HA Territory-wide PCI Audit 2003-06 06 Validation of risk prediction model PCI Audit Working Group Central Committee (Cardiac Services) HA Convention 2007
Background Participants: All HA hospitals via CCLs Mechanism: Prospective Comparative Audit Audit Period: 1 Jan 2003 31 Dec 2006 Audit Tools: PHCA s audit form Supplemented by Discharge summary epr consultation note Laboratory results (LIS) Death Registry On-site random record check
Objectives Compare baseline characteristics Compare standardized mortality and complication ratios among 10 CCLs Identify risk factors related to post-operation operation mortality and complication within 72 hours Validate the risk prediction model for post-pci mortality/complications
Baseline Characteristics 2003 2004 2005 2006 N= 3,904 N= 4,894 N= 4,784 N= 5,036 Male Sex 2,870 (74%) 3,639 (74%) 3,539 (74%) 3,709 (74%) Hypercholesterolemia 2,815 (72%) 3,726 (76%) 3,016 (63%) 3,354 (67%) Hypertension 2,573 (66%) 3,211 (66%) 3,039 (64%) 3,184 (63%) Smoking History 2,191 (56%) 2,567 (53%) 2,260 (47%) 2,315 (46%) Age 1,442 (37%) 1,882 (39%) 2,069 (43%) 2,197 (44%) Diabetes Mellitus 1,553 (40%) 1,903 (39%) 1,829 (38%) 1,954 (39%) Previous PCI 1,252 (32%) 1,604 (33%) 1,525 (32%) 1,599 (32%) CVA 297 (8%) 412 (8%) 284 (6%) 314 (6%) Renal Failure 180 (5%) 252 (5%) 236 (5%) 241 (5%)
ACS other than AMI, 678, 17.4% Primary (for AMI), 152, 3.9% Rescue (for AMI), 92, 2.4% Unplanned redo PCI, 7, 0.2% Case mix ACS other than AMI, 864, 17.7% Primary (for AMI), 145, 3.0% Rescue (for AMI), 44, 0.9% Unplanned redo PCI, 6, 0.1% 2003 2004 Elective, 3835, 78.4% (3904 cases) ACS other than AMI, 627, 13.1% Primary (for AMI), 166, 3.5% Elective, 2975, 76.2% Rescue (for AMI), 71, 1.5% (4894 cases) ACS other than AMI, 698, 13.9% Primary (for AMI), 159, 3.2% Rescue (for AMI), 79, 1.6% 2005* (4784 cases) Elective, 3920, 81.9% 2006* (5036 cases) Elective, 4100, 81.4% * Unplanned redo PCI are not categorized in 2005 and 2006 data
Severity of disease >2 vessels attempted, 226, 5.8% >2 vessels attempted, 377, 7.7% 2 vessels attempted, 1014, 26.0% 2 vessels attempted, 1349, 27.6% 2003 (3904 cases) 1 vessel attempted, 2664, 68.2% 2004 (4894 cases) 1 vessel attempted, 3168, 64.7% >2 vessels attempted, 294, 6.2% >2 vessels attempted, 413, 8.2% 2 vessels attempted, 1333, 27.9% 2 vessels attempted, 1387, 27.5% 2005 (4772 cases) (12 cases are excluded due to missing and invalid value) 1 vessel attempted, 3145, 65.9% 2006 (5036 cases) 1 vessel attempted, 3236, 64.3%
Characteristics of the worst lesion Type A, 481, 12.3% Type A, 440, 9.0% Type C, 1313, 33.6% Type C, 1672, 34.2% Type B1, 806, 20.6% Type B1, 1155, 23. 6% 2003 (3904 cases) Type B2, 1304, 33.4% 2004 (4894 cases) Type B2, 1627, 33.2% Type C, 1467, 30.7% Type A, 239, 5.0% Type B1, 1150, 24.0% Type C, 1804, 35.8% Type A, 336, 6.7% Type B1, 966, 19.2% 2005 (4784 cases) Type B2, 1928, 40.3% 2006 (5036 cases) Type B2, 1930, 38.3%
