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1 Relationship between Percutaneous Transluminal Coronary Angioplasty Volume and Immediate Outcome

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3 Relationship between Percutaneous Transluminal Coronary Angioplasty Volume and Immediate Outcome by Young-Ho Khang A thesis submitted in partial fulfillment of the requirement for the degree of Doctor of Philosophy in Medicine (Health Policy and Management) in Seoul National University, Seoul, Korea December, 1999 Doctoral Committee : Professor Lee, Young-Woo Chairman Associate Professor Kim, Yong-Ik Vice Chairman Associate Professor Oh, Byung-Hee Associate Professor Park, Byung-Joo Associate Professor Ahn, Hyeong-Sik

4 (percutaneous transluminal coronary angioplasty, PTCA) 1977.,, PTCA. PTCA.,, PTCA. PTCA PTCA.,., PTCA., - (volume-outcome relationship) (practice-makes-perfect hypothesis, ) (selective-referral pattern hypothesis, ) PTCA ,379 PTCA, 1,317 ( 95.5%). (, -coronary artery bypass graft, CABG-, ), - i -

5 , (56%), (63%). 1,317 70%, CABG 2.7%. PTCA 54%. 20 (1.5%), 26 (2.0%). 3 (20%, 50% ) %( 93.6%).,,.,, (P=0.023). 200, , 400 (X 2 tr en d = , P=0.0001). ( ) PTCA (transfer) PTCA -,.,.. - ii -

6 ,., PTCA.. : Percutaneous Transluminal Coronary Angioplasty, Volume, Outcome, Risk Adjustment, Quality of Care : iii -

7 List of T ables Table 1. The studies supporting volume-outcome relationship of percutaneous transluminal coronary angioplasty (PTCA) and their volume/outcome variables 7 Table 2. Recommendations for clinical competence in percutaneous transluminal coronary angioplasty minimum recommended number of cases per year 9 Table 3. Hospital percutaneous transluminal coronary angioplasty (PTCA) volumes during the study period, their volumes and proportions surveyed, and their volumes except repeated PTCAs 18 Table 4. Confounding variables: demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, and diagnosis 20 Table 5. Determination criteria of modified ACC/AHA legion type 22 Table 6. Beds, ownership, and education affiliation of hospitals, their number of operator, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in Table 7. Operators' intervention career, their experience trained at other countries, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in Table 8a. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded 33 Table 8b. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded 34 Table 9. Number of involved vessels and their proportion of total samples and of samples repeated PTCAs excluded 35 Table 10. Comparison of patient characteristics by hospitals or operators volume 37 - iv -

8 Table 11. Unadjusted comparison of outcome by hospital or operator volume 38 Table 12. Unadjusted comparison of intervention failure rate and major adverse outcome rate by patients' characteristics 40 Table 13. Hospital volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) 44 Table 14. Hospital volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) 45 Table 15. Operator volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) 46 Table 16. Operator volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) 47 Table 17. Variables associated with intervention failure or major adverse outcome in the logistic regression analysis and their distribution by hospital volume 51 Table 18. Outcomes by hospital volume among myocardial infarction patients who were transferred from the healthcare facilities where PTCA was not available 52 Table 19. PTCA outcome indicators and their results of other studies in Korea 61 Table 20. Risk factor profiles affecting outcomes of percutaneous transluminal coronary angioplasty by sex 65 Table 21. Comparisons of major risk factors affecting outcomes of percutaneous transluminal coronary angioplasty by smoking history 67 Table 22. Comparison of PTCA clinical outcomes by hospital's number of operator 69 - v -

9 List of Figures Figure 1. Weighted kappa values of inter-observer reliability tests by modified ACC/AHA lesion type (A, B1, B2, C). 26 Figure 2. Kappa values of inter-observer reliability tests by lesion type C. 27 Figure 3. Increases of percutaneous transluminal coronary angioplasty operators by year in Korea. 30 Figure 4. Distribution of intervention failure rate and major adverse outcome rate by hospital volumes vi -

10 List of Abbreviations 95% CI : Confidence interval ACC : American College of Cardiology AHA : American Heart Association AMI : Acute myocardial infarction ANOVA : Analysis of variance ARF : Acute renal failure BMI : Body mass index CABG : Coronary artery bypass graft COPD : Chronic obstructive pulmonary disease CRF : Chronic renal failure MI : Myocardial infarction PTCA : Percutaneous transluminal coronary angioplasty - vii -

11 ) PTCA - 6 ) 8 ) 9 ) - 10 ) 10 ) ) 15 ) 15 ) 17 2) 19 ) 19 ( ) : 19 ( ) : 19 ( ) 20 ( ) 23 ) 24 ) ) 26 ) 26 - viii -

12 ) 28 2) PTCA 29 ) PTCA 29 ) 31 ( ) 31 ( ) 32 ( ) 35 3) - 36 ) 36 ( ) 36 ( ) 38 ( ) 39 ) : 42 ( ) 42 ( ) 43 ( ) 46 4) :, 48 5) 50 6) ) 54 ) 54 ) : 57 ) 59 2) 60 ) PTCA 60 ) 63 ( ) 63 ( ) 66 ) - 68 ) 69 - ix -

13 ) ), 72 ) 72 ) 73 ) x -

14 1. PTCA 1977 Andreas R. Grüentzig (Grüentzig 1978),. PTCA (ideal lesion : proximal, non-calcified, discrete, and concentric lesion) ( 1992; 1995)., PTCA,. 63% 9.2% (,, ) (Dorros et al. 1983), 1% (Ellis et al. 1997; Hannan et al. 1997). PTCA., PTCA., 10 2 ( 1998)., ,.,,,. (OECD) 21,

