Background:Patient-reported outcomes (PROs) are increasingly used as endpoints in clinical trials. However, the magnitude of observed changes in control arms attributable to placebo effects, as compared with other benefits of trial participation, has not been described.This study seeks to estimate the magnitude of the placebo effect by calculating changes in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) scores, which quantify the impact of heart failure on patients' symptoms, function, and quality of life, after participants were unblinded to treatment. Methods:REDUCE LAP-HF II randomized participants to atrial shunt or sham procedure, with unblinding after 2 years. The KCCQ was collected at baseline, 2, and 3 years after randomization. KCCQ-OS change from baseline to 2 years (placebo effect plus other benefits from trial participation) and the change from 2 to 3 years (placebo effect loss after unblinding) were calculated in sham-treated patients using mean±SD, as were changes from 2 to 3 years in shunt-treated patients (placebo effect benefit). Results:The analytic cohort included 421 participants (median age 72 years, 65.6% female). Among sham-treated participants (N=182), the mean±SD KCCQ-OS 2-year improvement from baseline was +9.3±22.4 points, with a decrement after unblinding of -1.7±18.2 points from 2 to 3 years. Among shunt-treated patients (N=239), mean±SD KCCQ-OS 2-year improvement was +12.7±22.8 points, with an improvement after unblinding of +1.9±18.2 points. In a hypothetical unblinded trial where placebo effect benefit would be expected in the active intervention arm, and none in the untreated arm, the combined effects would be 3.6 points. Conclusions:In a sham-controlled device trial that collected PRO data during blinded allocation to treatment or sham and after unblinding, the estimated mean placebo effect benefit and loss on the KCCQ-OS were small (≤2 points). Finding a modest placebo effect on PROs may increase confidence in their use as clinical trial outcomes.

The extension of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy has driven a shift in focus toward procedural optimization, with the goals of maximal clinical improvement, durable outcomes, maintained coronary access, and avoidance of permanent pacemaker implantation. A TAVR CODE framework including 4 key fluoroscopic parameters-coaxiality, orientation, depth, and expansion-has recently been proposed to standardize the intraprocedural evaluation of optimal transcatheter heart valve (THV) implantation. Systematic implementation of these concepts during TAVR is expected to improve valve performance and durability. This is hypothesized to improve afterload reduction, enhance left ventricular reverse remodeling, and confer increased and longer lasting clinical benefits. To date, procedural strategies to optimize TAVR outcomes have been largely based upon expert opinion, supported predominantly by mechanistic and retrospective studies. Ongoing randomized trials are evaluating the effects of systematic pre- and postdilatation during TAVR, the impact of same-volume double-tap techniques with balloon-expandable valves, and the effectiveness of different commissural alignment techniques. Meanwhile, intravascular ultrasound is under investigation as a tool to evaluate THV expansion to guide postdilatation, while technical consistency may be improved by innovative THV designs that promote symmetrical expansion, better fluoroscopic visualization, and robotic insertion systems using artificial intelligence. In this article, we detail the possible impact of implementing the TAVR CODE framework on THV function, durability, and clinical outcomes, and provide an expert perspective on procedural strategies to achieve optimal index TAVR outcomes, including management frameworks and position statements according to contemporary best practices.

Patients with reduced left ventricular ejection fraction (LVEF) undergoing transcatheter aortic valve replacement remain a clinically vulnerable group. Although self-expanding valves (SEVs) and balloon-expandable valves are widely used, the optimal choice in patients with LVEF <40% remains uncertain. We aimed to synthesize the available evidence comparing these two valve types in this high-risk population. We conducted a systematic review and meta-analysis of observational studies comparing SEVs and balloon-expandable valves in patients with LVEF <40% undergoing transcatheter aortic valve replacement. Outcomes included changes in LVEF, aortic gradients, mortality, and safety endpoints. Pooled estimates were calculated using random-effects models, and multivariable meta-regression was performed to adjust for study-level confounding. Five studies comprising 5365 patients were included. SEVs were associated with a greater improvement in 1-month LVEF (mean difference, 2.33; 95% confidence interval [CI], 0.83 to 3.83; p = 0.01) and lower mean aortic gradients (mean difference, -2.72; 95% CI, -3.51 to -1.93; p < 0.01). Procedural mortality (risk ratio [RR], 0.89; 95% CI, 0.26-3.11; p = 0.86), 30-day mortality (RR, 1.52; 95% CI, 0.65-3.56; p = 0.33), and 1-year mortality (RR, 1.13; 95% CI, 0.69-1.84; p = 0.44) were similar. SEVs carried an increased risk of moderate or worse paravalvular leak (RR, 2.52; 95% CI, 1.46-4.36; p < 0.01). While SEVs may offer superior early LVEF improvement, they are associated with a higher rate of paravalvular leaks. Current data are observational and insufficient to recommend one valve type over another.

