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1.
  • Bath, Jonathan, et al. (author)
  • Contemporary outcomes after treatment of aberrant subclavian artery and Kommerell's diverticulum
  • 2023
  • In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 77:5, s. 1339-1348.e6
  • Journal article (peer-reviewed)abstract
    • Objective: Aberrant subclavian artery (ASA) and Kommerell's diverticulum (KD) are rare vascular anomalies that may be associated with lifestyle-limiting and life-threatening complications. The aim of this study is to report contemporary outcomes after invasive treatment of ASA/KD using a large international dataset.Methods: Patients who underwent treatment for ASA/KD (2000-2020) were identified through the Vascular Low Frequency Disease Consortium, a multi-institutional collaboration to investigate uncommon vascular disorders. We report the early and mid-term clinical outcomes including stroke and mortality, technical success, and other operative outcomes including reintervention rates, patency, and endoleak.Results: Overall, 285 patients were identified during the study period. The mean patient age was 57 years; 47% were female and 68% presented with symptoms. A right-sided arch was present in 23%. The mean KD diameter was 47.4 mm (range, 13.0-108.0 mm). The most common indication for treatment was symptoms (59%), followed by aneurysm size (38%). The most common symptom reported was dysphagia (44%). A ruptured KD was treated in 4.2% of cases, with a mean diameter of 43.9 mm (range, 18.0-100.0 mm). An open procedure was performed in 101 cases (36%); the most common approach was ASA ligation with subclavian transposition. An endovascular or hybrid approach was performed in 184 patients (64%); the most common approach was thoracic endograft and carotid-subclavian bypass. A staged operative strategy was employed more often than single setting repair (55% vs 45%). Compared with endovascular or hybrid approach, those in the open procedure group were more likely to be younger (49 years vs 61 years; P < .0001), female (64% vs 36%; P < .0001), and symptomatic (85% vs 59%; P < .0001). Complete or partial symptomatic relief at 1 year after intervention was 82.6%. There was no association between modality of treatment and symptom relief (open 87.2% vs endovascular or hybrid approach 78.9%; P = .13). After the intervention, 11 subclavian occlusions (4.5%) occurred; 3 were successfully thrombectomized resulting in a primary and secondary patency of 95% and 96%, respectively, at a median follow-up of 39 months. Among the 33 reinterventions (12%), the majority were performed for endoleak (36%), and more reinterventions occurred in the endovascular or hybrid approach than open procedure group (15% vs 6%; P = .02). The overall survival rate was 87.3% at a median follow-up of 41 months. The 30-day stroke and death rates were 4.2% and 4.9%, respectively. Urgent or emergent presentation was independently associated with increased risk of 30-day mortality (odds ratio [OR], 19.8; 95% confidence interval [CI], 3.3-116.6), overall mortality (OR, 3.6; 95% CI, 1.2-11.2) and intraoperative complications (OR, 8.3; 95% CI, 2.8-25.1). Females had a higher risk of reintervention (OR, 2.6; 95% CI, 1.0-6.5). At an aneurysm size of 44.4 mm, receiver operator characteristic curve analysis suggested that 60% of patients would have symptoms.Conclusions: Treatment of ASA/KD can be performed safely with low rates of mortality, stroke and reintervention and high rates of symptomatic relief, regardless of the repair strategy. Symptomatic and urgent operations were associated with worse outcomes in general, and female gender was associated with a higher likelihood of reintervention. Given the worse overall outcomes when symptomatic and the inherent risk of rupture, consideration of repair at 40 mm is reasonable in most patients. ASA/KD can be repaired in asymptomatic patients with excellent outcomes and young healthy patients may be considered better candidates for open approaches versus endovascular or hybrid modalities, given the lower likelihood of reintervention and lower early mortality rate.
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2.
  • Bissacco, Daniele, et al. (author)
  • Comparison of the Reproducibility of Ultrasound Calliper Placement Methods in Abdominal Aortic Diameter Measurements : A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies
  • 2023
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:5, s. 620-631
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To assess which ultrasound (US) method of maximum anteroposterior (AP) abdominal aortic diameter measurement can be considered most reproducible.DATA SOURCES: MEDLINE, Scopus, and Web of Science were searched (PROSPERO ID: 276694). Eligible studies reported intra- and or interobserver agreement according to Bland-Altman analysis (mean ± standard deviation [SD]) for abdominal aortic diameter AP US evaluations with an outer to outer (OTO), inner to inner (ITI), and or leading edge to leading edge (LELE) calliper placement.REVIEW METHODS: The Preferred Reporting Items for a Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies statement was followed. The QUADAS-2 tool and QUADAS-C extension were used for risk of bias assessment and the GRADE framework to rate the certainty of evidence. Pooled estimates (fixed effects meta-analysis, after a test of homogeneity of means) for each US method were compared with pairwise one sided t tests. Sensitivity analyses (for studies published in 2010 or later) and meta-regression were also performed.RESULTS: 21 studies were included in the qualitative analysis. Twelve were eligible for quantitative analysis. Studies showed heterogeneity in the US model and transducer used, sex of participants, and observer professions, expertise, and training. Included studies shared a common mean for each US method (OTO: p = 1.0, ITI: p = 1.0, and LELE: p = 1.0). A pooled estimate of interobserver reproducibility for each US method was obtained, combining the mean ± SD (Bland-Altman analysis) from each study: OTO: 0.182 ± 0.440; ITI: 0.170 ± 0.554; and LELE: 0.437 ± 0.419. There were no statistically significant differences between the methods (OTO vs. ITI: p = .52, OTO vs. LELE: p = .069, ITI vs. LELE: p = .17). Considering studies published in 2010 and later, the pooled estimate for LELE was the smallest, without statistically significant differences between the methods. Despite the low risk of bias, the certainty of the evidence for both meta-analysed outcomes remained low.CONCLUSION: The interobserver reproducibility for OTO and ITI was 2.5 times smaller (indicating better reproducibility) than LELE; however, without statistically significant differences between the methods and low GRADE evidence certainty. Additional data are needed to validate these findings, while inherent differences between the methods need to be emphasised.
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3.
  • Budtz-Lilly, Jacob, et al. (author)
  • European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair The EU-FBENDO-FAIL Registry
  • 2023
  • In: Annals of Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0003-4932 .- 1528-1140. ; 278:2, s. E389-E395
  • Journal article (peer-reviewed)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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4.
  • Burdess, Anne, et al. (author)
  • Early Experience With a Novel Dissection-Specific Stent-Graft to Prevent Distal Stent-Graft-Induced New Entry Tears After Thoracic Endovascular Repair of Chronic Type B Aortic Dissections
  • 2022
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 81, s. 36-47
  • Journal article (peer-reviewed)abstract
    • Background: The aim was to report short and mid-term outcomes of a novel, investigational, dissection-specific stent-graft (DSSG), specifically designed to address the features of chronic type B aortic dissection (CTBAD) and reduce the risk of distal stent-graft-induced new entry tears (dSINE).Materials and Methods: A retrospective single center cohort study of all patients undergoing TEVAR with the DSSG for CTBAD from January 1, 2017 to January 31, 2020. The DSSG, which is a modified stent-graft based on the Cook Zenith Alpha Thoracic platform, has no proximal barbs, and a customized longer body length with substantial taper. The second and third distal Z-stents are sited internally to avoid any contact of the metal skeleton with the dissection membrane and have reduced radial force, while the most distal stent was removed creating a distal 30 mm unsupported Dacron graft.Results: Sixteen patients (13 males, 3 females) with a median age of 66 years (range 31–79 years) underwent elective TEVAR of CTBAD using the DSSG. Six patients (38%) had an underlying connective tissue disorder. The median tapering was 10 mm (range 4 mm–21 mm) and median length 270 mm (range 210–380 mm). Technical success was achieved in all but one case (96%). One patient died within 30 days, due to retrograde type A dissection with cardiac tamponade. The 30-day rate of stroke, spinal cord ischemia, and re-interventions was 0%. After median imaging follow-up time of 17 months (range 1–31 months), one patient developed a dSINE 4 months after the index procedure. After median survival follow-up of 23 months (range 2–35 months), one late death occurred due to traumatic brain injury, while no aortic-related death occurred during follow-up. Complete false lumen (FL) thrombosis was achieved in 9 patients while the remaining 6 showed partial FL thrombosis. No instances of diameter increase at the level oftreated aortic segment were noted with serial measurements showing either stable (n = 7) or decreased (n = 8) maximal transverse diameter.Conclusions: Use of a novel DSSG with low radial force for TEVAR in the setting of CTBAD is safe and feasible. This early real-world experience shows promising mid-term effectiveness with low rates of dSINE or unplanned re-interventions and satisfactory aortic remodeling during follow-up. Longer follow-up is needed, however, before any firm conclusions can be drawn.
