Utilization Trends and Short-Term Outcomes for Transcatheter and Surgical Aortic Valve Replacement Surgery in New York.

BACKGROUND: Population-based utilization trends and outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) remain unknown. OBJECTIVES: To examine the utilization trends and outcomes of TAVR and SAVR in New York using all-inclusive aggregated statewide cardiac registries. METHODS: We described the utilization trends, compared baseline characteristics, and evaluated short-term outcomes of TAVR vs SAVR during 2011-2018 in New York. We applied Cox proportional hazards models to analyze changes in 30-day postoperative mortality for TAVR and SAVR. RESULTS: Of a total 37,566 aortic valve replacement (AVR) patients, 50.8% underwent TAVR and 49.2% received SAVR. TAVR's annual volume increased from 715 in 2012 to 4849 in 2018 (578.18% increase) whereas SAVR's annual volume decreased from 2619 in 2012 to 1855 in 2018 (29.17% decrease). TAVR patients were older, more likely to be female and white, and less likely to be Hispanic. Younger patients (<65 years) and Medicare managed-care patients received TAVR (vs SAVR) a lower percentage of the time relative to older patients (≥65 years) and Medicare fee-for-service patients, respectively. In 2018, the unadjusted 30-day mortality rate was 2.37% for TAVR whereas the rate was 0.97% for SAVR. There was significant annual improvement in 30-day mortality for TAVR (annual adjusted hazard ratio, 0.84, 95% confidence interval, 0.80-0.88) but not for SAVR (annual adjusted hazard ratio, 0.96; 95% confidence interval, 0.91-1.01). CONCLUSION: TAVR and AVR experienced massive growth whereas SAVR decreased in New York. Younger and Medicare managed-care patients had unique utilization trends. TAVR was associated with continuous improvement in 30-day postoperative mortality.

Differences in Long-term Outcomes After Coronary Artery Bypass Grafting Using Single vs Multiple Arterial Grafts and the Association With Sex.

IMPORTANCE: Sex-related differences in the outcome of using multiple arterial grafts during coronary artery bypass grafting (CABG) remain uncertain. OBJECTIVE: To compare the outcomes of the use of multiple arterial grafts vs a single arterial graft during CABG for women and men. DESIGN, SETTING, AND PARTICIPANTS: This statewide cohort study used data from New York's Cardiac Surgery Reporting System and New York's Vital Statistics file on 63 402 patients undergoing CABG from January 1, 2005, to December 31, 2014. Statistical analysis was performed from January 10 to August 20, 2020. EXPOSURES: Multiple arterial grafting or single arterial grafting. MAIN OUTCOMES AND MEASURES: Mortality, acute myocardial infarction (AMI), stroke, repeated revascularization, major adverse cardiac and cerebrovascular event (composite of mortality, AMI, and stroke), and major adverse cardiac event (composite of mortality, AMI, or repeated revascularization) were compared among propensity-matched patients and stratified by the risk of long-term mortality. RESULTS: Of the 63 402 patients (48 155 men [76.0%]; mean [SD] age, 69.9 [10.5] years) in the study, women had worse baseline characteristics than men for most of the explored variables. Propensity matching yielded a total of 9512 male pairs and 1860 female pairs. At 7 years of follow-up, mortality was lower among men who underwent multiple arterial grafting (adjusted hazard ratio, 0.80; 95% CI, 0.73-0.87) but not women who underwent multiple arterial grafting (adjusted hazard ratio, 0.99; 95% CI, 0.84-1.15). When stratified by the estimated risk of death, the use of multiple arterial grafts was associated with better survival and a lower rate of a major adverse cardiac event among low-risk, but not high-risk, patients of both sexes, and the risk cutoff was different for men and women. CONCLUSIONS AND RELEVANCE: This study suggests that women have a worse preoperative risk profile than men. Multiple arterial grafting is associated with better outcomes among low-risk, but not high-risk, patients, and the risk cutoffs differ between sexes. These data highlight the need for new studies on the outcome of multiple arterial grafts in women.

Association of Anesthesiologist Handovers With Short-term Outcomes for Patients Undergoing Cardiac Surgery.

