Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

First pilot case-control interventional study using autologous extracellular vesicles to treat chronic venous ulcers unresponsive to conventional treatments.

Current therapeutic approaches for chronic venous ulcers (CVUs) still require evidence of effectiveness. Diverse sources of extracellular vesicles (EVs) have been proposed for tissue regeneration, however the lack of potency tests, to predict in-vivo effectiveness, and a reliable scalability have delayed their clinical application. This study aimed to investigate whether autologous serum-derived EVs (s-EVs), recovered from patients with CVUs, may be a proper therapeutic approach to improve the healing process. A pilot case-control interventional study (CS2/1095/0090491) has been designed and s-EVs recovered from patients. Patient eligibility included two or more distinct chronic lesions in the same limb with 11 months as median persistence of active ulcer before enrollment. Patients were treated three times a week, for 2 weeks. Qualitative CVU analysis demonstrated that s-EVs-treated lesions displayed a higher percentage of granulation tissue compared to the control group (Sham) (s-EVs 3 out of 5: 75-100 % vs Sham: none), further confirmed at day 30. s-EVs-treated lesions also displayed higher sloughy tissue reduction at the end of treatment even increased at day 30. Additionally, s-EV treatment led to a median surface reduction of 151 mm2 compared to 84 mm2 in the Sham group, difference even more evident at day 30 (s-EVs 385 mm2vs Sham 106 mm2p = 0.004). Consistent with the enrichment of transforming growth factor-ß1 in s-EVs, histological analyses showed a regenerative tissue with an increase in microvascular proliferation areas. This study first demonstrates the clinical effectiveness of autologous s-EVs in promoting the healing process of CVUs unresponsive to conventional treatments.

Stent-Assisted Coil Embolization of a Saccular Visceral Aortic Aneurysm: Case Report and Review of the Literature.

PURPOSE: We present the results of unconventional endovascular treatment of a voluminous (65 mm) saccular visceral aortic aneurysm in a 78-year-old woman. Patient was deemed unfit for open surgery due to comorbidities. Fenestrated or branched endografting was also excluded due to the small diameter of the aorta, the severe stenosis at the origin of celiac trunk, and the anomalous origin of superior mesenteric artery arising infrarenally. CASE REPORT: After a preliminary selective angiography of the superior mesenteric artery showing valid anastomotic network with celiac trunk branches, an aortic self-expandable bare stent (Jotec E-XL) was deployed in the visceral aorta. Aneurysm sac embolization (Penumbra detachable Ruby Coils) in a coil-jailing technique was performed. Finally, an aortic cuff endograft (Gore) was deployed immediately above the origin of the left renal artery to cover the wide neck of the saccular aneurysm and improve sac exclusion. Hospital stay was uneventful, computed tomography (CT) at 12-month demonstrated aneurysm shrinkage to 62 mm without images of endoleak. Literature review showed how this technique has successfully been applied to manage similar cases of postsurgical and posttraumatic saccular aortic aneurysms in high-risk patients; however, long-term results are still unknown. CONCLUSION: Coil-jail technique for the treatment of saccular aortic aneurysms can be considered an alternative when open surgery or conventional endovascular treatment is not feasible. Technical success and mid-term outcomes are promising but strict follow-up is recommended. CLINICAL IMPACT: This study aims to share the unconventional endovascular treatment of a visceral aortic aneurysm in a patient unfit both for open and traditional endovascular surgery. To the best of our knowledge this is one of the first cases published in Literature, for this reason, a step-by-step video has been created to describe the procedure. Literature review was then performed to analyze midterm results of this technique. Despite being a treatment that is not recommended for conventional cases, the knowledge of endovascular devices and techniques may help to manage or simplify complex aortic diseases.

Surgical and endovascular treatment of late postcoarctation repair aortic aneurysms: Results from an international multicenter study.

