Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue®) in reducing time to haemostasis in patients undergoing peripheral vascular surgery. METHODS: From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue® (Group no-Bio, 50 patients) or use of Bioglue® (Group Bio, 50 patients) by a block randomization method 10:10 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples tT -test and Gehan-Breslow-Wilcoxon test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in Group Bio (52% vs. 24%, p = 0.004). Femoral endarterectomy was most common in Group Bio (44% vs. 24%, p = 0.03), whilst the percentage of lower limb vein bypasses was higher in Group no-Bio (50% vs. 36%, p = 0.03). Bovine pericardium was the preferred material in Group Bio (20 cases, 40%), whilst autologous vein is mostly used in Group no-Bio (26 cases, 52%) (p = 0.01). Time to haemostasis was faster in Group Bio (4.4 vs. 9.6 minutes, p < 0.001). The need for adjunctive stitches was higher in Group no-Bio (8 cases, 16%, Group Bio vs. 25 cases, 50%, Group no-Bio; p < 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%, Group Bio vs. 7 cases, 14%, Group no-Bio; p = 0.39). CONCLUSIONS: The protein-based tissue adhesive Bioglue® reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.

Fate of target visceral vessels in fenestrated and branched complex endovascular aortic repair.

OBJECTIVE: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results. METHODS: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions. RESULTS: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively. CONCLUSIONS: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss.

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry.

PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.

Elective or Urgent Carotid Endarterectomy in Symptomatic Patients: Analysis Based on the Type and Timing of Neurological Symptoms.

BACKGROUND: The aim of this study was to retrospectively analyse perioperative and long-term outcomes of carotid endarterectomy (CEA) performed in symptomatic patients in a high-volume academic vascular centre, stratifying them according to the type of preoperative symptoms and the timing of surgery with respect to the indexed neurological event. METHODS: From January 2014 to December 2020, 1,369 consecutive CEAs were performed at our institution. Data concerning these interventions were prospectively collected in a dedicated database including data concerning preoperative assessment, surgical details, perioperative (<30 days) outcomes, and long-term outcomes. A retrospective analysis of the database was performed, and 213 interventions performed in symptomatic patients were found. We identified 2 subgroups of patients: patients with stable neurological symptoms (not recent transient ischemic attack (TIA) or stable major disabling stroke, stable group, and 157 patients) and patients with unstable neurological symptoms (recent TIA, crescendo TIAs, stroke in evolution, acute/recent minor stroke, unstable group, and 56 patients). Perioperative outcomes were analysed in terms of mortality, major neurological events, and local or systemic complications The results were compared using the χ2 test; these were also analysed on the basis of the presenting symptom (isolated TIA, crescendo TIA, stroke in evolution, acute/recent minor stroke, stabilized stroke) and the timing of the intervention relative to the onset of the symptom. Long term results were analysed using the life-table analysis and Kaplan-Meier curves in terms of survival, stroke-free survival, absence of neurological symptoms, and absence of significant restenosis. RESULTS: Overall, 30-day stroke and death rate were 4.2%. (3.1% vs. 7%, P = 0.2). Two deaths occurred at 30 days, both in the stable group (mortality 1.2%, P = 0.4 compared to the unstable group), but no fatal strokes were recorded in the overall sample. No differences were found in terms of new perioperative neurological events and local complications between the 2 groups. We found a trend toward poorer perioperative results in patients operated on within 48 hr from the indexed event and in patients operated on for stroke in evolution or acute/recent stroke, whereas we found a trend toward better results in favour of patients operated on between 8 and 14 days (P = 0.08). The median duration of follow-up was 24.8 months (range 1-78); at 5 years we did not find significant differences in terms of survival and stroke-free survival rates between 2 groups. CONCLUSIONS: In our experience, carotid surgery in symptomatic patients provided satisfactory results, particularly in patients with stable neurological status. Among unstable patients, the rate of complications significantly increases, mainly among treated in the very early (<48 hr) period for stroke in evolution or acute/recent stroke. Once the perioperative risk is overcome, the results in the long-term setting are similarly good, both in stable and in unstable patients.

Total Iodine Contrast-free Strategy for the Endovascular Management of Abdominal Aortic Aneurysms in Chronic Kidney Disease Patients: A Pilot Study.

