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.

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.

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.

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.

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.

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.

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.

The new C3 Gore Excluder stent-graft: single-center experience with 100 patients.

OBJECTIVES: To present results from the first 100 patients treated with the new C3 Gore Excluder stent-graft in a single institution. METHODS: All patients treated with the C3 Excluder stent-graft between August 2010 and July 2013 in our institution were included. Patient demographics, treatment indication, need for intraoperative stent-graft repositioning, immediate technical success, survival, endoleak and migration rate, and need for reintervention during follow-up were analyzed. RESULTS: A total of 100 patients (86% male, mean age 71.1 ± 9.3 years) were enrolled. Elective abdominal aortic aneurysm (AAA) was the most common indication for treatment (n = 90), followed by common iliac artery aneurysm (n = 5), ruptured AAA (n = 2), type Ia endoleak (n = 1), and type IV endoleak (n = 1) after prior EVAR, and penetrating aortic ulcer (n = 1). Technical success was achieved in 98 patients. In two patients a small type I endoleak persisted at completion angiography, but had disappeared at the first control computed tomography angiogram. Stent-graft repositioning after initial deployment was required in 49 patients, almost equally distributed for level and contralateral gate reorientation. Exact positioning of the proximal trunk was achieved in 98 patients, with the remaining two cases within 5 mm of the intended location. Adverse events related to repositioning maneuvers were noticed in two cases. Mean follow-up duration was 12.2 ± 9.4 months (range 0-36 months). Eight patients died, none from aneurysm related causes. Cumulative patient survival was 96.2 ± 2.1% at 1 year, and 84 ± 6.1% at 2 years, respectively. No migration, or type I or III endoleak was detected during follow-up. Estimated freedom from reintervention was 96 ± 2.4% at 1 year, and 91 ± 5.2% at 2 years, respectively. CONCLUSIONS: The new C3 Excluder stent-graft provides excellent short-term outcomes and offers important advantages in terms of stent-graft repositioning to achieve high proximal deployment accuracy. Longer follow-up is required to confirm improved long-term outcome compared with the previous generation Excluder stent-graft.

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.

Real-world performance of the new C3 Gore Excluder stent-graft: 1-year results from the European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT).

OBJECTIVES: The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) provides "real-world" outcomes for the new C3 Gore Excluder stent-graft, and evaluates the new deployment mechanism. This report presents the 1-year results from 400 patients enrolled in this registry. METHODS: Between August 2010 and December 2012, 400 patients (86.8% male, mean age 73.9 ± 7.8 years) from 13 European sites were enrolled in this registry. Patient demographics, treatment indication, case planning, operative details including repositioning and technical results, and clinical outcome were analyzed. RESULTS: Technical success was achieved in 396/400 (99%) patients. Two patients needed intraoperative open conversion, one for iliac rupture, the second because the stent-graft was pulled down during a cross-over catheterization in an angulated anatomy. Two patients required an unplanned chimney renal stent to treat partial coverage of the left renal artery because of upward displacement of the stent-graft. Graft repositioning occurred in 192/399 (48.1%) patients, most frequently for level readjustment with regard to the renal arteries, and less commonly for contralateral gate reorientation. Final intended position of the stent-graft below the renal arteries was achieved in 96.2% of patients. Thirty-day mortality was two (0.5%) patients. Early reintervention (≤30 days) was required in two (0.5%) patients. Mean follow-up duration was 15.9 ± 8.8 months (range 0-37 months). Late reintervention (>30 days) was required in 26 (6.5%) patients. Estimated freedom from reintervention at 1 year was 95.2% (95% CI 92.3-97%), and at 2 years 91.5% (95% CI 86.8-94.5%). Estimated patient survival at 1 year was 96% (95% CI 93.3-97.6%) and at 2 years 90.6% (95% CI 85.6-93.9%). CONCLUSIONS: Early real-world experience shows that the new C3 delivery system offers advantages in terms of device repositioning resulting in high deployment accuracy. Longer follow-up is required to confirm that this high deployment accuracy results in improved long-term durability.

Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial.

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair.

OBJECTIVES: To review our experience with fenestrated endovascular aneurysm repair (F-EVAR) to treat complications after previous standard infrarenal endovascular aneurysm repair (EVAR). METHODS: A prospectively maintained database including all consecutive patients with juxtarenal abdominal aortic aneurysm that were treated with F-EVAR after failed previous EVAR within the period March 2002 to November 2012 at the University Medical Center of Groningen, Netherlands (up to October 2009), and the Klinikum Nürnberg Süd, Germany (from November 2009) was analyzed. Evaluated outcomes included initial technical success, operative mortality and morbidity, and late procedure-related events with regard to survival, target vessel patency, endoleak, renal function, and reintervention. RESULTS: A total of 26 patients (24 male, mean age 73.2 ± 6.5 years) were treated. All patients had proximal anatomies precluding endovascular reintervention with standard techniques. In 23 patients a fenestrated proximal cuff was used, and in three patients a bifurcated fenestrated stent graft. Technical success was achieved in 24 (92.3%) patients. One patient required on-table open conversion because of impossibility to retrieve the top cap as a result of twist of the ipsilateral limb. In the second patient the right kidney was lost due to inadvertent stenting in a smaller branch of the renal artery. Catheterization difficulties, all related to the passage through the limbs or struts of the previous stent graft, were encountered in 11 (42.3%) cases, including five (19.2%) patients with iliac access problems and six (23.1%) with challenging renal catheterization. Operative target vessel perfusion success rate was 94.6% (70/74). Operative mortality was 0%. Mean follow-up was 26.8 ± 28.5 months. No proximal type I endoleak was present on first postoperative CTA. The mean aneurysm maximal diameter decreased from 73 ± 20 mm to 66.7 ± 21 mm (p < .05). There were six late deaths, one of them aneurysm related. Estimated survival rates at 1 and 2 years were 94.1 ± 5.7% and 87.4 ± 8.4%, respectively. Patency during follow-up for the target vessels treated successfully with a fenestrated stent graft was 100% (70/70). Reintervention was required in four cases, including one acute conversion due to rupture, one for iliac limb occlusion and two for type Ib and II endoleak. Renal function deterioration was observed solely in the two cases of primary technical failure. CONCLUSIONS: F-EVAR represents a feasible option for the repair of juxtarenal abdominal aortic aneurysm after prior EVAR failure. It is advantageous in terms of mortality and less morbid than open surgery, but is associated with increased technical challenges because of the previously placed stent graft. Outcome seems related to initial technical success.

