Bailout Distal Internal Carotid Artery Stenting after Carotid Endarterectomy: Indications, Technique, and Outcomes.

BACKGROUND: Distal internal carotid artery (ICA) stenting may be employed as a bailout maneuver when an inadequate end point or clamp injury is encountered at the time of carotid endarterectomy (CEA) in a surgically inaccessible region of the distal ICA. We sought to characterize the indications, technique, and outcomes for this infrequently encountered clinical scenario. METHODS: We performed a retrospective review of all patients who underwent distal ICA stenting at the time of CEA at our institution between September 2008 and July 2022. Procedural details and postoperative follow-up were reviewed for each patient. RESULTS: Six patients were identified during the study period. All were male with an age range of 63 to 82 years. Five underwent carotid revascularization for asymptomatic carotid artery stenosis, and one patient was treated for amaurosis fugax. Three patients were on dual antiplatelet therapy preoperatively, whereas 2 were on aspirin monotherapy, and one was on aspirin and low-dose rivaroxaban. Five patients underwent CEA with patch angioplasty, and one underwent eversion CEA. The indication for stenting was distal ICA dissection due to clamp or shunt injury in 2 patients and an inadequate distal ICA end point in 4 patients. In all cases, access for stenting was obtained under direct visualization within the common carotid artery, and a standard carotid stent was deployed with its proximal aspect landing within the endarterectomized site. Embolic protection was typically achieved via proximal common carotid artery and external carotid artery clamping for flow arrest with aspiration of debris before restoration of antegrade flow. There was 100% technical success. Postoperatively, 2 patients were found to have a cranial nerve injury, likely occurring due to the need for high ICA exposure. Median length of stay was 2 days (range 1-7 days) with no instances of perioperative stroke or myocardial infarction. All patients were discharged on dual antiplatelet therapy with no further occurrence of stroke, carotid restenosis, or reintervention through a median follow-up of 17 months. CONCLUSIONS: Distal ICA stenting is a useful adjunct in the setting of CEA complicated by inadequate end point or vessel dissection in a surgically inaccessible region of the ICA and can minimize the need for high-risk extensive distal dissection of the ICA in this situation.

Discrepancies in clavicle-to-carotid bifurcation length measurements for transcarotid artery revascularization using different imaging modalities.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has emerged as an effective method for carotid artery stenting. However, anatomic eligibility for TCAR is most often limited by an inadequate clavicle-to-carotid bifurcation length of <5 cm. Preoperative clavicle-to-carotid bifurcation distances may be underestimated when using conventional straight-line measurements on computed tomographic angiography (CTA) imaging. We therefore compared clavicle-to-carotid bifurcation lengths as measured by straight-line CTA, center-line CTA, and intraoperative duplex ultrasound (US), to assess potential differences. METHODS: We conducted a single-center, retrospective review of consecutive TCAR procedures performed between 2016 and 2019 for atherosclerotic carotid disease. For each patient, we compared clavicle-to-carotid bifurcation lengths measured by straight-line CTA, center-line CTA using TeraRecon image reconstruction, and intraoperative duplex US with neck extension and rotation. We further assessed patient and imaging characteristics in individuals with a ≥0.5 cm difference among the measurement methods. In particular, common carotid artery (CCA) tortuosity, defined as the inability to visualize the entire CCA from clavicle to carotid bifurcation on both a single coronal and sagittal imaging cut, was examined as a contributing factor for these discrepancies. RESULTS: Of the 70 TCAR procedures identified, 46 had all three imaging modalities available for review. The median clavicle-to-carotid bifurcation length was found to be 6.4 cm (interquartile range [IQR], 5.4-6.7 cm) on straight-line CTA, 7.0 cm (IQR, 6.0-7.5 cm) on intraoperative duplex US, and 7.2 cm (IQR, 6.5-7.5 cm) on center-line CTA (P < .001). Patients with a ≥0.5 cm difference between their straight-line CTA and either their intraoperative duplex US or center-line CTA measurements were more likely to have tortuous CCAs (60.0% vs 19.1%; P = .01; 51.4% vs 0.0%; P = .01). There were no notable differences in age, gender, prior neck/cervical spine surgery, or neck immobility among these individuals. In patients with tortuous CCAs, duplex US and center-line CTA measurements added 1.0 cm (IQR, 0.6-1.5 cm) and 1.1 cm (IQR, 0.9-1.6 cm) more in length than straight-line CTA measurements, respectively. There was a strong linear correlation between the additional lengths provided by duplex US measurements and those provided by center-line CTA measurements for each individual within the tortuous CCA group (r = 0.83). CONCLUSIONS: The use of straight-line CTA during preoperative planning can underestimate the clavicle-to-carotid bifurcation lengths in patients undergoing carotid revascularization, particularly in those with tortuous CCAs. Both duplex US performed with extended-neck surgical positioning and center-line CTA provide similar and longer carotid length measurements, and should be utilized in patients with tortuous carotid vessels to better determine TCAR anatomic eligibility.

Wound location is independently associated with adverse outcomes following first-time revascularization for tissue loss.

