Health Policy and Planning Advance Access originally published online on March 20, 2008
Health Policy and Planning 2008 23(3):210-217; doi:10.1093/heapol/czn005
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The appropriateness of use of coronary angiography in Lebanon: implications for health policy
1 Department of Epidemiology & Population Health, Faculty of Health Sciences, American University of Beirut, Lebanon.
2 Lebanese Society of Cardiology.
3 Rizk Hospital, Beirut, Lebanon, and President, Lebanese Society of Cardiology.
4 Department of Internal Medicine, Cardiology division, American University of Beirut Medical Center, Lebanon.
* Corresponding author. Department of Epidemiology & Population Health, Faculty of Health Sciences, American University of Beirut, PO Box: 11-0236, Riad El Solh 1107 2020 Beirut, Lebanon. Tel: + 961 3 410893. Fax: +961 1 744470. E-mail: rt21{at}aub.edu.lb
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Abstract |
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Background Lebanon, characterized by a free-market health care system, has one of the highest reported per capita rates of cardiac catheterization facilities and coronary angiographies in the world. The aim of this study is to evaluate the appropriateness of performance of coronary angiography procedures in Lebanon.
Methods Data derived from the 2004 Lebanese Interventional Coronary Registry (LICOR) included 5418 patients aged 30 years and older who had not undergone prior percutaneous coronary intervention or coronary artery bypass grafting. Appropriateness was evaluated based on the Class I indications of the ACC/AHA guidelines for coronary angiography.
Findings The overall rate of appropriate procedures was 54.7% (95% CI 53.3–56.0%). Appropriateness varied significantly by gender and across administrative regions. Compared with females, males were more likely to be referred appropriately for coronary angiography (OR = 1.28, 95% CI = 1.15–1.44). Appropriateness was lowest (OR = 0.89, 95% CI = 0.71–1.12) in the region where the per capita density of cardiac catheterization labs increased by six-fold in the latter 2 years. The majority of the patients (84.3%) were not evaluated by any of the non-invasive tests prior to angiography, with only 10.8%, 4% and 1.5% of the patients referred for an exercise stress test, stress echocardiography and thallium stress tests, respectively.
Discussion Findings indicate a high rate of procedures conducted without appropriate indications and a low utilization rate of pre-interventional non-invasive testing. This may be attributed to three factors: a surplus of catheterization facilities in certain regions, the insignificant cost gradient between non-invasive testing and coronary angiography, and the wide case-based reimbursement of coronary angiography, unlike non-invasive testing, by public insurance schemes.
Key Words: Appropriateness, cardiovascular diseases, coronary angiography, medical technology, Lebanon
KEY MESSAGES
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Introduction |
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Triggered by escalating health care costs, quality assurance has recently commanded considerable attention in health care research (Bernstein et al. 1993a
; Bernstein et al. 1993b; Leape et al. 1993). The identification of use and overuse of several medical and surgical procedures has led to the critical examination of possible inappropriate care and questions as to whether or when interventions are needed. Consequently, guidelines that aim at optimizing patient outcomes and improving the effectiveness of care, by assisting physicians in applying evidence-based efficacious and cost-effective diagnostic and therapeutic strategies, have been developed.
To date no clinical guidelines have been promoted in Lebanon, a small middle-income country in the Mediterranean region, for the majority of invasive procedures including cardiac catheterization and coronary angiography. Driven by the economic interest of a free-market financing structure of the health care system, Lebanon has been experiencing a rapid expansion in technology, the fastest growth of which has been in cardiac surgery and cardiac catheterization (Lerberghe et al. 1997). In fact, the number of cardiac catheterization facilities in the country has risen by more than three-fold from 10 to 35 in less than a decade (Sibai et al. 2007). In 2004, a total of 20 069 cardiac catheterizations were performed, placing the country third worldwide in terms of per capita utilization rate after the United States and Germany, the latter of which is considered to have the highest rate in Europe (Sibai et al. 2007). The high rate of cardiac catheterization procedures in the country can hardly be explained by its demographic composition or epidemiologic position. The percentage of inhabitants aged 65 years and above does not exceed 7% and cardiovascular diseases constitute around 16% of prevalent health conditions among adults (Sibai et al. 2001). The question is whether a high rate of unnecessary procedures provides an explanation for the high utilization rate of coronary angiographies in the country.
