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Background: The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear., Methods: From January 2013 to June 2018, 234 556 patients underwent isolated SAVR (n = 144 177) or SAVR with coronary artery bypass grafting (CABG) (n = 90 379) within the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The association between annualized SAVR volume (group 1 [1-25 SAVRs], group 2 [26-50 SAVRs], group 3 [51-100 SAVRs], and group 4 [>100 SAVRs]) and operative mortality and composite major morbidity or mortality was assessed. Random effects models were used to evaluate whether historical (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes., Results: The annualized median number of SAVRs per site was 35 (interquartile range, 22-59; isolated aortic valve replacement [AVR], 20; AVR with CABG, 13). Among isolated SAVR cases, the mean operative mortality and composite morbidity or mortality were 1.5% and 9.7%, respectively, at the highest-volume sites (group 4), with significantly higher rates among progressively lower-volume groups (P trend < .001). After adjustment, lower-volume centers had increased odds of operative mortality (group 1 vs group 4 [reference]: adjusted odds ratio [AOR] for SAVR, 2.24 [95% CI, 1.91-2.64]; AOR for SAVR with CABG, 1.96 [95% CI, 1.67-2.30]) and major morbidity or mortality (AOR for SAVR, 1.53 [95% CI, 1.39-1.69]; AOR for SAVR with CABG, 1.46 [95% CI, 1.32-1.61]) compared with the highest-volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category, and prior outcomes explained a greater proportion of hospital operative outcomes than did prior volume., Conclusions: Operative outcomes after SAVR with or without CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive of future outcomes than is prior volume. Given the excellent outcomes observed at many lower-volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Refractory right ventricular failure at the time of left ventricular assist device implantation requires treatment with supplemental mechanical circulatory support. However, the optimal strategy for support remains unknown., Methods: All patients undergoing first-time durable left ventricular assist device implantation with a contemporary device were selected from The Society of Thoracic Surgeons National Database (2011 to 2019). Patients requiring right ventricular assist device (RVAD) or venoarterial extracorporeal membrane oxygenation (VA-ECMO) were included in the analysis. Patients were stratified by RVAD or VA-ECMO and by timing of placement (intraoperative vs postoperative)., Results: In all, 18 423 left ventricular assist device implants were identified, of which 940 (5.1%) required RVAD (n = 750) or VA-ECMO (n = 190) support. Patients receiving an RVAD more frequently had preoperative inotrope requirement (76% vs 62%, P < .01) and severe tricuspid regurgitation (20% vs 13%, P < .01). The RVAD patients had lower rates of postoperative renal failure (40% vs 51%, P = .02) and limb ischemia (4% vs 13%, P < .01), as well as significantly less operative mortality (41% vs 54%, P < .01). After risk adjustment with propensity score analysis, support with VA-ECMO was associated with a higher risk of mortality (risk ratio 1.46; 95% confidence interval, 1.21 to 1.77; P < .01) compared with patients receiving an RVAD. Importantly, institution of right ventricular support postoperatively was associated with higher mortality (1.43, P < .01) compared with intraoperative initiation., Conclusions: Patients with severe right ventricular failure in the setting of durable left ventricular assist device implantation may benefit from the use of RVAD over VA-ECMO. Regardless of the type of support, initiation at the index operation was associated with improved outcomes., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the applicability of pivotal transcatheter aortic valve replacement (TAVR) trials to the real-world population of Medicare patients undergoing TAVR., Background: It is unclear whether randomized controlled trial results of novel cardiovascular devices apply to patients encountered in clinical practice., Methods: Characteristics of patients enrolled in the U.S. CoreValve pivotal trials were compared with those of the population of Medicare beneficiaries who underwent TAVR in U.S. clinical practice between November 2, 2011, and December 31, 2017. Inverse probability weighting was used to reweight the trial cohort on the basis of Medicare patient characteristics, and a "real-world" treatment effect was estimated., Results: A total of 2,026 patients underwent TAVR in the U.S. CoreValve pivotal trials, and 135,112 patients underwent TAVR in the Medicare cohort. Trial patients were mostly similar to real-world patients at baseline, though trial patients were more likely to have hypertension (50% vs 39%) and coagulopathy (25% vs 17%), whereas real-world patients were more likely to have congestive heart failure (75% vs 68%) and frailty. The estimated real-world treatment effect of TAVR was an 11.4% absolute reduction in death or stroke (95% CI: 7.50%-14.92%) and an 8.7% absolute reduction in death (95% CI: 5.20%-12.32%) at 1 year with TAVR compared with conventional therapy (surgical aortic valve replacement for intermediate- and high-risk patients and medical therapy for extreme-risk patients)., Conclusions: The trial and real-world populations were mostly similar, with some notable differences. Nevertheless, the extrapolated real-world treatment effect was at least as high as the observed trial treatment effect, suggesting that the absolute benefit of TAVR in clinical trials is similar to the benefit of TAVR in the U.S. real-world setting., Competing Interests: Funding Support and Author Disclosures The study was funded by National Heart, Lung, and Blood Institute grant 1R01HL136708 (to Dr Yeh). Dr Butala is funded by the John S. LaDue Memorial Fellowship at Harvard Medical School; and has received consulting fees from and has ownership interest in HiLabs, outside the submitted work. Dr Secemsky has received grants from AstraZeneca, BD Bard, Boston Scientific, Cook Medical, Cardiovascular Systems, Inc., Medtronic, Philips, and the University of California, San Francisco; is a consultant for Cardiovascular Systems, Inc., Medtronic, and Philips; and is on the Speakers Bureaus of BD Bard, Cook Medical, and Medtronic. Dr Strom is funded by the National Heart, Lung, and Blood Institute (grant 1K23HL144907). Dr Brennan holds an Innovation in Regulatory Science Award from Burroughs Welcome Fund (1014158); is funded by the U.S. Food and Drug Administration (grant 1U01FD004591-01); and is a consultant for Edwards Lifesciences and Atricure. Dr Elmariah is funded by the American Heart Association (grant 19TPA34910170) and the U.S. Department of Defense (grant W81XWH1810080); has received grant support from Edwards Lifesciences and Svelte Medical; and has received consulting fees from AstraZeneca and Medtronic, outside the submitted work. Dr Yeh has received additional grant support from Abiomed, AstraZeneca, and Boston Scientific; and has received consulting fees from Abbott, Boston Scientific, Medtronic, and Teleflex, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patient prosthesis mismatch is associated with significant long-term morbidity and mortality after aortic valve replacement, but the role and outcomes of annular enlargement (AE) remain poorly defined. We hypothesized that increasing rates of AE may lead to improved outcomes for patients at risk for severe patient prosthesis mismatch., Methods: Patients over age 65 years undergoing surgical aortic valve replacement with or without coronary artery bypass grafting from 2008-2016 in The Society of Thoracic Surgeons Adult Cardiac Surgery Database with matching Centers for Medicare & Medicaid Services data were included (n=189,268). Univariate, multivariate, and time-to-event analysis was used to evaluate the association between AE and early and late outcomes. Patients were stratified by projected degree of patient prosthesis mismatch based on calculated effective orifice area index., Results: A total of 5412 (2.9%) patients underwent AE. The Society of Thoracic Surgeons Adult Cardiac Surgery Database-predicted mortality was similar between AE and non-AE groups (2.97% vs 2.99%, P = .052). Patients undergoing AE had higher risk-adjusted rates of 30-day complications and death (5.4% vs 3.4%, P < .0001), but no differences in long-term rates of stroke, heart failure re-hospitalization,s or aortic valve reoperation. Survival analysis demonstrated a higher risk of mortality with AE during the first 3 years, after which the survival curves cross, favoring AE., Conclusions: These data suggest that annular enlargement during surgical aortic valve replacement is associated with increased short-term risk in a Medicare