BACKGROUND: To retrospectively evaluate the feasibility and effectiveness of the endovascular treatment of patients with abdominal aortic aneurysm and chronic kidney disease (CKD) without the need for using iodinated contrast media throughout the diagnostic, therapeutic, and follow-up pathway. METHODS: A retrospective review of prospectively collected data concerning 251 consecutive patients presenting an abdominal aortic or aorto-iliac aneurysm who underwent endovascular aneurysm repair (EVAR) from January 2019 to November 2022 at our academic institution was performed in order to identify patients with feasible anatomy with respect to manufacturer's instructions for use and with CKD. Patients whose preoperative workout included duplex ultrasound and plain computed tomography for preprocedural planning were extracted from a dedicated EVAR database. EVAR was performed with the use of carbon dioxide (CO2) as the contrast media of choice, whereas follow-up examinations consisted of either duplex ultrasound, plain computed tomography, or contrast-enhanced ultrasound. Primary endpoints were technical success, perioperative mortality, and early renal function variations. Secondary endpoints were all-type endoleaks and reinterventions, midterm aneurysm-related and kidney-related mortality. RESULTS: Forty-five patients had CKD and were treated electively (45/251, 17.9%). Of them, 17 patients were managed with a total iodinated contrast media-free strategy and constituted the object of the present study (17/45, 37.8%; 17/251, 6.8%). In 7 cases, an adjunctive planned procedure was performed (7/17, 41.2%). No intraoperative bail-out procedures were needed. This extracted cohort of patients presented similar mean preoperative and postoperative (at discharge) glomerular filtration rate values, 28.14 (SD 13.09; median 28.06, interquartile range (IQR) 20.25) ml/min/1.73 m2 and 29.33 (SD 14.61; median 27.35, IQR 22) ml/min/1.73 m2, respectively (P = 0.210). Mean follow-up was 16.4 months (SD 11.89; median 18, IQR 23). During follow-up, no graft-related complications occurred in terms of either thrombosis, type I or III endoleaks, aneurysm rupture, or conversion. The mean glomerular filtration rate at follow-up was 30.39 ml/min/1.73 m2 (SD 14.45; median 30.75, IQR 21.93), with no significant worsening in comparison with preoperative and postoperative values (P = 0.327 and P = 0.856 respectively). No aneurysm- or kidney-related deaths occurred during follow-up. CONCLUSIONS: Our initial experience shows that total iodine contrast-free abdominal aortic aneurysm endovascular management in patients with CKD may be feasible and safe. Such an approach seems to guarantee the preservation of residual kidney function without increasing the risks of aneurysm-related complications in the early and midterm postoperative periods, and it could be considered even in the case of complex endovascular procedures.

A comparative analysis of anatomical variations of popliteal artery and its branches in concomitant aneurysmal disease.

OBJECTIVES: Open or endovascular treatment of popliteal artery aneurysms (PAAs) is still debated. Data about the popliteal artery anatomy and its branches are essential to plan a surgical approach. The aim of this study was to report the anatomical variations of the popliteal artery and its branches in a population with aneurysmal disease and compare them with a standard population with non-aneurysmal disease. METHODS: A retrospective review of consecutive patients who underwent surgical PAA repair in our center between January 2011 and December 2020 was performed. One-hundred-forty-six limbs in 128 patients underwent PAA treatment (Group 1). Computed tomography angiography images using a 128-section configuration were reviewed for anatomical variations of the popliteal artery and its branches. A control population of 178 limbs in 89 patients with non-aneurysmal disease was used to compare the outcomes (Group 2). All limbs were classified according to Kim's classification. The two groups were analyzed and compared by means of nonparametric Pearson chi-square test. RESULTS: Both groups were homogeneous in terms of demographics, risk factors, and clinical presentation. In Group 1, the limbs with PAA were classified as type IA, 133 (91.1%); type IB, 2 (1.4%); type IC, 0; type IIA1, 1 (0.7%); type IIA2, 1 (0.7%); type IIB, 4 (2.7%); type IIC, 0; type IIIA, 3 (2.1%); type IIIB, 0; and type IIIC, 2 (1.4%). In Group 2 the limbs with non-aneurysmal disease were classified as type IA, 163 (91.6%); type IB, 5 (2.8%); type IC, 1 (0.6%); type IIA1, 1 (0.6%); type IIA2, 3 (1.7%); type IIB, 2 (1.1%); type IIC, 0; type IIIA, 3 (1.7%); type IIIB, 0; and type IIIC, 0. No difference in terms of anatomy of the popliteal artery and its branches was found between the two groups (P = NS). CONCLUSIONS: Knowledge of anatomical variations of the popliteal artery and its branches is mandatory in case of the surgical approach. Anatomy in PAA patients is not different. Studies with larger population size are needed to validate these outcomes.

