Vascular surgery study of the CGuard MicroNet-covered stent in patients with indication to carotid revascularization: POLGUARD.

BACKGROUND: In a recent randomized study, MicroNet-covered stent (CGuard) significantly reduced procedural and post-procedural cerebral embolism in relation to a single-layer CREST study carotid stent, but real-life clinical practice data are limited. The aim is to prospectively assess clinical outcomes of CGuard as a routine revascularization tool for patients with indication to carotid revascularization. METHODS: From April 2019 to November 2021, 204 elective patients (age 71.0±7.1years, 69.6% males, 21.7% symptomatic) were enrolled. RESULTS: Mean basal peak-systolic velocity was 251.41±91.85 cm/s with angiographic diameter stenosis 89.7±8.46%. About 34.4% lesions were severely calcified, 6.8% were angulated, and 4.4% showed significant access tortuosity. Access was femoral, with 100% protection device (filter) use. Two hundred and three lesions in 203 patients were treated (1 cross-over to surgery for lack of effective access, no cross-over to other devices); in most cases (66.9%) the stent was placed directly. For pre-dilated lesions, mean balloon diameter was 3.36±0.34mm. Mean nominal stent diameter was 7.64±0.5 mm; length was 37.19±4.5 mm. All stents were post-dilated (balloon diameter 5.2±0.25 mm). Residual stenosis was <30% in all (3.77±6.91%). By discharge, there were 2 minor strokes (0.9%) and one transient ischemic attack. By 30-days, one other minor stroke occurred in relation to de-novo atrial fibrillation. With no deaths or myocardial infarctions, 30-day total death/stroke/myocardial infarction rate was 1.48%. No in-stent thrombosis or patency loss occurred by 30-days. In-stent peak-systolic velocity was 55.49±22.73 cm/s. CONCLUSIONS: Thirty-day results from POLGUARD study indicate safety and a low complication rate of the MicroNet-covered carotid stent use in every-day vascular surgery practice of carotid revascularization. Long-term observation is underway.

Optimal medical management in patients undergoing peripheral vascular interventions for chronic limb-threatening ischemia is associated with improved outcomes.

OBJECTIVE: Optimizing medical management and risk factor modification are underused strategies in patients with chronic limb-threatening ischemia (CLTI), despite evidence of improved outcomes. The Vascular Quality Initiative (VQI) registry is a tool to improve quality of vascular care. In this study, we used the VQI to evaluate trends in medical management in patients with CLTI undergoing peripheral vascular interventions (PVI), and the impact of changes in management on overall survival (OS), amputation-free survival (AFS), and limb salvage (LS). METHODS: Patients undergoing index PVI for CLTI between 2012 and 2016, with ≥24 months of follow-up were identified from the national VQI registry. Patient details including smoking status and medication use, OS, LS, and AFS were analyzed with linear-by-linear association, t test, and logistic regression. RESULTS: There were 12,370 PVI completed in 11,466 patients. There was a significant increase in infrapopliteal interventions (from 29.8% to 39.0%; P < .001) and PVI performed for tissue loss (from 59.1% to 66.5%; P < .001). The percentage of current smokers at time of PVI decreased (from 36.2% to 30.7%; P = .036). At discharge, statins were initiated in 25%, aspirin in 45%, and P2Y12 therapy in 58% of patients not receiving these medications before PVI. Over the course of follow-up, dual antiplatelet therapy (DAPT) (from 41.1% to 48.0%; P < .001), angiotensin-converting enzyme (ACE) inhibitor (from 46.2% to 51.3%; P < .001), and statin (from 70.4% to 77.5%; P < .001) use increased. Combined DAPT, ACE inhibitor and statin use increased from 33.6% to 39.6% (P ≤ .001). Significant improvement in 24-month OS and AFS was noted (OS, from 90.9% to 93.7% [P = .002]: AFS, from 81.2% to 83.1% [P = .046]), but not LS (from 89.6% to 89.0%; P = .83). Combined therapy with P2Y12 inhibitors, statins and ACE inhibitors was an independent predictor of improved OS (hazard ratio, 0.61; 95% confidence interval, 0.39-0.96; P = .034). DAPT was independent predictor of improved LS (hazard ratio, 0.83; 95% confidence interval, 0.79-0.87; P < .007). CONCLUSIONS: Antiplatelet, ACE inhibitor, and statin use increased over the study period and was associated with improved OS and AFS. LS trends did not change significantly over time, possibly owing to the inclusion of patients with a greater disease burden or inadequate medical management. Medical management, although improved, remained far from optimal and represents an area for continued development.

Impact of Statins on Survival and Limb Salvage in Patients Undergoing Peripheral Endovascular Intervention for Chronic Limb-Threatening Ischemia.