Angiographic result Angiographic Result 2003 2004 2005 2006 Successful 3,651 (94%) 4,568 (93%) 4,578 (96%) 4,803 (95%) Partially Successful 115 (3%) 182 (4%) 78 (2%) 100 (2%) Unsuccessful 138 (4%) 144 (3%) 128 (3%) 133 (3%) Total 3,904 (100%) 4,894 (100%) 4,784 (100%) 5,036 (100%)
Use of PCI devices/drugs 2003 2004 2005 2006 Balloon Stent Rotablator DCA Distal Protection Device Thrombectomy Device IABP/CPS Gp 2b3a Inhibitor Closure Devices (N=3,904) (N=4,894) (N=4,784) (N=5,036) 3,468 (89%) 4,458 (91%) 4,295 (90%) 4,622 (92%) 3,194 (82%) 4,472 (91%) 4,491 (94%) 4,756 (94%) 59 (2%) 55 (1%) 34 (1%) 45 (1%) 6 (0.2%) 143 (3%) 7 (0.2%) 1 (0.02%) 123 (3%) 111 (2%) 83 (2%) 71 (1%) 59 (2%) 64 (1%) 47 (1%) 90 (2%) 65 (2%) 105 (2%) 83 (2%) 89 (2%) 154 (4%) 116 (2%) 162 (3%) 164 (3%) 379 (10%) 478 (10%) 977 (20%) 1,204 (24%)
Major Complications within 72 hours on event basis (direct and indirect procedure causes included) 2003 2004 2005 2006 No. of cases Death 3,904 23 (0.6%) 4,894 30 (0.61%) 4,784 33 (0.7%) 5,036 25 (0.5%) Other major complications 45(1.2%) 89 (1.8%) 76 (1.6%) 82 (1.6%) MI-Non Q 21 (0.5%) 50 (1.0%) 31 (0.7%) 52 (1.0%) MI-Q wave 7 (0.2%) 5 (0.1%) 10 (0.2%) 8 (0.2%) Unplanned CABG 1 (0.03%) 6 (0.1%) 4 (0.1%) 3 (0.1%) Unplanned Re-PCI 10 (0.3%) 6 (0.1%) 8 (0.2%) 8 (0.2%) Stroke 0 (0%) 2 (0.04%) 4 (0.1%) 1 (0.02%) Bleeding with Hb Drop of >=3g/dl 6 (0.2%) 10 (0.2%) 12 (0.3%) 7 (0.1%) Cardiac Tamponade 5 (0.1%) 14 (0.3%) 11 (0.2%) 12 (0.2%) Vascular surgery or repair 2 (0.1%) 2 (0.04%) 1 (0.02%) 2 (0.04%)
Complications All Patients,2003~06 Indications Elective ACS other than AMI Primary (for AMI) Rescue (for AMI) Unplanned redo PCI* No. of cases 14830 2867 622 286 13 Death 13 (0.1%) 41 (1.4%) 39 (6.3%) 17 (5.9%) 1 (7.7%) Other major complications 202 (1.4%) 60 (2.1%) 21 (3.4%) 9 (3.1%) 0 (0%) MI-Non Q 121 (0.8%) 31 (1.1%) 2 (0.3%) MI-Q wave 21 (0.1%) 4 (0.1%) 4 (0.6%) 1 (0.4%) Unplanned CABG 6 (0.04%) 7 (0.2%) 1 (0.4%) Unplanned Re-PCI 16 (0.1%) 7 (0.2%) 8 (1.3%) 1 (0.4%) Stroke 3 (0.02%) 2 (0.1%) 2 (0.3%) Bleeding with Hb Drop of >=3g/dl 22 (0.2%) 8 (0.3%) 3 (0.5%) 2 (0.7%) Cardiac Tamponade 27 (0.2%) 8 (0.3%) 2 (0.3%) 5 (1.8%) Vascular surgery or repair 5 (0.03%) 2 (0.1%) * "Unplanned redo PCI" is not categorized in 2005 and 2006 data.
Mortality & Other major complications Primary PCI (for AMI) done 2003 2004 2005 2006 Overall No. of cases 152 145 166 159 622 Death 8 (5.3%) 11 (7.6%) 12 (7.2%) 8 (5%) 39 (6.3%) Other major complications 2 (1.3%) 6 (4.1%) 6 (3.6%) 7 (4.4%) 21 (3.4%) MI-Non Q 1 (0.7%) 1 (0.6%) 2 (0.3%) MI-Q wave 1 (0.7%) 1 (0.6%) 2 (1.3%) 4 (0.6%) Unplanned CABG 0 (0%) Unplanned Re-PCI 2 (1.3%) 2 (1.4%) 1 (0.6%) 3 (1.9%) 8 (1.3%) Stroke 2 (1.2%) 2 (0.3%) Bleeding with Hb Drop of >=3g/dl 1 (0.7%) 1 (0.6%) 1 (0.6%) 3 (0.5%) Cardiac Tamponade 1 (0.7%) 1 (0.6%) 2 (0.3%) Vascular surgery or repair 0 (0%) Among 622 cases with Primary PCI (for AMI) done, 3 cases have missing information on other major complications, and 2 of the aforesaid cases also have missing information on death.
