Medium-term outcomes of EXTra-design engineering inner-branch ENdografts for the treatment of complex aortic aneurysms from a multicenter collaboration.

OBJECTIVE: This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results. METHODS: A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events. RESULTS: Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches. CONCLUSIONS: EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions.

Outcomes after Endovascular Arch Repair in Patients with a Mechanical Aortic Valve: Results from a Multicentre Study.

OBJECTIVE: The aim of this study was to investigate outcomes after endovascular aortic arch repair in patients with a mechanical aortic valve where the valve needs to be crossed. METHODS: An international, multicentre, retrospective observational study was undertaken including all consecutive patients who underwent endovascular arch repair with mechanical aortic valve crossing. RESULTS: From March 2020 to August 2023, 12 patients were included in the study (median age 55 years, interquartile range 45, 67 years; 58% male). Five patients (42%) had a genetically confirmed connective tissue disorder (CTD) and three more had a high clinical suspicion of CTD. Most patients had a bileaflet valve (11/12; 92%) and one patient had a monoleaflet one. All patients had previously undergone surgical ascending aortic repair. Technical success was 100% with successful completion of the procedure with no valve damage. Two deaths (17%) were observed in the first 30 days post-operatively with no signs of valve malfunction: one patient died of major stroke due to excessive wire and sheath manipulation in the arch; and another due to cardiac arrest of unknown cause, with no valve damage being detected in the autopsy. No intra-operative technical difficulties regarding valve cannulation were observed. During a median follow up of eight months, one patient died fifteen months after the procedure owing to non-aortic related causes, and four endoleaks were present on the latest computed tomography angiography, none type I or III. CONCLUSION: Endovascular aortic arch repair in a selected group of patients with a mechanical aortic valve treated in experienced, high volume aortic centres seems technically feasible and reasonably safe. These preliminary results underline the complexity of the procedure and should be validated by larger cohort studies. With careful patient selection and adequate physician experience, the presence of a mechanical aortic valve could potentially no longer pose a major contraindication for endovascular arch repair in the future.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms.

OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.

The Development of Totally Percutaneous Aortic Arch Repair With Inner-Branch Endografts: Experience From 2 Centers.

OBJECTIVE: The main objective of this study is to present the experience of 2 centers undertaking total percutaneous aortic arch-branched graft endovascular repair using combination of femoral and axillary routes. The report summarizes the procedural steps, outcomes achieved, and the benefits of this approach, which eliminates the need for direct open surgical exposure of the carotid, subclavian, or axillary arteries, thereby reducing the unnecessary associated surgical risks. METHODS: Retrospectively collected data of 18 consecutive patients (15M:3F) undergoing aortic arch endovascular repair using a branched device between February 2021 and June 2022 at 2 aortic units. Six patients were treated for a residual aortic arch aneurysm following previous type A dissection with size range of (58-67 mm in diameter), 10 were treated for saccular or fusiform degenerative atheromatous aneurysm with size range of (51.5-80 mm in diameter), and 2 were treated for penetrating aortic ulcer (PAU) with size range of (50-55 mm). Technical success was defined as completion of the procedure and satisfactory placement of the bridging stent grafts (BSGs) in the supra-aortic vessels percutaneously including the brachiocephalic trunk (BCT), left common carotid artery (LCCA), and left subclavian artery (LSA) without the need for carotid, subclavian, or axillary cut down. The primary technical success was examined as primary outcome well as any other related complications and reinterventions as secondary outcomes. RESULTS: The primary technical success with our alternative approach was achieved in all 18 cases. There was one access site complication (groin haematoma), which was managed conservatively. There was no incidence of death, stroke, or cases of paraplegia. No other immediate complications were noted. Postoperative imaging confirmed supra-aortic branch patency, with satisfactory position of the BSGs and immediate aneurysm exclusion except in 4 patients who had type 1C endoleak (Innominate: 2, LSA 2) detected on the first postoperative scan. Three of them were treated with relining/extension, and 1 spontaneously resolved after 6 weeks. CONCLUSIONS: Total percutaneous aortic arch repair with antegrade and retrograde inner-branch endografts can be performed with promising early results. Dedicated steerable sheaths and appropriate BSG would optimize the percutaneous approach for aortic arch endovascular repairs. CLINICAL IMPACT: This article provides an alternative and innovative approach to improve the minimally invasive techniques in the endovascular treatment of the aortic arch conditions.

