| 1. |
- Budtz-Lilly, Jacob, et al.
(författare)
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Adapting to a total endovascular approach for complex aortic aneurysm repair : Outcomes after fenestrated and branched endovascular aortic repair
- 2017
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Ingår i: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 66:5, s. 1349-1356
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: This study reports the feasibility of adopting a total endovascular approach for the treatment of complex abdominal aortic aneurysms (AAAs) at a European aortic center and compares the short- and midterm results against those from large and multicenter studies.METHODS: All patients treated endovascular aortic repair (EVAR) for juxta/pararenal AAAs or thoracoabdominal aortic aneurysms (TAAAs), both elective and acute, as well as reoperations, from 2010 to 2015 were included. Treatment was fenestrated (FEVAR) or branched (BEVAR), and outcomes were analyzed for technical success and mortality at 30 and 90 days and by Kaplan-Meier curve estimates at 3 years. Outcomes on target vessels were reported as freedom from branch instability in the follow-up period. Reinterventions, endoleaks and perioperative and postoperative morbidities were analyzed.RESULTS: A total of 71 patients were treated for juxta/pararenal AAA (n = 40) or TAAA (n = 31): 14 type II, 4 type III, and 13 type IV. There were 47 FEVAR (including 2 physician-modified fenestrated grafts) and 24 BEVAR procedures performed. Four TAAAs were ruptured. No open repairs were performed for these pathologies in this period. Mortality was 2.8% (n = 2) at 30 days and 9.9% at 90 days (n = 7). One late rupture occurred in a patient whose treatment was a technical failure. Survival at 3 years was 77.9% ± 5.6% overall, 90.9% ± 5.2% for juxta/pararenal AAAs, and 60.7% ± 10.3% for TAAAs. Graft deployment was successful in 69 of 71 patients. Revascularization was successful in 205 of 208 target vessels (98.6%): 51 of 51 superior mesenteric arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries. There were 131 fenestrated bridging stent grafts and 74 branched bridging stent grafts. Technical success was 68 of 71 (95.7%). There were nine cases of branch instability (5 BEVARs, 4 FEVARs) in five patients (7.0%). Seven vessels (5 renal arteries and 2 superior mesenteric arteries) underwent reintervention: 5 for stenoses, 1 for occlusion, and 1 for stent migration. Freedom from branch instability at 3 years was 92.7% ± 2.5% overall, 88.6% ± 6.4% for BEVAR, and 94.6% for FEVAR.CONCLUSIONS: The short- and midterm results obtained here indicate that the benefits of a total endovascular treatment for complex aortic aneurysms, as demonstrated by large and multicenter studies, can be adapted and replicated at other centers with a dedicated aortic service. This may help guide future considerations of how to refer or treat this complex patient group.
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| 2. |
- Arndt, Helene, et al.
(författare)
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A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.
- 2022
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Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 64:5, s. 526-533
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Tidskriftsartikel (refereegranskat)abstract
- This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
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| 3. |
- Budtz-Lilly, Jacob, et al.
(författare)
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Correlations Between Branch Vessel Catheterization and Procedural Complexity in Fenestrated and Branched Endovascular Aneurysm Repair
- 2019
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Ingår i: Vascular and Endovascular Surgery. - : SAGE PUBLICATIONS INC. - 1538-5744 .- 1938-9116. ; 53:4, s. 277-283
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The use of fenestrated and branched endovascular technologies in complex aortic aneurysm repair (F/BEVAR) is increasing, with a trend toward using longer sealing zones and incorporating more target vessels. Successful aneurysm exclusion and prevention of long-term treatment failure need to be balanced against the increased complexity of more extensive procedures. The aim of this study was to analyze relationships between the number of catheterized vessels and multiple operative variables as a means for evaluating procedural complexity.Methods: Operative data from consecutive F/BEVAR procedures performed at a single center from 2012 to 2015 were analyzed. An equal number of EVAR procedures, randomly selected, from this period were also analyzed. Only intact aneurysms were included. Complex aneurysms were grouped based on the required number of target vessel catheterization. Ten procedural variables, categorized as perioperative, postoperative, and radiologic-related, were compared. Pearson correlation analysis and regression analysis were performed. The correlation coefficients, r, were classified using Cohen boundaries, r >= 0.5 indicating a strong relationship.Results: There were 63 EVAR, 40 FEVAR, and 22 BEVAR procedures. There was no significant difference in patient comorbidities between conventional EVAR and complex procedure groups. The complex procedures included 23 two-vessel, 20 three-vessel, and 19 four-vessel catheterizations. Strong linear relationships between the number of branch vessel catheterizations and the following variables were identified: accumulated skin dose (r = .504), contrast volume (r = .652), fluoroscopy duration (r = .598), number of angiography series (r = .650), anesthesiology duration (r = .742), procedure duration (r = .554), and total length of stay (r = .533).Conclusion: The complexity of FEVAR and BEVAR procedures reveals strong correlations between multiple peri- and postoperative variables. These exposures and risks should be borne in mind when considering treatment of complex abdominal aortic aneurysms as well as long-term clinical outcomes.
