Clinical Trial Diversity, Equity, and Inclusion: Roadmap of the Cardiothoracic Surgical Trials Network.

BACKGROUND: There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan of action to increase diversity among participating investigators and trial participants and is the focus of this review. METHODS: A review of literature and enrollment data from CTSN trials was conducted. RESULTS: CTSN completed more than a dozen major clinical trials (2008-2022), enrolling >4000 patients, of whom 30% were women, 11% were non-White, and 5.6% were Hispanic. CTSN also completed trials of hospitalized patients with coronavirus disease 2019, wherein enrollment was more diverse, with 42% women, and 58% were Asian, Black, Hispanic, or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and coronavirus disease trials highlights the need for a more comprehensive understanding of (1) the prevalence of underlying disease requiring cardiac interventions across broad populations, (2) differences in access to care and referral for cardiac surgery, and (3) barriers to enrollment in cardiac surgery trials. CONCLUSIONS: Committed to diversity, CTSN's multifaceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for nonparticipation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve.

Concomitant Treatment of Atrial Fibrillation in Isolated Coronary Artery Bypass Grafting.

BACKGROUND: Societal guidelines support concomitant management of atrial fibrillation (AF) in patients undergoing cardiac surgery. To assess real-world adoption and outcomes, this study evaluated Medicare beneficiaries with AF who underwent isolated coronary artery bypass grafting (CABG) with surgical ablation (SA) or left atrial appendage obliteration (LAAO) or both procedures in combination (SA + LAAO). METHODS: The US Centers for Medicare & Medicaid Services inpatient claims database identified all patients with AF who underwent isolated CABG from 2018 to 2020. Diagnosis-related group and International Classification of Diseases-10th revision procedure codes defined covariates for doubly robust risk adjustment. RESULTS: A total of 19,524 patients with preoperative AF who underwent isolated CABG were stratified by SA + LAAO (3475 patients; 17.8%), LAAO only (4541 patients; 23.3%), or no AF treatment (11,508 patients; 58.9%). After doubly robust risk adjustment, longitudinal analysis highlighted that concomitant AF treatment with SA + LAAO (hazard ratio [HR], 0.74; P = .049) or LAAO alone (HR, 0.75; P = . 031) was associated with a significant reduction in readmission for stroke at 3 years compared with no AF treatment. Furthermore, SA + LAAO (HR, 0.86; P = .016) but not LAAO alone (HR, 0.97; P = .573) was associated with improved survival compared with no AF treatment. Finally, SA + LAAO was associated with a superior composite outcome of freedom from stroke or death at 3 years compared with LAAO alone (HR, 0.86;, P = .033) or no AF treatment (HR, 0.81; P = .001). CONCLUSIONS: In Medicare beneficiaries with AF who underwent isolated CABG, concomitant AF treatment was associated with reduced 3-year readmission for stroke. SA + LAAO was associated with superior reduction in stroke or death at 3 years compared with LAAO alone or no AF treatment.

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves.

BACKGROUND: The relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients. METHODS: All patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed. RESULTS: A total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05). CONCLUSIONS: In this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.

Contemporary Coronary Artery Bypass Grafting vs Multivessel Percutaneous Coronary Intervention.

BACKGROUND: Interpretation of recent alterations to the guideline priority of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multivessel disease contests historical data and practice. To reevaluate contemporary outcomes, a large contemporary analysis was conducted comparing CABG with multivessel PCI among Medicare beneficiaries. METHODS: The United States Centers for Medicare and Medicaid Services database was evaluated all beneficiaries with acute coronary syndrome undergoing isolated CABG or multivessel PCI (2018-2020). Risk adjustment was performed using multilevel regression analysis, Cox proportional hazards time to event models, and inverse probability of treatment weighting propensity scores. RESULTS: A total of 104,127 beneficiaries were identified undergoing CABG (n = 51,389) or multivessel PCI (n = 52,738). Before risk adjustment, compared with PCI, CABG patients were associated with younger age (72.9 vs 75.2 years, P < .001), higher Elixhauser Comorbidity Index (5.0 vs 4.2, P < .001), more diabetes (48.5% vs 42.2%, P < .001), higher cost ($54,154 vs $33,484, P < .001), and longer length of stay (11.9 vs 5.8 days, P < .001). After inverse probability of treatment weighting propensity score adjustment, compared with PCI, CABG was associated with lower hospital mortality (odds ratio, 0.74; P < .001), fewer hospital readmissions at 3 years (odds ratio, 0.85; P < .001), fewer coronary reinterventions (hazard ratio, 0.37; P < .001), and improved 3-year survival (hazard ratio, 0.51; P < .001). CONCLUSIONS: Contemporary real-world data from Medicare patients with multivessel disease reveal that CABG outcomes were superior to PCI, providing important longitudinal data to guide patient care and policy development.

