Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Embolization using warmed glue via the triaxial microballoon occlusion system for various vascular disorders.

PURPOSE: We aimed to illustrate the benefits of using warmed glue for viscosity reduction via the triaxial microballoon system for the treatment of various vascular disorders. METHODS: Seven patients who underwent 10 treatment sessions for hemoptysis, type II endoleak, post-pancreatic surgical bleeding, spontaneous retroperitoneal bleeding, or ovarian tumor bleeding were evaluated based on technical and clinical outcomes. In the procedure, the triaxial system, consisting of a 4.5-Fr guiding catheter, a 2.8-Fr microballoon catheter, and a 1.9-Fr no-taper microcatheter, was advanced into the target lesion. Glue (33% n-butyl cyanoacrylate mixed with Lipiodol) warmed to 40°C was injected under balloon occlusion. RESULTS: The common hepatic, right bronchial, intercostals, internal mammary, costocervical, lateral thoracic, superior thoracic, thoracoacromial, inferior thyroid, iliolumbar, lumbar, internal pudendal arteries, and branch of the inferior mesenteric artery were successfully embolized; 100% technical success and 100% clinical success were obtained after each session. CONCLUSION: Our modified balloon-occluded glue embolization may lead to better handling with more distal glue penetration capability.

A Novel Technique for the Treatment of Type 2 Endoleak After Endovascular Aortic Repair: Sac Embolization with Balloon Occlusion of the Aorta (SEBOA).

PURPOSE: We presented a new method of sac embolization using n-butyl-cyanoacrylate (NBCA) with balloon occlusion of the aorta (SEBOA) that can facilitate decreasing flow rate of the involved branches with the goal of type 2 endoleak resolution after endovascular aortic repair (EVAR). TECHNIQUE: This technique is demonstrated in six patients who required type 2 endoleak treatment including previous technical failure. A transarterial approach was performed in four patients and transabdominal direct puncture in two. Technical success was defined as complete embolization of both involved branches and sac on postoperative CT. Sacography under balloon occlusion of the aorta demonstrated decreased flow rate of the all involved branches in all patients. SEBOA was performed using 25 or 33% of NBCA diluted with lipiodol. Technical success was obtained in 3 of 6 patients, and one major complication was observed with adhesion of NBCA to the microcatheter resulting in foreign body retention. CONCLUSION: SEBOA may help solve the difficulty of type 2 endoleak treatment after EVAR as decreased flow rate of the involved branches under balloon occlusion of the aorta was achieved in all patients. However, protocols regarding concentration of NBCA or using other embolic materials are needed to improve the success rate.

An Institution-Wide Algorithm for Treatment of Type II Endoleak Following Endovascular Aneurysm Repair (EVAR).

OBJECTIVES: Multiple endovascular techniques have been described for the treatment of persistent type II endoleaks (pT2ELs) causing aneurysm sac growth following endovascular aneurysm repair (EVAR). In the event of a failed endovascular procedure and a pT2EL, a consensus regarding further treatment is lacking, and the literature suggests repeated endovascular attempts are rarely successful. Herein, we propose an algorithm for definitive management of pT2ELs with persistent sac growth following EVAR. METHODS: A retrospective review of 29 patients who underwent treatment of persistent sac growth in the setting of pT2ELs was performed. Intervention methods were determined at the discretion of the operating surgeon. Aneurysmal sac enlargement was defined as a diameter increase > 5 mm, and persistent endoleak was defined as lasting greater than 6 months. RESULTS: From 2000 to 2015, 917 EVAR procedures were performed at our institution. Isolated pT2ELs with sac enlargement were identified in 29 patients. Twenty-five patients underwent direct translumbar sac puncture and coiling and/or Onyx (Onyx, Plymouth, Minnesota) embolization of the culprit vessels. Thirteen (52%) of 25 patients had pT2EL after first endovascular intervention, and 10 (40%) of 25 patients failed 2 endovascular treatments. Of those 10, 7 displayed persistent aneurysmal sac growth and underwent a third embolization procedure. Type II endoleaks persisted in 6 patients; 3 patients were subsequently treated with laparotomy, ligation of lumbar vessels, sac exploration, and sac plication around the endograft. Technical success for this technique was 100%. During a mean follow-up of 38.4 months, no recurrent T2ELs, stent graft migration, and/or disjunction were observed. CONCLUSIONS: We propose a new algorithm for the management of pT2ELs. If 2 endovascular procedures fail to control of the endoleak, repeat endovascular attempts are not recommended. Endovascular failure should be followed by laparotomy with surgical ligation of culprit feeding vessels followed by sac exploration and plication of the sac, and endoaneurysmorrhaphy.

Transcatheter transcaval embolization of a type II endoleak after EVAR using a transseptal needle-sheath system.

PURPOSE: The purpose of this study is to present an alternative technique for management of a type II endoleak associated with aneurysm sac enlargement. TECHNIQUE: We report the use of a transseptal needle-sheath system for a transcatheter transcaval embolization (TTE) in a 3-staged treatment of a persistent type II endoleak after abdominal EVAR. Inferior vena cava is cannulated through a femoral venous access, and aneurysmal sac access is gained with a puncture through the walls of the 2 vessels at the site where the vein is adjacent to the aneurysm. The whole system (sheath-dilator-needle) is then advanced across the vascular walls into the aortic sac. Thus, embolization with glue is performed. CONCLUSION: The TTE using a transseptal needle-sheath system demonstrated to be feasible and effective to treat a persistent type II endoleak after failure of 2 attempts of transarterial embolization of the feeding vessels.