OBJECTIVE: The formation of postaortic coarctation aneurysms (pCoAA) is well-described in the literature and carries a significant risk of rupture and death. Treatment strategies include open surgical, hybrid, and endovascular repair, depending on the clinical presentation, risk assessment, and anatomy. The aim of this study was to report the early and midterm results of open surgical and endovascular repair of pCoAA. METHODS: This is an international multicenter retrospective study including patients who underwent open surgical or endovascular repair for pCoAA between 2000 and 2021 at 14 highly specialized academic cardiovascular centers. The preoperative, intraoperative, and postoperative data were recorded and analyzed. RESULTS: A total of 74 patients (46 male; median age, 44 years; interquartile range [IQR], 35-53 years) underwent pCoAA repair. All patients had previously undergone surgical repair of aortic coarctation at a median age of 11 years for the index procedure (IQR, 7-17 years). The most common first surgical correction was synthetic patch aortoplasty in 48 patients, followed by graft interposition in 11. The median pCoAA diameter was 54 mm (IQR, 44-63 mm). The median time from the aortic coarctation repair to the pCoAA diagnosis was 33 years (IQR, 25-40 years). A total of 33 patients had symptoms at presentation, including thoracic or back pain in 8 patients. Open surgical repair was performed in 28 patients, including four frozen elephant trunk procedures and one Bentall. The remaining 46 patients underwent endovascular repair of the pCoAA. Two in-hospital deaths were observed (one frozen elephant trunk and one endovascular). After a median follow-up of 50 months (IQR, 14-127 months), there were a total of seven reinterventions. CONCLUSIONS: This international multicenter study demonstrates that patients with pCoAA can be safely treated with either open surgical or endovascular interventions. Because the median time between the coarctation repair and the aneurysm formation was more than 30 years, life-long surveillance of these patients is warranted.

Long-Term Outcomes of Open and Endovascular Abdominal Aortic Repair in Younger Patients.

BACKGROUND: Aim of this study is to evaluate long-term results in abdominal aortic aneurysm (AAA) surgery by either open aortic repair (OAR) or endovascular aortic repair (EVAR) in patients under 70 years of age. METHODS: A retrospective analysis of a prospectively collected database of patients with age under 70 years old undergoing elective infrarenal AAA surgery between 2010 and 2018 was performed. The study population was divided into 2 groups: OAR and EVAR. Primary end points were overall survival and aneurysm-related death, while secondary outcomes were need for reintervention and development of minor and major complications. RESULTS: One hundred ninety-one patients younger than 70 years old treated with elective AAA surgery were enrolled: 157 OAR (98% males, mean age 65 ± 4 years) and 34 EVAR (94% males, mean age 66 ± 4 years). Hospital stay, 30-day mortality, and need for reintervention were similar; OAR population presented higher incidence of postoperative major complications (18% vs. 2.9%; P = 0.01) while minor complications were 32% in the OAR versus 21% in the EVAR group (P = 0.08). Median follow-up was 69 months for OAR (interquartile range [IQR] 53 months) vs. 79 months (IQR 51 months) for EVAR (P = 0.9): long-term AAA-related reinterventions were more frequent after EVAR (1.9% OAR vs. 17% EVAR; P = 0.01) while AAA-related long-term mortality was similar in both subgroups (1.3% OAR and 3% EVAR; P = 0.8). At univariate analysis higher risk of reintervention was reported for conical necks in the EVAR group (P = 0.03) and for the concomitant presence of iliac aneurysms in both groups (P = 0.01). CONCLUSIONS: According to our data, EVAR in young patients is presenting an excessive rate of reintervention compared to OAR. The presence of conical neck is an independent predictor of EVAR failure and late reintervention, while it does not play a significant role in the OAR group. Open surgery should be considered the first option in younger patients with a long-life expectancy.

A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms.

