Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US.

Importance: Professional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI). Objective: To model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access. Design, Setting, and Participants: This cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020. Exposures: Within each hospital referral region, TAVI sites were categorized by volume (<50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region. Main Outcomes and Measures: The primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance. Results: The overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (-34; 95% CrI, -75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas. Conclusions and Relevance: In this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

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.

Impact of Hospital Practice and Staffing Differences on Transesophageal Echocardiography Use in Cardiac Valve or Coronary Artery Bypass Graft Surgery.

OBJECTIVES: To identify and quantify the predictors of intraoperative transesophageal echocardiography (TEE) use among the patients undergoing cardiac valve or isolated coronary artery bypass graft (CABG) surgery. DESIGN: An observational cohort study. SETTING: This study used the Centers for Medicare and Medicaid Services administrative claims dataset of the beneficiaries undergoing valve or isolated CABG surgery between 2013 to 2015. PARTICIPANTS: Adults aged ≥65 years of age undergoing cardiac valve or isolated CABG surgery. INTERVENTIONS: Generalized linear mixed-model (GLMM) analyses were used to examine the relationship between the TEE and patient characteristics, hospital factors, and staffing differences, while accounting for clustering within hospitals. The proportion of variation in TEE use attributable to patient-level characteristics was quantified using odds ratios. Hospital-level factors and staffing differences were quantified using the median odds ratios (MOR) and interval odds ratios (IOR). MEASUREMENTS AND MAIN RESULTS: Among 261,860 patients (123,702 valve procedures and 138,158 isolated CABG), the GLMM analysis demonstrated that the strongest predictor for intraoperative TEE use was the hospital where the surgery occurred (MOR for TEE of 2.57 in valve and 4.16 in isolated CABG). The TEE staffing variable reduced the previously unexplained across-hospital variability by 9% in valve and 21% in isolated CABG, and hospitals with anesthesiologist TEE staffing (versus mixed) were more likely to use TEE in both valve and CABG (MOR for TEE of 1.21 in valve and 1.84 in isolated CABG). CONCLUSION: Hospital practice was the strongest predictor for TEE use overall. In isolated CABG surgery, hospitals with anesthesiologist TEE staffing were a primary predictor for TEE use.

Coronary Endarterectomy: Analysis of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: Coronary endarterectomy (CE) is an uncommon and often unplanned technique used to approach difficult targets during coronary artery bypass grafting (CABG). We evaluated the outcomes of CABG with CE (CE-CABG) using The Society of Thoracic Surgeons Adult Cardiac Surgery Database. METHODS: All isolated, first-time, elective or urgent CABG cases from July 2011 to September 2019 in the Adult Cardiac Surgery Database were retrospectively reviewed. Because of a higher risk profile in the patients undergoing CE-CABG, we performed propensity score matching. Primary outcomes included operative mortality and postoperative myocardial infarction. For patients ≥65 years, long-term mortality and rehospitalization were evaluated using linked data from Centers for Medicare and Medicaid Services. RESULTS: Of the total 1 111 792 patients included, 32 164 (2.9%) had CE-CABG and 1 079 628 (97.1%) underwent CABG alone. The majority of CE-CABG involved a single-vessel endarterectomy (86.9%; n = 27 945); the left anterior descending was most common (40.9%; n = 13 161). Compared with propensity score-matched CABG, CE-CABG had increased operative mortality (3.2% vs 1.7%; P < .0001; odds ratio, 1.81; 95% CI, 1.63-2.01) and postoperative myocardial infarction (6.8% vs 3.9%; P < .0001; odds ratio, 1.80; 95% CI, 1.68-1.93). CE-CABG had higher risk of mortality in the first year and rehospitalization for myocardial infarction in the first 3 years but was comparable to CABG alone thereafter. Subgroup analysis showed no difference between CE-CABG of the left anterior descending compared with CE-CABG of other coronary arteries. CONCLUSIONS: This analysis demonstrates that CE-CABG has acceptable long-term outcomes and serves as a benchmark for what can be expected when this rare procedure is used.

Volume of frail patients predicts outcome in frail patients after cardiac surgery.