population. Survival curves crossed after 3 years, which may portend a benefit in select patients. However, annular enlargement is still only performed in the minority of patients who are at risk for patient prosthesis mismatch., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies., Background: Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints., Methods: Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated., Results: Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16)., Conclusions: Compared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database., Background: TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important., Methods: The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure., Results: A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality <4%: O/E 5.5; 4% to 8%: O/E 1.7; >8%: O/E 1.2)., Conclusions: SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients undergoing post infarction ventricular septal defect repair are at high risk for early morbidity and mortality, but little is known about subsequent clinical events. This study uses short-term clinical data from The Society of Thoracic Surgeons National Database linked with Medicare data to examine longer term outcomes in these patients., Methods: This was a retrospective review of The Society of Thoracic Surgeons National Database to link with Medicare data all adults (≥65 years) who underwent ventricular septal defect repair after a myocardial infarction between 2008 and 2012. The primary outcome was 1-year mortality. Risk factors for 1-year survival were modeled using a multivariable Cox regression., Results: Five hundred thirty-seven patients were identified using The Society of Thoracic Surgeons database and Medicare linkage. Median age was 74 years, and 277 patients (52%) were men. One hundred ninety-two patients (36%) were supported preoperatively with an intraaortic balloon pump. Surgical status was emergent or salvage in 138 (26%), and 158 patients (29%) died within 30 days and 207 (39%) within 1 year. Among patients who survived to hospital discharge, 44% were discharged to a facility and 172 (32%) experienced at least 1 all-cause readmission within 1 year. Unadjusted 1-year mortality rates were 13% for elective patients and 69% for emergency status (P < .01). On multivariable analysis emergency/salvage status, older age, and concomitant coronary artery bypass grafting were independently associated with worse 1-year survival., Conclusions: These data suggest the greatest mortality risk in this patient population occurs in the first 30 days. Emergency or salvage status strongly predicts 1-year mortality. Optimizing physiologic derangements before operative repair may be considered when possible in this subgroup of patients., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Stroke is a serious complication after transcatheter aortic valve replacement (TAVR), yet predictive models are not available. A new risk model for in-hospital stroke after TAVR was developed and used to estimate site-specific performance., Methods: We included 97,600 TAVR procedures from 521 sites in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from July 2014 to June 2017. Association between baseline covariates and in-hospital stroke was estimated by logistic regression. Discrimination was evaluated by C-statistic. Calibration was tested internally via cross-validation. Hierarchical modeling was used to estimate risk-adjusted site-specific performance., Results: Median age was 82 years, 44,926 (46.0%) were women, and 1,839 (1.9%) had in-hospital stroke. Covariates associated with stroke (odds ratio) included transapical access (1.44), access excluding transapical and transfemoral (1.77), prior stroke (1.57), prior transient ischemic attack (1.50), preprocedural shock, inotropes or mechanical assist device (1.48), smoking (1.28), porcelain aorta (1.23), peripheral arterial disease (1.21), age per 5 years (1.11), glomerular filtration rate per 5 mL/min (0.97), body surface area per m 2 (0.55 male; 0.43 female), and prior aortic valve (0.78) and nonaortic valvular (0.42) procedures. The C-statistic was 0.622. Calibration curves demonstrated agreement between observed and expected stroke rates. Hierarchical modeling showed 10 (1.9%) centers with significantly higher odds ratios for in-hospital stroke than their peers., Conclusions: A risk model for in-hospital stroke after TAVR was developed from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and used to estimate site-specific stroke performance. This model can serve as a valuable resource for quality improvement, clinical decision making, and patient counseling., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: National outcomes of robotic mitral valve repair (rMVr) compared with sternotomy (sMVr) in older patients are currently unknown., Methods: From 2011 to 2014, all patients aged 65 years and older undergoing MVr in The Society of Thoracic Surgeons Adult Cardiac Surgery Database linked to Medicare claims data were identified. Patients who underwent rMVr were propensity matched to patients who underwent sMVr. Standard differences and falsification outcome of baseline characteristics were tested to ensure a balanced match. Cox models were used to calculate 3-year mortality, heart failure readmission, and mitral valve reintervention, adjusting for competing risks where appropriate., Results: After matching, 503 rMVr patients from 65 centers and 503 sMVr from 251 centers were included. There were no significant differences in comorbidities or falsification outcome. Cardiopulmonary bypass and cross-clamp times were longer with rMVr versus sMVr at 125 versus 102 minutes (p < 0.0001) and 85 versus 75 minutes (p < 0.0001), respectively. The rMVr patients had shorter intensive care unit (27 vs 47 hours, p < 0.0001) and hospital stay (5 vs 6 days, p < 0.0001), less frequent transfusion (21% vs 35%, p < 0.0001), and less atrial fibrillation (28% vs 40%, p < 0.0001). Three-year mortality (hazard ratio, 1.21; 95% confidence interval, 0.68 to 2.16; p = 0.52), heart failure readmission (hazard ratio, 1.42; 95% confidence interval, 0.80 to 2.52, p = 0.10), and mitral valve reintervention (hazard ratio, 0.42; 95% confidence interval, 0.15 to 1.18; p = 0.22) did not differ between the groups., Conclusions: The rMVr procedure was associated with less atrial fibrillation, less frequent transfusion requirement, and shorter intensive care unit and hospital stay, without a significant difference in 3-year mortality, heart failure readmission, or mitral valve reintervention. In older patients, rMVr confers short-term advantages without a detriment to midterm outcomes., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The goal of this study was to determine the relationship of prosthesis-patient mismatch (PPM) with long-term survival and to assess whether growing concern about PPM has resulted in a decreased incidence over time., Methods: Using The Society of Thoracic Surgeons Adult Cardiac Surgery Database, we identified 59,779 patients ≥65 years old who underwent isolated surgical aortic valve replacement (AVR) between 2004 and 2014. The degree of PPM was calculated using literature-derived effective orifice areas for commonly used valves. Outcomes to 10 years were stratified by degree of PPM., Results: The distribution of PPM was as follows: 35%, none (n = 21,053); 54%, moderate (n = 32,243); and 11%, severe (n = 6,483). Compared with patients with no PPM, patients with moderate or severe PPM had a significantly increased risk of readmission for heart failure (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.09 to 1.21; HR, 1.37; 95% CI, 1.26 to 1.48) and redo AVR (HR, 1.41; 95% CI, 1.13 to 1.77; HR, 2.68; 95% CI, 2.01 to 3.56) for moderate or severe PPM, respectively. Survival was significantly worse for any degree of PPM (moderate to none: HR, 1.08; 95% CI, 1.05 to 1.12; severe to none: HR, 1.32; 95% CI, 1.25 to 1.39), with 10-year adjusted survival rates of 46%, 43%, and 35% for none, moderate, and severe, respectively (p < 0.001). The incidence of severe PPM decreased by 55% over the study period, from 13.8% in 2004 to 6.2% in 2014., Conclusions: Any degree of PPM significantly decreased long-term survival and increased readmission rates for both heart failure and reoperation for AVR. Temporal trends show a significant decrease in the incidence of PPM over the past decade., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Surgical ablation (SA) for atrial fibrillation (AF) concomitant to mitral valve repair/replacement (MVRR) improves longitudinal sinus rhythm. However, the risk of adding SA remains a clinical question. This study examined whether the addition of contemporary SA for AF has an impact on operative outcomes., Methods: The study cohort included 88,765 MVRR patients with or without