BACKGROUND: Complete handover of anesthesia care to a second anesthesiologist has been demonstrated to be associated with worse short-term adverse outcomes among cardiac surgery patients, but little information from multi-institutional studies is available. METHODS: New York's cardiac surgery registry was used to identify patients who underwent cardiac surgery in New York between 2010 and 2016 with and without complete handovers of anesthesia care. A retrospective observational study with inverse probability treatment weighting (IPTW) based on the propensity score was used to adjust for differences in preoperative patient characteristics while comparing differences in the primary outcome (in-hospital/30 day mortality), major complications in the index admission or within 30 days of the index surgery, readmissions within 30 days, and length of stay. RESULTS: A total of 8.5% of the 103,102 cardiac surgery procedures involved complete handovers. After adjustment, there was a difference between patients with and without handovers in the primary outcome (2.86% vs 2.48%, adjusted risk ratio [ARR] = 1.15 [1.01-1.31]). There was no difference in readmissions within 30 days (13.7% vs 14.4%, ARR = 0.95 [0.90-1.00]), and the differences in complications and length of stay were not clinically meaningful (adjusted differences of <10%). CONCLUSIONS: Cardiac surgery patients in New York who had complete anesthesia handovers experienced higher short-term mortality rates, but there were no meaningful differences in other outcomes. Unnecessary handovers should be carefully monitored.

Out-of-Hospital 30-day Deaths After Cardiac Surgery Are Often Underreported.

BACKGROUND: Operative mortality (in-hospital during the index admission or within 30 days of the procedure after discharge) is commonly used as a quality of care measure for public reporting of cardiac surgery outcomes, but the ability to capture out-of-hospital deaths accurately remains undetermined. The objective of the study was to estimate the impact of incomplete reporting of out-of-hospital deaths on hospital risk-adjusted mortality and outlier status. METHODS: New York State's 2014 to 2016 cardiac registry data were used to compare the capture of 30-day postprocedure deaths after discharge with and without the use of national and state-level vital statistics data for all 54,442 patients undergoing isolated coronary artery bypass graft, cardiac valve surgery, or both. Hospital risk-adjusted operative mortality rates and mortality outliers were compared based on statistical models that were developed with and without the use of vital statistics data. RESULTS: Thirty-day deaths postprocedure after discharge ranged from 10% to 39% of all operative deaths among cardiac surgical procedures. More than 30% of these deaths were missing without vital statistics confirmation for 7 of the 10 cardiac procedures examined, and more than 40% were missing for 5 of the procedures examined. When vital statistics data were used to confirm 30-day postprocedure deaths after discharge, an additional high outlier for valve surgery was identified. CONCLUSIONS: Operative mortality after cardiac surgery is often underreported owing to a considerable percentage of out-of-hospital cardiac surgery deaths that are missed by reporting centers. This can adversely affect the assessment of hospital risk-adjusted mortality in public reports.

Outcomes With Complete Versus Incomplete Revascularization in Patients With Multivessel Coronary Disease Undergoing Percutaneous Coronary Intervention With Everolimus Eluting Stents.

The aim of the study was to evaluate the outcomes with completeness of revascularization (CR) in patients with multivessel disease (MVD) who underwent PCI using everolimus-eluting stent (EES). Patients with MVD who underwent PCI using EES in New York State were chosen. Patients were categorized into CR, attempted but failed CR or incomplete revascularization (ICR). The primary outcome was death/myocardial infarction (MI). Secondary outcomes were death/MI/repeat revascularization and the individual components of the composite outcomes. Multiple propensity score adjustment analysis was used to adjust for differences in covariates among the 3 groups. Among 15,046 patients, 4,545 (30%) had CR. The strongest predictors of ICR were the number of vessels diseased (χ2 = 428.48; p <0.0001) and presence of chronic total occlusion (CTO) (χ2 = 184.27; p <0.0001). In the multiple propensity score-adjusted analysis, over a mean follow-up of 2.9 years, compared with CR, ICR was associated with significant higher risk of death/MI (17.49% vs 12.69%; hazard ratio [HR] = 1.15; 95% confidence interval [CI] 1.02 to 1.29; p = 0.02), death/MI/repeat revascularization (48.01% vs 37.85%; HR = 1.19; 95% CI 1.12 to 1.27; p <0.0001), death (12.41% vs 8.63%; HR = 1.16; 95% CI 1.00 to 1.35; p = 0.047), and repeat revascularization (39.16% vs 31.63%; HR = 1.20; 95% CI 1.12 to 1.28; p <0.0001), with numerically higher rates of MI (7.18% vs 4.90%; HR = 1.17; 95% CI 0.98 to 1.40; p = 0.09). The risk with attempted but failed CR was intermediate between CR and ICR. In conclusion, in patients with MVD who underwent PCI with EES, incomplete revascularization is associated with significantly higher risk of cardiovascular events including death compared with complete revascularization.

