Infrapopliteal Endovascular Interventions for Claudication Are Associated with Poor Long-Term Outcomes in Medicare-Matched Registry Patients.

BACKGROUND: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.

Sex-related Outcomes after Thoracic Endovascular Repair for intact isolated Descending Thoracic Aortic Aneurysm: A Retrospective Cohort Study.

OBJECTIVE: To evaluate the association between sex and outcomes following TEVAR for intact isolated descending thoracic aortic aneurysms (iiDTAA). SUMMARY BACKGROUND DATA: Data regarding sex-related long-term outcomes after TEVAR for iiDTAA are limited and conflicting results regarding perioperative outcomes have been reported. METHODS: We included all TEVAR for iiDTAA between 2014-2019 in the Vascular Quality Initiative linked to Medicare claims, allowing reliable assessment of long-term outcome data. Primary outcomes included 5-year mortality, reinterventions, and ruptures of the thoracic aorta. Secondarily we assessed perioperative outcomes. RESULTS: We identified 685 patients, of which 54% were females. Females had higher aortic size index (females vs. males: 3.31 [IQR, 2.81-3.85] cm/m2 vs. 2.93 [IQR, 2.42-3.36] cm/m2; P<.001), were more frequently symptomatic (31% vs. 20%; P=.001), had longer procedure time (111 [IQR, 72-165] min vs. 97 [IQR, 70-146] min) and more iliac procedures (16% vs. 7.6%; P=.001). Compared with males, females had similar rates of 5-year mortality (58% vs. 53%; HR, 0.93; 95%CI 0.71-1.22; P=.61), reinterventions (39% vs. 30%; HR, 1.12; 95%CI 0.73-1.73; P=.60) and late ruptures (0.6% vs. 1.2%; HR, 0.87; 95%CI 0.12-6.18; P=.89). After adjustment, these outcomes remained similar through 5-years. Furthermore, perioperative mortality was not significantly different between sexes (4.1% vs. 2.2%; P=.25), as were rates of any complication as a composite outcome (16% vs. 21%; P=.16), as well as of individual complications (all P>.05). CONCLUSIONS: Our findings suggest that females who undergo TEVAR for iiDTAA have similar 5-year and perioperative outcomes as compared with males.

In-hospital and one-year outcomes are similar for women and men following transcarotid artery revascularization in symptomatic and asymptomatic patients.

OBJECTIVE: In randomized controlled trials and retrospective series, women have higher rates of periprocedural stroke and death following carotid endarterectomy and transfemoral carotid artery stenting compared with men. We sought to compare outcomes by sex following transcarotid artery revascularization (TCAR) among patients in the Vascular Quality Initiative (VQI). METHODS: We reviewed all patients in the VQI who underwent TCAR from 2017 to 2020. We stratified the analysis by symptom status. The primary outcome was in-hospital stroke/death, and secondary outcomes were in-hospital stroke and death and 1-year stroke/death, stroke, and death. We used multivariable logistic and Cox regression models to assess the association of sex with in-hospital and 1-year outcomes after adjusting for preoperative and intraoperative characteristics. RESULTS: We identified 15,851 patients who underwent TCAR, of whom 7391 (47%) were symptomatic (2708 or 37% female) and 8460 (53%) were asymptomatic (3097 or 37% female). Women were less frequently considered anatomic high risk than men in both groups (symptomatic: 43% vs 46%; P = .004; asymptomatic: 44% vs 48%; P = .004). Among symptomatic patients, women more often had severe ≥70% stenosis (89% vs 87%; P = .02). There were no differences in in-hospital death, stroke, or stroke/death for women vs men following TCAR among symptomatic or asymptomatic patients (all P > .05). After adjusting for baseline differences between groups, female sex was not associated with in-hospital stroke/death in either symptomatic (odds ratio, 1.05; 95% confidence interval, 0.72-1.56) or asymptomatic (odds ratio, 0.93; 95% confidence interval, 0.53-1.63) patients undergoing TCAR. There were also no differences in 1-year stroke, death, or stroke/death risk for women compared with men with and without symptoms on unadjusted or adjusted analyses (P > .05). CONCLUSIONS: We found no sex differences in in-hospital or 1-year stroke/death following TCAR, regardless of symptom status. TCAR appears to be as safe of a surgical procedure for women as for men in patients with both symptomatic and asymptomatic carotid artery disease.

Patient-centered clinical success after lower extremity revascularization for complex diabetic foot wounds treated in a multidisciplinary setting.

