Rotational Mechanical Thrombectomy to Treat Iliac Limb Occlusion after Endovascular Aortic Aneurysm Repair: The Rotational Mechanical Thrombectomy Italian Study.

PURPOSE: To assess the safety and effectiveness of a rotational mechanical atherothrombectomy device in patients with symptomatic iliac limb occlusion after abdominal endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted on patients who underwent rotational mechanical thrombectomy using the Rotarex S device for symptomatic acute, subacute, or chronic graft limb thrombosis at 5 vascular centers between 2017 and 2021. This study comprised 23 male patients with a mean age of 74.5 years (SD ± 7.2) at the time of the procedure. The clinical presentation of the patients varied, with 1 patient experiencing acute limb ischemia and 11 patients (47.8%) experiencing disabling intermittent claudication. The remaining patients developed chronic limb-threatening ischemia after iliac limb occlusion. Early outcomes included technical success, postprocedural complications, and periprocedural mortality. Follow-up evaluations encompassed primary patency, patient survival, freedom from reintervention, and the need for surgical conversion. RESULTS: Technical success was achieved in all cases, with no occurrences of distal embolization during or after the procedure, and no periprocedural deaths were reported. Endograft relining was performed in 82.6% of patients to establish a new, nonthrombogenic surface within the graft. Over a median follow-up period of 8 months (interquartile range, 3-16 months), 2 patients experienced iliac limb reocclusion. No deaths or other reinterventions occurred during the observational follow-up period. CONCLUSIONS: Rotational mechanical thrombectomy for iliac limb occlusion after EVAR appears to be both safe and effective. This technique may uncover intraluminal defects contributing to graft occlusion and enable their resolution within the same procedure.

NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System.

OBJECTIVE: To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. SUMMARY BACKGROUND DATA: The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. METHODS: Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. RESULTS: Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.

A Multicenter Experience of Three Different "Iliac Branched" Stent Grafts for the Treatment of Aorto-Iliac And/Or Iliac Aneurysms.

BACKGROUND: The aim of study was to assess the safety and effectiveness of 3 different commercial iliac branch devices (IBDs): the Zenith Branch Iliac Endovascular Graft; the Gore Excluder Iliac Branch System and the E-liac Stent Graft System for the treatment of aorto-iliac or iliac aneurysms. METHODS: From January 2017 to February 2020, a retrospective reviewed was conducted on a total of 96 patients. Primary endpoint was IBD instability rate at 24 months. Secondary endpoints included onset of any endoleaks, buttock claudication, IBD-related reintervention and all-death rates, postoperative acute kidney, and changes in maximum diameter from baseline of the aortic aneurysmal sac. RESULTS: At 24 months, the branch instability rate was similar among the 3 IBDs employed [Jotec 1/24 (4.1%), Gore 1/12 (8.3%), Cook 6/47 (12.7%), P-value = 0.502]. As well, no statistical difference in terms of branch occlusion and branch-related endoleaks was observed. The Jotec group showed a significant decrease in maximum diameter from the baseline of the aortic aneurysmal sac when compared to the Gore group alone. No other differences were found relevant to the onset of any endoleaks, reinterventions, and all-death rates. At 24 months, the Kaplan-Meier estimate of survival freedom from any branch instability was 95.8%, 91.6%, and 86.8% for Jotec, Gore and Cook groups, respectively. CONCLUSIONS: The use of IBDs represents a safe method for preserving patency of the IIA during treatment of aorto-iliac or iliac aneurysms providing a low rate of IBD instability.

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry).