BACKGROUND AND AIMS:The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. METHODS:The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. RESULTS:One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (-11.6, 11.9), massive/torrential -5.8% (-17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (-3.0, 22.7), massive/torrential -15.2% (-28.9, -1.5)]. CONCLUSIONS:Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

Importance:Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited. Objective:To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. Design, Setting, and Population:Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026. Exposure:Device-enabled TTVR. Main Outcomes and Measures:Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes. Results:Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality (P = .47), heart failure hospitalization (P > .99), and functional outcomes (P = .55) when patients were stratified by baseline CIED status. Conclusions and Relevance:Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.

Importance Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited. Objective To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. Design, Setting, and Population Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026. Exposure Device-enabled TTVR. Main Outcomes and Measures Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes. Results Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality ( P = .47), heart failure hospitalization ( P > .99), and functional outcomes ( P = .55) when patients were stratified by baseline CIED status. Conclusions and Relevance Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.

Background Among patients treated for severe aortic stenosis, a small aortic annulus could have a different impact on outcomes according to body size. We aimed to compare forward‐flow hemodynamics and clinical outcomes after transcatheter aortic valve replacement in patients with small annuli according to aortic annular area (AAA) index, defined as computed tomography‐derived AAA divided by body surface area. Methods The TAVI‐SMALL 2 (International Multicenter Registry to Evaluate the Performance of Self‐Expandable Valves in Small Aortic Annuli 2) observational, retrospective, international cohort study enrolled patients with severe aortic stenosis and small annuli in 16 high‐volume centers between 2011 and 2020. Analyses comparing patients with low (ie, ≤2 cm2/m2) and high AAA index (ie, >2 cm2/m2) were conducted adopting propensity score methodology. Primary end points were predischarge device forward‐flow composite (including mean aortic gradient ≥20 mm Hg or severe prosthesis–patient mismatch), and clinical efficacy composite (including all‐cause death, transient ischemic attack/stroke, or hospitalization for heart failure) at 1‐year follow‐up. Results A total of 1256 patients were included in the analysis. In the 1:1 propensity score–matched population (n=688), the primary predischarge forward‐flow composite end point occurred in 48 patients (7.5%) overall and was more common in low versus high AAA index (9.7% versus 5.3%, P=0.034). The primary composite clinical efficacy end point occurred in 95 patients (18.1%), and no difference between groups was observed at 1‐year follow‐up (11.5% [95% CI, 7.8%–16.8%] versus 14.4% [95% CI, 10.4%–19.9%], hazard ratio, 0.89 [95% CI, 0.59–1.33]; Plog‐rank=0.842). Conclusions Among patients with small aortic annuli undergoing transcatheter aortic valve replacement, the novel AAA index further identifies patients at increased risk of predischarge suboptimal forward‐flow hemodynamics. No difference in clinical efficacy at 1‐year follow‐up was observed according to the AAA index.

