The comparative efficacy of bivalirudin is markedly attenuated by use of radial access: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

AIM: The purpose of our study was to evaluate the relative impact of bivalirudin on bleeding outcomes associated with trans-radial interventions (TRI) in real world practice. METHODS AND RESULTS: Data for patients undergoing percutaneous coronary intervention (PCI) between January 2010 and March 2014 at the 47 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) were utilized. Propensity matching was used within cohorts defined by access site. The impact of bivalirudin use on in-hospital outcomes was evaluated with Fisher's exact tests. Among patients undergoing trans-femoral interventions (TFI), use of bivalirudin was associated with a reduction in bleeding compared with both glycoprotein IIb/IIIa inhibitors (GPI; 1.67 vs. 3.46%, absolute risk reduction (ARR) 1.79%, odds ratio, OR, 0.47, confidence interval, CI, 0.41-0.54, number needed to treat, NNT 56, P < 0.001) and heparin (1.26 vs. 1.76%, ARR 0.5%, OR 0.71, CI 0.61-0.82, NNT 197, P < 0.001). Among patients undergoing TRI, there was a more modest absolute reduction in bleeding with bivalirudin compared with GPI (0.79 vs. 1.41%, ARR 0.62%, OR 0.56, CI 0.34-0.90, NNT 161, P = 0.016) and no difference in bleeding compared with heparin (0.46 vs. 0.46%, OR 1, CI 0.54-1.84, P = 1). CONCLUSION: Bivalirudin is markedly efficacious in reducing bleeding in patients undergoing TFI. The reduction in bleeding associated with bivalirudin use is minimal to absent in patients undergoing TRI. Given its lower cost and comparable outcomes, heparin should be the preferred anticoagulation strategy in those undergoing radial PCI.

Underutilization of Radial Access in Patients Undergoing Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: The purpose of this study was to evaluate the frequency and temporal trends in use of transradial access (TRA) for percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction (STEMI). The use of TRA has been associated with less bleeding and improved clinical outcomes in patients undergoing PCI for STEMI. METHODS AND RESULTS: The frequency of TRA compared with transfemoral access for patients undergoing PCI for STEMI or other indications (non-ST-segment-elevation myocardial infarction, unstable angina, and non-acute coronary syndrome) in The Blue Cross Blue Shield of Michigan Cardiovascular Consortium database between 2010 and 2013 was evaluated. Propensity matching was used to assess the relationship of TRA with in-hospital clinical end points of major bleeding, transfusion, and death. The TRA cohort of patients was stratified into deciles based on their predicted bleeding risk and compared with PCI indication. Of 122,728 PCI procedures, 17,912 (14.6%) were via TRA. Among patients with STEMI cases, 8.3% of the PCI cases were performed via TRA. The use of TRA increased over the study period although the growth was slower for STEMI than for other indications, P<0.001. The use of TRA for PCI in STEMI was associated with a lower rate of bleeding (11.7% versus 20.0%; P<0.001) and vascular complications (0.7% versus 2.6%; P=0.001), but no mortality difference (1.25% versus 2.33%; P=0.175). There was a strong negative association between the predicted risk of bleeding and the use of TRA (P<0.001). CONCLUSIONS: The use of radial access for PCI in STEMI is increasing but at a slower pace than for patients with other indications. TRA was associated with a reduction in bleeding and transfusion, but there is a strong negative correlation between the predicted risk of bleeding and actual use of TRA in STEMI.

Impact of worsening renal dysfunction on the comparative efficacy of bivalirudin and platelet glycoprotein IIb/IIIa inhibitors: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: Use of bivalirudin has been associated with a reduction in the incidence of bleeding in patients undergoing percutaneous coronary intervention. Patients with chronic kidney disease, a known predictor of post-percutaneous coronary intervention bleeding, are under-represented in clinical trials. METHODS AND RESULTS: We evaluated the outcome of 64,052 patients who underwent percutaneous coronary intervention from 2007 to 2009 at 33 hospitals in Michigan and were treated with bivalirudin (28,378) or with heparin and glycoprotein IIb/IIIa inhibitors (35,674). Propensity-matched analysis was adjusted for the nonrandomized use of the 2 strategies. Patients treated with bivalirudin were older, had a lower glomerular filtration rate, and had more comorbidities. Use of bivalirudin was associated with fewer transfusions (2.8% versus 4.2%; P<0.0001), gastrointestinal bleeds (0.5% versus 1.3%; P<0.0001), and vascular complications (1.0% versus 2.5%; P<0.0001), with no difference in survival. Bleeding complications were more common with worsening renal function, but use of bivalirudin was associated with less bleeding across the continuum of renal dysfunction. CONCLUSIONS: The risk of bleeding after percutaneous coronary intervention increases with worsening chronic kidney disease. Bivalirudin was associated with a dramatically reduced risk of bleeding across all categories of renal dysfunction. Our study findings suggest that bivalirudin monotherapy is an acceptable, if not the more appropriate alternative, to heparin and glycoprotein IIb/IIIa inhibitors in patients with chronic kidney disease.

