Optimising surveillance and re-intervention strategy following elective endovascular repair of abdominal aortic aneurysms

Background Elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm has an initial survival advantage over open repair (OR), but more frequent complications increase costs and long-term aneurysm-related mortality. Randomised controlled trials of EVAR versus OR have shown EVAR is not cost-effective over a patient’s lifetime. However, in the EVAR-1 trial, post-operative surveillance may have been sub-optimal, as the importance of sac growth as a predictor of graft failure was overlooked. Methods Real-world data informed a discrete event simulation model of post-operative outcomes following EVAR. Outcomes observed EVAR-1 were compared with those from five alternative post-operative surveillance and re-intervention strategies. Key events, quality-adjusted life years and costs were predicted. The impact of using complication and rupture rates from more recent devices, imaging and re-intervention methods was also explored. Results Compared with observed EVAR-1 outcomes, modelling full adherence to the EVAR-1 scan protocol reduced AAA deaths by 3% and increased elective re-interventions by 44%. European Society re-intervention guidelines provided the most clinically effective strategy, with an 8% reduction in AAA deaths, but a 52% increase in elective re-interventions. The cheapest and most cost-effective strategy used lifetime annual ultrasound in primary care with confirmatory CT if necessary, and reduced AAA-related deaths by 5%. Using contemporary rates for complications and rupture did not alter these conclusions. Conclusions All alternative strategies improved clinical benefits compared with the EVAR-1 trial. Further work is needed regarding the cost and accuracy of primary care ultrasound, and the potential impact of these strategies in the comparison with OR.Financial support from National Institute of Health Research and Camelia Botnar Arterial Foundation. The National Institute of Health Research (NIHR) had no role in study design, data collection, data analysis, data interpretation, in the writing of the report or in the decision to submit the article for publication. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the NIHR, UK NHS, or Department of Health. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication

Optimizing Surveillance and Re-intervention Strategy Following Elective Endovascular Repair of Abdominal Aortic Aneurysms

Background: EVAR for abdominal aortic aneurysm has an initial survival advantage over OR, but more frequent complications increase costs and long-term aneurysm-related mortality. Randomized controlled trials of EVAR versus OR have shown EVAR is not cost-effective over a patient's lifetime. However, in the EVAR-1 trial, postoperative surveillance may have been sub-optimal, as the importance of sac growth as a predictor of graft failure was overlooked. Methods: Real-world data informed a discrete event simulation model of postoperative outcomes following EVAR. Outcomes observed EVAR-1 were compared with those from 5 alternative postoperative surveillance and reintervention strategies. Key events, quality-adjusted life years and costs were predicted. The impact of using complication and rupture rates from more recent devices, imaging and re-intervention methods was also explored. Results: Compared with observed EVAR-1 outcomes, modeling full adherence to the EVAR-1 scan protocol reduced abdominal aortic aneurysm (AAA) deaths by 3% and increased elective re-interventions by 44%. European Society re-intervention guidelines provided the most clinically effective strategy, with an 8% reduction in AAA deaths, but a 52% increase in elective re-interventions. The cheapest and most cost-effective strategy used lifetime annual ultrasound in primary care with confirmatory computed tomography if necessary, and reduced AAA-related deaths by 5%. Using contemporary rates for complications and rupture did not alter these conclusions. Conclusions: All alternative strategies improved clinical benefits compared with the EVAR-1 trial. Further work is needed regarding the cost and accuracy of primary care ultrasound, and the potential impact of these strategies in the comparison with OR.Peer reviewe

Predicting risk of rupture and rupture-preventing reinterventions following endovascular abdominal aortic aneurysm repair

BackgroundClinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. The aim of this study was to develop a dynamic prognostic model to enable stratification of patients at risk of future secondary aortic rupture or the need for intervention to prevent rupture (rupture-preventing reintervention) to enable the development of personalized surveillance intervals. MethodsBaseline data and repeat measurements of postoperative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model, with external validation in a cohort from a single-centre vascular database. Longitudinal mixed-effects models were fitted to trajectories of sac diameter, and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models. ResultsSome 785 patients from the EVAR trials were included, of whom 155 (197 per cent) experienced at least one rupture or required a rupture-preventing reintervention during follow-up. An increased risk was associated with preoperative AAA size, rate of sac growth and the number of previously detected complications. A prognostic model using predicted sac growth alone had good discrimination at 2years (C-index 068), 3years (C-index 072) and 5years (C-index 075) after operation and had excellent external validation (C-index 076-079). More than 5years after operation, growth rates above 1mm/year had a sensitivity of over 80 per cent and specificity over 50 per cent in identifying events occurring within 2years. ConclusionSecondary sac growth is an important predictor of rupture or rupture-preventing reintervention to enable the development of personalized surveillance intervals. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up. Potential to tailor surveillancePeer reviewe