Studies examining the appropriateness of coronary angiography use have been conducted in Sweden (Bengston et al. 1994), Canada (McGlynn et al. 1994; Roos et al. 1994), the United States (Chassin et al. 1987; Bernstein et al. 1993a; McGlynn et al. 1994; Barnhart and Bernstein 2006), the United Kingdom (Hemingway et al. 2001), Israel (Mozes and Shabtai 1994), Italy (Rubboli et al. 2001), Germany (Brause et al. 2006), Switzerland (Schilling et al. 2003) and Brazil (Gontijo et al. 2005), and have yielded rates ranging between 34.5% in Brazil (Gontijo et al. 2005) and 91% in Canada (McGlynn et al. 1994; Roos et al. 1994), with the majority of studies showing appropriateness rates above 72%. Findings of these studies have influenced clinical decision-making and have often been instrumental in guiding governmental policies and insurance companies' schemes on optimal use of public and private funds. Using the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for coronary angiography (Scanlon et al. 1999), this study addresses the question of appropriateness in Lebanon where, in spite of scarce resources, the use of coronary angiography has been established to be significantly high (Sibai et al. 2007).
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Methods |
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Participants
The study sample is derived from the Lebanese Interventional Coronary Registry (LICOR) established in 2002 by the Lebanese Society of Cardiology and the Non-Communicable Disease Program at the Ministry of Public Health in Lebanon. Participation in the Registry is voluntary and no benefits are given to those hospitals that choose to participate. Data collectors in all participating hospitals were trained using the same data definitions to ensure consistency, and information was abstracted from both medical records and patient interviews. The staff at the Registry routinely monitored the information submitted by data collectors in each hospital. A total of 24 hospitals were enrolled in the Registry representing 68.6% of all hospitals with cardiac facilities in the country.
Patient consent was obtained before the interview, and confidentiality was maintained both in the interview schedule and in the computer software designed for data entry. Data were collected from January to December 2004, yielding a total of 6921 patient records. However, for the objectives of the study, patients aged less than 30 years and those who had undergone prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were excluded. The final analytic sample totalled 5418 patients of which 93.6% were residents of the country. The study protocol was approved by the Institutional Research Board of the American University of Beirut.
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Measures |
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The Registry included information on socio-demographics (age, gender and governorate, i.e. the administrative district in which the hospital is located), patient's clinical characteristics including symptoms on presentation, cardiovascular history and cardiovascular disease (CVD) risk factors (diabetes, hypertension, hypercholesterolemia, smoking and family history of CVD), and tests undertaken prior to angiography referral. Results of the cardiac enzymes (Troponin and CK-MB) and non-invasive tests (exercise stress test, stress echocardiography and thallium stress tests) were recorded in the Registry as positive, borderline, negative or missing. A four-category summary measure for the results of the three non-invasive tests was constructed, with patients being classified as: (1) positive, for those with a positive result in any of the tests; (2) negative, for those with a negative result in all of the performed tests; (3) not conducted, for those where none of the tests were performed, and finally; (4) borderline, for all remaining combinations.
Angiography results recorded in the data Registry files included: location, specific distribution and severity of the coronary occlusion in the arterial tree. Following the ACC/AHA recommendations (Scanlon et al. 1999), vessels with a narrowing of 50% or greater were considered to have significant disease, and for vessels that were occluded in multiple locations, the degree of narrowing was considered to be that of the most severe lesion. Only major coronaries were considered. These included the left main (LM), right coronary (RCA), left anterior descending (LAD) and the circumflex arteries (Cx). Consequently, angiography results were examined as the number of diseased coronaries categorized into: zero-vessel, one-vessel disease, two-vessel disease, and three-vessel or left main disease. Complications occurring during the procedure and post-angiography recommendations (no treatment, medical treatment, PCI or CABG) were also recorded.
Appropriateness of performing coronary angiography was assessed following the ACC/AHA guidelines (Scanlon et al. 1999) which have been commonly used for the evaluation of appropriateness of coronary angiography (Rubboli et al. 2001; Gontijo et al. 2005). Owing to the limitations in the Registry data, we could not apply the most validated RAND indicators to assess appropriateness (Bernstein et al. 1992). Moreover, because the ACC/AHA guidelines were not specifically taken into consideration while collecting the data for the Registry, this limited our ability to stratify procedures using all classifications of the ACC/AHA guidelines. Therefore, detection of angiographies which fall into the possibly appropriate class IIa classification was not feasible, and only class I indications, which include conditions for which there is hard evidence and/or a general agreement that the procedure is useful and effective, were considered in this study. Consequently, appropriateness was considered as a dichotomous variable with two options: angiography appropriate versus angiography not appropriate, with the latter category including angiographies that fall within class IIa, class IIb and class III of the ACC/AHA classification.
