Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Societa Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18 -member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when >70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two -hundred -forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first -round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available

Outcome Measures of In-Office Endovenous Radiofrequency Treatment of Varicose Vein Feasibility

RFA is a relatively new treatment, approved by the FDA in 1999 and is a minimally invasive intervention that has become one of the most common alternatives due to its many advantages, including decreased pain, less morbidity, shorter hospital stay and faster return to work. We retrospectively analyzed a total of 503 limbs submitted for surgical interventions for VVs using the RFA, combined or not with surgical phlebectomies and sclerotherapy, in our institution between April 2012 and December 2020. The technical success was 99.8%, as in one case the RFA catheter arrested at the first third of the thigh due to the tortuosity of the vessel. On the first post-operative day, the mean VAS scale was 0.32 ± 0.56 (0–2). Perioperative complications occurred in 77 cases (15.3%): intraoperative pain in 24 cases, in nine cases associated with vagal syndrome, superficial hematoma in 30 cases, EHIT in seven cases, phlebitis in 14 cases and paresthesia in two cases. RFA procedures had been shown to be cost-effective therapeutic options in adult patients requiring treatment due to the incompetence of the GSV. In our study, we highlighted that this technique is feasible as an ambulatory procedure; it improves quality of life and symptoms in the majority of patients with varicose veins, with a rapid return to normal life and work activities

Towards an entirely endovascular aortic world: an update of techniques and outcomes for endovascular and open treatment of type I, II, and III endoleaks

Endovascular aneurysm repair (EVAR) is largely the most adopted strategy for aneurysmal disease of the aorta. Nevertheless, the high incidence of reintervention makes it difficult to identify EVAR as a definitive solution; in particular, the most frequent indication of reintervention is endoleak, which is defined as persistent flow into the aneurysmal sac from different sources. Several treatment strategies are described. A contemporary literature search was performed with the intent of describing techniques and outcomes of endovascular and open strategies to type I, II, and III endoleak. Described techniques and outcomes were organized by indication (type I, II, and III endoleak) and by type of approach (endovascular, open, and laparoscopic) to give an overview of the current status of the treatment for the three most frequent types of endoleak. Several endovascular means are described in the literature for the treatment of endoleak

"Over-SIRIX". A new method for sizing aortic endografts in combination with the chimney grafts. early experience with aortic arch disease

Abstract BACKGROUND: Large gutters after chimney procedures are one of the main causes of type I endoleak (EL-I). This study aims to evaluate a new tailored planning named "Over-SIRIX," based on Osirix Imaging Software, to choose the correct main graft oversizing in order to minimize EL-I incidence. METHODS: From 2008 to 2015, 34 patients were treated with parallel grafts for aortic arch diseases at our institution. The study included 22 patients with single stent and antegrade flow configuration; they were divided into 2 groups (PRE- and POST-"Over-SIRIX"). "Over-SIRIX" was carried out in the retrospective group (PRE-"Over-SIRIX"), and it was used to plan the endovascular procedure in the prospective group (POST-"Over-SIRIX"). Through the multiplanar reconstruction (MPR) of the preoperative computed tomography angiography (CTA), the proximal neck of the chimney grafts was studied. Stent and endograft configurations were drawn in order to minimize the "gutters." To obtain the ideal main graft sizing (I-Size), a formula was used by adding the custom sizing (C-Size) to the disease oversizing (D-Over). The same MPR imaging was evaluated on postoperative CTA to study gutters area and presence of EL-I. RESULTS: The mean I-Size was 41.67 mm that was equivalent to an ideal oversizing of 19.3% (range 10-28%). The gutters area decreased from 7.3 to 1.7 mm2 (PRE/POST) and EL-I rate from 28.5% to 0% (PRE/POST). Gutters area bigger than 7.5 mm2 and planning made without "Over-SIRIX" were significantly associated (P < 0.05) to EL-I. CONCLUSIONS: "Over-SIRIX" appears to be a feasible method to customize planning during chimney technique, reducing the risk of EL-I which is significantly related to the presence and size of the gutters

Isolated Common Iliac Artery Aneurysms Treated Solely With Iliac Branch Stent-Grafts: Midterm Results of a Multicenter Registry

Purpose: To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA). Methods: From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5 +/- 7.8 years) for analysis. Mean CIAA diameter was 39.1 +/- 10.5 mm (range 25-65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed. Results: Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2 +/- 33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage 5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up. Conclusion: The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results

Popliteal artery aneurysm repair in the endovascular era: fourteen-years single center experience

