1. Larger Sheath Size for Infrainguinal Endovascular Intervention is Associated with Minor but Not Major Morbidity or Mortality
Scott R. Levin MD, Alik Farber MD, Daniel J. Bertges MD, Mead Ferris MD MS, Thomas W. Cheng MS, Nkiruka Arinze MD, Douglas W. Jones MD, Denis Rybin PhD, Jeffrey J. Siracuse, MD
Boston University School of Medicine
University of Vermont College of Medicine

2. Conflicts
None

3. Background
Access site hematomas are the most frequent complication of PVI, affecting 1-11%
Access site stenosis/occlusion occurs in 0.2%
Previous mostly single-center retrospective studies suggested fewer access site complications with smaller sheaths

4. Background Previous analyses had limitations: Broadly included
Infra- and suprainguinal arterial disease
Diagnostic and interventional procedures
Upper and lower extremity access sites
Antegrade and retrograde approaches  
Lacked risk-adjustment
Compared sheath sizes by subjective groupings
Inconsistently defined access site complications

5. Objectives
Investigate the effect of specific sheath sizes on outcomes after infrainguinal PVI via retrograde CFA access

6. Methods Study Design Data Source Sample Retrospective cohort study
VQI PVI registry ( )
Sample
Included infrainguinal PVI for occlusive disease via retrograde contralateral CFA access
Divided into cohorts corresponding to max sheath size

7. Methods Outcomes Variables Statistical Analysis
Primary: Access site hematoma, hematoma requiring intervention (thrombin injection/surgical treatment), stenosis/occlusion
Secondary: Post-procedural LOS > 1 day and 30-day mortality  
Variables
Demographics, medical history, procedural characteristics
Statistical Analysis 
One-way ANOVA and c2 test
Propensity score matching
Multivariable logistic regression

8. Sheath Distribution

9. Characteristics: Unmatched Cohorts
Select Characteristics
Overall N=36901
7 Fr
N= (14.1%)
6 Fr
N=24541
(66.5 %)
5 Fr
N=6221
(16.9%)
4 Fr N=914
(2.5%)
P- value
Age, years
69 ± 11.6
68.2 ± 11.2
69.2 ± 11.6
69.1 ± 12
69.5 ± 12.1
<.001
Female gender
15100 (40.9%)
1874 (35.9%)
10268 (41.8%)
2568 (41.3%)
390 (42.7%)
White race
27492 (74.5%)
4195 (80.3%)
18336 (74.7%)
4310 (69.3%)
651 (71.2%)
Ambulatory
26707 (72.6%)
4190 (80.4%)
17649 (72.1%)
4288 (69.1%)
580 (63.6%)
Diabetes
22050 (59.8%)
2783 (53.3%)
14608 (59.5%)
4035 (64.9%)
624 (68.3%)
ESRD
4072 (11%)
387 (7.4%)
2657 (10.8%)
861 (13.8%)
167 (18.3%)
Prior ipsilateral stent
4306 (11.7%)
666 (12.8%)
2831 (11.5%)
720 (11.6%)
89 (9.8%)
Anticoagulant
5251 (14.2%)
647 (12.4%)
3479 (14.2%)
979 (15.7%)
146 (16%)
Claudication
15367 (41.6%)
2957 (56.6%)
10286 (41.9%)
1921 (30.9%)
203 (22.2%)
Rest pain
4868 (13.2%)
717 (13.7%)
3254 (13.3%)
757 (12.2%)
140 (15.3%)
 <.001
Tissue loss
16666 (45.2%)
1551 (29.7%)
11001 (44.8%)
3543 (57%)
571 (62.5%)
Fem-pop intervention
31240 (84.7%)
4998 (95.7%)
21403 (87.2%)
4268 (68.6%)
Tibial intervention
13072 (35.4%)
1309 (25.1%)
8130 (33.1%)
3132 (50.3%)
501 (54.8%)
Stent
14447 (39.2%)
1803 (34.5%)
10989 (44.8%)
1554 (25%)
101 (11.1%)
Atherectomy
7843 (21.3%)
3132 (59.9%)
3946 (16.1%)
698 (11.2%)
67 (7.3%)
Closure device use
23490 (63.7%)
3558 (68.2%)
16143 (65.9%)
3634 (58.5%)
155 (17%)
Select Characteristics
Overall N=36901
7 Fr
N= (14.1%)
6 Fr
N=24541
(66.5 %)
5 Fr
N=6221
(16.9%)
4 Fr N=914
(2.5%)
P- value
Age, years
69 ± 11.6
68.2 ± 11.2
69.2 ± 11.6
69.1 ± 12
69.5 ± 12.1
<.001
Female gender
15100 (40.9%)
1874 (35.9%)
10268 (41.8%)
2568 (41.3%)
390 (42.7%)
White race
27492 (74.5%)
4195 (80.3%)
18336 (74.7%)
4310 (69.3%)
651 (71.2%)
Ambulatory
26707 (72.6%)
4190 (80.4%)
17649 (72.1%)
4288 (69.1%)
580 (63.6%)
Diabetes
22050 (59.8%)
2783 (53.3%)
14608 (59.5%)
4035 (64.9%)
624 (68.3%)
ESRD
4072 (11%)
387 (7.4%)
2657 (10.8%)
861 (13.8%)
167 (18.3%)
Prior ipsilateral leg stent
4306 (11.7%)
666 (12.8%)
2831 (11.5%)
720 (11.6%)
89 (9.8%)
Anticoagulant
5251 (14.2%)
647 (12.4%)
3479 (14.2%)
979 (15.7%)
146 (16%)
Claudication
15367 (41.6%)
2957 (56.6%)
10286 (41.9%)
1921 (30.9%)
203 (22.2%)
Rest pain
4868 (13.2%)
717 (13.7%)
3254 (13.3%)
757 (12.2%)
140 (15.3%)
 <.001
Tissue loss
16666 (45.2%)
1551 (29.7%)
11001 (44.8%)
3543 (57%)
571 (62.5%)
Fem-pop intervention
31240 (84.7%)
4998 (95.7%)
21403 (87.2%)
4268 (68.6%)
Tibial intervention
13072 (35.4%)
1309 (25.1%)
8130 (33.1%)
3132 (50.3%)
501 (54.8%)
Stent
14447 (39.2%)
1803 (34.5%)
10989 (44.8%)
1554 (25%)
101 (11.1%)
Atherectomy
7843 (21.3%)
3132 (59.9%)
3946 (16.1%)
698 (11.2%)
67 (7.3%)
Closure device use
23490 (63.7%)
3558 (68.2%)
16143 (65.9%)
3634 (58.5%)
155 (17%)
Outcome
Any hematoma
1019 (2.8%)
182 (3.5%)
673 (2.7%)
153 (2.5%)
11 (1.2%)
Hematoma requiring intervention
153 (.4%)
22 (.4%)
99 (.4%)
30 (.5%)
2 (.2%)
.656
Stenosis/occlusion
93 (.3%)
6 (.1%)
62 (.3%)
3 (.3%)
.083
Post-procedural LOS >1 day
9338 (25.3%)
947 (18.1%)
6201 (25.3%)
1935 (31.1%)
255 (27.9%)
30-day mortality
506 (1.4%)
45 (.9%)
352 (1.4%)
95 (1.5%)
14 (1.5%)
.007

