Protagoras 3.0: feasibility of current fenestrated endografts and chimney technique for complex abdominal aortic aneurysms.

BACKGROUND: The aim of this study was to evaluate the anatomical feasibility of current available fenestrated endografts (FEVAR) and on-label chimney technique (EnChEVAR) in patients with complex abdominal aortic aneurysms (C-AAA). METHODS: Feasibility of EnChEVAR (Endurant II/IIS CE-marked [Medtronic]) and 4 types of FEVAR (Zenith Fenestrated CE-marked, Zenith Fenestrated Low-Profile [LP] custom-made device [CMD] [Cook Medical], Fenestrated Anaconda LoPro90 CMD, Fenestrated Treo CMD [Terumo Aortic]) was assessed according to the manufacturer's instructions for use. Computed tomography angiograms of patients with C-AAA previously included in the Protagoras 2.0 study were retrospectively reviewed. The aortic coverage was ideally planned to involve a maximum of two chimney grafts or fenestrations. RESULTS: Iliac access and aortic neck of 73 C-AAAs were analyzed. The overall feasibility was significantly different between EnChEVAR (33%) and FEVAR (Zenith Fenestrated 15%, Zenith Fenestrated LP 15%, Fenestrated Anaconda LoPro90 45%, Fenestrated Treo 48%). The iliac access feasibility was significantly lower for Zenith Fenestrated with standard profile compared to all other grafts. The aortic neck feasibility was significantly higher for EnChEVAR and both Terumo Aortic fenestrated stent grafts, compared to both Cook Medical grafts. The treatment using any of the three current available fenestrated grafts with lower profile (Zenith Fenestrated LP, Fenestrated Anaconda LoPro90, Fenestrated Treo) would have been feasible in 71% of the cases. CONCLUSIONS: Most of the patients treated by ChEVAR would have not been treated by first generation fenestrated stent graft. The current available fenestrated endografts, with lower profile and suitable also for angulated necks, increase the anatomical feasibility.

Early multicentric outcomes of the on-label and CE-marked combination of the Endurant with the Radiant chimney graft for the chimney endovascular aortic repair (EnChEVAR): The LaMuR Registry.

BACKGROUND: The aim of this study was to evaluate the early results of the CE-marked standardized device combination consisting of Endurant and the Radiant chimney graft (En-ChEVAR) for the treatment of juxtarenal aortic aneurysms. METHODS: We analyzed multicentric non-industry sponsored case series evaluating the EnChEVAR technique for patients treated between December 2022 and February 2024. Clinical, perioperative procedure-related and radiological data were collected. The primary outcome measure was the freedom of a type Ia gutter-related endoleak at postoperative computed tomography angiography (CTA). Secondary outcome measures included early type Ia endoleak-related reinterventions, target vessel complications including dissection or loss of target vessel, major adverse events, and mortality. Continuous variables were presented as median (interquartile range [IQR]) and categorical variables as count and percentage. RESULTS: Ten patients were included in the present study. Eight (80%) were males, in nine cases a single chimney was implanted, and the other one was a double chimney graft placement. The treated aneurysms had an infrarenal neck length of 3.4 (1.2) mm. The rate of main body oversizing was 30%. The new neck length after chimney graft placement was 18 (3) mm. The median procedural time was 130 (17) mm, contrast medium use was 109 (26) mL, radiation time was 45 (12) min. The technical success was 100%. No type Ia endoleak was detected at the postoperative CTA. There were no target vessel issues. No major adverse events or death were observed. CONCLUSIONS: First reported cohort of patients treated with EnChEVAR demonstrated reproducible clinical and procedural outcomes within the 3 vascular centers with total exclusion of the aneurysms, patent renal arteries, and no evidence of gutter-related type IA endoleak. Further evidence with larger sample size of treated patients and longer follow-up are needed.

Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

Extravascular Ultrasound (EVUS) to Assess the Results of Peripheral Endovascular Procedures.

