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BMC2 VASCULAR INTERVENTION COLLABORATIVE OCTOBER 2013 Peter Henke, MD Project Director VIC Professor of Surgery University of Michigan and VA Ann Arbor Hospitals and Health Centers 1 29 Vascular Surgery Participating Hospitals - 2014 2 Vascular Surgery Dashboard Anticipate Completion: Q3 2013 Reporting Period Outcomes by procedure type Outcomes by procedure status (elective vs. emergent) Focused QI Goals Includes outcomes at 30 days 3 Vascular Surgery Dashboard 4 Special Initiatives in Vascular Surgery Pre-operative protocol for cardiac clearance/prevention of post-operative MI Transfusion guidelines Surgical site infection protocol – part of an effort to reduce readmissions at 30 days 5 Vascular Surgery Procedure Types Open Abdominal Aneurysm Repair Endovascular Abdominal Aneurysm Repair (EVAR) Open Bypass Procedures, upper and lower extremity Carotid Stenting Carotid Endarterectomy 6 VASCULAR SURGERY DATA YE 2012, Q1/Q2 2013 7 Discharges Collected to Date – YE 2012, Q1/Q2 2013 Vascular Surgery Discharges – 2583 (2673 Procedures) EVAR - 857 Open AAA - 167 Open Bypass - 1649 Carotid Discharges – 2395 (2407 Procedures) Carotid Stent - 503 Carotid Endarterectomy - 1904 Total Discharges YE 2012, Q1/Q2 2013 - 4978 Total Procedures YE 2012, Q1/Q2 2013 - 5080 8 CEA/CAS Indications YE 2012, Q1/Q2 2013 CAS Indications # Carotid Stent Procedures 503/2407 20.9% Symptomatic 217/503 43.1% Asymptomatic 286/503 56.9% CEA Indications # Carotid Endarterectomy Procedures 1904/2407 79.1% Symptomatic 642/1904 33.7% Asymptomatic 1262/1904 66.3% 9 Carotid Outcomes in Hospital YTD 2012, Q1/Q2 2013 Death Carotid Endarterectomy Carotid Stent 9/1904 = 0.5% 5/503 = 1% MI Stroke 11/1904 = 0.6% 43/1904 = 2.3% 4/503 = 0.8% 27/503 = 5.4% Combined Death/Stroke/MI (In hospital) Carotid Endarterectomy 59/1904 3.1% Carotid Stent 34/503 6.8% * CEA started data collection April 1, 2012 10 Carotid Outcomes at 30 Days Q1/Q2 2013 Combined Death, Stroke, & MI at 30 days* Carotid Endarterectomy 43/806 5.3% Carotid Stent 18/182 9.9% Death MI Stroke Carotid Endarterectomy 13/806 = 1.6% 4/806 = 0.5% 29/806 = 3.6% Carotid Stent 4/182 = 2.2% 2/182 = 1.1% 13/182 = 7.1% * 30 day data calculated for 2013 data only 11 Carotid Outcomes Common Odds Ratio in Stratified Outcomes CAS/CEA Death Stroke/TIA MI Odds Ratio 5.13 1.86 2.00 P-value 0.442 0.0676 0.686 Odds Ratio P-value Stroke/Death/MI Stroke/Death 2.07 2.14 0.01744 0.01896 *Matching sample, stratified by Asymptomatic 12 Adjusted Odds Ratio: Post-Procedure Stroke/Death/MI Significant Variables (P-value < 0.1, Blue < 0.05) Odds Ratio Lower Limit CI Upper Limit CI P-value Procedure Type: CAS 1.973 1.095 3.555 0.024 Urgent Cardiac Surgery w/in 30 days 6.640 1.324 33.298 0.021 Pre Procedure Aspirin 2.036 0.935 4.435 0.073 AUC = 68.8% 13 Adjusted Odds Ratio: Variables Used in Model Procedure Type (CAS & CEA) Age Hyperlipidemia Diabetes Asymptomatic Prior PCI Prior MI Prior CABG Two or more major coronary arteries with stenosis >70% Left Main coronary artery stenosis >50% MI within 6 weeks NYHA functional class III or IV within 6 weeks Permanent pacemaker or ICD Major Surgery Planned within next 8 weeks Urgent cardiac surgery within 30 days Pre procedure aspirin Pre procedure clopidogrel 14 Carotid Stent/Endarterectomy Medications YTD 2012, Q1/Q2 2013 Carotid Procedure Cardio-Protective