15 1997 ( 1998),. PTCA. PTCA. PTCA, (1999), (. 1986; 1991;. 1992; 1993;. 1994; 1994; 1994; 1995). (1998) (technology assessment in healthcare) PTCA, (4 ), (ecologic fallacy). ( 1997), 1983, ,000. PTCA 2 1,088, ACC/AHA 200 ( 17 ) ( 1997). PTCA - 2 -

16 ,,,. (high volumes lead to better results)' (Luft 1980; Luft et al. 1990), -,.,. Luft (1979),, (coronary artery bypass graft, CABG), Showstack (1987), Hannan (1991). Hannan (1989) CABG,,, Hosenpud (1994), Lavernia Guzman(1995), Hamilton Hamilton(1997), Begg (1998), Hannan (1998), Witt (1998) (palatoplasty), Norton (1998), Birkmeyer (1999) (pancreaticoduodenectomy), Sollano (1999) -. Shortell LoGerfo(1981), Thiemann (1999), Maerki (1986),,,. Farley Ozminkowski(1992), Jones Rowan(1995).. Mayfield (1990), - 3 -

17 . Sollno (1990) CABG. Wen (1996) (elective) -,. Kelly Hellinger(1986),. -., (maternity unit) (Phillips and Luft 1997),,, (accreditation),. American College of Cardiology( ACC) American Heart Association( AHA) (percutaneous transluminal coronary angioplasty, PTCA) CABG (Ryan et al, 1988; Ryan et al. 1990; Kirklin et al. 1991; Ryan et al. 1993). - (Hosenpud et al. 1994; Anthony 1988; McGregor and Pelletier 1978)., Croke(1991),., - 4 -

18 .,., -...,, PTCA.,,. -., PTCA., - ( ) ( ) PTCA

19 2. PTCA -. ) PTCA - PTCA -,,. Dorros (1983), Jacob (1986), Hamad (1988), Ritchie (1993), Jollis (1994), Ellis (1997) ( 1).,,,, 34 PTCA O'Neil (1996),. (low volume), (simple lesion), (Hamad et al. 1988)

20 Table 1. The studies supporting volume-outcome relationship of percutaneous transluminal coronary angioplasty (PTCA) and their volume/outcome variables Studies Volume variables Outcome variables Ellis et al physician volume composite outcome (mortality, Q-wave infarction, ( 75 vs 75) emergency bypass surgery) Jollis et al hospital/physician vol. mortality, bypass surgery ( 200 vs 200 / 75 vs 75) Hannan et al hospital/physician vol. mortality, bypass surgery ( 600 vs 600 / 75 vs 75) Ellis et al physician volume death, Q-wave infarction, bypass surgery, ( 75 vs 75) procedural success Kimmel et al. 1995a hospital volume emergency bypass surgery, MI *, in-hospital mortality ( 400 vs 400) Phillips et al hospital volume adverse outcome (CABG * after PTCA), mortality, ( 200 vs 200, length of stay, charges 400 vs 400) Shook et al physician volume emergency CABG after PTCA, in-hospital mortality, ( 50 vs 50) in-hospital morbidity(ventricular fibrillation, CABG during same hospitalization), length of stay, hospital costs Jollis et al hospital volume short-term mortality, CABG after PTCA ( 100 vs 100) Ritchie et al hospital volume CABG during the same hospitalization, death ( 200 vs 200) Hamad et al physician volume success rate ( 100 vs 100) Jacob et al physician volume success rate ( 2 vs 2 per month) Kelsey et al physician volume angiographic success rate, clinical success rate, ( 50 vs 50) * MI : myocardial infarction, CABG : coronary artery bypass graft. complications (MI, death, emergency CABG) - 7 -

21 ) -.,. Luft (1979), Kimmel (1995a).. PTCA Ritchie (1993), Jollis (1994) - (Kimmel et al. 1995a). Omoigui (1996) Topol (1995),,,. Meier (1984) (patient selection),., (heterogeneity)

22 ) -,., (cut-off point). ( 2). ACC/AHA (Ryan et al. 1990; Ryan et al. 1993) 200, 75, (Croke 1991)., Ritchie (1993), Jollis (1994) ACC/AHA, Kimmel (1995a) Shook (1996) - (dose-effect response). Table 2. Recommendations for clinical competence in percutaneous transluminal coronary angioplasty minimum recommended number of cases per year * Training Practicing Total number Cases Number of Cases per year of cases as primary operator to maintain competency Bethesda Conference(1985) * The Society for Cardiac Angiography(1988) ACC/AHA(1988) ACP/ACC/AHA(1990) ACC/AHA(1993) * Seventeenth Bethesda Conference The Society for Cardiac Angiography Ryan et al Ryan et al Ryan et al

23 ) - -,. PTCA Kimmel (1995a), Phillips (1995), Jollis (1994), Ritchie (1993), Ellis (1997), Ellis (1996), Shook (1995), Hamad (1988), Jacob (1986), Kelsey (1984). PTCA, Kelly Hellinger(1986), -.,.,,,. ).,. (success rate),