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5.
  • D'Oria, Mario, et al. (author)
  • A scoping review of the rationale and evidence for cost-effectiveness analysis of fenestrated-branched endovascular repair for intact complex aortic aneurysms
  • 2020
  • In: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 72:5, s. 1772-1782
  • 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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6.
  • D'Oria, Mario, et al. (author)
  • An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA)
  • 2023
  • In: Journal of Endovascular Therapy. - : Sage Publications. - 1526-6028 .- 1545-1550.
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA).METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa.RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making.CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology.CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.
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7.
  • D'Oria, Mario, et al. (author)
  • Association Between Hospital Volume and Failure to Rescue After Open or Endovascular Repair of Intact Abdominal Aortic Aneurysms in the VASCUNET and International Consortium of Vascular Registries
  • 2021
  • In: Annals of Surgery. - : Wolters Kluwer. - 0003-4932 .- 1528-1140. ; 274:5, s. 452-459
  • Journal article (peer-reviewed)abstract
    • Objective: To investigate the association between hospital volume and failure to rescue (FtR), after open repair (OAR), and endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) among centers participating in the VASCUNET and International Consortium of Vascular Registries.Summary of Background Data: FtR (ie, in-hospital death following major complications) is a composite end-point representing the inability to treat complications effectively and prevent death.Methods: Using data from 8 vascular registries, complication and mortality rates after intact AAA repair were examined (n = 60,273; EVAR-43,668; OAR-16,605). A restricted analysis using pooled data from 4 countries (Australia, Hungary, New Zealand, and USA) reporting data on all postoperative complications (bleeding, stroke, cardiac, respiratory, renal, colonic ischemia) was performed to identify risk-adjusted association between hospital volume and FtR.Results: The most frequently reported complications were cardiac (EVAR-3.0%, OAR-8.9%) and respiratory (EVAR-1.0%, OAR-5.7%). In adjusted analysis, 4.3% of EVARs and 18.5% of OARs had at least 1 complication. The overall FtR rate was 10.3% after EVAR and 15.7% after OAR. Subjects treated in the highest volume centers (Q4) had 46% and 80% lower odds of FtR after EVAR (OR = 0.54; 95% CI = 0.34-0.87; P = 0.04) and OAR (OR = 0.22; 95% CI = 0.11-0.44; P < 0.001) when compared to lowest volume centers (Q1), respectively. Colonic ischemia had the highest risk of FtR for both procedures (adjusted predicted risks, EVAR: 27%, 95% CI 14%-45%; OAR: 30%, 95% CI 17%-46%).Conclusions: In this multi-national dataset, FtR rate after intact AAA repair with EVAR and OAR is significantly associated with hospital volume. Hospitals in the top volume quartiles achieve the lowest mortality after a complication has occurred.
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8.
  • D'Oria, Mario, et al. (author)
  • Center volume and failure to rescue after open or endovascular repair of ruptured abdominal aortic aneurysms
  • 2022
  • In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 76:6, s. 1565-
  • Journal article (peer-reviewed)abstract
    • Background: The correlation between center volume and elective abdominal aortic aneurysm (AAA) repair outcomes is well established; however, these effects for either endovascular aneurysm repair (EVAR) or open aneurysm repair (OAR) of ruptured AAA (rAAA) remains unclear. Notably, the capacity to either avert or manage complications associated with postoperative mortality is an important cause of outcome disparities after elective procedures; however, there is a paucity of data surrounding nonelective presentations. Therefore, the purpose of this analysis was to describe the association between annual center volume, complications, and failure to rescue (FtR) after EVAR and OAR of rAAA.Methods: All consecutive endovascular and open rAAA repairs from 2010 to 2020 in the Vascular Quality Initiative were examined. Annual center volume (procedures/year per center) was grouped into quartiles: EVAR-Q1 (<14), 3.4%; Q2 (14-23), 12.8%; Q3 (24-37), 24.7%; and Q4 (>38), 59.1%; OAR-Q1 (<3), 5.4%; Q2 (4-6), 12.8%; Q3 (7-10), 22.7%; and Q4 (>10), 59.1%. The primary end point was FtR, defined as in-hospital death after experiencing one of six major complications (cardiac, renal, respiratory, stroke, bleeding, colonic ischemia). Risk-adjusted analyses for intergroup comparisons were completed using multivariable logistic regression.Results: The unadjusted in-hospital death rate was 16.5% and 28.9% for EVAR and OAR, respectively. Complications occurred in 45% of EVAR (n = 1439/3188) and 70% of OAR (n = 1366/1961) patients with corresponding FtR rates of 14% (EVAR) and 26% (OAR). For OAR, Q4-centers had a 43% lower FtR risk (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.4-0.9; P =.017) compared with Q1 centers. Centers performing fewer than five OARs/year had a 43% lower risk (OR, 0.57; 95% CI, 0.4-0.7; P <.001) of FtR and this decreased 4% for each additional five procedures performed annually (95% CI, 0.93-0.991; P =.013). However, there was no significant relationship between center volume and FtR after EVAR. The risk of FtR was strongly associated with a greater number of complications for both procedures (OR multiplied by 6.5 for EVAR and 1.5 for OAR for each additional complication; P <.0001). Among OAR patients with a single recorded complication, return to the operating room for bleeding had highest risk of in-hospital mortality (OR, 4.1; 95% CI, 1.1-4.8; P =.034), whereas no specific type of complication increased FtR risk after EVAR.Conclusions: FtR occurs commonly after EVAR and OAR of rAAA within Vascular Quality Initiative centers. Importantly, increasing center volume was associated with decreased FtR risk after OAR, but not EVAR. Complication pattern and frequency predicted FtR after either repair strategy. For stable patients, especially those deemed anatomically ineligible for EVAR, these findings emphasize the need to improve the coordination of regional referral networks that centralize rAAAs to high-volume centers. Moreover, hospitals that treat rAAA should invest in resources that develop protocols targeting specific complications to mitigate risk of preventable postoperative death.
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9.