OBJECTIVE: Recent data from major noncardiac surgery suggest that outcomes in frail patients are better predicted by a hospital's volume of frail patients specifically, rather than overall surgical volume. We sought to evaluate this "frailty volume-frailty outcome relationship" in patients undergoing cardiac surgery. METHODS: We studied 72,818 frail patients undergoing coronary artery bypass grafting or valve replacement surgery from 2010 to 2014 using the Nationwide Readmissions Database. Frailty was defined using the Johns Hopkins Adjusted Clinical Groups frailty-defining diagnoses indicator. Multilevel logistic regression was used to assess the independent effect of frailty volume by quartile on mortality, surgical complications, failure to rescue, nonhome discharge, 30-day readmissions, length of stay, and hospital costs in frail patients. RESULTS: In comparing the highest volume quartiles with the lowest, both overall cardiac surgical volume and volume for frail patients were significantly associated with shorter length of stay and reduced costs. However, frailty volume was also independently associated with significantly reduced in-hospital mortality (odds ratio, 0.79; 95% confidence interval, 0.67-0.94; P = .006) and failure to rescue (odds ratio, 0.83; 95% confidence interval, 0.70-0.98; P = .03), whereas no such association was seen between overall volume and either mortality (odds ratio, 0.94; 95% confidence interval, 0.74-1.10; P = .43) or failure to rescue (odds ratio, 0.98; 95% confidence interval, 0.83-1.17; P = .85). Neither frailty volume nor overall volume showed any significant relationship with the rate of 30-day readmissions. CONCLUSIONS: In frail patients undergoing cardiac surgery, surgical volume of frail patients was a significant independent of predictor of in-hospital mortality and failure to rescue, whereas overall surgical volume was not. Thus, the "frailty volume-outcome relationship" superseded the traditional "volume-outcome relationship" in frail patients with cardiac disease.

Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas.

Importance: Despite the benefits of high-technology therapeutics, inequitable access to these technologies may generate disparities in care. Objective: To examine the association between zip code-level racial, ethnic, and socioeconomic composition and rates of transcatheter aortic valve replacement (TAVR) among Medicare patients living within large metropolitan areas with TAVR programs. Design, Setting, and Participants: This multicenter, nationwide cross-sectional analysis of Medicare claims data between January 1, 2012, and December 31, 2018, included beneficiaries of fee-for-service Medicare who were 66 years or older living in the 25 largest metropolitan core-based statistical areas. Exposure: Receipt of TAVR. Main Outcomes and Measures: The association between zip code-level racial, ethnic, and socioeconomic composition and rates of TAVR per 100 000 Medicare beneficiaries. Results: Within the studied metropolitan areas, there were 7590 individual zip codes. The mean (SD) age of Medicare beneficiaries within these areas was 71.4 (2.0) years, a mean (SD) of 47.6% (5.8%) of beneficiaries were men, and a mean (SD) of 4.0% (7.0%) were Asian, 11.1% (18.9%) were Black, 8.0% (12.9%) were Hispanic, and 73.8% (24.9%) were White. The mean number of TAVRs per 100 000 Medicare beneficiaries by zip code was 249 (IQR, 0-429). For each $1000 decrease in median household income, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.2% (95% CI, 0.1%-0.4%) lower (P = .002). For each 1% increase in the proportion of patients who were dually eligible for Medicaid services, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 2.1% (95% CI, 1.3%-2.9%) lower (P < .001). For each 1-unit increase in the Distressed Communities Index score, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.4% (95% CI, 0.2%-0.5%) lower (P < .001). Rates of TAVR were lower in zip codes with higher proportions of patients of Black race and Hispanic ethnicity, despite adjusting for socioeconomic markers, age, and clinical comorbidities. Conclusions and Relevance: Within major metropolitan areas in the US with TAVR programs, zip codes with higher proportions of Black and Hispanic patients and those with greater socioeconomic disadvantages had lower rates of TAVR, adjusting for age and clinical comorbidities. Whether this reflects a different burden of symptomatic aortic stenosis by race and socioeconomic status or disparities in use of TAVR requires further study.

Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018.

