Three-Year Patency Results following Endovascular Transvenous Femoropopliteal Bypass.

Background and Objectives: Peripheral artery disease is one of the most common vascular pathologies. There is an ongoing debate among specialists on whether open or endovascular revascularization is preferred in cases of complex superficial femoral artery (SFA) lesions. The purpose of this study was to assess patency results of a relatively new transvenous endovascular bypass device. This could add to existing evidence and aid in comparison between open and endovascular bypass. Materials and Methods: Patients with complex TASC-C and D SFA lesions who had indications for revascularization were identified. Prospective analysis of stent graft patency from 54 transvenous femoropopliteal bypass procedures was performed. Patency was assessed by Duplex ultrasound every six months. Kaplan-Meier analysis was performed to assess primary, primary-assisted, and secondary patency of transvenous bypass. Results: Following endovascular transvenous femoropopliteal bypass, 3-year graft primary, primary-assisted, and secondary patency was 43.8%, 66.3%, and 73.9%, respectively. Conclusions: Transvenous endovascular femoropopliteal bypass is a viable option for selected patients who lack adequate saphenous vein or have comorbidities that increase the risk of open femoropopliteal bypass. Strict post-operative follow-up is necessary to improve patency rates.

Long term clinical and functional venous outcomes after endovascular transvenous femoro-popliteal bypass.

BACKGROUND: Peripheral artery disease is widespread in Western societies affecting around 13% of the population above 50 years of age. Despite recent improvements of endovascular treatment, open surgical bypass is still recommended as the treatment of choice for long segment TASC D lesions. The DETOUR procedure was introduced as an endovascular alternative in cases of long-segment superficial femoral artery occlusion. This unconventional technique raises several questions regarding the effect of the bypass graft on femoral venous physiology. METHODS: We conducted a 3-year follow-up study of subjects enrolled and treated in the prospective, multicenter DETOUR study at the Pauls Stradins clinical university hospital, Riga, Latvia. In total, 52 consecutive patients (54 procedures) were enrolled in this study from 2015 until 2019. We performed Venous Clinical Severity Score (VCSS) and Villalta (VS) Score assessments, Duplex ultrasound measuring femoral and popliteal vein diameters, venous occlusion plethysmography and digital photoplethysmography to assess and compare venous physiology at baseline and at follow-up visits every 6 months. RESULTS: At baseline mean femoral vein diameter was 11.1 mm (SD=1.5). At 36-months following intraluminal stent-graft placement, mean femoral vein diameter was 11.1 mm (SD=1.7) with no evidence of enlargement of the femoral vein (P=0.2). Popliteal vein diameter was not significantly changed during 24-months of follow-up (P=0.12) but showed a small (0.02 mm) statistically significant decrease in diameter at 36-months compared to baseline. During the study period, only one patient (1.9%) developed clinically significant ipsilateral DVT 1-month after surgery. Clinically silent femoral venous thrombosis was documented in 8 legs during 36-month follow-up. In one case the thrombus was occlusive and in 7 cases the thrombus was non-occlusive. At baseline, 48 of 52 patients (92%) had no or minor venous symptoms ([VCSS 0-2] with clinically significant venous symptoms in only 4 patients [VCSS≥3]). At one-month follow-up, the venous clinical severity score increased in all patients compared to baseline. At 6-month follow-up, the VCSS had returned to baseline in the majority of patients with no significant changes during the 3-year follow-up period. At baseline, all patients had a VS of 0-2 indicating minor or no venous symptoms (mean 0.4 [SD 0.7]). At the 1-month follow-up visit 3 patients (5.8%) had a VS≥3 (two patients had a score of 3 and one patient a score of 4), indicating significant venous symptoms. At the 6-month visit and thereafter, all the VS in all patients had returned to baseline. Transvenous endovascular procedure did not significantly alter venous physiology in treated leg. CONCLUSIONS: Percutaneous transvenous femoropopliteal bypass provided safe and effective lower-extremity revascularization with minimal effect on long-term venous function. The femoral and popliteal vein remained patent with no compensatory enlargement in response to the presence of the bypass graft within the femoral vein. During 3-year follow-up there were no significant changes in venous symptom scores or physiologic function.