24 (intermediate outcome indicator). - PTCA, Ritchie (1993), Kimmel (1995a), Ellis (1997) CABG, Kelsey (1984), Jacob (1986), Hamad (1988), Ellis (1996) PTCA. Phillips (1995), Shook (1996).,, CABG, ( ) (adverse outcome composite outcome) (Kelsey et al. 1984; Kimmel et al. 1995a; Ellis et al. 1996; Ellis et al. 1997), ( 1). ) (Luft 1980; Luft et al. 1987; Luft et al. 1990; Jones et al. 1995).,. (learning curve), (experience

25 curve).,, (Wright 1936; Lieberman 1984). 37 Lieberman (1984). (learning-by-doing) (Luft et al. 1979)., (Meier et al. 1984).. Ikhena (1999), Shackford (1999), Soot (1999), Rege Joehl(1999). - (Luft et al. 1987). Flood (1984c), Luft (1987). CABG (Luft et al. 1987; Farley et al. 1992), PTCA. Phillips (1995) PTCA

26 , PTCA,. Jollis (1994) PTCA -, (1), (2),, (3). Kimmel (1995a) PTCA -., PTCA (acute vessel closure),,,,,,,. PTCA.,,,., (Luft et al. 1987)

27 PTCA - (Jolis et al. 1994; Kimmel et al. 1995a; Phillips et al. 1995),

28 3. 1) ). PTCA PTCA, PTCA (PTCA, ). PTCA., , 34. (pretest)., ACC/AHA (modified ACC/AHA legion type), (cath sheet),. (admission note), (discharge summary), (progress note),, (nursing chart)

29 .,. CABG,. (echocardiography) Q CK-MB (3 ). PTCA,,,,,., 24 CABG,,. PTCA 1997 (junior staff), 2 ( : / ).. (lipid battery), (ejection fraction)., 3, 3.., MIBG scan,

30 1, ) 25, 60.,. PTCA (,, ) ,379 ( 3). 6, ,379 1, % W, 1 PTCA (fail) F, 1 PTCA, PTCA. 14, 1 PTCA, 6, 7 ( 200 1, 6 )

31 Table 3. Hospital percutaneous transluminal coronary angioplasty (PTCA) volumes during the study period, their volumes and proportions surveyed, and their volumes except repeated PTCAs Hos- Total Surveyed 1st PTCAs * Hos- Total Surveyed 1st PTCAs * pital volume volume (%) volume (% ) pital volume volume (%) volume (% ) A (100) 33 ( 83) B (100) 40 ( 77) C ( 97) 31 ( 94) D (100) 55 ( 87) E ( 95) 20 (100) F ( 86) 89 ( 79) G 9 9 (100) 9 (100) H ( 95) 72 ( 90) I (100) 13 ( 93) J (100) 13 ( 68) K (100) 38 ( 97) L (100) 36 ( 86) M ( 99) 86 ( 74) N (100) 70 ( 81) O (100) 17 ( 94) P ( 98) 156 ( 80) Q 2 2 (100) 2 (100) R (100) 52 ( 81) S ( 98) 70 ( 77) T (100) 16 ( 84) U (100) 41 ( 80) V 9 9 (100) 9 (100) W ( 78) 80 ( 76) X (100) 28 ( 93) Y 6 6 (100) 6 (100) * Refers to the hospital volumes when repeated PTCAs were excluded. Refers to the first PTCAs' proportion of the surveyed volume by hospital. Total 1,379 1,317 (96) 1,082 ( 82)

32 2) ) ( ) : - ACC/AHA (Ryan et al. 1990; Ryan et al. 1993). 400 (Kimmel et al. 1995a), 50 Shook (1996), Society for Cardiac Angiography (1988) 400, 50. ( ) :. (major adverse outcome), 24, 24 CABG. 1, 0. Ellis (1997), Ellis (1996), Kimmel (1995b), Kelsey (1984) CABG,., Ellis (1990), Hamad (1988), (1994) (,, CABG) 20% 50%. ( = 1, = 0 )

33 PTCA PTCA. PTCA (successful) (fail). " " " ". ( ) - ( 4). Table 4. Confounding variables: demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, and diagnosis Demographic risk factors age, sex, body mass index Preprocedural risk factors resting heart rate, ejection fraction, lipid battery (total cholesterol, TG, HDL) Past medical histories and comorbidity hypertension, diabetes mellitus, congestive heart failure, stroke valvular disease (aortic valve disease or mitral valve disease) smoking (current smokers, former smokers, non-smokers) respiratory disease (COPD * or asthma), renal disease (ARF * or CRF * or dialysis) previous PTCA * (or with stent), previous CABG * Diagnosis acute myocardial infarction within 24 hours before coronary angioplasty myocardial infarction within 1-14 days before coronary angioplasty Procedural risk factors number of vessels involved, number of stents, Type C lesion (modified ACC/AHA lesion type) * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, PTCA : percutaneous transluminal coronary angioplasty, CABG : coronary artery bypass graft.,, (body mass index)

34 .. (Ellis et al. 1997; Jollis et al. 1994; Ritchie et al. 1993) PTCA,.,,., , 30% 50% ( 50% = 0, 49% 30% = 1, 29% = 2 ).. Ellis (1990) ACC/AHA. (chronic obstructive pulmonary disease, COPD), (acute renal failure, ARF) (chronic renal failure) (dialysis).. Phillips (1995), Kimmel (1995b) Kimmel (1995b) 24, 1 14,.,. Q

