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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Carotid Endarterectomy Outcomes in the Elderly: A Canadian Institutional Experience.

BACKGROUND: Carotid endarterectomy (CEA) is a well-established surgical intervention for stroke prevention in patients with carotid stenosis of all ages. However, the decision to proceed to operate in the elderly involves a more complicated risk-benefit assessment due in part to increased comorbidities and reduced life expectancy. Some studies suggest that CEA is more risky in the elderly with worse outcomes, whereas others have found no difference. Our objective was to evaluate and compare outcomes of CEA between elderly and younger patients at our institution. METHODS: All hospital charts were reviewed for consecutive patients undergoing CEA from the Jewish General Hospital and the Royal Victoria Hospital from October 2009 to December 2015. Primary outcomes were ipsilateral stroke, death, and restenosis at 30 days and 1 year. Secondary outcomes were cranial nerve injury, myocardial infarction (MI), hematoma, wound infection, cerebral hyperperfusion, and transient ischemic attacks within 30 days. Primary and secondary outcomes were compared between patients aged ≥80 years and <80 years. RESULTS: A total of 361 patients were included in this study with a mean age of 70.2 ± 9.5 years (n = 247 [68.4%] male and n = 272 [75.8%] symptomatic). Elderly patients were more often symptomatic (93.8% vs. 71.6%, P < 0.0001) and had an increased length of stay (2.8 ± 5.3 vs. 1.6 ± 1.8, P = 0.001). There was no statistically significant difference in primary outcomes between patients aged <80 years and ≥80 years, including 30-day stroke (1.7% vs. 0%), death (no deaths in either group), restenosis (8.8% vs. 12.3%), 1-year stroke (1.7% vs. 0%), death (0.7% vs. 0%), or restenosis (14.9% vs. 13.8%). However, elderly patients had significantly increased MI risk postoperatively (4.6% vs. 0.7%, P = 0.01). Other complications, including cranial nerve injury (3.7% in <80 years vs. 4.6% in the elderly group), were similar between the groups. CONCLUSIONS: We found that CEA in the elderly does not have an increased risk of stroke or death up to one year postoperatively. However, the postoperative length of stay is increased and complicated by significantly more MIs, which should weigh into the decision of whether to perform CEA on an elderly patient.

Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions.

BACKGROUND: Exercise-based interventions have become part of the standard of care in rehabilitation programs for cardiovascular risk reduction and the promotion of a healthy lifestyle. The systematic review describes the current state of knowledge of the effects of preoperative exercise training (prehabilitation) on perioperative clinical outcomes in patients undergoing cardiac and vascular interventions. METHODS: Studies were systematically searched within 14 databases from inception to October 2016. Only studies that assessed a preoperative exercise program in adult patients undergoing cardiac or vascular interventions with clinical or patient-centered endpoints were included in the review. Two independent reviewers selected studies for inclusion, extracted data, and assessed quality using Cochrane Collaboration's tool for RCTs11111111111111111 and ROBINS-I tool for nonrandomized studies. RESULTS: Nine studies met our inclusion criteria and were stratified for qualitative analyses by cardiac (n = 7) and vascular (n = 2) procedures. Prehabilitation was associated with decreased length of stay, reduced postoperative complications, improved objective physical functioning, and improved subjective quality of life (SF-36 physical and mental health domains) measures in patients undergoing cardiac and vascular procedures. Given the amount of heterogeneity that was present in the designs, populations, and comparators among the included studies, we were unable to statistically pool data across trials. CONCLUSIONS: Our qualitative findings suggest that prehabilitation may improve clinical outcomes, physical performance, and health-related quality-of-life measures in patients undergoing cardiac and vascular surgery procedures.

Early North American experience with the INCRAFT device.

