Patient-Prosthesis Mismatch After Surgical Aortic Valve Replacement: Analysis of the PARTNER Trials.

BACKGROUND: Our objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials. METHODS: Surgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm2/m2) or severe (indexed effective orifice area ≤0.65 cm2/m2). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years. RESULTS: By the predicted PPM method (PPMP), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPMM), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPMP (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPMP (38.8%, P = .02). Using the PPMM method, there was no difference between the no (17.7%) and moderate PPMM groups (21.1%) in the primary outcome (P = .16). However, those with no PPMM or moderate PPMM were improved compared with severe PPMM (27.4%, P < .001 and P = .02, respectively). CONCLUSIONS: Severe PPM analyzed by PPMP was only 2.1% for surgical aortic valve replacement patients. The PPMM method overestimated the incidence of severe PPM relative to PPMP, but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical.

The non to moderately dilated root in acute type A aortic dissection: outcomes of the PENN-BERN registry in young, non-syndromic patients.

OBJECTIVES: There is an ongoing debate regarding whether patients benefit more from root replacement compared to a reconstruction of the sinuses of Valsalva in acute type A aortic dissection (aTAAD). In those with known or suspected connective tissue disorders, root replacement is considered appropriate. However, there are currently no diameter-based guidelines regarding the best approach in patients with minimally to moderately dilated root and no connective tissue disorders. METHODS: From January 2005 to December 2022, a two-centre registry of aTAAD was created. Patients were included based on their age (≤60 years), the absence of root entry and dilatation >50 mm and the absence of syndromic hereditable aortic disease. Patients were divided into 2 groups based on the proximal procedure, root reconstruction and root replacement. Propensity score pair matching was performed based on preoperative characteristics. RESULTS: Cumulative incidence of reintervention at 10 years was slightly higher after root reconstruction 13% vs 3.9% in the matched group (P = 0.040). Survival at 10 years was not affected by the procedure independently of the matching 72.1% vs 71.4% (P = 0.2). Uni- and multivariate Cox regressions showed that a root diameter of >40 mm was associated with a hazard ratio of 7.7 (95% confidence interval 2.6-23) and 5.4 (7-17), respectively, for reoperation for aneurysm and pseudoaneurysm. CONCLUSIONS: Rate of reoperation due to proximal pseudoaneurysm and aneurysm could be significantly reduced with a lower threshold of 40 mm to replace the aortic root in aTAAD than in elective cases.

The impact of reoperative surgery on aortic root replacement in the United States.

OBJECTIVE: Reoperative sternotomy is associated with poor outcomes after cardiac surgery. We aimed to investigate the impact of reoperative sternotomy on the outcomes after aortic root replacement. METHODS: All patients who underwent aortic root replacement from January 2011 to June 2020 were identified using the Society of Thoracic Surgeons Adult Cardiac Surgery Database. We compared outcomes between patients who underwent first-time aortic root replacement with those with a history of sternotomy undergoing reoperative sternotomy aortic root replacement using propensity score matching. Subgroup analysis was performed among the reoperative sternotomy aortic root replacement group. RESULTS: A total of 56,447 patients underwent aortic root replacement. Among them, 14,935 (26.5%) underwent reoperative sternotomy aortic root replacement. The annual incidence of reoperative sternotomy aortic root replacement increased from 542 in 2011 to 2300 in 2019. Aneurysm and dissection were more frequently observed in the first-time aortic root replacement group, whereas infective endocarditis was more common in the reoperative sternotomy aortic root replacement group. Propensity score matching yielded 9568 pairs in each group. Cardiopulmonary bypass time was longer in the reoperative sternotomy aortic root replacement group (215 vs 179 minutes, standardized mean difference = 0.43). Operative mortality was higher in the reoperative sternotomy aortic root replacement group (10.8% vs 6.2%, standardized mean difference = 0.17). In the subgroup analysis, logistic regression demonstrated that individual patient repetition of (second or more resternotomy) surgery and annual institutional volume of aortic root replacement were independently associated with operative mortality. CONCLUSIONS: The incidence of reoperative sternotomy aortic root replacement might have increased over time. Reoperative sternotomy is a significant risk factor for morbidity and mortality in aortic root replacement. Referral to high-volume aortic centers should be considered in patients undergoing reoperative sternotomy aortic root replacement.

