Outcomes of covered vs bare metal stents for the treatment of aortoiliac occlusive disease.

OBJECTIVE: We retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022. METHODS: All patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency. RESULTS: A total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate. CONCLUSIONS: All patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.

Aortic endarterectomy in patients with severe multivessel paravisceral and aortoiliac occlusive disease.

OBJECTIVE: Aortic endarterectomy (AE), once a treatment of choice for aortoiliac occlusive disease, is now rarely performed in favor of endovascular procedures or open aortobifemoral bypass. However, in select patients with paravisceral or aortoiliac occlusive disease, AE remains a viable alternative for revascularization, either as a primary procedure or after prior interventions have failed. Here, we evaluated outcomes for an extended series of patients undergoing paravisceral or aortoiliac endarterectomy, demonstrating that these procedures can be an excellent alternative with acceptable morbidity and mortality in properly selected patients. METHODS: A single institution retrospective review of 20 patients who underwent AE from 2017 to 2023 was performed. RESULTS: Five patients (25%) underwent paravisceral endarterectomy and 15 (75%) underwent aortoiliac endarterectomy. There were no perioperative mortalities. One paravisceral patient died 3 months postoperatively from complications of pneumonia. Three patients in the paravisceral group required reinterventions; one acutely due to thrombosis of the superior mesenteric artery (SMA) requiring extension of the endarterectomy and patch angioplasty on postoperative day 0, one due to stenosis at the distal edge of the endarterectomy 1 month postoperatively, successfully treated with SMA stenting, and one at 10-month follow-up due to SMA stenosis at the distal aspect of the endarterectomy, also successfully treated with SMA stenting. With these reinterventions, the 1-year primary patency in the paravisceral group was 40%, primary-assisted patency was 80%, and secondary patency was 100%. In the aortoiliac group, 1-year primary, primary-assisted, and secondary patency were 91%, 91%, and 100%, respectively. One patient developed iliac thrombosis 10 days postoperatively owing to an intimal flap distal to the endarterectomy site. She and one other patient, a young man with an undefined hypercoagulable disorder, ultimately required neoaortoiliac reconstructions at 18 and 32 months postoperatively, respectively (the latter in the setting of stopping anticoagulation). The remaining 13 patients experienced no complications. All patients had rapid resolution of clinical symptoms, and median postoperative ankle-brachial indexes of 1.06 on the right and 1.00 on the left, representing a median improvement from preoperative ankle-brachial indexes of +0.59 on the right and +0.56 on the left (P < .01 and P < .01). CONCLUSIONS: In this series of 20 patients undergoing paravisceral and infrarenal aortoiliac endarterectomy, AE was associated with no perioperative mortality, relatively low and manageable morbidity, and excellent clinical outcomes in patients with both paravisceral and aortoiliac occlusive disease. SMA-related early reintervention was not uncommon in the paravisceral group, and attention should be given particularly to the distal endarterectomy site. AE remains a viable treatment for severe multivessel paravisceral or aortoiliac occlusive disease isolated to the aorta and common iliac arteries in select patients.

Covered endovascular reconstruction of the aortic bifurcation: A systematic review aggregated data and individual participant data meta-analysis.

BACKGROUND: We investigated the early and midterm efficacy and safety of covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac disease (AID). METHODS: A systematic search on PubMed, Scopus, and Web of Science for articles published by August 2023 was performed. The primary end points were primary patency and secondary patency. RESULTS: Eleven retrospective case series, involving 579 patients, were incorporated in the review with 88.9% of the included lesions being categorized as Trans-Atlantic Inter-Society Consensus (TASC) C or D. The pooled primary patency estimates at 12, 24 and 36 months were 94.4% (95% confidence interval [CI], 89.4-99.7), 84.4% (95% CI, 72.3-98.5) and 83.8% (95% CI, 71.4-98.3) respectively. The mean primary patency time, representing the period during which individuals remained event-free, was 51.9 months (95% CI, 43.6-55.4). The pooled 36 months primary patency for studies with a predominantly claudicant patient population (>75% of patients) was 89.4% (95% CI, 78.5-100.0), compared with 71.5% (95% CI, 45.6-100.0) for studies with a mixed population (50% of patients). The pooled 36 months primary patency for studies with a predominantly TASC D patient population (>82% of patients) was 70.4% (95% CI, 46.4-100.0) compared with 91.0% (95% CI, 79.1-100.0) for studies with a more homogenous cohort. The pooled secondary patency estimates at 12, 24, and 36 months were 98.6% (95% CI, 96.2-100.0), 97% (95% CI, 93.1-100.0), and 97% (95% CI, 93.1-100.0), respectively. The pooled technical success, 30-day mortality and 30-day systemic complications estimates were 95.9% (95% CI, 93.7- 97.4), 1.9% (95% CI, 1.0-3.5), and 6.4% (95% CI, 4.4-9.1), respectively. The pooled intraoperative and postoperative 30-day CERAB-related complications estimates were 7.3% (95% CI, 2.0-23.0) and 4.2% (95% CI, 0.7-21.0), respectively. The pooled major amputation and target lesion reinterventions by the end of follow-up were 1.9% (95% CI, 1.0-3.4) and 13.9% (95% CI, 9.9-19.2), respectively. The pooled access site complication estimate was 11.7% (95% CI, 5.9-21.7). CONCLUSIONS: Although this review has showcased the safety and feasibility of the CERAB technique in treating AID, it has also highlighted the necessity for a close and prolonged follow-up period extending beyond 1 year. Moreover, the favorable secondary patency estimates predominantly attained via endovascular reinterventions emphasize a potentially advantageous characteristic of the CERAB technique, particularly valuable when addressing late-stage AID disease or anatomically complex lesions.

