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Purpose: Post-EVAR (endovascular aneurysm repair) aneurysm sac growth can be seen as therapy failure as it is a risk factor for post-EVAR aneurysm rupture. This study sought to identify preoperative patient predictors for developing post-EVAR aneurysm sac growth., Material and Methods: A systematic review was conducted to select potential predictive preoperative factors for post-EVAR sac growth (including a total of 34.886 patients), which were evaluated by a retrospective single-center analysis of patients undergoing EVAR between 2009 and 2019 (N=247) with pre-EVAR computed tomography scans and at least 1 year follow-up. The primary study outcome was post-EVAR abdominal aortic aneurysm (AAA) sac enlargement (≥5 mm diameter increase). Multivariate Cox regression and Kaplan-Meier survival curves were constructed., Results: Potential correlative factors for post-EVAR sac growth included in the cohort analysis were age, sex, anticoagulants, antiplatelets, renal insufficiency, anemia, low thrombocyte count, pulmonary comorbidities, aneurysm diameter, neck diameter, neck angle, neck length, configuration of intraluminal thrombus, common iliac artery diameter, the number of patent lumbar arteries, and a patent inferior mesenteric artery. Multivariate analysis showed that infrarenal neck angulation (hazard ratio, 1.014; confidence interval (CI), 1.001-1.026; p=0.034) and the number of patent lumbar arteries (hazard ratio, 1.340; CI, 1.131-1.588; p<0.001) were associated with post-EVAR growth. Difference in estimated freedom from post-EVAR sac growth for patients with ≥4 patent lumbar arteries versus <4 patent lumbar arteries became clear after 2 years: 88.5% versus 100%, respectively (p<0.001). Of note, 31% of the patients (n=51) with ≥4 patent lumbar arteries (n=167) developed post-EVAR sac growth. In our cohort, the median maximum AAA diameter was 57 mm (interquartile range [IQR] = 54-62) and the median postoperative follow-up time was 54 months (IQR = 34-79). In all, 23% (n=57) of the patients suffered from post-EVAR growth. The median time for post-EVAR growth was 37 months (IQR = 24-63). In 46 of the 57 post-EVAR growth cases (81%), an endoleak was observed; 2.4% (n=6) of the patients suffered from post-EVAR rupture. The total mortality in the cohort was 24% (n=60); 4% (n=10) was AAA related., Conclusions: This study showed that having 4 or more patent lumbar arteries is an important predictive factor for postoperative sac growth in patients undergoing EVAR., Clinical Impact: This study strongly suggests that having 4 or more patent lumbar arteries should be included in preoperative counseling for EVAR, in conjunction to the instructions for use (IFU)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited., Methods: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%., Results: A total of 201 patients were enrolled and randomly assigned to treatment ( N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (P superiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (P noninferiority = 0.0433)., Conclusion: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496) ., Competing Interests: Declaration of conflicting interestsHans van Overhagen, MD, PhD, serves as a consultant for Boston Scientific and Cordis. Masato Nakamura, MD, PhD, serves as a consultant for Terumo Co. and Boston Scientific; has received honoraria from Boston Scientific and Terumo Co. Patrick J Geraghty, MD, holds stock or stock options in MedAlliance SA, Aveera, Protexa, and Pulse Therapeutics. Sid Rao, MD, serves as a consultant for Cardiovascular Systems, Inc. and Philips. Max Arroyo, MD, has no conflicts of interest to declare. Yoshimitsu Soga, MD, serves as an advisor to Boston Scientific. Osamu Iida, MD, serves as a consultant for Boston Scientific. Ehrin Armstrong, MD, serves as a consultant for Abbott Vascular, Boston Scientific, Gore, Medtronic, Philips, and Shockwave Medical. Tatsuya Nakama, MD, serves as a consultant for Boston Scientific, BD, Cook Medical, Cordis, Kaneka, NIPRO, and OrbusNeichi. Masahiko Fujihara, MD, serves as a consultant for Boston Scientific. Mohammad M Ansari, MD, serves as an advisory board member for Boston Scientific, Medtronic, and Cordis; a steering committee member for Philips; a consultant for Boston Scientific, Terumo, Edwards, Gore, Abbott, Bard, and Medtronic; has research trials with Boston Scientific, Terumo, Gore, Abbott, and Reflow Medical. Santhosh J Mathews, MD, MS, serves as a consultant and