BACKGROUND:The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS:The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS:No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65-69 years, absolute risk reduction, 13%; P=0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P=0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75-79 years, 5.9%; 70-74 years, 5.1%; 65-69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P=0.73). Approximately one-third of younger patients (65-69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age (P=0.06). CONCLUSIONS:In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03042104.
This review provides a practical, evidence-based summary of optimal device selection for patients with aortic stenosis undergoing transcatheter aortic valve replacement in order to guide clinicians in providing the most current treatment options for their patients. The use of transcatheter heart valves has expanded to include younger patients and those with low or moderate surgical risk. There have been significant technological advances in both balloon-expandable and self-expanding valves to provide a minimally invasive approach toward valve replacement; however, device selection is based on numerous patient factors that have been better characterized in recent literature. Heart centers involving multi-disciplinary care teams are equipped to provide patients with advanced diagnostic imaging and novel transcatheter options for aortic valve replacement. Both balloon-expandable and self-expanding valves play an integral role and optimal device selection is achieved through a nuanced, bespoke approach that prioritizes the lifetime management of each patient. In our respective institutions, we have a multidisciplinary structural heart team with specialists in structural cardiology, cardiothoracic surgery, advanced cardiac imaging, heart failure, and electrophysiology. Our management strategy for patients with aortic stenosis is to provide a shared decision-making approach that prioritizes the patient’s preference while simultaneously offering a comprehensive overview of all treatment options available – both transcatheter and surgical – using the most current societal guidelines. For every TAVR case, multimodality imaging, such as pre-operative high resolution cardiac computed tomography and dedicated transthoracic echocardiogram imaging, is utilized for planning. Additionally, weekly conferences are held to review all scheduled structural cases for the following week, in order to evaluate patient profiles, review comprehensive imaging, and garner the opinions of team members for optimal technical approach and device selection. These discussions allow us to determine the benefit of either a balloon-expandable or self-expanding valve, decisions that are individualized based off of each patient’s risk profile, anatomy, and lifetime management considerations.
Background Patients who present with ST-elevation myocardial infarction (STEMI) to a hospital without primary percutaneous coronary intervention (PPCI) capability may be transferred for PPCI or receive fibrinolytic therapy, depending on whether the first medical contact to balloon time of ≤120 minutes can be achieved. We hypothesized that travel distance to the percutaneous coronary intervention (PCI) center might impact STEMI outcomes in a rural STEMI system of care. Methods We retrospectively analyzed 6225 consecutive STEMI patients from the Northern New England Cardiovascular Disease Study Group registry from 2018 to 2023. Residential distance to care was calculated by road travel distance between ZIP Code centroids and grouped into quartiles. Patients were categorized by treatment strategy: initial presentation to a PCI center, transfer for PPCI, or pharmacoinvasive PCI. The primary outcome was in-hospital mortality. Multivariable logistic regression evaluated the association between residential distance and treatment strategy with in-hospital mortality. Results The median residential distance to PCI center for STEMI patients in Northern New England was 38.2 miles (IQR, 47.1). Of the overall cohort, 44.4% (median travel distance: 17.2 miles) had index presentation to a PCI hospital, 23.8% (median travel distance: 40.1 miles) underwent interhospital transfer for primary PCI, and 31.9% (median travel distance: 66.5 miles) were transferred for pharmacoinvasive PCI after initial lytic therapy. There was no association between distance to PCI hospital and adjusted in-hospital mortality after STEMI, irrespective of the treatment group. Conclusions In Northern New England with contemporary regional STEMI referral networks, distance to PCI hospital did not impact STEMI mortality despite substantial travel distances for many patients.