SA, coronary artery bypass grafting (CABG), septal defect, and tricuspid repair in The Society of Thoracic Surgeons Database between 2011 and 2014. Group 1 did not have AF (No-AF) and did not receive SA (No-SA); group 2 had No-AF immediately preoperatively but received SA; group 3 had AF but No-SA; and group 4 had AF with SA. Groups 3 and 4 were stratified into paroxysmal versus nonparoxysmal AF. With the use of logistic regression, with group 1 as reference, risk-adjusted odds ratios (OR) for mortality were compared for SA performance, AF type, and SA technique., Results: Group 3 had higher age, New York Heart Association class, redo operations, and unadjusted mortality than group 4. Relative to group 1, group 3 had an OR for mortality of 1.15 (95% confidence interval: 1.04 to 1.27, p < 0.01). OR increments were similar for paroxysmal and nonparoxysmal AF. In group 4, concomitant SA was independently associated with lower AF-related relative risk (OR 1.08), to a level that was not different from group 1 (p = 0.13). Observed treatment effects were equivalent for paroxysmal and nonparoxysmal AF and across all levels of baseline risk., Conclusions: For patients with AF at the time of mitral operation, the performance of SA seems associated with a lower risk-adjusted operative mortality compared with patients who do not undergo ablation., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty., Background: Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients., Methods: Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test)., Results: Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups., Conclusions: A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Off-pump coronary artery bypass grafting (OPCAB) has been shown to be an effective strategy for surgical revascularization. The purpose of this study was to define the incidence of intraoperative conversion from OPCAB to on-pump coronary artery bypass grafting (ONCAB) and report outcomes based on the reason for conversion., Methods: Starting in July 2007, the Society of Thoracic Surgeons database captured patients that were planned OPCAB but then were converted to ONCAB. A total of 196,576 patients undergoing planned OPCAB within the Society of Thoracic Surgeons National Database from July 2007 to June 2014 were evaluated. Patients were grouped according to their intraoperative conversion to cardiopulmonary bypass: (1) planned conversion, (2) unplanned conversion for visualization, (3) unplanned conversion for hemodynamic instability, and (4) no conversion (OPCAB). Multiple logistic regression analysis was used to determine risk factors for conversion., Results: The overall rate of conversion from OPCAB to ONCAB was 5.5%, with 49.6% of the conversions being planned. When compared with those not undergoing conversion (OPCAB, 30-day mortality observed to expected ratio [O/E], 0.8), those undergoing conversion to ONCAB experienced greater 30-day mortality regardless of etiology of conversion (planned conversion O/E, 1.4; unplanned conversion for visualization O/E, 1.6; and unplanned conversion for hemodynamic instability O/E, 2.7). Similar O/E ratios were observed for renal failure and prolonged ventilation following conversion. Logistic regression analysis showed advanced age, ejection fraction less than 35%, preoperative intraaortic balloon pump placement, increasing number of diseased coronary arteries, preoperative heart failure within 2 weeks, and urgent procedural status were all independent predictors for conversion to ONCAB (p ≤ 0.01)., Conclusions: Intraoperative conversion from OPCAB to ONCAB remains a morbid event with a risk of mortality much higher than expected. Surgeons should consider elective ONCAB in those with a high risk for conversion during OPCAB., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The art and science of outcomes analysis, quality improvement, and patient safety continue to evolve, and cardiothoracic surgery leads many of these advances. The Society of Thoracic Surgeons (STS) National Database is one of the principal reasons for this leadership role, as it provides a platform for the generation of knowledge in all of these domains. Understanding these topics is a professional responsibility of all cardiothoracic surgeons. Therefore, beginning in January 2016, The Annals of Thoracic Surgery began publishing a monthly series of scholarly articles on outcomes analysis, quality improvement, and patient safety. This article provides a summary of the status of the STS National Database as of October 2016 and summarizes the articles about the STS National Database that appeared in The Annals of Thoracic Surgery 2016 series, "Outcomes Analysis, Quality Improvement, and Patient Safety.", (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Anticoagulation with warfarin following bioprosthetic mitral valve replacement (BMVR) is recommended by multiple practice guidelines. We assessed practice variability and patient characteristics associated with warfarin prescription following BMVR., Methods: We analyzed 7,637 patients in the Society of Thoracic Surgeons Database (January 1, 2008 to June 30, 2011) who were discharged following isolated primary nonemergent BMVR. Patients requiring preoperative warfarin, those with preoperative atrial fibrillation, or those with a contraindication to warfarin were excluded. The association between patient, hospital, and surgeon characteristics and warfarin prescription were evaluated., Results: Fifty-eight percent of this cohort (median age, 66 years; female sex, 58.7%) was prescribed warfarin. Patients receiving warfarin were older (67 vs 65 years; P < .0001), were less likely to have had preoperative stroke (9.3% vs 12.1%; P < .001), CHF (51.4% vs 54.1%; P < .02), or dialysis (4.9% vs 9.0%; P < 0.001), and had a longer postoperative length of stay (8.0 vs 7.0 days; P < 0.01). Warfarin was prescribed less often for patients with postoperative GI events (44.4% vs 55.6%; P < .001) but more often for patients with postoperative myocardial infarction (75.8% vs 24.2%; P < .001) or new atrial fibrillation (68% vs 32%; P < .001) and those requiring blood transfusions intraoperatively (55.7% vs 44.3%; P < .001) or postoperatively (57% vs 43%; P < .03). Similar rates of warfarin prescription were observed in patients requiring reoperation for bleeding (54.9% vs 45.1%; P = .20) and those with postoperative stroke (53.6 % vs 46.4 %; P = .30). After adjusting for patient characteristics, significant surgeon and hospital variation in warfarin prescription at hospitals was observed., Conclusions: Although patient characteristics and postoperative events may be associated with the prescription of warfarin following BMVR, substantial surgeon and hospital variability remains. This variability largely ignores the established practice guidelines and warrants further study to define the optimal anticoagulation strategy in patients undergoing BMVR., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with substantial mortality. We evaluated outcomes of patients in The Society of Thoracic Surgeons Adult Cardiac Surgery Database who underwent coronary artery bypass graft surgery (CABG) in the setting of AMI-CS., Methods: All patients with AMI-CS who underwent nonelective CABG or CABG with ventricular assist device implantation within 7 days after myocardial infarction were enrolled. The primary analysis sample consisted of patients who underwent surgery between June 2011 and December 2013. Baseline characteristics, operative findings, outcomes, and the utilization of mechanical circulatory support (MCS) were assessed in detail in this population. We also evaluated trends in unadjusted mortality for all patients undergoing CABG or CABG with ventricular assist device for AMI-CS from January 2005 to December 2013., Results: A total of 5,496 patients met study criteria, comprising 1.5% of all patients undergoing CABG during the study period. Overall operative mortality was 18.7%, decreasing from 19.3% in 2005 to 18.1% in 2013 (p < 0.001). Use of MCS increased from 5.8% in 2011 to 8.8% in 2013 (p = 0.008). Patients receiving MCS had a high proportion of cardiovascular risk factors or high clinical acuity. Patients requiring preoperative and patients requiring intraoperative or postoperative MCS had operative mortality of 37.2% and 58.4%, respectively. Patients undergoing CABG as a salvage procedure had an operative mortality of 53.3%, and a high incidence of reoperation (21.8%), postoperative respiratory failure requiring prolonged ventilation (59.7%), and renal failure (18.5%)., Conclusions: Most patients undergoing CABG for AMI-CS have a sizeable but not prohibitive risk. Patients who require MCS and those undergoing operation as a salvage procedure reflect higher risk populations., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD., Methods: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, 