BACKGROUND: Despite the benefits of novel therapeutics, inequitable diffusion of new technologies may generate disparities. We examined the growth of transcatheter aortic valve replacement (TAVR) in the United States to understand the characteristics of hospitals that developed TAVR programs and the socioeconomic status of patients these hospitals served. METHODS: We identified fee-for-service Medicare beneficiaries aged 66 years or older who underwent TAVR between January 1, 2012, and December 31, 2018, and hospitals that developed TAVR programs (defined as performing ≥10 TAVRs over the study period). We used linear regression models to compare socioeconomic characteristics of patients treated at hospitals that did and did not establish TAVR programs and described the association between core-based statistical area level markers of socioeconomic status and TAVR rates. RESULTS: Between 2012 and 2018, 583 hospitals developed new TAVR programs, including 572 (98.1%) in metropolitan areas, and 293 (50.3%) in metropolitan areas with preexisting TAVR programs. Compared with hospitals that did not start TAVR programs, hospitals that did start TAVR programs treated fewer patients with dual eligibility for Medicaid (difference of -2.83% [95% CI, -3.78% to -1.89%], P≤0.01), higher median household incomes (difference $2447 [95% CI, $1348-$3547], P=0.03), and from areas with lower distressed communities index scores (difference -4.02 units [95% CI, -5.43 to -2.61], P≤0.01). After adjusting for the age, clinical comorbidities, race and ethnicity and socioeconomic status, areas with TAVR programs had higher rates of TAVR and TAVR rates per 100 000 Medicare beneficiaries were higher in core-based statistical areas with fewer dual eligible patients, higher median income, and lower distressed communities index scores. CONCLUSIONS: During the initial growth phase of TAVR programs in the United States, hospitals serving wealthier patients were more likely to start programs. This pattern of growth has led to inequities in the dispersion of TAVR, with lower rates in poorer communities.

Application of machine learning approaches to administrative claims data to predict clinical outcomes in medical and surgical patient populations.

OBJECTIVE: This study aimed to develop and validate a claims-based, machine learning algorithm to predict clinical outcomes across both medical and surgical patient populations. METHODS: This retrospective, observational cohort study, used a random 5% sample of 770,777 fee-for-service Medicare beneficiaries with an inpatient hospitalization between 2009-2011. The machine learning algorithms tested included: support vector machine, random forest, multilayer perceptron, extreme gradient boosted tree, and logistic regression. The extreme gradient boosted tree algorithm outperformed the alternatives and was the machine learning method used for the final risk model. Primary outcome was 30-day mortality. Secondary outcomes were: rehospitalization, and any of 23 adverse clinical events occurring within 30 days of the index admission date. RESULTS: The machine learning algorithm performance was evaluated by both the area under the receiver operating curve (AUROC) and Brier Score. The risk model demonstrated high performance for prediction of: 30-day mortality (AUROC = 0.88; Brier Score = 0.06), and 17 of the 23 adverse events (AUROC range: 0.80-0.86; Brier Score range: 0.01-0.05). The risk model demonstrated moderate performance for prediction of: rehospitalization within 30 days (AUROC = 0.73; Brier Score: = 0.07) and six of the 23 adverse events (AUROC range: 0.74-0.79; Brier Score range: 0.01-0.02). The machine learning risk model performed comparably on a second, independent validation dataset, confirming that the risk model was not overfit. CONCLUSIONS AND RELEVANCE: We have developed and validated a robust, claims-based, machine learning risk model that is applicable to both medical and surgical patient populations and demonstrates comparable predictive accuracy to existing risk models.

Association between Transesophageal Echocardiography and Clinical Outcomes after Coronary Artery Bypass Graft Surgery.

