| 1. |
- Dias, N., et al.
(author)
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Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms
- 2023
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In: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 278:4, s. 568-577, s. 568-577
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Journal article (peer-reviewed)abstract
- 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.
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| 2. |
- Huber, Thomas S., et al.
(author)
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Chronic mesenteric ischemia : Clinical practice guidelines from the Society for Vascular Surgery
- 2021
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In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 73:1, s. 87S-115S
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Journal article (peer-reviewed)abstract
- Background: Chronic mesenteric ischemia (CMI) results from the inability to achieve adequate postprandial intestinal blood flow, usually from atherosclerotic occlusive disease at the origins of the mesenteric vessels. Patients typically present with postprandial pain, food fear, and weight loss, although they can present with acute mesenteric ischemia and bowel infarction. The diagnosis requires a combination of the appropriate clinical symptoms and significant mesenteric artery occlusive disease, although it is often delayed given the spectrum of gastrointestinal disorders associated with abdominal pain and weight loss. The treatment goals include relieving the presenting symptoms, preventing progression to acute mesenteric ischemia, and improving overall quality of life. These practice guidelines were developed to provide the best possible evidence for the diagnosis and treatment of patients with CMI from atherosclerosis. Methods: The Society for Vascular Surgery established a committee composed of vascular surgeons and individuals experienced with evidence-based reviews. The committee focused on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/open revascularization, and surveillance/remediation. A formal systematic review was performed by the evidence team to identify the optimal technique for revascularization. Specific practice recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation system based on review of literature, the strength of the data, and consensus. Results: Patients with symptoms consistent with CMI should undergo an expedited workup, including a computed tomography arteriogram, to exclude other potential causes. The diagnosis is supported by significant arterial occlusive disease in the mesenteric vessels, particularly the superior mesenteric artery. Treatment requires revascularization with the primary target being the superior mesenteric artery. Endovascular revascularization with a balloon-expandable covered intraluminal stent is there commended initial treatment with open repair reserved for select younger patients and those who are not endovascular candidates. Long-term follow-up and surveillance are recommended after revascularization and for asymptomatic patients with severe mesenteric occlusive disease. Patient with recurrent symptoms after revascularization owing to recurrent stenoses should be treated with an endovascular-first approach, similar to the de novo lesion. Conclusions: These practice guidelines were developed based on the best available evidence. They should help to optimize the care of patients with CMI. Multiple areas for future research were identified. (J Vasc Surg 2021;73:87S-115S.)
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| 3. |
- Abdelhalim, Mohamed A., et al.
(author)
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Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms
- 2023
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In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 78:4, s. 854-862.e1
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Journal article (peer-reviewed)abstract
- OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs).METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM).RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively.CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.
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| 4. |
- Berczeli, Marton, et al.
(author)
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Integration of a Custom-Made Fenestration to Simplify Acute Reno-Visceral In Situ Aortic Repair
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In: Journal of Endovascular Therapy. - 1526-6028.
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Journal article (peer-reviewed)abstract
- Purpose: To illustrate the technique of antegrade in situ laser fenestration (ISLF) on a predesign custom-manufactured stent-graft with single reinforced fenestration for use in emergency endovascular repair of complex abdominal aortic aneurysms (AAAs). Technique: A short custom-made device (CMD) fenestrated graft was predesigned with a single preloaded 8 mm strut-free fenestration at 12 o’clock position. A modified preloaded system was used to allow unilateral access from the distal port if necessary. After bilateral percutaneous femoral access, the graft was deployed under fusion guidance with the CMD fenestration matching the superior mesenteric artery (SMA) origin and immediately bridged as per standard technique. The aneurysm was then excluded with a bifurcated device. A large steerable sheath was used to allow for sequential antegrade laser in situ fenestration and stenting of the renal arteries. Conclusions: Single-vessel customized short fenestrated grafts for the SMA and antegrade in situ laser renal fenestrations are technically feasible for repair of acute complex AAAs even after previous infrarenal reconstruction. It could become an off-the-shelf solution to limit aortic coverage and reno-visceral ischemia, even in patients with a narrow aortic diameter at the renal level. Clinical Impact: Single-vessel precustomized short fenestrated grafts for the SMA combined with renal artery antegrade ISLF can be a feasible option for the acute repair of patients with complex aneurysms and a narrow aortic diameter at the reno-visceral segment. It may limit aortic coverage and reno-visceral ischemic time and also be applicable after previous infrarenal endovascular aneurysm repair (EVAR).
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| 5. |
- Berczeli, Márton, et al.
(author)
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Multicentre Experience with Novel Bidirectional Double Cuffed Inner Branches for Complex Endovascular Aortic Repair
- 2024
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In: European journal of vascular and endovascular surgery. - 1078-5884.
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Journal article (peer-reviewed)abstract
- Objective: This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). Methods: A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative data, and follow up data were collected. Results were presented as number or median (interquartile range) unless otherwise stated. Results: Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. Conclusion: The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.
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| 6. |
- Dias, Nuno V., et al.