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Statistical analysis |
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Descriptive statistics, frequencies and means were computed, as appropriate, for demographic and clinical characteristics, presenting complaints, non-invasive tests performed, post-angiography recommendations and results of the angiography. Except for Beirut, the capital Governorate and the reference category, governorates were designated by codes (A-E) to maintain confidentiality of the interventional cardiologists in the areas. Associations between results of angiography (anatomic disease) and the total number of CVD risk factors as well as the performance of prior evaluation (cardiac enzymes and non-invasive testing) were examined using chi-square test or, when cell counts were less than 5, Fisher's exact test. Variations in the rate of appropriateness by baseline characteristics and angiography results were examined using chi-square and student's t-test for categorical and continuous variables, respectively. Finally, age-adjusted odds ratios (OR) and multivariate ORs adjusted for age, gender and total number of CVD risk factors and their 95% confidence interval were estimated with appropriateness as the dependent variable and baseline characteristics and angiography results as independent variables. Owing to the large sample size, a P-value <0.01 was considered statistically significant in order to minimize type I error. All analysis was conducted using SPSS v.15.
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Results |
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Table 1 shows the demographic profile and baseline clinical characteristics of the patients included in this study. Patients’ age ranged between 30 and 95 years with a mean of 60.5 years and a standard deviation (SD) of 11.7 years. The majority of the patients in the study were men (63.3%), and these presented to the angiography at a significantly younger age (59.0 ± 11.9) compared with women (63.1 ± 10.9). More than two-thirds of the sample was derived from angiographies conducted in Beirut and its surrounding Governorate (B) (33.5% and 35.4%, respectively). Hypertension was the most commonly reported CVD risk factor, reaching a prevalence of around 60%, and smoking was reported in half of the study subjects. Around 62% of the patients had a previous history of angina, 8.3% had undergone coronary angiography in the past while 12.6% sustained a previous myocardial infarction. Unstable angina was the most frequent complaint (35.1%) followed by stable angina (21.2%) and atypical chest pain (20%). Cardiac enzymes measures (CK-MB and Troponin) were not conducted in 74.6% of the subjects. Similarly, 84.3% of the patients were not referred for any of the non-invasive tests. The exercise stress test, stress echocardiography and thallium stress test were performed in 10.8%, 4% and 1.5% of the patients, respectively (data not shown).
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Based on the ACC/AHA guidelines, results of the angiography indicated that the LAD was the most commonly occluded artery (43.2%), followed by the RCA (32.6%) and the Cx (21.6%). The LM was narrowed by at least 50% in 3.9% of the patients. A substantial proportion of the sample had zero-vessel disease (43%), with wide variations across cardiac catheterization laboratories, ranging between 34.7% and 72%, and across governorates (39.7% to 46.5%). A total of 53 cases (around 1%) were reported to suffer from one or more complications related to the procedure. The most commonly reported complication was acute MI (0.4%), followed by perforation (0.2%) and new EKG changes (0.2%). Around 44% of the patients were recommended medical therapy, while 28.4% and 19.6% were referred for PCI and CABG, respectively (data not shown).
Findings showed a strong, positive and graded association between the total number of CVD risk factors and the number of diseased coronaries (Table 2). The relationship between the number of diseased vessels with the results of the tests, performed prior to angiography referral, was more evident for cardiac enzymes than the non-invasive tests. Compared with three-vessel disease, the likelihood of zero-vessel disease was around 1.5 times (86.8% vs. 61.2%) for those where cardiac enzymes were not performed.
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Following the ACC/AHA class I indications for coronary angiography, 54.7% of the total sample was rated as appropriate (95% confidence interval 53.3% to 56.0%) (Table 3). Males were significantly more likely to be referred appropriately for coronary angiography compared with females (OR = 1.28, 95% confidence interval 1.15 to 1.44). The rate of appropriate interventions was significantly disproportionate between Governorates, with Governorate E presenting with the lowest proportion of appropriate procedures (44.4%, OR = 0.89, 95% confidence interval 0.71 to 1.12). Further analysis of the data showed that variation in the rate of appropriate procedures by hospital is wide ranging, from as low as 30.6% to as high as 98.8%. Variations by hospital, however, did not correlate with the number of procedures conducted within the centres (r = 0.06, P-value = 0.797) (data not shown).