BACKGROUND:The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) intervention was superior to clinical surveillance with delayed TAVR in patients with asymptomatic severe aortic stenosis. Cardiac biomarkers are associated with maladaptive remodeling, symptom onset, and worse outcomes after TAVR. Whether elevated biomarkers identify asymptomatic patients more likely to benefit from early intervention is unknown. METHODS:A core laboratory measured NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity cardiac troponin T (hs-cTnT) levels. Associations between biomarker levels and risk of the trial primary end point (death, stroke, or unplanned cardiovascular hospitalization) and other secondary end points were examined with Kaplan-Meier curves and Cox proportional hazard models. Interaction tests were performed to assess whether the treatment effect of early TAVR, compared with clinical surveillance, differed according to biomarker levels. RESULTS:Among 901 patients randomized in EARLY TAVR, 798 (89%) had biospecimens measured (median NT-proBNP level, 287 [145, 601]; median hs-cTnT level, 14.6 [10.5, 21.0]). Higher levels of NT-proBNP and hs-cTnT were broadly associated with higher event rates for multiple end points. In general, there was no significant interaction between baseline biomarkers and treatment group with respect to any composite or individual end point examined, although trends broadly demonstrated a greater relative benefit of early TAVR at lower biomarker levels. There was a significant interaction between hs-cTnT level and treatment group with respect to death or heart failure hospitalization (P interaction=0.04) and heart failure hospitalization alone (P interaction=0.03) such that the relative benefit of early TAVR was greater for patients with normal, rather than elevated, levels of hs-cTnT at baseline. For some end points, higher baseline NT-proBNP level was associated with numerically greater absolute risk reduction with early TAVR than were lower NT-proBNP levels. CONCLUSIONS:In patients with asymptomatic severe high-gradient aortic stenosis, higher NT-proBNP and hs-cTnT levels were broadly associated with higher event rates, as expected. However, the relative benefit of an early TAVR strategy was consistent regardless of baseline biomarker levels and, contrary to our hypothesis, tended to be more pronounced in patients with the lowest biomarker levels. These findings suggest limited value for single measurements of these biomarkers to guide the timing of TAVR in asymptomatic patients. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03042104.
BACKGROUND:Mitral clip detachment with embolization is an exceedingly rare complication with an incidence rate of <0.1%. Our case report describes a patient with subacute MitraClip (Abbott) embolization into the noncoronary sinus (NCS). CASE SUMMARY:Our patient was an 84-year-old man with a history of heart failure with preserved ejection fraction and severe mitral regurgitation requiring transcatheter-edge-to-edge repair with 3 MitraClips 2 weeks before presentation. He presented with acute decompensated heart failure with an elevated pro-B-type natriuretic peptide value (5,883 pg/mL), a chest radiograph revealing a displaced clip, and a transthoracic echocardiogram confirming severe mitral regurgitation with a flail leaflet. Eventually, a transesophageal echocardiogram revealed embolization to the NCS. DISCUSSION:Using a heart team approach in addition to palliative care, we discussed surgical and nonsurgical options. Despite his high surgical risk, the patient preferred a surgical approach. The MitraClip was successfully retrieved, and a mitral bioprosthesis was implanted. TAKE-HOME MESSAGES:MitraClip embolization is rare, with limited understanding of risk factors and optimal management strategy. Risk factors may include suboptimal intraoperative images, technical challenges, and complex anatomy. Management requires a heart team approach with consideration for palliative care involvement.
BACKGROUND:For patients with asymptomatic severe aortic stenosis (AS), the EARLY TAVR trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS). OBJECTIVES:In this study, the authors sought to evaluate whether baseline left ventricular (LV) health altered the treatment effect of early intervention and to examine longitudinal LV health under different treatment strategies. METHODS:At 75 centers in the United States and Canada, 901 patients underwent randomization to TAVR (n = 455) or CS (n = 446). Echocardiographic measurements were made in a core laboratory. The protocol defined integrated LV health as the composite of absolute LV global longitudinal strain (GLS) ≥15%, LV mass index (LVMi) <115 g/m2 (men) or <95 g/m2 (women), and left atrial volume index (LAVi) ≤34 mL/m2. Integrated LV health was a prespecified secondary endpoint and the protocol outlined longitudinal measurements to be made in the intention-to-treat (ITT) and valve implant populations. As a stratification variable for effect-modification testing, LV health was not prespecified, so those analyses are exploratory. The trial's primary endpoint and 2 secondary composites were examined. RESULTS:At randomization, in the ITT population, 27% had normal integrated LV health (64% normal LVMi, 42% normal LAVi, 88% normal GLS). Abnormal integrated LV health and each component were generally associated with higher event rates across several composite endpoints. Benefit of early TAVR, compared with CS, was consistently observed regardless of whether LV health (evaluated as an integrated measure and as individual components) was normal or not. In the ITT population, the CS group exhibited normal LV health less frequently at 2 years than those treated early according to the integrated LV health measure (35.9% vs 48.1%; P < 0.001) and component measures. Among CS patients undergoing delayed AVR, LV health tended to decline from randomization to preprocedure (P < 0.10 for all measures except GLS), but baseline LV health did not predict timing of conversion to AVR nor severity of presentation. CONCLUSIONS:For patients with asymptomatic severe AS, the benefit of early TAVR, compared with CS, is consistent regardless of baseline LV health according to integrated or individual measures. These exploratory findings suggest limited value for measures of LV health to guide the timing of TAVR in asymptomatic patients. Whether the worsening of LV health associated with CS and delayed aortic valve replacement underlies increased clinical events in that treatment arm requires further study. (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).
