A Meta-Analysis of Mid-Term Outcomes of Endovascular Aneurysm Sealing.

BACKGROUND-AIM: Several studies have been published showing conflicting results on the outcome after endovascular aneurysm sealing (EVAS). The aim of the present study is to conduct a systematic review and meta-analysis of published evidence to assess the efficacy of EVAS in the management of patients with abdominal aortic aneurysm (AAA). METHODS: An electronic search of the English medical literature, from 2010 to March 2021, was conducted using MEDLINE, EMBASE, and Cochrane databases to find studies relevant to outcome after EVAS. RESULTS: The final analysis included 12 articles published between 2011 and 2021, including 1440 patients. In total, 79.3% of the included patients underwent aneurysm treatment according to the instructions for use. Technical success was 98.8%. Overall, 30-day mortality was 1.3%. Procedure-related complications were reported in 4% of the cohort. During median follow-up of 28.1 months (range 9-72 months), the pooled estimate of endoleak type I, migration and reinterventions was 16% (95% confidence interval [CI]=7-25), 16% (95% CI=9-23), and 19% (95% CI=11-28), respectively. In a sub-analysis, 7 studies (703 patients) reported outcome with a mean follow-up of more than 2 years (range 24-72 months). In these studies, the pooled estimate of endoleak type I, migration, and reinterventions was 25% (95% CI=13-38), 22% (95% CI=19-26), and 27% (95% CI=21-33), respectively. CONCLUSION: Patients who have been treated with EVAS are in high risk for reintervention especially beyond 2 years following implantation. Close surveillance for patients treated with EVAS is mandatory.

Molecular pathways to high-level azithromycin resistance in Neisseria gonorrhoeae.

BACKGROUND: The prevalence of azithromycin resistance in Neisseria gonorrhoeae is increasing in numerous populations worldwide. OBJECTIVES: To characterize the genetic pathways leading to high-level azithromycin resistance. METHODS: A customized morbidostat was used to subject two N. gonorrhoeae reference strains (WHO-F and WHO-X) to dynamically sustained azithromycin pressure. We tracked stepwise evolution of resistance by whole genome sequencing. RESULTS: Within 26 days, all cultures evolved high-level azithromycin resistance. Typically, the first step towards resistance was found in transitory mutations in genes rplD, rplV and rpmH (encoding the ribosomal proteins L4, L22 and L34 respectively), followed by mutations in the MtrCDE-encoded efflux pump and the 23S rRNA gene. Low- to high-level resistance was associated with mutations in the ribosomal proteins and MtrCDE efflux pump. However, high-level resistance was consistently associated with mutations in the 23S ribosomal RNA, mainly the well-known A2059G and C2611T mutations, but also at position A2058G. CONCLUSIONS: This study enabled us to track previously reported mutations and identify novel mutations in ribosomal proteins (L4, L22 and L34) that may play a role in the genesis of azithromycin resistance in N. gonorrhoeae.

State-of-the-art overview on biological treatment for CRSwNP.

BACKGROUND: The majority of patients with uncontrolled severe CRSwNP, asthma and atopic dermatitis share a similar T helper 2 type inflammation linked to their underlying phenotype. This discovery has triggered new research around treatments targeting specific cytokines driving inflammation in CRSwNP like IL-4, IL-13, IL-5 and IgE. Biologicals are increasingly tested as additional tre- atment for patients suffering from severe chronic rhinosinusitis with nasal polyps (CRSwNP). Their efficacy has been demonstrated in multiple studies. All studies differ in terms of baseline characteristics of included patients and outcome parameters analysed. AIMS: A comparative analysis of the efficacy of reported biologicals for CRSwNP based on the published data for phase 2 and 3 studies. The aim was to provide a comprehensive overview across the different biologicals and outcome parameters. METHODS: In a first step we critically selected out of all available phase 2 and 3 clinical trials the ones containing the most rigorous and compatible study designs. Meaning studies that comply with a need for a clear definition of CRSwNP, at least two administra- tion doses, comparable timeframes and the same outcome parameters studied. This assessment was performed using a PRISMA search. We retained 7 studies with significant data for dupilumab, mepolizumab and omalizumab. In a second step the effect-sizes of treatment with those biologicals were compared for the most important outcome parameters both patient relevant (nasal con- gestion, smell loss and SNOT-22 scores) and patient irrelevant (CT scan Lund-Mackay, smell test and nasal polyp scores). Therapy duration of 16 to 25 weeks was chosen for evaluation of efficacy. RESULTS: A direct comparison of efficacy between dupilumab, mepolizumab and omalizumab is challenging given differences in inclusion criteria, outcome parameters and time-points of analyses. We have been able to conclude that effect sizes of dupilumab, mepolizumab and omalizumab seem large enough to reflect a major reduction in symptom burden as experienced by patients suffering from refractory CRSwNP. The effect size of dupilumab on both patient relevant and patient irrelevant parameters of smell loss are clearly significant and reflect the clinical experience of major reduction of smell impairment in treated patients. CONCLUSION: Despite the heterogeneity of protocols, dosages and time-points of analyses of biological trials in CRSwNP, this over- view highlights outcomes of biological treatment in CRSwNP in a comprehensive way. Real-life registries, comparative trials and/ or endotype-driven treatment plans are needed to provide the answers to the multiple questions that are still open today.

