Endosutured aneurysm repair (ESAR) of abdominal aortic aneurysms with short necks achieves acceptable mid-term outcomes - results from the PERU registry.

INTRODUCTION: The study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair (ESAR) using the Heli-FX EndoAnchor system. METHODS: This is a retrospective study of prospectively collected data from nine vascular surgery departments between June 2010 - December 2019, including treated AAAs with neck lengths ≤ 10mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each centre's practice. There were two subgroups further assessed according to neck length, A (≥4 and < 7mm) and B (≥7 and ≤10mm). The main outcomes analysed were technical success, freedom from type Ia endoleaks (TIaEL), sac size increase, all-cause (ACM) and aneurysm related mortality (ARM). RESULTS: 76 patients were included in the study, 17 fell into Subgroup A and 59 into subgroup B. Median follow-up for the cohort was 40.5 (IQR 12-61) months. A median of 6 (IQR 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (p=0.534) for subgroups A and B respectively. Six out of ten (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for subgroup A and 88% at both intervals in subgroup B (p=0.545). In total, there were 7 (9.2%) patients presenting with type Ia endoleaks over the entire study period. Two (11.8%) in subgroup A and 5 (8.5%) in subgroup B (p=0.679). There were more patients with sac regression in subgroup B (subgroup A=6 - 35.3% versus subgroup B=34 - 57.6%, p=0.230) with no statistical significance. ACM was 19 (25%) patients, with no difference (4 - 23.5% versus 15 - 25.4%, p=0.874) between subgroups; whereas ARM occurred in one patient from subgroup A and 3 from subgroup B. CONCLUSIONS: This study demonstrates reasonable outcomes for patients with short-necked AAAs treated by ESAR in terms of type Ia endoleaks up to 5 year follow up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

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 Potential Relation Between polytetrafluoroethylene Grafts after Open Reconstructions for Abdominal Aortic Aneurysm and Perigraft Seromas.

BACKGROUND: The presence of sac enlargement after abdominal aortic aneurysm (AAA) open repair, a condition usually called perigraft seroma (PGS), nearly always has a benign behavior. Some theories implicated for PGS formation include coagulation abnormalities, fibroblast inhibition, low-grade infection, or improper graft handling. METHODS: This is a retrospective study including patients treated for AAA in 2 academic vascular surgery departments from 2007 to 2014, where 1 center preferably used polytetrafluoroethylene (PTFE) grafts whereas the preference of other center was mostly Dacron graft. The definition of PGS was conceived as a fluid collection around the graft on CT scan imaging with a radiodensity ≤25 Hounsfield units, reaching at least 30 mm in diameter and beyond the third postoperative month. Analysis was performed between patients with and without PGS. RESULTS: Seventy-eight patients met the inclusion criteria: 42 received Dacron and 36 PTFE grafts. Twenty-three (29.5%) patients accomplished the PGS diagnosis. Having a PTFE graft was the strongest factor for PGS formation on multivariate analysis. The medium seroma size was 42 mm (range, 30-90.6 mm) and the mean time from AAA repair to PGS detection was 26 months (range, 4-106 months). Three patients of the 23 with PGS required surgical repair, all of them were successfully treated: 2 by endovascular means and the remaining with explantation and Dacron reconstruction. CONCLUSIONS: PGS formation is not an unusual complication after open reconstructions for AAA treatment. This is especially true for PTFE grafts, and thus, closer follow-up is warranted if using this material. Treatment is clearly needed when symptoms appear; however, preventive strategies with either endovascular relining or reopen reconstructions require an individual approach counterbalancing benefits versus risk of the procedures.

Innominate Artery Dissection Caused by Video-Mediastinoscopy.

Mediastinoscopy is considered a safe technique to biopsy mediastinal lesions. Among its complications, vascular ones are the most common. We present a rare case of intimal dissection of the innominate artery during the performance of a mediastinoscopy that caused an ischemic attack from which the patient recovered completely without long-term sequelae. We analyze the possible causes and risk factors of this complication.

Systematic Review on the Use of Physician-Modified Endografts for the Treatment of Aortic Arch Diseases.

