Use of oral anticoagulants in patients with valvular atrial fibrillation: findings from the NCDR PINNACLE Registry.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Retroperitoneal hematoma after percutaneous coronary intervention: prevalence, risk factors, management, outcomes, and predictors of mortality: a report from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry.

OBJECTIVES: This study sought to evaluate the prevalence, risk factors, outcomes, and predictors of mortality of retroperitoneal hematoma (RPH) following percutaneous coronary intervention. BACKGROUND: Retroperitoneal hematoma is a serious complication of invasive cardiovascular procedures. METHODS: The study sample included 112,340 consecutive patients undergoing percutaneous coronary intervention in a large, multicenter registry between October 2002 and December 2007. End points evaluated included the development of RPH and mortality. RESULTS: Retroperitoneal hematoma occurred in 482 (0.4%) patients. Of these, 92.3% were treated medically and 7.7% underwent surgical repair. Female sex, body surface area <1.8 m(2), emergency procedure, history of chronic obstructive pulmonary disease, cardiogenic shock, pre-procedural IV heparin, pre-procedural glycoprotein IIb/IIIa inhibitors, adoption of sheath size >or=8-F, and use of vascular closure devices were independent predictors of RPH, whereas the use of bivalirudin was associated with a lower risk. The development of RPH was associated with a higher frequency of post-procedure myocardial infarction (5.81% vs. 1.67%, p < 0.0001), infection and/or sepsis (17.43% vs. 3.00%, p < 0.0001), and heart failure (8.00% vs. 1.63%, p < 0.0001). In-hospital mortality was significantly higher in patients who developed RPH than in patients who did not (6.64% vs. 1.07%, p < 0.0001). Among patients with RPH, independent predictors of death were history of myocardial infarction, cardiogenic shock, pre-procedural creatinine >or=1.5 mg/dl, and left ventricular ejection fraction <50%. CONCLUSIONS: Retroperitoneal hematoma is an uncommon complication of contemporary percutaneous coronary intervention associated with high morbidity and mortality. The identification of risk factors for the development of RPH could lead to modification of procedure strategies aimed toward reducing its incidence.

The association between guideline-based treatment instructions at the point of discharge and lower 1-year mortality in Medicare patients after acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) initiative in Michigan.

BACKGROUND: The American College of Cardiology's Guidelines Applied in Practice (GAP) initiative for acute myocardial infarction (AMI) has been shown to increase the use of guideline-based therapies and improve outcomes in patients with AMI. It is unknown whether hospitals that are more successful in using the standard discharge contract--a key component of GAP that emphasizes guideline-based medications, lifestyle modification, and follow-up planning--experience a proportionally greater improvement in patient outcomes. METHODS: Medicare patients treated for AMI in all 33 participating GAP hospitals in Michigan were enrolled. We aggregated the hospitals into 3 tertiles based on the rates of discharge contract use: 0% to 8.4% (tertile 1), >8.4% to 38.0% (tertile 2), and >38.0% to 61.1% (tertile 3). We analyzed 1-year follow-up mortality both pre- and post-GAP and compared the mortality decline post-GAP with discharge contract use according to tertile. RESULTS: There were 1368 patients in the baseline (pre-GAP) cohort and 1489 patients in the post-GAP cohort. After GAP implementation, mortality at 1 year decreased by 1.2% (P = .71), 1.2% (P = .68), and 6.0% (P = .03) for tertiles 1, 2, and 3, respectively. After multivariate adjustment, discharge contract use was significantly associated with decreased 1-year mortality in tertile 2 (odds ratio 0.43, 95% CI 0.22-0.84) and tertile 3 (odds ratio 0.45, 95% CI 0.27-0.75). CONCLUSIONS: Increased hospital utilization of the standard discharge contract as part of the GAP program is associated with decreased 1-year mortality in Medicare patient populations with AMI. Hospital efforts to promote adherence to guideline-based care tools such as the discharge contract used in GAP may result in mortality reductions for their patient populations at 1 year.

Blood transfusion and in-hospital outcomes in anemic patients with myocardial infarction undergoing percutaneous coronary intervention.

Studies have shown poor prognostic implications of anemia in patients with myocardial infarction (MI) and in patients undergoing percutaneous coronary intervention (PCI). The impact of blood transfusion in these populations remains controversial. The objective of this study was to examine the effect of transfusion on in-hospital mortality in anemic patients undergoing PCI for MI. Data from 67,051 PCIs (June 1, 1997 to January 31, 2004) were prospectively collected in a multicenter registry (Blue Cross Blue Shield of Michigan Cardiovascular Consortium). Of these, 4,623 patients who were classified as anemic according to the World Health Organization criteria underwent PCI within 7 days of presentation with acute MI. A propensity score for being transfused was estimated for each patient, and propensity matching and a prediction model for in-hospital death were developed. The average age was 67.8 years, 57.7% of patients were men, and 22.3% of patients received a transfusion during hospitalization. Transfused patients, compared to nontransfused patients, were more likely to be older, female, have lower preprocedure hemoglobin levels, more comorbidities, and a higher unadjusted in-hospital mortality rate (14.52% vs. 3.01%, p < 0.0001). After adjustment for comorbidities and propensity for transfusion, blood transfusion was associated with a higher risk of in-hospital mortality (adjusted odds ratio = 2.02, 95% confidence interval 1.47-2.79, p < 0.0001). In anemic patients undergoing PCI for MI, transfusion was associated with an increased crude and adjusted rate of in-hospital mortality. A randomized controlled trial is needed to determine the value of transfusion and the ideal transfusion criteria.