Importance:Patent foramen ovale (PFO) closure decreases recurrent stroke but increases atrial fibrillation (AF). Careful selection of patients in whom PFO is more likely to be the cause of stroke may improve outcomes by avoiding closure in patients unlikely to benefit. Objective:To determine whether the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system identifies who will experience net benefit and net harm from PFO closure. Design, Setting, and Participants:This meta-analysis was a secondary analysis of individual participant-level data from the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) consortium meta-analysis, including all 6 randomized trials of transcatheter PFO closure vs antithrombotic therapy alone. Participants were young and middle-aged adults (mean [SD] age, 45 [10] years) with a PFO and an otherwise cryptogenic stroke. The trials were conducted in hospitals in North America, Europe, Australia, Brazil, and South Korea from 2000 to 2017. The current analysis, involving all trial participants, was performed from January to August 2025. Interventions:Transcatheter PFO closure plus antithrombotic therapy vs antithrombotic therapy alone. Main Outcomes and Measures:The primary efficacy end point was recurrent ischemic stroke. The primary safety end point was first-ever detection of AF beyond the periprocedural period (>45 days after randomization). Results:The 6 trials enrolled 3740 patients (1889 who had PFO closure, 1851 who had medical therapy); 2058 patients (55.0%) were male, and 1682 (45.0%) were female. Among patients in all 6 trials, PASCAL classified PFO relatedness to the index stroke as probable in 1382 patients (37.0%), possible in 1811 (48.4%), and unlikely in 547 (14.6%); among the 2967 patients in the 4 trials with broad entry criteria, PASCAL classified PFO relatedness as probable in 860 patients (29.0%), possible in 1565 (52.7%), and unlikely in 543 (18.3%). The reduction in the absolute rate of recurrent ischemic strokes over 5 years was greater than the increase in first-ever detection of AF in the postperiprocedural period as follows: in the probable group, fewer strokes, -2.5% (95% CI, -4.2% to -1.3%) vs more late AF, 1.3% (95% CI, 0.0% to 2.5%), and in the possible group, fewer strokes -3.4% (95% CI, -5.4% to -1.3%) vs more late AF, 1.1% (95% CI, -0.5% to 2.6%). Reduction in recurrent ischemic strokes was not observed and increase in first-ever detected postperiprocedural AF was magnified in the unlikely group (more strokes, 0.4%; 95% CI, -4.0% to 4.8%, vs more late AF, 4.6%; 95% CI, 0.3% to 8.9%). Conclusion and Relevance:Among young and middle-aged patients with PFO and otherwise cryptogenic stroke, the PASCAL classification algorithm distinguished the 4 of every 5 patients in the probable and possible groups with net benefit and the 1 of every 5 patients in the unlikely group with net harm from closure.

Background Degenerated bioprosthetic mitral valves (MVs) are associated with significant morbidity and health care expenditures. For certain patients, valve-in-valve transcatheter MV replacement (ViV TMVR) has emerged as a promising treatment option due to fewer complications and shorter hospital length of stay when compared with redo surgical MV replacement (redo-SMVR). We constructed a decision-analytic model comparing the cost-effectiveness of ViV TMVR to redo-SMVR for the management of degenerated bioprosthetic valves. Methods Cost-effectiveness was determined by calculating deaths averted and incremental cost-effectiveness ratios (ICERs). Uncertainty was addressed by plotting cost-effectiveness planes and acceptability curves for various willingness-to-pay thresholds. The main outcome was ICERs defined as United States (US) dollars/deaths averted. Results In the base case analysis, the cost associated with ViV TMVR was estimated at $87,724 with a 0.93 probability of survival at 1 month. For the redo-SMVR strategy, the cost was $104,444, and the probability of survival at 1 month was 0.89. Overall, ViV TMVR resulted in savings of $418,001 per death averted (ICER, −$418,001/death averted). In cost-effectiveness acceptability curves, ViV TMVR was cost-effective in 83% to 88% of simulations for a willingness-to-pay threshold ranging from $0 to $100,000. Conclusions ViV TMVR is an effective strategy that may result in significant health care savings for the management of degenerated bioprosthetic valves.

The introduction of transcatheter aortic valve replacement (TAVR) over two decades ago has fundamentally reshaped the management and treatment landscape for the treatment of severe aortic stenosis by introducing a less invasive approach compared to a surgical aortic valve replacement (SAVR). The field continues to rapidly evolve as clinical studies expand the indications for TAVR across all surgical risk strata. However, it is unclear whether TAVR can be safely applied to patients with complex aortic valve and root pathologies as well as match the long-term durability demonstrated by SAVR. Thus, optimizing patient selection to maximize net clinical benefit, by defining the indications and limitations of TAVR, continue to be areas of active research and discourse. To this end, the annual ‘Beyond the Guidelines’ session at the 2026 Cardiovascular Research Technologies (CRT) convened an expert panel to highlight the current state of evidence, summarize the accumulated evidence in current domains of clinical equipoise where investigative efforts are focused, and identify key areas of clinical unmet need. This article summarizes the expert panel discussions of current evidence supporting the latest societal guidelines on management of severe aortic stenosis, the accumulation of investigative evidence in established clinical domains of equipoise including TAVR for aortic stenosis in asymptomatic patients; those with bicuspid aortic valves, treatment of transcatheter aortic valve failure, and expert opinions on emerging areas of unmet need where future investigative efforts may need to be focused.

