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Objective To evaluate whether transcatheter or surgical aortic valve replacement (TAVR or SAVR) affects clinical and haemodynamic outcomes in symptomatic patients with moderately-severe aortic stenosis (AS).Methods Echocardiographic evidence of severe AS for enrolment in the Evolut Low Risk trial was based on site-reported measurements. For this post hoc analysis, core laboratory measurements identified patients with symptomatic moderately-severe AS (1.0

Objective: New echocardiographic definitions have been proposed for hemodynamic structural valve deterioration. We aimed to study their consistency in classifying structural valve deterioration after surgical aortic valve replacement. Methods: Data were used of patients undergoing surgical aortic valve replacement in a multicenter, prospective cohort study with a 5-year follow-up. All patients received the same stented bioprosthesis. Echocardiographic parameters were assessed by an independent core laboratory. Moderate or greater stenotic hemodynamic structural valve deterioration was defined according to Capodanno and colleagues, Dvir and colleagues, and the Valve Academic Research Consortium 3; regurgitation data were not considered in this analysis. Consistency was quantified on the basis of structural valve deterioration classification at subsequent time points. Results: A total of 1118 patients received implants. Patients’ mean age was 70 years, and 75% were male. Hemodynamic structural valve deterioration at any visit was present in 51 patients (4.6%), 32 patients (2.9%), and 34 patients (3.0%) according to Capodanno, Dvir, and Valve Academic Research Consortium 3. A total of 1064 patients (95%) were never labeled with structural valve deterioration by any definition. After the first classification with structural valve deterioration, 59%, 59%, and 65% had no subsequent structural valve deterioration classification according to Capodanno, Dvir, and Valve Academic Research Consortium 3, respectively. Conclusions: The current definitions of hemodynamic structural valve deterioration are strong negative predictors but inconsistent positive discriminators for the detection of stenotic hemodynamic structural valve deterioration. Although the diagnosis of structural valve deterioration may be categorical, echocardiographic indices lack this degree of precision in the first 5 years after surgical aortic valve replacement. The inconsistency of current structural valve deterioration definitions impedes the detection of true valve degeneration, which challenges the clinical usefulness of these definitions.

Background: There is conflicting evidence regarding the effect of residual transmitral mean pressure gradient (TMPG) after mitral transcatheter edge-to-edge repair (M-TEER). Different TMPG cutoffs have been employed in prior studies with varying results. Objectives: The purpose of this study was to examine the association between residual TMPG and M-TEER outcomes. Methods: Consecutive patients undergoing M-TEER at our institution between 2014 and 2022 were included and divided based on quartiles of predischarge TMPG. Outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazard models. We performed subgroup analyses according to mitral regurgitation (MR) mechanism. The primary outcome was all-cause mortality or heart failure hospitalization. Results: We included 283 patients (age 76.7 ± 10.8 years, 42.8% women, 78.4% Caucasian, and baseline TMPG 2.4 ± 1.3 mm Hg). Higher baseline TMPG was a predictor of increased TMPG after M-TEER (coefficient 0.60 [95% CI: 0.40-0.70]; P

Background: Although various hemodynamic parameters to assess prosthetic performance are available, prosthesis–patient mismatch (PPM) is defined exclusively by effective orifice area (EOA) index thresholds. Adjusting for the Society of Thoracic Surgeons predicted risk of mortality (STS PROM), we aimed to explore the added value of postoperative hemodynamic parameters for the prediction of all-cause mortality at 5 years after aortic valve replacement. Methods: Data were obtained from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial, a multicenter prospective cohort study examining the performance of the Avalus bioprosthesis. Candidate predictors were assessed at the first follow-up visit; patients who had no echocardiography data, withdrew consent, or died before this visit were excluded. Candidate predictors included peak jet velocity, mean pressure gradient, EOA, predicted and measured EOA index, Doppler velocity index, indexed internal prosthesis orifice area, and categories for PPM. The performance of Cox models was investigated using the c-statistic and net reclassification improvement (NRI), among other tools. Results: A total of 1118 patients received the study valve, of whom 1022 were eligible for the present analysis. In univariable analysis, STS PROM was the sole significant predictor of all-cause mortality (hazard ratio, 1.40; 95% confidence interval, 1.26-1.55). When extending the STS PROM with single hemodynamic parameters, neither the c-statistics nor the NRIs demonstrated added prognostic value compared to a model with STS PROM alone. Similar findings were observed when multiple hemodynamic parameters were added. Conclusions: The STS PROM was found to be the main predictor of patient prognosis. The additional prognostic value of postoperative hemodynamic parameters for the prediction of all-cause mortality was limited.