Mortality & Other major complications Intercurrent Cardiogenic Shock No. of cases 2003 2004 57 64 2005 2006 Overall 70 62 253 Death 10 (17.5%) 14 (21.9%) 19 (27.1%) 11 (18%) 54 (21.3%) Other major complications 2 (3.5%) 6 (9.4%) 5 (7.1%) 0 (0.0%) 13 (5.1%) MI-Non Q 1 (1.6%) 1 (1.4%) 2 (0.8%) MI-Q-wave 1 (1.8%) 1 (0.4%) Unplanned CABG 0 (0%) Unplanned Re-PCI 2 (2.9%) 2 (0.8%) Stroke 2 (2.9%) 2 (0.8%) Bleeding with Hb Drop of >=3g/dl 2 (3.1%) 1 (1.4%) 3 (1.2%) Cardiac Tamponade 1 (1.8%) 3 (4.7%) 4 (1.6%) Vascular surgery or repair 0 (0%) Among 253 cases with Intercurrent cardiogenic shock, 3 cases have missing information on death and other major complications.
Post-PCI PCI Mortality, 2003~06 2003 2004 2005 2006 Overall No. of cases 3,904 4,894 4,784 5,036 18,618 Deaths within 72 hours 23 (0.6%) 30 (0.6%) 33 (0.7%) 25 (0.5%) 111(0.6%) Deaths within 30 days * 50 (1.3%) 66 (1.3%) 79 (1.7%) 69 (1.4%) 264(1.4%) * In cases with incomplete death date, impute month end when death day is missing and impute year end when death month is missing.
Univariate & Multivariate Analyses (2003 ~ 2006)
Mortality within 72 hours
Mortality Univariate analysis (2003 ~ 06) No. of cases = 18,553 Deaths: N=111 (0.6%) A. Pre-Intervention Status Heart Failure Sustained Ventricular Tachycardia or Ventr icular Fibr illation N(%) None/Other HF/Past Hx of HF 18,303 57 (0.3%) Intercurrent Cardiogenic Shock 250 54 (21.6%) None 18,100 76 (0.4%) Intercurrent VT/VF (within 24hrs) 240 32 (13.3%) All other VT/VF excluding 1 o VT/VF 170 2 (1.2%) Angina Type No Angina 1,191 3 (0.3%) <0.01 Major Native Arteries with >=50% lesions No. of cases Death Stable 11,109 9 (0.1%) Unstable 6,211 98 (1.6%) no LM involved 17,671 87 (0.5%) LM involved 882 24 (2.7%) p-value <0.01 <0.01 <0.01
Mortality Univariate analysis (2003 ~ 06) No. of cases = 18,553 Deaths: N=111 (0.6%) B. Co-morbidity/Risk Factors No. of cases Death N(%) p-value Renal Failure Yes 904 24 (2.7%) <0.01 No 17,582 85 (0.5%) Cerebrovascular Disease Yes 1,299 22 (1.7%) <0.01 No 17,243 89 (0.5%) Previous Percutaneous Coronary Yes 5,962 26 (0.4%) 0.053 Intervention No 12,588 85 (0.7%) Sex Female 4,847 38 (0.8%) 0.065 Male 13,706 73 (0.5%) Peripheral Vascular Disease Yes 585 7 (1.2%) 0.089 No 17,944 103 (0.6%) Hypertension Yes 11,963 79 (0.7%) 0.069 No 6,539 29 (0.4%) Age less than 70 10,994 58 (0.5%) 0.146 70 and over 7,559 53 (0.7%) Previous CABG Yes 514 1 (0.2%) 0.378 No 18,037 110 (0.6%) Smoking History 0.335 Diabetes Mellitus Family History of premature CAD No 8,900 52 (0.6%) Now or Stop<1 Yr 4,525 30 (0.7%) Yes but Stop>1 Yr 4,775 21 (0.4%) Yes 7,217 47 (0.7%) No 11,229 61 (0.5%) Yes 456 2 (0.4%) No 17,185 95 (0.6%) 0.374 1
Mortality Univariate analysis (2003 ~ 06) No. of cases = 18,553 Deaths: N=111 (0.6%) C. Procedure Summary No. of cases Death N(%) p-value Indications Primary or Rescue AMI/Unplanned redo PCI 918 57 (6.2%) <0.01 Characteristic of the worst lesion Elective/ACS other than AMI 17,635 54 (0.3%) Type A/B1 5,547 10 (0.2%) Type B2/C 13,006 101 (0.8%) <0.01
