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.

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.

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.

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.

Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.

BACKGROUND: Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes. METHODS AND RESULTS: Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The concordance between baseline and outcomes data collected within nontrial data sets and trial information, including adjudicated end point events, will be assessed. We will compare the study results obtained using these alternative data sources to those derived using trial-ascertained variables and end points using trial-adjudicated end points and covariates. CONCLUSIONS: Linkage of trials to registries and claims data represents an opportunity to use alternative data sources in place of and as adjuncts to randomized clinical trial data but requires further validation. The results of this research will help determine how these data sources can be used to improve our present and future understanding of new medical treatments.

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.

Contemporary management and outcomes of acute type A aortic dissection: An analysis of the STS adult cardiac surgery database.

PURPOSE: Management of acute type A aortic dissection (AAAD) is challenging and operative strategies are varied. We used the STS Adult Cardiac Surgery Database (STS ACSD) to describe contemporary surgical strategies and outcomes for AAAD. METHODS: Between July 2011 and September 2012, 2982 patients with AAAD underwent operations at 640 centers in North America. RESULTS: In this cohort, median age was 60 years old, 66% were male, and 80% had hypertension. The most common arterial cannulation strategies included femoral (36%), axillary (27%), and direct aortic (19%). The median perfusion and cross-clamp times were 181 and 102 min, respectively. The lowest temperature on bypass showed significant variation. Hypothermic circulatory arrest (HCA) was used in 78% of cases. Among those undergoing HCA, brain protection strategies included antegrade cerebral perfusion (31%), retrograde cerebral perfusion (25%), both (4%), and none (40%). Median HCA plus cerebral perfusion time was 40 min. Major complications included prolonged ventilation (53%), reoperation (19%), renal failure (18%), permanent stroke (11%), and paralysis (3%). Operative mortality was 17%. The median intensive care unit and hospital length of stays were 4.7 and 9.0 days, respectively. Among 640 centers, the median number of cases performed during the study period was three. Resuscitation, unresponsive state, cardiogenic shock, inotrope use, age >70, diabetes, and female sex were found to be independent predictors of mortality. CONCLUSIONS: These data describe contemporary patient characteristics, operative strategies, and outcomes for AAAD in North America. Mortality and morbidity for AAAD remain high.

Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery.

Importance: The left atrial appendage is a key site of thrombus formation in atrial fibrillation (AF) and can be occluded or removed at the time of cardiac surgery. There is limited evidence regarding the effectiveness of surgical left atrial appendage occlusion (S-LAAO) for reducing the risk of thromboembolism. Objective: To evaluate the association of S-LAAO vs no receipt of S-LAAO with the risk of thromboembolism among older patients undergoing cardiac surgery. Design, Setting, and Participants: Retrospective cohort study of a nationally representative Medicare-linked cohort from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2012). Patients aged 65 years and older with AF undergoing cardiac surgery (coronary artery bypass grafting [CABG], mitral valve surgery with or without CABG, or aortic valve surgery with or without CABG) with and without concomitant S-LAAO were followed up until December 31, 2014. Exposures: S-LAAO vs no S-LAAO. Main Outcomes and Measures: The primary outcome was readmission for thromboembolism (stroke, transient ischemic attack, or systemic embolism) at up to 3 years of follow-up, as defined by Medicare claims data. Secondary end points included hemorrhagic stroke, all-cause mortality, and a composite end point (thromboembolism, hemorrhagic stroke, or all-cause mortality). Results: Among 10 524 patients undergoing surgery (median age, 76 years; 39% female; median CHA2DS2-VASc score, 4), 3892 (37%) underwent S-LAAO. Overall, at a mean follow-up of 2.6 years, thromboembolism occurred in 5.4%, hemorrhagic stroke in 0.9%, all-cause mortality in 21.5%, and the composite end point in 25.7%. S-LAAO, compared with no S-LAAO, was associated with lower unadjusted rates of thromboembolism (4.2% vs 6.2%), all-cause mortality (17.3% vs 23.9%), and the composite end point (20.5% vs 28.7%) but no significant difference in rates of hemorrhagic stroke (0.9% vs 0.9%). After inverse probability-weighted adjustment, S-LAAO was associated with a significantly lower rate of thromboembolism (subdistribution hazard ratio [HR], 0.67; 95% CI, 0.56-0.81; P < .001), all-cause mortality (HR, 0.88; 95% CI, 0.79-0.97; P = .001), and the composite end point (HR, 0.83; 95% CI, 0.76-0.91; P < .001) but not hemorrhagic stroke (subdistribution HR, 0.84; 95% CI, 0.53-1.32; P = .44). S-LAAO, compared with no S-LAAO, was associated with a lower risk of thromboembolism among patients discharged without anticoagulation (unadjusted rate, 4.2% vs 6.0%; adjusted subdistribution HR, 0.26; 95% CI, 0.17-0.40; P < .001), but not among patients discharged with anticoagulation (unadjusted rate, 4.1% vs 6.3%; adjusted subdistribution HR, 0.88; 95% CI, 0.56-1.39; P = .59). Conclusions and Relevance: Among older patients with AF undergoing concomitant cardiac surgery, S-LAAO, compared with no S-LAAO, was associated with a lower risk of readmission for thromboembolism over 3 years. These findings support the use of S-LAAO, but randomized trials are necessary to provide definitive evidence.

