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J Am Coll Cardiol, 2005; 46:625-632, doi:10.1016/j.jacc.2005.05.048
(Published online 27 July 2005). © 2005 by the American College of Cardiology Foundation |







* Division of Cardiology, University of Michigan Medical Center, Ann Arbor, Michigan, USA
St. Joseph Mercy Hospital, Ann Arbor, Michigan
Blue Cross Blue Shield of Michigan, Detroit, Michigan, USA
¶ St. John's Hospital and Medical Center, Detroit, Michigan
Oakwood Hospital, Dearborn, Michigan
|| Spectrum Health, Grand Rapids, Michigan
# McLaren Regional Medical Center, Flint, Michigan
** St. Joseph Hospital, Pontiac, Michigan

Ingham Regional Medical Center, Lansing, MichiganUSA

Sparrow Medical Center, Lansing, Michigan
Manuscript received September 24, 2004; revised manuscript received May 10, 2005, accepted May 22, 2005.
* Reprint requests and correspondence: Dr. Mauro Moscucci, University of Michigan Hospital, Division of Cardiology, Taubman Center B1-226, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-0311 (Email: moscucci{at}med.umich.edu).
| Abstract |
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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.
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| Methods |
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Coronary artery stenoses were classified with the modified ACC/American Heart Association (AHA) lesion classification. In addition, angiographic characteristics, including the presence of visible thrombus and of moderate or heavy calcification, were collected for each lesion.
Operator volume. A total of 165 operators performing PCI on 18,504 patients during the full calendar year 2002 were included in this analysis. All participating institutions collected operator volume data as part of their own quality assurance program. The volume data collected included procedures performed in the specific institution and in other institutions. In the registry, to ensure operator confidentiality, each operator is assigned a code number by the submitting institution. Therefore, to ensure accuracy in the assigned volume variableparticularly for operators who might have been performing procedures in more than one institutionfor each operator, the annual procedure volume in the registry was confirmed against the procedure volume provided by the hospital administration of each institution.
Operators were grouped by quintile (Q) according to the number of procedures performed as follows: the first quintile included operators performing 1 to 33 PCI/year (393 or 2.2% of total procedures), the second quintile included operators performing 34 to 89 PCI/year (2,105 or 11.4% of total procedures), the third quintile included operators performing 90 to 139 PCI/year (3,117 or 16.8% of total procedures), the fourth quintile included operators performing 140 to 206 procedures/year (5,134 or 27.9% of total procedures), and the fifth quintile included operators performing 207 to 582 procedures/year (7,755 or 41.9% of total procedures). The ACC and AHA currently recommend a minimum of 75 PCI/year per operator (1). Therefore, a secondary analysis was performed with the 75 PCI/year as a cutoff to differentiate "low volume operators" from "high volume operators."
Missing data.
Baseline demographics (including age and gender), comorbidities, procedure, and outcome data were recorded in every case. Among the other data elements, baseline creatinine and ejection fraction were missing in 8.7% and 19.7% of cases, respectively. Missing values for creatinine were coded as
1.5 mg/dl, whereas missing values for the ejection fraction were imputed with a linear regression model, including age, left ventricular end diastolic pressure, cardiogenic shock, history of prior CABG, history of prior MI, gender, and history of congestive heart failure (57).
Clinical end point. The primary end point was a composite of major adverse cardiovascular events (MACE), including in-hospital death, CABG surgery, stroke or transient ischemic attack, MI, and repeat PCI at the same site during the index hospital stay. The secondary end point was in-hospital death.
Statistical analysis. Data are expressed as mean ± standard deviation or as percentage. Analysis of variance was used for differences between means, and Pearson chi-square test was used for differences in frequencies. Trends across quintile of procedure volume were evaluated with the Cochran-Armitage trend test for significance.