Multiple Versus Single Arterial Coronary Bypass Graft Surgery for Multivessel Disease.

BACKGROUND: Despite recent guideline statements, there is still wide practice variation in the use of multiple arterial grafts (MAGs) versus single arterial grafts (SAGs) for patients with multivessel disease undergoing coronary artery bypass graft surgery. This may be related to differences in findings between observational and randomized controlled studies. OBJECTIVES: This study sought to compare intermediate-term MAG and SAG outcomes with enhanced matching to reduce selection bias. METHODS: New York's cardiac registry identified 63,402 multivessel disease patients undergoing coronary artery bypass graft surgery between January 1, 2005, and December 31, 2014, to compare outcomes (median follow-up 6.5 years) for patients receiving SAGs and MAGs. SAG and MAG patients were propensity matched using 38 baseline characteristics to reduce selection bias. The primary endpoint was mortality, and secondary endpoints included repeat revascularization and a composite endpoint of mortality, acute myocardial infarction, and stroke. RESULTS: Before matching, 20% of procedures employed MAG. At 1 year, there was no mortality difference between matched MAG and SAG patients (2.4% vs. 2.2%, adjusted hazard ratio [AHR]: 1.11; 95% confidence interval [CI]: 0.93 to 1.32). At 7 years, MAG patients had lower mortality (12.7% vs. 14.3%, AHR: 0.86; 95% CI: 0.79 to 0.93), a lower composite outcome (20.2% vs. 22.8%, AHR: 0.88; 95% CI: 0.83 to 0.93), and a lower repeat revascularization rate (11.7% vs. 14.6%, AHR: 0.80; 95% CI: 0.74 to 0.87). At 7 years, the subgroups for which MAG did not have a lower mortality rate included patients with off-pump surgery, 2-vessel disease with right coronary artery disease, recent acute myocardial infarction, renal dysfunction, and patient ≥70 years of age. CONCLUSIONS: Mortality and the composite outcome were similar between MAG and SAG patients at 1 year, but lower for MAG after 7 years. Patients of higher volume MAG surgeons experienced lower MAG mortality.

Retooling of Paper-based Outcome Measures to Electronic Format: Comparison of the NY State Public Risk Model and EHR-derived Risk Models for CABG Mortality.

BACKGROUND: Risk adjustment is critical in the comparison of quality of care and health care outcomes for providers. Electronic health records (EHRs) have the potential to eliminate the need for costly and time-consuming manual data abstraction of patient outcomes and risk factors necessary for risk adjustment. METHODS: Leading EHR vendors and hospital focus groups were asked to review risk factors in the New York State (NYS) coronary artery bypass graft (CABG) surgery statistical models for mortality and readmission and assess feasibility of EHR data capture. Risk models based only on registry data elements that can be captured by EHRs (one for easily obtained data and one for data obtained with more difficulty) were developed and compared with the NYS models for different years. RESULTS: Only 6 data elements could be extracted from the EHR, and outlier hospitals differed substantially for readmission but not for mortality. At the patient level, measures of fit and predictive ability indicated that the EHR models are inferior to the NYS CABG surgery risk model [eg, c-statistics of 0.76 vs. 0.71 (P<0.001) and 0.76 vs. 0.74 (P=0.009) for mortality in 2010], although the correlation of the predicted probabilities between the NYS and EHR models was high, ranging from 0.96 to 0.98. CONCLUSIONS: A simplified risk model using EHR data elements could not capture most of the risk factors in the NYS CABG surgery risk models, many outlier hospitals were different for readmissions, and patient-level measures of fit were inferior.

Mitral valve repair versus replacement for patients with preserved left ventricular function without heart failure symptoms.