BACKGROUND: Coronary artery bypass graft (CABG) surgery is the most widely performed cardiac surgery in the United States. Transesophageal echocardiography (TEE) is frequently used in a variety of cardiac surgical procedures, but its clinical benefit in isolated CABG surgery is unclear, and guidelines remain indeterminate. The aim of this study was to compare clinical outcomes among patients undergoing isolated CABG surgery with versus without TEE in order to test the hypothesis that TEE would be associated with improved clinical outcomes after CABG surgery. METHODS: A matched retrospective cohort study was conducted among Medicare beneficiaries undergoing isolated CABG surgery with versus without intraoperative monitoring using TEE in the United States. The primary analysis was a near/far instrumental variable match that paired hospitals with similar characteristics and patient populations but with opposing probabilities for using TEE in CABG surgery. Outcomes included 30-day mortality, a composite outcome of stroke or 30-day mortality, length of hospitalization, and incidence of esophageal perforation. RESULTS: Of 114,871 patients undergoing isolated CABG surgery, 65,471 (57%) underwent TEE and 49,400 (43%) did not. Hospital-level instrumental variable matched analysis demonstrated that among the subset of 968 matched hospitals, TEE receipt was associated with lower 30-day mortality (3.7% vs 4.9%, P < .001), a lower incidence of the composite outcome of stroke or 30-day mortality (4.5% vs 5.6%, P < .001), no difference in length of hospitalization (10.32 vs 10.52 days, P = .26), and no difference in the incidence of esophageal perforation (0.01% vs 0.01%, P = .63). These results were replicated in surgeon-level and patient-level matched-pair instrumental variable analyses, and all analyses were robust to sensitivity analyses that tested for biases introduced by unmeasured confounding. CONCLUSIONS: The findings from this study suggest that TEE may offer a clinical benefit to cardiac surgical patients undergoing isolated CABG surgery.

Dynamic Volumetric Assessment of the Aortic Root: The Influence of Bicuspid Aortic Valve Competence.

BACKGROUND: Aortic root evaluation is conventionally based on 2-dimensional measurements at a single phase of the cardiac cycle. This work presents an image analysis method for assessing dynamic 3-dimensional changes in the aortic root of minimally calcified bicuspid aortic valves (BAVs) with and without moderate to severe aortic regurgitation. METHODS: The aortic root was segmented over the full cardiac cycle in 3-dimensional transesophageal echocardiographic images acquired from 19 patients with minimally calcified BAVs and from 16 patients with physiologically normal tricuspid aortic valves (TAVs). The size and dynamics of the aortic root were assessed using the following image-derived measurements: absolute mean root volume and mean area at the level of the ventriculoaortic junction, sinuses of Valsalva, and sinotubular junction, as well as normalized root volume change and normalized area change of the ventriculoaortic junction, sinuses of Valsalva, and sinotubular junction over the cardiac cycle. RESULTS: Normalized volume change over the cardiac cycle was significantly greater in BAV roots with moderate to severe regurgitation than in normal TAV roots and in BAV roots with no or mild regurgitation. Aortic root dynamics were most significantly different at the mid-level of the sinuses of Valsalva in BAVs with moderate to severe regurgitation than in competent TAVs and BAVs. CONCLUSIONS: Echocardiographic reconstruction of the aortic root demonstrates significant differences in dynamics of BAV roots with moderate to severe regurgitation relative to physiologically normal TAVs and competent BAVs. This finding may have implications for risk of future dilatation, dissection, or rupture, which warrant further investigation.

Transesophageal Echocardiography, Mortality, and Length of Hospitalization after Cardiac Valve Surgery.

BACKGROUND: Despite recommendations regarding the use of intraoperative transesophageal echocardiography (TEE), there is no randomized evidence to support its use in cardiac valve surgery. The purpose of this study was to compare the clinical outcomes of patients undergoing open cardiac valve repair or replacement surgery with and without transesophageal echocardiographic monitoring. The hypothesis was that transesophageal echocardiographic monitoring would be associated with lower 30-day mortality and shorter length of hospitalization. METHODS: In this observational retrospective cohort study, Medicare claims were used to test the association between perioperative TEE and 30-day all-cause mortality and length of hospitalization among patients undergoing open cardiac valve repair or replacement surgery between January 1, 2010, and October 1, 2015. Baseline characteristics were defined by inpatient and outpatient claims. Medicare death records were used to ascertain 30-day mortality. Statistical analyses included regression models and propensity score matching. RESULTS: A total of 219,238 patients underwent open cardiac valve surgery, of whom 85% underwent TEE. Patients who underwent TEE were significantly older and had greater comorbidities. After adjusting for patient demographics, clinical comorbidities, surgical characteristics, and hospital factors, including annual surgical volume, the TEE group had a lower adjusted odds of 30-day mortality (odds ratio, 0.77; 95% CI, 0.73 to 0.82; P < .001), with no difference in length of hospitalization (<0.01%; 95% CI, -0.61% to 0.62%; P = .99). Results were similar across all analyses, including a propensity score-matched cohort. CONCLUSIONS: Transesophageal echocardiographic monitoring in cardiac valve repair or replacement surgery was associated with lower 30-day risk-adjusted mortality, without a significant increase in length of hospitalization. These findings support the use of TEE as routine practice in open cardiac valve repair or replacement surgery.

