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1.
  • Abdelhalim, Mohamed A., et al. (author)
  • Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms
  • 2023
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 78:4, s. 854-862.e1
  • 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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  • Dias, N., et al. (author)
  • Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms
  • 2023
  • In: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 278:4, s. 568-577, s. 568-577
  • 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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  • Dias-Neto, Marina, et al. (author)
  • Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms
  • 2023
  • In: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 77:6, s. 1588-1597
  • 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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  • Eilenberg, Wolf, et al. (author)
  • Vascular Surgery in Unreal Times
  • 2020
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 60:2, s. 167-168
  • Journal article (other academic/artistic)
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  • Haulon, Stéphan, et al. (author)
  • Global experience with an inner branched arch endograft.
  • 2014
  • In: Journal of Thoracic and Cardiovascular Surgery. - : Elsevier BV. - 1097-685X .- 0022-5223. ; 148:4, s. 1709-1716
  • Journal article (peer-reviewed)abstract
    • Branched endografts are a new option to treat arch aneurysm in high-risk patients.
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  • Hertault, Adrien, et al. (author)
  • Results of F-EVAR in Octogenarians.
  • 2014
  • In: Annals of Vascular Surgery. - : Elsevier BV. - 1615-5947 .- 0890-5096. ; 28:6, s. 1396-1401
  • Journal article (peer-reviewed)abstract
    • to evaluate the clinical outcomes after fenestrated endovascular aortic aneurysm repair (F-EVAR) in octogenarians.
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  • Konstantinou, Nikolaos, et al. (author)
  • Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function
  • 2021
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 73:5, s. 1566-1572
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported.METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes.RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively.CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.
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  • Sobocinski, Jonathan, et al. (author)
  • Malperfusions in Acute Type B Aortic Dissection—Predictors of Outcomes
  • 2019
  • In: Annals of Vascular Surgery. - : Elsevier BV. - 0890-5096. ; 59, s. 119-126
  • Journal article (peer-reviewed)abstract
    • Background: Acute type B aortic dissection (AoD) with malperfusion is a rare and complex disease. In this specific setting, invasive treatment is generally required to improve aortic branch vessel flow. Thoracic aorta stent grafting (TEVAR) of the proximal descending thoracic aorta to cover/exclude the proximal intimal entry tear would promote resolution of the dynamic component (the most prevalent) of the malperfusion conflict by redirecting the flow within the true lumen. The aim was to study outcomes of patients undergoing TEVAR for acute (<14 days) type B AoD complicated with malperfusion and to depict any preoperative and intraoperative predictors that could affect the prognosis of those patients. Methods: From March 2005 to January 2016, all patients treated with TEVAR for acute type B AoD with malperfusion in 2 European high-volume aortic centers were retrospectively studied. Preoperative, intraoperative, and postoperative details were collected. Preoperative computed tomography angiogram was reanalyzed on a dedicated 3D workstation (Aquarius iNtuition Viewer, TeraRecon). Thirty-day malperfusion-related complication and mortality rates were determined. Logistic regression model was used to assess preoperative and intraoperative factors affecting postoperative outcomes; in particular, details on the mechanisms of malperfusion and organ(s) involved were entered into the model and tested. Results: A total of 41 patients (60 years old [interquartile range (IQR): 51–68.5]; 78% men) have been included in the analysis. Patients were mostly (68.3%) affected by only 1 malperfusion syndrome, with renal ischemia being the most frequent (53.6%). The median length of aortic coverage was 197 mm (IQR: 157–209). Additional visceral/renal/iliac stentings were performed after stent graft implantation for 25 branches in 17 patients (41%). The 30-day mortality rate was 17.1%. All but 2 early deaths were related to malperfusion. The number of malperfusion syndromes was the only independent factor associated to increasing 30-day malperfusion-related complications or deaths (3 vs 1, HR = 30.3 [P = 0.001]; 3 vs 2, HR = 9.9 [P = 0.004]). Conclusions: Prognosis of patients with acute type B AoD complicated initially with malperfusion syndrome(s) is severe, especially if several territories are ischemic. Early identification of those complications can be lifesaving but still lacks hard criteria.