PURPOSE: This study reports the outcomes from a Multicenter Registry on unibody stent-graft system for the treatment of spontaneous infrarenal acute aortic syndrome (MURUSSIAS registry). MATERIALS AND METHODS: The retrospective MURUSSIAS registry included spontaneous infrarenal acute aortic dissection (IAAS) managed with the unibody stent-graft system (AFX endovascular AAA system; Endologix Inc., Irvine, California) outside the current instruction for use. IAAS considered aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Indications to IAAS treatment were symptoms, associated dilated abdominal aorta (>3 cm), rapidly-growing (>0.5 cm/6 months) aorta, IAAS disease progression. Measured results were technical success, early (within 30 days) and midterm outcomes (after 30 days), including mortality, complications, symptoms recurrence, type I/III endoleak occurrence, stent-graft patency, survival, and freedom from reintervention. The mean follow-up was 22.12 ± 17 months. RESULTS: The MURUSSIAS registry included 83 patients from 7 participating centers. IAAS indication to treatment were symptoms in 42 (51%). In 14 (17%) patients, the infrarenal aortic length was <80 mm, and in 28 (34%), the aortic bifurcation diameter was <16 mm. Technical success was 100%. Mortality occurred early in 1 (1%) and at the midterm in 3 (4%) patients. Complications occurred early in 10 (12%) patients (1 severe, 3 moderates, and 6 mild) and at midterm in 2 (2%) (2 moderate). No symptoms' recurrence or type I/III endoleaks were registered. The 36-month estimated survival and freedom from reinterventions were 89% and 92%, respectively. CONCLUSIONS: The MURUSSIAS registry is the largest collection of spontaneous IAAS managed endovascularly using the AFX endovascular AAA system. The IAAS peculiar anatomic features were fitted with the used technique with excellent results. This treatment strategy might be considered in IAAS unless specifically-designed endovascular solutions will be available also in the emergent setting. Further studies are required to assess the longer-term performances and the stability of the reported technique. CLINICAL IMPACT: The lack of specifically designed devices for infrarenal acute aortic syndrome (IAAS) disease remains an issue principally for its specific anatomic features. The MURUSSIAS registry retrospectively examined the outcomes of spontaneous IAAS treated using the unibody stent-graft system in a spontaneous national study; and reports the largest available data on this topic. The use of the unibody stent-graft system showed to fit the anatomic peculiarities of IAAS with excellent outcomes. This IAAS treatment strategy should be considered unless specifically designed endovascular solutions will be available.

Efficacy and one-year outcomes of Luminor® paclitaxel-coated drug-eluting balloon in the treatment of popliteal artery atherosclerosis lesions.

PURPOSE: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences. METHODS: From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months. RESULTS: Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively. CONCLUSIONS: In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

Endovascular Treatment of Spontaneous and Isolated Infrarenal Acute Aortic Syndrome with Unibody Aortic Stent-Grafts.

INTRODUCTION: Spontaneous acute aortic syndrome (IAAS) is rarely localized in the infrarenal aorta. The endovascular approach is preferred over conventional open surgery with fewer complications. However, dedicated endovascular devices for IAAS treatment are unavailable. The aim was to report a large single-center experience using unibody stent-grafts to address IAAS. METHODS: From April 2016 to March 2019, a retrospective analysis of patients presenting spontaneous and isolated IAAS was performed. Patients addressed with the unibody stent-graft (AFX endovascular AAA system; Endologix Inc., Irvine, CA) were included in the study. Indications to IAAS treatment were persistent symptoms and/or dilated abdominal aorta (>3 cm). The measured outcomes were technical success; early outcomes (<30 days) including mortality, morbidity, symptoms recurrence, and endoleak occurrence; and late outcomes (>30 days) including mortality, symptoms recurrence, endoleak occurrence, stent-graft patency, and survival. Median follow-up was 23.77 ± 10 months. RESULTS: Twenty-one patients with IAAS were included. Indications to treatment were symptoms in 14 (67%) patients and dilated abdominal aorta in 7 (33%). Technical success was achieved in all cases. No perioperative mortality and 1 (4.8%) early femoral access complication was encountered. During the follow-up were registered 1 (4.8%) aortic unrelated death and 1 (4.8%) stent-graft limb stenosis. The 36 months estimated survival and freedom from reintervention were 92% (CI: 37-43; SE: 1.7) and 94% (CI: 37-44; SE: 1.7), respectively. CONCLUSIONS: The endovascular treatment of IAAS with unibody stent-graft (AFX endovascular AAA system; Endologix Inc.) is safe and effective with promising mid-term outcomes. The use of unibody stent-grafts expands the endovascular indication, despite the usual anatomic IAAS features. Larger studies with longer follow-up are required to validate the outcomes of the reported technique.

