A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair.

OBJECTIVE: 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 has been developed. Core outcome sets, 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. METHODS: 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. RESULTS: 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 two (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: mortality at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, 5 year survival, and continued sac growth. CONCLUSION: 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 define instruments for cognitive functioning is needed.

Medical Note Quality Audit at the Vascular Surgical Unit Compared With the British Medical Journal (BMJ) Guidelines.

Effective medical notes ensure comprehensive documentation in healthcare. This study evaluates medical note quality in the vascular unit at Mater Dei Hospital using British Medical Journal (BMJ) guidelines. Two cycles examine 17 parameters pre- and post-intervention, revealing notable, significant enhancements in patient identifiers, clinical summaries, examination, and planning. Future prospects involve digitizing note-taking, utilizing artificial intelligence (AI) for data organization, and simplifying entry methods. Implementation of electronic solutions is encouraged for improved accuracy, efficiency, and continuity of patient care.

A SiMplified bARe-Wire Target Vessel (SMART) Technique for Fenestrated Endovascular Aortic Repair.

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.

In Situ Laser Fenestration Technique: Bench-Testing of Aortic Endograft to Guide Clinical Practice.

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.

Treatment of Peripheral Arterial Occlusive Disease around the Globe: Malta.

INTRODUCTION: Malta is a small island in the middle of the Mediterranean with a population of 514,564 inhabitants and is served by one public tertiary hospital, Mater Dei Hospital. The Vascular unit was set up in 2007. The aim of this review is to analyse the work related to peripheral arterial occlusive disease (PAOD) in Malta with an in-depth focus on amputations and revascularisation procedures since the introduction of the Vascular unit. METHOD: Various sources of data have been interrogated to address this subject. Population and prevalence data on obesity and type II diabetes mellitus from 2003 to 2019 was obtained from the National Statistics Office, the World Health Organization, and the International Diabetes Federation, respectively. The Maltese Vascular Register (MaltaVasc), and in-hospital reports from 2003 to 2019 was used to obtain data on revascularisation procedures, major amputations and minor amputation rates in Malta. RESULTS: Malta has one of the highest rates of obesity in Europe. In 2015, the prevalence rate was 30.6%. Similarly, data from the International Diabetes Federation Atlas showed that the prevalence rate of T2DM among adults was 14% in 2017. There was a mean of 33 open/hybrid procedures per 100,000 population (28-38, 95% confidence interval) between 2005 and 2009 and a mean of 57 endovascular procedures per 100,000 population (46-68, 95% confidence interval) during the same time-period. From 2009 to 2019, there was a mean of 16 major amputations and 78 minor amputations per 100,000 population. CONCLUSION: A significant reduction in major amputation rates with an increase in minor amputation rates and revascularisation rates has been noted since the establishment of the vascular unit in Malta. During this period, there has been an increase in prevalence in obesity and T2DM together with an aging population.

Midterm results of endovascular aneurysm sealing to treat abdominal aortic aneurysm.

BACKGROUND: Endovascular aneurysm sealing (EVAS) represents a novel approach to the treatment of abdominal aortic aneurysms. It uses polymer technology to achieve an anatomic seal within the sac of the aneurysm. This cohort study reports the early clinical outcomes, technical refinements, and learning curve during the initial EVAS experience at a single institution. METHODS: Results from 150 consecutive EVAS cases for intact, infrarenal abdominal aortic aneurysms are reported here. These cases were undertaken between March 2013 and July 2015. Preoperative, perioperative, and postoperative data were collected for each patient prospectively. RESULTS: The median age of the cohort was 76.6 years (interquartile range, 70.2-80.9 years), and 87.3% were male. Median aneurysm diameter was 62.0 mm (IQR, 58.0-69.0 mm). Adverse neck morphology was seen in 69 (46.0%) patients, including aneurysm neck length <10 mm (17.3%), neck diameter >32 mm or <18 mm (8.7%), and neck angulation >60 degrees (15.3%). Median follow-up was 687 days (IQR, 463-897 days); 37 patients (24.7%) underwent reintervention. The rates of unresolved endoleak are 1.3% type IA, 0.7% type IB, and 2.7% type I. There were no type III endoleaks. There have been seven secondary ruptures in this cohort; all but one of these patients survived after reintervention. Only one rupture occurred in an aneurysm that had been treated within the manufacturer's instructions for use (IFU). CONCLUSIONS: The rate of unresolved endoleaks is satisfactorily low. The incidence of secondary rupture is of concern; however, when the IFU are adhered to, the rate is very low. The results of this study suggest that working within the IFU yields better clinical results.

