Gender-Related Disparities Among Vascular Surgeons in Italy: Results from a Cross-Sectional Survey.

BACKGROUND: To assess the presence, quality and impact of gender-related discrepancies in academic vascular surgery at a national level. METHODS: This was an anonymous national structured nonvalidated cross-sectional survey on gender disparity perceptions, named "I love it when you call me Señorita", distributed to 645 participants from academic Italian vascular centers. Endpoints were related to job-related characteristics, satisfaction, and sexual harassment. RESULTS: The survey yielded a 27% response rate (n = 174, 78 males and 96 females). Significant differences between male and female responders were found in terms of job satisfaction (83.3% vs. 53.1%, P < 0.001), perception of career opportunities (91.7% vs. 67.9%, P < 0.001), surgical activity in the operating theater (34.6% vs. 7.3%, P < 0.001), involvement in scientific activities (contribution in peer-reviewed articles: 37.2% vs. 9.4%, P < 0.001; scientific meeting attendance/year: 42.3% vs. 20.8%, P = 0.002), and perception of lower peer support at work (2.6% vs. 22.9%, P < 0.001). In addition, female physicians more frequently suffered sexual harassment from male peers/colleagues (10% vs. 34%, P < 0.001), male health-care workers (7% vs. 26%, P = 0.001), or patients/caregivers independently from their sex (6% vs. 38.5%, P < 0.001 for males and 5% vs. 22%, P = 0.001 for females). CONCLUSIONS: A significant number of the female vascular surgeons in Italian academic vascular centers responding to the survey have experienced workplace inequality and sexual harassment. Substantial efforts and ongoing initiatives are still required to address gender disparities, emphasizing the need for the promotion of specific guidelines within scientific societies.

Perceptions, awareness, and implementation surrounding the assessment of frailty amongst vascular surgeons in Italy: Results from a nationwide cross-sectional survey.

OBJECTIVES: We conducted this survey to gain insight into the real-life application and perceptions regarding the importance of peri-operative frailty assessment amongst vascular surgeons in Italy. METHODS: Italian vascular surgeons were invited to participate in the survey using the list provided by the Italian Society for Vascular and Endovascular Surgery (1050 invited participants). A dedicated link to the survey was emailed through Google Forms, and reminders were automatically sent on a bi-weekly basis for a total of 8 weeks before stopping data collection. RESULTS: The survey was completed by 225 respondents, thereby yielding an overall 21.5% response rate. While the vast majority of respondents stated they were aware of the meaning of frailty (93%) and agreed that its assessment was clinically relevant for patients undergoing vascular surgery (99%), only 44% of surveyed surgeons reported that they used a specific tool for peri-operative frailty assessment. However, most respondents indicated that routine evaluation of frailty was not performed at their institution (87%). The main limitations were identified as being the lack of confidence in choosing the best tool, followed by lack of awareness, lack of skilled operators, and lack of time. CONCLUSIONS: Our study showed that whilst most vascular surgeons in Italy are aware of the importance of frailty in affecting surgical outcomes across various interventions in the elective and non-elective settings, there is poor implementation of formal frailty assessment.

CO2 is the contrast media to choose in patients with initial Chronic Kidney Disease undergoing endovascular aneurysm repair to prevent further renal function deterioration.

OBJECTIVE: Even low quantities of iodine contrast media (ICM) could be responsible for exacerbation of a chronic kidney disease (CKD). Aim of this study was to determine whether it is more reasonable to perform endovascular aneurysm repair (EVAR) procedures in patients with initial CKD using CO2 rather than ICM to prevent further kidney deterioration. METHODS: A retrospective analysis was performed at our institution to identify patients with preoperative CKD at initial stage (class G3a-G3b according to KDOQI-KDIGO classification) who underwent either CO2-EVAR or ICM-EVAR. Primary endpoint was renal function evaluation; secondary endpoints were technical success, perioperative complications, hospital stay, and reinterventions and overall mortality at follow-up. RESULTS: Both CO2-EVAR and ICM-EVAR groups were composed of 21 patients. There were no differences in demographics, anatomy, and comorbidities, apart from worse ASA score in CO2-EVAR group (100% vs 57.1%, p = .001). Preoperative serum creatinine and glomerular filtration rates (GFR) were comparable (1.73 vs 1.6 mg/dl, p = .082 and 39.71 vs 43.04 mL/min/1.73 m2, p = .935). At follow-up (16.7 ± 18.1 months), CO2-EVAR was not associated with significant changes in creatinine and GFR, whereas ICM-EVAR determined a significant increase in creatinine (1.6 mg/dl vs 1.91 mg/dl, p = .04) and decrease in GFR values (43 vs 37.9 mL/min/1.73 m2, p = .04), determining the need for dialysis in one patient. CONCLUSIONS: ICM seems to be a determining factor in worsening renal function; therefore, an effort should be made to standardize the use of CO2 as the contrast medium of choice in patients with initial renal insufficiency undergoing EVAR.