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest Trial (GOT ICE): A Randomized Clinical Trial Comparing Outcomes After Aortic Arch Surgery.

BACKGROUND: Deep hypothermia has been the standard for hypothermic circulatory arrest (HCA) during aortic arch surgery. However, centers worldwide have shifted toward lesser hypothermia with antegrade cerebral perfusion. This has been supported by retrospective data, but there has yet to be a multicenter, prospective randomized study comparing deep versus moderate hypothermia during HCA. METHODS: This was a randomized single-blind trial (GOT ICE [Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest]) of patients undergoing arch surgery with HCA plus antegrade cerebral perfusion at 4 US referral aortic centers (August 2016-December 2021). Patients were randomized to 1 of 3 hypothermia groups: DP, deep (≤20.0 °C); LM, low-moderate (20.1-24.0 °C); and HM, high-moderate (24.1-28.0 °C). The primary outcome was composite global cognitive change score between baseline and 4 weeks postoperatively. Analysis followed the intention-to-treat principle to evaluate if: (1) LM noninferior to DP on global cognitive change score; (2) DP superior to HM. The secondary outcomes were domain-specific cognitive change scores, neuroimaging findings, quality of life, and adverse events. RESULTS: A total of 308 patients consented; 282 met inclusion and were randomized. A total of 273 completed surgery, and 251 completed the 4-week follow-up (DP, 85 [34%]; LM, 80 [34%]; HM, 86 [34%]). Mean global cognitive change score from baseline to 4 weeks in the LM group was noninferior to the DP group; likewise, no significant difference was observed between DP and HM. Noninferiority of LM versus DP, and lack of difference between DP and HM, remained for domain-specific cognitive change scores, except structured verbal memory, with noninferiority of LM versus DP not established and structured verbal memory better preserved in DP versus HM (P = 0.036). There were no significant differences in structural or functional magnetic resonance imaging brain imaging between groups postoperatively. Regardless of temperature, patients who underwent HCA demonstrated significant reductions in cerebral gray matter volume, cortical thickness, and regional brain functional connectivity. Thirty-day in-hospital mortality, major morbidity, and quality of life were not different between groups. CONCLUSIONS: This randomized multicenter study evaluating arch surgery HCA temperature strategies found low-moderate hypothermia noninferior to traditional deep hypothermia on global cognitive change 4 weeks after surgery, although in secondary analysis, structured verbal memory was better preserved in the deep group. The verbal memory differences in the low- and high-moderate groups and structural and functional connectivity reductions from baseline merit further investigation and suggest opportunities to further optimize brain perfusion during HCA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02834065.

Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark.

BACKGROUND: The use of transcatheter aortic valve replacement for severe aortic stenosis in low-risk patients necessitates an evaluation of contemporary long-term, real-world outcomes of similar patients undergoing surgical aortic valve replacement (SAVR) in a national cohort. METHODS: All patients undergoing primary, isolated SAVR in The Society of Thoracic Surgeons (STS) database between 2011 and 2019 were examined. The study population of 42,586 adhered to the inclusion/exclusion criteria of the Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut Low Risk randomized trials. Patients were further stratified by STS predicted risk of mortality (PROM), age, and left ventricular ejection fraction. The primary end-point was all-cause National Death Index mortality. Unadjusted survival to 8 years was estimated using the Kaplan-Meier method. RESULTS: Mean age was 74.3 ± 5.7 years and mean STS PROM was 1.9% ± 0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1, 3, 5, and 8 years was 2.6%, 4.5%, 7.1%, and 12.4%, respectively. In subset analyses, survival was significantly better for (1) lower STS PROM (P < .001), (2) younger vs older age (P < .001), and (3) higher vs lower left ventricular ejection fraction (P < .001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival after SAVR was 95%. CONCLUSIONS: The results of this national study confirm that long-term survival after SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and transcatheter aortic valve replacement and may assist in the clinical decision-making process for patients of lower surgical risk.

Validation of the GERAADA score to predict 30-day mortality in acute type A aortic dissection in a single high-volume aortic centre.