Gait Speed Predicts 30-Day Mortality After Transcatheter Aortic Valve Replacement: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Surgical risk scores do not include frailty assessments (eg, gait speed), which are of particular importance for patients with severe aortic stenosis considering transcatheter aortic valve replacement. METHODS AND RESULTS: We assessed the association of 5-m gait speed with outcomes in a cohort of 8039 patients who underwent transcatheter aortic valve replacement (November 2011-June 2014) and were included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for Society of Thoracic Surgeons-predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The overall median gait speed was 0.63 m/s (25th-75th percentile, 0.47-0.79 m/s), with the slowest walkers (<0.5 m/s) constituting 28%, slow walkers (0.5-0.83 m/s) making up 48%, and normal walkers (>0.83 m/s) constituting 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for the slowest, slow, and normal walkers, respectively (P<0.001). Each 0.2-m/s decrease in gait speed corresponded to an 11% increase in 30-day mortality (adjusted odds ratio, 1.11; 95% confidence interval, 1.01-1.22). The slowest walkers had 35% higher 30-day mortality than normal walkers (adjusted odds ratio, 1.35; 95% confidence interval, 1.01-1.80), significantly longer hospital stays, and a lower probability of being discharged to home. CONCLUSIONS: Gait speed is independently associated with 30-day mortality after transcatheter aortic valve replacement. Identification of frail patients with the slowest gait speeds facilitates preprocedural evaluation and anticipation of a higher level of postprocedural care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528.

Predicting risk of cardiac events among ST-segment elevation myocardial infarction patients with conservatively managed non-infarct-related artery coronary artery disease: An analysis of the Duke Databank for Cardiovascular Disease.

BACKGROUND: Recent randomized evidence has demonstrated benefit with complete revascularization during the index hospitalization for multivessel coronary artery disease ST-segment elevation myocardial infarction (STEMI) patients; however, this benefit likely depends on the risk of future major adverse cardiovascular events (MACE). METHODS: Using data from Duke University Medical Center (2003-2012), we identified those at high risk for 1-year MACE among 664 STEMI patients with conservatively managed non-infarct-related artery (non-IRA) lesions. Using multivariable logistic regression, we identified clinical and angiographic characteristics associated with MACE (death, myocardial infarction, urgent revascularization) to 1 year and developed an integer-based risk prediction model for clinical use. RESULTS: In this cohort (median age 60 years, 30% female), the unadjusted Kaplan-Meier rates for MACE at 30 days and 1 year were 10% and 28%, respectively. Characteristics associated with MACE at 1 year included reduced left ventricular ejection fraction, hypertension, heart failure, higher-risk non-IRA vessels (left main), renal insufficiency, and greater % stenosis of non-IRA lesions. A 15-point risk score including these variables had modest discrimination (C-index 0.67) across a spectrum of subsequent risk (4%-88%) for 1-year MACE. CONCLUSIONS: There is a wide spectrum of risk following primary percutaneous coronary intervention for STEMI patients with multivessel disease. Using readily available clinical characteristics, the expected incidence of MACE by 1 year can be calculated with a simplified risk score, facilitating a tailored approach to clinical care.

Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009).

OBJECTIVES: To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG). BACKGROUND: DES reduce target vessel revascularization in patients with failing SVGs; however, compared with bare metal stents (BMS), DES have been variably associated with increased mortality. METHODS: Clinical records from National Cardiovascular Data Registry(®) CathPCI Registry(®) (49,325 older individuals [≥65 years] who underwent SVG stenting 2005-2009) were linked to Medicare claims to create a longitudinal record. Death, myocardial infarction (MI), and urgent revascularization with DES versus BMS were evaluated to 3 years using propensity matching (PM). Results were stratified by clinical presentation (acute coronary syndrome [ACS], non-ACS), previous lesion treatment (in-stent, de novo), and graft segment (aortic, body, distal anastomosis). RESULTS: In this older cohort (median age, 75 years), acute presentations were prevalent (ACS, 69%; TIMI flow <3, 45%), and adverse clinical outcomes were common by 3 years (death, 24.5%; MI, 14.6%; urgent revascularization, 29.5%). Among DES patients (n = 31,403), 3-year mortality was lower (vs. BMS) (22.7% vs. 28.0%, P < 0.001; PM hazard ratio [HR] 0.87, 95% confidence interval 0.83-0.91), and no difference was observed in the adjusted risk for MI (PM HR 0.97, 0.91 to 1.03) or urgent revascularization (PM HR 1.04, 0.99-1.08). These findings were independent of clinical presentation, previous lesion treatment, and graft segment (P interaction, ns). CONCLUSIONS: In this large SVG PCI cohort, all-cause mortality was lower among those receiving DES, and no difference in MI or urgent revascularization was observed to 3 years. © 2015 Wiley Periodicals, Inc.

Practice patterns and clinical outcomes after hybrid coronary revascularization in the United States: an analysis from the society of thoracic surgeons adult cardiac database.

BACKGROUND: Hybrid coronary revascularization (HCR) involves a combination of surgical and percutaneous techniques, which in selected patients may present an alternative to conventional coronary artery bypass grafting (CABG). METHODS AND RESULTS: Patients were included who underwent HCR (staged/concurrent) or isolated CABG in the Society of Thoracic Surgeons Adult Cardiac Surgery Database (July 2011 to March 2013). HCR represented 0.48% (n=950; staged=809, concurrent=141) of the total CABG volume (n=198,622) during the study period, and was performed in one-third of participating centers (n=361). Patients who underwent HCR had higher cardiovascular risk profiles in comparison with patients undergoing CABG. In comparison with CABG, median sternotomy (98.5% for CABG, 61.1% for staged HCR, and 52.5% for concurrent HCR), direct vision harvesting (98.9%, 66.0%, and 68.1%) and cardiopulmonary bypass (83.4%, 45%, and 36.9%) were less frequently used for staged and concurrent HCR, whereas robotic assistance (0.7%, 33.0%, and 30.5%) was more common. After adjustment, no differences were observed for the composite of in-hospital mortality and major morbidity (odds ratio, 0.93; 95% confidence interval, 0.75-1.16; P=0.53 for staged HCR, and odds ratio, 0.94; 95% confidence interval, 0.56-1.56; P=0.80 for concurrent HCR in comparison with CABG). There was no statistically significant association between operative mortality and either treatment group (odds ratio, 0.74; 95% confidence interval, 0.42-1.30; P=0.29 for staged HCR, and odds ratio, 2.26; 95% confidence interval, 0.99-5.17; P=0.053 for concurrent HCR in comparison with CABG). CONCLUSION: HCR, either as a staged or concurrent procedure, is performed in one-third of US hospitals and is reserved for a highly selected patient population. Although HCR may appear to be an equally safe alternative for CABG surgery, further randomized study is warranted.

Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves.

BACKGROUND AND AIM OF THE STUDY: Since the voluntary recall of St. Jude Medical (SJM) Silzone impregnated heart valves, no large-scale study has examined their long-term outcomes. METHODS: Using Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (1993-2004), the clinical outcomes were evaluated through eight years among those patients who received SJM mechanical heart valves during the Silzone era (March 1998 to December 1999; n = 3,775), relative to those in both the pre-Silzone era (January 1993 to February 1998; n = 13,570) and the post-Silzone era (January 2000 to December 2004; n = 6,882). An inverse probability weighting was used to balance the observed differences in case mix. RESULTS: During the Silzone era, 79% of all implanted mechanical heart valves were manufactured by SJM. By eight years post-implantation, the most common adverse events in this Medicare-linked cohort (median age 71 years) were death (43.5%) and thromboembolism (14.7%), while valve reoperation (1.7%) and endocarditis (1.4%) were less common. Patients treated during the Silzone era experienced a lower associated risk of mortality to eight years than those in both the pre-Silzone era (adjusted hazards ratio (HR) 0.93, 95% confidence interval (CI) 0.88-0.98) and post-Silzone era (adjusted HR 0.92, CI 0.67-0.98), while the adjusted eight-year risks of reoperation, thromboembolism and endocarditis were similar across the three eras for the overall cohort and among both aortic valve and mitral valve patients. CONCLUSION: Medicare patients who received SJM mechanical heart valves during the Silzone era experienced similar clinical outcomes as those treated before or after the Silzone era. These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals.

Clinical outcomes at 1 year following transcatheter aortic valve replacement.

IMPORTANCE: Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. OBJECTIVE: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. EXPOSURE: Transcatheter aortic valve replacement. MAIN OUTCOMES AND MEASURES: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. RESULTS: The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71). CONCLUSIONS AND RELEVANCE: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

Long-term safety and effectiveness of mechanical versus biologic aortic valve prostheses in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database.

BACKGROUND: There is a paucity of long-term data comparing biological versus mechanical aortic valve prostheses in older individuals. METHODS AND RESULTS: We performed follow-up of patients aged 65 to 80 years undergoing aortic valve replacement with a biological (n=24 410) or mechanical (n=14 789) prosthesis from 1991 to 1999 at 605 centers within the Society of Thoracic Surgeons Adult Cardiac Surgery Database using Medicare inpatient claims (mean, 12.6 years; maximum, 17 years; minimum, 8 years), and outcomes were compared by propensity methods. Among Medicare-linked patients undergoing aortic valve replacement (mean age, 73 years), both reoperation (4.0%) and endocarditis (1.9%) were uncommon to 12 years; however, the risk for other adverse outcomes was high, including death (66.5%), stroke (14.1%), and bleeding (17.9%). Compared with those receiving a mechanical valve, patients given a bioprosthesis had a similar adjusted risk for death (hazard ratio, 1.04; 95% confidence interval, 1.01-1.07), higher risks for reoperation (hazard ratio, 2.55; 95% confidence interval, 2.14-3.03) and endocarditis (hazard ratio, 1.60; 95% confidence interval, 1.31-1.94), and lower risks for stroke (hazard ratio, 0.87; 95% confidence interval, 0.82-0.93) and bleeding (hazard ratio, 0.66; 95% confidence interval, 0.62-0.70). Although these results were generally consistent among patient subgroups, bioprosthesis patients aged 65 to 69 years had a substantially elevated 12-year absolute risk of reoperation (10.5%). CONCLUSIONS: Among patients undergoing aortic valve replacement, long-term mortality rates were similar for those who received bioprosthetic versus mechanical valves. Bioprostheses were associated with a higher long-term risk of reoperation and endocarditis but a lower risk of stroke and hemorrhage. These risks varied as a function of a patient's age and comorbidities.

Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare & Medicaid services payer databases.

BACKGROUND: Black, Hispanic, and Asian patients have been underrepresented in percutaneous coronary intervention clinical trials; therefore, there are limited data available on outcomes for these race/ethnicity groups. METHODS AND RESULTS: We examined outcomes in 423 965 patients in the National Cardiovascular Data Registry CathPCI Registry database linked to Medicare claims for follow-up. Within each race/ethnicity group, we examined trends in drug-eluting stent (DES) use, 30-month outcomes, and relative outcomes of DES versus bare metal stents. Overall, 390 351 white, 20 191 black, 9342 Hispanic, and 4171 Asian patients > 65 years of age underwent stent implantation from 2004 through 2008 at 940 National Cardiovascular Data Registry participating sites. Trends in adoption of DES were similar across all groups. Relative to whites, black and Hispanic patients undergoing percutaneous coronary intervention had higher long-term risks of death and myocardial infarction (blacks: hazard ratio, 1.28; 95% confidence interval, 1.24-1.32; Hispanics: hazard ratio, 1.15; 95% confidence interval, 1.10-1.21). Long-term outcomes were similar in Asians and whites (hazard ratio, 0.99; 95% confidence interval, 0.92-1.08). Use of DES was associated with better 30-month survival and lower myocardial infarction rates compared with the use of bare metal stents among all race/ethnicity groups except Hispanics, who had similar outcomes with DES or bare metal stents. CONCLUSIONS: Black and Hispanic patients undergoing percutaneous coronary intervention had worse long-term outcomes relative to white and Asian patients. Compared with bare metal stent use, DES use was generally associated with superior long-term outcomes in all racial and ethnic groups, although these differences were not statistically significant in Hispanic patients.

Endoscopic harvesting device type and outcomes in patients undergoing coronary artery bypass surgery.

OBJECTIVE: To evaluate angiographic and clinical outcomes associated with open and closed dissection tunnel endoscopic vein harvesting (EVH) devices. BACKGROUND: A previous PREVENT-IV (PRoject of Ex-vivo Vein graft ENgineering via Transfection IV) analysis reported that EVH for coronary artery bypass graft surgery was associated with worse outcomes than with traditional vein harvesting; however, outcomes by EVH device type were not available. METHODS: Using data from the PREVENT-IV trial, we compared 1549 patients from 75 surgical sites who underwent EVH with open (n = 390) or closed (n = 1159) harvest tunnel devices. Outcomes included the incidence of vein graft failure at 12 to 18 months and a composite of death, myocardial infarction, and revascularization through 5 years. RESULTS: Among patients undergoing open and closed tunnel EVH, no difference in the per-patient incidence of vein graft failure (43.8% vs 47.1%; adjusted odds ratio, 0.91; 95% confidence interval, 0.53-1.55; P = 0.724) or per-graft incidence of vein graft failure (25.5% vs 25.9%; adjusted odds ratio, 0.96; 95% confidence interval, 0.59-1.55; P = 0.847) was observed. At 5 years, no difference was observed in the primary composite clinical outcome between patients who underwent open and closed system EVH (21.5% vs 23.9%; adjusted hazard ratio, 0.85; 95% confidence interval, 0.66-1.10; P = 0.221). CONCLUSIONS: No differences in angiographic or clinical outcomes were observed among patients who underwent open versus closed tunnel endoscopic harvesting for coronary bypass surgery. These findings suggest that the risks associated with EVH that were reported in a previous PREVENT-IV analysis are not related to a specific EVH device.

Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

OBJECTIVE: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

Long-term survival after aortic valve replacement among high-risk elderly patients in the United States: insights from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, 1991 to 2007.

BACKGROUND: Surgical aortic valve replacement (AVR) remains the standard of care for the treatment of operable, symptomatic aortic valve disease; however, to date, there are limited national data on the contemporary long-term outcomes after AVR in older individuals. METHODS AND RESULTS: We examined long-term survival among 145 911 AVR patients ≥ 65 years of age undergoing AVR at 1026 centers with participation in the Society of Thoracic Surgeons Adult Cardiac Surgery Database from 1991 to 2007. In-hospital complications and long-term survival were stratified by age, Society of Thoracic Surgeons perioperative risk of mortality, and several comorbidities. The median patient age was 76 years; 16% had chronic lung disease, 6% had preoperative renal failure, 38% had heart failure, and 12% had prior cardiac surgery. The median survival in patients 65 to 69, 70 to 79, and ≥ 80 years of age undergoing isolated AVR was 13, 9, and 6 years, respectively. For AVR plus coronary artery bypass graft procedures, median survival was 10, 8, and 6 years, respectively. Although only 5% of isolated AVR patients had a high Society of Thoracic Surgeons perioperative risk of mortality (≥ 10%), their median survival was 2.5 to 2.7 years. Severe lung disease and renal failure were each associated with a ≥ 50% reduction in median survival among all age groups compared with those who did not have these comorbidities, whereas left ventricular dysfunction and prior cardiac operation were associated with a 25% reduction in median survival. CONCLUSION: Long-term survival after surgical AVR in the elderly is excellent, although patients with a high Society of Thoracic Surgeons perioperative risk of mortality and those with certain comorbidities carry a particularly poor long-term prognosis.

Short- and long-term outcomes of coronary stenting in women versus men: results from the National Cardiovascular Data Registry Centers for Medicare & Medicaid services cohort.

BACKGROUND: Conflicting evidence exists on sex-based outcomes after coronary stenting. METHODS AND RESULTS: Data on 426 996 patients ≥65 years old (42.3% women) from the National Cardiovascular Data Registry CathPCI Registry (2004-2008) were linked to Medicare inpatient claims to compare in-hospital outcomes by sex and long-term outcomes by sex and stent type. In-hospital complications were more frequent in women than in men: death (3869 [2.2%] versus 3737 [1.6%]; adjusted odds ratio, 1.41; 95% confidence interval [CI], 1.33-1.49), myocardial infarction (2365 [1.3%] versus 2858 [1.2%]; odds ratio, 1.19; 95% CI, 1.11-1.27), bleeding (7860 [4.4%] versus 5627 [2.3%]; odds ratio, 1.86; 95% CI, 1.79-1.93), and vascular complications (2381 [1.3%] versus 1648 [0.7%]; odds ratio, 1.85; 95% CI, 1.73-1.99). At 20.4 months, women had a lower adjusted risk of death (hazard ratio [HR], 0.92; 95% CI, 0.90-0.94) but similar rates of myocardial infarction, revascularization, and bleeding. Relative to bare metal stent use, drug-eluting stent use was associated with similar improved long-term outcomes in both sexes: death (women: adjusted HR, 0.78; 95% CI, 0.76-0.81; men: HR, 0.77; 95% CI, 0.74-0.79), myocardial infarction (women: HR, 0.79; 95% CI, 0.74-0.84; men: HR, 0.81; 95% CI, 0.77-0.85), and revascularization (women: HR, 0.93; 95% CI, 0.90-0.97; men: HR, 0.91; 95% CI, 0.88-0.94). There was no interaction between sex and stent type for long-term outcomes. CONCLUSIONS: In contemporary coronary stenting, women have a slightly higher procedural risk than men but have better long-term survival. In both sexes, use of a drug-eluting stent is associated with lower long-term likelihood for death, myocardial infarction, and revascularization.