[Monitoring with four recovery phases. First experiences in FACT]. / Monitoren met vier herstelfasen; eerste ervaringen binnen FACT.

BACKGROUND: Following an audit, the flexible assertive community treatment-teams (FACT-teams), in Winterswijk, the Netherlands, set out to discover a more recovery-oriented approach to treatment and monitoring. Their findings support researching four recovery phases described previously.
AIM: A pilot-study to investigate the possibilities to create a more recovery-oriented working method by applying the four recovery phases - ranging from being overwhelmed by the condition to living past the condition - in FACT-teams.
METHOD: The FACT-teams started to monitor patients during the recovery phases and developed a semi-structured interview that can be used to determine the current recovery phase. After the phase has been determined, a plan is written on how to progress to the next phase.
RESULTS: Monitoring during the recovery phases proved to be useful in showing both succesfull and stagnating treatments. The recovery phases also became part of the standard treatment plans in the electronic patient dossier. An important result of this project was the recovery-oriented interview we developed.
CONCLUSION: Monitoring and interviewing based on the four recovery phases subjectively leads to more in-depth and more recovery-oriented evaluations of treatment. More empirical research into this method is necessary.

Outcome after Interruption or Preservation of Internal Iliac Artery Flow During Endovascular Repair of Abdominal Aorto-iliac Aneurysms.

AIM: The aim was to conduct a systematic review of the literature investigating outcomes after interruption or preservation of the internal iliac artery (IIA) during endovascular aneurysm repair (EVAR). METHODS: A systematic review was undertaken using the MEDLINE and EMBASE databases to identify studies reporting IIA management during EVAR. The search identified 57 articles: 30 reported on IIA interruption (1468 patients) and 27 on IIA preservation (816 patients). RESULTS: The pooled 30 day buttock claudication (BC) rate was 29.2% (95% CI 24.2-34.7). Patients undergoing bilateral IIA interruption had a higher incidence of BC than patients with unilateral IIA interruption (36.5% vs. 27.2%, OR 1.7, 95% CI 1.11-2.6, p = .01). During a median follow up of 17 months, the pooled rate of persistent BC was 20.5% (95% CI 15.7-26.2). Of the patients, 93.9% underwent an endovascular revascularization procedure for IIA preservation. Most patients (87.6%) had an iliac branched device, and technical success was 96.2%. Within 30 days of EVAR, 4.3% of internal iliac branches occluded. During a median follow up of 15 months, the pooled occlusion rate at the site of IIA revascularization was 8.8% (95% CI 6.8-11.3). In patients treated with an iliac-branched device, 5.2% of internal iliac branches and 1.7% of external iliac arteries occluded. The pooled BC rate on the side of the IIA revascularization during follow up was 4.1% (95% CI 2.9-5.9). Pooled rates of late device related endoleak type I or III and secondary procedures on the side of the previous IIA revascularization were 4.6% (95% CI 3.2-6.5) and 7.8% (95% CI 5.7-10.7) respectively. CONCLUSION: Unilateral or bilateral IIA occlusion during EVAR seems to carry a substantial risk of significant ischemic complications in nearly one quarter of patients. Bilateral IIA occlusion was related to a significantly higher rate of BC. IIA preservation techniques represent a significant improvement in the treatment of aorto-iliac aneurysms and have been associated with high technical success and low morbidity.

