Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes.

INTRODUCTION: The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). METHODS: Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA). RESULTS: Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2-620) days, 3 more patients died due to non-aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches. CONCLUSION: The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance. CLINICAL IMPACT: This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients.

Y una vez más: respetemos las instrucciones de uso y no tentemos a la suerte / And once again: Respect the instructions for use and let us not tempt fate

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The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial.

BACKGROUND: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. METHODS/DESIGN: This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality. DISCUSSION: EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

Actualización sobre las características pronósticas y el manejo terapéutico de la úlcera aórtica penetrante / Prognosis and therapeutic management of penetrating aortic ulcer. An update

La úlcera aórtica penetrante es una entidad poco frecuente e infradiagnosticada con características propias respecto la disección clásica. Se presenta una revisión actualizada de la enfermedad centrándose sobre todo en las características pronósticas y el manejo terapéutico

Penetrating aortic ulcer is a rare and underdiagnosed condition, with its own characteristics regarding classical dissection. An updated review is presented, focusing on its prognosis and therapeutic management

Evolución terapéutica y controversias actuales en la cirugía de los aneurismas toracoabdominales / Therapeutic outcomes and current controversies in thoracoabdominal aneurysm surgery

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Aneurysmal degeneration of the inflow artery after arteriovenous access for hemodialysis.

OBJECTIVES: After arteriovenous fistula creation, the arterial flow increase can lead to aneurysmal degeneration, even increased after fistula ligation or renal transplant immunosuppression. The aim of this study is to describe the therapeutic options and outcomes of true aneurysms of the inflow artery after arteriovenous fistula for hemodialysis. METHODS: Prospectively collected data of patients with true aneurysmal degeneration of the inflow artery after fistula creation (excluding pseudoaneuryms, anastomotic or infected aneurysms, or surgical complications), surgically repaired between January 2010 and February 2014 (cohort study) have been included. Patient demographics and access characteristics, symptoms, treatment, and follow-up have been reviewed. RESULTS: 12 patients (75% men, median age 63 years) were treated for aneurysmal degeneration of the axillary (1), brachial (6), or radial (5) artery. They had had a previous distal arteriovenous fistula (7 radiocephalic, 3 brachiocephalic, 2 brachiobasilic) created 15.6 years before (range 9.9-28.5) and the majority of them were currently ligated or thrombosed. Most patients were symptomatic (pain [6], distal embolization [1]). They were treated by means of a bypass (using the cephalic [3], basilic [4], or saphenous vein [2]), direct ligature (2), or excision with end-to-end reconstruction (1). No major complications or ischemic symptoms occurred before discharge. After a median follow-up of 8.6 months (3.1-36.5), one patient needed re-operation for new proximal brachial aneurysmal degeneration, and another presented with an asymptomatic post-traumatic thrombosis of the proximal axillary artery and brachial bypass. No other complications, bypass dilatation or ischemic symptoms occurred during follow-up. CONCLUSIONS: Inflow artery aneurysmal degeneration can occur after long-term arteriovenous access. Surgical treatment by autogenous bypass exclusion in most cases (or ligation or end-to-end reconstructions in selected cases) is a safe and effective option.

Secondary procedures in thoracic aorta.

Secondary procedures for thoracic aorta are very demanding to the patient, with significantly high perioperative mortality and morbidity. The aim of this paper was to review the most remarkable secondary procedures following open and endorepairs of thoracic aorta. The PubMed database was searched without any year limits. Search terms used %were "thoracic", "aorta" and "reintervention". Two authors independently reviewed abstracts identified by the search and subsequently the reference lists of eligible series were scrutinized in order to detect any additional relevant articles. Different early and late complications following open an endovascular repair of thoracic aorta were described adding their incidence and their potential solutions with secondary interventions. Secondary interventions after open repair (OR) are more related to bleeding and progression of the aortic disease issues and open surgery is again the most common solution. However, in more fragile patients with favorable anatomy, endovascular repair can be offered as a secondary procedure. Reinterventions after endovascular treatment of thoracic aorta diseases (TEVAR) are mostly related to endoleaks and also to the aortic disease progression. Hopefully, the oncoming technological improvements together with the optimized operator expertise can reduce the incidence of secondary procedures following TEVAR for all the aortic pathologies.