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A strong positive association was found between the number of diseased coronaries and appropriateness of angiography (Table 3). Patients with three-vessel or left main disease were almost 3.5 times more likely (95% confidence interval 2.83 to 4.41) to be appropriately referred to coronary angiography compared with patients with not-significantly occluded vessels. Furthermore, PCI or CABG were over five times more common among patients appropriately referred to angiography compared with no recommended treatment.
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Discussion |
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The present study evaluated the appropriateness of use of coronary angiography in Lebanon and examined the extent of utilization of clinical testing prior to the invasive procedure. Findings indicate a relatively high prevalence rate of coronary angiographies not following ACC/AHA class I indications (45.3%) with the majority of patients (84.3%) not undergoing any of the non-invasive tests prior to referral. Appropriateness showed a graded relation with the number of diseased vessels at angiography, supporting the internal validity of the ratings (Hemingway et al. 1999
, 2001), and varied significantly by gender and across administrative Governorates. Men in this study were more likely to undergo coronary angiography for appropriate indications compared with women. The observed gender disparity in our study is likely to be confounded by a number of factors as men are less likely to present with atypical symptoms, and false positive non-invasive tests are less common in men compared with women (Douglas and Ginsburg 1996).
There are marked differences between and within countries in appropriateness rates of coronary angiographies (Chassin et al. 1987; Gray et al. 1990; Bernstein et al. 1993a; Bengston et al. 1994; Gray and Hampton. 1994; McGlynn et al. 1994; Mozes and Shabtai 1994; Roos et al. 1994; Hemingway et al. 2001; Rubboli et al. 2001; Schilling et al. 2003; Gontijo et al. 2005; Barnhart and Bernstein 2006; Brause et al. 2006), and these are closely related to differentials in sample selection, clinical guidelines (Brook et al. 1988; Bernstein et al. 1993a; Selby et al. 1996), approaches to deriving appropriateness (Kahan et al. 1996; Ayanian et al. 1998) and regulatory environments (Shekelle et al. 1998). Our result for the appropriate performance of coronary angiography (54.7%) is higher than that found in Brazil (34.5%) (Gontijo et al. 2005) using the same appropriateness criteria, but lower than the rate estimated in studies from other countries such as Sweden, Canada, Italy, Switzerland, Germany and the UK (62–91%) (Bengston et al. 1994; McGlynn et al. 1994; Roos et al. 1994; Hemingway et al. 2001; Rubboli et al. 2001; Schilling et al. 2003; Brause et al. 2006). The lower appropriateness rate in Lebanon compared with Western countries is likely partly attributable to our definition of appropriateness to include class I procedures only, due to limitations in the data available in the Registry, as opposed to the combination of class I/IIa adopted in other studies (Rubboli et al. 2001). Nevertheless, overuse of coronary angiography appears to be prevalent in Lebanon as the rate of non-significant disease was greater in our study (43%) compared with that reported, for example, in the Appropriateness for Coronary Revascularization (ACRE) study (Hemingway et al. 2001) (30.7%), and around 1.8 times the rate in the Euro Heart Survey (24%) (Lenzen et al. 2005). Hence, in comparison with the Euro Heart Survey, a relatively smaller share of patients was directed to PCI (28.4% vs. 58%, respectively) or CABG (19.6% vs. 21%, respectively) (Lenzen et al. 2005). In addition, post-hoc analysis of the data showed that more than half of the inappropriate procedures ended up reporting results with normal coronaries (<50% stenosis), with only 8.7% showing multi-vessel disease (OR for normal coronaries = 3.2; vs OR for multi-vessel disease = 1.2).
Questions arise as to what are the possible reasons for the high rate of unnecessary or inappropriate coronary angiographies in the Lebanon context? The practice pattern of physicians referring patients to coronary angiography in Lebanon has several important features that merit consideration and could be critical for explaining our findings. A substantial fraction of the patients did not undergo prior non-invasive testing before referral to angiography, with findings showing wide disparities with those published in the literature. For example, the exercise stress test and stress imaging tests were not performed, respectively, in 89% and 97% of the Lebanese patient sample, in contrast to 24% and 82% of the patients in the Euro Heart Survey (Daly et al. 2005). Furthermore, the extent of utilization of non-invasive testing in patients who were subsequently found to have normal coronaries is less than one-third the rate identified from a recent study conducted in Australia (18% vs. 63.7%) (Leung et al. 2005). The implications of the low utilization of pre-interventional testing in our study are worrying. Non-invasive tests have an established diagnostic value in the investigation of patients with suspected CAD (Gibbons et al. 1997), allowing physicians to stratify patients into those that may benefit from more invasive investigations (Leung et al. 2005). Also, prior clinical testing, including non-invasive tests, act as a 'gate-keeper' for coronary angiographies, decreasing the number of unnecessary referrals and procedures, and reducing follow-up costs (Shaw et al. 1999).
