International Collaborative Study Comparing Outcomes of Fenestrated Endovascular Aortic Repair in OCtogenarian vs Non-Octogenarian Patients: The FEVOC study.

OBJECTIVE: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians. SUMMARY BACKGROUND DATA: Few studies looking at octogenarian-specific outcomes with diverging results. METHODS: Retrospective, multicentre cohort study including consecutive patients undergoing elective FEVAR for cAAAs or type IV thoracoabdominal aortic aneurysms between 2007-2022 in eight high-volume centres. Octogenarians vs. non-octogenarians were compared. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival and reintervention rates. RESULTS: A total of 729 patients (median age of 74.8 years [IQR 69.2 - 79.14]) were included, 169 (23%) of which were octogenarians, with 316 (43.3%) patients undergoing juxta/pararenal aneurysm repair. Although octogenarians presented less complex but larger (61 mm vs. 58 mm) aneurysms, the number of fenestrations was similar across groups. No differences in in-hospital mortality (4.1 vs. 3.0%), MAE (16.6% vs 12.2%) or reintervention rates (11.2 vs. 10%) were found. Multivariable logistic regression of in-hospital mortality identified BMI (OR 0.66, 95% CI 0.51-0.95, P=0.003), chronic heart failure (OR 7.70, 95% CI 1.36-36.15, P=0.003) and GFR<45 ml/min/1.73 m2 (OR 5.25, 95% CI 1.20-22.86, P=0.027) as independent predictors. Median follow-up was 41 months. The 1, 2 and 5-year survival rates were 91.3%, 81.8% and 49.5% in octogenarians vs 90.6%, 86.5% and 68.8% in non-octogenarian patients (Log-rank: =0.001). Freedom from aortic-related death and freedom from reintervention at five-years were similar across groups (log-rank=0.94 and .76, respectively). Age>80 was not an independent predictor of 30-day or long-term mortality on multivariable and Cox regression analysis. CONCLUSIONS: Elective FEVAR in octogenarians appears to be safe, with similar outcomes as in younger patients. Future studies looking at improved patient selection methods to ensure long-term survival benefits in both octogenarians and younger patients are warranted.

Multicentric Use of Commercially Available Infrarenal Endografts During Fenestrated Endovascular Aortic Repair: A Feasibility Study.

PURPOSE: This study aimed to assess the feasibility and short-term outcomes of different manufactured proximal and distal stent graft components during fenestrated endovascular aortic repair (FEVAR). MATERIALS AND METHODS: A multicenter retrospective review was conducted at 3 aortic centers, involving all consecutive patients who underwent FEVAR utilizing a customized Dacron-based tubular proximal and a distal bifurcated polytetrafluoreten (PTFE)-based commercially available stent grafts. Primary outcomes were 30 day mortality, major adverse events, and technical and clinical success. Secondary outcomes assessed stent graft migration, occurrence of types I/III endoleak, and reintervention. RESULTS: A total of 23 FEVAR cases across all centers were included in this study. Technical success was achieved in all cases, with a median procedure time of 183 (153-244) minutes. There were no major adverse events, except for 1 transient acute renal failure. The median follow-up period was 23 (17-28) months. All target vessels retained patent with the exception of 1 right renal fenestration that showed signs of kinking at the first follow-up, and despite secondary intervention with relining and distal extension, there was an occlusion afterward and 1 hepatic artery with a separate fenestration. This and 1 successful relining of a superior mesenteric artery kink were the only reinterventions in this cohort. One case of persistent type 1b endoleak was reported in a patient with chronic type B aortic dissection, which resolved with distal extension on the external iliac artery 5 months after the index procedure. No deaths occurred throughout the follow-up with, and there were no signs of stent graft migration or type 3 endoleak. CONCLUSION: The use of commercially available PTFE-based bifurcated stent grafts to extend distally the tubular graft appears to be a feasible approach during FEVAR, with promising short-term outcomes. Further studies are necessary to define the applicability of this solution and evaluate long-term outcomes. CLINICAL IMPACT: This multicentric study on fenestrated endovascular aortic repair (FEVAR) demonstrates the feasibility and good short-term outcomes of utilizing a PTFE-based commercially available stent graft to extend the proximal tubular custom-made fenestrated stent graft. The high technical success rate, absence of major adverse events, and low occurrence of complications such as stent graft migration and endoleaks highlight the potential clinical benefits of this approach with an off-the-shelf distal extension whose delivery system does not cross the fenestrations intraoperatively.