OBJECTIVE: Physician-oriented outcomes, such as patency and amputation-free survival (AFS), have traditionally been markers of success after lower extremity revascularization. Previous studies have defined clinical success based on a composite of patient-centered outcomes and have shown this outcome to be achieved in less than 50% of patients, far lower than standard physician-oriented outcomes. The purpose of this study is to evaluate clinical success after lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for tissue loss in diabetic patients treated in a multidisciplinary setting to better understand what factors are associated with success from a patient's perspective. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from July 2012 to January 2020 were enrolled in a prospective database. Patients who underwent either LEB or PVI for ulcer or gangrene were included in the analysis. Clinical success was defined as the composite outcome of secondary patency to the point of wound healing, limb salvage for 1 year, maintenance of ambulatory status for 1 year, and survival for 6 months. Secondary outcomes included 1-year wound healing, patency, and AFS. RESULTS: A total of 134 revascularizations were performed in 131 patients, including 91 (68%) PVI and 43 (32%) LEB. Patients were more frequently male (64%) and black (61%), and 16% were dialysis-dependent. All patients had tissue loss (53% ulcer, 47% gangrene). There were 5 (3.7%) wound, ischemia, and foot infection stage 1, 6 (6.0%) stage 2, 29 (22%) stage 3, and 92 (69%) stage 4 limbs at the time of revascularization. Overall, 76.9% of patients preserved secondary patency to the point of wound healing, 92.5% had limb salvage for 1 year, 90.3% had maintenance of ambulatory status for 1 year, and 96.3% survived for 6 months. The clinical success composite outcome was achieved in 71.6% of patients and was not statistically different between those undergoing PVI vs LEB (69.2% vs 76.7%, P = .37). Secondary patency, limb salvage, and AFS at 1 year were 80.8% ± 3.6%, 91.8% ± 2.3%, and 83.3% ± 3.1%, respectively. Wound healing at 1 year was 84.3% ± 3.4%. The only covariate associated with clinical failure on multivariable analysis was increased age (odds ratio, 0.95; 95% confidence interval, 0.91-0.99; P = .008). CONCLUSIONS: Among diabetic patients presenting with tissue loss, the composite outcome of patient-centered clinical success is lower than traditional physician-centered outcomes after lower extremity revascularization, mostly due to low rates of secondary patency to the point of wound healing. In the current study, clinical failure was only associated with older age and was no different after PVI compared with LEB.

Use of Intravascular Ultrasound During First-Time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries.

BACKGROUND: Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI. METHODS: We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS. RESULTS: We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons. CONCLUSIONS: Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.

Drug-Eluting Stents are Associated with Superior Mid-Term Outcomes for the Treatment of Infrainguinal Bypass Graft Stenoses.

BACKGROUND: We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study is to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses. METHODS: We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (August 2010-August 2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups. RESULTS: Seventy-two consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1 ± 10.6 years, 55.6% were male, and 48.6% were Black. In total, 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n = 67) were treated with PTA, 17.8% (n = 27) with PCB, 20.4% (n = 31) with DCB, and 17.8% (n = 27) with eDES. Median follow-up was 28.5 months (interquartile range 11.5-51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24 months postintervention, PP was significantly better for eDES (72.9%, 95% confidence interval [CI] 49.8-85.6), followed by PCB (55.9%, 95% CI 34.2-72.9), PTA (34.4%, 95% CI 21.7-47.4), and DCB (33.6%, 95% CI 14.5-53.9) (P = 0.03). PAP, LS, and mortality did not significantly differ between modalities (P > 0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (hazard ratio versus PTA 0.15, 95% CI 0.05-0.47). CONCLUSIONS: eDES is associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.

The long-term implications of access complications during endovascular aneurysm repair.

BACKGROUND: Access issues are one of the most common complications of endovascular aneurysm repair (EVAR). However, contemporary rates as well as risk factors for complications and the subsequent impact of access complications on mortality are poorly described. METHODS: We studied all EVAR for intact abdominal aortic aneurysms without prior aortic surgery in the Vascular Quality Initiative between 2011 and 2018. We studied factors associated with access complications (thrombosis, embolus, wound infection, hematoma, and conversion to cutdown), as well as the interaction with female sex and the impact on survival using multilevel logistic regression and propensity weighting. Multiple imputation was used for missing data. RESULTS: There were 33,951 EVAR during the study period (91% elective, 9% symptomatic); most cases (70%) involved an attempt at percutaneous access on at least one side, with 30% bilateral cutdowns and 0.1% iliac conduits. There were 1553 patients (4.6%) who experienced at least one access complication. Access complications were almost twice as common in female patients (7.5% vs 3.9%; P < .001). The factors associated with access complications included female sex (odds ratio [OR], 2.7; 95% confidence interval [CI], 2.0-3.6; P < .001), age (OR, 1.05 per 5 years; 95% CI, 1.02-1.1; P < .01), aortouni-iliac device (OR, 1.6; 95% CI, 1.1-2.3; P < .01), smoking (OR, 1.4; 95% CI, 1.1-1.7; P < .01), body mass index of less than 16 (OR, 1.8; 95% CI, 1.3-2.5; P = .001), dual antiplatelet therapy (1.3; 95% CI, 1.02-1.6 P = .03), prior infrainguinal bypass (OR, 1.8; 95% CI, 1.3-2.7; P < .01), and beta blocker use (OR, 1.2; 95% CI, 1.03-1.4; P = .02). Conversion from percutaneous access to open cutdown was associated with higher rates of complications than planned open cutdown (8.6% vs 2.9%; P < .001). In propensity-weighted analysis, percutaneous access was associated with significantly lower odds of access complications in women (OR, 0.6; 95% CI, 0.4-0.96; P = .03). Patients who experienced an access complication had more than four times the odds of perioperative death (OR, 4.2; 95% CI, 2.5-7.1; P < .001), and a 60% higher risk of long-term mortality (hazard ratio, 1.6; 95% CI, 1.2-2.1; P = .001). In addition to death, patients with access site complications had higher rates of other major complications, including reoperation during the index hospitalization (19% vs 1.2%; P < .001), myocardial infarction (3.5% vs 0.7%; P < .001), stroke (0.8% vs 0.2%; P < .001), acute kidney injury (12% vs 3%; P < .001), and reintubation (5.7% vs 0.8%). CONCLUSIONS: Although access complications are infrequent in the current era, they are associated with both perioperative and long-term morbidity and mortality. Female patients in particular are at high risk of access complications, but may benefit from percutaneous access.