It is likely that reimbursement schemes of the various diagnostic procedures in Lebanon play an important role in the clinical practice of interventional cardiologists in the country. While non-invasive testing is much cheaper than coronary angiography in the US and Europe, this is not the case in Lebanon whereby the cost gradient between non-invasive testing, especially nuclear testing, and coronary angiography is not considerable (nuclear testing is sometimes more expensive than coronary angiography in Lebanon). Consequently, it becomes more cost-effective to refer patients directly to coronary angiography than doing a stress test followed by angiography. Furthermore, the procedure of coronary angiography, unlike non-invasive testing, is widely reimbursed by public insurance schemes in the country, and there is some concern that this case-based reimbursement might have encouraged an overuse of the procedure without appropriate indications. Also, the abundance of cardiac catheterization facilities in the country might have led to a supply-induced demand resulting in medically unjustified utilization of the procedure (Lange and Hillis 1998). In fact, the overall density of cardiac catheterization centres in Lebanon is considered one of the highest in the world (9.32 per 1 000 000 individuals) and almost three times that of France (2.92), recognized to have one of the highest rates in Europe (Blanchard and Lablanche 2000). Inappropriateness of use of coronary angiography in our study varied across regions and was highest in the Governorate which has witnessed an increase of cardiac catheterization facilities from 1 to 6 between 2002 and 2004. This yields a density of cardiac catheterization of 12.7 per 1 000 000 individuals and places the area at over four times the estimated requirement of cardiac catheterization labs (2.9 per 1 000 000 population) (Hackett 2003). This fact corroborates findings from other studies indicating the close relation between over-use of coronary angiography and the availability of cardiac catheterization facilities (Every et al.1993; Wennberg et al. 1997).
The findings of this study should, however, be considered in light of the following limitations. A small percentage of the patients included in the registry were not residents of Lebanon (6.4%) which might include a group of individuals, both Lebanese living abroad and non-Lebanese in neighbouring countries, coming specifically for the procedure. However, sub-analysis revealed that the exclusion of this group does not alter significantly the overall rate of appropriate coronary angiographies in Lebanon. Moreover, because of limitations in the data available in the Registry, analysis of the study outcome could not differentiate between class IIa, IIb and III procedures. Another limitation of our study is the lack of an expert panel to assess the appropriateness similar to the validated RAND indicators that are used widely in the literature (Bernstein et al. 1992). Furthermore, the information on the use of pre-angiography tests in the Registry relied on hospital and doctors' records data, which are sometimes incomplete or missing. The high rate of under-use of pre-interventional tests may imply either that the test was not performed or that the test results were not recorded. Finally, despite the fact that hospitals were recruited nationwide and that the participation rate was approximately 70%, study hospitals may not have been typical of all hospitals; for example, those hospitals that chose to participate may be particularly interested in quality assurance.
In spite of the above, this is the first study that we are aware of to investigate the appropriateness of use of coronary angiography in Lebanon or the Arab countries. Study findings reinforce important relationships between supply of technology and demand for health care in an environment dominated by private for-profit health care and a rapid diffusion of high-tech medical devices. With the intention of promoting rational use of coronary angiography, clinical guidelines need to be established and disseminated to physicians and cardiologists in Lebanon, and monitoring and control of practice need to be observed. Moreover, a revision of the cost gradient between non-invasive testing and coronary angiography as well as the reimbursement of non-invasive testing by public insurance schemes would contribute to a higher utilization of non-invasive testing prior to angiography and, consequently, less unnecessary or inappropriate referrals to an invasive procedure. Policy efforts should also extend to evaluate the use of other technologies in the country.
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Acknowledgements |
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This study would not have been possible without the efforts of the Lebanese Interventional Coronary Registry members: Georges Ghanem, MD; Wael Chalak, MD; Joseph Haddad, MD; Samih Lawand, MD; Antoine Estephan, MD; Salim Adib, MD, DrPH and Georges Saade, MD.
This work was supported by a grant from the Lebanese National Council for Scientific Research (LNCSR). The funding source did not interfere with the design, collection and data analysis, or in the reporting of the results and the decision to submit the manuscript for publication.
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Accepted for publication 4 March 2008.
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