35 CK-MB fraction 3.,, (worst lesion type). 50%. (proximal), (middle), (distal) ( left circumflex artery ), 50%. 5 ACC/AHA. Table 5. Determination criteria of modified ACC/AHA legion type 1. Type A lesions (minimally complex) discrete (length < 10mm) readily accessible smooth contour less than totally occlusive no major side branch involvement concentric nonangulated segment ( <45 ) little or no calcification not ostial in location absence of thrombus 2. Type B lesions (moderately complex) : Type B1 - one, Type B2 - two or more tubular (length 10 to 20mm) eccentric moderate tortuosity of proximal segment irregular contour moderately angulated segment ( >45, <90 ) moderate or heavy calcification total occlusions <3 month old ostial in location some thrombus present bifurcation lesions requiring double guide wires 3. Type C lesions (severe complex) diffuse (length > 2cm) excessive tortuosity of proximal segment extremely angulated segments > 90 total occlusions > 3 month and/or bridging collaterals inability to protect major side branches degenerated vein grafts with friable lesions

36 ( ) -. Phillips (1995),., Luft (1987), Showstack (1987) CABG. Phillips (1995) PTCA (transfer). PTCA, -., -, PTCA,., PTCA. PTCA ( 1997) PTCA, PTCA 3 PTCA

37 ) ( )..,. 5 ( 2, 3 ) PTCA 110 (inter-observer reliability)..,. (intra-observer reliability), 13,. ),,. ACC/AHA 200 ( 199 = 1, 200 = 0 ), 75 ( 74 = 1, 75 = 0 ), ( = 1, = 0 ) ( = 1, = 0 )

38 20% (stepwise logistic regression). P 0.2,, (dummy variable)... PTCA, PTCA Windows PC-SAS ver. 6.12, 5%

39 4. 1) ) 5 ( 200 2, 3 ) 110 ( 1, %). 1 ( ), 1 ( ), 1 ( ) 3.., 4 (A = 1', B1 = '2', B2 = '3', C = '4') C (lesion type C). Cath sheet N= Low volume Fellow High volume Fellow High volume Resident Figure 1. Weighted kappa values of inter-observer reliability tests by modified ACC/AHA lesion type (A, B1, B2, C)

40 %., 3 2. Cath sheet N= Low volume Fellow High volume Fellow High volume Resident Figure 2. Kappa values of inter-observer reliability tests by lesion type C. ' C', ' C' %.,

41 ) (intra-observer reliability) ,,, (N = 115) 2, (N = 25) (N = 39) (A, B1, B2, C) %, 30% 49%, 50%, 25 1 (96%) % 10% ( : 80% 70% 90% ), 7.7% 15% 20%, 50% ( : 60% 40%)

42 2) PT CA ) PTCA , , , 5 (20%). 72%. PTCA %. Table 6. Beds, ownership, and education affiliation of hospitals, their number of operator, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 Hospital characteristics Number Percent Number of total hospitals PTCA volume attempted in Hospital beds, beds , Ownership public private Educational affiliation * yes no Number of operator, persons * Refers to whether a hospital is affiliated with medical school. 60, % %,

43 . 45%. Table 7. Operators' intervention career, their experience trained at other countries, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 Operator characteristics Number Percent PTCA volume attempted in Intervention career, years Training at other countries yes no , Figure 3. Increases of percutaneous transluminal coronary angioplasty operators by year in Korea

44 ) ( ) PTCA (N= 1,379) 1, %, %, (28 94 ) , 100 (sinus tachycardia) 4.3%. (N= 1,317) 1,092 (82.9%), MIBG scan, 195 (14.8%), 1, %. 30% 16.6%, 30 49% 18.9%. 43.9%, 23.4%, 4.0%, 3.8%. 2.4%,, 1.7%. PTCA 17.8%, CABG 2.7%.,, %, %., (single vessel disease) 54.7%, (double vessel disease) 31.5%, (triple vessel disease) 13.7%. PTCA %. lesion type 28.2% type C lesion

45 1, %,, CABG, %. (20%, 50% ) %( 93.6%). ( ) 1,317 PTCA 1, %.,,,,. 2.7% CABG 1.8% % 9.0%, % 10.3%. 2.2%, 6.7%

46 Table 8a. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded All surveyed Repeated PTCAs excluded Patient characteristics Number % or No. of Number % or No. of mean sd missing mean sd missing Sex Female Age, years Mean SD 1, , Body mass index (kg/m 2 ) 1, Resting heart rate Mean SD 1, , Ejection fraction, % Mean SD 1, , Total cholesterol Mean SD 1, , Triglyceride Mean SD 1, HDL Mean SD 1, Hypertension Diabetes mellitus Congestive heart failure Valvular disease (aortic or mitral) Stroke Respiratory disease (COPD or asthma) Smoking current smokers former smokers nonsmokers Kidney disease (ARF or CRF or dialysis) Previous PTCA (or with stent) Previous CABG Diagnosis MI (within previous 1-14 days) AMI (within 24 hours before PTCA) * * Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction

47 Table 8b. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded All surveyed Repeated PTCAs excluded Patient characteristics Number % or No. of Number % or No. of mean sd missing mean sd missing Involved vessels single double triple Number of stents Worst lesion type A B B C Major adverse outcome death during same hospitalization emergency CABG after PTCA AMI within 24 hours after PTCA Intervention failure * Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction

48 ( ) 50% 9. Table 9. Number of involved vessels * repeated PTCAs excluded and their proportion of total samples and of samples Vessels All surveyed Repeated PTCAs excluded (N=1,317) (N=1,082) No. of vessels % No. of vessels % Left main coronary artery Left anterior descending Left anterior descending, proximal Left anterior descending, middle Left anterior descending, distal Left circumflex Left circumflex, proximal Left circumflex, distal Right coronary Right coronary, proximal Right coronary, middle Right coronary, distal * Refers to the vessels involved more than 50% or over. (left main coronary artery) 50% 1.7%, (left anterior descending artery) 73.1%. 40.3%, (right coronary artery) 45.2% 50%.,, 43.8%. PTCA ( 9)