OBJECTIVES: This study aimed to evaluate employing the German Registry of Acute Aortic Dissection Type A (GERAADA) score to predict 30-day mortality in an aortic centre in the USA. METHODS: Between January 2010 and June 2021, 689 consecutive patients underwent surgery for acute type A dissection at a single institution. Excluded were patients with missing clinical data (N = 4). The GERAADA risk score was retrospectively calculated via a web-based application. Model discrimination power was calculated with c-statistics from logistic regression and reported as the area under the receiver operating characteristic curve with 95% confidence intervals. The calibration was measured by calculating the observed versus estimated mortality ratio. The Brier score was used for the overall model evaluation. RESULTS: Included were 685 patients [mean age 60.6 years (SD: 13.5), 64.8% male] who underwent surgery for acute type A aortic dissection. The 30-day mortality rate was 12.0%. The GERAADA score demonstrated very good discrimination power with an area under the receiver operating characteristic curve of 0.762 (95% confidence interval 0.703-0.821). The entire cohort's observed versus estimated mortality ratio was 0.543 (0.439-0.648), indicating an overestimation of the model-calculated risk. The Brier score was 0.010, thus revealing the model's acceptable overall performance. CONCLUSIONS: The GERAADA score is a practical and easily accessible tool for reliably estimating the 30-day mortality risk of patients undergoing surgery for acute type A aortic dissection. This model may naturally overestimate risk in patients undergoing surgery in experienced aortic centres.

Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years.

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Volume-failure-to-rescue relationship in acute type A aortic dissections: An analysis of The Society of Thoracic Surgeons Database.

OBJECTIVE: To determine the relationship between volume of cases and failure-to-rescue (FTR) rate after surgery for acute type A aortic dissection (ATAAD) across the United States. METHODS: The Society of Thoracic Surgeons adult cardiac surgery database was used to review outcomes of surgery after ATAAD between June 2017 and December 2021. Mixed-effect models and restricted cubic splines were used to determine the risk-adjusted relationships between ATAAD average volume and FTR rate. FTR calculation was based on deaths associated with the following complications: venous thromboembolism/deep venous thrombosis, stroke, renal failure, mechanical ventilation >48 hours, sepsis, gastrointestinal complications, cardiopulmonary resuscitation, and unplanned reoperation. RESULTS: In total, 18,192 patients underwent surgery for ATAAD in 832 centers. The included hospitals' median volume was 2.2 cases/year (interquartile range [IQR], 0.9-5.8). Quartiles' distribution was 615 centers in the first (1.3 cases/year, IQR, 0.4-2.9); 123 centers in the second (8 cases/year, IQR, 6.7-10.2); 66 centers in the third (15.6 cases/year, IQR, 14.2-18); and 28 centers in the fourth quartile (29.3 cases/year, IQR, 28.8-46.0). Fourth-quartile hospitals performed more extensive procedures. Overall complication, mortality, and FTR rates were 52.6%, 14.2%, and 21.7%, respectively. Risk-adjusted analysis demonstrated increased odds of FTR when the average volume was fewer than 10 cases per year. CONCLUSIONS: Although high-volume centers performed more complex procedures than low-volume centers, their operative mortality was lower, perhaps reflecting their ability to rescue patients and mitigate complications. An average of fewer than 10 cases per year at an institution is associated with increased odds of failure to rescue patients after ATAAD repair.

Outcomes of aortic valve repair with the reimplantation technique and maintenance of commissural orientation.