BACKGROUND: The total endovascular approach is in current evolution, and many series have described variable outcomes for branched technology, chimney techniques, or fenestrated repair; and even a combination of some of them. We aim to describe the current outcomes on physician-modified endograft for the treatment of arch diseases. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for this systematic review. The search was applied to MEDLINE, EMBASE, Google Scholar, and Cochrane Central Register of Controlled Trials. We used the following search terms in all possible combinations: home-made, physician-modified, surgeon-modified, on-table modification, hand-made, endograft, endovascular, aortic arch, and TEVAR: a thorough search of the English-language literature published until March 2020 was performed to identify studies using physician-modified endograft for the treatment of arch diseases. Only studies with treatment of 3 patients or more and with a minimum of 6-month follow-up were enrolled in the systematic review, whereas case reports were excluded from the analysis. RESULTS: Six articles participated in the systematic review after the exclusions, including a total of 239 patients for analysis. Four high-volume centers provided data including a high rate of single fenestrations in zone 2, accounting for nearly 70% of the cases. About 80.3% were males, and 67.4% received urgent treatment mainly for acute/subacute dissection (64.4%). Thoracic aortic aneurysm and/or postdissection arch aneurysm was the second leading cause of treatment with 25.9%. There was a technical success of 93.7% reaching up to 98.3% when additional procedures were performed. The 30-day mortality, stroke/transient ischemic attack, paraplegia, and stent-induced new entry rates were 2.9%, 2.1%, 0.4%, and 0.4%, respectively; whereas, overall mortality of the study was 4.6% at a mean follow-up of 33.2 ± 14.8 months. CONCLUSIONS: Endograft modification for aortic arch diseases' treatment demonstrates to be safe and highly effective, especially for aortic dissections needing single zone 2 fenestrations. Although outcomes achieved in the study seem encouraging, these are achieved at high-volume experienced centers, thus, they need to be judiciously evaluated, whereas proctoring may be a good alternative if one patient may benefit from the technique in an unexperienced center.

Pelvic radiation therapy as a potential risk factor for ischemic colitis complicating abdominal aortic reconstruction.

A 78-year-old man with a 56-mm juxtarenal aneurysm and previous pelvic radiotherapy for prostate cancer (3 years earlier) who was disease free during follow-up received elective aortoaortic bypass suprarenal clamping through a transperitoneal approach. After the patient experienced initial abdominal pain and diarrhea, a computed tomography scan showed mild sigmoid inflammation, and the patient received conservative treatment. One month after discharge, the patient underwent urgent laparotomy and bowel and sigmoid resection for an enterocutaneous fistula. At 6-month follow-up, he has recovered, although a bowel stoma remains.

Adapting Vascular Surgery Practice to the Current COVID-19 Era at a Tertiary Academic Center in Madrid.

BACKGROUND: The epidemic potential of coronavirus infection is now a reality. Since the first case detected in late 2019 in China, a fast worldwide expansion confirms it. The vascular patient is at a higher risk of developing a severe form of the disease because of its nature associating several comorbid states, and thus, some vascular surgery communities from many countries have tried to stratify patients into those requiring care during these uncertain times. METHODS: This is an observational study describing the current daily vascular surgery practice at one tertiary academic hospital in Madrid region, Spain-one of the most affected regions worldwide due to the COVID-19 outbreak. We analyzed our surgical practice since March 14th when the lockdown was declared up to date, May 14th (2 months). Procedural surgical practice, organizational issues, early outcomes, and all the troubles encountered during this new situation are described. RESULTS: Our department is composed of 10 vascular surgeons and 4 trainees. Surgical practice has been reduced to only urgent care, totaling 50 repairs on 45 patients during the period. Five surgeries were performed on 3 COVID-19-positive patients. Sixty percent were due to critical limb ischemia, 45% of them performed by complete endovascular approach, whereas less than 10% of repairs were aorta related. We were allocated to use a total of 5 surgical rooms in different locations, none our usual, as it was converted into an ICU room while performing 50% of those repairs with unusual nursery staff. CONCLUSIONS: The COVID-19 outbreak has dramatically changed our organization and practice in favor of urgent or semiurgent surgical care alone. The lack of in-hospital/ICU beds and changing nursery staff changed the whole availability organization at our hospital and was a key factor in surgical decision-making in some cases.

Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients.

BACKGROUND: The use of EndoAnchors is increasing; however, not much about appropriate use in terms of aortic wall penetration (AWP) is described. We aim to evaluate the procedural and anatomical conditions related with borderline (b) or absence (ab) of AWP when checked on first CT-scan after the Endosutured aortic repair (ESAR) for hostile neck anatomies (HNA). METHODS: This study with NCT04100499 is a single center prospective evaluation of patients receiving EndoAnchors for prevention or treatment of a proximal EVAR failure. AWP was evaluated on first CT-scan and findings correlated with neck anatomical features and procedural data. The sum of borderline and absence of AWP was considered as Inadequate - In-AWP (failure). Adjunctive procedures, reinterventions, all-cause mortality, absence of type Ia EL and aneurysm related mortality are also described. RESULTS: Forty-eight patients were treated during the study period and 43 high-surgical risk patients were finally included in the study for analysis with at least one HNA criteria (58%) and associating two in 21% or even three in 21%. A total of 250 EndoAnchors were deployed at a median 6 (range, 4-10) per case. From those, 31 (12.5%) achieved b-AWP and 11 (4.4%) ab-AWP, meaning 42 (16.8%) EndoAnchors with In-AWP. Univariate-analysis showed being an occasional user and a therapeutic case as predictor for at least one and more failures. The only predictor on multivariate analysis for two or more EndoAnchors with In-AWP was being an occasional user. Cumulative-survival and freedom from type-Ia EL at 2-years was 84% and 95%; respectively. CONCLUSIONS: Outcomes of the ESAR therapy should be validated according to their aortic wall penetration checked on first CT-scan. EndoAnchors use in HNA should not be considered an easy approach for the endovascular technique, especially for therapeutic cases. An individual and specific case analysis counterbalancing inadequate use of the device in unexperienced users should be evaluated against the increased risk of proximal failure as in standard EVAR alone during HNA treatment.

Evaluation of EndoAnchor Aortic Wall Penetration After Thoracic Endovascular Aortic Repair.

Purpose: To analyze aortic wall penetration of Heli-FX EndoAnchors after use in seal zones in the aortic arch or descending thoracic aorta during thoracic endovascular aortic repair (TEVAR). Materials and Methods: From May 2014 to May 2019, 25 patients (mean age 70.5±10 years; 16 women) were treated with TEVAR and adjunctive use of the Heli-FX device in 3 academic vascular surgery departments. Computed tomography scans were retrospectively reviewed to determine the location [arch or descending thoracic aorta (DTA)] of the EndoAnchors and the adequacy of aortic wall penetration, defined as adequate (≥2 mm), partial (<2 mm), or inadequate wall penetration (including loss). Endoleaks, reinterventions, and mortality were assessed. Results: A total of 161 EndoAnchors were deployed (median 7 per patient, range 4-9). Twenty-two EndoAnchors were place in the arch (zones 0-2) and 139 in the DTA (zones 3-5). A larger proportion of arch deployments (27%) had suboptimal penetration compared with the DTA (6.5%; p<0.005), resulting in a 91% adequate wall penetration rate for the series overall. Three EndoAnchors were lost (and only 1 retrieved) in 3 different patients, with no additional morbidity; thus, an overall deployment success rate of 88% was achieved. At a mean follow-up of 16.6±14 months, 4 patients required 5 (successful) reinterventions, including one for a type Ia endoleak treated with chimney TEVAR. One patient died 10 months after treatment due to endograft infection, without an opportunity for surgical correction. Conclusion: EndoAnchors have a higher risk of maldeployment in the arch, though this may be attributable to the small learning curve experience in this location. The best aortic wall penetration for this series was in the DTA, where EndoAnchors proved useful for distal endograft fixation during TEVAR.

Partial Renal Coverage after Endovascular Aortic Aneurysm Repair with Suprarenal Fixation Seems Not to be Associated with Early Renal Impairment.

