Objectives

We sought to develop a prediction score with data from the Vascular Quality Initiative (VQI) EVAR in efforts to assist endovascular specialists in deciding whether or not a patient is appropriate for short-stay discharge.

Background

Small series describe short-stay discharge following elective EVAR. Our study aims to quantify characteristics associated with this decision.

Methods

The VQI EVAR and NSQIP datasets were queried. Patients who underwent elective EVAR recorded in VQI, between 1/2010-5/2017 were split 2:1 into test and analytic cohorts via random number assignment. Cross-reference with the Medicare claims database confirmed all-cause mortality data. Bootstrap sampling was employed in model. Deep learning algorithms independently evaluated each dataset as a sensitivity test.

Results

Univariate outcomes, including 30-day survival, were statistically worse in the DD group when compared to the SD group (all P < 0.05). A prediction score, SD-EVAR, derived from the VQI EVAR dataset including pre- and intra-op variables that discriminate between SD and DD was externally validated in NSQIP (Pearson correlation coefficient = 0.79, P < 0.001); deep learning analysis concurred. This score suggests 66% of EVAR patients may be appropriate for short-stay discharge. A free smart phone app calculating short-stay discharge potential is available through QxMD Calculate https://qxcalc.app.link/vqidis.

Conclusions

Selecting patients for short-stay discharge after EVAR is possible without increasing harm. The majority of infrarenal AAA patients treated with EVAR in the United States fit a risk profile consistent with short-stay discharge, representing a significant cost-savings potential to the healthcare system.

BACKGROUND: Endovascular aneurysm repair (EVAR) is often attempted in patients with marginal anatomy. These patients midterm outcomes are available in the Vascular Quality Initiative for analysis. STUDY DESIGN: Retrospective analysis of prospectively collected data in the Vascular Quality Initiative from patients who underwent elective infrarenal EVAR between 2011 and 2018. Each EVAR was identified as either on- or off-instructions for use (IFU) based on aortic neck criteria. Multivariable logistic regression models were used to assess associations between aneurysm sac enlargement, reintervention, and type Ia endoleak with IFU status. Kaplan-Meier time-to-event models estimated reintervention, aneurysm sac enlargement, and overall survival. RESULTS: We identified 5,488 patients with at least 1 follow-up recorded. Those treated off-IFU included 1,236 patients ([23%] mean follow-up 401 days) compared with 4,252 (77%) treated on-IFU (mean follow-up 406 days). There was no evidence of significant differences in crude 30-day survival (96% vs 97%; p = 0.28) or estimated 2-year survival (97% vs 97%; log-rank p = 0.28). Crude type Ia endoleak frequency was greater in patients treated off IFU (2% vs 1%; p = 0.03). Off-IFU EVAR was associated with type Ia endoleak on multivariable regression model (odds ratio 1.84 [95% CI 1.23 to 2.76]; p = 0.003). Patients treated off IFU vs on IFU experienced had increased risk of reintervention within 2 years (7% vs 5%; log-rank p = 0.02), a finding consistent with results from the Cox modeling (hazard ratio 1.38 [95% CI 1.06 to 1.81]; p = 0.02). CONCLUSIONS: Patients treated off IFU were at greater risk for type Ia endoleak and reintervention, although they had similar 2-year survival compared with those treated on IFU. Patients with anatomy outside IFU should be considered for open surgery or complex endovascular repair to reduce the probability for revision.

Objective

Vascular surgeons treating patients with ruptured abdominal aortic aneurysm must make rapid treatment decisions and sometimes lack immediate access to endovascular devices meeting the anatomic specifications of the patient at hand. We hypothesized that endovascular treatment of ruptured abdominal aortic aneurysm (rEVAR) outside manufacturer instructions-for-use (IFU) guidelines would have similar in-hospital mortality compared to patients treated on-IFU or with an infrarenal clamp during open repair (ruptured open aortic aneurysm repair [rOAR]).

Methods

Vascular Quality Initiative datasets for endovascular and open aortic repair were queried for patients presenting with ruptured infrarenal AAA between 2013-2018. Graft-specific IFU criteria were correlated with case-specific proximal neck dimension data to classify rEVAR cases as on- or off-IFU. Univariate comparisons between the on- and off-IFU groups were performed for demographic, operative and in-hospital outcome variables. To investigate mortality differences between rEVAR and rOAR approaches, coarsened exact matching was used to match patients receiving off-IFU rEVAR with those receiving complex rEVAR (requiring at least one visceral stent or scallop) or rOAR with infrarenal, suprarenal or supraceliac clamps. A multivariable logistic regression was used to identify factors independently associated with in-hospital mortality.

