Abstract
Objective:
Antegrade femoral artery access is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CD) for antegrade access (AA) is still considered outside the instructions for use for most devices. We hypothesized that CD use for antegrade femoral access would not be associated with an increased odds of access site complications.
Methods:
The Vascular Quality Initiative was queried from 2010 to 2019 for infrainguinal peripheral vascular interventions performed via femoral AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce imbalance between the groups.
Results:
Overall, 11,562 cases were identified and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have coronary artery disease (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P < .05). CD patients were more likely to be obese (31.6% vs 27.0%), have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 ± 1.0 F vs 5.5 ± 1.0 F; P < .05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P < .01) or a hematoma requiring reintervention (0.63% vs 1.26%; P < .01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P = .47) compared with no CD. On multivariable analysis, CD cases had significantly decreased odds of developing any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59–0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38–0.81). A sensitivity analysis after coarsened exact matching confirmed these findings.
Conclusions:
In this nationally representative sample, CD use for AA was associated with a lower odds of hematoma in selected patients. Extending the instructions for use indications for CDs to include femoral AA may decrease the incidence of access site complications, patient exposure to reintervention, and costs to the health care system.
Keywords: Closure devices, Antegrade access, Femoral access, Access site complications
Although retrograde access (RA) is more commonly used, lower extremity disease may be safely treated with ipsilateral femoral artery antegrade access (AA).1,2 AA plays an important role in patients with a narrow or heavily calcified aortic bifurcation, prior aortoiliac or aortofemoral bypass, aortic stent graft, bilateral kissing iliac stents with a raised bifurcation, and patients with tortuous iliofemoral anatomy that makes crossing the aortic bifurcation challenging.3–5 Although femoral AA can be more technically difficult than RA, and certain patient factors such as obesity may preclude the use of AA, AA has been reported to have a similar incidence of access site complications compared with RA.6,7
Arterial access closure devices (CD) allow for expedient closure, avoidance of prolonged manual compression, decreased operating room or angiosuite use, and improved patient satisfaction after peripheral vascular intervention (PVI).8 However, the instructions for use (IFU) for most CDs indicate their use only for femoral RA. An abundance of data exists supporting the use of CDs for femoral artery access; however, these studies do not differentiate between patients with RA vs AA.8,9 Although prima facie it seems unlikely that CDs would function differently whether access was retrograde or antegrade, this finding has yet to be described in a large cohort.
The objective of this study was to examine the association of CD use in femoral AA with access site complications, including hematoma, stenosis, or occlusion. We hypothesized that CD use would demonstrate no difference in the incidence of access site complications compared with no CD use.
METHODS
Prospectively collected data from the 2010 to 2019 Society for Vascular Surgery Vascular Quality Initiative (VQI) infrainguinal PVIs database was retrospectively analyzed. The VQI has been previously described in the literature.10 Briefly, the VQI is a national quality improvement database that collects patient-level data on commonly performed vascular procedures, including in-hospital and long-term outcomes. Data are entered by participating hospitals and are available to participating institutions after submission and approval of a written data request. All variables used in this study had a missingness of less than 10%. Missing data were grouped with the referent group to create a conservative estimate for all independent variables. These data were deidentified and did not include any protected health information, which is therefore not considered human research, is exempt from institutional review board approval, and does not require informed consent.
All patients undergoing an infrainguinal PVI with femoral AA were included (Fig). Patients who had a femoral artery cutdown, upper extremity access, or access site other than the femoral artery were excluded. Patients with multiple access sites (ie, bilateral femoral or femoral and upper extremity) were excluded as well, owing to the inability to determine the location of the access site complication.
Fig.
Cohort inclusion criteria. PVI, Peripheral vascular intervention; SVS, Society for Vascular Surgery; VQI, Vascular Quality Initiative.
The primary outcomes were periprocedural access site complications, which included the development of an access site hematoma or access site stenosis or occlusion as defined in the VQI. The secondary outcome was periprocedural development of an access site hematoma requiring an intervention, which was defined as transfusion to treat associated blood loss, thrombin injection, or surgical repair.
