Severe inframalleolar disease is an independent predictor of adverse limb outcomes after endovascular revascularization in chronic limb-threatening ischemia.

OBJECTIVE: In the present study, we evaluated the effects of inframalleolar (IM) disease on the occurrence of major adverse limb events (MALE) in patients undergoing endovascular revascularization for chronic limb-threatening ischemia (CLTI). METHODS: Patients who had undergone endovascular revascularization for CLTI between January 2015 and December 2019 at two university-affiliated hospitals were reviewed retrospectively. Patients with severe IM disease (pedal score of 2) were compared with those with mild to moderate IM disease (score of 0 or 1) using the Global Vascular Guidelines. The primary outcome was MALE (open revascularization, acute leg ischemia, major amputation). The secondary outcomes were mortality, reintervention, major adverse cardiac events, and perioperative complications ≤30 days after endovascular revascularization, primary limb-based patency, and the occurrence of any limb event (defined as any amputation, acute leg ischemia, or open revascularization). Kaplan-Meier estimates were used to compare the primary outcome, and the Cox proportion hazard model was used to assess the effects of IM disease. RESULTS: The study included 167 limbs in 149 patients (36% female; mean age, 74 ± 12 years). Severe IM disease was identified in 71 limbs (43%). No differences were found in the baseline characteristics, except for a higher prevalence of dyslipidemia in the patients with severe IM disease (66% vs 43%; P = .003). Most patients in both groups had had a WIfI (Wound, Ischemia, foot Infection) score of 4 (severe IM disease, 64%; vs mild to moderate IM disease, 57%; P = .462) and GLASS (global limb anatomic severity scale) III anatomy (severe IM disease, 54%; vs mild to moderate IM disease, 48%; P = .752). The Kaplan-Meier estimates showed that severe IM disease was associated with lower freedom from MALE (69% vs 82%; P = .026). The Cox proportion hazard regression model showed that severe IM disease was an independent predictor of increased MALE and amputation risk (hazard ratio, 1.715; 95% confidence interval, 1.015-2.896; P = .044) after adjusting for covariates. During follow-up, patients with severe IM disease had had mortality (27% vs 31%; P = .567) and reintervention (42% vs 38%; P = .608) similar to those for patients with mild to moderate IM disease. Primary limb-based patency was also similar (79% vs 84%; P = .593) at a mean follow-up of 3.8 ± 0.8 years. CONCLUSIONS: Severe IM disease was prevalent in 43% of limbs that had undergone endovascular revascularization for CLTI and was associated with lower freedom from MALE. Severe IM disease also independently increased the hazard of adverse limb outcomes and amputations in patients with CLTI by >70%, highlighting its importance as a measure of foot perfusion.

A systematic review and meta-analysis of the effect of obesity on patients undergoing lower extremity revascularization.

OBJECTIVE: In the present review, we assessed the effect of obesity on clinical outcomes for patients with peripheral arterial disease who had undergone endovascular or open lower extremity revascularization surgery. METHODS: A systematic search strategy of MEDLINE, EMBASE, CINAHL, Web of Science, and Cochrane Library was conducted. The included studies had compared obese and nonobese cohorts with peripheral arterial disease who had undergone endovascular or open lower extremity revascularization. The outcomes included mortality, major adverse cardiovascular events, major adverse limb events, surgical site infections, endovascular access site complications, and perioperative complications. RESULTS: Eight studies were included with 171,648 patients. The obese patients (body mass index ≥30 kg/m2) were more likely to be women, to have diabetes, and to have more cardiovascular comorbidities despite being younger. No association was found between obesity and peripheral arterial disease severity. Obesity was associated with an overall 22% decreased mortality risk after lower extremity revascularization (risk ratio [RR], 0.78; 95% confidence interval [CI], 0.71-0.85; P < .001; I2 = 0%; GRADE (grading of recommendations assessment, development, evaluation), very low quality). A subgroup analysis by intervention type showed similar findings (endovascular: RR, 0.79; 95% CI, 0.71-0.87; P < .001; I2 = 0%; open: RR, 0.70; 95% CI, 0.51-0.95; P = .024; I2 = 43%). Obesity was associated with a 14% decreased risk of major adverse cardiovascular events for open surgery only (RR, 0.86; 95% CI, 0.76-0.98; P = .021; I2 = 0%; GRADE, very low quality). Obesity was associated with an increased risk of surgical site infections pooled across intervention types (RR, 1.69; 95% CI, 1.34-2.14; P < .001; I2 = 78%; GRADE, very low quality). No association was found between obesity and major adverse limb events (RR, 1.02; 95% CI, 0.93-1.11; P = .73; I2 = 15%; GRADE, very low quality) or endovascular access site complications (RR, 1.11; 95% CI, 0.76-1.63; P = .58; I2 = 86%; GRADE, very low quality). Pooled perioperative complications did not differ between the obese and nonobese cohorts (RR, 1.04; 95% CI, 0.84-1.28; P = .73; I2 = 92%; GRADE, very low quality). CONCLUSIONS: Obesity was associated with reduced mortality risk with both endovascular and open surgery, although a reduction in major adverse cardiovascular events was only observed with open surgery. In addition, obese patients had an increased risk of surgical site infections. Obesity was not associated with major adverse limb events, endovascular access site complications, or perioperative complications. The GRADE quality of evidence was very low. The findings from the present review suggest a survival advantage for obese patients with peripheral arterial disease. Future studies could focus on prospectively investigating the effect of obesity on peripheral arterial disease outcomes. A nuanced evaluation of body mass index as a preoperative risk factor is warranted.

