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

Conflicts None

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

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

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

Methods Study Design Data Source Sample Retrospective cohort study VQI PVI registry (2010-2017) Sample Included infrainguinal PVI for occlusive disease via retrograde contralateral CFA access Divided into cohorts corresponding to max sheath size

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

Sheath Distribution

Characteristics: Unmatched Cohorts Select Characteristics Overall N=36901 7 Fr N=5225 (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=5225 (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

Outcomes: Unmatched Cohorts Overall N=36901 7 Fr N=5225 (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

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

Multivariable Analysis Any Hematoma   OR 95% CI P-value 7 Fr sheath 4.24 2.28 - 7.89 <.001 6 Fr sheath 3.11 1.69 - 5.7 5 Fr sheath 2.72 1.46 - 5.05 .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 .98 - 18.8 .054 6 Fr Sheath 2.92 .71 - 11.97 .137 5 Fr Sheath 3 .71 - 12.68 .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

Multivariable Analysis Post-Procedural LOS > 1 Day   OR 95% CI  P-value 7 Fr Sheath 4.29 .98 - 18.8 .054 6 Fr Sheath 2.92 .71 - 11.97 .137 5 Fr Sheath 3 .71 - 12.68 .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 .39 - 1.4 .349 6 Fr sheath .99 .57 - 1.73 .984 5 Fr sheath .91 .51 - 1.64 .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

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