Background Coronary microvascular function and hemodynamics may play a role in coronary circulation and myocardial remodeling in patients with aortic stenosis (AS). We aimed to evaluate the relationship between myocardial blood flow and myocardial function in patients with AS, no AS, and aortic valve sclerosis. Methods and Results We included consecutive patients who had resting transthoracic echocardiography and clinically indicated positron emission tomography myocardial perfusion imaging to capture their left ventricular ejection fraction, global longitudinal strain (GLS), and myocardial flow reserve (MFR). The primary outcome was major adverse cardiovascular event (all‐cause mortality, myocardial infarction, or late revascularization). There were 2778 patients (208 with aortic sclerosis, 39 with prosthetic aortic valve, 2406 with no AS, and 54, 49, and 22 with mild, moderate, and severe AS, respectively). Increasing AS severity was associated with impaired MFR (P

Objectives: A flow-gradient classification is used to determine the indication for intervention for patients with severe aortic stenosis (AS) with discordant echocardiographic parameters. We investigated the agreement in flow-gradient classification by stroke volume (SV) measurement at the left ventricular outflow tract (LVOT) and at the left ventricle. Methods: Data were used from a prospective cohort study and patients with severe AS (aortic valve area index ≤0.6 cm2/m2) with preserved ejection fraction (>50%) were selected. SV was determined by an echocardiographic core laboratory at the LVOT and by subtracting the 2-dimensional left ventricle end-systolic from the end-diastolic volume (volumetric). Patients were stratified into 4 groups based on SV index (35 mL/m2) and mean gradient (40 mm Hg). The group composition was compared and the agreement between the SV measurements was investigated using regression, correlation, and limits of agreement. In addition, a systematic LVOT diameter overestimation of 1 mm was simulated to study flow-gradient reclassification. Results: Of 1118 patients, 699 were eligible. The group composition changed considerably as agreement on flow state occurred in only 50% of the measurements. LVOT SV was on average 15.1 mL (95% limits of agreement −24.9:55.1 mL) greater than volumetric SV. When a systematic 1-mm LVOT diameter overestimation was introduced, the low-flow groups halved. Conclusions: There was poor agreement in the flow-gradient classification of severe AS as a result of large differences between LVOT and volumetric SV. Furthermore, this classification was sensitive to small measurement errors. These results stress that parameters beyond the flow-gradient classification should be considered to ensure accurate recommendations for intervention.

Background Pulmonary hypertension (PH) and secondary mitral regurgitation (MR) are associated with adverse outcomes after mitral transcatheter edge‐to‐edge repair. We aim to study the prognostic value of invasively measured right ventricular afterload in patients undergoing mitral transcatheter edge‐to‐edge repair. Methods and Results We identified patients who underwent right heart catheterization ≤1 month before transcatheter edge‐to‐edge repair. The end points were all‐cause mortality and a composite of mortality and heart failure hospitalization at 2 years. Using the receiver operating characteristic curve–derived threshold of 0.6 for pulmonary effective arterial elastance ([Ea], pulmonary artery systolic pressure/stroke volume), patients were stratified into 3 profiles based on PH severity (low elastance [HE]: Ea

Background Prior studies investigating the impact of residual mitral regurgitation (MR), tricuspid regurgitation (TR), and elevated predischarge transmitral mean pressure gradient (TMPG) on outcomes after mitral transcatheter edge‐to‐edge repair (TEER) have assessed each parameter in isolation. We sought to examine the prognostic value of combining predischarge MR, TR, and TMPG to study long‐term outcomes after TEER. Methods and Results We reviewed the records of 291 patients who underwent successful mitral TEER at our institution between March 2014 and June 2022. Using well‐established outcomes‐related cutoffs for predischarge MR (≥moderate), TR (≥moderate), and TMPG (≥5 mm Hg), 3 echo profiles were developed based on the number of risk factors present (optimal: 0 risk factors, mixed: 1 risk factor, poor: ≥2 risk factors). Discrimination of the profiles for predicting the primary composite end point of all‐cause mortality and heart failure hospitalization at 2 years was examined using Cox regression. Overall, mean age was 76.7±10.6 years, 43.3% were women, and 53% had primary MR. Two‐year event‐free survival was 61%. Predischarge TR≥moderate, MR≥moderate, and TMPG≥5 mm Hg were risk factors associated with the primary end point. Compared with the optimal profile, there was an incremental risk in 2‐year event‐rate with each worsening profile (optimal as reference; mixed profile: hazard ratio (HR), 2.87 [95% CI, 1.71–5.17], P

Background. Tricuspid regurgitation (TR) is a high-prevalence disease associated with poor quality of life and mortality. This quantitative patient preference study aims to identify TR patients’ perspectives on risk-benefit tradeoffs. Methods. A discrete-choice experiment was developed to explore TR treatment risk-benefit tradeoffs. Attributes (levels) tested were treatment (procedure, medical management), reintervention risk (0%, 1%, 5%, 10%), medications over 2 y (none, reduce, same, increase), shortness of breath (none/mild, moderate, severe), and swelling (never, 3× per week, daily). A mixed logit regression model estimated preferences and calculated predicted probabilities. Relative attribute importance was calculated. Subgroup analyses were performed. Results. An online survey was completed by 150 TR patients. Shortness of breath was the most important attribute and accounted for 65.8% of treatment decision making. The average patients’ predicted probability of preferring a “procedure-like” profile over a “medical management-like” profile was 99.7%. This decreased to 78.9% for a level change from severe to moderate in shortness of breath in the “medical management-like” profile. Subgroup analysis confirmed that patients older than 64 y had a stronger preference to avoid severe shortness of breath compared with younger patients ( P