Contrast arteriography (CA) is considered the gold standard to evaluate any phase in peripheral arterial disease (PAD) interventions, from diagnostics to final results. Nevertheless, duplex ultrasonography (DUS) mostly used for the pre/postoperative phase and follow-up control, could be a potential intraoperative adjunctive imaging tool to assess the effects of endovascular revascularization in patients with iliac and femoropopliteal lesions. The PAD "duplex-assisted" protocol includes a preoperative DUS control followed by an intraoperative and a postoperative control. The most important parameters are pulsed doppler spectral analysis and waveform changes, which are impossible to detect with intravascular ultrasound (IVUS). By using a similar acronym, the intraoperative DUS has been previously described as extravascular ultrasound (EVUS). B-mode imaging, color flow, and peak systolic velocity (PSV) are considered. EVUS could be very useful to evaluate the effects of endovascular treatment, mainly in cases of unclear CAs, severe calcifications and/or dissections. In the context of the "leaving nothing behind" strategy, EVUS can drive the physician to evaluate the absence of flow-limiting dissections and decide which target lesion should be treated with antirestenotic therapy, further vessel preparation, or stenting. The EVUS protocol could be a safe and feasible option to improve the completion assessment of endovascular PAD treatment. A better ultrasound waveform is a sign of improved luminal gain and compliance, which is extremely important to finalize the results of new peripheral device technology, such as intravascular lithotripsy.

A Rare but Fatal Behçet Variant: The Hughes-Stovin Syndrome-Successful Case Report and New Evidence from Literature Review.

Hughes-Stovin syndrome (HSS) is a rare potentially fatal vasculitis supposedly belonging to the spectrum of Behçet disease without ocular involvement. HSS tends to play by a temporal pattern, starting with thrombosis and followed by formation of pulmonary aneurysms. Since its mortality can reach 25% of cases, early recognition and appropriate therapy represent the major clinical challenges. We describe a rare case of HSS successfully treated via multidisciplinary management by an endovascular approach and immunosuppressive therapy.

The new educational project Televascular Games during the Coronavirus Disease 2019 pandemic.

Objective: To report methodology and first-year results of a new educational project called Televascular Games," which took place during coronavirus disease 2019 pandemic. Methods: Complex aneurysmal aortic disease was discussed during a 2-hour competition webinar, according to three modalities. (1) Planning case competition (PCC): Two to four preoperative computed tomography angiography (CTA) scans of an already performed selected case were submitted for the competition. CTA scans were uploaded anonymously, without any reference to the center or the surgeon who performed the case. The competitor had to prepare a presentation of how he or she would have diagnosed, sized, planned, treated, and followed up the case, of the medical therapy and of the bail-out maneuvers. (2) Challenging case competition (CCC): The competitor elaborates a presentation of an already treated case concerning an aortic topic and discusses sizing, planning, treatment, possible bail-out maneuvers and obtained results. For the CCC and PCC, the competitors with the best score were preselected to present and discuss their plan during the webinars. (3) Quiz competition: Two to six CTA scans of already performed selected aortic cases were submitted for the competition. A quiz with multiple choice questions was answered by the competitors. The top four competitors were selected for the webinars and then they discussed the cases during the webinar. Finally, at the end of the case discussion, the effective case resolution and follow-up were shown. A final winner was voted via televoting, based on six preestablished criteria. The project was endorsed by different national and international societies. Results: Between October 2020 and December 2021, there were 12 Italian and 1 international webinars with 1695 participants overall (mean, 130; range, 86-177). Competitors were 54 years of age (mean, 27 years; range, 22-38 years). Two editions were CCCs, two quiz competitions, and nine PCCs. The reliability of the interobserver sizing of competitors was κ = 0.43 and κ = 0.62 for the proximal and distal sealing measurements respectively and very good (κ = 0.88-0.95) in the evaluation of orientation of the vessels, presence of angulations, calcifications, and thrombus. The sizing discrepancy resulted in a significant variability of the planning (κ = 0.45). The project ranked 9.6 on a 10-point rating scale by all the participants and competitors. Conclusions: The formula of gaming and collegial discussion of aortic cases herein reported has proved valid and attractive during coronavirus disease 2019 pandemic period. The variability of the results on sizing and planning suggested to confer with a second opinion, especially for less experienced surgeons.