Multimodal Prehabilitation for Patients Undergoing Endovascular Aortic Aneurysm Repair Surgery: A Feasibility Study.

BACKGROUND: Elective treatment options for aortic abdominal aneurysms include open repair or the less-invasive endovascular aortic aneurysm repair (EVAR). Recovery from EVAR is generally considered easier and faster than open repair. Despite this, EVAR remains a major procedure, and average return to preoperative quality of life is at least 3 months. The purpose of this study is to determine the safety and feasibility of multimodal prehabilitation, a multidisciplinary preoperative optimization intervention, in patients undergoing EVAR and its impact on perioperative functional capacity and quality of life. METHODS: Candidates for EVAR with an infra-renal abdominal aortic aneurysm <7.5cm were invited to participate in a 6-week multimodal prehabilitation program that included (1) supervised and home-based exercise, (2) nutritional support, (3) psychosocial support, and (4) smoking cessation. Functional capacity and quality of life were assessed at baseline, before surgery and 6 weeks postoperatively. Recruitment rate, safety, and compliance were also assessed. RESULTS: A total of 24 patients were included, 17 males (70%) and 7 females (30%). No adverse events occurred during the program. Compliance to each component of the program (median [Q1-Q3]) was 66% [67] for supervised training, 100% [67] for home-based training, and 100% [100] for nutrition. The multimodal prehabilitation program elicited a significant increase in functional capacity and quality of life preoperatively. CONCLUSION: Multimodal prehabilitation for patients awaiting EVAR is feasible and safe. Multimodal prehabilitation improves both functional capacity and quality of life preoperatively. Further research is needed to assess the impact of multimodal prehabilitation on postoperative quality of life and functional capacity. CLINICAL IMPACT: Multimodal prehabilitation is safe and feasible in patients awaiting endovascular aneurysm repair. The importance of this finding is that multimodal prehabilitation can be safely delivered preoperatively in patients awaiting EVAR. Although further research is needed, multimodal prehabilitation seems to improve preoperative functional capacity and quality of life. This could have an impact for the future implementation of prehabilitation interventions in order to increase functional reserve and quality of life preoperatively so that this high-risk population can cope better with the surgical stress and return to their normal life faster postoperatively.

Perioperative Glycemic Surveillance and Control-Current Practices, Efficacy and Impact on Postoperative Outcomes following Infrainguinal Vascular Intervention.

BACKGROUND: Perioperative glycemic control plays a pivotal role in improving postsurgical outcomes. Hyperglycemia occurs frequently in surgical patients and has been associated with higher rates of mortality and postoperative complications. However, no current guidelines exist regarding intraoperative glycemic monitoring of patients undergoing peripheral vascular procedures and postoperative surveillance is often restricted to diabetic patients. We sought to characterize the current practices around glycemic monitoring and efficacy of perioperative glycemic control at our institution. We also examined the impact of hyperglycemia in our surgical population. METHODS: This was a retrospective cohort study performed at the McGill University Health Centre and Jewish General Hospital in Montreal, Canada. Patients undergoing elective open lower extremity revascularization or major amputation between 2019 and 2022 were included. Data collected from the electronic medical record included standard demographics, clinical, and surgical characteristics. Glycemic measurements and perioperative insulin use were recorded. Outcomes included 30-day mortality and postoperative complications. RESULTS: A total of 303 patients were included in the study. Overall, 38.9% of patients experienced perioperative hyperglycemia defined as glucose ≥180 mg/dL (10 mmol/L) during their hospital admission. Only 12 (3.9%) patients within the cohort underwent any intraoperative glycemic surveillance, while 141 patients (46.5%) had an insulin sliding scale prescribed postoperatively. Despite these efforts, 51 (16.8%) patients remained hyperglycemic for at least 40% of their measurements during their hospitalization. Hyperglycemia in our cohort was significantly associated with an increased risk of 30-day acute kidney injury (11.9% vs. 5.4%, P = 0.042), major adverse cardiac events (16.1% vs. 8.6%, P = 0.048), major adverse limb events (13.6% vs. 6.5%, P = 0.038), any infection (30.5% vs. 20.5%, P = 0.049), intensive care unit admission (11% vs. 3.2%, P = 0.006) and reintervention (22.9% vs. 12.4%, P = 0.017) on univariate analysis. Furthermore, multivariable logistic regression including the covariates of age, sex, hypertension, smoking status, diabetic status, presence of chronic kidney disease, dialysis, Rutherford stage, coronary artery disease and perioperative hyperglycemia demonstrated a significant relationship between perioperative hyperglycemia and 30-day mortality (odds ratio [OR]: 25.00, 95% confidence interval [CI]: 2.469-250.00, P = 0.006), major adverse cardiac events (OR: 2.08, 95% CI: 1.008-4.292, P = 0.048), major adverse limb events (OR: 2.24, 95% CI: 1.020-4.950, P = 0.045), acute kidney injury (OR: 7.58, 95% CI: 3.021-19.231, P < 0.001), reintervention (OR: 2.06, 95% CI: 1.117-3.802, P = 0.021), and intensive care unit admission (OR: 3.38, 95% CI: 1.225-9.345, P = 0.019). CONCLUSIONS: Perioperative hyperglycemia was associated with 30-day mortality and complications in our study. Despite this, intraoperative glycemic surveillance occurred rarely in our cohort and current postoperative glycemic control protocols and management failed to achieve optimal control in a significant percentage of patients. Standardized glycemic monitoring and stricter control in the intraoperative and postoperative period therefore represent an area of opportunity for reducing patient mortality and complications following lower extremity vascular surgery.

