Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE)

The objective of these Guidelines was to revise and update the previous 2016 Italian Guidelines on Abdominal Aortic Aneurysm Disease, in accordance with the National Guidelines System (SNLG), to guide every practitioner toward the most correct management pathway for this pathology. The methodology applied in this update was the GRADE-SIGN version methodology, following the instructions of the AGREE quality of reporting checklist as well. The first methodological step was the formulation of clinical questions structured according to the PICO (Population, Intervention, Comparison, Outcome) model according to which the Recommendations were issued. Then, systematic reviews of the Literature were carried out for each PICO question or for homogeneous groups of questions, followed by the selection of the articles and the assessment of the methodological quality for each of them using qualitative checklists. Finally, a Considered Judgment form was filled in for each clinical question, in which the features of the evidence as a whole are assessed to establish the transition from the level of evidence to the direction and strength of the recommendations. These guidelines outline the correct management of patients with abdominal aortic aneurysm in terms of screening and surveillance. Medical management and indication for surgery are discussed, as well as preoperative assessment regarding patients' background and surgical risk evaluation. Once the indication for surgery has been established, the options for traditional open and endovascular surgery are described and compared, focusing specifically on patients with ruptured abdominal aortic aneurysms as well. Finally, indications for early and late postoperative follow-up are explained. The most recent evidence in the Literature has been able to confirm and possibly modify the previous recommendations updating them, likewise to propose new recommendations on prospectively relevant topics

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P < 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

Comparison of ultrasound- versus fluoroscopy-guidEd femorAl access In tranS-catheter aortic valve replacement In the Era of contempoRary devices: The EASIER registry

Background: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. Methods: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. Results: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). Conclusions: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs

Multicentre comparison between open conversions and semi-conversions for late endoleaks after EVAR

Objective: The aim of this study is to compare early and follow-up outcomes of late open conversions (LOC, with complete or partial endograft explantation) and semi-conversions (SC, with endograft preservation) after endovascular aneurysm repair in a multicenter experience. Methods: All LOC and SC performed from 1997 to 2020 in 11 vascular centers were compared. Endograft infections or thrombosis were excluded. Primary endpoints were early mortality and long-term survival estimates. Secondary endpoints were differences in postoperative complication rates and conversion-related complications during follow-up. Results: In the considered period, 347 patients underwent surgery for endovascular aneurysm repair complications. Among these, 270 were operated on for endoleaks (222 LOC, 48 SC). The two groups were homogeneous in terms of American Society of Anesthesiologists score (LOC, 3.2 ± 0.7; SC, 3 ± 0.5; P = .128) and main endograft characteristics (suprarenal fixation, bifurcated/aorto-uni-iliac configuration). The mean age was 75 ± 8 years for LOC and 79 ± 7 years for SC (P = .009). Reasons for LOC were: 62.2% (138/222) type I endoleak, 21.6% (48/222) type II endoleak, 7.7% (17/222) type III endoleak, and 8.5% (19/222) endotension. Indications for SC were: 64.6% (31/48) type II endoleak, 33.3% (16/48) type I endoleak, and 2.1% (1/48) type III endoleak. Thirty-day mortality was 12.2% (27/222) in the LOC group, and 10.4% (5/48) in the SC group (P = .73). Postoperative complication rate was higher in the LOC group (45.5% vs 29.2%; P = .04). The estimated survival rate after LOC was 80% at 1 year and 64% at 5 years; after SC, it was 72% at 1 year and 37% at 5 years (log-rank P = .01). During the median follow-up of 21.5 months (interquartile range, 2.4-61 months), an endoleak after SC was found in the 38.3% of the cases; sac growth was recorded in the 27.7% of SC patients. Conclusions: SC has an early benefit over LOC in terms of reduced postoperative complications but has a significantly inferior mid-term survival. The high rates of persistent and/or recurrent endoleaks reduce SC durability

Twenty-Five Year Multicentre Experience of Explantation of Infected Abdominal Aortic Endografts