Contemporary use of prasugrel in clinical practice: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: Prasugrel is a recently approved thienopyridine for use in patients with acute coronary syndromes undergoing percutaneous coronary intervention. There are no data on contemporary use of prasugrel in routine clinical practice. METHODS AND RESULTS: We assessed the patterns of prasugrel use among 55 821 patients who underwent percutaneous coronary intervention and were discharged alive from January 2010 to December 2011 at 44 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Potential inappropriate therapy was defined as use in patients who had a history of cerebrovascular disease, weighed <60 kg, or were aged ≥75 years old. Clopidogrel was prescribed to 83% (n=46 574) and 17% (n=9247) of patients received prasugrel on hospital discharge. A steady, linear increase in prasugrel use was seen during the study period, with discharge prescription increasing from 8.4% in quarter 1 of 2010 to 22.3% in quarter 4 of 2011. Of the total cohort, 69.1% of patients presented with acute coronary syndrome, and in this group, 17.2% received prasugrel. Among patients prescribed prasugrel, 28.3% (n=2614) received the medication for indications outside of acute coronary syndromes. One or more known contraindications to the drug were present in 6% to 10% of patients discharged on this agent. CONCLUSIONS: There has been a steady increase in the use of prasugrel with the drug being used in ≈22% of patients undergoing percutaneous coronary intervention by study end. Prasugrel use in patients with known contraindications is not uncommon and may be a suitable target for focused quality improvement efforts.

Safety of contemporary percutaneous peripheral arterial interventions in the elderly insights from the BMC2 PVI (Blue Cross Blue Shield of Michigan Cardiovascular Consortium Peripheral Vascular Intervention) registry.

OBJECTIVES: This study sought to evaluate the effect of age on procedure type, periprocedural management, and in-hospital outcomes of patients undergoing lower-extremity (LE) peripheral vascular intervention (PVI). BACKGROUND: Surgical therapy of peripheral arterial disease is associated with significant morbidity and mortality in the elderly. There are limited data related to the influence of advanced age on the outcome of patients undergoing percutaneous LE PVI. METHODS: Clinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups: < 70 years, between 70 and 80 years, and ≥ 80 years (elderly group). RESULTS: In our cohort, 7,769 patients underwent LE PVI. The elderly patients were more likely to be female and to have a greater burden of comorbidities. Procedural success was lower in the elderly group (74.2% for age ≥ 80 years vs. 78% for age 70 to < 80 years and 81.4% in patients age < 70 years, respectively; p < 0.0001). Unadjusted rates of procedure-related vascular access complications, post-procedure transfusion, contrast-induced nephropathy, amputation, and major adverse cardiac events were higher in elderly patients. After adjustment for baseline covariates, the elderly patients were more likely to experience vascular access complications; however, advanced age was not found to be associated with major adverse cardiac events, transfusion, contrast-induced nephropathy, or amputation. CONCLUSIONS: Contemporary PVI can be performed in elderly patients with high procedural and technical success with low rates of periprocedural complications including mortality. These findings may support the notion of using PVI as a preferred revascularization strategy in the treatment of severe peripheral arterial disease in the elderly population.

Trends and disparities in referral to cardiac rehabilitation after percutaneous coronary intervention.