Impact of Transcatheter Mitral Valve Repair Availability on Volume and Outcomes of Surgical Repair.

BACKGROUND: The impact of transcatheter edge-to-edge repair (TEER) on national surgical mitral valve repair (MVr) volume and outcomes is unknown. OBJECTIVES: This study aims to assess the impact of TEER availability on MVr volumes and outcomes for degenerative mitral regurgitation. METHODS: MVr volume, 30-day and 5-year outcomes, including mortality, heart failure rehospitalization and mitral valve reintervention, were obtained from the Society of Thoracic Surgeons database linked with Medicare administrative claims and were compared within TEER centers before and after the first institutional TEER procedure. A difference-in-difference approach comparing parallel trends in coronary artery bypass grafting outcomes was used to account for temporal improvements in perioperative care. RESULTS: From July 2011 through December 2018, 13,959 patients underwent MVr at 278 institutions, which became TEER-capable during the study period. There was no significant change in median annualized institutional MVr volume before (32 [IQR: 17-54]) vs after (29 [IQR: 16-54]) the first TEER (P = 0.06). However, higher-risk (Society of Thoracic Surgeons predicted risk of mortality ≥2%) MVr procedures declined over the study period (P < 0.001 for trend). The introduction of TEER was associated with reduced risk-adjusted odds of mortality after MVr at 30 days (adjusted OR: 0.73; 95% CI: 0.54-0.99) and over 5 years (adjusted HR: 0.75; 95% CI: 0.66-0.86). These improvements in 30-day and 5-year mortality were significantly greater than equivalent trends in coronary artery bypass grafting. CONCLUSIONS: The introduction of TEER has not significantly changed overall MVr case volumes for degenerative mitral regurgitation but is associated with a decrease in higher-risk surgical operations and improved 30-day and 5-year outcomes within institutions adopting the technology.

Early trends in ECMO mortality during the first quarters of 2019 and 2020: Could we have predicted the onset of the pandemic?

OBJECTIVE: To compare mortality trends in patients requiring Extracorporeal Membrane Oxygenation (ECMO) support between the first quarters of 2019 and 2020 and determine whether these trends might have predicted the severe acute respiratory syndrome coronavirus-2 (SARS)-Cov-2 pandemic in the United States. METHODS: We analyzed 5% Medicare claims data at aggregate, state, hospital, and encounter levels using MS-DRG (Medicare Severity-Diagnosis Related Group) codes for ECMO, combining state-level data with national census data. Necessity and sufficiency relations associated with change in mortality between the 2 years were modeled using qualitative comparative analysis (QCA). Multilevel, generalized linear modeling was used to evaluate mortality trends. RESULTS: Based on state-level data, there was a 3.36% increase in mortality between 2019 and 2020. Necessity and sufficiency evaluation of aggregate data at state and institutional levels did not identify any association or combinations of risk factors associated with this increase in mortality. However, multilevel and generalized linear models using disaggregated patient-level data to evaluate institution mortality and patient death, identified statistically significant differences between the first (p = .019) and second (p = .02) months of the 2 years, the first and second quarters (p < .001 and p = .042, respectively), and the first 6 months (p < .001) of 2019 and 2020. CONCLUSION: Mortality in ECMO patients increased significantly during the first quarter of 2020 and may have served as an early warning of the SARS-Cov-2 pandemic. Granular data shared in real-time may be used to better predict public health threats.