Role of historical and procedural staging during elective fenestrated and branched endovascular treatment of extensive thoracoabdominal aortic aneurysms.

OBJECTIVE: Procedural staging is often performed to reduce the incidence of spinal cord ischemia (SCI) during endovascular treatment of extensive thoracoabdominal aortic aneurysms (TAAAs). However, its role in the case of previous thoracic or infrarenal aortic repair (historical staging) has been controversial. In the present study, we evaluated the SCI rates when procedural staging was routinely used and studied its potential benefits when previous aortic repairs had already been performed. METHODS: The data from patients treated electively with fenestrated/branched endovascular aortic repair for extent I, II, III, and V TAAAs were retrieved from a multicenter registry (four high-volume national teaching hospitals) and analyzed. The primary endpoint was the rate of SCI and its association with preoperative and postoperative variables, including historical staging, procedural staging, and an impaired collateral network (subclavian or hypogastric stenosis >75% per occlusion). Variables were defined in accordance with the Society for Vascular Surgery reporting standards. A logistic regression model with stepwise selection was used to identify the predictors of SCI. RESULTS: A total of 240 patients (76% male; median age, 73 years) were analyzed. Of the 240 patients, 43 (18%) had presented with an impaired collateral network, 136 (57%) had had historical staging, and 157 (65%) had received procedural staging. Preoperative spinal fluid cerebrospinal drainage was performed in 130 patients (54%). Permanent grade 3 SCI was observed in 13 patients (5%) and was negatively affected by both an impaired collateral network (odds ratio [OR], 17.3; 95% confidence interval [CI], 1.7-176; P = .016) and the presence of bilateral iliac occlusive disease (OR, 10.1; 95% CI, 1.1-98.3; P = .046). Both historical (OR, 0.02; 95% CI, 0.001-0.46; P = .014) and procedural (OR, 0.01; 95% CI, 0.02-0.7; P = .019) staging mitigated the permanent SCI rates. The need for postoperative transfusions (OR, 1.4; 95% CI, 1.1-1.8; P = .014) and the occurrence of postoperative renal complications (OR, 6.5; 95% CI, 1.2-35.0; P < .001) were associated with the development of SCI. Among the patients with historical staging, no further benefit from procedural staging was observed (SCI with procedural staging, 1%; vs no staging, 2%; P = NS). CONCLUSIONS: For patients with extensive TAAAs treated with fenestrated/branched endovascular aortic repair, both historical and planned procedural staging were associated with reduced permanent SCI rates. However, no additional benefit was observed when procedural staging was performed in patients with historical staging and an intact collateral network. The protective role of preoperative cerebrospinal fluid drainage placement requires further investigation.

Endovascular Reconstruction for Total Aorto-Iliac Occlusion.

OBJECTIVES: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. METHODS: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. RESULTS: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. CONCLUSIONS: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.

Sex Influence on Fenestrated and Branched Endovascular Aortic Aneurysm Repair: Outcomes From a National Multicenter Registry.

