Purpose: To investigate the outcomes of patients who were treated for thoracoabdominal aortic aneurysms (TAAAs) using custom-made fenestrated-branched stent-grafts. Methods: A consecutive series of 108 patients (mean age 73.5 years; 73 men) with TAAA were treated with E-xtra Design Engineering customized fenestrated-branched stent-grafts between November 2011 and January 2017. Data on baseline characteristics, procedures, and clinical follow-up were collected from 6 regional European surgical centers for retrospective analysis of endoleaks, reinterventions, and target vessel patency. The median aneurysm diameter was 6.75 cm (range 5.5–13). The distribution of the TAAA according to the modified Crawford classification of extent was 25 (24%) type I, 19 (17%) type II, 20 (18%) type III, 29 (27%) type IV, and 15 (14%) type V. Results: Technical success was achieved in 95% (103/108) of cases. Major early perioperative complications occurred in 40 (37%) patients. The 30-day mortality was 9.2% (10/108), and perioperative spinal cord ischemia was observed in 6 (5.5%) patients [2 (1.8%) permanent]. During the mean follow-up of 17.6 months (range 3–52), 28 (26%) patients required late reintervention. Two patients died due to aneurysm- or procedure-related causes. The estimated survival rates at 1, 2, and 4 years were 87%, 84%, and 51%, respectively. The estimated target vessel patency rates at the same time points were 95%, 91%, and 90%, respectively. The freedom from reintervention estimates were 84% and 73% at 1 and 4 years, respectively. Conclusion: Endovascular repair of TAAA using Jotec customized fenestrated-branched stent-grafts appears to be safe and effective in the early to midterm. The considerable rate of secondary interventions indicates that further improvements, graft surveillance, and follow-up are required.
26 October 2016 in Journal of Endovascular Therapy
Purpose: To assess the technical success and clinical outcome of reinterventions using the Nellix Endovascular Aneurysm Sealing (EVAS) System to treat complications after endovascular aneurysm repair (EVAR). Methods: Fifteen consecutive patients (mean age 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median 7.85-cm diameter; range 6.5–11). Eight patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate. Results: Technical success was 100%. All endoleaks were successfully sealed, and no additional intervention was required. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months postoperatively. One renal artery guidewire injury led to nephrectomy because of active bleeding. No reinterventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range 3–24). Conclusion: The present preliminary experience demonstrates that the use of EVAS/chEVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available.
18 February 2016 in The Thoracic and Cardiovascular Surgeon
Background We demonstrate our initial experience and first results of the endovascular aneurysm sealing (EVAS) technology with chimney grafts for the treatment of paravisceral aneurysms. Methods We present a consecutive series of seven patients with a mean age of 75 years who had been treated by four-vessel-chimney EVAS (ChEVAS) between May 2014 and May 2015. All patients were ASA grade ≥ III and were not eligible for fenestrated/branched endovascular aortic repair (fEVAR/brEVAR) due to urgency (n = 5) or anatomical constraints (n = 2). Results Total 28 renovisceral target vessels were treated by balloon-expandable covered stents and 14 Nellix devices were used to seal the paravisceral aorta. Overall, 16 Nellix (Endologix Inc., Irvine, California, United States) devices and 65 covered stents were implanted with a technical success of 100%. Perioperatively, one patient with ruptured aneurysm died due to respiratory failure following splenic laceration/splenectomy (mortality = 14%) and in one patient, laceration of an axillary access vessel occurred. At a median follow-up of 6 months, all six surviving patients were well and no reinterventions were necessary. One chimney was found occluded without clinical sequelae resulting in a patency rate of 96%. Conclusion Four-vessel ChEVAS may serve as alternative treatment option in highly selected cases of either acute paravisceral aortic pathology and/or situations, where the implantation of fEVAR/brEVAR is hampered by anatomical constraints. Further follow-up and a multicenter study are of course warranted to corroborate these initial results.