Multimodal Prehabilitation for Peripheral Arterial Disease Patients with Intermittent Claudication-A Pilot Randomized Controlled Trial.

BACKGROUND: To establish the feasibility and safety of multimodal prehabilitation (MP), and to obtain pilot data on the change in quality of life, functional walking capacity, and the need for surgery for a full-scale trial. METHODS: Pilot randomized controlled trial that included patients older than 50 years old suffering from moderate to severe intermittent claudication and who were candidates for endovascular revascularization (ER). Participants were excluded if they presented with ischemic rest pain, gangrene or ulceration of the index leg, significant lesions in the iliac vessels, planned surgical bypass, comorbidities in which exercise was contraindicated or if they were unable to speak English or French. Participants were randomized in a 1:1 ratio to 12 weeks of MP or institutional standard of care (unsupervised walking advice). MP consisted of i)1 weekly supervised exercise session; ii) home-based exercise prescription; iii) nutritional counseling and supplementation; iv) smoking cessation therapy; and v) psychosocial support. Feasibility and safety were measured with recruitment and retention rates, as well as the occurrence of any adverse events. In addition, barriers to attend supervised sessions and compliance to each component were assessed. Change in functional walking capacity, health-related quality of life, and the rates of patients deciding not to undergo ER were collected and analyzed throughout the follow-up period of 12 months. RESULTS: Of the 37 patients referred for eligibility, 27 (73%) accepted to participate in the trial and were randomized. Of the 27 patients included, 24 completed the 12-week program. Adherence to each prehabilitation component was 83% interquartile range [72,93] for supervised exercise, 90% [83,96] for home-based exercise and 69% [45,93] for nutritional sessions. Fifty percent of patients were referred for and underwent psychosocial intervention and 40% of the active smokers enrolled in the smoking cessation program. No adverse events were observed during the program. The 2 main barriers for not fully adhering to the intervention were excessive pain while performing the exercises and the difficulty to keep up with the prescribed exercises. A statistically significant mean change (standard deviation (SD)) was seen in the MP group versus standard of care for functional capacity, mean (SD) 6 Min Walk Test 60 (74) vs. -11 (40) meters P < 0.05, and quality of life mean (SD) VascuQol 1.15 (0.54) vs. -0.3 (1.09) points P < 0.05. There was no statistically significant difference between groups in the rates of patients deciding to undergo ER during the 1-year follow-up period. CONCLUSIONS: The results of this pilot trial demonstrate that MP is safe and feasible. A 12-week MP program seems to improve quality of life and functional walking capacity to a greater extent than unsupervised walking advice. There is a need for a large-scale trial to investigate the effectiveness of MP at improving quality of life and assessing its impact on the rates of patients deciding not to undergo or delay ER. The long-term functional and quality of life outcomes of the patients deciding to undergo ER after prehabilitation also need to be assessed.

Association Between Obesity and Outcomes Following Endovascular Aneurysm Repair.