Fenestrated Endovascular Repair using Short Tipped Distal Components with "No Cross" Concept to Prevent Crushing of Target Vessel Bridging Stents.

OBJECTIVE: To compare and evaluate early and midterm outcomes of a "no cross" novel approach with short tip vs. standard tip introducer systems for all distal components to prevent target vessel bridging stent kink or collapse during fenestrated endovascular aortic repair (FEVAR). METHODS: A retrospective analysis was conducted on all patients who underwent FEVAR at a tertiary referral centre between October 2016 and July 2022. The inclusion criterion was the use of renal artery fenestrations. Patients who had chronic dissections were included. Endpoints were analysed in two groups comprising the "no cross" group and the standard group, with all cases being consecutive in their respective groups. Cone beam computed tomography was used intra-operatively in all cases, and post-operative compute tomography angiograms and re-interventions were reviewed. Primary endpoints included technical success, intra-operative adjunctive procedures, adverse events related to the fenestration, and re-interventions, while secondary endpoints were secondary interventions and overall mortality. RESULTS: A total of 70 patients (35 in each group) were enrolled in the study, with 64 (91%) having juxta-renal aneurysms. There were no differences in demographics, cardiovascular risk factors, or aneurysm characteristics between the two groups. The "no cross" group demonstrated a significantly higher technical success rate (100% in all cases) compared with the standard group (29 cases, 83%; p = .010). Additionally, there were statistically significantly fewer intra-operative adjunctive procedures required in the "no cross" group (1.5% of fenestrations) compared with the standard group (8.2% of fenestrations) (p = .013). Overall median follow up was 32 months (interquartile range 22, 62 months). CONCLUSION: Implementation of a novel "no cross" concept during FEVAR, utilising a short dilator introducer tip on the distal bifurcated component and iliac extensions, significantly reduces intra-operative fenestration related adverse events and enhances technical success. Further studies with larger patient populations and longer follow up are needed to confirm these findings.

Multicentre Experience with Novel Bidirectional Double Cuffed Inner Branches for Complex Endovascular Aortic Repair.

OBJECTIVE: This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative data, and follow up data were collected. Results were presented as number or median (interquartile range) unless otherwise stated. RESULTS: Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. CONCLUSION: The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms.

OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.

Inferior Vena Cava-Balloon Occlusion and Its Effect on the Myocardium During Endograft Deployment in the Arch.

PURPOSE: To evaluate the impact of cava balloon occlusion on the myocardium during endovascular repair of thoracic aortic pathologies. MATERIAL AND METHODS: A prospective observational cohort study of 21 patients who underwent endovascular repair of aortic arch and thoracic aorta in a single tertiary referral center with use of inferior vena cava (IVC) balloon occlusion as a method of intraoperative cardiac output reduction. Pre-, intra-, and postoperative measurements of heart rate, blood pressure, stroke volume index, and central venous oxygen saturation were noted. High-sensitive serum troponin levels were also analyzed according to a pre-established protocol. Endpoints were cardiac troponin T levels after induced hypotension and left ventricular ejection fraction during follow-up. Secondary endpoints were procedure technical success and overall survival. RESULTS: Twenty-one patients (18 male, median age 69, (62-75, IQR)) enrolled in the study between May 2015 and January 2019. Indication for endovascular treatment was an aortic arch aneurysm (n=10), descending aortic aneurysm (n=8), lusorian artery aneurysm (n=2), and thoracoabdominal aortic aneurysm (n=1). Median time to reach half mean arterial pressure was 60 seconds while median recovery time of blood pressure was 135 seconds. In 5 (24%) cases, we observed a > 50% change of Troponin T on the reference level. Technical success was achieved in all cases. Two (10%) patients developed new and persistent atrial fibrillation and 1 (5%) suffered a peri-operative ST-elevation myocardial infarction. CONCLUSION: The use of IVC balloon occlusion is a feasible technique for cardiac output reduction during endovascular repair of thoracic aortic pathologies. One fourth of the patients develop significant troponin leakage but the significance of the finding needs further studies.

Integration of a Custom-Made Fenestration to Simplify Acute Reno-Visceral In Situ Aortic Repair.