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System.

PURPOSE: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. MATERIALS AND METHODS: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. RESULTS: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan-Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. CONCLUSIONS: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass.

OBJECTIVE: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease. METHODS: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR. RESULTS: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism. CONCLUSIONS: The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.

Endovascular thrombectomy in anterior circulation stroke and clinical value of bridging with intravenous thrombolysis.

BACKGROUND: Bridging treatment with intravenous thrombolysis (IVT) before endovascular thrombectomy (EVT) in acute ischemic stroke is applied under the assumption of benefits for patients with large vessel occlusion (LVO). However, the benefit of this additional step has not yet been proven. PURPOSE: To compare procedural parameters (procedural time, number of attempts), complications, and clinical outcome in patients receiving EVT vs. patients with bridging treatment. MATERIAL AND METHODS: In this prospective study all patients had acute anterior cerebral circulation occlusion and were treated with EVT. All patients were selected for treatment based on clinical criteria, multimodal computed tomography (CT) imaging. Eighty-four patients were treated with bridging IVT followed by EVT; 62 patients were treated with EVT only. RESULTS: Bridging therapy did not influence endovascular procedure time ( P = 0.71) or number of attempts needed ( P = 0.63). Bleeding from any site was more common in the bridging group (27, 32%) vs. the EVT group (12, 19%) ( P = 0.09). Functional independence modified Rankin Scale after 90 days was slightly higher in the bridging group (44%) vs. the EVT group (42%) ( P = 0.14). Mortality did not differ significantly at 90 days: 17% in the bridging group vs. 21% in EVT alone ( P = 0.57). Both treatment methods showed high recanalization rates: 94% in the bridging group and 89% for EVT alone. CONCLUSION: Bridging treatment in LVO did not show benefits or elevated risks of complications in comparison to EVT only. The bridging group did not show significantly better neurological outcome or significant impact on procedural parameters vs. EVT alone.

Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair.

PURPOSE: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double "D-shaped" stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. METHODS: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). RESULTS: Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5-50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. CONCLUSION: Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.

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.

Editor's Choice - Occurrence and Classification of Proximal Type I Endoleaks After EndoVascular Aneurysm Sealing Using the Nellix™ Device.

OBJECTIVE/BACKGROUND: Proximal type I endoleaks are associated with abdominal aortic aneurysm (AAA) growth and rupture and necessitate repair. The Nellix™ EndoVascular Aneurysm Sealing (EVAS) system is a unique approach to AAA repair, where the appearance and treatment of endoleaks is also different. This study aimed to analyse and categorise proximal endoleaks in an EVAS treated cohort. METHODS: All patients, treated from February 2013 to December 2015, in 15 experienced EVAS centres, presenting with proximal endoleak were included. Computed tomography scans were analysed by a core laboratory. A consensus meeting was organised to discuss and qualify each case for selection, technical aspects, and possible causes of the endoleak. Endoleaks were classified using a novel classification system for EVAS. RESULTS: During the study period 1851 patients were treated using EVAS at 15 centres and followed for a median of 494 ± 283 days. Among these, 58 cases (3.1%) developed a proximal endoleak (1.5% early and 1.7% late); of these, 84% of 58 patients were treated outside the original and 96% outside the current, refined, instructions for use. Low stent positioning was the most likely cause in 44.6%, a hostile anatomy in 16.1%, and a combination of both in 33.9%. Treatment, by embolisation or proximal extension, was performed in 47% of cases, with a technical success of 97%. CONCLUSION: The overall incidence of proximal endoleak after EVAS is 3.1% after a mean follow-up period of 16 months, with 1.5% occurring within 30 days. Their occurrence is related to patient selection and stent positioning. Early detection and classification is crucial to avoid the potential of sac rupture.

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.

Imaging After Nellix Endovascular Aneurysm Sealing: A Consensus Document.

Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications.

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.