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11.
  • Sobocinski, Jonathan, et al. (author)
  • Thoracic endovascular aortic repair with stent grafts alone or with a composite device design in patients with acute type B aortic dissection in the setting of malperfusion
  • 2020
  • In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214. ; 71:2, s. 2-407
  • Journal article (peer-reviewed)abstract
    • Objective: The objective of this study was to compare short-term outcomes in patients who underwent thoracic endovascular aortic repair (TEVAR) with stent grafts alone or with a composite device design (stent graft plus bare-metal aortic stent) for acute type B aortic dissection in the setting of malperfusion. Methods: This retrospective analysis included patients with acute (≤14 days of symptom onset) complicated type B dissection in the setting of malperfusion who were treated with stent grafts alone (TEVAR cohort) at two European institutions vs those who underwent TEVAR with a composite device design (Cook Medical, Bloomington, Ind) in the investigational STABLE I feasibility study and STABLE II pivotal study (STABLE cohort). Preoperative characteristics and 30-day outcomes (including mortality, malperfusion-related mortality, morbidity, and secondary interventions) were compared between the two groups. Results: The TEVAR cohort (41 patients; mean age, 58.8 ± 12.7 years; 78.0% male) and the STABLE cohort (84 patients; mean age, 57.8 ± 11.7 years; 71.4% male) were largely similar in preoperative medical characteristics, with more STABLE patients presenting with a history of hypertension (79.8% vs 58.5%; P = .018). The TEVAR and STABLE groups had similar lengths of dissection (451.8 ± 112.7 mm vs 411.8 ± 116.4 mm; P = .10) and similar proximal and distal extent of dissection. At presentation, the two groups exhibited comparable organ system involvement in malperfusion: renal (53.7% TEVAR, 57.1% STABLE), gastrointestinal (41.5% TEVAR, 44.0% STABLE), lower extremities (34.1% TEVAR, 52.4% STABLE), and spinal cord (9.8% TEVAR, 2.4% STABLE). The 30-day rate of all-cause mortality was 17.1% (7/41) in the TEVAR group and 8.3% (7/84) in the STABLE group (P = .22). The 30-day rate of malperfusion-related mortality (deaths from bowel/mesenteric ischemia or multiple organ failure) was 12% (5/41) in the TEVAR group and 2.4% (2/84) in the STABLE group (P = .038). The 30-day morbidity, for the TEVAR and STABLE groups, respectively, included bowel ischemia (9.8% [4/41] vs 2.4% [2/84]; P = .09), renal failure requiring dialysis (7.3% [3/41] vs 9.5% [8/84]; P > .99), paraplegia or paraparesis (4.9% [2/41] vs 3.6% [3/84]; P = .66), and stroke (2.4% [1/41] vs 10.7% [9/84]; P = .16). The occurrence of 30-day secondary intervention was similar in the TEVAR and STABLE groups (7.3% [3/41] vs 7.1% [6/84]; P > .99). True lumen expansion in the abdominal aorta was significantly greater in the STABLE group. Conclusions: In patients with acute type B aortic dissection in the setting of branch vessel malperfusion, the use of a composite device with proximal stent grafts and distal bare aortic stent appeared to result in lower malperfusion-related mortality than the use of stent grafts alone. The 30-day rates of morbidity and secondary interventions were similar between the groups.