23 January 2016 in Journal of Endovascular Therapy
Purpose: To assess the feasibility and effectiveness of the Nellix prosthesis in the treatment of common iliac artery aneurysms. Methods: Between May 2013 and June 2015, 230 patients underwent implantation of the Nellix device at 2 institutions. Fifty of these patients (mean age 76 years; 35 men) were identified as having 60 common iliac artery aneurysms (CIAAs) with a median diameter of 4 cm (range 3.5–7). The majority of patients had aortoiliac aneurysms (5, 70%), 10 (20%) had isolated CIAAs, and 5 (10%) had iliac anastomotic aneurysms after aortoiliac bypass. In 20 patients, the iliac aneurysm was the indication for the intervention; in the other 30 patients, the endovascular iliac repair was an adjunct procedure to endovascular aneurysm sealing (EVAS). An iliac branch device (IBD) was used when feasible to preserve flow to the internal iliac artery. Results: Seventeen (34%) patients underwent elective implantation of the Nellix graft in combination with an IBD, 33 (66%) patients underwent Nellix sealing of the CIAA using 1 (n=5), 2 (n=22), or 3 Nellix grafts (2 bilateral grafts and 1 graft as an extension to the external iliac artery in 6 patients). The technical success rate was 100%, and no graft-related complications were reported postoperatively. No buttock claudication, reinterventions, graft thrombosis, or endoleaks were observed during a mean follow-up of 12 months. Conclusion: Our initial experience demonstrates that Nellix grafts are feasible and safe for the treatment of extensive iliac artery aneurysms. The long-term durability of these grafts should be validated in larger patient cohorts before this promising alternative endovascular technique can gain widespread acceptance.
2 May 2017 in The Thoracic and Cardiovascular Surgeon
Background To analyze utilization of a perfusion branch for temporary sac perfusion to reduce the spinal cord ischemia (SCI) in the endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). Methods Between January 2012 and August 2016, 30 patients (18, men; median age 72 years) were treated for TAAAs with total endovascular repair using customized branched/fenestrated endografts in our institution. The median aneurysm size was 6.6 cm. Types of TAAA were: type I, 9 (30%), type II, 5 (16.6%), type III, 4 (13.3%), type IV, 6 (20%), and type V, 6 (20%). Ten patients received a perfusion branch to create an intentional endoleak, which was occluded with vascular plugs in mean interval time of 8.2 weeks (range: 6–10). Staged procedure and automated cerebrospinal fluid drainage were used in 23 (77%) and 24 (80%) patients, respectively. Results The technical success was 97%; 107 renovisceral target vessels were revascularized (32 fenestrations, 75 branches). At the time of the planned reinterventions, the mean arterial pressure (MAP) gradients were measured between the temporarily perfused aneurysm sac and the aortic endografts, and they were significantly higher (mean gradients 42.5 ± 10 mm Hg; range: 30–60) within the aortic grafts. The in-hospital and 30-day mortality was 3.3%. The incidence of postoperative SCI was 3/20 (15%) in the standard group and 0% in the group of the perfusion branch (p = 0.28). The mean follow-up was 12 months (range: 2–51). Conclusion We experience that the use of a dedicated perfusion branch is feasible and may serve as protective adjunct to reduce the risk of SCI in endovascular treatment of TAAA. The risk of rupture in interval appears to be low. Larger series and multicenter studies are warranted to corroborate these results.
Background/Objectives: Retrograde false lumen perfusion after thoracic endovascular aortic repair (TEVAR) can compromise positive remodeling and clinical outcomes. The aim of this study is to describe the feasibility and outcomes of a false lumen thrombosis technique. Methods: A single-center, retrospective analysis of patients between January 2017 and January 2022 who underwent TEVAR in conjunction with false lumen embolization. Results: Twelve patients (83% type A, 17% type B; 33% with frank rupture; mean age 65 years; eleven men) underwent 13 false lumen embolization procedures with a 92% technical success rate and a 100% clinical success rate. Positive aortic remodeling was observed in all the patients. The maximum thoracic aortic diameter remained stable (p = 0.526) but the true lumen increased from 22 to 33 mm (p = 0.009) and the false lumen decreased from 41 to 20 mm (p = 0.076) after a median follow-up of 31 months. Conclusions: False lumen embolization using the candy-plug is safe and promotes positive aortic remodeling.