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.

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.

High plateletcrit is associated with early loss of patency after open and endovascular interventions for chronic limb ischemia.

OBJECTIVE: Plateletcrit (PCT) reflects the total platelet mass in blood and can be calculated from a complete blood count. We examined the effect of PCT on outcomes of endovascular and open interventions for chronic limb ischemia. METHODS: Patients who underwent revascularization for chronic limb ischemia (Rutherford categories 3-6) between June 2001 and December 2014 were retrospectively identified. PCT on admission was recorded. Patients and limbs were divided into tertiles of low (0.046-0.211), medium (0.212-0.271), and high (0.272-0.842) PCT. Patency, limb salvage, major adverse limb events, major adverse cardiac events, and survival rates were calculated using Kaplan-Meier analysis and compared with log-rank test. Cox regression analysis was used for multivariate analysis. RESULTS: A total of 1431 limbs (1210 patients) were identified and divided into low PCT (477 limbs in 407 patients), medium PCT (477 limbs in 407 patients), and high PCT (477 limbs in 396 patients) groups. The patients in the high tertile were 2 years older that the patients in the other two tertiles (P = .009). Five-year primary patency was 65% ± 3% in the low-PCT group compared with 55% ± 3% and 51% ± 3% in the medium and high PCT groups, respectively (P = .004). Five-year secondary patency was 81% ± 2% in the low PCT group compared with 82% ± 2% and 72% ± 3% in the medium and high PCT groups, respectively (P = .02). Five-year limb salvage rate was 86% ± 2% in the low PCT group compared with 79% ± 3% and 74% ± 3% in the medium PCT and high PCT groups, respectively (P = .004). Multivariate regression analysis showed that low PCT was independently associated with primary patency after endovascular interventions (hazard ratio, 0.67 [0.47-0.95]; P = .02) but not after open interventions (hazard ratio, 0.72 [0.43-1.21]; P = .21). CONCLUSIONS: High PCT is associated with poor patency and limb salvage rates after interventions for lower extremity chronic limb ischemia. Multivariate regression analysis confirmed association of low PCT with improved primary patency after endovascular interventions but not after open interventions. High PCT may be a marker of increased platelet reactivity and could be used to identify patients at high risk for early thrombosis and failure after interventions.

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.

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.

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.

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.

Utility of duplex ultrasound in detecting and grading de novo femoropopliteal lesions.

BACKGROUND: Digital subtraction angiography (DSA) is the gold standard for diagnosing lower extremity (LE) arterial lesions. However, duplex ultrasound (DUS) is a widely used, safe, and noninvasive method of detecting LE lesions. The purpose of this study was to establish DUS criteria for detecting and grading de novo stenotic lesions in the femoropopliteal arterial segment. METHODS: A prospective database was established including all patients who underwent LE endovascular interventions between 2004 and 2009. Patients with de novo stenotic lesions in the femoropopliteal segment were selected. DUS and DSA data pairs ≤30 days apart were analyzed. Peak systolic velocity (PSV; cm/s), velocity ratio (Vr), and DSA stenosis were noted. Linear regression and receiver operator characteristic (ROC) curves were used. RESULTS: Two hundred seventy-five lesions in 200 patients were analyzed. Indications were claudication (50.5%), rest pain (12.5%), and tissue loss (37.0%). Mean time interval between DUS and DSA was 24 days. Both PSV (R = .80, R(2) = .641; P < .001) and Vr (R = .73, R(2) = .546; P < .001) showed strong correlation with the degree of angiographic stenosis. ROC analysis showed that to detect ≥70% stenosis, a PSV of 200 cm/s had 89.2% sensitivity and 89.7% specificity, and a Vr of 2.0 had 88.7% sensitivity and 90.2% specificity. Similarly, to differentiate between <50% and ≥50% stenosis, PSV of 150 cm/s and Vr of 1.5 were highly specific and predictive. Combining PSV 200 cm/s and Vr 2.0 for ≥70% stenosis gave 79.0% sensitivity, 99.0% specificity, 99.0% positive predictive value, and 85.0% negative predictive value. CONCLUSION: DUS shows a strong agreement with angiography and has good accuracy in detecting femoropopliteal lesions. We propose DUS criteria of PSV 200 cm/s and Vr 2.0 to differentiate between <70% and ≥70% de novo stenosis in the femoropopliteal arterial segment.

Endovascular management of type B aortic dissection after attempted central venous catheterization.

A 41-year-old woman, status postmastectomy for breast cancer had an attempted 8-F left subclavian vein chemotherapy port placed in her. She developed severe upper back pain radiating to the left shoulder. A computed tomographic scan and angiography revealed catheter placement in the left subclavian artery and a type B aortic dissection. A thoracic stent-graft was used to treat the aortic dissection. While removing the catheter, a covered stent was deployed to seal the arterial puncture and a balloon-expandable stent was placed over a persistent subclavian dissection. This case illustrates an example of the feasibility of endovascular management to treat serious iatrogenic access complications.

Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions.

OBJECTIVE: Distal embolization (DE) during percutaneous lower extremity revascularization (LER) may cause severe clinical sequelae. To better define DE, we investigated which lesion types and treatment modalities increase the risk for embolization. METHODS: A prospective registry of LER from 2004 to 2009 was reviewed. All cases with runoff evaluated before and after intervention were included. Angiograms and operative reports were reviewed for evidence of DE. Interventions included percutaneous transluminal angioplasty (PTA), with or without stent placement, and atherectomy with four different devices. Chi-square analysis and Fisher's exact test were used to assess significance. Patency rates were calculated using Kaplan-Meier analysis and compared using log-rank analysis. RESULTS: There were 2137 lesions treated in 1029 patients. The embolization rate was 1.6% (34 events). Jetstream (Pathway, Kirkland, Wash) and DiamondBack 360 (Cardiovascular Systems Inc, St Paul Minn) devices had a combined embolization rate of 22% (8 of 36), 4 of 18 (22%) in each group, which was significantly higher than with PTA alone (5 of 570, 0.9%), PTA and stent (5 of 740, 0.7%), SilverHawk (ev3, Plymouth, Minn) atherectomy (14 of 736, 1.9%), and laser atherectomy (2 of 55, 3.6%; P < .001). There was a significantly higher rate of embolization for in-stent restenosis (6 of 188, 3.2%) and chronic total occlusions (15 of 615, 2.4%) compared with stenotic lesions (13 of 1334, 0.9%; P = .01). The embolization rate was significantly higher in Transatlantic Inter-Society Consensus (TASC) II C and D lesions compared with TASC A and B lesions (P = .018). DE rates were not affected by preoperative runoff status (P = .152). Patency was restored at the completion of the procedure in 32 of 34 cases of DE. The 24-month primary patency, assisted primary patency, and secondary patency in the DE group was 54.0% ± 11.9%, 70.0% ± 10.3%, and 73.2% ± 10.3%, respectively, and was 44.4% ± 1.7%, 61.5% ± 1.7%, and 68.2% ± 1.6%, respectively, when embolization did not occur (P > .05). Limb salvage was 72.6% ± 3.1% in lesions in which no DE occurred vs 83.3% ± 15.2% in lesions in which DE occurred (P = .699). CONCLUSIONS: DE is a rare event that occurs more often with the Jetstream and DiamondBack 360 devices. In-stent and complex native lesions are at higher risk for DE. DE is typically reversible with endovascular techniques and has no effect on patency rates and limb salvage.

Closed-cell stents present with higher velocities on duplex ultrasound compared with open-cell stents after carotid intervention: short- and mid-term results.

BACKGROUND: The purpose of this study was to evaluate the effect of carotid cell design on duplex ultrasound velocity readings in the immediate postoperative period and over time. METHODS: A prospective database encompassing all patients treated with carotid artery stents between 2003 and 2008 was established and analyzed for stent type (closed-cell vs. open-cell), indications, and comorbidities. Patients were followed up clinically and with duplex ultrasound immediately after surgery, and every 6 months thereafter. Peak systolic velocities (PSV), end diastolic velocities (EDV), and internal carotid artery (ICA) to common carotid artery (CCA) ratios of PSV were recorded. RESULTS: A total of 214 interventions with 157 (73.3%) open-cell and 57 (26.7%) closed-cell types of carotid stents were performed in 205 patients. Two groups were similar regarding demographics, comorbidities, lesions characteristics, and stent length and diameter. The only difference was a significantly higher mean age (74.4 ± 10.1 vs. 70.9 ± 9.7 years; p = 0.027) and a history of myocardial infarction (34.5% vs. 15.6%; p = 0.004) in the closed-cell group versus open-cell group. Immediately after surgery PSV (115.9 ± 66.1 vs. 93.1 ± 38.7 cm/s; p = 0.003) and ICA/CCA ratio (2.08 ± 1.66 vs. 1.45 ± 0.52; p = 0.001) were significantly higher in closed-cell compared with open-cell group. This difference persisted during the follow-up period of 20.2 +/- 16.4 months; PSV (147.2 ± 108.8 vs. 110.0 ± 51.9; p = 0.003) and ICA/CCA ratio (2.61 ± 2.31 vs. 1.76 ± 0.81; p = 0.001). Patients with diabetes and calcified lesions had higher PSV and ICA/CCA ratio immediately after surgery (p > 0.05 and p < 0.05 for those with diabetes and calcified lesions, respectively) and over time. The number of readings showing significant restenosis (PSV >300 cm/s) over time were significantly higher in closed-cell 5 (8.7%) versus open-cell 1 (0.06%). EDV was not statistically different in the two groups (p > 0.05). CONCLUSION: Our study suggests that duplex criteria to screen for poststent restenosis may require modification according to stent-type. However, long-term effect of stent design on restenosis is still to be established.