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  • Tenorio, Emanuel R, et al. (author)
  • Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections
  • 2021
  • In: Journal of Vascular Surgery. - : Elsevier BV. - 1097-6809 .- 0741-5214. ; 74:4, s. 4-1065
  • Journal article (peer-reviewed)abstract
    • PURPOSE: To evaluate the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections.METHODS: We reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) between 2016 to 2019. All patients received three vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate (IA), left common carotid (LCCA) and left subclavian arteries (LSA). The antegrade inner branches were accessed via carotid or upper extremity access. A preloaded catheter was used for access to the retrograde LSA branch via trans-femoral approach. End-points were technical success, mortality, major adverse events (MAEs), any stroke (minor or major) or transient ischemia attack (TIA), secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality and patient survival.RESULTS: There were 39 patients (31 male patients [79%], mean age 70±7) treated for 14 (36%) degenerative and 25 (64%) chronic post-dissection arch aneurysms. Clinical characteristics included American Society of Anesthesiologist (ASA) classification > 3 in 28 patients (95%) and prior median sternotomy for ascending aortic repair in 28 patients (72%). Technical success rate was 100%. There were two in-hospital or 30-day deaths (5%) and two strokes (one minor). Combined mortality/any stroke rate was 8% (n=3). MAEs occurred in 10 patients (26%), including respiratory failure in four patients (10%) and estimated blood loss >1L, myocardial infarction and acute kidney injury in two patients each (5%). Median follow up was 3.2 months (IQR, 1 to 14). Twelve patients (31%) required secondary interventions to treat vascular access complications in five patients, endoleak in six patients (three type II, one type IC, one type IA/IB, one type IIIA) and target vessel stenosis in one patient. At 1-year, primary and secondary patency rates and freedom from target vessel instability were 95%±5%, 100% and 91%±5%. Freedom from aortic-related mortality and patient survival were 94%±4% and 90%±6%, respectively.CONCLUSION: This multicenter global experience demonstrates the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. Mortality and stroke rates compare favorably to open surgical repair in a higher risk group of patients. Rate of secondary interventions was high (31%), emphasizing need for larger experience and longer follow-up.
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  • Verscheure, Dorian, et al. (author)
  • Endovascular Treatment of Post Type A Chronic Aortic Arch Dissection With a Branched Endograft : Early Results From a Retrospective International Multicenter Study
  • 2021
  • In: Annals of Surgery. - : Wolters Kluwer. - 0003-4932 .- 1528-1140. ; 273:5, s. 997-1003
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: The objective of this study was to evaluate the outcome of endovascular aortic arch repair for chronic dissection with a custom-made branched endograft.BACKGROUND: Acute type A aortic dissections are often treated with prosthetic replacement of the ascending aorta. During follow-up, repair of an aneurysmal evolution of the false lumen distal to the ascending prosthesis can be a challenge both for the surgeon and the patient.METHODS: We conducted a multicenter, retrospective study of consecutive patients from 14 vascular units treated with a custom-made, inner-branched device (Cook Medical, Bloomington, IN) for chronic aortic arch dissection. Rates of in-hospital mortality and stroke, technical success, early and late complications, reinterventions, and mortality during follow-up were evaluated.RESULTS: Seventy consecutive patients were treated between 2011 and 2018. All patients were considered unfit for conventional surgery. In-hospital combined mortality and stroke rate was 4% (n = 3), including 1 minor stroke, 1 major stroke causing death, and 1 death following multiorgan failure. Technical success rate was 94.3%. Twelve (17.1%) patients required early reinterventions: 8 for vascular access complication, 2 for endoleak correction, and 2 for pericardial effusion drainage. Median follow-up was 301 (138-642) days. During follow-up, 20 (29%) patients underwent secondary interventions: 9 endoleak corrections, 1 open repair for prosthetic kink, and 10 distal extensions of the graft to the thoracic or thoracoabdominal aorta. Eight patients (11%) died during follow-up because of nonaortic-related cause in 7 cases.CONCLUSIONS: Endovascular treatment of aortic arch chronic dissections with a branched endograft is associated with low mortality and stroke rates but has a high reintervention rate. Further follow-up is required to confirm the benefits of this novel approach.
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