BACKGROUND: Efforts to achieve optimal seal during endovascular aortic aneurysm repair (EVAR) may produce partial coverage of the lowest renal artery and in some cases even occlusion. This coverage might alter the renal ostial flow, which could finally affect renal function. We sought to evaluate the incidence of renal ostium coverage and its possible effects on renal function. METHODS: All patients undergoing elective EVAR with suprarenal fixation devices between January 2014, and December 2017, at our institution were identified. Patients with preoperative and postoperative computed tomography angiography (CTA), as well as the preoperative, postoperative, and one year postintervention creatinine levels and estimated glomerular filtration rate (eGFR) were included in the present study. Patients in hemodialysis, with a preoperative eGFR <30 mL/min, urgent EVAR, neck adjunctive procedures, excessive aortic thrombus, or procedure-related reintervention were excluded. RESULTS: A total of 127 patients received EVAR for aortoiliac aneurysmatic pathologies between January 2014, and December 2017. Forty-three of them met the inclusion criteria having a median follow-up of 18.8 months (range; 12.0-53.9). Twenty-six (60.5%) patients presented at least one criterion of hostile neck condition and 23 (53.5%) had a preoperative eGFR <60 mL/min. The average distance from the proximal endograft fabric to the lower renal artery was 1.5 mm (range, 0.0-6.0) while a total of 15 renal ostia (34.9%) suffered unintended partial coverage (range, 20 to 75% of the renal ostium) in the postoperative CTA. Nine of these patients (60%) had a hostile neck condition. Eight patients (18.6%) suffered significant deterioration (>20% of the eGFR), 27 patients (62.8%) maintained their renal function and 8 (18.6%) presented an improvement of the eGFR in the latest available blood sample. Renal function impairment showed no significant association with renal ostium coverage (P = 0.561), hostile neck condition (P = 0.973), or the diameter of the renal artery (P = 0.835). In the subgroup analysis, patients with the eGFR <60 mL/min did not show significantly greater renal function deterioration (P = 0.568). CONCLUSIONS: Partial renal coverage is not an uncommon phenomenon occurring in one-third of the treated patients. However, it was not associated with renal function impairment in the early term. Further studies with longer follow-up are needed to confirm our results in the long haul.

Multicenter Registry about the Use of EndoAnchors in the Endovascular Repair of Abdominal Aortic Aneurysms with Hostile Neck Showed Successful but Delayed Endograft Sealing within Intraoperative Type Ia Endoleak Cases.

BACKGROUND: The durability of endovascular aortic aneurysms repair (EVAR) is highly related to several anatomical constraints. The term "hostile neck" describes several anatomical features that usually make EVAR treatment technically demanding despite having higher risk of failure. The aim of the study was to describe a multicenter experience with EVAR and an adjunctive use of EndoAnchors in hostile neck anatomies. METHODS: Data were prospectively collected from 4 academic vascular centers including 46 patients with a hostile neck treated by standard EVAR with the adjunctive use of EndoAnchors. Twenty-two of them (47.8%, group A) had an intraoperative type Ia endoleak, and 24 (52.2%) patients were treated in a preventive manner (group B). Primary endpoints were technical and procedural success. Secondary endpoints were regression of the aneurysm sac, freedom from type Ia endoleak, and reinterventions. RESULTS: Neck length and diameter showed no statistical difference in preoperative measures, 9.1 ± 6.9 mm and 8.6 ± 2.8 mm and 25.4 ± 4.7 mm and 27.3 ± 4.7 mm, in group A and B, respectively. Aneurysm sac diameter decreased from 58.2 ± 8 mm and 57.9 ± 9.8 mm to 55.7 ± 8.5 mm and 53.8 ± 10.4 mm in group A and B; respectively, at the last computed tomography scan. Technical and procedural success was 97.8% and 100%, respectively, for group B. Group A showed persistence of type Ia endoleak at completion angiogram in 9 (40.9%) patients. Five of them showed early spontaneous sealing at the first (30 days) computed tomography angiography (CTA), and in the remaining 4, a delayed spontaneous sealing was diagnosed at 12-month CTA. No neck-related secondary procedures were performed. Overall survival was 91%. CONCLUSIONS: Our study shows that additional use of EndoAnchors can successfully improve the sealing of abdominal endografts in case of intraoperative type Ia endoleaks in hostile neck anatomies, representing a safe and effective endovascular alternative in our armamentarium. However, meticulous radiological follow-up is necessary because complete resolution of all observed intraoperative type Ia endoleaks was not observed until the 12-month CTA follow-up.