INTRODUCTION: Women are generally underrepresented in trials focusing on aortic aneurysm. Nevertheless, sex-related differences have recently emerged from several studies and registries. The aim of this research was to assess whether sex-related anatomical disparities existed in fenestrated and branched aortic repair candidates and whether these discrepancies could influence endovascular repair outcomes. METHODS: Data from all consecutive patients treated during the 2008-2019 period within the Italian Multicenter fenestrated or branched endovascular aortic repair (F/BEVAR) Registry were included in the present study. Propensity matching was performed using a logistic regression model adjusted for demographic data and comorbidities to obtain comparable male and female samples. The selection model led to a final study population of 176 patients (88 women and 88 men) among the total initial cohort of 596. Study endpoints were technical and clinical success, overall survival, aneurysm-related death, and reintervention rates evaluated at 30 days and during follow-up. RESULTS: Twenty-eight patients (15.9%) received urgent/emergent repair. In most of the cases (71.6%), women received treatment for extensive thoracoabdominal pathology (Crawford type I, II, or III aneurysm rather than type IV or juxta-pararenal) versus 46.6% of men (p=0.001). Female patients presented with more challenging iliac accesses with at least one side considered hostile in 27.3% of the cases (vs 13.6% in male patients, p=0.039). Finally, women had significantly smaller visceral vessels. Women had significantly worse operative outcomes, with an 86.2% technical success rate versus 96.6% in the male population (p=0.016). No differences were recorded in terms of 30-day reinterventions between men and women. The 5-year estimate of freedom from late reintervention, according to Kaplan-Meier analysis, was 85.6% in men versus 81.6% in women (p=ns). No aneurysm-related death was recorded during follow-up (median observational time, 23 months [interquartile range, 7-45 months]). CONCLUSION: Women presented a significantly higher incidence of thoracoabdominal aneurysms, smaller visceral vessels, and more complex iliofemoral accesses, resulting in a significantly lower technical success after F/BEVAR. Further studies assessing sex-related differences are needed to properly determine the impact on outcomes and stratify procedural risks. CLINICAL IMPACT: Women are generally underrepresented in trials focusing on aortic aneurysms. Aiming to assess whether sex may affect outcomes after a complex endovascular aortic repair, a propensity score selection was applied to a total population of 596 patients receiving F/BEVAR aortic repair with the Cook platform, matching each treated female patient with a corresponding male patient. Women presented more frequently a thoracoabdominal aneurysm extent, smaller visceral vessels, and complex iliofemoral accesses, resulting in significantly worse operative outcomes, with an 86.2% technical success versus 96.6% (p=0.016). No differences were recorded in terms of short-term and mid-term reinterventions. According to these results, careful and critical assessment should be posed in case of female patients receiving complex aortic repair, especially regarding preoperative anatomical evaluation and clinical selection with appropriate surgical risk stratification.

Fenestrated and Branched Endografts for Post-Dissection Thoraco-Abdominal Aneurysms: Results of a National Multicentre Study and Literature Review.

OBJECTIVE: Fenestrated and branched endografting (F/B-EVAR) has been proposed as an endovascular solution for chronic post-dissection thoraco-abdominal aneurysms (PD-TAAAs). The aim of this study was to analyse the experience of four high volume centres nationwide and the current available literature. METHODS: Data on patients undergoing F/B-EVAR in four Italian academic centres between 2008 and 2019 were collected, and those from patients with PD-TAAAs were analysed retrospectively. Peri-operative morbidity and mortality were assessed as early outcomes. Survival, freedom from re-intervention (FFR), target visceral vessel (TVV) patency, and aortic remodelling were assessed as follow up outcomes. A MEDLINE search was performed for studies published from 2008 to 2020 reporting on F/B-EVAR in PD-TAAAs. RESULTS: Among 351 patients who underwent F/B-EVAR for TAAAs, 37 (11%) had PD-TAAAs (Crawford's extent I-III: 35% - 95%). Overall, 135 TVVs (from true lumen 120; false lumen seven; both true and false lumen eight) were accommodated by fenestrations (96% - 71%) and branches (39% - 29%). Technical success (TS) was achieved in 34 (92%) cases with three failures due to endoleaks (Ia: 1; Ic: 1; III: 1). There were no 30 day deaths. No cases of permanent spinal cord ischaemia (SCI) were recorded and six (16%) patients suffered from transient deficits. Renal function worsening (eGFR < 30% than baseline) and pulmonary complications were reported in two (5%) and four (11%) cases, respectively. From the Kaplan-Meier analysis, three year survival, FFR, and TVV patency were 81%, 66%, and 97%, respectively. Radiological imaging was available for 30 (81%) patients at 12 months with complete false lumen thrombosis in 26 (87%). Two hundred and fifty-six patients were reported in seven published papers with TS, 30 day mortality, and SCI ranging from 99% to 100%, 0 to 6%, and 0 to 16%, respectively. The mean follow up ranged from 12 to 26 months, with estimated two year survival between 81% and 90% and a re-intervention rate between 19% and 53%. CONCLUSION: F/B-EVAR is effective to treat PD-TAAAs. A high re-intervention rate is necessary to complete the aneurysm exclusion and promote aortic remodelling successfully.

Autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene as graft materials for below-the-knee femoro-popliteal bypass in patients with critical limb ischemia: A propensity score-matched analysis.