: We report a multicenter experience of open conversions (OC) for aortic endograft infections (AEI). We retrospectively analyzed all patients who underwent OC for AEI after endovascular aneurysm repair (EVAR), from 1997 to 2021 in 12 Italian centers. The endpoints were as follows: mortality (30-days, in-hospital), major postoperative complications. Follow-up data included: survival, aortic-related complications, infection persistence or reoccurrence. Fifty-eight patients (mean age: 73.8 ± 6.6 years) were included. Median time from EVAR to OC was 14 months (interquartile range 7-45). Thirty-five patients (60.3%) were symptomatic at presentation. Aortic reconstruction was anatomic in 32 patients (55.2%), extra-anatomic in 26 (44.8%). Thirty-day mortality was 31% (18/58). Six additional patients died after 30 days during the same hospitalization (in-hospital mortality: 41.4%). Most common post-operative complications included respiratory failure (38.6%) and renal insufficiency (35.1%). During 28.1 ± 4 months follow-up, 4 aneurysm-related deaths were recorded. Infection re-occurred in 29.4% of the patients. Estimated survival was 50% at 1 year, and 30% at 5 years, and was significantly lower for patients who underwent extra-anatomic reconstructions (37 vs 61% at 1 year, 16 vs 45% at 5 years; log-rank P = .021). OC for AEI is associated with high early mortality. The poor mid-term survival is influenced by aortic complications and infection re-occurrence

Covered versus Bare-metal Kissing Stents for the Reconstruction of the Aortic Bifurcation in the ILIACS registry

Objective: We compared the early and mid-term 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, mid-term 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. Conclusion: In the present multicenter study, the use of kissing stents for the treatment of the aortic bifurcation provided good early and mid-term 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

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

Mid-term results on a new self-expandable covered stent combined with branched stent-grafts: insights from a multicenter Italian registry

Objective: To investigate the technical periprocedural and mid-term outcomes of endovascular repairs with multibranched (BEVAR) or iliac-branch devices (IBD) combined with a new self-expanding covered stent. Methods: The COBRA (COvera in BRAnch) registry is a physician-initiated, multicenter, ambispective, observational registry (ClinicalTrials.gov Identifier: NCT04598802) enrolling patients receiving a BEVAR or IBD procedure mated with Bard Covera Plus (Tempe, Arizona, USA) covered stent, designed to evaluate the outcomes of the covered stent mated with patient-specific and off-the-shelf branched stent-graft. Primary endpoints were technical success, branch instability, and freedom from aortic and branch-related reintervention within 30 days and at follow-up. Preoperative characteristics, comorbidities, and outcomes definition were graded according to the Society for Vascular Surgery reporting standards. Results: Two hundred eighty-four patients [76 years (70-80); 79% males] in 24 centers were enrolled for a total of 708 target vessels treated. The CSs were mated with an off-the-shelf graft in 556 vessels (79%) and a custom-made graft in 152 (21%). Three-hundred-seven adjunctive relining stents in 277 vessels (39%) were deployed, of which 116 (38%) proximal, 66 (21%) intrastent and 125 (41%) distal. Adjunctive relining stent placement was more frequent when landing in a vessel branch instead of the main trunk (59%vs39%, p=.031), performing a percutaneous access (49%vs35%, p<.001), using a stent with a diameter ≥8mm (44%vs36%, p=.032) and a length ≥80mm (65%vs55%, p=.005), when a post-dilatation was not performed (45%vs29%, p<.001) and when an inner-branch configuration was used (55%vs35%, p<.001). Perioperative technical bridging success was 98%. Eight patients (3%) died in the perioperative period. Two deaths (1%) were associated with renal branch occlusion followed by acute kidney injury and paraplegia. Follow-up data were available for 638 vessels (90%) at a median of 32 months (Q1, Q3: 21,46). A branch instability was reported in 1% of branches. Forty-six (17%) patients died during follow-up, nine (3%) of them due to aortic-related causes. Primary patency rates at one year, two and three years were 99% (581/587), 99% (404/411), and 97% (272/279) respectively. Branch instability was associated with patient-specific devices (9% vs 4%, p=.014) and intrastent adjunctive stent placement (12% vs 2%, p=.003), especially when a bare metal balloon-expandable stent was used (25%vs3%, p<.001). Conclusions: The use of this new self-expanding covered stent mated with branched endografts proved to be safe and feasible with high technical procedural success rates. Low rates of branch instability were observed at mid-term follow-up. Comparative studies with other commercially available covered stents are warranted