BACKGROUND: Obesity is prevalent in patients with abdominal aortic aneurysms (AAA). There is an association between increasing body mass index (BMI) and increased overall cardiovascular mortality and morbidity. This study aims to assess the difference in mortality and complication rates between normal weight (NW), overweight (OW), and obese patients undergoing endovascular aneurysm repair (EVAR) for infrarenal AAA. METHODS: This is a retrospective analysis of consecutive patients undergoing EVAR for AAA between January 1998 and December 2019. Weight classes were defined as: BMI<18.5 kg/m2, underweight; BMI 18.5-24.9 kg/m2, NW; BMI 25.0-29.9 kg/m2, OW; BMI 30.0-39.9 kg/m2, obese; BMI>39.9 kg/m2 morbidly obese. Primary outcomes were long-term all-cause mortality and freedom from reintervention. Secondary outcome was aneurysm sac regression (defined as a reduction in sac diameter of 5 mm or more). Kaplan-Meier survival estimates and mixed model analysis of variance were used. RESULTS: The study included 515 patients (83% males, mean age 77 ± 8 years) with a mean follow-up of 3.8 ± 2.8 years. In terms of weight class, 2.1% (n = 11) were underweight, 32.4% (167) were NW, 41.6% (n = 214) were OW, 21.2% (n = 109) were obese, and 2.7% (n = 14) were morbidly obese. Obese patients were younger (mean difference -5.0 years) but had a higher prevalence of diabetes mellitus (33.3% vs. 10.6% for NW) and dyslipidemia (82.4% vs. 60.9% for NW). Obese patients had similar freedom from all-cause mortality (88%) compared to OW (78%) and NW (81%) patients. The same findings were evident for freedom from reintervention where obese (79%) was similar to OW (76%) and NW (79%). At a mean follow-up of 5.1 ± 0.4 years, sac regression was observed similarly across weight classes at 49.6%, 50.6%, and 51.8% for NW, OW, and obese, respectively (P = 0.501). There was a significant difference in mean AAA diameter pre- and post-EVAR [F(2,318) = 24.37, P < 0.001] across weight classes. NW [mean reduction 4.8 mm (2.0-7.6 mm, P < 0.001)], OW [mean reduction 3.9 mm (1.5-6.3 mm, P < 0.001)], and obese [mean reduction 5.7 mm (2.3-9.1 mm, P < 0.001)] achieved similar reductions. CONCLUSIONS: Obesity was not associated with increased mortality or reintervention in patients undergoing EVAR. Obese patients achieved similar rates of sac regression on imaging follow-up.

Feasibility and Cost Analysis of Ambulatory Endovascular Aneurysm Repair.

PURPOSE: We sought to compare the costs of ambulatory endovascular aneurysm repair (a-EVAR) and inpatient EVAR (i-EVAR) at up to 1-year of follow-up. MATERIALS AND METHODS: A retrospective cohort study of consecutive patients undergoing elective EVAR between April 2016 and December 2018 at two academic centers. Patients planned for a-EVAR were compared with i-EVAR. Costs at 30 days and 1 year were extracted. These included operating room (OR) use, bed occupancy, laboratory and imaging, emergency department (ED) visits, readmissions, and reinterventions. Baseline characteristics were compared. Multiple regression model was used to identify predictors of increased EVAR costs. Repeated measures analysis of variance (ANOVA) was used to compare cost differences at 30 days and 1 year via an intention-to-treat analysis. Bonferroni post hoc test compared between-group differences. A p value<0.05 was considered statistically significant. RESULTS: One hundred seventy patients were included. Most underwent percutaneous EVAR (>94%) under spinal anesthesia (>84%). Ambulatory endovascular aneurysm repair was successful in 84% (84/100). Ambulatory endovascular aneurysm repair patients (76±8 years) were younger than i-EVAR (78±9 years). They also had a smaller mean aneurysm diameter (56±6 mm) compared with i-EVAR (59±6 mm). Emergency department visits, readmissions, and reinterventions were similar up to 1 year (all p=NS). Ambulatory endovascular aneurysm repair costs showed a non-statistically significant reduction in total costs at 30 days and 1 year by 27% and 21%, respectively. Patients younger than 85 years and males had a 30-day cost reduction by 34% (p=0.027) and 33% (p=0.035), respectively with a-EVAR. CONCLUSIONS: Same-day discharge is feasible and successful in selected patients. Patients younger than 85 years and males have a short-term cost benefit with EVAR done in the ambulatory setting without increased complications or reinterventions. CLINICAL IMPACT: This study shows the overall safety of ambulatory EVAR with proper patient selection. These patient had similar post-intervention complications to inpatients. Same day discharge also resulted in short-term reduction in costs in male patients and patients younger than 85 years.

Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair.

OBJECTIVE: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002-2010, n=47), T2 (2011-2014, n=47), and T3 (2015-February 2019, n=47). RESULTS: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3.Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. CONCLUSION: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Comorbid Depression is Associated with Increased Major Adverse Limb Events in Peripheral Arterial Disease: A Systematic Review and Meta-analysis.