Results of current endovascular treatments for visceral artery aneurysms.

OBJECTIVE: This single-center retrospective cohort study aimed to analyze the early and long-term results of endovascular treatment for true visceral artery aneurysms (VAAs). Moreover, a comparison with the results of our previously published historical series of open surgical procedures was performed. METHODS: From January 2008 to December 2021, 78 consecutive patients were treated at our institution for true VAAs. All demographic data, procedural details, perioperative outcomes, and follow-up data were collected prospectively from a dedicated database. A retrospective analysis identified 72 patients who underwent endovascular surgery. Early results were analyzed in terms of technical success, conversion to open surgery, mortality, and local and systemic morbidities. Follow-up results were analyzed in terms of survival, need for open or endovascular reintervention, and freedom from complications at the level of the treated visceral artery. These results were then compared with those of our historical open surgical group (1982-2007), which included 54 interventions. RESULTS: In four cases, the planned endovascular procedure could not be completed, and the overall technical success rate was 94.5%. No deaths occurred during the hospital stay or within 30 days after surgery. Overall, the 30-day perioperative complication rate was 5.8%, with an early reintervention rate of 2.9%. The median follow-up time was 29 months (range, 1-132 months). The estimated 7-year survival rate was 88% (standard error [SE]. 0.05). The estimated 7-year aneurysm-related complication-free rate was 85.5% (SE, 0.06), with reintervention-free and aneurysm-related complication-free survival rates of 93.3% (SE, 0.04) and 75.6% (SE, 0.07), respectively. At the 7-year follow-up, the survival rate was similar between the endovascular and open groups. There was a trend toward a higher aneurysm-related complication rate in the endovascular group than in the open group (14.5% vs 6.4%; P = .07). However, no significant differences in reintervention-free and overall estimated aneurysm-related complication-free survival rates were found between the two groups. CONCLUSIONS: Endovascular repair is safe and effective in patients with VAAs, with low perioperative complication rates. The long-term outcomes were satisfactory and comparable with those of the historical series of open surgical repairs. Even if there is a trend toward a higher risk of late aneurysm-related complications among endovascular patients, it does not imply an increased need for late reinterventions.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

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.

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.

Predicting early mortality following single-stage coronary artery or valve surgery and carotid endarterectomy.

BACKGROUND: Surgical management of coexisting cardiac disease and extra-cranial carotid artery disease is a controversial area of debate. Thus, in this challenging scenario, risk stratification may play a key role in surgical decision making. AIM: To report the results of single-stage coronary/valve surgery (CVS) and carotid endarterectomy (CEA), and to identify predictive factors associated with 30-day mortality. METHODS: This was a multicenter, retrospective study of prospectively maintained data from three academic tertiary referral hospitals. For this study, only patients treated with single-stage CVS, meaning coronary artery bypass surgery or valve surgery, and CEA between March 1, 2000 and March 30, 2020, were included. Primary outcome measure of interest was 30-day mortality. Secondary outcomes were neurologic events rate, and a composite endpoint of postoperative stroke/death rate. RESULTS: During the study period, there were 386 patients who underwent the following procedures: CEA with isolated coronary artery bypass graft in 243 (63%) cases, with isolated valve surgery in 40 (10.4%), and combination of coronary artery bypass grafting and valve surgery in 103 (26.7%). Postoperative neurologic event rate was 2.6% (n = 10) which includes 5 (1.3%) transient ischemic attacks and 5 (1.3%) strokes (major n = 3, minor n = 2). The 30-day mortality rate was 3.9% (n = 15). Predictors of 30-day mortality included preoperative left heart insufficiency (odds ratio [OR]: 5.44, 95% confidence interval [CI]: 1.63-18.17, p = .006), and postoperative stroke (OR: 197.11, 95% CI: 18.28-2124.93, p < .001). No predictor for postoperative stroke and for composite endpoint was identified. CONCLUSIONS: Considering that postoperative stroke rate and mortality was acceptably low, single-stage approach is an effective option in such selected high-risk patients.

