Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians

ObjectiveThis study determined outcome and quality of life (QOL) in octogenarians, compared with patients aged <80 years, 1 year after endovascular aortic aneurysm repair (EVAR).MethodsFrom March 2009 until April 2011, 1263 patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) registry with an abdominal aortic aneurysm were treated with EVAR using the Endurant endograft (Medtronic Cardiovascular, Santa Rosa, Calif). The patients were grouped according to those aged ≥80 years (290 [22.9%]) and those aged <80 years (973 [77.1%]) at the time of the procedure. QOL was assessed using composite EuroQoL 5-Dimensions Questionnaire (EQ-5D) index scores. Baseline, perioperative, and follow-up data were analyzed at 1 year.ResultsOctogenarians had poorer anatomic characteristics. The technical success rate was almost 99% for both cohorts, with no deaths. The duration of the implant procedure was significantly longer in the elderly patients (P = .002), with significant differences in overall (P < .001) and postprocedure (P < .001) hospital stays in favor of the younger group. At 1 year, there was a significant difference in all-cause mortality (P = .002) and in the number of major adverse events (P = .003), including secondary rupture (P = .01), to the detriment of octogenarians. There were no significant differences in conversion to open surgery or in overall secondary endovascular procedures. The octogenarians scored lower in their overall health care perception (P < .001) but with no significant difference in the EQ-5D index. Compared with the group aged <80 years, they had still not completely recovered their QOL after 1 year (P = .01).ConclusionsOctogenarians are more difficult to treat by EVAR than younger patients due to poorer anatomic suitability and a higher incidence of complications. Recovery of QOL in octogenarians takes longer (>12 months) than expected

A systematic review of anatomic predictors of abdominal aortic aneurysm remodeling after endovascular repair

Objective: The long-term outcomes after endovascular abdominal aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) have been inferior to those after open surgical repair with regard to reinterventions and late mortality. AAA sac remodeling after EVAR has been associated with endoleaks, reinterventions, and mortality. Therefore, knowledge of the predictors of AAA sac remodeling could indirectly give insight into the long-term EVAR outcomes. In the present review, we aimed to provide an overview of the evidence for anatomic predictors of positive and negative AAA sac remodeling after EVAR. Methods: A systematic literature review and analysis were conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) and Cochrane guidelines. The PubMed and Scopus databases were searched using terms of AAA sac growth, shrinkage, and remodeling. Eligible studies were identified, and only those studies that had included currently used endografts were included. Results: A total of 19 studies that had reported on a total of 27 anatomic parameters of the aortoiliac anatomy were included. Only 4 parameters had been investigated by more than five studies, 7 parameters were investigated by three to five studies, 7 parameters were investigated by two studies, and 9 parameters were investigated by one study. For the presence of neck thrombus, three of four studies had reported similar results, indicating that the presence of neck thrombus might predict for less AAA sac shrinkage. AAA thrombus, the total AAA volume, the flow-lumen volume, aortic calcification, and the number of hostile neck parameters were only investigated by two to three studies. However, these parameters seemed promising for the prediction of sac remodeling. For hostile neck anatomy, neck length, infrarenal neck angulation, and patency of the inferior mesenteric artery, no significant association with any category of AAA sac remodeling was found. Conclusions: The present review demonstrates neck thrombus, AAA thrombus, number of hostile neck parameters, total AAA volume, AAA flow-lumen volume, and aortic calcification as important anatomic features that are likely to play a role in AAA remodeling after endovascular repair and should be further explored using advanced imaging techniques. We also found that strong, consistent evidence regarding the anatomic predictors of AAA sac remodeling after EVAR is lacking. Therefore, further research with large patient groups for a broad range of predictors of AAA sac change after EVAR is needed to complement the current gap in the evidence

Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair

Introduction The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). Methods A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. Results A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate &gt;10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth &gt;5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was &gt;50%. Conclusion There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.</p

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA):Study protocol for a randomized controlled trial

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT0193616

Survival After Endovascular Aneurysm Sealing Compared With Endovascular Aneurysm Repair