PURPOSE: To illustrate the technique of antegrade in situ laser fenestration (ISLF) on a predesign custom-manufactured stent-graft with single reinforced fenestration for use in emergency endovascular repair of complex abdominal aortic aneurysms (AAAs). TECHNIQUE: A short custom-made device (CMD) fenestrated graft was predesigned with a single preloaded 8 mm strut-free fenestration at 12 o'clock position. A modified preloaded system was used to allow unilateral access from the distal port if necessary. After bilateral percutaneous femoral access, the graft was deployed under fusion guidance with the CMD fenestration matching the superior mesenteric artery (SMA) origin and immediately bridged as per standard technique. The aneurysm was then excluded with a bifurcated device. A large steerable sheath was used to allow for sequential antegrade laser in situ fenestration and stenting of the renal arteries. CONCLUSIONS: Single-vessel customized short fenestrated grafts for the SMA and antegrade in situ laser renal fenestrations are technically feasible for repair of acute complex AAAs even after previous infrarenal reconstruction. It could become an off-the-shelf solution to limit aortic coverage and reno-visceral ischemia, even in patients with a narrow aortic diameter at the renal level. CLINICAL IMPACT: Single-vessel precustomized short fenestrated grafts for the SMA combined with renal artery antegrade ISLF can be a feasible option for the acute repair of patients with complex aneurysms and a narrow aortic diameter at the reno-visceral segment. It may limit aortic coverage and reno-visceral ischemic time and also be applicable after previous infrarenal endovascular aneurysm repair (EVAR).

Estimation of the Added Cancer Risk Derived From EVAR and CTA Follow-Up.

OBJECTIVE: The aim of this study was to assess the risk of radiation-induced cancer development in patients that have undergone an infrarenal EVAR, stratifying the relative contributions of the procedure and the preoperative and postoperative CTAs. METHODS AND MATERIALS: The organ-specific absorbed radiation doses from CTA and the EVAR procedure were estimated from the radiation exposures of 95 and 45 male patients, respectively. Lifetime attributable risk (LAR) cancer predictions were calculated for 14 different organs. Life expectancy was assumed from a previous cohort of patients undergoing infra-renal EVAR. RESULTS: The calculated total excess cancer risk was 0.0046, ie, 1 out of 220 patients will develop a neoplasm after being exposed to the ionizing radiation from the preoperative CTA, the EVAR and annual CTA examinations for 15 years. The procedure and the preoperative CTA contributed with 38% of the total excess risk, while the rest was derived from the follow-up. If the entire CTA based follow-up would have been eliminated, an excess risk of 0.0018 (1/560) would remain. CONCLUSIONS: 1 out of 219 patients who have undergone EVAR of an infra-renal AAA have a lifetime risk of developing cancer secondary to the radiation exposures related to the procedure and the CTAs used preoperatively and during follow-up. This risk derives mostly from the yearly postoperative CTAs, underlining the potential benefits of reducing or replacing their use. CLINICAL IMPACT: A simulation-based estimation reinforced the potential deleterious effects of the radiation exposure for patients undergoing Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysms (AAA) and subsequently followed by yearly Computer Tomography Angiographies (CTAs). The risk could be as high as 1 out 219 patients developing a neoplasm after 15 years. The largest exposure derives from the follow-up CTAs and efforts to minimize their use as well as the intraoperative radiation are greatly needed. The simulation-based estimations done in this study reinforce potential deleterious effects of the radiation exposure for patients undergoing EVAR of AAA. Efforts should be done to minimize the intraoperative radiation and the number of CTAs used during follow-up.

Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study.

PURPOSE: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. MATERIAL AND METHODS: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. RESULTS: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60±14% at 3 years that went up to 92±8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. CONCLUSION: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. CLINICAL IMPACT: This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Conservative Management First Strategy in Aortic Vascular Graft and Endograft Infections.

OBJECTIVE: The aim of this study was to describe and present the outcomes of a specific treatment protocol for aortic vascular graft and endograft infections (VGEIs) without explantation of the infected graft. METHODS: This was a retrospective, observational single centre cohort study carried out between 2012 and 2022 at a tertiary hospital. An aortic VGEI was defined according to the Management of Aortic Graft Infection Collaboration (MAGIC) criteria. Fitness for graft excision was assessed by a multidisciplinary team and included an evaluation of the patient's general condition, septic status, and anatomical complexity. Antimicrobial treatments were individualised. The primary outcome was survival at the last available follow up; secondary outcomes were antimicrobial treatment duration, infection eradication, treatment failure despite antimicrobial treatment, and the development of aortic fistulation. RESULTS: Fifty patients were included in the study, of whom 42 (84%) had had previous endovascular repair. The median patient age was 72 years (range 51 - 82 years) and median duration of treatment with antimicrobials was 18 months (range 1 - 164 months). Kaplan-Meier analysis estimated the 30 day survival to be 98% (95% confidence interval [CI] 96 - 100), the one year survival rate to be 88% (95% CI 83.4 - 92.6), and the three year survival rate to be 79% (95% CI 72.7 - 84.7). Twenty-four (48%) patients were able to discontinue antibiotic treatment after a median of 16 months (range 4 - 81 months). When categorised according to infected graft location, deaths occurred in four (40%) patients with thoracic, two (40%) with paravisceral, seven (30%) with infrarenal VGEIs, and in one (25%) patient with an aorto-iliac VGEI; no (0%) patient with a thoraco-abdominal VGEI died. CONCLUSION: Identifying the microbiological aetiology in patients with aortic VGEI enables individualised, specific antibiotic treatment, which may be useful in patients with a VGEI excluded from surgery. This single centre retrospective analysis of patients with VGEIs without fistula selected for conservative treatment suggests that conservative management of aortic VGEIs with targeted antibiotic therapy without graft excision is potentially effective, and that antimicrobial treatment will not necessarily be needed indefinitely.

