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Objective: We evaluated the safety and efficacy of multilayer flow modulator (MFM) stents (Cardiatis, Isnes, Belgium) for the treatment of complex aortic lesions., Methods: A systematic electronic research was conducted for studies reported from December 2008 to May 2020. Data extracted from 15 eligible case series (CS) were appropriately pooled and analyzed in a meta-analysis. The patient baseline characteristics were recorded, and 16 outcomes of interest were studied. The primary end points included 30-day all-cause and aneurysm-related mortality, aneurysm-related mortality at 1 year, vessel patency, and any endoleaks, ruptures, reinterventions, and aneurysm exclusion at the end of follow-up., Results: A total of 39 studies (15 CS and 24 case reports), involving 429 patients, met the inclusion criteria. Overall, 436 lesions were treated, and 1521 aortic branches were covered by the multilayer stent. The mean follow-up for the 15 CS with 404 patients was 14.6 months. Compliance with the instructions for use was reported by eight CS, with 75% of the procedures performed within the instructions for use. However, 41% of the patients reported by 12 CS had undergone a previous aortic intervention. The pooled 30-day all-cause and 30-day aneurysm-related mortality rates were 0.56% (95% confidence interval [CI], 0.00%-2.54%) and 0.00% (95% CI, 0.00%-0.80%), respectively. The pooled aneurysm-related mortality at 1 year of follow-up was 5.25% (95% CI, 0.07%-14.91%). The pooled vessel patency at the end of follow-up was 99.12% (95% CI, 97.73%-99.93%). The pooled reintervention and endoleak rates at the end of follow-up were 10.94% (95% CI, 3.64%-20.67%) and 10.70% (95% CI, 4.45%-18.66%), respectively. The crude spinal cord ischemia and renal failure rates were 0.69% and 1.8%, respectively., Conclusions: The results from the present review and meta-analysis have indicated the safety and efficacy of MFM stents for treating challenging aortic pathologic lesions when used as first-line treatment and within the instructions for use. The almost zero pooled 30-day all-cause and aneurysm-related mortality rates combined with the low crude spinal cord ischemia and renal failure rates indicate the use of MFM stents is a good treatment option for complex aortic lesions in the short- and mid-term periods. The lack of long-term follow-up warrants further research concerning the efficacy of the device in the long term., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair., Methods: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals., Results: Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98-99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83-15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00-1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02-84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91-3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97-96.29) at a mean six months follow-up period., Conclusions: Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

Background: Endovascular treatment of thoracoabdominal aortic aneurysms is becoming increasingly popular in clinical practice, mainly because of its reduced perioperative mortality and morbidity. However, the custom-made stent graft platform that companies offer requires detailed preoperative planning and production time that can take up to 12 weeks. This may delay surgery in elective patients and is not an option for urgent or emergent cases. To surpass this limitation, the t-Branch (Cook Medical, Bloomington, Ind) was launched in 2012 in Europe as the first off-the-shelf standardized multibranched endograft for the endovascular treatment of thoracoabdominal aneurysms. Our aim was to systematically evaluate all published experience with this commercially available off-the-shelf thoracoabdominal stent graft., Methods: We performed a systematic inquiry of the medical databases to identify all published studies that reported on the outcomes of patients treated with the t-Branch stent graft and then conducted a qualitative synthesis and meta-analysis of the results. The main end points studied were technical success, mortality, major stroke, spinal cord ischemia, primary branch patency, and renal insufficiency during the first 30 days along with midterm mortality and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs)., Results: We identified seven retrospective studies published between 2014 and 2018, with a total of 197 patients (mean age, 72.3 ± 7 years; 70% male). Among 165 patients, 45% were symptomatic and 19% were treated for a ruptured aortic aneurysm. In 197 patients, pooled technical success was 92.75% (95% CI, 