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.

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.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

In situ laser fenestration of the Thoraflex Hybrid frozen elephant trunk for emergent revascularization of the left subclavian artery and laser fenestration for spinal cord perfusion.

In situ laser fenestration (ISLF) has emerged as a promising technique for emergent revascularization of the left subclavian artery in the case of thoracic endovascular aortic repair coverage, presenting excellent technical success rates in most studies. We describe a case of ISLF of the Thoraflex Hybrid frozen elephant trunk device to achieve immediate left subclavian artery revascularization. We demonstrate the feasibility and technical success of using ISLF in this setting, providing a less invasive alternative to conventional surgical revascularization when required.

Statin therapy after elective abdominal aortic aneurysm repair improves long-term survival.

BACKGROUND: Patients with abdominal aortic aneurysms are at high risk of cardiovascular events. Although statin therapy is indicated for most of these patients, no specific recommendation regarding the intensity of therapy exists. The aim of this study was to assess the possible effect of statin therapy on survival of patients undergoing abdominal aortic aneurysm repair and to investigate if high-intensity statin therapy was superior to low-moderate-intensity therapy. METHODS: Data from nationwide Swedish registers on hospital admissions, operations, and medications for patients undergoing elective abdominal aortic aneurysm repair from 2006 to 2018 were collected. The effect of statin use was evaluated in three separate propensity score matched cohorts: perioperative mortality was analysed according to whether patients were on statins before abdominal aortic aneurysm repair or not; long-term survival was assessed according to whether patients were on statins during follow-up or not; and, for those on statins after surgery, long-term survival was analysed according to whether patients were on high-intensity or low-moderate-intensity statin therapy. RESULTS: Preoperative statin use did not reduce 90-day perioperative mortality (OR 0.99, 95% c.i. 0.77 to 1.28), whilst there was a marked benefit regarding long-term survival for postoperative statin users (HR 1.43, 95% c.i. 1.34 to 1.54). High-intensity statin therapy had no advantage over low-medium-intensity statin therapy with regards to long-term survival (HR 1.00, 95% c.i. 0.80 to 1.25). CONCLUSION: In this nationwide propensity score matched cohort study, preoperative statin treatment had no benefit regarding 90-day perioperative survival, but postoperative statin treatment markedly improved long-term survival. No additional benefit regarding high-dose statin treatment could be confirmed in this analysis.

Editor's Choice - Systematic Review and Meta-Analysis of Contemporary Abdominal Aortic Aneurysm Growth Rates.

OBJECTIVE: To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes. DATA SOURCES: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases. REVIEW METHODS: Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404). RESULTS: Of 8 717 titles identified, 43 studies and 28 277 patients were included: 1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 - 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 - 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 - 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 - 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 - 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 - 2.32; GRADE = high). CONCLUSION: This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable to demonstrate any clinically meaningful AAA growth rate reduction concomitant with changed AAA epidemiology. This suggests that the RESCAN recommendations on small AAA surveillance are still valid. However, sub-analysis results from RCTs and high quality study data indicate potential lower AAA growth rates of 1.88 - 2.09 mm/year, findings that should be validated in a high quality prospective registry.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

A novel off-the-shelf single-fenestrated stent graft for emergent complex aortic aneurysm repair.

The off-the-shelf single fenestrated stent graft is based on the Cook Zenith fenestrated platform (Cook Medical Europe) with a premade 8-mm fenestration for the superior mesenteric artery (SMA). The device is suitable for emergency treatment of paravisceral aneurysms when combined with in situ laser fenestration for the renal arteries (and, if required, the celiac trunk). The presence of a premade SMA fenestration results in minimal visceral ischemia time. We present the case of a 69-year-old woman with a ruptured Crawford type I thoracoabdominal aortic aneurysm and a tandem abdominal aortic aneurysm that was treated successfully using the single fenestrated device with in situ laser fenestration for the renal arteries, with no SMA ischemia time. A 6-month computed tomography angiogram showed patent renovisceral stents without an endoleak.

Urgent endovascular mycotic aortic arch aneurysm repair using in situ laser fenestration and selective arterial perfusion with venoarterial extracorporeal membrane oxygenation.

In recent years, mycotic aortic aneurysms have been increasingly treated successfully by endovascular means. The introduction of custom-made fenestrated and branched devices, parallel graft techniques, and in situ fenestration has enabled total endovascular treatment also for arch pathologies. We describe a total endovascular repair of a mycotic arch aneurysm with in situ laser fenestration using venoarterial extracorporeal membrane oxygenation to preserve flow to vital organs.

Patients' health and quality of life after complex endovascular aortic repair: A prospective cohort study.

