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.

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.

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.

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.

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.

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.

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.

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.

Poorer limb salvage in African American men with chronic limb ischemia is due to advanced clinical stage and higher anatomic complexity at presentation.

OBJECTIVE: African Americans (AAs) with symptomatic peripheral arterial disease (PAD) have been reported to have fewer revascularization attempts and poorer patency and limb salvage (LS) rates than Caucasians (CAUs). This study compared the outcomes between AA and CAU men with chronic limb ischemia. METHODS: All AA and CAU men who underwent treatment for symptomatic PAD between November 1, 2003, and May 31, 2012, were included. Patency rates, LS, major adverse cardiovascular and limb events, amputation-free survival, and survival were compared before and after propensity score matching and with multivariate (Cox regression) analysis. RESULTS: Of the 834 men (1062 limbs), 107 were AA (137 limbs) and 727 were CAU (925 limbs). AAs were more likely to have insulin-dependent diabetes mellitus, hypertension, dialysis dependence, lower albumin levels, and critical limb ischemia (73% vs 61%; P = .006), whereas CAUs had more coronary artery disease, dyslipidemia, and chronic obstructive pulmonary disease. In patients with critical limb ischemia, primary amputation rates (10.9% vs 7.2%; P = .209) were similar between groups; however, infrapopliteal interventions were more frequent in AAs (62.6% vs 44.3%; P = .004). Perioperative morbidity and mortality rates were similar. Mean follow-up was 38.5 ± 28.9 months (range, 0-119 months). Patency rates, major adverse limb and cardiovascular events, amputation-free survival, and survival were similar in AAs and CAUs; however, the LS rate was significantly lower in AA (73% ± 6% vs 83% ± 2%; P = .048), mainly due to the difference in the endovascular-treated group (5-year LS, 69% ± 7% in AAs vs 84% ± 2% in CAUs; P = .025). All outcomes were similar in propensity score-matched cohorts. In multivariate analysis, insulin-dependent diabetes mellitus, gangrene, poor functional capacity, dialysis-dependence, and need for infrapopliteal revascularization were independently associated with limb loss, whereas race was not. CONCLUSIONS: AA men with symptomatic PAD were found to have lower LS rates than CAUs. However, this was likely due to presenting with advanced ischemia or with poor prognostic factors that are independently associated with limb loss.

Endoscopic vein harvest does not negatively affect patency of great saphenous vein lower extremity bypass.

OBJECTIVE: Although endoscopic vein harvest (EVH) has been reported to reduce the morbidity and length of stay compared with open vein harvest (OVH) for infrainguinal bypass procedures, there have been concerns about decreased graft patency and increased rates of reinterventions with EVH compared with OVH. We started using EVH in 2008, and currently it is our preferred approach. The goal of this study was to see if EVH is comparable to OVH in terms of graft patency and limb salvage and associated with fewer wound complications. METHODS: The study included 153 patients undergoing 171 elective lower extremity bypass procedures with single-piece autologous great saphenous vein from June 1, 2001, to December 31, 2014. Patients were observed postoperatively clinically and with duplex ultrasound evaluation. Patency, limb salvage rates, and postoperative complications were compared between OVH and EVH. RESULTS: There were 78 patients who had 88 EVH conduits and 75 patients who had 83 OVH conduits; 78.2% of the EVH group and 80% of the OVH group had critical limb ischemia (P = .237). Comorbidities were similar, but the EVH group had a significantly higher number of patients receiving antiplatelet drugs, enteric-coated acetylsalicylic acid (94.9% vs 70.7%; P < .001), and clopidogrel (62.8% vs 44%; P = .02), whereas the OVH group had more patients receiving warfarin anticoagulation (33.3% vs 20.5%; P = .073). Mean vein diameter was not signifciantly different (EVH, 3.2 ± 0.7 mm; OVH, 3.2 ± 0.8 mm; P = .598). Wound complication rates were significantly higher in the OVH group (EVH, 13.6%; OVH, 43.4%; P < .001), with 4.5% of patients in the EVH group and 18.1% of patients in the OVH group requiring débridement for wound complications (P = .005). Mean length of stay was shorter in the EVH group (EVH, 7.5 ± 6.4 days; OVH, 9.6 ± 11.0 days; P = .126). Early and late patency rates (EVH vs OVH 12- and 60-month primary patency, 73% ± 5% and 64% ± 6% vs 72% ± 5% and 56% ± 7 [P = .785]; assisted primary patency, 81% ± 5% and 77% ± 5% vs 81% ± 5% and 70% ± 6% [P = .731]; secondary patency, 87% ± 4% and 85% ± 4% vs 82% ± 4% and 73% ± 6% [P = .193]) and limb salvage rates (critical limb ischemia only, 12 and 60 months, 94% ± 3% and 81% ± 7% vs 83% ± 5% and 81% ± 5% [P = .400]) were similar between the groups. CONCLUSIONS: In experienced hands, EVH is associated with a significant decrease in wound complications with similar graft patency, reintervention rates, and limb salvage.