  • D'Oria, Mario, et al. (author)
  • Comparison of early and mid-term outcomes after fenestrated-branched endovascular aortic repair in patients with or without prior infrarenal repair
  • 2021
  • In: Journal of Endovascular Therapy. - : Sage Publications. - 1526-6028 .- 1545-1550. ; 29:4, s. 544-554
  • Journal article (peer-reviewed)abstract
    • Objective: The purpose of this study was to compare short- and mid-term outcomes of fenestrated-branched endovascular repair (F-BEVAR) of pararenal (PRAA)/thoracoabdominal (TAAA) aortic aneurysms in patients with or without prior endovascular/open (EVAR/OAR) infrarenal aortic repair.Methods: Data from consecutive F-BEVAR (2010-2019) at two high-volume aortic centers were retrospectively reviewed. Primary endpoints were technical success, 30-day mortality, and overall survival. Secondary endpoints included 30-day major adverse events (MAE), freedom from type I/III endoleaks, reinterventions, sac expansion, and target vessel (TV) primary patency.Results: A total of 222 consecutive patients were included for analysis; of these 58 (26.1%) had prior infrarenal repair (EVAR=33, OAR=25) and 164 (73.9%) had native PRAA/TAAA. At baseline, patients with prior infrarenal repair were older (mean age=75.1 vs 71.6 years, p=.005) and the proportion of females was lower (8.6% vs 29.3%, p=.002). Technical success was 97.8% (n=217) in the entire cohort, without any significant differences between study groups (94.8% vs 98.8%, p=.08). At 30 days, there were no significant differences between patients with prior infrarenal repair as compared with those without in rate of MAE (44.8% vs 54.9%, p=.59). The 5-year estimate of survival for those who underwent native aortic repair was 61.6%, versus 61.3% for those who had a previous repair (p=.67). The 5-year freedom from endoleaks I/III estimates were significantly lower in patients who had prior infrarenal repair as compared with patients undergoing treatment of native aneurysms (57.1% vs 66.1%, p=.03), mainly owing to TV-related endoleaks (ie, type IC and/or IIIC endoleaks). No significant differences were found between study groups in rates of reinterventions and TV primary patency. Five-year estimates of freedom from sac increase >5mm were significantly lower in patients who received F-BEVAR after previous infrarenal repair as compared with those who underwent treatment of native aneurysms (48.6% vs 77.5%, p=.002).Conclusions: F-BEVAR is equally safe and feasible for treatment of patients with prior infrarenal repair as compared with those undergoing treatment for native aneurysms. Increased rates of TV-related endoleaks were observed which could lead to lower freedom from aneurysm sac shrinkage during follow-up. Nevertheless, the 5-year rates of reinterventions and TV patency were similar, thereby indicating that overall effectiveness of treatment remained satisfactory at mid-term.
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10.
  • D'Oria, Mario, et al. (author)
  • Frequency and type of interval adverse events during the waiting time to complex aortic endovascular repair.
  • 2022
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 75:6, s. 1821-1828.e1
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: Aim of the study was to evaluate the frequency and type of adverse events that may occurs during the waiting time to complex aortic endovascular repair.METHODS: This is a retrospective study of all elective patients with complex aortic aneurysms (including pararenal/suprarenal, thoracoabdominal, or aortic arch aneurysms) that required a custom-made device (CMD) from Cook Medical at a tertiary referral vascular center (Nov 2010 - May 2020). The waiting time was defined as interval between date of stent-graft order and date of procedure or cancellation date. Interval adverse events were defined as any event that occurred during waiting time which led to either mortality, aneurysm rupture, or cancellation of the planned procedure.RESULTS: A total of 235 patients (mean age 72 years, 25% females) had a CMD graft ordered (201 planned as single-stage procedures). The median waiting time until surgery was 106 days (IQR:77-146) in the whole cohort and 101 days (IQR:77-140) among single-stage procedures. The planned procedure was carried out electively in 219 (93%), with an overall thirty-day elective mortality of 2% (N=5). There were 16 interval adverse events during waiting time. Of these, 10 were aneurysm ruptures and six were cancellations of the procedure owing to non-aneurysm-related deaths (3% of the entire cohort). A total of 10 interval deaths were registered (4.2%), four were aneurysm-related. Risk of rupture during waiting time (Kaplan-Meier) was 6.1% (SD 2.3) at 180 days. The median time from stent-graft order to aneurysm rupture was 101 days (IQR: 54-200 days). Out of the 10 aneurysm ruptures that occurred, six underwent emergent repair with 0% mortality at thirty-days (one open repair, one T-Branch, one physician-modified endograft, two cases in which the CMD was already available, one case in which a different CMD was available).CONCLUSIONS: The median waiting time from stent-graft order to implantation was about fifteen weeks. During this time, a substantial proportion may suffer from adverse events, either related to aneurysm rupture or underlying comorbidity. Rupture risk during waiting time exceeded the risk of perioperative mortality; efforts to decrease this can therefore significantly improve outcome. A combination of different techniques may play a vital role to reduce the mortality in case of interval ruptures.
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11.
  • D'Oria, Mario, et al. (author)
  • Long-term survival after repair of ruptured abdominal aortic aneurysms is improving over time : Nationwide analysis during twenty-four years in Sweden (1994-2017)
  • 2021
  • In: Annals of Surgery. - : Wolters Kluwer. - 0003-4932 .- 1528-1140. ; 277:3, s. 670-677
  • Journal article (peer-reviewed)abstract
    • Objective: To investigate long-term survival after ruptured abdominal aortic aneurysms (rAAA) repair in Sweden during twenty-four years (1994-2017).Summary Background Data: Management of rAAA has seen significant changes in the past decades, with the shifting from open (OAR) to endovascular (EVAR) being the most striking, thereby enabling treatment of elderly patients with multiple comorbidities.Methods: A registry-based nationwide cohort study was performed, and three 8-year periods (1994-2001, 2002-2009, 2010-2017) were compared for crude long-term survival with Kaplan-Meier and multivariable Cox proportional hazards analyses. Relative survival compared to matched general population referents was estimated.Results: Overall, 8,928 rAAA repair subjects were identified (1994-2001 N=3,368; 2002-2009 N=3,405; 2010-2017 N=2,155). The proportion of octogenarians (20.6%; 27.5%; 34.0%; p<.001), women (14.3%; 18.5%; 20.6%; p<.001), and EVAR procedures (1.5%; 14.9%; 35.5%; P<.001) increased over time. The crude 5-year survival was 36%; 44%; 43% (p<.0001). Multivariable Cox proportional hazard analysis displayed a decreasing mortality hazard ratio (HR) over time (1.00; 0.80; 0.72; p<.001). Use of EVAR was associated with reduced hazards of crude long-term mortality (HR=0.80, P<.001). Relative survival for patients surviving the perioperative period (i.e. 90 days) was lower than matched general population referents, and was stable over time (relative 5-year survival: 86% vs 88% , vs 86% p<.001).Conclusions: Nationwide analysis of long-term outcomes after repair of rAAA in Sweden during 24 years (1994-2017) has revealed that, despite changes in the baseline population characteristics as well as in the treatment strategy, long-term survival improved over time. 
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12.
  • D'Oria, Mario, et al. (author)
  • Microsurgical Salvage of Acute Lower Limb Ischemia after Iatrogenic Femoral Injury during Orthopedic Surgery in a Pediatric Patient
  • 2020
  • In: Annals of Vascular Surgery. - : Elsevier BV. - 0890-5096 .- 1615-5947. ; 69, s. 452.e5-452.e11
  • Journal article (peer-reviewed)abstract
    • Acute lower limb ischemia (ALLI) in the pediatric population is rare but may lead to limb loss and life-long complications. We report the technique and outcomes of microsurgical salvage of ALLI in a preterm newborn after open reduction of congenital hip dysplasia. A 2-month-old girl was born premature at week 36 with congenital bilateral hip dysplasia. The initial management attempted was conservative and entailed placement of bilateral Von Rosen splints. The treatment was successful on the left side, but the patient had recurrent unstable hip dislocation on the right side. Subsequently, 2 attempts at close reduction under general anesthesia were done and both were unsuccessful in maintaining the right hip in the acetabulum. Therefore, an open reduction of the right hip was planned through a medial/obturator approach. During the surgical procedure, the neurovascular femoral bundle (including the superficial femoral artery [SFA], femoral vein [FV], and femoral nerve) was accidently transected with subsequent development of ALLI. Therefore, the FV was harvested distally to the injury site and a 4-cm long healthy segment was obtained. It was reversed, flushed with heparin, spatulated at both extremities, and interposed to the SFA in end-to-end fashion using two 9/0 polypropylene interrupted sutures under microscope. Reperfusion of the limb was noted immediately after releasing the vascular clamps. The final ischemia time at completion of the surgical procedure was 6 hr. Thereby, prophylactic 4-compartment fasciotomies were performed in the right leg. The patient tolerated the procedure well and the postoperative clinical course was free from adverse events. Duplex ultrasound examination at 6 weeks after the intervention confirmed sustained clinical success and showed no signs of venous thromboembolism. At the same time, X-ray examination of the right hip confirmed adequate and stable reduction of the joint in the acetabulum. ALLI due to accidental arterial injury during orthopedic surgical procedures for congenital defects in newborns is a rare but potentially devastating complication. Microsurgical salvage is a safe, feasible, and effective option to restore limb flow. Multidisciplinary expertise and meticulous technique are mandatory in order to achieve satisfactory and durable outcomes.