OBJECTIVE: Few studies adequately evaluate the impact of wound location on patient outcomes after lower extremity revascularization. Consequently, we evaluated the relationship between lower extremity wound location and long-term outcomes. METHODS: We reviewed all patients at our institution undergoing any first-time open surgical bypass or percutaneous transluminal angioplasty with or without stenting for tissue loss between 2005 and 2014. We categorized wounds into three distinct groups: forefoot (ie, toes and metatarsal heads), midfoot (ie, dorsal, plantar, lateral, medial surfaces excluding toes, metatarsal heads, or heel), and heel. Limbs with multiple wounds were excluded from analyses. We compared rates of perioperative complications, wound healing, reintervention, limb salvage, amputation-free survival, and survival using χ2, Kaplan-Meier, and Cox regression analyses. RESULTS: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1126 underwent a first-time revascularization for tissue loss, of which 253 patients had multiple wounds, 197 had wounds proximal to the ankle, 100 had unreliable wound information, and 576 (forefoot, n = 397; midfoot, n = 61; heel, n = 118) fit our criteria and had a single foot wound with reliable information regarding wound specifics. Patients with forefoot, midfoot, and heel wounds had similar rates of coronary artery disease, hypertension, diabetes, and smoking history (all P > .05). Conversely, there were significant differences in patient age (71 vs 69 vs 70 years), prevalence of gangrene (41% vs 5% vs 21%), and dialysis dependence (18% vs 17% vs 30%) (all P < .05). There were no statistically significant differences in perioperative mortality (1.3% vs 4.9% vs 4.2%; P = .06) or postoperative complications among the three groups. Between forefoot, midfoot, and heel wounds, there were significant differences in unadjusted 6-month rates of complete wound healing (69% vs 64% vs 53%), 3-year rates of amputation-free survival (54% vs 57% vs 35%), and survival (61% vs 72% vs 41%) (all P < .05). After adjustment, compared with forefoot wounds, heel wounds were associated with higher rates of incomplete 6-month wound healing (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.]), major amputation or mortality (HR, 1.7; 95% CI, 1.1-2.7), and all-cause mortality (HR, 1.8; 95% CI, 1.1-3.0), but not major amputation alone (HR, 2.1; 95% CI, 0.9-4.5). In open surgical bypass-first patients, heel wounds were solely associated with an increased risk of all-cause mortality (HR, 1.7; 95% CI, 1.1-2.8), whereas heel wounds in percutaneous transluminal angioplasty-first patients were associated with an increased risk of incomplete wound healing (HR, 2.2; 95% CI, 1.3-3.7), major amputation or mortality (HR, 2.3; 95% CI, 1.1-5.4), and all-cause mortality (HR, 2.8; 95% CI, 1.1-7.2). CONCLUSIONS: Heel wounds confer considerably higher short- and long-term morbidity and mortality compared with midfoot or forefoot wounds in patients undergoing any first-time lower extremity revascularization.

Validation of the Global Limb Anatomic Staging System in first-time lower extremity revascularization.

OBJECTIVE: The Global Limb Anatomic Staging System (GLASS) was developed as a new anatomic classification scheme to grade the severity of chronic limb threatening ischemia. We evaluated the ability of this anatomic grading system to determine major adverse limb events after lower extremity revascularization. METHODS: We performed a single-institutional retrospective review of 1060 consecutive patients who had undergone 1180 first-time open or endovascular revascularization procedures for chronic limb threatening ischemia from 2005 to 2014. Using the review of angiographic images, the limbs were classified as GLASS stage 1, 2, or 3. The primary composite outcome was reintervention, major amputation (below- or above-the-knee amputation), and/or restenosis (>3.5× step-up by duplex criteria) events (RAS). The secondary outcomes included all-cause mortality, failure to cross the lesion by endovascular methods, and a comparison between bypass vs endovascular intervention. Kaplan-Meier estimates were used to determine the event rates at 1 and 5 years, and Cox regression analysis was used to adjust for baseline differences among the GLASS stages. RESULTS: Of all patients undergoing first-time revascularization, imaging studies were available for 1180 procedures (91%) for GLASS grading. Of these procedures, 552 were open bypass (47%) and 628 were endovascular intervention (53%). Compared with GLASS stage 1 disease (n = 267, 23%), stage 2 (n = 367; 31%) and stage 3 (n = 546; 42%) disease were associated with a greater risk of RAS at 1 year (stage 1, 33% vs stage 2, 48% vs stage 3, 53%) and 5 years (stage 1, 45% [reference]; stage 2, 65%; hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.3-2.2; P < .001; stage 3, 69%; HR, 2.3; 95% CI, 1.7-2.9; P < .001). These differences were mainly driven by reintervention and restenosis rather than by major amputation. The 5-year mortality was similar for stage 2 and 3 compared with stage 1 disease (stage 1, 40% [reference]; stage 2, 45%; HR, 1.1; 95% CI, 0.8-1.4; P = .69; stage 3, 49%; HR, 1.2; 95% CI, 1.0-1.6; P = .11). For all attempted endovascular interventions, failure to cross a target lesion increased with advancing GLASS stage (stage 1, 4.5% vs stage 2, 6.3% vs stage 3, 13.3%; P < .01). Compared with open bypass (n = 552; 46.8%), endovascular intervention (n = 628; 53.3%) was associated with a higher rate of 5-year RAS for GLASS stage 1 (49% vs 34%; HR, 1.9; 95% CI, [1.1-3.5; P = .03), stage 2 (69% vs 52%; HR, 1.7; 95% CI, 1.2-2.5; P < .01), and stage 3 (83% vs 61%; HR, 1.5; 95% CI, 1.2-2.0; P < .01) disease. CONCLUSIONS: For patients undergoing first-time lower extremity revascularization, the GLASS can be used to predict for reintervention and restenosis. Bypass resulted in better long-term outcomes compared with endovascular intervention for all GLASS stages.

Enhanced Post-Operative Recovery with Continuous Peripheral Nerve Block After Lower Extremity Amputation.