OBJECTIVE: Depression is a significant risk factor for death in coronary artery disease. Conversely, the research surrounding depression and peripheral arterial disease is limited. This review aimed to systematically evaluate the available literature on the impact of comorbid depression on adverse outcomes in peripheral arterial disease. DATA SOURCES: A systematic review and meta-analysis were performed using the following databases MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane Library from inception until July 2021. REVIEW METHODS: Included studies compared depressed and non-depressed patients with peripheral arterial disease. The outcomes included death, major adverse cardiovascular events, and major adverse limb events. RESULTS: A total of 9 297 articles were searched. Of these, seven studies were identified. Depressed patients were more likely to be women, diabetic, have a history of smoking, and have chronic limb threatening ischaemia, despite being younger than non-depressed patients. There was a 20% increase in major adverse limb events in depressed patients (RR 1.20, 95% CI 1.11 - 1.31, z = 3.9, p < .001, GRADE strength: very low) but no increased risk of death (RR 1.03, 95% CI 0.72 - 1.40, z = 0.06, p = .95, GRADE strength: very low) or major adverse cardiovascular events (RR 1.16, 95% CI 0.67 - 2.01, z = 0.54, p = .59, GRADE strength: very low). A follow up meta-regression of various comorbidities and demographic variables did not demonstrate a significant contribution to the observed risk ratio for major adverse limb events. CONCLUSION: Depression was reported in 13% of patients with peripheral arterial disease, associated with more medical comorbidity, and a 20% increased risk of major adverse limb events. Although the strength of this evidence is very low, the current state of the literature remains limited. Future studies should prospectively assess the impact of depression and its relationship to medical comorbidities and high risk health behaviours.

Low Psoas Muscle Area is Associated with Increased Mortality and Spinal Cord Injury After Complex Endovascular Aortic Aneurysm Repair.

BACKGROUND: Low psoas muscle area (PMA) is associated with worse post-operative outcomes. Our objective was to evaluate the association of PMA and postoperative outcomes in patients undergoing fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient characteristics, anatomical and clinical information, and post-operative outcomes were collected from patients undergoing F/BEVAR between 2005-February 2019 who were deemed too high-risk for open repair. PMA was measured using a validated web-based software (coreslicer.com). Post-operative outcomes were compared between patients with low PMA (lowest quartiles) and high PMA (highest quartiles). RESULTS: We included 129 patients with a mean age of 74.6 ± 8.1, 81.4% male, and a mean follow-up of 29.4 ± 32.2 months. Patients in the low PMA group were more likely to be female (33.8% vs. 3.1%, P < 0.0001), less likely to have hypertension (72.3% vs. 87.5%, P = 0.03), dyslipidemia (63.1% vs. 78.1%, P = 0.06), and a trend towards a greater history of endovascular aneurysm repair (4.6% vs. 0%, P = 0.08). There were no significant differences in aneurysm or device characteristics between groups. In a multivariate model including age, sex, aneurysm type, and presence of prophylactic spinal drain, the low PMA group had a significantly increased risk of spinal cord injury (odds ratio 12.7, 95% CI 1.1-143.6). There were no significant differences in other 30-day outcomes. When compared to the highest quartile, the lowest PMA quartile patients had a hazard ratio of 4.6 (95% CI 1.2-17.6) for mortality during follow-up in a model with age, sex, and aneurysm type. For each 1 cm2 increase in PMA, the HR was 0.90 (95% CI 0.82-0.99) for mortality during follow-up. CONCLUSIONS: In high-risk patients undergoing F/BEVAR low PMA is associated with spinal cord injury and mortality during follow-up. We found no association between PMA and 30-day mortality. PMA measurement is a simple method to assess for sarcopenia and frailty and may be useful for risk stratification pre-operatively.

Outcomes of endovascular treatment of patients with intermittent claudication due to femoropopliteal disease.

OBJECTIVE: Our objective was to evaluate the outcomes of endovascular treatment in patients with moderate and severe claudication due to femoropopliteal disease, that is, disease of the superficial femoral and popliteal arteries. METHODS: A retrospective review of all patients with moderate and severe claudication (Rutherford 2 and 3) undergoing endovascular treatment for FP disease between January 2012 and December 2017 at two university-affiliated hospitals was performed. All procedures were performed by vascular surgeons. Primary outcomes were mortality, freedom from reintervention, major adverse limb events defined as major amputations, open surgical revascularization, or progression to chronic limb-threatening ischemia (CLTI) at 30 days, 1 year, 2 years, and last follow-up. Unadjusted odds ratios were calculated to identify variables associated with adverse outcomes, and Kaplan-Meier survival curves were used to determine mortality and freedom from reintervention. RESULTS: Eighty-five limbs in 74 patients were identified on review. Mean age was 69.6 ± 9.8 years and 74.3% were males. At a median follow-up of 49.0 ± 25.5 months, all-cause mortality rate was 8.1% (6 patients) with 16.7% being due to cardiovascular causes. Reintervention rates were 1.2%, 16.5%, and 21.2% at 30 days, 1 year, and 2 years, respectively. Major adverse limb events occurred in 3 patients and rates were 0%, 1.2%, and 2.4% at 30 days, 1 year, and 2 years, respectively. Progression to CLTI was 0%, 1.2%, and 1.2% at 30 days, 1 year, and 2 years, respectively. Claudication had improved or resolved in 55.6% (n = 34 patients), stable in 38.9% (n = 21 patients), and worse in 5.6% (n = 3 patients) Age ≥ 70 years (OR = 4.09 (1.14-14.66), p = 0.027), TASCII A lesion (OR = 4.67 (1.14-19.17), p = 0.025), and presence of 3-vessel runoff (OR = 3.70 (1.18-11.59), p = 0.022) predicted symptoms' improvement. TASCII A lesions were less likely to require reintervention (OR = 0.23 (0.06-0.86), p = 0.020). Reintervention within 1 year (OR = 11.67 (0.98-138.94), p = 0.017), reintervention with a stent (OR = 14.40 (1.19-173.67), p = 0.008) and more than one reintervention (OR = 39.00 (2.89-526.28), p < 0.001) predicted major adverse limb events. CONCLUSIONS: Careful patient selection is important when planning endovascular treatment in patients with intermittent claudication and FP disease. This could result in symptomatic improvement in more than half of the patients. Adverse outcomes such as major adverse limb events, progression to CLTI, and amputations occur at low rates.