Clinical Outcome of Isolated Popliteal Artery Aneurysms Treated with a Heparin-bonded Stent Graft.

OBJECTIVE: The use of self-expanding stent grafts for treatment of popliteal artery aneurysms (PAA) is a matter of debate, although several studies have shown similar results compared with open surgery. In recent years, a new generation stent graft, with heparin-bonding technology, became available. The aim of this study is to present the results of endovascular PAA repair with heparin-bonded stent grafts. METHODS: Data on all patients with PAA treated with a heparin-bonded polytetrafluoroethylene (ePTFE) stent graft between April 2009 and March 2014 were gathered in a database and retrospectively analyzed. Data were collected from four participating hospitals. Standard follow-up consisted of clinical assessment, and duplex ultrasound at 6 weeks, 6 months, 12 months, and annually thereafter. The primary endpoint of the study was primary patency. Secondary endpoints were primary-assisted and secondary patency and limb salvage rate. RESULTS: A total of 72 PAA was treated in 70 patients. Mean age was 71.2 ± 8.5 years and 93% were male (n = 65). The majority of PAA were asymptomatic (78%). Sixteen cases (22%) had a symptomatic PAA, of which seven (44%) presented with acute ischemia. Early postoperative complications occurred in two patients (3%). Median follow-up was 13 months (range 0-63 months). Primary patency rate at 1 year was 83% and after 3 years 69%; primary assisted patency rate was 87% at 1 year and 74% after 3 years. Secondary patency rate was 88% and 76% at 1 and 3 years, respectively. There were no amputations during follow-up. CONCLUSION: Endovascular treatment of PAA with heparin-bonded stent grafts is a safe treatment option with good early and mid-term patency rates comparable with open repair using the great saphenous vein.

Mid-term Outcomes of Renal Branches Versus Renal Fenestrations for Thoraco-abdominal Aneurysm Repair.

OBJECTIVE/BACKGROUND: The objective was to investigate renal outcomes following endovascular repair of thoraco-abdominal aortic aneurysms (TAAA) comparing fenestrations with branches for the renal arteries. METHODS: Renal outcomes following TAAA endovascular repair performed with renal branches were collected from five high volume European centers and compared with renal outcomes following TAAA endovascular repair performed with renal fenestrations at one center. Renal re-intervention and occlusion rates, and freedom from any renal outcome and death were analyzed by patient and target vessel. Estimated glomerular filtration rate (eGFR) was calculated and collected pre-operatively and at the last available follow up. RESULTS: In total, 449 patients were included in this retrospective study (235 treated with branched devices [BEVAR] and 214 with fenestrated devices [FEVAR]). Altogether, 856 renal vessels were analyzed (445 perfused by branches and 411 by fenestrations). Both groups were comparable except for sex and smoking habits. Technical success rates were 95% and 99%, respectively. Mean ± SD follow up was 19 ± 18 months after BEVAR and 24 ± 20 months after FEVAR. During follow up, renal re-intervention rates were similar in both groups (4.7% vs. 5.2%). The renal occlusion rate was significantly higher following BEVAR (9.6% vs. 2.3%; p < .01), and the 2 year freedom for renal occlusion rate was 90.4% (SE 85.8-95.3%) following BEVAR and 97.1% (SE 94.6-99.7%) following FEVAR (p < .01). During follow up, a 12% median decrease in eGFR was observed following BEVAR versus 9% following FEVAR (non-significant). The 2 year survival rates were 73.4% (SE 66.6-80.9%) and 81.8% (SE 76.1-87.9%) following BEVAR and FEVAR, respectively. CONCLUSION: Mid-term renal outcomes following endovascular repair of TAAA are satisfactory. Endograft designs incorporating renal fenestrations rather than renal branches are associated with significantly lower occlusion rates. A prospective trial is now required to confirm these results.

Fenestrated Endovascular Aortic Aneurysm Repair as a First Line Treatment Option to Treat Short Necked, Juxtarenal, and Suprarenal Aneurysms.

