Publications by authors named "Michel M P J Reijnen"

158 Publications

Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair.

J Endovasc Ther 2021 Sep 27:15266028211047941. Epub 2021 Sep 27.

Department of Surgery, Division of Vascular Surgery, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.

Introduction: The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR).

Methods: A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR.

Results: A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%.

Conclusion: There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211047941DOI Listing
September 2021

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

Trials 2021 Sep 19;22(1):639. Epub 2021 Sep 19.

Department of Vascular Surgery, Dijklander ziekenhuis, Maelsonstraat 3, 1624, NP, Hoorn, The Netherlands.

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 < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT 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}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD [email protected] 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD [email protected] 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05552-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449992PMC
September 2021

US Velocimetry in Participants with Aortoiliac Occlusive Disease.

Radiology 2021 11 24;301(2):332-338. Epub 2021 Aug 24.

From the Department of Vascular Surgery, Rijnstate Hospital, Wagnerlaan 55, 6815 AD Arnhem, the Netherlands (S.E., M.v.H., E.G.J., M.M.P.J.R.); Multi-modality Medical Imaging Group (S.E., M.v.H., E.G.J., M.M.P.J.R.) and Physics of Fluids Group (S.E., M.v.H., G.P.R.L., M.V.), Technical Medical (TechMed) Centre, University of Twente, Enschede, the Netherlands; and Department of Biomedical Engineering, Thorax Center, Erasmus MC, Rotterdam, the Netherlands (J.V., J.G.B.).

Background The accurate quantification of blood flow in aortoiliac arteries is challenging but clinically relevant because local flow patterns can influence atherosclerotic disease. Purpose To investigate the feasibility and clinical application of two-dimensional blood flow quantification using high-frame-rate contrast-enhanced US (HFR-CEUS) and particle image velocimetry (PIV), or US velocimetry, in participants with aortoiliac stenosis. Materials and Methods In this prospective study, participants with a recently diagnosed aortoiliac stenosis underwent HFR-CEUS measurements of the pre- and poststenotic vessel segments (August 2018 to July 2019). Two-dimensional quantification of blood flow was achieved by performing PIV analysis, which was based on pairwise cross-correlation of the HFR-CEUS images. Visual inspection of the entire data set was performed by five observers to evaluate the ability of the technique to enable adequate visualization of blood flow. The contrast-to-background ratio and average vector correlation were calculated. In two participants who showed flow disturbances, the flow complexity and vorticity were calculated. Results Thirty-five participants (median age, 67 years; age range, 56-84 years; 22 men) were included. Visual scoring showed that flow quantification was achieved in 41 of 42 locations. In 25 locations, one or multiple issues occurred that limited optimal flow quantification, including loss of correlation during systole ( = 12), shadow regions ( = 8), a short vessel segment in the image plane ( = 7), and loss of contrast during diastole ( = 5). In the remaining 16 locations, optimal quantification was achieved. The contrast-to-background ratio was higher during systole than during diastole (11.0 ± 2.9 vs 6.9 ± 3.4, respectively; < .001), whereas the vector correlation was lower (0.58 ± 0.21 vs 0.47 ± 0.13; < .001). The flow complexity and vorticity were high in regions with disturbed flow. Conclusion Blood flow quantification with US velocimetry is feasible in patients with an aortoiliac stenosis, but several challenges must be overcome before implementation into clinical practice. Clinical trial registration no. NTR6980 © RSNA, 2021
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1148/radiol.2021210454DOI Listing
November 2021

Assessment of fenestrated Anaconda stent graft design by numerical simulation: Results of a European prospective multicenter study.

J Vasc Surg 2021 Aug 20. Epub 2021 Aug 20.

Department of Vascular Surgery, CHU Saint-Etienne, France.

Objective: A crucial step in designing fenestrated stent grafts for treatment of complex aortic abdominal aneurysms is the accurate positioning of the fenestrations. The deployment of a fenestrated stent graft prototype in a patient-specific rigid aortic model can be used for design verification in vitro, but is time and human resources consuming. Numerical simulation (NS) of fenestrated stent graft deployment using the finite element analysis has recently been developed; the aim of this study was to compare the accuracy of fenestration positioning by NS and in vitro.