Aortobifemoral bypass vs covered endovascular reconstruction of aortic bifurcation.

BACKGROUND: Covered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly used as a first line-treatment in patients with aortoiliac occlusive disease (AIOD). We sought to compare the outcomes of patients who underwent CERAB compared with the gold standard of aortobifemoral bypass (ABF). METHODS: The Vascular Quality Initiative was queried for patients who underwent ABF or CERAB from 2009 to 2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest-neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALEs), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were used. RESULTS: A total of 3944 ABF and 281 CERAB cases were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009 and 2021. Compared with ABF, patients who underwent CERAB were more likely to be older (64.7 vs 60.2; P < .001) and more often had diabetes (40.9% vs 24.1%; P < .001) and end-stage renal disease (1.1% vs 0.3%; P = .03). In the matched analysis (229 CERAB vs 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs 83.2% [±3%]; P < .001) and lower rates of MALE (5.2% [±0.9%] vs 14.1% [±3%]; P < .001), with comparable primary patency rates (98.3% [±0.3%] vs 96.6% [±1%]; P = .6) and amputation-free survival (99.3% [±0.3%] vs 99.4% [±0.6%]; P = .9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% [±6%] vs 92.9% [±0.9%]; P < .001). Matched analysis also revealed shorter length of stay (1 vs 7 days; P < .001), as well as lower pulmonary (1.2% vs 6.6%; P = .01), renal (1.8% vs 10%; P < .001), and cardiac (1.8% vs 12.8%; P < .001) complications among CERAB patients. CONCLUSIONS: CERAB had lower perioperative morbidity compared with ABF with a similar primary patency 1-year estimates. However, patients who underwent CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment for patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared with the established durability of ABF and further define the role of CEARB in the treatment of AIOD.

A Cost-Consequence Analysis Comparing Balloon-Expandable Covered Stents for the Management of Aortoiliac Occlusive Disease.

PURPOSE: To compare procedural and long-term costs associated with the use of Balloon-Expandable Covered Stents (BECS) in the management of Aortoiliac Occlusive Disease (AIOD). MATERIALS AND METHODS: A cost-consequence model was developed to simulate the intra- and post-operative management of patients with AIOD from the perspective of private health-payers. The study assessed the costs of the LifeStream (BD, Franklin Lakes, New Jersey), iCAST/Advanta V12 (Getinge, Goteborg, Sweden), BeGraft Peripheral (Bentley, Hechingen, Germany), and Viabahn Balloon Expandable (VBX) (W.L. Gore, Flagstaff, Arizona) BECS devices. Device costs were identified from the Australian Prosthesis List, whereas clinical outcomes of BECS were estimated from a systematic review of the literature. Costs were calculated over 24 and 36 month time horizons and reported in US dollars. RESULTS: Long-term, per-patient cost of each device at 24 and 36 months was $6253/$6634 for the LifeStream; $6359/$6869 for the iCAST/Advanta V12; $4806 (data available to 24 months) for the BeGraft Peripheral; and $4839/$5046 for the Viabahn VBX, respectively. Most of the cost difference was attributed to the number of stents required per treated limb and frequency of clinically-driven target lesion revascularization events. CONCLUSIONS: Best-available clinical evidence and economic modeling demonstrates that the BeGraft Peripheral and Viabahn VBX were of similar cost and the least costly options at 24 months, whereas at 36 months, the lowest cost BECS option for the treatment of AIOD was the Viabahn VBX. CLINICAL IMPACT: This analysis supports economically informed decision-making for health-payers managing systems that care for patients with AIOD. Stent length and avoiding reintervention were identified as key areas of cost-saving for future BECS development.

