BMC2 Vascular intervention collaborative October 2013

Peter Henke, MDProject Director VICProfessor of Surgery

University of Michigan and VA Ann Arbor Hospitals and Health Centers

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29 Vascular Surgery Participating Hospitals - 2014

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Vascular Surgery Dashboard

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Anticipate Completion:Q3 2013 Reporting Period

Outcomes by proceduretype

Outcomes by procedure status (elective vs. emergent)

Focused QI GoalsIncludes outcomes

at 30 days

Vascular Surgery Dashboard

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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

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Vascular Surgery Procedure Types

Open Abdominal Aneurysm Repair Endovascular Abdominal Aneurysm Repair

(EVAR) Open Bypass Procedures, upper and lower

extremity Carotid Stenting Carotid Endarterectomy

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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

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CEA/CAS IndicationsYE 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%



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Carotid Outcomes in HospitalYTD 2012, Q1/Q2 2013

Combined Death/Stroke/MI (In hospital)Carotid Endarterectomy 59/1904 3.1%

Carotid Stent 34/503 6.8%

Death MI StrokeCarotid Endarterectomy 9/1904 = 0.5% 11/1904 = 0.6% 43/1904 = 2.3%

Carotid Stent 5/503 = 1% 4/503 = 0.8% 27/503 = 5.4%

* CEA started data collection April 1, 201210

Carotid Outcomes at 30 DaysQ1/Q2 2013

Combined Death, Stroke, & MI at 30 days*Carotid Endarterectomy 43/806 5.3%

Carotid Stent 18/182 9.9%

* 30 day data calculated for 2013 data only

Death MI StrokeCarotid 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%

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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

Stroke/Death/MI Stroke/Death

Odds Ratio 2.07 2.14

P-value 0.01744 0.01896

*Matching sample, stratified by Asymptomatic12

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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%

Adjusted Odds Ratio: Post-Procedure Stroke/Death/MI

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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

Carotid Stent/Endarterectomy MedicationsYTD 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 excluded15

30 Day Follow-Up: Medication ComplianceCarotid Stent/Endarterectomy (YTD 2012, Q1/Q2 2013)

Total # of patients with follow-up data* 2034/2244 90.6%

ASA 1756/1844 95.2%

Antiplatelets (excluding ASA) 850/960 88.5%

Statin 1605/1667 96.3%

Beta Blocker 1063/1186 89.6%

* 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

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Open AAA / EVAR IndicationsYTD 2012, Q1/Q2 2013

Open AAA Indications# Open AAA Procedures 167/2673 6.2%



Ruptured AAA 41/167 24.6%

EVAR Indications# EVAR Procedures 857/2673 32.1%



Ruptured AAA 51/857 6.0%

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EVAR /Open AAA Repair Outcomes

Death at 30 Days YE 2012, Q1/Q2 2013EVAR 34/857 4.0%

Open AAA 34/167 20.4%

Death at 30 Days Q1/Q2 2013EVAR 11/312 34.3%

Elective EVAR 5/273 1.8%

Emergent EVAR/Rupture 6/39 15.4%

Open AAA 10/74 13.5%

Elective Open AAA 1/51 2.0%

Emergent Open AAA/Rupture 9/23 39.1%

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EVAR /Open AAA Repair Outcomes YE 2012, Q1/Q2 2013

Major Morbidities at 30 DaysEVAR 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 201319

Open BypassYE 2012, Q1/Q2 2013

Total Open Bypass Procedures 1649/2673 = 61.7%Inflow Aorto-Bifemoral/Femoral 163/1649 = 9.9% Femoral-Femoral 208/1649 = 12.6% Axillary-Femoral 84/1649 = 5.1% Other Inflow 125/1649 = 7.6%Outflow Femoral-Popliteal 649/1649 = 39.4% Femoral-Tibial 229/1649 = 13.9% Popliteal-Tibial 36/1649 = 2.2% Other Outflow 135/1649 = 8.2%Upper Extremity/Misc 20/1649 = 1.2% 20

Open BypassYE 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 selected21

Open Bypass Outcomes at 30 DaysYE 2012, Q1/Q2 2013

Death at 30 DaysOpen Bypass 41/1559 = 2.7%

Major Morbidities at 30 daysAmputation 90/1559 = 5.8%

MI 39/1559 = 2.5%

Post Op Transfusion 364/1559 = 23.3%

Graft Thrombosis 45/1559 = 2.9%

* 2013 Discharge level rates for Open Bypass22

Vascular Surgery Medications Open AAA, EVAR, Open Bypass (YE 2012, Q1/Q2 2013)

Vascular Surgery Cardio Protective Medication UseAdmission 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 excluded23

Readmission 30 Day Follow- Up YE 2012, Q1/Q2 2013

All Procedures

Total number of patients readmitted to the hospital

170/2082 8.2%

Wound Infection 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%

*Note: One patient missing reason for readmission Multiple reasons for readmission may be selected

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Readmission 30 Day Follow-Up YE 2012, Q1/Q2 2013 Open Bypass

Readmission Rate at 30 daysOverall 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%

*Note: Multiple reasons for readmission may be selected

Additional outcomes at 30 DaysBypass Patent 541/566 = 95.6%Bypass Revision 8/566 = 1.4%

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SURGICAL SITE INFECTIONSURGICAL SITE INFECTION

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BMC2 SSI Definition

To qualify for infection/sepsis outcome

a. Treatment with antibioticsb. Positive cultureOption 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

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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 42/557 = 7.5% Elective Bypass 29/425 = 6.8% Urgent/Emergent Bypass 13/132 = 9.8%