Medication Use Admission Discharge ASA 2054/2331 = 88.1% 2172/2315 = 93.8% Beta Blocker 1338/2353 = 56.9% 1407/2338 = 60.2% Statin 1793/2282 = 78.6% 1968/2294 = 85.8% *Patients listed as contraindicated to a specific medication are excluded 15 30 Day Follow-Up: Medication Compliance Carotid Stent/Endarterectomy (YTD 2012, Q1/Q2 2013) Total # of patients with follow-up data* 2034/2244 90.6% 1756/1844 95.2% 850/960 88.5% Statin 1605/1667 96.3% Beta Blocker 1063/1186 89.6% ASA Antiplatelets (excluding ASA) * 30 Day compliance calculated only for patients discharged on a specific medication. * Patients marked as contraindicated/not documented at follow up are excluded, creating different denominators 16 Open AAA / EVAR Indications YTD 2012, Q1/Q2 2013 Open AAA Indications # Open AAA Procedures 167/2673 6.2% Asymptomatic 77/167 46.1% Symptomatic 90/167 53.9% Ruptured AAA 41/167 24.6% EVAR Indications # EVAR Procedures 857/2673 32.1% Asymptomatic 554/857 64.6% Symptomatic 303/857 35.4% Ruptured AAA 51/857 6.0% 17 EVAR /Open AAA Repair Outcomes Death at 30 Days YE 2012, Q1/Q2 2013 EVAR 34/857 4.0% Open AAA 34/167 20.4% Death at 30 Days Q1/Q2 2013 EVAR 11/312 34.3% Elective EVAR 5/273 1.8% Emergent EVAR/Rupture 6/39 15.4% 10/74 13.5% Elective Open AAA 1/51 2.0% Emergent Open AAA/Rupture 9/23 39.1% Open AAA 18 EVAR /Open AAA Repair Outcomes YE 2012, Q1/Q2 2013 Major Morbidities at 30 Days EVAR Open AAA MI 12/857 = 1.4% 11/167 = 6.6% Transfusion 87/857 = 10.2% 65/167 = 38.9% New Dialysis 16/857 = 1.9% 11/167 = 6.6% Bowel Ischemia* 2/312 = 0.6% 1/74 = 1.4% * Bowel Ischemia added for 2013 19 Open Bypass YE 2012, Q1/Q2 2013 Total Open Bypass Procedures Inflow 1649/2673 = 61.7% Aorto-Bifemoral/Femoral Femoral-Femoral Axillary-Femoral 163/1649 = 9.9% 208/1649 = 12.6% 84/1649 = 5.1% Other Inflow Outflow Femoral-Popliteal Femoral-Tibial 649/1649 = 39.4% 229/1649 = 13.9% Popliteal-Tibial 36/1649 = 2.2% Other Outflow Upper Extremity/Misc 125/1649 = 7.6% 135/1649 = 8.2% 20/1649 = 1.2% 20 Open Bypass YE 2012, Q1/Q2 2013 Indications* Claudication Only 458/1420 = 32.3% Rest Pain 791/1420 = 55.7% Ulcer / Tissue Loss 435/1420 = 30.6% Acute Limb Ischemia 352/1420 = 24.8% * Lower Extremity Bypass only * Multiple indications may be selected 21 Open Bypass Outcomes at 30 Days YE 2012, Q1/Q2 2013 Death at 30 Days Open Bypass 41/1559 = 2.7% Major Morbidities at 30 days Amputation 90/1559 = 5.8% MI 39/1559 = 2.5% Post Op Transfusion Graft Thrombosis 364/1559 = 23.3% 45/1559 = 2.9% * 2013 Discharge level rates for Open Bypass 22 Vascular Surgery Medications Open AAA, EVAR, Open Bypass (YE 2012, Q1/Q2 2013) Vascular Surgery Cardio Protective Medication Use Admission Discharge ASA 1817/2476 = 73.3% 2053/2407 = 85.3% Beta Blocker 1473/2521 = 58.4% 1605/2462 = 65.2% Statin 1719/2491 = 69.0% 1825/2444 = 74.7% *Patients listed as contraindicated to a specific medication are excluded 23 Readmission 30 Day Follow- Up YE 2012, Q1/Q2 2013 All Procedures Total number of patients readmitted to the hospital 170/2082 8.2% 103/169* 61% Lymph Leak 36/169 21.3% Thrombectomy/Lysis 20/169 11.8% Anticoagulation Complication 11/169 6.5% Graft Infection 5/169 3.0% Wound Infection *Note: One patient missing reason for readmission Multiple reasons for readmission may be selected 24 Readmission 30 Day Follow-Up YE 2012, Q1/Q2 2013 Open Bypass Readmission Rate at 30 days Overall