Real-world performance of the new C3 Gore Excluder stent-graft: 1-year results from the European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT).

OBJECTIVES: The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) provides "real-world" outcomes for the new C3 Gore Excluder stent-graft, and evaluates the new deployment mechanism. This report presents the 1-year results from 400 patients enrolled in this registry. METHODS: Between August 2010 and December 2012, 400 patients (86.8% male, mean age 73.9 ± 7.8 years) from 13 European sites were enrolled in this registry. Patient demographics, treatment indication, case planning, operative details including repositioning and technical results, and clinical outcome were analyzed. RESULTS: Technical success was achieved in 396/400 (99%) patients. Two patients needed intraoperative open conversion, one for iliac rupture, the second because the stent-graft was pulled down during a cross-over catheterization in an angulated anatomy. Two patients required an unplanned chimney renal stent to treat partial coverage of the left renal artery because of upward displacement of the stent-graft. Graft repositioning occurred in 192/399 (48.1%) patients, most frequently for level readjustment with regard to the renal arteries, and less commonly for contralateral gate reorientation. Final intended position of the stent-graft below the renal arteries was achieved in 96.2% of patients. Thirty-day mortality was two (0.5%) patients. Early reintervention (≤30 days) was required in two (0.5%) patients. Mean follow-up duration was 15.9 ± 8.8 months (range 0-37 months). Late reintervention (>30 days) was required in 26 (6.5%) patients. Estimated freedom from reintervention at 1 year was 95.2% (95% CI 92.3-97%), and at 2 years 91.5% (95% CI 86.8-94.5%). Estimated patient survival at 1 year was 96% (95% CI 93.3-97.6%) and at 2 years 90.6% (95% CI 85.6-93.9%). CONCLUSIONS: Early real-world experience shows that the new C3 delivery system offers advantages in terms of device repositioning resulting in high deployment accuracy. Longer follow-up is required to confirm that this high deployment accuracy results in improved long-term durability.

Current technology for the treatment of infection following abdominal aortic aneurysm (AAA) fixation by endovascular repair (EVAR).

In recent years, in parallel with the increase of endovascular aortic repair (EVAR) procedures performances, a rise of late open surgical removal of EVAR implants has been observed, due to non-endovascularly correctable graft complications. Among them endograft infection is a rare but devastating occurrence, accounting for an incidence ranging from 0.2% to 0.7% in major series, and almost 1% of all causes of endograft explantations. However, a real estimation of the incidence of the problem respect to the number of EVAR implantations is difficult to obtain. Time to infection is usually defined as the period between EVAR and presentation of symptoms that leads to the infection diagnosis. It can be extremely variable, depending on bacterial virulence and host conditions. The diagnosis of an endograft infection is usually based on a combination of clinical symptoms, imaging studies and microbial cultures whenever possible. If computed tomography (CT) scan is employed in almost 100% of infection diagnosis, a combination of fluorodeoxyglucose-positron emission tomography (FDG-PET) and CT scan is nowadays used with increasing frequency in order to rise the likelihood of detecting a graft infection, since even cultures of blood or samples collected from the infected field can sometimes be negative. Complete graft excision seems the best approach whenever a surgical reconstruction could be attempted. In situ reconstruction can be performed by the interposition of an autologous vein, a cryopreserved allograft or a rifampin-soaked Dacron graft. The so-called conventional treatment contemplates the re-establishment of vascularization through extranatomical routes, thus preserving the new graft material from possible contamination by the surgical field just cleaned. When severe comorbid conditions did not allow graft excision, a conservative treatment should be taken into account. It is mainly based on broad-spectrum or culture-specific antibiotic therapy combined, whenever possible, with percutaneous drainage of the infectious cavity or aneurismal sac followed by irrigation with saline and antibiotic solutions. New techniques of percutaneous drainage under CT scan guidance can allow expedite collection of fluid material for microbial culture or fluid drainage, catheter positioning to collect infectious material from the cavity and perform irrigation of the infected field or injection of iodine contrast when the suspicion of aortoenteric fistula exists.