Background: Debate still persists on whether valve-sparing root reimplantation (VSRR) of a very asymmetric bicuspid aortic valve (BAV) should be completed such that the asymmetry of the native commissural orientation is retained, or if it should be made symmetric (180°-180°). Herein, we present our approach, in which the native asymmetry is preserved, and the valve is reimplanted in a 210°-150° orientation. Methods: A retrospective review was performed of 130 patients with BAV who underwent VSRR between January 1, 2004 and March 1, 2023 at a single institution. Of this total, 37 were reimplanted asymmetrically (210°-150°). The primary outcome was > moderate aortic insufficiency (AI). Secondary outcomes included severe aortic stenosis (AS), reintervention, and survival. Results: The included 37 patients were mostly male [94.6% (35/37)] with mean age of 46.3 years, and with low rates of comorbidities. At least moderate AI was present in 40.5% (15/37) prior to surgery. All BAV in this series were Sievers Type 1 with a mean commissural angle of 128.2°. Leaflet repair was required in 81.1% (30/37), most commonly involving central plication of the conjoined cusp [96.7% (29/30)] and raphe release [73.3% (22/30)]. There was no 30-day mortality or stroke. At 10 years, the cumulative incidences of > moderate AI, severe AS, and reintervention were 7.6% (0-17.2%), 7.1% (0-19.7%), and 5.3% (0.3-22%), respectively. There was no mortality for the entire duration of the study period. Conclusions: This series demonstrates excellent 10-year outcomes of maintaining commissural orientation in asymmetric BAV reimplantation procedures. However, further study with additional patients, longer follow-up, and direct comparison to symmetric reimplantation for similar BAV morphology is required.

Valve-sparing root reimplantation with a Valsalva graft for a trileaflet aortic valve.

Valve-sparing root reimplantation has become an attractive alternative to conventional aortic root replacement in young patients as a means to avoid the anticoagulation required for mechanical roots while improving the durability compared to bioprosthetic valved conduits. In this video tutorial, we present our step-by-step process for performing a valve-sparing root reimplantation with a Valsalva graft for a patient with an aortic root aneurysm and a trileaflet aortic valve.

Midterm Results of an Algorithmic 3-Pronged Approach to Bicuspid Aortic Valve Repair.

BACKGROUND: This study evaluated midterm outcomes of a 3-pronged algorithm for bicuspid aortic valve (BAV) repair. Valve-sparing root reimplantation (VSRR) was performed for patients with aortic root dilatation. In those without a root aneurysm, external subannular ring (ESAR) was performed for annuli ≥28 mm and subcommissural annuloplasty (SCA) for annuli <28 mm. METHODS: This was a retrospective review of prospectively collected data of 242 patients undergoing primary BAV repair from April 29, 2004, to March 1, 2023, at a single institution. Primary end points were mortality, structural valve degeneration (SVD), which was defined as a composite of more than moderate aortic insufficiency or severe aortic stenosis, and reintervention. RESULTS: The algorithm was used to treat 201 patients; of these, 130 underwent VSRR, 35 had ESAR, and 36 underwent SCA. Most were men with mean age of 43.8 years (SD, 12.0 years), which was similar between groups. Preoperative aortic insufficiency more than moderate was more common for ESAR compared with VSRR and SCA (74.3% vs 37.7% vs 44.4%, P < .001). At 30 days, mortality was 0.8% (n = 1) for VSRR and 0% for ESAR and SCA. At 6 years, overall Kaplan-Meier survival was 98.9% (95% CI, 97.3%-100%), with no differences between groups (P = .5). The cumulative incidence of SVD was 4.7% (95% CI, 0.1%-9.2%) for VSRR, 6.4% (95% CI, 0%-14.6%) for ESAR, and 0% for SCA (P = .4). Similarly, the cumulative incidence of reintervention with all-cause mortality as a competing risk was 2.2% (95% CI, 0.4%-6.9%), 6.1% (95% CI, 1%-17.9%), and 0% for VSRR, ESAR, and SCA, respectively (P = .506). CONCLUSIONS: A 3-pronged algorithmic approach to BAV repair results in excellent survival and freedom from reoperation at 6 years.

Over 8-year survival after ascending endovascular repair of type A intramural haematoma.

Acute type A aortic syndromes are catastrophic events whose management relies primarily on conventional surgery. For several years, various endovascular attempts have been described; however, long-term data are inexistent. We describe a case of stenting of the ascending aorta for a type A intramural haematoma with survival and freedom from reintervention at >8 years postoperatively.

Elevated Serum Fibroblast Growth Factor 23 (FGF-23) Perseveres into a Convalescence Period After Elective Cardiac Surgery, with Receptor Activator of Nuclear Factor κB Ligand (RANKL) and Cartilage Oligomeric Matrix Protein (COMP) Being Part of the Peri-Surgical -Pro-Arteriosclerotic Inflammatory Response.