OBJECTIVE: The purposes of this study are to compare outcomes of mitral valve repair (MV-repair) and mitral valve replacement for patients with severe mitral regurgitation with preserved ventricular function and no congestive heart failure (CHF) symptoms and to examine variations in surgeon choice of procedure and outcomes by surgeon volume. METHODS: In total, 2259 consecutive patients in 42 New York State hospitals with the characteristics mentioned previously who underwent mitral valve repair (1801, 79.7%) or replacement between January 1, 2008, and December 31, 2014, were identified from a mandatory statewide clinical registry. Propensity-matching was used to compare mortality and competing risk analyses were used to compare nonfatal outcomes. Median follow-up was 4.0 years. The use of mitral repair and risk-adjusted mortality for surgery were also examined as a function of individual surgeon mitral case volume. RESULTS: Propensity-matched patients who underwent MV-repair experienced a significantly lower mortality rate at 4 years (3.5% vs 12.1%, P < .001). Greater-volume surgeons were more likely to perform MV-repairs (92% vs 84%, 74%, and 69% in lower volume quartiles, respectively). No significant differences in mortality were observed among volume quartiles. CONCLUSIONS: Patients with chronic severe primary mitral valve regurgitation with preserved ventricular function and no CHF symptoms who underwent MV-repair experienced lower mortality and no different reoperation, CHF, or stroke readmission rates than patients who underwent replacement. Greater-volume surgeons were more likely than their lower volume counterparts to choose mitral repair. Repair should be considered as the surgical option for these patients whenever possible.

2017 Versus 2012 Appropriate Use Criteria for Percutaneous Coronary Interventions: Impact on Appropriateness Ratings.

OBJECTIVES: The purpose of this study is to revisit cases rated as "inappropriate" in the 2012 appropriate use criteria (AUC) using the 2017 AUC. BACKGROUND: AUC for coronary revascularization in patients with stable ischemic heart disease (SIHD) were released in January 2017. Earlier 2012 AUC identified a relatively high percentage of New York State patients for whom percutaneous coronary intervention (PCI) was rated as "inappropriate" versus optimal medical therapy alone. METHODS: New York State's PCI registry was used to rate inappropriateness of patients undergoing PCI in 2014 using the 2012 and 2017 AUC, and to examine patient characteristics for patients rated differently. RESULTS: A total of 911 of 9,261 (9.8%) patients who underwent PCI in New York State in 2014 with SIHD without prior coronary artery bypass grafting were rated as "inappropriate" using the 2012 AUC, but only 171 (1.8%) patients were rated as "rarely appropriate" ("inappropriate" in 2012 AUC terminology) using the 2017 AUC. A total of 26% of all 8,407 patients undergoing PCI in New York State with 1- to 2-vessel SIHD were without high-risk findings on noninvasive testing and were either asymptomatic or without antianginal therapy. No current or past randomized controlled trials have focused on these patients. CONCLUSIONS: The percentage of 2014 New York State PCI patients with SIHD who are rated "rarely appropriate" has decreased substantially using 2017 AUC in comparison with the older 2012 AUC. However, for many low-risk patients undergoing the procedure, the relative benefits of optimal medical therapy with and without PCI are unknown. Randomized controlled trials are needed to study these groups.

Female-specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of randomised controlled trials including 3758 patients.

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is the first area of interventional cardiology where women are treated as often as men. In this analysis of the gender specific results of randomised controlled trials (RCTs) comparing TAVI with surgical aortic valve replacement (SAVR) we aimed to determine whether gender affects the survival comparison between TAVI and SAVR. We identified all RCTs comparing TAVI versus SAVR for severe AS and reporting 1 and/or 2year survival. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I2. Four RCTs met the criteria, totalling 3758 patients, 1706 women and 2052 men. Amongst females, TAVI recipients had a significantly lower mortality than SAVR recipients, at 1year (OR 0.68; 95%CI 0.50 to 0.94) and at 2years (OR 0.74; 95%CI 0.58 to 0.95). Amongst males there was no difference in mortality between TAVI and SAVR, at 1year (OR 1.09; 95%CI 0.86 to 1.39) or 2years (OR 1.05; 95%CI 0.85 to 1.3). The difference in treatment effect between genders was significant at both 1year (pinteraction=0.02) and 2years (pinteraction=0.04). In women TAVI has a 26 to 31% lower mortality odds than SAVR. In men, there is no difference in mortality between TAVI and SAVR.

Changes in Percutaneous Coronary Interventions Deemed "Inappropriate" by Appropriate Use Criteria.