Results

621 patients were treated with rEVAR, with 65% classified as on-IFU and 35% off-IFU. The off-IFU group was more frequently female (25% vs. 18%, P = 0.05) and had larger aneurysms (76 vs. 72 mm, P= 0.01) but otherwise was not statistically different from the on-IFU cohort. In-hospital mortality was significantly higher in patients treated off-IFU vs. on-IFU (22% vs. 14%, P= 0.02). Off-IFU rEVAR was associated with longer operative times (135 min vs. 120 min, P= 0.004) and increased intraoperative blood product utilization (2 units vs. 1 unit, P= 0.002). When off-IFU patients were matched to complex rEVAR and rOAR patients, no baseline differences were found between the groups. Overall in-hospital complications associated with off-IFU were reduced compared to more complex strategies (43% vs. 60-81%, P< 0.001) and in-hospital mortality was significantly lower for off-IFU rEVAR patients compared to the supraceliac clamp group (18% vs. 38%, P= 0.006). However, there was no significantly increased mortality associated with complex rEVAR, infrarenal rOAR or suprarenal rOAR compared to off-IFU rEVAR (all P> 0.05). This finding persisted in a multivariate logistic regression.

Conclusions

Off-IFU rEVAR yields inferior in-hospital survival compared to on-IFU rEVAR but remains associated with reduced in-hospital complications when compared with more complex repair strategies. When compared with matched patients undergoing rOAR with an infrarenal or suprarenal clamp, survival was no different from off-IFU rEVAR. Taken together with the growing available evidence suggesting reduced long-term durability of off-IFU EVAR, these data suggest that a patient's comorbidity burden should be key in making the decision to pursue off-IFU rEVAR over a more complex repair when proximal neck violations are anticipated preoperatively.

Objective

Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA).

Methods

This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias.

Results

Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings.

Conclusion

In this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach.

Background

There are substantial racial and socioeconomic disparities underlying endovascular abdominal aortic aneurysm repair (EVAR) in the United States. To date, race-based variations in reinterventions following elective EVAR have not been studied. Here, we aim to examine racial disparities associated with reinterventions following elective EVAR in a real-world cohort.

Materials and methods

We used the Vascular Quality Initiative EVAR dataset to identify all patients undergoing elective EVAR between January 2009 and December 2018 in the United States. We compared the association of race with reinterventions after EVAR and all-cause mortality using Welch two-sample t-tests, multivariate logistic regression, and Cox proportional hazards analyses adjusting for baseline differences between groups.

Results

At median follow-up of 1.1 ± 1.1 y (1.3 ± 1.4 y Black, 1.1 ± 1.1 y White; P = 0.02), a total of 1,164 of 42,481 patients (2.7%) underwent reintervention after elective EVAR, including 2.7% (n = 1,096) White versus 3.2% (n = 68) Black (P = 0.21). Black patients requiring reintervention were more frequently female, more frequently current or former smokers, and less frequently insured by Medicare/Medicaid (P < 0.05). After adjusting for baseline differences, the risk of reintervention after elective EVAR was significantly lower for Black versus White patients (HR 0.74, 95% CI 0.55-0.99; P = 0.04). All-cause mortality was comparable between groups (HR 0.81, 95% CI 0.33-2.00, P = 0.65).

Conclusions

There are significant differences between Black and White patients in the risk of reintervention after elective EVAR in the United States. The etiology of this difference deserves investigation.

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.

The 2020 Global Vascular Guidelines aim at improving decision making in Chronic Limb-Threatening Ischemia (CLTI) by providing a framework for evidence-based revascularization. Herein, the Global Limb Anatomic Staging System (GLASS) serves to estimate the chance of success and patency of arterial pathway revascularization based on the extent and distribution of the atherosclerotic lesions. We report the preliminary feasibility results and observer variability of the GLASS. GLASS is a part of the new global guideline and posed as a promising additional tool for EBR strategies to predict the success of lower extremity arterial revascularization. This study reports on the consistency of GLASS scoring to maximize inter-observer agreement and facilitate its application. GLASS separately scores the femoropopliteal (FP) and infrapopliteal (IP) segment based on stenosis severity, lesion length and the extent of calcification within the target artery pathway (TAP). In our stepwise approach, we used two angiographic datasets. Each following step was based on the lessons learned from the previous step. The primary outcome was inter-observer agreement measured as Cohen's Kappa, scored by two (step 1 + 2) and four (step 3) blinded and experienced observers, respectively. Steps 1 (n = 139) and 2 (n = 50) were executed within a dataset of a Dutch interventional RCT in CLTI. Step 3 (n = 100) was performed in randomly selected all-comer CLTI patients from two vascular centers in the United States. In step 1, kappa values were 0.346 (FP) and 0.180 (IP). In step 2, applied in the same dataset, the use of other experienced observers and a provided TAP, resulted in similar low kappa values 0.406 (FP) and 0.089 (IP). Subsequently, in step 3, the formation of an altered stepwise approach using component scoring, such as separate scoring of calcification and adding a ruler to the images resulted in kappa values increasing to 0.796 (FP) and 0.730 (IP). This retrospective GLASS validation study revealed low inter-observer agreement for unconditioned scoring. A stepwise component scoring provides acceptable agreement and a solid base for further prospective validation studies to investigate how GLASS relates to treatment outcomes.