BACKGROUND: Despite progress in perioperative care standards, there has not been a significant risk reduction in morbidity and mortality rates of lower extremity amputations, an intermediate risk surgery performed on high risk patients. The single-shot peripheral nerve block has shown equivocal impact on postoperative course following lower extremity amputation. Hence, we assessed the potential of preemptive use of continuous catheter-based peripheral nerve block in lower extremity amputations for reduction in pulmonary complications, acute post-operative pain scores, and opioid use in post-operative period. METHODS: A retrospective review of a quality improvement project initiated in 2018 was conducted to compare outcomes amongst general anesthesia in combination with a catheter-based peripheral nerve block (catheter group) and general anesthesia alone in patients receiving lower extremity amputation. The rate of postoperative pulmonary complications was identified as a primary endpoint. The secondary outcomes assessed were acute post-operative pain scores and opioid consumption up to 48 hours. Our analysis was adjusted for potential confounding variables inclusive of demographics, medical comorbidities, type of surgical procedure and smoking status. RESULTS: Ninety-six patients were included in the study (61 in the general anesthesia group, 35 in the catheter group). After adjusting for baseline demographics, comorbidities, surgical technique and smoking status, the odds of postoperative pulmonary complications were significantly lower with catheter-based peripheral nerve block in comparison to general anesthesia alone, OR 0.11 [95% CI, 0.01- 0.88] (P = 0.048). The decrease in acute pain scores was also observed in the catheter group when compared to general anesthesia alone, OR 0.72 [95% CI, 0.56 - 0.93] (P = 0.012). Similarly, the opioid consumption was also lower in the catheter group in comparison to general anesthesia alone, OR 0.97 [95% CI, 0.95 - 0.99] (P = 0.025). CONCLUSION: Preemptive use of continuous peripheral nerve block in patients undergoing lower extremity amputation reduces the incidence of pulmonary complications, acute postoperative pain scores and narcotic use in post-operative period.

Preoperative risk score for access site failure in ultrasound-guided percutaneous aortic procedures.

OBJECTIVE: The factors associated with access site failure after ultrasound-guided percutaneous access for aortic endograft procedures remain poorly characterized. We developed a prediction model to risk stratify patients for access site failure. METHODS: We performed a retrospective institutional review of consecutive patients who underwent endovascular aneurysm repair (EVAR), fenestrated EVAR (FEVAR), or thoracic endovascular aortic repair (TEVAR) from 2014 to 2016. We excluded patients undergoing direct aortic access through sternotomy and patients treated with physician-modified endografts, given reporting restrictions. Our primary outcome was groin access site failure, which included bleeding and thrombosis. An 8-point risk model was created for access site failure using multivariable fractional polynomials and internally validated using bootstrapping. RESULTS: We identified 469 femoral arteries from 247 patients undergoing endovascular aortic repair procedures (EVAR, 75%; FEVAR, 8.0%; TEVAR, 17%). Surgeons performed percutaneous access in 97.2% of the femoral arteries, with 99.6% ultrasound use. Twenty-seven (5.9%) access site failures occurred (17 bleeding, 10 thrombosis), all treated with groin cutdown, for a successful percutaneous femoral artery access rate of 94%. Of the 215 patients with attempted bilateral percutaneous access, 90% had successful bilateral access. However, FEVAR had lower rates of successful bilateral access (FEVAR, 78%; EVAR, 91%; TEVAR, 94%; P = .03). Factors independently associated with percutaneous access site failure were femoral artery outer wall diameter (per millimeter increase: odds ratio [OR], 0.003 [0.0002-0.1]; P < .001), femoral artery stenosis >50% (OR, 22.3 [2.7-183.2]; P < .01), and urgent/emergent intervention (OR, 3.6 [1.2-11.0]; P = .03). A risk prediction model based on these criteria produced a C statistic of 0.89, a Hosmer-Lemeshow goodness of fit of 0.99, and a Brier score of 0.04. Excluding treatment for ruptured aneurysms, cutdown for access failure and planned initial groin cutdown resulted in longer postoperative lengths of stay and higher rates of access-related readmission, return to operating room, groin infection, and myocardial infarction compared with successful percutaneous access. There was no difference in major adverse events between planned initial groin cutdown and cutdown after failure; however, the small number of patients in these two comparison groups limits the statistical power to detect a difference. CONCLUSIONS: Percutaneous ultrasound-guided access can be safely performed in almost all patients undergoing endovascular aortic procedures, but access site failures do occur. This risk score can help users select patients with high likelihood of success, identify patients who need close scrutiny with postclosure femoral duplex ultrasound, and provide patient guidance about risk of unplanned groin cutdown.

Outcomes after first-time lower extremity revascularization for chronic limb-threatening ischemia between patients with and without diabetes.