Colorectal Surgical Site Infection Prevention Kits Prior to Elective Colectomy Improve Outcomes.

INTRODUCTION: Patient compliance with preoperative mechanical and antibiotic bowel preparation, skin washes, carbohydrate loading, and avoidance of fasting are key components of successful colorectal ERAS and surgical site infection (SSI)-reduction programs. In July 2016, we began a quality improvement project distributing a free SSI Prevention Kit (SSIPK) containing patient instructions, mechanical and oral bowel preparation, chlorhexidine washes, and carbohydrate drink to all patients scheduled for elective colectomy, with the goal of improving patient compliance and rates of SSI. METHODS: This was a prospective data audit of our first 221 SSIPK+ patients, who were compared to historical controls (SSIPK-) of 1760 patients undergoing elective colectomy from January 2013 to March 2017. A 1:1 propensity score system accounted for nonrandom treatment assignment. Matched patients' complications, particularly postoperative infection and ileus, were compared. RESULTS: SSIPK+ (n = 219) and SSIPK- (n = 219) matched patients were statistically identical on demographics, comorbidities, BMI, surgical indication, and procedure. SSIPK+ patients had higher compliance with mechanical (95% vs 71%, P < 0.001) and oral antibiotic (94% vs 27%, P < 0.001) bowel preparation. This translated into lower overall SSI rates (5.9% vs 11.4%, P = 0.04). SSIPK+ patients also had lower rates of anastomotic leak (2.7% vs 6.8%, P = 0.04), prolonged postoperative ileus (5.9% vs 14.2%, P < 0.01), and unplanned intubation (0% vs 2.3%, P = 0.02). Furthermore, SSIPK+ patients had shorter mean hospital length of stay (3.1 vs 5.4 d, P < 0.01) and had fewer unplanned readmissions (5.9% vs 14.6%, P < 0.001). There were no differences in rates of postoperative pneumonia, urinary tract infection, Clostridium difficile colitis, sepsis, or death. CONCLUSION: Provision of a free-of-charge SSIPK is associated with higher patient compliance with preoperative instructions and significantly lower rates of surgical site infections, lower rates of prolonged postoperative ileus, and shorter hospital stays with fewer readmissions. Widespread utilization of such a bundle could therefore lead to significantly improved outcomes.

Open Versus Fenestrated Endovascular Repair of Complex Abdominal Aortic Aneurysms.

OBJECTIVE: To compare outcomes of fenestrated (FEVAR) and open repairs of complex abdominal aortic aneurysms (cAAA). BACKGROUND: FEVAR has emerged as an alternative to open surgery for treating cAAA, but direct comparisons are limited. METHODS: We studied all repairs of intact or symptomatic cAAA in the Vascular Quality Initiative between 2012 and 2018, excluding chimney/snorkels and any devices implanted under Investigational Device Exemption studies. We compared open repairs, commercially available FEVAR devices and physician-modified endografts (PMEG) using inverse probability weighting. As a secondary analysis, we compared PMEG separately. RESULTS: We identified 3253 cAAA repairs: 2125 open (65%), 877 FEVAR (27%), and 251 PMEG (8%). Patients undergoing FEVAR were older, with larger aneurysms, and more comorbidities. Propensity-weighted perioperative mortality was similar between open repair and FEVAR (4.7% vs 3.3%, respectively, P = 0.17), but open repair was associated with higher rates of myocardial infarction (5.0% vs 3.0%, P = 0.03), acute kidney injury (25% vs 16%, P < 0.001), and new dialysis (4.3% vs 2.1%, P = 0.003). However, propensity-weighted long-term mortality was higher following FEVAR [Hazard Ratio (HR) 1.7 (1.1-2.6), P = 0.02]. Although outcomes of commercially available FEVAR and PMEG were similar, there was a trend toward higher long-term mortality with PMEG compared to FEVAR [HR 1.7 (0.9-3.1), P = 0.09). CONCLUSIONS: In patients undergoing cAAA repair, open surgery was associated with higher overall survival than FEVAR and similar perioperative mortality, but longer lengths of stay, and higher rates of postoperative renal dysfunction and MI. PMEG were associated with similar perioperative results as commercially available FEVAR, but further study is needed to establish their long-term durability.