BACKGROUND Receptor activator of nuclear factor kappa B ligand (RANKL), osteoprotegerin (OPG), cartilage oligomeric matrix protein (COMP), bone morphogenetic protein (BMP-2), and fibroblast growth factor 23 (FGF-23) are involved in inflammation, calcium deposition, and fibrosis of blood vessels. Acute changes in these factors may contribute to the progression of arteriosclerosis, especially if their elevated serum levels persist postoperatively. MATERIAL AND METHODS A total of 90 patients (79 White, 4 African American, and 7 Other) undergoing elective heart surgery were enrolled in the study. Blood was collected before surgery and after surgery at 24 hours, 7 days, and 3 months to allow for longitudinal comparisons. After the plasma isolation, several biomarkers levels were studied using an enzymatic-linked assay. Demographic and clinical information were obtained from electronic health records. RESULTS At 24 hours after surgery, RANKL (RANKLbaseline=248.7±215.7 vs RANKLt24h=376.4±329.7; P=0.035), and BMP-2 (BMP-2baseline=283.7±255.4 vs BMP-2t24h=482.4; P=0.015) were significantly elevated compared to baseline, with levels returning to baseline at 7 days. FGF-23 increased significantly from baseline (FGF-23baseline=1020±1210) to 7 days (FGF-237d=2191±5188; P=0.029) and remained significantly higher than baseline at 3 months (FGF-233m=2041±3521; P=0.044). White blood cells (WBC) remained elevated at discharge (WBCbaseline=6.8±2.1 vs WBC24h=15.0±5.3 vs WBCdischarge=8.8±3.4). IL-8 and C-reactive protein normalized at 3 months. Estimated blood loss was significantly correlated with RANKL at 24 hours (r²=0.33; P=0.035). Serum creatinine levels after surgery at 24 hours (r²=0.41; p=0.008) and 7 days (r²=0.59; P=0.000) was strongly correlated with COMP. CONCLUSIONS Persistent elevation of serum FGF-23 indicates a potential for accelerated arteriosclerosis after cardiac surgery.

Explant of a transcatheter valve-in-transcatheter valve with pericardial patch repair of the aortic root.

Surgically explanting a failed transcatheter aortic valve can be challenging due to substantial neoendothelialization and may require concomitant and often unanticipated repairs of the aortic root and ascending aorta. We describe the explant of a failed transcatheter aortic valve-in-transcatheter aortic valve with surgical aortic valve replacement and pericardial patch repair of the aortic root. This case report illustrates that appropriate patient selection is essential for transcatheter aortic valve replacement, especially as transcatheter technology expands to lower-risk and younger patients.

The Penn Classification System for Malperfusion in Acute Type A Dissection: A 25-Year Experience.

BACKGROUND: The University of Pennsylvania classification system (Penn class) of acute type A aortic dissection (aTAAD) is used to evaluate the impact of malperfusion on surgical outcomes. The purpose of this analysis was to determine the validity of Penn class in a larger and more contemporary cohort and to compare its performance with other classification systems. METHODS: This was a retrospective study of patients who underwent aTAAD repair at our institution from 1993 to 2020. Patients were assigned to Penn class on the basis of burden of preoperative malperfusion syndrome. The association of Penn class and 30-day mortality was evaluated by multivariable regression. The discriminatory ability of Penn class for mortality was determined by a bootstrapped C statistic. RESULTS: There were 1192 patients, of whom 50% were assigned to Penn class A (no ischemia), 21% (253/1192) to class B (local ischemia), 14% (171/1192) to class C (generalized ischemia), and 14% (167/1192) to class B-C (combined ischemia). The incidence of mortality rose significantly with increasing Penn class from 5% (31/601) in class A to 35% (59/167) in class B-C (P < .001). After adjustment, 30-day mortality increased significantly with class B (odds ratio [OR], 2.43; 95% CI, 1.38-4.27), class C (OR, 3.39; 95% CI, 1.90-6.03), and class B-C (OR, 13.08; 95% CI, 7.90-22.15) compared with class A. The C statistic was 0.77 (95% CI, 0.72-0.80) and was significantly higher than for models featuring alternative classification systems (P < .05). CONCLUSIONS: Penn class provides excellent discrimination for 30-day mortality after repair of aTAAD.

Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies.

Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.