OBJECTIVE: The effect of diabetes type and insulin dependence on short- and long-term outcomes after lower extremity revascularization for chronic limb-threatening ischemia (CLTI) warrants additional study and more targeted focus. We sought to address this paucity of information by evaluating outcomes in insulin-dependent and noninsulin-dependent patients after any first-time revascularization. METHODS: We reviewed all limbs undergoing first-time infrainguinal bypass grafting (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. Based on preoperative medication regimen, patients were categorized as having insulin-dependent diabetes (IDDM), noninsulin-dependent diabetes (NIDDM), or no diabetes (NDM). Outcomes included wound healing; major amputation; RAS events (reintervention, major amputation, or stenosis); major adverse limb events; and mortality. Outcomes were evaluated using χ2, Kaplan-Meier, and Cox regression analyses. RESULTS: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1294 limbs (646 BPG, 648 PTA/S) fit our criteria. Overall, our analysis included 703 IDDM, 262 NIDDM, and 329 NDM limbs. IDDM patients, compared with NIDDM and NDM patients, were younger (69 vs 73 vs 77 years; P < .001) and more often presented with tissue loss (89% vs 77% vs 67%; P < .001), coronary artery disease (57% vs 48% vs 43%; P < .001), and end-stage renal disease (26% vs 13% vs 12%; P < .001). Perioperative complications, including mortality (3% vs 2% vs 5%; P = .07), did not differ between groups; however, complete wound healing at 6-month follow-up was significantly worse among IDDM patients (41% vs 49% vs 61%; P < .001). IDDM patients had significantly higher 3-year major amputation rates (23% vs 11% vs 8%; P < .001). Multivariable analyses illustrated that compared with NDM, IDDM was associated with significantly higher risk of both major amputation and RAS events after any first-time intervention (hazard ratio, 2.0 [95% confidence interval, 1.1-4.1] and 1.4 [1.1-1.8], respectively). Similar associations between IDDM and both major amputation and RAS events were found in patients undergoing a PTA/S-first intervention (4.1 [1.3-12.6] and 1.5 [1.1-2.2], respectively), whereas IDDM in BPG-first patients was associated with only incomplete wound healing (2.0 [1.4-4.5]). Last, compared with NDM, NIDDM was associated with lower late mortality (0.7 [0.5-0.9]). CONCLUSIONS: Compared with NDM, IDDM is associated with similar perioperative and long-term mortality but a higher risk of incomplete wound healing, major amputation, and future RAS events, especially after a PTA/S-first approach. NIDDM, on the other hand, is associated with lower long-term mortality and few adverse limb events. Overall, these data demonstrate both the importance of distinguishing between diabetes types and the potential long-term benefit of a BPG-first strategy in appropriately selected IDDM patients with CLTI.

Outcomes after first-time lower extremity revascularization for chronic limb-threatening ischemia in insulin-dependent diabetic patients.

OBJECTIVE: Historically, open surgical bypass provided a durable repair among diabetic patients with chronic limb-threatening ischemia (CLTI). In the current endovascular era, however, the difference in long-term outcomes between first-time revascularization strategies among patients with insulin-dependent diabetes mellitus (IDDM) is poorly understood. METHODS: We reviewed the records of all patients with IDDM undergoing a first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. We defined IDDM as use of chronic insulin administration at baseline to control blood glucose levels and recorded the most recent glycated hemoglobin value available within 3 months before the procedure and fasting blood glucose level on the day of the procedure. We compared rates of wound healing, restenosis, reintervention, major amputation, and mortality between BPG and PTA/S in our population using χ2, Kaplan-Meier, and Cox regression analyses. As a sensitivity analysis, we calculated propensity scores and employed inverse probability weighting to account for nonrandom assignment to BPG vs PTA/S. RESULTS: Of 2869 infrainguinal revascularizations from 2005 to 2014, 655 limbs (316 BPG, 339 PTA/S) in 580 patients fit our criteria and underwent a first-time revascularization for CLTI. Patients undergoing BPG, compared with PTA/S, were similar in age (69 vs 68 years; P = .55), had similar rates of tissue loss (87% vs 91%; P = .07) and dialysis dependence (26% vs 28%; P = .55), were less likely to be hypertensive (84% vs 92%; P < .001), and were more likely to be current smokers (21% vs 14%; P = .02). There were no differences between BPG and PTA/S patients in mean glycated hemoglobin levels (8.1% vs 8.0%; P = .51) or mean fasting blood glucose levels (158 vs 150 mg/dL; P = .18). Although total hospital length of stay was significantly longer among BPG patients (11 vs 8 days; P < .001), perioperative complications did not differ, including acute kidney injury (19% vs 23%; P = .24), hematoma (6.0% vs 3.8%; P = .20), acute myocardial infarction (1.3% vs 2.1%; P = .43), and mortality (3.8% vs 3.0%; P = .55). BPG-first patients had significantly lower unadjusted 6-month rates of incomplete wound healing (49% vs 57%) and 5-year rates of restenosis (53% vs 72%) and reintervention (47% vs 58%; all P < .05). After adjustment, multivariable analysis suggested PTA/S-first intervention to be significantly associated with higher risk of restenosis (hazard ratio, 1.9; 95% confidence interval, 1.3-2.7) and reintervention (1.9 [1.2-2.7]). These results remained robust after inverse probability weighting. CONCLUSIONS: Among patients with IDDM and CLTI, a bypass-first strategy is associated with similar 30-day outcomes and lower restenosis and reintervention rates. These data suggest that a bypass-first approach may best serve appropriately selected, anatomically suitable patients with IDDM and pedal ischemia that requires revascularization.

Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training.

OBJECTIVE: Endovascular aneurysm repair has led to a significant reduction in vascular trainee experience in the surgical treatment of aortic aneurysms. We sought to evaluate whether the vascular training paradigm or the "endovascular first" approach to lower extremity vascular disease has had a similar effect on trainee experience with infrapopliteal endovascular therapy and vein bypass. METHODS: Deidentified data were provided by the Vascular Surgery Board on the number of procedures performed by each 2014 fellowship and residency (0 + 5) graduate during training. Data were analyzed using parametric and nonparametric methods, where appropriate. RESULTS: Of 125 trainees (109 fellows, 16 residents), 33 (27%) performed 10 or fewer infrapopliteal vein bypasses and 37 (29%) performed 10 or fewer infrapopliteal endovascular procedures during their training. Eleven trainees (9%) performed 10 or fewer of both procedures. There was a positive correlation between number of infrapopliteal vein bypass and endovascular procedures performed (r = 0.19; P = .03). There was no difference between fellows and residents in the mean number of bypass operations performed during training (17.3 vs 19.1; P = .50; range, 0-53). However, residents performed more infrapopliteal endovascular procedures than fellows did (median, 29 vs 16; P = .03; range, 0-128). CONCLUSIONS: More than one in four graduates of both training paradigms finish with a low number of infrapopliteal bypasses and endovascular interventions. The number of these procedures needed for proficiency is not known. Vascular surgery training programs should critically evaluate the number of infrapopliteal procedures required to achieve proficiency.