Background: Transcatheter tricuspid valve replacement (TTVR) with the EVOQUE system has emerged as an effective therapy for severe tricuspid regurgitation. The costs and resource utilization associated with TTVR, particularly in the context of major adverse events (MAEs), remain uncharacterized. The objective of the study was to quantify the impact of in-hospital MAEs on length of stay (LOS) and costs of TTVR admissions. Methods: This analysis included patients with symptomatic, ≥severe tricuspid regurgitation who underwent TTVR in the TRISCEND II trial. Hospital billing data were obtained for 155 patients to assess procedural costs, nonprocedural costs, and LOS. MAEs during the index hospitalization were adjudicated, and their impact on costs and LOS were evaluated using multivariable regression models. Results: The mean total LOS was 6.4 ± 5.5 days, with mean admission costs of $80,005 ± $26,958 including the device cost. MAEs occurred in 20% of patients and most commonly consisted of new pacemaker or cardiac implantable electronic device (CIED) implantation (9.7%) and severe bleeding (9.0%). Adjusted analyses identified new renal replacement therapy (RRT) ($75,308, frequency 1.9%) and new pacemaker or CIED implantation ($34,322) as the largest independent contributors to increased costs. New RRT (13.0 days), stroke (10.1 days), and new pacemaker or CIED (4.2 days) were associated with the greatest increases in LOS. Overall, MAEs accounted for $5156 and 0.7 days per patient of the total index admission cost and LOS, respectively. Conclusions: In the TRISCEND II trial, new pacemaker or CIED implantation and new RRT most substantially increased hospital costs and LOS following TTVR.

BACKGROUND:As transcatheter aortic valve replacement (TAVR) expands to patients with longer life expectancy, the impact of failure mechanisms on outcomes of TAVR-explant and redo-TAVR remains uncertain. We sought to evaluate outcomes of TAVR reintervention based on the failure mechanism of the index transcatheter aortic valve. METHODS:From 2009 to 2022, 553 patients from 29 centers in the EXPLANTORREDO-TAVR registry (Explant or Redo Transcatheter Aortic Valve Replacement) underwent TAVR-explant or redo-TAVR for transcatheter aortic valve failure. Patients with endocarditis were excluded. Patients with structural valve deterioration (SVD, N=224 [64.9%]) were compared with those with nonstructural valve dysfunction (NSVD, N=121 [35.1%]), comprising paravalvular leak (86.0%) and prosthesis-patient mismatch (14.0%). Outcomes were assessed at 30 days and 1 year. RESULTS:Mean age was 75.6±9.3 years, with 42% women. There were no differences in reintervention type between groups (redo-TAVR in 58.0% SVD versus 49.6% NSVD; TAVR-explant: 42.0% versus 50.4%; P=0.14). Compared with NSVD, SVD was the predominant mode of failure in balloon-expandable valves (50.7% versus 24.8%; P<0.001), had a longer time to reintervention (50.7 versus 5.5 months; P<0.001), and favored non-balloon-expandable valves at redo-TAVR (56.9% versus 33.3%; P=0.003). Mortality at 30 days and 1 year did not differ significantly between SVD and NSVD for either redo-TAVR (30 days: 3.2% versus 1.7%, P=1.00; 1 year: 18.0% versus 12.0%; P=0.47) or TAVR-explant (30 days: 16.3% versus 12.1%, P=0.63; 1 year: 40.0% versus 29.5%; P=0.39). There were also no differences in risk-adjusted 3-year cumulative mortality between groups (redo-TAVR: hazard ratio, 1.30 [95% CI, 0.68-2.46], P=0.43 [ref=NSVD]; TAVR-explant: hazard ratio, 1.24 [95% CI, 0.64-2.41]; P=0.53). CONCLUSIONS:SVD and NSVD failures had distinct valve types and reintervention timing, with SVD having a longer time to TAVR reintervention, but the failure mechanism did not impact reintervention type or clinical outcomes.

