Anxiety and Depression Following Aortic Valve Replacement.

Background The aim of this study was to identify patients vulnerable for anxiety and/or depression following aortic valve replacement (AVR) and to evaluate factors that may mitigate this risk. Methods and Results This is a retrospective cohort study conducted using a claims database; 18 990 patients (1/2013-12/2018) ≥55 years of age with 6 months of pre-AVR data were identified. Anxiety and/or depression risk was compared at 3 months, 6 months, and 1 year following transcatheter aortic valve replacement or surgical AVR (SAVR) after risk adjustment using logistic regression and Cox proportional hazards models. Separate models were estimated for patients with and without surgical complications and discharge location. Patients with SAVR experienced a higher relative risk of anxiety and/or depression at 3 months (12.4% versus 8.8%; adjusted hazard ratio [HR] 1.39 [95% CI, 1.19-1.63]) and 6 months (15.6% versus 13.0%; adjusted HR, 1.24 [95% CI, 1.08-1.42]), with this difference narrowing by 12 months (20.1% versus 19.3%; adjusted HR, 1.14 [95% CI, 1.01-1.29]) after AVR. This association was most pronounced among patients discharged to home, with patients with SAVR having a higher relative risk of anxiety and/or depression. In patients who experienced operative complications, there was no difference between SAVR and transcatheter aortic valve replacement. However, among patients without operative complications, patients with SAVR had an increased risk of postoperative anxiety and/or depression at 3 months (adjusted HR, 1.47 [95% CI, 1.23-1.75]) and 6 months (adjusted HR 1.26 [95% CI, 1.08-1.46]), but not at 12 months. Conclusions There is an associated reduction in the risk of new-onset anxiety and/or depression among patients undergoing transcatheter aortic valve replacement (versus SAVR), particularly in the first 3 and 6 months following treatment.

Strategies for Mechanical Right Ventricular Support During Left Ventricular Assist Device Implant.

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.

Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice: Findings From EXTEND-CoreValve.

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.

Association Between Patient Survival and Clinician Variability in Treatment Rates for Aortic Valve Stenosis.

Background Patients with symptomatic severe aortic stenosis (ssAS) have a high mortality risk and compromised quality of life. Surgical/transcatheter aortic valve replacement (AVR) is a Class I recommendation, but it is unclear if this recommendation is uniformly applied. We determined the impact of managing cardiologists on the likelihood of ssAS treatment. Methods and Results Using natural language processing of Optum electronic health records, we identified 26 438 patients with newly diagnosed ssAS (2011-2016). Multilevel, multivariable Fine-Gray competing risk models clustered by cardiologists were used to determine the impact of cardiologists on the likelihood of 1-year AVR treatment. Within 1 year of diagnosis, 35.6% of patients with ssAS received an AVR; however, rates varied widely among managing cardiologists (0%, lowest quartile; 100%, highest quartile [median, 29.6%; 25th-75th percentiles, 13.3%-47.0%]). The odds of receiving AVR varied >2-fold depending on the cardiologist (median odds ratio for AVR, 2.25; 95% CI, 2.14-2.36). Compared with patients with ssAS of cardiologists with the highest treatment rates, those treated by cardiologists with the lowest AVR rates experienced significantly higher 1-year mortality (lowest quartile, adjusted hazard ratio, 1.22, 95% CI, 1.13-1.33). Conclusions Overall AVR rates for ssAS were low, highlighting a potential challenge for ssAS management in the United States. Cardiologist AVR use varied substantially; patients treated by cardiologists with lower AVR rates had higher mortality rates than those treated by cardiologists with higher AVR rates.

Sex disparities in patients with symptomatic severe aortic stenosis.

BACKGROUND: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients. METHODS: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable. RESULTS: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69). CONCLUSIONS: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.

Aortic Annular Enlargement in the Elderly: Short and Long-Term Outcomes in the United States.

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.

