| 1. |
- D'Oria, Mario, et al.
(författare)
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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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Ingår i: Journal of Endovascular Therapy. - : Sage Publications. - 1526-6028 .- 1545-1550. ; 31:2, s. 282-294
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Tidskriftsartikel (refereegranskat)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. |
- Gavali, Hamid, et al.
(författare)
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Semi-Conservative Treatment Versus Surgery in Abdominal Aortic Graft and Endograft Infections
- 2023
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 397-406
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft-preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort.METHODS: Patients with abdominal AGI-related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for definition of AGI. Multivariable regression was performed to identify factors associated with mortality.RESULTS: A total of 169 patients with surgically treated abdominal AGI were identified, comprising 43 SC [14 endografts; 53% with a graft-enteric fistula (GEF) in total] and 126 RS [26 endografts; 50% with a GEF in total]. The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan-Meier estimated 5-year survival for SC versus RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan-Meier estimated 5-year survival for SC patients with a GEF versus without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC versus RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in 5-year survival comparing SC versus RS (HR 1.0, 95% CI 0.6 - 1.5).CONCLUSION: In this national AGI cohort, we could not identify any mortality difference comparing SC versus RS for AGI when adjusting for comorbidities. Presence of GEF likely negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC-treated patients.
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| 3. |
- Hansson, Markus, et al.
(författare)
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A phase 1 dose-escalation study of antibody BI-505 in relapsed/refractory multiple myeloma.
- 2015
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Ingår i: Clinical Cancer Research. - 1078-0432. ; 21:12, s. 2730-2736
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: This multicenter, first-in-human study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of BI-505, a human anti-ICAM-1 monoclonal antibody, in advanced relapsed/refractory multiple myeloma patients. Experimental design: BI-505 was given intravenously, every two weeks, at escalating doses from 0.0004 to 20 mg/kg, with extension of therapy until disease progression for responding or stable patients receiving 0.09 mg/kg or higher doses. Results: A total of 35 patients were enrolled. The most common adverse events were fatigue, pyrexia, headache, and nausea. Adverse events were generally mild to moderate and those attributed to study medication were mostly limited to the first dose, and manageable with premedication and slower infusion. No maximum tolerated dose was identified. BI-505's half-life increased with dose while clearance decreased, suggesting target-mediated clearance. The ICAM-1 epitopes on patient bone marrow myeloma were completely saturated at 10 mg/kg doses. Using the International Myeloma Working Group criteria, seven patients on extended therapy had stable disease for more than two months. Conclusion: BI-505 can be safely administered at doses that saturate myeloma cell ICAM-1 receptors in patients. This study was registered at www.clinicaltrials.gov (NCT01025206).
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| 4. |
- Karelis, Angelos, et al.
(författare)
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Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study
- 2023
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Ingår i: Journal of Endovascular Therapy. - : SAGE PUBLICATIONS INC. - 1526-6028 .- 1545-1550.
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. Material and Methods: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. Results: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60 +/- 14% at 3 years that went up to 92 +/- 8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. Conclusion: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. Clinical Impact This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.
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| 5. |
- Konstantinou, Nikolaos, et al.
(författare)
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Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function
- 2021
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Ingår i: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 73:5, s. 1566-1572
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Tidskriftsartikel (refereegranskat)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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| 6. |
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| 7. |
- Malina, Martin, et al.
(författare)
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Feasibility of a branched stent-graft in common iliac artery aneurysms.
- 2006
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Ingår i: Journal of Endovascular Therapy. - 1545-1550. ; 13:4, s. 496-500
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the short-term feasibility, efficacy, and safety of a modular bifurcated stent-graft with an internal iliac artery (IIA) side branch for endovascular repair of aortoiliac aneurysms. Methods: Between 2002 and 2005, 10 male patients (median age 75 years, range 59–83) were treated with a bifurcated stent-graft that included a unilateral side branch for the IIA. The median diameters of the abdominal aortic and common iliac artery (CIA) aneurysms were 56 mm (range 33–80) and 40 mm (range 27–60), respectively. Four patients were treated mainly for the CIA aneurysm. Postoperative endoleaks, patency rate, and vessel morphology were determined with contrast-enhanced computed tomography (CT). Results: All endografts were implanted in the desired position. One IIA occluded intraoperatively, and 1 external iliac artery occlusion was noted 6 months postoperatively; both occlusions were asymptomatic and remain untreated. Three graft-related endoleaks were treated with implantation of adjunctive stent-grafts (2 intraoperative and 1 late). Median follow-up by CT was 2 months (1 week to 32 months). One patient died of myocardial infarction 13 days postoperatively; the stent-graft was patent at autopsy. Conclusion: Stent-grafts with an IIA side branch offer an opportunity to repair aortoiliac aneurysms without sacrificing the IIA. Implantation of the IIA branch is more complex than routine endovascular aneurysm repair and may have contributed to a periprocedural cardiac death. More patients and longer follow-up are needed to verify these data.
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| 8. |
- Sobocinski, Jonathan, et al.
(författare)
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Malperfusions in Acute Type B Aortic Dissection—Predictors of Outcomes
- 2019
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Ingår i: Annals of Vascular Surgery. - : Elsevier BV. - 0890-5096. ; 59, s. 119-126
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Tidskriftsartikel (refereegranskat)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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| 9. |
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| 10. |
- Sveinsson, Magnus, et al.
(författare)
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Juxtarenal endovascular therapy with fenestrated and branched stent grafts after previous infrarenal repair
- 2019
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Ingår i: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 70:6, s. 1747-1753
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Tidskriftsartikel (refereegranskat)abstract
- Background: The treatment strategy for proximal aortic disease or type I endoleak after previous infrarenal repair has traditionally been open surgery. As endovascular treatment options with fenestrated and branched stent grafts increasingly rival open surgery for juxtarenal and pararenal aortic aneurysms, secondary proximal repair may similarly be performed endovascularly. Fenestrated stent grafts are individually tailored to each patient, whereas a more readily available "off-the-shelf" branched stent graft is often suitable in more urgent settings. Methods: All patients who had been reoperated on with a proximal fenestrated or branched cuff after previous infrarenal endovascular or open repair from two tertiary referral centers between 2002 and 2015 were included in the analysis. Patients were retrospectively enrolled in a digital database. Data were collected from chart review and digital imaging. Results: There were 43 patients, 37 (86%) male and six (14%) female, who were treated. The indications for proximal endovascular repair were type I endoleak (58%), proximal aneurysm formation (30%), and stent graft migration (12%). Median follow-up time was 33 months (range, 3-120 months); 34 patients (79%) received a fenestrated cuff, and branched stent grafts were used in 8 (19%) cases. The majority of grafts had three (47%) or four (49%) fenestrations or branches. Technical success was accomplished in 93% of cases. In two cases, the celiac trunk occluded; in one case, the hepatic artery was overstented, and a renal artery could not be cannulated in one case. Median hospital stay was 5 days (range, 2-57 days). The 30-day mortality was 0%, and 1-year mortality was 5%. One patient died of an aneurysm-related cause during the study period. Conclusions: An endovascular approach with fenestrated or branched stent grafts for treatment of proximal endoleak, proximal aneurysm formation, or pseudoaneurysms after previous infrarenal repair seems to be a valid alternative to open surgery.
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