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The key concepts (calibration, discrimination, and discordance) important in understanding and comparing risk models are best conveyed graphically. To illustrate this, models predicting death and acute kidney injury in a large cohort of PCI patients differing in the number of predictors included are presented. Calibration plots, often presented in the current literature, present the agreement between predicted and observed risk for deciles of risk. Risk distribution curves present the frequency of different levels of risk. Scatterplots of the risks assigned to individuals by different models show the discordance of the individual risk estimates. Increasing the number of predictors in these models produce increasingly disperse and progressively skewed risk distribution curves. These resemble the lognormal distributions expected when risk predictors interact multiplicatively. These changes in the risk distribution curves correlate with improved measures of discrimination., 14 pages, 7 figures

Objective: To study the association of the fragmented QRS complex versus the Q wave with myocardial scar and viability. Background: A prior study has suggested that the fragmented QRS complex on an electrocardiogram (ECG) is a highly sensitive and specific marker of myocardial scar as detected by regional perfusion abnormalities on a nuclear stress test. There is no external validation of this data. Methods: We correlated the ECG and nuclear perfusion images of 460 consecutive patients with known or suspected coronary artery disease. The presence of fragmented QRS or Q waves in two contiguous ECG leads was correlated with major coronary artery distributions on nuclear perfusion imaging. Results: For the 1842 evaluated territories, the fragmented QRS complex was not superior to the Q wave in detecting fixed or mixed myocardial defects. The fragmented QRS complex was associated with worse sensitivity (1.7%) in comparison to the Q wave (31.7%) for identifying myocardial scar. The fragmented QRS complex carried a higher false positive rate in patients with normal perfusion scans (15.8%, 221 segments), in comparison to Q waves (1.4%, 17 segments). Conclusion: In our study population, both the fragmented QRS and Q wave had poor sensitivity and specificity in detecting fixed or mixed myocardial scar. Larger studies are needed to evaluate fragmented QRS as a surrogate of myocardial scar before it can be incorporated into clinical practice. Ann Noninvasive Electrocardiol 2010;15(4):308‐314

ObjectivesThe purpose of this study was to characterize long-term outcomes of percutaneous coronary intervention (PCI) in elderly diabetic patients in routine practice.BackgroundAlthough drug-eluting stent (DES) implantation in diabetic patients is common practice, pivotal randomized trials enrolled

ObjectivesWe sought to compare the nephrotoxicity of the iso-osmolar contrast medium, iodixanol, to low-osmolar contrast media (LOCM).BackgroundContrast-induced acute kidney injury (CI-AKI) is a common cause of in-hospital renal failure. A prior meta-analysis suggested that iodixanol (Visipaque, GE Healthcare, Princeton, New Jersey) was associated with less CI-AKI than LOCM, but this study was limited by ascertainment bias and did not include the most recent randomized controlled trials.MethodsWe searched Medline, Embase, ISI Web of Knowledge, Google Scholar, Current Contents, and International Pharmaceutical Abstracts databases, and the Cochrane Central Register of Controlled Trials from 1980 to November 30, 2008, for randomized controlled trials that compared the incidence of CI-AKI with either iodixanol or LOCM. Random-effects models were used to calculate summary risk ratios (RR) for CI-AKI, need for hemodialysis, and death.ResultsA total of 16 trials including 2,763 subjects were pooled. There was no significant difference in the incidence of CI-AKI in the iodixanol group than in the LOCM group overall (summary RR: 0.79, 95% confidence interval [CI]: 0.56 to 1.12, p = 0.19). There was no significant difference in the rates of post-procedure hemodialysis or death. There was a reduction in CI-AKI when iodixanol was compared with ioxaglate (RR: 0.58, 95% CI: 0.37 to 0.92; p = 0.022) and iohexol (RR: 0.19, 95% CI: 0.07 to 0.56; p = 0.002), but no difference when compared with iopamidol (RR: 1.20, 95% CI: 0.66 to 2.18; p = 0.55), iopromide (RR: 0.93, 95% CI: 0.47 to 1.85; p = 0.84), or ioversol (RR: 0.92, 95% CI: 0.60 to 1.39; p = 0.68).ConclusionsThis meta-analysis including 2,763 subjects suggests that iodixanol, when compared with LOCM overall, is not associated with less CI-AKI. The relative renal safety of LOCM compared with iodixanol may vary based on the specific type of LOCM.