49 3) - ) ( ) ( 200, 75 ) 10.,,,,., ( %) ( %) (P<0.001)., 100 (p=0.047). T-,. (P=0.011), (P<0.01). (P=0.002). CABG (P=0.012). 24 (P=0.016) 1 14 (P=0.051), 1 14 (P=0.001). 50%,. 1 (P=0.001)

50 Table 10. Comparison of patient characteristics by hospitals or operators volume Patient characteristics Hospital volume Operator volume P value P value N=278 N=804 N=365 N=717 Female, % Age, years Body mass index (kg/m 2 ) Resting heart rate Ejection fraction < Total cholesterol Triglyceride HDL Hypertension Diabetes mellitus Congestive heart failure Valvular disease (aortic or mitral) Stroke Respiratory disease (COPD or asthma) Kidney disease (ARF /CRF /dialysis) Smoking current smokers former smokers non-smokers Previous CABG Diagnosis others MI (1-14 days) AMI (within 24hrs) * Involved vessels single double triple Number of stents Lesion type C * Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Two-tailed Fisher's exact test. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction

51 ' C', (P=0.078), (P=0.001). ( ),. 200, (P=0.001), 75 ( 11). Table 11. Unadjusted comparison of outcome by hospital or operator volume Patient outcome Hospital volume Operator volume P value P value N=278 N=804 N=365 N=717 Major adverse outcome * death during same hospitalization AMI within 24 hours after PTCA emergency CABG after PTCA Intervention failure * Refers to at least one complication of death during same hospitalization after intervention or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. Two-tailed Fisher's exact test. CABG : coronary artery bypass graft

52 ( ). (P=0.044).. 10 (X 2 tr en d = , P=0.0007), (X 2 tr en d =8.880, P=0.0029). (N=72) (N= 1,010) ( ) (P=0.0016), (N=24) ( ) (N= 1,058) ( ) (P=0.0011). 100 (Fisher's exact test, P<0.05). (total cholesterol), (triglyceride), (HDL, high density lipoprotein) 0.2. (X 2 tr en d = , P=0.0013), (X 2 tr en d =22.694, P=0.0001). (N=71) % (N=986) % (P<0.001), (N=24) % (N= 1,033) % (P<0.001).,,, CABG,

53 Table 12. Unadjusted comparison of intervention failure rate and major adverse outcome rate by patients' characteristics Characteristics Intervention failure * Major adverse outcome Rate P value Rate P value Gender Male Female Age, years Resting heart rate Ejection fraction, % Hypertension No Yes Diabetes mellitus No Yes Congestive heart failure No Yes Valvular disease No (aortic or mitral) Yes Stroke No Yes Respiratory disease No (COPD ** or asthma) Yes Kidney disease No (ARF ** or CRF ** or dialysis) Yes Smoking current smokers former smokers non-smokers Previous CABG ** No Yes Diagnosis others MI within 1-14 days AMI within 24 hours Involved vessels single double triple Lesion type C No Yes * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. Refers to at least one complication of death during same hospitalization after PTCA or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Likelihood ratio test for trend. Two-tailed Fisher's exact test. ** COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction

54 P 0.052, ( ) (P=0.008). 24 (P=0.001) ( = 0, 1 14 = 1, 24 = 2 ), (X 2 tr en d =22.161, P=0.0001).. ACC/AHA C, (P<0.01)

55 ) : ( ),. 0.2 ( 12). 0.2.,, (25 ) (6 ), 0, 1,051., 3 ( 49 = 0, = 1, 60 = 2 ), 2 ( 50 = 0, 50 = 1 ). 12 4, 3., (current smoker = 0, former smoker or non-smoker = 1),, (current smoker or former smoker = 0, non-smoker = 1)

56 , 24, ( = 0, 1 14 = 1, 24 = 2 ). 4 (A, B1, B2, C)., ' C' ' C'.,. ( ) 1, 0, (200 = 1, 200 = 0 ) (por = 3.692, 95% CI : ). 60 (95% CI : ), 100 (95% CI : ), 50% (95% CI : ), CABG (95% CI : ), 24 (95% CI : ), C (95% CI : ) ( 13)

57 Table 13. Hospital volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Hospital volume High, (74.6) Low, (25.4) Age, years (16.6) (30.6) (52.8) Resting heart rate (95.3) ( 4.7) Ejection fraction, % (62.9) (37.1) Previous CABG No 1032 (98.2) Yes 19 ( 1.8) Diagnosis Others 954 (90.8) AMI, within 24 hours 97 ( 9.2) Lesion type C No 762 (72.5) Yes 289 (27.5) * Missing values (N=31) were excluded. Chi-square for Covariates : with 8 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, CABG : coronary artery bypass graft. (, CABG, ), (200 = 1, 200 = 0 ) (por = 3.136, 95% CI : ). 100 (95% CI : ), 30% (95% CI : ), (95% CI : ), 1 14 (95% CI : ) 24 (95% CI : ), C (95% CI : )