Semi-Conservative Treatment Versus Radical Surgery in Abdominal Aortic Graft and Endograft Infections.

OBJECTIVE: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort. METHODS: Patients with abdominal AGI related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for the definition of AGI. Multivariable regression was performed to identify factors associated with mortality. RESULTS: One hundred and sixty-nine patients with surgically treated abdominal AGI were identified, comprising 43 SC (14 endografts; 53% with a graft enteric fistula [GEF] in total) and 126 RS (26 endografts; 50% with a GEF in total). The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan-Meier estimated five year survival for SC vs. RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan-Meier estimated five year survival for SC patients with a GEF vs. without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC with RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in five year survival comparing SC vs. RS (HR 1.0, 95% CI 0.6 - 1.5). CONCLUSION: In this national AGI cohort, there was no mortality difference comparing SC and RS for AGI when adjusting for comorbidities. Presence of GEF probably negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC treated patients.

Long-term outcomes after fenestrated endovascular aortic repair for juxtarenal aortic aneurysms.

OBJECTIVE: Fenestrated endovascular aortic aneurysm repair (FEVAR) for juxtarenal aortic aneurysm (jAAA) disease is safe and effective with good short- and mid-term outcomes. The durability issues have mainly focused on the proximal and distal seal and target vessel (TV) instability, and long-term data are scarce. In previous studies, we have reported the short-term outcomes after FEVAR and compared our early and late experience and the long-term results for the early cohort. In the present report, we have provided the long-term outcomes for our late experience cohort who had undergone FEVAR at the Vascular Center (Skåne University Hospital, Malmö, Sweden). METHODS: Consecutive patients who had undergone FEVAR for jAAAs from 2007 to 2011 were included in the present study. Data were collected retrospectively from the medical and imaging records. The follow-up protocol consisted of a clinical examination 1 month postoperatively and computed tomography angiography combined with plain abdominal radiography at 1 and 12 months and annually thereafter. The primary endpoints were TV instability, reinterventions, and survival. Changes in the aneurysm diameter and renal function and the incidence and type of endoleaks were also analyzed. RESULTS: A total of 94 patients were included in the present study. The median follow-up time was 89 months (range, 0-152 months). A total of 280 fenestrations or scallops were used, of which 205 were stented. Technical success was 89.4%. Primary TV patency was 94% ± 1% at 1 year, 90% ± 2% at 3 years, and 89% ± 2% at 5 years. Of the 94 patients, 37 (39.4%) had required a total of 70 reinterventions. The mean time to the first reintervention was 21 ± 3.97 months. Five patients (5.3%) had died of aneurysm-related causes. Overall survival was 95.7% ± 2.1% at 1 year, 87.1% ± 3.5% at 3 years, and 71.0% ± 4.7% at 5 years. A stable or decreasing aortic diameter after treatment was seen in 91% of the cases. The mean glomerular filtration rate had decreased from 59.2 ± 14.9 mL/min/1.73 m2 preoperatively to 50.0 ± 18.6 mL/min/1.73 m2 at the end of follow-up. CONCLUSIONS: The results of the present study have shown that the long-term results after treatment of jAAAs with FEVAR remain good and the treatment is safe and effective. Although the need for reintervention remained high, long-term renal function and survival support the use of FEVAR as a valid treatment option for jAAA disease.

Double-Cuff Bidirectional Branch in Endovascular Aortic Repair: A New Way of Increasing the Flexibility of Inner Branch Endografting.