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| 4. |
- Budtz-Lilly, Jacob, et al.
(författare)
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Editor's Choice - Assessment of International Outcomes of Intact Abdominal Aortic Aneurysm Repair over 9 Years
- 2017
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 54:1, s. 13-20
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Tidskriftsartikel (refereegranskat)abstract
- Background: Case mix and outcomes of complex surgical procedures vary over time and between regions. This study analyses peri-operative mortality after intact abdominal aortic aneurysm (AAA) repair in 11 countries over 9 years. Methods: Data on primary AAA repair from vascular surgery registries in 11 countries for the years 2005-2009 and 2010-2013 were analysed. Multivariate adjusted logistic regression analyses were carried out to adjust for variations in case mix. Results: A total of 83,253 patients were included. Over the two periods, the proportion of patients >= 80 years old increased (18.5% vs. 23.1%; p < .0001) as did the proportion of endovascular repair (EVAR) (44.3% vs. 60.6; p < .0001). In the latter period, 25.8% of AAAs were less than 5.5 cm. The mean annual volume of open repairs per centre decreased from 12.9 to 10.6 between the two periods (p < .0001), and it increased for EVAR from 10.0 to 17.1 (p < .0001). Overall, peri-operative mortality fell from 3.0% to 2.4% (p < .0001). Mortality for EVAR decreased from 1.5% to 1.1% (p < .0001), but the outcome worsened for open repair from 3.9% to 4.4% (p = .008). The peri-operative risk was greater for octogenarians (overall, 3.6% vs. 2.1%, p < .0001; open, 9.5% vs. 3.6%, p < .0001; EVAR, 1.8% vs. 0.7%, p < .0001), and women (overall, 3.8% vs. 2.2%, p < .0001; open, 6.0% vs. 4.0%, p < .0001; EVAR, 1.9% vs. 0.9%, p < .0001). Peri-operative mortality after repair of AAAs <5.5 cm was 4.4% with open repair and 1.0% with EVAR, p < .0001. Conclusions: In this large international cohort, total peri-operative mortality continues to fall for the treatment of intact AAAs. The number of EVAR procedures now exceeds open procedures. Mortality after EVAR has decreased, but mortality for open operations has increased. The peri-operative mortality for small AM treatment, particularly open surgical repair, is still considerable and should be weighed against the risk of rupture.
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| 5. |
- Budtz-Lilly, Jacob, et al.
