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Background: The purpose of this study was to develop a long-term model to predict mortality after percutaneous coronary intervention in both patients with ST-segment elevation myocardial infarction and those with more stable coronary disease., Methods and Results: The American College of Cardiology Foundation CathPCI Registry data were linked to the Centers for Medicare and Medicaid Services 100% denominator file by probabilistic matching. Preprocedure demographic and clinical variables from the CathPCI Registry were used to predict the probability of death over 3 years as recorded in the Centers for Medicare and Medicaid Services database. Between 2004 and 2007, 343 466 patients (66%) of 518 195 patients aged ≥65 years undergoing first percutaneous coronary intervention in the CathPCI Registry were successfully linked to Centers for Medicare and Medicaid Services data. This study population was randomly divided into 60% derivation and 40% validation cohorts. Median follow-up was 15 months, with mortality of 3.0% at 30 days and 8.7%, 13.4%, and 18.7% at 1, 2, and 3 years, respectively. Twenty-four characteristics related to demographics, clinical comorbidity, prior history of disease, and indices of disease severity and acuity were identified as being associated with mortality. The C indices in the validation cohorts for patients with and without ST-segment elevation myocardial infarction were 0.79 and 0.78. The model calibrated well across a wide range of predicted probabilities., Conclusions: On the basis of the large and nationally representative CathPCI Registry, we have developed a model that has excellent discrimination, calibration, and validation to predict survival up to 3 years after percutaneous coronary intervention.

Objectives: We sought to create contemporary models for predicting mortality risk following percutaneous coronary intervention (PCI)., Background: There is a need to identify PCI risk factors and accurately quantify procedural risks to facilitate comparative effectiveness research, provider comparisons, and informed patient decision making., Methods: Data from 181,775 procedures performed from January 2004 to March 2006 were used to develop risk models based on pre-procedural and/or angiographic factors using logistic regression. These models were independently evaluated in 2 validation cohorts: contemporary (n = 121,183, January 2004 to March 2006) and prospective (n = 285,440, March 2006 to March 2007)., Results: Overall, PCI in-hospital mortality was 1.27%, ranging from 0.65% in elective PCI to 4.81% in ST-segment elevation myocardial infarction patients. Multiple pre-procedural clinical factors were significantly associated with in-hospital mortality. Angiographic variables provided only modest incremental information to pre-procedural risk assessments. The overall National Cardiovascular Data Registry (NCDR) model, as well as a simplified NCDR risk score (based on 8 key pre-procedure factors), had excellent discrimination (c-index: 0.93 and 0.91, respectively). Discrimination and calibration of both risk tools were retained among specific patient subgroups, in the validation samples, and when used to estimate 30-day mortality rates among Medicare patients., Conclusions: Risks for early mortality following PCI can be accurately predicted in contemporary practice. Incorporation of such risk tools should facilitate research, clinical decisions, and policy applications., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Treatment of coronary artery disease (CAD) is evolving with better medications, improvements in percutaneous coronary intervention (PCI), and enhanced techniques for coronary artery bypass grafting (CABG)., Methods: In this study, 18,481 patients with significant (>75% stenosis) CAD treated at a single center between 1986 and 2000 were assigned to one of three groups based on initial treatment strategy: medical therapy (MED) (n = 6862), PCI (n = 6292), or CABG (n = 5327). Each group was categorized into 3 groups according to baseline severity of CAD: low-severity (predominantly 1-vessel), intermediate-severity (predominantly 2-vessel), and high-severity (all 3-vessel), and prospectively evaluated in Cox models for all-cause mortality adjusted for cardiac risk, comorbidity, and propensity for selection of a specific treatment. Treatments were compared for the entire period and three eras (1: 1986 to 1990; 2: 1991 to 1995; 3: 1996 to 2000), the last encompassing widespread availability of PCI with stenting., Results: Survival significantly improved in all groups for all degrees of CAD, despite increasing severity of illness. Revascularization strategies provided significant survival over MED with 8.1, 10.6, and 23.6 additional months per 15 years of follow-up for low-severity, intermediate-severity, and high-severity CAD, respectively. Therapeutic improvements led to increased survival of 5.3 additional months per 7 years of follow-up (95% confidence interval, 0.2 to 10.2; p = 0.039) in era 3 for CABG compared with PCI for high-severity CAD., Conclusions: Initial revascularization strategies result in significant survival advantage over MED for all CAD levels. Patients with high-severity CAD have reduced survival with PCI compared with those initially treated with CABG.