BACKGROUND: Despite the known benefits of cardiac rehabilitation in patients with coronary artery disease, referral rates to rehabilitation programs remain low. We determined the incidence and determinants of cardiac rehabilitation referral rates for patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The incidence and predictors of referral to cardiac rehabilitation were assessed among 145,661 consecutive patients undergoing PCI and surviving to hospital discharge across 31 hospitals in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium between 2003 and 2008. The 6-year cardiac rehabilitation referral rate was 60.2%. Younger age, male gender, white race, and presentation with acute or severe disease (ie, acute myocardial infarction [AMI] in the previous 24 hours and ST-elevation myocardial infarction) were associated with increased referral to rehabilitation (all P < .0001). Most medical comorbidities were associated with decreased referral. Referral rates for cardiac rehabilitation were below the rates of other AMI quality-of-care indicators and more variable across hospital sites. Race-specific referral rates differed significantly in the lowest referring hospitals (P < .0001) but not in the highest referring hospitals (P = .16). Women had a 0.7% relative decrease in referral as compared to men (P = .0188) in the highest referring hospitals but a 26.7% relative decrease in referral in the lowest referring hospitals (P = .02). CONCLUSIONS: Over one third of patients undergoing PCI are not referred for cardiac rehabilitation. Referral rates are below the rates of other AMI quality-of-care performance measures and more variable across sites. Racial and gender disparities in referral to rehabilitation exist but are concentrated at the lowest referring hospitals.

Trends in door-to-balloon time and mortality in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: In patients with acute ST-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention, current guidelines for reperfusion therapy recommend a door-to-balloon (DTB) time of less than 90 minutes. Considerable effort has focused on reducing DTB time with the assumption that a reduction in DTB time translates into a significant reduction in mortality; however, the clinical impact of this effort has not been evaluated. Therefore, our objective was to determine whether a decline in DTB time in patients with STEMI was associated with an improvement in clinical outcomes. METHODS: We assessed the yearly trend in DTB time for 8771 patients with STEMI who were undergoing primary percutaneous coronary intervention from 2003 to 2008 as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and correlated it with trends in in-hospital mortality. Patients were stratified according to risk of death using a mortality model to evaluate whether patient risk factors affect the relationship between DTB time and mortality. RESULTS: Median DTB time decreased each year from 113 minutes in 2003 to 76 minutes in 2008 (P < .001), and the percentage of patients who were revascularized with a DTB time of less than 90 minutes increased from 28.5% in 2003 to 67.2% in 2008 (P < .001). In-hospital mortality remained unchanged at 4.10% in 2003, 4.02% in 2004, 4.40% in 2005, 4.42% in 2006, 4.73% in 2007, and 3.62% in 2008 (P = .69). After the differences in baseline characteristics were adjusted for, there was no difference in the standardized mortality ratios (SMRs) across the study period (SMR, 1.00; 95% confidence interval [CI], 0.74-1.26 in 2003 compared with SMR, 0.95; 95% CI, 0.77-1.13 in 2008). CONCLUSIONS: There has been a dramatic reduction in median DTB time and increased compliance with the related national guideline. Despite these improvements, in-hospital mortality was unchanged over the study period. Our results suggest that a successful implementation of efforts to reduce DTB time has not resulted in the expected survival benefit.

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.

Evidence-based performance and quality improvement in the acute cardiac care setting.

This article was originally planned to appear in the October 2007 issue of Critical Care Clinics. The goal of this article is to summarize the indicators, processes, and dimensions of care that are linked to desired clinical outcomes of the most commonly encountered conditions in the acute cardiovascular care setting, and specifically, acute coronary syndromes and congestive heart failure. Additionally, it reinforces the concepts of best cardiovascular care practice and reviews some of the highly successful quality initiatives that have demonstrated a link between hospital process performance and outcomes. Particular attention is focused on the evidence-based treatments and diagnostic evaluation and processes of inpatient cardiovascular care, which lead to desired outcomes meaningful to patients and where available, provide physicians with the strategies and tools to be successful in translating scientific evidence into effective and rewarding care.

The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention: insights from a large regional registry of contemporary percutaneous coronary intervention.