Thoracic Endovascular Aneurysm Repair Trends and Outcomes in Over 27,000 Medicare Patients for Descending Thoracic Aneurysms.

BACKGROUND: Since United States Food and Drug Administration approval in 2005, thoracic endovascular aneurysm repair (TEVAR) has replaced open surgery to become the preferred treatment for descending thoracic aneurysms (DTAs). This study investigated TEVAR trends during the previous 15 years regarding patient and hospital characteristics and their effect on survival. METHODS: Between 2000 and 2014, 27,079 Medicare patients underwent TEVAR for DTA. We analyzed TEVAR trends during this period and stratified hospitals based on the number of cases completed during the previous 5 years: low (0-19 cases), medium (20-99 cases), and high (≥100 cases) volume. Trends over time were calculated using Poisson regression to determine the average annual percentage changes (aAPC). Survival was calculated using a multivariate Cox regression and adjusted logistic regression with a restricted cubic spline. RESULTS: TEVAR volume significantly increased from 81 cases in 2000 to 3478 cases in 2014 (aAPC, 16.2%; P < .001). During the study period, the proportion of cases performed at medium-volume centers increased (aAPC, 5.2%; P < .001). Thirty-day mortality after TEVAR increased in the recent period (2013-2014) to 8.8% as compared with 6.6% in the early years (2004-2006) of TEVAR (P < .001), and a significant contribution was due to increased patient comorbidity score (aAPC, 1.6%; P < .001). Lastly, TEVAR center volume was significantly associated with 30-day survival when fewer than 33 cases were done in the prior 5 years. CONCLUSIONS: From 2000 to 2014, TEVAR volume accelerated, and centers are gaining more experience. TEVAR patients have become more acute, and mortality has increased over this period. Patient selection and procedural experience are critical to improving outcomes.

Causes, Risk Factors, and Costs of 30-Day Readmissions After Mitral Valve Repair and Replacement.

BACKGROUND: Postsurgical readmissions are an increasingly scrutinized marker of health care quality. We sought to estimate the risk factors and costs associated with readmissions after mitral valve (MV) surgery in a large, nationally representative cohort. METHODS: Adult patients undergoing MV repair or replacement were queried from the National Readmissions Database from 2010 to 2014. Data were collected on the prevalence and indications for readmission within 30 days as well as the hospital-, procedure, and patient-level risk factors as determined by multivariable logistic regression. RESULTS: Among 76,342 patients undergoing MV surgery, the rate of 30-day readmission was 17.0%. Those undergoing replacement procedures had significantly higher readmission rates (20.7% vs 13.1%; P < .001) compared with repair. Significant independent predictors of readmission after both MV repair and replacement included length of stay ≥8 days, chronic lung disease, chronic renal disease, and low hospital procedural volume for MV surgery. Readmissions to nonindex hospitals accounted for 26.6% of all readmissions. The most common indications for readmission were heart failure (21.4%), arrhythmia (17.0%) and respiratory diagnoses (15.0%), and infections (10.2%). The mean cost per readmission was $15,397, and among readmitted patients, the cost of readmission accounted for 17.8% of the total cost of the episode of care. CONCLUSIONS: Nearly 1 in 5 patients undergoing MV surgery are readmitted within 30 days. Treatment at a low-volume center was strongly associated with readmission, and much of the readmission burden falls on nonindex hospitals. Further characterization of readmissions may improve the quality of care associated with MV surgery.

Geographically Derived Socioeconomic Factors to Improve Risk Prediction in Patients Having Aortic Valve Replacement.