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.

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.

A morphovolumetric analysis of aneurysm sac evolution after elective endovascular abdominal aortic repair.

OBJECTIVE: Abdominal aortic aneurysm (AAA) sac shrinkage after endovascular aortic repair (EVAR) has been regarded as positive marker of EVAR success durability. The purpose of this study was to describe the morphovolumetric changes of the AAA sac during follow-up after elective EVAR and to analyze sac shrinkage-related variables. METHODS: This is a single-center, retrospective, observational cohort study from a tertiary referral university hospital. All patients treated with EVAR between January 2013 and December 2018 were identified. Inclusion criteria were elective EVAR for AAA, preoperative computed tomography angiography within 6 months before EVAR and at least one postoperative computed tomography angiography during the follow-up, using a standardized protocol. Aneurysm sac shrinkage was defined as diameter decrease of 1 cm or more, volume shrinkage threshold was identified by a 16% decrease compared with the preoperative value. Primary outcomes were early (≤30 days) and late survival, and freedom from aneurysm-related mortality (ARM), and aortic reintervention. RESULTS: There were 149 of the 325 patients (45.8%) who met the inclusion criteria: 133 (89.3%) were male and 16 (10.7%) female. The mean age was 74 ± 7 years (range, 55-87 years); the median AAA diameter was 56 mm (interquartile range, 50.0-61.2 mm) and the median volume was 138.8 cm3 (range, 99.0-178.3 cm3). Primary technical success was achieved in 145 patients (97.3%). The in-hospital mortality rate was 1.3%. The median follow-up was 42 months (interquartile range, 22.5-58.0 months). Both AAA diameter and volume decreased (P = .001 and P = .035, respectively) compared with preoperative measurements. Diameter shrinkage was adjudicated in 27 patients (18.1%), volume shrinkage was observed in 42 patients (28.2%). A Cox regression analysis demonstrated an association between the AAA diameter shrinkage and the preoperative diameter (P = .002; hazard ratio, 1.03; 95% confidence interval [CI], 1.011-1.052). The presence of a persistent endoleak predicted the absence of volume shrinkage (P = .001; hazard ratio, 7.75; 95% CI, 2.282-26.291). The estimated freedom from ARM was 97.5 ± 1.0% (95% CI, 93-99) at 12 months, and 96 ± 2% (95% CI, 90-98) at both 36 and 60 months. Aortic reintervention during the follow-up period was necessary in 7 patients (4.7%). ARM was only observed in the group characterized by the concomitant absence of diameter and volume shrinkage. CONCLUSIONS: Volumetric analysis showed to have higher sensitivity than the simple two-dimensional measurement of the diameter to study AAA sac changes after EVAR. Although no predictor was found to be associated with AAA volume shrinkage, ARM occurred only in the group of AAAs with the absence of volume shrinkage.

Outcomes Analysis of Surgical Conversion for Kissing-Stent Occlusion.

BACKGROUND: We aimed to describe the operative outcomes following open aortoiliac/femoral graft reconstruction for bilateral kissing-stent (KS) occlusion. METHODS: This is a bicentric, retrospective, observational cohort study. Between September 2007 and December 2019, 205 patients were treated with KS for aortoiliac reconstruction. Only those who had bilateral KS occlusion with subsequent aortoiliac/femoral graft replacement were included in this analysis. Primary outcomes were early (<30 days) and late survival, postoperative (<30 days) complications, and patency rates. RESULTS: Nine patients (male, n = 7) were analyzed. The patient's mean age was 60 ± 5 years (range 55-62). Median delay from initial KS procedure was 36 months (interquartile range [IQR] 19-252). On admission, all patients presented with a worse Rutherford class compared to their initial pre-KS clinical presentation. Aortobifemoral bypass was performed in 5 patients, and aortobi-iliac reconstruction in 4 patients. There were no perioperative deaths and only 1 new case of erectile dysfunction occurred. At a median follow-up time of 24 months (IQR 12-54), primary patency rate was 88.9%. CONCLUSIONS: Open aortic reconstruction after KS occlusion was feasible and effective. Endovascular repair for aortoiliac obstructive disease may be pursued as first-line treatment even in complex lesions.

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.

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.

Acute Thrombosis of an Aortic Prosthetic Graft in a Patient with Severe COVID-19-Related Pneumonia.

