Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft.

OBJECTIVE: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). METHODS: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. RESULTS: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. CONCLUSIONS: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.

Long-term results of fenestrated and branched endovascular aneurysm repair for complex abdominal and thoracoabdominal aortic aneurysms in young and fit patients.

BACKGROUND: Endovascular repair of complex abdominal (CAAA) and thoracoabdominal aortic aneurysms (TAAA) with fenestrated and branched devices (F/BEVAR) represents the first-line treatment in old or unfit patients. Currently, the widespread diffusion of these techniques has led to a progressive increase of complex endovascular procedures also in younger and fitter patients, but the related results have been only minimally reported without long-term data. We investigated the long-term results of F/BEVAR for CAAA and TAAA repair in young and fit patients. METHODS: All consecutive patients, aged 70 or younger, undergone F/BEVAR for CAAA and TAAA over the last 13 years at two tertiary Institutions were included in the study. All subjects presented a low to intermediate risk according to the Society for Vascular Surgery (SVS) clinical comorbidity grading system. The primary endpoints were technical and clinical success, late overall and aortic-related survival. Major complications and specific target vessel-related outcomes were investigated as secondary endpoints. RESULTS: A total of 183 patients (155 males, 84.7%; mean age 64.5 + 5.7 years, range 33-70) underwent F/BEVAR during the study period, for a total of 167 (91.3%) degenerative and 16 (8.7%) post-dissection aneurysms including 44 (24%) juxtarenal, 33 (18%) pararenal and 106 (58%) thoraco-abdominal aortic aneurysms. Technical and clinical success were achieved in 176 (96.2%) and 171 patients (93.4%), respectively. Four patients (2.2%) died perioperatively, of which 2 (1.1%) operated in emergency. Postoperatively, 5 patients (2.7%) presented permanent grade 3 spinal cord injury, and 3 (1.6%) renal failure needing permanent dialysis. The mean follow-up was 65.7 + 39.6 months (range 1-158). Estimated overall and aortic-related survival at 12, 60, and 120 months was 94.0%, 85.1%, 72.2%, and 97.8%, 97.8%, 96.2%, respectively, while reintervention and branch instability-free survival at the same time spam was 84.4%, 71.8%, 71.8%, and 93.2%, 86.3%, 72.2%, respectively. An aneurysm growth > 5 mm was detected in 6 patients (3.3%) while a sac shrinkage > 5 mm was achieved in 118 cases (64.5%). The Cox regression analysis demonstrated the need for unplanned procedure as the only risk factor for overall mortality [OR=3.331 (1.397-7.940), p < 0.01]. CONCLUSION: F/BEVAR in young and fit patients led to a low perioperative mortality and major morbidity, and favorable overall survival rate in the long-term making this technique particularly appealing in such a subgroup of patients. The availability of long-term data derived from the results of young patients, may additionally provide helpful information to re-define indication for treatment and allow future targeted device and technique improvements.

Editor's Choice - Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia.

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Technical note: An alternative use of a steerable homemade for the treatment of chronic total occlusion of an iliac artery.

INTRODUCTION: The complexity of the peripheral recanalization comes from the difficulty to cross the lesion or get into the subintimal space and its re-entry afterward, with a high risk of complications like artery dissection and/or rupture, which are life-threatening complications. To our knowledge, we report the first case of the use of a homemade steerable sheath for the successful revascularization of a heavy chronic total occlusion in a patient with unsuitable upper vascular access. TECHNIQUE: By contralateral vascular access and the use of a 6Fr 55-cm Cook Flexor sheath and a pre-looped 0.014" choice guidewire, a steerable homemade sheath was used to achieve the support, pushability, and steer needed to access the subintimal space at the origin of a heavy occluded common iliac artery, thus giving us the ability to cross the lesion. CONCLUSIONS: The homemade steerable sheath is feasible, quick, cheap, and easy to use, sparing the use of re-entry systems and catheters for the attempts of subintimal navigation. In addition, this technique gives the advantage to steer the catheters and wires as needed, avoiding non-desired re-entry points with secondary collaterals lumen compromise or extensive dissections.