RATIONALE: Complex endovascular aortic repair often involves multiple major procedures over time with a high risk of complications and little time for recovery. This exposes patients to great stress, both physically and mentally, with potentially long-lasting effects. There is limited knowledge about these effects and who is most at risk - information on this could help vascular nurses and other healthcare professionals anticipate and meet care needs. AIM: To investigate the health and quality of life effects of complex endovascular aortic repair, in relation to patients' demographic and health characteristics. DESIGN: A prospective cohort study. METHODS: Patients undergoing elective complex endovascular aortic repair were consecutively recruited from one university hospital during one year (n=25). Self-report questionnaires on health disability (WHODAS 2.0), quality of life (WHOQoL-BREF) and symptoms of anxiety and depression (HADS) were filled out preoperatively and repeated one and six months postoperatively. Prospective changes in health and quality of life, and associations with patient demographics and preoperative health characteristics, were assessed. Ethical approval was obtained prior to study performance. RESULTS: Overall, patients had significantly greater health disability at one month (WHODAS 2.0 score median 31.5, range 1.1-63.0) than preoperatively (median 13.6, range 0.0-41.3) (n=22, p=.017); the majority had recovered at six months (median 11.4, range 3.3-58.7) (n=18, p=.042). No significant effects were seen in quality of life and symptoms of anxiety and depression (p>.05). However, the participants showed heterogeneity, with certain individuals not recovered at six months (n=8). Factors associated with worse six-month outcomes were being female, age < 70 years, postoperative complications, and history of anxiety or depression. CONCLUSIONS: Complex endovascular aortic repair have limited long-term negative effects on patients' health and quality of life. However, some patients are not recovered at six months postoperatively, which could be explained by individual characteristics. To improve recovery outcomes, vascular nurses and other health care professionals should be aware of the possible recovery trajectories and factors associated with impaired recovery, and use them to anticipate and meet the patients' individual care needs.

Conflicting European and North American Society Abdominal Aortic Aneurysm (AAA) Volume Guidelines Differentially Discriminate Peri-operative Mortality After Elective Open AAA Repair.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) guidelines endorse a minimum abdominal aortic aneurysm (AAA) repair volume of 20 open (OAR) and or endovascular (EVAR) AAA repair procedures per year as a proxy for high quality care. In contrast, the Society for Vascular Surgery (SVS) espouses 10 exclusively OARs per year. Given the differences in these volume standards and definitions, debate persists regarding surgeon credentialing and healthcare resource allocation. This analysis aimed to determine which society endorsed volume benchmark better discriminates OAR mortality. METHODS: A retrospective national registry based cohort analysis. Patients undergoing elective OAR were compared between centres meeting either ESVS (≥ 20 AAA procedures/year) or SVS (≥ 10 OARs/year) volume thresholds within the Vascular Quality Initiative (2010 - 2020). The primary outcome was in hospital death. Logistic regression was used for risk adjusted comparisons. RESULTS: A total of 8 761 OARs were performed at 193 US centres, and the median (IQR) volume was 6.6 (3.3, 9.9) OARs/year. When applying the SVS centre volume definition, the proportion of centres meeting ESVS and SVS minimum case thresholds was 12% (n = 22) and 25% (n = 48), respectively. The absolute mortality difference was 0.3% between centres performing ≥ 20 vs. ≥ 10 OARs/year (2.6% vs. 2.9%; p = .51). There was an incremental association between OAR volume and crude mortality rate; however, this absolute difference between lower and higher thresholds was only 0.2%/procedure (OR 0.98, 95% CI 0.97 - 0.99; p < .001). Moreover, no difference in risk adjusted mortality was detected between volume standards (≥ 10 vs. ≥ 20; p = .78). In sub-analysis, the ESVS ≥ 20 total composite AAA repair volume threshold was not associated with mortality (p = .17); however, increasing the proportion of OAR cases making up the total annual AAA centre volume inversely correlated with mortality (p = .008). CONCLUSION: It appears that the SVS endorsed AAA centre volume threshold using exclusively OAR had a modest ability to discriminate peri-operative mortality outcomes and was superior to the current composite ESVS volume guideline in differentiating centre performance. These findings raise questions regarding the clinical validity of using EVAR as a volume proxy for OAR.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Comparing maximum diameter and volume when assessing the growth of small abdominal aortic aneurysms using longitudinal CTA data: cohort study.

BACKGROUND: Monitoring of abdominal aortic aneurysms (AAAs) is currently based on serial measurements of maximum aortic diameter. Additional assessment of aneurysm volume has previously been proposed to possibly improve growth prediction and treatment decisions. To evaluate the use of supplementing volume measurements, the authors aimed to characterise the growth distribution of AAA volume and to compare the growth rates of the maximum diameter and volume at the patient level. METHODS: Maximum diameter and volume were monitored every 6 months in 84 patients with small AAAs, with a total of 331 computed tomographic angiographies (with initial maximum diameters of 30-68 mm). A previously developed statistical growth model for AAAs was applied to assess the growth distribution of volume and to compare individual growth rates for volume and for maximum diameter. RESULTS: The median (25-75% quantile) expansion in volume was 13.4 (6.5-24.7) % per year. Cube root transformed volume and maximum diameter showed a closely linear association with a within-subject correlation of 0.77. At the surgery threshold maximum diameter of 55 mm, the median (25-75% quantile) volume was 132 (103-167) ml. In 39% of subjects, growth rates for volume and maximum diameter were equivalent, in 33% growth was faster in volume and in 27% growth was faster in maximum diameter. CONCLUSION: At the population level, volume and maximum diameter show a substantial association such that the average volume is approximately proportional to the average maximum diameter raised to a power of three. At the individual level, however, in the majority of patient's AAAs grow at different pace in different dimensions. Hence, closer monitoring of aneurysms with sub-critical diameter but suspicious morphology may benefit from complementing maximum diameter by volume or related measurements.