Outcomes of “Anterior Versus Posterior Divisional Branches of the Hypogastric Artery as Distal Landing Zone for Iliac Branch Devices”: The International Multicentric R3OYAL Registry

Objective: The aim of this multicentric registry was to assess the outcomes of “anteRior versus posteRior divisional bRanches Of the hYpogastric artery as distAl landing zone for iLiac branch devices (R3OYAL).” Methods: The main exposure of interest for the purpose of this study was the internal iliac artery (IIA) divisional branch (anterior vs posterior) that was used as distal landing zone. Early endpoints included technical success and adverse events. Late endpoints included survival, primary/secondary IIA patency, and IIA branch instability. Results: A total of 171 patients were included in the study, of which 50 received bilateral implantation of iliac branch devices (IBDs). This resulted in a total of 221 incorporated IIAs included in the final analysis, of which 40 were anterior divisional branches and 181 were posterior divisional branches. Technical success was high in both groups (anterior division: 98% vs posterior division: 100%, P =.18). Occurrence of any adverse event was noted in 14% of patients in both groups (P = 1.0). The overall rate of freedom from the composite IBD branch instability did not show significant differences between patients receiving distal landing in the anterior or posterior division of the IIA at 3 years (79% vs 87%, log-rank test =.215). The 3-year estimates of IBD patency were significantly lower in patients who received distal landing in the anterior divisional branch than those who received distal landing in the posterior divisional branch (primary patency: 81% vs 96%, log-rank test =.009; secondary patency: 81% vs 97%, log-rank test <.001). Conclusions: The use of the anterior or posterior divisional branches of the IIA as distal landing zone for IBD implantation shows comparable profiles in terms of immediate technical success, perioperative safety, and side-branch instability up to 3 years. However, IBD patency at 3 years was higher when the distal landing zone was achieved within the posterior divisional branch of the IIA. Clinical Impact: The results from this large multicentric registry confirm that use of the anterior or posterior divisional branches of the internal iliac artery (IIA) as distal landing zone for implantation of iliac branch devices (IBD) shows comparable profiles of safety and feasibility, thereby allowing to extend the indications for endovascular repair of aorto-iliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Although mid-term rates of device durability and branch instability seem to be similar, the rates of primary and secondary IBD patency at three years was favored when the distal landing zone was achieved in the posterior divisional branch of the IIA

Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures

Objective: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. Methods: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessel repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. Results: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 – 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 – 12.1; p =.026), branched and fenestrated procedure (OR 3.4, 95% CI 1.2 – 9.6; p =.019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 – 20.7; p =.001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 – 9.0; p =.013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 – 13.8; p =.037), and aortic arch procedure (OR 7.3, 95% CI 1.7 – 31.1; p =.007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of adjunctive endovascular procedures was recorded in the percutaneous cohort (p <.001). Conclusion: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure

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

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Reduced costs with bisoprolol treatment for heart failure - An economic analysis of the second Cardiac Insufficiency Bisoprolol Study (CIBIS-II)

Background Beta-blockers, used as an adjunctive to diuretics, digoxin and angiotensin converting enzyme inhibitors, improve survival in chronic heart failure. We report a prospectively planned economic analysis of the cost of adjunctive beta-blocker therapy in the second Cardiac Insufficiency BIsoprolol Study (CIBIS II). Methods Resource utilization data (drug therapy, number of hospital admissions, length of hospital stay, ward type) were collected prospectively in all patients in CIBIS . These data were used to determine the additional direct costs incurred, and savings made, with bisoprolol therapy. As well as the cost of the drug, additional costs related to bisoprolol therapy were added to cover the supervision of treatment initiation and titration (four outpatient clinic/office visits). Per them (hospital bed day) costings were carried out for France, Germany and the U.K. Diagnosis related group costings were performed for France and the U.K. Our analyses took the perspective of a third party payer in France and Germany and the National Health Service in the U.K. Results Overall, fewer patients were hospitalized in the bisoprolol group, there were fewer hospital admissions perpatient hospitalized, fewer hospital admissions overall, fewer days spent in hospital and fewer days spent in the most expensive type of ward. As a consequence the cost of care in the bisoprolol group was 5-10% less in all three countries, in the per them analysis, even taking into account the cost of bisoprolol and the extra initiation/up-titration visits. The cost per patient treated in the placebo and bisoprolol groups was FF35 009 vs FF31 762 in France, DM11 563 vs DM10 784 in Germany and pound 4987 vs pound 4722 in the U.K. The diagnosis related group analysis gave similar results. Interpretation Not only did bisoprolol increase survival and reduce hospital admissions in CIBIS II, it also cut the cost of care in so doing. This `win-win' situation of positive health benefits associated with cost savings is Favourable from the point of view of both the patient and health care systems. These findings add further support for the use of beta-blockers in chronic heart failure

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

Venous oxygenation in sickle cell patients and controls using quantitative susceptibility mapping versus T2- relaxation-under-spin-tagging

In 15 homozygous sickle-cell disease patients (SCD; hemoglobin-SS) and 12 healthy controls (HC; 10 Hb-AA, 2 Hb-AS), we compared a quantitative susceptibility mapping (QSM)-based estimate of venous oxygen saturation (Yv) with T2-relaxation-under-spin-tagging (TRUST)-based estimates using bovine-hemoglobin (TRUST-HbBV), hemoglobin-S (TRUST-HbS), or hemoglobin-A (TRUST-HbA) calibrations. Agreement between methods varied, with QSM-Yv estimates in HC and SCD respectively on average 5-6% higher versus TRUST-HbBV, 5% higher and 9% lower versus TRUST-HbS, and 9% higher and 2% lower versus TRUST-HbA. Across all comparisons, the limits of agreement were wide (18-26%) underscoring the need for further studies comparing non-invasive methods with gold-standard jugular vein catheterization