Disappearing multiple visceral aneurysms in Vascular Ehlers-Danlos syndrome.

OBJECTIVE: To assess the complex management of arterial anomalies in Vascular Ehlers-Danlos Syndrome (vEDS). METHODS: We report the case of a 34-year-old male, diagnosed with vEDS, who presented with acute intraperitoneal hemorrhage caused by the rupture of a splenic artery aneurysm, treated in emergency with coil embolization and splenectomy. Computed Tomography (CT) scan showed the concomitant presence of right renal artery (RRA) and common hepatic artery (CHA) aneurysms. RESULTS: Both aneurysms were conservatively managed and the patient went through serial CT imaging. After 3 months, rapid regression of the vascular abnormalities led to complete disappearing of RRA and CHA aneurysms, confirmed at 24-month imaging follow-up. In the same time span, two pseudoaneurysms developed in other sites used for transarterial access, requiring two secondary interventions. The present case emphasizes the unpredictability of disease's evolution and arterial complications in vEDS. Conservative management of complex lesions such as visceral artery aneurysms, which in this case resulted to be the best strategy, avoided the risks associated with surgical intervention in such fragile tissues. The reported complications underline that operative indications should be carefully weighed in these patients.

Outcomes of multibranched off-the-shelf stent graft in elective and urgent/emergent repair of complex aortic aneurysms with narrow internal aortic lumen.

OBJECTIVES: To assess the outcomes of Cook t-Branch off-the-shelf multibranched stent graft in the treatment of complex aortic aneurysms with narrow internal aortic lumen. METHODS: Between 2016 and 2020, 48 patients (mean age, 73 years) underwent elective or urgent or emergent Cook t-Branch implantation for thoracoabdominal or para/juxtarenal aortic aneurysms in two Italian vascular centers. Among these, 20 patients presented a paravisceral or pararenal luminal diameter of less than 25 mm. Major clinical and radiologic outcomes of patients with narrow aortic lumen were compared with patients with a larger lumen in a multicenter, nonrandomized, retrospective fashion. RESULTS: The in-hospital mortality was 10% (5% in the elective setting). Spinal cord ischemia occurred in 6% of the cases. During a mean follow-up of 18 months (range, 1-63 months), late t-Branch procedure-related mortality and the need for reintervention was 0% and 12%, respectively. Comparing the outcomes of patients with large internal aortic lumen (group 1) with patients with small lumen (group 2), no significant difference was found regarding fluoroscopy time (P = .3); technical success (P = 1); early (P = .4) and late (P = 1) mortality; spinal cord ischemia (P = .2); bowel ischemia (P = .5); renal (P = .7), cardiac (P = 1), and respiratory complications (P = 1); reintervention rate (P = 1); and primary patency rate of stented target vessels (P = 1). CONCLUSIONS: The use of the Cook t-Branch in our experience was safe and effective in the treatment of complex aortic aneurysms regardless the caliber of the aortic lumen. With all the limitations of a small sample size, this approach has demonstrated to be feasible when maneuverability is decreased, with low mortality and morbidity, and acceptable reintervention rates. Perioperative mortality remains closely related to clinical presentation. Large-scale studies are needed to confirm these results.

Complete Transfemoral Endovascular Repair with Homemade Steerable Sheath of Intercostal Artery Patch Aneurysm after Open Repair of Thoracoabdominal Aortic Aneurysm.

The aim of this paper is to describe a case of complete transfemoral approach for endovascular treatment of a large intercostal patch aneurysm with custom-made stent-graft in a patient with Loeys-Dietz syndrome and previous multiple aortic operations. Three aortic components were used to exclude a 65-mm intercostal patch aneurysm. Because of the reimplantation site of supra-aortic trunks in a previous open arch repair, we used a complete transfemoral approach with a homemade steerable sheath to deliver all the renovisceral bridging stents through the downward side-branches. No major complications were registered. A 6-month follow-up resulted uneventfully, and an initial shrinkage of the aneurysmal lesion was found. The use of a homemade steerable sheath was safe and effective for catheterization and stenting of all the target vessels through the downward side branches.