58 Table 14. Hospital volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Hospital volume High, (74.6) Low, (25.4) Age, years (16.6) (30.6) (36.9) (15.9) Resting heart rate 99 1,002 (95.3) ( 4.7) Ejection fraction, % (62.9) (20.5) (16.6) Congestive heart failure No 1,008 (95.9) Yes 43 ( 4.1) Renal disease No 1,031 (98.1) (ARF or CRF or dialysis) Yes 20 ( 1.9) Smoking history Yes 631 (60.0) (current or former) No 420 (40.0) Diagnosis others 844 (80.3) MI, within 1-14 days 110 (10.5) AMI, within 24 hours 97 ( 9.2) Lesion type C No 762 (72.5) Yes 289 (27.5) * Missing values (N=31) were excluded. Chi-square for Covariates : with 13 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, ARF : acute renal failure, CRF : chronic renal failure

59 ( ) 1, 0, (75 = 1, 75 = 0 ) (por = 1.198, 95% CI : ). Table 15. Operator volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Operator volume High, (66.4) Low, (33.6) Age, years (16.6) (30.6) (52.8) Resting heart rate 99 1,002 (95.3) ( 4.7) Ejection fraction, % (62.9) (37.1) Congestive heart failure No 1,008 (95.9) Yes 43 ( 4.1) Respiratory disease No 1,027 (97.7) (COPD or asthma) Yes 24 ( 2.3) Previous CABG No 1,032 (98.2) Yes 19 ( 1.8) Diagnosis Others 954 (90.8) AMI, within 24 hours 97 ( 9.2) Lesion type C No 762 (72.5) Yes 289 (27.5) * Missing values (N=31) were excluded. Chi-square for Covariates : with 10 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, COPD : chronic obstructive pulmonary disease, CABG : coronary artery bypass graft

60 (, CABG, ), (75 = 1, 75 = 0 ) (por = 0.536, 95% CI : ). Table 16. Operator volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Operator volume High, (66.4) Low, (33.6) Age, years (16.6) (30.6) (36.9) (15.9) Resting heart rate 99 1,002 (95.3) ( 4.7) Ejection fraction, % (62.9) (20.5) (16.6) Congestive heart failure No 1,008 (95.9) Yes 43 ( 4.1) Respiratory disease No 1,027 (97.7) (COPD or asthma) Yes 24 ( 2.3) Renal disease No 1,031 (98.1) (ARF or CRF or dialysis) Yes 20 ( 1.9) Smoking history Yes 631 (60.0) (current or former) No 420 (40.0) Previous CABG No 1,032 (98.2) Yes 19 ( 1.8) Diagnosis Others 844 (80.3) MI, within 1-14 days 110 (10.5) AMI, within 24 hours 97 ( 9.2) Lesion type C No 762 (72.5) Yes 289 (27.5) * Missing values (N=31) were excluded. Chi-square for Covariates : with 15 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft

61 4) :,,.,. G(X ) = L og ( P 1 - P ) = 0 + i X i + j X j + + p X p ( 1) PTCA, -, PTCA.,., ' C',., ,,

62 0.2 (30 ) (8 ), 1,279. P L og ( P f ail 1 - P f ail ) = * AGE * AGE * HR * EF * R_DIS * P_CABG * AMI Pfa il : probability of intervention failure AGE50 AGE60 : '1' = 50 patient age < 60, '0' = otherwise : '1' = 60 patient age, '0' = otherwise HR100 EF50 : '1' = 100 heart rate, '0' = otherwise : '1' = ejection fraction < 50, '0' = otherwise R_DIS : '1' = respiratory diseases such as chronic obstructive pulmonary disease or asthma, '0' = otherwise P_CABG AMI : '1' = history of previous coronary artery bypass graft, '0' = otherwise : '1' = acute myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). '0' = otherwise L og ( P compl. 1 - P com pl. ) = * SEX * AGE * AGE * HR * EF * EF * R_DIS * P_CABG * MI_ * AMI Pco m p l. : probability of major adverse outcome (complication) such as death during same hospitalization, emergency CABG within 24 hours after PTCA, and acute myocardial infarction within 24 hours after PTCA. SEX : '1' = female, '0' = male AGE60 : '1' = 60 patient age < 70, '0' = otherwise AGE70 : '1' = 70 patient age, '0' = otherwise HR100 : '1' = 100 heart rate, '0' = otherwise EF50 : '1' = 30 ejection fraction < 50, '0' = otherwise EF30 : '1' = ejection fraction < 30, '0' = otherwise R_DIS : '1' = respiratory diseases such as chronic obstructive pulmonary disease or asthma, '0' = otherwise P_CABG : '1' = history of previous coronary artery bypass graft, '0' = otherwise MI_14 : '1' = myocardial infarction occurred between 1 day and 14 days before PTCA '0' = otherwise AMI : '1' = acute myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). '0' = otherwise

63 5), -,, 200, , 400..,, (P=0.023). 200, , 400 (X 2 tr en d = , P=0.0001) (P=0.208), (X 2 tr en d =2.629, P=0.105) , , ACC/AHA 200. P=0.023 P=0.181 P=0.208 P=0.873 Figure 4. Distribution of intervention failure rate and major adverse outcome rate by hospital volumes

64 6) - PTCA,. ( ). Jollis (1994), Phillips (1995),. PTCA,. Table 17. Variables associated with intervention failure or major adverse outcome in the logistic regression analysis and their distribution by hospital volume Outcome associated with variables Low High in the logistic regression analysis P value N=804 N=278 Age, 60 years Intervention failure * Resting heart rate, 100 Intervention failure, adverse outcome Ejection fraction, 50% Intervention failure Ejection fraction, 30% Adverse outcome Previous CABG Intervention failure Diagnosis, MI (1-14 days) Adverse outcome Diagnosis, AMI (within 24hrs) Intervention failure, adverse outcome Lesion type C Intervention failure, adverse outcome * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. CABG : coronary artery bypass graft. Refers to the myocardial infarction occurred within 1-14 days before PTCA. Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave)