BACKGROUND: Recent studies have demonstrated relatively high rates of percutaneous coronary interventions (PCIs) classified as "inappropriate." The New York State Department of Health shared rates with hospitals and announced the intention of withholding reimbursement pending demonstration of clinical rationale for Medicaid patients with inappropriate PCIs. OBJECTIVES: The objective was to examine changes over time in the number and rate of inappropriate PCIs. METHODS: Appropriate use criteria were applied to PCIs performed in New York in patients without acute coronary syndromes or previous coronary artery bypass graft surgery in periods before (2010 through 2011) and after (2012 through 2014) efforts were made to decrease inappropriateness rates. Changes in the number of appropriate PCIs were also assessed. RESULTS: The percentage of inappropriate PCIs for all patients dropped from 18.2% in 2010 to 10.6% in 2014 (from 15.3% to 6.8% for Medicaid patients, and from 18.6% to 11.2% for other patients). The total number of PCIs in patients with no acute coronary syndrome/no prior coronary artery bypass graft surgery that were rated as inappropriate decreased from 2,956 patients in 2010 to 911 patients in 2014, a reduction of 69%. For Medicaid patients, the decrease was from 340 patients to 84 patients, a decrease of 75%. For a select set of higher-risk scenarios, there were higher numbers of appropriate PCIs per year in the period from 2012 to 2014. CONCLUSIONS: The inappropriateness rate for PCIs and the use of PCI for elective procedures in New York has decreased substantially between 2010 and 2014. This decrease has occurred for a large proportion of PCI hospitals.

Revascularization in Patients With Multivessel Coronary Artery Disease and Severe Left Ventricular Systolic Dysfunction: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery.

BACKGROUND: Guidelines recommend coronary artery bypass graft surgery (CABG) over percutaneous coronary intervention (PCI) for multivessel disease and severe left ventricular systolic dysfunction. However, CABG has not been compared with PCI in such patients in randomized trials. METHODS AND RESULTS: Patients with multivessel disease and severe left ventricular systolic dysfunction (ejection fraction ≤35%) who underwent either PCI with everolimus-eluting stent or CABG were selected from the New York State registries. The primary outcome was long-term all-cause death. Secondary outcomes were individual outcomes of myocardial infarction, stroke, and repeat revascularization. Among the 4616 patients who fulfilled our inclusion criteria (1351 everolimus-eluting stent and 3265 CABG), propensity score matching identified 2126 patients with similar propensity scores. In the short term, PCI was associated with a lower risk of stroke (hazard ratio [HR], 0.05; 95% confidence interval [CI], 0.01-0.39; P=0.004) in comparison with CABG. At long-term follow-up (median, 2.9 years), PCI was associated with a similar risk of death (HR, 1.01; 95% CI, 0.81-1.28; P=0.91), a higher risk of myocardial infarction (HR, 2.16; 95% CI, 1.42-3.28; P=0.0003), a lower risk of stroke (HR, 0.57; 95% CI, 0.33-0.97; P=0.04), and a higher risk of repeat revascularization (HR, 2.54; 95% CI, 1.88-3.44; P<0.0001). The test for interaction was significant (P=0.002) for completeness of revascularization, such that, in patients in whom complete revascularization was achieved with PCI, there was no difference in myocardial infarction between PCI and CABG. CONCLUSIONS: Among patients with multivessel disease and severe left ventricular systolic dysfunction, PCI with everolimus-eluting stent had comparable long-term survival in comparison with CABG. PCI was associated with higher risk of myocardial infarction (in those with incomplete revascularization) and repeat revascularization, and CABG was associated with higher risk of stroke.

Appending Limited Clinical Data to an Administrative Database for Acute Myocardial Infarction Patients: The Impact on the Assessment of Hospital Quality.

BACKGROUND: Hospitals' risk-standardized mortality rates and outlier status (significantly higher/lower rates) are reported by the Centers for Medicare and Medicaid Services (CMS) for acute myocardial infarction (AMI) patients using Medicare claims data. New York now has AMI claims data with blood pressure and heart rate added. OBJECTIVE: The objective of this study was to see whether the appended database yields different hospital assessments than standard claims data. METHODS: New York State clinically appended claims data for AMI were used to create 2 different risk models based on CMS methods: 1 with and 1 without the added clinical data. Model discrimination was compared, and differences between the models in hospital outlier status and tertile status were examined. RESULTS: Mean arterial pressure and heart rate were both significant predictors of mortality in the clinically appended model. The C statistic for the model with the clinical variables added was significantly higher (0.803 vs. 0.773, P<0.001). The model without clinical variables identified 10 low outliers and all of them were percutaneous coronary intervention hospitals. When clinical variables were included in the model, only 6 of those 10 hospitals were low outliers, but there were 2 new low outliers. The model without clinical variables had only 3 high outliers, and the model with clinical variables included identified 2 new high outliers. CONCLUSION: Appending even a small number of clinical data elements to administrative data resulted in a difference in the assessment of hospital mortality outliers for AMI. The strategy of adding limited but important clinical data elements to administrative datasets should be considered when evaluating hospital quality for procedures and other medical conditions.