OBJECTIVE: Patients in the Valiant Evo U.S. and international clinical trials had positive short-term outcomes; however, late structural failures, including type IIIb endoleaks have been recently discovered. Type IIIb endoleaks are serious adverse events because the repressurization of the aneurysm sac increases the risk of rupture. The purpose of the present study was to detail the imaging patterns associated with the structural failures with the aim of increasing awareness of failing graft presentation, early recognition, and prompt treatment. METHODS: The Valiant Evo clinical trial was a prospective, single-arm investigation of a thoracic stent graft system. With the recent late structural failures, sites were requested to submit all available imaging studies to date to allow the core laboratory to assess for structural failures such as type IIIb endoleaks, stent ring fractures, and stent ring enlargement. Of the 100 patients originally enrolled in the trial from 2016 to 2018, the core laboratory assessed the imaging studies performed at ≥1 year for 83 patients. RESULTS: No structural failures of the graft were reported through 1 year of follow-up. At 1 to 4 years, graft structural failures were detected in 11 patients with descending thoracic aortic aneurysms. Of the 11 patients, 5 had a type IIIb endoleak. Four of the five had imaging findings showing stent fractures consistent with the location of the graft seam and one had a type IIIb endoleak attributed to calcium erosion with no stent fracture or ring enlargement. Of the four patients with stent fracture in line with the graft seam, three underwent a relining procedure that successfully excluded the type IIIb endoleak. One of these three patients died 4 days later of suspected thoracic aortic rupture because the distal thoracic endovascular aortic repair extension had been landed in a previously dissected and fragile section of the aorta. The remaining six patients had had stent ring enlargement. One of the six patients had had persistent aneurysm expansion from the time of implantation onward and had died of unknown causes. The remaining five patients have continued to be monitored. CONCLUSIONS: In the present preliminary analysis, the imaging patterns associated with type IIIb endoleaks, stent fractures, and stent ring enlargement appear to be related to the loss of seam integrity or detachment of the stent rings from the surface of the graft material. The imaging patterns we have detailed should be closely monitored using computed tomography angiography surveillance to allow structural failures to be promptly identified and treated.

Clinical trial outcomes and thoracic aortic morphometry after one year with the Valiant Navion stent graft system.

AUTHORS' NOTE: On February 17, 2021, Medtronic Incorporated issued a global voluntary recall of the Valiant Navion Thoracic Stent Graft System (the device under study in the Valiant Evo Global Clinical Program that is the subject of this publication), and instructed physicians to immediately cease use of the Valiant Navion system and return any unused product. Medtronic initiated the recall in response to three clinical trial subjects recently observed with stent fractures, two of whom have confirmed type IIIb endoleaks. The data collection, analysis, and manuscript submission occurred before the notice of this recall, and, specifically, the 100 procedures reviewed for this series were free of events at 1 year related to the reason for this device recall. The authors of this article and the manufacturer were unaware of the recently detected adverse events at the time of the preparation of the manuscript, and the 1-year trial results, and imaging-based analyses described are unchanged. Management of thoracic aortic aneurysms continues to be a challenging problem and outcomes are dependent on patient anatomy. The present publication focuses on the importance of achieving proximal and distal seals and the consideration of the temporal changes of the aortic morphology as a part of the TEVAR planning process. The authors believe there is still scientific merit in disclosing this information, despite the current nonavailability of the Valiant Navion system. OBJECTIVE: The Valiant Navion stent graft system (Medtronic Inc, Santa Rosa, Calif) is a third-generation device with improved conformability. We have reported the 1-year clinical trial outcomes, with a focus on an imaging-based analysis of the aortic morphology. We assessed the effects of graft implantation on the native anatomy and the effects of the 1-year changes in thoracic aorta morphology on the original seal zones of the stent graft. METHODS: A total of 100 subjects were enrolled in a prospective single-arm clinical trial investigating the Valiant Navion stent graft system. An independent core laboratory (Syntactx, New York, NY) assessed the anatomic characteristics and performance outcomes. RESULTS: Through 1 year of follow-up, the freedom from all-cause mortality, aneurysm-related mortality, and secondary procedures was 89.8%, 97.0%, and 94.8% respectively. Of the 100 patients, 5 had undergone a total of six secondary procedures, and 9 patients had developed an endoleak (type Ia and Ib in 1, type Ia in 1, type Ib in 3, and type II in 4 patients) within the first year. After 1 year, 2 of 76 patients (2.6%) had had an increase in their maximum aneurysm diameter of ≥5 mm, 62 (81.6%) had had stable sacs, and 12 (15.8%) had experienced sac shrinkage. Although no deployment failures had occurred, 36 of the 100 proximal (36%) and 31 of the 100 distal (31%) attachment zones were considered short according to our definitions. The stent graft had conformed to the native anatomy at implantation, because the preprocedural thoracic aorta tortuosity (1.45 ± 0.02) had not significantly changed at 1 month after implantation (1.46 ± 0.02). Despite a natural increase in thoracic tortuosity after 1 year (1.49 ± 0.02), wall apposition had been maintained over time, as evidenced by the low endoleak rates. Aortic elongation and dilation had occurred at the proximal end of the graft by an average of 1.2 mm and 1.6 mm, respectively. Aortic remodeling was more pronounced at the distal end, with an average increase of 4.2 mm in length and 2.8 mm in diameter. CONCLUSIONS: The included patients had had positive 1-year outcomes with high freedom from mortality, endoleak development, and secondary procedures. Aortic elongation and dilation were more prevalent at the distal end, emphasizing the importance of distal attachment zone consideration as part of preoperative planning. Because aortic remodeling can be expected to continue over time, additional follow-up and imaging analysis in the trial will be necessary to assess the aortic morphology and its effects on stent graft performance.