Bicuspid aortic valve (BAV) is a common congenital valvular malformation, which may lead to early aortic valve disease and bicuspid-associated aortopathy. A novel BAV classification system was recently proposed to coincide with transcatheter aortic valve replacement being increasingly considered in younger patients with symptomatic BAV, with good clinical results, yet without randomized trial evidence. Procedural technique, along with clinical outcomes, have considerably improved in BAV patients compared with tricuspid aortic stenosis patients undergoing transcatheter aortic valve replacement. The present review summarizes the novel BAV classification systems and examines contemporary surgical and transcatheter approaches.

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization‐by‐Doing) between the 2 countries. Methods and Results The patient‐level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J‐TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45–97) in the United States and 28 (interquartile range, 19–41) in Japan. Overall, patients in J‐TVT were older (United States: mean‐age, 80.1±8.7 versus Japan: 84.4±5.2; P

Background Transcatheter aortic valve replacement with supra‐annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self‐expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In‐hospital, 30‐day, and 1‐year clinical outcomes were based on the Society of Thoracic Surgeons‐American College of Cardiology‐Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty‐day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all‐cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all‐cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all‐cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all‐cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self‐expandable supra‐annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high‐volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre‐SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9–9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In‐hospital all‐cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

Background Chronic aortic regurgitation (AR) can be associated with myocardial scarring. It is unknown if scarring in AR is linked to poor outcomes and whether aortic valve replacement impacts this association. We investigated the relationship of myocardial scarring to mortality in chronic AR using cardiac magnetic resonance. Methods and Results We enrolled patients with moderate or greater AR between 2009 and 2019 and performed a blinded assessment of left ventricle remodeling, AR severity, and presence and extent of myocardial scarring by late gadolinium enhancement. The primary outcome was all‐cause mortality. We followed 392 patients (median age 62 [interquartile range, 51–71] years), and 78.1% were men, and 25.8% had bicuspid valves. Median aortic valve regurgitant volume was 39 mL (interquartile range, 30–60). Myocardial scar was present in 131 (33.4%) patients. Aortic valve replacement was performed in 165 (49.1%) patients. During follow‐up, up to 10.8 years (median 32.3 months [interquartile range, 9.8–69.5]), 51 patients (13%) died. Presence of myocardial scar (hazard ratio [HR], 3.62; 95% CI, 2.06–6.36; P

Aortic stenosis (AS) is a common valvular heart disease in the aging population that is characterized by a variable period of asymptomatic phase before development of symptoms and severe AS. Mortality and morbidity is substantial even after aortic valve replacement, in part related to persistent left ventricular hypertrophy, diastolic dysfunction, and heart failure. Renin‐angiotensin system (RAS) blockade therapy is associated with modulation of adverse left ventricular remodeling, reduction in myocardial hypertrophy, and fibrosis, resulting in clinical improvements in patients with congestive heart failure There are emerging data to suggest benefit of RAS blockade in patients with AS before and after AVR with regard to potentially slower progression of aortic valve calcification, left ventricular mass and survival benefit in favor of RAS blockade group before AVR, and also survival benefit in patients after AVR. We review the available data to understand the role of RAS blockade before AVR and in patients undergoing surgical AVR and transcatheter AVR. There are significant survival advantages of RAS inhibition in patients with AS undergoing surgical AVR or transcatheter AVR. On the basis of existing literature, adequately powered randomized trials are needed to evaluate the role of RAS inhibition in patients with AS.

Background Gait speed is a reliable measure of physical function and frailty in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Slow gait speed pre‐TAVR predicts worse clinical outcomes post‐TAVR. The consequences of improved versus worsened physical function post‐TAVR are unknown. Methods and Results The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Randomized Clinical Evaluation) trial randomized high/extreme risk patients to receive a mechanically‐expanded or self‐expanding transcatheter heart valve. Of 874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis. Slow gait speed in the 5‐m walk test was defined as

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long‐term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System—Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre‐specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Background Blood pressure (BP) guidelines for patients with aortic stenosis or a history of aortic stenosis treated with aortic valve replacement (AVR) match those in the general population, but this extrapolation may not be warranted. Methods and Results Among patients enrolled in the Medtronic intermediate, high, and extreme risk trials, we included those with a transcatheter AVR (n=1794) or surgical AVR (n=1103) who were alive at 30 days. The associations between early (average of discharge and 30 day post‐AVR) systolic BP (SBP) and diastolic BP (DBP) measurements and clinical outcomes between 30 days and 1 year were evaluated. Among 2897 patients, after adjustment, spline curves demonstrated an association between lower SBP (