* Lower Extremity Bypass Only28

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

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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 only30

Predictors of Surgical Site Infection

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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 0.537 0.292 0.987Both Prosthetic and Vein Graft (Compared to Prosthetic) 3.026 1.034 8.860

Vein Graft (Compared to Prosthetic) 1.588 0.933 2.703AUC ~ 74%

Gender Age BMI Ethnicity Ambulatory Status Smoking Status Pre-op Resting Pulse Pre-op Blood Pressure Family History of Premature CAD Hypertension Hyperlipidemia Renal Failure/Current Dialysis Diabetes

Pre-Procedure Variables in SSI Model

CHF Significant Valve Disease COPD CVD/TIA CAD Prior PCI Prior MI Prior CABG Current/Recent GI Bleed Afib Other Atherosclerotic Disease Pre-Procedure Hemoglobin Pre-Procedure Creatinine

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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)

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SSI: Post-Op Hemoglobin

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POST-OPERATIVE MIPOST-OPERATIVE MI

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Post-Operative MI RateYE 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 MINon 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

Current Renal Failure 2.5% 8.2% 3.5 .035

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Post-Op MI: Pre-Operative Medications

Cardioprotective MedicationsPost-Op MI vs. Non MI

Non MI MI Odds Ratio P

Pre-op Medication

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

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*Patients listed as contraindicated to a specific medication are excluded

Post-OP MI: Pre-Operative Testing

Pre-Operative Testing: Post-Op MI vs. Non MINon 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

Cardiac Stress Test 38% 29% 0.6 .183

Normal 64% 29% NA NA

Abnormal 36% 71% 0.2 .009

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Post-Op MI: Pre-Operative Patient History

Patient History Comparison: Hospitals with MI >3% and Hospitals with MI <= 3%

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Post-Op MI: Pre-Operative Medications

Pre-Op Medication Comparison: Hospitals with MI >3% and Hospitals with MI <= 3%

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POST-OPERATIVE TRANSFUSIONPOST-OPERATIVE TRANSFUSION

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Post-Operative Transfusion RateYE 2012, Q1/Q2 2013

Overall Transfusion Rate*All Procedures 516/2583 = 20.0% Non-Emergent Procedures 448/2471 = 17.7%

Patients transfused with hemoglobin > 8.0

152/448 = 33.9%

* Discharge level transfusion rates for Open Bypass, EVAR, and Open AAA – PRBCs only

Procedure Specific Transfusion RateOpen Bypass 364/1559 = 23.3%EVAR 87/857 = 11.9%Open AAA 65/167 = 40.1%

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Post-Operative Transfusion RateYE 2012, Q1/Q2 2013

Procedure Specific Transfusion Rate EVAR (All) 87/857 = 10.2%

Elective EVAR 61/806 = 7.6%Emergent/Rupture EVAR 26/51 = 51%

Open AAA (All) 65/167 = 38.9%Elective Open AAA 39/125 = 31.2%Emergent/Rupture Open AAA

26/42 = 61.9%

Open Bypass 364/1559 = 23.3%

* 2013 Discharge level rates for Open Bypass, EVAR, and Open AAA45

Predictors of Post-Operative Transfusion (Elective Procedures)

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Significant Variables (P-value < 0.1, Blue < 0.05)Variable Odds Ratio Lower Limit CI Upper Limit CIFemale Gender 2.146 1.503 3.063

Procedure Type Open Bypass (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

EBL 1.001 1.000 1.001AUC = 84.6% 448 Events YTD 2012, Q1/Q2 2013 (Excludes Emergent Procedures)

Pre-Procedure Variables in Transfusion Model

Gender Age BMI Ethnicity Renal Failure/Current Dialysis Renal Transplant Pre-Procedure Hemoglobin Pre-Procedure Creatinine Pre-Procedure Aspirin Pre-Procedure Clopidogrel Pre-Procedure Prasugrel Pre-Procedure Warfarin

CHF Ejection Fraction Significant Valve Disease COPD CVD/TIA CAD Prior PCI Prior MI Prior CABG Current/Recent GI Bleed Afib Other Atherosclerotic Disease

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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

Transfusion: Predictive Pre-Operative Variables

YE 2012, Q1/Q2 2013 (Excludes Emergent Procedures)

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Post-Op Transfusion: OE Plot (Blinded)

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Post-Operative Hemoglobin by Decile

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Vascular Surgery Survey Results

Do you transfuse at a threshold of:

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Do you use clinical parameters to decide when to transfuse in addition to Hgb? If so:

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Does your hospital employ techs, nurses, PAs or other professionals who obtain femoral artery

access in the cath lab?:

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In a patient with a post operative NSTEMI and Hgb = 9.5, would you transfuse?:

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In a post procedure patient with CAD and without symptoms of ischemia and a Hgb = 7.5,

would you transfuse this patient?

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VIC VASCULAR SURGERY GOALSVIC VASCULAR SURGERY GOALS

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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 post-

procedure hemoglobin > 8.0 to <= 10%

Post-Operative MI Reduce hospital post-operative MI rate to < 3%

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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 REPORT59

Pre-Operative Cardiac Clearance:

European Society of Cardiology

Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery

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Post-Op Transfusion

Goal – Establish Transfusion Guidelines for Vascular Surgery Patients Utilizing:

A. Dr. Carson’s ExpertiseB. Collaborative FeedbackC. Evidence-Based Literature/Data

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Welcome Dr. Carson

Jeffrey L Carson, MDVice Chair, ResearchRichard C Reynolds Professor of MedicineChief, Division of General Internal MedicineRutgers Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey 08901

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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

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BMC2 Vascular intervention collaborative October 2013

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