The DETOUR procedure: no more need for conventional bypass surgery?

BACKGROUND: Long segment occlusive disease in the superficial femoral artery remains a treatment challenge despite advances in open surgical and endovascular approaches. We report initial clinical results of an entirely new procedure to perform percutaneous femoro-popliteal bypass using the DETOUR System. First-in-human patients were performed in New Zealand from December 2013 to June 2014. After modifications to the technique and devices had significantly refined the procedure, the Detour I Trial commenced. METHODS: Review of initial results in the first five patients treated at a single site enrolled in IRB-approved, prospective clinical study using the DETOUR System. All patients signed informed consent with planned 2-year follow-up. The DETOUR System was used to create a stent graft bypass which originates in the SFA, travels through the femoral vein, and ends in the popliteal artery, bypassing the diseased segment. RESULTS: A cohort of patients were treated in Latvia from January 2015 to October 2015. The initial five patients in this cohort (age 67.2±11.4 years) with long femoral artery occlusions (29.5±14.1 cm) were treated at a single clinical site. TORUS stent grafts were successfully implanted in all 5 patients (100%) using an 8F delivery system. There were no perioperative 30-day major adverse events (death, major bleeding, deep vein thrombosis, target vessel revascularization or major amputation) observed. At 24 months' follow-up, the primary patency rate was 80% (4/5) and primary assisted patency was 100% (5/5). Significant improvement in ankle-brachial index and Rutherford class were observed in all patients. There was a single secondary procedure performed in these patients (proximal stent edge stenosis at 24 months). The venous function has not been damaged or compromised in any patient. CONCLUSIONS: Early results suggest that properly-selected patients with long-segment occlusive disease above the knee can be safely treated using the DETOUR System for percutaneous bypass, with favorable clinical outcomes extending to 2 years. Further clinical investigation is warranted to evaluate the role of this approach in the treatment of long femoral lesions.

Preservation of hypogastric flow and control of iliac aneurysm size in the treatment of aortoiliac aneurysms using the Nellix EndoVascular Aneurysm Sealing endograft.

OBJECTIVE: The purpose of this study was to determine the long-term effectiveness of endovascular aneurysm sealing (EVAS) in the treatment of complex aortoiliac aneurysms with preservation of hypogastric artery flow. METHODS: We reviewed all patients with abdominal aortic aneurysms (AAAs) and common iliac aneurysms (CIAs) enrolled and treated in prospective studies of EVAS using the Nellix endograft (Endologix, Irvine, Calif) at two centers from 2008 to 2014. Patients with 1 year or more of computed tomography follow-up underwent quantitative morphometric assessment by two independent vascular radiologists blinded to clinical outcome results. Hypogastric patency and CIA diameter changes over time were assessed and compared in three treatment groups: totally excluded CIA, partially excluded CIA, and untreated CIA. RESULTS: Among 125 patients with EVAS, 68 patients (mean age, 75 ± 8 years; 79% men) had both AAA (mean diameter, 55.8 ± 2.0 mm) and CIA (median diameter, 23.4; interquartile range, 21.3-27.0 mm), with bilateral CIAs in 33 patients. Treatment of 101 CIAs included complete CIA exclusion in 40 (39.6%), partial CIA exclusion in 33 (32.7%), and no CIA treatment in 28 (27.7%), with successful AAA exclusion in all patients. Internal iliac flow was preserved in all 122 hypogastric arteries that were patent before treatment (14 hypogastric arteries were occluded at baseline). During the 5-year follow-up period (median follow-up, 24.7 months; range, 11.5-61.7 months), three patients required secondary treatment with hypogastric occlusion and graft extension to the external iliac. Thus, internal iliac flow was maintained in 98% of at-risk hypogastric arteries. There were no aneurysm-related clinical events, except for the three secondary treatments. Totally excluded iliac aneurysms did not change in diameter over time (P = .85), whereas untreated CIAs enlarged at a rate of 0.16 mm/y (95% confidence interval, 0.09-0.23; P < .0001). Partially excluded CIAs enlarged at a higher rate of 0.59 mm/y (95% confidence interval, 0.47-0.71; P < .0001). Enlargement ≥3 mm occurred only in partially treated CIAs larger than 3 cm. CONCLUSIONS: EVAS was effective in treating aortoiliac aneurysms with preservation of internal iliac patency in most cases. Complete CIA exclusion prevented aneurysm enlargement over time, whereas partial exclusion did not prevent continued CIA enlargement, particularly in larger aneurysms.