Mortality and cost of post-cardiotomy extracorporeal support in the United States.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been used increasingly for cardiopulmonary rescue. Despite recent advances however, post-cardiotomy shock (PCS)-ECMO survival remains comparatively poor. We sought to evaluate outcomes and define factors that predict in-hospital mortality. METHODS: We used the Nationwide Inpatient Sample (NIS) to evaluate adult hospitalizations with a primary procedure code for coronary artery bypass grafting (CABG), and/or valve procedures performed between 2013 and 2018, which also required post cardiotomy ECMO support. Patient-related factors and hospital costs were evaluated to identify those associated with in-hospital mortality. RESULTS: There were 1,247,835 admissions for cardiac surgical procedures during the study period. Post-cardiotomy shock-ECMO support was provided in 4475 (0.3%) within the study cohort. A total of 2000 (44.7%) hospitalizations involved isolated valvular procedures, 1700 (38.0%) isolated CABG, and 775 (17.3%) involved a combination of both. Overall, in-hospital mortality was 42.1% (n = 1880). Factors significantly associated with in-hospital mortality included patients with multiple comorbidities (> 7) and those undergoing combination of valve and CABG procedures. Only 26.6% of those who survived to discharge, were discharged home independently. CONCLUSION: Survival to independent home discharge is rare following PCS-ECMO. Its high mortality is associated with multiple comorbidities and combination of CABG and valve surgery.

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

OBJECTIVE: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services-linked data. METHODS: A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model. RESULTS: A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies. CONCLUSIONS: In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.

Outcome and Cost of Nurse-Led vs Perfusionist-led Extracorporeal Membrane Oxygenation.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a resource-intense modality of care whose use has grown exponentially. We examined volume and utilization trends to identify the financial break-even point that might serve to dichotomize between nurse specialist-led and perfusionist-led ECMO programs. METHODS: Data pertaining to patients who required ECMO support between 2018 and 2019 were reviewed. ECMO staffing costs were estimated based on national trends and modeled by annual utilization and case volume. A break-even point was derived from a comparison between nurse specialist-led and perfusionist-led models. For each scenario, direct medical costs were calculated based on utilization, which was in turn defined by "low" (4 days), "average" (10 days), and "high" (30 days) duration of time spent on ECMO. RESULTS: Within the study time frame, there was a total of 107 ECMO cases with a mean ECMO duration of 11 days. Overall, ECMO nursing personnel costs were less than those for perfusionists ($108,000 vs $175,000). Programmatic costs were higher in the perfusionist-led vs nurse specialist-led model when annual utilization was greater than 10 cases and ECMO duration was longer than a mean of 9.7 days. There was no difference in survival between the 2 models. CONCLUSIONS: Use of a perfusionist-led ECMO model may be more cost-conscious in the context of low utilization, smaller case volume and shorter ECMO duration. However, once annual case volume exceeds 10 and mean ECMO duration exceeds 10 days, the nurse specialist-led model may be more cost-conscious.

Current Penetration, Completeness, and Representativeness of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) is the largest cardiac surgical database in the world. Linked data from STS ACSD and the Centers for Medicare and Medicaid Services (CMS) database were used to determine contemporary completeness, penetration, and representativeness of STS ACSD. METHODS: Variables common to both STS and CMS databases were used to link STS procedures to CMS data for all CMS coronary artery bypass grafting surgery (CABG) discharges between 2000 and 2018, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS: Center-level penetration (number of CMS sites with at least 1 matched STS participant divided by total number of CMS CABG sites) increased from 45% in 2000 to 95% in 2018. In 2018, 949 of 1004 CMS CABG sites (95%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations at STS sites divided by total number of CMS CABG hospitalizations) increased from 51% in 2000 to 97% in 2018. In 2018, 68,584 of 70,818 CMS CABG hospitalizations (97%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2018. In 2018, 66,673 of 68,108 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS: Linkage of the STS and CMS databases demonstrates high and increasing penetration and completeness of STS ACSD. STS ACSD now includes 97% of CABG in the United States.

