Outcome of Ruptured Abdominal Aortic Aneurysm Repair in Octogenarians: A Systematic Review and Meta-Analysis

Objective: This meta-analysis sought to identify the mortality and ambulatory state 30 days and one year post-operatively in octogenarians treated for ruptured abdominal aortic aneurysm (rAAA) by endovascular aneurysm repair (EVAR) or open repair (OR). rAAA is a life threatening emergency occurring increasingly in octogenarians. Surgical treatment, open or endovascular, offers the only chance of survival albeit with significant mortality and morbidity rates and a high burden to society. In order to make an informed decision on management, contemporary treatment outcomes should be known. The aim of this study was to perform a systematic review and meta-analysis on rAAA repair in octogenarians. Methods: The Pubmed, Embase and Cochrane databases were searched for articles published between 2013 and October 2018 on octogenarians treated for a rAAA. Meta-analysis was performed using the random effects model to calculate the 30 day and one year mortality. Results: The search resulted in a total of 1569 articles, of which eight retrospective studies could be included, reporting on 7526 patients. All studies reported 30 day mortality in octogenarians, and the one year mortality was addressed in four studies. Ambulatory state was not reported. Meta-analysis showed a 30 day mortality of 43% (95% confidence interval (CI) 33–53) and a one year mortality of 47% (95% CI 32–62). Patients after EVAR had a significant lower mortality at 30 days (risk ratio (RR) 0.50, 95% CI 0.38–0.67) and at one year (RR 0.65, 95% CI 0.44–0.96). Conclusion: The 30 day and one year mortality rates for rAAA repair in octogenarians are similar to the outcome at all ages, with a significant survival advantage of EVAR over OR. Patients should therefore not be denied treatment of a rAAA based on age alone

Editor's Choice – Sex Differences in Response to Administration of Heparin During Non-Cardiac Arterial Procedures

Objective: Females are more prone to complications during non-cardiac arterial procedures (NCAPs) than males. The current study investigated the difference in the effect of peri-procedural prophylactic heparin in males and females, using the activated clotting time (ACT). This was a retrospective analysis of a prospective multicentre cohort study. Methods: All patients undergoing elective NCAP using heparin and ACT measurements between January 2016 and March 2020 were included. Two heparin dosage protocols were used: weight based dosing of 100 IU/kg (international units per kilogram) or a bolus of 5 000 IU. The primary outcome was the anticoagulatory effect of heparin after five minutes, measured by ACT. Secondary outcomes were the effect of heparin after 30 minutes, bleeding complications, and arterial thromboembolic complications (ATECs). Results: A total of 778 patients were included; 26% were female. After 100 IU/kg (n = 300), females more often reached longer ACT (< 200 seconds: 22% vs. 25%, p = .62; 200 – 250 seconds: 41% vs. 53%, p = .058; 251 – 280 seconds, 26% vs. 15%, p = .030). The mean ACT after 100 IU/kg heparin was 233 seconds (95% confidence interval [CI] 224 – 243) for females and 226 seconds (95% CI 221 – 231) for males (p = .057). After a bolus of 5 000 IU of heparin (n = 411), females reached significantly higher levels of anticoagulation than males (mean ACT 204 seconds vs. 190 seconds: p ≤ .001; ACT < 200 seconds: 44% vs. 66%; p < .001; ACT 200 – 250 seconds: 47% vs. 30%, p = .001; ACT 251 – 280 seconds: 7.8% vs. 2.3%, p = .009). Thirty minutes after heparin administration, 58% of all patients had an ACT < 200 seconds. ATECs did not differ between females and males (6.9% vs. 5.1%, p = .33) but bleeding complications were higher in females (27% vs. 16%, p = .001). Conclusion: Heparin leads to significantly longer ACT in females during NCAP. Further research is needed to investigate whether individually based heparin protocols lead to fewer bleeding complications and lower incidence of ATECs

Weight Based Heparin Dosage with Activated Clotting Time Monitoring Leads to Adequate and Safe Anticoagulation in Non-Cardiac Arterial Procedures