Chimney Technique with Nellix EndoVascular Aneurysm Sealing System in a Patient with Single Kidney and Juxtarenal Abdominal Aortic Aneurysm.

We present a saccular asymptomatic juxtarenal abdominal aortic aneurysm in a 70-year-old male with a very short left renal artery supplying the only kidney. The case was successfully treated with the Nellix EndoVascular Aneurysm Sealing system combined with a chimney technique.

Aortic neck enlargement after endovascular aneurysm repair using balloon-expandable versus self-expanding endografts.

OBJECTIVE: This study evaluated changes in aortic neck diameter after endovascular aneurysm repair (EVAR) using a balloon-expandable stent (BES) endograft compared with a commercially available self-expanding stent (SES) endograft. We hypothesized that forces applied to the aortic neck by SES endografts may induce aortic neck enlargement over time and that such enlargement may not occur in aneurysm patients treated with a device that does not use a proximal SES. METHODS: This was a retrospective quantitative computed tomography (CT) image analysis of patients treated with the Nellix (Endologix, Irvine, Calif) BES (n = 49) or the Endurant II (Medtronic, Minneapolis, Minn) SES (n = 56) endograft from 2008 to 2010. Patients with preimplant, postimplant, and at least 1-year serial CT scans underwent quantitative morphometric assessment by two independent vascular radiologists blinded to the outcome results. Changes in the infrarenal neck over time were compared with the suprarenal aorta for each patient. RESULTS: Follow-up extended to 4.8 years for the BES and to 4.6 years for the SES, with no significant difference in median follow-up time (34 months for BESs and 24 months for SESs; P = .06). There were no differences in preimplant neck diameter (25.2 ± 0.9 mm vs 25.7 ± 1.1 mm; P = .54) or length (27.7 ± 3.7 mm vs 23.6 ± 3.7 mm; P = .12) between BESs and SESs at baseline. After implantation, neck diameter increased by 1.1 ± 0.5 mm in BES patients and 2.6 ± 0.5 mm in SES patients (P = .07) compared with the preoperative diameter. At 3 years, neck diameter increased by 0.5 ± 0.9 mm in BES patients and by 3.8 ± 1.0 mm in SES patients (P = .0002) compared with the first postoperative CT scan. The annual postimplant rate of increase in the infrarenal neck diameter was fivefold greater in SES patients (1.1 ± 0.1 mm/y) than in BES patients (0.22 ± 0.04 mm/y; P < .0001). There were no significant differences in the diameter of the suprarenal aorta at baseline or at 3 years and no differences in the annual rate of change in suprarenal aortic diameter between BES and SES endografts. CONCLUSIONS: EVAR using SES endografts resulted in progressive infrarenal aortic neck enlargement, whereas EVAR using BES endografts resulted in no neck enlargement over time. These data suggest that infrarenal neck enlargement after EVAR with SES endografts is likely related to the force exerted by SES elements rather than disease progression in the infrarenal neck.

Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery.

UNLABELLED: An increasing number of patients with abdominal aortic aneurysms are treated using endovascular rather than open surgical techniques. The Vascular Surgery Center, P. Stradins Clinical University Hospital, has the largest worldwide experience using a new type of endoprosthesis, which fills and anchors the device in the aneurysm sac. Within the framework of a clinical trial, the quality-of-life evaluation of patients treated using this type of device was carried out. MATERIALS AND METHOD: A cohort study was conducted from 2008 to 2011 comparing the quality of life (QOL) of patients after abdominal aortic aneurysm repair with either the new endovascular treatment method (EVAR) or open surgery (OS). Each group comprised 20 patients, and the quality-of life-evaluation was performed using the SF-36 questionnaire before operation, 1 month after operation, and 1 year after operation. RESULTS: One month after operation, an improved QOL was documented in the EVAR group (47 [SD, 3] in the EVAR group vs. 38 [SD, 3] in the OS group, P<0.001). One year after operation, a significant improvement in QOL persisted although the difference between the groups diminished (48 [SD, 4] in the EVAR group vs. 42 [SD, 3] in the OS group, P<0.001). CONCLUSIONS: The patients with abdominal aortic aneurysms who underwent EVAR using the new sac-anchoring endoprosthesis have improved health-related quality of life compared to the patients undergoing open surgical repair. The improvement in quality of life remained slightly better in the EVAR group 1 year after operation.