Incremental effect of complications on mortality and hospital costs in adult ECMO patients.

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) is a resource-intense modality whose usage is expanding rapidly. It is a costly endeavor and best conducted in a multidisciplinary setting. There is a growing impetus to mitigate the mortality and costs associated with ECMO. We sought to examine the impact of complications on mortality and hospital costs in patients on ECMO. METHODS: Using the NIS database, we performed multivariable logistic regression to assess the influence of complications on the primary outcome, in-hospital mortality. Similarly, we performed multivariable survey linear regression analysis to evaluate the effect of the complications on hospital costs. RESULTS: Of the 12,637 patients supported using ECMO between 2004 and 2013, 9836 (78%) developed at least one complication. The three most common complications were acute kidney injury (32.8%), bloodstream infection (31.8%), and bleeding (27.8%). An ECMO hospitalization with no complications was associated with median costs of $53,470, a single complication with costs of $97,560, two complications with costs of $139,035, and three complication with costs of $162,284. A single complication was associated with a 165% increase in odds of mortality. Two or three complications resulted in 375% or 627% higher odds of mortality, respectively. Having one, two, or three complications was associated with 24%, 38%, or 38% increase in median costs respectively (Figure 1). Complications associated with the highest median costs were central line-associated bloodstream infection $217,751; liver failure $176,201; bloodstream infection $169,529. CONCLUSION: In-hospital mortality and costs increase with each incremental complication in patients on ECMO. Accurate prediction and mitigation of complications is likely to improve outcomes and cost.

Vascular Complications Increase Hospital Charges and Mortality in Adult Patients on Extracorporeal Membrane Oxygenation in the United States.

Patients on extracorporeal membrane oxygenation (ECMO) who suffer vascular complications frequently accrue additional procedures and costs. We sought to evaluate the effect of ECMO-related vascular complications on hospital charges and in-hospital mortality. Adult discharges involving ECMO from 2004 to 2013 in the National Inpatient Sample were examined. There were 12,636 patients in the cohort. Vascular complications, focusing on arterial complications were identified using ICD-9-CM diagnosis and procedure codes. A multivariable survey linear regression model using median hospital charges was used to model the effect of vascular complications on charges. We used multivariable survey logistic regression to evaluate the effect of vascular complications on in-hospital mortality. Of the 12,636 patients examined, 6467 (51.2%) had ECMO-related vascular complications. Median charges in patients with vascular complications were $ 477,363 (interquartile range: 258,660-875,823) and were $ 282,298 (interquartile range: 130,030-578,027) without vascular complications. On multivariable analysis, patients with vascular complications had 24% higher median charges than patients without vascular complications (Ratio: 1.24; 95% confidence interval [CI]: 1.16-1.33; P < 0.0001) and 34% higher odds of experiencing in-hospital mortality than patients without vascular complications (adjusted odds ratio: 1.34; 95% CI:1.08-1.66; P = 0.009). Vascular complications occur in over half of ECMO patients and are associated with an increased risk of high hospital charges and in-hospital mortality. These findings support the need for identification and modification of risk factors for ECMO-related vascular complications. Furthermore, the standardization of protocols using evidence-based measures to mitigate vascular complications may improve overall ECMO outcomes.

Usefulness of Semisupervised Machine-Learning-Based Phenogrouping to Improve Risk Assessment for Patients Undergoing Transcatheter Aortic Valve Implantation.