Methods: All consecutive cases of complex aortic abdominal aneurysm treated with the Fenestrated Anaconda (Terumo Aortic) in six European centers were included in a prospective, observational study. To compare fenestration positioning, the distance from the center of the fenestration to the proximal end of the stent graft (L) and the angular distance from the 0° position (C) were measured and compared between in vitro testing (L1, C1) and NS (L2, C2). The primary hypothesis was that ΔL (|L2 - L1|) and ΔC (|C2 - C1|) would be 2.5 or less mm in more than 80% of the cases. The duration of both processes was also compared.

Results: Between May 2018 and January 2019, 50 patients with complex aortic abdominal aneurysms received a fenestrated stent graft with a total of 176 fenestrations. The ΔL and ΔC was 2.5 mm or less for 173 (98%) and 174 (99%) fenestrations, respectively. The NS process duration was significantly shorter than the in vitro (2.1 days [range, 1.0-5.2 days] vs 20.6 days [range, 9-82 days]; P < .001).

Conclusions: Positioning of fenestrations using NS is as accurate as in vitro and could significantly decrease delivery time of fenestrated stent grafts.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2021.07.225DOI Listing
August 2021

An International, Multicenter Retrospective Observational Study to Assess Technical Success and Clinical Outcomes of Patients Treated with an Endovascular Aneurysm Sealing Device for Type III Endoleak.

J Endovasc Ther 2021 Aug 3:15266028211031933. Epub 2021 Aug 3.

Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands.

Introduction: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR.

Methods: This is an international, retrospective, observational cohort study including data from 8 European institutions.

Results: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5-89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%.

Conclusion: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211031933DOI Listing
August 2021

Survival After Endovascular Aneurysm Sealing Compared With Endovascular Aneurysm Repair.

J Endovasc Ther 2021 10 21;28(5):788-795. Epub 2021 Jun 21.

Department of Radiology, Auckland City Hospital, Auckland, New Zealand.

Introduction: Endovascular aneurysm sealing (EVAS) is a sac-filling device with a blunted systemic inflammatory response compared to conventional endovascular aneurysm repair (EVAR), with a suggested impact on all-cause mortality. This study compares mortality after both EVAS and EVAR.

Materials And Methods: This is a retrospective observational study including data from 2 centres, with ethical approval. Elective procedures on asymptomatic infrarenal aneurysms performed between January 2011 until April 2018 were enrolled. Laboratory values (serum creatinine, haemoglobin, white blood cell count, platelet count) were measured pre- and postoperatively and at 1 and 2 years, respectively. Mortality and cause of death were recorded during follow-up.

Results: A total of 564 patients were included (225 EVAS, 369 EVAR), after propensity score matching there were 207 patients in both groups. Baseline characteristics were similar, except for larger neck angulation and more pulmonary disease in the EVAR group. The median follow-up time was 49 (EVAS) and 44 (EVAR) months. No significant differences regarding creatinine and haemoglobin were observed. Preoperative white blood cell count was higher in the EVAR group (p=0.011), without significant differences during follow-up. Median platelet count was lower in the EVAR group preoperatively (p=0.001), but was significantly higher at 1 year follow-up (p=0.003). There were 43 deaths within the EVAS group (20.8%) and 52 within the EVAR group (25.1%) (p=0.293). Of these, 4 were aneurysm related (EVAS n=3, EVAR n=1; p=0.222) and 14 cardiovascular (EVAS n=6, EVAR n=8, p=0.845). For the EVAS cohort, survival was 95.5% at 1 year and 74.9% at 5 years. For the EVAR cohort, this was 93.3% at 1 year and 75.5% at 5 years. No significant differences were observed in causes of death.

Conclusion: This study showed comparable survival rates through 5 years between EVAS and EVAR with a tendency toward higher inflammatory response in the EVAR patients through the first 2 years.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211025030DOI Listing
October 2021

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

Eur J Vasc Endovasc Surg 2021 08 16;62(2):177-185. Epub 2021 Jun 16.

Department of Surgery, Rijnstate, Arnhem, the Netherlands; Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, the Netherlands. Electronic address:

Objective: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device.

Methods: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up.

Results: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months.