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 one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) 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 the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record., Conclusions: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: In this study, we sought to determine the clinical outcomes after transcatheter aortic valve replacement (TAVR) among patients with chronic lung disease (CLD) and to evaluate the safety of transaortic versus transapical alternate access approaches in patients with varying severities of CLD., Methods: Clinical records for patients undergoing TAVR from 2011 to 2014 in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Medicare hospital claims (n = 11,656). Clinical outcomes were evaluated across strata of CLD severity, and the risk-adjusted association between access route and post-TAVR mortality was determined among patients with severe CLD., Results: In this cohort (median age, 84 years; 51.7% female), moderate to severe CLD was present in 27.7% (14.3%, moderate; 13.4%, severe). Compared with patients with no or mild CLD, patients with severe CLD had a higher rate of post-TAVR mortality to 1-year (32.3% versus 21.0%; adjusted hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.31 to 1.66), as did those with moderate CLD (25.5%; adjusted HR, 1.16; 95% CI, 1.03 to 1.30). The adjusted rate of mortality was similar for transapical versus transaortic approaches to 1 year (adjusted HR, 1.17; 95% CI, 0.83 to 1.65)., Conclusions: Moderate or severe CLD is associated with an increased risk of death to 1-year after TAVR, and among patients with severe CLD, the risk of death appears to be similar with either transapical or transaortic alternate-access approaches. Further study is necessary to understand strategies to mitigate risk associated with CLD and the long-term implications of these findings., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Accurate risk assessment in patients presenting for aortic valve replacement (AVR) after prior coronary artery bypass grafting (CABG) is essential for appropriate selection of surgical versus percutaneous therapy., Methods: We included 6,534 patients in The Society for Thoracic Surgeons (STS) Adult Cardiac Surgery Database (October 2009 through December 2013) who underwent elective, isolated reoperative AVR for aortic stenosis after prior CABG. Case-specific PROM was calculated and observed-to-expected ratios were inspected across the spectrum of risk. A cohort-specific recalibration equation was derived using logistic regression: = expit(-0.6453+0.6147*logit(PROM) -0.0709*logit(PROM)(ˆ)2), where PROM is the predicted risk of mortality. The proportion of patients reclassified as low (PROM < 4%), intermediate (4% to < 8%), high (8% to < 12%), and very high risk (≥ 12%) was calculated using the recalibration equation. The performance of the cohort-specific recalibration equation was then compared with the generic recalibration for quarterly STS reports., Results: The STS online risk calculator overestimates risk for low, intermediate, and high risk categories. Using the recalibrated risk equation, a substantial proportion of patients were reclassified as the following: 25.5% from intermediate to low risk; 39.7% from high to intermediate risk; and 41.5% from very high to high risk. Comparison of the cohort-specific recalibration equation to the generic quarterly STS recalibration demonstrated very similar results., Conclusions: In patients presenting for AVR after prior CABG, the STS online risk calculator overestimates risk for all but the highest risk patients. Using a cohort-specific recalibration equation, a substantial proportion of patients would be downgraded to lower risk categories. The cohort-specific recalibration correlates well with the existing generic quarterly STS recalibration. The findings of this study support recommendations for periodic recalibration of the online risk calculator in order to facilitate clinical decision making in real time., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The Society of Thoracic Surgeons (STS) National Database is the foundation for most of the Society's quality, research, and patient safety activities. Beginning in January 2016 and repeating each year, The Annals of Thoracic Surgery will publish a monthly Database series of scholarly articles on outcomes analysis, quality improvement, and patient safety. Six articles will be directly derived from the STS National Database and will be published every other month: three articles on outcomes and quality (one each from the STS Adult Cardiac Surgery Database, the STS Congenital Heart Surgery Database, and the STS General Thoracic Surgery Database), and three articles on research (one from each of these three specialty databases). These six articles will alternate with five additional articles on topics related to patient safety. The final article, to be published in December, will provide a summary of the prior 11 manuscripts. This series will allow STS and its Workforces on National Databases, Research Development, and Patient Safety to convey timely information aimed at improving the quality and safety of cardiothoracic surgery., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States., Methods: Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored., Results: Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012)., Conclusions: Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Risk-adjusted mortality (RAM) models are increasingly used to evaluate hospital performance, but the validity of the RAM method has been questioned. Providers are concerned that these methods might not adequately account for the highest levels of risk and that treating high-risk cases will have a negative impact on RAM rankings., Methods: Using cases of isolated coronary artery bypass grafting (CABG) performed at 1002 sites in the United States participating in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database from 2008 to 2010 (N = 494,955), the STS CABG RAM model performance in high-risk patients was assessed. The ratios of observed to expected (O/E) perioperative mortality were compared among groups of hospitals with varying expected risks. Finally, RAM rates during the overall study period for each site were compared with its performance in a simulated "nightmare year" in which the site's highest risk cases over a 3-year period were concentrated into a 1-year period of exceptional risk., Results: The average predicted mortality for center risk groups ranged from 1.46% for the lowest risk quintile to 2.87% for the highest. The O/E ratios for center risk quintiles 1 to 5 during the overall period were 1.01 (95% confidence interval, 0.96% to 1.06%), 1.00 (0.95% to 1.04%), 0.98 (0.94% to 1.03%), 0.97 (0.93% to 1.01%), and 0.80 (0.77% to 0.84%), respectively. The sites' risk-adjusted mortality rates were not increased when the centers' highest risk cases were concentrated into a single "nightmare year.", Conclusions: Our results show that the current risk-adjusted models accurately estimate CABG mortality and that hospitals accepting more high-risk CABG patients have equal or better outcomes than do those with predominately lower-risk patients., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The goal of this study was to examine the calibration of a validated risk-adjustment model in very high-risk percutaneous coronary intervention (PCI) cases and assess whether sites' case mix affects their performance ratings., Background: There are concerns that treating PCI patients with particularly high-risk features such as cardiogenic shock or prior cardiac arrest may adversely impact hospital performance ratings. However, there is little investigation on the validity of these concerns., Methods: We examined 624,286 PCI procedures from 1,168 sites that participated in the CathPCI Registry in 2010. Procedural risk was estimated using the recently published Version 4 National Cardiovascular Data Registry (NCDR) PCI risk-adjusted mortality (RAM) model. We calculated observed/expected mortality using several risk classification methods, and simulated hospital performance after combining their highest risk cases over 2 years into a single year., Results: In 2010, crude in-hospital PCI mortality was 1.4%. The NCDR model was generally well calibrated among high risk, however there was slight overprediction of risk in extreme cases. Hospitals treating the highest overall expected risk PCI patients or those treating the top 20% of high-risk cases had lower (better) RAM ratings than centers treating lower-risk cases (1.25% vs. 1.51%). The observed/expected ratio for top-risk quintile versus low-risk quintile was 0.91 (0.87 to 0.96) versus 1.10 (1.03 to 1.17). Combining all