Endovascular Treatment of Spontaneous Internal Carotid Artery Dissection with Proximal Embolic Protection Device.

BACKGROUND: The aim of this study was to report the feasibility and outcomes with the endovascular treatment of spontaneous internal carotid artery dissections (ICADs) using a proximal embolic protection device (EPD). METHODS: This is a retrospective analysis of patients treated for spontaneous symptomatic ICAD using a proximal EPD from January 2017 to December 2018. Indication for treatment was the presence of neurologic symptoms. Early outcomes measured included technical success, perioperative mortality, and major cardiovascular or cerebrovascular complications. Late outcomes were recurrent neurologic symptoms, patency, and reinterventions. RESULTS: A total of 4 male patients with ICAD were included. A preoperative cerebral computed tomography positive for cerebral ischemic events was reported in all cases. In 3 patients, the neurologic symptoms consisted of a transient ischemic attack; the remaining patient presented an amaurosis fugax and aphasia. In 2 patients, ICAD was associated with a carotid significant stenosis. In all patients, the reported approach was feasible with no complications and complete anatomic dissection resolution. At a mean follow-up of 18 months, all stents are patent and no restenosis recurrence or complications were registered. CONCLUSIONS: The use of proximal EPDs allowed the treatment of ICAD under flow arrest, minimizing the risk of stroke during the endovascular maneuvers. Larger series are required to validate this treatment strategy.

Managing Peripheral Artery Disease in Diabetic Patients: A Questionnaire Survey from Vascular Centers of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS).

BACKGROUND: The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded on October 1, 2018, to enhance cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic arteriopathy has been selected as the very first topic to be investigated by the federation. METHODS: MeFAVS members were asked to reply to a questionnaire on the management of diabetic ischemic foot. Results were collected and analyzed statistically. The questionnaire consisted of 15 multiple choice answers regarding diabetic foot (DF) diagnosis and treatment. The questionnaire was submitted to 21 centers on April 20, 2019. RESULTS: Response rate was 62%. The survey revealed that vascular surgeons, diabetologists, and wound care nurses made-up the core of the diabetic teams present in 76.9%, 69.3%, and 92.3% of the centers, respectively. Diabetic teams were most often led by vascular surgeons (53.8%) and diabetologists (42.2%), but only in 7.9% of cases by nurses. Duplex ultrasonography and computed tomographic angiography were the most commonly available tools used to assess diabetic peripheral arterial disease (PAD). Surgical wound care was undertaken by vascular surgeons in the majority of cases, and only in 46.2% of the cases to orthopedic or plastic surgeons, while nonsurgical wound care was handled by specialized nurses (76.6%) and diabetologists (53.8%). First-line revascularization was preferred over conservative treatment (61.5% vs 53.8%) and endovascular strategy (45.3%) over open (33.7%) or hybrid (21.0%) surgery. Vascular surgeons and interventional radiologists were found to be the most common performers of endovascular revascularization (92.3% and 53.8%, respectively). Amputations had an overall rate of 16.6% (range 4-30%) and a mean reintervention rate of 22.5%, and were usually performed by vascular surgeons for both minor and major interventions (84.6%) followed by orthopedic surgeons (15.4% minor and 30.8% major). The availability of a DF clinic (84.6%) and endovascular (53.8%) and open surgery (46.2%) capabilities were considered fundamental to reduce amputation rates. CONCLUSIONS: Especially since the introduction and spreading of new endovascular techniques for the treatment of DF, it is a common consensus amongst vascular surgeons that a standardized approach to the discipline is necessary in order to improve outcomes such as amputation-free survival and mortality and it is with this perspective and purpose that transnational cooperation amongst vascular professionals and residents in training are aiming for greater proficiency in endovascular and open surgery.

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair.