Chimney endovascular aneurysm repair (ChEVAR) for hostile neck complex aneurysm.

OBJECTIVE: Recent guidelines recognize the role of chimney endovascular aneurysm repair (ChEVAR) in the treatment of complex aortic disorders. The optimal configuration and number of visceral vessels that can be incorporated is still controversial. We aim to review outcomes from a multi-institutional decade-long experience with ChEVAR. METHODS: Patients undergoing ChEVAR with multiple (≥2) chimney branches were selected from a prospectively maintained database at the two academic university hospitals. All patients were poorly suited for fenestrated or branched endograft repair (F/BEVAR) and deemed poor-risk for open surgery. RESULTS: Forty-nine multiple ChEVAR were performed in 44 men and 5 women, with complete outcome data at a mean follow-up of 18 months. Overall, 2 patients died during follow-up (4%) with no aneurysm-related mortality and two ruptures after ChEVAR (4.1%) due to a type Ib endoleak from iliac limb pullout and persistent gutter-flow, both repaired with endovascular means. No stroke or spinal cord ischemia was noted during the follow-up period. Reintervention was undertaken in eight patients (16.3%) with five reinterventions for persistent gutter-flow and four chimney graft-associated. Three-vessel ChEVAR was performed in 16 patients, with two-vessel ChEVAR in 33 patients for a total of 114 chimney branches (mean 2.3 chimneys per patient). There were 21 superior mesenteric artery (SMA), 45 right renal, 46 left renal artery (LRA), and two accessory LRA chimneys placed. Antegrade configuration of chimney branches was chosen in 43 patients (88%). There were no significant differences between three-vessel and two-vessel ChEVAR upon univariate analysis in aneurysm size (65.6 vs 60.5 mm; p = 0.059), iliac diameter (7.3 vs 7.1 mm; p = 0.85), or endograft oversizing (30 vs 32.5%; p = 0.43). Three-vessel ChEVAR was associated with a larger aneurysm neck diameter (28.4 vs 25.0 mm; p = 0.021), shorter native infrarenal neck (0.5 vs 3.37 mm; p = 0.002) as well as longer seal zone (36.33 vs 22.67 mm; p = 0.005) compared with two-vessel ChEVAR. At follow-up, there were no significant differences in gutter area between three-vessel and two-vessel ChEVAR (18.9 vs 15.7 mm3; p = 0.73) nor the rate of persistent gutter-flow (12.5 vs 9.1%; p = 0.71). CONCLUSION: Reintervention to multiple chimney grafts and for persistent gutter-flow is higher compared to single chimneys and demands close surveillance. However, based upon this combined transantlantic experience, we believe multiple ChEVAR provides a reasonable and safe option for complex aortic aneurysm repair when open or custom endografts are not available or indicated based on their Instructions For use, even when triple chimney grafts are required. The optimal configuration for multiple ChEVAR still warrants further study, although theoretical preliminary advantages may exist for a combination of antegrade and retrograde chimneys.

Multicenter Mid-Term Outcomes of the Chimney Technique in the Elective Treatment of Degenerative Pararenal Aortic Aneurysms.