Semisupervised machine-learning methods are able to learn from fewer labeled patient data. We illustrate the potential use of a semisupervised automated machine-learning (AutoML) pipeline for phenotyping patients who underwent transcatheter aortic valve implantation and identifying patient groups with similar clinical outcome. Using the Transcatheter Valve Therapy registry data, we divided 344 patients into 2 sequential cohorts (cohort 1, n = 211, cohort 2, n = 143). We investigated patient similarity analysis to identify unique phenogroups of patients in the first cohort. We subsequently applied the semisupervised AutoML to the second cohort for developing automatic phenogroup labels. The patient similarity network identified 5 patient phenogroups with substantial variations in clinical comorbidities and in-hospital and 30-day outcomes. Cumulative assessment of patients from both cohorts revealed lowest rates of procedural complications in Group 1. In comparison, Group 5 was associated with higher rates of in-hospital cardiovascular mortality (odds ratio [OR] 35, 95% confidence interval [CI] 4 to 309, p = 0.001), in-hospital all-cause mortality (OR 9, 95% CI 2 to 33, p = 0.002), 30-day cardiovascular mortality (OR 18, 95% CI 3 to 94, p <0.001), and 30-day all-cause mortality (OR 3, 95% CI 1.2 to 9, p = 0.02) . For 30-day cardiovascular mortality, using phenogroup data in conjunction with the Society of Thoracic Surgeon score improved the overall prediction of mortality versus using the Society of Thoracic Surgeon scores alone (AUC 0.96 vs AUC 0.8, p = 0.02). In conclusion, we illustrate that semisupervised AutoML platforms identifies unique patient phenogroups who have similar clinical characteristics and overall risk of adverse events post-transcatheter aortic valve implantation.

The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications.

BACKGROUND: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system. METHODS: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices. RESULTS: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001). CONCLUSIONS: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.

Acute In Vivo Functional Assessment of a Biodegradable Stentless Elastomeric Tricuspid Valve.

Degradable heart valves based on in situ tissue regeneration have been proposed as potentially durable and non-thrombogenic prosthetic alternatives. We evaluated the acute in vivo function, microstructure, mechanics, and thromboresistance of a stentless biodegradable tissue-engineered heart valve (TEHV) in the tricuspid position. Biomimetic stentless tricuspid valves were fabricated with poly(carbonate urethane)urea (PCUU) by double-component deposition (DCD) processing to mimic native valve mechanics and geometry. Five swine then underwent 24-h TEHV implantation in the tricuspid position. Echocardiography demonstrated good leaflet motion and no prolapse and trace to mild regurgitation in all but one animal. Histology revealed patches of proteinaceous deposits with no cellular uptake. SEM demonstrated retained scaffold microarchitecture with proteinaceous deposits but no platelet aggregation or thrombosis. Explanted PCUU leaflet thickness and mechanical anisotropy were comparable with native tricuspid leaflets. Bioinspired, elastomeric, stentless TEHVs fabricated by DCD were readily implantable and demonstrated good acute function in the tricuspid position.

Distressed communities are associated with worse outcomes after coronary artery bypass surgery.

OBJECTIVES: Although low socioeconomic status has been associated with increased risk of complications after cardiac surgery, analyses have typically focused on insurance status, race, or median income. We sought to determine if the Distressed Communities Index, a composite socioeconomic metric, could predict operative mortality after coronary artery bypass grafting. METHODS: All patients who underwent isolated coronary artery bypass grafting (2011-2018) in the National Society of Thoracic Surgeons adult cardiac surgery database were analyzed. Clinical data were paired with the Distressed Communities Index, which accounts for unemployment, education level, poverty rate, median income, business growth, and housing vacancies by ZIP code. Developed by the Economic Innovation Group, Distressed Communities Index scores range from 0 (no distress) to 100 (severe distress). A distressed community was defined as one having a Distressed Communities Index of 75 or greater for univariate analyses. RESULTS: Of the 575,900 patients undergoing coronary artery bypass grafting with a Distressed Communities Index score, the median age was 65 years. The operative mortality rate was 2.0%, and the composite morbidity or mortality rate was 11.5%. Distressed communities were associated with increased Society of Thoracic Surgeons predicted risk of mortality (1.97% vs 1.85%, P < .0001) and risk of composite morbidity or mortality (12.8% vs 11.7%, P < .0001). After adjusting for Society of Thoracic Surgeons risk model, the Distressed Communities Index remained significantly associated with mortality (odds ratio, 1.12; P < .0001) and composite morbidity and mortality (odds ratio, 1.03; P = .002). CONCLUSIONS: Patients from distressed communities are at increased risk for adverse events and death after coronary artery bypass grafting. The Distressed Communities Index is a useful, holistic measure of socioeconomic status that may help identify high-risk patients for quality improvement and should be considered when building risk models or comparing hospitals.