Hospital Volume Matters: The Volume-Outcome Relationship in Open Juxtarenal AAA Repair.

OBJECTIVE: We studied whether the volume-outcome relationship would persist in more complex aortic operations. BACKGROUND: Despite the added complexity of the involvement of the renal arteries in open juxtarenal abdominal aortic aneurysm (AAA) repair, the volume effect in these difficult operations has yet to be defined. METHODS: We identified all patients in the Vascular Quality Initiative (VQI) who underwent open AAA repair from 2003 to 2016. We calculated each hospital's average annual volume for total open AAA repairs, and total open juxtarenal AAA repairs. We compared adjusted perioperative and long-term survival across quintiles of hospital volume, and constructed models including both volume metrics to evaluate the cross-volume effects. RESULTS: Of 8880 total open AAA repairs, there were 3470 open juxtarenal cases. Centers with low (<4), medium (4-14), and high (>14) volumes of open juxtarenal repair demonstrated adjusted perioperative mortality of 9.0%, 4.9%, and 3.9%, respectively (P < 0.01). When both volume metrics were considered, open juxtarenal volume, but not total open AAA volume was associated with perioperative mortality (lowest quintile of juxtarenal volume: OR 2.36 [1.29-4.30], P < 0.01). Hospital volume was not associated with adjusted long-term mortality. High volume centers were more likely to use renal protective strategies such as mannitol and cold renal perfusion (both P < 0.01). Low volume centers performed a similar proportion of cases each year, but 22 centers (13%) did stop performing repairs during the study period. CONCLUSION: Hospitals with low annualized volumes of open juxtarenal repair have higher perioperative mortality, irrespective of their total open aortic volume. Complex open AAA repairs should be performed at experienced centers, and future efforts should focus on centralization of complex aortic care.

Concordance Between Registry and Administrative Data in the Determination of Comorbidity: A Multi-institutional Study.

OBJECTIVE: To characterize agreement between administrative and registry data in the determination of patient-level comorbidities. BACKGROUND: Previous research finds poor agreement between these 2 types of data in the determination of outcomes. We hypothesized that concordance between administrative and registry data would also be poor. METHODS: A cohort of inpatient operations (length of stay 1 day or greater) was obtained from a consortium of 8 hospitals. Within each hospital, National Surgical Quality Improvement Program (NSQIP) data were merged with intra-institutional inpatient administrative data. Twelve different comorbidities (diabetes, hypertension, congestive heart failure, hemodialysis-dependence, cancer diagnosis, chronic obstructive pulmonary disease, ascites, sepsis, smoking, steroid, congestive heart failure, acute renal failure, and dyspnea) were analyzed in terms of agreement between administrative and NSQIP data. RESULTS: Forty-one thousand four hundred thirty-two inpatient surgical hospitalizations were analyzed in this study. Concordance (Cohen Kappa value) between the 2 data sources varied from 0.79 (diabetes) to 0.02 (dyspnea). Hospital variation in concordance (intersite variation) was quantified using a test of homogeneity. This test found significant intersite variation at a level of P < 0.001 for each of the comorbidities except for dialysis (P = 0.07) and acute renal failure (P = 0.19). These findings imply significant differences between hospitals in their generation of comorbidity data. CONCLUSION: This study finds significant differences in how administrative versus registry data assess patient-level comorbidity. These differences are of concern to patients, payers, and providers, each of which had a stake in the integrity of these data. Standardized definitions of comorbidity and periodic audits are necessary to ensure data accuracy and minimize bias.

Index and follow-up costs of endovascular abdominal aortic aneurysm repair from the Endurant Stent Graft System Post Approval Study (ENGAGE PAS).