Proportional meta-analysis of open surgery or fenestrated endograft repair for postdissection thoracoabdominal aneurysms.

OBJECTIVE: To determine outcomes of postdissection thoracoabdominal aneurysms by either open or endovascular repair with fenestrated or branched endografts. METHODS: A systematic review was conducted for open or endovascular repair of postdissection thoracoabdominal aneurysms, between January 2009 and February 2020. A meta-analysis was performed for postoperative complications and both early and late mortality and reinterventions. RESULTS: Fifteen noncomparative studies (eight endovascular repair and seven open repair) were suitable for meta-analysis. Overall, 1337 patients were included, 1068 in the open repair group (73% male; mean age 58 years) and 269 in the endovascular repair group (79% male; mean age 65 years). The 30-day mortality was 6% for open repair vs 3% for endovascular repair (P = .35), whereas the 30-day reintervention rate was 3% for open repair vs 1% for endovascular repair (P = .66). The only significant difference was reported for 30-day respiratory complication rate (30% open repair vs 2% endovascular repair; P < .01). The incidence of spinal cord ischemia was 9% for open repair vs 8% for endovascular repair (P = .95). The mean follow-up was 44 months: 48 months (range, 10-72 months) after open repair and 17 months (range, 12-25 months) after endovascular repair (P < .01). Late aortic reinterventions were more frequent after endovascular repair (11% vs 32%; P < .001). The late overall mortality rate was 19% for open repair vs 7% for endovascular repair (P = .08), whereas aortic-related mortality was 7% for open repair vs 3% for endovascular repair (P = .22). CONCLUSIONS: In the absence of comparative studies, this meta-analysis showed that endovascular repair seems to be a viable alternative for patients unfit for open repair.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry.

OBJECTIVE: To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. METHODS: For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. RESULTS: Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). CONCLUSIONS: Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.

Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry.

OBJECTIVE: The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry). METHODS: All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg). RESULTS: Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased >5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P < .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure. CONCLUSIONS: In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining.

Iliac Branch Devices With Standard vs Fenestrated/Branched Stent-Grafts: Does Aneurysm Complexity Produce Worse Outcomes? Insights From the pELVIS Registry.

Purpose: To compare the outcomes of iliac branch devices (IBD) used in combination with standard endovascular aneurysm repair (EVAR) vs with fenestrated/branched EVAR (f/bEVAR) to treat complex aortoiliac aneurysms. Materials and Methods: The pELVIS Registry database containing the outcomes of IBD use at 8 European centers was interrogated to identify all IBD procedures that were combined with either standard EVAR or f/bEVAR. Among 669 patients extracted from the database, 629 (mean age 72.1±8.8 years; 597 men) had received an IBD combined with standard EVAR vs 40 (mean age 71.1±8.0 years; 40 men) who underwent f/bEVAR with an IBD. The mean aortic aneurysm diameters were 46.4±13.3 mm in the f/bEVAR patients vs 45.0±15.5 mm in the standard EVAR cases. The groups were similar in terms of baseline clinical characteristics and aneurysm morphology. The Kaplan-Meier method was used to compare patient survival, IBD occlusion, type III endoleak, and aneurysm-related reinterventions in follow-up. The estimates are presented with the 95% confidence interval (CI). Results: Technical success was 100% in the f/bEVAR+IBD group and 99% in the EVAR+IBD group (p=0.85). The 30-day mortality was 0% vs 0.5%, respectively (p=0.66), while the 30-day reintervention rates were 7.5% vs 4.1% (p=0.31). The mean follow-up was 32.1±21.3 months for f/bEVAR+IBD patients (n=30) and 35.5±26.8 months for EVAR+IBD patients (n=571; p=0.41). The 12-month survival estimates were 93.4% (95% CI 93.2% to 93.6%) in the EVAR+IBD group vs 93.6% (95% CI 93.3% to 93.9%) for the f/bEVAR+IBD group (p=0.93). There were no occlusions or type III endoleaks in the f/bEVAR+IBD group at 12 months, while the estimates for freedom from occlusion and from type III endoleak in the EVAR+IBD group were 97% (95% CI 96.8% to 97.2%) and 98.5% (95% CI 98.4% to 98.6%), respectively. The 12-month estimates for freedom for aneurysm-related reintervention were 93% (95% CI 92.7% to 93.3%) in the EVAR+IBD group vs 86.4% (95% CI 85.9% to 86.9%) in the f/bEVAR+IBD patients (p=0.046). Conclusion: Treatment of complex aortoiliac disease with f/bEVAR+IBD can achieve equally good early and 1-year outcomes compared to treatment with IBDs and standard bifurcated stent-grafts, except for a somewhat higher reintervention rate in f/bEVAR patients.