Mortality Multivariate analysis (2003 ~ 06) No. of PCI cases = 18,393 (Death = 107, 0.58%) OR 95 % C.I. p-value Angina type Unstable Angina no angina or stable angina Vs 6.35 (3.23, 12.47) <.0001 Heart failure Intercurrent Cardiogenic shock None/Other HF/APO/Past Hx of HF Vs 12.14 (7.03, 20.99) <.0001 Sustained VT/VF Intercurent VT/VF None or other VT/VF Vs 4.28 (2.42, 7.56) <.0001 Major native arteries LM involved No LM involved Vs 2.90 (1.64, 5.13) 0.0002 Cerebrovascular disease Yes No Vs 3.05 (1.78, 5.22) <.0001 Renal failure Yes No Vs 4.15 (2.42, 7.14) <.0001 Indications Goodness-of-fit Primary or Rescue AMI/Unplanned redo PCI Vs Elective/ACS other than AMI 2.76 (1.60, 4.74) 0.0003 p-value of Hosmer & Lemeshow test 0.24 Area under ROC curve 0.90
Standardized Mortality Ratio (SMR) (2003~2006) Excluding cases with missing angina type, heart failure, sustained VT/VF, major native arteries, CVA, renal failure or indications No outliers identified 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 Hospital 0.0 A B C D E F G H I J Expected no. of deaths = sum of predicted probability of death from multiple logistic regression model for each hospital
Non-death Complication within 72 hours
Complication Univariate analysis (2003 ~ 06) No. of cases = 18,448 Complications: N=292 (1.6%) A. Pre-Intervention Status Heart Failure N(%) None/Other HF/Past Hx of HF 18,198 279 (1.5%) Intercurrent Cardiogenic Shock 250 13 (5.2%) Angina Type No Angina 1,168 19 (1.6%) <0.05 Major Native Arteries with >=50% lesions Sustained Ventricular Tachycardia or Ventricular Fibrillation No. of cases Complications Unstable 6,196 120 (1.9%) Stable 11,042 153 (1.4%) no LM involved 17,576 270 (1.5%) LM involved 872 22 (2.5%) None 17,995 281 (1.6%) Intercurrent VT/VF (within 24hours) 240 5 (2.1%) All other VT/VF excluding 1 o VT/VF 170 3 (1.8%) p-value <0.01 <0.05 0.621
Complication Univariate analysis (2003 ~ 06) No. of cases = 18,448 Complications: N=292 (1.6%) B. Co-morbidity/Risk Factors Age No. of Complications cases N(%) 70 and over 7,515 149 (2.0%) less than 70 10,933 143 (1.3%) Yes 1,287 33 (2.6%) No 17,150 258 (1.5%) p-value <0.01 Cerebrovascular Disease <0.01 Sex Female 4,817 94 (2.0%) <0.05 Male 13,631 198 (1.5%) Previous CABG Yes 513 14 (2.7%) <0.05 No 17,933 277 (1.5%) Renal Failure Yes 897 21 (2.3%) 0.074 No 17,484 271 (1.5%) Smoking History No 8,858 153 (1.7%) 0.154 Now or Stop<1 Yr 4,505 58 (1.3%) Yes but Stop>1 Yr 4,735 75 (1.6%) Hypertension Yes 11,899 196 (1.6%) 0.388 No 6,498 96 (1.5%) Peripheral Vascular Disease Yes 579 11 (1.9%) 0.496 No 17,845 280 (1.6%) Previous Percutaneous Coronary Yes 5,924 97 (1.6%) 0.658 Intervention No 12,521 194 (1.5%) Diabetes Mellitus Yes 7,166 117 (1.6%) 0.717 No 11,175 175 (1.6%) Family History of premature CAD Yes 452 7 (1.5%) 1 No 17,093 276 (1.6%)
Complication Univariate analysis (2003 ~ 06) No. of cases = 18,448 Complications: N=292 (1.6%) C. Procedure Summary No. of Complications cases N(%) p-value Indications Primary or Rescue AMI/Unplanned redo PCI 917 30 (3.3%) <0.01 Elective/ACS other than AMI 17,531 262 (1.5%) Characteristic of the worst lesion Type A/B1 5,541 46 (0.8%) Type B2/C 12,907 246 (1.9%) <0.01