Percutaneous mechanical thrombectomy for limb graft occlusion after endovascular aneurysm repair: Results of a case series.

OBJECTIVE: Limb graft occlusion (LGO) is a recognised complication after endovascular aneurysm repair (EVAR). We present outcomes of a case series of LGO treated by percutaneous mechanical thrombectomy (PMT). METHODS: Six male patients (mean age 70.5 ± 7.5 years) presented with LGO after EVAR (n = 4), fenestrated EVAR with an iliac branch device (n = 1), branched EVAR (n = 1). Median time to occlusion was 28.5(IQR 90) weeks; all occlusions were unilateral. The presenting symptom was intermittent claudication (n = 4), chronic limb-threatening ischaemia (n = 1) or acute limb ischaemia (n = 1). PMT was undertaken using the 10F Rotarex Rotational Excisional Atherectomy System (Becton, Dickinson and Company, Franklin Lakes, USA) with optional stenting/reline of the affected limb. RESULTS: LGO was cleared in all 6 cases by PMT with limb stenting (n = 4)/limb reline (n = 2)/outflow stenting (n = 2). Post-operatively, novel oral anticoagulant therapy supplemented prior antiplatelet therapy in all cases. Length of stay was 2 (IQR 19) days. All cleared limbs remain patent at median 15 (IQR 185) weeks follow-up. CONCLUSION: This case series indicates that percutaneous mechanical thrombectomy is associated with high technical success rates and subsequent acceptable ensuing short-to-midterm patency. This approach is a valid alternative to surgical interventions in such cases, and represents our primary approach when LGO is encountered after EVAR.

Use of the Off-The-Shelf Pre-Cannulated E-Nside Endograft to Overcome Anatomical Challenges in Urgent Complex Endovascular Aortic Repair.

Treatment options for large or symptomatic complex aortic aneurysms that require urgent intervention remain limited. Patient factors and comorbidities often make open surgery unappealing, leading to increasing interest in endovascular solutions that can be employed in the urgent setting, such as off-the-shelf endografts. The E-nsideTM (Jotec GmbH, Hechingen, Germany) is a new off-the-shelf endograft with 4 pre-cannulated inner branches that has recently become available in Europe. We report the urgent treatment of 2 large complex aortic aneurysms using this device and discuss the benefits of this new technology. The E-nside off-the-shelf endograft with inner branches is a useful addition to our treatment options for complex aortic aneurysms, particularly those with a narrow aortic lumen. Pre-cannulation of branches provides consistent access to the branches and a readily available option for establishment of a through and through wire for added stability during cannulation and bridging stent-grafts placement. The design of inner branches provides flexibility during deployment of the endograft and cannulation of the target vessels in varied, challenging anatomies.

Endovascular Treatment of Post Type A Chronic Aortic Arch Dissection With a Branched Endograft: Early Results From a Retrospective International Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the outcome of endovascular aortic arch repair for chronic dissection with a custom-made branched endograft. BACKGROUND: Acute type A aortic dissections are often treated with prosthetic replacement of the ascending aorta. During follow-up, repair of an aneurysmal evolution of the false lumen distal to the ascending prosthesis can be a challenge both for the surgeon and the patient. METHODS: We conducted a multicenter, retrospective study of consecutive patients from 14 vascular units treated with a custom-made, inner-branched device (Cook Medical, Bloomington, IN) for chronic aortic arch dissection. Rates of in-hospital mortality and stroke, technical success, early and late complications, reinterventions, and mortality during follow-up were evaluated. RESULTS: Seventy consecutive patients were treated between 2011 and 2018. All patients were considered unfit for conventional surgery. In-hospital combined mortality and stroke rate was 4% (n = 3), including 1 minor stroke, 1 major stroke causing death, and 1 death following multiorgan failure. Technical success rate was 94.3%. Twelve (17.1%) patients required early reinterventions: 8 for vascular access complication, 2 for endoleak correction, and 2 for pericardial effusion drainage. Median follow-up was 301 (138-642) days. During follow-up, 20 (29%) patients underwent secondary interventions: 9 endoleak corrections, 1 open repair for prosthetic kink, and 10 distal extensions of the graft to the thoracic or thoracoabdominal aorta. Eight patients (11%) died during follow-up because of nonaortic-related cause in 7 cases. CONCLUSIONS: Endovascular treatment of aortic arch chronic dissections with a branched endograft is associated with low mortality and stroke rates but has a high reintervention rate. Further follow-up is required to confirm the benefits of this novel approach.

