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.

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.