The best conditions for parallel stenting during EVAR: an in vitro study.

OBJECTIVES: The aim of this study is to identify which endograft, and to what degree of oversizing, in combination with what type of parallel stent, may result in the most adequate fit in a juxtarenal abdominal aneurysmal neck when using a parallel-stent technique. MATERIALS/METHODS: In-vitro silicon aneurysmal neck models of different diameters, with one side-branch, were constructed. Two different endografts (Medtronic-Endurant Abdominal Stent Graft and Gore-Excluder abdominal aortic aneurysm Endoprosthesis; three diameters each), and two stents (self-expanding Gore Viabahn Endoprosthesis and balloon-expandable Atrium Advanta V12; 6-mm diameter) were tested, applying three endograft-oversizing degrees (15%, 30% and 40%). After remodelling using the kissing-balloon technique at 37 °C, the 36 endograft-stent-oversizing combinations were scanned by computed tomography (CT). The size of the results in gutters, parallel-stent compression and main stent-graft infolding were recorded. RESULTS: Increasing oversizing (15%, 30% and 40%) significantly decreased gutter areas (11.5, 6.2, 4.3 mm(2), P < 0.001); nevertheless, main endograft infolding of most 40%-oversized stent grafts was detected, particularly with Excluder devices. Lower stent compression, but wider gutters, were observed with the Excluder when compared to Endurant stent grafts, and with V12 when compared to Viabahn parallel stents. The Endurant-Viabahn combination resulted in maximum stent compression (35%). CONCLUSIONS: Better endograft-stent apposition was achieved when using 30% endograft oversizing. Lower stent compression, but wider gutters, were observed with the Excluder stent-graft and V12 parallel stent, achieving maximum stent compression with the Endurant-Viabahn combination.

The Bolton Treovance abdominal stent-graft: European clinical trial design.

Endovascular aortic repair (EVAR) has emerged as a promising, less invasive alternative to conventional open surgery for the treatment of infrarenal abdominal aortic aneurysms (AAAs). In the last 20 years, the application rate of EVAR and its clinical results have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary re-interventions. The Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain) is a new-generation endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. In particular, it is provided with some innovative features as a double layer of proximal barbs (suprarenal and infrarenal) for supplemental fixation, dull barbs between modules to avoid potential leg disconnections, detachable outer sheath provided with a new-design hemostatic valve, and a double improved mechanism (slow motion and "pin and pull") for precise stent-graft deployment. A European prospective, non-randomized, multi-institutional, "first-in-human" trial (the ADVANCE trial) was conducted from March to December 2011 to assess the safety and performance of the Treovance stent-graft system before commercialization. Thirty patients with anatomically suitable non-ruptured AAAs were enrolled at five clinical sites in Italy, Spain, and Germany. EVAR was completed successfully in all patients. The stent-graft was delivered and deployed safely even in heavily angulated or calcified anatomies. No 30-day device-related complications nor deaths were observed. Preliminary experience with the Treovance abdominal stent-graft within the ADVANCE trial was satisfactory with regard to technical success and perioperative clinical results. Follow-up data are needed to assess mid- and long-term clinical outcomes, along with durability of this new-generation endovascular device.

Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients.