Background:Recent data demonstrate near equalization in the use of transcatheter aortic valve replacement (TAVR) and isolated bioprosthetic surgical aortic valve replacement (SAVR) in patients aged <65 years for treatment of isolated aortic stenosis (AS). Whether these trends are also seen across the entire spectrum of aortic valve replacement (AVR) procedures (including mechanical SAVR and concomitant procedures) is unknown. Methods:This retrospective study included patients aged <65 years who underwent AVR for severe AS in the multicenter Northern New England Cardiovascular Disease Group registry between 2015 and 2023. Patients were stratified by approach: TAVR, isolated SAVR, and combined SAVR (SAVR with concomitant procedures). Results:Of 1254 patients younger than 65 years who underwent AVR, 21.9% underwent TAVR, 39.7% underwent isolated SAVR, and 38.4% underwent combined SAVR. TAVR utilization more than doubled during the study period, with near equalization of TAVR and isolated bioprosthetic SAVR (28.3% and 30.8% of all AVR in 2021-2023, respectively). However, when including mechanical AVR and combined SAVR, TAVR only comprised approximately one-fourth of all AVR procedures. TAVR patients had a significantly higher burden of comorbidities compared with patients receiving isolated or combined SAVR. Conclusions:In this multicenter study, there is a consistent increase in TAVR use in patients <65 years old with preferential TAVR utilization in patients with higher comorbidities and risk. While approximately 50% of younger patients with isolated AS are receiving TAVR in recent study years, the overall utilization of TAVR in the broader group of patients with both isolated and combined AS remains approximately 25% of the overall AVR cohort.
Despite 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines that recommend surgical aortic valve replacement (SAVR) for patients with symptomatic severe aortic stenosis (AS) aged <65 years, we demonstrated dramatic growth in transcatheter aortic valve replacement (TAVR) utilization in younger patients aged <65 years from 2015 to 2021 using the United States nationwide Vizient Clinical Data Base.1Otto C.M. Nishimura R.A. et al.Writing Committee Members2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.J Am Coll Cardiol. 2021; 77: e25-e197https://doi.org/10.1016/j.jacc.2020.11.018Crossref PubMed Scopus (804) Google Scholar,2Sharma T. Krishnan A.M. Lahoud R. Polomsky M. Dauerman H.L. National trends in TAVR and SAVR for patients with severe isolated aortic stenosis.J Am Coll Cardiol. 2022; 80: 2054-2056https://doi.org/10.1016/j.jacc.2022.08.787Crossref PubMed Scopus (40) Google Scholar More recently, a French national registry described more modest growth of TAVR in young patients with isolated AS with only 11.1% of patients aged <65 years receiving TAVR in 2020.3Prosperi-Porta G. Nguyen V. Willner N. et al.Association of age and sex with use of transcatheter aortic valve replacement in France.J Am Coll Cardiol. 2023; 82: 1889-1902https://doi.org/10.1016/j.jacc.2023.08.044Crossref PubMed Scopus (1) Google Scholar Whether this difference in temporal trend observations is due to registry characteristics, patient characteristics, different years of inclusion, or true differences in national approaches to AS management is unclear. We hypothesized that TAVR adoption has continued to grow among younger patients with isolated severe AS and sought to confirm our prior Vizient-based findings using a different regional US registry with granular data. Further, we sought to update contemporary temporal trends beyond the years represented in the prior French (2015-2020) and US Vizient (2015-2021) studies.2Sharma T. Krishnan A.M. Lahoud R. Polomsky M. Dauerman H.L. National trends in TAVR and SAVR for patients with severe isolated aortic stenosis.J Am Coll Cardiol. 2022; 80: 2054-2056https://doi.org/10.1016/j.jacc.2022.08.787Crossref PubMed Scopus (40) Google Scholar,3Prosperi-Porta G. Nguyen V. Willner N. et al.Association of age and sex with use of transcatheter aortic valve replacement in France.J Am Coll Cardiol. 2023; 82: 1889-1902https://doi.org/10.1016/j.jacc.2023.08.044Crossref PubMed Scopus (1) Google Scholar The Northern New England Cardiovascular Disease Group Consortium (NNECDSG) is a regional collaborative of 4 cardiovascular programs in Northern New England (Maine, New Hampshire, and Vermont). We identified all patients who underwent TAVR or isolated SAVR for severe AS from 2016 to 2022. Exclusion criteria included concomitant procedures, endocarditis, emergent procedures, and prior aortic valve replacement. The details of our study design are similar to our prior NNECDSG analysis on AVR trends from 2016 to 2019.4Sharma T. Tapales A.J.D. Ross C.S. et al.Concordance of guideline-based risk stratification and selection of patients for transcatheter aortic valve implantation or surgical replacement.Am J Cardiol. 