OBJECTIVE: To compare the outcomes of heparin bonded expanded polytetrafluoroethylene (HePTFE) and autologous saphenous vein (ASV) in patients undergoing below-knee (BK) femoro-popliteal bypass for critical limb ischemia (CLI). DESIGN: Retrospective single-centre matched case-control study. METHODS: From 2003 to 2019, 275 consecutive BK bypasses for CLI were performed, 109 with the ASV and 166 with a HePTFE graft. All the baseline characteristics that were reliably measured and were potentially relevant in the decision-making process were included as confounders in a logistic regression model and the factors that were significantly different between the two groups then used to perform a propensity matching analysis. Propensity score-based matching was performed in a 1:1 ratio to compare outcomes. Arterial hypertension, hyperlipemia, the need for tibial anastomosis at the distal level and the run-off status were the covariates included in the matching. Follow-up outcomes were estimated by Kaplan-Meier methods and compared with log rank test. RESULTS: After propensity matching, 101 HePTFE bypasses were matched with 101 ASV bypasses. The median duration of follow-up was 37 months (range 1-192). The 5-year survival rate was 67.5% (standard error (SE) 0.05) in the HePTFe group and 64.5% (SE 0.06) in the ASV group (p = 0.8, log rank 0.04). Primary patency rates were 38% (SE 0.06) in the HePTFE group and 41% (SE 0.06) in the ASV group (p = 0.7, log rank 0.3). Also assisted primary patency and secondary patency rates did not differ in the two groups. Amputation-free survival was 53% (SE 0.05) in the HePTFE group and 58% (SE 0.06) in the ASF group (p = 0.6, log rank 0.2). CONCLUSIONS: HePTFE provided 5-year similar results to those obtained with use of the ASV in equivalent patients with CLI undergoing below-knee or tibial bypass.

Covered versus bare metal kissing stents for reconstruction of the aortic bifurcation in the ILIACS registry.

OBJECTIVE: We compared the early and midterm outcomes of polytetrafluoroethylene covered stents (CSs) vs bare metal stents (BMSs) used in the kissing conformation for the reconstruction of the aortic bifurcation in aortoiliac obstructive disease. METHODS: A multicenter cohort registry (2015-2019) collected data from 1306 patients who had undergone endovascular treatment of aortoiliac arterial obstructive disease. Only patients who had received bilateral iliac kissing stents for TransAtlantic Inter-Society Consensus (TASC) class C and D lesions were included in the present analysis. The 30-day outcomes, midterm primary patency, and limb salvage rates were compared between the CSs and BMSs in matched patient cohorts after propensity score matching. The follow-up results were analyzed using Kaplan-Meier curves. Cox proportional hazards models were used to identify the predictors of primary patency. RESULTS: A total of 336 patients were treated with kissing stents, 201 with CSs (60%) and 135 with BMSs (40%). In the unmatched cohort, patients receiving CSs were more likely to have critical limb ischemia (41% vs 30%; P = .038), complex iliac lesions, such as TASC D (90% vs 56%; P < .01), and iliac occlusions (59% vs 44%; P < .01). After propensity score matching, 220 patients were selected (110 with CSs and 110 with BMSs), without differences in the clinical presentation (critical limb ischemia, 41% vs 33%; P = .167), or anatomic complexity (TASC D, 66% vs 60%, P = .21; iliac occlusion, 48% vs 49%, P = .89). The 30-day mortality was 0%. The early medical (unmatched, 5% vs 4%, P = 1.00; matched, 5% vs 4%, P = .75) and surgical (unmatched, 5% vs 5%, P = 1.00; matched, 5% vs 3%, P = .72) complication rates were similar between the CSs and BMSs. However, the CSs resulted in a lower risk of intraoperative iliac rupture (0% vs 3.5%; P = .013) and greater ankle-brachial index improvement (0.43 ± 0.22 vs 0.36 ± 0.24; P = .02). At 36 months, the overall primary patency (92% ± 7% vs 92% ± 8%; P = .38), secondary patency (98% ± 3% vs 98% ± 4%; P = .50), and limb salvage (93% ± 9% vs 97% ± 5%; P = .20) rates were similar. In cases of moderate to severe iliac calcification, the CSs showed better results in the matched cohort (100% vs 89% ± 9%; P = .048). On multivariate analysis, CS use (hazard ratio [HR], 1.67; P = .45) did not significantly affect primary patency, but older age (HR, 0.93; P = .03) and kissing stent diameter ≥8 mm (HR, 0.25; P = .03) were significantly associated. CONCLUSIONS: In the present multicenter study, the use of kissing stents for the treatment of the aortic bifurcation provided good early and midterm results. CSs were preferred for more complex lesions, were protective from iliac rupture, and allowed for greater ankle-brachial index improvement. The 3-year patency rates were similar between the CSs and BMSs. However, CSs showed improved results in the case of moderate to severe calcification.