Surgical ablation of atrial fibrillation concomitant to coronary-artery bypass grafting provides cost-effective mortality reduction.

BACKGROUND: Data on the longitudinal impact of surgical ablation (SA) for atrial fibrillation (AF) in patients undergoing coronary artery bypass grafting (CABG) remain limited. This study examined 2-year risk-adjusted mortality and total hospital costs in Medicare beneficiaries with AF requiring CABG with or without SA. METHODS: CABG was performed in 3745 Medicare beneficiaries with AF in 2013, with concomitant SA in 17% (626 of 3745). Risk-adjusted mortality, morbidity, and cost during the first 2 postoperative years for patients with SA and those without SA were compared. A piecewise Cox proportional hazard model (0-90 days and 91-729 days) was used to risk-adjust mortality. RESULTS: Compared with the no SA group, the SA group had lower rates of heart failure before surgery (31% vs 36%), chronic lung disease (27% vs 33%), renal failure (4% vs 7%), and urgent or emergent presentation (34% vs 49%) (all P < .05). Risk-adjusted index admission costs were higher with SA (rate ratio [RR], 1.11; P < .01), as were readmissions for AF (hazard ratio [HR], 1.14; 95% confidence interval [CI], 1.00-1.29; P = .04) and pacemaker/defibrillator implantation (HR, 1.37; 95%, 1.08-1.74; P = .01). Risk-adjusted inpatient days and inpatient costs were similar after 2 years (RR, 0.97; P = .31 and RR = 1.04; P = .17, respectively); however, the risk-adjusted hazard for late mortality (91-729 days) was significantly lower with SA (HR, 0.71; 95% CI, 0.52-0.97; P = .03). CONCLUSIONS: In patients with AF requiring CABG, SA was associated with a 29% lower risk-adjusted hazard for late mortality. Index hospital costs were higher with SA, but total inpatient costs were not different in the 2 groups after 2 years. SA appears to be a cost-effective intervention to enhance late 2-year survival in patients with AF undergoing CABG.

Pre- Versus Post-Procedure Health Care Resource Utilization in Patients Undergoing Commercial Transcatheter Mitral Valve Repair.

OBJECTIVES: The aim of this study was to assess the real-world impact of transcatheter mitral valve repair (TMVR) on hospitalizations and Medicare costs pre- versus post-TMVR. BACKGROUND: TMVR is effective in degenerative mitral regurgitation (MR) and appropriately selected patients with functional MR with high surgical risk. METHODS: Patients undergoing TMVR in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from 2013 to 2018 were linked to Medicare claims data. Rates of hospitalizations, hospitalized days, and Medicare costs were compared 1-year pre-TMVR to 1-year post-TMVR. RESULTS: Across 246 sites, 4,970 patients with a median age of 83 years (interquartile range: 77 to 87 years) were analyzed. The TMVR indication was degenerative MR in 77.5% and functional MR in 16.7%. From pre- to post-TMVR, heart failure (HF) hospitalization rates (479 vs. 370 hospitalizations/1,000 person-years; rate ratio [RR]: 0.77) and cardiovascular hospitalizations (838 vs. 632; RR: 0.75) decreased significantly (p < 0.001 for all). Similarly, the rates of hospitalized days decreased for HF and cardiovascular causes (p < 0.05 for all). Following TMVR, the odds of having no Medicare costs for HF hospitalizations increased (69% vs. 79%; odds ratio: 1.67; p < 0.001). However, the average total Medicare costs per day alive among patients with any HF hospitalizations after TMVR increased significantly (p < 0.001). The HF hospitalization rates decreased for patients with functional MR (683 vs. 502; RR: 0.74) and those with degenerative MR (431 vs. 337; RR: 0.78) (p < 0.001). CONCLUSIONS: TMVR is associated with a decrease in cardiovascular and HF hospitalizations and a greater likelihood of having no HF Medicare costs in the year after TMVR, regardless of MR etiology. Further work is necessary to elucidate the reasons for increased costs among patients with HF hospitalizations post-TMVR.

Patient and Hospital Characteristics of Mitral Valve Surgery in the United States.