Conclusion: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejvs.2021.04.006DOI Listing
August 2021

Efficacy of an Autologous Blood Patch for Prolonged Air Leak: A Systematic Review.

Ann Thorac Surg 2021 Jun 9. Epub 2021 Jun 9.

Department of Thoracic Surgery, Rijnstate Hospital, Arnhem, Netherlands; Multi-Modality Medical Imaging Group, TechMed Center, University of Twente, Enschede, Netherlands.

Background: Prolonged air leak after pulmonary surgery remains a clinical challenge and sometimes needs surgical reintervention. An autologous blood patch (ABP) may provide a noninvasive method to stop air leak. Its value, however, is debatable. The aim of this systematic review is to synthesize evidence regarding the efficacy of ABP in patients with prolonged air leak.

Methods: A comprehensive search for published studies was performed in the Medline database, Embase, and the Cochrane library. Randomized controlled trials, case-control studies, and case series in which a postoperative ABP was performed were included. Findings from these studies were tabulated and data were synthesized graphically (PROSPERO registration number CRD42020157591).

Results: A total of eight studies was included in the analysis, comprising 151 patients. Studies demonstrated heterogeneity in ABP timing and practice, and an intermediate to high risk of bias was scored. The majority of studies demonstrated a beneficial effect of the ABP, with a high rate of success of more than 89%. One randomized trial did not find a difference in time to cessation of air leak after ABP compared with conservative tube thoracostomy. The overall complication rate was 10%.

Conclusions: Quality of included studies is limited owing to lack of comparison groups. Synthesized data in this review demonstrate a high rate of successful procedures and acceptable complication rates, and seems encouraging enough to justify a large randomized clinical trial on the use of ABP for patients who have prolonged air leak after thoracic surgery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.athoracsur.2021.05.047DOI Listing
June 2021

Hemodynamic Comparison of Stent-Grafts for the Treatment of Aortoiliac Occlusive Disease.

J Endovasc Ther 2021 08 2;28(4):623-635. Epub 2021 Jun 2.

Multi-Modality Medical Imaging (M3I) Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

Purpose: To compare the flow patterns and hemodynamics of the AFX stent-graft and the covered endovascular reconstruction of aortic bifurcation (CERAB) configuration using laser particle image velocimetry (PIV) experiments.

Materials And Methods: Two anatomically realistic aortoiliac phantoms were constructed using polydimethylsiloxane polymer. An AFX stent-graft with a transparent cover made with a new method was inserted into one phantom. A CERAB configuration using Atrium's Avanta V12 with transparent covers made with a previously established method was inserted into the other phantom, both modified stent-grafts were suitable for laser PIV, enabling visualization of the flow fields and quantification of time average wall shear stress (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT).

Results: Disturbed flow was observed at the bifurcation region of the AFX, especially at the end systolic velocity (ESV) time-point where recirculation was noticeable due to vortical flow. In contrast, predominantly unidirectional flow was observed at the CERAB bifurcation. These observations were confirmed by the quantified hemodynamic results from PIV analysis where mean TAWSS of 0.078 Pa (range: 0.009-0.242 Pa) was significantly lower in AFX as compared with 0.229 Pa (range: 0.013-0.906 Pa) for CERAB (p<0.001). Mean OSI of 0.318 (range: 0.123-0.496) in AFX was significantly higher than 0.252 (range: 0.055-0.472) in CERAB (p<0.001). Likewise, mean RRT of 180 Pa (range: 9-3603 Pa) in AFX was also significantly higher than 88 Pa (range: 2-840 Pa) in CERAB (p=0.0086).

Conclusion: In this in vitro study, the flow pattern of a modified AFX stent-graft was found to be more disturbed especially at the end systolic phase, its hemodynamic outcomes less desirable than CERAB configuration.

Clinical Relevance: While the AFX stent-graft has an advantage over the CERAB configuration in eliminating radial mismatch, and maintaining the anatomical bifurcation for future endovascular intervention, this in vitro study revealed that the associated lower TAWSS, higher OSI and RRT may predispose to thrombosis and are, thus, less desirable as compared to a CERAB configuration. Further investigation is warranted to confirm whether these findings translate into the clinical setting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211016431DOI Listing
August 2021

Blood Flow Quantification in Peripheral Arterial Disease: Emerging Diagnostic Techniques in Vascular Surgery.