To compare outcomes of popliteal artery aneurysm (PAA) repair by endovascular treatment, great saphenous vein (GSV) bypass, and prosthetic bypass.Single center retrospective analysis of patients presenting PAA from 2000 to 2013. Patients were divided into endovascular treatment (group A); GSV bypass (group B); and prosthetic graft bypass (group C). Outcomes were technical success, perioperative mortality, and morbidity. Survival, primary and secondary patency, and freedom from reintervention rate were estimated. Differences in ankle-brachial index (ABI), in-hospital length of stay (InH-Los), red blood cell (RBC) transfusion, and limb loss were reported. Mean follow-up was 49 (median: 35; 1-145; SD 42) months.Sixty-seven patients were included; 25 in group A, 28 in group B, and 14 in group C. PAA was symptomatic in 23 (34%) cases. Technical success was 100%. No perioperative death occurred. Three (4.5%) perioperative complications were reported with no significant difference between groups (P = 0.866). Five-years estimated survival was 78%. Estimated 5-years primary patency for groups A, B, and C was 71%, 81%, and 69%, respectively (P = 0.19). Estimated 5-years secondary patency for groups A, B, and C was 88%, 85%, and 84% (P = 0.85). Estimated 5-years freedom from reintervention for groups A, B, and C was 62%, 84%, and 70%, respectively (P = 0.16). A significant difference between preoperative ABI versus postoperative ABI was observed (P = 0.001). InH-LoS was significantly shorter in group A (P < 0.001). RBC transfusions were required significantly less in group A when compared to group C (P = 0.045). Overall limb salvage was achieved in all but 1 patient.PAA repair has good early and long-term outcomes with different treatment options. Endovascular treatment was not inferior to surgical repair with a reduced InH-LoS and RBC transfusion. It can be successfully employed even in nonelective setting. A randomized controlled trial with long-term follow-up and appropriate patient inclusion criteria is necessary to compare these 3 treatment options

The "Open branch" technique. A new way to prevent paraplegia after total endovascular repair of thoracoabdominal aneurysm

Introduction: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAA) has been proved to be an effective strategy to reduce the risk of spinal cord is- chemia (SCI). Several techniques have been described: some imply the staged coverage of the aorta, other the temporarily perfusion of the sac through a branch left unstented or a dedicated branch that will be occluded later. The aim of those is to facilitate the expansion of the collateral network that perfuses the spinal cord. However, each of them, have some disadvantages such as the need of two interventions of big magnitude and the risk of target vessel occlusion or endograft displacement. We describe a new technique to treat TAAA in a staged manner. Technique: The first step of our technique is the thoracoabdominal endograft deployment with the branching of all target vessels; one of these is branched with a bare stent inside which a covered stent will be placed in a second step, which can be perfomed under local anesthesia. We named this tech- nique “open branch” (OB). Before insertion of the covered stent, a balloon is inflated inside the bare stent to simulate the complete sac exclusion to evaluate eventual neu- rological complication. Results: Two patients with Crawford type II TAAA and one with a suprarenal aneurysm following the open repair of an infrarenal aortic aneurysm were treated. No cases of SCI were observed after the two procedures. Median interval time between the two procedures was 8, 6 weeks (4–16). Between the two steps, no aneu- rysm growth or rupture and no branch occlusion or endograft displacement was observed. Conclusions:Thesethreecasesof“OB”techniqueshowthatthisisasafeand feasible alternative strategy to treat TAAA in a staged manner

Surgical conversion with graft salvage as a definitive treatment for persistent type II endoleak causing sac enlargement

Objective The goal of this study was to present open surgical conversion with graft salvage or "semiconversion" as a definitive and safe treatment for untreatable and persistent type II endoleaks causing sac enlargement after endovascular aneurysm repair. Methods Between January 2001 and December 2014, 25 of 1623 endovascular aortic repair (EVAR) patients were selected as candidates for open semiconversion. The indication was persistent type II endoleak in 13 patients (12 of whom received previous attempts of embolization), type I and II endoleak in 2 patients, and sac growth without imaging evidence of endoleak in the other 10. After the infrarenal aorta was prepared (via a retroperitoneal access, whenever possible), the technique consisted of performing a banding of the neck with Teflon (DuPont, Wilmington, Del), a sacotomy to remove the thrombus or the hygroma, or both, and then suturing all of the feeding vessels that were found. Proximal and distal fenestrations were performed to avoid sac repressurization. Results The semiconversion was performed after a mean of 74 months after the initial EVAR. The mean aneurysm size at the time of the EVAR was 6.0 cm (range, 5.0-9.5 cm), and the mean aneurysm size at the time of the semiconversion was 7.7 cm (range, 5.5-11.5 cm). The overall aneurysm size increase was 38%, and the average growth rate was 8.2% per year. One patient had a stable aneurysm size but was treated because of an emergency condition. Technical success was 100%, with resolution of the endoleak and no perioperative deaths. Four cardiac deaths were registered at 12, 26, 30, and 60 months (mean follow-up, 42 months; range, 1-80 months). Conclusions Graft salvage appears to be a valid option compared with open repair when considering treatment of persistent type II endoleak. This case series shows that semiconversion is a safe and effective treatment for otherwise untreatable type II endoleak