PURPOSE: Chimney endovascular abdominal aortic aneurysm repair (CHEVAR) has predominantly been described as an alternative technique for the management of urgent presentations of degenerative pararenal aortic aneurysms (dPAAs). However, the role of CHEVAR in the treatment of asymptomatic patients remains unknown. The aim of current multinational study was to evaluate the outcomes of elective CHEVAR of dPAAs. MATERIAL AND METHODS: Retrospective analysis of 267 consecutive dPAA patients treated with elective CHEVAR at 13 European and US centers from 2008 to 2014. Primary endpoints were 30 days and out of hospital CHEVAR-related mortality. Secondary endpoints included persistent type Ia endoleak or endotension, angiographically confirmed occlusion and/or high-grade chimney graft (CG) or involved splanchnic vessel stenosis identified at index procedure and/or during follow-up, as well as CHEVAR-related re-intervention. RESULTS: Mean follow-up time was 25.5±13.3 months. The 442 visceral vessels were involved and mean number of CGs per patient was 1.63±0.7. 436 targeted vessels were successfully cannulated. The aortic graft intentionally covered 6 renal arteries and immediate technical success was 98.6%. The 30 days mortality was 1.9% (n=5), while the in-hospital complication rate was 10.1% (n=27) including 3 strokes, 1 permanent dialysis, and 1 intestinal ischemia. No 30 day type Ia endoleaks were detected and 3.2% of CGs (n=14, including the intentionally covered) had evidence of occlusion and/or stenosis. The overall CHEVAR-related mortality was 2.2% (n=6). Freedom from primary and secondary type Ia endoleak/endotension rates at 3 years was 93.0% and 98.0%, respectively. Primary and secondary CG patency was 87.0% and 89.0%. Primary and secondary endovascular freedom from any endpoint at 3 years was 81.0% and 94.0% respectively. CONCLUSION: Elective use of CHEVAR in the management of dPAAs seems to be durable. These results are comparable to published outcomes with other total endovascular strategies, which justifies an expanded role for CHEVAR in the treatment of asymptomatic patients presenting with dPAAs.

Successful conversion strategy in patient submitted to EVAR demanding open surgery: comparative analysis 1997-2011 vs 2012-2020.

Late open conversion in our center has been reviewed in the past 8 years, comparing 1997-2011 (first period group A) with 2012-2020 (second period group B). A retrospective analysis of patients treated at our centre by standard EVAR for infrarenal aortic aneurysm requiring late open conversion between January 1997 and February 2020 was performed. All stent grafts were implanted according to their current IFU all patients. The data concerning intra and postoperative complications were collected. Post-operative evaluated data include: ICU (Intensive Care Unit) stay, major peri-operative (<30 days) complications, in hospital mortality, length of hospital stay, 30-days mortality, and mid-term outcomes. Between January 2012 and February 2020 (group B), in our institution 8 patients previously treated by stent graft with endoleak underwent open surgery. The incidence of conversions and the 30-day mortality rate were compared with that of previous years, from January 1997 to December 2011 (group A). 481 patients submitted to EVAR in a second part of the analysis have been considered, 8 patients underwent late open conversion (1.7%) (Group B) due to endoleak. Among January 1997 and December 2011 overall 268 EVAR were performed; during this first study period, surgical conversion had been performed in 14 patients (5.2%) (Group A). The average time from EVAR to open conversion was four years (range 12-88 months) in Group B, and it was 30 months (range 1-82 months) in Group A. In most cases, in both group A and group B the proximal aortic cross-clamping were infrarenal. After the emergent procedure in Group B (12.5%), we have observed a death, whereas three patients died in Group A in urgent situations (21.4%). The more frequent indication for open surgery is the Endoleak type 1 and migration in the two considered periods. Adherence with current IFU and the technical progress in endoprosthesis design maintain lower rate incidence. In most cases, open surgery for prostheses that require explantation can be performed with infrarenal clamping. Partial removal of the endoprosthesis in selected cases makes open conversion easier and appears durable. The results are unfair by numerous comorbidities; in both periods, urgent graft removal seems to elevate both mortality and morbidity, compared to elective surgery.

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry.

OBJECTIVE: To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. METHODS: For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. RESULTS: Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). CONCLUSIONS: Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.

Polyester Stent Graft Devices and Higher Risk of Post-Implantation Syndrome after EVAR: Single-Center Analysis of 367 Patients.

BACKGROUND: The post-implantation syndrome may occur shortly after endovascular aneurysm repair in patients treated for abdominal aortic aneurysm. Different types of biomaterials may provoke varying inflammatory responses in patients receiving different endografts. The purpose of this article is to evaluate the PIS after EVAR and the influence of different types of device fabric. METHODS: All patients submitted to elective AAA endovascular repair at our institution from January 2014 to December 2019 were enrolled. The PIS was defined by a body temperature of >38°C and WBC >12'000/µl without any evidence of an infection during (48h) the observation period. RESULTS: Three hundred and sixty-seven patients (89% males) were enrolled in this study and post-implantation syndrome occurred in 41 cases (11.2%). The incidence of PIS was significantly higher (P< 0.001) in patients treated with polyester stent grafts (39/201, 19,4%) compared to patients with PTFE stent grafts (2/166, 1,2%). CRP was related to the presence of PIS with a cut-off values of 109.31 mg/dL (P = 0.0052). The median in-hospital stay considering the polyester group was 6,2 days, while in the PTFE group it was 5,6 days (P = 0.04). CONCLUSIONS: The postoperative inflammatory response after EVAR seems significantly higher by using polyester stent graft compared to PTFE devices. CRP could be a useful biomarker in defining PIS. Multi-center studies are necessary to confirm these data.