BACKGROUND: Statin therapy is recommended in all patients with peripheral arterial disease (PAD). Its impact on reduction in mortality has been well-documented, yet effect on limb-specific outcomes has been less conclusive. Differences among PAD subgroups or variability of statin use may contribute to the inconsistent findings. We evaluated statin use in patients who underwent peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI) and its impact on overall survival (OS), amputation-free survival (AFS) and limb salvage (LS). METHODS: The national Vascular Quality Initiative was queried for the index PVI for CLTI during the period 2010-2016; follow-up (FU) through 2020. Demographics, comorbidities, operative details, and FU status were recorded. Patients were categorized as E-Statin: statin use pre-PVI through discharge (D/C) and FU or N-Statin: No statins pre-PVI, at D/C or any time during FU. The propensity score matched model (PSM) was constructed. Groups were compared using chi-square, Kaplan-Meier survival and Cox regression analysis. RESULTS: There were 9,089 index PVI in 8,402 patients; E-Statin: 7149 index PVI in 6,591 patients; and N-Statin: 1940 index PVI in 1811 patients. The mean age was 69 ± 12 years and 58% were male. Statin use was associated with improved 3-year OS-E Statin: 92.9% ± 0.9 versus N Statin: 91.1% ± 2.2%; P = 0.003; hazard ratio (HR): Exp (B) (95% confidence interval): 0.66 (0.44-0.99); P = 0.047 and remained significant following PSM: E Statin: 95.1% ± 0.2% versus 90.8% ± 0.3%; P = 0.02; HR: 0.50 (0.27-0.92); P = 0.025. No significant differences in 3-year LS or AFS were noted between the prematched groups; LS: E Statin: 83.7% ± 0.8 versus N Statin: 84.0% ± 1.7%; P = 0.89; HR: 1.09 (0.88-1.35); P = 0.44; AFS-E Statin: 77.2% ± 1.1% versus 76.1% ± 2.5%; P = 0.17; HR: 0.97 (0.79-1.18); P = 0.74. or following PSM: AFS: 80.2% ± 2.8% vs. 74.7% ± 3.9%; P = 0.53, HR: 0.92 (0.72-1.19); P = 0.54; LS 85.3% ± 1.9% vs. 83.5% ± 2.6%; P = 0.51, HR: 1.08 (0.83-1.4); P = 0.57. Statins significantly improved LS among those with renal failure: 67.8% ± 2.6% vs. 59.7% ± 4.4%; P = 0.003; HR: 56 (0.40-0.79); P = 0.001. CONCLUSIONS: Statins are independently associated with improved OS in patients who undergo PVI for CLTI and should be considered for all barring intolerance. Statin use was associated with improved LS in patients with end-stage renal disease. Additional research is needed in this area, particularly, the impact of statin therapy in high-risk CLTI subgroups.

Comparison of outcomes for balloon angioplasty, atherectomy, and stenting in the treatment of infrapopliteal disease for chronic limb-threatening ischemia.

OBJECTIVE: We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of infrapopliteal disease (IPD) with chronic limb-threatening ischemia (CLTI). METHODS: All index peripheral vascular interventions for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the peripheral vascular intervention type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS. RESULTS: The 3-year LS for stenting vs POBA was 87.6% vs 81.9% (P = .006) but was not significant on Cox regression analysis (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.56-0.76; P = .08). AFS was superior for stenting vs POBA (78.1% vs 69.5%; P = .001; HR, 0.73; 95% CI, 0.60-0.90; P = .003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P = .11) and for stenting and atherectomy (87.6% vs 84.8%; P = .23). The LS rate after propensity score matching for POBA vs stenting was 83.4% vs 88.2% (P = .07; HR, 0.71; 95% CI, 0.50-1.017; P = .062). The AFS rate for stenting vs POBA was 78.8% vs 69.4% (P = .005; HR, 0.69; 95% CI, 0.54-0.89; P = .005). No significant differences were found between stenting and atherectomy (P = .21 for atherectomy; and P = .34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8 months vs 7.7 months; P = .001; stenting vs atherectomy, 13.5 months vs 6.8 months; P < .001). CONCLUSIONS: Stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determining the treatment strategy for this challenging anatomic segment.

P2Y12 inhibitor monotherapy is associated with superior outcomes as compared with aspirin monotherapy in chronic limb-threatening ischemia.

OBJECTIVE: Antiplatelet therapy is recommended in patients with peripheral arterial disease to reduce cardiovascular risk and improve outcomes. However, issues including the drug of choice and use of dual antiplatelet therapy (DAPT) vs monotherapy remain unclear. This study aims to compare the impact of aspirin (ASA) monotherapy, P2Y12 monotherapy, and DAPT on limb salvage (LS), amputation-free survival (AFS), and overall survival (OS) in patients undergoing lower extremity peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: The Vascular Quality Initiative PVI registry was used to identify index procedures completed for CLTI between March 1, 2010 and September 30, 2017. Patients were categorized by antiplatelet use at the time of last follow-up. Patients not on antiplatelet therapy were compared with ASA, P2Y12 monotherapy, and DAPT. Propensity score-matched samples were created for direct ASA vs P2Y12 and P2Y12 vs DAPT comparisons; veracity was confirmed by χ2 and Hosmer-Lemeshow tests. Kaplan-Meier and Cox regression were performed for OS, AFS, and LS. RESULTS: A total of 12,433 index PVI were completed for CLTI in 11,503 subjects in the pre-matched sample. Antiplatelet use at follow-up was: 12% none, 31% ASA, 14% P2Y12, and 43% DAPT. Median follow-up was 1389 days. P2Y12 monotherapy was associated with improved outcomes as compared with ASA monotherapy, OS (87.8% vs 85.5%l P = .026; Cox hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.68-0.98; P = .03), AFS (79.6% vs 74.8%; P < .001; Cox HR, 0.75; 95% CI, 0.65-0.86; P < .001) and LS (89.5% vs 86.8%; P = .013; Cox HR, 0.74; 95% CI, 0.60-0.91; P = .004). P2Y12 monotherapy and DAPT had comparable OS (87.8% vs 88.9%; P = .62; Cox HR, 0.94; 95% CI, 0.77-1.14; P = .50), AFS (79.6% vs 81.5%; P = .33; Cox HR, 0.92; 95% CI, 0.78-1.07; P = .28), and LS (91.7% vs 89.4; P = .03; Cox HR, 0.80; 95% CI, 0.64-1.00; P = .06). CONCLUSIONS: P2Y12 monotherapy was associated with superior OS, AFS, and LS as compared with ASA monotherapy, and comparable OS, LS, and AFS with DAPT in patients undergoing PVI for CLTI. P2Y12 monotherapy may be considered over ASA monotherapy and DAPT in patients with CLTI, especially in patients with high bleeding risk.