Early outcomes of Jotec inner-branched endografts in complex endovascular aortic aneurysm repair.

OBJECTIVE: Complex aortic endografts have evolved to include inner branches to overcome specific challenges with existing technologies. We have reported the early outcomes of endovascular aortic aneurysm repair (EVAR) using a Jotec inner branched endograft (iBEVAR). METHODS: All patients who had undergone complex EVARs using extra-design engineering iBEVAR (Jotec GmbH, Hechingen, Germany) from 2018 to 2020 at a single center were reviewed. The patient demographics, cardiovascular risk factors, anatomic features of the aneurysms, and target vessels were recorded. The reasons for using inner branches instead of fenestrated and standard branched endografts and the procedural details, outcomes, and reintervention during follow-up were examined. RESULTS: A total of 110 patients were treated with branched and fenestrated endografts during the study period, of whom 18 patients had had a patient-specific custom-made iBEVAR endograft with downward inner branches. The technical success rate was 100%. A total of 68 target vessels were cannulated, and bridging stent-grafts were placed successfully in all. The reasons for choosing the iBEVAR design included unfavorable target vessel trajectory for fenestrated repair (n = 15), excessive infrarenal aortic angulation and/or adverse iliac access vessels for fenestrated repair (n = 11), the presence of a narrow aortic lumen (n = 14), and/or to reduce aortic coverage compared with that with standard outer branched repair (n = 14). We also used iBEVAR to treat type Ia endoleaks after failed EVAR with a short main body (n = 5). The median contrast volume used was 120 mL (range, 48-200 mL), with a median fluoroscopy screening time of 66 minutes (range, 35-136 minutes) and a median dose-area product of 17,832 dGy∙cm2 (range, 8260-55,070 dGycm2). No 30-day mortality and no major complications occurred. One early intervention was required for a suspected type Ib endoleak from an iliac limb and one late intervention for in-stent stenosis in a renal bridging stent-graft. One patient had died of non-aortic-related causes at 3 months. All other patients continued with follow-up with their aneurysms excluded, patent target vessels, and no type I or III endoleak identified at a median follow-up of 12 months (range, 1-26 months). CONCLUSIONS: The use of Jotec extra-design engineering endografts incorporating downward inner branches resulted in satisfactory early outcomes with a low reintervention rate. The technology has the potential to be a useful addition to our armamentarium for treating complex aortic endografts; however, long-term outcomes data are needed.

"Awake" Spinal Cord Monitoring Under Local Anesthesia and Conscious Sedation in Fenestrated and Branched Endovascular Aortic Repair.