Bifurcated Endografts for the Treatment of Aortoiliac Disease a Systematic Review and Individual Patient Data (IPD) Meta-Analysis.

BACKGROUND: This review aimed to assess the efficacy and safety of bifurcated endografts in the treatment of aortoiliac disease (AOID). METHODS: A systematic search on PubMed, Scopus, and Web of Science was performed. The primary endpoint was primary patency, whereas secondary endpoints included reintervention, technical, clinical success, and overall postoperative complications. RESULTS: Ten studies with a total of 365 patients were included in this review. Most included studies used the AFX unibody endograft, one study the Excluder endograft, and one the Powerlink endograft. The majority of included patients displayed TransAtlantic InterSociety Consensus (TASC) D aortoiliac lesions (56.1% 205/365). The pooled primary patency estimates at 12, 24, and 36 months were 93.93% (95% confidence interval [CI]: 87.7-100), 91.46% (95% CI: 84.6-98.8), and 90.25% (95% CI: 82.6-98.6), respectively. The mean primary patency time was 85.74 months (95% CI: 71.99-86.88). The pooled freedom from reintervention estimates at 12, 24, and 36 months were 91.94% (95% CI: 81.4-100), 91.03% (95% CI: 79.8-100), and 91.03% (95% CI: 79.8-100), respectively. The pooled estimates of major complications (rupture, graft thrombosis, amputation) were 11.12% (95% CI, 0.05%-3.03%), 3.76% (0.32%-9.45%), and 0.38% (0%-2.59%), whereas the pooled estimates for minor complications (hematoma, groin infection, dissection) and overall mortality were 5.27% (95% CI, 1.11%-11.38%), 6.93% (95% CI, 2.94%-12.16%), 2.19% (95% CI, 0.06%-6.14%), and1.57% (95% CI, 0.13-3.97), respectively. Technical and clinical success estimates were 99.92% (95% CI: 98.86%-100%) and 99.47% (95% CI: 94.92%-100%), respectively. CONCLUSION: The application of bifurcated endografts may present a safe and viable option in the treatment of AOID, with preliminary results indicating promising primary patency outcomes. However, the definitive assessment of their efficacy and safety will be better determined through long-term follow-up studies and high-quality randomized controlled trials, which are essential to substantiate these initial findings. CLINICAL IMPACT: Bifurcated endograft application may be a safe and viable alternative for high-risk patients with complex AOID TASC C and D lesions with encouraging primary patency outcomes potentially comparable to those of open surgery. Non-negligible postoperative complication rates were also noted. High-quality randomized controlled trials and studies comparing CERAB, kissing stenting, and the use bifurcated endografts for the treatment of AOID is necessary to draw more definite conclusions.

Efficacy and Safety of Covered Stents Versus Bare-Metal Stents for Aortoiliac Occlusive Disease: A Systematic Review and Meta-Analysis.

PURPOSE: This study aimed to assess the efficacy and safety outcome of covered stents (CSs), as compared with bare-metal stents (BMSs), for the treatment of patients with aortoiliac occlusive disease (AIOD). MATERIALS AND METHODS: A systematic literature search was conducted in PubMed, Embase, and Cochrane Library up to August 2023 to identify all studies comparing efficacy and safety outcomes of CSs versus BMSs for treating AIOD. Our outcome was primary patency, secondary patency, technical success, ankle-brachial index (ABI) variation, target lesion revascularization (TLR), limb salvage, complications, and long-term survival. Dichotomous outcomes were pooled as relative risks (RR) or hazard ratio with the 95% confidence interval (CI). Continuous outcomes were pooled as weighted mean differences and 95% CI. Model selection was based on the heterogeneity of the included studies. RESULTS: There were 10 studies (2 randomized controlled trials, 8 retrospective cohort studies), comprising 1676 sample size. Compared with BMSs, CSs use was associated with better primary patency of patients with a Trans-Atlantic Inter-Society Consensus II (TASC) D lesion (RR, 1.15, 95% CI, 1.04 to 1.27, p=0.007), TLR (RR, 0.39, 95% CI, 0.27 to 0.56, p<0.001), technical success (RR, 1.01, 95% CI, 1.00 to 1.02, p=0.010), and long-term survival (RR, 1.06, 95% CI, 1.01 to 1.11, p=0.020). There is no difference between CSs and BMSs regarding primary patency of all patients, secondary patency, variation in ABI, limb salvage, and complications. CONCLUSIONS: Compared with BMSs, CSs used in AIOD was associated with more favorable primary patency in patients with TASC D lesions, TLR, technical success rates, and patient long-term survival. These results provide evidence of the advantages of using CSs for AIOD treatment. Future studies focusing on long-term variations in ABI, primary patency of different degrees of calcification, vascular segments, and TASC classification are warranted. CLINICAL IMPACT: Although several studies evaluated the clinical efficacy of CS in the context of AIOD treatment, the significance and consistency of these findings were not determined to date. We found that CS was used in AIOD associated with better technical success rate, long-term patient survival, lower target lesion revascularization, and higher primary patency of patients with a Trans-Atlantic Inter-Society Consensus II D lesion when compared with BMSs. Our study provides evidence supporting the superiority of CSs over BMSs in the treatment of AIOD, and furnishing clinicians with guidance for treatment decisions.