Treatment outcomes in diabetic patients with chronic limb-threatening ischemia.

OBJECTIVE: There are conflicting reports about outcomes after infrainguinal bypass for chronic limb-threatening ischemia (CLTI) in patients with diabetes. We compared perioperative outcomes between patients with and patients without diabetes in the current era. METHODS: The National Surgical Quality Improvement Program vascular module, 2011 to 2014, was used to identify patients undergoing infrainguinal revascularization for CLTI. Patients with and without diabetes were compared in terms of presentation, comorbidities, operative approach, and 30-day outcomes. Major adverse limb events (MALEs) included 30-day major reintervention or amputation, and major adverse cardiovascular events (MACEs) included 30-day myocardial infarction, cardiac arrest, stroke, or death. Multivariable logistic regression was used to adjust for baseline differences. RESULTS: We identified 8887 patients undergoing open (5744; 50% diabetic) or endovascular (3143; 62% diabetic) treatment for CLTI. Patients with diabetes were younger and more often nonwhite, nonsmokers, and obese. Patients with diabetes presented more often with tissue loss (71% vs 47%; P < .001) and were more likely to be treated with endovascular intervention (41% vs 29%; P < .001). The 30-day mortality was similar before (open, 3.1% vs 2.8% [P = .53]; endovascular, 2.6% vs 2.1% [P = .37]) and after adjustment for baseline differences (open: odds ratio [OR], 1.1 [95% confidence interval (CI), 0.7-1.5]; endovascular: OR, 1.2 [95% CI, 0.7-2.0]). Patients with diabetes had longer lengths of stay (open, 8 vs 6 days [P < .001]; endovascular, 3 vs 2 days [P < .001]) and higher 30-day readmission rates (open, 21% vs 18% [P < .01]; endovascular, 20% vs 15% [P < .01]); however, these differences were no longer significant after adjustment for baseline differences. Patients with diabetes had a higher rate of MACEs (7.0% vs 5.1%; P < .01) and lower rate of MALEs (8.1% vs 10%; P < .01) after bypass. After adjustment, patients with diabetes still had a lower rate of MALEs (OR, 0.7; 95% CI, 0.6-0.9) but no longer had a higher rate of MACEs (OR, 1.2; 95% CI, 0.9-1.6). CONCLUSIONS: CLTI patients with diabetes undergoing revascularization have similar 30-day outcomes compared with those without diabetes, although they appear to be at lower risk for MALEs after bypass. Prolonged length of stay and readmission in patients with diabetes is not due to underlying diabetic disease but likely secondary to other baseline comorbidities, such as higher rates of tissue loss. Concern for worse perioperative outcomes in patients with diabetes after lower extremity bypass is unsubstantiated and should not discourage a physician from performing an open bypass.

Results for primary bypass versus primary angioplasty/stent for lower extremity chronic limb-threatening ischemia.

BACKGROUND: Long-term results comparing percutaneous transluminal angioplasty with or without stenting (PTA/S) and open surgical bypass for chronic limb-threatening ischemia (CLTI) in patients who have had no prior intervention are lacking. METHODS: All patients undergoing a first-time lower extremity revascularization for CLTI by vascular surgeons at our institution from 2005 to 2014 were retrospectively reviewed. Outcomes included perioperative complications, wound healing, restenosis, primary patency, reintervention, major amputation, RAS events (ie, reintervention, major amputation, or stenosis), and mortality. Outcomes were evaluated using χ2, Kaplan-Meier, and Cox regression analyses. RESULTS: Of the 2869 total lower extremity revascularizations performed between 2005 and 2014, there were 1336 that fit our criteria of a first-time lower extremity intervention for CLTI (668 bypass procedures and 668 PTA/S procedures). Bypass patients were younger (71 vs 72 years; P = .02) and more often male (62% vs 56%; P < .02). Total mean hospital length of stay (LOS) was significantly longer after a first-time bypass (10 vs 8 days; P < .001), as were mean preoperative LOS (4 vs 3 days; P < .01) and postoperative LOS (7 vs 5 days; P < .001). There was no difference in perioperative mortality (3% vs 3%; P = .63). Surgical site infection occurred in 10% of bypass patients. Freedom from reintervention was significantly higher in patients undergoing a first-time bypass procedure (62% vs 52% at 3 years; P = .04), as was freedom from restenosis (61% vs 45% at 3 years; P < .001). Complete wound healing at 6-month follow-up was significantly better after an initial bypass (43% vs 36%; P < .01). A Cox regression model of all patients showed that reintervention was predicted by a first-time PTA/S (hazard ratio, 1.6; 95% confidence interval, 1.3-2.1) and both preoperative femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and TASC D lesions (2.0 [1.3-3.1] and 1.8 [1.3-2.7], respectively). Major amputation among all patients was predicted by an initial presentation of gangrene (2.5 [1.3-5.0]), dialysis dependence (1.9 [1.3-2.9]), diabetes (2.0 [1.1-3.8]), and preoperative femoropopliteal TASC D lesions (2.1 [1.1-4.0]) and was not predicted by procedure type. CONCLUSIONS: In this retrospective analysis, bypass for the primary treatment of CLTI showed improved 6-month wound healing, higher freedom from restenosis, improved patency rates, significantly fewer reinterventions, and higher survival than PTA/S within 3 years; however, a bypass-first approach was associated with increased total hospital LOS and wound infection. Perioperative mortality and amputation rates were similar between procedure types.

Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system after first-time lower extremity revascularizations.

OBJECTIVE: The Society for Vascular Surgery (SVS) Wound, Ischemia and foot Infection (WIfI) classification system was proposed to predict 1-year amputation risk and potential benefit from revascularization. Our goal was to evaluate the predictive ability of this scale in a real-world selection of patients undergoing a first-time lower extremity revascularization for chronic limb-threatening ischemia (CLTI). METHODS: From 2005 to 2014, 1336 limbs underwent a first-time lower extremity revascularization for CLTI, of which 992 had sufficient data to classify all three WIfI components (wound, ischemia, and foot infection). Limbs were stratified into the SVS WIfI clinical stages (from 1 to 4) for 1-year amputation risk estimation, a novel WIfI composite score from 0 to 9 (that weighs all WIfI variables equally), and a novel WIfI mean score from 0 to 3 (that can incorporate limbs missing any of the three WIfI components). Outcomes included major amputation; revascularization, major amputation, or stenosis (>3.5× step-up by duplex; RAS) events; and death. Predictors were identified using Cox regression models and Kaplan-Meier survival estimates. RESULTS: Of the 1336 first-time procedures performed, 992 limbs were classified in all three WIfI components (524 endovascular and 468 bypass; 26% rest pain and 74% tissue loss). Cox regression demonstrated that a one-unit increase in the WIfI clinical stage increases the risk of major amputation (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.7-3.2) and RAS events in all limbs (HR, 1.2; 95% CI, 1.1-1.3). Separate models of the entire cohort, a bypass-only cohort, and an endovascular-only cohort showed that a one-unit increase in the WIfI mean score is associated with an increase in the risk of major amputation (all three cohorts: HR, 5.3 [95% CI, 3.6-6.8], 4.1 [2.4-6.9], and 6.6 [3.8-11.6], respectively) and RAS events (all three cohorts: HR, 1.7 [95% CI, 1.4-2.0], 1.9 [1.4-2.6], and 1.4 [1.1-1.9], respectively). The novel WIfI composite and WIfI mean scores were the only consistent predictors of death among the three cohorts, with the WIfI mean score proving most strongly predictive in the entire cohort (HR, 1.4; 95% CI, 1.1-1.7), the bypass-only cohort (HR, 1.5; 95% CI, 1.1-1.9), and the endovascular-only cohort (HR, 1.4; 95% CI, 1.0-1.8). Although the individual WIfI wound component was able to predict mortality among all patients (HR, 1.1; 95% CI, 1.0-1.2) and bypass-only patients (HR, 1.2; 95% CI, 1.1-1.3), neither the additional individual WIfI components nor the WIfI clinical stage were able to significantly predict mortality among any cohort. CONCLUSIONS: This study supports the ability of the SVS WIfI classification system to predict major amputation; however, the novel WIfI mean and WIfI composite scores predict amputation, RAS events, and mortality more consistently than any other current WIfI scoring system. The WIfI mean score allows inclusion of all limbs, and both novel scoring systems are easier to conceptualize, give equal weight to each WIfI component, and may provide clinicians more effective comparisons in outcomes between patients.

Patient selection and perioperative outcomes are similar between targeted and nontargeted hospitals (in the National Surgical Quality Improvement Program) for abdominal aortic aneurysm repair.

OBJECTIVE: The targeted vascular module in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) consists of self-selected hospitals that choose to collect extra clinical details for better risk adjustment and improved procedure-specific outcomes. The purpose of this study was to compare patient selection and outcomes between targeted and nontargeted hospitals in the NSQIP regarding the operative management of abdominal aortic aneurysm (AAA). METHODS: We identified all patients who underwent endovascular aneurysm repair (EVAR) or open AAA repair from 2011 to 2013 and compared cases by whether the operation took place in a targeted or nontargeted hospital. EVAR and open repair as well as intact and ruptured aneurysms were evaluated separately. Only variables contained in both modules were used to evaluate rupture status and operation type. All thoracoabdominal aneurysms were excluded. Univariate analysis was performed for intact and ruptured EVAR and open repair grouped by complexity, defined as visceral involvement in open repair and a compilation of concomitant procedures for EVAR. Multivariable models were developed to identify effect of hospital type on mortality. RESULTS: There were 17,651 AAA repairs identified. After exclusion of aneurysms involving the thoracic aorta (n = 352), there were 1600 open AAA repairs at targeted hospitals (21% ruptured) and 2725 at nontargeted hospitals (19% ruptured) and 4986 EVARs performed at targeted hospitals (6.7% ruptured) and 7988 at nontargeted hospitals (5.2% ruptured). There was no significant difference in 30-day mortality rates between targeted and nontargeted hospitals for intact aneurysms (EVAR noncomplex, 1.8% vs 1.4% [P = .07]; open repair noncomplex, 4.2% vs 4.5% [P = .7]; EVAR complex, 5.0% vs 3.2% [P = .3]; open repair complex, 8.0% vs 6.0% [P = .2]). For ruptured aneurysms, again there was no difference in mortality between the targeted and nontargeted hospitals (EVAR noncomplex, 23% vs 25% [P = .4]; open repair noncomplex, 38% vs 34% [P = .2]; EVAR complex, 29% vs 33% [P = 1.0]; open repair complex, 27% vs 41% [P = .09]). Multivariable analysis further demonstrated that having an operation at a targeted vs nontargeted hospital had no impact on mortality for both intact and ruptured aneurysms (odds ratio, 1.1 [0.9-1.4] and 1.0 [0.8-1.3], respectively). CONCLUSIONS: This analysis highlights the similarities between targeted and nontargeted hospitals within the NSQIP for AAA operative management and suggests that data from the targeted NSQIP, in terms of AAA management, are generalizable to all NSQIP hospitals.

Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system following infrapopliteal endovascular interventions for critical limb ischemia.

OBJECTIVE: The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee has composed a new threatened lower extremity classification system that reflects the three major factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Our goal was to evaluate the predictive ability of this scale following any infrapopliteal endovascular intervention for critical limb ischemia (CLI). METHODS: From 2004 to 2014, a single institution, retrospective chart review was performed at the Beth Israel Deaconess Medical Center for all patients undergoing an infrapopliteal angioplasty for CLI. Throughout these years, 673 limbs underwent an infrapopliteal endovascular intervention for tissue loss (77%), rest pain (13%), stenosis of a previously treated vessel (5%), acute limb ischemia (3%), or claudication (2%). Limbs missing a grade in any WIfI component were excluded. Limbs were stratified into clinical stages 1 to 4 based on the SVS WIfI classification for 1-year amputation risk, as well as a novel WIfI composite score from 0 to 9. Outcomes included patient functional capacity, living status, wound healing, major amputation, major adverse limb events, reintervention, major amputation, or stenosis (RAS) events (> ×3.5 step-up by duplex), amputation-free survival, and mortality. Predictors were identified using Kaplan-Meier survival estimates and Cox regression models. RESULTS: Of the 596 limbs with CLI, 551 were classified in all three WIfI domains on a scale of 0 (least severe) to 3 (most severe). Of these 551, 84% were treated for tissue loss and 16% for rest pain. A Cox regression model illustrated that an increase in clinical stage increases the rate of major amputation (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.3). Separate regression models showed that a one-unit increase in the WIfI composite score is associated with a decrease in wound healing (HR, 1.2; 95% CI, 1.1-1.4) and an increase in the rate of RAS events (HR, 1.2; 95% CI, 1.1-1.4) and major amputations (HR, 1.4; 95% CI, 1.2-1.8). CONCLUSIONS: This study supports the ability of the SVS WIfI classification system to predict 1-year amputation, RAS events, and wound healing in patients with CLI undergoing endovascular infrapopliteal revascularization procedures.

Open surgical revision provides a more durable repair than endovascular treatment for unfavorable vein graft lesions.

OBJECTIVE: Lower extremity bypass grafts that develop stenoses are commonly treated with either open surgical or endovascular revision. Vein graft stenoses with unfavorable lesions (multiple lesions, lesions >2 cm in length, lesions in grafts <3 months old, lesions in grafts <3 mm in diameter) fare worse than those with favorable lesions when treated with endovascular therapy. However, it is not known if unfavorable lesions fare better with surgical revision than with endovascular treatment or than favorable lesions treated with surgery. METHODS: We performed a retrospective review of 175 vein graft revisions performed at a single institution from 2000 to 2010. Characteristics of lesions treated with surgical and endovascular revision were identified. Cox proportional hazard models were used to identify predictors of revision failure (restenosis >75%, revision, or amputation). RESULTS: Ninety-one failing vein grafts (52%) were treated with surgical revision and 84 with endovascular treatment (48%), with a median follow-up of 30 months. Favorable lesions fared better than unfavorable lesions after endovascular treatment, with 12-month freedom from failure of 59% vs 34% (P < .01), but not after surgical revision (66% vs 62%; P = .90). Unfavorable lesions had better freedom from failure after surgery than endovascular treatment (62% vs 34%; P < .01), and results in favorable lesions were similar (66% vs 59%; P = .57). CONCLUSIONS: For the treatment of failing vein grafts, endovascular therapy appears adequate for favorable lesions and surgical revision is more durable for unfavorable lesions.

Outcomes for symptomatic abdominal aortic aneurysms in the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: Historically, symptomatic abdominal aortic aneurysms (AAAs) were found to have intermediate mortality compared with asymptomatic and ruptured AAAs; but with wider use of endovascular aneurysm repair (EVAR), a more recent study suggested that mortality of symptomatic aneurysms was similar to that of asymptomatic AAAs. These prior studies were limited by small numbers. The purpose of this study was to evaluate the mortality and morbidity associated with symptomatic AAA repair in a large contemporary population. METHODS: All patients undergoing infrarenal AAA repair were identified in the 2011 to 2013 American College of Surgeons National Surgical Quality Improvement Program, vascular surgery targeted module. We excluded acute conversions to open repair and those for whom the surgical indication was embolization, dissection, thrombosis, or not documented. We compared 30-day mortality and major adverse events for asymptomatic, symptomatic, and ruptured AAA repair, stratified by EVAR and open repair, with univariate analysis and multivariable logistic regression. RESULTS: There were 5502 infrarenal AAAs identified, 4495 asymptomatic aneurysms (830 open repair, 3665 [82%] EVAR), 455 symptomatic aneurysms (143 open repair, 312 [69%] EVAR), and 552 ruptured aneurysms (263 open repair, 289 [52%] EVAR). Aneurysm diameter was similar between asymptomatic and symptomatic AAAs when stratified by procedure type, but it was larger for ruptured aneurysms (EVAR: symptomatic 5.8 ± 1.6 cm vs ruptured 7.5 ± 2.0 cm [P < .001]; open repair: symptomatic 6.4 ± 1.9 cm vs ruptured 8.0 ± 1.9 cm [P < .001]). The proportion of women was similar in symptomatic and ruptured AAAs (27% vs 23%, respectively; P = .14) but lower in asymptomatic AAAs (20%; P < .001). Symptomatic AAAs had intermediate 30-day mortality compared with asymptomatic and ruptured aneurysms after both EVAR (1.4% asymptomatic vs 3.8% symptomatic [P = .001]; symptomatic vs 22% ruptured [P < .001]) and open repair (4.3% asymptomatic vs 7.7% symptomatic [P = .08]; symptomatic vs 34% ruptured [P < .001]). After adjustment for age, gender, repair type, dialysis dependence, and history of severe chronic obstructive pulmonary disease, patients undergoing repair of symptomatic AAAs were twice as likely to die within 30 days compared with those with asymptomatic aneurysms (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.3-3.5). When stratified by repair type, the effect size and direction of the ORs were similar (EVAR: OR, 2.4 [95% CI, 1.2-4.7]; open repair: OR, 1.8 [95% CI, 0.86-3.9]) although not significant for open repair. Patients with ruptured aneurysms had a sevenfold increased risk of 30-day mortality compared with symptomatic patients (OR, 6.5; 95% CI, 4.1-10.6). CONCLUSIONS: Patients with symptomatic AAAs had a twofold increased risk of perioperative mortality compared with patients with asymptomatic aneurysms undergoing repair. Furthermore, patients with ruptured aneurysms have a sevenfold increased risk of mortality compared with patients with symptomatic aneurysms.