(author)
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Double-Cuff Bidirectional Branch in Endovascular Aortic Repair : A New Way of Increasing the Flexibility of Inner Branch Endografting
- 2022
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In: Journal of Endovascular Therapy. - : SAGE Publications. - 1526-6028 .- 1545-1550.
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Journal article (peer-reviewed)abstract
- Purpose: The purpose of the study was to describe the design and implantation of a branched stent-graft during endovascular aortic repair incorporating double-cuff bidirectional inner branch. Technique: A new double-cuff bidirectional antegrade and retrograde inner branched stent-graft with large diamond-shaped fenestration was designed for incorporation of a splenic artery. The inner cuffs of the branch were accessible using brachial and/or femoral access. The splenic artery was originating from an aortic segment with narrow inner aortic luminal diameter in a patient with extent IV thoracoabdominal aortic aneurysm with bilobed configuration. The retrograde, more distal inner cuff of the branch was extended into the splenic artery using a self-expandable bridging stent-graft from the femoral approach, whereas the antegrade, more proximal inner cuff of the branch was intentionally occluded using an endovascular plug. The recovery was uneventful and a computed tomography angiography 30 days postoperatively showed patency of all the target vessels without signs of endoleaks. Conclusion: This is the first design of a double-cuff bidirectional inner branched stent-graft. The technique can potentially expand the applications of directional branches to patients with more difficult anatomy in the thoracoabdominal or aortic arch segments. Potential indications are patients with target arteries that are not ideally suited for caudally-oriented branches, patients with accessory vessels, or targets with early branch bifurcations. Clinical Impact: This report describes the use of a branched endograft with a new double-cuff bidirectional branch that can potentially address many of the limitations of current BEVAR solutions, such as early bifurcations, double arteries with adjacent origins and arteries with less favorable trajectories for the traditional caudally-oriented branches.
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| 7. |
- Dias-Neto, Marina, et al.
(author)
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Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms
- 2023
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In: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 77:6, s. 1588-1597
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Journal article (peer-reviewed)abstract
- Objective: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs).Methods: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single-or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality.Results: A total of 1947 patients (65% male; mean age, 71 +/- 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9 +/- 1.3% vs 79.6 +/- 1.7%) and 3 years (72.7 +/- 2.1% vs 64.2 +/- 2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach.Conclusions: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.
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| 8. |
- D'Oria, Mario, et al.
(author)
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A scoping review of the rationale and evidence for cost-effectiveness analysis of fenestrated-branched endovascular repair for intact complex aortic aneurysms
- 2020
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In: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 72:5, s. 1772-1782
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Research review (peer-reviewed)abstract
- Background: Cost-effectiveness analysis of new interventions is increasingly required by policymakers. For intact complex aortic aneurysms (CAAs), fenestrated-branched endovascular aneurysm repair (F/B-EVAR) offers a minimally invasive alternative option for patients who are physically ineligible for open surgical repair (OSR). Thus, F/B-EVAR is increasingly used, but whether it represents a cost-effective treatment option remains unknown.Methods: A scoping review of the literature was conducted from the PubMed, Ovid Embase, and Scopus databases. They were searched to identify relevant English-language articles published from inception to December 31, 2019. All costs in the identified literature were transformed to U.S. dollar values by the following exchange rate: 1 GBP = 1.3 USD; 1 EUR = 1.1 USD.Results: At this literature search, no randomized clinical trials assessing cost-effectiveness of F/B-EVAR vs OSR for intact CAAs were found. Also, no health economic evaluation studies were found regarding use of F/B-EVAR in patients unfit for OSR. A Markov model analysis based on seven observational center- or registry-based studies published from 2006 to 2014 found that the incremental cost-effectiveness ratio for F/B-EVAR vs OSR was $96,954/quality-adjusted life-year. In the multicenter French Medical and Economical Evaluation of Fenestrated and Branched Stent-grafts to Treat Complex Aortic Aneurysms (WINDOW) registry (2010-2012), F/B-EVAR had a higher cost than OSR for a similar clinical outcome and was therefore economically dominated. At 2 years, costs were higher with F/B-EVAR for juxtarenal/pararenal aneurysms and infradiaphragmatic thoracoabdominal aneurysms but similar for supradiaphragmatic thoracoabdominal aneurysms. The higher costs were related to a $24,278 cost difference of the initial admission (95% of the difference at 2 years) due to stent graft costs. Both these studies, however, included a highly varying center experience with complex endovascular aortic repair, and their retrospective design is subject to selection bias for chosen treatment, which could affect the studied outcome. In contrast, in amore recent U.S. database analysis (879 thoracoabdominal aortic aneurysm repairs, 45% OSRs), the unadjusted total hospitalization cost of OSR was significantly higher compared with F/B-EVAR (median, $44,355 vs $36,612; P = .004). In-hospital mortality as well as major complications were two to three times higher after OSR, indicating that endovascular repair might be the economically dominant strategy.Conclusions: The literature regarding cost-effectiveness analysis of F/B-EVAR for intact CAAs is scarce and ambiguous. Based on the limited nonrandomized available evidence, stent grafts are the main driver for F/B-EVAR expenses, whereas cost-effectiveness in relation to OSR may vary by health care setting and selection of patients.
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| 9. |
- 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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| 10. |
- 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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