Demographic variables examined included age, sex, white race, preoperative ambulatory status (independent or with assistance), Medicare/Medicaid as primary insurer, obesity (body mass index ≥30 kg/m2), current smoking status, coronary artery disease (CAD), hypertension, diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, or dialysis (functioning renal transplant or on hemodialysis or peritoneal dialysis), and preoperative medications (angiotensin-converting enzyme inhibitor, aspirin, statin, P2Y12 inhibitors, and anticoagulant [warfarin, direct thrombin inhibitors, or factor Xa inhibitors]). Prior operative history included history of coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), carotid endarterectomy, carotid artery stent, major amputation (below knee or proximal amputation), inflow stent, angioplasty, or bypass, and infrainguinal stent, angioplasty, or bypass. Procedural details that were examined included elective operation, indication for procedure, right-sided access, ultrasound-guided access, largest sheath used, amount of contrast, and heparin reversal with protamine.
There were a total of seven unique CDs registered in this cohort: Perclose (Abbott, Santa Clara, Calif), Starclose (Abbott), Mynx (Cardinal Health, Dublin, Ohio), Angioseal (Terumo, Somerset, NJ), Femoral Introducer Sheath & Hemostasis (Morris Innovative, Bloomington, Ind), ExoSeal Vascular Closure System (Cordis, Santa Clara, Calif), TR Band (Terumo), and other. Consistent with the VQI Society for Vascular Surgery Device Identification Policy, the identities of the individual CDs were blinded, and analysis was constrained to CDs as a whole.
Statistical analysis.
All statistical analyses were performed using STATA version 15.0 (StataCorp, College Station, Tex). Cases were then stratified into whether a CD was used or not. Summary statistics were reported using mean and standard deviation for continuous variables, along with frequency and percentage for categorical variables. Between group differences were calculated using a χ2 test for categorical variables and a two-tailed Student t-test for continuous variables. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. Variables returning a P value of less than .10 on univariate analyses progressed to inclusion in the multivariable models. The models were constructed in a stepwise manual method using a P value of less than .05 for retention in the models.
To decrease imbalance and bias associated with observational data, the two groups (CD and no CD) were then matched on aspirin use and baseline demographics, comorbidities, operative history, and procedural details that differed on baseline analyses (P < .05) using coarsened exact matching (CEM).11 In brief, CEM organizes variables to discrete values using a binning strategy. Each participant is then assigned a bin signature, which is used to match between groups. CEM reduces imbalance, model dependence, estimation error, researcher bias, and variance between groups. This decrease in imbalance is denoted by the L1 statistic; imbalance decreases as the L1 statistic declines. Sensitivity analyses then assessed the association between CDs and the outcomes of interest after CEM.
RESULTS
Overall, 164,532 cases of infrainguinal PVI were identified and 11,562 patients (7.0%) had isolated percutaneous AA (Fig). Of these, a CD was used in 5693 cases (49.2%) (Table I). Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have CAD (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P < .05). CD use was associated with obesity (31.6% vs 27.0%), elective operations (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 ± 1.0 F vs 5.5 ± 1.0 F; P < .05 for all; Table II).
Table I.
Baseline characteristics
| Characteristics | CD (n = 5693) | No CD (n = 5869) | P valuea |
|---|---|---|---|
| Demographics | |||
| Age, years | .077 | ||
| <60 | 1146 (20.1) | 1090 (18.6) | |
| 60–69 | 1539 (27.0) | 1554 (26.5) | |
| 70–79 | 1635 (28.7) | 1724 (29.4) | |
| ≥80 | 1373 (24.1) | 1501 (25.6) | |
| Female sex | 1866 (32.8) | 1984 (33.8) | .244 |
| White | 4221 (74.1) | 4683 (79.8) | <.001 |
| Ambulatory | 4220 (74.1) | 4441 (75.2) | .207 |
| Medicare/Medicaid | 3577 (67.9) | 3429 (66.4) | .128 |
| Comorbidities | |||
| Obese | 1799 (31.6) | 1586 (27.0) | <.001 |
| Current smoker | 1425 (25.0) | 1382 (23.6) | .065 |
| CAD | 1690 (29.7) | 1958 (33.4) | <.001 |
| Prior CABG or PCI | 1868 (32.8) | 2082 (35.5) | .003 |
| Prior CEA or CAS | 157 (2.8) | 147 (2.5) | .416 |
| Hypertension | 4981 (87.5) | 5190 (88.4) | .123 |
| Diabetes | 3330 (58.5) | 3385 (57.7) | .376 |
| Congestive heart failure | 1226 (21.5) | 1398 (23.8) | .003 |
| COPD | 1205 (21.2) | 1228 (20.9) | .749 |
| Dialysis | 754 (13.2) | 828 (14.0) | .233 |
| Preoperative medications | |||
| ACE inhibitor | 2573 (45.2) | 2466 (42.0) | .001 |
| Aspirin | 3908 (68.7) | 4251 (72.4) | <.001 |
| Anticoagulant | 97 (1.7) | 94 (1.6) | .715 |
| P2Y12 inhibitor | 2432 (42.7) | 2438 (41.5) | .200 |
| Statin | 3789 (66.6) | 4044 (68.9) | .007 |
ACE, Angiotensin-converting enzyme; CABG, coronary artery bypass graft; CAD, coronary artery disease; CAS, carotid artery stent; CD, closure device; CEA, carotid endarterectomy, COPD, chronic obstructive pulmonary disease; PCI, percutaneous coronary intervention.