INTRODUCTION: Endovascular repair of thoracoabdominal aortic aneurysms carries a risk of spinal cord ischemia, the causes of which remain uncertain. We hypothesized that local anesthesia (LA) with conscious sedation could abrogate the potential suppressive cardiovascular effects of general anesthesia (GA) and facilitate intraoperative monitoring of neurological function. Here, we examine the feasibility of this technique during fenestrated (FEVAR) or branched endovascular aortic repair (BEVAR). MATERIALS AND METHODS: Consecutive patients undergoing FEVAR or BEVAR under LA and conscious sedation by a team at a single center were analyzed. Patients received conscious sedation using intravenous remifentanil and propofol infusions in conjunction with a local anesthetic agent. No patient had a prophylactic spinal drain inserted. Outcome measures included conversion to GA, need for vasopressors and/or spinal drainage, length of stay, complications, and patient survival. RESULTS: A total of 44 patients underwent FEVAR or BEVAR under LA and conscious sedation. The cohort included thoracoabdominal aortic aneurysms (n=41) and pararenal aneurysms treated with endografts covering the supraceliac segment (n=3). Four patients (9%) required conversion to GA at a median operative duration of 198 minutes (range 97-495 minutes). Vasopressors were required intraoperatively in 3 of the cases that were converted to GA. No patient developed spinal cord ischemia and none had insertion of a spinal drain. The median hospital length of stay was 4 days (range 2-41 days). Postoperative delirium and hospital-acquired pneumonia was seen in 7% of patients. All patients survived to 30 days, with 95% alive at a median follow-up of 15 months (range 3-26 months). CONCLUSION: LA and conscious sedation is a feasible anesthetic technique for the endovascular repair of thoracoabdominal aortic aneurysms.

The Early Outcomes of BeGraft Peripheral Plus in Branched Endovascular Repair of Thoracoabdominal Aneurysms.

OBJECTIVE: No bridging stent-graft (BSG) has been specifically designed for branched endovascular aortic repair (BEVAR) and therefore different "off-label" stent-grafts have been used. Recently, a third generation of balloon-expandable stent-graft has become available. Here we evaluate the outcomes of the BeGraft Peripheral Plus (B+) used as a BSG for internal/externalor inner branches during BEVAR. MATERIALS AND METHODS: Consecutive patients undergoing BEVAR using B+ as a BSG since its release in 2017 were included into the study. The primary endpoints were technical success and target vessel patency during follow-up. Secondary endpoints included the need for adjunct extension and relining of the BSG, branch instability rate, including occlusion, reinterventions for restonosis, kink, fracture, or endoleak (types 1 and 3). RESULTS: A total of 163 visceral branches in 46 patients were included with a median follow-up 15 months (4-36 months). Primary technical success was achieved in all visceral branches (69 inner branches and 94 internal/external branches) with the exception of 1 BSG that required serial dilatation until full expansion was achieved with overall branch patency was 98% at 2 years. An additional stent-graft was necessary in 35 branches (21%) following deployment of a B+ BSG to cover a longer bridging distance and optimize the distal and proximal sealing. Relining of B+ BSG was not routinely carried out during the index procedure and a self-expanding uncovered nitinol stent was necessary in only 3% of branches to smooth the distal transition zone between the BSG and target vessel. There were 4 events (2.4%) of branch related instability, including 2 occlusions and 2 late reinterventions for a partial in-stent-graft thrombosis. CONCLUSION: Our study findings show satisfactory early outcomes of B+ as a BSG in BEVAR with low occlusion and reintervention rates. Extensions of BSG might be required to achieve adequate seal in the target vessels but routine relining BSG in branches was not required.

Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study.

OBJECTIVE: This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). MATERIALS AND METHODS: Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. RESULTS: A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4-6) and 52% with IC (Rutherford 1-3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42-90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1-91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). CONCLUSION: Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.

WILD Sheath Technique: "WIre Loop Directional" Sheath for Retrograde Femoral Access in Branched Endovascular Aortic Aneurysm Repair.

Branched endovascular aortic aneurysm repair (BEVAR) necessitates upper limb access (ULA) to facilitate the antegrade cannulation of downward directional branches and the placement of the bridging stent grafts. Various technical solutions to avoid ULA have been proposed and successfully applied in a limited number of cases. This can be necessary in specific clinical scenarios such as hostile aortic arch and descending thoracic aortic anatomy, or in the case of previous aortic arch and supra-aortic vessels surgery complicating the conventional approach with ULA in BEVAR. Taking inspiration from the prior description of a precursory technique, we report the application of our technique in BEVAR procedures, using standard introducer sheaths as a directional stable platform to facilitate an "All Femoral Access" (AFA) approach without the need for ULA, snaring or commercial steerable sheaths. Our concept is based on utilizing a wire loop to form a directional sheath (WILD sheath technique).

Techniques for Infrapopliteal Arterial Bifurcation Stenting.