Assessing the effectiveness of newer treatments for rare diseases can be challenging because of the small number of patients treated at individual centers. We enrolled patients undergoing percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy (HOCM) at five international centers (1 Japan, 2 United Kingdom, and 2 United States). Our study group developed standard data definitions regarding clinical symptom severity, previous HOCM treatment, procedure status, and outcome, and entered patient data directly into a shared, web-based registry system. In the first 10 months of 1998, 51 patients were enrolled in our registry, with 47 ultimately receiving the PTSMA procedure. Although HOCM is consider a single disease, there were significant differences among centers in patient characteristics (age, gender, and family history of HOCM), symptom severity, diagnostic techniques (measurements taken after provocation), and treatment (amount of alcohol used, timing of injection, and number of branches attempted).

Objectives: The objective of this study was to identify preprocedure patient factors associated with percutaneous intervention costs and to examine the impact of these patient factors on economic profiles of interventional cardiologists., Background: There is increasing demand for information about comparative resource use patterns of interventional cardiologists. Economic provider profiles, however, often fail to account for patient characteristics., Methods: Data were obtained from Duke Medical Center cost and clinical information systems for 1,949 procedures performed by 13 providers between July 1, 1997, and December 31, 1998. Patient factors that influenced cost were identified using multiple regression analysis. After assessing interprovider variation in unadjusted cost, mixed linear models were used to examine how much cost variability was associated with the provider when patient characteristics were taken into account., Results: Total hospital costs averaged $15,643 (median, $13,809), $6,515 of which represented catheterization laboratory costs. Disease severity, acuity, comorbid illness and lesion type influenced total costs (R(2) = 38%), whereas catheterization costs were affected by lesion type and acuity (R(2) = 32%). Patient characteristics varied significantly among providers. Unadjusted total costs were weakly associated with provider, and this association disappeared after accounting for patient factors. The provider influence on catheterization costs persisted after adjusting for patient characteristics. Furthermore, the pattern of variation changed: the adjusted analysis identified three new outliers, and two providers lost their outlier status. Only one provider was consistently identified as an outlier in the unadjusted and adjusted analyses., Conclusions: Economic profiles of interventional cardiologists may be misleading if they do not adequately adjust for patient characteristics before procedure.

Objectives: We compared the acute and one year medical costs and outcomes of coronary stenting with those for balloon angioplasty (percutaneous transluminal coronary angioplasty) in contemporary clinical practice., Background: While coronary stent implantation reduces the need for repeat revascularization, it has been associated with significantly higher acute costs compared with coronary angioplasty., Methods: We studied patients treated at Duke University between September 1995 and June 1996 who received either coronary stent (n = 384) or coronary angioplasty (n = 159) and met eligibility criteria. Detailed cost data were collected initially and up to one year following the procedure. Our primary analyses compared six and 12 month cumulative costs for coronary angioplasty- and stent-treated cohorts. We also compared treatment costs after excluding nontarget vessel interventions; after limiting analysis to those without prior revascularization; and after risk-adjusting cumulative cost estimates., Results: Baseline clinical characteristics were generally similar between the two treatment groups. The mean in-hospital cost for stent patients was $3,268 higher than for those receiving coronary angioplasty ($14,802 vs. $11,534, p < 0.001). However, stent patients were less likely to be rehospitalized (22% vs. 34%, p = 0.002) or to undergo repeat revascularization (9% vs. 26%, p = 0.001) than coronary angioplasty patients within six months of the procedure. As such, mean cumulative costs at 6 months ($19,598 vs. $19,820, p = 0.18) and one year ($22,140 vs. $22,571, p = 0.26) were similar for the two treatments. Adjusting for baseline predictors of cost and selectively examining target vessel revascularization, or those without prior coronary intervention yielded similar conclusions., Conclusions: In contemporary practice, coronary stenting provides equivalent or better one-year patient outcomes without increasing cumulative health care costs.