A pilot study of the enhanced recovery after surgery protocol in aortic surgery.

OBJECTIVE: We tested the outcomes with the use of the enhanced recovery after surgery protocol in patients who had undergone open abdominal aortic aneurysm (AAA) repair (enhanced recovery after vascular surgery [ERAVS] protocol). We compared them with those obtained for patients who had undergone endovascular aneurysm repair (EVAR) and for a historical control group of standard open AAA repair in a prospective, single-center pilot study. METHODS: From June to December 2019, all patients who were candidates for open AAA repair at our department were enrolled in the ERAVS protocol (ERAVS group; 17 patients). During the same period, 18 patients had undergone EVAR (EVAR group). The historical control group of standard open AAA repair included 32 patients who had undergone surgery during the 6 months before the study period (standard protocol open repair [OR] group). The three groups were compared on an "on-treatment" basis (prospectively for the ERAVS and EVAR groups and retrospectively for the OR group) in terms of the time to discharge (TTD), interval to the resumption of oral intake, time to ambulation, resumption of bowel function, and postoperative pain. Comparisons were performed using the one-way analysis of variance test, Tukey post hoc test for quantitative data, and χ2 test for qualitative data. RESULTS: The ERAVS protocol was successfully applied for all but one patient (feasibility rate, 94%). The mean TTD was 5.1 days in the ERAVS group, 3.5 days in the EVAR group, and 8.4 days in the OR group [P < .001; F(2,64) = 11.3], with a significant difference between the OR and ERAVS and EVAR groups (P = .1 and P < .001, respectively) but not between the EVAR and ERAVS groups (P = .4). The ERAVS group had intervals to the resumption of oral intake and ambulation similar to those of the EVAR group. In contrast, these were significantly longer for the OR group. The mean time to the resumption of bowel function was similar in the ERAVS and OR groups (2.6 and 2.9 days, respectively; P = .6). In the ERAVS group, the mean value of the maximum referred pain using the numeric rating scale was 3.75 (range, 1-6). The corresponding values for the EVAR and OR groups were 2.6 (range, 0-6) and 4.9 [range, 1-8; F(2,62) = 15.4; P < .001]. The post hoc test showed a significant difference between the OR group and the ERAVS and EVAR group (P = .01 and P < .001, respectively) but not between the ERAVS and EVAR groups (P = .07). CONCLUSIONS: In our early experience, the ERAVS protocol appeared to be effective in reducing the TTD and improving the postoperative outcomes compared with the OR group, without significant differences compared with the EVAR group.

Preoperative and postoperative predictors of clinical outcome of fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms in an Italian multicenter registry.