Background: To present a technique of sheath supported contralateral limb gate (CLG) cannulation of modular bifurcated stent-graft in endovascular abdominal aortic repair. Materials and methods: After totally percutaneous bilateral femoral access, the 9F introducer sheath is exchanged to a 30 cm 12 fr introducer sheath over a stiff wire contralateral to the intended main stent-graft insertion side and advanced into the aorta below the lowest renal artery. Parallel to the stiff wire within the sheath an additional standard J-tip guidewire with a 5 fr Pigtail angiographic catheter is advanced to the level of the renal arteries. After main body deployment, the 12 fr introducer sheath and J-tip wire with pigtail catheter are retracted until the CLG opening level, maintaining the stiff "buddy" wire in position to support the 12 fr sheath, maintaining its distal opening close to the contralateral gate opening to achieve easy cannulation. Results: Retrospective analysis of video archive from July 2016 to February 2018 evidenced 55 recorded EVAR cases. All CLG cannulations were obtained with Standard J-tip or Terumo Glidewire wires and with Pig-Tail or Berenstein catheters. Technical success was 100 %. Mean fluoroscopy time to accomplish CLG cannulation was 37.6 33 (range 1-105) seconds. The aortic carrefour angulation on coronal axis strongly correlates with cannulation time p = <.001, with longer cannulation time for higher carrefour angulations on coronal axis (Pearson correlation coefficient 0.47). Conclusions: The use of 12 fr sheath with parallel wire introduction technique, appears to be a safe and reliable tool to facilitate CLG cannulation during EVAR procedures.

Patient-Specific Rehearsal Feasibility Before Endovascular Repair of Ruptured Abdominal Aortic Aneurysm.

Purpose: To evaluate the feasibility of a patient-specific rehearsal (PsR) before emergency endovascular aneurysm repairs (eEVAR) and its influence on the operation. Materials and Methods: From February 2016 to October 2016, 10 consecutive patients (mean age 75±7.4 years; 9 men) presenting with a ruptured abdominal aortic aneurysm (rAAA) suitable for standard EVAR were enrolled in the study. A 3-dimensional (3D) model of the abdominal aorta was generated on a virtual reality simulator based on the patient's computed tomography (CT) images. Following the patient-specific simulation setup, PsR was conducted during patient admission or in parallel with the preoperative eEVAR workup. Measured outcomes were PsR feasibility only in the first 4 patients and impact on operative performance thereafter (changes in device selection, the planning process, clinical outcomes, perioperative mortality, and complication rates). Technical metrics and timing of system setup, rehearsal, interval from patient arrival to the actual procedure, and eEVAR were recorded. Results: Mean time for 3D model creation was 21.3±7.8 minutes (range 13-37); there was a significant positive relationship between aortic neck diameter and segmentation time (p=0.003). The overall mean time for simulator setup and PsR was 54±14 minutes (range 37-80); PsR alone was completed in a mean 31±40 minutes (95% confidence interval -60 to -2.2). The actual eEVAR procedure duration was 69±16 minutes (range 45-90). No delay in the actual eEVAR procedure was registered owing to the PsR pathway. In 6 patients, preprocedure rehearsal induced changes in operative strategy, including device selection, main body introduction side, and/or deployment configuration. In 4 cases, rehearsal was performed twice to achieve optimal performance. Conclusion: PsR before eEVAR was feasible in all cases and caused no time delays in the actual eEVAR procedure. PsR optimized eEVAR planning by identifying optimal strategy for stent-graft component selection and deployment.

Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair.