Background: With the expectation that physicians who perform larger numbers of coronary angioplasty procedures will have better outcomes, the American College of Cardiology/ American Heart Association guidelines recommend minimum physician volumes of 75 procedures per year. However, there is little empirical data to support this recommendation., Methods and Results: We examined in-hospital bypass surgery and death after angioplasty according to 1992 physician and hospital Medicare procedure volume. In 1992, 6115 physicians performed angioplasty on 97,478 Medicare patients at 984 hospitals. The median numbers of procedures performed per physician and per hospital were 13 (interquartile range, 5 to 25) and 98 (interquartile range, 40 to 181), respectively. With the assumption that Medicare patients composed one half to one third of all patients undergoing angioplasty, these median values are consistent with an overall physician volume of 26 to 39 cases per year and an overall hospital volume of 196 to 294 cases per year. After adjusting for age, sex, race, acute myocardial infarction, and comorbidity, low-volume physicians were associated with higher rates of bypass surgery (P < .001) and low-volume hospitals were associated with higher rates of bypass surgery and death (P < .001). Improving outcomes were seen up to threshold values of 75 Medicare cases per physician and 200 Medicare cases per hospital., Conclusions: More than 50% of physicians and 25% of hospitals performing coronary angioplasty in 1992 were unlikely to have met the minimum volume guidelines first published in 1988, and these patients had worse outcomes. While more recent data are required to determine whether the same relationships persist after the introduction of newer technologies, this study suggests that adherence to minimum volume standards by physicians and hospitals will lead to better outcomes for elderly patients undergoing coronary angioplasty.

Background: Studies have reported that blacks undergo fewer coronary-revascularization procedures than whites, but it is not clear whether the clinical characteristics of the patients account for these differences or whether they indicate underuse of the procedures in blacks or overuse in whites., Methods: In a study at Duke University of 12,402 patients (10.3 percent of whom were black) with coronary disease, we calculated unadjusted and adjusted rates of angioplasty and bypass surgery in blacks and whites after cardiac catheterization. We also examined patterns of treatment after stratifying the patients according to the severity of disease, angina status, and estimated survival benefit due to revascularization. Finally, we compared five-year survival rates in blacks and whites., Results: After adjustment for the severity of disease and other characteristics, blacks were 13 percent less likely than whites to undergo angioplasty and 32 percent less likely to undergo bypass surgery. The adjusted black:white odds ratios for receiving these procedures were 0.87 (95 percent confidence interval, 0.73 to 1.03) and 0.68 (95 percent confidence interval, 0.56 to 0.82), respectively. The racial differences in rates of bypass surgery persisted among those with severe anginal symptoms (31 percent of blacks underwent surgery, vs. 45 percent of whites, P<0.001) and among those predicted to have the greatest survival benefit from revascularization (42 percent vs. 61 percent, P<0.001). Finally, unadjusted and adjusted rates of survival for five years were significantly lower in blacks than in whites., Conclusions: Blacks with coronary disease were significantly less likely than whites to undergo coronary revascularization, particularly bypass surgery - a difference that could not be explained by the clinical features of their disease. The differences in treatment were most pronounced among those predicted to benefit the most from revascularization. Since these differences also correlated with a lower survival rate in blacks, we conclude that coronary revascularization appears to be underused in blacks.

Background: Previous studies have found that hospitals at which more procedures, such as coronary-artery bypass grafting (CABG) and other vascular surgery, are performed have lower rates of mortality related to these procedures than hospitals where fewer such procedures are performed., Methods: We examined the relation between the number of percutaneous transluminal coronary angioplasty (PTCA) procedures performed at hospitals (volume) and short-term mortality in a population of 217,836 Medicare beneficiaries 65 years of age or older who underwent angioplasty in the United States from 1987 through 1990., Results: The unadjusted in-hospital mortality among patients who underwent PTCA increased from 2.5 percent among the 10 percent of patients treated in hospitals with the highest volume of such procedures to 3.9 percent among the 10 percent of patients treated in hospitals with the lowest volume. The rate of bypass surgery after PTCA also increased, from 2.8 percent among patients in the highest-volume hospitals to 5.3 percent among those in the lowest-volume hospitals. Higher rates of mortality and CABG persisted in all the groups of patients treated in hospitals that performed fewer than 100 angioplasty procedures per year in Medicare beneficiaries; this volume in Medicare beneficiaries can be extrapolated to an overall annual volume of 200 to 400 angioplasty procedures. In a logistic-regression model, the volume of PTCA procedures at a hospital was found to be a highly significant predictor of in-hospital mortality (P < 0.001). These results suggest that if the hospitals with the lowest volume had achieved the experience and technical results of the highest-volume hospitals, 381 fewer patients would have undergone CABG and there would have been 300 fewer in-hospital deaths in the population we studied., Conclusions: Hospitals that perform more PTCA procedures have lower short-term mortality rates after the procedure. These data provide evidence in support of the regionalization of angioplasty services.