Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.

OBJECTIVES: We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). METHODS: The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. RESULTS: Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. CONCLUSIONS: This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aorto-Iliac Occlusive Disease.

Endovascular treatment options of aorto-iliac occlusive disease have emerged, leading to better outcomes in more complex pathology, which typically involves a reconstruction of the aortic bifurcation. The Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) configuration was introduced in 2013, in an attempt to optimize outcomes, when compared to the kissing stent configuration, which was traditionally the preferred endovascular technique for this pathology. CERAB aims to optimize geometry, and with that the arterial flow patterns that are associated with loss of patency. In CERAB, the aortic bifurcation is reconstructed using three balloon-expandable covered stents in a tight connection with each other and with an appropriate wall apposition, thereby minimizing geometrical mismatch (Fig. 1a-c). The reconstruction can be extended on both sides and could be combined with chimney, or parallel, grafts in aortic side branches that need to be preserved. In the current paper, the details of the CERAB technique are described and supported by evidence derived from pre-clinical studies that confirm the more optimal geometry and flow patterns compared to kissing stents. Also, a summary is provided of published clinical evidence, including technical and clinical outcomes of the technique. These data show promising early results, with patency rates in line with those achieved with open surgery, also in patients with extensive disease. Finally, the potential modes of failures and future developments are discussed.

Drug-coated balloon angioplasty for the treatment of edge stenosis after self-expanding covered stent placement for superficial femoral artery occlusive disease.

BACKGROUND: Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. PURPOSE: The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. METHOD: We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). RESULTS: A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). CONCLUSION: The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

Update on covered endovascular reconstruction of the aortic bifurcation.

OBJECTIVE: The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique was introduced in 2009 in order to provide an anatomically and physiologically optimal endovascular reconstruction of the aortic bifurcation. METHOD: In the current review, all available evidence on this technique was summarized. RESULTS: In vitro studies have shown a more favorable geometry of CERAB compared to kissing stents, leading to better local flow conditions. The results of CERAB are at least as good as those achieved with kissing stents in a more complex group of treated patients. The mid-term patency rates approach those of surgical reconstruction. Initial data show that the technique can also be used in combination with chimney grafts in order to preserve side branches. CONCLUSION: CERAB has proven to be the most optimal endovascular treatment option for aorto-iliac occlusive disease with regard to geometry and flow and is related to promising clinical outcomes. Prospective and comparative trials are necessary to elucidate the most optimal treatment algorithm for patients with aorto-iliac occlusive disease.

Pulmonary complications and survival after elective infrarenal endovascular abdominal aneurysm repair in patients with documented chronic obstructive pulmonary disease.

BACKGROUND: Elective abdominal aortic aneurysm (AAA) repair is advocated in patients where risk of rupture exceeds the risks of peri-procedural morbidity and mortality. Chronic obstructive pulmonary disease (COPD) is a known risk factor for AAA and increased operative morbidity in general. Since literature on the correlation between the clinical classification of COPD and morbidity following endovascular infrarenal AAA repair (EVAR) is scarce, assessment per individual remains a challenge. OBJECTIVE: To analyse the pulmonary and all-cause morbidity and mortality in patients with documented COPD and relate this to their GOLD classification. METHODS: Sixty-eight patients with COPD, documented by a lung function test, who underwent elective EVAR between July 2002 and July 2018 were retrospectively reviewed. The primary endpoint was the incidence of 30-day pulmonary adverse events. Procedural characteristics, length of hospital stay, pulmonary and all-cause morbidity including major adverse events (MAEs) during follow-up and five-year survival divided per GOLD classification were the secondary endpoints. RESULTS: There was no statistically significant difference in the incidence of pulmonary adverse events between GOLD I/II and GOLD III/IV patients. There was neither procedural nor 30-day mortality in either group. Through 30 days and 1 year, there was no difference in pulmonary and all-cause morbidity between groups. Three MAEs occurred in the GOLD I/II group versus 2 MAE in the GOLD III/IV group during the first postoperative year. The five-year survival was 66.0%, 60.9% and 61.9% for patients with GOLD I, GOLD II and GOLD III, respectively. Three of four GOLD IV died within the first year after EVAR. CONCLUSION: EVAR can be safely performed in patients with COPD, with low 30-day morbidity and mortality rates. Although severe co-morbidity should be taken into account, EVAR seems to be justified in patients with COPD with a GOLD classification I, II or III. Further research should focus on optimising the pulmonary condition in patients selected for EVAR.

The Nellix™ EndoVascular sealing system in patients with abdominal aortic aneurysms in conjunction with iliac artery occlusive disease.