OBJECTIVES: This study sought to assess whether the use of eptifibatide instead of abciximab is associated with a difference in outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Pooled data from randomized controlled trials suggest that the use of abciximab may be associated with a survival advantage in patients undergoing primary PCI for acute STEMI. However, a large proportion of patients in the community are treated with eptifibatide, an agent that shares some but not all pharmacological properties with abciximab. METHODS: We evaluated the outcomes of 3,541 patients who underwent primary PCI for STEMI from October 2002 to July 2006 in a large regional consortium and who were treated with abciximab (n = 729) or with eptifibatide (n = 2,812). RESULTS: There was no difference in the incidence of in-hospital death (4.1% with abciximab vs. 3.5% with eptifibatide, p = 0.39), recurrent myocardial infarction (0.8% vs. 1.2%, p = 0.42), or stroke/transient ischemic attack (0.7% vs. 0.6%, p = 0.80). There was no difference in the need for blood transfusion (12.4% vs. 11.7%, p = 0.61), whereas there was a greater incidence of gastrointestinal bleeding with abciximab (4.8% vs. 2.8%, p = 0.01). In parsimonious risk-adjusted models, no significant difference between abciximab and eptifibatide was observed with respect to any of the outcomes measures. CONCLUSIONS: Currently, eptifibatide is used as the adjunct antiplatelet agent in the majority of patients undergoing primary PCI. There is no apparent difference in early outcomes of patients treated with eptifibatide compared with patients treated with abciximab.

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.

Temporal trends, safety, and efficacy of bivalirudin in elective percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

OBJECTIVE: To evaluate the safety and efficacy of bivalirudin based therapy among patients undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease in a large multicenter registry. BACKGROUND: The REPLACE I trial demonstrated the non-inferiority of a strategy of bivalirudin compared with heparin and glycoprotein (GP) IIbIIIa inhibition in patients undergoing PCI. There is a paucity of outcome data with bivalirudin use in the setting of real-world PCI practice. METHODS: We evaluated the outcome of 11,719 patients who underwent elective PCI for stable coronary artery disease (CAD) from 2002 to 2004 in a large regional consortium, and who were treated with bivalirudin (n = 2051) or with heparin and GP IIbIIIa inhibitors (n = 9,668). The primary endpoints were transfusion and in-hospital major adverse cardiovascular events (MACE) defined as the composite of death, MI, stroke, and any coronary artery bypass grafting (CABG) or target lesion revascularization. RESULTS: Compared with patients who received heparin plus GP IIbIIIa inhibitors, patients who received bivalirudin had a similar incidence of post-procedural MI, stroke, in-hospital death, MACE (2.88 vs. 2.48, P = 0.30), or transfusion (2.83% vs. 2.41%, P = 0.27). Patients at greater risk of bleeding were more likely to be treated with bivalirudin. After adjusting for the propensity to receive bivalirudin and for baseline co-morbidities, there was no difference in the odds of MACE or the need for transfusion between the two groups. CONCLUSION: Compared with heparin plus GP IIbIIIa inhibition, use of bivalirudin in patients undergoing PCI for stable CAD is associated with similar ischemic and bleeding complications. Given the ease of administration and lower cost, bivalirudin provides an attractive treatment option in this patient population.

Impact of congestive heart failure in patients with non-ST-segment elevation acute coronary syndromes.

The presence of congestive heart failure (CHF) has been associated with treatment disparities and worse outcomes in patients with ST-segment elevation myocardial infarction, but the incidence and effect of CHF in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACSs) has not been well characterized. We evaluated 45,744 patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) who were treated at 424 hospitals in the CRUSADE Quality Improvement Initiative between March 2000 and March 2003. Treatment patterns and in-hospital outcomes in patients with signs of CHF on presentation and those who developed in-hospital CHF were compared with those in patients without CHF. In total, 10,398 patients (22.7%) had signs of CHF on presentation, and 1,664 patients (3.6%) later developed in-hospital CHF. Compared with patients without CHF, early (<24 hours from presentation) medications and invasive cardiac procedures were used less often in patients with signs of CHF on presentation. Likewise, patients with in-hospital CHF were less likely than those without CHF to receive acute antiplatelet agents and undergo cardiac catheterization but more likely to receive acute beta blockers, angiotensin-converting enzyme inhibitors, and heparin and to undergo coronary artery bypass grafting. Adjusted mortality was higher in patients with signs of CHF on presentation (odds ratio 2.64, 95% confidence interval 2.31 to 3.01) and those with in-hospital CHF (odds ratio 4.93, 95% confidence interval 4.05 to 5.99) than in patients without CHF. In conclusion, CHF occurs frequently in patients with NSTE ACS but is associated with less aggressive treatment and a higher risk of mortality. Further study is needed to determine the causes of these treatment differences and the optimal therapeutic approach for patients with NSTE ACS and concomitant CHF.

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.

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.

Relationship between operator volume and adverse outcome in contemporary percutaneous coronary intervention practice: an analysis of a quality-controlled multicenter percutaneous coronary intervention clinical database.