the high-risk patients over a 2-year period into a single year also did not negatively impact the site's RAM ratings., Conclusions: Evaluation of a contemporary sample of PCI cases across the United States showed no evidence that treating high-risk PCI cases adversely affects hospital RAM rates., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: We studied the association between components of chronic lung disease (CLD) assessment and operative outcomes in patients undergoing aortic valve replacement (AVR) for aortic stenosis., Methods: From 2011 to 2012, 9,177 patients included in The Society of Thoracic Surgeons (STS) Cardiac Surgery Database underwent AVR for aortic stenosis with complete pulmonary function tests (PFT) and CLD data (31% of AVRs). We evaluated markers of CLD and their association with operative mortality, pulmonary morbidity, and length of hospital stay using multivariable logistic regression analysis., Results: In a selected population of AVR patients with PFTs, CLD was prevalent in 50% (mild, 25.6%; moderate, 13.2%; severe, 11.2%). Predicted forced expiratory volume in 1 second (FEV1) was obtained in all patients and diffusion capacity of the lung for carbon monoxide (DLCO), arterial oxygen tension (PaO2), and arterial carbon dioxide tension (PaCO2) in 31%. The STS predicted risk of operative mortality, mortality, pulmonary morbidity, and hospital stay increased with severity of CLD and with low FEV1, DLCO, and PaO2. Moderate and severe CLD were independently associated with operative mortality (odds ratio [OR] 2.88, 95% confidence interval [CI]: 2.0-4.5), pulmonary morbidity (OR 2.33, 95% CI: 1.93-2.8), and prolonged hospital stay (OR 2.73, 95% CI: 2.17-3.45). Low FEV1 was independently associated with pulmonary morbidity and prolonged hospital stay. Low PaO2 and DLCO were independently associated with a combined mortality and pulmonary morbidity endpoint., Conclusions: CLD is associated with adverse operative outcomes in selected patients with aortic stenosis undergoing AVR. FEV1, DLCO, and PaO2 may add important information to current risk adjustment models beyond the broad CLD classification., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals' surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown., Methods: We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers., Results: From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08)., Conclusions: Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: National prosthesis use in active aortic valve infective endocarditis (IE) is unreported. Prosthesis usage and outcomes in patients undergoing an aortic valve operation with active IE was evaluated., Methods: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was used to identify patients with active IE who underwent an aortic valve operation from January 1, 2005, to June 30, 2011. All patients with active IE were included. Demographics, procedures, outcomes, and trends were analyzed., Results: Of 11,560 patients who were identified as having active IE, 8,421 (73%) had no prior operations (primary) and 3,139 (27%) had a history of any prior cardiac operation (reoperative). Operations for primary vs reoperative patients included isolated replacement in 88.5% vs 58.7% and root replacement in 7.2% vs 29.9%. Major morbidity was 60.8% vs 68%, and the unadjusted mortality rate was 9.8% vs 21.1%. Over time, for primary operations, biologic valve use increased (57% to 67%), and mechanical and homograft valve use decreased (30% to 24% and 9% to 6%; p < 0.001). For reoperations, biologic valve use increased (38% to 52%), and mechanical and homograft use decreased (20% to 17% and 38% to 28%; p < 0.001). Homografts were used more often in reoperations (32% vs 7%)., Conclusions: Morbidity and mortality rates death are high for operations for active IE. Biologic valves were increasingly used vs mechanical and homograft valves. Homograft valves were used more often in reoperative patients after any prior cardiac operation. The mortality rate varied among prosthesis groups but may be related to the severity of infection and type of procedure performed., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Society of Thoracic Surgeons (STS) is developing a portfolio of composite performance measures for the most commonly performed adult cardiac procedures. This manuscript describes the third composite measure in this series, aortic valve replacement (AVR) combined with coronary artery bypass grafting surgery (CABG)., Methods: We identified all patients in the STS Adult Cardiac Surgery Database who underwent AVR+CABG during recent 3-year (July 1, 2009, through June 30, 2012) and 5-year (July 1, 2007, through June 30, 2012) periods. Variables from the STS risk model for AVR+CABG were used to adjust morbidity and mortality outcomes. Evidence for internal mammary artery use in AVR+CABG was examined. We compared composite measures constructed using 3 or 5 years of outcomes with Bayesian credible intervals of 90%, 95%, or 98%. The final STS AVR+CABG composite performance measure is based on 3 years of data and 95% credible intervals. It includes risk-adjusted mortality and morbidity but not internal mammary artery use., Results: Median composite score is 91.0% (interquartile range, 89.5% to 92.2%). There were 2.6% (24 of 915) one-star (lower performing) and 6.5% (59 of 915) three-star (higher performing) programs. Morbidity and mortality decrease monotonically as star ratings increase. The percentage of three-star programs increased substantially among programs that performed more than 150 procedures over 3 years compared with those performing 25 to 50 procedures (32.8% versus 1.6 %). Measure reliability was 0.51., Conclusions: The STS has developed a composite performance measure for AVR+CABG based on 3-year data samples and 95% credible intervals. This composite measure identified 9.1% of STS participants as having higher or lower than expected performance., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Although the operative risk of multivalve operations has historically been high, current outcomes are poorly understood. We sought to evaluate factors influencing contemporary results of triple-valve operations using The Society of Thoracic Surgeons Adult Cardiac Surgery Database., Methods: Among patients undergoing combined mitral, aortic, and tricuspid valve (triple- valve) operations between 1993 and 2011, aortic valve repair patients were excluded and those having aortic valve replacement were analyzed according to whether they underwent repair vs replacement of the mitral valve (MV) and tricuspid valve (TV). Temporal trends in operative death and clinical outcomes were examined using unadjusted and adjusted analyses., Results: A total of 8,021 triple-valve patients were studied. The median (25th percentile, 75th percentile) age was 67 years (59, 77 years), 4,809 (60%) were women, 4,488 (56%) had New York Heart Association class III to IV symptoms, and the mean (25th percentile, 75th percentile) ejection fraction was 50% (40%, 60%). MV repair was performed in 2,728 (34%) patients overall and increased over time from 13% (1993 to 1997) to 41% (2008 to 2011). TV repair was performed in 7,512 (94%) patients overall and increased over time from 86% (1993 to 1997) to 96% (2008 to 2011). Unadjusted operative mortality decreased from 17% in 1993 to 9% in 2011. Adjusted odds ratios (95% confidence intervals) of operative mortality were lower in those having MV repair (0.72 [0.61 to 0.85]), TV repair (0.64 [0.50 to 0.83]), and MV+TV repair (0.46 [0.34 to 0.63]) compared with those having replacements. Unadjusted and adjusted odds of stroke were similar between groups and not significant for all., Conclusions: This large series demonstrates that surgical results of triple-valve operations have continued to improve during the past 18 years. MV and TV repair were associated with improvements in early survival. Although further study is required to understand late outcomes, these data suggest that broader efforts to perform MV repair instead of replacement in this high-risk patient population appear warranted., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Hybrid coronary revascularization (HCR) combines bypass grafting of the left anterior descending (LAD) coronary artery with percutaneous coronary intervention (PCI) of non-LAD vessels. HCR has been performed as an alternative to CABG or multi-vessel PCI in thousands of patients since the late 1990s. In this review article, we provide an overview on patient selection, procedural sequence and timing, use of surgical techniques and anti-platelet agents. Additionally, patient recovery, satisfaction, costs and clinical outcomes of individual studies after HCR are evaluated. Future directions are also discussed, including the need for adequately powered randomized trials.