Long Term Outcomes of Endovascular Aortic Repair in Patients With Abdominal Aortic Aneurysm and Ectatic Common Iliac Arteries.

OBJECTIVE: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs). METHODS: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention. RESULTS: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2). CONCLUSION: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures.

Oxygen Delivery Therapy with EPIFLO Reduces Wound Hyperperfusion in Patients with Chronic Leg Ulcers: A Laser Speckle Contrast Analysis.

BACKGROUND: Today transdermal continuous oxygen therapy (TCOT) is used in wound care to promote healing by improving local hypoxia and preventing infection, and it has been described to reduce local inflammation over 1 month of administration. The present study aims to investigate the effects of this treatment on wound microcirculation through laser speckle contrast analysis (LASCA). METHODS: 20 adult patients (mean age: 76 ± 11.5 years) were prospectively enrolled. Inclusion criteria were presence of venous or mixed lower limb ulcers from three or more months without dimension reduction and without indication to surgery and weekly treatment by our outpatient clinic with silver dressings. Subjects underwent 1 month of TCOT (EPIFLO®) in addition to foam dressing. The primary endpoint was the comparison of ulcer and healthy skin perfusion through LASCA, performed before and after the treatment period. Secondary considered endpoints were wound area, wound area severity index and PUSH Tools 3.0 ulcer severity scales, and pain assessment (Numerical Rating Scale [NRS]). RESULTS: Before treatment, the wound area was significantly more perfused than healthy skin (+45%; P = 0.005). At the end of the study, this difference was not significant anymore (+20.5%; P = 0.11). Ulcer perfusion decreased (-12.5%, P = 0.047), whereas healthy skin perfusion did not vary significantly. A reduction of the wound dimension (median difference: 2 cm; P = 0.009) and pain (median difference: 2 NRS point; P < 0.001) after therapy were assessed. CONCLUSIONS: LASCA shows that 1 month of TCOT can help reduce hyperperfusion of ulcer bed in patients with chronic lower limb ulcers, strengthening the hypothesis that this treatment effectively contrasts inflammation. This could correlate with the area and pain reduction assessed; however, the absence of a control group in this study does not allow a generalization of this hypothesis. Larger, controlled trials are needed to properly assess the relationship between TCOT effects on wound microenvironment and effective healing process.

Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial.

OBJECTIVE: The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented. METHODS: The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported. RESULTS: Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P < .0001; performance goal of 16%) experienced a MDE within 30 days of the index procedure. Two secondary procedures (n = 1 retrograde type A dissection; n = 1 aortic arch rupture) were required, and in the first 30 days, two patients died leading to a freedom from all-cause mortality of 97.7%. Endoleaks at 1 month were reported in 2.5% of patients (n = 1 type Ia; n = 1 type II). CONCLUSIONS: Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years.

Short- and Midterm Outcomes of Open Repair and Fenestrated Endografting of Pararenal Aortic Aneurysms in a Concurrent Propensity-Adjusted Comparison.