Values are number (%). Boldface entries indicate statistical significance (P < .05).
Calculated using a χ2 test for categorical variables and a Student t-test for continuous variables.
Table II.
Procedural details
| Characteristics | CD (n = 5693) | No CD (n = 5869) | P valuea |
|---|---|---|---|
| Operative history | |||
| Prior major amputation (ipsilateral or contralateral) | 870 (15.3) | 1118 (19.1) | <.001 |
| Prior inflow stent or angioplasty | <.001 | ||
| None | 4989 (87.6) | 4990 (85.0) | |
| Ipsilateral | 222 (3.9) | 247 (4.2) | |
| Contralateral | 177 (3.1) | 216 (3.7) | |
| Bilateral | 305 (5.4) | 416 (7.1) | |
| Prior inflow bypass | <.001 | ||
| None | 5429 (95.4) | 5483 (93.4) | |
| Ipsilateral | 74 (1.3) | 81 (1.4) | |
| Contralateral | 52 (0.9) | 58 (1.0) | |
| Bilateral | 138 (2.4) | 247 (4.2) | |
| Prior infrainguinal stent or angioplasty | .001 | ||
| None | 3436 (60.4) | 3338 (56.9) | |
| Ipsilateral | 1067 (18.7) | 1237 (21.1) | |
| Contralateral | 657 (11.5) | 698 (11.9) | |
| Bilateral | 533 (9.4) | 596 (10.2) | |
| Prior infrainguinal bypass | <.001 | ||
| None | 5088 (89.4) | 4918 (83.8) | |
| Ipsilateral | 228 (4.0) | 335 (5.7) | |
| Contralateral | 284 (5.0) | 435 (7.4) | |
| Bilateral | 93 (1.6) | 181 (3.1) | |
| Procedural details | |||
| Elective | 4703 (82.6) | 4703 (80.1) | .001 |
| Indication | <.001 | ||
| Occlusive disease | 5105 (89.7) | 5509 (93.9) | |
| Aneurysm | 231 (4.1) | 105 (1.8) | |
| Occlusive or aneurysm | 40 (0.7) | 24 (0.4) | |
| None/unknown | 317 (5.6) | 231 (3.9) | |
| Right-sided access | 3105 (54.5) | 3168 (54.0) | .550 |
| Ultrasound guidance | 4299 (75.5) | 3556 (60.6) | <.001 |
| Largest sheath size, F | 6.0 ± 1.0 | 5.5 ± 1.0 | <.001 |
| Contrast, mL | 76.6 ± 51.4 | 77.6 ± 53.3 | .317 |
| Protamine | 883 (15.5) | 1505 (25.6) | <.001 |
CD, Closure device.
Values are mean ± standard deviation or number (%). Boldface entries indicate statistical significance (P < .05).
Calculated using a χ2 test for categorical variables and a Student t-test for continuous variables.
CD cases were less likely to develop an access site hematoma (2.55% vs 3.53%; P = .002) or a hematoma requiring reintervention (0.63% vs 1.26%; P = .001) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P = .467) compared with no CD (Table III). On multivariable adjusted analysis, patients treated with a CD had significantly decreased odds of developing any access site hematoma (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.59–0.95; Table IV) and a hematoma requiring intervention (OR, 0.56; 95% CI, 0.38–0.81; Table V). Consistent with baseline analyses, there was no significant association between CD and access site stenosis or occlusion on multivariable analysis (Table VI).
Table III.
Access site complications
| Access site complications | CD (n = 5693) | No CD (n = 5869) | P valuea |
|---|---|---|---|
| Hematoma | .004 | ||
| No | 5548 (97.5) | 5662 (96.5) | |
| Minor | 109 (1.91) | 133 (2.27) | |
| Transfusion | 20 (0.35) | 39 (0.66) | |
| Thrombin injection | 3 (0.05) | 12 (0.20) | |
| Operative treatment | 13 (0.23) | 23 (0.39) | |
| Any hematoma | 145 (2.55) | 207 (3.53) | .002 |
| Hematoma requiring intervention | 36 (0.63) | 74 (1.26) | .001 |
| Access site stenosis or occlusion | 17 (0.30) | 13 (0.22) | .467 |
CD, Closure device.
