| 1. |
- D'Oria, Mario, et al.
(author)
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Outcomes of "Anterior Versus Posterior Divisional Branches of the Hypogastric Artery as Distal Landing Zone for Iliac Branch Devices" : The International Multicentric R3OYAL Registry
- 2024
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In: Journal of Endovascular Therapy. - : Sage Publications. - 1526-6028 .- 1545-1550. ; 31:2, s. 282-294
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Journal article (peer-reviewed)abstract
- Objective: The aim of this multicentric registry was to assess the outcomes of "anteRior versus posteRior divisional bRanches Of the hYpogastric artery as distAl landing zone for iLiac branch devices (R3OYAL)."Methods: The main exposure of interest for the purpose of this study was the internal iliac artery (IIA) divisional branch (anterior vs posterior) that was used as distal landing zone. Early endpoints included technical success and adverse events. Late endpoints included survival, primary/secondary IIA patency, and IIA branch instability.Results: A total of 171 patients were included in the study, of which 50 received bilateral implantation of iliac branch devices (IBDs). This resulted in a total of 221 incorporated IIAs included in the final analysis, of which 40 were anterior divisional branches and 181 were posterior divisional branches. Technical success was high in both groups (anterior division: 98% vs posterior division: 100%, P = .18). Occurrence of any adverse event was noted in 14% of patients in both groups (P = 1.0). The overall rate of freedom from the composite IBD branch instability did not show significant differences between patients receiving distal landing in the anterior or posterior division of the IIA at 3 years (79% vs 87%, log-rank test = .215). The 3-year estimates of IBD patency were significantly lower in patients who received distal landing in the anterior divisional branch than those who received distal landing in the posterior divisional branch (primary patency: 81% vs 96%, log-rank test = .009; secondary patency: 81% vs 97%, log-rank test < .001).Conclusions: The use of the anterior or posterior divisional branches of the IIA as distal landing zone for IBD implantation shows comparable profiles in terms of immediate technical success, perioperative safety, and side-branch instability up to 3 years. However, IBD patency at 3 years was higher when the distal landing zone was achieved within the posterior divisional branch of the IIA.Clinical Impact: The results from this large multicentric registry confirm that use of the anterior or posterior divisional branches of the internal iliac artery (IIA) as distal landing zone for implantation of iliac branch devices (IBD) shows comparable profiles of safety and feasibility, thereby allowing to extend the indications for endovascular repair of aorto-iliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Although mid-term rates of device durability and branch instability seem to be similar, the rates of primary and secondary IBD patency at three years was favored when the distal landing zone was achieved in the posterior divisional branch of the IIA.
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| 2. |
- Gouveia e Melo, Ryan, et al.
(author)
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Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms
- 2022
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 64:2-3, s. 188-199
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Research review (peer-reviewed)abstract
- Objective: To perform a systematic review and meta-analysis of the outcomes of physician modified endografts (PMEG) for the treatment of thoraco-abdominal (TAAA) and complex abdominal aortic aneurysms (C-AAA).Data Sources: MEDLINE, CENTRAL, Web of Science Core Collection, Scielo, and Open Grey.Review Methods: The databases were searched from inception to July 2021 for studies reporting on outcomes of PMEGs for TAAA or C-AAA repair. A systematic review was conducted (protocol CRD42021267856) and data were pooled using a random effects model of proportions. The outcomes analysed were major adverse events at 30 days (30 day mortality, myocardial infarction, respiratory failure requiring prolonged ventilation [> 24 hours or re-intubation], renal failure requiring dialysis, bowel ischaemia requiring surgery, major stroke, or definitive paraplegia); technical success; 30 day mortality; ruptures; spinal cord ischaemia; endoleaks; re-interventions; and target vessel patency.Results: Twenty studies were included. Overall study quality assessment was found to be low. Overall, 909 PMEGs were reported and analysed. Regarding aneurysm location (n = 867), 222 patients had extent I - III TAAAs and 645 had C-AAA or extent IV TAAA. Regarding presentation, 14 studies reported whether the patients were treated in an elective or urgent setting (n = 782). Overall, 500 (63.9%) patients were treated in an elective setting and 282 (36.1%) in an urgent setting. Major adverse events (at 30 days) occurred in 15.5% of patients (95% confidence interval [CI] 10.8 - 20.8; I-2 = 63%, 135/832 cases): 11.6% (95% CI 8.1 - 15.7; I-2 = 0%, 23/280 cases) for elective patients and 24.6% for urgent (95% CI 14.1 - 36.6; I-2 = 65%, 50/192 cases). Overall technical success was 97.2% (95% CI 95.4 - 98.7; I-2 = 0%, 587/611 cases): 98.0% (95% CI 92.1 - 100; I-2 = 0%, 106/113cases) for extent I - III TAAAs and 99.4% (95% CI 97.5 - 100; I-2 = 0%, 317/324 cases) for C-AAA and extent IV TAAAs. Regarding technique, technical success was 96.1% for fenestrated endovascular repair (FEVAR; 95% CI 93.2 - 98.4; I-2 = 0%, 313/329 cases) and 99.8% for FEVAR/branched endovascular repair (95% CI 99.8 - 100; I-2 = 0%, 17/18 cases).Conclusion: Physician modified fenestrated or branched grafts for endovascular aortic repair seem feasible and safe in the short term. However, the quality of the available data is low, which highlights the need for better and more accurate data regarding this technique.
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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. |
- Tsilimparis, Nikolaos, et al.
(author)
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Pre-Loaded Fenestrated Thoracic Endografts for Distal Aortic Arch Pathologies : Multicentre Retrospective Analysis of Short and Mid Term Outcomes
- 2021
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In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 887-895
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Journal article (peer-reviewed)abstract
- Objective: To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies.Methods: This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan–Meier survival analysis.Results: One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 – 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively.Conclusion: This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates.
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