Transcatheter Aortic Valve Replacement in Asian Patients

BackgroundIn the Asian cohort, data are limited on the risk for coronary obstruction due to sinus of Valsalva (SOV) sequestration in redo transcatheter aortic valve replacement (TAVR) procedures. ObjectivesThe aim of this study was to assess the potential risk for coronary obstruction in simulated redo TAVR in Asian patients. MethodsPost-TAVR computed tomographic data from 788 patients who received balloon-expandable (BE) SAPIEN 3 transcatheter aortic valves (TAVs) and 334 patients who received self-expanding (SE) Evolut R or Evolut PRO TAVs were analyzed. The risk for coronary obstruction due to SOV sequestration in redo TAVR, defined as the TAV commissure level above the sinotubular junction (STJ) and a TAV-to-STJ distance <2.0 mm in each coronary sinus, was retrospectively evaluated. ResultsThe potential risks for coronary obstruction due to SOV sequestration at 1 or both coronary arteries were identified in 52.1% of the BE TAV group and 71.3% of the SE TAV group (P < 0.001). After adjusting for multiple covariates, STJ diameter, STJ height, TAV oversizing degree by area, and implantation depth were independently associated with SOV sequestration risk in the BE TAV group, whereas STJ diameter and implantation depth were independently associated with SOV sequestration risk in the SE TAV group. ConclusionsCoronary obstruction due to SOV sequestration in redo TAVR may occur in a substantial number of Asian patients. This finding suggests the importance of considering the structural feasibility of future redo TAVR when implanting the first TAV, especially in Asian patients with long life expectancy.

TCT-248 Assessment of Coronary Cannulation, Commissure and Coronary Alignment Post-TAVR With the New Supra-Annular, Self-Expanding Evolut FX System

TCT-248 Assessment of Coronary Cannulation, Commissure and Coronary Alignment Post-TAVR With the New Supra-Annular, Self-Expanding Evolut FX System

Transcarotid versus transaxillary access for transcatheter aortic valve replacement with a self-expanding valve: Apropensity-matched analysis.

The Transcatheter Valve Therapy Registry was queried for TAVR procedures using transaxillary and transcarotid access between July 2015 and June 2021. Patients received a self-expanding Evolut R, PRO, or PRO+valve (Medtronic) and had 1-year follow-up. Thirty-day and 1-year outcomes were compared in transcarotid and transaxillary groups after 1:2 propensity score-matching. Multivariable regression models were fitted to identify predictors of key end points. The propensity score-matched cohort included 576 patients receiving transcarotid and 1142 receiving transaxillary access. Median procedure time (99 vs 118 minutes; P<.001) and hospital stay (2 vs 3days; P<.001) were shorter with transcarotid versus transaxillary access. At 30days, patients with transcarotid access had similar mortality (Kaplan-Meier estimates 3.7% vs 4.3%, P=.57) but significantly lower stroke (3.1% vs 5.9%; P=.017) and mortality or stroke (6.0% vs 8.9%; P=.033) compared with patients receiving transaxillary access. Similar differences were observed at 1year. Transaxillary access was associated with increased risk of 30-day stroke (hazard ratio, 2.14; 95% confidence interval, 1.27-3.58) by multivariable regression analysis. Transcarotid versus transaxillary access for TAVR using a self-expanding valve is associated with procedural benefits and significantly lower stroke and mortality or stroke at 30days. In patients with unsuitable femoral anatomy, transcarotid access may be the preferred delivery route for self-expanding valves.

Assessment of Hypoattenuated Leaflet Thickening Following Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve

Assessment of Hypoattenuated Leaflet Thickening Following Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve

Being prepared for redo-TAVI in self-expanding Evolut valves - important insights.

Being prepared for redo-TAVI in self-expanding Evolut valves - important insights.

Non-contrast transcatheter aortic valve implantation for patients with aortic stenosis and chronic kidney disease: a pilot study.

Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI). Of note, it is associated with a threefold increase in all-cause and cardiac death. We propose a new non-contrast strategy for evaluating and performing the TAVI procedure that can be especially valuable for patients with aortic stenosis (AS) and chronic kidney disease (CKD) to prevent AKI. Patients with severe symptomatic AS and CKD stage ≥3a were evaluated for TAVI using four non-contrast imaging modalities for procedural planning: transesophageal echocardiogram (TEE), cardiac magnetic resonance, multidetector computed tomography (MDCT), and aortoiliac CO2 angiography. Patients underwent transfemoral (TF) TAVI using the self-expandable Evolut R/Pro, and the procedures were guided by fluoroscopy and TEE. Contrast MDCT and contrast injection at certain checkpoints during the procedure were used in a blinded fashion to guarantee patient safety. A total of 25 patients underwent TF-TAVI with the zero-contrast technique. The mean age was 79.9 ± 6.1 years, 72% in NYHA class III/IV, with a mean STS-PROM of 3.0% ± 1.5%, and creatinine clearance of 49 ± 7 ml/min. The self-expandable Evolut R and Pro were implanted in 80% and 20% of patients, respectively. In 36% of the cases, the transcatheter heart valve (THV) chosen was one size larger than the one by contrast MDCT, but none of these cases presented adverse events. Device success and the combined safety endpoint (at 30 days) both achieved 92%. Pacemaker implantation was needed in 17%. This pilot study demonstrated that the zero-contrast technique for procedural planning and THV implantation was feasible and safe and might become the preferable strategy for a significant population of CKD patients undergoing TAVR. Future studies with a larger number of patients are still needed to confirm such interesting findings.

Cusp overlap versus standard three-cusp technique for self-expanding Evolut transcatheter aortic valves.

Reducing rates of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is important for achieving the best procedural outcomes. The cusp overlap technique (COT) implements procedural steps including an overlap angulation of the right and left coronary cusp to mitigate this complication. We investigated the incidence of PPI and complication rates following the COT compared to the standard three-cusp implantation technique (3CT) in an all-comers cohort. Atotal of 2,209 patients underwent TAVI with the self-expanding Evolut platform from January 2016 to April 2022 at five sites. Baseline, procedural and in-hospital outcome characteristics were compared for both techniques before and after one-to-one propensity score matching. Atotal of 1,151 patients were implanted using the 3CT and 1,058 using the COT. At discharge, the rates of PPI (17.0 vs 12.3%; p=0.002) and moderate/severe paravalvular regurgitation (4.6% vs 2.4%; p=0.006) were significantly reduced with the COT compared with 3CT within the unmatched cohort. Overall procedural success and complication rates were similar; major bleeding was less common in the COT group (7.0% vs 4.6%; p=0.020). These results remained consistent after propensity score matching. In multivariable logistic regression analysis, right bundle branch block (odds ratio [OR] 7.19, 95% confidence interval [CI]: 5.18-10.0; p<0.001) and diabetes mellitus (OR 1.38, 95% CI: 1.05-1.80; p=0.021) emerged as predictors of PPI, whereas the COT (OR 0.63, 95% CI: 0.49-0.82; p<0.001) was protective. The introduction of the COT was associated with asignificant and relevant reduction of PPI and paravalvular regurgitation rates without an increase in complication rates.

Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON

Introduction and objectivesNo comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. MethodsMulticenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. ResultsA total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. ConclusionsIn patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.Full English text available from:www.revespcardiol.org/en

Outcomes and Hemodynamic Performances of Transcatheter Aortic Valve Replacement with Two Generations of Self-Expanding Transcatheter Aortic Valves.

The superiority of the new-generation self-expanding Evolut R compared with the first-generation CoreValve with regards to outcomes after transcatheter aortic valve replacement (TAVR) is unclear. The aim of this study was to investigate the hemodynamic and clinical performance of Evolut R compared with its direct predecessor, CoreValve, in a Taiwanese population. This study included all consecutive patients who underwent TAVR with either CoreValve or Evolut R between March 2013 and December 2020. Thirty-day Valve Academic Research Consortium-2 (VARC-2)-defined outcomes and hemodynamic performances were investigated. There were no significant differences in baseline demographic characteristics between the patients receiving CoreValve (n = 117) or Evolut R (n = 117). Aortic valve-in-valve procedures for failed surgical bioprosthesis and procedures under conscious sedation were performed significantly more often with Evolut R. Pre-dilatation was performed significantly more often and contrast media volume was significantly higher with CoreValve. Stroke (0% vs. 4.3%, p = 0.024) and the need for emergent conversion to open surgery (0% vs. 5.1%, p = 0.012) were significantly lower in Evolut R than in CoreValve recipients. Evolut R significantly reduced 30-day composite safety endpoint (4.3% vs. 15.4%, p = 0.004). Advancements in transcatheter valve technologies have resulted in improved outcomes for patients undergoing TAVR with self-expanding valves. With the new-generation Evolut R, device success was high and the 30-day composite safety endpoint was significantly reduced after TAVR compared with CoreValve.