BACKGROUND: Endovascular treatment of infrapopliteal peripheral arterial disease (PAD) is an established and effective treatment strategy for patients with symptomatic PAD. Increasingly, complex infrapopliteal lesions are treated with an endovascular first approach, especially in the setting of critical limb ischemia (CLI) for limb salvage, avoiding major amputations which impact on mobility and quality of life. However, many complex infrapopliteal lesions involving the bifurcation of the tibial arteries remain challenging to treat because of recoil or acute dissection after angioplasty and may require stenting using specialized techniques. METHODS AND RESULTS: We illustrated techniques for infrapopliteal arterial bifurcation stenting using case-based examples. The techniques covered include the single-stent, culottes, kissing, crush, and T-stenting techniques, and each is considered based on individual strengths and limitations. CONCLUSIONS: Infrapopliteal bifurcation stenting allows complex bifurcation lesions to be treated effectively when flow-limiting complications are encountered after angioplasty.

Mid-Term Outcomes of the Iliac Branch Endoprosthesis with Standardized Combinations of Bridging Stent-Grafts for Endovascular Treatment of Aortoiliac Disease with or Without Co-existing Hypogastric Aneurysms (The HYPROTECT Study).

PURPOSE: To evaluate retrospectively the 2-year outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in patients with and without coexisting hypogastric artery (HA) aneurysms in a large contemporary multicentric European experience using dedicated bridging devices. METHODS: The study included all consecutive patients treated at participating institutions with the Gore Excluder IBE device who received a covered stent (i.e., stent-graft) from the same manufacturer. Technical success was defined as deployment of endografts with complete exclusion of the aneurysm(s), patency of target vessels, and absence of type 1 and 3 endoleak. Assessment of follow-up outcomes included freedom from HA branch instability defined as the composite cumulative endpoint of any HA branch-related complication. RESULTS: A total of 437 patients were included for analysis from 22 European vascular surgery centers. Patients were categorized into two subgroups: subgroup A (n = 269) if they did not have concomitant hypogastric aneurysms, otherwise they were categorized into subgroup B (n = 168). Finally, 78 (18%) had bilateral IBE with a total of 515 IBE included in the study. Balloon expandable stents were deployed in 19 (6.3%) subgroup A patients compared with 46 (21.7%,) in subgroup B, p < .001. The two-year estimate for freedom of HA branch instability was significantly higher for patients in group A as compared with patients in group B (94% vs. 90%, p = .045). At univariate regression, the number of stent-grafts used was associated with higher risk of iliac branch instability (p = .021), while in multivariate regression for the use of more than 2 bridging stent-grafts the risk of instability increased by 2.35 times. CONCLUSIONS: This large contemporary European multicentric experience with the use of the Gore Excluder IBE in patients with or without associated HA aneurysms shows satisfactory mid-term outcomes when the device is used in conjunction with both self-expandable and balloon-expanding stent-grafts from the same manufacturer. Although primary patency of the iliac branch was as high as 90%, caution and strict follow-up must be exercised when multiple bridging stent-grafts are used over longer distances.

Safety of carotid endarterectomy following thrombolysis for acute ischemic stroke.

BACKGROUND: The timing of carotid endarterectomy (CEA) following thrombolysis for acute ischemic stroke remains controversial. We have described our unit's experience and performed a systematic review and pooled data synthesis of the safety of CEA in this group of patients. METHODS: Retrospective analysis of patients who had undergone CEA following thrombolysis between 2010 and 2012 was performed. A systematic review of the literature was also performed using PUBMED, EMBASE, and major conference proceedings. The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH) and ischemic stroke. The secondary outcome measures were 30-day postoperative all-cause morbidity and mortality. RESULTS: Seven patients underwent CEA following thrombolysis with mean age ± standard deviation of 70.57 ± 7.57. Five were men and five had CEA under local anesthesia. CEA was performed in median of 7 days (range, 2-12) after onset of stroke. Thirty-day morbidity was 14% (1/7) with one patient who experienced ICH postoperatively. There was no mortality. Nine studies were identified for systemic review. Seventy patients were included in the pooled data synthesis. One patient (1%) experienced postoperative ICH. When our series was included, the 30-day postoperative ICH was 3% (2/77). The overall 30-day postoperative morbidity was 4% (3/77), and there was no mortality. CONCLUSIONS: Despite slightly higher rates of postoperative hemorrhagic strokes than those in randomized trials, CEA appears safe following thrombolysis for acute ischemic stroke. However, more data on the timing of surgery is needed.

Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) carries a 3%-6.1% stroke risk, including risk of 'silent' cerebral infarction (SCI). Stent-grafts are manufactured in room air and retain air. Instructions for use recommend saline flushing to 'de-air' the system prior to insertion, but substantial amounts of air are released when deploying them, potentially leading to downstream neuronal injury and SCI. Carbon dioxide (CO2) is more dense and more soluble in blood than air, without risk of bubble formation, so could be used in addition to saline to de-air stents. This pilot trial aims to assess the feasibility of a full-scale randomised controlled trial (RCT) investigating the neuroprotective benefit against SCI with the use of CO2-flushed aortic stent-grafts. METHODS AND ANALYSIS: This is a multicentre pilot RCT, which is taking place in vascular centres in the UK, USA and New Zealand. Patients identified for TEVAR will be enrolled after informed written consent. 120 participants will be randomised (1:1) to TEVAR-CO2 or TEVAR-saline, stratified according to TEVAR landing zone. Participants will undergo preoperative neurocognitive tests and quality of life assessments, which will be repeated at 6 weeks, or first outpatient appointment, and 6 months. Inpatient neurological testing will be performed within 48 hours of return to level 1 care for clinical stroke or delirium. Diffusion-weighted MRI will be undertaken within 72 hours postoperatively (1-7 days) and at 6 months to look for evidence and persistence of SCI. Feasibility will be assessed via measures of recruitment and retention, informing the design of a full-scale trial. ETHICS AND DISSEMINATION: The study coordination centre has obtained approval from the London Fulham Research Ethics Committee (19/LO/0836) and Southern Health and Disability Ethics Committee (NZ) and UK's Health Regulator Authority (HRA). The study has received ethical approval for recruitment in the UK (Fulham REC, 19/LO/0836), New Zealand (21/STH/192) and the USA (IRB 019-264, Ref 378630). Consent for entering into the study will be taken using standardised consent forms by the local study team, led by a local PI. The results of the trial will be submitted for publication in an open access journal. TRIAL REGISTRATION NUMBER: NCT03886675.

Predictors of percutaneous access-related complications in aortic endovascular procedures: 'real-world' insights and a comparison to open access.

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) is becoming increasingly popular due to fewer access-related complications, shorter procedural times and length of stay (LOS). Our aim was to explore factors associated with access-related complications and their impact on procedural time and LOS. METHODS: We retrospectively analyzed consecutive aorto-iliac endovascular procedures in a tertiary hub comprising 2 institutions and 18 consultant vascular surgeons and interventional radiologists between 2016-2017. Access-related complications were defined as: bleeding requiring cutdown or return to theatre, acute limb ischemia or common femoral artery (CFA) pseudoaneurysm requiring intervention and wound infection or dehiscence needing hospitalization. RESULTS: Of 511 patients, 354 (69%) had a percutaneous approach via 589 CFA access sites. In this percutaneous group, access-related complications occurred in 11% of sites (65/589); Their rate varied with procedure type ranging between 3.6% to 17.6%. The most common complication was bleeding due to closure device failure in 8.5% (50/589) of access sites. When uncomplicated, percutaneous interventions were faster compared to open surgical access (P<0.0001). Operation time and median LOS (3 vs. 2 days) were longer for elective standard EVAR patients experiencing access-related complications (P=0.033). In the percutaneous group, multivariate regression analysis demonstrated significant associations between access-related complications and eGFR (odds ratio (OR) 0.984 [0.972-0.997], P=0.014), CFA depth (OR 1.026 [1.008-1.045], P=0.005), device used (Prostar vs. Proglide (OR 2.177 [1.236-3.832], P=0.007) and procedural type (complex vs. standard EVAR) (OR 2.017 [1.122-3.627], P=0.019). We developed a risk score which had reasonably good predictive power (C-statistic 0.716 [0.646-0.787], P<0.0001) for avoiding access complications. CONCLUSIONS: Physiological (low eGFR level), anatomical (increased CFA depth) and technical factors (choice of device and complex procedures) were identified as predictors of access-related complications in this large retrospective series. These are important for safe selection of patients that would benefit from percutaneous access.