Potential clinical feasibility and financial impact of same-day discharge in patients undergoing endovascular aortic repair for elective infrarenal aortic aneurysm.

OBJECTIVE: The purpose of this study was to evaluate the potential feasibility and financial impact of same-day discharge after elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm. METHODS: All elective EVARs performed between January 2012 and June 2013 were identified. Demographics, comorbidities, complications, nursing care, financial data, and length of stay were analyzed. RESULTS: Sixty-seven (73%) EVARs were performed electively, 73% percutaneously. Intraoperative complications were blood loss requiring transfusion (4.5%), thrombosis (3%), femoral artery injury (1.5%), postoperative urinary retention (4.5%), myocardial infarction (3%), respiratory failure (1.5%), congestive heart failure (1.5%), and hemodynamic or rhythm alterations (37%; evident in 88% <6 hours; 13% required therapy). Monitoring only was needed in 28 patients (42%), intensive care in 15%. Seventy-two percent were discharged on postoperative day one; 6% were readmitted <30 days. Telemetry, oxygen, intravenous hydration, and urinary catheters (routine services) were used for shorter periods in uncomplicated patients and those discharged on postoperative day 1. Total hospital costs were $29,479: operating room, 80.3%; anesthesia, 2.2%; preadmission, 1%; postanesthesia unit, 3.1%; intensive care unit, 1.9%; floor, 4.7%; laboratory and diagnostic tests, 1.2%; pharmacy, 1.4%; other, 4.2%. Total cost was similar for those discharged <20 hours or ≥24 to 31 hours postoperatively (P = .51) and for monitoring only vs others ($28,146 vs $30,545; P = .12). Pharmacy ($351 vs $509; P = .05), laboratory work ($86 vs $355; P = .01), and diagnostic testing ($4 vs $254; P = .02) costs were lower for uncomplicated cases. CONCLUSIONS: Same-day discharge is clinically feasible in >40% of elective EVARs but requires coordination for adequate postoperative monitoring. Significant savings are unlikely as most cost is operating room and device related, and further reduction of costs in uncomplicated cases is unlikely.

Ambulatory percutaneous endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) has been associated with fewer groin wound complications and shorter operative times, but same-day discharge (SDD) has not been reported. The goal of our article is to assess the feasibility and safety of ambulatory PEVAR and identify patient characteristics that are eligible for this approach. METHODS: Consecutive patients who underwent elective endovascular abdominal aortic aneurysm repair (EVAR) between March 2011 and December 2012 were reviewed. SDD was discussed during the preoperative visit with patients who were functionally independent, without significant comorbidities, and had favorable anatomy. These patients were given the option to be discharged in the evening of the PEVAR after 6 hours of bed rest if the procedure was uneventful. Causes for discharge delay and early outcomes were analyzed. RESULTS: During the study period, 79 patients underwent abdominal aortic aneurysm (AAA) repair, 64 of whom (mean age, 70.2 ± 9.9; range, 59-97) had elective EVAR (3 ruptures, 5 acute presentations, 3 fenestrated EVARs, 4 elective open AAA repairs were excluded). Fifty-three patients (83%) had bilateral percutaneous access, seven had unilateral percutaneous (11%) access, and the remaining four (6%) had bilateral femoral endarterectomies. The percutaneous closure success rate was 96% in 113 attempts (three conversions for inadequate hemostasis, one for inability to deploy device). Mean length of stay was 1.3 ± 1.4 days (median, 1 day) with no 30-day mortality. Twenty-one patients (33%) were discharged the same day (SDD group), 24 (37%) on postoperative day (POD) 1, 16 (25%) on POD 2/3, and 3 (5%) stayed ≥ 4 days. One patient in the SDD group was readmitted on POD 3 after EVAR for severe postimplantation syndrome. Of the 23 patients who were discharged on POD 1, 10 were kept overnight due to severe chronic obstructive pulmonary disease, coronary artery disease, or advanced age, three transportation issues, two inability to void, two patient preference, two for renal protection, and four due to unplanned femoral cutdown. Patients in the SDD group were significantly younger (66.5 ± 5.4 years vs 72.0 ± 10.6 years; P = .029), had smaller AAAs (5.3 ± 0.5 cm vs 5.9 ± 1.0 cm; P = .013), less blood loss (115 ± 90 mL vs 232 ± 198 mL; P = .012), and shorter operating time (79 ± 24 minutes vs 121 ± 73 minutes; P = .013). There were fewer American Society of Anesthesiologists 4 patients in the SDD group (24% vs 48%; P = .056). The majority (81%) of patients in all groups had general anesthesia (86% vs 79% SDD vs others; P = .523). CONCLUSIONS: Ambulatory PEVAR was found to be feasible and safe in one-third of patients undergoing elective EVAR who did not have excessive medical risk, had good functional capacity, and underwent an uneventful procedure. The impact of SDD on cost-effectiveness needs to be further assessed and may not be feasible in hospitals reimbursed based on admission status.