National survey of vascular surgery residents and fellows on radiation exposure and safety practices.

OBJECTIVE: The objective of the present study was to evaluate radiation safety practices, radiation training, and radiation exposure among senior vascular residents and fellows in Accreditation Council for Graduate Medical Education-accredited programs across the United States. METHODS: Anonymous surveys were sent to all Accreditation Council for Graduate Medical Education program directors to be distributed to postgraduate year 4 to 7 vascular trainees for completion. The survey questions focused on program type (single vs multiple hospital site), familiarity with their radiation officer, formal radiation training, frequency of radiation feedback, use of safety equipment, and adherence to as low as reasonably achievable principles. RESULTS: A total of 95 trainees responded (27% response rate). Of the 95 trainees, 49 (51.6%) had reported they had never met their radiation safety officer, 74 (77.9%) reported they had received formal radiation safety education, 50 (53%) reported receiving feedback regarding their monthly radiation exposure, and 24 (25%) reported never having received such feedback. All the findings were more common among the multiple hospital site program respondents. CONCLUSIONS: It should be of significant concern that such a high number of trainees have been exceeding radiation exposure limits. Programs should strive to reduce radiation exposure through formal training, provision of safety equipment, modeling by attendings of adherence to as low as reasonably achievable principles, and timely feedback on radiation exposure.

Need for Routine Preoperative Insertion of Indwelling Urinary Catheter Prior to Endovascular Repair of Abdominal Aortic Aneurysm.

BACKGROUND: Evaluate outcomes following urinary catheter (UC) versus no urinary catheter (NUC) insertion in elective endovascular repair (EVAR) of abdominal aortic aneurysm (AAA). METHODS: Retrospective record review of all elective EVAR at a university affiliated medical center over a 5-year period. Statistical analysis included Chi Sq, Independent Student t Test. RESULTS: Six surgeons performed 272 elective EVAR. Three surgeons preferred selective insertion of indwelling UC, such that 86 (32%) EVAR were completed without indwelling urinary catheters (NUC). Differences between NUC versus UC included; male: (86% vs. 70%; P = 0.004), CAD: (45% vs. 33%; p = 0.046), conscious sedation: (36% vs. 8%; P < 0.001), bilateral percutaneous EVAR (PEVAR): (100% vs. 90%; P = 0.01), within ProglideTM IFU guidelines (87% vs 75%; P = .05), major adverse operative event (MAOE): (3.5% vs. 10%; P = 0.05) and mean operative time (185 ± 73 vs. 140 ± 37; P < 0.001). Intra-operative catheterization was never required among NUC. Postoperative adverse urinary events (AUE) were more common among UC (11.4% vs. 8.1%; P = 0.41); with longer times to straight catheterization/reinsertion (1575 ± 987 vs, 522 ± 269 min; P = 0.015) and lower likelihood of eligibility for same day discharge (SDD); (41% vs. 59%; P = 0.008). Ineligibility for SDD was due to AUE in 18% of UC patients. CONCLUSION: Selective preoperative UC insertion should be considered for EVAR, with particular consideration to no preoperative catheterization in men meeting Proglide IFU. Adverse urinary events occurred less frequently among NUC and were identified/ treated earlier. Moreover, AUEs were the most common reason for potential SDD ineligibility among UC patients. Selective policies may facilitate SDD.

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. METHODS: In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. RESULTS: A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). CONCLUSIONS: The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.

The selection of patients for ambulatory endovascular aneurysm repair of elective asymptomatic abdominal aortic aneurysm.