Values are number (%). Boldface entries indicate statistical significance (P < .05).
Calculated using a χ2 test.
Table IV.
Multivariable analysis of any access site hematoma
| Covariates | OR | 95% CI | P value |
|---|---|---|---|
| CD | 0.75 | 0.59–0.95 | .018 |
| Age, years: Ref <60 | |||
| 60–69 | 0.76 | 0.50–1.14 | .180 |
| 70–79 | 1.48 | 1.06–2.08 | .022 |
| >80 | 1.75 | 1.24–2.46 | .001 |
| Female sex | 1.50 | 1.21–1.86 | <.001 |
| Prior inflow stent or angioplasty: Ref none | |||
| Ipsilateral | 1.68 | 1.12–2.53 | .012 |
| Contralateral | 1.17 | 0.68–2.02 | .571 |
| Bilateral | 1.35 | 0.94–1.96 | .105 |
| Prior infrainguinal bypass: Ref none | |||
| Ipsilateral | 1.47 | 0.96–2.24 | .074 |
| Contralateral | 1.64 | 1.12–2.42 | .012 |
| Bilateral | 1.02 | 0.46–2.25 | .959 |
| Contrast, mL | 1.002 | 1.000–1.005 | .027 |
| Elective | 0.75 | 0.59–0.96 | .022 |
| Diabetes | 0.70 | 0.55–0.88 | .003 |
| Prior major amputation (ipsilateral or contralateral) | 0.70 | 0.51–0.96 | .027 |
CD, Closure device; CI, confidence interval; OR, odds ratio.
Boldface entries indicate statistical significance (P < .05).
Table V.
Multivariable analysis of access site hematoma requiring intervention
| Covariates | OR | 95% CI | P value |
|---|---|---|---|
| CD | 0.56 | 0.38–0.81 | .002 |
| Age, years: Ref <60 | |||
| 60–69 | 0.96 | 0.44–2.08 | .918 |
| 70–79 | 2.46 | 1.31–4.61 | .005 |
| >80 | 2.67 | 1.36–5.22 | .004 |
| Prior infrainguinal bypass: Ref none | |||
| Ipsilateral | 1.94 | 0.96–3.90 | .063 |
| Contralateral | 1.87 | 1.04–3.35 | .037 |
| Bilateral | 2.48 | 1.11–5.50 | .026 |
| Female sex | 1.99 | 1.34–2.97 | .001 |
| Congestive heart failure | 1.72 | 1.11–2.68 | .016 |
| Elective | 0.56 | 0.35–0.89 | .015 |
CD, Closure device; CI, confidence interval; OR, odds ratio.
Boldface entries indicate statistical significance (P < .05).
Table VI.
Multivariable analysis of access site stenosis or occlusion
| Covariates | OR | 95% CI | P value |
|---|---|---|---|
| CD | 1.43 | 0.60–3.39 | .414 |
| Prior CABG or PCI | 2.65 | 1.35–5.21 | .005 |
| Elective | 0.32 | 0.14–0.72 | .006 |
CABG, Coronary artery bypass graft; CI, confidence interval; OR, odds ratio; PCI, percutaneous coronary intervention.
Boldface entries indicate statistical significance (P < .05).
Using CEM, the groups were then matched on white race, obesity, CAD, congestive heart failure, aspirin use, elective status, ultrasound guidance, largest sheath size used, heparin reversal with protamine, and prior CABG or PCI, major amputation, inflow stent, angioplasty, or bypass, and infrainguinal stent, angioplasty, or bypass. Prematching imbalance of L1 = 0.65 decreased post-match to an imbalance of L2 = 0.03, which indicated a decreased imbalance between the groups. After CEM, 5975 total cases were included, and a CD was used in 3273 cases (Supplementary Tables I and II, online only). Although differences between groups were still appreciated among some variables, the degree of differences were smaller than before CEM. Sensitivity analyses after CEM confirmed associations between CD use and any access site hematoma (OR, 0.74; 95% CI, 0.54–1.00) and access site hematoma requiring intervention (OR, 0.54; 95% CI, 0.29–0.99; Table VII).
Table VII.