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13.
  • D'Oria, Mario, et al. (author)
  • Narrative review on endovascular techniques for left subclavian artery revascularization during thoracic endovascular aortic repair and risk factors for postoperative stroke
  • 2021
  • In: Interactive Cardiovascular and Thoracic Surgery. - : Oxford University Press (OUP). - 1569-9293 .- 1569-9285. ; 32:5, s. 764-772
  • Research review (peer-reviewed)abstract
    • OBJECTIVESThe aim of this study was to present a narrative review on endovascular techniques (ET) for revascularization of the left subclavian artery (LSA) during zone 2 thoracic endovascular aortic repair (TEVAR) and on risk factors for postoperative stroke following TEVAR procedures.METHODSNon-systematic search of the literature from the PubMed, Ovid and Scopus databases to identify relevant English-language articles fully published in the period 1 January 2010–1 August 2020.RESULTSCurrent general agreement is that LSA revascularization should be always attempted in the elective setting. Under urgent circumstances, it can be delayed but might be considered during the same session on a case-by-case basis. Three ET are currently available: (i) chimney/snorkels (also known as parallel grafts), (ii) fenestrations or branches and (iii) proximal scallops. The main issue with ET is the potential for increased peri-operative stroke risk owing to increased manipulation within the aortic arch. Also, they are relatively novel and further assessment of their long-term durability is needed. Intra-operative embolism and loss of left vertebral artery perfusion are hypothesized as the main causes of stroke in patients undergoing TEVAR.CONCLUSIONSThe overall risk of stroke seems higher without LSA revascularization during zone 2 TEVAR. As LSA revascularization might have a direct effect in preventing posterior stroke, it should be routinely performed in elective cases, while a case-by-case evaluation can be made under urgent circumstances. While ET can provide effective options for LSA revascularization during zone 2 TEVAR, they are novel and need further durability assessment. Stroke after TEVAR is a multifactorial pathological process and preventing TEVAR-related cerebral injury remains a significant unmet clinical need.
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14.
  • D’Oria, Mario, et al. (author)
  • Novel insights into thoracic endografts technology for prevention of distal stent-graft induced new entry (dSINE) following endovascular repair of type B aortic dissections : from bench to bedside
  • 2024
  • In: Expert Review of Medical Devices. - : Taylor & Francis. - 1743-4440 .- 1745-2422. ; 21:5, s. 391-398
  • Research review (peer-reviewed)abstract
    • Introduction: Endovascular treatment of type B aortic dissections (TBAD) has currently acquired a primary therapeutic role when anatomically feasible. The main issue with thoracic endovascular aortic repair (TEVAR) for aortic dissection is the actual nature of the aortic wall, which is structurally compromised and more fragile. Indeed, a wealth of data have shown that TEVAR for TBAD will lead, in a substantial proportion of cases, to a device-related adverse event named distal stent-graft induced new entry (dSINE).Areas Covered: Currently available aortic stent-grafts have not been specifically devised for the treatment of aortic dissection. A novel dissection specific stent-graft (DSSG) was developed, which is a custom-made device based on the Zenith Alpha Thoracic platform (Cook Medical). The DSSG has several unique properties that, in principle, make its use optimal in TBAD patients.Expert Opinion: TEVAR in the setting of aortic dissections remains technically challenging. The occurrence of dSINE represents a unique complication in this scenario and may lead to high rates of aortic-related adverse events and need for secondary interventions. The use of a novel custom-made DSSG in the setting of chronic TBAD has been proven to be safe, feasible and effective. However, even this approach may fail to completely prevent dSINE formation.
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15.
  • D'Oria, Mario, et al. (author)
  • 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
  • In: Journal of Endovascular Therapy. - : Sage Publications. - 1526-6028 .- 1545-1550. ; 31:2, s. 282-294
  • 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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16.
  • D'Oria, Mario, et al. (author)
  • Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair
  • 2021
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 859-868
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To review experience of fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal/thoraco-abdominal aortic aneurysms (PRAA/TAAA) and to assess the association between pre-operative moderate to severe chronic kidney disease (CKD) and post-operative outcomes.METHODS: All consecutive patients undergoing (elective and non-elective) F-BEVAR at a single centre (1 January 2011 - 1 July 2019) were identified. Renal function was calculated as the estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula. Accordingly, presence of moderate to severe CKD was defined as eGFR < 60 mL/min/1.73m2.RESULTS: Overall, 202 consecutive patients (mean age 72 ± 8 years; 25% women) underwent F-BEVAR for the treatment of PRAA/TAAA during the study period. Of these, 51 had a history of moderate to severe CKD (none on chronic haemodialysis). No statistically significant differences were found in demographics and major comorbidities between patients with or without a history of CKD. The overall peri-operative mortality rate was 2%, without statistically significant differences between study groups (p = .26). Patients with prior CKD had statistically significantly higher rates of acute kidney injury (AKI) (37% vs. 12%, p < .001). At three years, overall survival was statistically significantly lower in patients with history of CKD compared with those without pre-operative CKD (57% vs. 82%, p = .010). Similarly, freedom from renal function decline at three years was statistically significantly poorer in patients with prior history of CKD compared with those without pre-operative CKD (43% vs. 80%, p = .020). In a multivariable analysis CKD was independently associated with higher odds of peri-operative AKI (OR 2.8, 95% CI 1.9 - 5.8, p = .030), renal function decline (OR 4.9, 95% CI 1.7 - 9.2, p = .003), and all cause mortality (HR 3.2, 95% CI 1.2 - 8.6, p = .020).CONCLUSION: Despite low peri-operative mortality rates that are comparable to patients with unimpaired renal function, occurrence of AKI was statistically significantly higher in subjects with pre-existing moderate to severe CKD. History of CKD was independently associated to renal function decline and poorer midterm survival.
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17.
  • D'Oria, Mario, et al. (author)
  • PRINciples of optimal antithrombotiC therapy and coagulation managEment during elective fenestrated and branched EndovaScular aortic repairS (PRINCE2SS) : An International Expert Based Delphi Consensus Study
  • 2022
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 63:6, s. 838-850
  • Journal article (peer-reviewed)abstract
    • ObjectiveManagement of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres.MethodsEight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts’ responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers’ consistency was graded using Cohen’s k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k.ResultsSixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage.ConclusionBased on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues.
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18.
  • D'Oria, Mario, et al. (author)
  • Reply
  • 2022
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 76:6, s. 1759-1759
  • Journal article (other academic/artistic)
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19.
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20.
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21.
  • DOria, Mario, et al. (author)
  • Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease : An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials
  • 2024
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 101, s. 164-178
  • Journal article (peer-reviewed)abstract
    • Background:The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results.Methods:This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated.Results:A total of 2,337 patients were included in the systematic review and meta -analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed -totreat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all -cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all -cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.305.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta -analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all -cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%.Conclusions:The data supporting clinical efficacy endpoints of RCTs that examined paclitaxelbased devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.
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22.