Extra-anatomic bypass procedures for severe aortoiliac occlusive disease-A cohort study.

OBJECTIVES: Extra-anatomic bypass (ExAB) grafting has been questioned due its inferior durability compared to anatomic bypass for aortoiliac occlusive disease (AIOD). This study aims to present early and late outcomes of patients treated with ExAB as well as to evaluate potential prognostic factors. METHODS: This is a retrospective cohort study presenting a series of patients treated with ExAB for AIOD. All patients were treated between 2005 and 2022 within the Vascular Surgery Unit of a University Surgery Clinic. Both early (30-day) and late outcomes were evaluated. Univariate and multivariate analyses were conducted for potential predictors. Kaplan-Meier curve was produced for long-term patency. RESULTS: A total of 41 patients were treated (85.3% males; mean age: 76.3 ± 4.2 years). Indication for treatment included severe claudication or critical limb ischemia (Rutherford stages III-VI). The following procedures were recorded: Femorofemoral bypass (FFB; n = 21) and axillofemoral bypass (AxFB; n = 20). All procedures were conducted using synthetic grafts with external rings. Early outcomes included no death, no myocardial infarction, no major bleeding, no graft infection, and no major amputation. Regarding late outcomes, 14.6% patients were lost after the first month. For the rest of patients (n = 35), five-year primary patency was 88.6%, primary-assisted patency was 94.3%, and secondary patency was also 94.3%. Limb salvage was 100% within follow-up. Endarterectomy at the distal anastomosis was the only independent predictor associated with worse patency in the long-term (OR = 5.356; 95% CI (1.012-185.562); p = .041). CONCLUSIONS: FFB and AxFB is a safe and durable strategy for treating patients with severe AIOD where no other option is feasible. Regarding predictors, only endarterectomy at the distal anastomosis site was associated with an increased risk for graft failure.

Comprehensive management of challenging recurrent aortoiliac and lower extremity occlusive disease with simultaneous modified-covered endovascular reconstruction of the aortic bifurcation, inferior mesenteric artery snorkel, and lower extremity bypass.

OBJECTIVES: Despite recent advancements in endovascular technology and proven durability of open surgeries, managing extensive aortoiliac occlusive disease (AIOD) with concurrent severe lower extremity (LE) arterial occlusion remains a formidable challenge. This paper introduces a comprehensive approach to addressing recurrent AIOD and LE occlusive diseases by employing modified-CERAB, inferior mesenteric artery (IMA) snorkel, and LE bypass in a challenging case. METHODS: A 56-year-old male patient presented with subacute bilateral lower extremity rest pain with dry gangrene in the left great toe and a complex medical history. His history included a hostile abdomen stemming from past ischemic bowel episodes and multiple bowel resections through laparotomies. Furthermore, the patient had a persistent left ventricular thrombus (LVT), stage-2 chronic kidney disease (CKD), diabetes, and was currently experiencing bilateral LE rest pain and dry gangrene in the left great toe, accompanied by severe dermatitis in both LEs. RESULTS: He successfully underwent modified-CERAB with a concurrent snorkel technique for IMA preservation, along with an LE bypass to resolve bilateral LE critical ischemia. CONCLUSION: This comprehensive management approach, combining simultaneous modified-CERAB, IMA snorkel, and LE bypass, provides an effective alternative for addressing complex AIOD and LE occlusive disease patients with hostile abdomen.

Gender disparities in patients with aortoiliac disease requiring open operative intervention.