Multivariable analysis of access complications with matched data comparing the use of closure devices (CD)a
| Complication | OR | 95% CI | P value |
|---|---|---|---|
| Any hematomab | 0.74 | 0.54–1.00 | .053 |
| Hematoma requiring interventionc | 0.54 | 0.29–0.99 | .047 |
| Stenosis or occlusiond | 0.97 | 0.28–3.42 | .963 |
CABG, Coronary artery bypass graft; CI, confidence interval; CHF, congestive heart failure; OR, odds ratio; PCI, percutaneous coronary intervention.
Boldface entries indicate statistical significance (P < .05).
Matched for white race, obesity, coronary artery disease, CHF, aspirin use, elective procedure, ultrasound guidance, largest sheath size used, heparin reversal with protamine, and prior CABG or PCI, major amputation, inflow stent or angioplasty, inflow bypass, infrainguinal stent or angioplasty, and infrainguinal bypass.
Adjusted for age, sex, elective operation, volume of contrast used, history of diabetes, prior major amputation, prior inflow stent or angioplasty, and prior infrainguinal bypass.
Adjusted for age, sex, elective operation, CHF, and prior infrainguinal bypass.
Adjusted for elective operation and history of CABG or PCI.
DISCUSSION
In this nationally representative surgical quality improvement database, CD use for femoral AA was associated with lower odds of any access site hematoma and hematoma requiring intervention when compared with no CD use. Although the overall incidence of access site stenosis or occlusion was generally low (0.26%), the use of a CD was not associated with an increased odds for stenosis or occlusion. These results collectively suggest that CDs may be safely used for femoral AA and may improve access site outcomes and the incidence of complications in selected cases.
On baseline analyses, patients who were treated with a CD had a higher proportion of obesity, which has previously been reported to independently predict access site complications in patients undergoing antegrade PVI, even when a CD was used.12 The burden of overall atherosclerotic disease was lower in the CD group compared with the no CD group, as indicated by a lower proportion of patients with a history of CAD, CABG, PCI, major amputation, and previous inflow or infrainguinal stent, angioplasty, or bypass. Patients receiving an intervention owing to occlusive disease were also less likely to be treated with a CD. This finding likely represents a hesitancy to use a CD in atherosclerotic or stenosed vessels, because deployment is anecdotally more challenging. Reports suggest that CDs have similar efficacy and rates of complications in patients with peripheral artery disease or calcified plaque.13–16 CDs had a lower proportion of patients treated with aspirin, which may be protective against postoperative hematoma, but they also had a 10% lower rate of heparin reversal with protamine.
Patients treated with a CD had a larger mean sheath size, which has been reported to be independently associated with access site complications after femoral RA and AA.17,18 Patients treated with a CD were also 15% more likely to have had ultrasound-guided access, which has been reported to be protective from access site complications.19,20 After CEM, differences in baseline characteristics, including a history of previous inflow or infrainguinal stent, angioplasty, or bypass, indication for intervention, ultrasound guidance, largest sheath size, and heparin reversal with protamine were ameliorated and the results of the multivariable models remained largely unchanged.
Cragg et al21 reported in a prospective study of 556 patients undergoing femoropopliteal angioplasty that compared with femoral RA, AA did not have a significantly higher rate of access site complications (AA, 3.7% vs RA, 1.1%; P = .186), which were defined as retroperito-neal hematoma, pseudoaneurysm, hematoma requiring transfusion, arteriovenous fistula formation, acute thrombosis, and need for surgical repair. Although not statistically significant, Cragg et al21 also reported fewer access site complications in patients treated with CDs. Siracuse et al7 also reported no difference in access site complications, including hematoma, between femoral RA and AA, although this study did not report on the use of CDs.
Owing to the VQI device identification policy, the identities of the individual devices were unable to be determined in the current study. However, previous reports support the feasibility and safety of the use of a wide range of CDs for femoral AA.22 Duda et al23 examined the use of suture-mediated CDs, Techstar and Prostar Plus devices (Abbott) in 80 patients undergoing femoropopliteal angioplasty and reported an access site hematoma rate of 5%.23 Collagen- and polyethylene glycol plug-mediated CDs have also been reported to perform adequately in femoral AA. In 2374 diabetic patients with critical limb ischemia, the use of the Angio-Seal CD for femoral AA was associated with the lowest rate of major access-site complications (20/1889 [1.1%]) compared with RA Angio-Seal use (5/278 [1.8%]) and manual compression (4/205 [2.0%]).24 Pruski et al25 reported a 95% (63/66) procedure success rate and no major access site complications after using the Mynx CD for femoral AA for PVI. However, it is important to note that the Angio-Seal device is the only CD that includes use for AA in the IFU.