Sex differences in the application of evidence-based therapies for the treatment of acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice projects in Michigan.

BACKGROUND: Studies have shown that women with acute myocardial infarction (AMI) are less likely to receive evidence-based care compared with men. The American College of Cardiology's AMI Guidelines Applied in Practice (GAP) program has been shown to increase the rates of evidence-based medicine use and reduce mortality in patients with AMI. The objective of this study was to investigate the relative benefits of the GAP program in men and women. METHODS: By using a predesign-postdesign, standard orders, and a discharge tool to improve evidence-based indicator rates and long-term mortality in patients with AMI in Michigan, this study compared the success of GAP in men vs women. Logistic regression was used to develop predictive models for death at 30 days and 1 year in men and women. RESULTS: Use of evidence-based care, including use of beta-blockers and aspirin in men and women at hospital discharge and lipid-lowering agent use in men, was higher in the post-GAP sample (P<.01 for all). Use of the discharge tool promoted by the GAP program was independently protective against death at 1 year in women (adjusted odds ratio, 0.46; 95% confidence interval, 0.27-0.79), and a trend existed for similar results in men (adjusted odds ratio, 0.62; 95% confidence interval, 0.36-1.06). However, the tool was used slightly less often with women (27.9% vs 33.96%; P=.003). CONCLUSIONS: The GAP program increased the use of evidence-based therapies in male and female patients. In addition, the GAP discharge tool may decrease mortality rates at 1 year in patients with AMI; however, the tool was used less often with women. Greater use of the GAP discharge tool in women might narrow the post-MI sex mortality gap.

Association of a continuous quality improvement initiative with practice and outcome variations of contemporary percutaneous coronary interventions.

BACKGROUND: The objective of this study was to evaluate the association of a continuous quality improvement program with practice and outcome variations of percutaneous coronary intervention (PCI). METHODS AND RESULTS: Data on consecutive PCI were collected in a consortium of 5 hospitals; 3731 PCIs reflected care provided at baseline (January 1, 1998, to December 31, 1998), and 5901 PCIs reflected care provided after implementation of a continuous quality improvement intervention (January 1, 2002, to December 31, 2002). The intervention included feedback on outcomes, working group meetings, site visits, selection of quality indicators, and use of bedside tools for quality improvement and risk assessment. Postintervention data were compared with baseline and with 10,287 PCIs from 7 hospitals added to the consortium in 2002. Quality indicators included use of preprocedural aspirin or clopidogrel, use of glycoprotein IIb/IIIa receptor blockers and postprocedural heparin, and amount of contrast media per case. Outcomes selected included emergency CABG, contrast nephropathy, myocardial infarction, stroke, transfusion, and in-hospital death. Compared with baseline and the control group, the intervention group at follow-up had higher use of preprocedural aspirin and glycoprotein IIb/IIIa blockers, lower use of postprocedural heparin, and a lower amount of contrast media per case (P<0.05). These changes were associated with lower rates of transfusions, vascular complications, contrast nephropathy, stroke, transient ischemic attack, and combined end points (all P<0.05). CONCLUSIONS: Our nonrandomized, observational data suggest that implementation of a regional continuous quality improvement program appears to be associated with enhanced adherence to quality indicators and improved outcomes of PCI. A randomized clinical trial is needed to determine whether this is a "causal" or a "casual" relationship.

Guideline-based standardized care is associated with substantially lower mortality in medicare patients with acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) Projects in Michigan.

OBJECTIVES: We sought to assess the impact of the American College of Cardiology's Guidelines Applied in Practice (GAP) project for acute myocardial infarction (AMI) care, encompassing 33 acute-care hospitals in southeastern Michigan, on rates of mortality in Medicare patients treated in Michigan. BACKGROUND: The GAP project increases the use of evidence-based therapies in patients with AMI. It is unknown whether GAP also can reduce the rate of mortality in patients with AMI. METHODS: Using a before (n = 1,368) and after GAP implementation (n = 1,489) cohort study, 2,857 Medicare patients with AMI were studied to assess the influence of the GAP program on mortality. Multivariate models tested the independent impact of GAP after controlling for other conditions on in-hospital, 30-day, and one-year mortality. RESULTS: Average patient age was 76 years, 48% were women, and 16% represented non-white minorities. The rate of mortality decreased after GAP for each interval studied: hospital, 10.4% versus 13.6%; 30-day, 16.7% versus 21.6%; and one-year, 33.2% versus 38.3%; all p < 0.02. After multivariate adjustment, GAP correlated with a 21% to 26% reduction in mortality, particularly at 30 days (odds ratio of GAP to baseline 0.74; 95% confidence interval [CI] 0.59 to 0.94; p = 0.012) and one year (odds ratio 0.78; 95% CI 0.64 to 0.95; p = 0.013), particularly in the patients for whom a standard discharge tool was used (1-year mortality, odds ratio 0.53; 95% CI 0.36 to 0.76; p = 0.0006). CONCLUSIONS: Embedding AMI guidelines into practice was associated with improved 30-day and one-year mortality. This benefit is most marked when patients are cared for using standardized, evidence-based clinical care tools.