A systematic review and meta-analysis of endovascular juxtarenal aortic aneurysm repair demonstrates lower perioperative mortality compared with open repair.

OBJECTIVE: The objectives of the present study were to summarize and pool the available data from studies that had directly compared endovascular and open repair of juxtarenal aortic aneurysms. METHODS: OVID Medline and Embase were searched for studies from January 2000 to December 2018 that had compared endovascular vs open repair of juxtarenal aortic aneurysms. Studies that had included patients with pararenal and suprarenal aneurysms were also included. The endovascular interventions included short-neck standard endovascular aneurysm repair (EVAR), parallel grafts, and fenestrated/branched EVAR. The primary outcomes were 30-day mortality, perioperative reinterventions, acute renal failure, permanent dialysis, stroke, and spinal cord ischemia. The secondary outcomes were myocardial infarction, bowel and limb ischemia, length of stay, and long-term survival. The data were pooled, and a meta-analysis using a random effects model was performed. RESULTS: A total of 20 studies met the inclusion criteria. Of the 20 studies, five had contained duplicated data and one had included only 2-year follow-up data. Therefore, 14 studies with 5121 patients (1506 endovascular, 3615 open) were included for analysis. The patients undergoing endovascular repair were older (mean difference, 3.42; 95% confidence interval [CI], 2.54-4.3; P < .001; I2 = 56%), more likely to be men (odds ratio [OR], 1.33; 95% CI, 1.02-1.73; P = .04; I2 = 33%), and more likely to have diabetes (OR, 1.24; 95% CI, 1.04-1.50; P = .02; I2 = 0%), coronary artery disease (OR, 1.64; 95% CI, 1.03-2.62; P = .04; I2 = 75%), and chronic kidney disease (OR, 1.52; 95% CI, 1.07-2.15; P = .02; I2 = 50%). Endovascular repair was associated with significantly decreased 30-day mortality (OR, 0.50; 95% CI, 0.34-0.74; P < .001; I2 = 0%). This remained significant when including only fenestrated EVAR (OR, 0.55; 95% CI, 0.36-0.85; P = .007; I2 = 0%). Endovascular repair also resulted in a significantly decreased incidence of acute renal failure (OR, 0.50; 95% CI, 0.28-0.89; P = .02; I2 = 67%), an increased incidence of spinal cord ischemia (OR, 3.14; 95% CI, 1.08-9.09; P = .03; I2 = 0%), a decreased incidence of bowel ischemia (OR, 0.50; 95% CI, 0.24-1.05; P = .07; I2 = 7%), and decreased length of stay (mean difference, -5.99 days; 95% CI, -7.42 to -4.57 days; P < .00001; I2 = 78%). No significant differences were found for the other outcomes. Of the nine studies that had reported long-term survival (1-7 years of follow-up), eight had found no significant differences between groups (data not pooled) and one study had found improved long-term survival in the open repair group. Reinterventions during follow-up were increased in the endovascular group. CONCLUSIONS: Pooling data from 14 studies, we found endovascular repair was associated with lower 30-day mortality, acute renal failure, bowel ischemia, and length of stay but with increased spinal cord ischemia. These data were limited by the risk of bias of the included studies. Further long-term studies are needed to determine whether these differences persist during long-term follow-up.

Long-term survival after endovascular and open repair in patients with anatomy outside instructions for use criteria for endovascular aneurysm repair.