The ExoSeal Vascular Closure System is the most studied CD for femoral AA, although the studies are limited by small sample sizes. Boschewitz et al26 reported a 98% (145/148) technical success using the ExoSeal, no major access site complications, and a single occurrence of an access site hematoma of less than 3 cm (1/148 [0.7%]). However, there was a significant association (P < .05) between preoperative aspirin, clopidogrel, and abciximab use with requiring additional manual compression for hemostasis.26 In the current study, no preoperative medications were associated with access site hematoma and were therefore not included in the multivariable models. In two other studies using the ExoSeal CD for femoral AA, rates of postoperative hematoma were 3.4% (2/59) and 5.4% (9/168).27,28 Similar to the previously mentioned studies, the use of the Starclose CD has also been reported to be safe and efficacious in femoral AA, which was demonstrated in 30 patients with critical limb ischemia who underwent peripheral angioplasty.29
The data reported in this study suggest that CDs decrease hematoma formation without increasing vessel stenosis when deployed for femoral AA closure, which is consistent with the results reported in other studies. However, this is the largest and most nationally representative sample size studied to date. Using CDs for femoral AA may decrease access site complications and operating room use.
Limitations.
This study has limitations. Although data in the VQI are collected prospectively, this was a retrospective review of a large database. Although the VQI collects data on the development of access site arteriovenous fistula and pseudoaneurysms, these variables were very poorly reported with a missing rate of more than 60%. This study therefore cannot make any meaningful conclusions on the effect of CDs on access site arteriovenous fistula or pseudoaneurysm. The VQI does collect data on failed CD deployment attempts but the variable had only started to be recorded in 2015 and is very poorly reported (<50%) in the years that it was collected and was therefore not included in this study. Therefore, we cannot accurately determine the rate of CD deployment failure. However, because patients with femoral artery cut-downs were excluded from this study, that would include patients who had failed CD deployment and required a cutdown to salvage. Owing to the way the VQI PVI data are organized, this study did not include patients with multiple access sites (ie, bilateral femoral or femoral and upper extremity). Owing to the VQI device identification policy, the identities of the individual CDs were unable to be determined and analyses were only able to be completed using an aggregate CD variable. It is possible that only certain CDs, or that certain forms of CDs (ie, suture mediated or collagen mediated), may confer a lesser odds of access site hematoma. Although, owing to the low incidence of access site complications, even if CD identities were known, analyses of individual devices would likely be limited by low power. Further study of these individual devices will be required before making formal changes to the IFU.
Analyses of access site stenosis or occlusion are likely underpowered as the incidence of complication was low (only 30 total recorded cases). Access site stenosis or occlusion may also be underreported since it may not present acutely or be initially symptomatic and would therefore not be recorded in the VQI. Last, because the VQI does not collect long-term follow-up data on access site complications, all of the data presented in this study represents periprocedural outcomes and conclusions cannot be made regarding the long-term impact of CDs.
CONCLUSIONS
In this nationally representative sample, the use of CDs for AA was associated with a lower odds of postoperative hematoma and hematoma requiring reintervention. CDs for AA may improve access site outcomes with a commensurate increase in patient satisfaction and cost savings to the health care system.
Supplementary Material
ARTICLE HIGHLIGHTS.
Type of Research: Retrospective analysis of prospectively collected registry data from the Vascular Quality Initiative
Key Findings: Closure device (CD) use for antegrade femoral artery access in 5693 infrainguinal peripheral vascular interventions was independently associated with a decreased odds for developing any access site hematoma (odds ratio, 0.75) or a hematoma requiring intervention (odds ratio, 0.56), and was not associated with access site stenosis or occlusion compared with no CD.
Take Home Message: The use of CDs for antegrade femoral artery access is safe, efficacious, and associated with a decreased odds of access site hematoma.
Acknowledgments
Supported by institutional start-up funds (J.C.I.) with additional student research support from the Society for Vascular Surgery Student Research Fellowship Award and the American Heart Association Student Scholarship (J.L.R.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Society for Vascular Surgery or American Heart Association. The funding organizations were not involved in the design and conduct of the study, collection, management, analysis, and interpretation of the data, or preparation, review or approval of the manuscript.
Footnotes
Presented at the Thirty-fourth Annual Meeting of the Western Vascular Society, Maui, Hawaii, September 28 to October 1, 2019.
Additional material for this article may be found online at www.jvascsurg.org.
The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
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