Utilization and 1-Year Mortality for Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement in New York Patients With Aortic Stenosis: 2011 to 2012.

OBJECTIVES: The purpose of this study was to investigate changes in the use of transcatheter aortic valve replacement (TAVR) relative to surgical aortic valve replacement (SAVR) and to examine relative 1-year TAVR and SAVR outcomes in 2011 to 2012 in a population-based setting. BACKGROUND: TAVR has become a popular option for patients with severe aortic stenosis, particularly for higher-risk patients. METHODS: New York's Cardiac Surgery Reporting System was used to identify TAVR and SAVR volumes and to propensity match TAVR and SAVR patients using numerous patient risk factors contained in the registry to compare 1-year mortality rates. Mortality rates were also compared for different levels of patient risk. RESULTS: The total number of aortic valve replacement patients increased from 2,291 in 2011 to 2,899 in 2012, an increase of 27%. The volume of SAVR patients increased by 7.1% from 1,994 to 2,135 and the volume of TAVR patients increased 157% from 297 to 764. The percentage of SAVR patients that were at higher risk (≥3% New York State [NYS] score, equivalent to a Society of Thoracic Surgeons score of about 8%) decreased from 27% to 23%, and the percentage of TAVR patients that were at higher risk decreased from 83% to 76%. There was no significant difference in 1-year mortality between TAVR and SAVR patients (15.6% vs. 13.1%; hazard ratio [HR]: 1.30 [95% confidence interval (CI): 0.89 to 1.92]). There were no differences among patients with NYS score <3% (12.5% vs. 10.2%; HR: 1.42 [95% CI: 0.68 to 2.97]) or among patients with NYS score ≥3% (17.1% vs. 14.5%; HR: 1.27 [95% CI: 0.81 to 1.98]). CONCLUSIONS: TAVR has assumed a much larger share of all aortic valve replacements for severe aortic stenosis, and the average level of pre-procedural risk has decreased substantially. There are no differences between 1-year mortality rates for TAVR and SAVR patients.

Revascularization in Patients With Multivessel Coronary Artery Disease and Chronic Kidney Disease: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery.

BACKGROUND: Randomized trials of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) routinely exclude patients with chronic kidney disease (CKD). OBJECTIVES: This study evaluated outcomes of PCI versus CABG in patients with CKD. METHODS: Patients with CKD who underwent PCI using everolimus-eluting stents were propensity-score matched to patients who underwent isolated CABG for multivessel coronary disease in New York. The primary outcome was all-cause mortality. Secondary outcomes were myocardial infarction (MI), stroke, and repeat revascularization. RESULTS: Of 11,305 patients with CKD, 5,920 patients were propensity-score matched. In the short term, PCI was associated with a lower risk of death (hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.35 to 0.87), stroke (HR: 0.22; 95% CI: 0.12 to 0.42), and repeat revascularization (HR: 0.48; 95% CI: 0.23 to 0.98) compared with CABG. In the longer term, PCI was associated with a similar risk of death (HR: 1.07; 95% CI: 0.92 to 1.24), higher risk of MI (HR: 1.76; 95% CI: 1.40 to 2.23), a lower risk of stroke (HR: 0.56; 95% CI: 0.41 to 0.76), and a higher risk of repeat revascularization (HR: 2.42; 95% CI: 2.05 to 2.85). In the subgroup with complete revascularization with PCI, the increased risk of MI was no longer statistically significant (HR: 1.18; 95% CI: 0.67 to 2.09). In the 243 matched pairs of patients with end-stage renal disease on hemodialysis, PCI was associated with significantly higher risk of death (HR: 2.02; 95% CI: 1.40 to 2.93) and repeat revascularization (HR: 2.44; 95% CI: 1.50 to 3.96) compared with CABG. CONCLUSIONS: In patients with CKD, CABG is associated with higher short-term risk of death, stroke, and repeat revascularization, whereas PCI with everolimus-eluting stents is associated with a higher long-term risk of repeat revascularization and perhaps MI, with no long-term mortality difference. In the subgroup on dialysis, the results favored CABG over PCI.

Thirty-Day Readmissions After Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis in New York State.