Symptomatic Aortic Bare-Metal Stent Fracture after PETTICOAT Technique for Complicated Type B Aortic Dissection.

BACKGROUND: Aortic bare-metal stent rupture is an exceptional complication, associated with high risk of aorta rupture and death. We describe a successful endovascular approach for a symptomatic aortic bare-metal stent fracture after the provisional extension to induce complete attachment (PETTICOAT) technique. METHODS: A 53-year-old man with a complicated type B aortic dissection (visceral malperfusion) was treated with thoracic endovascular aortic repair (TEVAR) and "PETTICOAT" technique. The 1-, 6-, and 12-month follow-up scans showed progressive aortic remodeling. After 15 months from the initial procedure, the patient was admitted to the emergency department with severe thoracic pain and two syncopal episodes. Urgent angio-computed tomography (CT) showed bare-metal stent rupture and aortic dilatation to 45 mm at the site of stent fracture. RESULTS: He was urgently treated with TEVAR to cover the entire length of the bare-metal stent under local anesthesia and motor-evoked potential (MEP) monitoring. If signs of medullary ischemia are observed in the MEP register, a carotid-subclavian bypass was planned. At 12 months of follow-up, the patient remains asymptomatic. CT scan at 1 month and 12 months showed no signs of endoleak and aortic remodeling to 40 mm. CONCLUSIONS: Although unusual, this case demonstrates the possibility of material fatigue/failure and highlights the need of close imaging follow-up after TEVAR for treatment of aortic diseases.

Descending Aorta Rupture after Transcatheter Aortic Valve Embolization.

BACKGROUND: To report a case of rupture of the descending aorta after aortic migration during transcatheter aortic valve replacement (TAVR). METHODS: An 85-year-old man with a severe and symptomatic aortic stenosis underwent elective TAVR, which complicated with embolization into the ascending aorta. While repositioning into the descending aorta, the procedure complicated with aortic rupture. RESULTS: The patient required urgent thoracic intravalve stent-graft implantation (thoracic endovascular aortic repair [TEVAR]). Reintervention with other stent graft was required 2 days after initial procedure as proximal rupture was again diagnosed. Patient was discharged 50 days later because of other medical complications. He remains stable at 1 year of follow-up. CONCLUSIONS: TEVAR is a valid and safe option in the treatment of iatrogenic acute aortic rupture due to TAVR.

Outcomes of open and endovascular repair of inflammatory abdominal aortic aneurysms.

Objective Reports on inflammatory aortic abdominal aneurysm treatment are scarce. Traditionally, open surgery has been validated as the gold standard of treatment; however, high technical skills are required. Endovascular aortic repair has been suggested as a less invasive treatment by some authors offering good results. The purpose of our study was to report our experience and outcomes in the treatment of inflammatory aortic abdominal aneurysm using both approaches. Material and methods A retrospective review and data collection of all patients treated for inflammatory aortic abdominal aneurysm between 2000 and 2015 was done in one academic center. Diagnosis of inflammatory aortic abdominal aneurysm was based on preoperative CT-scan imaging. Type of treatment, postoperative and long-term morbidity and mortality are described. Abdominal compressive symptoms (hydronephrosis) severity and relief after treatment are described. Results Thirty-four patients with intact inflammatory aortic abdominal aneurysm were included. Twenty-nine (85.3%) patients were treated by open means and the remaining five (14.7%) with endovascular aortic repair. Nearly 90% were considered high-risk patients. Median follow-up was 46 months (range 24-112). The two groups were comparable, except for the age and preoperative hydronephrosis. There was no statistical significance in blood transfusion requirements, intensive care hospitalization, 30-day and long-term mortality between the two groups. Preoperative hydronephrosis was diagnosed in four (13.8%) patients in the open surgery group and three (60%) patients in the endovascular aortic repair group. Improvement of hydronephrosis was recognized in three out of the four patients in the open repair group and two out of the three in the endovascular aortic repair group. Renal function remained stable in both groups during follow-up. Conclusions Open surgery remains a safe and valid option for the treatment of inflammatory aortic abdominal aneurysm. Although our study included a small number of patients with endovascular aortic repair treatment, results are promising. Further randomized controlled studies may be necessary to assess long-term effectiveness of endovascular aortic repair treatment in this disease.