Two-year single centre results with covered endovascular reconstruction of aortic bifurcation (CERAB) in the treatment of extensive aorto-iliac occlusive disease.

OBJECTIVE: To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. METHODS: A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients' clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate. RESULTS: During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37-79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1-9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6-48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) (P < 0.001) and target lesion revascularization rate was 12.5%. At two years, the limb salvage rate was 100%, and primary and secondary patency rates were 87.5% and 100%, respectively. CONCLUSION: CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.

Treatment of carotid stenosis: surgery and stent in comparison.

Carotid stenosis in the extracranial tract determines 10-15% of all ischaemic strokes. The aim of treatment, therefore, is to prevent major neurological events. Carotid endarterectomy surgery has proved effective in this regard, with various randomized studies that have demonstrated its validity in both symptomatic and asymptomatic patients. As an alternative, since the late 1990s, the endovascular treatment of carotid stenosis by stenting has gradually established itself. Numerous controlled clinical trials have compared surgery and carotid stenting in terms of perioperative outcomes (death, stroke, and myocardial infarction within 30 days of the procedure) and stroke prevention ipsilateral to the lesion treated during follow-up, evaluating both symptomatic and asymptomatic patients. From the systematic review of the data, it is legitimate to state that stenting may represent a safe alternative to conventional surgery in patients with symptomatic carotid stenosis under the age of 70, while endarterectomy is clearly safer and more effective than endovascular treatment for symptomatic older patients. On the other hand, as regards asymptomatic patients, the available evidence is limited and further data are needed to compare the two methods and to compare them with the best current medical therapy in order to draw conclusions.

Long-term results of hybrid repair techniques for Kommerell's diverticulum.

OBJECTIVE: The aim of this study was to evaluate early and late results of hybrid repair techniques for Kommerell's diverticulum (KD). METHODS: All patients who underwent hybrid repair (thoracic endovascular aortic repair + supra-aortic debranching) for KD between 2009 and 2018 were included in this retrospective multicenter study (three Italian centers). A proximal landing zone (PLZ) of at least 2 cm of healthy aorta was considered adequate for the deployment of a standard thoracic stent graft. The early end points were technical success, in-hospital mortality, and cerebrovascular events. Late outcomes included survival, reintervention, and patency of supra-aortic debranching. We used an embryogenetic anomaly based aortic arch classification for PLZ evaluation to identify the most appropriate hybrid adjunct. RESULTS: Sixteen patients with KD were included. According to the aforementioned classification, stent graft deployment was required in six patients (37.5%) in PLZ 0, nine patients (56.3%) in PLZ 1, and one patient (6.3%) in PLZ 2. Technical success was achieved in all patients. One patient (6.3%) died in the hospital because of posterior cerebral hemorrhage after total debranching (PLZ 0). No further cerebrovascular events were observed. One patient (6.3%) had an asymptomatic left subclavian artery-right left subclavian artery bypass occlusion and required early reintervention. The 30-day secondary patency of supra-aortic debranching was 100%. Two type II endoleaks (12.5%) were detected at 1 month through computed tomography angiography. Further transient complications were found in three cases: hemidiaphragm paralysis in one patient and recurrent laryngeal nerve paralysis in two patients. At a mean follow-up of 48 months, four patients had died because of nonaortic reasons, and one RCCA-right subclavian artery bypass had lost its patency. None of the patients reported any growth of KD after hybrid repair. Ten patients (62.5%) showed aneurysmal sac shrinkage of at least 5 mm. CONCLUSIONS: Hybrid repair is confirmed to be a safe and effective approach for KD. Operative risk is associated primarily with the invasiveness of the hybrid adjunct.

Secondary aortoenteric fistula successfully treated with staged endovascular repair and duodenal resection without graft removal.

Secondary aorto-enteric fistulae (SAEF) are rare life-threatening complications that occur after abdominal aortic graft implant to treat aortic aneurysm or occlusive disease. Conventional treatments such as extra-anatomic bypass grafting with aortic ligation and subsequent graft removal with bowel repair are associated with a 25% to 90% operative mortality rate. In the emergency setting, patients unsuitable for major arterial surgery may benefit from a staged, less invasive approach. We present a case of SAEF treated with endoluminal deployment of a stent graft followed by duodenojejunal resection and anastomosis without further aortic reconstruction and graft removal.

