Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

The Ultra-Low-Profile Minos Endograft in Abdominal Aortic Aneurysms with Standard and Hostile Anatomy. A Multicenter Retrospective Study.

BACKGROUND: Narrow and tortuous iliac axes are the second most common reason the feasibility of endovascular aortic repair (EVAR), and low-profile endografts were conceived to overcome the limitation of narrow and tortuous iliac axes. This study aims to report the initial results of EVAR performed with the ultra-low-profile Minos® abdominal endograft through a retrospective study conducted across 3 high-volume centers. METHODS: We retrospectively reviewed a prospectively maintained database collecting all consecutive EVAR performed with the Minos endograft across 3 Centers of Vascular Surgery between 2020 and 2023. Patients' clinical and operative data, perioperative, and postoperative outcomes were recorded. RESULTS: Ninety patients received EVAR with the Minos endograft. Assisted technical success was 100%, with 6 unplanned adjunctive procedures. Two perioperative complications required reinterventions: 1 access site surgical bleeding and an iliac limb occlusion. All unplanned adjunctive procedures and early reinterventions (8 in 7 patients) occurred in abdominal aortic aneurysms with hostile iliac arteries or narrow carrefour. Over a mean follow-up of 14.2 ± 9.6 months, no deaths were observed, and all patients completed the scheduled surveillance protocol. Late reinterventions were 6 (6.7%): 2 type IA endoleaks (ELs), 1 type IB EL, 1 type II EL, and 2 limb occlusions. There was no significant difference in reintervention rates between aneurysms with hostile and standard anatomy. CONCLUSIONS: The Minos endograft is safe and effective in treating aneurysms with hostile and standard anatomy, and its results are maintained at a mean follow-up of 14 months. A larger sample size and a longer follow-up are necessary to assess the results on the longer term.

Five-Year Outcomes of Endovascular Aortic Repair With the TREO Abdominal Endograft.

PURPOSE: Newer generation abdominal endografts, including Treo (Terumo Aortic, Sunrise, Florida), have shown optimal safety and effectiveness in treating abdominal aortic aneurysms (AAAs), even with hostile anatomy over the short- and mid-term. The durability of such results, however, is still a controversial issue, due to the paucity of long-term data. Our aim is to show the long-term outcomes of endovascular aortic repair of both standard and hostile AAAs with the Treo endograft on a cohort of patients treated between 2016 and 2017. METHODS: We analyzed the postoperative follow-up of 37 consecutive patients who have undergone endovascular aortic repair (EVAR) with the Treo Endograft between 2016 and 2017, whose baseline clinical conditions, operative data, and short-term outcomes had been published in 2018. All patients were followed up by computed tomography angiography (CTA) at 6 and 12 months and 5 years postoperatively. Primary endpoints were aortic-related mortality, type I-III endoleak (EL), and reintervention rate. Secondary endpoints were the rates of type II ELs and aneurysm sac regression. RESULTS: Of 37 patients, 27 had at least one criterion of anatomic hostility and 11 were performed outside the device-specific instructions for use (IFU). In the perioperative period, we observed 100% technical success, with no perioperative mortality. Over a mean follow-up of 5.5 years (66 months), 3 patients (8.1%) were lost to follow-up and 3 (8.1%) died of non-aortic causes (overall survival: 91.9%). One type IA EL of an AAA with a hostile neck (but within the IFU) and a type III EL of an AAA with standard anatomy were observed and treated by endovascular relining (overall reintervention rate: 5.5%). Four type II ELs were associated with aneurysm sac stability over time and are still under surveillance. Mean aneurysm shrinkage was 11.25±8.30 mm. CONCLUSION: The optimal results of the Treo Endograft in terms of complication and reintervention rates reported over the mid-term by the current literature (ITA-ENDOBOOT registry) are maintained on the long term, both in case of hostile and friendly aortic anatomy, with a satisfactory shrinkage rate of the aneurysm sac. CLINICAL IMPACT: The innovative characteristics of Treo and its short-term results are well-known and reported. The present case series contributes to the scientific validation of a new-generation abdominal aortic endograft over the long-term, focusing especially on its performance in treating AAAs with hostile anatomy. Its 5-years outcomes confirm the optimal results already reported over the short- and mid-term.

Mini-Surgical Access Prevents Local Complications and Reduces Costs in Endovascular Aortic Repair.

BACKGROUND: This study aims to propose a minimally invasive surgical approach to the common femoral artery in endovascular aortic repair and assess its value by a single-center retrospective study including 118 patients. METHODS: Between 2017 and 2022, all patients receiving endovascular treatment for thoracic and abdominal aortic aneurysms in our center had the anterior wall of the common femoral artery exposed, through a 2-3 cm transverse groin incision, instead of a complete surgical cutdown. We access the artery with a purse-string suture, held tight with a tourniquet. After procedure completion, we tie the purse-string closing the arteriotomy. We retrospectively analyzed the cohort of all consecutive patients treated with endovascular aortic repair in this period and recorded primary and assisted technical success, operative time, in-hospital length of stay, access failure, and access-related complications, comparing the results with the current literature. RESULTS: All procedures were successful, with no perioperative mortality. Primary technical success was achieved in 116 patients; 2 required adjunctive procedures. No access failure or access-related complications (thrombosis, groin hematoma, lymphocele, wound dehiscence, or infection) occurred. Two accesses required conversion to complete femoral artery exposure and endarterectomy. Operatory time and length of in-hospital stay were comparable to the outcomes of the major studies reporting on percutaneous access, saving the costs of the closure devices. CONCLUSIONS: Minimally invasive surgical access is safe and feasible for endovascular aortic procedures. Compared to the costs of percutaneous access found in literature, it is cost-effective. It can be chosen whenever the percutaneous approach is not feasible or at a high risk of complications.