BACKGROUND: Randomized controlled trials of long-term survival for infrarenal abdominal aortic aneurysms have compared open surgical repair (OSR) with endovascular aneurysm repair (EVAR) in patients with suitable aortic anatomy for EVAR. However, in clinical practice, patients who do not meet instructions for use (IFU) criteria are often still treated by EVAR despite that some studies show higher graft-related adverse events. The goal of this study was to compare the long-term survival of EVAR and OSR in patients with anatomy outside IFU criteria for EVAR. METHODS: This multicenter retrospective cohort study included patients with at least one anatomic IFU violation for EVAR undergoing either elective EVAR or elective OSR for abdominal aortic aneurysm. Demographics, anatomic data, and follow-up data of patients were collected from three academic centers from 2003 to 2016. Device-specific IFU were used for EVAR patients, whereas generic IFU for EVAR were applied to the OSR patients. The primary outcomes were 30-day mortality and long-term all-cause mortality. Secondary outcomes were aneurysm-related mortality and perioperative complications at 30 days. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Inverse propensity score weights were used to adjust for differences in treatment selection. RESULTS: The study population included 202 EVAR patients and 224 OSR patients with at least one anatomic IFU violation for EVAR. EVAR patients were older (78.1 ± 7.3 vs 70.9 ± 7.0 years; P < .001) and less likely to be hypertensive (69.3% vs 79.0%; P = .02) compared with OSR patients. OSR patients were more likely to have proximal aortic neck IFU violations (75.0% vs 47.1%; P < .001) and were less likely to have iliac IFU violations (65.2% vs 79.2%; P < .001). All-cause mortality was 37.6% in the EVAR group and 24.1% in the OSR group with a median follow-up time of 5.2 (3.5-7.2) and 5.4 (2.8-9.3) years, respectively (P < .002). Kaplan-Meier survival analysis revealed a significant association between patients undergoing OSR and increased long-term survival (log-rank P < .0001). When adjusted for possible confounders and weighted for propensity for treatment through Cox hazard modeling, the association remained significant (hazard ratio, 0.6; 95% confidence interval, 0.4-0.9). Aneurysm-related mortality was 3.5% in the EVAR group and 2.2% in the OSR group during long-term follow-up (P < .001). CONCLUSIONS: Our study identified that patients with IFU violations have higher overall long-term survival with open surgery compared with EVAR. Caution should be applied in considering standard EVAR for patients with anatomy outside of IFU.

Cryopreserved Cadaveric Arterial Allograft for Arterial Reconstruction in Patients with Prosthetic Infection.

OBJECTIVE: The aim of this study was to report outcomes of cryopreserved arterial allografts used as a vascular substitute in the setting of prosthetic material infection. METHODS: A retrospective analysis of prospectively collected data was conducted including all consecutive interventions performed with cryopreserved arterial allografts used for vascular reconstruction in the setting of prosthetic material infection between January 2005 and December 2014. Five year outcomes included allograft related re-interventions, survival, primary patency, and limb salvage rates. RESULTS: Fifty-three procedures were performed using cryopreserved allografts for vascular prosthetic infection: 25 procedures (47%) were performed at aorto-iliac level (Group 1) and 28 procedures (53%) at peripheral level (Group 2). The mean follow-up was 52 months. Five year allograft related re-intervention was 55% in Group 1 (6 allograft ruptures and 5 allograft aneurysm degenerations) and 33% in Group 2 (2 allograft ruptures and 7 allograft aneurysm degenerations). Five year survival was 40% and 68%, primary patency was 89% and 59% and limb salvage was 100% and 89% for Group 1 and 2 respectively. CONCLUSION: Use of cryopreserved arterial allografts provides acceptable results but is tempered by suboptimal 5 year outcomes with high re-intervention rates.

Anatomical Study of Healthy Aortic Arches.

BACKGROUND: With the steady increase of endovascular procedures involving the aortic arch (AA), an actual depiction of its anatomy has become mandatory. It has also become necessary to evaluate the natural evolution of the AA morphology as part of the evaluation of endovascular devices durability. The objective of this study was to perform a morphological and anatomical study of the AA and of the supra aortic trunks (SAT) in healthy patients, with an evaluation of their evolution with time, with a specific orientation applied to endovascular therapies of the AA. METHODS: Sixty-one patients (31 men, mean age 50.8 [18-82]) with a normal anatomy were included in the study. Measurements included the diameters of the AA and SAT in 17 locations, their distance and angulation based on computed tomography angiography data. Statistical analysis focused on descriptive statistics, differences between genders, as well as correlations with age. RESULTS: Aortic diameters (mean ± SD) were 29.5 ± 3.9 mm at the ascending aorta, 28.6 ± 3.9 mm at the innominate artery (IA), 27.1 ± 3.2 mm at the left common carotid artery (LCCA), 25.3 ± 3.0 mm at the left subclavian artery (LSCA), 23.9 ± 3.3 mm at the descending aorta. Mean angulation of the AA was 82° (95% confidence interval [CI]: 78.95-85.19°), mean angulation between LSCA/LCCA was -5.7° (95% CI: -0.9 to 18.7°) and -1.8° (95% CI: 5.4-26.4°) between LCCA/IA. Mean distance between the LSCA and the LCCA was 14.3 mm (95% CI: 13-15.6 mm) and 21.8 mm (95% CI: 20.3-23.4 mm) between LCCA and IA. All diameters of the AA increased with age (P < 0.05). Men had diameters statistically (P < 0.05) greater than women except at the LCCA ostium level. A statistically significant increase of the distances between the LSCA and the LCCA, between the LSCA and the IA and between the IA and the LCCA was found with age, P = 0.027, <0.01 and 0.012 respectively. CONCLUSIONS: This study allows obtaining accurate information of the AA and the SAT anatomy. It enabled to obtain a better understanding of the three-dimensional aspects of the AA, confirmed the variability and heterogeneity of the SAT disposition, and discussed the principles of vascular aging.