  • D'Oria, Mario, et al. (author)
  • Short-term and Mid-term Outcomes after Use of the Native Infrarenal Aorta as Distal Landing Zone for Fenestrated-Branched Endovascular Aortic Repair
  • 2021
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 72, s. 114-123
  • Journal article (peer-reviewed)abstract
    • Background: This study aimed to examine outcomes after use of the native infrarenal aorta as distal landing zone for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal-thoracoabdominal aortic aneurysms (PRAA-TAAA). Methods: All F-BEVAR procedures for treatment of PRAA-TAAA (2011-2019) at 2 aortic centers were examined. The outcomes of interest were as follows: i) technical success, ii) perioperative morbidity, iii) preservation of lumbar arteries and the inferior mesenteric artery, iv) type IB endoleaks, v) reinterventions, vi) survival, vii) aneurysm sac behavior, and viii) infrarenal aortic changes. Results: Twenty consecutive patients with distal landing in the native infrarenal aorta were included (median age 71 years; 25% men). The median number of visible lumbar arteries at baseline was 7, and a patent inferior mesenteric artery (IMA) before the operation was present in 19 (95%) of the cases. There were no deaths within 30 days. One patient (5%), operated on with a 4-BEVAR for a type 2 TAAA, experienced spinal cord ischemia (permanent paraplegia). The median decrease in the number of visible lumbar arteries at the first postoperative scan was 3 from the baseline value, whereas a patent IMA was preserved in 12 out of 19 patients. Only in one case (5%), a type IB endoleak was noted for an overall technical success rate of 95%, which required a standard EVAR 20 months after the initial operation. The median follow-up duration for the study cohort was 491 days; all patients were alive at the longest available individual follow-up, and no instances of new-onset type IB endoleaks were observed. Another 3 late reinterventions (in addition to the one mentioned previously) were performed during midterm follow-up, all because of target vessel instability. In patients with >= 12 months of follow-up after the index procedure (n = 12, 60% of the entire cohort), no instances of aneurysm sac increase >5 mm were noted; the median largest aortic diameter was 51 mm with a median difference from baseline of -6 mm. The median distal landing zone diameter increase was 4 mm from baseline but never beyond the nominal stent-graft diameter, whereas the median aortic bifurcation diameter differed 1 mm from baseline. Conclusions: This preliminary experience shows that the use of the native infrarenal aorta as a distal landing zone for F-BEVAR is safe in the short term and midterm in patients with suitable anatomy, allowing the sparing of collateral vessels. Longer follow-up is warranted to assess durability.
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23.
  • D'Oria, Mario, et al. (author)
  • The Association Between Body Mass Index and Death Following Elective Endovascular and Open Repair of Abdominal Aortic Aneurysms in the Vascular Quality Initiative
  • 2023
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 66:1, s. 27-36
  • Journal article (peer-reviewed)abstract
    • Objective: The effect of body mass index (BMI) on post-operative outcomes after abdominal aortic aneurysm (AAA) repair remains poorly defined. The association between BMI and death following elective endovascular aneurysm repair (EVAR) and open aneurysm repair (OAR) of AAA in a large national quality registry is investigated.Methods: All elective AAA repairs within the Society for Vascular Surgery Vascular Quality Initiative (VQI; 2010 to September 2021) were reviewed (EVAR, n = 53 426; OAR, n = 9 479). All analyses were conducted separately for EVAR and OAR patients. The primary end points were 30 day mortality and five year survival rates. Study cohorts were divided into World Health Organisation BMI categories (C1 < 18.5, C2 18.5 <= BMI < 25, C3 25 <= BMI < 30, C4, 30 <= BMI < 35, C5 35 <= BMI < 40, C6 >= 40). BMI was examined as both a categorical and continuous variable. Logistic and Cox proportional hazards regression were used for risk adjustment.Results: Among EVAR patients, BMI distribution was C1, 1 216 (2%); C2, 14 687 (28%); C3, 20 516 (38%); C4, 11 352 (21%); C5, 3 947 (7%); C6, 1 708 (3%). Class 1, 2, and 6 BMI patients experienced an increased 30 daymortality rate (C1 2.6%; C2 1.3%; C6 1.4% vs. C3 - 5 0.7%; p < .001) and C1 and C2 had correspondingly inferior long termsurvival (five years: C1 69 +/- 3%; C2 79 +/- 1% vs. C3 - 6 86 - 88 +/- 2%; log rank p <.001). These survival disparities persisted after risk adjustment formultiple confounders. In the OAR cohort, BMI distribution was C1, 280 (3%); C2, 2 862 (30%); C3, 3 587 (38%); C4, 1 940 (21%); C5, 581 (6%); C6, 229 (2%). Crude 30 day mortality rates were increased for both the lowest and highest BMI patients (C1 12%, C6 7% vs. C2 - 5 3 - 4%; p < .001); these differences also persisted in long term survival (five years: C1 71 +/- 6%, C6 82 +/- 6% vs. C2 - 6 85 - 88 +/- 3%; log rank p <.001). In risk adjusted analysis, both low and high BMI OAR patients had an increased 30 day and long term mortality rate.Conclusion: Within the VQI, both the extreme low (< 18.5) and high (>= 40) BMI groups experienced an increased 30 day mortality rate after both elective EVAR and OAR. By comparison, while the lowest BMI cohort was significantly associated with decreased long term survival after both procedures, the highest BMI group only experienced reduced long termsurvival after OAR. Based upon this large real world registry analysis of elective AAA repairs, differential metabolic signatures exist within extreme BMI categories, which may inform peri-operative risk stratification and clinical decision making.
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24.
  • D'Oria, Mario, et al. (author)
  • Use of Fenestrated Stent-Grafts for Preservation of Spinal Artery Flow During Endovascular Repair of Thoracoabdominal Aortic Disease
  • 2021
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 70, s. 566.e15-566.e20
  • Journal article (peer-reviewed)abstract
    • We illustrate the safety and feasibility of the application of fenestrated stent-grafts for the preservation of spinal artery flow during endovascular repair of thoracoabdominal aortic aneurysms (TAAA) in 2 patients deemed high-risk for spinal cord ischemia (SCI). In one case, an unstented fenestration was used in a 78-year-old male treated for distal stent-graft induced new entry tear. In the other case, a fenestration with a bridging stent-graft was used to revascularize a spinal artery in a 66-year-old female with Marfan disease and island patch aneurysm following open TAAA reconstruction. Both procedures were successful without any postoperative neurologic complication. The unstented fenestration led to a type III endoleak that required the relining of the aortic stent-graft 2 years later. The stented spinal fenestration was patent at a 5-year imaging follow-up.
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25.
  • Grandi, Alessandro, et al. (author)
  • Risk Prediction Models for Peri-Operative Mortality in Patients Undergoing Major Vascular Surgery with Particular Focus on Ruptured Abdominal Aortic Aneurysms : A Scoping Review
  • 2023
  • In: Journal of Clinical Medicine. - : MDPI. - 2077-0383. ; 12:17
  • Research review (peer-reviewed)abstract
    • Purpose. The present scoping review aims to describe and analyze available clinical data on the most commonly reported risk prediction indices in vascular surgery for perioperative mortality, with a particular focus on ruptured abdominal aortic aneurysm (rAAA). Materials and Methods. A scoping review following the PRISMA Protocols Extension for Scoping Reviews was performed. Available full-text studies published in English in PubMed, Cochrane and EMBASE databases (last queried, 30 March 2023) were systematically reviewed and analyzed. The Population, Intervention, Comparison, Outcome (PICO) framework used to construct the search strings was the following: in patients with aortic pathologies, in particular rAAA (population), undergoing open or endovascular surgery (intervention), what different risk prediction models exist (comparison), and how well do they predict post-operative mortality (outcomes)? Results. The literature search and screening of all relevant abstracts revealed a total of 56 studies in the final qualitative synthesis. The main findings of the scoping review, grouped by the risk score that was investigated in the original studies, were synthetized without performing any formal meta-analysis. A total of nine risk scores for major vascular surgery or elective AAA, and 10 scores focusing on rAAA, were identified. Whilst there were several validation studies suggesting that most risk scores performed adequately in the setting of rAAA, none reached 100% accuracy. The Glasgow aneurysm score, ERAS and Vancouver score risk scores were more frequently included in validation studies and were more often used in secondary studies. Unfortunately, the published literature presents a heterogenicity of results in the validation studies comparing the different risk scores. To date, no risk score has been endorsed by any of the vascular surgery societies. Conclusions. The use of risk scores in any complex surgery can have multiple advantages, especially when dealing with emergent cases, since they can inform perioperative decision making, patient and family discussions, and post hoc case-mix adjustments. Although a variety of different rAAA risk prediction tools have been published to date, none are superior to others based on this review. The heterogeneity of the variables used in the different scores impairs comparative analysis which represents a major limitation to understanding which risk score may be the "best" in contemporary practice. Future developments in artificial intelligence may further assist surgical decision making in predicting post-operative adverse events.