(författare)
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Editor's Choice - The Impact of Centralisation and Endovascular Aneurysm Repair on Treatment of Ruptured Abdominal Aortic Aneurysms Based on International Registries
- 2018
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 181-188
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Current management of ruptured abdominal aortic aneurysms (RAAA) varies among centres and countries, particularly in the degree of implementation of endovascular aneurysm repair (EVAR) and levels of vascular surgery centralisation. This study assesses these variations and the impact they have on outcomes.Materials and methods: RAAA repairs from vascular surgical registries in 11 countries, 2010-2013, were investigated. Data were analysed overall, per country, per treatment modality (EVAR or open aortic repair [OAR]), centre volume (quintiles IV), and whether centres were predominantly EVAR (>= 50% of RAAA performed with EVAR [EVAR(p)]) or predominantly OAR [OAR(p)]. Primary outcome was peri-operative mortality. Data are presented as either mean values or percentages with 95% CI within parentheses, and compared with chi-square tests, as well as with adjusted OR.Results: There were 9273 patients included. Mean age was 74.7 (74.5-74.9) years, and 82.7% of patients were men (81.9-83.6). Mean AAA diameter at rupture was 7.6 cm (7.5-7.6). Of these aneurysms, 10.7% (10.0-11.4) were less than 5.5 cm. EVAR was performed in 23.1% (22.3-24.0). There were 6817 procedures performed in OAR(p) centres and 1217 performed in EVAR(p) centres. Overall peri-operative mortality was 28.8% (27.9-29.8). Peri-operative mortality for OAR was 32.1% (31.0-33.2) and for EVAR 17.9% (16.3-19.6), p < .001, and the adjusted OR was 0.38 (0.31-0.47), p < .001. The peri-operative mortality was 23.0% in EVAR(p) centres (20.6-25.4), 29.7% in OAR(p) centres (28.6-30.8), p < .001; adjusted OR = 0.60 (0.46-0.78), p < .001. Perioperative mortality was lower in the highest volume centres (QI > 22 repairs per year), 23.3% (21.2-25.4) than in QII-V, 30.0% (28.9-31.1), p < .001. Peri-operative mortality after OAR was lower in high volume centres compared with the other centres, 25.3% (23.0-27.6) and 34.0% (32.7-35.4), respectively, p < .001. There was no significant difference in peri-operative mortality after EVAR between centres based on volume.Conclusions: Peri-operative mortality is lower in centres with a primary EVAR approach or with high case volume. Most repairs, however, are still performed in low volume centres and in centres with a primary OAR strategy. Reorganisation of acute vascular surgical services may improve outcomes of RAAA repair.
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| 6. |
- Budtz-Lilly, Jacob, et al.
(författare)
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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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Ingår i: Annals of Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0003-4932 .- 1528-1140. ; 278:2, s. E389-E395
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Tidskriftsartikel (refereegranskat)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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| 7. |
- Budtz-Lilly, Jacob, 1974-
(författare)
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On Surgical Treatment of Aortic Pathology
- 2019
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The use of endovascular aneurysm repair (EVAR) in the treatment of abdominal aortic aneurysms has advanced from a premature characterization as a “failed experiment” in early 2000 to the predominant modern method of treatment. Technology has accommodated initial shortcomings, but it has also led to expansions in the treatment of ruptured aneurysms and complex aortic pathologies. The overall aim of this thesis is to characterize the contemporary utilization of endovascular repair in the international setting and to evaluate its expanding use in complex aortic disease treatment.Paper I is an analysis of outcomes after intact aneurysm treatment from registries of 12 countries. From 2005 to 2013, and with 83,253 patients included, it was shown that the use of EVAR has increased while, the perioperative mortality has decreased. This was counterbalanced by a worsening mortality for those patients treated with open aortic repair.Paper II is an analysis of ruptured aneurysms from the above-mentioned international registries. EVAR is also increasing for these patients, although open repair is still the predominant treatment strategy in most centres. Perioperative mortality was superior for EVAR patients, despite increased age and comorbidities. An association between patient-volume and perioperative mortality could be shown for open repair, but the same could not be demonstrated for EVAR.Paper III is an evaluation of the adaptation of a total endovascular approach for the treatment of complex abdominal aortic aneurysms from a single centre. The technical success and midterm mortality, as well as post-operative complications, including spinal ischemia, were similar to those reported from large and multi-centre analyses. Previous studies reveal disparate results for centres performing open complex aortic repair. The results here suggest that a total endovascular approach is feasible for dedicated centres contemplating this strategy. Paper IV is an analysis of multiple pre-, peri-, and post-operative variables documented from complex aneurysm procedures. A relationship between increased complexity and variables such as anaesthesia duration, bleeding, hospital stay, and radiation exposure was found. As patients and their comorbidities increase, a decision to embark on a complex procedure should be made with due diligence to these relationships.Paper V is a technical analysis of patients following acute treatment for Type A aortic dissections. Many patients are unfit for open aortic arch repair. Based on current availability of endovascular aortic stentgrafts, it was shown that the majority of patients can be treated endovascularly, while anticipated device improvements should further increase the proportion of eligibility.