Complication Multivariate analysis (2003 ~ 06) No. of PCI cases = 18,437 (Complication = 291, 1.58%) OR 95 % C.I. p-value Heart failure Cerebrovascular disease Age Intercurrent Cardiogenic shock None/Other HF/Past Hx of HF Yes No >=70 Vs below 70 Vs Vs 2.14 (1.12, 4.10) 0.0222 1.58 (1.09, 2.29) 0.0154 1.45 (1.15, 1.83) 0.0018 Indications Charactreristic of worst lesion Goodness-of-fit Primary or Rescue AMI/Unplanned redo PCI Elective/ACS other than AMI Type B2/C Type A/B1 p-value of Hosmer & Lemeshow test 0.23 Area under ROC curve 0.63 Vs Vs 1.67 (1.08, 2.60) 0.0217 2.16 (1.57, 2.96) <.0001
Standardized Complication Ratio (SCR) (2003~2006) Excluding cases with missing heart failure, CVA, age, indications or Characteristic of worst lesion Heterogenous group of complications (from mild to severe) Hospital Expected no. of complications = sum of predicted probability of complications from multiple logistic regression Amodel for each hospital B C D E F G H I J 0.0 0.5 1.0 1.5 2.0 2.5 3.0
Development and Validation of a predictive model for Post-PCI mortality within 72 hours Excluding cases with unknown outcome within 72 hours post-pci PCI data for 2003-2006 No. of PCI cases = 18,618 Deaths = 111 (0.6%) Training Dataset 2003-2005 No. of PCI cases = 13,582 Deaths = 86 (0.6%) Validation Dataset 2006 No. of PCI cases = 5,036 Deaths = 25 (0.5%)
Receiver operating characteristic (ROC) curves of multiple logistic regression models in Sheet "Model" for training dataset (Years 2003-2005) and validation dataset (Year 2006) 1 ROC curve 0.9 0.8 0.7 Sensitivity 0.6 0.5 0.4 0.3 0.2 0.1 Training dataset (area under curve=0.923) Validation dataset (area under curve=0.831) 0 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1 - Specificity
Predictors of Mortality OR Intercurrent cardiogenic shock 12.1 Unstable Angina 6.4 Intercurrent VT/VF 4.3 Renal Failure 4.2 Hx of CVA 3.1 Left Main involvement 2.9 Primary/Rescue PCI for AMI 2.8
Predictors of non-death complications OR Type B2/C lesions 2.2 Intercurrent cardiogenic shock 2.1 Primary/Rescue PCI for AMI 1.7 Hx of CVA 1.6 Age 70 1.5
Limitations No data on 6-month 6 month redo-pci for Target Lesion Revascularization (TLR) Self-reported reported cases 2003 a full-time audit nurse to check data accuracy 2004-5 a part-time time audit nurse 2006 onwards data accuracy ensured by individual institutions
Way Forward Individual CCLs responsible for data accuracy A designated medical staff as point of contact Half-yearly outstanding report list to individual CCL for FU Collaborate with HI & IT Team GRR for PCI reports integrating audit capability (All the 10 CCLs are using the GRR PCI reporting system since January 2005) Data Quality cross-check check with data warehouse e.g. death registry, LIS, MOE Generic reports by CDARS Individual hospital vs. all hospital average With validated risk prediction model for PCI procedures in HA hospitals Uphold the standard of PCI procedures performed in HA hospitals Interventional Cardiologists more willing to take up high-risk cases Patients more well-informed of the risks of PCI
Acknowledgement Hong Kong Public Hospital Cardiologists Association HA Central Committee (Cardiac Services) HAHO Statistics and Research Section HAHO HI & IT Team HAHO Clinical Effectiveness Unit HAHO Central Audit Committee
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