OBJECTIVES: The outcomes of fenestrated endovascular aneurysm repair (FEVAR) as a first line strategy is reported. METHODS: All consecutive patients treated with FEVAR for short neck, juxtarenal, or suprarenal aortic aneurysms under the guidance of the senior author within the period January 2010 to December 2014 were included. Data were collected from a prospectively maintained database. Analyzed outcomes included technical success, defined by successful stent graft implantation with patent stented target vessels and no Type I/III endoleak, operative mortality and morbidity, target vessel patency, endoleak, re-intervention, and death. Survival, target vessel stent patency, and re-intervention during follow up were calculated by Kaplan-Meier analysis. RESULTS: A total of 281 patients (245 male, mean age 72.1 ± 7.7 years) were treated. The mean aneurysm diameter was 60.2 ± 9.3 mm and median proximal neck length 2 mm (range 0-10 mm). Technical success was 96.8% (272/281). Technical failure included one intra-operative death due to embolization and cardiac arrest, one open conversion due to iliac rupture, and seven target vessel complications. The thirty day mortality was 0.7% (2/281). Mean follow up was 21 ± 15.9 months. Estimated survival at 1 and 3 years was 94.7% ± 1.6% and 84.6% ± 3.0%, respectively. Estimated freedom from re-intervention at 1 and 3 years was 96.1% ± 1.4%, and 90% ± 2.7%. Estimated target vessel stent patency at 1 and 3 years was 98.6% ± 0.5%, and 98.1% ± 0.6%, respectively. Mean aneurysm sac diameter decreased from 60.2 ± 9.3 mm pre-operatively to 53.2 ± 12.8 mm (p < .001). CONCLUSIONS: FEVAR as a first line strategy was associated with high technical success and a low operative mortality rate. Efficacy and durability in the mid-term appear very good, with significant regression of aneurysm sac diameter, high target vessel patency, and acceptable rate of re-intervention.

Editor's Choice - Effect of Branch Stent Choice on Branch-related Outcomes in Complex Aortic Repair.

OBJECTIVES: The use of branched stent grafts for the treatment of thoracoabdominal aneurysms [TAAA] is increasing, but mating stent graft choice has not been studied. This study combined experience of five high volume centres to assess a preferred mating stent. METHODS: Data from five centres were retrospectively combined. Patients were included if they underwent stent graft for treatment of TAAA that used only branches to mate with visceral and renal vessels. All patients with fenestrations in their device were excluded. Perioperative details, reintervention, occlusion, and death were recorded. Outcome of occlusion or reintervention, as well as a composite outcome of any death, occlusion, or reintervention was planned using a per-patient, and per-branch analysis. RESULTS: In 235 included patients, there were 940 vessels available for placement of mating stent. The average age of included patients was 70 years (SD 7.9), and 179 of the 235 were male. Medical comorbidities included diabetes in 29/234 (12.4%), current smoker in 81/233 (34.8%), and COPD in 77/234 (32.9%). The primary stent deployed was self-expanding in 556 branches, balloon expandable in 231 branches, and was unknown in 92 branches. After a mean of 20.7 months (SD 25) follow-up, there have been 44 incidents of occlusion or reintervention, of which 40 culprit stents are known. Where the stent placed is known, the event rate in renal branches (35/437, 8%) is higher than that of visceral branches (8/443, 1.8%). There is no difference in occlusion or reintervention between self-expanding and balloon expandable stents (HR 0.95, p = .91) but there is a statistically significant difference between renal and visceral artery occlusions (HR 3.51, p = 0.001). CONCLUSION: There appears to be no difference in occlusion or reintervention rate for branch vessels mated with balloon expandable compared with self-expanding stents. Renal events appear to outnumber visceral events in this population.

Stent Graft Dislocation after EVAR Treated with an Endostapling Fixation System.