Endovascular Treatment of a Ruptured Pararenal Abdominal Aortic Aneurysm in a Patient With Coronavirus Disease-2019: Suggestions and Case Report.

The aim of this report is to discuss emergent repair for complex aortic diseases in patients affected by novel coronavirus pneumonia (coronavirus disease-2019 [COVID-19]), describing a case of ruptured pararenal aortic aneurysm. An eighty-year-old man with COVID-19 was admitted for ruptured aneurysm of the pararenal aorta and hemorrhagic shock. Endovascular repair was chosen, and a proximal extension of the previous abdominal endograft was performed with parallel stents in the right renal artery and the superior mesenteric artery. Endovascular treatment and early anticoagulation are the key for success for vascular emergencies in patients with COVID-19, despite the risk of late endoleak.

Robotic Treatment of Complex Splenic Artery Aneurysms with Deep Hilar Location: Technical Insights and Midterm Results.

BACKGROUND: Splenic artery aneurysms are rare, but their occurrence is burdened by considerable mortality and morbidity rates. Although the indications to treatment are quite clear-cut, there is still debate on the first-choice technique of treatment (endovascular, open, or laparoscopic surgery). Recently, robotic surgery has been proposed as an alternative option in patients at high surgical risk. The present case series aims to assess the value of robotic treatment of splenic artery aneurysms in patients unfit for surgery. METHODS: All cases of splenic artery aneurysms treated by robotic surgery at our center between 2014 and 2018 were retrospectively reviewed. Primary endpoints were clinical and technical success and disease-free survival. RESULTS: Robotic surgery was used to treat four patients affected by splenic artery aneurysms, with the guidance of 3D printed patient-specific models. All patients, after aneurysm excision, received reconstruction of the splenic artery by direct anastomosis. All cases were treated successfully without mortality. Reintervention-free survival at 24-month mean follow-up is 100%, and no systemic complication of clinical relevance was reported. The mean time of organ ischemia was 45 min. CONCLUSIONS: Robotic surgery is a safe and effective option in treating visceral aneurysms, providing the possibility to reconstruct the splenic artery after aneurysm excision.

Failure of Sandwich Technique for Thoracoabdominal Aneurysm Treated with Custom-Made Fenestrated Endograft.

BACKGROUND: Custom-made fenestrated and branched endografts are considered the gold standard devices for thoracoabdominal repair, with lower perioperative mortality and morbidities than open surgical repair. Although they are not feasible in urgent and emergent settings, in which sandwich techniques are often necessary, custom-made devices can still be used as bail-out options to correct late complications such as high-flow endoleaks, as shown in this case report. METHODS: A complex, symptomatic thoracoabdominal aneurysm, unsuitable for open repair, was treated by sandwich technique on the celiac trunk despite having a short distal neck. After the finding of a high-flow type IB endoleak during postoperative follow-up, reintervention was planned with a custom-made endograft with a distal scallop, to preserve patency of the superior mesenteric artery. RESULTS: The procedure achieved technical success, with complete exclusion of the aneurysm and patency of all the visceral arteries. CONCLUSIONS: Bail-out endovascular repair with custom-made endografts after failure of parallel graft repair of thoracoabdominal aneurysms is a valuable treatment option preventing the risks related to an open conversion.

Robotic Surgery for Elective Repair of Visceral and Renal Artery Aneurysms: A Systematic Review.

Background: The treatment choice of visceral artery aneurysms in an elective setting is debated. The durability and the risk of reintervention with endovascular treatment are still reasons for concern, whereas open surgery is invasive and burdened by major complications. In anecdotal reports and isolated studies, robotic-assisted surgery seems to provide the possibility of a minimally invasive treatment and the durability of traditional open surgery, but the literature supporting this view is scarce. This review aims to collect the results of robotic-assisted surgery in the treatment of visceral artery aneurysms. Methods: A systematic search of the main research databases was performed: the study endpoints were mortality and conversion rates, perioperative morbidity, and freedom from late complications and reinterventions. Results: We identified 16 studies on 53 patients. All cases underwent successful resection, with three conversions to laparoscopy. Perioperative and aneurysm-related mortality were nil. Over a median follow-up of 9 months, two reinterventions were reported (3.6%). Conclusion: The robotic technique is safe and effective in treating splenic and renal artery aneurysms, and it should be considered as a valuable alternative to endovascular and open repair, although larger sample sizes and a longer-term follow-up are necessary to confirm such results.