OBJECTIVES: To identify candidates undergoing elective endovascular aneurysm repair (EVAR) of asymptomatic infrarenal abdominal aortic aneurysm who are eligible for early (≤6 hours) hospital discharge or to have EVAR performed in free-standing ambulatory surgery centers. METHODS: A retrospective medical record review of all elective EVAR performed at a university medical center over 5 years was undertaken. Potential candidates for early discharge or to have EVAR performed in a free-standing ambulatory surgery setting were defined as those who used routine monitoring services only or had self-limited minor adverse events (AE) that were identified, treated, and resolved within 6 hours of surgery. Risk factors for ineligibility were determined by logistic regression. Sensitivity, specificity, negative and positive predictive values were measured to determine the veracity of the risk factor profile. RESULTS: There were 272 elective EVARs; the mean patient age was 74 years (range, 52-94 years), and 75% were male. Twenty-five operative major AEs (MAE) occurred in 21 patients (7.7%): bleeding (5.9%), thrombosis (1.8%), and arterial injury (1.8%). Percutaneous EVAR (PEVAR) attempted in 260 patients (96%) was successful in 238 (88%). Failed PEVAR was associated with operative MAE (P < .001). Combined operative/postoperative MAE occurred in 43 patients (15.8%); 17 (6%) required intensive care admission; 88% directly from the operating room/postanesthesia care unit. Only two MAE (0.7%) occurred beyond 6 hours; (congestive heart failure at 24 hours, thrombosis/reoperation at 15 hours). Other AE included nausea (17%), blood pressure alteration (15%), and urinary retention (13%). Need for nonroutine services or treatment of other AE occurred in 131 (48%) patients with 79 (29%) developing or requiring treatment ≥6 hours postoperatively. However, 22 (8%) were treated/resolved in <6 hours; 30 (11%) patients required monitoring only and 36% had no complications, so, overall eligibility for same-day discharge/free-standing ambulatory surgery center was 55%. Failed PEVAR (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.25-4.49; P = .008), PEVAR performed outside of instructions for use (IFU) criteria (OR, 2.84; 95% CI, 1.07-7.56; P = .037), Endologix AFX graft (OR, 1.66; 95% CI, 1.19-2.33; P = .003) were independent predictors of MAE or AE occurring/requiring treatment >6 hours postoperatively; EVAR, which did not require an additional aortic cuff, was associated with a lower incidence (OR, 0.17; 95% CI, 0.04-0.65; P = .01). Neither aortic nor limb IFU were independent predictors. Profiles using PEVAR IFU, PEVAR failure, and graft type demonstrated only moderate sensitivity (63%), specificity (71%), positive predictive value (70%), and negative predictive value (63%). CONCLUSIONS: More than one-half of all patients who undergo EVAR are ready for discharge within 6 hours postoperatively. Failed PEVAR, aortic cuffs, and Endologix AFX graft were independent predictors of MAE or AE occurring/requiring treatment for ≥6 hours. However, sensitivity parameters of this profile were insufficient to advocate EVAR in free-standing ambulatory surgical units at this time, but hospital-based ambulatory admission with same-day discharge would be a viable option because of easy inpatient transition for those requiring continued care.

Improved survival with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in chronic limb-threatening ischemia.

OBJECTIVE: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) reduce the risk of cardiovascular events in patients with peripheral artery disease. However, their effect on limb-specific outcomes is unclear. The objective of this study was to assess the effect of ACE inhibitors/ARBs on limb salvage (LS) and survival in patients undergoing peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: The Vascular Quality Initiative registry was used to identify patients undergoing PVI for CLTI between April 1, 2010, and June 1, 2017. Patients with complete comorbidity, procedural, and follow-up limb and survival data were included. Propensity score matching was performed to control for baseline differences between the groups. LS, amputation-free survival (AFS), and overall survival (OS) were calculated in matched samples using Kaplan-Meier analysis. RESULTS: A total of 12,433 limbs (11,331 patients) were included. The ACE inhibitors/ARBs group of patients had significantly higher prevalence of coronary artery disease (31% vs 27%; P < .001), diabetes (67% vs 57%; P < .001), and hypertension (94% vs 84%; P < .001) and lower incidence of end-stage renal disease (7% vs 12%; P < .001). Indication for intervention was tissue loss in 64% of the ACE inhibitors/ARBs group vs 66% in the no ACE inhibitors/ARBs group (P = .005). Postmatching survival analysis at 5 years showed improved OS (81.8% vs 79.9%; P = .01) and AFS (73% vs 71.5%; P = .04) with ACE inhibitors/ARBs but no difference in LS (ACE inhibitors/ARBs, 88.3%; no ACE inhibitors/ARBs, 88.1%; P = .56). After adjustment for multiple variables in a Cox regression model, ACE inhibitors/ARBs were associated with improved OS (hazard ratio, 0.89; 95% confidence interval, 0.80-0.99; P = .03) and AFS (hazard ratio, 0.92; 95% confidence interval, 0.84-0.99; P = .04). CONCLUSIONS: ACE inhibitors/ARBs are independently associated with improved survival and AFS in patients undergoing PVI for CLTI. LS rates remained unaffected. Further research is required to investigate the use of ACE inhibitors/ARBs in this population of patients, especially CLTI patients with other indications for therapy with ACE inhibitors/ARBs.

Angiotensin Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers (ACEI/ARB) are Associated with Improved Limb Salvage after Infrapopliteal Interventions for Critical Limb Ischemia.