Importance: Volume metrics may have relevance in the evaluation of valve center expertise. However, a paucity of data exists regarding the quantity, volume, and geographic location of mitral valve (MV) surgical centers in the United States and the proportion of underserved populations they treat. Objectives: To evaluate the hospital, patient, and procedural characteristics of mitral valve repair or replacement (MVRR) in the United States as a function of hospital procedure volume. Design, Setting, and Participants: This cross-sectional, multicenter observational study was conducted from July 2014 to June 2018. Patients in the Society of Thoracic Surgeons Adult Cardiac Surgery Database undergoing any surgical procedure involving MVRR in the United States were included. Main Outcomes and Measures: Volume distribution of MVRR by hospital and hospital referral region. Results: There were 165 405 MVRRs performed in 1082 centers during the study period, of which 86 488 (52.3%) were MV repairs. There were 575 centers (53.1%) that performed 25 or more MVRRs per year. The geographic distribution of centers performing 25 or more MVRRs per year differed from those performing fewer than 25 MVRRs per year. Of 304 designated hospital referral regions, 235 (77.3%) had at least 1 center performing 25 or more MVRRs per year, representing accessibility to 1 or more such centers for 296.4 million of 320.1 million US residents (92.6% of the US population; Midwest, 60.0 million of 68.0 million [88.4%]; South, 112.6 million of 122.6 million [91.9%]; West, 68.6 million of 72.9 million [94.1%]; and Northeast, 54.9 million of 56.6 million [97.1%]). Of 304 hospital referral regions, 168 (55.3%) had at least 1 center performing 40 or more MVRRs per year, representing accessibility to 1 or more such centers for 259.8 million of 317.90 million (81.7%) of the US population (Midwest, 50.5 million of 67.9 million [74.5%]; South, 94.5 million of 121.1 million [78.1%]; West, 64.0 million of 72.8 million [88.0%]; Northeast, 50.1 million of 56.3 million [90.2%]). More black and Hispanic patients received operations in centers performing 25 or more MVRRs per year (22 984) vs those performing fewer than 25 MVRRs per year (3227), yet the proportion was higher in lower-volume centers (22 984 of 148 385 [15.5%] vs 3227 of 17 020 [19.0%]; P < .001). In centers performing 25 or more MVRRs per year vs fewer than 25 MVRRs per year, there was a lower percentage of Medicare and Medicaid patients (47 920 of 148 385 [32.3%] vs 6183 of 17 020 [.3%]; P < .001) and patients from rural zip codes (21 208 of 148 385 [14.3%] vs 3146 of 17 020 [18.5%]; P < .001). Conclusions and Relevance: Fifty-three percent of all centers performed 25 or more MVRRs per year, and 92.6% of the US population lived in an hospital referral region with at least 1 such center. Disparities in race/ethnicity, rurality, and insurance status exist among patients being treated at centers with different volumes. These data indicate that efforts to centralize care based on volume metrics will need to balance access vs quality.

Lung transplantation and Affordable Care Act Medicaid expansion in the era of lung allocation score - a retrospective study.

This study evaluated the impact of Medicaid eligibility expansion (ME) on lung transplant (LT) listings and Medicaid coverage. Data on LT candidates aged 18-64 were obtained from the Scientific Registry of Transplant Recipients (N = 9153). The impact of ME was evaluated by comparing LT listings in 2011-2013 with listings in 2014-2016, as well as comparing states that had and had not adopted ME in 2014. LT listings increased by 7.7% nationally post-ME. In ME states, LT listings increased by 15.2%, whereas nonexpansion states decreased by 1.5%. LT candidates with Medicaid increased after ME nationally (8.3% vs. 9.9%, P = 0.006) and in ME states (9.7% vs. 11.5%, P = 0.036), but not in nonexpansion states (6.6% vs. 7.7%, P = 0.170). Following multivariable adjustment, LT listings in ME states had 58% greater odds for Medicaid compared to nonexpansion states (P < 0.001). Expansion of Medicaid provided greater healthcare access and increased LT listings, but only within states that adopted eligibility expansion.