Preliminary Clinical and Radiologic Outcome of Matched Patients with Thoracoabdominal Aortic Aneurysms Treated by Low-Profile vs Standard Profile Branched Aortic Endografts.

BACKGROUND: Durability of low-profile branched aortic stent-grafts (LPSG) in the treatment of patients with thoracoabdominal aortic aneurysms (TAAA) remains unclear. Objective of this study is to compare the outcomes of LPSG with standard profile branched aortic stent-grafts (SPSG). METHODS: Between January 2016 and January 2020, 225 consecutive patients with TAAA were treated by branched endovascular aortic repair (BEVAR). Twenty-four patients who were treated with a LPSG were compared to 24 patients who received SPSG as a control group. Control patients were selected according to aneurysm size (maximum aneurysm diameter) and extension (Crawford classification) as well as availability of adequate preoperative and postoperative CT-angiograms at 24 months. The primary endpoint was ongoing clinical success defined as successful implantation and freedom from aneurysm- or procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion or rupture and conversion. Secondary endpoints were radiological changes of the branched endograft (migration, shortening, scoliosis, lordosis, and fracture). RESULTS: After a median follow-up of 22.6 (LPSG) and 26.2 months (SPSG), no significant difference was found in terms of technical success (100% in both groups), late mortality (4.2% vs 0%), aneurysm diameter increase (4.2% in both groups) and reinterventions (25% vs 37.5%). Infection, thrombosis, aneurysm expansion or rupture and conversion were not observed. Radiological analysis of aortic graft remodeling showed no fracture and no significant migration, shortening, scoliosis and lordosis of the LPSG (6.1 mm, 7.5 mm, 12.8° and 6.1°) compared to SPSG (3.9 mm, 5.1 mm, 7.9° and 5.6°) after 2 years. CONCLUSION: The clinical and radiological findings of the present study showed no increased mortality and complications for the matched patients who underwent treatment with low-profile vs standard-profile BEVAR. This study provides preliminary evidence of safety and efficacy of low-profile branched endografts in patients with demanding iliac access vessels.

The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures.

OBJECTIVE: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency. METHODS: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%]). RESULTS: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99). CONCLUSION: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency.

Outcomes of elective use of the chimney endovascular technique in pararenal aortic pathologic processes.

OBJECTIVE: In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting. METHODS: We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure. RESULTS: All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively. CONCLUSIONS: The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting.

Long-term chimney/snorkel endovascular aortic aneurysm repair experience for complex abdominal aortic pathologies within the PERICLES registry.