ObjectivesThe objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy.BackgroundPrevious studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied.MethodsWe evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI.ResultsThe REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06% vs. 1.85%, p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3% vs. 3.9%). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6% vs. 24.4%, p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0% vs. 3.3%, p = 0.69).ConclusionsCompared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding.

ObjectivesThis 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).BackgroundSurgical 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.MethodsClinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups

ObjectivesThis study sought to compare in-hospital mortality and bleeding complications for procedures performed by sleep-deprived versus non–sleep-deprived operators.BackgroundTo optimize the safety of percutaneous coronary intervention (PCI), it is essential to determine whether physicians performing emergent, middle-of-the-night procedures, and who may be sleep-deprived as a consequence, have equally safe outcomes when performing cases the following day.MethodsWe used CathPCI registry data to compare in-hospital mortality and bleeding complications for procedures performed by sleep-deprived versus non–sleep-deprived operators using logistic regression with generalized estimating equations to account for within-operator clustering. Outcomes were risk-adjusted using previously validated models for in-hospital mortality and bleeding. Our cohort included 1,509,096 daytime PCI procedures performed by 5,014 operators between 7 am and midnight from July 1, 2009, through June 30, 2012. Operators were assumed to be acutely sleep-deprived if they began a middle-of-the-night PCI between midnight and 6:59 am and performed a next-day PCI between 7 am and midnight, and chronically sleep deprived if they had performed multiple middle-of-the-night PCI procedures during the previous 7 days.ResultsOnly 2.4% of all daytime PCI procedures were performed by operators who had performed at least 1 middle-of-the-night PCI procedure earlier that day. In adjusted analyses, when comparing procedures performed by acutely sleep-deprived with non–sleep-deprived operators, there were no significant differences in mortality (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 0.94 to 1.12; p = 0.61) or bleeding (OR: 1.03, 95% CI: 0.98 to 1.08; p = 0.19). However, a greater degree of chronic sleep deprivation was associated with a higher adjusted risk of bleeding (OR: 1.19, 95% CI: 1.05 to 1.34; p = 0.007).ConclusionsDaytime PCI procedures are uncommonly performed by sleep-deprived operators. We found no signal of increased complications when acutely sleep-deprived operators performed PCI but an increased risk of bleeding associated with procedures performed by operators with greater degrees of chronic sleep deprivation.

ObjectivesThis study sought to examine the prevalence and clinical implications of morbid obesity among patients undergoing percutaneous coronary intervention (PCI).BackgroundThe prevalence of obesity, and morbid obesity in particular, continues to rise rapidly in the United States. Obese patients are at increased risk for cardiac disease and are more likely to need invasive cardiac procedures. There is a paucity of contemporary data on the prevalence and clinical implications of morbid obesity among patients undergoing PCI.MethodsWe examined the prevalence of morbid obesity (body mass index [BMI] ≥40 kg/m2) among 227,044 patients undergoing PCI and enrolled in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry from 1998 to 2009.ResultsThe proportion of morbidly obese patients undergoing PCI increased from 4.38% in 1998 to 8.36% in 2009. Compared with overweight patients (BMI 25 to 30 kg/m2), these patients had significantly increased vascular complications (adjusted odds ratio [OR]: 1.31; 95% CI: 1.17 to 1.47; p < 0.0001), contrast-induced nephropathy (adjusted OR: 1.89; 95% CI: 1.70 to 2.11; p < 0.0001), nephropathy requiring dialysis (adjusted OR: 4.08; 95% CI: 2.98 to 5.59; p < 0.0001), and mortality (adjusted OR: 1.63; 95% CI: 1.33 to 2.00; p < 0.0001).ConclusionsMorbid obesity is increasing in prevalence among patients undergoing PCI and is associated with a higher risk of mortality and morbidity. These epidemiological changes have important implications for technical considerations of cardiac catheterization, design of the catheterization lab to accommodate these patients, and most importantly, for societal effort toward prevention of obesity.