BACKGROUND: Angiotensin-converting enzyme Inhibitors and Angiotensin II Receptor Blockers (ACEI/ARB) reduce the risk of cardiovascular events and mortality in patients with peripheral arterial disease (PAD). However, their effect on limb-specific outcomes is unclear. The objective of this study is to assess the effect of ACEI/ARB on patency and limb salvage in patients undergoing interventions for critical limb ischemia (CLI). METHODS: Patients undergoing infrainguinal revascularization for CLI (Rutherford 4-6) between 06/2001 and 12/2014 were retrospectively identified. Primary Patency (PP), Secondary Patency (SP), Limb Salvage (LS), major adverse cardiac events (MACE), and survival rates were calculated using Kaplan-Meier. Multivariate analysis was performed using Cox regression. RESULTS: A total of 755 limbs in 611 patients (311 ACEI/ARB, 300 No ACEI/ARB) were identified. Hypertension (86% vs. 70%, P < 0.001), diabetes (68% vs. 55%, P = 0.001) and statin use (61% vs. 45%, P < 0.001) were significantly greater in the ACEI/ARB group. Interventions were performed mostly for tissue loss (83% ACEI/ARB vs. 84% No ACEI/ARB, P = 0.73). Comparing ACEI/ARB versus No ACEI/ARB, in femoropopliteal interventions, 60-month PP (54% vs. 55%, P = 0.47), SP (76% vs. 75%, P = 0.83) and LS (84% vs. 87%, P = 0.36) were not significantly different. In infrapopliteal interventions, 60-month PP (45% vs. 46%, P = 0.66) and SP (62% vs. 75%, P = 0.96) were not significantly different. LS was significantly greater in ACEI/ARB (75%), as compared to No ACEI/ARB (61%) (P = 0.005). Cox regression identified diabetes (HR 2.4 (1.4-4.1), P = 0.002), ESRD (HR 3.5 (2.1-5.7), P < 0.001), hypertension (HR 0.4 (0.2-0.6), P < 0.001), and ACEI/ARB (HR 0.6 (0.4-0.9), P = 0.03), as factors independently associated with LS after infrapopliteal interventions. Freedom from MACE (ACEI/ARB 37% vs. 32%, P = 0.82) and overall survival (ACEI/ARB 42% vs. 35% No ACEI/ARB, P = 0.84) were not significantly different. CONCLUSIONS: ACEI/ARB is associated with improved limb salvage in CLI patients undergoing infrapopliteal interventions, but not after femoropopliteal interventions. ACEI/ARB had no impact on patency rates. They were also associated with a trend toward improved survival and freedom from MACE. Our findings suggest that the use of ACEI/ARB may improve outcomes in the high-risk CLI patient population.

Comparison of Autologous Vein and Bovine Carotid Artery Graft as a Bypass Conduit in Arterial Trauma.

BACKGROUND: Surgical revascularization is the mainstay treatment in treating most traumatic arterial injuries, and autologous great saphenous vein is widely regarded as the conduit of choice. However, the use of the great saphenous vein may be limited by many factors, and there are little data to guide management in this setting. Bovine carotid artery graft (Artegraft, Inc., North Brunswick, NJ, USA) is a biologic conduit that has been used in select trauma cases at our center. The objective of this study was to review and compare our experience with autologous vein and bovine carotid artery in traumatic arterial injuries requiring bypass or interposition. METHODS: This is a retrospective review of all patients with a traumatic arterial injury repaired with autologous vein or bovine carotid artery graft at a single center between April 2014 and October 2016. Outcomes of interest included differences in duration of ischemia, operative times, patency, limb salvage, graft-related complications, and functional status. RESULTS: Thirty patients were included in this study. Seventeen (57%) injuries were to the lower extremity (LE) and 13 (43%) to the upper extremity. Bovine carotid artery graft was used as a conduit in 12 (40%) cases, while autologous vein was used in 18 (60%) patients. Patients were predominantly male (90%). Mean age was 31 ± 15 years. Comorbidities did not differ significantly between the groups. Mean follow-up duration was 19 ± 13 months. Overall primary patency was 82%: bovine versus autologous vein (78% vs. 85%; P = 0.68). Overall secondary patency was 91%: bovine versus autologous vein (78% vs. 100%; P = 0.16). Overall limb salvage was 90%: bovine versus autologous vein (82% vs. 94%; P = 0.28). When comparing bovine carotid artery graft to autologous vein in LE interventions, primary patency (50% vs. 71%; P = 0.40), secondary patency (75% vs. 100%; P = 0.23), and limb salvage (80% vs. 86%; P = 0.76) did not differ significantly. There were no early or late graft infections with either conduit. There were no significant differences in ambulatory status at discharge by graft type. Overall survival was 100%. CONCLUSIONS: In this series, there is a trend toward improved patency and limb salvage with autologous vein. Autologous vein should be the standard of care for revascularization of traumatic arterial injuries. Bovine carotid artery graft appears be a viable alternative, especially in patients requiring urgent revascularization, that does not significantly compromise patency, limb salvage, or functional outcomes.

Rupture of a previously thrombosed hepatic artery aneurysm.

Hepatic artery aneurysm (HAA) is a rare form of visceral artery aneurysm. Historically, most HAAs were ruptured at presentation, but advances in imaging have led to an increase in the diagnosis of asymptomatic HAAs. Description of the natural history of patent HAAs has been difficult because of their rarity, even more so for less common thrombosed HAAs. We report the case of a 74-year-old man who experienced the rupture of a previously thrombosed HAA. He was successfully surgically treated with ligation of the aneurysm. Our case provides insight into the progression and management of thrombosed HAAs.

Outcomes after Lower Extremity Revascularization for Treatment of Critical Limb Ischemia with Tissue Loss in Patients with Chronic Immune-Mediated Inflammatory Disease.