OBJECTIVES: The aim of our study was to evaluate the volume-outcome relationship in a large, quality-controlled, contemporary percutaneous coronary interventions (PCI) database. BACKGROUND: Whether the relationship between physician volume of PCI and outcomes still exists in the era of coronary stents is unclear. METHODS: Data on 18,504 consecutive PCIs performed by 165 operators in calendar year 2002 were prospectively collected in a regional consortium. Operators' volume was divided into quintiles (1 to 33, 34 to 89, 90 to 139, 140 to 206, and 207 to 582 procedures/year). The primary end point was a composite of major adverse cardiovascular events (MACE) including death, coronary artery bypass grafting, stroke or transient ischemic attack, myocardial infarction, and repeat PCI at the same site during the index hospital stay. RESULTS: The unadjusted MACE rate was significantly higher in quintiles one and two of operator volume when compared with quintile five (7.38% and 6.13% vs. 4.15%, p = 0.002 and p = 0.0001, respectively). A similar trend was observed for in-hospital death. After adjustment for comorbidities, patients treated by low volume operators had a 63% increased odds of MACE (adjusted odds ratio [OR] 1.63, 95% confidence interval [CI] 1.29 to 2.06, p < 0.0001 for quintile [Q]1; adjusted OR 1.63, 95% CI 1.34 to 1.90, p < 0.0001 for Q2 vs. Q5), but not of in-hospital death. Overall, high volume operators had better outcomes than low volume operators in low-risk and high-risk patients. CONCLUSIONS: Although the relationship between operator volume and in-hospital mortality is no longer significant, the relationship between volume and any adverse outcome is still present. Technological advancements have not yet completely offset the influence of procedural volume on proficiency of PCIs.

Development of a multicenter peripheral arterial interventional database: the PVD-QI2.

BACKGROUND: The number of peripheral vascular intervention (PVI) procedures performed is steadily increasing in the United States. PVD-QI 2 is a prospective, multicenter observational study designed to improve the quality of care for patients undergoing PVI and to better understand the effectiveness and appropriateness of PVI in improving outcomes of peripheral arterial disease. The registry aims to elucidate which comorbid conditions and procedure-related variables are associated with beneficial or adverse outcomes after vascular interventions. METHODS: Five centers are currently prospectively collecting data on consecutive PVIs performed at their institutions and will include patients with both claudication and critical limb ischemia. A common data collection form and a standard set of definitions were developed during several planning meetings. Information on patient demographics, clinical history, comorbid conditions, treatment approaches, and in hospital outcomes are being collected. Patients will be followed up at 30 days, 6 months, and 1 year after each procedure to identify recurrent vascular events, medication use, lifestyle modifications (regular exercise, dietary modification), self-reported walking scores, and mortality. Data validity will be assured through review of data form accuracy by a trained nurse, by automatic database diagnostic routines, and by site visits that include review of angiography suite logs and randomly selected charts. CONCLUSIONS: The development of a quality-controlled PVI registry requires the commitment and collaboration of clinician-investigators and hospital systems devoted to understanding factors that contribute to quality outcomes. Central to achievement of this goal is the creation of a careful diagnostic and data quality assessment system. This registry will provide important clinical insights into patient demographic and clinical characteristics, procedural characteristics, and current practice patterns that foster or impede achievement of long-term quality-based clinical outcomes for patients with peripheral arterial disease.

Complementary and alternative medicine (CAM) use patterns and disclosure to physicians in acute coronary syndromes patients.

This study assessed the frequency and types of CAM therapies used by patients hospitalized with acute coronary syndromes for general health purposes and cardiac reasons. We profiled CAM users including gender differences and degree of disclosure with treating physicians'. Data collection occurred via semi-structured interview and included demographics, past medical history, CAM use, physician visits, and patient-physician communications. Eight hundred and forty-six patients were screened for eligibility with 223 patients meeting eligibility criteria and completing data collection. Sixty-three percent of this sample used at least one CAM therapy for general health purposes in the year prior to the index hospitalization. Only 11.7% of patients reported using CAM for cardiac specific reasons. Women were more likely to use CAM relative to men and also tended to use a greater number of CAM therapies. More than one third (35.9%) of the patients that used CAM therapies did not inform their physician. Only a small fraction of CAM use was specific to cardiovascular health. These data suggest that a significant portion of patients do not report CAM use to their physicians and physicians seldom ask.