Incidence, risk factors, and prognosis of inhospital heart failure after percutaneous coronary intervention: insight from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: Prior history of heart failure (HF) has been shown to be a predictor of poor outcomes after percutaneous coronary intervention (PCI). Clinical predictors of the development of inhospital HF and its prognostic significance after PCI have yet to be defined. In this study, we sought to identify the incidence, risk factors, and prognosis of inhospital HF after PCI. METHODS: Using a contemporary registry of consecutive PCIs, the incidence of HF after PCI was identified. Multivariate logistic regression analysis was used to determine predictors of the development of HF after PCI as well as the impact of HF on inhospital mortality. RESULTS: The incidence of HF after PCI in the overall patient population was 1.4%. Independent predictors of HF were female sex, age > or = 60 years, exceeding a maximum weight- and creatinine-adjusted contrast dose, diabetes, prior HF, prior gastrointestinal bleeding, prior chronic obstructive pulmonary disease, history of atrial fibrillation, American College of Cardiology type B2 or C vessel, emergency PCI, ejection fraction < 50%, myocardial infarction with or without cardiogenic shock, and repeat angiography. After adjustment for comorbidities, the development of HF was independently associated with an increased risk of inhospital death (adjusted OR 2.48, 95% CI 1.77-3.48). CONCLUSIONS: The development of HF is a relatively uncommon occurrence after PCI and is associated with a poor prognosis. The identification of risk factors for HF could foster the development of interventions aimed toward its prevention in high-risk patients.

Public reporting and case selection for percutaneous coronary interventions: an analysis from two large multicenter percutaneous coronary intervention databases.

OBJECTIVES: The purpose of this research was to determine the potential effect of public reporting on case selection for percutaneous coronary intervention (PCI). BACKGROUND: Previous studies have suggested that public reporting of coronary artery bypass graft surgery (CABG) mortality might result in case selection bias and in denial of care to or out migration of high-risk patients. The potential effect of public reporting on case selection for PCI is unknown. METHODS: We compared demographics, indications, and outcomes of 11,374 patients included in a multicenter (eight hospitals) PCI database in Michigan where no public reporting is present, with 69,048 patients in a statewide (34 hospitals) PCI database in New York, where public reporting is present. The primary end point was in-hospital mortality. RESULTS: Patients in Michigan more frequently underwent PCI for acute myocardial infarction (14.4% vs. 8.7%, p < 0.0001) and cardiogenic shock (2.56% vs. 0.38%, p < 0.0001) than those in New York. The Michigan cohort also had a higher prevalence of congestive heart failure and extracardiac vascular disease. The unadjusted in-hospital mortality rate was significantly lower in New York than in Michigan (0.83% vs. 1.54%, p < 0.0001; odds ratio [OR] 0.54, 95% confidence interval [CI] 0.45 to 0.63). However, after adjustment for comorbidities, there was no significant difference in mortality between the two groups (adjusted OR 1.05, 95% CI 0.84 to 1.31, p = 0.70, c-statistic 0.88). CONCLUSIONS: There are significant differences in case mix between patients undergoing PCI in Michigan and New York that result in marked differences in unadjusted mortality rates. A propensity in New York toward not intervening on higher-risk patients because of fear of public reporting of high mortality rates is a possible explanation for these differences.

Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome.

BACKGROUND: Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule has the potential to affect data collection in outcomes research. METHODS: To examine the extent to which data collection may be affected by the HIPAA Privacy Rule, we used a quasi-experimental pretest-posttest study design to assess participation rates with informed consent in 2 cohorts of patients eligible for the University of Michigan Acute Coronary Syndrome registry. The pre-HIPAA period included telephone interviews conducted at 6 months that sought verbal informed consent from patients. In the post-HIPAA period, informed consent forms were mailed to ask for permission to call to conduct a telephone interview. The primary outcome measure was the percentage of patients who provided consent. Incremental costs associated with the post-HIPAA period were also assessed. RESULTS: The pre-HIPAA period included 1221 consecutive patients with acute coronary syndrome, and the post-HIPAA period included 967 patients. Consent for follow-up declined from 96.4% in the pre-HIPAA period to 34.0% in the post-HIPAA period (P<.01). In general, patients who returned written consent forms during the post-HIPAA period were older, were more likely to be married, and had lower mortality rates at 6 months. Incremental costs for complying with the HIPAA Privacy Rule were $8704.50 for the first year and $4558.50 annually thereafter. CONCLUSIONS: The HIPAA Privacy Rule significantly decreases the number of patients available for outcomes research and introduces selection bias in data collection for patient registries.