BACKGROUND: COVID-19 infection has been reported to be related with an increased risk of thrombotic complications because of the hypercoagulability state and inflammation. At the moment, no reports are available regarding thrombosis of prosthetic vascular grafts. We present the case of a patient with COVID-19-related pneumonia, who suffered from the acute thrombosis of a previously implanted aortic graft. METHODS AND RESULTS: A 67-year-old male patient, who had undergone open repair of an abdominal aortic aneurysm with a bifurcated graft 6 years before, was admitted to the emergency department with high fever for a week without cough or dyspnea. Thoracic ultrasound showed signs of bilateral interstitial pneumonia, and the Sars-Cov-2 swab was positive. Antiretroviral therapy and prophylactic low molecular weight heparin treatment were initiated. Owing to the progressive impairment of the respiratory function, the patient was intubated after eight days from the admission, the day after he showed signs of bilateral acute limb ischemia. A duplex ultrasound demonstrated the complete thrombosis of the aortic graft without flow at the femoral level. An urgent angio-computed tomography scan for revascularization purpose was requested, but the patient died on the arrival in the radiological suite. CONCLUSIONS: Acute thrombosis of vascular prosthetic grafts is a possible, catastrophic complication of COVID-19 infection. In COVID-19 patients with prosthetic graft, an aggressive antithrombotic treatment could be considered to prevent such an event.

Results of infrainguinal revascularization with bypass surgery using a heparin-bonded graft for disabling intermittent claudication due to femoropopliteal occlusive disease.

BACKGROUND: The purpose of this study was to analyze the results of infrainguinal revascularization for disabling intermittent claudication (IC) due to femoropopliteal occlusive disease using bypass graft (BPG) surgery with a heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft. METHODS: Between 2002 and 2016, we performed 1400 BPGs with HB-ePTFE interventions in patients with femoropopliteal occlusive disease, of which IC was an indication in 485 (34.6%) patients. Early major end points were in-hospital mortality and major complications; late major end points were primary patency, freedom from redo bypass, freedom from progression to critical limb ischemia, and freedom from above-knee amputation or prosthetic graft infection. RESULTS: We performed 200 (41.2%) above-knee BPGs and 231 (47.6%) below-knee BPGs; 54 (11.1%) BPGs targeted a tibial artery. In-hospital death occurred in two (0.4%) patients. Overall, the major complication rate was 4.3%. The median duration of follow-up was 33 months (range, 1-150 months; interquartile range [IQR], 14-62.8 months); the cumulative follow-up index for survival was 0.75 ± 0.25. During the follow-up, 56 (11.6%) patients died. Estimated primary patency of the BPG was 86.1% ± 1.6% (95% confidence interval [CI], 82.7-88.9) at 12 months, 68.4% ± 2.4% (95% CI, 63.5-72.9) at 36 months, and 57.7% ± 2.9% (95% CI, 52.0-63.2) at 60 months. On multivariate analysis, runoff status (no or one vessel), site of the distal anastomosis (below the knee), and postoperative medical treatment (oral anticoagulants) impaired primary patency. Estimated freedom from redo bypass was 96.1% ± 0.9% (95% CI, 93.9-97.5) at 12 months, 84.8% ± 1.9% (95% CI, 80.7-88.2) at 36 months, and 76.4% ± 2.6% (95% CI, 71.0-81.1) at 60 months. Both the runoff status (no or one vessel) and the diameter of the graft (6 mm) were significantly associated with the need for redo bypass. Freedom from progression to critical limb ischemia was 86.1% ± 2.2% (95% CI, 81.2-89.9) at 60 months. During the follow-up, there were 20 (4.1%) above-knee amputations, which occurred at a median of 33 months (range, 2-107 months; IQR, 14-63 months) after the indexed BPG intervention. Prosthetic graft infection occurred in seven (1.4%) patients, with a median delay from index procedure to presentation with graft infection of 33 months (range, 1-72 months; IQR, 14-62.5 months), resulting in a freedom from prosthetic graft infection rate of 98.2% ± 2% (95% CI, 95.8-99.2) at 60 months. CONCLUSIONS: In patients suffering from lifestyle-disabling IC with long or complex occlusive lesions of the femoropopliteal segment, open BPG surgery with Hb-ePTFE graft had an acceptably low mortality rate. A poor runoff status was a significant predictor of loss of graft patency, especially after a below-knee anastomosis, as was the need for redo bypass. Dual antiplatelet therapy had significantly better results against follow-up thrombosis, and 8-mm grafts showed better freedom from redo bypass compared with 6-mm grafts.