OBJECTIVE: Peripheral artery disease is known to affect males and females in different proportions. Disparate surgical outcomes have been quantified after endovascular aortic aneurysm repair, arteriovenous fistula creation, and treatment of critical limb ischemia. The aim of this study is to objectively quantify the sex differences in outcomes in patients undergoing open surgical intervention for aortoiliac occlusive disease. METHODS: Patients were identified in the aortoiliac occlusive disease Vascular Quality Initiative database who underwent aorto-bifemoral bypass or aortic thromboendarterectomy as determined by Current Procedural Terminology codes between 2012 and 2019. Patients with a minimum of 1-year follow-up were included. Risk differences (RDs) by sex were calculated using a binomial regression model in 30-day and 1-year incidence of mortality and limb salvage. Additionally, incidence of surgical complications including prolonged length of stay (>10 days), reoperation, and change in renal function (>0.5 mg/dl rise from baseline), were recorded. Inverse probability weighting was used to standardize demographic and medical history characteristics. Multivariate logistic regression models were employed to conduct analyses of the before mentioned clinical outcomes, controlling for known confounders. RESULTS: Of 16,218 eligible patients from the VQI data during the study period, 6538 (40.3%) were female. The mean age, body mass index, and race were not statistically different between sexes. Although there was no statistically significant difference detected in mortality between males and females at 30 days postoperatively, females had an increased crude 1-year mortality with an RD of 0.014 (95% confidence interval, 0.01-0.02; P value < .001. Males had a higher rate of a postoperative change in renal function with an RD of -0.02 (95% confidence interval, -0.03 to -0.01; P < .001). CONCLUSIONS: Although there was no sex-based mortality difference at 30 days, there was a statistically significant increase in mortality in females after open aortoiliac intervention at 1 year based on our weighted model. Male patients are statistically significantly more likely to have a decline in renal function after their procedures when compared with females. Postoperative complications including prolonged hospital stay, reoperation, and wound disruption were similar among the sexes, as was limb preservation rates at 1 year. Further studies should focus on elucidating the underlying factors contributing to sex-based differences in clinical outcomes following aortoiliac interventions.

Open abdominal aortic repair in the current era has more complications for occlusive disease than for aneurysm repair.

BACKGROUND: Endovascular intervention has become the first-line treatment of patients with abdominal aortic aneurysms (AAAs) or aortoiliac occlusive disease (AIOD). However, open abdominal aortic repair remains a valuable treatment option for patients who are younger, those with unfavorable anatomy, and patients for whom endovascular intervention has failed. The cohort of patients undergoing open repair has become highly selected; nevertheless, updated outcomes or patient selection recommendations have been unavailable. In the present study, we explored and compared the characteristics and postoperative outcomes of patients who had undergone open abdominal aortic repair from 2009 to 2018. METHODS: Patients who had undergone open AAA (n = 9481) or AIOD (n = 9257) repair were collected from the National Surgical Quality Improvement Program database. The primary outcome was the 30-day mortality. The secondary outcomes included 30-day return to the operating room, total operative time, total hospital stay, and postoperative complications. Unmatched and matched differences between the two groups and changes over time were analyzed. Univariate and multivariate regression analyses were conducted to assess the risk factors predicting for 30-day mortality. RESULTS: After propensity matching (n = 4980), those in the AIOD group had had a higher 30-day mortality rate (5.1% vs 4.1%; P = .021), a higher incidence of wound complications (7.4% vs 5.1%; P<.0001) and an increased 30-day return to the operating room (14.2% vs 9.1%; P < .0001). More open AIOD cases (P = .02) and fewer open AAA cases (P = .04) had been treated in the second half of the decade than in the first. The factors associated with an increased odds of 30-day mortality included advanced age, American Society of Anesthesiologists score ≥III, functional dependence, blood transfusion <72 hours before surgery, weight loss in previous 6 months, and a history of chronic obstructive pulmonary disease. CONCLUSIONS: From 2009 to 2018, the number of open AAA repairs decreased and the proportion of open abdominal AIOD cases increased. Open AIOD surgery was associated with higher 30-day mortality, increased return to the operating room, and increased wound complications vs open AAA repair. Multiple risk factors increased the odds for perioperative mortality. Thus, open abdominal aortic repair should be selectively applied to patients with fewer risk factors.

Outcomes of Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Procedure for the Treatment of Extensive Aortoiliac Occlusive Disease Using the BeGraft Balloon-Expandable Covered Stent: A Multicenter Observational Study.