BACKGROUND: Several low-profile grafts have been created for use in endovascular aneurysm repair in patients with small or difficult to access vessels. Our objective was to evaluate the outcomes of patients undergoing endovascular aneurysm repair with the INCRAFT device in a real-world North American setting. METHODS: Consecutive patients undergoing INCRAFT implantation between March 2015 and December 2016 at two McGill University teaching hospitals were enrolled in a prospectively maintained registry. Clinical characteristic and perioperative outcomes were entered into the registry. Two authors performed anatomic measurements from preoperative and postoperative computed tomography angiograms and intraoperative angiograms independently. In cases of disagreement a consensus was reached. RESULTS: We included 61 patients with a median follow-up of 363 days (mean, 344 ± 244 days). Minimum left and right access vessel sizes were 7.5 ± 1.7 mm and 7.4 ± 1.5 mm, respectively. More than 90% of grafts were implanted for aneurysm size or growth. Vessel access was percutaneous in 95% of cases. We had a mean length of stay of 0.88 ± 1.8 days with 57.3% of patients discharged the same day. There were 14 procedural type II endoleaks, 10 new type II leaks that were discovered during follow-up, and 11 that resolved for 77% of patients remaining endoleak free during follow-up. There were no 30-day mortalities. Three cancer-related deaths occurred during follow-up. Early complications included one access site repair for bleeding, one access site repair for dissection, and two aortounilateral conversions with femoral-femoral bypass owing to inadvertent ipsilateral gate cannulation. Long-term complications included one graft limb thrombosis, one intervention for type II endoleak with sac expansion that subsequently became infected and was explanted, and one intervention for a type III endoleak for an intervention. During follow-up, 95% of patients remained reintervention free. CONCLUSIONS: Use of the INCRAFT device in a real-world North American setting is relatively safe and effective, and is associated with a low rate of perioperative complications. However, we experienced early issues with inadvertent cannulation and deployment of the contralateral limb in the ipsilateral gate. Therefore, we recommend deploying the entire ipsilateral limb before cannulating the contralateral limb. Data with additional follow-up are needed to assess the long-term effectiveness of the INCRAFT device.

Safety and feasibility of endovascular aortic aneurysm repair as day surgery.

OBJECTIVE: The adoption of endovascular aneurysm repair (EVAR) during the past two decades has led to significantly shorter length of stay as well as lower hospital resource use. Currently, most patients are admitted to the hospital after EVAR; however, there are no standard observation periods, and timing of discharge is based on clinical judgment. The aim of this study was to confirm the safety and feasibility of performing EVAR as outpatient surgery. METHODS: We developed criteria to identify patients for potential same-day discharge (infrarenal aneurysm, low perioperative risk, to be accompanied for first 24 hours). We then implemented a prospective trial that observed patients planned for same-day discharge and compared them with a historical control group (patients who had undergone EVAR during the previous 2 years and met same-day discharge criteria). Basic demographic and operative data as well as length of stay, inpatient and perioperative complications, emergency department visits, readmissions, reinterventions, and deaths were collected. The primary outcome was the 30-day complication rate, and the study was powered to assess noninferiority. RESULTS: Prospectively, we assessed 266 patients and planned 110 (41%) for outpatient EVAR (62% of historical controls met outpatient criteria). Demographic characteristics were similar between planned outpatients and historical controls. In planned outpatients, hospital stay was significantly shorter (0.7 ± 2.6 days vs 2.5 ± 6.9 days; P < .01), and 79% were discharged the same day of surgery. The 30-day follow-up was available for all study patients and 94% of control patients; there were no differences in complication (11% vs 9%), readmission (2% vs 4%), reintervention (4% vs 4%), or mortality (1% vs 1%) rates, but study patients had significantly more emergency department visits (15% vs 6%; P < .05). Unsuccessful same-day discharge was associated with longer operative times, increased blood loss, and use of general anesthesia. CONCLUSIONS: In selected patients undergoing elective EVAR, same-day discharge is feasible without increasing complication rates. Health resource utilization remains a challenge in transitioning to an outpatient model.

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

BACKGROUND: Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. METHODS: Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. RESULTS: In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). CONCLUSIONS: FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding.

A National Survey on Teaching and Assessing Technical Proficiency in Vascular Surgery in Canada.