Prevalence and risk factors for heparin-bonded expanded polytetrafluoroethylene vascular graft infection after infrainguinal femoropopliteal bypasses.

BACKGROUND: To analyze the prevalence and predictors of prosthetic vascular graft infection (PVGI) in a multicenter registry. METHODS: This registry-based, multicenter study retrospectively evaluated PVGI that developed after infrainguinal revascularization performed with a heparin-bonded expanded polytetrafluoroethylene graft that was used in 1400 interventions between 2002 and 2016. A prosthetic graft with infection was defined as direct involvement of the graft with positive bacterial cultures of graft or perigraft material, intraoperative gross purulence or failure of graft incorporation, or exposed graft in an infected wound. RESULTS: Critical limb ischemia (CLI) was the main indication for bypass (n = 915 [65%]). The median duration of follow-up was 29 months (range, 1-168 months; interquartile range, 12-60 months). A total of 33 heparin-bonded expanded polytetrafluoroethylene grafts (2.3%) became infected; the median time to occurrence was 5 months (range, 1-54 months; interquartile range; 2.00-13.25 months). Freedom from PVGI at 1 year was 98% (standard error, 0.4; 95% confidence interval [CI], 97.2-98.9), and 97% (standard error, 0.6; 95% CI, 95.6-98.0) at 5 years. The multivariate model identified CLI (P = .042; hazard ratio, 0.39; 95% CI, 0.164-0.969) to be independently associated with PVGI. In-hospital mortality of PVGI treatment was 12% (n = 4/33). Freedom from major amputation was significantly different between patients with PVGI and those who did not experience this complication (at 1 year, 67.0% vs 88.5%; Log-rank χ2 = 22.5; P = .001). CONCLUSIONS: In our "real-world" multicenter experience the prevalence of PVGI after infrainguinal femoropopliteal bypasses was relatively low at 2.3%, but still associated with significant mortality and limb loss. CLI was the only significant predictor of PVGI. This conclusion is reasonable; however, more comprehensive data are required to confirm these findings, because the presence of ischemic ulcers or gangrene was not predictive of PVGI.

Outcomes From the Multicenter Italian Registry on Primary Endovascular Treatment of Aortoiliac Occlusive Disease.

Purpose: To report the results of endovascular treatment of iliac and complex aortoiliac occlusive disease (AIOD) in a multicenter Italian registry. Materials and Methods: A retrospective, multicenter, observational cohort study analyzed 713 patients (mean age 68±10 years; 539 men) with isolated iliac and complex aortoiliac lesions treated with primary stenting between January 2015 and December 2017. Indications for treatment were claudication in 406 (57%) patients and critical limb ischemia in 307 (43%). According to the TransAtlantic Inter-Society Consensus II (TASC) classification, the lesions were categorized as type A (104, 15%), type B (171, 24%), type C (170, 24%), and type D (268, 37%). Early (<30 days) endpoints included mortality, thrombosis, and major complications. Late major outcomes were primary and secondary patency and freedom from reintervention as estimated by Kaplan-Meier analysis; estimates are given with the 95% confidence intervals (CIs). Associations between baseline variables and primary patency were sought with multivariate analysis; the results are presented as the hazard ratio (HR) and 95% CI. Results: Technical success was achieved in 708 (99%) lesions; in-hospital mortality was 0.6% (n=4). The median follow-up was 11 months (range 0-42). The estimated primary patency rate was 96% (95% CI 94% to 97%) at 1 year and 94% (95% CI 91% to 96%) at 2 years. The estimated secondary patency was 99% (95% CI 97% to 99%) at 1 year and 98% (95% CI 95% to 99%) at 2 years. The estimated freedom from reintervention was 98% (95% CI 96% to 99%) at 1 year and 97% (95% CI 94% to 98.5%) at 2 years. Cox regression analysis demonstrated that the application of a covered stent was associated with an increased need for reintervention (HR 1.4, 95% CI 1.10 to 1.74, p=0.005). Chronic obstructive pulmonary disease was associated with decreased primary patency (HR 3.7, 95% CI 1.25 to 10.8, p=0.018). Conclusion: Endovascular intervention with primary stent placement for aortoiliac occlusive disease achieved satisfactory 2-year patency regardless of the complexity of the lesion. Almost all TASC lesions should be considered for primary endovascular intervention if suitable.

Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease.

PURPOSE: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. MATERIALS AND METHODS: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. RESULTS: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. CONCLUSION: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.