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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 P 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.

Background— Although prior studies have shown a relationship between anemia and in-hospital mortality after coronary artery bypass grafting and acute myocardial infarction (MI), the prognostic implication of anemia in patients undergoing percutaneous coronary intervention (PCI) is unknown. Therefore, we evaluated the relationship between anemia and outcomes of PCI. Methods and Results— Clinical and outcome data on 48 851 consecutive PCIs were prospectively collected. Patients were classified as anemic using the World Health Organization definition (P P ≤0.0001) and postprocedural MI (2.0% versus 1.6% in men; 2.4% versus 1.6% in women; P ≤0.02) and a higher combined major cardiovascular events end point, including death, MI, and cerebrovascular event (5.0% versus 2.6% in men; 5.1% versus 3.5% in women; P P P =0.02) and major cardiovascular events (OR, 1.2; 95% CI, 1.05 to 1.34). Significant gender interactions were observed for death in men and for MI in women. Conclusions— Preprocedural anemia is associated with increased adverse in-hospital outcomes after PCI. Whether optimization of hemoglobin before PCI is of clinical benefit will need to be determined in a randomized clinical trial.

This study was undertaken to determine the incidence, risk factors, and in-hospital outcome of nephropathy requiring dialysis (NRD) after percutaneous coronary intervention (PCI), and to evaluate the role of a weight- and creatinine-adjusted maximum radiographic contrast dose (MRCD) on NRD. Data were obtained from a registry of 16,592 PCIs. The data were divided into development and test sets. Univariate predictors were identified and a multivariate logistic regression model was developed. The MRCD was calculated for each patient as: MRCD = 5 ml x body weight (kilograms)/serum creatinine (milligrams per deciliter). Predictive accuracy was assessed by receiver-operating characteristic curve analysis. In the development set, 41 patients (0.44%) developed NRD with a subsequent in-hospital mortality rate of 39.0%. NRD increased with worsening baseline renal dysfunction. Other risk factors included peripheral vascular disease, diabetes mellitus, congestive heart failure, and cardiogenic shock. There was a direct relation between the number of risk factors and NRD. After adjustment for baseline risk factors, MRCD was the strongest independent predictor of NRD (adjusted odds ratio 6.2, 95% confidence interval 3.0 to 12.8). NRD and in-hospital mortality were both significantly higher in patients who exceeded the MRCD compared with patients who did not (p

The past decade has been characterized by increased scrutiny of outcomes of surgical and percutaneous coronary interventions (PCIs). This increased scrutiny has led to the development of regional, state, and national databases for outcome assessment and for public reporting. This report describes the initial development of a regional, collaborative, cardiovascular consortium and the progress made so far by this collaborative group. In 1997, a group of hospitals in the state Michigan agreed to create a regional collaborative consortium for the development of a quality improvement program in interventional cardiology. The project included the creation of a comprehensive database of PCIs to be used for risk assessment, feedback on absolute and risk-adjusted outcomes, and sharing of information. To date, information from nearly 20,000 PCIs have been collected. A risk prediction tool for death in the hospital and additional risk prediction tools for other outcomes have been developed from the data collected, and are currently used by the participating centers for risk assessment and for quality improvement. As the project enters into year 5, the participating centers are deeply engaged in the quality improvement phase, and expansion to a total of 17 hospitals with active PCI programs is in process. In conclusion, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium is an example of a regional collaborative effort to assess and improve quality of care and outcomes that overcome the barriers of traditional market and academic competition.

Procainamide is a class IA antiarrhythmic drug indicated for the treatment of life-threatening or symptomatic ventricular arrhythmias. The current sustained-release formulation requires 6-hour dosing (qid). To improve patient compliance, a new sustained-release formulation for twice-daily (bid) administration has been developed (Procanbid, Parke-Davis). This study assesses the pharmacologic equivalence of the bid and qid formulations in the suppression of symptomatic ventricular premature depolarizations (VPDs). Fourteen centers enrolled a total of 99 patients with frequent symptomatic VPDs (average ≥20 VPDs/hr) who previously responded to and tolerated the procainamide qid formulation. During the first week of the double-blind phase, patients were randomized to either placebo or procainamide dosages of 1000, 2000, or 4000 mg/d (bid or qid formulations). In the second week, the patients were crossed over to the alternate formulation. Seventy-seven patients qualified for the primary activity analysis. The bid and qid formulations showed comparable effectiveness in the suppression of mean VPDs with a linear dose-response relationship. The VPD suppression was not attenuated towards the end of the dosing interval for either formulation. Sixty-eight of these patients entered an optional 1-year extension to receive the bid formulation. Thirty-seven (54%) patients had adverse effects. Of those, 15 (22%) had side effects considered treatment related. Most of the adverse events occurred during the first 6 weeks of treatment. Only a few patients (8%) withdrew as a consequence of treatment with the bid formulation. The overall safety profile of the bid formulation was similar to other formulations, and the procainamide bid formulation has a low proarrhythmic rate (`3%). In conclusion, the effectiveness of the twice-daily formulation of procainamide in the suppression of VPDs is comparable to the currently available qid formulation.

We evaluated the frequency and prognosis of emergency coronary artery bypass grafting (CABG) after percutaneous coronary intervention (PCI) for acute myocardial infarction in a large, multicenter registry of contemporary PCI. In this study, emergency CABG occurred in 2% of cases, and was associated with high in-hospital mortality (20%) and with a high incidence of stroke (8%), renal failure requiring dialysis (8.3%), and bleeding (63.3%).

Background Risk-adjustment models for percutaneous coronary intervention (PCI) mortality have been recently reported, but application in bedside prediction of prognosis for individual patients remains untested. Methods and Results Between July 1, 1997 and September 30, 1999, 10 796 consecutive procedures were performed in a consortium of 8 hospitals. Predictors of in-hospital mortality were identified by use of multivariate logistic regression analysis. The final model was validated by use of the bootstrap technique. Additional validation was performed on an independent data set of 5863 consecutive procedures performed between October 1, 1999, and August 30, 2000. An additive risk-prediction score was developed by rounding coefficients of the logistic regression model to the closest half-integer, and a visual bedside tool for the prediction of individual patient prognosis was developed. In this patient population, the in-hospital mortality rate was 1.6%. Multivariate regression analysis identified acute myocardial infarction, cardiogenic shock, history of cardiac arrest, renal insufficiency, low ejection fraction, peripheral vascular disease, lesion characteristics, female sex, and advanced age as independent predictors of death. The model had excellent discrimination (area under the receiver operating characteristic curve, 0.90) and was accurate for prediction of mortality among different subgroups. Near-perfect correlation existed between calculated scores and observed mortality, with higher scores associated with higher mortality. Conclusions Accurate predictions of individual patient risk of mortality associated with PCI can be achieved with a simple bedside tool. These predictions could be used during discussions of prognosis before and after PCI.