Long-term prognostic risk in lower extremity peripheral arterial disease as a function of the number of peripheral arterial lesions

Background:  Although patients with peripheral artery disease (PAD) are known to have an increased risk of adverse prognosis, simple techniques to further risk-stratify PAD patients would be clinically useful. A plausible but unexplored factor to predict such risk would be greater disease burden, manifested as multiple lower extremity lesions. The aim of this study was to examine the association between having multiple versus isolated lower extremity PAD lesions and long-term prognosis. Methods and results:  A prospective cohort of 756 newly diagnosed PAD patients underwent duplex ultrasound testing to determine the number of lower extremity lesions. Cox regression models examined the independent association of lesion number (≥3 and 2 versus 1) and adverse prognosis (defined as a composite end point comprising first occurrence of either lower extremity amputation, admission for heart failure, nonfatal stroke, myocardial infarction, or unstable angina or mortality), adjusting for demographic and clinical risk factors. Analyses were replicated using an advanced Cox-based model for multiple events. A total of 173 patients (23%) had ≥3 lesions, 197 (26%) had 2 lesions, and 386 (51%) had 1 lesion. After a median follow-up of 3.2 years, patients with ≥3 lesions had an increased risk of experiencing a first adverse event (adjusted hazard ratio 1.60, 95% CI 1.08-2.38, P=0.020) and an increased risk of having multiple events (adjusted hazard ratio 1.53, 95% CI 1.08-2.18, P=0.018). Patients with 2 lesions had a prognosis similar to those with 1 lesion. Conclusions:  Among PAD patients, a greater number of lesions is associated with an increased risk of an adverse prognosis over 3 years of follow-up. Assessing the number of lower extremity lesions might serve as a simple risk-stratification tool at initial PAD diagnosis

The upside down Gore Excluder contralateral leg without extracorporeal predeployment for aortic or iliac aneurysm exclusion

Endovascular techniques, including branched devices to preserve the internal iliac artery are evolving rapidly, but in cases in which the diameter of the proximal sealing zone is larger than that of the distal sealing zone, a reversed tapered device is needed. We describe the off label use of the Gore Excluder contralateral leg endoprosthesis in an upside down configuration to accommodate this diameter mismatch. The preinsertion technical steps of stent graft preparation, which do not require extracorporeal predeployment, are described in detail. As such, an aneurysm of the internal iliac artery and a saccular abdominal aortic aneurysm were successfully excluded

A heparin-bonded vascular graft generates no systemic effect on markers of hemostasis activation or detectable heparin-induced thrombocytopeniaassociated antibodies in humans

ObjectivesAlmost a third of patients who undergo peripheral bypass procedures do not have suitable veins, making the use of prosthetic materials necessary. Prosthetic materials can cause platelet adhesion and activation of the coagulation cascade on the graft. One potential strategy to reduce this thrombogenicity is to covalently bind heparin to the endoluminal surface of grafts. This human in vivo study examined systemic effects of the endoluminal heparin and addressed whether graft implantation results in (1) a measurable reduction of systemic markers of hemostasis activation compared with control grafts and (2) antibody formation against heparin, potentially responsible for heparin-induced thrombocytopenia (HIT).MethodsThe study included 20 patients undergoing femoropopliteal bypass grafting, of whom 10 received a standard Gore-Tex Thin Walled Stretch Vascular Graft (W. L. Gore & Associates, Flagstaff, Ariz) and 10 received a heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft (Gore-Tex Propaten Vascular Graft). Blood samples were drawn before and directly after the operation and at days 1, 3, 5, and week 6 after surgery. Established markers of in vivo activation of platelets and blood coagulation (prothrombin fragment 1+2, fibrinopeptide A, soluble glycoprotein V, thrombin-antithrombin complexes, and D-dimers) were measured using standard commercially available techniques. Antiplatelet factor 4/heparin antibody titers were measured using a commercially available enzyme-linked immunosorbent assay, and platelet counts were determined.ResultsNo statistical differences were observed in any of the markers of in vivo activation of platelets and blood coagulation between patients receiving Propaten or control ePTFE. Moreover, no antibodies against heparin could be demonstrated up to 6 weeks after implantation.ConclusionsNo measurable effect of heparin immobilization on systemic markers of hemostasis was found using a heparin-bonded ePTFE graft in vivo. Also, no antibodies against heparin could be detected up to 6 weeks after implantation

Evaluation of electrocardiogram-gated computed tomography angiography to quantify changes in geometry and dynamic behavior of the iliac artery after placement of the Gore Excluder Iliac Branch Endoprosthesis

BACKGROUND: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is designed to treat iliac aneurysms with preservation of blood flow through the internal iliac artery (IIA). Little is known about the influence of IBE placement on the IIA geometry. This study aimed to provide detailed insights in the dynamic behavior and geometry of the common iliac artery (CIA) and IIA trajectory and how these are influenced after treatment with an IBE. METHODS: Pre- and postoperative electrocardiogram-gated computed tomography angiography (ECG-gated CTA) scans were acquired in a prospective study design and analyzed with in-house written algorithms designed for aorto-iliac and endoprosthesis deformation evaluation. Cardiac pulsatility-induced motion patterns and pathlengths were computed by tracking predefined locations on the aorto-iliac tract. Centerlines through the CIA-IIA trajectory were used to investigate the static and dynamic geometry, including curvature, torsion, length and Tortuosity Index (TI). RESULTS: Fourteen CIA-IIA trajectories were analyzed before and after IBE placement. Cardiac pulsatility-induced motion and pathlengths increased after IBE placement, especially at mid IIA and the first IIA bifurcation (P≤0.04). After IBE placement, static and dynamic curvature, length and TI decreased significantly (P<0.05). Furthermore, the average dynamic torsion increased significantly (P=0.030). The remaining geometrical outcomes were not statistically significant. CONCLUSIONS: The placement of an IBE device stiffens and straightens the CIA-IIA trajectory. Its relation with clinical outcome is yet to be investigated, which can be done thoroughly with the ECG-gated CTA algorithms used in this study