BACKGROUND: Intravascular ultrasound (IVUS) has been introduced as diagnostic adjunct to provide new insights into the diagnosis and therapy of vascular disease. Herein, we compared the outcomes of conventional endovascular aneurysm repair (EVAR) and EVAR with IVUS in patients presenting with infrarenal abdominal aortic aneurysm using a propensity-matched cohort. METHODS: From May 2013 to August 2017, 221 patients were retrospectively analyzed. Of that, 122 patients were eligible for inclusion and underwent propensity score matching. Perioperative mortality and morbidity, renal function impairment, endoleak incidence, mean contrast medium usage, operative time, radiation exposure (including fluoroscopy time, dose-area product [DAP], and digital subtraction angiography [DSA] runs), survival, and freedom from reintervention were the outcomes measured. RESULTS: After matching, 52 patients were included, 26 in the conventional EVAR group and 26 in the EVAR with IVUS group. No perioperative mortality or type I/III endoleak were registered. One perioperative lymphatic fistula and one iliac limb occlusion were observed. In the EVAR with IVUS group, a significant reduction of contrast medium (92 [vs. 51 ± 17] vs. 51 [20-68] mL; P = 0.003) and radiation exposure including fluoroscopy time (12 [9-16] vs. 20 [12-25] min; P = 0.001), DAP (15 [9-21] vs. 32 [16-44] G*cm2; P = 0.002), and DSA runs (2 [1-3] vs. 3 [2-4]; P = 0.04) was reported. No differences were observed in terms of glomerular filtration rate (86 [45-121] vs. 90 [38-117] mL/min; P = 0.14) and operation time (176 [124-210] vs. 179 [120-210]; P = 0.48). Survival at 36 months was 93% for standard EVAR and 92% for EVAR with IVUS (P = 0.845). Freedom from reintervention at 36 months was 85.5% in both the groups (P = 0.834). CONCLUSIONS: In this preliminary experience, the use of IVUS during EVAR was feasible with no registered postoperative complications. A significant reduction of contrast medium usage and radiation exposure was observed with the use of IVUS. The IVUS is an adjunctive tool to consider in the vascular surgeon armamentarium, especially in centers where advanced radiological tools of imaging fusion are not available.

Incidence and prognostic factors related to major adverse cerebrovascular events in patients with complex aortic diseases treated by the chimney technique.

OBJECTIVE: Endovascular aneurysm repair (EVAR) with the chimney technique (ch-EVAR) has been used for the treatment of aortic aneurysms as an alternative approach to fenestrated endografting or open repair. Nonetheless, the need for an upper extremity arterial access may contribute to a higher risk for periprocedural cerebrovascular events. This study reports on the perioperative cerebral and major adverse cardiac and cerebrovascular events (MACCE) after ch-EVAR. METHODS: The PERICLES registry (PERformance of the chImney technique for the treatment of Complex aortic pathoLogiES) is an international, retrospective multicenter study evaluating the performance of ch-EVAR for the treatment of complex aortic pathologies. For the purpose of the current analysis, 425 patients treated by ch-EVAR between 2008 and 2014 were included. The primary outcome of this analysis was the incidence of procedure related cerebrovascular events defined as transient ischemic attack or stroke. The secondary end point was in-hospital MACCE, including acute coronary syndrome, stroke, and death of any cause. RESULTS: The incidence of clinical relevant cerebrovascular events was 1.9% (8/425). A postoperative transient ischemic attack was observed in four patients (0.95%) and a stroke in additional four (0.95%). Three patients died during the hospital stay secondary to sequelae from postoperative stroke. A prior history of stroke/transient ischemic attack, atrial fibrillation, previous carotid revascularization, or known carotid artery disease did not significantly increase the risk for adverse neurologic events. The overall MACCE rate amounted to 8.5% (36/425). Logistic regression analysis revealed that the use of bilateral upper extremity access (odds ratio [OR], 2.79; 95% confidence interval [CI], 1.04-7.45]), aneurysm rupture (OR, 5.33; 95% CI, 1.74-16.33), and a prolonged operation time (>290 minutes; OR, 1.005; 95% CI, 1.001-1.008) were associated with a significantly increased risk for MACCE. CONCLUSIONS: This analysis demonstrates that ch-EVAR is associated with a relatively low rate of cerebrovascular events. However, a postoperative stroke is associated with increased mortality. Ruptured aneurysms, bilateral upper extremity access as in case of multiple chimney graft placement, and longer operative times were identified as independent risk factors for MACCE.

Early outcomes with a single-sided access endovascular stent.

OBJECTIVE: The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. METHODS: Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. RESULTS: In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. CONCLUSIONS: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.

Collected Transatlantic Experience From the PERICLES Registry: Use of Chimney Grafts to Treat Post-EVAR Type Ia Endoleaks Shows Good Midterm Results.