Stent-graft migration and type I endoleak are major complications after endovascular aneurysm repair (EVAR). We present a case of an 88-year-old female patient with a 56-mm-diameter progredient infrarenal AAA, with severely angulated proximal aneurysm neck and iliac arteries. EVAR was performed using a Gore Excluder stent-graft. -Computed tomography angiography (CTA) at one week postoperatively demonstrated a dislocation of the stent-graft and a proximal Type I endoleak. Placement of a proximal cuff with the use of 6 endostaples resulted in proximal neck seal and exclusion of the endoleak. CTA 2 years postoperatively showed no signs of a proximal type I endoleak. Use of an endostapling fixation system is a viable treatment option in cases of stent-graft dislocation resulting from angulation of the proximal neck.

Percutaneous endovascular thrombosuction for acute lower limb ischemia: a 5-year single center experience.

AIM: The aim of this paper was to report a 5-year single center experience with the use of percutaneous endovascular thrombosuction (PET) for acute lower limb ischemia (ALLI). METHODS: All patients that underwent PET for ALLI within the period January 2009-December 2013 in our institution were included. Data were collected retrospectively. RESULTS: A total of 262 patients (132 female, mean age 74.5±11 years) were treated. Level of severity of ALLI preoperatively was stratified as class I (viable) in 76% (199/262) of patients, class IIa (threatened marginally) in 19.4% (51/262), and class IIb (threatened immediately) in 4.6% (12/262). Initial technical success was 91% (237/262). Additional PTA was performed in 29.8% (78/262) of patients, and PTA with stenting in 27.5% (72/262). Open surgery due to technical failure of PET was required in 4.2% (11/262) of patients. Thirty-day mortality was 4.6% (12/262). Perioperative complications occurred in 9.2% (24/262). Thirty-day amputation rate was 3.8% (10/262). The mean duration of follow-up was 26.2±16 months. Estimated cumulative survival was 84.2±2.5% at 1 year, and 73.7±3.6% at 3 years. Estimated freedom from amputation during follow-up was 92.4±1.8% at 1 year, and 91.2±2% at 3 years. Estimated freedom from reintervention was 90.4±2% at 1 year, and 80±3.7% at 3 years. CONCLUSION: PET in selected patients with ALLI provides high initial technical success, low mortality and morbidity rates, and favorable early and mid-term limb salvage rates.

Editor's Choice - Ten-year Experience with Endovascular Repair of Thoracoabdominal Aortic Aneurysms: Results from 166 Consecutive Patients.

OBJECTIVE: To present a 10 year experience with endovascular thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated and branched stent grafts. MATERIALS AND METHODS: Consecutive patients with TAAA treated with fenestrated and branched stent grafts within the period January 2004-December 2013. Data were collected prospectively. RESULTS: 166 patients (125 male, 41 female, mean age 68.8 ± 7.6 years) were treated. The mean TAAA diameter was 71 ± 9.3 mm. Types of TAAA were: type I, n = 12 (7.2%), type II, n = 50 (30.1%), type III, n = 53 (31.9%), type IV, n = 41 (24.8%), and type V, n = 10 (6%). Fifteen (9%) patients had an acute TAAA (11 contained rupture, 4 symptomatic). One hundred and eight (65%) patients were refused for open surgery earlier. Seventy eight (47%) patients had previously undergone one or more open/endovascular aortic procedures. Technical success was 95% (157/166). Thirty day operative mortality was 7.8% (13/166), with an in hospital mortality of 9% (15/166). Peri-operative spinal cord ischemia (SCI) was observed in 15 patients (9%), including permanent paraplegia in two (1.2%). Mean follow up was 29.2 ± 21 months. During follow up 40 patients died, two of them probably from aneurysm related cause. Re-intervention, mostly by endovascular means, was needed in 40 (24%) patients. Estimated survival at 1, 2, and 5 years was 83% ± 3%, 78% ± 3.5%, and 66.6% ± 6.1%, respectively. Estimated target vessel stent patency at 1, 2, and 5 years was 98% ± 0.6%, 97% ± 0.8%, and 94.2% ± 1.5%, respectively. Estimated freedom from re-intervention at 1 and 3 years was 88.3% ± 2.7%, and 78.4% ± 4.5%, respectively. CONCLUSIONS: Endovascular repair of TAAA with fenestrated and branched stent grafts in high volume centers appears safe and effective in the mid-term in a high risk patient cohort. A considerable reintervention rate should be acknowledged, however.

Exploring the relationship of autonomic and endocrine activity with social functioning in adults with autism spectrum disorders.