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\ub110 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 (&lt;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

Outcomes Analysis of 677 Cases from the Multicenter Italian Registry on Primary Endovascular Treatment of Iliac and Aorto-Iliac Arteries Obstructive Disease (Iliacs Registry)

Introduction - Endovascular revascularization has become the first-line strategy for iliac obstructive lesions (IOL), and also used increasingly as an alternative to conventional surgery for complex aorto-iliac obstructive disease (AIOD). Owing to the good results resembling those of open sur- gery, an endovascular-first strategy have been considered for complex AIOD even in the most recent guidelines if done by an experienced team and if it does not compromise subsequent surgical options. The aim of this study was to analyze the results of the endovascular treatment of IOL and AIOD in a multicenter Italian registry. Methods - Over a 3-year period, ending in December 2017, 677 treatments were performed for IOL and AIOD in eleven Italian hospitals and collected into a dedicated registry database. Intermittent claudication was an indication in 376 (55.5%) patients, whereas critical limb threatening ischemia in 298 (44.0%). Postoperative anti-thrombotic therapy was left at center’s discretion: follow-up evalua- tion was performed at 1, 6 and 12 months after the intervention. Early (&lt;30 days) major end-points were mortality and major complications; late major end-point was freedom from reintervention. Early results were compared with the Chi-square test and the Wilcoxon’s signed rank test; follow-up results were analyzed with Kaplan-Meier survival estimates andcompared with log- rank test. Univariate and multivariate (forward Cox regression) analysis was used to identify potentially sig- nificantpredictors of need for reintervention. Results - We treated 511 (75.4%) males. Overall, mean age was 68 10 (range, 22-96; IQR, 62-76). Accordingly to the TASC II classification we treated 98 (14.5%) type A, 163 (24.1%) type B, 164 (24.2%) type C, and 248 (36.6%) type D lesions: stenoses were 370 (56.2%) and occlusions were 288 (43.8%). We used a totally percutaneous approach in 473 (69.9%): hybrid intervention was carried out in 204 (30.1%) patients, mostly with femoral endarterectomy plus patch plasty. A covered stent was implanted in 207 (30.6%) cases. Overall, a kissing-stent configuration was performed in 243 (36.1%) lesions. Primary technical success was ob- tained in 671 (99.3%) cases: earl mortality occurred in 3 (0.4%) cases, and postoperative complication was observed in 51 (7.5%) patients. Mean ankle-brachial index improved significantly from preoperative to postoperative period (0.5 0.2 vs. 0.9 0.1, P &lt; 0.001). Median hos- pitalization was 5 days (IQR, 2-7). Early thrombosis, major amputation, and mortality was observed in 10 (1.5%), 3 (0.5%), and 4 (0.6%) cases, respectively. During the follow- up 21 (3.1%) died: the estimated survival was 96.3% at 12 months (95%CI: 93.8-97.8) and 90.2% at 36 months (95% CI: 82.7-94.7). Follow-up thrombosis occurred in 17 (2.5%) cases. Estimated primary patency and freedom from rein- tervention was 96% (IC95%: 93.3-97.7) and 97.2% (95%CI: 94.5-98.6) at 12 months, and 95% (95%CI: 89.0-97.6) for both outcomes at 36 months. At Cox regression analysis, no pre/intra/or-postoperative parameters independently predicted loss of primary patency and need for reintervention. Conclusion - In this “real world” registry experience, endovascular revascularization showed to be safe and effective. No independent predictors were found to be associated with the need of reintervention thus indicating that endovascular revascularization for IOL and AOID can be an effective and durable first-line alternative even for the treatment of complex AOI