65 17 ( 13, 14) (odds ratio)... Table 18. Outcomes by hospital volume among myocardial infarction patients who were transferred from the healthcare facilities where PTCA was not available Intervention failure Major adverse outcome Success Failure No Yes Acute myocardial infarction occurred within 24 hours before PTCA High volume (N=81), (87.7) 10 (12.3) 76 (93.8) 5 ( 6.2) Low volume (N=13), (76.9) 3 (23.1) 11 (84.6) 2 (15.4) P value P=0.381 * P=0.248 * Myocardial infarction occurred within 14days before PTCA High volume (N=173), (90.8) 16 ( 9.2) 164 (94.8) 9 ( 5.2) Low volume (N=35), (82.9) 6 (17.1) 30 (85.7) 5 (14.3) P value P=0.223 * P=0.065 * * Two-tailed Fisher's exact test. Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave)., PTCA ,

66 ,,

67 5. 1) ),.. (gold standard) A, B1, B2, C ( ) %. ' C', %., 2.. 5, (1)

68 , (2). 3.. PTCA., Ellis (1990) 58%, 1 (level) 35%, 2 7%. Ellis (1990) , ' C' (. 1996), 4 ' C' -..,. 2.2%(24 ), CABG,,

69 PTCA PTCA %. PTCA,,, 6 ( 200 ). " " " ". 6,.,., 1,317 1,092 (82.9%), MIBG scan. 30%, 30% 49%, 50%, 25 1 (96%).., 39 lesion 89.7% 10% ( : 80% 70% 90% ), 7.7% 15% 20%, 50% ( : 60% 40%). PTCA. 1997, 2 ( : / )

70 ,.. ( 75 ) ( 75 ),.. ) :., (, ),.,,. /, /

71 .. (bifurcation, thrombus, angulation ), ' C'.., (information bias)..,., -., (score-carding),,

72 ). (thrombolytics), (bifurcation), (angulation), (thrombus),...,,

73 2) ) PTCA 1997 ACC/AHA %, ACC/AHA %. ACC/AHA, PTCA ,317 PTCA %,, CABG, %. 3 (20%, 50% ) %( 93.6%)., 10. (1986), PTCA 73%,, (1992) %. 93.6% (1999) 94.8%, (1999)

74 , (1986), 3.0%, 9.0% 1 2%, 0 2%. 1.5%, 2.2%, Ellis (1997) ( , 1.3%, 4.5%),. (1992) (steerable guide wire, low profile balloon ). Table 19. PTCA outcome indicators and their results of other studies in Korea Study Study period No. of Outcome indicators Results sample (1994) success rate 91.7% emergency CABG * 0.7% mortality 1.3% (1994) success rate 90.0% AMI * 1.7% (1992) success rate 90.0% ventricular fibrillation or arrythmia 2.1% (1991) success rate 82.5% (without AMI) AMI 3.8% emergency CABG 1.7% mortality(ventricular fibrillation) 0.5% (1986) success rate 73.0% AMI 9.0% death 3.0% * AMI : acute myocardial infarction, CABG : coronary artery bypass graft. PTCA (. 1999) ,

75 (32 87 ), 32.4% 30.2%., PTCA 36.0%, 17.9%, 43.7% 23.0%., (1999) 65.7%,, 25.4%, 8.9%, 54.7%, 31.5%, 13.7%., 50%, (1999). (1999) PTCA 15.2%, CABG 2.1%, 17.8%, 2.7%. PTCA (. 1999) %, 1), 53.4%. PTCA 200,, % PTCA. 1). PTCA ,

76 ) ( ) 3 25 PTCA, 30%. PTCA, (1986) 21%, (1991) 22%, (1992) 30.3%, (1994) 28.1%, (1999).. PTCA, PTCA (P=0.048)., 20%., (sex bias in the delivery of medical care)., (Hussain et al. 1997). (Tobin et al. 1987; Khan et al. 1990; Ayanian & Epstein 1991; Steingart et al. 1991). Tobin (1987), Khan (1990) CABG. Tobin (1987) (radionuclide scan) 4% CABG, 40%

77 CABG, CABG (underuse). Khan (1990) CABG. Ayanian Epstein(1991),. Steingart (1991). PTCA (Holmes et al. 1988; Kelsey et al. 1993; Hussain et al. 1997), Kelsey (1993) PTCA,..,,, CABG ( 20). Hussain (1997) PTCA., 1980 (Hussain et al. 1997)

78 Table 20. Risk factor profiles affecting outcomes of percutaneous transluminal coronary angioplasty by sex Characteristics Male (N=745) Female (N=337) P value Age, years Mean SD Resting heart rate Ejection fraction, % Congestive heart failure Respiratory disease (COPD * or asthma) Kidney disease (ARF * or CRF * or dialysis) Previous CABG * AMI within 24 hours Lesion type C * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes(cm-mb fraction 3 fold increase) or electrocardiographic changes(new Q-wave)...,