OBJECTIVE: Trials for endovascular aneurysm repair (EVAR) report lower perioperative mortality and morbidity, but also higher costs compared with open repair. However, few studies have examined the subsequent cost of follow-up evaluations and interventions. Therefore, we present the index and 5-year follow-up costs of EVAR from the Endurant Stent Graft System Post Approval Study. METHODS: From August 2011 to June 2012, 178 patients were enrolled in the Endurant Stent Graft System Post Approval Study de novo cohort and treated with the Medtronic Endurant stent graft system (Medtronic Vascular, Santa Rosa, Calif), of whom 171 (96%) consented for inclusion in the economic analysis and 177 participated in the quality-of-life (QOL) assessment over a 5-year follow-up period. Cost data for the index and follow-up hospitalizations were tabulated directly from hospital bills and categorized by Uniform Billing codes. Surgeon costs were calculated by Current Procedural Terminology codes for each intervention. Current Procedural Terminology codes were also used to calculate imaging and clinic follow-up reimbursement as surrogate to cost based on year-specific Medicare payment rates. Additionally, we compared aneurysm-related versus nonaneurysm-related subsequent hospitalization costs and report EuroQol 5D QOL dimensions. RESULTS: The mean hospital cost per person for the index EVAR was $45,304 (interquartile range [IQR], $25,932-$44,784). The largest contributor to the overall cost was operating room supplies, which accounted for 50% of the total cost at a mean of $22,849 per person. One hundred patients had 233 additional post index admission inpatient admissions; however, only 32 readmissions (14%) were aneurysm related, with a median cost of $13,119 (IQR, $4570-$24,153) compared with a nonaneurysm-related median cost of $6609 (IQR, $1244-$26,466). Additionally, 32 patients were admitted a total of 37 times for additional procedures after index admission, of which 14 (38%) were aneurysm-related. The median cost of hospitalization for aneurysm-related subsequent intervention was $22,023 (IQR, $13,177-$47,752), compared with a median nonaneurysm-related subsequent intervention cost of $19,007 (IQR, $8708-$33,301). After the initial 30-day visit, outpatient follow-up imaging reimbursement averaged $550 per person per year ($475 for computed tomography scans, $75 for the abdomen), whereas annual office visits averaged $107 per person per year, for a total follow-up reimbursement of $657 per person per year. There were no significant differences in the five EuroQol 5D QOL dimensions at each follow-up compared with baseline. CONCLUSIONS: Costs associated with index EVAR are driven primarily by cost of operating room supplies, including graft components. Subsequent admissions are largely not aneurysm related; however, cost of aneurysm-related hospitalizations is higher than for nonaneurysm admissions. These data will serve as a baseline for comparison with open repair and other devices.

Transabdominal open abdominal aortic aneurysm repair is associated with higher rates of late reintervention and readmission compared with the retroperitoneal approach.

OBJECTIVE: Limited data exist comparing the transabdominal and retroperitoneal approaches to open abdominal aortic aneurysm (AAA) repair, especially late mortality and laparotomy-related reinterventions and readmissions. Therefore, we compared long-term rates of mortality, reintervention, and readmission after open AAA repair through a transabdominal compared with a retroperitoneal approach. METHODS: We identified all patients in the Vascular Quality Initiative (VQI) undergoing open AAA repair from 2003 to 2015. Patients with rupture or supraceliac clamp were excluded. We used the VQI linkage to Medicare to ascertain rates of long-term outcomes, including rates of AAA-related and laparotomy-related (ie, hernia, bowel obstruction) reinterventions and readmissions. We used multivariable Cox regression to account for differences in comorbidities, aneurysm details, and operative characteristics. RESULTS: We identified 1282 patients in the VQI with linkage to Medicare data, 914 (71%) who underwent a transperitoneal approach and 368 (29%) who underwent a retroperitoneal approach. Patients who underwent a retroperitoneal approach were slightly more likely to have preoperative renal insufficiency but were otherwise similar in terms of demographics and comorbidities. They more often had a clamp above at least one renal artery (61% vs 36%; P < .001) and underwent concomitant renal revascularization (9.5% vs 4.3%; P < .001). Patients who underwent a transabdominal approach more often presented with symptoms (14% vs 9.0%; P < .01) and had a femoral distal anastomosis (15% vs 7.1%; P < .001). There was no difference in 5-year survival (62% vs 61%; log-rank, P = .51). However, patients who underwent a transabdominal approach experienced higher rates of repair-related reinterventions and readmissions (5-year: 42% vs 34%; log-rank, P < .01), even after adjustment for demographic and operative differences (hazard ratio, 1.5; 95% confidence interval, 1.1-1.9; P < .01). CONCLUSIONS: A transabdominal exposure for AAA repair is associated with higher rates of late reintervention and readmission than with the retroperitoneal approach, which should be considered when possible in operative decision-making.

The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes. The VISION CRN began in September 2015 and held its first strategic meeting on September 10, 2018, at the FDA headquarters in Silver Spring, Maryland. VISION is a collaboration of the Vascular Quality Initiative (VQI), the FDA, and other stakeholders. At this annual meeting, leaders from the FDA, VQI, industry representatives, population health researchers, and regulatory science experts gathered to discuss strategic goals and opportunities for VISION. One of the key focus areas for VISION is linkage of VQI registry data to Medicare, longitudinal data sources maintained by various states, and other relevant data sources, as a model for efficient, cost-saving, and effectual evidence generation and appraisal. This would provide the means to expand data collection, assess long-term procedural outcomes across the carotid, lower extremity, aortic, and venous intervention datasets, and execute registry-based trials through the CRN structure in an efficient, cost-effective manner. Looking forward, VISION strives to validate long-term outcome data in the VQI using industry datasets, in hopes of using CRNs to make device regulatory decisions. With the guidance of a steering committee, VISION will provide vascular surgeons, industry, and regulators the appropriate data to improve care for patients with vascular disease.