BACKGROUND: To evaluate outcomes after lower extremity revascularization for critical limb ischemia with tissue loss in patients with chronic immune-mediated inflammatory disease. METHODS: A retrospective medical record review of all lower extremity revascularization for critical limb ischemia with tissue loss at a university-affiliated hospital over a 3-year period was completed for demographics, comorbidities, lower extremity revascularization indication, angiogram results, complications, mortality, limb salvage, and reintervention. Chronic immune-mediated inflammatory disease (CIID) and control (no autoimmune disease) were compared by chi-squared test, Student's t-test, Kaplan-Meier, and Cox Regression. RESULTS: There were 349 procedures performed (297 patients): (1) 44 (13%) primary amputations and (2) 305 (87%) lower extremity revascularizations, in which 83% were endovascular interventions; 12% was bypass; and 5% was hybrid, in which 40% was infrainguinal and 60% was infrageniculate, 72% Wounds Ischemia Infection Score System (WIFi) tissue loss class 2-3, 35% CIID. No differences were noted between CIID and control for primary amputation (P = 0.11), lower extremity revascularization type (P = 0.50), or lower extremity revascularization anatomic level (P = 0.43). Mean age was 71 + 13 years, and 56% of the patients were of male gender. Those with CIID were of similar age as controls (71 ± 14 vs. 71 ± 13; P = 0.87) and presented with comparable runoff: (1) ≤1 vessel (52% vs. 47%; P = 0.67), (2) WIFi tissue loss classification class 2-3 (66% vs. 76%; P = 0.09), and (3) WIFi infection classification class 2-3 (29% vs. 30%; P = 0.9). They were also less likely to be male (47% vs. 61%; P = 0.022) or current smokers (13% vs. 27%; P = 0.008). Postoperative mortality (P = 0.70) morbidity and reoperation (0.31) were comparable. Twenty-four-month survival was similar for CIID and control (83% ± 5% vs. 86% + 3%; P = 0.78), as was the amputation-free interval (69% ± 5% vs. 61% ± 4%; P = 0.18) and need for target extremity revascularization (40% vs. 53%; P = 0.04). Use of steroids and other anti-inflammatory medications was associated with improved 24-month amputation-free interval (87% ± 9% vs. 63% ± 3%; P = 0. 05). Dialysis (odds ratio: 2.6; 1.5-4.7; P = 0.001), WIFi infection class 2-3 (odds ratio: 2.8; 1.6-4.9; P < 0.001), prerunoff vessel (0-1 vs. 2-3) to the foot (odds ratio: 0.52; 0.37-0.73; P < 0.001), steroids/other anti-inflammatory agents (0.29; 0.06-0.96; P = 0.04), and statins (0.44; 0.25-0.77; P = 0.005) were independent predictors of 24-month amputation-free interval (Cox proportional hazard ratio). CONCLUSIONS: Patients with critical limb ischemia, tissue loss, and concomitant CIID can be successfully treated with lower extremity revascularization with similar limb salvage and need for reintervention. Steroid/anti-inflammatory use appears beneficial.

Metformin Is Associated with Improved Survival and Decreased Cardiac Events with No Impact on Patency and Limb Salvage after Revascularization for Peripheral Arterial Disease.

BACKGROUND: The incidence of cardiovascular and limb-specific adverse outcomes is higher in peripheral arterial disease (PAD) patients with diabetes. Metformin is associated with improved cardiovascular morbidity and mortality. However, the effect of metformin on limb-specific outcomes is unclear. The objective of this study was to assess the effect of metformin on outcomes after intervention for PAD. METHODS: Patients who underwent revascularization for chronic limb ischemia (Rutherford 3-6) between June 2001 and December 2014 were retrospectively identified. Primary patency (PP), secondary patency (SP), limb salvage (LS), major adverse limb events (MALE), major adverse cardiac events (MACE), and survival rates were compared using Kaplan-Meier and Cox regression. RESULTS: One thousand sixty-four limbs in 1204 patients were identified (147 metformin, 196 other hypoglycemics [OH], 216 insulin, and 645 nondiabetics (nondiabetes mellitus [DM]). Non-DM had significantly lower incidence of CAD (46%) than insulin (65%), metformin (56%), and OH groups (63%) (P < 0.001). Insulin patients (17%) had significantly higher incidence of end-stage renal disease (ESRD) than non-DM (3%), metformin (1.4%), and OH groups (8%) (P < 0.001). Ninety four percent of patients in the metformin group were on aspirin, which was significantly higher than non-DM (86%), OH (83%), and insulin groups (86%) (P = 0.02). Similarly, statin use was significantly higher in the metformin group (71%) than in OH (64%), insulin (61%), and non-DM groups (55%) (P = 0.002). Majority of patients in the insulin group presented with critical limb ischemia (CLI) (93%), which was significantly greater than the metformin (59%), OH (72%), and non-DM groups (50%) (P < 0.001). Sixty-month PP was significantly greater in non-DM group (62%) (P = 0.005) in overall comparison with no significant difference between metformin (56%), OH (60%), and insulin (51%) groups (P = 0.06). Sixty-month SP was similar in metformin (76%), OH (85%), insulin (76%), and non-DM (80%) groups (P = 0.27). LS was significantly worse in insulin group (62%) (P < 0.001) with no significant difference between metformin (84%), OH (83%), and non-DM (87%) groups (P = 0.45). Freedom from MALE at 60 months was 53% in the insulin group, which was significantly worse as compared with metformin (71%), OH (70%), and non-DM (67%) groups (P = 0.001). Sixty-month survival was significantly improved in metformin (60%) and non-DM (60%) groups as compared with that in OH (41%) and insulin groups (30%) (P < 0.001). Freedom from MACE was significantly greater in metformin (44%) and non-DM (52%) groups than that in OH (37%) and insulin groups (25%) (P < 0.001). Metformin use (HR, 0.7 [0.5-0.9]; P = 0.008) was an independent factor associated with freedom from mortality. CONCLUSIONS: Metformin is associated with improved survival and decreased incidence of adverse cardiac events in PAD patients. However, it did not have an impact on patency or LS rates after open and endovascular interventions. LS was worse in diabetic patients primarily treated with insulin.