OBJECTIVE: The early and short-term efficacy of the snorkel/chimney technique for endovascular aortic aneurysm repair (ch-EVAR) have been previously reported. However, long-term ch-EVAR performance, vessel patency, and patient survival remain unknown. Our study evaluated the late outcomes to identify possible predictors of failure within the PERICLES (performance of the chimney technique for the treatment of complex aortic pathologies) registry. METHODS: Clinical and radiographic data from patients who had undergone ch-EVAR from 2008 to 2014 in the PERICLES registry were updated with an extension of the follow-up. Regression models were used to evaluate the relevant anatomic and operative characteristics as factors influencing the late results. We focused on patients with ≥30 months of follow-up (mean, 46.6 months; range, 30-120 months). RESULTS: A total of 517 patients from the initial PERICLES registry were included in the present analysis, from which the mean follow-up was updated from 17.1 months to 28.2 months (range, 1-120 months). All-cause mortality at the latest follow-up was 25.5% (n = 132), with an estimated patient survival of 87.6%, 74.4%, and 66.1% at 1, 3, and 5 years, respectively. A subgroup of 244 patients with 387 chimney grafts placed (335 renal arteries, 42 superior mesenteric arteries, 10 celiac arteries) and follow-up for ≥30 months was used to analyze specific anatomic and device predictors of adverse events. In the subgroup, the technical success was 88.9%, and the primary patency was 94%, 92.8%, 92%, and 90.5% at 2.5, 3, 4, and 5 years, respectively. The mean aneurysm sac regression was 7.8 ± 11.4 mm (P < .0001). Chimney graft occlusion had occurred in 24 target vessels (6.2%). Late open conversion was required in 5 patients for endograft infection in 2, persistent type Ia endoleak in 2, and endotension in 1 patient. The absence of an infrarenal neck (odds ratio, 2.86; 95% confidence interval, 1.32-6.19; P = .007) was significantly associated with long-term device-related complications. A sealing zone diameter >30 mm was significantly associated with persistent or late type Ia endoleak (odds ratio, 4.86; 95% confidence interval, 1.42-16.59; P = .012). CONCLUSIONS: The present analysis of the PERICLES registry has provided the missing long-term experience for the ch-EVAR technique, showing favorable results with more than one half of the patients surviving for >5 years and a chimney graft branch vessel patency of 92%. The absence of an infrarenal neck and treatment with a sealing zone diameter >30 mm were the main anatomic long-term limits of the technique, requiring adequate preoperative planning and determination of the appropriate indication.

Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair.

OBJECTIVES: The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year. METHODS: Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability. RESULTS: At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms (p = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm (p = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3-0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance (p = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months. CONCLUSIONS: Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.

Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft.

PURPOSE: To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy. MATERIALS AND METHODS: A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications. RESULTS: The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears. CONCLUSION: Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

Use of Stainless-Steel, Balloon-Expandable Chimney Grafts Is Durable Though Caution Is Required When Lining Angulated Renal Arteries.

PURPOSE: To analyze the overall performance of flexible nitinol stents used to line chimney grafts (CGs) during chimney endovascular aneurysm repair (chEVAR) of pararenal pathologies. MATERIALS AND METHODS: A retrospective review was conducted of all 116 elective patients (mean age 74.3±7.2 years; 103 men) who underwent chEVAR with balloon-expandable Advanta V12/iCAST CGs in combination with the Endurant stent-graft between January 2009 and December 2017 at a single center. CG lining with a nitinol stent was electively performed in 43 target vessels of 32 patients. The Kaplan-Meier method was used to estimate the primary outcomes of CG patency and freedom from reintervention (FFR) at the patient level and according to the use of a stent to line the CG. Estimates are reported with the 95% confidence interval (CI). Adjusted odds ratios (ORs) were calculated to identify any confounding effect between the presence/absence of a stent lining or according to the number of CGs. RESULTS: The mean radiological follow-up was 27.3 months (range 22.1-32.6). During this time, 8 CGs (4.7%) became occluded, 6 of them were lined with stents. Restoration of patency was possible in 3 of the 4 occluded stents that were associated with symptoms. First-year primary patency estimates were 96.9% (95% CI 92.5% to 100%) for the unlined group vs 77.1% (95% CI 58% to 95.3%; p=0.001) for the lined group, while FFR was 87.6% (95% CI 79.9% to 95.2%) vs 83.4% (95% CI 68.1% to 98.6%; p=0.82), respectively. Lining represented an independent risk factor for CG occlusion (OR 9.9, p=0.006). CONCLUSION: CG lining performed mainly in angulated renal arteries during chEVAR was significantly associated with CG occlusion. These findings highlight the importance of not having the distal part of the CG impinge on the angulated segment of the target vessel.

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.

BACKGROUND: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). METHODS: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n = 18) with de novo lesions; Group B (n = 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. RESULTS: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P = 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P = 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P = 1) and 4 cases (11.1% vs. 16.7%; P = 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. CONCLUSIONS: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.