Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Mid-term Results of Endovascular Reconstruction of Aortic Bifurcation Using COVERA Stent Graft.

INTRODUCTION: This article aims to evaluate the short-term and mid-term performance of a self-expanding covered stent (COVERA Plus, Bard Tempe, Arizona) during the treatment of Trans-Atlantic Inter-Society Consensus (TASC) C/D aortoiliac obstructive lesions involving the aortic bifurcation. METHODS: A single-center retrospective review of all patients who underwent endovascular reconstruction of the aortoiliac bifurcation for obstructive disease, with the use of Covera, from January 2018 to March 2023. All patients received a postoperative CTA (computed tomography angiography) scan within 1 month from the intervention. Precision of deployment, stent conformation, and stent symmetry were evaluated at the arterial phase of the CTA. Early outcomes were technical success and freedom from open aortic reintervention and/or mortality. Late outcomes were primary and assisted primary patency rates and freedom from reintervention. RESULTS: During the study period, 35 patients underwent primary endovascular treatment of obstructive lesions involving the aortic bifurcation with parallel COVERA stents. Aortoiliac lesions were classified as TASC-IIC in 23 (65.7%) patients and TASC D in 12 (34.2%). Median follow-up was 49 months (interquartile [IQR]: 18-60). Overall survival was 97.1% (95% confidence interval [CI]=91-100) at 60 months. During follow-up, there were one early stent stenosis, treated with an angioplasty and stent relining with an estimated primary patency at 60 months of 97.1% (95% CI=94-100) and a primary-assisted patency of 100%. Estimated freedom from all types of reinterventions at 60 months was 94.3% (95% CI=89-99.3). CONCLUSIONS: The new self-expanding covered Bard COVERA Plus stent used for endovascular treatment of TASC C/D aorto iliac disease proved to be safe and feasible with high technical procedural success rates. Comparison with other types of stents is necessary to further assess the role of the COVERA Plus stent in aortic bifurcation repair. CLINICAL IMPACT: This study investigates the safety and feasibility of the new self-expanding covered Bard Covera Plus stent used for endovascular treatment of TASC C/D aorto iliac disease. The retrospective analysis of 35 patients highlights high technical success and primary patency rate at 60 months. The geometric analysis also helped to underline how this stent can be used precisely in particular conditions. These findings suggest the need for further research to compare COVERA with other types of stents in aortic bifurcation repair.

Intraoperative Transit-Time Flow as a Predictor of Failure after Infrainguinal Revascularization with Heparin-Bonded Expanded Polytetrafluoroethylene Graft.

BACKGROUND: The heparin-bonded expanded polytetrafluoroethylene (He-ePTFE) conduit is an option for patients requiring infrainguinal revascularization (iIR), but the risk of failure may be unpredictable, especially in cases with poor run-off. Intraoperative transit-time flow (TTF) provides an automated and quantitative analysis of flow and may serve as an adjunct evaluation during surgical revascularization. The aim of this study was to assess TTF in patients undergoing iIR with He-PTFE at 3 referral hospitals and to establish a predictive flow threshold for graft occlusion. METHODS: A prospective registry initiated in 2020 enrolled patients undergoing iIR using He-PTFE for critical limb ischemia or severe claudication, and TTF measurement was analyzed. Preoperative assessments of anatomical and clinical characteristics were available for all patients. The HT353 Optima Meter (Transonic Systems Inc., Ithaca, NY, USA) was used in all procedures according to a standardized protocol. The institutional ethics committee approved the study. A predictive model using receiver operating characteristic curve analysis was utilized to establish the threshold of flow, and variables were compared. Anatomical and clinical evaluation were reported according to Rutherford grade, Global Limb Anatomic System and Wound, Ischemia, and foot Infection classification. The main outcome considered was the correlation between TTF and graft occlusion. Secondary outcomes included survival, other predictors of graft occlusion, freedom from major adverse cardiovascular events, and freedom from major amputation. RESULTS: Among 68 patients, 55.8% had Rutherford 5-6, 45.6% had Global Limb Anatomic System 3 and 73.5% had Wound, Ischemia, and foot Infection 3-4. Distal anastomosis was at tibial level in 23.5% and mean diameter of conduit was 6.4 mm. Basal and postoperative TTF were 27.8 ± 15.6 ml/min and 109.0 ± 53.0 ml/min, respectively. After a mean follow-up of 18 ± 13 months, 7 (10.9%) patients presented graft occlusion and 5 (7.8%) required major amputation. TTF threshold = 80 ml/min revealed a sensitivity and specificity of 81.8% (95% confidence interval 48.2-97.7) and 80.7% (95% confidence interval 68.1-90.0) respectively, and it was selected as cut-off for graft occlusion. Freedom from graft occlusion in patients with TTF >80 ml/min vs. TTF ≤80 ml/min at 6, 12, and 24 months was 95.7% (standard error (SE) = 0.030) vs. 65.5% (SE = 0.115), 95.7% (SE = 0.030) vs. 58.9% (SE = 0.120) and 90.9% (SE = 0.054) vs. 51.6% (SE = 0.126), P = 0.0003. No statistical difference in primary patency, secondary patency and limb salvage was observed. At multivariate analysis, distal anastomosis at tibial vessel (odds ratio 8.50) and TTF ≤80 ml/min (odds ratio 9.39) were independent predictors of graft occlusion. CONCLUSIONS: These results suggest that TTF may serve as a valuable tool in the management of iIR. A TTF measurement of ≤80 ml/min should be regarded as a predictor of graft occlusion, prompting consideration of additional intraoperative maneuvers to enhance arterial flow. Caution should be exercised in patients requiring direct tibial artery revascularization, as it represents a predictor of failure independent of TTF levels. Larger cohorts of patients and longer follow-up periods are necessary to confirm these findings.

Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA): Derivation and validation of a novel risk score.

OBJECTIVE: The aim of the present study was to develop and validate a risk prediction model for the prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA). METHODS: Data were collected retrospectively from a dedicated database of consecutive patients who had undergone elective CEA for severe (>70% using the NASCET [North American Symptomatic Carotid Endarterectomy Trial] criteria) asymptomatic carotid stenosis at two Italian University Hospitals from 2008 through 2016. Internal validation of the score was performed after random sampling in a 3:1 fashion. The primary end point of the PREMY2SE-CEA risk score was the 5-year mortality. RESULTS: Of the 1214 patients, 901 were included in the derivation cohort and 313 in the validation cohort. Using multivariable logistic regression with backward elimination, a parsimonious model was derived. A risk score incorporating eight risk factors was generated and found to be highly predictive of long-term mortality in the derivation (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.28-1.41; P < .001) and validation (OR, 1.29; 95% CI, 1.21-1.37; P <.001) cohorts. The discrimination power in the receiver operating characteristic curve analysis was C = 0.775 (95% CI, 0.74-.80), and the optimism-corrected area under the curve in the bootstrapped samples was 0.761 (P < .001). A strong correlation was found between the predicted and actual mortality rates in the validation cohort (r = 0.71; P < .001). CONCLUSIONS: In the present study, we have described the development, evaluation, and validation of a risk prediction model (PREMY2SE-CEA) for long-term mortality after CEA in asymptomatic patients. Physicians could use the PREMY2SE-CEA risk scoring tool to complement their estimates of life expectancy and prompt selective consideration of prophylactic CEA to improve the long-term benefits of interventions.

Results of iliac branch devices for hypogastric salvage after previous aortic repair.

OBJECTIVE: The aim of this multicentric study was to assess the "REsults of iliac branch deviceS for hypogastriC salvage after previoUs aortic rEpair (RESCUE)." METHODS: All consecutive patients who underwent implantation of iliac branch devices (IBDs) after previous open aortic repair (OAR) or endovascular aortic repair (EVAR) at seven centers were captured. The study cohort was divided into two groups according to the type of repair originally performed. Early outcomes included immediate technical success and perioperative adverse events. Late outcomes included survival, side branch (SB) primary patency, SB instability, and new onset buttock claudication. RESULTS: A total of 94 patients (82 male) were included in the study, 10 of them received bilateral implantation of IBDs. This resulted in a total of 104 devices included in the final analysis. Indication for treatment were endoleak 1b or progressive iliac aneurysmal degeneration or distal para-anastomotic aortic aneurysms; 73 were implanted after previous EVAR and 31 after previous OAR. Technical success was 100% in both groups. The 3-year rate of freedom from SB instability was 90.1% after previous EVAR and 85.4% after previous OAR, respectively (P = .05). The 3-year estimates of SB primary patency were significantly lower in patients who had received OAR as compared with those that had received EVAR (89.8% vs 94.9%; P = .05). CONCLUSIONS: Endovascular treatment with IBDs following previous OAR or EVAR is safe and effective up to 3 years. Freedom from SB instability during follow-up was lower in patients who had previously undergone OAR than EVAR.

Celiac Artery Coverage After Thoracic Endovascular Aortic Procedure: A Meta-Analysis of Early and Late Results.

BACKGROUND/AIM: Clinical outcomes of celiac artery (CA) coverage during aortic procedures are often contradicting and the fate of this additional maneuver is still unclear. This study summarizes the results of available literature and aims to clarify the impact of CA coverage during thoracic endovascular aneurysm repair (TEVAR) in patients with inadequate distal sealing zone. METHODS: Prospective and retrospective, observational original articles focused on CA coverage during elective/urgent TEVAR for descending thoracic aortic pathology (DTAP) were included. PubMed/MEDLINE, Embase, and Cochrane Central Register of Controlled Trials database were examined to identify articles published from January 2007 to December 2020, according to PRISMA guidelines. Early and late visceral (any sign or symptom reported) and neurological (both transient and permanent) complications were considered as primary outcomes. Onset of any endoleak, type IB endoleak, need of reintervention, and TEVAR-related mortality were considered as secondary outcomes. RESULTS: A total of 5618 articles were extracted for analysis and 13 studies were finally included in the synthesis. A total of 178 CAs were covered during 2653 TEVAR (7%). Spinal cord ischemia was 8% (95% CI, 5-14%, I2 0%) Any endoleak and type IB endoleak was observed in 12% (95% CI, 6-21%, I2 17%) and 5% (95% CI, 2-11%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reoperation was necessary in 8% (95% CI, 4-14%, I2 0%), the majority of which (14/18, 78%) performed for distal sealing failure; mortality rate was 9% (95% CI, 5-14%, I2 0%). Out of 178 patients, 168 (94%) were available for follow-up, ranged 12 to 42 months. Visceral complications, any endoleak, and type IB endoleak were identified in 15% (95% CI, 10-23%, I2 45%), 20% (95% CI, 13-29%, I2 8%), and 8% (95% CI, 4-15%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reintervention was required in 8% (95% CI, 4-14%, I2 0%). Mortality rate was 17% (95% CI, 12-25%, I2 4%). CONCLUSIONS: Celiac artery coverage in DTAP should be regarded as a "bailout" procedure especially in urgent/emergent settings but requires caution in elective cases. Even if transient visceral ischemia is frequent, life-threatening complications are rare. Early and late mortality rates are similar to standard TEVAR although the risk of type IB endoleak and reintervention may be an issue.