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| 8. |
- Budtz-Lilly, Jacob, et al.
(författare)
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Outcomes of endovascular aortic repair in the modern era.
- 2018
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Ingår i: Journal of Cardiovascular Surgery. - 0021-9509 .- 1827-191X. ; 59:2, s. 180-189
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Forskningsöversikt (refereegranskat)abstract
- Monitoring outcomes following endovascular aortic repair (EVAR) is critical. Although evidence from randomized controlled trials has solidified the role of EVAR, the analysis of outcomes and "real-world" data has uncovered limitations, improved the selection of appropriate patients, and underscored the importance of instructions for use. Subsequent studies demonstrated the learning curve of EVAR and gradual improvement of outcomes over time. Outcomes analyses will continue to play an important role, particularly as technological growth of endovascular therapy has enabled treatment of more complex aneurysm pathologies and patients. The important analyses are herein reviewed, following the development of EVAR in the treatment of intact abdominal aortic aneurysms (AAA) to ruptured AAAs, and finally to complex aneurysms, including thoracoabdominal aortic aneurysms and mycotic aneurysms. This includes an overview of the more recent results from analyses of branched and fenestrated EVAR, as well as the use of chimney grafts. It is emphasized that the success of endovascular repair has paradoxically been hampered by its rapid growth and early achievements. Even the most advanced engineering developments cannot overcome the long-term effects of the progression of aortic disease. The long-term benefits thus require careful planning and considerations of the natural history of aneurysms and the life expectancy of the patient. Large and international data registry collaborations should continue to play a role in providing outcomes analyses to guide future improvements.
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| 9. |
- Budtz-Lilly, Jacob, 1974-, et al.
(författare)
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Technical eligibility for endovascular treatment of the aortic arch after open type A aortic dissection repair
- 2021
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Ingår i: Journal of Thoracic and Cardiovascular Surgery. - : Elsevier BV. - 0022-5223 .- 1097-685X. ; 162:3, s. 770-777
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveThe objective was to report on the technical eligibility of patients previously treated for Stanford type A aorta dissection for endovascular aortic arch repair based on contemporary anatomic criteria for an arch inner-branched stent graft.MethodsAll patients treated for type A aorta dissection from 2004 to 2015 at a single aortic center were identified. Extent of repair and use of circulatory arrest were reported. Survival and reoperation were assessed using Kaplan–Meier and competing risk models. Anatomic assessment was performed using 3-dimensional computed tomography imaging software. Primary outcome was survival of 1 year or more and fulfillment of the arch inner-branched stent graft anatomic criteria.ResultsA total of 198 patients were included (158 DeBakey I, 32 DeBakey II, and 8 intramural hematoma). Mortality was 30 days (16.2%), 1 year (16.3%), and 10 years (45.0%). A total of 129 patients had imaging beyond 1 year (mean, 47.8 months), and 89 patients (69.0%) were eligible for arch inner-branched stent grafting. During follow-up, 19 patients (14.7%) met the threshold criteria for aortic arch treatment, of whom 14 (73.7%) would be considered eligible for arch inner-branched stent graft. Patients who underwent type A aorta dissection repair with circulatory arrest and no distal clamp were more often eligible for endovascular repair (88.8%) than those operated with a distal clamp (72.5%; P = .021). Among patients who did not meet the arch inner-branched stent graft anatomic criteria, the primary reasons were mechanical valve (40%) and insufficient proximal seal (30%).ConclusionsMore than two-thirds of patients post–type A aorta dissection repair are technically eligible for endovascular arch inner-branched stent graft repair. The development of devices that can accommodate a mechanical aortic valve and a greater awareness of sufficient graft length would significantly increase availability.
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