Differences in patient selection and outcomes based on abdominal aortic aneurysm diameter thresholds in the Vascular Quality Initiative.

OBJECTIVE: Randomized trials have shown no benefit for repair of small abdominal aortic aneurysms (AAAs), although repair of small AAAs is widely practiced. It has also been suggested that repair of large-diameter AAAs may incur worse outcomes. We sought to examine differences in patient selection, operative outcomes, and survival after elective endovascular aneurysm repair (EVAR) based on AAA diameter thresholds. METHODS: Elective EVARs for asymptomatic AAAs in the Vascular Quality Initiative were studied from 2003 to 2017. AAAs were classified by diameter as small (<5 cm in women, <5.5 cm in men), medium (5-6.5 cm in women, 5.5-6.5 cm in men), and large (≥6.5 cm). Patient characteristics and operative factors were compared using univariate analyses and established risk prediction models. Effects of AAA diameter on reintervention and mortality were assessed using Kaplan-Meier and multivariable Cox regression analyses. RESULTS: Of 22,975 patients undergoing EVAR, 41% (9353), 47% (10,842), and 12% (2780) had small, medium, and large AAAs, respectively. Patients with small AAAs were younger and had fewer comorbidities. Consequently, patients with small AAAs were more likely to have low predicted operative mortality risk and 5-year mortality risk based on risk models (P < .001 for both). For operative outcomes, 30-day mortality was significantly different across diameter categories (small, 0.4%; medium, 0.9%; large, 1.6%; P < .001). EVAR for large AAAs had the highest rates of multiple medical complications, including myocardial infarction (P < .001), respiratory complications (P = .001), and renal complications (P < .001). In contrast, EVAR for small AAAs had the lowest rates of type I endoleak at completion and reoperation during index hospitalization, shortest operative times, and shortest hospital length of stay (P < .001 for all). Aneurysm diameter was associated with differential 1-year reintervention-free survival (92% small vs 89% medium vs 82% large; P < .001) and 5-year overall survival (88% small vs 81% medium vs 75% large; P < .001). Multivariable models showed that compared with medium AAAs, small AAAs had an independent protective effect against 1-year reintervention or death (hazard ratio [HR], 0.82; P = .003) and 5-year mortality (HR, 0.78; P = .001). Conversely, compared with medium AAAs, large AAAs carried an independent increased risk of 1-year reintervention or death (HR, 1.75; P < .001) and 5-year mortality (HR, 1.50; P < .001). CONCLUSIONS: Small AAAs represent >40% of elective EVARs in the Vascular Quality Initiative. Patients with small AAAs selected for repair are younger and have fewer comorbidities. Consequently, EVAR for small AAAs carries lower risk of operative and 5-year mortality. Aneurysm diameter is independently associated with reinterventions and mortality after EVAR, suggesting that AAA diameter may have an important clinical effect on outcomes.

Factors associated with postoperative renal dysfunction and the subsequent impact on survival after open juxtarenal abdominal aortic aneurysm repair.