Ablation of atrial fibrillation during coronary artery bypass grafting: Late outcomes in a Medicare population.

BACKGROUND: This study compares outcomes of patients with preoperative atrial fibrillation undergoing coronary artery bypass grafting (CABG) with or without concomitant atrial fibrillation ablation in a nationally representative Medicare cohort. OBJECTIVES: This study examined early and late outcomes in CABG patients with a preoperative history of atrial fibrillation to determine the correlation between surgical atrial fibrillation ablation to mortality and stroke or systemic embolization. METHODS: In the Medicare-linked Society of Thoracic Surgeons database, 361,138 patients underwent isolated CABG from 2006 to 2013; 34,600 (9.6%) had preoperative atrial fibrillation; 10,541 (30.5%) were treated with surgical ablation (ablation group), and 23,059 were not (no ablation group). Propensity score matching was performed using a hierarchical mixed model. Long-term survival was summarized using Kaplan-Meier curves and Cox regression models with robust variance estimation. The stroke or systemic embolization incidence was modeled using the Fine-Gray model. Median follow-up was 4 years. RESULTS: Long-term mortality in propensity score-matched CABG patients (mean age 74 years; Society of Thoracic Surgeons risk score, 2.25) receiving ablation versus no ablation was similar (log-rank P = .30). Stroke or systemic embolization occurred in 2.2% versus 2.1% at 30 days and 9.9% versus 12.0% at 5 years (Gray P = .0091). Landmark analysis from 2 to 5 years showed lower mortality (hazard ratio, 0.89; 95% confidence interval 0.82-0.97; P = .0358) and lower risk of stroke or systemic embolization (hazard ratio, 0.73; 95% confidence interval, 0.61-0.87; P = .0006) in the ablation group. CONCLUSIONS: Concomitant ablation in CABG patients with preoperative atrial fibrillation is associated with lower stroke or systemic embolization and mortality in patients who survive more than 2 years.

Anticoagulation and amiodarone for new atrial fibrillation after coronary artery bypass grafting: Prescription patterns and 30-day outcomes in the United States and Canada.

OBJECTIVE: We sought to elucidate national practice patterns regarding anticoagulation and antiarrhythmic medication use at discharge and examine short-term patient outcomes. METHODS: In this retrospective cohort study, we analyzed the data of patients from the Society of Thoracic Surgeons Adult Cardiac Surgery Database from July 2011 to June 2018 who underwent first-time isolated coronary artery bypass graft surgery (CABG) and developed new post-CABG atrial fibrillation (AF) without significant complications. In total, 166,747 patients met study criteria. We examined 30-day outcomes. RESULTS: In total, 166,747 patients were analyzed and divided into 4 groups based on discharge medications: amiodarone with or without anticoagulation, anticoagulation alone, and neither. Demographic characteristics were similar among the 4 groups. In total, 25.7% of patients were discharged on anticoagulation with an average CHA2DS2-VASc score of 3.2 ± 1.3. Anticoagulation use at discharge was not associated with lower 30-day stroke readmissions (adjusted odds ratio [AOR], 0.87; 95% confidence interval [CI], 0.65-1.16; P = .35). Adjusted 30-day readmissions for major bleeding were significantly more common in anticoagulated patients (AOR, 4.30; 95% CI, 3.69-5.03; P < .0001). Among those discharged off anticoagulation, there was no significant difference in adjusted 30-day stroke rates based on amiodarone use at discharge (AOR, 1.19; 95% CI, 0.85-1.66; P = .31). CONCLUSIONS: Post-CABG anticoagulation for new AF is associated with increased bleeding and no difference in stroke at 30 days. Prospective randomized studies are needed to formalize safe and efficacious short- and long-term management strategies.

Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.

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.

Reoperation After Transcatheter Aortic Valve Replacement: An Analysis of the Society of Thoracic Surgeons Database.

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.

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study.