79 ( ) (current smoker vs former/non smoker) P 0.052, (current/former smoker vs nonsmoker) (P=0.008). (Doyle et al. 1964; Doll & Peto 1976), (procoagulant effect) PTCA (Quillen et al. 1993; Hung et al. 1995), (Barbash et al. 1993; Gomez et al. 1993; Zijlstra et al. 1993; Barbash et al. 1995a; Barbash et al. 1995b; Grines et al. 1995; Gottlieb et al. 1996). (smoker's paradox),. (1), (2), (3) (sudden death), (4) (Barbash et al. 1995a). PTCA, PTCA Hasdai (1999),,,.., ( 21), (P=0.001),

80 (ANOVA),, (P<0.001). CABG,, (X 2 tr en d = , P=0.0001). Table 21. Comparisons of major risk factors affecting outcomes of percutaneous transluminal coronary angioplasty by smoking history Characteristics Current smokers Former smokers Non-smokers P value (N=495) (N=150) (N=437) Female, % Age, years Mean SD * Resting heart rate Ejection fraction, % Mean SD Congestive heart failure Respiratory diseases (COPD * or asthma) Kidney diseases (ARF * or CRF * or dialysis) Previous CABG * AMI within 24 hours Lesion type C * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, SD : standard deviation. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes(cm-mb fraction 3 fold increase) or electrocardiographic changes(new Q-wave). chi-square test comparing current smokers, former smokers, and non-smokers, ANOVA test, chi-square test comparing current smokers and former/non smokers as two groups, chi-square test for trend comparing current smokers, former smokers, and non-smokers as three group., P 0.052, P 0.008,. 14 (por = 2.765, 95% CI : ),

81 (95% CI : ). ) - 200, 75. Kelly Hellinger(1986)., ( 14)..., 2... ( 75 ) ( 75 ),.,. PTCA,

82 .,, Table 22. Comparison of PTCA clinical outcomes by hospital's number of operator No. of operator, 2 No. of operator, >3 P value (N=430) (N=652) Intervention failure * Major adverse outcome * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. At least one complication of death during same hospitalization after intervention or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. ) 200, , 400, (P=0.023), 200, , 400 (X 2 tr e n d = , P=0.0001) (P=0.208), , ACC/AHA

83 . 200, 400., ) - '.,., -,.. -,. - ( ), PTCA

84 14.,..,.,,.. Hannan (1997) (longitudinal data)

85 3), ).,. PTCA,.,.,., 25.., (, 24, 24 CABG). 2.2%., -. (1), (2),.,

86 .,....,.,, (Hannan 1999). ),, PTCA PTCA. (1999), PTCA,,, PTCA

87 . -,. )., -.. PTCA.,., -. Hannan (1997).,.., -.,. ( : 2 PTCA, PTCA ),

88 ( : ), ( : )

89 6. (percutaneous transluminal coronary angioplasty, PTCA) 1977.,,,, PTCA ( ) PTCA ( 1,317, 95.5%),. 200, 75, PTCA (volume-outcome relationship). (,, ).,.., PTCA -,., PTCA

90 , (low volume) (high volume).. PTCA,

91 ,,,,,,,. Coronary Artery Stenting ; 26(3): ,,,,,,,. (Coronary Angioplasty). 1994; 24(3): ,,,,,,,,,,. Palmaz-Schatz Stenting ;27(1):56-64.,,,,,,,,, ; 22(6): , , ,,.., pp ,,. [ ] ; 38(6): , , 1993.,,,,,,,,, ; 23(6):

92 ,,,,,,. (PTCA). 1986; 3: ; 22(6): , , ( )., pp20-46 Anthony C. Federal financing of transplantation. Transplant Proc 1988;20(suppl): Ayanian JZ, Epstein AM. Differences in the use of procedures between women and men hospitalized for coronary heart disease. N Engl J Med 1991; 325 : Barbash GI, Reiner J, White HD, Wilcox RG, Armstrong PW, Sadowski Z, Morris D, Aylward P, Woodlief LH, Topol EJ, Califf RM, Ross AM. Evaluation of paradoxic beneficial effects of smoking in patients receiving thrombolytic therapy for acute myocardial infarction: mechanism of the "smoker's paradox" from the GUSTO- Trial, with angiographic insights. J Am Coll Cardiol 1995a; 26: Barbash GI, White HD, Diaz MR, Hampton JR, Heikkila J, Kristinsson A, Moulopoulos S, Paolasso EAC, Van Der Werf, Pehrsson K, Sandoe E, Simes J, Wilcox RG, Verstraete M, Von Der Lippe G, Van De Werf. Acute myocardial infarction in the young - the role of smoking. Eur Heart J 1995b; 16: Barbash GI, White HD, Modan M, Diaz R, Hampton JR, Heikkila J, Kristinsson A, Moulopoulos S, Paolasso EAC, Van der Werf T, Pehrsson K, Sandoe E, Simes J, Wilcox RG, Verstraete M, Von Der Lippe G, Van De Verf F. Significance of smoking in patients receiving thrombolytic therapy for acute myocardial infarction: experience gleaned from the international tissue plasminogen activator/streptokinase mortality trial. Circulation 1993; 87: Begg CB, Cramer LD, Hoskins WJ, Brennan MF. Impact of hospital on operative mortality for major cancer surgery. JAMA 1998; 280(20): Birkmeyer JD, Finlayson SR, Tosteson AN, Sharp SM, Warshaw AL, Fisher ES. Effect of hospital volume on in-hospital mortality with pancreaticoduodenectomy. Surgery 1999; 125(3): Croke RP. Case volume and clinical competence.[letter] Circulation 1991; 83(1):