PURPOSE: The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique offers an alternative for Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions involving the aortic bifurcation. The study aims to evaluate the outcomes of the CERAB technique for extensive aortoiliac occlusive disease (AIOD) using the BeGraft balloon-expandable covered stent (BECS). MATERIALS AND METHODS: This is a physician-initiated, multicenter, retrospective, observational study. Between June 2017 and June 2021, all consecutive patients who underwent the CERAB procedure using the BeGraft stent (Bentley InnoMed, Hechingen, Germany) in 3 clinics were enrolled. Patients' demographics, lesion characteristics, and procedural results were collected and retrospectively analyzed. Follow-up was done at 1, 6, and 12 months and then annually with clinical examination, ankle-brachial index (ABI), and duplex ultrasound. The primary endpoint was the patency at 12 months. Secondary endpoints included procedural-related complications, secondary patency, freedom from target lesion revascularization (TLR), and clinical improvement. RESULTS: In all, 120 patients (64 men) with a median age of 65 years (range: 34-84 years) were analyzed. Most patients had extensive AIOD classified as TASC II C (n=32; 26.7%) or TASC II D (n=81; 67.5%). The median duration of the procedure was 120 minutes (interquartile range [IQR]: 80-180 minutes). All 454 BeGraft stents (137 aortic and 317 peripheral) were successfully delivered and deployed. The overall procedural complication rate was 14 (11.7%). The median hospital length of stay was 5 days (IQR: 3-6 days). All patients improved clinically, and the ABI increased significantly (p<0.05). The median follow-up was 19 months (range: 6-56 months). The primary patency rate, secondary patency rate, and freedom from TLR at 12 months were 94.5%, 97.3%, and 93.5%, respectively. CONCLUSIONS: The CERAB procedure with BeGraft BECSs has a high technical success rate, favorable patency outcomes, and low morbidity, even in relatively ill patients with extensive AIOD. Prospective randomized studies on the CERAB technique are definitely recommended. CLINICAL IMPACT: This study evaluates the outcomes of BeGraft stents used during the covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure. To date, several balloon-expandable covered stents have been used for this technique with satisfactory results. This study showed the safety and excellent patency of the CERAB technique in extensive AIOD using BeGraft balloon-expandable covered stents.

Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis.

INTRODUCTION: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. RESULTS: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. CONCLUSION: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. CLINICAL IMPACT: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

Hypogastric artery luminal diameter predicts common-external iliac stent patency and major adverse limb events in patients with aortoiliac occlusive disease.

OBJECTIVE: Hypogastric coverage may be required for occlusive disease at the iliac arterial bifurcation. In this study, we sought to determine patency rates of common-external iliac artery (C-EIA) bare metal stents (BMS) spanning the hypogastric origin in patients with aortoiliac occlusive disease (AIOD). In addition, we sought to identify predictors of C-EIA BMS patency loss and major adverse limb events (MALE) in patients requiring hypogastric coverage. We hypothesized that worsening stenosis of the hypogastric origin would negatively influence C-EIA stent patency and freedom from MALE. METHODS: This is a single center, retrospective review of consecutive patients undergoing elective, endovascular treatment of aortoiliac disease (AIOD) between 2010 and 2018. Only patients with C-EIA BMS coverage of a patent IIA origin were included in the study. Hypogastric luminal diameter was determined from preoperative CT angiography. Analysis was performed using Kaplan-Meier survival analysis, univariable and multivariable logistic regression, and receiver operator characteristics (ROC). RESULTS: There were 236 patients (318 limbs) who were included in the study. AIOD was TASC C/D in 236/318 (74.2%) of cases. C-EIA stent primary patency was 86.5% (95% confidence interval: 81.1, 91.9) at 2 years and 79.7% (72.8, 86.7) at 4 years. Freedom from ipsilateral MALE was 77.0% (71.1, 82.9) at 2 years and 68.7% (61.3, 76.2) at 4 years. Luminal diameter of the hypogastric origin was most strongly associated with loss of C-EIA BMS primary patency in multivariable analysis (hazard ratio: 0.81, p = .02). Insulin-dependent diabetes, Rutherford's class IV or above, and stenosis of the hypogastric origin were significantly predictive of MALE in both univariable and multivariable analyses. In ROC analysis, luminal diameter of the hypogastric origin was superior to chance in prediction of C-EIA primary patency loss and MALE. Hypogastric diameter >4.5 mm had a negative predictive value of 0.94 for C-EIA primary patency loss and 0.83 for MALE. CONCLUSIONS: Patency rates of C-EIA BMS are high. Hypogastric luminal diameter is an important and potentially modifiable predictor of C-EIA BMS patency and MALE in patients with AIOD.

Procalcitonin kinetics following abdominal aortic surgery and its value for postoperative intestinal ischaemia detection.