Introduction Endovascular aneurysm sealing (EVAS) is a sac-filling device with a blunted systemic inflammatory response compared to conventional endovascular aneurysm repair (EVAR), with a suggested impact on all-cause mortality. This study compares mortality after both EVAS and EVAR. Materials and Methods This is a retrospective observational study including data from 2 centres, with ethical approval. Elective procedures on asymptomatic infrarenal aneurysms performed between January 2011 until April 2018 were enrolled. Laboratory values (serum creatinine, haemoglobin, white blood cell count, platelet count) were measured pre- and postoperatively and at 1 and 2 years, respectively. Mortality and cause of death were recorded during follow-up. Results A total of 564 patients were included (225 EVAS, 369 EVAR), after propensity score matching there were 207 patients in both groups. Baseline characteristics were similar, except for larger neck angulation and more pulmonary disease in the EVAR group. The median follow-up time was 49 (EVAS) and 44 (EVAR) months. No significant differences regarding creatinine and haemoglobin were observed. Preoperative white blood cell count was higher in the EVAR group (p=0.011), without significant differences during follow-up. Median platelet count was lower in the EVAR group preoperatively (p=0.001), but was significantly higher at 1 year follow-up (p=0.003). There were 43 deaths within the EVAS group (20.8%) and 52 within the EVAR group (25.1%) (p=0.293). Of these, 4 were aneurysm related (EVAS n=3, EVAR n=1; p=0.222) and 14 cardiovascular (EVAS n=6, EVAR n=8, p=0.845). For the EVAS cohort, survival was 95.5% at 1 year and 74.9% at 5 years. For the EVAR cohort, this was 93.3% at 1 year and 75.5% at 5 years. No significant differences were observed in causes of death. Conclusion This study showed comparable survival rates through 5 years between EVAS and EVAR with a tendency toward higher inflammatory response in the EVAR patients through the first 2 years

Incidence and predictive factors for endograft limb patency of the fenestrated Anaconda endograft used for complex endovascular aneurysm repair

Objective: In the present study, we have described the incidence, risk factors, and outcomes of treatment of limb occlusion for patients who had undergone treatment of complex thoracoabdominal aortic aneurysms with the fenestrated Anaconda endograft (Terumo Aortic, Inchinnan, UK). Methods: Between June 2010 and May 2018, 335 patients had undergone elective fenestrated aortic aneurysm repair at 11 participating centers using the fenestrated Anaconda endograft with a median follow-up of 14.3 months (interquartile range, 27.4 months). The primary outcome measure was freedom from limb occlusion. The secondary outcome measures were freedom from limb-related reintervention, secondary patency, and the risk factors associated with limb occlusion. Results: Of the 335 patients, 30 (9.0%) had presented with limb occlusion during follow-up with a freedom from limb occlusion rate of 98.5%, 91.2%, and 81.7% at 30 days and 1 and 5 years, respectively. In 87% of the cases, no obvious cause for limb occlusion was documented. Primary occlusion had occurred within 30 days in 36.7% and within 1 year in 80.0%. Of the 30 patients, 23 (77%) had undergone an occlusion-related reintervention and 7 (23.3%) had been treated conservatively. The freedom from limb occlusion-related reintervention at 30 days and 1 and 5 years was 97.8%, 93.2%, and 88.6%, respectively. Secondary patency was 91.3% after 1 month and 86.2% after 1 and 5 years. Female sex (odds ratio [OR], 3.27; 95% confidence interval [CI], 1.28-8.34; P = .01) was a statistically significant predictor for limb occlusion. A greater proportion of thrombus in the aneurysm sac appeared to be protective for limb occlusion (0% vs 50%: OR, 0.08; 95% CI, 0.020.38; P = .00), as did iliac angulation (OR, 0.99; 95% CI, 0.98-1.00; P = .04). Conclusions: Limb occlusion remains a significant impediment of endograft durability for patients treated with the fenestrated Anaconda endograft, especially for female patients. In contrast, a high aneurysmal thrombus load and a high degree of iliac angulation appeared to be protective for limb occlusion, for which no obvious cause could be identified