BACKGROUND: Several studies have compared short-term and medium-term mortality rates for patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR), but no studies have compared short-term readmission rates for the 2 procedures. METHODS AND RESULTS: New York's Cardiac Surgery Reporting System was used to propensity match 617 TAVI and 1981 SAVR patients using numerous patient risk factors contained in the registry. The 389 propensity-matched pairs were then used to analyze differences in readmission rates between the 2 groups. TAVI and SAVR readmission rates were also compared for patients with a history of congestive heart failure and for patients aged ≥80. Also, reasons for readmission for TAVI and SAVR patients were examined and compared. Readmission rates were not statistically different for all propensity-matched TAVI and SAVR patients (respective rates, 18.8% and 19.3%; P=0.86). After further adjustment using a logistic regression model, there was still no significant difference (adjusted odds ratio, 0.97; 95% confidence interval [0.68-1.39]). For patients aged ≥80, the 30-day readmission rates were 19.9% and 22.0% (P=0.59), and when further adjusted using the logistic regression model, adjusted odds ratio=0.89 (0.55-1.45). For patients with a history of congestive heart failure, the respective rates were 22.8% and 20.4% (P=0.56), and with further adjustment, adjusted odds ratio became 1.15 (0.72-1.82). CONCLUSIONS: There are no statistically significant differences between TAVI and SAVR patients in short-term readmission rates.

Everolimus Eluting Stents Versus Coronary Artery Bypass Graft Surgery for Patients With Diabetes Mellitus and Multivessel Disease.

BACKGROUND: In patients with diabetes mellitus and multivessel disease, coronary artery bypass graft surgery and percutaneous coronary intervention are treatment options. However, there is paucity of data comparing coronary artery bypass graft surgery against newer generation stents. METHODS AND RESULTS: Patients included in the New York State registries who had diabetes mellitus and underwent isolated coronary artery bypass graft surgery or percutaneous coronary intervention with everolimus eluting stent (EES) for multivessel disease were included. Propensity score matching was used to assemble a cohort with similar baseline characteristics. The primary outcome was all-cause mortality. Secondary outcomes were myocardial infarction (MI), stroke, and repeat revascularization. Short-term (within 30 days) and long-term outcomes were evaluated. Among 16,089 patients with diabetes mellitus and multivessel disease, 8096 patients with similar propensity scores were included. At short-term, EES was associated with a lower risk of death (hazard ratio [HR] =0.58; 95% confidence interval [CI], 0.34-0.98; P=0.04) and stroke (HR=0.14; 95% CI, 0.06-0.30; P<0.0001) but higher risk of MI (HR=2.44; 95% CI, 1.13-5.31; P=0.02). At long-term, EES was associated with a similar risk of death (425 [10.50%] versus 414 [10.23%] events; HR=1.12; 95% CI, 0.96-1.30; P=0.16), a lower risk of stroke (118 [2.92%] versus 157 [3.88%] events; HR=0.76; 95% CI, 0.58-0.99; P=0.04) but a higher risk of MI (260 [6.42%] versus 166 [4.10%] events; HR=1.64; 95% CI, 1.32-2.04; P<0.0001) and repeat revascularization (889 [21.96%] versus 421 [10.40%] events; HR=2.42; 95% CI, 2.12-2.76; P<0.0001). The higher risk of MI was not seen in the subgroup of EES patients who underwent complete revascularization (HR=1.37; 95% CI, 0.76-2.47; P=0.30). CONCLUSIONS: In patients with diabetes mellitus and multivessel disease, EES was associated with lower upfront risk of death and stroke when compared with coronary artery bypass graft surgery. However, at long-term, EES was associated with similar risk of death, a higher risk of MI (in those with incomplete revascularization), and repeat revascularization but a lower risk of stroke.

Everolimus-eluting stents or bypass surgery for multivessel coronary disease.