Background: Unfractionated heparin has an unpredictable effect in an individual patient. The activated clotting time (ACT) can be used to measure the effect of heparin in the individual patient and guide additional heparin dosages. Previous cohort studies showed that a standardized bolus of 5,000 IU during noncardiac arterial procedures (NCAP) does not lead to an adequate ACT in the vast majority of patients. The aim of this study was to investigate whether an initial heparin dose of 100 IU/kg leads to an adequate but safe ACT, from 200 to 300 s. Methods: In this multicenter prospective study, 186 patients undergoing NCAP were enrolled and received an initial heparin dose of 100 IU/kg. Target ACT was set at ≥250 s initially; during the course of the study the target ACT was lowered to ≥200 s. After the initial heparin dose, additional heparin dosages were administered depending on the ACT values following a heparin dose protocol. ACT measurements and complications were monitored. Results: The mean baseline ACT was 134 ± 17 s. The mean ACT 5 minutes after the initial heparin dose was 227 ± 37 s. After the initial dose of heparin, 78 and 46% of patients reached an ACT of 200 and 250 s, respectively. Seven patients (4%) reached an ACT of 300 s or more. Ninety-four patients (51%) received at least one additional dose of heparin. After one additional dose of heparin, 91% of patients reached an ACT of 200 s and 13 patients (7%) reached an ACT of 300 s or more. Arterial thromboembolic complications occurred in 4.3% and bleeding complications occurred in 9.7%. Conclusions: A bolus of 100 IU/kg of heparin during NCAP results in adequate coagulation in most patients. ACT measurements enable accurate additional dosing, ensuring the individual patient tailored and safe coagulation. Key words: anticoagulants; heparin; blood coagulation tests; vascular surgical procedures; peripheral vascular diseas

Survival and Living Situation After Ruptured Abdominal Aneurysm Repair in Octogenarians

Objective: To determine the 30 day and one year mortality and post-operative living situation in octogenarians treated for ruptured abdominal aortic aneurysm (rAAA). Methods: A retrospective study was performed at four centres in the Netherlands. All consecutive patients aged ≥80 years, presenting with a rAAA between January 2013 and October 2018, were included. The primary outcomes were post-operative living situation and one year mortality. Results: In total, 157 patients were included. Forty-seven received palliative care and 110 patients had surgery. After endovascular or open repair, the one year mortality rate was 50.0%. The 30 day mortality rate was 40.8% (95% confidence interval [CI] 27–55) and 31.7% (95% CI 20–44), for endovascular and open repair, respectively (p =.32). Sixty-five per cent of survivors were discharged home, while 34.8% went to a nursing home for rehabilitation. Of the surviving patients, 82.6% went back to living in their pre-rupture home situation. Of the investigated variables, only a high body mass index proved a significant predictor of death at 30 days and one year. Compared with operated patients, patients turned down for surgery were older (mean age 87.5 ± 3.8 vs. 84.0 ± 3.5; p 80% returned to their own home after rehabilitation

sj-docx-1-jet-10.1177_15266028231213611 – Supplemental material for The Additional Value of Activated Clotting Time–Guided Heparinization During Interventions for Peripheral Arterial Disease

Supplemental material, sj-docx-1-jet-10.1177_15266028231213611 for The Additional Value of Activated Clotting Time–Guided Heparinization During Interventions for Peripheral Arterial Disease by Liliane C. Roosendaal, Mila Radović, Max Hoebink, Arno M. Wiersema, Jan D. Blankensteijn and Vincent Jongkind in Journal of Endovascular Therapy</p

sj-docx-1-jet-10.1177_15266028231199714 – Supplemental material for Perprocedural Heparinization in Non-cardiac Arterial Procedures: The Current Practice in the Netherlands

Supplemental material, sj-docx-1-jet-10.1177_15266028231199714 for Perprocedural Heparinization in Non-cardiac Arterial Procedures: The Current Practice in the Netherlands by Liliane C. Roosendaal, Max Hoebink, Arno M. Wiersema, Kak K. Yeung, Jan D. Blankensteijn and Vincent Jongkind in Journal of Endovascular Therapy</p

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair

Background: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200–220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. Methods: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200–220 s. If the ACT after 5 min is 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. Discussion: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. Trial registration {2a}: NTR NL8421 ClinicalTrials.gov NCT04061798. Registered on 20 August 2019 EudraCT 2018-003393-27 Trial registration: data set {2b}: ClinicalTrials.gov: NCT04061798NTR: [email protected]@wiersema.n

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair

Background: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200–220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. Methods: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200–220 s. If the ACT after 5 min is 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. Discussion: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. Trial registration {2a}: NTR NL8421 ClinicalTrials.gov NCT04061798. Registered on 20 August 2019 EudraCT 2018-003393-27 Trial registration: data set {2b}: ClinicalTrials.gov: NCT04061798NTR: [email protected]@wiersema.n