Readmission Rate 135/1081 = 12.5% Lymph Leak (seroma) 20/135 = 14.8% Wound Infection/dehiscence 90/135 = 66.7% Graft Infection 5/135 = 3.7% Anticoagulation Complication 9/135 = 6.7% Thrombectomy/lysis 19/135 = 14.1% Additional outcomes at 30 Days Bypass Patent Bypass Revision 541/566 = 95.6% 8/566 = 1.4% *Note: Multiple reasons for readmission may be selected 25 SURGICAL SITE INFECTION 26 BMC2 SSI Definition To qualify for infection/sepsis outcome a. Treatment with antibiotics b. Positive culture Option to select: Access site Central Line/IV Blood Graft infection Pulmonary UTI Wound site Unknown Includes post-procedure outcomes and readmission for wound infection at 30 days 27 Surgical Site Infection Rate (Open Bypass) YE 2012, Q1/Q2 2013 Open Bypass SSI Rate at 30 Days* YE 2012, Q1/Q2 2013 135/1420 = 9.5% Open Bypass SSI Rate at 30 Days (Q1/Q2 2013 only)* Overall Rate Elective Bypass Urgent/Emergent Bypass 42/557 = 7.5% 29/425 = 6.8% 13/132 = 9.8% * Lower Extremity Bypass Only 28 Surgical Site Infection: Best Practice Administer prophylactic antibiotics Weight based dosing Antibiotic redosing in procedures lasting >3 hours Pre-operative prep = chlorhexidine & alcohol Decrease post-operative transfusion 29 SSI: Procedure Details (Open Bypass) YE 2012, Q1/Q2 2013 Intra Operative Measures* Antibiotics Pre Procedure 1632/1649 = 99.0% Vascular Procedures > 3 hrs Duration 1202/1649 = 73% Antibiotics Re-Dosed in Procedures > 3 hrs Duration 645/1202 = 53.7% Chlorhexidine Based Skin Prep 1234/1649 = 74.8% * Open Bypass Procedures only 30 Predictors of Surgical Site Infection Significant Variables (P-value < 0.1, Blue < 0.05) Variable Odds Ratio LCL UCL Transfusion During Procedure 3.083 1.757 5.410 BMI 1.057 1.015 1.100 Pre-Operative Resting Pulse 1.017 1.002 1.033 Pre-Operative Blood Pressure 0.991 0.980 1.001 Current Smoker 2.351 0.929 5.946 Hx Hypertension 0.512 0.245 1.070 Hx CHF 1.832 1.037 3.237 Hx CVD/TIA 1.711 1.005 2.913 Chlorhexidine Based Skin Prep Both Prosthetic and Vein Graft (Compared to Prosthetic) 0.537 0.292 0.987 3.026 1.034 8.860 Vein Graft (Compared to Prosthetic) AUC ~ 74% 1.588 0.933 2.703 31 Pre-Procedure Variables in SSI Model Gender CHF Age Significant Valve Disease BMI COPD Ethnicity CVD/TIA Ambulatory Status CAD Smoking Status Prior PCI Pre-op Resting Pulse Prior MI Pre-op Blood Pressure Prior CABG Family History of Premature CAD Current/Recent GI Bleed Hypertension Afib Hyperlipidemia Other Atherosclerotic Disease Renal Failure/Current Dialysis Pre-Procedure Hemoglobin Diabetes Pre-Procedure Creatinine 32 SSI: Predictive Pre-Operative Variables Significant Variables (P-value < 0.1, Blue < 0.05) Variable Odds Ratio Lower Limit CI Upper Limit CI BMI 1.055 1.018 1.093 Pre-Ambulation w/Assist 0.570 0.309 1.051 Pre-Operative Resting Pulse 1.021 1.006 1.035 Pre-Operative Blood Pressure 0.989 0.979 0.999 Hyperlipidemia 0.532 0.286 0.991 Hx CHF 2.076 1.120 3.851 Hx CVD/TIA 1.881 1.163 3.042 Hx Prior CABG 0.552 0.294 1.038 AUC = 72.4% 115 Events YE 2012, Q1/Q2 2013 (Excludes Emergent Procedures) 33 SSI: OE Plot (Blinded) 34 SSI: Post-Op Hemoglobin 35 POST-OPERATIVE MI 36 Post-Operative MI Rate YE 2012, Q1/Q2 2013 MI Rate at 30 Days (All Procedures) Overall Post-Op MI Rate 84/4978 = 1.7% CVOD (CEA/CAS) 26/2395 = 1.1% Open Bypass 39/1559 = 2.5% EVAR 12/857 = 1.4% Elective EVAR 8/806 = 1.0% Emergent EVAR/Rupture 4/51 = 