Predicting risk of rupture and rupture-preventing re-interventions utilising repeated measures on aneurysm sac diameter following endovascular abdominal aortic aneurysm repair

Clinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. This study developed a dynamic prognostic model to enable stratification of patients at risk of future secondary rupture or rupture preventing re-intervention (RPR) to enable the development of personalised surveillance intervals. Baseline data and repeat measurements of post-operative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model with external validation in a cohort from Helsinki. Longitudinal mixed-effects models were fitted to trajectories of sac diameter and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models. 785 patients from the EVAR trials were included of which 155 (20%) suffered at least one rupture or RPR during follow-up. An increased risk was associated with pre-operative AAA size, rate of sac growth, and the number of previously detected complications. A prognostic model using only predicted sac growth had good discrimination at 2-years (C-index = 0.68), 3-years (C-index= 0.72) and 5-years (C-index= 0.75) post-operation and had excellent external validation (C-indices 0.76 to 0.79). After 5-years post-operation, growth rates above 1mm/year had a sensitivity of over 80% and specificity over 50% in identifying events occurring within 2 years. Secondary sac growth is an important predictor of rupture or RPR. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up

Custom Made Candy Plug for Distal False Lumen Occlusion in Aortic Dissection: International Experience

Objective: To evaluate early and midterm outcomes of the Candy Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection (AD) in a more real world cohort of patients from an international multicentre registry. Methods: A multicentre retrospective study was conducted of all consecutive patients from the contributing centres with subacute and chronic AD treated with the CP technique from October 2013 to April 2020 at 18 centres. Results: A custom made CP was used in 155 patients (92 males, mean age 62 ± 11 years). Fourteen (9%) presented with ruptured false lumen aneurysms. Technical success was achieved in all patients (100%). Clinical success was achieved in 138 patients (89%). The median hospital stay was 7 days (1 – 77). The 30 day mortality rate was 3% (n = 5). Stroke occurred in four patients (3%). Spinal cord ischaemia occurred in three patients (2%). The 30 day computed tomography angiogram (CTA) confirmed successful CP placement at the intended level in all patients. Early complete FL occlusion was achieved in 120 patients (77%). Early (30 day) CP related re-intervention was required in four patients (3%). The early (30 day) stent graft related re-intervention rate was 8% (n = 12). Follow up CTA was available in 142 patients (92%), with a median follow up of 23 months (6 – 87). Aneurysmal regression was achieved in 68 of 142 patients (47%); the aneurysm diameter remained stable in 69 of 142 patients (49%) and increased in five of 142 patients (4%). A higher rate of early FL occlusion was detected in the largest volume centre patients (50 [88%] vs. 70 [71%] from other centres; p = .019). No other differences in outcome were identified regarding volume of cases or learning curve. Conclusion: This international CP technique experience confirmed its feasibility and low mortality and morbidity rates. Aortic remodelling and false lumen thrombosis rates were high and support the concept of distal FL occlusion in AD using the CP technique

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms

Objective: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. Results: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. Conclusions: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years

The Influence of Music and Music Therapy on Pain-induced Neuronal Oscillations Measured by Magnetencephalography

Modern forms of music therapy are clinically established for various therapeutic or rehabilitative goals, especially in the treatment of chronic pain. However, little is known about the neuronal mechanisms that underlie pain modulation by music. Therefore, we attempted to characterize the effects of music therapy on pain perception by comparing the effects of 2 different therapeutic concepts, referred to as receptive and entrainment methods, on cortical activity recorded by magnetencephalography in combination with laser heat pain. Listening to preferred music within the receptive method yielded a significant reduction of pain ratings associated with a significant power reduction of delta-band activity in the cingulate gyrus, which suggests that participants displaced their focus of attention away from the pain stimulus. On the other hand, listening to self-composed pain music and healing music within the entrainment method exerted major effects on gamma-band activity in primary and secondary somatosensory cortices. Pain music, in contrast to healing music, increased pain ratings in parallel with an increase in gamma-band activity in somatosensory brain structures. In conclusion, our data suggest that the 2 music therapy approaches operationalized in this study seem to modulate pain perception through at least 2 different mechanisms, involving changes of activity in the delta and gamma bands at different stages of the pain processing system

Pre-Loaded Fenestrated Thoracic Endografts for Distal Aortic Arch Pathologies: Multicentre Retrospective Analysis of Short and Mid Term Outcomes.

OBJECTIVE To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies. METHODS This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan-Meier survival analysis. RESULTS One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 - 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively. CONCLUSION This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates