***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To assess the efficacy of endovascular aneurysm repair ( EVAR ) against st and ard alternative management in patients with large abdominal aortic aneurysm ( AAA ) . DESIGN Two national , multicentre r and omised trials - EVAR trials 1 and 2 . SETTING Patients were recruited from 38 out of 41 eligible UK hospitals . PARTICIPANTS Men and women aged at least 60 years , with an AAA measuring at least 5.5 cm on a computerised tomography scan that was regarded as anatomically suitable for EVAR , were assessed for fitness for open repair . Patients considered fit were r and omised to EVAR or open repair in EVAR trial 1 and patients considered unfit were r and omised to EVAR or no intervention in EVAR trial 2 . INTERVENTIONS EVAR , open repair or no intervention . MAIN OUTCOME MEASURES The primary outcome was mortality ( operative , all-cause and AAA related ) . Patients were flagged at the UK Office for National Statistics with central ly coded death certificates assessed by an Endpoints Committee . Power calculations based upon mortality indicated that 900 and 280 patients were required for EVAR trials 1 and 2 , respectively . Secondary outcomes were graft-related complications and re interventions , adverse events , renal function , health-related quality of life and costs . Cost-effectiveness analyses were performed for both trials . RESULTS Recruitment occurred between 1 September 1999 and 31 August 2004 , with targets exceeded in both trials : 1252 r and omised into EVAR trial 1 ( 626 to EVAR ) and 404 r and omised into EVAR trial 2 ( 197 to EVAR ) . Follow-up closed in December 2009 with very little loss to follow-up ( 1 % ) . In EVAR trial 1 , 30-day operative mortalities were 1.8 % and 4.3 % in the EVAR and open-repair groups , respectively : adjusted odds ratio 0.39 [ 95 % confidence interval ( CI ) 0.18 to 0.87 ] , p = 0.02 . During a total of 6904 person-years of follow-up , 524 deaths occurred ( 76 AAA related ) . Overall , there was no significant difference between the groups in terms of all-cause mortality : adjusted hazard ratio ( HR ) 1.03 ( 95 % CI 0.86 to 1.23 ) , p = 0.72 . The EVAR group did demonstrate an early advantage in terms of AAA-related mortality , which was sustained for the first few years , but lost by the end of the study , primarily due to fatal endograft ruptures : adjusted HR 0.92 ( 95 % CI 0.57 to 1.49 ) , p = 0.73 . The EVAR procedure was more expensive than open repair ( mean difference £ 1177 ) and not found to be cost-effective , but the model was sensitive to alternative assumptions . In EVAR trial 2 , during a total of 1413 person-years of follow-up , a total of 305 deaths occurred ( 78 AAA related ) . The 30-day operative mortality was 7.3 % in the EVAR group . However , this group later demonstrated a significant advantage in terms of AAA-related mortality , but this became apparent only after 4 years : overall adjusted HR 0.53 ( 95 % CI 0.32 to 0.89 ) , p = 0.02 . Sadly , this advantage did not result in any benefit in terms of all-cause mortality : adjusted HR 0.99 ( 95 % CI 0.78 to 1.27 ) , p = 0.97 . Overall , EVAR was more expensive than no intervention ( mean difference £ 10,222 ) and not found to be cost-effective . CONCLUSIONS EVAR offers a clear operative mortality benefit over open repair in patients fit for both procedures , but this early benefit is not translated into a long-term survival advantage . Among patients unfit for open repair  , EVAR is associated with a significant long-term reduction in AAA-related mortality but this does not appear to influence all-cause mortality . TRIAL REGISTRATION Current Controlled Trials IS RCT N 55703451 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 16 , No. 9 . See the HTA programme website for further project information OBJECTIVE This study assessed preliminary results of the Ventana Fenestrated System ( Endologix , Irvine , Calif ) as an off-the-shelf integrated device for juxtarenal aortic aneurysm ( JAA ) or pararenal aortic aneurysm ( PAA ) endovascular repair . METHODS From November 2010 to April 2012 , seven centers enrolled 31 patients with JAAs or PAAs in an international clinical trial of the Ventana Fenestrated System .  Clinical and laboratory evaluations were done predischarge and at 1 month , with continuing follow-up through 5 years . Core laboratory computed tomography imaging assessment s were performed at 1 month and at each subsequent follow-up . RESULTS Patients ( mean age , 73 years ; 90 % male ) presented with mean aneurysm sac diameter of 6.0 cm . One patient with a short , reversed tapered infra-superior mesenteric artery ( SMA ) neck was enrolled under a protocol waiver . Among the 31 patients , one of five Ventana device models was used to preserve main renal arteries , the SMA , and celiac arteries ; 20 patients ( 65 % ) received the same Ventana device ( aligned fenestrations , 28-mm diameter ) . Median fluoroscopy and procedure times were 49 and 197 minutes , respectively ; median hospital length of stay was 3.0 days . The 1-month clinical success rate was 94 % ( 29 of 31 ) , with no perioperative mortality . One intervention on day 26 was done to resolve limb kink/occlusion . A type IA endoleak and renal occlusion secondary to procedural device damage led to a reintervention on day 52 and dialysis at 5 months . During follow-up to 23 months , three non-aneurysm-related deaths occurred . No aneurysm rupture or conversion to open repair has occurred . One late migration with endoleak and covered renal stent fracture/occlusion occurred at 8 months in the patient with a short , reverse tapered infra-SMA neck performed under a protocol waiver , which was managed successfully with bilateral renal bypasses and endovascular repair of the endoleak . Another patient underwent late endovascular interventions to resolve bilateral renal stenosis . CONCLUSIONS The multicenter experience of the Ventana Fenestrated System supports its safety and early-term to midterm effectiveness for the endovascular repair of JAAs and PAAs . This off-the-shelf integrated system permits endovascular treatment of JAAs or PAAs ; however , further exp and ed clinical experience and longer-term follow-up are needed to more fully assess this device system PURPOSE This study aims to evaluate the medium-term outcomes following aortic aneurysm repair using  fenestrated endografts performed in 16 French academic centres . MATERIAL S AND METHODS A retrospective analysis of prospect ively collected data was carried out . This study included all patients treated with fenestrated endografts in France between May 2004 and January 2009 . Patients were judged to be at high risk for open surgical repair .  Fenestrated endografts were design ed using computed tomography ( CT ) reconstructions performed on three-dimensional ( 3D ) workstations . All patients were evaluated with CT , duplex ultrasound and plain film radiograph at discharge , 6 , 12 , 18 and 24 months , and annually thereafter . RESULTS A total of 134 patients ( 129 males ) were treated over the study period . Median age and aneurysm size were 73 years ( range 48 - 91 years ) and 56 mm ( range 45 - 91 mm ) , respectively . A total of 403 visceral vessels were perfused through a fabric fenestration , including 265 renal arteries . One early conversion to open surgery was required . Completion angiography and discharge CT scan showed that 398/403 ( 99 % ) and 389/394 ( 99 % ) respective target vessels were patent . The 30-day mortality rate was 2 % ( 3/134 ) . Pre-discharge imaging identified 16 ( 12 % ) endoleaks : three type I , 12 type II and one type III . After the procedure , transient or permanent dialysis was required in four ( 3 % ) and two ( 1 % ) patients , respectively . The median duration of follow-up was 15 months ( range 2 - 53 months ) . No aneurysms ruptured or required open conversion during the follow-up period . Twelve of 131 patients ( 9 % ) died during follow-up ( actuarial survival at 12 and 24 months : 93 % and 86 % , respectively ) . Median time from procedure to death was 15 months . None of these deaths were aneurysm related . Aneurysm sac size decreased by more than 5 mm in 52 % , 65.6 % and 75 % of patients at 1 , 2 and 3 years , respectively . Three ( 4 % ) patients had sac enlargement within the first year , associated with a persistent endoleak . During follow-up , four renal artery occlusions were detected . A total of 12 procedure-related re- interventions were performed in 12 patients during follow-up , including six to correct endoleaks , and five to correct threatened visceral vessels . CONCLUSIONS The use of endovascular prostheses with graft material incorporating the visceral arteries is safe and effective in preventing rupture in the medium term . A predictable high mortality rate was depicted during follow-up in this high-risk cohort . Meticulous follow-up to assess sac behaviour and visceral ostia is critical to ensure optimal results BACKGROUND Short-term survival benefits of endovascular aneurysm repair ( EVAR ) compared with open repair ( OR ) of intact abdominal aortic aneurysms have been shown in r and omised trials , but this early survival benefit is soon lost . Survival benefit of EVAR was unclear at follow-up to 10 years . OBJECTIVE To assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures ( EVAR trial 1 ; EVAR-1 ) ; and against no intervention in patients unfit for OR ( EVAR trial 2 ; EVAR-2 ) . To appraise the long-term significance of type II endoleak and define criteria for intervention . DESIGN Two national , multicentre r and omised controlled trials : EVAR-1 and EVAR-2 . SETTING Patients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004 . PARTICIPANTS Men and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm ( as identified by computed tomography scanning ) , anatomically suitable and fit for OR were r and omly assigned 1 : 1 to either EVAR ( n = 626 ) or OR ( n = 626 ) in EVAR-1 using computer-generated sequences at the trial hub . Patients considered unfit were r and omly assigned to EVAR ( n = 197 ) or no intervention ( n = 207 ) in EVAR-2 . There was no blinding . INTERVENTIONS EVAR , OR or no intervention . MAIN OUTCOME MEASURES The primary end points were total and aneurysm-related mortality until mid-2015 for both trials . Secondary outcomes for EVAR-1 were re interventions , costs and cost-effectiveness . RESULTS In EVAR-1 , over a mean of 12.7 years ( st and ard deviation 1.5 years ; maximum 15.8 years ) , we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [ adjusted hazard ratio ( HR ) 1.11 , 95 % confidence interval ( CI ) 0.97 to 1.27 ; p = 0.14 ] . At 0 - 6 months after r and omisation , patients in the EVAR group had a lower mortality ( adjusted HR 0.61 , 95 % CI 0.37 to 1.02 for total mortality ; HR 0.47 , 95 % CI 0.23 to 0.93 for aneurysm-related mortality ; p = 0.031 ) , but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality ( adjusted HR 1.25 , 95 % CI 1.00 to 1.56 , p = 0.048 for total mortality ; HR 5.82 , 95 % CI 1.64 to 20.65 , p = 0.0064 for aneurysm-related mortality ) . The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture , with increased cancer mortality also observed in the EVAR group . Overall , aneurysm reintervention rates were higher in the EVAR group than in the OR group , 4.1 and 1.7 per 100 person-years , respectively ( p < 0.001 
    Output:
    
Operative mortality contributed to most of the uncertainty in the decision model .
Conclusions In the case of “ maturing technologies ” , decision modelling indicates the likely direction of costs and benefits and guides the development of further research projects .
In our analysis of fEVAR versus OSR , decision uncertainty , particularly around operative mortality , might be effectively resolved by a short-term RCT , or possibly a well-conducted comparative observational study .