LB-8 | Performance and Use of the Evolut FX Transcatheter Aortic Valve System: Updated Results from the Evolut FX Limited Market Release Clinical Survey

The next generation supra-annular, self-expanding Evolut FX TAVR system (Medtronic, Minneapolis, MN) has been designed to improve ease of use through enhanced deliverability and trackability. We report FX system procedural outcomes following design enhancements. Physician feedback was obtained (Jun 24–Sept 11, 2022) at 69 US centers with a high level of implant experience (Group 1) and a broader range of implant experience and volume (Group 2). Survey results compared Evolut FX to the predicate PRO+ system using descriptive statistics. 539 surveys (1/case) were collected. Evolut FX valves (23 mm, 7%; 26 mm, 30%; 29 mm, 45%; 34 mm, 19%) were implanted via transfemoral (TF) access in 97% of cases. The cusp-overlap (CO) technique was used in 89% (457/516) of cases. Commissural alignment at the CO view based on TAV marker orientation was achieved in 96% (447/465) of TF cases. Group 2 operators (n=248) reported using the radiopaque commissure markers to assess implant depth in 89% of cases, to visualize pre-deployment commissure alignment in 85% of cases and to remove parallax in the LAO view in 62% of cases. During initial deployment, no noticeable ventricular movement of the Evolut FX device was reported in 79% of cases; 79% of operators rated the FX as having a more predictable deployment. Better deliverability and tracking was noted with Evolut FX compared to the PRO+ system (Figure). Survey results from the first real-world experience using Evolut FX reported improved deliverability, tracking and deployment compared to PRO+. A high (>95%) rate of commissural alignment was achieved, which may facilitate future coronary access.

Commissural and Coronary Alignment After Transcatheter Aortic Valve Replacement Using the New Supra-Annular, Self-Expanding Evolut FX System

HomeCirculation: Cardiovascular InterventionsAhead of PrintCommissural and Coronary Alignment After Transcatheter Aortic Valve Replacement Using the New Supra-Annular, Self-Expanding Evolut FX System No AccessLetterRequest AccessAboutView PDFSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessLetterRequest AccessCommissural and Coronary Alignment After Transcatheter Aortic Valve Replacement Using the New Supra-Annular, Self-Expanding Evolut FX System Sung-Han Yoon, MD, Shayef Gabasha, MD, Luis Augusto Palma Dallan, MD, Anene Ukaigwe, MD, Gilbert H.L. Tang, MD, MSc, MBA, Gregory Rushing, MD, Mark Pelletier, MD, Steven Filby, MD, Cristian Baeza, MD and Guilherme F. Attizzani, MD Sung-Han YoonSung-Han Yoon https://orcid.org/0000-0003-0465-7061 Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Shayef GabashaShayef Gabasha Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Luis Augusto Palma DallanLuis Augusto Palma Dallan https://orcid.org/0000-0002-8122-6647 Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Anene UkaigweAnene Ukaigwe Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Gilbert H.L. TangGilbert H.L. Tang https://orcid.org/0000-0001-7219-990X Department of Cardiovascular Surgery, Mount Sinai Health System, New York (G.H.L.T.). Search for more papers by this author , Gregory RushingGregory Rushing Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Mark PelletierMark Pelletier Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Steven FilbySteven Filby Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author , Cristian BaezaCristian Baeza https://orcid.org/0000-0003-2001-332X Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author and Guilherme F. AttizzaniGuilherme F. Attizzani Correspondence to: Guilherme F. Attizzani, MD, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, 11100 Euclid Ave, Cleveland, OH 44106. Email E-mail Address: [email protected] https://orcid.org/0000-0001-9233-1242 Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, OH (S.-H.Y., S.G., L.A.P.D., A.U., G.R., M.P., S.F., C.B., G.F.A.). Search for more papers by this author Originally published3 Apr 2023https://doi.org/10.1161/CIRCINTERVENTIONS.122.012657Circulation: Cardiovascular Interventions. 2023;0:e012657FootnotesThis manuscript was sent to S. Chiu C. Wong, Guest Editor, for review by expert referees, editorial decision, and final disposition.For Sources of Funding and Disclosures, see page XXX.Correspondence to: Guilherme F. Attizzani, MD, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, 11100 Euclid Ave, Cleveland, OH 44106. Email guilherme.[email protected]org Previous Back to top Next FiguresReferencesRelatedDetails Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.122.012657PMID: 37009735 Originally publishedApril 3, 2023 Keywordsheart valvecoronary accesscommissural alignmentaortic roottranscatheter aortic valve replacementPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular Interventions