David Share

Nephropathy requiring dialysis after percutaneous coronary intervention and the critical role of an adjusted contrast dose

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 <0.001). In conclusion, NRD following PCI is a rare complication with a poor prognosis. Baseline clinical characteristics identify patients at greatest risk for NRD. Optimization of procedural variables such as timing of the intervention relative to the diagnostic catheterization, staging coronary procedures, or dosing within the MRCD may help reduce the risk of this complication in high-risk patients. A risk prediction tool for NRD with guidelines for prevention is presented.

Hospital Complication Rates With Bariatric Surgery in Michigan

CONTEXT Despite the growing popularity of bariatric surgery, there remain concerns about perioperative safety and variation in outcomes across hospitals. OBJECTIVE To assess complication rates of different bariatric procedures and variability in rates of serious complications across hospitals and according to procedure volume and center of excellence (COE) status. DESIGN, SETTING, AND PATIENTS Involving 25 hospitals and 62 surgeons statewide, the Michigan Bariatric Surgery Collaborative (MBSC) administers an externally audited, prospective clinical registry. We evaluated short-term morbidity in 15,275 Michigan patients undergoing 1 of 3 common bariatric procedures between 2006 and 2009. We used multilevel regression models to assess variation in risk-adjusted complication rates across hospitals and the effects of procedure volume and COE designation (by the American College of Surgeons or American Society for Metabolic and Bariatric Surgery) status. MAIN OUTCOME MEASURE Complications occurring within 30 days of surgery. RESULTS Overall, 7.3% of patients experienced perioperative complications, most of which were wound problems and other minor complications. Serious complications were most common after gastric bypass (3.6%; 95% confidence interval [CI], 3.2%-4.0%), followed by sleeve gastrectomy (2.2%; 95% CI, 1.2%-3.2%), and laparoscopic adjustable gastric band (0.9%; 95% CI, 0.6%-1.1%) procedures (P < .001). Mortality occurred in 0.04% (95% CI, 0.001%-0.13%) of laparoscopic adjustable gastric band, 0 sleeve gastrectomy, and 0.14% (95% CI, 0.08%-0.25%) of the gastric bypass patients. After adjustment for patient characteristics and procedure mix, rates of serious complications varied from 1.6% (95% CI, 1.3-2.0) to 3.5% (95% CI, 2.4-5.0) (risk difference, 1.9; 95% CI, 0.08-3.7) across hospitals. Average annual procedure volume was inversely associated with rates of serious complications at both the hospital level (< 150 cases, 4.1%; 95% CI, 3.0%-5.1%; 150-299 cases, 2.7%; 95% CI, 2.2-3.2; and > or = 300 cases, 2.3%; 95% CI, 2.0%-2.6%; P = .003) and surgeon level (< 100 cases, 3.8%; 95% CI, 3.2%-4.5%; 100-249 cases, 2.4%; 95% CI, 2.1%-2.8%; > or = 250 cases, 1.9%; 95% CI, 1.4%-2.3%; P = .001). Adjusted rates of serious complications were similar in COE and non-COE hospitals (COE, 2.7%; 95% CI, 2.5%-3.1%; non-COE, 2.0%; 95% CI, 1.5%-2.4%; P = .41). CONCLUSIONS The frequency of serious complications among patients undergoing bariatric surgery in Michigan was relatively low. Rates of serious complications are inversely associated with hospital and surgeon procedure volume, but unrelated to COE accreditation by professional organizations.

Simple Bedside Additive Tool for Prediction of In-Hospital Mortality After Percutaneous Coronary Interventions

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.

The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity.

Objective:To evaluate the comparative effectiveness of sleeve gastrectomy (SG), laparoscopic gastric bypass (RYGB), and laparoscopic adjustable gastric banding (LAGB) procedures. Background:Citing limitations of published studies, payers have been reluctant to provide routine coverage for SG for the treatment of morbid obesity. Methods:Using data from an externally audited, statewide clinical registry, we matched 2949 SG patients with equal numbers of RYGB and LAGB patients on 23 baseline characteristics. Outcomes assessed included complications occurring within 30 days, and weight loss, quality of life, and comorbidity remission at 1, 2, and 3 years after bariatric surgery. Results:Matching resulted in cohorts of SG, RYGB, and LAGB patients that were well balanced on baseline characteristics. Overall complication rates among patients undergoing SG (6.3%) were significantly lower than for RYGB (10.0%, P < 0.0001) but higher than for LAGB (2.4%, P < 0.0001). Serious complication rates were similar for SG (2.4%) and RYGB (2.5%, P = 0.736) but higher than for LAGB (1.0%, P < 0.0001). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB (69%, P < 0.0001), but was 77% higher for SG than for LAGB (34%, P < 0.0001). SG was similarly closer to RYGB than LAGB with regard to remission of obesity-related comorbidities. Conclusions:With better weight loss than LAGB and lower complication rates than RYGB, SG is a reasonable choice for the treatment of morbid obesity and should be covered by both public and private payers.