Late-Onset Paraplegia After Endovascular Repair of Type B Aortic Dissection Managed by Urgent Left Subclavian Artery Revascularization: A Case Report.

Spinal cord ischemia is one of the most unpredictable and feared complications after open surgical or endovascular thoracic aortic repair. Protection of collateral network branches that contribute blood supply to spinal cord is fundamental in the prevention of this catastrophic condition. We report the case of a patient who underwent emergent endovascular treatment for a type B aortic dissection complicated by rupture of the false lumen, with intentional coverage of the left subclavian artery without revascularization. The patient developed paraplegia on the 10th postoperative day, which did not significantly improve with immediate cerebrospinal fluid drainage but fully recovered after urgent left carotid-subclavian bypass.

Open Surgery and Endovascular Techniques in Treatment of Acute Abdominal Arteriovenous Fistulas.

Acute abdominal arteriovenous fistulas in the setting of ruptured abdominal aortic aneurysms are a life-threatening condition; thus, a prompt diagnosis is required for proper treatment. Open, endovascular, and hybrid repair have been proposed for their management, with pros and cons for each method. In particular, the evolution of endoluminal techniques guarantees an increasing feasibility of these procedures, and a significant reduction in morbidity and mortality rates was usually associated with open surgery. Nevertheless, some concerns still remain regarding the midterm and long-term follow-up. The aim of this article was to review and compare the reported clinical and technical results of conventional open surgery and endoluminal techniques in this scenario and to report the case of an acute aorto-iliac fistula due to a ruptured common iliac artery aneurysm into the iliac vein that was managed by endovascular repair at our institution.

Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease: The Regeneration Study.

BACKGROUND: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. METHODS: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. RESULTS: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6-13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak). CONCLUSIONS: The RelayPro has a 3-4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.

A national cross-sectional survey on time-trends for endovascular repair of genetically-triggered aortic disease and connective tissue disorders over two decades.

BACKGROUND: By this survey, we aim to gain national-based information regarding trends in endovascular repair (ER) for the treatment of aortic disease in patients with genetically-triggered aortic disease (GTAD) and connective tissue disorder (CTD) over the last two decades. METHODS: All Italian vascular surgery centers (N.=80) were invited to participate in an anonymous electronic cross-sectional survey on ER for GTAD/CTD. RESULTS: Overall, 29 institutions completed the survey, thereby yielding a 36% response rate. The percentage of responding institutions rises to 64% if only regional hubs were considered (23/36). The median number of index procedures per center was 6.2, and a steady increase in the overall number of interventions over time was also noted. Most patients were males (73%) with a median age of 48 years. The most common endovascular procedure was TEVAR (N.=101), followed by F/BEVAR (N.=43) and EVAR (N.=37). The overall technical success rate was 83.4% while major adverse events and mortality at thirty days were reported at 18.2% and 9.9%, respectively. An additional 5.0% mortality rate was noted for an overall one-year mortality of 14.9%, while 3.7% of all treated patients were diagnosed with a type 1 endoleak. CONCLUSIONS: This national cross-sectional survey, investigating trends in ER of GTADs and CTDs over two decades, highlights a consistent increase in the use of endovascular techniques for their treatment. Early mortality was acceptably low, yet influenced by the urgency of presentation. At one-year follow-up, a 5% additional death rate was noted, and the reintervention rate remained below one in ten.

Early and midterm results of covered balloon-expandable stents (VBX-Gore) for endovascular treatment of chronic aorto-iliac occlusion.