BACKGROUND: This survey aims to explore trainees' perspectives on how Canadian vascular surgery training programs are using simulation in teaching and assessing technical skills through a cross-sectional national survey. METHODS: A 10-min online questionnaire was sent to Program Directors of Canada's Royal College of Physicians and Surgeons' of Canada approved training programs in vascular surgery. This survey was distributed among residents and fellows who were studying in the 2013-2014 academic year. RESULTS: Twenty-eight (58%) of the 48 Canadian vascular surgery trainees completed the survey. A total of 68% of the respondents were part of the 0 + 5 integrated vascular surgery training program. The use of simulation in the assessment of technical skills at the beginning of training was reported by only 3 (11%) respondents, whereas 43% reported that simulation was used in their programs in the assessment of technical skills at some time during their training. Training programs most often provided simulation as a method of teaching and learning endovascular abdominal aortic or thoracic aneurysm repair (64%). Furthermore, 96% of trainees reported the most common resource to learn and enhance technical skills was dialog with vascular surgery staff. CONCLUSIONS: Surveyed vascular surgery trainees in Canada report that simulation is rarely used as a tool to assess baseline technical skills at the beginning of training. Less than half of surveyed trainees in vascular surgery programs in Canada report that simulation is being used for skills acquisition. Currently, in Canadian training programs, simulation is most commonly used to teach endovascular skills.

Patency of the contralateral internal iliac artery in aortouni-iliac endografting.

OBJECTIVE: This study determined the outcome of the contralateral internal iliac artery (IIA) in patients undergoing aortouni-iliac (AUI) endovascular abdominal aortic aneurysm repair (EVAR) with a femorofemoral bypass. METHODS: This retrospective study evaluated 131 consecutive patients undergoing AUI EVAR with femorofemoral bypass at the McGill University Health Center from October 2001 to November 2010. One hundred patients with preoperatively patent contralateral IIA met inclusion criteria for the study. Preoperative demographics and preoperative and postoperative contrast-enhanced computed tomography (CT) scans with multiplanar reconstruction were reviewed for all patients. The last available postoperative CT imaging for all patients was identified and evaluated for contralateral IIA patency. Patency in preoperative and postoperative CT scans was defined as contrast enhancement of the IIA in continuity with the external iliac artery and absence of >50% stenosis at the origin of the IIA. Clinical outcome focused on postoperative pelvic ischemia and reported symptoms of buttock claudication. RESULTS: Mean age at the time of operation was 77.6 ± 6.7 years, and 78% were male. Mean clinical follow-up was 29.2 months after surgery, and mean follow-up of imaging with intravenous contrast was 30.6 months. The last imaging follow-up showed 67 patients (67%) had a patent contralateral IIA and that the IIAs in 33 patients (33%) were occluded (25 [76%]) or stenotic (8 [24%]). Of the patients with IIA occlusion, 80% (20 of 25) were occluded on the first postoperative imaging (median, 8.5 days). Buttock claudication was reported in 18% (6 of 33 patients) with an occluded IIA compared with only 3% (2 of 67 patients) of patients with a patent contralateral IIA on final imaging follow-up (18% vs 3%; P = .014). There were no observed cases of buttock necrosis, spinal ischemia, or colonic ischemia. CONCLUSIONS: Our findings suggest that AUI EVAR with femorofemoral bypass is associated with a significant incidence of contralateral IIA malperfusion on postoperative CT imaging. Occlusion appears to occur early in the postoperative period in most patients, and patient-reported buttock claudication is observed significantly more frequently in patients with an occluded IIA compared with those with a patent IIA. More serious pelvic ischemic complications were not seen in this series. Further study is required to determine whether modification of the procedure can prevent contralateral IIA occlusion and the development of buttock claudication.

Sheath-shunt technique for avoiding lower limb ischemia during complex endovascular aneurysm repair.

Complex aortic aneurysms are now being repaired by endovascular techniques, albeit with a potentially increased risk of lower limb ischemia-reperfusion injury. We report a simple technique to maintain perfusion to the lower limb during endovascular repair, using one additional introducer sheath placed antegrade, distal to the stent graft introduction site, and connected to the side arm of the working sheath in the contralateral artery. This allows continuous perfusion of the limb distal to the main stent graft introduction site. In our initial experience with 12 cases, with confirmed occlusion of the native arterial system by the stent graft introducer sheath, arterial occlusion time was 165 ± 84 minutes. Use of the sheath-shunt technique resulted in pulsatile flow in all cases, with an average flow of 42.2 ± 13.2 mL/min, and actual ischemia time was reduced to 14 ± 11 minutes. There were no complications related to the use of this technique. Given the limited risk of this technique coupled with a potential benefit, we propose its consideration in patients undergoing complex endovascular repair.