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164 Volume Outcome KCE reports 113 6.3.7 Discussion PCI is one of those procedures for which volume thresholds have been established. The US Agency for Healthcare Research and Quality (AHRQ) applies a lower threshold of >200 PTCA per year and an upper threshold of >400 PTCA per year. 29 The US Leapfrog Group uses the cut off of 400 PCI per year to select providers. 126 Finally, the American College of Cardiology/American Heart Association recommends more than 400 PCI per year per hospital and at least 75 PCI per year for operators. Hospitals that perform less than 200 PCI per year are labelled as low-volume hospitals. 279 6.3.7.1 External validation of the definition of the procedure The external validation is based on data from the Belgian Working Group for Interventional Cardiology (BWGIC) and the Belgian Association for Cardio-Thoracic Surgery (BACTS) for the year 2004 in Belgium, as published in KCE report 66 (table 1.2 on page 11 in this report). 265 Table 6.36: PCI: Types of stents KCE project 2004 Volume Outcome BWGIC 2004 265 Number Pct. Number Pct. Plain balloon angioplasty 2 144 10% 2 108 9% Bare Metal Stent (BMS) 15 431 68% 15 696 67% Drug Eluting Stent (DES) 2 776 12% 5 622 24% No information 2 210 10% - - Total PCI 22 561 100% 23 426 100% The total number of PCI is very comparable, but the number of DES is a lot less in our database (i.e. 50%) than registered in the BWGIC register. This could be explained by the reimbursement criteria for DES in Belgium. In 2004, there was only one approved indication for reimbursement i.e. diabetes. Neyt et al. mentioned that DES were also used in non-diabetics (about 14% of non-diabetics received DES or a combination of DES and BMS during their PCI in 2004). In these cases, the hospitals have to bear the additional cost themselves and can not invoice the NIHDI code 686464. Experts that were consulted for KCE report 66, suggested that DES were also implanted in nondiabetics with a high risk of re-stenosis, such as chronic total occlusion, in-stent restenosis after prior BMS, multi-vessel stenting, etc. On the other hand, however, Neyt et al. showed that other factors played a role as well. Patients in a private room, for example, had a higher probability of getting a DES. 265 6.3.7.2 Summarized results of literature review The systematic literature search identified six systematic reviews in which the VOA for PCI was studied. 1, 5, 59, 60, 64, 67 These systematic reviews discussed 41 primary studies of which 23 were published between 2000 and 2005. 282-304 The discussion below will primarily be based on the evidence report by the German Institute for Quality and Efficiency in Health Care (IQWiG) because it dates from 2006 and was assessed as very good quality (see Appendix 7). 67 Additionally, several primary studies will be used for the discussion, especially those published in 2004 and 2005 because they allow an evaluation of the volume-outcome relationship in contemporary PCI practice where coronary stents and new anti-platelet agents (i.e. glycoprotein IIb/IIIa receptor blockers) are widespread. On the basis of all six systematic reviews we concluded in Table 2.2 (page 19) that there were conflicting results in relation to the volume-outcome association between volume (hospital or interventionist) and mortality in case of patients undergoing a PCI for mixed indications (elective and primary) and between hospital volume and emergency CABG rate. The term conflicting results means that there are primary studies that indicate a positive relation with volume and other studies that indicate a negative relation with volume. On the other hand, we concluded that there was an inverse relation between volume (hospital or interventionist) and mortality for primary PCI, and between interventionist volume and emergency CABG rate.
KCE Reports 113 Volume Outcome 165 6.3.7.3 Comparative analysis of literature and Belgian data DEFINITION OF VOLUME Figure 6.13 shows that 8 out of 29 (27%) B2/B3 centres have less than 400 procedures per year (dashed red line in Figure 6.13) which is the upper threshold of several organisations in order to be labelled as high-volume centre (see page 164). Only 1 out of 29 (3%) B2 and B3 centres has less than 200 PCI procedures per year and can be considered a low-volume centre according to the same thresholds. Operators perform on average 93 PCI per year, with a median of 50 PCI per annum, as is illustrated in Table 6.31. This means that many of the Belgian operators do not comply with the operator threshold of 75 PCI per year by the American College of Cardiology. 279 OUTCOME Overall in-hospital mortality after PCI was 1.81% in Belgian B2/B3 hospitals (Table 6.32). There is, however, a relation with the principal diagnosis: in-hospital mortality is much higher among patients admitted with a myocardial infarction i.e. 5.11% (Table 6.33). Similar differences are present in scientific literature where a distinction is made between articles that only study primary PCI and those that analyse PCI for all indications (i.e. primary and elective PCI). Primary PCI is synonym for immediate PCI and is performed on patients with an acute myocardial infarction, within a limited number of hours after the onset of symptoms. Epstein et al. analysed more than half a million hospitalizations with a PCI (primary and elective) performed nationwide in the USA between 1998 and 2001. They found a crude in-hospital mortality of 1.50% for these patients; this seems comparable with the Belgian 1.8%. 283 Zahn et al. used data of almost 5 000 patients treated with a primary PCI in German hospitals between 1994 and 2000. In-hospital mortality was 9.3% for these patients with an acute myocardial infarction. 287 This is even higher than the 5.11% that was found in Belgian data. Table 6.32 shows a CABG rate of 1.07% in Belgian hospitals after PCI. This percentage is comparable with the one mentioned by Hannan et al.; same-stay CABG rate of 0.91% after PCI performed in New York between 1998 and 2000. 284 Moscucci et al., on the other hand, observed an emergency CABG rate of 0.44% among 18 500 PCIs which were performed in Michigan hospitals in 2002. 285 AMI rate after PCI is extremely high in Belgian data: 11.6% after exclusion of stays with AMI as principal diagnosis (see Table 6.32). Moscucci et al. found a MI rate of only 1.37% in their database. 285 This discrepancy proves once again that the use of codes from administrative data is not an ideal method to accurately identify the occurrence of AMI as a complication, as was also the case for CEA. PATIENT CASE MIX Almost three out of four (73%) Belgian PCI patients are male. They have an average age of 65.5 and a mean Charlson score of 1.0 (Table 6.34). In relation to age and gender, Belgian patients are very comparable to those described in the primary studies that were identified. There were, however, only a few studies that mention the Charlson score. Kansagra et al. found a mean Charlson score of 0.9 among almost 100 000 patients who underwent PCI in the USA in 2001. 290 Ho et al., on the other hand, found much lower Charlson scores, but they described an evolution in mean Charlson score across different time periods: 0.24 in 1984-1987, 0.35 in 1988-1992 and 0.46 in 1993- 1996. 301 These numbers suggest that patients who received PCI become frailer over time, which could explain the mean score of 1.0 in Belgian data. Table 6.34 shows a difference in case mix between Belgian centres i.e. a higher percentage of patients with Charlson score >3, with AMI as principal diagnosis or with a higher severity index in low-volume hospitals. When we compare these results with published studies that are also limited to administrative data, there is a resemblance. Epstein et al. also found a slightly higher proportion of PCI patients with a myocardial infarction in low-volume (
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