PURPOSE: The purpose of the study was to describe the design and implantation of a branched stent-graft during endovascular aortic repair incorporating double-cuff bidirectional inner branch. TECHNIQUE: A new double-cuff bidirectional antegrade and retrograde inner branched stent-graft with large diamond-shaped fenestration was designed for incorporation of a splenic artery. The inner cuffs of the branch were accessible using brachial and/or femoral access. The splenic artery was originating from an aortic segment with narrow inner aortic luminal diameter in a patient with extent IV thoracoabdominal aortic aneurysm with bilobed configuration. The retrograde, more distal inner cuff of the branch was extended into the splenic artery using a self-expandable bridging stent-graft from the femoral approach, whereas the antegrade, more proximal inner cuff of the branch was intentionally occluded using an endovascular plug. The recovery was uneventful and a computed tomography angiography 30 days postoperatively showed patency of all the target vessels without signs of endoleaks. CONCLUSION: This is the first design of a double-cuff bidirectional inner branched stent-graft. The technique can potentially expand the applications of directional branches to patients with more difficult anatomy in the thoracoabdominal or aortic arch segments. Potential indications are patients with target arteries that are not ideally suited for caudally-oriented branches, patients with accessory vessels, or targets with early branch bifurcations. CLINICAL IMPACT: This report describes the use of a branched endograft with a new double-cuff bidirectional branch that can potentially address many of the limitations of current BEVAR solutions, such as early bifurcations, double arteries with adjacent origins and arteries with less favorable trajectories for the traditional caudally-oriented branches.

Endovascular Treatment of Post Type A Chronic Aortic Arch Dissection With a Branched Endograft: Early Results From a Retrospective International Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the outcome of endovascular aortic arch repair for chronic dissection with a custom-made branched endograft. BACKGROUND: Acute type A aortic dissections are often treated with prosthetic replacement of the ascending aorta. During follow-up, repair of an aneurysmal evolution of the false lumen distal to the ascending prosthesis can be a challenge both for the surgeon and the patient. METHODS: We conducted a multicenter, retrospective study of consecutive patients from 14 vascular units treated with a custom-made, inner-branched device (Cook Medical, Bloomington, IN) for chronic aortic arch dissection. Rates of in-hospital mortality and stroke, technical success, early and late complications, reinterventions, and mortality during follow-up were evaluated. RESULTS: Seventy consecutive patients were treated between 2011 and 2018. All patients were considered unfit for conventional surgery. In-hospital combined mortality and stroke rate was 4% (n = 3), including 1 minor stroke, 1 major stroke causing death, and 1 death following multiorgan failure. Technical success rate was 94.3%. Twelve (17.1%) patients required early reinterventions: 8 for vascular access complication, 2 for endoleak correction, and 2 for pericardial effusion drainage. Median follow-up was 301 (138-642) days. During follow-up, 20 (29%) patients underwent secondary interventions: 9 endoleak corrections, 1 open repair for prosthetic kink, and 10 distal extensions of the graft to the thoracic or thoracoabdominal aorta. Eight patients (11%) died during follow-up because of nonaortic-related cause in 7 cases. CONCLUSIONS: Endovascular treatment of aortic arch chronic dissections with a branched endograft is associated with low mortality and stroke rates but has a high reintervention rate. Further follow-up is required to confirm the benefits of this novel approach.

Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections.