2022; 173: 94-99https://doi.org/10.1016/j.amjcard.2022.02.042Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Temporal trends in TAVR vs SAVR utilization were compared according to the 3 guideline-recommended age strata: <65 years, 65 to 80 years, and >80 years. Multivariable logistic regression analysis was used to identify independent predictors of TAVR in patients aged <65 years (variables included age, sex, body mass index, left ventricular ejection fraction, urgent vs elective clinical status, New York Heart Association class IV status, bicuspid aortic valve anatomy, and relevant comorbidities, ie, chronic kidney disease [CKD], chronic obstructive pulmonary disease, diabetes mellitus, congestive heart failure, home oxygen use, peripheral vascular disease, prior coronary artery bypass grafting (CABG), prior percutaneous coronary intervention, and prior stroke). Univariate predictors (P < .10) of TAVR were included in the multivariable model. Each site's institutional review board approved participation in the NNECDSG registry. Of 6728 patients (40.2% women) undergoing isolated AVR for AS, 1634 (33.4% women) underwent SAVR and 5094 (42.4% women) underwent TAVR. Patients aged <65 years, 65 to 80 years, and >80 years comprised 11.2%, 47.4%, and 41.4% of the overall study population, respectively. For patients aged >80 years, TAVR remained the dominant modality of treatment throughout the study period, with utilization rates increasing from 86.1% in 2016 to 97.8% in 2022 (Ptrend < 0.001). In the 65 to 80 years age group, TAVR utilization increased by 2-fold from 42.1% to 80.6% (Ptrend < 0.001) (Figure 1A, B). In patients aged <65 years, TAVR increased dramatically (272%) and by 2022, TAVR comprised 51.7% of all isolated AVRs (Figure 1C). In the <65 years age cohort, the mean age of the patients was 60.7 ± 4.6 years in the TAVR group vs 58.1 ± 6.0 years in the SAVR group (P < .001). The average Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 3.5 ± 3.1% vs 1.5 ± 1.4% in the TAVR vs SAVR groups, respectively (P < .001). Specifically, within the TAVR group, the proportion of patients aged <65 years with low (STS-PROM<4%), intermediate (STS-PROM 4% to 8%), and high (STS-PROM ≥8%) surgical risk was 67.4%, 24.7%, and 7.9%, respectively. In the SAVR cohort, 94.6%, 4.6%, and 0.8% had low, intermediate, and high surgical risk, respectively. From 2016 to 2022, the proportion of TAVR patients aged <65 years at low surgical risk, as estimated by STS-PROM, increased from 55% to 73.3%. The observed 30-day mortality rates in patients aged <65 years who underwent TAVR vs SAVR were 0.9% vs 0.8% (P = .89). TAVR patients <65 years old were less likely to have bicuspid aortic valve disease (17.0% vs 44.2%, P < .001) and more likely to have prior CABG (17.0% vs 0.8%; P < .001). The most powerful independent predictors of TAVR utilization in patients aged <65 years included prior CABG (OR, 33.4; 95% CI, 7.4-152.0), CKD (OR, 3.96; 95% CI, 1.47-10.67), and congestive heart failure (OR, 2.24; 95% CI, 1.39-3.60). On the contrary, bicuspid aortic valve disease was the most potent predictor of SAVR among young patients with isolated severe AS (OR, 0.30; 95% CI, 0.19-.049). There are 4 main observations from our regional study of AVR temporal trends: (1) these results are concordant with our prior analysis of TAVR utilization in patients aged <65 years in the United States using the Vizient Clinical Database which demonstrated near equalization of TAVR vs SAVR by 2021; (2) to our knowledge, this represents the first temporal trend analysis of TAVR vs SAVR that incorporates both pre-COVID pandemic and the pandemic calendar years; (3) consistent with our 2 prior temporal trends studies, TAVR utilization is predicted by prior CABG and congestive heart failure, while SAVR is predicted by bicuspid aortic valve disease; and (4) we demonstrate that the growth of TAVR in younger adults <65 years of age is driven by increased TAVR utilization in low surgical risk patients. In contrast, a national registry from France reported that although the proportion of TAVR increased by 63.2% from 2015 to 2020, TAVR comprised only 11.1% of all isolated AVR by 2020.3Prosperi-Porta G. Nguyen V. Willner N. et al.Association of age and sex with use of transcatheter aortic valve replacement in France.J Am Coll Cardiol. 