OBJECTIVE: The ENGAGE registry was undertaken to examine the real-world outcome after endovascular abdominal aortic aneurysm (AAA) repair (EVAR) with the Endurant Stent Graft in a large, contemporary, global series of patients. METHODS: From March 2009 to April 2011, 1262 AAA patients (89.6% men; mean age 73.1 years, range 43-93 years) were enrolled from 79 sites in 30 countries and treated with Endurant. Results are described following the reporting standards for EVAR. Follow-up data were tabulated for all 1262 patients at a 30-day follow-up and for the first 500 patients at a 1-year follow-up. RESULTS: Intra-operative technical success was achieved in 99.0% of cases. Within 30 days, adverse events were reported in 3.9% of patients, including a 1.3% mortality rate. Type-I or -III endoleaks were identified in 1.5% of cases. Estimated overall survival, aneurysm-related survival and freedom from secondary interventions at 1 year were 91.6%, 98.6% and 95.1%, respectively. At 1 year, aneurysm size increased ≥ 5 mm in 2.8% and decreased ≥ 5 mm in 41.3% of cases. CONCLUSION: Early results from this real world, global experience are promising and indicate that endovascular AAA repair with the Endurant Stent Graft is safe and effective across different geographies and standards of practice. Longer-term follow-up is necessary to assess durability of these results.

No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry.

AIM: This study aimed to compare the differences in perioperative outcome after endovascular repair of symptomatic abdominal aneurysms (S-AAAs) and elective non-symptomatic AAAs (E-AAAs). Data from the ENGAGE Registry were used for the analysis. METHODS: Between March 2009 and December 2010, 1200 AAA patients were enrolled from 79 sites in 30 countries and treated with an Endurant Stent Graft. S-AAAs defined as AAAs accompanied by abdominal or back pain, without rupture, were present in 185 (15.4%) patients and E-AAAs in 1015 (84.6%) patients. Multivariate logistic regression was used to compare results. RESULTS: At baseline, E-AAA patients had larger aneurysms on average (P = 0.006) and scored higher ASA classification more often (P = 0.001). Further analyses were corrected for baseline differences. Operation time and technical success were comparable, and S-AAAs were admitted to the Intensive Care Unit (ICU) as often as E-AAAs (35.7% vs. 33.4%, P = 0.479). Post-operative hospitalisation was similar (4.83 ± 5.29 in E-AAAs and 4.37 ± 3.49 in S-AAAs, P = 0.360). No differences in the occurrence of major adverse events, including mortality, within the 30-day post-implantation were seen between S-AAA and E-AAA patients, respectively, 3.2% and 4.2% (P = 0.572). CONCLUSION: With contemporary devices and technical proficiency, there is no difference in outcome between symptomatic AAA and elective non-symptomatic AAA patients if treated with endovascular techniques.

Worldwide experience with the Endurant Stent graft: review of the literature.

The Endurant Stent-graft System (Medtronic Vascular, Santa Rosa, CA) is a next-generation device intended to expand the applicability of endovascular aortic repair (EVAR). To date, the Endurant has been evaluated in 9 short- and intermediate-term studies, several in patients presenting with challenging aneurysm anatomies. Consistently, the device in these studies has been shown to be safe and effective, with an excellent rate of deployment success and with very low rates of type I/III endoleaks and reinterventions. Single center experience with Endurant in challenging anatomies with short kinked necks and calcified angulated iliac arteries in patients unfit for open repair and challenging anatomies show promising early results with no difference in mortality, morbidity and reintervention rates, but need cautious application for EVAR outside of the device-specific IFU. The Endurant Stent-graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1266-patient 80-site worldwide prospective postmarket study initiated to augment the knowledge base (poolable and comparable) about EVAR in a real-world population implanted with the Endurant. Technical and clinical data for ENGAGE patients will be reported through the expected completion of 5-year follow-up for all ENGAGE registry patients in 2018. We discuss the evolving challenges for EVAR that the Endurant and other next-generation stent-grafts are designed to address and review outcomes published with the Endurant since the CE marking of the device in July 2008.

Early abdominal aortic endografts: a decade follow-up results.