Early results of endovascular aneurysm sealing with chimney grafts to treat juxtarenal and suprarenal abdominal aortic aneurysms.

BACKGROUND: The treatment of juxtarenal abdominal aortic aneurysms is challenging. Open surgical repair is not a viable option for many patients. The use of endovascular aneurysm sealing (EVAS) with chimney grafts (Ch-EVAS) has been proposed as an immediately available, off-the-shelf option for individuals with juxtarenal aneurysms who require urgent treatment or are unsuitable for fenestrated or branched devices. This study reports the outcomes from our first patients to undergo this procedure. METHODS: Data were collected prospectively for 62 consecutive patients undergoing Ch-EVAS at our institution. The procedures were undertaken for intact juxtarenal or suprarenal aneurysms in patients who were unfit for open repair or needed urgent treatment or when the aneurysm morphology was unsuitable for treatment with fenestrated or branched endografts. RESULTS: Between July 2013 and June 2016, there were 62 patients who were treated with Ch-EVAS; 77.4% were male, and the mean age was 73.9 years. Median aneurysm diameter was 64.5 mm. Eight suprarenal aneurysms were treated, with three chimney grafts. Of 54 juxtarenal aneurysms treated, 21 cases used two chimney grafts and 33 cases used one chimney graft. Median follow-up was 407 days. Eleven patients underwent reintervention. There were five type IA endoleaks, all successfully treated. One type IB and one type II endoleak occurred, neither requiring treatment. There were four minor strokes. Chimney patency is 97%. CONCLUSIONS: These results in a group of high-risk patients suggest that Ch-EVAS is a viable alternative to custom-made devices in patients who are unfit for open surgery. Longer term follow-up and data from the international registry will determine the widespread applicability and durability of this technique.

Editor's Choice - The Implications of Non-compliance to Endovascular Aneurysm Repair Surveillance: A Systematic Review and Meta-analysis.

OBJECTIVE/BACKGROUND: Increasingly, reports show that compliance rates with endovascular aneurysm repair (EVAR) surveillance are often suboptimal. The aim of this study was to determine the safety implications of non-compliance with surveillance. METHODS: The study was carried out according to the Preferred Items for Reporting of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. An electronic search was undertaken by two independent authors using Embase, MEDLINE, Cochrane, and Web of Science databases from 1990 to July 2017. Only studies that analysed infrarenal EVAR and had a definition of non-compliance described as weeks or months without imaging surveillance were analysed. Meta-analysis was carried out using the random-effects model and restricted maximum likelihood estimation. RESULTS: Thirteen articles (40,730 patients) were eligible for systematic review; of these, seven studies (14,311 patients) were appropriate for comparative meta-analyses of mortality rates. Three studies (8316 patients) were eligible for the comparative meta-analyses of re-intervention rates after EVAR and four studies (12,995 patients) eligible for meta-analysis for abdominal aortic aneurysm related mortality (ARM). The estimated average non-compliance rate was 42.0% (95% confidence interval [CI] 28-56%). Although there is some evidence that non-compliant patients have better survival rates, there was no statistically significant difference in all cause mortality rates (year 1: odds ratio [OR] 5.77, 95% CI 0.74-45.14; year 3: OR 2.28, 95% CI 0.92-5.66; year 5: OR 1.81, 95% CI 0.88-3.74) and ARM (OR 1.47, 95% CI 0.99-2.19) between compliant and non-compliant patients in the first 5 years after EVAR. The re-intervention rate was statistically significantly higher in compliant patients from 3 to 5 years after EVAR (year 1: OR 6.36, 95% CI 0.23-172.73; year 3: OR 3.94, 85% CI 1.46-10.69; year 5: OR 5.34, 95% CI 1.87-15.29). CONCLUSION: This systematic review and meta-analysis suggests that patients compliant with EVAR surveillance programmes may have an increased re-intervention rate but do not appear to have better survival rates than non-compliant patients.

Systematic Review of Reintervention After Thoracic Endovascular Repair for Chronic Type B Dissection.

This review analyzed the incidence, mechanisms, and risk factors of aortic-related reintervention after endovascular repair of chronic dissections. The systematic review identified 28 studies describing 1,249 patients at median 27 months follow-up (range, 10.3 to 64.4). There were six reinterventions, 0.7 ruptures, and 1.2 surgical conversions per 100 patient-years of follow-up. Stent-related reinterventions were more frequent than nonstent related (80.2% vs 19.8%). Distal false lumen perfusion was the most common complication (40.5%). No individual risk factor-treatment timing, disease extent, covered aorta length, or remodelling-was associated with reintervention. Further investigation based on consistent reporting standards is required.