How A Regional Collaborative Of Hospitals And Physicians In Michigan Cut Costs And Improved The Quality Of Care

There is evidence that collaborations between hospitals and physicians in particular regions of the country have led to improvements in the quality of care. Even so, there have not been many of these collaborations. We review one, the Michigan regional collaborative improvement program, which was paid for by a large private insurer, has yielded improvements for a range of clinical conditions, and has reduced costs in several important areas. In general and vascular surgery alone, complications from surgery dropped almost 2.6 percent among participating Michigan hospitals-a change that translates into 2,500 fewer Michigan patients with surgical complications each year. Estimated annual savings from this one collaborative are approximately

Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions.

20 million, far exceeding the cost of administering the program. Regional collaborative improvement programs should become increasingly attractive to hospitals and physicians, as well as to national policy makers, as they seek to improve health care quality and reduce costs.

Association of a Continuous Quality Improvement Initiative With Practice and Outcome Variations of Contemporary Percutaneous Coronary Interventions

OBJECTIVES The aim of this study was to evaluate the association between calculated creatinine clearance (CCC)-based contrast dose and renal complications in patients undergoing percutaneous coronary interventions (PCI). BACKGROUND Excess volumes of contrast media are associated with renal complications in patients undergoing cardiac procedures. Because contrast media are excreted by the kidney, we hypothesized that a dose estimation on the basis of CCC would provide a simple strategy to define a safe dose of contrast media. METHODS We assessed the association between CCC-based contrast dose and the risk of contrast-induced nephropathy (CIN) and need for in-hospital dialysis in 58,957 patients undergoing PCI and enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry from 2007 to 2008. Patients receiving dialysis at the time of the procedure were excluded. RESULTS The risk of CIN and nephropathy requiring dialysis (NRD) was directly associated with increasing contrast volume adjusted for renal function. The risk for CIN and NRD approached significance when the ratio of contrast dose/CCC exceeded 2 (adjusted odds ratio [OR] for CIN: 1.16, 95% confidence interval [CI]: 0.98 to 1.37, adjusted OR for NRD: 1.72, 95% CI: 0.9 to 3.27) and was dramatically elevated in patients exceeding a contrast to CCC ratio of 3 (adjusted OR for CIN: 1.46, 95% CI: 1.27 to 1.66, adjusted OR for NRD: 1.89, 95% CI: 1.21 to 2.94). CONCLUSIONS Our study supports the need for minimizing contrast dose in patients with renal dysfunction. A contrast dose on the basis of estimated renal function with a planned contrast volume restricted to less than thrice and preferably twice the CCC might be valuable in reducing the risk of CIN and NRD.

Prognostic Implication of Anemia on In-Hospital Outcomes After Percutaneous Coronary Intervention

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.

Reliability and validity of utilization review criteria. Appropriateness Evaluation Protocol, Standardized Medreview Instrument, and Intensity-Severity-Discharge criteria.

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 (<12.0 g/dL in women and <13.0 g/dL in men). A total of 6471 men (21.7%) and 4659 women (30.4%) were anemic. Anemic men and women were older and had a higher percentage of comorbidities compared with their nonanemic cohorts (P <0.0001 for all comparisons). When compared with nonanemic patients, anemic patients had higher in-hospital mortality (3.0% versus 0.8% in men; 2.4% versus 1.5% in women; 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 <0.0001). After adjustment for comorbidities, anemia was associated with a higher risk of in-hospital mortality (odds ratio [OR], 2.29; 95% CI, 1.79 to 2.92; P <0.0001) and MI (OR, 1.34; 95% CI, 1.05 to 1.72; 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.

Trends in Door-to-Balloon Time and Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

A study was conducted to assess the reliability and validity of the Appropriateness Evaluation Protocol (AEF), the Standardized Medreview Instrument (SMI) and the Intensity-Severity-Discharge criteria set (ISD), three utilization review instruments used to determine whether inpatient care is required. Reliability and validity were assessed for retrospective application of these instruments to charts of a sample of 119 medical cases from 21 hospitals in the state of Michigan. The reliability of each instrument was determined by having the instrument applied by two different nurse reviewers to each hospital record. Results indicated that the AEP and ISD were moderately reliable, while the SMI had low reliability. The validity of each instrument was tested by comparing the judgments of nurse reviewers using the instruments with the judgment of a panel of physicians. The AEP and ISD were found to be moderately valid and the SMI was found to have low validity. Results suggested that the SMI should not be used. The modest level of validity of the other two instruments suggests that payment should never be denied on the basis of the instrument alone. Payment should be denied only if a physician confirms the judgment based on the instrument that inpatient care was not required.