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

Assessment of changes in stent graft geometry after chimney endovascular aneurysm sealing

Background: Chimney endovascular aneurysm sealing (ch-EVAS) could potentially minimize gutter-associated endoleaks in patients with juxtarenal abdominal aortic aneurysms resulting from the use of the conformable endobags surrounding the chimney stent grafts (ch-SGs). The aim of the present study was to quantify the (non)apposition of the endobags in the proximal aortic neck, migration of the endograft stent frames, and changes in geometry of the ch-SGs during the follow-up period. Methods: The prospective data from 20 patients undergoing elective ch-EVAS were retrospectively reviewed. The aortic anatomy was analyzed on preoperative and postoperative computed tomography scans. The (non)apposition of the endobags in the aortic neck, Nellix (Endologix, Irvine, Calif) stent frame migration, and chimney graft geometry and migration were assessed. Results: The median preoperative infrarenal neck lengthwas 4.0 mm (interquartile range [IQR], 0-6.0 mm). The median seal length in the juxtarenal aortic neck at the first follow-up was 23.0 mm (IQR 18.0-30.8 mm). Five type IA endoleaks were identified on postoperative imaging; one at 1 month and four newly diagnosed at 1 year. Of these five type IA endoleaks, two were type Is1 (not extending into the aneurysm sac) and did not need reintervention and other three were type Is2 (extending into the aneurysmsac). One of these patients died of malignancy before reintervention could be performed. Bilateral ch-SG occlusions in one patient were documented at the 1-month follow-up (patient needed hemodialysis) and two patients with a new single ch-SG occlusion were found at the 1-year follow-up. No reinterventions were performed for the ch-SG occlusions. An occluded Nellix stent frame in one patient was treated with femorofemoral crossover bypass. Kaplan-Meier estimate of reintervention-free survival was 85.0% after 1 year. Migration >= 5 mm of the proximal end of the Nellix stent frames was observed in 20.0% of the patients, but no reintervention was performed at the 1-year follow-up. Imaging showed 20.1% of the available sealing surface was not used, and the nonapposition surface increased to 30.6% of the preoperative aortic neck surface at 1 year. Median migration was 3.5 mm (IQR, 2.4-5.0 mm) and 3.1 mm (IQR, 2.0-4.8 mm) for the left and right proximal end of the Nellix stent frames, respectively, and was 3.0 mm (IQR, 2.2-4.8 mm) for the proximal end of the ch-SGs at 1 year of follow-up. Conclusions: Substantial distal migration of the Nellix endograft and positional changes of the ch-SGs in the juxtarenal aortic neck were observed at 1 year of follow-up, resulting in a 25.0% type IA endoleak rate, with three of these type IA endoleaks extending into the aneurysm sac. The reintervention-free survival rate was 85.0% at 1 year in this cohort of 20 patients. Careful follow-up after ch-EVAS is advised because changes are often subtle. The authors have stopped the ch-EVAS procedure so far. Long-term follow-up data on the stability of the Nellix endograft and the consequences of migration on ch-SGs is required before this technique should be used in clinical practice

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

Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms

Objective: In this study, we analyzed the procedural success and early outcome of endovascular treatment of a multicenter cohort of patients with common iliac artery (CIA) aneurysms treated with the new GORE EXCLUDER (W. L. Gore & Associates, Flagstaff, Ariz) iliac branch endoprosthesis (IBE). Methods: A retrospective cohort analysis was performed in 13 sites in The Netherlands. Anatomic, demographic, procedural, and follow-up data were assessed from hospital records. Results: From November 2013 to December 2014, 51 CIA aneurysms were treated with an IBE in 46 patients. The median diameter of the treated aneurysm was 40.5 (range, 25.0-90.0) mm. The mean procedural time was 198 +/- 56 minutes. All but one implantation were successful; two type Ib endoleaks were noticed, resulting in a procedural success rate of 93.5%. The two type Ib endoleaks spontaneously disappeared at 30 days. There was no 30-day mortality. Ipsilateral buttock claudication was present in only two cases at 30 days and disappeared during follow-up. The incidence of reported erectile dysfunction was low and severe ischemic complications were absent. After a mean follow-up of 6 months, data on 17 treated aneurysms were available. Two showed a stable diameter, whereas 15 showed a mean decrease of 3.9 +/- 2.2 mm (P <.001). Reinterventions were performed in two patients (7.1%). The 6-month primary patency of the internal component of the IBE device was 94%. Conclusions: The use of the GORE EXCLUDER IBE device for CIA aneurysms is related to high procedural success, high patency rates, and low reintervention rates at short-term follow-up. Prospective data with longer follow-up are awaited to establish the role of the device in the treatment algorithm of CIA aneurysms