PURPOSE: The aim of this retrospective analysis was to evaluate the performance of the chimney (ch) technique in the treatment of type Ia endoleaks after standard endovascular aneurysm repair (EVAR). METHODS: Between January 2008 and December 2014, 517 chEVAR procedures were performed in 13 US and European vascular centers (PERICLES registry). Thirty-nine patients (mean age 76.9±7.1 years; 33 men) were treated for persistent type Ia endoleak and had computed tomography angiography or magnetic resonance angiography follow-up at >1 month. Endurant abdominal stent-grafts were used in the 20 cases. Single chimney graft placement was performed in 18 (46%) patients and multiple in 21 (54%). Overall, 70 visceral vessels were targeted for revascularization. RESULTS: Technical success was achieved in 35 (89.7%) cases; 3 persistent type Ia endoleaks and 1 chimney graft occlusion were detected within the first 30 days. Thirty-day mortality was 2.6%. Two other deaths (not aneurysm related) occurred during a mean follow-up of 21.9 months (0.23-71.3). Primary patency of the chimney grafts was 94.3% at 36 months. In a subgroup analysis comparing Endurant to other stent-grafts, no significant differences were observed regarding persistent endoleak [1/20 (5%) vs 2/19 (11%), p=0.6] or reintervention [1/20 (5%) vs 0/19 (0%)]. CONCLUSION: The present series demonstrates that chEVAR in the treatment of post-EVAR type Ia endoleaks has satisfactory results independent of the abdominal and chimney graft combinations. Midterm results show that chEVAR is an effective method for treating type Ia endoleaks.

Symptomatic Deep Femoral Artery Pseudoaneurysm Endovascular Exclusion. Case Report and Literature Review.

Deep femoral artery pseudoaneurysms (DFAPs) are rare and generally occur after penetrating trauma or surgical procedures. A 36-year-old obese man presented with pain in correspondence of the anterior-lateral thigh after 6 months from gunshot wound. Duplex and computed tomography (CT) showed a bilobed right DFAP (maximal diameter 12.9 cm). The patient was managed urgently, under local anesthesia, by placement in the distal DFA of a Viabahn 8 × 100-mm stent graft (W L Gore & Associates, Inc). The postoperative course was uneventful, and the 24-month CT showed regular stent-graft patency and 20-mm DFAP shrinkage. The literature review reported 8 cases of DFAPs; of these 6 were managed by endovascular mean (3 stent-graft implantations and 3 coil embolization). The remaining 2 cases were managed surgically (one of these after failed coil embolization). In conclusion, the use of covered stent graft was effective to treat a DFAP localized in the medium DFA. This tool allowed maintaining the native DFA patency and the preservation of its main branches.

Predilation technique with balloon angioplasty to facilitate percutaneous groin access of large size sheath through scar tissue.

Purpose Percutaneous remote access for endovascular aortic repair is an advantageous alternative to open access. Previous surgery in the femoral region and the presence of synthetic vascular grafts in the femoral/iliac arteries represent major limitations to percutaneous remote access. The aim of this study was to evaluate an original technique used for enabling percutaneous remote access for thoracic or abdominal endovascular aortic repair in patients with scar tissue and/or a vascular graft in the groin. Methods Twenty-five consecutive patients with a thoracic (11/25; 44%) or an aortic aneurysm (14/25; 66%) and with a synthetic vascular graft in the groin (16/25; 64%) or a redo groin access (9/25; 36%) were managed through the percutaneous remote access. In all patients, a percutaneous transluminal angioplasty balloon was used to predilate the scar tissue and the femoral artery or the synthetic vascular graft after preclosing (ProGlide®; Abbott Vascular, Santa Clara, CA, USA). In 10 patients, requiring a 20 Fr sheath, a 6 mm percutaneous transluminal angioplasty balloon was used; and in the remaining 15, requiring a 24 Fr sheath, an 8 mm percutaneous transluminal angioplasty balloon. Preclosing was exclusively performed using ProGlide®. Mean follow-up was 15 months. Results In all cases, stent-graft deployment was successful. There was one surgical conversion (4%; 1/25) due to bleeding from a femoral anastomosis. Two cases required additional percutaneous maneuvers (postclosing with another system in one patient and endoluminal shielding with stent-graft in the other patient). No pseudoaneurysm or access complication occurred during the follow-up. Conclusions Percutaneous access in redo groins with scar tissue and/or synthetic vascular graft using ultrasound-guided punction, preclosing with ProGlide® system and predilation with percutaneous transluminal angioplasty balloon to introduce large size sheath as used for endovascular aortic repair showed to be feasible, safe and with few local complications.