Risk factors and consequences of persistent type II endoleaks.

OBJECTIVE: Type II endoleaks are common after endovascular aneurysm repair (EVAR), but their clinical significance remains undefined and their management controversial. We determined risk factors for type II endoleaks and associations with adverse outcomes. METHODS: We identified all EVAR patients in the Vascular Study Group of New England abdominal aortic aneurysm database. Patients were subdivided into two groups: (1) those with no endoleak or transient type II endoleak and (2) persistent type II endoleak or new type II endoleak (no endoleak at completion of case). Patients with other endoleak types and follow-up shorter than 6 months were excluded. Multivariable analysis was used to evaluate predictors of persistent or new type II endoleaks. Kaplan-Meier and Cox regression analysis were used to evaluate predictors of reintervention and survival. RESULTS: Two thousand three hundred sixty-seven EVAR patients had information on endoleaks: 1977 (84%) were in group 1, of which 79% had no endoleaks at all, and 21% had transient endoleaks that resolved at follow-up. The other 390 (16%) were in group 2, of which 31% had a persistent leak, and 69% had a new leak at follow-up that was not seen at the time of surgery. Group 2 was older (mean age, 75 vs 73 years; P < .001) and less likely to have chronic obstructive pulmonary disease (COPD; 24% vs 34%; P < .001) or elevated creatinine levels (2.6% vs 5.3%; P = .027). Coil embolization of one or both hypogastric arteries was associated with a higher rate of persistent type II endoleaks (12 vs 8%; P = .024), as was distal graft extension (12% vs 8%; P = .008). In multivariable analysis, COPD (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.5-0.9; P = .017) was protective against persistent type II endoleak, while hypogastric artery coil embolization (OR, 1.5; 95% CI, 1.0-2.2; P = .044), distal graft extension (OR, 1.6; 95% CI, 1.1-2.3; P = .025), and age ≥ 80 (OR, 2.7; 95% CI, 1.4-5.3; P = .004) were predictive. Graft type was also associated with endoleak development. Persistent type II endoleaks were predictive of postdischarge reintervention (OR, 15.3; 95% CI, 9.7-24.3; P < .001); however, they were not predictive of long-term survival (OR, 1.1; 95% CI, 0.9-1.6; P = .477). CONCLUSIONS: Persistent type II endoleak is associated with hypogastric artery coil embolization, distal graft extension, older age, the absence of COPD, and graft type, but not with aneurysm size. Persistent type II endoleaks are associated with an increased risk of reinterventions, but not rupture or survival. This reinforces the need for continued surveillance of patients with persistent type II endoleaks and the importance of follow-up to detect new type II endoleaks over time.

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease: Executive summary.

Recommended reporting standards for lower extremity ischemia were last published by the Society for Vascular Surgery in 1997. Since that time, there has been a proliferation of endovascular therapies for the treatment of chronic peripheral arterial disease. The purpose of this document is to clarify and update these standards, specifically for reports on endovascular treatment. The document is divided into sections: Claudication Reporting, Critical Limb Ischemia Reporting, Preintervention Assessment and Nonanatomic Treatment, Intervention, Outcome Measures - Procedural, Outcome Measures - Disease Specific, and Complications.

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease.

Peripheral arterial disease (PAD) represents a spectrum from asymptomatic stenosis to limb-threatening ischemia. The last decade has seen a tremendous increase in the variety of endovascular devices and techniques to treat occlusive disease. Like many evolving technologies, the literature surrounding therapy for endovascular arterial disease consists of mixed-quality manuscripts without clear standardization. Accordingly, critical evaluation of the reported results may be problematic. As such, providers and their patients make treatment decisions without the full benefit of a comparative effectiveness framework. The purpose of this document is to provide a summary for the reporting of endovascular revascularization techniques in the setting of chronic disease. Much of the work in this document is based on prior publications and standards proposed by the Society for Vascular Surgery. We have also made recommendations based on current literature and have attempted to acknowledge shortcomings and areas for future research. The various sections contain summaries of required reporting standards and should serve as a guide for the design of clinical trials and as reference for journal editors and reviewers when considering scientific work pertaining to endovascular therapy for chronic lower extremity arterial disease. An Appendix is provided with commonly used abbreviations in this document.