83.9%-98.7%), and in 10% of the cases, an early endoleak was detected (95% CI, 0%-43.7%). Early mortality was 5.8% (95% CI, 2.5%-10%), and major stroke was observed in 4% of the patients (95% CI, 0.96%-8.40%). The rate of spinal cord ischemia was 12.2% (95% CI, 4.1%-23.2%), with the rate of permanent paraplegia at 1.3% (95% CI, 0%-8.7%). Acute renal failure was 18.7% (95% CI, 9.1%-30.4%), whereas primary branch patency was calculated at 98.2% (95% CI, 96.7%-99.2%). Mean follow-up was 15 ± 7 months. During this time, midterm mortality (after 30 days) was 6.9% (95% CI, 2.44%-12.8%) and pooled reintervention rate was 5.7% (95% CI, 1.70%-11.4%)., Conclusions: This pooled analysis indicated good technical success rate after t-Branch endograft implantation, with acceptable mortality and neurologic complications despite a high rate of urgent procedures. Thoracoabdominal endovascular repair with the t-Branch endograft is a feasible and safe therapeutic option for elective and urgent patients., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Common iliac artery aneurysms are present in more than a third of patients with abdominal aortic aneurysm and may pose a challenge during open and endovascular repair. Although embolization of the internal iliac artery is an established method, it may be complicated with buttock claudication, erectile dysfunction, colon ischemia, and pelvic necrosis. Iliac branch devices (IBDs), which permit preservation of the hypogastric artery, have been used to prevent these complications. We conducted a meta-analysis to assess the safety and outcomes of IBDs and to explore potential differences between the commercially available types of IBDs., Methods: The meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. After review of the literature, 36 eligible studies with a total of 1502 patients were included in our study. A meta-analysis was performed with investigation of the following outcomes: technical success rate, 30-day mortality, 30-day patency, follow-up patency, endoleak, buttock claudication, and IBD-associated reintervention. Furthermore, we conducted a subgroup meta-analysis by commercial type of endograft among the outcomes of interest., Results: Among all eligible studies, technical success of the method was 97.35% (95% confidence interval [CI], 96.27-98.29). The endoleak rate postoperatively and during the follow-up period was 12.68% (95% CI, 8.80-17.07). The 30-day patency of IBDs was estimated at 97.59% (95% CI, 96.49-98.54), whereas follow-up patency was 94.32% (95% CI, 91.70-96.54). Furthermore, reintervention rate associated with IBDs was 6.96% (95% CI, 5.10-9.03), and buttock claudication during the follow-up period was 2.15% (95% CI, 1.25-3.22)., Conclusions: IBD seems to be a safe, feasible, and effective technique for the treatment of aortoiliac aneurysms in select patients with suitable anatomy. Further results are awaited to explore the long-term efficacy and durability of these devices., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of the study was to present the results for patients with atherosclerotic aneurysm of the descending thoracic aorta (DTA) treated with a novel thoracic stent graft., Methods: A single-center retrospective review of prospectively collected data was performed. We extracted demographic variables as well as atherosclerotic comorbidities and operation-related and imaging-related data from patients' medical records. We estimated technical success rate, in-hospital and 30-day mortality, and mortality at the end of follow-up as well as complication and reintervention rate in our study cohort. Follow-up computed tomography angiography was performed after 1 month and 6 months and yearly thereafter., Results: A total of 30 patients (80% male; mean age, 73.7 ± 6.33 years) were treated with Ankura Thoracic Stent Graft (Lifetech, Shenzhen, China) for DTA aneurysm from February 2014 until June 2017. Technical success of the thoracic endovascular aortic repair (TEVAR) was 97% (29/30 patients). A surgical conduit was required in one patient; in three patients, we intentionally covered the left subclavian artery because of insufficient proximal landing zone. No aorta-related deaths were recorded during follow-up. During the early postoperative period, two patients (7%) with long DTA coverage developed paralysis or paraparesis, which immediately resolved after lumbar drainage. No renal complications requiring dialysis were observed. One patient (3%) developed postoperative pulmonary infection, whereas access site complications were 7%. Two symptomatic patients treated outside instructions for use (7%) developed early type IA endoleak and one patient (3%) developed type