BACKGROUND: Renal dysfunction is a well-described complication of open juxtarenal abdominal aortic aneurysm repair, but the associated risk factors and corresponding impact on survival are not well described. METHODS: We identified all patients not on hemodialysis undergoing open repair of nonruptured juxtarenal aneurysms in the Vascular Quality Initiative from 2003 to 2017. We used mixed-effects logistic regression to determine factors associated with in-hospital postoperative renal dysfunction, including acute kidney injury (AKI, defined as serum creatinine concentration increase >0.5 mg/dL) and new renal replacement therapy (RRT), as well as the association between postoperative renal function and perioperative mortality. Cox regression was used to determine the association between postoperative renal complications and long-term survival. RESULTS: We identified 2635 open juxtarenal repairs, of which 621 (24%) were complicated by AKI. The majority of these (20% of the overall cohort) were AKI alone, but 2.2% required temporary RRT and an additional 1.7% were permanently dialysis dependent. Factors independently associated with postoperative renal dysfunction included renal-visceral ischemia time (per minute: odds ratio [OR], 1.01 [1.01-1.02]; P < .001), clamp site (above both renal arteries: OR, 1.4 [1.1-1.8; P = .02]; supraceliac: OR, 1.7 [1.1-2.5; P = .01]), statin use (OR, 1.5 [1.1-2.0]; P = .01), male sex (OR, 1.7 [1.2-2.2]; P = .002), and preoperative renal function (glomerular filtration rate [GFR] of 45-60 mL/min/1.73 m2: OR, 1.8 [1.3-2.5; P < .001]; GFR of 30-45 mL/min/1.73 m2: OR, 1.9 [1.2-2.8; P = .003]; GFR of <30 mL/min/1.73 m2: OR, 6.2 [3.1-12.2; P < .001]). When renal-visceral ischemia time was categorized, there was no difference in risk of postoperative renal dysfunction until >25 minutes, but risk increased stepwise thereafter (25-39 minutes: OR, 1.6 [1.2-2.1; P = .004]; 40+ minutes: OR, 2.6 [1.9-3.5; P < .001]). Neither mannitol nor the use of cold renal perfusion was associated with renal complications or mortality in the overall cohort, but cold renal perfusion was associated with lower risk of AKI when clamp times exceeded 25 minutes (OR, 0.4 [0.2-0.97]; P = .041). Postoperative renal dysfunction was associated with higher adjusted perioperative mortality (AKI: OR, 2.6 [1.4-5.0; P < .01]; RRT: OR, 10.5 [4.0-27.6; P < .001]) and significantly higher risk of long-term mortality (AKI: hazard ratio, 1.5 [1.0-2.1; P = .049]; RRT: hazard ratio, 5.8 [3.2-10.3; P < .001]). CONCLUSIONS: Postoperative renal dysfunction, even a mild elevation in creatinine concentration, is associated with higher perioperative and long-term mortality. Although the routine use of mannitol and cold renal perfusion was not associated with postoperative renal dysfunction after open juxtarenal repair, cold renal perfusion was associated with lower risk of AKI if clamp times exceeded 25 minutes.

The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative.

BACKGROUND: Endovascular repair of complex abdominal aortic aneurysms has become increasingly common, but reports have mostly been limited to single centers and single devices. METHODS: We studied all endovascular repairs of complex abdominal aortic aneurysms (zone 6 or caudal) from 2014 to 2018 in the Vascular Quality Initiative. This included all commercially available fenestrated endovascular aneurysm repair (FEVAR), chimney/snorkel repairs, and physician-modified endografts (PMEGs), exclusive of investigational device exemptions and clinical trial devices. We used inverse probability-weighted multilevel logistic regression to compare rates of perioperative outcomes including death, acute kidney injury (AKI), and major adverse cardiac events (MACEs; the composite of death/stroke/myocardial infarction) and Cox regression for long-term mortality. RESULTS: During the study period, surgeons performed 1396 complex endovascular repairs: 1308 (94%) elective, 63 (4.5%) for symptomatic aneurysms, and 25 (1.8%) for rupture. The number of centers performing complex endovascular repairs expanded steadily from 39 in 2014 to 81 in 2017. There were 880 FEVAR (63%), 256 PMEG (18%), and 260 chimney/snorkel repairs (19%). In elective cases, 3214 visceral vessels were incorporated and revascularized; 120 repairs (9%) involved one vessel, 481 (38%) repairs involved two vessels, 560 (44%) involved three vessels, and 113 (9%) involved four vessels. The mean number of arteries incorporated was 2.5 ± 0.8, with PMEGs involving the most arteries (3.3 ± 0.8 for PMEG vs 2.5 ± 0.6 for FEVAR and 1.9 ± 0.9 for chimney/snorkel; P < .001). PMEGs were used to treat more extensive aneurysms, and more incorporated the celiac and superior mesenteric arteries. There was no change in aneurysm extent, but the length of proximal seal extended over time. Chimney/snorkel cases employed more arm or neck access, had longer procedure times, and used more contrast material. Rates of perioperative death (3.4% for FEVAR vs 2.7% for PMEG vs 6.1% for chimney/snorkel; P = .13) and AKI (17% vs 18% vs 19%; P = .42) were similar, but chimney/snorkel was associated with higher rates of stroke (0.8% vs 0.9% vs 3.3%; P = .03) and MACEs (6.1% vs 5.4% vs 11.7%; P = .02). After adjustment, rates of perioperative death, AKI, and overall complications remained similar, but chimney/snorkel was associated with significantly higher odds of stroke (odds ratio [OR], 7.3 [1.5-36.4]; P = .015), myocardial infarction (OR, 18.7 [2.6-136.8]; P = .004), and MACEs (OR, 11.1 [2.1-58.9]; P = .005). Overall survival after elective repair was 91% at 1 year and 88% at 3 years, with no difference between repair types in crude or adjusted analysis. CONCLUSIONS: The Vascular Quality Initiative provides a unique opportunity to study the real-world application and outcomes of complex endovascular aneurysm repair. Perioperative morbidity appears to be higher after chimney/snorkel repair, but further study is needed to confirm these findings and to establish the durability of these novel technologies.

Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival.