Independent predictors of in-hospital mortality and MACE were determined by stepwise multivariate logistic regression analysis. Those variables with p value <0.2 in univariate analysis were included in stepwise regression procedures for MACE and for in-hospital mortality. The following variables were evaluated in the stepwise regression process: age, gender, hypertension, diabetes mellitus, extra-cardiac vascular disease (defined as any history of peripheral vascular disease or stroke), congestive heart failure, renal failure requiring dialysis, gastro-intestinal bleeding, chronic obstructive pulmonary disease, atrial fibrillation, history of cardiac arrest, prior history of percutaneous intervention, prior history of coronary artery bypass surgery, creatinine
1.5 mg/dl, MI within 7 days, MI within 24 h, cardiac arrest, prior thrombolysis, cardiogenic shock, ventricular tachycardia or fibrillation in the setting of acute MI, emergency angioplasty, rescue angioplasty after failed thrombolysis, unstable angina (requiring intravenous nitroglycerin and heparin treatment), number of diseased vessels (>70% stenosis), left ventricular ejection fraction <50%, ACC type C stenosis, visible thrombus on the initial coronary angiogram, prior history of MI, left main stenosis (>70%), anemia (hemoglobin <10 g/dl), and the presence of moderate or heavy calcification. Model discrimination was assessed with the c-statistic, and goodness of fit was assessed with the Hosmer-Lemeshow statistics. Three groups of models were fitted. In the first group, hospitals were considered as fixed effects; in the second group, a random effect was included, assuming normal hospital-effect distributions; and in the third group, generalized estimating equations were fitted to control for clustering and variation by hospital (8). Standardized event ratios (observed/predicted) and 95% confidence intervals were also calculated (9).
A prior study has suggested that low volume of procedures (coronary artery bypass surgery) might be a negative correlate of worse outcomes in high-risk patients, but not in low-risk patients (10); however, a more recent study has shown that the relationship between operator volume and outcomes might be independent of patients' risk (11). To explore this potential relationship further, predicted probabilities of MACE for individual patients were calculated. Patients were stratified in quartiles of predicted risk of MACE, and observed and predicted rates of MACE were then calculated according to the quintile of operator volume. An additional analysis was performed by dividing procedures according to the day of the week (weekend vs. weekday).
Statistical analysis was performed with SAS version 8.2 (SAS Institute, Cary, North Carolina).
| Results |
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75 PCI/year per operator) are shown in Table 4. After adjustment for comorbidities, no significant differences in MACE and mortality were observed in the group of patients treated by operators performing <75 PCI/year when compared with the group of patients treated by operators performing
75 PCI/year (adjusted OR for death 0.81, 95% CI 0.47 to 1.41, p = 0.46; adjusted OR for MACE 1.05, 95% CI 0.83 to 1.32, p = 0.67). This lack of difference was due to the inclusion in the high volume group (
75 procedures/year) of operators classified as "low volume" in the quintile analysis, and to pooling all operators in only two groups; however, when data were analyzed according to the day of the week (weekends vs. weekdays), significant differences emerged. The unadjusted "weekend" MACE rate for operators performing <75 procedures/year was 15.79%, compared with a MACE rate of 8.45% for operators performing
75 procedures/year (p = 0.01); weekday mace rates were 3.85% and 4.32%, respectively (p = 0.41).
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| Discussion |
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The relationship between low procedure volume and adverse outcomes has been previously shown for PCI, for coronary artery bypass surgery and more recently, for other surgical cardiovascular and cancer resection procedures (13,14). Although the continued importance of this relationship for coronary artery bypass surgery was recently confirmed with contemporary clinical data (15), for PCI, the majority of the studies available either predate the widespread introduction in interventional practice of coronary stenting and of glycoprotein receptor blockers or was obtained through analysis of Medicare claims data. Recognized limitations related to analysis of Medicare data include the need to extrapolate total number of procedures from the number of Medicare procedures, the often incomplete reporting in Medicare claims of comorbidities that have been shown to be important risk factors for adverse outcomes (14,16), and the potential for miscoding of complications as comorbidities (17).