IB endoleak; type II endoleak was recorded in 3% of the study cohort. During the 30-day postoperative period, two patients died of non-TEVAR-related causes, one of gastrointestinal bleeding and the other of pulmonary infection. During a median follow-up of 31.7 (range, 38.4) months, two more patients also died of non-TEVAR-related causes, one of stroke from carotid artery disease and the other of motor vehicle trauma. In the rest of the cohort, no other adverse events were noted., Conclusions: This novel endograft showed early evidence of a safe, effective, and durable endoprosthesis for the treatment of DTA aneurysms., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Conventional open total arch replacement is the treatment of choice for surgical aortic arch pathologies. However, it is a two-stage procedure related to high cumulative and interval mortality rates. Hybrid type III aortic arch reconstruction, the so-called "frozen elephant trunk" is a one-stage alternative approach., Methods: A meta-analysis and detailed review of the literature published from January 2013 until December 2016, concerning frozen elephant trunk hybrid approach was conducted and data for morbidity and mortality rates were extracted., Results: Among 989 patients included, the pooled 30-day or in-hospital mortality rate was 5.04% (95%CI=1.13-10.74), stroke rate was 2.38% (95%CI=0.13-6.30), and the irreversible paraplegia due to spinal cord injury rate was 0.63% (95%CI=0.00-2.73). Finally, the pooled cumulative survival at 1year was remarkably high (86.7%, 95%CI=81.08-92.90)., Conclusions: Frozen elephant trunk is a safe alternative to conventional elephant trunk repair for extensive aortic arch pathologies with acceptable short- and mid-term results, avoiding the interval mortality hazard., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Introduction: Conventional open total arch replacement is the treatment of choice for surgical aortic arch pathologies. However, it is an invasive procedure, requiring cardiopulmonary bypass and deep hypothermic circulatory arrest leading to significant morbidity and mortality rates. Hybrid aortic arch debranching procedures without (type I) or with (type II) ascending aorta replacement seek to limit operative, bypass, and circulatory arrest times by making the arch repair procedure simpler and shorter., Material and Methods: A meta-analysis and detailed review of the literature published from January 2013 until December 2016, concerning hybrid aortic arch debranching procedures was conducted and data for morbidity and mortality rates were extracted., Results: As far as type I hybrid aortic arch reconstruction is concerned, among the 122 patients included, the pooled endoleak rate was 10.78% (95%CI=1.94-23.40), 30-day or in-hospital mortality was 3.89% (95%CI=0.324-9.78), stroke rate was 3.79% (95%CI=0.25-9.77) and weighted permanent paraplegia rate was 2.4%. In terms of type II hybrid approach, among 40 patients, endoleak rate was 12.5%, 30-day or in-hospital mortality rate was 5.3%, stroke rate was 2.5%, no permanent paraplegia was noticed and late mortality rate was 12.5%., Conclusions: Hybrid aortic arch debranching procedures are a safe alternative to open repair with acceptable short- and mid-term results. They extend the envelope of intervention in aortic arch pathologies, particularly in high-risk patients who are suboptimal candidates for open surgery., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Objective: Conventional open surgery encompassing cardiopulmonary bypass has been traditionally used for the treatment of ascending aorta diseases. However, more than one in five of these patients will be finally considered unfit for open repair. We conducted a systematic review and meta-analysis to investigate the role of thoracic endovascular aortic repair (TEVAR) for aortic diseases limited to the ascending aorta., Methods: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We investigated patients' baseline characteristics along with early (30 days/in-hospital stay) and late (beyond 30 days/in-hospital stay) outcomes after TEVAR limited to the ascending aorta and not involving the arch vessels. Separate analyses for case reports and case series were conducted, and pooled proportions with 95% confidence intervals (CIs) of outcome rates were calculated., Results: Approximately 67% of the patients had a prior cardiac operation. TEVAR was performed mainly for acute or chronic Stanford type A dissection (49%) or pseudoaneurysm (28%). The device was usually delivered through the femoral artery (67%), and rapid ventricular pacing was used in nearly half of the patients. Technical success of the method was 95.5% (95% CI, 