Pre-emptive nonselective perigraft aortic sac embolization with coils to prevent type II endoleak after endovascular aneurysm repair.

OBJECTIVE: Pre-emptive selective embolization of inferior mesenteric artery (IMA), lumbar arteries (LAs), and perigraft sac for prevention of type II endoleak (T2EL) has not been widely adopted. We perform pre-emptive nonselective perigraft aortic sac embolization with coils (PNPASEC) in patients at high risk for development of T2EL (four or more patent LAs, patent IMA ≥3 mm, and ≥30-mm aortic flow lumen). The goal of this study was to see whether PNPASEC decreases T2ELs requiring reinterventions. METHODS: All 266 patients undergoing elective endovascular aneurysm repair between September 1, 2007, and October 31, 2015, were retrospectively evaluated from a prospectively maintained database. Patients (N = 212; 211 men) with preoperative and postoperative contrast-enhanced computed tomography scans were included. Our PNPASEC technique involves leaving a wire in the sac after cannulation of the contralateral gate and inserting large (0.035-inch) coils into the sac after bifurcated graft deployment. T2EL and reintervention rates were compared between patients who underwent PNPASEC (group I) and those who met the criteria but did not have PNPASEC (group II) and those who did not meet the criteria (Group III). RESULTS: Forty-seven (22.2%) patients were PNPASEC candidates and 165 (77.8%) patients (group III) were not. Among PNPASEC candidates, 16 (7.5%) underwent PNPASEC (group I) and 31 (14.6%) did not (group II). There were no significant differences between groups in terms of comorbidities, aneurysm size, and anatomic and neck characteristics. Mean number of patent LAs was similar between group I (4.5 ± 0.8) and group II (4.5 ± 0.9), which was significantly greater than in group III (1.9 ± 1.3; P < .001); 43.6% of group III patients had patent IMA. Mean follow-up was 44 ± 25 months. T2EL at 6 months was observed in 48.4% in group II, 3.0% in group III, and 6.3% in group I (P < .001). Sac diameter increase was seen in 38.7% in group II vs 6.1% in group III and 6.3% in group I (P < .001), with complete sac shrinkage in 23.3% in group II vs 23.8% in group III and 50.0% in group I (P = .09). T2EL-related interventions were performed in 29.0% in group II vs 1.2% in group III and 6.3% in group I (P < .001). Any endoleak at last follow-up was seen in 25.8% in group II vs 2.4% in group III and none in group I (P < .001). CONCLUSIONS: Nonselective perigraft sac coil embolization in patients at high risk for T2EL (20% of patients undergoing endovascular aneurysm repair) is effective in preventing development of T2EL and is associated with decrease in sac size and reintervention rates.

Long-term Durability of Infrainguinal Endovascular and Open Revascularization for Disabling Claudication.

BACKGROUND: Infrainguinal revascularization for disabling claudication (DC) is frequently performed, but long-term results are still unknown. In this study, we compared clinical outcomes of infrainguinal endovascular (EV) and open interventions for DC after the failure of medical management. METHODS: One hundred ninety-four patients with DC (Rutherford category 3) who had open (n = 53) or EV (n = 141) interventions were grouped as open-great saphenous vein (GSV) (n = 21), open-prosthetic (n = 32), EV-Trans-Atlantic Inter-Society Consensus II (TASC II) A and B (AB) (n = 48), and EV-TASC II C and D (CD) (n = 93). Patency, primary clinical success (PCS; sustained improvement in symptoms without reintervention), and secondary clinical success (SCS; sustained improvement in symptoms with reintervention) rates were compared. RESULTS: Mean follow-up was 57 ± 33 months. Five-year primary patency was 58% in open-GSV, 40% in open-prosthetic, 72% in EV-AB, and 38% in EV-CD (P < 0.001). Five-year secondary patency was 77% in open-GSV, 50% in open-prosthetic, 96% in EV-AB, and 61% in EV-CD (P < 0.001). Freedom from major adverse limb events was 73% in open-GSV, 77% in EV-AB, 70% in EV-CD, and 67% in open-prosthetic (P = 0.279). Five-year PCS was 46% in open-GSV, 40% in open-prosthetic, 57% in EV-AB, and 44% in EV-CD (P = 0.02). Five-year SCS was 78% in open-GSV, 78% in open-prosthetic, 85% in EV-AB, and 84% in EV-CD (P = 0.732). A total of 116 reinterventions were performed, 10 in 6 limbs (27%) in open-GSV, 18 in 12 limbs (36%) in open-prosthetic, 26 in 15 limbs (24%) in EV-AB, and 62 in 39 limbs (36%) in EV-CD. Reinterventions included 71 (61%) EV and 45 (39%) open procedures. CONCLUSIONS: Durability of infrainguinal interventions in claudicants depends mainly on anatomic complexity of disease. Good long-term clinical success can be achieved with both open and EV interventions, albeit with high reintervention rates, especially in patients with TASC II C and D disease. A considerable subset of EV patients will eventually require surgical revascularization to maintain clinical benefit. In this study, almost 20% of patients undergoing EV for TASC II C and D disease eventually required surgical bypass.