OBJECTIVE: The purpose of our study was to describe perioperative kinetics of procalcitonin (PCT) in patients undergoing aortic surgery, to compare the kinetics in the open abdominal aortic aneurysm (AAA) repair and aortobifemoral bypass for aortoiliac occlusive disease (AIOD), and to evaluate the ability of PCT to detect intestinal ischaemia. METHODS: A prospective non-randomized observational cohort study in 80 patients (62 men and 18 women) undergoing elective aortic surgery was performed. Serum PCT was measured at baseline and defined intraoperative and postoperative timepoints up to postoperative day 7. MRI contrast-enhanced imaging was used to detect intestinal ischaemia. RESULTS: The comparison of the AAA and AIOD cohort did not show any significant difference in PCT levels. Patients with intestinal ischaemia had higher serum PCT at multiple timepoints postoperatively. The most accurate timepoints for early diagnosis were postoperative day 3, followed by 24 h after declamping of the vascular reconstruction, and postoperative day 7. The sensitivity and negative predictive values were 100% in all mentioned timepoints. However, event at the best timepoint the specificity was 89% and the positive predictive value 43%. CONCLUSIONS: Procalcitonin levels in the postoperative period at proper timepoints might help to detect postoperative intestinal ischaemia. The limitation of this marker is its low specificity for intestinal ischaemia and low positive predictive value. The highest value of this marker is that it can rule out this complication because normal PCT levels mean that intestinal ischaemia is very unlikely.

Aortoiliac occlusive disease - a novel classification system based on anatomical segments and disease severity for management planning.

AIMS: The aim of this classification system is to provide vascular surgeons with a simple tool that categorises disease severity by anatomical segment in aortoiliac occlusive disease and thus guide decision making and management strategies. Disease of the common femoral arteries is included as the distal extent of disease with respect to access for both open and endovascular intervention is essential to management planning. METHODS: The classification system designates diseased segment letters and numbers to guide treatment planning. The degree of disease other than stenotic or occluded is not required. In a similar manner to the TNM classification, anatomy and disease severity - based on angiography, CTA, and MRA - are categorised using a simple, user-friendly method. Two clinical cases are presented to exemplify the clinical application of this classification system. RESULTS: A simple and useful classification system is presented and ease of use exemplified by two clinical cases. CONCLUSIONS: Management strategies for peripheral artery disease in general, aortoiliac occlusive disease specifically, have evolved rapidly in recent years. Existing classification systems, such as TASC II, steer the clinician towards specific treatment approaches. However, the first step in the management decision-making process is the accurate identification of the arterial segments that require treatment. None of the existing classification systems specifically address anatomy as an entity in itself. This classification system provides an intuitive framework, based on letters and numbers, that provides specific information on arterial segments and disease severity in aortoiliac occlusive disease on which clinicians can base management decisions. It has been developed to bolster this aspect of the vascular surgery armamentarium; to be used as a decision making and management planning tool, in partnership with, not instead of, existing classification systems.

Transbrachial and transfemoral approaches combined with visceral protection for the treatment of juxtarenal aortoiliac occlusive disease: Technical issues and clinical outcomes.

PURPOSE: To evaluate the safety and efficacy of transbrachial and transfemoral approaches combined with visceral protection for the endovascular treatment of juxtarenal aortoiliac occlusive disease (AIOD) over an average 19-month follow-up period. METHODS: In this retrospective analysis, all patients with juxtarenal AIOD at a single institution were reviewed from June 2015 to January 2020. Patient characteristics, angiographic results, and follow-up outcomes were retrospectively recorded. The indications for treatment were critical limb threatening ischemia in 12 patients and bilateral claudication in five patients. Percutaneous access via the left brachial artery was first obtained to recanalize the infrarenal occluded lesions. After that, femoral accesses were achieved. A 4-Fr catheter, a 4 mm balloon, or a 6-Fr 90-cm-long sheath was used to complete visceral artery protection. RESULTS: A total of 17 juxtarenal AIOD patients (14 males; mean age, 63.4 ± 8.1 years) underwent endovascular treatment. The technical success rate was 100%. Complete reconstruction was achieved in 15 (88.2%) patients. The infrarenal aorta was reconstructed with kissing covered stent grafts (n = 7), kissing bare-metal stents (n = 2), covered stent grafts (n = 2), bare-metal stents (n = 1), or the off-label use of iliac limb stent grafts (n = 5). Renal embolization was found in 3 (17.6%) patients during intraoperative angiography. There was 1 (5.9%) case of distal runoff embolization after CDT and 1 (5.9%) case of left iliac artery rupture. One (5.9%) death occurred due to acute myocardial infarction 20 days after the operation. The average follow-up period was 19.3 ± 16.7 months (range, 1-54 months) in the remaining 16 cases. The renal artery patency rate was 100%. The estimated cumulative primary patency rates were 92.3% at 12 months and 59.3% at 36 months according to the Kaplan-Meier method. CONCLUSIONS: Transbrachial and transfemoral approaches combined with visceral protection offer a safe and effective alternative to open revascularization for the endovascular treatment of juxtarenal AIOD.

Thoracofemoral bypass outcomes in the Vascular Quality Initiative.