BACKGROUND:Transcatheter mitral valve replacement (TMVR) may benefit patients at high surgical risk with mitral regurgitation (MR). OBJECTIVES:The authors report 30-day and 1-year outcomes of transfemoral TMVR. METHODS:The MISCEND (Edwards Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device) study is a prospective, single-arm, multicenter evaluation of the Eos transcatheter mitral valve replacement system for clinically significant, symptomatic MR. Performance and safety endpoints included device success, procedural success, 30-day rate of MR ≤1+ and 30-day composite major adverse event rate. Additional clinical, echocardiographic, functional, and quality-of-life outcomes were assessed through 1 year. RESULTS:Sixty patients (median age 79.5 years, Society of Thoracic Surgeons score 5.2%, 40% men, 43.3% with functional MR) were enrolled. Device and procedural success rates were 100.0%. The 30-day composite major adverse event rate was 43.3%, including all-cause mortality (5.0%), all-cause hospitalization (21.7%), nonelective mitral valve reintervention (1.7%), severe bleeding (28.3%), renal complication requiring unplanned dialysis or renal replacement therapy (5.0%), and major cardiac structural complication (8.3%). The rate of MR ≤1+ was 98.1% at 30 days and 100.0% at 1 year, with none/trace MR in 63.0% and 78.4% of patients, respectively. One-year outcomes showed significant improvements in 6-minute walk distance (40.5 m; 95% CI: 13.8-97.2 m; P = 0.003) and Kansas City Cardiomyopathy Questionnaire overall score (17.7 points; 95% CI: 11.2-27.3 points; P < 0.01), with 86.8% of patients in NYHA functional class I/II. Rates of mortality and left ventricular pseudoaneurysm were 20.3% and 10.0%, respectively. CONCLUSIONS:1-year MISCEND results demonstrate the feasibility of TMVR with the Eos system. Although safety concerns related to left ventricular pseudoaneurysm resulted in the cessation of study enrollment, learnings will inform future therapy development.

BACKGROUND:Five-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed. METHODS:Patients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years. RESULTS:A total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan-Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, -2.6 percentage points; 95% confidence interval [CI], -9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan-Meier estimates for the incidence of components of the first primary end point were as follows: death, 19.5% and 16.8%; stroke, 8.5% and 8.1%; and rehospitalization, 20.6% and 23.5%. The mean (±SD) aortic-valve gradients assessed by echocardiography at 7 years were 13.1±8.5 mm Hg after TAVR and 12.1±6.3 mm Hg after surgery. The percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.5% in the surgery group. Patient-reported outcomes were similar in the two groups. CONCLUSIONS:Among low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

BACKGROUND:Hospitals and health systems must balance the demand for transcatheter aortic valve replacement (TAVR) against financial sustainability. Patients may be eligible for both TAVR and surgical aortic valve replacement (SAVR), but financial realities for hospitals may affect differential access to those therapies. We sought to understand the landscape of costs and reimbursement for TAVR and SAVR in the US and to understand the association of procedural reimbursement with receipt of either. METHODS:We included fee-for-service Medicare beneficiaries undergoing isolated TAVR or SAVR in 2016-2019. For each TAVR and SAVR, inpatient revenues and direct costs were calculated at the claim level. The contribution margin (CM) for each TAVR or SAVR was then calculated as total revenues minus total direct costs, which defines the net profit for the procedure for the hospital. Multivariate logistic regressions were used to identify hospital characteristics associated with positive TAVR CMs. Multivariate linear regression was used to assess the relationship between relative volume of TAVR cases and relative differences in TAVR versus SAVR CMs at the hospital level. RESULTS:Of 542 sites, 377 (69.6%) had positive CMs, and 165 (30.4%) had negative CMs for TAVR; 505 (93.2%) had positive CMs for SAVR. Median revenues, costs, and CMs for TAVR decreased between 2016 and 2019. The median (IQR) total CM per hospital for TAVR decreased from $10,574 ($1,331-$22,259) in 2016 to $6,744 ($6,099-$17,511) in 2019 (P < 0.001). Teaching hospital status (aOR 1.77, 95% CI 1.07-2.93) and for-profit status (aOR 3.7, 95% CI 1.8-7.6) were associated with increased odds of positive TAVR CMs relative to nonteaching hospital status and nonprofit status, respectively, in multivariate logistic regression models. The median (IQR) proportion of TAVR of total AVR was 76.67% (69.6%-82.5%) compared with 74.6% (66.9%-80.4%) at hospitals with negative TAVR CMs (P = .04). There was no significant linear relationship between hospital-level difference in median TAVR and SAVR CMs and hospital-level proportion of TAVR of total AVR in multivariate models. CONCLUSIONS:Most hospitals had positive CMs for TAVR and nearly all had positive CMs for SAVR. Positive CMs for TAVR for individual hospitals were associated with a significant increase in the utilization of TAVR. However, the magnitude of difference in TAVR versus SAVR CM was not associated with differential procedural use.