87.8-99.8). Among the early outcomes, conversion to open repair was 0.7% (95% CI, 0.1-4.8), whereas mortality was 2.9% (95% CI, 0.02-8.6). We estimated a pooled rate of 1.8% (95% CI, 0.1-7.0) for neurologic events (stroke or transient ischemic attack) and 0.8% (95% CI, 0.1-5.6) for myocardial infarction. Late endoleak was recorded in 16.4% (95% CI, 8.2-26.0), and 4.4% (95% CI, 0.1-12.4) of the population died in the postoperative period. Finally, reoperation was recorded in 8.9% (95% CI, 3.1-16.4) of the study sample., Conclusions: TEVAR in the ascending aorta seems to be safe and feasible for selected patients with various aortic diseases, although larger studies are required., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To describe a case of anaphylactic reaction during implantation of the Ovation Abdominal Stent Graft System in a patient treated for abdominal aortic aneurysm (AAA)., Case Report: An 82-year-old man with a 5.3-cm asymptomatic AAA underwent endovascular repair using an Ovation stent-graft. Polymer was infused into the inflatable rings of the aortic body under continuous angioscopy, but the rings were not filled, even though the entire amount of the polymer was administered. Simultaneously, the patient presented with a severe anaphylactic reaction resulting in cardiopulmonary arrest. He was successfully resuscitated, but the procedure was abandoned; the patient refused any further treatment., Conclusion: A rupture of the Ovation main body's polymer-filled rings may lead to extremely severe anaphylactic reaction., (© The Author(s) 2015.)

We present 3 cases of stent graft infection in patients who were treated with preservation of the endograft. In the first patient, the contamination of the endograft was the consequence of a bleeding aortoenteric fistula, whereas in the second patient, the endograft was implanted into a ruptured contaminated aortic aneurysm because of the patient's hemodynamic instability. In the third patient, the presence of a consistent type Ia endoleak after a chimney graft procedure followed by secondary interventions led to an infection of the stent graft. In each case, a laparotomy was performed with debridement, followed by appropriate antibiotic therapy. The first patient suffered a fatal pulmonary embolism. The other 2 patients are alive 4 and 24 months after the diagnosis of endograft infection. In unstable patients or those with severe comorbidities who cannot tolerate endograft excision and aortic reconstruction, surgical debridement followed by appropriate antibiotic therapy can be a temporary or bridging solution., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: Endograft infection after thoracic endovascular aortic repair (TEVAR) is associated with a substantial mortality rate that exceeds 70% in the largest published series. The aim of this study was to review all published reports on infection after TEVAR treated with either preservation of the endograft or surgical excision of the stent graft with the intention of providing a comparison of the safety, efficacy, and durability of the two different treatment strategies., Methods: An extensive electronic health database search was undertaken to identify all articles that were published up to December 2013 reporting on endograft infection after TEVAR. Overall, 55 patients treated with endograft preservation (group A) and 41 patients treated with endograft explantation (group B) were included in this review., Results: The most frequently isolated microorganisms were Streptococcus species (29.4%) and Staphylococcus species (29.4%). The mortality for both groups was 66.6%. The in-hospital mortality rate in group A was 42% and reached 81.8% in a mean follow-up period of 8.6 months. The in-hospital mortality rate in group B was 36.6%. Four (9.7%) further deaths due to reinfection or fistula recurrence were recorded in a mean follow-up period of 15.3 months, leading to an overall mortality of 46.3%. The meta-analysis showed a trend of better outcome with endograft explantation compared with endograft preservation (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.18-1.48). In group A, a trend of better outcome was revealed when drainage and repair of the fistula were applied (OR, 2.22; 95% CI, 0.55-8.90). A trend of worse outcomes was detected in fistula patients compared with nonfistula patients (OR, 1.26; 95% CI, 0.43-3.74)., Conclusions: Endograft preservation seems not a durable option. It can be offered to patients who refuse surgery or as a palliative option or bridging procedure for severely ill patients. Compared with antibiotic therapy alone, antibiotic therapy followed by drainage and repair of the fistula may