OBJECTIVE: We evaluated the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections. METHODS: We reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) from 2016 to 2019. All patients received three-vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate, left common carotid, and left subclavian arteries. The antegrade inner branches were accessed via a carotid or an upper extremity approach. A preloaded catheter was used for access to the retrograde left subclavian artery branch via a transfemoral approach. The endpoints were technical success, mortality, major adverse events, any stroke (minor or major) or transient ischemia attack, secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality, and patient survival. RESULTS: A total of 39 patients (31 men [79%]; mean age, 70 ± 7 years) had undergone treatment of 14 degenerative (36%) and 25 chronic (64%) postdissection arch aneurysms. The clinical characteristics included American Society of Anesthesiologists class ≥III in 28 patients (95%) and previous median sternotomy for ascending aortic repair in 28 patients (72%). The technical success rate was 100%. Two patients had died in-hospital or within 30 days (5%), and two patients had experienced a stroke (one minor). The combined mortality and any stroke rate was 8% (n = 3). Major adverse events occurred in 10 patients (26%), including respiratory failure in 4 (10%) and estimated blood loss >1 L, myocardial infarction, and acute kidney injury in 2 patients each (5%). The median follow-up was 3.2 months (interquartile range, 1-14 months). Of the 39 patients, 12 (31%) required secondary interventions to treat vascular access complications in 5, endoleak in 6 (three type II, one type Ic, one type Ia/Ib, one type IIIa), and target vessel stenosis in 1 patient. At 1 year, the primary and secondary patency rates and freedom from target vessel instability were 95% ± 5%, 100%, and 91% ± 5%, respectively. Freedom from aortic-related mortality and patient survival was 94% ± 4% and 90% ± 6%, respectively. CONCLUSIONS: The findings from the present multicenter global experience have demonstrated the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. The mortality and stroke rates compare favorably with those after open surgical repair in a higher risk group of patients. However, the rate of secondary interventions was high (31%), emphasizing need for greater experience and longer follow-up.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Five Year Results of Off the Shelf Fenestrated Endografts for Elective and Emergency Repair of Juxtarenal Abdominal Aortic Aneurysm.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is a well established treatment for complex abdominal aortic aneurysms (AAAs). FEVAR with custom made devices (CMDs) has limitations in both the emergency and elective settings due to time consuming manufacture. "Off the shelf" (OTS) fenestrated stent grafts are a potential solution. The primary goal was to evaluate the five year outcome of the COOK Zenith p-Branch OTS device at a single centre. METHODS: Patients with juxtarenal AAA meeting the inclusion criteria for the COOK Zenith p-Branch device were enrolled in a prospective, non-randomised, non-comparative trial from July 2012 to September 2015. Demographic, anatomical, procedure related, and five year follow up data were collected, analysed, and adjudicated by a core laboratory. The primary aims were to assess intervention free survival and overall survival at five years. RESULTS: Twenty-three patients were treated and 21 completed follow up. Mean time to p-Branch implantation after patient presentation was 28 hours (range 0-122 hours) in emergency cases and 67 days (range 20-112 days) in elective cases. Median procedure time was 283 minutes (range 161-475 minutes) and technical success was 91%. Mean follow up was 45 months (standard deviation ± 24.4 months). The most common adverse events were renal injuries. Primary target vessel patency was 96.4% and 94.0% after one and five years respectively. Mean time to first re-intervention was 469 days (range 0-1 567 days). Survival during the follow up period was 76%, with no aneurysm related deaths. CONCLUSION: FEVAR with the COOK Zenith p-Branch device is safe and effective for juxtarenal AAA in a selected patient population, in both elective and emergency settings. Long term outcomes are acceptable although inferior to CMDs. Mid and long term outcomes emphasise the p-Branch as a possible endovascular treatment for juxtarenal aortic pathology where CMD is not an option. Further innovation to address target vessel complications is needed, as these seem more prevalent than after repair with CMDs.

Guided Aspiration for Determining the Microbiological Aetiology of Aortic Vascular Graft and Endograft Infections.

OBJECTIVE: Open and endovascular aortic repair may be complicated by aortic vascular graft or endograft infection (VGEI). Confirming the microbiological aetiology is a key element in providing the best available treatment to patients with a VGEI. The primary aim of this study was to describe the technique of direct aneurysm sac guided aspiration (DASGA) in determining the microbiological aetiology in a cohort of patients with VGEIs, and to report its diagnostic value. METHODS: This was a retrospective observational single centre study performed between the years 2011 to 2020 in Malmö, Sweden. Patients with a suspected aortic VGEI, where a DASGA was performed at the Vascular Centre, were included in the study. RESULTS: In total, 31 guided aspirations were performed in 27 patients (25 male [93%]; median age 77 years [range 57 - 82 years]). The combination of culture and 16S rRNA/18S rRNA gave a microbial aetiology in 25/31 (81%) DASGAs. Importantly, excluding three cases where infection was ruled out, this rate increases up to 89%. A polymicrobial aetiology was found in six (24 %) cases. The most common bacteria found were Cutibacterium spp. (n = 8) and Listeria monocytogenes (n = 4). In total, the dominant aetiology could be further characterised into normal gut flora (n = 12; 48%) or skin commensals (n = 8; 32%). No patients had persistent morbidity related to the DASGA. CONCLUSION: DASGA can be used successfully to determine the microbiological aetiology of open and endovascular graft infections. This method appears to be safe, with a high success rate for confirming the microbiological aetiology of VGEIs, particularly if standard culturing methods are combined with 16S rRNA/18S rRNA. Finding the causative microbial aetiology is crucial, and in the vast majority of cases translumbar puncture can be used without serious complications.