OBJECTIVE: Thoracofemoral bypass (TFB) has been used infrequently but is an alternative for select patients with aortoiliac occlusive disease. Limited data are available in the reported data regarding TFB, with all studies small, single-center series. We aimed to describe the perioperative and long-term survival, patency, and rate of major perioperative complications after TFB in a large national registry. METHODS: The Vascular Quality Initiative suprainguinal bypass module was used to identify patients who had undergone TFB for occlusive disease from 2009 to 2019. A descriptive analysis was performed to provide the rates of survival, patency, major complications, and freedom from major amputation in the perioperative period and at 1 year of follow-up. Major complications were compared by procedure indication, with categorical variables analyzed using χ2 tests and continuous variables using analysis of variance. Kaplan-Meier curve analysis was used to estimate survival at the 1- and 5-year follow-up intervals and freedom from major amputation at 1 year. RESULTS: A total of 154 TFB procedures were identified. Of the 154 patients, 59 (38.3%) had undergone previous inflow bypass and 22 (14.2%) had undergone previous leg bypass. The procedure indications included claudication (n = 66; 42.9%), rest pain (n = 59; 38.3%), tissue loss (n = 19; 12.3%), and acute limb ischemia (n = 10; 6.5%). Major complications (eg, wound infection, respiratory, major stroke, new dialysis, cardiac, embolic, major amputation, occlusion) occurred in 31.2% of the cohort. When examined by indication, the acute limb ischemia and claudication cohorts had an increased rate of major complications (acute limb ischemia, 60.0%; claudication, 34.8%; critical limb ischemia, 24.4%; P = .05). The survival rate at 30 days was 95.5%, with a Kaplan-Meier estimated 1-year survival rate of 92.7% ± 2.2%. Primary patency at discharge from the index hospitalization was 92.9% and 89.0% at 1 year. Postoperative major amputation was required for 1 patient during the index hospitalization, for a Kaplan-Meier estimated freedom from major amputation at 1 year of 97.1% ± 2.2%. Two patients developed in-hospital bypass occlusion and three patients developed occlusion within 1 year, for an overall freedom from occlusion rate of 96.8% at 1 year. CONCLUSIONS: TFB is associated with a high rate of perioperative major complications; however, the long-term survival and patency after TFB remained acceptable when performed for limb salvage. The high perioperative complication rates of TFB procedures performed for claudication suggest TFB should be used rarely in this population. These data can be used to counsel patients and aid in decision making before operative intervention.

Hemodynamic Comparison of Stent-Grafts for the Treatment of Aortoiliac Occlusive Disease.

PURPOSE: To compare the flow patterns and hemodynamics of the AFX stent-graft and the covered endovascular reconstruction of aortic bifurcation (CERAB) configuration using laser particle image velocimetry (PIV) experiments. MATERIALS AND METHODS: Two anatomically realistic aortoiliac phantoms were constructed using polydimethylsiloxane polymer. An AFX stent-graft with a transparent cover made with a new method was inserted into one phantom. A CERAB configuration using Atrium's Avanta V12 with transparent covers made with a previously established method was inserted into the other phantom, both modified stent-grafts were suitable for laser PIV, enabling visualization of the flow fields and quantification of time average wall shear stress (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT). RESULTS: Disturbed flow was observed at the bifurcation region of the AFX, especially at the end systolic velocity (ESV) time-point where recirculation was noticeable due to vortical flow. In contrast, predominantly unidirectional flow was observed at the CERAB bifurcation. These observations were confirmed by the quantified hemodynamic results from PIV analysis where mean TAWSS of 0.078 Pa (range: 0.009-0.242 Pa) was significantly lower in AFX as compared with 0.229 Pa (range: 0.013-0.906 Pa) for CERAB (p<0.001). Mean OSI of 0.318 (range: 0.123-0.496) in AFX was significantly higher than 0.252 (range: 0.055-0.472) in CERAB (p<0.001). Likewise, mean RRT of 180 Pa-1 (range: 9-3603 Pa-1) in AFX was also significantly higher than 88 Pa-1 (range: 2-840 Pa-1) in CERAB (p=0.0086). CONCLUSION: In this in vitro study, the flow pattern of a modified AFX stent-graft was found to be more disturbed especially at the end systolic phase, its hemodynamic outcomes less desirable than CERAB configuration. CLINICAL RELEVANCE: While the AFX stent-graft has an advantage over the CERAB configuration in eliminating radial mismatch, and maintaining the anatomical bifurcation for future endovascular intervention, this in vitro study revealed that the associated lower TAWSS, higher OSI and RRT may predispose to thrombosis and are, thus, less desirable as compared to a CERAB configuration. Further investigation is warranted to confirm whether these findings translate into the clinical setting.