The Gore Hybrid Vascular Graft in renovisceral debranching for complex aortic aneurysm repair.

OBJECTIVE: This study reports our initial experience with the Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) for staged hybrid open renovisceral debranching and endovascular aneurysm repair in patients affected by thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms (PAAAs). METHODS: Between December 2012 and December 2013, we analyzed outcomes of 13 patients who underwent open surgical debranching of renovisceral vessels for thoracoabdominal aortic aneurysm and PAAAs. All patients were considered at high risk for conventional surgery. Inclusion criterion was treatment by open surgical debranching of at least one visceral artery (renal artery, superior mesenteric artery [SMA], or celiac trunk [CT]) using the GHVG. In a second step, the aortic stent graft was implanted to exclude the aneurysm. If required, parallel grafts to the remaining visceral arteries were deployed in the same procedure. One patient had a symptomatic descending thoracic aortic aneurysm and another had a ruptured PAAA. Perioperative measured outcomes were immediate technical success rate, mortality, and morbidity. Median follow-up was 24.8 months (range, 0-15; mean, 8.2; standard deviation, 4 months). RESULTS: All open surgical debranching of renovisceral vessels were completed as intended. GHVG was used to revascularize 20 visceral vessels in 13 patients with a mean of 1.54 vessels per patient. Six renal arteries (30%; 2 right and 4 left), 9 SMAs (45%), and 5 CTs (25%) were debranched. In nine of 13 (66%) patients, other renovisceral arteries were addressed with chimney/periscope, Viabahn Open Revascularization Technique, and end-to-side anastomosis. Two of 13 patients (15%) died of bowel ischemia. Neither patient had GHVG revascularization to the SMA or CT. Perioperative complications occurred in three patients (23%; 1 renal hematoma, 1 respiratory insufficiency, and 1 small-bowel ischemia related to a SMA GHVG thrombosis). At 24 months, estimated survival was 85%, and estimated primary and secondary patency were 94% and 100%, respectively. CONCLUSIONS: This limited series extracted from a more consistent hybrid procedure experience showed a mortality rate similar to most recent reports. Technical feasibility and the short-term patency rate of the GHVG for renovisceral debranching during staged hybrid open and endovascular procedures were satisfactory. Use of GHVGs may represent a useful revascularization adjunct to minimize visceral ischemia in these challenging patients.

Long-term results of simplified frozen elephant trunk technique in complicated acute type A aortic dissection: A case-control study.

AIM: To describe the long-term experience of a simplified frozen elephant trunk technique (sFETT) used in complicated acute type A aortic dissection (AAAD) treatment. METHODS AND RESULTS: Between January 2001 and December 2012, 34 patients (mean age 59.9 ± 11.0 years) with complicated AAAD (DeBakey I) underwent an emergency surgery including sFETT. sFETT consisted in gluing the dissected aortic arch wall layers with gelatine-resorcinol adhesive and video-assisted antegrade open arch aortic stent-graft deployment in the arch or proximal descending aorta. In addition to sFETT, the aortic root was addressed with standard techniques. A 30-day mortality was 14.7% (five patients) due to bleeding (1), multiple organ failure (2), and colon ischemia (2). Postoperative morbidity included neurological (2), renal (1) and cardio-pulmonary complications (4), as well as wound infection (1). Mean follow-up was 74.4 ± 45.0 months. Actual survival rates were 73.5% at 1 year, 70.2% at 5 years, and 58.5% at 13 years of follow-up. Six patients died during long-term follow-up from heart failure (1) and unknown reasons (5). Five patients required reoperation for aortic arch (3) or aorto-iliac (2) progression of aneurysm during the mid- and long-term follow-up. The remaining patients showed favorable evolution of the dissected aorta with false lumen occlusion in most cases and stable aortic diameters. CONCLUSIONS: In AAAD patients, sFETT as used in our series is an easy and safe technique to repair the aortic arch. Long-term results after sFETT showed false lumen occlusion and stable aortic diameter in up to 13 years of follow-up.

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

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