BACKGROUND: Results of trials and registry studies have shown lower long-term mortality after coronary-artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI) among patients with multivessel disease. These previous analyses did not evaluate PCI with second-generation drug-eluting stents. METHODS: In an observational registry study, we compared the outcomes in patients with multivessel disease who underwent CABG with the outcomes in those who underwent PCI with the use of everolimus-eluting stents. The primary outcome was all-cause mortality. Secondary outcomes were the rates of myocardial infarction, stroke, and repeat revascularization. Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: Among 34,819 eligible patients, 9223 patients who underwent PCI with everolimus-eluting stents and 9223 who underwent CABG had similar propensity scores and were included in the analyses. At a mean follow-up of 2.9 years, PCI with everolimus-eluting stents, as compared with CABG, was associated with a similar risk of death (3.1% per year and 2.9% per year, respectively; hazard ratio, 1.04; 95% confidence interval [CI], 0.93 to 1.17; P=0.50), higher risks of myocardial infarction (1.9% per year vs. 1.1% per year; hazard ratio, 1.51; 95% CI, 1.29 to 1.77; P<0.001) and repeat revascularization (7.2% per year vs. 3.1% per year; hazard ratio, 2.35; 95% CI, 2.14 to 2.58; P<0.001), and a lower risk of stroke (0.7% per year vs. 1.0% per year; hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). The higher risk of myocardial infarction with PCI than with CABG was not significant among patients with complete revascularization but was significant among those with incomplete revascularization (P=0.02 for interaction). CONCLUSIONS: In a contemporary clinical-practice registry study, the risk of death associated with PCI with everolimus-eluting stents was similar to that associated with CABG. PCI was associated with a higher risk of myocardial infarction (among patients with incomplete revascularization) and repeat revascularization but a lower risk of stroke. (Funded by Abbott Vascular.).

Assessing hospital performance for acute myocardial infarction: how should emergency department transfers be attributed.

BACKGROUND: The Centers for Medicare and Medicaid Services publicly reports risk-standardized mortality rates (RSMRs) to assess quality of care for hospitals that treat acute myocardial infarction patients, and the outcomes for inpatient transfers are attributed to transferring hospitals. However, emergency department (ED) transfers are currently ignored and therefore attributed to receiving hospitals. METHODS: New York State administrative data were used to develop a statistical model similar to the one used by Centers for Medicare and Medicaid Services to risk-adjust hospital 30-day mortality rates. RSMRs were calculated and outliers were identified when ED transfers were attributed to: (1) the transferring hospital and (2) the receiving hospital. Differences in hospital outlier status and RSMR tertile between the 2 attribution methods were noted for hospitals performing and not performing percutaneous coronary interventions (PCIs). RESULTS: Although both methods of attribution identified 3 high outlier non-PCI hospitals, only 2 of those hospitals were identified by both methods, and each method identified a different hospital as a third outlier. Also, when transfers were attributed to the referring hospital, 1 non-PCI hospital was identified as a low outlier, and no non-PCI hospitals were identified as a low outlier with the other attribution method. About one sixth of all hospitals changed their tertile status. Most PCI hospitals (89%) that changed status moved to a higher (worse RSMR) tertile, whereas the majority of non-PCI hospitals (68%) that changed status were moved to a lower (better) RSMR tertile when ED transfers were attributed to the referring hospital. CONCLUSIONS: Hospital quality assessments for acute myocardial infarction are affected by whether ED transfers are assigned to the transferring or receiving hospital. The pros and cons of this choice should be considered.

Appropriateness of diagnostic catheterization for suspected coronary artery disease in New York State.

BACKGROUND: Appropriate use criteria for diagnostic catheterization (DC) were recently published. These criteria are yet to be examined for a large population of patients undergoing DC. METHODS AND RESULTS: New York State's Cardiac Diagnostic Catheterization Database was used to identify patients undergoing DC for coronary artery disease between 2010 and 2011 for suspected coronary artery disease. Patients were rated by the appropriate use criteria as appropriate, uncertain, and inappropriate for DC. The relationships between various patient characteristics and the appropriateness ratings were examined, along with the relationships between hospital-level inappropriateness, for DC and 2 other hospital-level variables (hospital DC volume and percutaneous coronary intervention inappropriateness). Of the 8986 patients who could be rated for appropriateness, 35.3% were rated as appropriate, 39.8% as uncertain, and 24.9% as inappropriate. Of the 2240 patients rated as inappropriate, 56.7% were asymptomatic/had no previous stress test/had low or intermediate global coronary artery disease risk, 36.0% had a previous stress test with low-risk findings and no symptoms, and 7.3% were symptomatic/had no previous stress test/had low pretest probability. The median hospital-level inappropriateness rate was 28.5%, with a maximum of 48.8% and a minimum of 8.6%. Hospital-level inappropriateness was not related to hospital volume or inappropriateness for percutaneous coronary intervention. CONCLUSIONS: One quarter of patients undergoing DC for suspected coronary artery disease were rated as inappropriate for the procedure, approximately two thirds of these inappropriate patients had no previous stress test, and ≈90% of inappropriate patients with no previous stress test were asymptomatic with low or intermediate global risk scores.