Association Between the Lockdown for SARS-CoV-2 (COVID-19) and Reduced Surgical Site Infections after Vascular Exposure in the Groin at Two Italian Academic Hospitals.

BACKGROUND: The aim of this study was to evaluate whether the scrupulous hygiene rules and the restriction of contacts during the lockdown owing to the COVID-19 pandemic affected the rate and severity of surgical site infections (SSI) after vascular exposure in the groin at two Italian University Hospitals. METHODS: Starting from March 2020, strict hygiene measures for protection of health care workers (HCW) and patients from COVID-19 infection were implemented, and partly lifted in July 2020. The main exposure for analysis purposes was the period in which patients were operated. Accordingly, study subjects were divided into two groups for subsequent comparisons (preCOVID-19 era: March-June 2018-2019 versus COVID-19 era: March-June 2020). The primary endpoint was the occurrence of superficial and/or deep SSI within 30 days after surgery. The Centers for Disease Control and Prevention definitions were used to classify superficial and deep SSI. RESULTS: A total of 194 consecutive patients who underwent vascular exposure in the groin were retrospectively analyzed. Of those, 60 underwent surgery from April 1, 2018 to June 30 of the same year; 83 from April 1, 2019 to June 30 of the same year; and 51 from April 1, 2020 to June 30 of the same year. The mean age of the study cohort was 75 years and 140 (72%) were males. Patients who were operated in the COVID-19 era were less likely to develop SSI (10% vs. 28%; P = 0.008), including both deep SSI (4% vs. 13%; P = 0.04) and superficial SSI (6% vs. 15%; P = 0.05). After multivariate adjustments, being operated in the COVID-19 era was found to be a negative predictor for development of an SSI (odds ratio [OR] = 0.31; 95% confidence interval [CI] = 0.09-0.76; P < 0.001) or deep SSI (OR = 0.21; 95% CI = 0.03-0.98; P < 0.001). Operative time was also found as independent predictor for the development of deep SSI (OR = 1.21; 95%CI = 1.21-1.52; P = 0.02). Using binary logistic regression, there were no independent predictors of superficial SSI that could be identified. CONCLUSIONS: Vascular exposure in the groin carries a non-negligible risk of SSI. In this study, we provided important insights that are simple and easily viable precautions (such as the universal use of surgical masks both for patients and health care professionals during wound care, the widespread diffusion of hand sanitizers, and the reduction of the number of visitors in the surgical wards) could be promising and safe tools for SSI risk reduction.

Ten-year experience with use of cryopreserved allografts for redo infrapopliteal bypass.

INTRODUCTION: The aim of this study is to report the early and late outcomes of cryopreserved saphenous vein (CSV) in redo infrainguinal bypass and to investigate possible predictors of primary patency loss. METHODS: All patients who underwent a redo bypass for critical limb ischemia from January 2010 to December 2020 were reviewed. Early and late complications were analyzed and included. The endpoints of the study were all cause mortality, major limb amputation, and primary patency (PP). RESULTS: Data were collected from 95 patients. Among the entire cohort, 16 (16.8%) patients received a cryopreserved vessel bypass with anastomosis in the popliteal artery and 79 (83.2%) patients had cryopreserved vessel bypasses with distal anastomosis in tibial vessels. Median duration of follow-up was 73 months; during this, period estimated survival at 5 years was 80.5 ± 4% (95% CI, 78.0-91.2) and estimates of freedom from limb amputation was 90.3 ± 3.2% (95% CI, 87.3-98.1). Overall, the estimated primary patency of the bypass was 43.7 ± 6.7% (95% CI, 30.2-51.4). On multivariable analysis, intraprocedural tibial vessel angioplasty (HR = 2.3, p = 0.01), distal anastomosis in tibial vessels (HR = 3.6, p = 0.36), and the use of a composite graft (HR = 2.4, p = 0.01) were independently associated with loss of PP. CONCLUSIONS: The use of CSV in redo bypass is an effective strategy in salvaging threatened lower extremities and in preventing or delaying limb amputation. Our results confirm that further attempts at revascularization are generally appropriate, even in technically changing patients.