advisory board member for Philips, Boston Scientific, Abbott Vascular, and Reflow Medical; a consultant for Penumbra, Cordis, and Shockwave. Yann Gouëffic, MD, PhD, has received research funding from Abbott, Boston Scientific, General Electric, Veryan, WL Gore, and personal fees and grants from Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, and WL Gore. Michael R Jaff, DO, is an employee of Boston Scientific, is a board member of Access Vascular; serves as a consultant for Gilde Healthcare; has an equity investment in R3 Vascular and EFemoral. Ido Weinberg, MD, serves as a consultant to Magneto Thrombectomy Solutions and Penumbra, Inc.; is an employee of VasCore. Duane S Pinto, MD, MPH, serves as a consultant to Abbott Vascular, Abiomed, Biotronik, Boston Scientific, Magenta Medical, Medtronic, NuPulseCV, Terumo; has employment with JenaValve Technology. Norihiko Ohura, MD, serves as a consultant for Boston Scientific. Kara Couch, MS, CRNP, CWCN-AP, FAAWC, serves as a consultant for Boston Scientific and vTail; is on the speaker’s bureau for 3M, Urgo Medical North America, and Organogenesis, Inc. Jihad A Mustapha, MD, serves as a consultant to Angiodynamics, BD Bard, Cardiovascular Systems, Inc., Medtronic, Philips; a consultant and researcher for Avinger, Boston Scientific, Endologix, and Terumo; is Chief Medical Officer for Micromedical; has equity ownership and is a researcher and board member of CardioFlow; has equity ownership of Iatri; is a researcher and has stock options in Reflow Medical.

Purpose: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study., Materials and Methods: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory., Results: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively., Conclusions.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years., Clinical Impact: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.T. is a consultant for Cordis and has received educational grants from Medtronic, Cook, Gore, Boston Scientific, and Biotronik, and is CEO and cofounder of Vascupedia and the Foundation for Cardiovascular Research and Education. L.B. has been a consultant for Cordis. R.K. received honoraria from W.L. Gore and C.R. Bard. J.J.W. is a consultant for Cordis and cofounder of the Haga Vascular Research Foundation. H.v.O. is a Cordis and Boston Scientific consultant and cofounder of the Haga Vascular Research Foundation. K.S. has consulted for Phillips, Shockwave, and Terumo; received honoraria from Medtronic, Boston Scientific, and Biotronic; and is a cofounder of Vascupedia and the Foundation for Cardiovascular Research and Education.

Objective: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study., Methods: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success., Results: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%., Conclusions: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Low profile endovascular aneurysm repair (EVAR) devices such as the Cordis INCRAFT AAA Stent Graft System may expand the category of patients suitable for endovascular repair. We report our experience with the INCRAFT system in treating ruptured abdominal aortic aneurysms (rAAA)., Methods: We included all patients presenting with rAAA from 2015 to 2019 in our hospital who were treated by percutaneous EVAR with the INCRAFT system. The primary outcome was technical success, referring to adequate stent graft placement. Secondary outcomes included completion of the procedure under local anesthesia and mortality at 30-days, one year and long-term follow-up., Results: Fifteen male patients (mean age: 74 years, SD 6.7) were treated for rAAA with a median aneurysm diameter of 8.25 cm (SD 1.66). The device was successfully delivered and deployed in all subjects. Per-procedurally one type I endoleak required additional stent placement and one patient developed an acute thrombosis of the device main body and iliac limbs requiring thrombectomy. 80.0% of patients were successfully treated under local anesthesia only. The 30 day and one year mortality were 26.6% and 33.3% respectively. Long-term survival was 60.0% at a median follow-up period of 57 months, with two patients requiring late reintervention for an endoleak., Conclusions: The INCRAFT system can be used to percutaneously treat rAAA with a high technical success rate and mortality similar to reported in the literature for other devices. The large majority of procedures can be completed with only local anesthesia., (Copyright © 2021 Elsevier Inc. All rights reserved.)