Background: Understanding the operative outcomes of mitral valve (MV) surgery across the spectrum of predicted risk of mortality (PROM) is necessary to determine the best use of novel percutaneous approaches., Methods: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was utilized to study isolated MV operations during two time periods: era 1 (2002 to 2006, n = 37,743) and era 2 (2007 to 2010, n = 40,093). In each era, four PROM groups were defined: low risk (PROM 0% to <4%); intermediate risk (PROM 4% to <8%); high risk (PROM 8% to <12%); and extreme risk (PROM ≥ 12%). In each risk group, mortality rates and observed to expected mortality ratios were compared across eras., Results: A total of 63,645 cases (82%) were classified as low risk, 8,032 (10%) as intermediate risk, 2,765 (4%) as high risk, and 3,394 (4%) as extreme risk. Sixty-seven percent of MV repairs (n = 30,488) and 18% of MV replacements (n = 5,749) had a PROM less than 1%. PROM less than 4% was seen for 93% of MV repairs (n = 42,196) and 66% of replacements (n = 21,449). Across the two eras, the MV repair rate increased from 54.8% to 61.8% (p = 0.0017); and a significant reduction in operative mortality was observed in high risk and extreme risk cohorts (p < 0.05)., Conclusions: The frequency with which MV repair for isolated MV disease is performed has increased over time and is associated with very low early mortality. A significant reduction in mortality among patients at highest risk has occurred, and must be considered as patients are evaluated for percutaneous therapies., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to update and validate a contemporary model for inpatient mortality following percutaneous coronary intervention (PCI), including variables indicating high clinical risk., Background: Recently, new variables were added to the CathPCI Registry data collection form. This modification allowed us to better characterize the risk of death, including recent cardiac arrest and duration of cardiogenic shock., Methods: Data from 1,208,137 PCI procedures performed between July 2009 and June 2011 at 1,252 CathPCI Registry sites were used to develop both a "full" and pre-catheterization PCI in-hospital mortality risk model using logistic regression. To support prospective implementation, a simplified bedside risk score was derived from the pre-catheterization risk model. Model performance was assessed by discrimination and calibration metrics in a separate split sample., Results: In-hospital mortality was 1.4%, ranging from 0.2% among elective cases (45.1% of total cases) to 65.9% among patients with shock and recent cardiac arrest (0.2% of total cases). Cardiogenic shock and procedure urgency were the most predictive of inpatient mortality, whereas the presence of a chronic total occlusion, subacute stent thrombosis, and left main lesion location were significant angiographic predictors. The full, pre-catheterization, and bedside risk prediction models performed well in the overall validation sample (C-indexes 0.930, 0.928, 0.925, respectively) and among pre-specified patient subgroups. The model was well calibrated across the risk spectrum, although slightly overestimating risk in the highest risk patients., Conclusions: Clinical acuity is a strong predictor of PCI procedural mortality. With inclusion of variables that further characterize clinical stability, the updated CathPCI Registry mortality models remain well-calibrated across the spectrum of PCI risk., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There are limited data available to inform decision making regarding warfarin thromboprophylaxis early after mitral valve repair., Methods: We studied 13,082 patients from The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) who underwent primary mitral valve repair between January 1, 2008, and June 30, 2010. Excluded were those having other major concomitant operations or with an indication/contraindication to warfarin. The predictors of warfarin administration at dismissal were evaluated., Results: In this cohort (median age 58 years; 59% male), warfarin was prescribed at hospital dismissal for 46% (5,963) of patients. Median postoperative length of stay was 5 days overall (6 days warfarin versus 5 days, p < 0.0001). Substantial surgeon and center variation existed, and multivariable analysis identified that warfarin use was more common among patients with postoperative atrial fibrillation (odds ratio [OR] 4.04, 95% confidence interval [CI]: 3.57 to 4.58), postoperative neurologic events (stroke OR 1.72, 95% CI: 1.08 to 2.71; transient ischemic attack/reversible ischemic neurologic deficit OR 6.29, 95% CI: 2.67 to 14.84), and preoperative arrhythmia (OR 2.49, 95% CI: 1.84 to 3.38). Warfarin use was less common among patients having surgery in the more recent era (OR 0.92, 95% CI: 0.89 to 0.96, per half-year increase in date of surgery), those requiring intraoperative transfusion of red blood cells (OR 0.82, 95% CI: 0.71 to 0.96), and patients with advanced heart failure (New York Heart Association functional class IV OR 0.77, 95% CI: 0.59 to 1.00)., Conclusions: At present, half of patients are prescribed warfarin after isolated mitral valve repair in North American cardiac surgical practice which may impact the length of hospital stay. Although patient-level predictors of warfarin prescription exist, center- and surgeon-level variations are prominent. There is a pressing need for a randomized trial both to guide therapy and to ascertain the potential for resource conservation., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Mitral valve (MV) repair is performed with less frequency than MV replacement in older persons, with referral often delayed until symptoms are severe. Surgical practice in this population remains inconsistent in the absence of national MV repair outcomes. The goal of this study was to assess durability and longitudinal outcomes after isolated primary MV repair in patients aged 65 years or more., Methods: We linked clinical data from The Society of Thoracic Surgeons adult cardiac surgery database (STS) to longitudinal claims data from the Centers for Medicare and Medicaid Services (CMS). Between January 1991 and December 2007, we identified 14,604 isolated nonemergent primary MV repair operations in STS-CMS data. These were longitudinally examined for mortality, mitral reoperation, and readmissions for heart failure, bleeding, and stroke. Predictors of 5-year death after MV repair were identified using Cox proportional hazard modeling., Results: The study cohort had a mean age of 73.3±5.5 years, ejection fraction 54.0%±12.9%; 55.8% (8,148 of 14,604) were female; and 8.4% (1,233 of 14,604) were non-Caucasian. Operative mortality was 2.59% (378 of 14,604). Mean follow-up was 5.9±3.9 years (range, 1.0 to 18.0). Survival during follow-up was 74.9% (10,934 of 14,604). The number of observed events for mitral reoperation, heart failure, bleeding, and stroke were 552 of 14,604 (3.7%), 2,681 of 14,604 (18.4%), 1,051 of 14,604 (7.2%), and 1,131 of 14,604 (7.7%), respectively. The 10-year Kaplan-Meier event rates for mitral reoperation, heart failure, bleeding, and stroke were 6.2%, 30.1%, 15.3%, and 16.4%, respectively. The 10-year actuarial survival of 57.4% was equivalent to the matched US population., Conclusions: Utilizing linked STS and CMS databases, we demonstrate that MV