Disappointing results of popliteal aneurysm endovascular treatment with a new self-expandable covered stent.

PURPOSE: To describe our clinical experience of endovascular exclusion of popliteal artery aneurysms using the new self-expandable covered stent SOLARIS® (Scitech Medical, Brazil), and to report its results in the context of surgical and endovascular treatment of popliteal artery aneurysms. CASE REPORT: Among 20 popliteal artery aneurysms undergoing open or endovascular repair in 2022 and 2023, two patients were successfully treated with the Solaris stentgraft. Both patients had a patent popliteal artery and three run-off vessels. After stentgraft implantation, they received dual antiplatelet therapy for three months and they were followed-up with Duplex scan and clinical evaluation after three months, and every six months thereafter. After three months, one Solaris stentgraft had complete thrombosis and the other ruptured, requiring surgical removal. No complications were observed among the other aneurysms treated with open repair or with the Viabahn® stentgraft. CONCLUSIONS: Endovascular treatment of popliteal aneurysms with the new covered self-expandable stent Solaris resulted in severe complications in the two cases reported, and in worse short-term outcomes than endovascular repair with Viabahn® and open repair. Its off-label use to treat popliteal artery aneurysms should be therefore discouraged.

Current Debates in the Management of Visceral Artery Aneurysms: Where the Guidelines Collide.

On one hand, the main difficulties in establishing a wide, evidence-based consensus about the best approach to visceral artery aneurysms (VAAs) and pseudoaneurysms (VAPAs) are the paucity of data, due to their rarity in the general population, and the extreme heterogeneity of this group of diseases, which encompasses different aneurysm types, with different degrees of rupture risks according to their anatomical locations [...].

Endovascular and Open Surgical Treatment of Ruptured Splenic Artery Aneurysms: A Case Report and a Systematic Literature Review.

BACKGROUND: Ruptured splenic artery aneurysms (r-SAA), although rare, are burdened by high morbidity and mortality, even despite emergent surgical repair. It is suggested that endovascular treatment can achieve reduction in peri-operative death and complication rates, as in other vascular diseases, but evidence of such benefits is still lacking in this particular setting. We report a case of an r-SAA treated by trans-arterial embolization and then converted to open surgery for persistent bleeding, and we provide a systematic review of current results of open and endovascular repair of r-SAAs. MATERIALS AND METHODS: A 50-year-old male presenting in shock for a giant r-SAA underwent emergent coil embolization and recovered hemodynamic stability. On the following day, he underwent laparotomy for evacuation of the huge intraperitoneal hematoma, but residual bleeding was noted from the splenic artery, which was ligated after coil removal, and a splenectomy was performed. A systematic literature review of the reported mortality and complications of r-SAA undergoing open (OSR) or endovascular (EVT) treatment was performed using the main search databases. All primary examples of research published since 1990 were included regardless of sample size. The main outcome measures were mortality and reinterventions. Secondary outcomes were post-operative complications. RESULTS: We selected 129 studies reporting on 350 patients-185 treated with OSR and 165 with EVT. Hemodynamically unstable patients and ruptures during pregnancy were more frequently treated with open repair. Overall, there were 37 deaths (mortality: 10.6%)-24 in the OSR group and 13 in the EVTr group (mortality: 12.9% and 7.8% respectively, p-value: 0.84). There were 37 reinterventions after failed or complicated endovascular repair -6 treated with endovascular re-embolization and 31 with laparotomy and splenectomy (22.4%); there were 3 (1.6%) reinterventions after open repair. Overall complication rates were 7.3% in the EVT group (n: 12) and 4.2% in the OSR group (n: 7), and did not require reintervention. No significant differences in overall complications or in any specific complication rate were observed between the two groups. CONCLUSIONS: Current results of r-SAA treatment show equipoise terms of morbidity and mortality between open and endovascular repair; however, in case of hemodynamic instability and rupture during pregnancy, open surgery might still be safer. Moreover, endovascular repair is still burdened by a significantly higher rate of reinterventions, mostly with conversions to open surgery.

Spinal cord ischemia complicating treatment of abdominal aortic aneurysms: a legal overview.

BACKGROUND AND AIM: Spinal cord ischemia following open or endovascular aneurysm repair of the abdominal aorta is rare but highly disabling complication. The aim of this work is to report on its occurrence and its legal consequences. METHODS: We report a case of spinal cord ischemia complicating an endovascular aortic repair, its management and sequalae, comparing it with the existing literature and we examine its legal consequences resulting in a malpractice lawsuit and the final decision of the judge. RESULTS: Although the causal relation between SCI and the neurological deficits reported were assessed by the Court, no element of responsibility imputable to the Hospital or the Medical Staff were found, since the defendant had made every effort to prevent it in the preoperatory setting, and to treat it once it established in the post-operative phase. CONCLUSIONS: predictable but unpreventable complications of necessary interventions rule out medical malpractice, as long as the patient is fully informed about the risks and benefits of the treatment, and provided that in the perioperative setting all due measures are taken in order to prevent it and treat it.