PURPOSE: To compare outcomes of patients treated for pararenal aortic aneurysms using fenestrated endovascular aneurysm repair (fEVAR) vs open surgical repair (OSR) in 3 high-volume centers. MATERIALS AND METHODS: A multicenter retrospective analysis was conducted of 200 pararenal abdominal aortic aneurysm patients electively treated with OSR (n=108) or fEVAR (n=92) from 1998 to 2015 at 3 tertiary institutions. Endpoints were 30-day morbidity and mortality, late reinterventions, visceral artery occlusion, and mortality. Analysis was conducted on the entire population and on a propensity score-matched population constructed on age, gender, coronary artery disease (CAD), and chronic renal failure. RESULTS: In the total cohort, fEVAR patients were significantly (p<0.001) older and had higher frequencies of CAD (p<0.001) and previous stroke (p=0.003). OSR patients had higher risk of perioperative morbidity (OR 2.5, 95% CI 1.09 to 5.71, p=0.033), specifically respiratory failure (OR 4.06, 95% CI 1.12 to 4.72, p=0.034). These findings were confirmed in the propensity-adjusted analysis, where cardiac complications were also higher after OSR (OR 12.8, 95% CI 0.07 to 0.21, p=0.02). No difference in perioperative mortality (2.2% in fEVAR vs 1.9% in OSR) was identified. Mean follow-up was 50 months (range 0-119). Four-year results showed higher survival (91.2% vs 69.3%, p=0.02) and freedom from reintervention (95.6% vs 77.8%, p=0.01) after OSR in the unmatched population, with a small but significant (p=0.021) difference in the risk of late visceral artery occlusion/stenosis after fEVAR. On propensity analysis, no differences in late survival were found between groups. CONCLUSION: fEVAR and OSR may afford similar early and midterm survival rates. Higher risks of perioperative systemic complications after OSR are counterbalanced by higher risks of late visceral vessel patency issues and need for reintervention after fEVAR. Both procedures are safe and effective in the long term in experienced centers, where patient evaluation should drive the treatment strategy.

Impact of the Supra-Aortic Trunks and Circle of Willis Patency on the Neurological Compensation during Carotid Endarterectomy.

BACKGROUND: One of the most critical phases of carotid endarterectomy (CEA) is the carotid cross-clamping test, which is a concrete evaluation of efficacy of collateral cerebral perfusion. Some studies revealed a strong correlation between tolerance to carotid cross-clamping and postoperative transient ischemic attack (TIA)/stroke complications. The aim of the study is to make a global analysis of supra-aortic trunks (SAT) and circle of Willis (CoW) patency to predict the tolerance to carotid cross-clamping preoperatively. METHODS: We observed retrospectively 503 patients who underwent CEA under local anesthesia between January 2012 and 2017. We analyzed single preoperative risk factors, drug therapy, and vessels patency of the group of patients who did or did not present neurological symptoms at carotid cross-clamping. Afterward, we created a cerebral perfusion score (PTOT) to estimate the efficacy of collateral cerebral perfusion and we compared the results from both groups. The score ranges from 0 (hypothetical total occlusion of the SAT and CoW) to 0.65 in case of patency of all arterial districts. Moreover, we evaluated postoperative complication rates. RESULTS: Patients with previous neurological symptoms, female gender, and diabetes correlate with a lower tolerance to carotid cross-clamping (odds ratio: 2.57, 2.78, and 2.57, respectively; P value < 0.05). The SAT and CoW score revealed that patients with score <0.2 more frequently did not tolerate carotid cross-clamping (P value 0.01). Patients who required an intraoperative shunt presented a higher risk of TIA/stroke within 30 days from surgery than those with a better neurological compensation (P value 0.03). CONCLUSIONS: The efficacy of cerebral mechanisms of compensation during carotid cross-clamping reflects the capability of the brain to adapt to ischemic insults, and this also correlates with the postoperative risk of TIA/stroke. It is possible to identify preoperatively patients with a higher risk of neurological intolerance at carotid cross-clamping. This score could be a useful method to make a further stratification of risk of neurological complications and eventually to prefer a general anesthesia and the use of shunt for those with PTOT < 0.2.

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.

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study.

OBJECTIVE: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. METHODS: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. RESULTS: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. CONCLUSIONS: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.