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Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to present a new technique for fenestrated endovascular aortic aneurysm repair (FEVAR) and to review its preliminary results. The SiMplified bARe-wire Target vessel (SMART) technique for FEVAR aims to simplify the procedure by avoiding guiding sheaths into visceral arteries during the main graft deployment. Materials and Methods: The SMART technique requires a 12 to 16Fr contralateral introducer, depending on number of fenestrations—compared with standard 18 to 22Fr for 3 to 4 FEVAR—to achieve target vessel catheterization and stenting during FEVAR by avoiding the use of parallel 6 to 7Fr guiding sheaths into each visceral vessel. Fenestrations are sequentially catheterized, assisted by a steerable sheath. A Rosen wire is maintained in each fenestration, with a single sheath parked in the final target vessel while releasing the fenestrated graft. Data on patients treated for pararenal or thoracoabdominal aortic aneurysms with FEVAR, adopting the SMART technique, were retrospectively reviewed. End points were technical success, intraprocedural variables, 90-day mortality, major adverse events (MAEs), and target vessel patency. Results: From May 2018 to December 2020, 57 consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. Median total procedure time and total fluoroscopy time were 223 (196–271) minutes and 81 (71–94) minutes, respectively. Primary technical success was 96.4% (55/57). No misalignment occurred from graft deployment. The total number of fenestrations was 169, including 54 left and 53 right renal arteries, 43 superior mesenteric arteries and 18 celiac trunks (3.0±0.9 vessels/patient), with target vessel technical success of 98.2%. During the first 90 days, there were no deaths (0%). The MAEs included acute kidney injury (AKI) in 3 patients (5%) with no new dialysis onset, respiratory failure requiring prolonged ventilation in 2 patients (4%), myocardial ischemia in 1 patient (2%), but no lower limb ischemia, stroke, or spinal cord ischemia (SCI) occurred. After a mean follow-up of 14±10 months, there was 1 aortic-related death. Primary and assisted primary target vessel patency was 94.6%±1.8 and 97.0%±1.3% respectively. Conclusions: The SMART technique proved to be a safe alternative to standard FEVARs, with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity. Clinical Impact: This study evalautes the outcome of fenestrated endovascular aortic repair (FEVAR) procedures at Uppsala university hospital using a simplified bare-wire Target vessel (SMART) technique. The SMART technique requires a smaller contralateral introducer compared to standard 18-22Fr for 3-4 FEVAR to achieve target vessel catetherization and stenting. Fifty-seven consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. The SMART technique proved to be a safe alternative to standard FEVARs with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity. [ABSTRACT FROM AUTHOR]

Purpose: In situ laser fenestration (ISLF) is a recently introduced technology that offers the potential to perform total endovascular treatment of aortic arch and thoracoabdominal aortic pathologies in the acute setting. This experiment's aim was to assess ISLF in some currently common aortic endografts and bridging stent-grafts. Materials and Methods: Three different aortic endografts were evaluated: (1) Zenith Alpha, (2) Zenith TX2, and (3) Conformable GORE TAG. Each endograft was submerged in 37°C saline to create fenestrations using the 308 nm CVX-300 Excimer Laser System fitted with a 2.3 mm diameter Turbo-Elite laser atherectomy catheter compatible with a 0.018″ guidewire. Three different 8 mm bridging stent-grafts were evaluated: (1) BeGraft peripheral, (2) BeGraft peripheral plus, and (3) GORE VIABAHN VBX Balloon Expandable. All bridging stent-grafts were deployed and exposed to different balloon sizes and pressures. The ISLFs and bridging stent-grafts were then evaluated for any tears, stenoses, and seal. Results: A laser fenestration was consistently rapidly obtained in the Zenith Alpha and the Zenith TX2 endografts while it proved difficult to achieve a timely fenestration in the C-TAG. No fabric tears were noted in the Zenith Alpha and Zenith TX2 when inflating Armada (Abbott) 8 mm balloon in the fenestrations with pressures up to 15 atmospheres (rated burst pressure) nor when flaring bridging stent-grafts with balloons up to 12 mm in diameter at 10 atmospheres, while major tears were frequently noted in the C-TAG when the Armada 8 mm balloons were inflated. BeGraft Peripheral and BeGraft Peripheral Plus were all firmly attached to the fenestrations showing good seal on manual testing, while every sixth VBX bridging stent-graft displayed poorer attachment to the fenestration before dilatation at high pressure. Commonly, significant stenoses remained in the bridging stent-grafts after dilatation at nominal pressure, which could only be eradicated with high-pressure balloons. Conclusion: In this limited bench-test, Dacron endografts responded well to the ISLF technology. Satisfactory deployment of the bridging stent was noted only after inflation and/or flaring with high-pressure balloons. Further work with different types of commercially-available bridging stent-grafts and endografts to assess the durability of in situ fenestration (ISF) and bridging stents in ISF is recommended. Clinical Impact: This report on experimental in situ laser fenestration provide important insights for clinicians considering using in situ laser fenestration of aortic stentgrafts in vivo. In particular, different laser settings were tested together with a selection of aortic stentgrafts. Also, the target pressure needed in PTA balloons to dilate the fenestrations and any subsequent tears in the fabric were noted. This was followed by deployment of assorted balloon-expandable stentgrafts with estimation of residual stenosis and seal. [ABSTRACT FROM AUTHOR]