control the sepsis, providing, however, mainly a temporary benefit. The presence of fistula is a predictor of dismal outcome. Endograft explantation remains the "gold standard" of treatment. The mortality rate of surgical conversion is much higher in the presence of fistula., (Copyright © 2014 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To review the published outcomes of aortic endograft infection treated with preservation of the stent-graft., Methods: An extensive electronic health database search was undertaken to identify all articles published up to May 2013 that reported endograft infection after endovascular aneurysm repair (EVAR) in which treatment included preservation of the stent-graft. The search found 17 articles with 29 patients (27 men; mean age 73.1±7.6 years) fulfilling the inclusion criteria., Results: In 2 (7%) cases, the endograft infection was diagnosed within 30 days of the initial procedure; 4 (14%) were identified within 3 months and the remaining 23 (79%) within 12 months. Staphylococcus species, Streptococcus species, and Escherichia coli were the most common isolated microorganisms. Seven (24%) had a secondary aortoenteric fistula after EVAR. Twelve (41%) patients received only antibiotic therapy, while the remaining had an additional procedure (drainage, surgical debridement, sac irrigation, and/or omentoplasty). The in-hospital mortality was 21% (n=6). During a mean follow-up of 11.4±3.1 months, 7 more patients died (overall mortality 45%). None of the 7 patients with fistula survived. Half (50%) of the 12 patients who received only antibiotic therapy died, while 7 (41%) of the 17 patients who underwent an additional procedure died during follow-up., Conclusion: Among patients treated for endograft infection without explantation, those with aortoenteric fistula had the worst outcome. There is evidence for lower mortality in patients who underwent an additional procedure, such as drainage, surgical debridement, and sac irrigation. Larger studies are needed to examine the efficacy of this approach compared to surgical conversion with endograft excision and in situ reconstruction or extra-anatomical bypass.

Objective: To evaluate the impact of endograft type on the inflammatory response after elective endovascular repair of abdominal aortic aneurysms., Methods: From January 2011 to November 2011, we included 100 consecutive patients who underwent elective abdominal aortic aneurysm endovascular repair. Thirteen patients were excluded from the analysis: four with cancer, three with autoimmune disease, two because of recent infection, two who were receiving long-term anti-inflammatory medication, and two because of recent surgery. Temperature, white blood cell count, platelet count, and serum concentrations of cytokines (interleukin [IL]-6, IL-8, and IL-10) were measured preoperatively, 24 hours postoperatively, and 48 hours postoperatively. The study sample was divided into four groups with respect to the type of endograft used: group A, n = 28 (Anaconda; Sulzer Vascutek, Bad Soden, Germany); group B, n = 26 (Zenith; Cook Inc, Bloomington, Ind); group C, n = 23 (Excluder; W. L. Gore and Assoc, Flagstaff, Ariz); and group D, n = 10 (Endurant; Medtronic, Minneapolis, Minn). Endograft configurations included bifurcated grafts only., Results: Epidemiologic characteristics, atherosclerotic risk factors, type of anesthesia, mean blood loss during surgery, and baseline serum levels of cytokines did not differ among the four groups. Mean elevated temperature was more pronounced postoperatively in group A. Serum levels of IL-6 and IL-10 were significantly higher 24 hours and 48 hours postoperatively compared with preoperative levels in all groups. Patients in group C showed the smallest increase in levels of serum IL-6 and IL-10 at 24 hours and 48 hours postoperatively. Mean difference in cytokine levels after aneurysm exclusion was greater for group A vs group C (P < .01) compared with group A vs B (P < .05). No differences in the mortality and morbidity rates were observed among the four groups., Conclusions: Endograft type appears to influence the inflammatory response after endovascular aortic repair. The postimplantation syndrome was apparent during the first 24 hours and decreased afterward. Anaconda and Zenith endografts induced a more intense inflammatory response. A "milder" inflammatory activation was observed in patients with an Excluder endograft. The postimplantation syndrome was not associated with perioperative adverse clinical events showing a benign course. The possible long-term sequelae of postimplantation syndrome require further investigation., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)