[Hybrid operating rooms: only for advanced endovascular procedures?]. / Angio-Hybrid-Operationsraum: Grundvoraussetzung nur für komplexe endovaskuläre Eingriffe?

The evolution of endovascular techniques has led to the concept of the "hybrid operating room" (hybrid OR). A hybrid OR combines the sterility of an OR in an operating theatre environment with a high-quality fixed imaging system. On the basis of these advantages it would be desirable that an angio-hybrid OR becomes a standard requirement for endovascular surgery. In Great Britain guidelines have already been published that require a hybrid OR even for normal endovascular management of the infrarenal aorta. However, in Germany there are no guidelines from professional societies or formal rules from the federal joint committee, thus in this article a classification of endovascular procedures according to their complexity and the necessary infrastructures are proposed in order to define particular procedures that should only be performed in an angio-hybrid OR. According to our experience, endovascular procedures can be classified into four categories based on their complexity and the requirements regarding fluoroscopy: level 1: standard EVAR, TEVAR, iliac and popliteal artery procedures; level 2: iliac branched (IBD) and standard (2 fenestrations for the renal arteries and a scallop for the superior mesenteric artery) fenestrated stent-grafting; level 3: more complex fenestrated procedures (three or four fenestrations); and level 4: branched stent-grafting for TAAA. At this moment it is still acceptable to perform level 1 and level 2 procedures outside of a hybrid OR. In our opinion, it is not recommended to perform level 3 and level 4 endovascular procedures without a hybrid OR.

ADSORB: a study on the efficacy of endovascular grafting in uncomplicated acute dissection of the descending aorta.

Acute dissection of the descending thoracic aorta carries a 30-day mortality of around 10% with best medical treatment (BMT). In addition, about 25% will develop an aneurysm during the following 4-5 years. This is the first ever randomised trial on acute dissections comparing BMT with BMT and stent grafting of the proximal tear in patients having an uncomplicated acute dissection of the descending aorta. The commonly used temporal definition of acute dissection being within 14 days of onset of symptoms is applied. A total of 61 patients will be randomised and followed at regular intervals (1, 3, 6, 12, 18, 24, 30 and 36 months) after acute dissection. Thrombosis of the false lumen, aortic enlargement and rupture are the primary end points. The study will examine whether aortic remodelling occurs after stent grafting in acute type B dissections, and its effect on aneurysm formation, rupture and re-intervention.

Is it time to eliminate CT after EVAR as routine follow-up?

Growing concerns regarding radiation exposure, contrast induced nephropathy and increasing costs lead us to reconsider the necessity of CTA for all EVAR patients. The purpose of this study is to compare the results of different follow-up imaging modalities with the aim of finding a rationale to the optimal follow-up imaging protocol. We reviewed recent literature regarding post EVAR imaging modalities and compared it to our experience with different follow-up protocols. Modalities compared were CTA, DUS, CEUS, and plain abdominal X-ray with regard to detection of complications, cost, overall impact to the patient, and on decision making regarding reintervention. CTA is related to increased follow-up costs and a much higher exposure to radiation compared to other modalities. The cumulative radiation dose can have a significant impact on the attributable lifetime cancer risk of patients. Renal function deterioration during post EVAR follow-up is higher compared to open repair. Plain abdominal X-ray is the best manageable modality and a well established tool in documenting migration kinking and stent fracture. Plain X-Ray cannot be used as a standalone imaging modality since it doesn't allow direct detection of endoleaks. As far as detection of endoleaks is concerned recent meta-analyses show a sensitivity of 66-77% for DUS and 81-98% for CEUS, respectively. Most endoleaks missed by DUS and CEUS are type II endoleaks with no need for reintervention. Our data in a cohort of 62 patients do show a sensitivity of 66.7% for DUS, and do correlate with current literature. No endoleaks requiring reintervention were missed. A follow-up protocol comprising of DUS/CEUS and plain abdominal X-ray gives a wide range of information covering EVAR related risks and is associated with less radiation exposure, avoidance of renal function deterioration due to repeated contrast agent application and an important decrease in the cost of EVAR follow-up. CTA should be reserved for cases of inconclusive ultrasound, signs of complications and unfavourable anatomy.