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| 2. |
- Budtz-Lilly, Jacob, et al.
(author)
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European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair The EU-FBENDO-FAIL Registry
- 2023
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In: Annals of Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0003-4932 .- 1528-1140. ; 278:2, s. E389-E395
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Journal article (peer-reviewed)abstract
- Objective:To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR).Methods:Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm.Background:Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes.Results:There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P<0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P=0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P=0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P=0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P=0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%).Conclusions:Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.
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| 3. |
- Prendes, Carlota F., et al.
(author)
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Endovascular Aortic Repair in Nonagenarian Patients
- 2021
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In: Journal of the American College of Cardiology. - : Elsevier. - 0735-1097 .- 1558-3597. ; 77:15, s. 1891-1899
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Journal article (peer-reviewed)abstract
- BackgroundThe increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial.ObjectivesThis study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs).MethodsThis retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events.ResultsA total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed.ConclusionsAge was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised.
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| 4. |
- Prendes, Carlota F., et al.
(author)
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"In vitro" evaluation of the optimal degree of oversizing of thoracic endografts in prosthetic landing areas : A Pilot Study
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Other publication (other academic/artistic)abstract
- Objectives: The optimal degree of proximal thoracic endograft oversizing when aiming for durable sealing in prosthetic grafts in unknown. The aim of this study was to create an in vitro model for testing different oversized thoracic endografts in a reproducible and standardized manner, and subsequently determining the optimal oversizing range when planning procedures with proximal landing in prosthetic zones in the descending thoracic aorta or aortic arch.Materials and Methods: An in-vitro model consisting of a fixated 24mm polyethylene terephthalate (Dacron) graft sutured proximally and distally to two specifically designed 40mm rings, with four force sensing resistors attached at 4 equally distant positions and a USB camera attached proximally for photographic and video documentation was used for deployment of Zenith TX2 (Cook Medical, Bloomington, IN, USA) dissection platform endografts with diameters between 24 and 36mm. After deployment, ballooning with a 32mm compliant balloon was performed to simulate real life conditions. Assessment of oversizing included visual inspection, calculation of the valley areas created between the prosthetic wall and the stentgraft fabric, distance between stentgraft peaks, radial force exerted by the proximal sealing stent and the pull-out force necessary for endograft extraction.Results: A total of 70 endografts were deployed: 10x 24mm, 10x 26mm, 10x 28mm, 10x30mm, 10x32mm, 10x34mm and 10x36mm, with oversizing ranging between 0-50%. Two cases of infolding occurred with 50% oversizing. Valley areas increased from 8.79 ± 0,23 mm with 16.7% oversizing to 14.26 ± 0.45 mmÇ for 50% oversizing (p<.001). There was a significant difference in the pull-out force required for endografts <10% oversizing vs. 10% oversizing or more (p<.001), which reached a plateau at approximately 4 N after oversizing > 15%. The mean radial force of the proximal sealing stent was greater after remodelling with a compliant balloon (.55 ± .02 N vs .60 ± .02 N after ballooning (p<.001)). However, larger oversizing did not lead to an increase in the radial force exerted by the proximal sealing stent.Conclusion: The findings of this study offer additional insight into the mechanics of oversized stentgrafts in surgical grafts. In endografts with the z-stent design (TX2), oversizing below 16.7% resulted in reduced resistance to displacement forces, while oversizing > 50% was associated to major infolding in 20% of the cases. Long-term in vitro and in vivo testing are required to understand how these mechanical properties impact clinical outcomes of oversizing.
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| 5. |
- Prendes, Carlota F., et al.
(author)
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International Collaborative Study Reporting Outcomes on Fenestrated Endovascular Aortic Repair in OCtogenarian Patients : The FEVOC study
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Other publication (other academic/artistic)abstract
- 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.Methods: Retrospective, multicentre cohort study including 8 centres across Europe and New Zealand. Consecutive patients undergoing elective FEVAR for the treatment of juxta/pararenal or type IV thoracoabdominal aortic aneurysms between 2013 and 2021 were included. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival rates and mid-to-long term reintervention rates.Results: A total of 729 patients were included, of which 169 were octogenarians. Octogenarian patients were more frequently male and had larger (61mm vs. 58mm) aneurysms. No differences in 30-day mortality (4.7% vs. 3.9%) or 30-day complication rates (29% vs 28.4%) were found. Median follow-up was 23.56 months. The 1, 2 and 5-year survival rates for octogenarian vs nonoctogenarian patients were 90.7%, 80.1% and 40.1% vs. 90.2%, 85.5% and 68.1%, respectively (p=.001). Cox regression analysis found a BMI ≥ 30 (HR 0.50, 95% CI 0.28-0.88), chronic heart failure (HR 2.14, 95% CI 1.04 – 4.39) and AAA diameter between 60-70mm (HR 2.35, 95% CI 1.31 – 4.23) to be predictors of longterm mortality.Conclusions: Thirty-day outcomes after FEVAR were similar in octogenarians and younger patients. However, mid to long term survival rates, especially after 3 years, are considerably low in both groups. Whilst FEVAR in octogenarians can be performed safely and with good early outcomes, methods to improve case selection and ensure patient benefit in the long term are highly of interest.
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| 6. |
- Prendes, Carlota F., et al.
(author)
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Pregnancy and Aortic Dissection
- 2020
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 60:2, s. 309-311
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Research review (peer-reviewed)
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| 7. |
- Prendes, Carlota F., et al.
(author)
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Systematic review and meta-analysis of contemporary abdominal aortic aneurysm growth rates
- 2024
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In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 67:1, s. 132-145
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Research review (peer-reviewed)abstract
- 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.
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| 8. |
- Wanhainen, Anders, et al.
(author)
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European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms
- 2024
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 67:2, s. 192-331
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Journal article (peer-reviewed)abstract
- ObjectiveThe 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.MethodsThe 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.ResultsA 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.ConclusionThe 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.
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