repair is a safe and durable long-term option for older patients. Survival restored to the normal population suggests repair may suppress the longitudinal impact of mitral regurgitation in the elderly and that the practice of delayed referral should be reevaluated. These data provide a contemporary longitudinal benchmark of MV repair outcomes., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices., Methods: The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386). Analysis of long-term outcomes was accomplished through linkage to Medicare claims data. Short-term and long-term (7 years) adverse outcomes were assessed and compared between the 2 TMR device types., Results: The use of TMR in conjunction with CABG surgery is increasing. This study showed modest differences in short-term morbidity and mortality between the 2 devices. In combination with CABG, after risk adjustment, patients treated with the holmium:YAG laser (experienced a higher rate of operative mortality (3.5% vs 2.5%; adjusted hazard ratio 1.39, 95% confidence level 1.03 to 1.87) but no difference in the composite short-term rate of major morbidity or mortality, compared with the Heart Laser CO2 transmyocardial revascularization system (PLC Medical Systems, Inc, Milford, MA). However, there were no clinically meaningful differences in long-term results., Conclusions: Modest differences in short-term morbidity and mortality between the 2 devices suggest the usefulness of further research., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the long-term effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS)., Background: Improved recanalization techniques have increased interest in percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). The long-term effectiveness of DES and BMS is not known., Methods: We used data from 10,261 stable patients age ≥65 years at 889 U.S. hospitals who underwent CTO PCI from January 1, 2005, to December 31, 2008, in the NCDR (National Cardiovascular Data Registry) CathPCI Registry with linked Medicare inpatient claims for follow-up. Patient and procedural characteristics, and 30-month death, myocardial infarction, revascularization, and hospitalization for bleeding were evaluated by stent type. Outcomes following stenting were adjusted and compared using propensity score matching., Results: DES were used for CTO PCI in 8,218 (80%) and BMS in 2,043 (20%). DES patients were younger (74.0 vs. 75.5 years, p < 0.001), had longer lesions (18.8 vs. 16.5 mm, p < 0.001), received more stents (≥2 stents in 45.7% vs. 37.9%, p < 0.001), and underwent multivessel PCI (18.9% vs. 15.1%, p < 0.001). DES implantation was associated with a lower hazard of mortality (hazard ratio [HR]: = 0.72, 95% confidence interval [CI]: 0.60 to 0.86, p < 0.001), a similar hazard for myocardial infarction (HR: 0.85, 95% CI: 0.61 to 1.19, p = 0.35), and subsequent revascularization (HR: 0.94, 95% CI: 0.79 to 1.12, p = 0.48), including PCI (HR: 0.98, 95% CI: 0.83 to 1.19, p = 0.87) and coronary artery bypass grafting (HR: 0.71, 95% CI: 0.46 to 1.10, p = 0.12). Hospitalization for bleeding was also similar for DES versus BMS (HR: 0.92; 95% CI: 0.61 to 1.39, p = 0.70)., Conclusions: Compared with BMS, DES use in stable patients undergoing CTO PCI was associated with lower mortality, as well as similar myocardial infarction and repeat revascularization rates without an increase in subsequent bleeding requiring hospitalization., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Mitral valve repair is acknowledged as desirable and superior to replacement for virtually all mitral pathology. Utilizing The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD), a multivariable model was created that included patient clinical characteristics and surgeon-specific mitral volume to predict the likelihood of mitral valve repair., Methods: Between January 2005 and December 2007, 28,507 patients undergoing isolated mitral valve surgery (with or without tricuspid valve surgery, with or without atrial fibrillation surgery) by 1,088 surgeons at 639 hospitals in the STS ACSD were identified. Patient characteristics independently associated with mitral valve repair were identified using a generalized estimating equations logistic regression model. Observed mitral valve repair rates were plotted against surgeon-specific annual mitral volume, and predicted probabilities of mitral repair by surgeon volume were calculated after adjusting for patient baseline covariates., Results: On average, patients undergoing mitral valve surgery were 62 years old, with 51% female and 82% Caucasian. Among surgeons performing mitral procedures, the mean rate of mitral valve repair was 41% (range, 0% to 100%) and the median number of mitral valve operations per year was 5 (range, 1 to 166). Several patient characteristics were independently associated with a decreased odds of mitral repair (versus replacement), including mitral stenosis (odds ratio 0.09; 95% confidence interval: 0.08 to 0.11) and active endocarditis (odds ratio 0.21; 95% confidence interval: 0.17 to 0.25). While substantial variability in repair rates was observed among low-volume surgeons, increased surgeon-level mitral volume was independently associated with an increased probability of mitral repair., Conclusions: This analysis demonstrates marked variability in the frequency of mitral valve repair, and the influence of both patient- and surgeon-level factors on the likelihood of mitral valve repair. Increasing surgeon-specific annual mitral valve volume is associated with a higher probability of mitral repair. Identification of these predictors of mitral valve repair creates substantial opportunity for quality improvement in patient outcomes in mitral valve surgery, potentially through education, adoption of best practices, and improved mitral repair enabling technology., (Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Centers for Medicare and Medicaid Services (CMS) Medicare database complements The Society of Thoracic Surgeons (STS) database by providing information about long-term outcomes and cost. This study demonstrates the feasibility of linking STS data to CMS data and examines the penetration, completeness, and representativeness of the STS database., Methods: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft surgery (CABG) hospitalizations discharged between 2000 and 2007, 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 one matched STS participant divided by the total number of CMS CABG sites) increased from 45% to 78%. In 2007, 854 of 1,101 CMS CABG sites (78%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% to 84%. In 2007, 94,409 of 111,967 CMS CABG hospitalizations (84%) were 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 the total number of CMS CABG cases at STS sites) increased from 88% to 97%. In 2007, 88,857 of 91,363 CMS CABG hospitalizations at STS sites (97%) were linked to an STS record., Conclusions: The successful linking of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data will facilitate studying long-term outcomes of cardiothoracic surgery., (Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to compare the value of serial assessment with hand-carried ultrasound (HCU) of the inferior vena cava (IVC) with brain natriuretic peptide (BNP) to identify patients with acute decompensated heart failure (ADHF) who will be readmitted