Several studies indicate that autonomic and endocrine activity may be related to social functioning in individuals with autism spectrum disorder (ASD), although the number of studies in adults is limited. The present study explored the relationship of autonomic and endocrine activity with social functioning in young adult males with ASD compared to young adult males without ASD. Autonomic and endocrine activity (i.e. heart rate, heart rate variability and salivary cortisol) were measured during rest and social interaction. No differences in heart rate, heart rate variability and cortisol between both groups were found during rest and social interaction. Repeated measures ANOVA's indicate a main effect of time for heart rate and cortisol, indicating an increase in these measures for both groups. An interaction effect between time and group was found for heart rate, with the ASD group showing a blunted increase in heart rate from rest to social interaction as compared to those without ASD. Future research should focus on replicating the present findings with larger sample sizes which also enables assessing inter-individual variability in autonomic and endocrine activity in relation to social functioning.

Common iliac and hypogastric aneurysms: open and endovascular repair.

Currently, there are a variety of open surgical, endovascular, and hybrid options to treat iliac artery aneurysms (IAA). Anatomy of the common iliac artery (CIA) with regard to proximal and distal neck, involvement of the iliac bifurcation, and choice to preserve the ipsilateral internal iliac artery (IIA) all play a role in the decision process towards the preferred treatment method. This manuscript describes the available open surgical and endovascular techniques for the treatment of IAA. Indications, advantages and limitations, and outcomes of each technique are discussed.

Endostaples: are they the solution to graft migration and Type I endoleaks?

Effective proximal sealing, especially in the long-term, remains a limitation of contemporary endovascular aortic aneurysm repair (EVAR). Endostaples that fixate the proximal stent-graft to the aortic neck wall, aiming for better apposition and proximal sealing have been recently introduced in clinical practice to address this problem. Initial experimental studies have shown that endostaples can increase proximal stent-graft fixation to levels equivalent or superior to that of a hand-sewn anastomosis. Further clinical studies aimed to investigate whether this increased proximal fixation results in reduced migration and better sealing with lower rates of type I endoleak. The present chapter discusses the efficacy of endostaples in reducing migration and type I endoleak after EVAR, based on published clinical data.

Outcomes of fenestrated/branched endografting in post-dissection thoracoabdominal aortic aneurysms.

OBJECTIVES: Fenestrated/branched thoracic endovascular repair (F/Br-TEVAR) is increasingly applied for atherosclerotic thoracoabdominal aortic aneurysm (TAAA); however, use in post-dissection TAAAs is still very limited. Experience with F/Br-TEVAR in the treatment of post-dissection TAAA is presented. METHODS: Data were analysed from prospectively maintained databases including all patients with post-dissection TAAAs that underwent F/Br-TEVAR within the period January 2010 to July 2013 in two vascular institutions. Evaluated outcomes included initial technical success, operative mortality and morbidity, late survival, endoleak, aneurysm diameter regression, renal function, and reintervention during follow-up (FU). RESULTS: A total of 31 patients (25 male, mean age 65 ± 11.4 years) were treated. Technical success was 93.5% and 30-day mortality 9.6%. Temporary spinal cord ischaemia occurred in four (12.6%) patients, with no case of permanent paraplegia. Mean FU was 17.0 ± 10 months. There were seven late deaths, all aneurysm unrelated. Estimated overall survival rates were 83.9 ± 6.7, 76.4 ± 7.9 and 71.6 ± 8.7% at 6, 12, and 18 months, respectively. Impairment of renal function occurred in two (6.4%) patients. Endoleaks were diagnosed in 12 patients during FU, including six type IB endoleaks and six type II endoleaks. Reintervention was required in seven (22.5%) patients. Mean aneurysm sac regression was 9.3 ± 8.7 mm, with a false lumen thrombosis rate of 66.7% and 88.2% for patients with a FU longer than 6 and 12 months respectively. CONCLUSIONS: F/Br-EVAR is feasible for patients with a post-dissection TAAA. Although associated with additional technical challenges, and a significant need for reintervention, it leads to favourable aneurysm morphologic changes, and may play a more prominent role in the future for this type of pathology if long-term results confirm the good initial outcome.