Evaluation of Nitinol Stents Using a 3-Dimensional Printed Superficial Femoral Artery Model: A Preliminary Study.

BACKGROUND: Mechanical tests assessing Nitinol stents used for the superficial femoral artery (SFA) are designed without taking into account their deployment environments. The objectives of this study were (1) to create normal and pathologic femoral artery models, (2) to run mechanical tests reproducing the stresses of the SFA, and (3) to study and compare Nitinol stents in those conditions. METHODS: Femoral artery models with identical mechanical properties to the SFA were created using the 3-dimensional printing technology. Those models were designed with and without an asymmetric focal 50% stenosis. Three mechanical tests (bending-compression, bending-compression-torsion, and multiple bending tests) were created and 1 flexible stent was tested, of 6 and 7-mm diameter. Three samples of the stent, LifeStent (Bard(®)), were deployed and tested in the models. Stents alone were evaluated in the same conditions. The analysis focused on the comparison of rheologic curves, level of kink, and the energy deployed for each stent to kink. RESULTS: In the 3 tests, all stents deployed in the models presented a kink during their evaluation. When tested alone, during the compression-bending and bending-compression-torsion tests, no plicature was observed. During the multiple bending test, the energy deployed to plicature for the stent tested alone was of 1.4 ± 0.10 and 2.84 ± 0.1 J compared with 9.7 ± 0.6 and 8.25 ± 0.6 J when deployed in the model for the Lifestent 6 × 80 and 7 × 80 mm, respectively. For all of these 3 tests, 6-mm diameter stents exhibited a level of kink and energy of kink higher than 7 mm stents. The behavior of the stents changed in the stenosed model whatever diameter is taken into account. Analysis of the rheologic curves showed a decrease in the inflection of the curve related to the plication. In the bending-compression test, the presence of a stenosis lead to an early plication of the model, with less deployed kinking energy whereas in the bending, compression, and torsion test, this earliness was absent. CONCLUSIONS: This study permitted the creation of a mechanical test platform evaluating Nitinol stents in bending situations. It tends to confirm the mechanical deleterious effect of excessive oversizing. This study confirms the necessity to evaluate Nitinol stents in their deployment environments.

Midterm failure after endovascular treatment of a persistent sciatic artery aneurysm.

Persistent sciatic artery (PSA) is a rare arterial embryologic malformation that tends to present early atherosclerotic degeneration such as aneurysmal formation. Open surgical treatment of PSA aneurysms has been considered as the gold standard but endovascular techniques have been recently proposed in the literature. We report the case of a 65-year-old man, diagnosed with a PSA aneurysm on peripheral thromboembolic complications. We achieved an endovascular repair with a covered stent. Despite an uneventful postoperative course, the covered stent demonstrated fracture and thrombosis 6 months after implantation without any symptoms.

Temporary Vascular Debranching to Facilitate Retroperitoneal Tumour en bloc Resection.

BACKGROUND: Oncovascular teams are known to be a cornerstone in planning and facilitating en bloc resection of large retroperitoneal masses. Vascular surgeons can help with dissection close to major vessels by vascular reconstruction when necessary, and also in performing specific procedures that can facilitate safe and optimal tumour mass resection. Two cases are reported where temporary vascular debranching of major arteries allowed safe tumour harvesting. CASE REPORTS: A 68 year old man with a necrotic retroperitoneal carcinoma underwent en bloc resection with temporary debranching of the coeliac trunk, superior mesenteric artery, and right renal artery using a multibranched bypass from the axillary artery. The post-operative course included septic shock related to pulmonary infection requiring a 10 day stay in the intensive care unit (ICU). Renal function was normalised on day two. The patient was discharged on day 18. However, he died 78 months post-operatively from pulmonary metastases after anti-angiogenic treatment.A 34 year old man with a retroperitoneal mature teratoma underwent en bloc resection with temporary debranching of the coeliac trunk, superior mesenteric artery, left and right renal arteries, and left and right common iliac arteries, with a multibranched bypass from the axillary artery. Post-operatively he required a five day stay in the ICU. Acute kidney injury (AKI) was noted, but it resolved without dialysis. The patient was discharged on day 16. After 78 months follow up he presented with chronic renal failure requiring dialysis. Follow up computed tomography angiography showed pulmonary metastases; although the metastases were manageable with surgical treatment, the patient refused further care. CONCLUSIONS: Temporary extra-anatomical bypass from the axillary artery to the visceral arteries could be considered as an option to provide adequate perfusion and to prevent visceral ischaemia during en bloc resection of large retroperitoneal masses.