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26.
  • Habib, Mohammed, et al. (author)
  • Descending thoracic aortic emergencies : Past, present, and future
  • 2023
  • In: Seminars in Vascular Surgery. - : Elsevier. - 0895-7967 .- 1558-4518. ; 36:2, s. 139-149
  • Research review (peer-reviewed)abstract
    • The most important descending thoracic aortic (DTA) pathologies are aneurysms, dissections, and traumatic injuries. In acute settings, these conditions can constitute a significant risk of bleeding or ischemia of vital organs, resulting in a fatal outcome. Morbidity and mortality associated with aortic pathologies remain significant, despite improvements in medical therapy and endovascular techniques. In this narrative review, we present an overview of the transitions in the management of these pathologies and discuss current challenges and future perspectives. Diagnostic challenges include differentiating between thoracic aortic pathologies and cardiac diseases. Efforts have been made to identify a blood test that can rapidly differentiate these pathologies. Computed tomography is the cornerstone of diagnosing thoracic aortic emergencies. Our understanding of DTA pathologies has improved substantially due to the significant advancement in imaging modalities in the last 2 decades. On the basis of this understanding, the treatment of these pathologies has been revolutionized. Unfortunately, robust evidence from prospective and randomized studies is still lacking for the management of most DTA diseases. Medical management plays a crucial role in achieving early stability during these life-threatening emergencies. This includes intensive care monitoring, heart rate and blood pressure control, and considering permissive hypotension for patients presenting with ruptured aneurysms. Over the years, surgical management of DTA pathologies changed from open repair to endovascular repair with dedicated stent-grafts. Techniques in both spectrums have improved substantially.
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27.
  • Janko, Matthew, et al. (author)
  • Contemporary Outcomes After Partial Resection of Infected Aortic Grafts
  • 2021
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 76, s. 202-210
  • Journal article (peer-reviewed)abstract
    • INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection.METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed.RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01)CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.
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28.
  • Janko, Matthew R., et al. (author)
  • In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement
  • 2022
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 76:2, s. 546-
  • Journal article (peer-reviewed)abstract
    • Objective: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. Methods: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. Results: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P <.001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P <.001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). Conclusions: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.
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29.
  • Jonsson, Gisli, et al. (author)
  • Spinal drain-related complications after complex endovascular aortic repair using a prophylactic automated volume-directed drainage protocol
  • 2023
  • In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 78:3
  • Journal article (peer-reviewed)abstract
    • Objective: A commonmeasure to lower the risk for spinal cord ischemia (SCI) during complex endovascular aortic repair (cEVAR) is prophylactic cerebrospinal fluid drainage (CSFD). This method has caused controversy because of drainrelated complications. Spinal drains are usually pressure directed. The objective of this study was to evaluate the risk of CSFD-related complications and SCI within the context of an automated volume-directed drain protocol.Methods: This is a retrospective, single-center study of all cEVARs with CSFD at a tertiary vascular center between January 2014 and December 2020. Demographics, complications, and spinal drain data were recorded. All drainages were volume based using an automatic drainage system (LiquoGuard7; Moller Medical GmbH). Spinal drain complications were categorized as disabling and nondisabling according to the modified Rankin scale. The primary end point was any CSFDrelated complication.Results: A total of 448 cEVAR patients were identified, of whom 147 (32.8%) had prophylactic CSFD. The mean age was 69 years (63% male). The most common pathology (61%) was thoracoabdominal aortic aneurysm, and the most common procedure was branched EVAR (55.1%). Eighteen (12.2%) patients developed a CSFD-related complication, whereof three (2%) were disabling. Nineteen (13%) patients developed SCI: 12 (8.4%) paraparetic, 5 (3.4%) paraplegic, and 2 (1.4%) paresthesias. Of these, 13 (68%) had full reversal of symptoms, whereas 6 patients (4%) had residual symptoms and were deemed disabling. Drain-related complications were more common in patients with SCI (31.6%) compared with those without (9.4%, P 1/4 .014). In the latter group, only two patients (1.6%) developed a disabling drain-related complication.Conclusions: Selective use of prophylactic, automated volume-directed CSFD in patients at high risk for SCI was associated with a high incidence of complications and should be used with caution. Among those developing SCI, reversalwas achieved frequently with increased CSFD volume, but at the price ofmore bleeding complications. (J Vasc Surg 2023;78:575-83.)
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30.
  • Langefeld, Carl D., et al. (author)
  • Transancestral mapping and genetic load in systemic lupus erythematosus
  • 2017
  • In: Nature Communications. - : NATURE PUBLISHING GROUP. - 2041-1723. ; 8
  • Journal article (peer-reviewed)abstract
    • Systemic lupus erythematosus (SLE) is an autoimmune disease with marked gender and ethnic disparities. We report a large transancestral association study of SLE using Immunochip genotype data from 27,574 individuals of European (EA), African (AA) and Hispanic Amerindian (HA) ancestry. We identify 58 distinct non-HLA regions in EA, 9 in AA and 16 in HA (similar to 50% of these regions have multiple independent associations); these include 24 novel SLE regions (P < 5 x 10(-8)), refined association signals in established regions, extended associations to additional ancestries, and a disentangled complex HLA multigenic effect. The risk allele count (genetic load) exhibits an accelerating pattern of SLE risk, leading us to posit a cumulative hit hypothesis for autoimmune disease. Comparing results across the three ancestries identifies both ancestry-dependent and ancestry-independent contributions to SLE risk. Our results are consistent with the unique and complex histories of the populations sampled, and collectively help clarify the genetic architecture and ethnic disparities in SLE.
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31.
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32.
  • Lopez Espada, Cristina, et al. (author)
  • The VASCUNExplanT Project : An International Study Assessing Open Surgical Conversion of Failed Non-Infected Endovascular Aortic Aneurysm Repair
  • 2023
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:5, s. 653-660
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: The need for open surgical conversion (OSC) after failed endovascular aortic aneurysm repair (EVAR) persists, despite expanding endovascular options for secondary intervention. The VASCUNExplanT project collected international data to identify risk factors for failed EVAR, as well as OSC outcomes. This retrospective cross sectional study analysed data after OSC for failed EVAR from the VASCUNET international collaboration.METHODS: VASCUNET queried registries from its 28 member countries, and 17 collaborated with data from patients who underwent OSC (2005 - 2020). Any OSC for infection was excluded. Data included demographics, EVAR, and OSC procedural details, as well as post-operative mortality and complication rates.RESULTS: There were 348 OSC patients from 17 centres, of whom 33 (9.4%) were women. There were 130 (37.4%) devices originally deployed outside of instructions for use. The most common indication for OSC was endoleak (n = 143, 41.1%); ruptures accounted for 17.2% of cases. The median time from EVAR to OSC was 48.6 months [IQR 29.7, 71.6]; median abdominal aortic aneurysm diameter at OSC was 70.5 mm [IQR 61, 82]. A total of 160 (45.6%) patients underwent one or more re-interventions prior to OSC, while 63 patients (18.1%) underwent more than one re-intervention (range 1 - 5). Overall, the 30 day mortality rate post-OSC was 11.8% (n = 41), 11.1% for men and 18.2% for women (p = .23). The 30 day mortality rate was 6.1% for elective cases, and 28.3% for ruptures (p < .0001). The predicted 90 day survival for the entire cohort was 88.3% (95% CI 84.3 - 91.3). Multivariable analysis revealed rupture (OR 4.23; 95% CI 2.05 - 8.75; p < .0001) and total graft explantation (OR 2.10; 95% CI 1.02 - 4.34; p = .04) as the only statistically significant predictive factors for 30 day death.CONCLUSION: This multicentre analysis of patients who underwent OSC shows that, despite varying case mix and operative techniques, OSC is feasible but associated with significant morbidity and mortality rates, particularly when performed for rupture.