BACKGROUND: Endovascular treatment is nowadays accepted as first-line treatment for most patients with aorto-iliac obstructive disease (AIOD), including those with Trans-Atlantic Inter-Society Consensus II (TASC-II) lesion types C and D. Aim of the study was to evaluate the role of Viabahn VBX (W. L. Gore and Associates, Flagstaff, AZ, USA), in patients with chronic occlusive aorto-iliac disease (ChO). METHODS: A retrospective review of patients undergone elective endovascular repair with VBX (W. L. Gore and Associates) for ChO at five referral vascular institutions in Italy from 2018 to 2022 was conducted. Primary endpoints were technical success and the incidence of any early and midterm procedure-related reintervention. Secondary endpoints were clinical success, primary and secondary patency. RESULTS: Among 89 included patients, technical success was obtained in 87 patients (97.8%). Postoperative complication requiring early surgical reintervention was necessary in 5 (6%), all but one for arterial bleeding. Clinical improvement of at least 3 classes was observed in 49 (55%). After a mean follow-up of 24.1 months ±14.1, primary patency and freedom from any procedure-related reintervention at 12, 24 and 36 months was 83.0% and 94.8%, 80.0% and 91.5%, 77.9% and 89.3%, respectively. Secondary patency was 100%. TASC-II D lesion (OR=3.67, 95% CI: 1.1289-11.9823, P=0.03) and Grade III iliac calcification (OR=3.41, 95% CI: 1.0944-10.6428, P=0.03) were identified as independent predictors for procedure-related reintervention. CONCLUSIONS: Use of VBX (W. L. Gore and Associates) in ChO was safe and effective with low rate of stenosis/occlusion in the early and mid-term follow-up. TASC-II D and Grade III calcifications resulted as independent predictors for procedure-related reintervention.

Acute ischemia of the upper and lower limbs: Tailoring the treatment to the underlying etiology.

Acute limb ischemia (ALI) can be a devastating clinical emergency with potentially limb- or life-threatening consequences. It is defined as a quickly developing or sudden decrease in limb perfusion producing new or worsening symptoms and signs, often threatening limb viability. ALI is commonly related to an acute arterial occlusion. Rarely, extensive venous occlusion can lead to upper and lower extremities ischemia (ie, phlegmasia). The incidence of acute peripheral arterial occlusion causing ALI is approximately 1.5 cases per 10,000 people per year. The clinical presentation depends on the etiology and whether the patient has underlying peripheral artery disease. Except for traumas, the most common etiologies are embolic or thrombotic events. Peripheral embolism, likely related to embolic heart disease, is the most common cause of acute upper extremity ischemia. However, an acute thrombotic event may occur in native arteries, at the site of a pre-existing atherosclerotic plaque, or as a failure of previous vascular interventions. The presence of an aneurysm may predispose to ALI for both embolic and thrombotic mechanisms. Immediate diagnosis, accurate assessment of limb viability, and prompt intervention, when needed, play important roles in salvaging the affected limb and preventing major amputation. Severity of symptoms is usually dependent on the amount of surrounding arterial collateralization, which may often reflect a pre-existing chronic vascular disease. For this reason, early recognition of the underlying etiology is crucial for choice of best management and definitely for treatment success. Any error in the initial evaluation may negatively affect the functional prognosis of the limb and endanger the patient's life. The aim of this article was to discuss diagnosis, etiology, pathophysiology, and treatment of patients with acute ischemia of the upper and lower limbs.

Shamblin III Chemodectoma: The vascular surgeon's point of view.

Chemodectomas (CBTs) are the most frequently encountered tumours at the carotid bifurcation. Even if rare and commonly benign, their development close to the head and neck structures is often source of morbidity by compression and infiltration. Therefore, in order to avoid permanent neurologic or vascular complications these infrequent lesions need to be early removed. The total excision may be technically challenging and requires extensive expertise in surgical neck anatomy and a cooperative multidisciplinary approach. Almost a quarter of CBTs infiltrate carotid vessels so vascular expertise is pivotal in their resection. The present study aims to give an overview of vascular specificity and procedures required during surgical excision of such tumors to assist and guide treating physicians who encounter CBTs. This overview will particularly emphasize current therapeutic options: we discuss the referral criteria that should guide the decision about what type of preoperative care and surgical procedure should be offered to the affected patients. We also specify the epidemiologic data, screening recommendations and outcomes achieved with the different therapeutic approaches. The clinical, operative and follow-up data about a case of a Shamblin III carotid body tumour surgically removed by a multidisciplinary team at our Institution are also reported.