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