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33.
  • Machin, Matthew, et al. (author)
  • A core outcome set for intact abdominal aortic aneurysm repair
  • 2024
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165.
  • Journal article (peer-reviewed)abstract
    • Objective: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair.Methods: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting.Results: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth.Conclusion: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.
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34.
  • Mastrorilli, Davide, et al. (author)
  • Early and Late Outcomes of Ultrasound-Guided Direct Transabdominal Embolization of Isolated Type 2 Endoleaks after Endovascular Aortic Repair
  • 2020
  • In: Annals of Vascular Surgery. - : ELSEVIER SCIENCE INC. - 0890-5096 .- 1615-5947. ; 68, s. 252-260
  • Journal article (peer-reviewed)abstract
    • Background: The aim of this study is to report the early and late outcomes of ultrasound-guided direct transabdominal embolization (UGDTE) of isolated type 2 endoleak (T2EL) after endovascular aneurysm repair (EVAR).Methods: Forty-two consecutive T2EL patients were treated between February 2000 and September 2017 by UGDTE after previous EVAR. During the study period, UGDTE was the firs-line technique implemented for treatment of T2EL. All procedures were carried out using the same predefined technique. Aneurysm sac size change from the index treatment, freedom from recurrent endoleak after treatment, demographics, risk factors, and procedural factors were analyzed with univariate analysis.Results: During the study interval, 612 patients underwent standard EVAR for abdominal aortic aneurysm treatment and 111 (18.2%) developed an isolated T2EL. Of these, 42 (6.8%) consecutive patients were deemed suitable and treated with UDGT. Median imaging follow-up duration was 18.7 months. Median fluoroscopic and procedure times were 7 and 58 minutes, respectively. The rate of immediate technical success was 100%. Ten patients (23.8%) underwent reintervention for recurrent T2EL. Freedom from reintervention for T2EL at 1, 2, and 4 years was 81%, 78%, and 71%. No aneurysm-related mortality occurred during the follow-up period.Conclusions: The use of UGDTE for treatment of isolated T2EL after EVAR is a safe and feasible technique when performed by experienced operators, resulting in high technical success and low complication rates in selected patients. Although being effective in obtaining T2EL exclusion, up to one-third of the patients may require repeat intervention during long-term follow-up. Therefore, lifelong surveillance after the procedure is recommended.
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35.
  • Mezzetto, Luca, et al. (author)
  • Scoping review of radiologic assessment and prognostic impact of skeletal muscle sarcopenia in patients undergoing endovascular repair for aortic disease
  • 2022
  • In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 76:5, s. 1407-1416
  • Research review (peer-reviewed)abstract
    • Objective: The primary objectives of our scoping review were to evaluate the methods used by research groups to assess the incidence of sarcopenia in patients with aortic disease and the extent of the evidence base that links sarcopenia to the survival of patients undergoing elective endovascular aortic repair and to identify the recurring themes or gaps in the literature to guide future research. Methods: A scoping review in accordance with the PRISMA (preferred reporting items for systematic reviews and metaanalyses) protocols extension for scoping reviews was performed. The available studies included those fully reported in English (last query, April 30, 2022). The following PICO question was used to build the search equation: "in patients with aortic disease [population] undergoing endovascular repair [intervention], what was the prevalence and prognosis of radiologically defined sarcopenia [comparison] on the short- and long-term outcomes?" Results: A total of 31 studies were considered relevant, and 18 were included in the present scoping review. In brief, 12 studies had focused on standard endovascular aneurysm repair (EVAR), 2 on thoracic EVAR, and 4 on complex EVAR. All but two studies were retrospective in design, and only one study had included patients from a multicenter database. Sarcopenia had generally been defined using the computed tomography angiography (CTA) findings of the cross-sectional area of the psoas muscle at L3 or L4, sometimes with normalization against the height. Overall, despite the heterogeneity in the methods used for its definition, sarcopenia was highly prevalent (range, 12.5%-67.6%). The patients with sarcopenia had had higher rates of mortality (ratio ranged from 2.28 [95% confidence interval, 1.35-3.84] to 6.34 [95% confidence interval, 3.37-10.0]) and adverse events (41% vs 16%; P = .020). Conclusions: Sarcopenia, as identified using computed tomography angiography-based measurements of the skeletal muscle mass, was prevalent among patients undergoing elective EVAR, thoracic EVAR, or complex EVAR. The presence of sarcopenia has been shown to have a negative prognostic impact, increasing the operative risk and has been linked to poorer long-term survival.
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36.
  • Moffatt, Clare, et al. (author)
  • International Multi-Institutional Experience with Presentation and Management of Aortic Arch Laterality in Aberrant Subclavian Artery and Kommerell's Diverticulum
  • 2023
  • In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 95, s. 23-31
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch.METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions.RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change.CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.
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37.
  • Prendes, Carlota F., et al. (author)
  • Systematic review and meta-analysis of contemporary abdominal aortic aneurysm growth rates
  • 2024
  • In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 67:1, s. 132-145
  • Research review (peer-reviewed)abstract
    • Objective: To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes.Data sources: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases.Review methods: Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404).Results: Of 8 717 titles identified, 43 studies and 28 277 patients were included:1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 – 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 – 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 – 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 – 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 – 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 – 2.32; GRADE = high).Conclusion: This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable to demonstrate any clinically meaningful AAA growth rate reduction concomitant with changed AAA epidemiology. This suggests that the RESCAN recommendations on small AAA surveillance are still valid. However, sub-analysis results from RCTs and high quality study data indicate potential lower AAA growth rates of 1.88 – 2.09 mm/year, findings that should be validated in a high quality prospective registry.
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38.
  • Reintam Blaser, A., et al. (author)
  • Incidence, diagnosis, management and outcome of acute mesenteric ischaemia: a prospective, multicentre observational study (AMESI Study)
  • 2024
  • In: Critical Care. - : BioMed Central (BMC). - 1364-8535 .- 1466-609X. ; 28:1
  • Journal article (peer-reviewed)abstract
    • Background: The aim of this multicentre prospective observational study was to identify the incidence, patient characteristics, diagnostic pathway, management and outcome of acute mesenteric ischaemia (AMI). Methods: All adult patients with clinical suspicion of AMI admitted or transferred to 32 participating hospitals from 06.06.2022 to 05.04.2023 were included. Participants who were subsequently shown not to have AMI or had localized intestinal gangrene due to strangulating bowel obstruction had only baseline and outcome data collected. Results: AMI occurred in 0.038% of adult admissions in participating acute care hospitals worldwide. From a total of 705 included patients, 418 patients had confirmed AMI. In 69% AMI was the primary reason for admission, while in 31% AMI occurred after having been admitted with another diagnosis. Median time from onset of symptoms to hospital admission in patients admitted due to AMI was 24 h (interquartile range 9-48h) and time from admission to diagnosis was 6h (1–12 h). Occlusive arterial AMI was diagnosed in 231 (55.3%), venous in 73 (17.5%), non-occlusive (NOMI) in 55 (13.2%), other type in 11 (2.6%) and the subtype could not be classified in 48 (11.5%) patients. Surgery was the initial management in 242 (58%) patients, of which 59 (24.4%) underwent revascularization. Endovascular revascularization alone was carried out in 54 (13%), conservative treatment in 76 (18%) and palliative care in 46 (11%) patients. From patients with occlusive arterial AMI, revascularization was undertaken in 104 (45%), with 40 (38%) of them in one site admitting selected patients. Overall in-hospital and 90-day mortality of AMI was 49% and 53.3%, respectively, and among subtypes was lowest for venous AMI (13.7% and 16.4%) and highest for NOMI (72.7% and 74.5%). There was a high variability between participating sites for most variables studied. Conclusions: The overall incidence of AMI and AMI subtypes varies worldwide, and case ascertainment is challenging. Pre-hospital delay in presentation was greater than delays after arriving at hospital. Surgery without revascularization was the most common management approach. Nearly half of the patients with AMI died during their index hospitalization. Together, these findings suggest a need for greater awareness of AMI, and better guidance in diagnosis and management. Trial registration: NCT05218863 (registered 19.01.2022).