BACKGROUND: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. METHODS: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). RESULTS: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial's primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65-1.09]; P=0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66-1.11]; P=0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes (Pnoninferiority<0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial's primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 [95% CI, 0.79-1.48]; P=0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73-1.41]; P=0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims (Pnoninferiority<0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). CONCLUSIONS: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Disease: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis. METHODS: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). RESULTS: After exclusions, there were 170 959 eligible procedures at 593 sites during the specified interval. Of these, 5412 TAVR procedures (3.2%) were performed in patients with bicuspid AV, including 3705 with current-generation devices. In comparison with patients with tricuspid valves, patients with bicuspid AV were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Operative Mortality score. When current-generation devices were used to treat patients with bicuspid AV, device success increased (93.5 versus 96.3; P=0.001) and the incidence of 2+ aortic insufficiency declined (14.0% versus 2.7%; P<0.001) in comparison with older-generation devices. With current-generation devices, device success was slightly lower in the bicuspid (versus tricuspid) AV group (96.3% in bicuspid versus 97.4% in tricuspid, P=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among patients with bicuspid AV (2.7% versus 2.1%; P<0.001). A lower 1-year adjusted risk of mortality (hazard ratio, 0.88 [95% CI, 0.78-0.99]) was observed for patients with bicuspid AV versus patients with tricuspid AV in the Medicare-linked cohort, whereas no difference was observed in the 1-year adjusted risk of stroke (hazard ratio, 1.14 [95% CI, 0.94-1.39]). CONCLUSIONS: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bicuspid AV versus tricuspid AV disease. With newer-generation devices, TAVR is a viable treatment option for patients with bicuspid AV disease.

Association of postoperative complications and outcomes following coronary artery bypass grafting.

BACKGROUND: The long-term effects of postoperative complications following coronary artery bypass grafting (CABG) are unknown. METHODS: Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database were queried for isolated CABG records from 2007 through 2012. Unadjusted and adjusted associations between individual postoperative complications and both mortality and all-cause rehospitalization were evaluated to 7 years using Cox proportional-hazards models and cumulative incidence functions. Because of nonproportional hazards, associations are presented as early (0 to 90 days) and late (90 days to 7 years). RESULTS: Of the 294,533 isolated CABG patients who had records linked to Medicare for long-term follow-up (median age, 73 years; 30% female), 120,721 (41%) experienced at least 1 of the complications of interest, including new-onset atrial fibrillation (30.0%), prolonged ventilation (12.3%), renal failure (4.5%), reoperation (3.5%), stroke (1.9%), and sternal wound infection (0.4%). Each of the 6 postoperative complications was associated with a significantly increased risk of mortality and rehospitalization to 7 years despite adjustment for baseline characteristics and the presence of multiple complications. Although the predominant effect of postoperative complications was observed in the first 90 days, the increased risk-adjusted hazard for death and rehospitalization continued through 7 years. CONCLUSIONS: Postoperative complications are associated with an increased risk of both early and late mortality and all-cause rehospitalization, particularly during the "value" window within 90 days of CABG. These findings underscore the need to develop avoidance strategies as well as cost-adjustment methods for each of these complications.

Longitudinal Outcomes After Surgical Repair of Postinfarction Ventricular Septal Defect in the Medicare Population.

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.

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. METHODS: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. RESULTS: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. CONCLUSIONS: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement: Findings From the EXTEND Study.

BACKGROUND: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. METHODS: Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of International Classification of Diseases,Ninth andTenthRevisions, Clinical Modification billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared. RESULTS: Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 International Classification of Diseases, Ninth Revision, Clinical Modification codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 International Classification of Diseases, Tenth Revision, Clinical Modification codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%. CONCLUSIONS: In linked clinical trial and Medicare claims data, 4 International Classification of Diseases, Ninth Revision, Clinical Modification and 3 International Classification of Diseases, Tenth Revision, Clinical Modification billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.

Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

BACKGROUND: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. METHODS AND RESULTS: Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication. CONCLUSIONS: Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.