OBJECTIVE: Complex aortic aneurysms (juxtarenal aortic aneurysms [JAAA], pararenal aortic aneurysms [PAAAs], thoracoabdominal aortic aneurysms TAAAs) are treated with increasing frequency through fenestrated and branched endovascular repair (F/B-EVAR); however, the outcome of these procedures is usually reported separately by single experiences and wider overviews are not frequent. The aim of this study was therefore to report an Italian experience analyzing the results obtained in four academic centers to evaluate the predictors of outcomes. METHODS: Between 2008 and 2019, all consecutive patients undergoing F/B-EVAR in four Italian university centers were recorded prospectively and analyzed retrospectively. Preoperative comorbidities and postoperative complications were classified according with the Society for Vascular Surgery reporting standard. Postoperative complications and 30-day/in-hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions and target visceral vessels patency were assessed as follow-up outcomes by Kaplan-Meier analysis. Risk factors for 30-day/in-hospital mortality and spinal cord ischemia (SCI) were determined by multivariate analysis. Risk factors for follow-up mortality and reinterventions were evaluated by Cox regression model. RESULTS: Five hundred ninety-six patients underwent F/B-EVAR for 124 JAAAs (21%), 121 PAAAs (20%), and 351 TAAAs (59%). Elective and urgent procedures were performed in 520 (87%) and 76 (13%) cases, respectively. Postoperative cardiac, pulmonary, and renal complications were reported in 41 (7%), 50 (8%), and 80 (13%) patients, respectively. Seven bowel ischemia (1%) and 23 cerebrovascular complications (4%) occurred. Forty-seven (8%) patients suffered SCI with 17 cases (3%) of permanent paraplegia. Crawford's extent I-II-III TAAAs (odds ratio [OR], 13.41; 95% confidence interval [CI], 1.77-101.65; P = .012) and postoperative renal complications (OR, 3.84; 95% CI, 1.70-8.69; P = .001) independently predicted SCI. Thirty-two patients (5%) died in the perioperative period. Preoperative chronic renal failure (OR, 7.81; 95% CI, 7.81-26.31; P = .001), postoperative bowel ischemia (OR, 26.97; 95% CI, 3.37-215.5; P = .002), cardiac complications (OR, 5.77; 95% CI, 1.41-23.64; P ≤ .001), cerebrovascular complications (OR, 28.63; 95% CI, 5.20-157.5; P < .001), and SCI (OR, 5.99; 95% CI, 1.12-32.5; P = .036) were independently correlated with 30-day/in-hospital mortality. The mean follow-up was 25 ± 7 months. Freedom from target visceral vessels occlusion and freedom from reintervention were 96% and 92% at 1 year and 93% and 85% at 3 years, respectively. TAAAs (hazard ratio [HR]. 3.16; 95% CI, 1.68-5.92; P ≤ .001), postdissection TAAAs (HR, 2.20; 95% CI, 1.30-4.90; P = .05) and postoperative bowel ischemia (HR, 11.98; 95% CI, 1.53-93.31; P = .018) were independent predictors of reinterventions. Survival was 88% and 78% at 1 and 3 years, respectively. Preoperative chronic renal failure (HR, 2.39; 95% CI, 1.59-3.59; P ≤ .001), urgent repair (HR, 1.80; 95% CI, 1.03-3.20; P = .039), TAAAs (HR, 2.01; 95% CI, 1.13-3.56; P = .017), postoperative bowel ischemia (HR, 5.55; 95% CI, 2.11-14.59; P = .001), cardiac complications (HR, 3.89; 95% CI, 2.25-6.71; P ≤ .001), and pulmonary complications (HR, 1.97; 95% CI, 1.56-3.35; P = .013) were independent predictors of mortality during follow-up. CONCLUSIONS: F/B-EVAR is associated with satisfactory midterm outcomes in a nationwide experience. A variety of risk factors should be considered in F/B-EVAR indications and postoperative patient management to decrease the risk of postoperative complications and improve midterm outcomes.

Hybrid Surgical Approach to a Giant Post-Coarctation Aortic Aneurysm.

PURPOSE: To report a rare case of giant aortic coarctation (CoA)-related descending thoracic aneurysmal degeneration, complicated by an acute aortic dissection. CASE REPORT: A 57-year-old man referred with acute chest pain to the emergency department. A computed tomography angiography (CTA) revealed a CoA with a giant post-stenotic descending thoracic aneurysm (14 cm) and a concomitant left subclavian artery (LSA) aneurysm, complicated by an acute type B aortic dissection. A single-stage hybrid procedure was planned in an urgent setting. Initially, a left common carotid-to-left subclavian artery (LCCA-LSA) bypass was performed to gain a suitable proximal landing zone, the procedure was then completed with 3 thoracic endografts and 1 aortic dissection stent through a percutaneous femoral approach. The patient was discharged in postoperative day 8th without complications; the CTA performed at 1 month demonstrated patency of supra-aortic and visceral vessels, dilation of CoA site and exclusion of the false lumen. CONCLUSIONS: CoA is a congenital malformation rarely found in adults that may represent a challenge for the surgeon, especially when combined with a complication like an acute aortic dissection. This case shows that a hybrid approach is a safe and feasible treatment option even in such complex anatomies.

Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry.

Purpose: To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9±2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1-127) and 29.3 months (range 1-127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%). Conclusion: IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation.

A propensity score-matched comparison of two commercially available iliac branch devices in patients with similar clinical and anatomic preoperative features.