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39.
  • Scali, Salvatore, et al. (author)
  • Conflicting European and North American Society Abdominal Aortic Aneurysm (AAA) Volume Guidelines Differentially Discriminate Peri-operative Mortality After Elective Open AAA Repair
  • 2023
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:6, s. 756-764
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: The European Society for Vascular Surgery (ESVS) guidelines endorse a minimum abdominal aortic aneurysm (AAA) repair volume of 20 open (OAR) and or endovascular (EVAR) AAA repair procedures per year as a proxy for high quality care. In contrast, the Society for Vascular Surgery (SVS) espouses 10 exclusively OARs per year. Given the differences in these volume standards and definitions, debate persists regarding surgeon credentialing and healthcare resource allocation. This analysis aimed to determine which society endorsed volume benchmark better discriminates OAR mortality.METHODS: A retrospective national registry based cohort analysis. Patients undergoing elective OAR were compared between centres meeting either ESVS (≥ 20 AAA procedures/year) or SVS (≥ 10 OARs/year) volume thresholds within the Vascular Quality Initiative (2010 - 2020). The primary outcome was in hospital death. Logistic regression was used for risk adjusted comparisons.RESULTS: A total of 8 761 OARs were performed at 193 US centres, and the median (IQR) volume was 6.6 (3.3, 9.9) OARs/year. When applying the SVS centre volume definition, the proportion of centres meeting ESVS and SVS minimum case thresholds was 12% (n = 22) and 25% (n = 48), respectively. The absolute mortality difference was 0.3% between centres performing ≥ 20 vs. ≥ 10 OARs/year (2.6% vs. 2.9%; p = .51). There was an incremental association between OAR volume and crude mortality rate; however, this absolute difference between lower and higher thresholds was only 0.2%/procedure (OR 0.98, 95% CI 0.97 - 0.99; p < .001). Moreover, no difference in risk adjusted mortality was detected between volume standards (≥ 10 vs. ≥ 20; p = .78). In sub-analysis, the ESVS ≥ 20 total composite AAA repair volume threshold was not associated with mortality (p = .17); however, increasing the proportion of OAR cases making up the total annual AAA centre volume inversely correlated with mortality (p = .008).CONCLUSION: It appears that the SVS endorsed AAA centre volume threshold using exclusively OAR had a modest ability to discriminate peri-operative mortality outcomes and was superior to the current composite ESVS volume guideline in differentiating centre performance. These findings raise questions regarding the clinical validity of using EVAR as a volume proxy for OAR.
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40.
  • Wanhainen, Anders, et al. (author)
  • European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms
  • 2024
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 67:2, s. 192-331
  • Journal article (peer-reviewed)abstract
    • ObjectiveThe European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy.MethodsThe guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence.ResultsA total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed.ConclusionThe ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.
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41.
  • Xodo, Andrea, et al. (author)
  • Peri-Operative Management of Patients Undergoing Fenestrated-Branched Endovascular Repair for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms : Preventing, Recognizing and Treating Complications to Improve Clinical Outcomes
  • 2022
  • In: Journal of Personalized Medicine. - : MDPI AG. - 2075-4426. ; 12:7
  • Research review (peer-reviewed)abstract
    • The advent and refinement of complex endovascular techniques in the last two decades has revolutionized the field of vascular surgery. This has allowed an effective minimally invasive treatment of extensive disease involving the pararenal and the thoracoabdominal aorta. Fenestrated-branched EVAR (F/BEVAR) now represents a feasible technical solution to address these complex diseases, moving the proximal sealing zone above the renal-visceral vessels take-off and preserving their patency. The aim of this paper was to provide a narrative review on the peri-operative management of patients undergoing F/BEVAR procedures for juxtarenal abdominal aortic aneurysm (JAAA), pararenal abdominal aortic aneurysm (PRAA) or thoracoabdominal aortic aneurism (TAAA). It will focus on how to prevent, diagnose, and manage the complications ensuing from these complex interventions, in order to improve clinical outcomes. Indeed, F/BEVAR remains a technically, physiologically, and mentally demanding procedure. Intraoperative adverse events often require prolonged or additional procedures and complications may significantly impact a patient's quality of life, health status, and overall cost of care. The presence of standardized preoperative, perioperative, and postoperative pathways of care, together with surgeons and teams with significant experience in aortic surgery, should be considered as crucial points to improve clinical outcomes. Aggressive prevention, prompt diagnosis and timely rescue of any major adverse events following the procedure remain paramount clinical needs.
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42.
  • Zuccon, Gianmarco, et al. (author)
  • Incidence, Risk Factors, and Prognostic Impact of Type Ib Endoleak Following Endovascular Repair for Abdominal Aortic Aneurysm : Scoping Review
  • 2023
  • In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 352-361
  • Research review (peer-reviewed)abstract
    • Objective: The primary objectives of this scoping review were to assess the rate of and risk factors for type Ib endoleak and to evaluate the extent of the evidence base that links type Ib endoleak to short and long term outcomes in patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA).Methods: Potentially eligible studies were searched in the Cochrane Central Register of Controlled Trials, MEDLINE, Web of Science Core Collection, SciELO Citation Index, Russian Science Citation Index, and KCI-Korean Journal Database. A scoping review was performed according to PRISMA extension for Scoping Reviews.Results: A total of 27 articles (four prospective registries and 23 retrospective cohort studies) dealing with type Ib endoleak were included in the final analysis. The number of patients reported on was 7 197, with follow up ranging between 12 months and 93 months. The reported frequency of type Ib endoleak in patients treated with EVAR ranged from 0% to 8%, Patient and or procedure related factors associated with risk of type Ib endoleak were (1) common iliac artery (CIA) diameter ˃ 18 mm requiring use of flared stent graft limbs (FLs) ˃ 20 mm, (2) length of CIA landing zone ˂ 20 mm, (3) marked iliac tortuosity, and (4) large initial AAA diameter. Depending on the study, 50 – 100% of type Ib endoleaks were corrected by endovascular means, with a reported immediate technical success of 100% in the studies providing this information.Conclusion: Type Ib endoleak after EVAR has been reported to occur in 0 – 8% of cases. Several anatomical features, including CIA diameter ˃ 18 mm or requiring the use of FLs ˃ 20 mm, length of CIA landing zone ˂ 20 mm, marked iliac tortuosity, and large initial AAA diameter, could increase the risk of type Ib endoleak and may require alternative therapeutic options and or more stringent follow up. Therefore, this updated scoping review provides a comprehensive summary of the frequency, risk factors, prognosis, and treatment of type Ib endoleaks, and has identified knowledge gaps in the literature to guide further studies.
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