BACKGROUND: The early survival advantage of endovascular aneurysm repair (EVAR) compared with open repair reverses over time, possibly because of higher rates of reintervention related to endoleaks and aneurysm sac expansion. Therefore, we sought to examine the association between sac behavior, endoleaks, reintervention, and long-term survival. METHODS: We reviewed all patients undergoing EVAR in the Vascular Quality Initiative between 2003 and 2017 with an imaging study at 1 year postoperatively (±6 months). We defined aneurysm sac changes by Society for Vascular Surgery guidelines (change ≥5 mm) and determined independent predictors of sac behavior, new endoleak, and reintervention using hierarchical logistic regression. We employed Cox regression to examine the association between sac behavior and long-term survival. We performed propensity matching between patients with sac regression and those with failure to regress as a secondary analysis. RESULTS: Of 30,074 EVAR patients, 14,817 (49%) had a 1-year imaging study and were included in this study. At 1 year, 40% of sacs regressed, 35% remained stable, and 25% expanded. Factors independently associated with sac expansion were age (by decade: odds ratio [OR], 1.07; 95% confidence interval [CI], 1.01-1.13; P = .02), appearance of new endoleak (OR, 1.23; 95% CI, 1.10-1.37; P = .001), smaller aortic diameter (diameter <5 cm: OR, 1.37; 95% CI, 1.21-1.55; P < .001), anemia (OR, 1.47; 95% CI, 1.20-1.80; P < .001), rupture (OR, 1.33; 95% CI, 1.07-1.65; P = .01), and chronic kidney disease (OR, 1.15; 95% CI, 1.05-1.25; P < .01), whereas former smoking (OR, 0.86; 95% CI, 0.76- 0.96; P < .01), cerebrovascular disease (OR, 0.82; 95% CI, 0.67-0.99; P = .04), and statin therapy at discharge (OR, 0.83; 95% CI, 0.75-0.91; P < .001) were associated with lower risk of expansion. Both sac expansion (OR, 2.3; 95% CI, 2.0-2.7; P < .001) and a stable sac (OR, 3.1; 95% CI, 2.7-3.5; P < .001) were associated with the development of new endoleaks. Any failure of the aneurysm sac to regress was associated with long-term mortality compared with sac regression (stable sac size: hazard ratio, 1.2; 95% CI, 1.03-1.4; P = .02; sac expansion: hazard ratio, 1.6; 95% CI, 1.3-2.1; P < .001). This association persisted in patients without documented endoleaks and remained robust after accounting for reinterventions and endoleaks seen in follow-up or on completion angiography. In the propensity-matched cohort, patients with failure to regress experienced lower long-term survival (77% at 10 years compared with 82% for patients with sac regression; P = .01). CONCLUSIONS: After EVAR, aneurysm sac behavior is associated with the development of new endoleaks, reintervention, and long-term mortality. Not only sac expansion but any failure of the sac to regress is associated with higher long-term mortality, independent of reinterventions or endoleaks, and may be modified by statin therapy. Further study is needed to establish whether patients with stable sacs could benefit from selective reintervention.

Comparable perioperative outcomes, long-term outcomes, and quality of life in a retrospective analysis of ulcerative colitis patients following 2-stage versus 3-stage proctocolectomy with ileal pouch-anal anastomosis.

PURPOSE: Many surgeons assume 3-stage ileal pouch-anal anastomosis (IPAA) is safer than 2-stage IPAA in patients with active ulcerative colitis (UC), although recent data suggest outcomes are comparable. This study aimed to compare perioperative complications, late complications, and functional outcomes after 2- versus 3-stage IPAA in patients with active UC. METHODS: A retrospective review was conducted of patients who underwent 2- or 3-stage IPAA for active UC from 2000 to 2015 in a high-volume institution. Patients completed quality-of-life surveys 6 months following ileostomy reversal. Perioperative and late complications were recorded. Outcomes were compared with the Fisher exact test, and multivariable logistic regression was used to adjust for potential confounders. RESULTS: We identified 212 patients who underwent 2- or 3-stage IPAA for active UC, of whom 157 patients (74.1%) underwent 2-stage procedures and 55 (25.9%) underwent 3-stage procedures. More patients undergoing 2-stage procedures were taking immunomodulators preoperatively (46.3% vs. 23.1%, p = 0.01), but there was no difference in use of steroids (p = 0.09) or biologic agents (p = 0.85). Three-stage procedures were more likely to be urgent (78.6% vs. 30.2%, p < 0.001). There were no differences in perioperative complications (p = 0.50), anastomotic leak (p = 0.94), pouchitis (p = 0.45), pouch failure (p = 0.46), perceived quality of life (p = 0.68), number of bowel movements per day (p = 0.27), or sexual satisfaction (p = 0.21) between the 2- and 3-stage groups. CONCLUSIONS: Patients undergoing 2-stage compared to 3-stage IPAA for active ulcerative colitis have comparable outcomes and quality of life following ileostomy reversal. Two-stage IPAA appears to be safe and appropriate, even in high-risk patients.

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.