Management of Extensive Aorto-Iliac Disease: A Systematic Review and Meta-Analysis of 9319 Patients.

PURPOSE: Despite advances in endovascular management of aorto-iliac occlusive disease (AIOD) including covered endovascular reconstruction of aortic bifurcation (CERAB) techniques, guidelines for management of symptomatic Trans-Atlantic Inter-Society Consensus (TASC II) type C/D lesions favour open surgical revascularisation. This meta-analysis investigates outcomes in patients with TASC II C/D lesions treated with open bypass procedures (OS), standard endovascular treatments (SEV) or CERAB. METHODS: Multiple databases (MEDLINE, EMBASE and the Cochrane database) were searched to identify studies reporting endovascular and open treatment of extensive AIOD. Studies were independently assessed. Outcomes reported included 30-day morbidity/mortality and patency rates. RESULTS: A total of 9319 patients undergoing intervention for extensive AIOD were identified from 66 studies. Median patient age was 64 years (n = 3204) for SEV, 58 years (n = 240) for CERAB and 59 years for OS (n = 5875). Pooled meta-analysis for 30-day morbidity in patients undergoing SEV, CERAB and OS was 9, 10 and 15%, respectively. Thirty-day mortality rate was 0.79, 0 and 3% in the SEV, CERAB and OS groups, respectively. In these groups, one-year primary and secondary patency was 90, 88, 96 and 96, 97, and 97% whilst three-year primary and secondary patency was 78, 82, 93 and 93, 97, 97% respectively. Five-year primary and secondary patency was 71 and 89% for SEV and 88 and 95% for OS, respectively. CERAB data were only available to 3 years. CONCLUSIONS: This meta-analysis shows that thirty-day morbidity and mortality favours endovascular techniques. Primary patency remains better with OS in both early and midterms;; however, secondary patency is comparable in all groups. These findings suggest that SEV/CERAB may be considered as an alternative to OS in higher-risk patients.

Cerebrospinal fluid drainage in the treatment of spontaneous spinal cord ischemia: a case report.

A patient with spontaneous acute spinal cord ischemia successfully treated with cerebrospinal fluid drainage is reported. There are no consensus guidelines on the management of spinal cord ischemia. Various preventive and rehabilitative measures have been suggested, but the best treatment remains unknown.

Leiomyosarcoma of the inferior vena cava: clinical experience with four cases.

BACKGROUND: Leiomyosarcoma of the inferior vena cava is a rare tumor that presents in an insidious manner with non-specific symptoms. Given its rarity, there are no consensus guidelines to its management. The aim of this study was to report the clinical experience in the management of patients presenting to our institution during a 12 year period. PATIENTS AND METHODS: Four patients with leiomyosarcomas of the inferior vena cava were managed at our institution during the period reviewed. Patient details were identified through a search of the pathology department computerized database, and case notes were retrospectively reviewed to obtain details of presentation and management. RESULTS: There were 3 females and 1 male with a mean age of 59 years. All tumors were identified within 2 months of first symptoms. Three of the 4 had localized tumors whilst 1 patient had lung metastases at presentation. The three patients with resectable tumors underwent radical surgical excision of the tumor, and two patients had postoperative radiotherapy. One patient died of recurrence at 7 months, and another at 30 months. The third patient is currently well and disease free at 16 months. The fourth patient with metastatic disease was treated with chemotherapy alone and survived 36 months. CONCLUSION: Leiomyosarcoma of the inferior vena cava is an uncommon tumor that presents with non-specific symptoms. At the time of presentation, tumors are usually large and resection is challenging but probably offers the best opportunity for long-term survival.