7.8% Open AAA 7/167 = 4.2% Elective Open AAA 3/125 = 2.4% Emergent Open AAA/Rupture 4/42 = 9.5% Bypass and AAA procedures: MI = 2.2% (58/2583) 37 Post-Op MI: Pre-Operative Patient History Patient History: Post-Op MI vs. Non MI Non MI MI Odds Ratio P Hyperlipidemia 83% 92% 2.2 .170 Hypertension 86% 100% X .001 Diabetes 34% 47% 1.8 .066 CHF 15% 27% 2.1 .040 Hx CAD 51% 69% 2.2 .009 Prior PCI 23% 39% 2.1 .015 Prior MI 28% 49% 2.5 .002 Prior CABG 22% 35% 1.9 .038 2.5% 8.2% 3.5 .035 Current Renal Failure 38 Post-Op MI: Pre-Operative Medications Cardioprotective Medications Post-Op MI vs. Non MI Non MI MI Odds Ratio P Beta Blocker 60% 80% 2.6 .005 Statin 69% 82% 2.0 0.062 Aspirin 75% 84% 1.7 0.240 ACE Inhibitor 44% 43% 1.0 1.00 Pre-op Medication *Patients listed as contraindicated to a specific medication are excluded 39 Post-OP MI: Pre-Operative Testing Pre-Operative Testing: Post-Op MI vs. Non MI Non MI MI Odds Ratio P Cardiac Consult (pre-op) 46% 67% 2.4 .004 EKG 80% 84% 1.3 .716 Normal 34% 19% NA NA Abnormal 66% 81% 0.5 .089 38% 29% 0.6 .183 Normal 64% 29% NA NA Abnormal 36% 71% 0.2 .009 Cardiac Stress Test 40 Post-Op MI: Pre-Operative Patient History Patient History Comparison: Hospitals with MI >3% and Hospitals with MI <= 3% 41 Post-Op MI: Pre-Operative Medications Pre-Op Medication Comparison: Hospitals with MI >3% and Hospitals with MI <= 3% 42 POST-OPERATIVE TRANSFUSION 43 Post-Operative Transfusion Rate YE 2012, Q1/Q2 2013 Overall Transfusion Rate* All Procedures Non-Emergent Procedures Patients transfused with hemoglobin > 8.0 516/2583 = 20.0% 448/2471 = 17.7% 152/448 = 33.9% Procedure Specific Transfusion Rate Open Bypass EVAR Open AAA 364/1559 = 23.3% 87/857 = 11.9% 65/167 = 40.1% * Discharge level transfusion rates for Open Bypass, EVAR, and Open AAA – PRBCs only 44 Post-Operative Transfusion Rate YE 2012, Q1/Q2 2013 Procedure Specific Transfusion Rate EVAR (All) Elective EVAR Emergent/Rupture EVAR 87/857 = 10.2% 61/806 = 7.6% 26/51 = 51% Open AAA (All) Elective Open AAA 65/167 = 38.9% 39/125 = 31.2% Emergent/Rupture Open AAA Open Bypass 26/42 = 61.9% 364/1559 = 23.3% * 2013 Discharge level rates for Open Bypass, EVAR, and Open AAA 45 Predictors of Post-Operative Transfusion (Elective Procedures) Significant Variables (P-value < 0.1, Blue < 0.05) Variable Odds Ratio Lower Limit CI Upper Limit CI 2.146 1.503 3.063 (Compared to EVAR) 1.853 1.115 3.081 BMI 0.963 0.935 0.991 Hx Hyperlipidemia 0.635 0.390 1.036 Hx CVD/TIA 1.417 0.980 2.047 Current/Recent GI Bleed 2.168 0.937 5.018 Hx Other Atherosclerotic Disease 1.413 0.986 2.024 Renal Failure/Current Dialysis 2.780 1.214 6.369 Pre-op Pulmonary Consult 2.540 1.443 4.474 IV Heparin Post Procedure 2.305 1.512 3.514 Anemia Pre Procedure 3.622 2.512 5.221 Female Gender Procedure Type Open Bypass EBL AUC = 84.6% 1.001 1.000 1.001 448 Events YTD 2012, Q1/Q2 2013 (Excludes Emergent Procedures) 46 Pre-Procedure Variables in Transfusion Model Gender CHF Age Ejection Fraction BMI Significant Valve Disease Ethnicity COPD Renal Failure/Current Dialysis CVD/TIA Renal Transplant CAD Pre-Procedure Hemoglobin Prior PCI Pre-Procedure Creatinine Prior MI Pre-Procedure Aspirin Prior CABG Pre-Procedure Clopidogrel Current/Recent GI Bleed Pre-Procedure Prasugrel Afib Pre-Procedure Warfarin Other Atherosclerotic Disease 47 Transfusion: Predictive Pre-Operative Variables YE 2012, Q1/Q2 2013 (Excludes