Socioeconomic status (SES) has been associated with adverse outcomes after cardiac surgery, but is not included in commonly applied risk adjustment models. This study evaluates whether inclusion of SES improves aortic valve replacement (AVR) risk prediction models, as this is the most common elective operation performed at our institution during the study period. All patients who underwent AVR at a single institution from 2005 to 2015 were evaluated. SES measures included unemployment, poverty, household income, home value, educational attainment, housing density, and a validated SES index score. The risk scores for mortality, complications, and increased length of stay were generated using models published by the Society for Thoracic Surgeons. Univariate models were fitted for each SES covariate and multivariable models for mortality, any complication, and prolonged length of stay (PLOS). A total of 1,386 patients underwent AVR with a 2.7% mortality, 15.1% complication rate, and 9.7% PLOS. In univariate models, higher education was associated with decreased mortality (odds ratio [OR] 0.96, p = 0.04) and complications (OR 0.97, p <0.01). Poverty was associated with increased length of stay (OR 1.02, p = 0.02). In the multivariable models, the inclusion of SES covariates increased the area under the curve for mortality (0.735 to 0.750, p = 0.14), for any complications (0.663 to 0.680, p <0.01), and for PLOS (0.749 to 0.751, p = 0.12). The inclusion of census-tract-level socioeconomic factors into the the Society of Thoracic Surgeons risk predication models is new and shows potential to improve risk prediction for outcomes after cardiac surgery. With the possibility of reimbursement and institutional ranking based on these outcomes, this study represents an improvement in risk prediction model.

Stroke After Transcatheter Aortic Valve Replacement: Incidence, Definitions, Etiologies and Management Options.

Neurologic complications after transcatheter aortic valve replacement are devastating. The etiologies of stroke in this setting are best addressed in an integrated fashion during each phase of the perioperative pathway. The conduct of this triphasic approach will continue to be refined to reduce the stroke risks even further, given the major focus on aspects such as embolic protection devices and valve thrombosis. This neurologic focus in transcatheter aortic valve replacement has transformed the investigational approach to neurologic events in cardiovascular clinical trials, resulting in novel guidelines for the diagnosis and assessment of neurologic injury after cardiovascular interventions.

Long-term outcome of surgical cryoablation for refractory ventricular tachycardia in patients with non-ischemic cardiomyopathy.

Aims: Limited data exist on the long-term outcome of patients (pts) with non-ischemic cardiomyopathy (NICM) and ventricular tachycardia (VT) refractory to conventional therapies undergoing surgical ablation (SA). We aimed to investigate the long-term survival and VT recurrence in NICM pts with VT refractory to radiofrequency catheter ablation (RFCA) who underwent SA. Methods and results: Consecutive pts with NICM and VT refractory to RFCA who underwent SA were included. VT substrate was characterized in the electrophysiology lab and targeted by RFCA. During SA, previous RFCA lesions/scars were identified and targeted with cryoablation (CA; 3 min/lesion; target -150 °C). Follow-up comprised office visits, ICD interrogations and the social security death index. Twenty consecutive patients with NICM who underwent SA (age 53 ± 16 years, 18 males, LVEF 41 ± 20%; dilated CM = 9, arrhythmogenic right ventricular CM = 3, hypertrophic CM = 2, valvular CM = 4, and mixed CM = 2) were studied. Percutaneous mapping/ablation in the electrophysiology lab was performed in 18 and 2 pts had primary SA. During surgery, 4.9 ± 4.0 CA lesions/pt were delivered to the endocardium (2) and epicardium (11) or both (7). VT-free survival was 72.5% at 1 year and over 43 ± 31 months (mos) (range 1-83mos), there was only one arrhythmia-related death. There was a significant reduction in ICD shocks in the 3-mos preceding SA vs. the entire follow-up period (6.6 ± 4.9 vs. 2.3 ± 4.3 shocks/pt, P = 0.001). Conclusion: In select pts with NICM and VT refractory to RFCA, SA guided by pre-operative electrophysiological mapping and ablation may be a therapeutic option.

Outcomes, readmissions, and costs in transfemoral and alterative access transcatheter aortic valve replacement in the US Medicare population.

OBJECTIVE: To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). METHODS: All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. RESULTS: TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). CONCLUSIONS: For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.