10. Outcomes: Unmatched Cohorts
Overall N=36901
7 Fr
N= (14.1%)
6 Fr
N=24541
(66.5 %)
5 Fr
N=6221
(16.9%)
4 Fr N=914
(2.5%)
P- value
Any hematoma
1019 (2.8%)
182 (3.5%)
673 (2.7%)
153 (2.5%)
11 (1.2%)
<.001
Hematoma requiring intervention
153 (.4%)
22 (.4%)
99 (.4%)
30 (.5%)
2 (.2%)
.656
Stenosis/occlusion
93 (.3%)
6 (.1%)
62 (.3%)
3 (.3%)
.083
Post-procedural
LOS >1 day
9338 (25.3%)
947 (18.1%)
6201 (25.3%)
1935 (31.1%)
255 (27.9%)
30-day mortality
506 (1.4%)
45 (.9%)
352 (1.4%)
95 (1.5%)
14 (1.5%)
.007

11. Outcomes: 1:1 Matched Cohorts
Overall N=2032
7 Fr N=508
6 Fr N=508
5 Fr N=508
4 Fr N=508
P- value
Any hematoma
47 (2.3%)
17 (3.3%)
8 (1.6%)
5 (1%)
.019
Hematoma requiring intervention
6 (.3%)
3 (.6%)
2 (.4%)
0 (0%)
1 (.2%)
.342
Stenosis/occlusion
8 (.4%)
.799
Total LOS
(mean ± SD)
4 ± 8.8
3.4 ± 11.4
4.3 ± 8.4
4.3 ± 7.8
3.9 ± 7.2
.335
Post-procedural
LOS > 1 day
620 (30.5%)
163 (32.1%)
176 (34.6%)
162 (31.9%)
119 (23.4%)
.001
30-day mortality
33 (1.6%)
10 (2%)
9 (1.8%)
6 (1.2%)
.782

12. Multivariable Analysis
Any Hematoma OR
95% CI
P-value
7 Fr sheath
4.24
<.001
6 Fr sheath
3.11
5 Fr sheath
2.72
.002
Adjusted for female gender, white race, protamine use, age, prior leg stent, discharge statin, diabetes, closure device use, pre-procedural statin, rest pain, urgency, CHF, pre-procedural aspirin, intra-procedural stent, tissue loss
Hematoma Requiring Intervention OR
95% CI 
P-value
7 Fr Sheath
4.29
.054
6 Fr Sheath
2.92
.137
5 Fr Sheath 3
.135
Adjusted, for pre-procedural anticoagulant, female gender, discharge aspirin, urgency, age, tissue loss, atherectomy, discharge statin, closure device use, pre-procedural statin, renal failure, CHF, protamine use, COPD, non-ambulatory, CAD, prior leg stent, rest pain

13. Multivariable Analysis
Post-Procedural LOS > 1 Day OR
95% CI 
P-value
7 Fr Sheath
4.29
.054
6 Fr Sheath
2.92
.137
5 Fr Sheath 3
.135
Adjusted, for pre-procedural anticoagulant, female gender, discharge aspirin, urgency, age, tissue loss, atherectomy, discharge statin, closure device use, pre-procedural statin, renal failure, CHF, protamine use, COPD, non-ambulatory, CAD, prior leg stent, rest pain
30-Day Mortality OR
95% CI
P-value
7 Fr sheath
.74
.349
6 Fr sheath
.99
.984
5 Fr sheath
.91
.755
Adjusted for tissue loss, rest pain, renal failure, pre-procedural aspirin, urgent, pre-procedural anticoagulant, non-ambulatory, pre-procedural statin, CHF, CAD, white race, pre-procedural P2Y12 antagonist, COPD, number of arteries treated, age, tibial intervention, discharge P2Y12 antagonist, discharge anticoagulant, discharge aspirin, discharge statin, prior inflow stent, prior smoking, obesity, prior leg stent, current smoking

14. Conclusions
Larger sheaths for infrainguinal PVI were associated with increased minor access site hematomas, however there was no association with major morbidity or mortality
Longer post-procedural LOS more likely with larger sheaths, possibly related to conservative treatment of hematomas