Emergent Procedures) Significant Variables (P-value < 0.1, blue < 0.05) Variable Odds Ratio Lower Limit CI Upper Limit CI Female 1.564 1.137 2.149 Age 0.985 0.971 1.000 BMI 0.973 0.949 0.998 Pre Procedure Clopidogrel 1.469 1.055 2.047 Pre Procedure Hemoglobin 0.665 0.614 0.720 Other Atherosclerotic Disease 1.351 0.995 1.835 AUC = 76.8% 448 Events YTD 2012, Q1/Q2 2013 48 Post-Op Transfusion: OE Plot (Blinded) 49 Post-Operative Hemoglobin by Decile 50 Transfusion VASCULAR SURGERY SURVEY RESULTS SEPTEMBER/OCTOBER 2013 9 RESPONDENTS 51 Vascular Surgery Survey Results Do you transfuse at a threshold of: 52 Vascular Surgery Survey Results Do you use clinical parameters to decide when to transfuse in addition to Hgb? If so: 53 Vascular Surgery Survey Results Does your hospital employ techs, nurses, PAs or other professionals who obtain femoral artery access in the cath lab?: 54 Vascular Surgery Survey Results In a patient with a post operative NSTEMI and Hgb = 9.5, would you transfuse?: 55 Vascular Surgery Survey Results In a post procedure patient with CAD and without symptoms of ischemia and a Hgb = 7.5, would you transfuse this patient? 56 VIC VASCULAR SURGERY GOALS 57 2014 Vascular Surgery QI Goals Surgical Site Infection (To Reduce Readmissions) Chlorhexidine & Alcohol Skin Prep >=90% Antibiotic redosing in procedures > 3 hours @100% Transfusion Decrease transfusion rate in patients with a postprocedure hemoglobin > 8.0 to <= 10% Post-Operative MI Reduce hospital post-operative MI rate to < 3% 58 Surgical Site Infection Administer antimicrobial agents for prophylaxis with a particular procedure or disease according to evidence-based standards and guidelines for best practices. Administer intravenous antimicrobial prophylaxis within one hour before incision to maximize tissue concentration (two hours are allowed for the administration of vancomycin and fluoroquinolones). Administer a prophylactic antimicrobial agent with an adequate dose based on BMI. Redose prophylactic antimicrobial agents in procedures > 3 hours and every 3 hours as necessary. Discontinue the prophylactic antimicrobial agent within 24 hours after surgery (within 48 hours is allowable for cardiothoracic procedures). Preoperatively, use solutions that contain Chlorhexidine plus Alcohol as skin antiseptic preparations and allow appropriate drying time per product guidelines. Reference: Safe Practices for Better Healthcare–2010 Update, A CONSENSUS REPORT 59 Pre-Operative Cardiac Clearance: European Society of Cardiology Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery 60 Post-Op Transfusion Goal – Establish Transfusion Guidelines for Vascular Surgery Patients Utilizing: A. Dr. Carson’s Expertise B. Collaborative Feedback C. Evidence-Based Literature/Data 61 Welcome Dr. Carson Jeffrey L Carson, MD Vice Chair, Research Richard C Reynolds Professor of Medicine Chief, Division of General Internal Medicine Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey 08901 62 Dr. Carson Principal Investigator: Transfusion Thresholds in Myocardial Necrosis (MINT) The MINT Study: Determine the differences between setting a transfusion trigger at one of two different hemoglobin levels Transfusion Therapy Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) RCT to determine if a higher transfusion threshold improves functional recovery and reduces morbidity and mortality 63