Ellis et al. (18) analyzed clinical data from a quality-controlled, clinical, multi-institutional database of PCIs. The patient population included patients treated during calendar year 1993 and 1994, a time-period predating the widespread use of coronary stents and of glycoprotein IIb/IIIa receptor blockers. They found that operators performing <70 procedures per year had significantly worse outcomes than the remainder of the group. In addition, the best outcomes were observed in a high volume group of operators performing >270 procedures per year. Similar results were reported by Hannan et al. (19) in an analysis of data from the New York State Department of Health Coronary Angioplasty Reporting System obtained between January 1, 1991, and December 31, 1994 and by Jollis et al. (2,3) in two separate analyses of claim data from the Medicare database. Both analyses also predated the widespread introduction of coronary stents and of glycoprotein IIb/IIIa receptor blockers in interventional practice, and both reports showed better outcomes with high volume operators, including lower mortality rates. More, recently, McGrath et al. (20) analyzed relatively contemporary data (calendar year 1997) from the Medicare database. Given that Medicare patients represent 35% to 45% of total PCI procedure volume, they estimated that 30 PCI per operator per year on Medicare patients could be extrapolated to a total procedure volume of 70 PCI per operator per year. Stent use was 50.6% for operators performing <30 Medicare PCI/year and 61.1% for operator performing >60 Medicare PCI/year. A significant relationship between operator volume and outcomes was also reported in their study, with better outcomes observed in patients treated by high volume operators when compared with patients treated by low volume operators.
Our results are at odds, however, with a report from the Northern New England Cardiovascular study group with data from 1994 through 1996 and using a similar sample size and methodology. In that study, no significant relationship was found between annual operator procedure volume and outcomes (21). Whether this discrepancy indicates that the results of this type of analysis cannot be generalized remains to be determined.
The ACC and AHA currently recommend a minimum of 75 PCI/year per operator. In our analysis, we were not able to confirm a relationship between operator volume and outcomes when this cutoff was used. The analysis of volume, by quintile and by individual operator, suggested that this finding was due to the inclusion in the high volume group (
75 procedures/year) of operators classified as "low volume" in the quintile analysis and to pooling all operators in only two groups. In addition, significant variability in clinical outcomes was observed in the low volume group.
Our analysis of contemporary practice supports the hypothesis that technological advancements have not yet completely offset the influence of procedural volume in determining proficiency of contemporary PCIs. Whereas the relationship between operator volume and in-hospital mortality is no longer significant, the relationship between volume and any major adverse outcome is still present. In addition, this relationship appears to be relatively independent of patient-specific risk, thus suggesting that it remains to be determined whether it can be further offset by meticulous risk stratification and case selection. Although procedure volume is only a poor surrogate of quality and outcomes, and it should not be used as a replacement for appropriately risk-adjusted outcomes, annual procedure volume is clear and easily understandable information for patients undergoing PCI. Thus, it seems appropriate to continue to include operator procedure volume among the several quality indicators of contemporary PCI practice, with the understanding that, as of today, its value is not as important as it was in the pre-stent/pre-glycoprotein receptor blockers era.
Our study has several limitations. All the hospitals participating in the consortium were relatively high volume institutions performing
644 procedures/year, and therefore, we could not evaluate the interaction between low volume institutions (<400 procedures/year) and low volume operators. Biomarkers of myocardial necrosis after the procedure were not obtained on a routine basis in all patients, but were rather obtained when it was felt indicated by the physicians in charge of post-procedure care. Further analysis (data not shown) revealed no changes in the results, however, when post-procedure MI was excluded from the combined outcome (MACE) variable. Low volume operators appeared to have a higher case-mix of difficult caseslesions with higher frequency of visible thrombus or calcificationbut a lower frequency of type C lesions. We could not determine whether these differences were due to a different case-mix or to a different interpretation of the coronary angiograms. Although the risk adjustment model accounted for these differences, we cannot exclude that we were unable to adjust fully for these differences.
We were also unable to determine the potential effect of board certification or of number of years in practice, operator-specific characteristics that might offset the influence of volume. In addition, since we only analyzed data from a regional consortium, our results should not necessarily be generalized to other regions of the nation or of the world.
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| References |
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