OBJECTIVES: To report the results of long-term follow-up of abdominal aortic aneurysms (AAAs) treated with endografts more than a decade ago. DESIGN: Retrospective analysis of estimated long-term follow-up, mortality and morbidity in terms of complications and re-interventions, using the Kaplan-Meier survival analysis. MATERIALS/METHODS: Between March 1997 and January 2000, 61 patients with AAA (53 asymptomatic, four symptomatic and three ruptured) were treated with aortic endografts. All preoperative, operative and follow-up data were recorded according to the EUROpean collaborators on Stent graft Techniques for abdominal aortic Aneurysm (EUROSTAR) criteria. RESULTS: The primary technical success rate was 98.4%. The majority of used devices were Vanguard (65.0%), and in a bifurcated configuration (86.7%). At 10-year follow-up, the estimated cumulative follow-up rate was 82.0%; complications occurred in 74.6% of the patients and re-interventions were required in 56.9%. The Vanguard endograft was related to a higher incidence of re-interventions (P=0.012). The combined in-hospital or AAA-related mortality rate was 5.0% at 30 days and 8.2% at a 10-year follow-up (1.8% and 5.0% in elective cases, respectively). CONCLUSIONS: Early abdominal endografts are associated with high incidence of complications (74.6%) and re-interventions (56.9%) at a 10-year follow-up; however, the mortality rate related to the procedure or aneurysm is low (5.0% in elective cases). Early endografts need lifelong strict surveillance.

Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled.

AIM: The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1200-patient multicenter prospective study initiated to augment the knowledge base (poolable and comparable) about endovascular aortic repair (EVAR) in a real-world population implanted with a single latest-generation stent graft system (Endurant). With enrollment ongoing at 80 high-volume sites, the registry has limited inclusion/exclusion criteria or procedural specification. Technical and clinical data will be reported through 5 years. METHODS: An interim analysis was performed on investigator-reported data for the first 180 patients enrolled. These patients were asymptomatic elderly males (92.1%) with considerable comorbidities. For 47.3% of the patients, the American Society of Anesthesiologists risk class was either III or IV. The Endurant stent graft was successfully deployed in 99.4% of patients for elective treatment of abdominal aortic aneurysm. RESULTS: Through 30 days, the rate of all-cause mortality was 1.7% (N=3), with all 3 deaths classified as procedure-related but not device-related. The rate of secondary endovascular procedures was 1.1%, and the rate of conversion to open repair was 0.6%. At postprocedure and at 30-day follow-up, there were no type I or type III endoleaks and no instances of stent graft kinking, thrombosis, or occlusion. ENGAGE represents the largest real-world registry for any single EVAR stent graft. CONCLUSION: The interim results through 30 days of the first 180 patients enrolled are promising. Longer-term follow-up for more patients will be reported.

European experience with Relay: a new stent graft and delivery system for thoracic and arch lesions.

AIM: Thoracic endografting is a very attractive therapeutic approach for thoracic aorta pathologies. Still some technological limitations need to be solved. Relay represents a new endograft specifically designed for thoracic aorta. The two-year clinical outcomes are presented. METHODS: RESTORE is a multicenter, European, prospective and monitored clinical registry. Patients with thoracic pathologies (acute or elective) suitable to be treated with Relay stent-graft were consecutively enrolled. Preoperative demographic data, procedure details, in hospital assessment and two year-follow-up outcomes were registered and analyzed. RESULTS: A cohort of 150 patients (125 males and 25 females) was included. Aneurysm was the most common pathology treated (64.7%) followed by dissections (19.3%). Overall technical success rate was 97.33%. Paraplegia rate was 3.3%, recovered paraparesis in 3.3% of the cases and stroke rate was only 0.6%. Successful reinterventions were necessary in 8.7% of the cases; one trans-thoracic intervention due to a retrograde type A dissection. The 30-day mortality rate was 10%. Four non-related mortality were recorded during surveillance. Reintervention rate during two year-follow-up was 8.9% due to two stent graft migrations, three proximal type I endoleak, four type III endoleak and five distal type I endoleaks. No open conversion was needed during follow-up. No wire form ruptures were observed during the follow-up period. CONCLUSION: Relay provides a safe and accurate thoracic stent grafting for different aortic pathologies with acceptable mortality and morbidity. Associated stroke rate was clearly inferior to the expected.