Introduction Concomitant abdominal aortic aneurysm formation and aortoiliac occlusive disease is a challenging combination, often requiring open reconstructive surgery. In this study, we have assessed a single center experience of the Nellix EndoVascular Aneurysm Sealing System in the treatment of an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Methods Retrospectively case files of patients treated with Nellix EndoVascular Aneurysm Sealing System in a single center were reviewed. The primary endpoints of the study were the technical success of Nellix EndoVascular Aneurysm Sealing System in patients with coincidental iliac artery occlusive disease and the successful exclusion of the aneurysm during follow-up. Results Of the 96 patients that were treated with Nellix EndoVascular Aneurysm Sealing System, five were identified that had an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Treated patients had either unilateral (n = 4) or bilateral (n = 1) common iliac artery occlusive disease varying from 70% stenosis to complete occlusions. The lesion length varied from 5 to 50 mm and in two cases it involved an occluded bare metal stent. The indication for surgery was the abdominal aortic aneurysm in all patients, including three also suffering from claudication. In all patients the iliac artery occlusive disease was pretreated with balloon-expandable covered stents. Technical success was achieved in all five patients. After a median follow-up of nine months all stents were patent with no signs of endoleak and stable aneurysm diameters. All patients were free of intermittent claudication or ischemic wounds. Conclusion Nellix EndoVascular Aneurysm Sealing System seems feasible and safe in patients with a combination of abdominal aortic aneurysm and iliac artery occlusive disease.

In vivo geometry of the kissing stent and covered endovascular reconstruction of the aortic bifurcation configurations in aortoiliac occlusive disease.

Objectives Various configurations of kissing stent (KS) configurations exist and patency rates vary. In response the covered endovascular reconstruction of the aortic bifurcation configuration was designed to minimize mismatch and improve outcome. The aim of the current study is to compare geometrical mismatch of kissing stent with the covered endovascular reconstruction of the aortic bifurcation configuration in vivo. Methods Post-operative computed tomographic data and patient demographics from 11 covered endovascular reconstruction of the aortic bifurcation and 11 matched kissing stent patients were included. A free hand region of interest and ellipse fitting method were applied to determine mismatch areas and volumes. Conformation of the stents to the vessel wall was expressed using the D-ratio. Results Patients were mostly treated for Rutherford category 2 and 3 (64%) with a lesion classification of TASC C and D in 82%. Radial mismatch area and volume for the covered endovascular reconstruction of the aortic bifurcation group was significantly lower compared to the kissing stent configuration ( P < 0.05). The D-ratio did not significantly differ between groups. Measurements were performed with good intra-class correlation. There were no significant differences in the post-procedural aortoiliac anatomy. Conclusions The present study shows that radial mismatch exists in vivo and that large differences in mismatch exist, in favour of the covered endovascular reconstruction of the aortic bifurcation configuration. Future research should determine if the decreased radial mismatch results in improved local flow profiles and subsequent clinical outcome.

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair.

Since the introduction of fenestrated endovascular aneurysm repair (FEVAR) in 1996, great advances have been made in endograft development. Custom-made and off-the-shelf fenestrated and branched endografts have been used to treat patients with complex abdominal aortic and thoraco-abdominal aneurysms. Most experience has been gained with the Cook Zenith® fenestrated endograft (Cook Medical Inc., Limerick, Ireland). The Cook Zenith® endograft is customized with fenestrations, (fixed) inner or outer branches, or a combination of them, to cover a wide range of complex aneurysms. There are limitations to the number, location, and size of the fenestrations and to the maximal angulation of the aorta. Because the production of a custom-made fenestrated endograft takes several weeks, and is therefore not available for emergency cases, off-the-shelf fenestrated endograft were developed. One of these grafts was the Endologix Ventana™ (Endologix, Inc., Irvine, California). This endograft was withdrawn from enrollment due to a high reintervention rate. Vascutek Ltd. developed the custom-made Vascutek Fenestrated Anaconda™ endograft (Vascutek Ltd., Inchinnan, Scotland) to treat patients where other endografts were not suitable-like in a more tortuous aorta with an angulation up to 90°. Additionally, the unsupported proximal body enables a high number and large size of fenestrations if needed. First reports of custom-made fenestrated and (inner and outer) branched JOTEC E-xtra DESIGN ENGINEERING (JOTEC GmbH, Hechingen, Germany) for aortic aneurysms seem promising, but larger series need to be reported to be able to draw conclusions. Both custom-made Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have good reported clinical outcomes with a perioperative mortality between 4.1 and 6.7% and a reintervention rate of <10% at one year. Knowledge on the long-term outcome of both devices is still limited.

Long-term results and predictors of failure after mechanochemical endovenous ablation in the treatment of primary great saphenous vein incompetence.

BACKGROUND: Mechanochemical endovenous ablation (MOCA) was introduced to treat superficial venous insufficiency of the lower leg with less pain and haematoma. Long-term outcome is still lacking. The purpose was to report long-term outcome and to analyse possible predictors for failure. METHODS: The study was a retrospective pooled analysis of two prospective cohorts previously reported, but with prolonged long-term outcome up to 5-years follow-up. RESULTS: 163 treated legs were analysed. Mean follow-up was 5.4±0.6 years, in which 33 total failures occurred. Four procedures were partially successful. VCSS improved significantly and remained stable after 1 and 2-years, but significantly rose again after 5-years. AVVQ dropped significantly, but increased after 1 year to 4.3 and 6.1 at 5-years follow-up. CONCLUSION: MOCA was effective with minimal pain perioperative. However, anatomical success deteriorated after 1-year and showed even less results after 5-years, mainly due to partly recanalization, while clinical results were less affected. There were no clear clinical predictors for failure.