ObjectivesThis study sought to examine sex-related differences in outcomes related to peripheral vascular intervention (PVI) procedures.BackgroundPercutaneous PVI is frequently performed for the treatment of peripheral arterial disease (PAD). However, little is known about sex-related differences related to PVI procedures.MethodsWe assessed the impact of sex among 12,379 patients (41% female) who underwent lower extremity (LE)-PVI from 2004 to 2009 at 16 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI registry. Multivariate propensity-matched analyses were performed to adjust for differences in baseline characteristics, procedural indications, and comorbidities on the basis of sex.ResultsCompared with men, women were older and have multilevel disease and critical limb ischemia. In a propensity-matched analysis, female sex was associated with a higher rate of vascular complications, transfusions, and embolism. No differences were observed for in-hospital death, myocardial infarction, or stroke or transient ischemic attack. Technical success was more commonly achieved in women (91.2% vs. 89.1%, p = 0.014), but because of a higher complication rate, the overall procedural success rates were similar in men and women (79.7% vs. 81.6%, p = 0.08).ConclusionsWomen represent a significant proportion of patients undergoing LE-PVI, have a more severe and complex disease process, and are at increased risk for adverse outcomes. Despite higher complications rates, women had similar procedural success compared with men, making PVI an effective treatment strategy among women with LE-PAD.

ObjectivesThis study sought to evaluate the prevalence, risk factors, outcomes, and predictors of mortality of retroperitoneal hematoma (RPH) following percutaneous coronary intervention.BackgroundRetroperitoneal hematoma is a serious complication of invasive cardiovascular procedures.MethodsThe 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.ResultsRetroperitoneal 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

ObjectivesThis 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).BackgroundPooled 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.MethodsWe 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).ResultsThere 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.ConclusionsCurrently, 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.

ObjectivesWe sought to investigate the impact of body mass index (BMI) on short- and long-term outcomes after initial revascularization with percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG).BackgroundEquivocal results exist on the impact of BMI on the risk of in-hospital complications after PTCA or CABG, and no long-term mortality data exist from a large series of revascularized patients.MethodsFrom the randomized series and observational registry of the Bypass Angioplasty Revascularization Investigation (BARI), 2,108 patients who had PTCA and 1,526 patients who had CABG were evaluated by taking their BMI at study entry. They were classified as follows: low (

ObjectivesWe evaluated the association between guiding catheter size and complications of percutaneous coronary intervention (PCI).BackgroundThe association between guiding catheter size and complications of PCI in contemporary practice remains controversial.MethodsProcedure and outcome variables from 103,070 consecutive patients that underwent PCI with 6-F (n = 64,335), 7-F (n = 32,676), and 8-F (n = 6,059) guide catheters were compared.ResultsCompared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with incrementally more contrast agent use, and more post-PCI complications including contrast-induced nephropathy, vascular access site complications, bleeding, transfusion, major adverse cardiac event, and death. After multivariate analysis, the use of larger guides were associated with a higher risk of contrast-induced nephropathy (7-F odds ratio [OR]: 1.18, p = 0.0004; 8-F OR: 1.44, p < 0.0001), vascular complications (7-F OR: 1.19, p = 0.0002, 8-F OR: 1.68, p < 0.0001), decline in hemoglobin >3 g/dl (7-F OR: 1.12, p < 0.0001, 8-F OR: 1.72, p < 0.0001), and post-procedure blood transfusion (7-F OR: 1.08, p = 0.03; 8-F OR: 1.80, p < 0.0001), whereas major adverse cardiac events (7-F OR: 1.06, p = 0.13; 8-F OR: 1.37, p < 0.0001) and in-hospital mortality (7-F OR: 1.11, p = 0.13; 8-F OR: 1.34, p = 0.03) were increased with 8-F but not 7-F guides.ConclusionsCompared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications, greater need for post-procedure transfusion, and 8-F guides with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality. These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.