3D Printed Abdominal Aortic Aneurysm Phantom for Image Guided Surgical Planning with a Patient Specific Fenestrated Endovascular Graft System.

Following new trends in precision medicine, Juxatarenal Abdominal Aortic Aneurysm (JAAA) treatment has been enabled by using patient-specific fenestrated endovascular grafts. The X-ray guided procedure requires precise orientation of multiple modular endografts within the arteries confirmed via radiopaque markers. Patient-specific 3D printed phantoms could familiarize physicians with complex procedures and new devices in a risk-free simulation environment to avoid periprocedural complications and improve training. Using the Vascular Modeling Toolkit (VMTK), 3D Data from a CTA imaging of a patient scheduled for Fenestrated EndoVascular Aortic Repair (FEVAR) was segmented to isolate the aortic lumen, thrombus, and calcifications. A stereolithographic mesh (STL) was generated and then modified in Autodesk MeshMixer for fabrication via a Stratasys Eden 260 printer in a flexible photopolymer to simulate arterial compliance. Fluoroscopic guided simulation of the patient-specific FEVAR procedure was performed by interventionists using all demonstration endografts and accessory devices. Analysis compared treatment strategy between the planned procedure, the simulation procedure, and the patient procedure using a derived scoring scheme. RESULTS: With training on the patient-specific 3D printed AAA phantom, the clinical team optimized their procedural strategy. Anatomical landmarks and all devices were visible under x-ray during the simulation mimicking the clinical environment. The actual patient procedure went without complications. CONCLUSIONS: With advances in 3D printing, fabrication of patient specific AAA phantoms is possible. Simulation with 3D printed phantoms shows potential to inform clinical interventional procedures in addition to CTA diagnostic imaging.

Factors that affect cost and clinical outcome of endovascular aortic repair for abdominal aortic aneurysm.

OBJECTIVE: This study evaluated the effect of indication for use (IFU), additional graft components, and percutaneous closure of endovascular aortic repair (PEVAR) on clinical outcomes and cost of endovascular aortic repair (EVAR). METHODS: Clinical and financial data were obtained for all elective EVARs completed at a university-affiliated medical center between January 2012 and June 2013. Data were analyzed by χ2, Student t-test for independent samples, and Kaplan-Meier survival. RESULTS: There were 67 elective EVARs. Additional cuffs/extensions were used in 37%, increasing the baseline graft cost by 36% (P < .001), total costs by 20% (P < .001), and negatively affecting the contribution margin. Aortic neck IFU (P = .02), failure of the index graft to seal the neck (P = .02), and need for an additional cuff (P = .008) were related to the need for reintervention for type Ia endoleak for graft B (Excluder; W. L. Gore and Associates, Flagstaff, Ariz), whereas limb IFU was related to the need for additional limb extension for graft A (Powerlink; Endologix, Irvine, Calif; P < .001). Limb extension (P = .06) and failure of the index graft to provide an adequate seal (P < .001) were associated with reintervention for type Ib endoleak. Reintervention-free rates at 24 months were 96% for graft A and 94% for graft B (P =.54), but different patterns in reintervention emerged: graft A required reoperation early (<2 months) then stabilized; graft B did not require reintervention until 24 months, but rates increased substantially by 25 months. PEVAR was attempted in 61 (91%): 49 (73%) bilaterally, 7 (10%) unilaterally, and 5 (8%) failed. The mean number of closure devices was four (range, 1-9): $1000 (3.5% of total cost). Bilateral PEVAR was associated with shorter operating time than unilateral PEVAR/failed PEVAR (P < .001) and lower operating room use costs (P = .005) and total hospital costs (P = .003) than failed PEVAR. The contribution margin was higher for bilateral PEVAR than unilateral PEVAR/failed PEVAR (P = .005). Patients with bilateral PEVAR and unilateral PEVAR were more often discharged on postoperative day 1 than those with failed PEVAR (P = .002). Hospital length of stay (P = .49), operating room duration (P = .31), and total costs (P = .72) were similar for unsuccessful PEVAR and EVAR completed with cutdown. CONCLUSIONS: Higher rates of reintervention occurred when EVAR was performed outside of IFU guidelines or when additional components were needed. Additions raised graft costs significantly above baseline. Notable differences in graft performance in complex anatomy and varied patterns of reoperation could be useful in the graft selection process to improve outcome and contain costs. Bilateral PEVAR was associated with lower costs and postoperative day 1 discharge. Attempting PEVAR may be reasonable unless there is serious concern for failure.