2023; 82: 1889-1902https://doi.org/10.1016/j.jacc.2023.08.044Crossref PubMed Scopus (1) Google Scholar Given the consistency of our Vizient and Northern New England database analyses, our results are consistent with a true difference in national approaches to the treatment of isolated severe AS between Europe and the US. This hypothesis is also supported by recent data from the California State Discharge Administrative Database that demonstrate 45.7% TAVR utilization in 2021 in young adults aged ≤60 years.5Malas J. Guidelines versus practice: a statewide survival analysis of SAVR versus TAVR in patients aged ≤ 60 Years.https://www.tctmd.com/slide/guidelines-versus-practice-statewide-survival-analysis-savr-versus-tavr-patients-aged-60Date accessed: February 1, 2024Google Scholar In contrast to the French registry study, we did not use a comorbidity index to analyze predictors of TAVR in younger patients; instead, we analyzed individual univariate clinical predictors and found that TAVR is clearly favored in patients with prior CABG, CKD, and congestive heart failure, while SAVR is favored in young patients with bicuspid aortic valve disease. Notably, our results are consistent using 2 different database analyses.2Sharma T. Krishnan A.M. Lahoud R. Polomsky M. Dauerman H.L. National trends in TAVR and SAVR for patients with severe isolated aortic stenosis.J Am Coll Cardiol. 2022; 80: 2054-2056https://doi.org/10.1016/j.jacc.2022.08.787Crossref PubMed Scopus (40) Google Scholar,4Sharma T. Tapales A.J.D. Ross C.S. et al.Concordance of guideline-based risk stratification and selection of patients for transcatheter aortic valve implantation or surgical replacement.Am J Cardiol. 2022; 173: 94-99https://doi.org/10.1016/j.amjcard.2022.02.042Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Finally, the French registry suggested an interaction of sex with TAVR utilization, whereas our study observed a univariate association of TAVR utilization with female sex, and multivariable analysis did not show female sex to be an independent predictor of TAVR utilization in young patients (OR, 1.30, 95% CI, 0.83-2.04). The strength of this study is the use of a unique US multicenter data set and expanded time frame including 2022 data to confirm prior Vizient study results. We do acknowledge that these practice patterns seen in Northern New England might not be reflective of the national US practice. In conclusion, our study suggests that as of 2022, TAVR is now utilized in the majority of adults aged 60 years and older with isolated severe AS with important implications for lifetime management strategies. Harold L. Dauerman—consultant to Medtronic, Boston Scientific, and Edwards Lifesciences; research grants from Boston Scientific and Medtronic. None of the other authors have relevant conflicts of interest to disclose. This work was not supported by funding agencies in the public, commercial, or not-for-profit sectors.
Background: Women have historically had higher mortality following STEMI than men. The difference in mortality is in part related to higher bleeding rates in women when compated to men. Little is known about the mortality differences in women versus men in the current era of radial first and other bleeding avoidance stategie for PCI. Methods: We queried in the NNE database to identofy all PCI cases between 2019 and 2023. From the dataset, patients who underwent PCI for an indication of STEMI were identified, and demographic as well as procedural variables were collected. Patients with shock prior to PCI were excluded. In-hosptial outcomes were assessed including bleeding and need for transfusion. Mortality was obtained from discharge vital status. Standard statisical methods were used to assess significance of differences, using STATA for calculations. Results: A total of 22,681 pateints were identified who underwent PCI between 2019 and 2023. Of these, 4,356 (19.2%) underwent PCI for STEMI and did not have shock. Of the patients with STEMI, 3,198 (73.4%) were men and 1,158 (26.6%) were women. When compared with men, women tended to be older, have smaller BSA, and similar BMI. Procedurally, the percent radial cases and IIBIIIA receptor inhibitor use were similar between men and women. In-hospital mortalty was 3.3% for women and 1.7% for men (p<0.01) during this time period. Bleeding rates and need for transfusion were not different between men and women (Table 1). Conclusions: Desipite similar rates of radial access and bleeding, women undergoing PCI for STEMI in Northern New England continue to have nearly double the mortality of men. More study is needed to understand these diferences and optmimize outcomes for women.
BACKGROUND:Longer term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry. OBJECTIVES:The aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS:From September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U. RESULTS:A total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25). CONCLUSIONS:TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform.