Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial.
ABSTRACT: INTRODUCTION:Spinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS2ACE) has been proved recently to be a feasible enhanced approach to staged repair. METHODS AND ANALYSIS:This randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 1:1 ratio to standard aneurysm repair or to MIS2ACE in 1-3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1?year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions. ETHICS AND DISSEMINATION:This trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial. TRIAL REGISTRATION NUMBER:NCT03434314.
Project description:<h4>Introduction</h4>Type II endoleak (EL) is frequently seen after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) and is often considered responsible for aneurysm sac enlargement if it persists. In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres. At present, there is a lack of robust evidence to support the efficacy of pre-emptive embolisation of IMA on reduction of persistent type II EL with subsequent sac shrinkage.<h4>Method and analysis</h4>This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation.<h4>Ethics and dissemination</h4>The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page.<h4>Trial registration number</h4>UMIN000035502.
Project description:<h4>Introduction</h4>In patients with large abdominal aortic aneurysm (AAA), open surgical or endovascular aneurysm repair procedures are often used to minimise the risk of aneurysm-related rupture and death; however, aneurysm repair itself carries a high risk. Low cardiopulmonary fitness is associated with an increased risk of early post-operative complications and death following elective AAA repair. Therefore, fitness should be enhanced before aneurysm repair. High-intensity interval exercise training (HIT) is a potent, time-efficient strategy for enhancing cardiopulmonary fitness. Here, we describe a feasibility study for a definitive trial of a pre-operative HIT intervention to improve post-operative outcomes in patients undergoing elective AAA repair.<h4>Methods and analysis</h4>A minimum of 50 patients awaiting elective repair of a 5.5-7.0 cm infrarenal AAA will be allocated by minimisation to HIT or usual care control in a 1:1 ratio. The patients allocated to HIT will complete three hospital-based exercise sessions per week, for 4 weeks. Each session will include 2 or 4 min of high-intensity stationary cycling followed by the same duration of easy cycling or passive recovery, repeated until a total of 16 min of high-intensity exercise is accumulated. Outcomes to be assessed before randomisation and 24-48 h before aneurysm repair include cardiopulmonary fitness, maximum AAA diameter and health-related quality of life. In the post-operative period, we will record destination (ward or critical care unit), organ-specific morbidity, mortality and the durations of critical care and hospital stay. Twelve weeks after the discharge, participants will be interviewed to reassess quality of life and determine post-discharge healthcare utilisation. The costs associated with the exercise intervention and healthcare utilisation will be calculated.<h4>Ethics and dissemination</h4>Ethics approval was secured through Sunderland Research Ethics Committee. The findings of the trial will be disseminated through peer-reviewed journals, and national and international presentations.<h4>Trial registration</h4>Current Controlled Trials ISRCTN09433624.
Project description:INTRODUCTION:Strict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as 'low risk' for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance. METHODS AND ANALYSIS:The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient's medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients. ETHICS AND DISSEMINATION:The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal. TRIAL REGISTRATION NUMBER:The Netherlands Trial Registry, NL6953 (old: NTR28773).
Project description:<h4>Introduction</h4>In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'<h4>Methods and analysis</h4>UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.<h4>Ethics and dissemination</h4>The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.<h4>Trial registration number</h4>ISRCTN85731188.
Project description:Open thoracoabdominal aortic aneurysm (TAAA) repair remains a surgical challenge. Hybrid and total endovascular repair have emerged as alternatives in treating TAAA. Total endovascular TAAA repair may be best performed with branched/fenestrated stent grafts. However, these technologies are not yet widely available. Thus, currently total endovascular TAAA repair using the chimney/snorkel techniques is considered a viable option in many centers. In this article, we briefly review 2 readily available techniques with off-the-shelf devices, hybrid procedure using total abdominal debranching, and total endovascular repair using chimney/snorkel procedures. The hybrid TAAA repair avoids thoracotomy but requires laparotomy and carries high morbidity and mortality (eg, operative mortality, 4%-26% and renal failure, 4%-26%), comparable to traditional open repair. The staged hybrid approach has been proposed to minimize the invasiveness of the procedure, whereas the associated risk of interval aortic deaths is not negligible. Total endovascular repair reduces the morbidity and mortality after TAAA repair (eg, operative mortality, 3%-20% and renal failure, 0%-20%). However, it is technically demanding and the risks of future reinterventions-and need for repetitive surveillance-is inevitable (eg, immediate type I endoleak, 7%-16% and 1-year branch patency, 93%-98%). Currently, there are not enough data to determine which less-invasive option for open repair in patients with TAAA is superior. These alternatives should complement each other and be applied to carefully selected populations as a part of the overall toolbox in treating TAAA.
Project description:Randomized trials and observational studies have shown that perioperative morbidity and mortality are lower with endovascular repair of abdominal aortic aneurysm than with open repair, but the survival benefit is not sustained. In addition, concerns have been raised about the long-term risk of aneurysm rupture or the need for reintervention after endovascular repair.We assessed perioperative and long-term survival, reinterventions, and complications after endovascular repair as compared with open repair of abdominal aortic aneurysm in propensity-score-matched cohorts of Medicare beneficiaries who underwent repair during the period from 2001 through 2008 and were followed through 2009.We identified 39,966 matched pairs of patients who had undergone either open repair or endovascular repair. The overall perioperative mortality was 1.6% with endovascular repair versus 5.2% with open repair (P<0.001). From 2001 through 2008, perioperative mortality decreased by 0.8 percentage points among patients who underwent endovascular repair (P=0.001) and by 0.6 percentage points among patients who underwent open repair (P=0.01). The rate of conversion from endovascular to open repair decreased from 2.2% in 2001 to 0.3% in 2008 (P<0.001). The rate of survival was significantly higher after endovascular repair than after open repair through the first 3 years of follow-up, after which time the rates of survival were similar. Through 8 years of follow-up, interventions related to the management of the aneurysm or its complications were more common after endovascular repair, whereas interventions for complications related to laparotomy were more common after open repair. Aneurysm rupture occurred in 5.4% of patients after endovascular repair versus 1.4% of patients after open repair through 8 years of follow-up (P<0.001). The rate of total reinterventions at 2 years after endovascular repair decreased over time (from 10.4% among patients who underwent procedures in 2001 to 9.1% among patients who underwent procedures in 2007).Endovascular repair, as compared with open repair, of abdominal aortic aneurysm was associated with a substantial early survival advantage that gradually decreased over time. The rate of late rupture was significantly higher after endovascular repair than after open repair. The outcomes of endovascular repair have been improving over time. (Funded by the National Institutes of Health.).
Project description:BACKGROUND:The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. METHODS:An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. RESULTS:The analysis included 2783 patients, with 14?245 person-years of follow-up (median 5·5?years). Early (0-6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P?=?0·022) in the period from 6 months to 4 years after randomization. CONCLUSION:The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5?years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle?:?brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM?(Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.
Project description:<h4>Objectives</h4>Our goal was to identify the inferior mesenteric artery diameter and number of patent lumbar arteries causing a significant type 2 endoleak to develop after infrarenal endovascular aneurysm repair.<h4>Material and methods</h4>Included were patients who underwent infrarenal endovascular aneurysm repair between April 2002 and January 2017. Patients with an aneurysm involving the iliac arteries were excluded. Significant type 2 endoleak was defined as a type 2 endoleak observed after infrarenal endovascular aneurysm repair and accompanied by abdominal aneurysm growth of at least 5 mm during that time.<h4>Results</h4>A total of 277 patients were included. Mean follow-up was 38.9 (standard deviation 121.6) months. Immediately after infrarenal endovascular aneurysm repair, type 2 endoleaks occurred in 55 patients (20%), resolving spontaneously in 2 patients 6 months after infrarenal endovascular aneurysm repair. Thirty (10.8%) patients revealed a significant type 2 endoleak with aneurysm sack enlargement > 5 mm during follow-up, for which inferior mesenteric artery or lumbar artery coiling was performed. Mean time for coiling after primary infrarenal endovascular aneurysm repair was 25.4 (standard deviation 19.10) months. Twenty-three patients (8.3%) showed a non-significant type 2 endoleak during follow-up (no aneurysm sack enlargement). We found that the inferior mesenteric artery diameter and number of patent lumbar arteries were factors associated with a significant type 2 endoleak (odds ratio 1.755, P = 0.001; odds ratio 1.717, P < 0.001, respectively). Prior to endovascular aneurysm repair, the inferior mesenteric artery was patent in 212 (76.5%) patients; its median diameter measured 3 (0.5-3.8) mm. The median number of patent lumbar arteries was 3 (2-4). According to our receiver operating characteristic curve analysis, an inferior mesenteric artery diameter ≥3 mm (sensitivity 93.3%, specificity 65%) and ≥3 patent lumbar arteries (sensitivity 87.5%, specificity 43.6%) proved to be optimal cut-off values related to developing a significant type 2 endoleak. We therefore propose a composite score for the development of a significant type 2 endoleak [(inferior mesenteric artery diameter + patent lumbar arteries)/2].<h4>Conclusions</h4>Patients in whom the diameter of the inferior mesenteric artery is ≥ 3 mm and with ≥ 3 patent lumbar arteries carry a higher risk of developing significant type 2 endoleak after infrarenal endovascular aneurysm repair.
Project description:<h4>Objectives</h4>The primary aim of this study was to investigate the rate of sac enlargement and secondary procedures after 5?years when instructions for use are strictly applied with endovascular aortic repair. The secondary aim was to investigate if strict indications with endovascular aortic repair, rendering more open operations, would change the general outcome of patients with abdominal aortic aneurysm.<h4>Materials and methods</h4>Patients having their abdominal aortic aneurysm procedure in a single institution between 01 January 2002 and 31 December 2006 were included. Indications for endovascular aortic repair were as follows: aortic neck: length 15?mm or more, diameter 32?mm or less and straight configuration; iliac arteries: length?>?10?mm, 7.5-20?mm in diameter. Sac enlargement was defined as an increase in diameter of 5?mm or more.<h4>Results</h4>A total of 123 patients were intended to be treated electively with endovascular aortic repair from 2002 to 2007 using Cook Zenith stent grafts. In the same period, 147 patients were treated with elective open repair. At 5?years, 7.3% (N?=?9) of the elective intended-to-treat patients with endovascular aortic repair had a sac enlargement. Thirty-five percent of the patients were registered with endoleaks, 13% of the patients had secondary procedures, 12.2% of the patients had early and 6.5% late complications during the follow-up period. Aneurysm rupture was seen in 1.6% of the patients. During the 5-year follow-up period, 34 (27.6%) of the endovascular aortic repair patients died. Five-year mortality for open repair was 23.8%, and 12.2% of the open repair patients had secondary procedures.<h4>Conclusion</h4>Endovascular aortic repair for abdominal aortic aneurysm in accordance with instructions for use gives a low long-term risk for increased diameter and low rate of secondary procedures. There was similar mortality after elective endovascular aortic repair and open repair for abdominal aortic aneurysm. Applying endovascular aortic repair according to instructions for use does not seem to change the general outcome of patients with abdominal aortic aneurysm but improves the outcome with the method.
Project description:<h4>Background</h4>Thoracic and abdominal aortic stent grafts are firmer and more rigid than the native aorta. Aortic implanted devices have been implicated in the development of acute systolic hypertension, elevated pulse pressure, and reduced coronary perfusion.<h4>Case summary</h4>We report four cases of staged thoracic endovascular aortic repair (TEVAR) and then endovascular aneurysm repair (EVAR). All patients had TEVAR first for thoracic aortic aneurysm and later on developed infra-renal abdominal aortic aneurysm (AAA) that required EVAR. There were three males and one female with a median age of 74.5 years (range 67.5-78.5). None of the patients developed aortic-related major clinical adverse effects or required any aortic intervention during their follow-up. However, within 2 years, all patients developed symptomatic left ventricular hypertrophy with diastolic dysfunction. All patients had bilateral lower limb oedema, with on and off chest pain and shortness of breath (SOB), necessitating coronary angiograms, which showed no evidence of coronary artery disease. Three patients died from cardiovascular-related morbidities, and the fourth patient is still complaining of SOB despite a normal coronary angiogram.<h4>Discussion</h4>Aortic-endograft compliance mismatch is an invisible enemy, with troubling consequences for the aorta proximal and distal to the endograft. Aortic stiffness due to vascular endograft could lead to cardiovascular adverse events, even in the absence of direct aortic-related complications. After combined TEVAR and EVAR, the compliance mismatch and elasticity loss are even more pronounced than with TEVAR alone, which necessitates patient monitoring for the development of cardiovascular complications.