OBJECTIVE: The objective of this study was to compare the perioperative and midterm results of Zenith Bifurcated Iliac Side (ZBIS; Cook Medical, Bloomington, Ind) and Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) iliac branch devices (IBDs) in treatment of dilated iliac bifurcations in patients with similar anatomic and clinical preoperative features. METHODS: Between July 2007 and May 2018, 190 IBDs were implanted at two high-volume Italian vascular and endovascular centers. Among the series, preoperative propensity score matching based on preoperative anatomic and clinical factors was performed, and two homogeneous groups were created: group 1, 35 Cook ZBIS IBD implants; and group 2, 35 Gore IBE devices. Early results were analyzed in terms of technical success, death, conversion to open surgery, and occurrence of major local and systemic complications. Follow-up results were analyzed in terms of patency of the IBD, freedom from type I and type III endoleaks, aneurysm-related reintervention, and aneurysm-related death. RESULTS: Technical success was achieved in all implants from both groups. Perioperative IBD-related complications and major complications occurred in one case from group 1 (P = .49). No perioperative mortality was recorded in the two groups. Mean postoperative follow-up was 46.7 months in group 1 (standard deviation, ± 36.3) and 20.8 months in group 2 (standard deviation, ± 15.9; P < .0001). None of the IBDs or target hypogastric arteries occluded during follow-up in this series. Estimated 36-month freedom from type I and type III endoleaks was 97% (standard error [SE], 0.03) in group 1 and 87% (SE, 0.09) in group 2 (P = .34; log-rank, 0.9). Estimated freedom from IBD-related reintervention was 97% (SE, 0.03) in group 1 and 93% (SE, 0.06) in group 2 (P = .81; log-rank, 0.05). The estimated rates of overall survival at 36 months from the IBD implantation were 95% (SE, 0.04) in group 1 and 88% (SE, 0.08) in group 2 (P = .03; log-rank, 4.7); freedom from aneurysm-related death was 100% in group 1 and 93% (SE, 0.06) in group 2 (P = .19; log-rank, 1.7). CONCLUSIONS: The propensity score-matched comparison between the Cook ZBIS and Gore IBE devices showed similar, satisfying perioperative and midterm results in the experience of two high-volume Italian vascular centers.

Female sex is associated with comparable 5-year outcomes after contemporary endovascular aneurysm repair despite more challenging anatomy.

BACKGROUND: Women with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival. METHODS: We compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching. RESULTS: There were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair. CONCLUSIONS: Despite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

OBJECTIVE: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. RESULTS: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. CONCLUSION: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

A Retrospective Comparison Between Hybrid Treatment and Prosthetic Above-the-Knee Femoro-Popliteal Bypass in the Management of the Obstructive Disease of the Superficial Femoral Artery.

OBJECTIVE: We assessed early and late outcomes following hybrid intervention (common femoral artery endarterectomy and superficial femoral artery (SFA) stenting) versus above-the-knee (AK) femoro-popliteal bypass performed for peripheral artery occlusive disease (PAOD) in a double-center retrospective comparative cohort study. MATERIALS AND METHODS: From January 2006 to December 2017, 82 hybrid revascularizations with femoral endarterectomy and SFA stenting (HY Group) and 98 AK femoro-popliteal bypasses with femoral endarterectomy (BP Group) were performed at two academic vascular centers. The two groups were compared in terms of preoperative and intraoperative details and of perioperative (<30 days) outcomes with χ2 test. Long-term results were compared using Kaplan-Meier curves and log-rank test. RESULTS: No differences were found in demographics variables, risk factors, comorbidities and clinical presentation between the two groups. Also perioperative outcomes were similar between the two groups. Median duration of follow-up was 38 months. At five years, the estimated survival rate was 60% in HY Group and 77.5% in BP Group (p = 0.002) Five-year primary patency rates were 46% in HY Group and 64% in BP Group (p = 0.005). Overall, 13 patients in HY Group required conversion to open surgery and 6 patients in BP Group underwent below-knee (n = 4) or distal (n = 2) bypass. The 5-year rate of limb maintenance was 85% in HY Group and 94% in BP Group (p = 0.1) and was not significantly different regardless of presentation, claudication or critical limb ischemia. CONCLUSIONS: In patients with PAOD due to complex long lesions of the infrainguinal arteries, open-surgical treatment with AK bypass provided better long-term survival and patency rates compared to a hybrid approach.