or seek emergency department treatment after hospital discharge., Background: Congestive heart failure (CHF) is a leading cause for hospitalization and, once hospitalized, patients with CHF frequently are readmitted. To date, no reliable index exists that can be used to predict whether patients with ADHF can be discharged with low readmission likelihood., Methods: A total of 75 patients who were admitted with a primary diagnosis of ADHF were followed. All patients were assessed at admission and discharge with the use of routine clinical evaluation, BNP measurement, and HCU evaluation of the IVC by physicians with limited training in ultrasound., Results: During the 30-day follow-up, 31 patients were rehospitalized or presented to the emergency department. Patients who were subsequently readmitted could not be differentiated from those who were not readmitted by their demographics, comorbidities, vital signs, presence of symptoms/signs suggestive of persistent congestion, hospital length of stay, or net volume removal. Routine laboratory tests, including assessment of renal function, also failed to predict readmission with the exception of serum sodium. Although admission BNP was similar in patients readmitted and not readmitted, pre-discharge log-transformed BNP was greater in patients who subsequently were readmitted. Patients who required repeat hospitalization had a larger IVC size on admission as well as at discharge. In addition, patients who were readmitted had persistently plethoric IVCs with lower IVC collapsibility indexes. At discharge, only serum sodium, log-transformed BNP, IVC size, and collapsibility were statistically significant predictors of readmission., Conclusions: This study confirms that, once hospitalized, patients with CHF frequently are readmitted. Bedside evaluation of the IVC with a HCU device at the time of admission and discharge, as well as pre-discharge BNP, identified patients admitted with ADHF who were more likely to be readmitted to the hospital.

Background: Rapid prediction of the effect of volume expansion is crucial in unstable patients receiving mechanical ventilation. Both radial artery pulse pressure variation (DeltaPP) and change of aortic blood flow peak velocity are accurate predictors but may be impractical point-of-care tools., Purposes: We sought to determine whether respiratory changes in the brachial artery blood flow velocity (DeltaVpeak-BA) as measured by internal medicine residents using a hand-carried ultrasound (HCU) device could provide an accurate corollary to DeltaPP in patients receiving mechanical ventilation., Methods: Thirty patients passively receiving volume-control ventilation with preexisting radial artery catheters were enrolled. The brachial artery Doppler signal was recorded and analyzed by blinded internal medicine residents using a HCU device. Simultaneous radial artery pulse wave and central venous pressure recordings (when available) were analyzed by a blinded critical care physician., Results: A Doppler signal was obtained in all 30 subjects. The DeltaVpeak-BA correlated well with DeltaPP (r = 0.84) with excellent agreement (weighted kappa, 0.82) and limited intraobserver variability (2.8 +/- 2.8%) [mean +/- SD]. A DeltaVpeak-BA cutoff of 16% was highly predictive of DeltaPP > or = 13% (sensitivity, 91%; specificity, 95%). A poor correlation existed between the CVP and both DeltaVpeak-BA (r = - 0.21) and DeltaPP (r = - 0.16)., Conclusions: The HCU Doppler assessment of the DeltaVpeak-BA as performed by internal medicine residents is a rapid, noninvasive bedside correlate to DeltaPP, and a DeltaVpeak-BA cutoff of 16% may prove useful as a point-of-care tool for the prediction of volume responsiveness in patients receiving mechanical ventilation.

Chemically modified phosphorothioate oligodeoxynucleotides (ODNs) have become critical tools for research in the fields of gene expression and experimental therapeutics. Bioanalytical assays were developed that utilized fast anion-exchange high-performance liquid chromatography (HPLC) and capillary gel electrophoresis (CGE) for the determination of 20-mer ODNs in biological fluids (plasma and urine) and tissues. A 20 mer ODN in the antisense orientation directed against DNA methyltransferase (denoted as MT-AS) was studied as the model ODN. The anion-exchange HPLC method employed a short column packed with non-porous polymer support and a ternary gradient elution with 2 M lithium bromide containing 30% formamide. Analysis of the MT-AS is accomplished within 5 min with a detection limit of approximately 3 ng on-column at 267 nm. For plasma and urine, samples were diluted with Nonidet P-40 in 0.9% NaCl and directly injected onto the column, resulting in 100% recovery. For tissue homogenates, a protein kinase K digestion and phenol-chloroform extraction were used, with an average recovery of about 50%. Since the HPLC assay cannot provide one-base separation, biological samples were also processed by an anion-exchange solid-phase extraction and a CGE method to characterize MT-AS and its catabolites of 15-20-mer, species most relevant to biological activity. One base separation, under an electric field of 400 V/cm at room temperature, was achieved for a mixture of 15-20-mer with about 50 pg injected. Assay validation studies revealed that the combined HPLC-CGE methods are accurate, reproducible and specific for the determination of MT-AS and its catabolites in biological fluids and tissue homogenates, and can be used for the pharmacokinetic characterization of MT-AS.

A sensitive and reproducible HPLC procedure was developed for the simultaneous determination of the diastereoisomers of the synthetic amino acid L-buthionine-(SR)-sulfoximine (BSO) in human plasma and urine. Plasma samples were prepared for analysis by addition of internal standard (L-norleucine) followed by ultrafiltration using disposable centrifugal filtration units. Urine samples received internal standard followed by solid phase extraction using disposable C18 cartridges. All samples were derivatized with phenylisothiocyanate (PITC). The derivatized amino acids were separated by HPLC on an octyldecyl column (250 mm x 4.6 mm I.D., 5 microns particle size) using a mobile phase of sodium acetate-acetonitrile-triethylamine-ethylaminediaminetetraacetic acid. The column effluent was monitored at 254 nm and quantitation was performed using peak areas. The linear range for each diastereoisomer of L-(SR)-BSO was from 2 to 100 micrograms/ml in plasma and from 10 to 1000 micrograms/ml in urine. The method is reproducible, convenient and sensitive, illustrating its utility for application in pharmacokinetic studies.

A high-performance liquid chromatographic method for the determination of ethacrynic acid (EA) in human plasma is described. Plasma was prepared for analysis by addition of 4-(2,4-dichlorophenoxy)-butyric acid as an internal standard followed by acidification with hydrochloric acid and extraction with ethyl acetate. Separation was by isocratic reversed-phase chromatography, the column effluent was monitored at 280 nm and quantitation was performed using peak-area ratios. The linear range for EA determination was from 0.5 to 25 micrograms/ml with a lower limit of detection of 0.1 microgram/ml. The reported method is convenient, sensitive and reproducible, illustrating its usefulness for pharmacokinetic studies.