Surg Technol Int 2021 05;38:294-304

Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands.

The assessment of local blood flow patterns in patients with peripheral arterial disease is clinically relevant, since these patterns are related to atherosclerotic disease progression and loss of patency in stents placed in peripheral arteries, through mechanisms such as recirculating flow and low wall shear stress (WSS). However, imaging of vascular flow in these patients is technically challenging due to the often complex flow patterns that occur near atherosclerotic lesions. While several flow quantification techniques have been developed that could improve the outcomes of vascular interventions, accurate 2D or 3D blood flow quantification is not yet used in clinical practice. This article provides an overview of several important topics that concern the quantification of blood flow in patients with peripheral arterial disease. The hemodynamic mechanisms involved in the development of atherosclerosis and the current clinical practice in the diagnosis of this disease are discussed, showing the unmet need for improved and validated flow quantification techniques in daily clinical practice. This discussion is followed by a showcase of state-of-the-art blood flow quantification techniques and how these could be used before, during and after treatment of stenotic lesions to improve clinical outcomes. These techniques include novel ultrasound-based methods, Phase-Contrast Magnetic Resonance Imaging (PC-MRI) and Computational Fluid Dynamics (CFD). The last section discusses future perspectives, with advanced (hybrid) imaging techniques and artificial intelligence, including the implementation of these techniques in clinical practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
May 2021

The relation between physical fitness, frailty and all-cause mortality after elective endovascular abdominal aortic aneurysm repair.

J Vasc Surg 2021 Oct 1;74(4):1172-1182.e2. Epub 2021 May 1.

Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands; Multi-Modality Medical Imaging group, TechMed Centre, University of Twente, Enschede, The Netherlands. Electronic address:

Background: Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality.

Methods: Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses.

Results: There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho = 0.163; P = .001), but not between the METs and 1-year all-cause mortality (Rho = -0.083; P = .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho = 0.255; P < .001 and Rho = -0.154; P = .004). When stratified by the MFI-5, the 1- and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P = .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P = .090). The 5-year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P = .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution.

Conclusions: There is a significant positive association between the MFI-5 and both the 1- and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2021.04.039DOI Listing
October 2021

Changes in Noninvasive Arterial Stiffness and Central Blood Pressure After Endovascular Abdominal Aneurysm Repair.

J Endovasc Ther 2021 06 9;28(3):434-441. Epub 2021 Apr 9.

Department of Surgery, Ziekenhuis Rijnstate, Arnhem, The Netherlands.

Purpose: To evaluate the impact of elective endovascular aneurysm repair (EVAR) on the carotid-femoral pulse wave velocity (cfPWV) and central pressure waveform, through 1-year follow-up.

Materials And Methods: A tonometric device was used to measure cfPWV and estimate the central pressure waveform in 20 patients with an infrarenal abdominal aortic aneurysm scheduled for elective EVAR. The evaluated central hemodynamic parameters included the central pressures, the augmentation index (AIx), and the subendocardial viability ratio (SEVR). AIx quantifies the contribution of reflected wave to the central systolic pressure, whereas SEVR describes the myocardial perfusion relative to the cardiac workload. Measurements were performed before EVAR, at discharge, and 6 weeks and 1 year after EVAR.

Results: CfPWV was increased at discharge (12.4±0.4 vs 11.3±0.5 m/s at baseline; p=0.005) and remained elevated over the course of 1-year follow-up (6 weeks: cfPWV = 12.2±0.5 m/s; 1 year: cfPWV = 12.2±0.7 m/s, p<0.05). After an initial drop in systolic central pressure at discharge, all the central pressures increased thereafter up to 1 year, without significant differences compared with baseline. The same was observed for the AIx and SEVR.

Conclusion: Endovascular aortic aneurysm repair caused an increase in pulse wave velocity compared with baseline, which remained elevated through 1 year follow-up, which may be related to an increased cardiovascular risk. However, no differences in central pressure, augmentation index, and subendocardial viability ration were observed during follow-up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211007460DOI Listing
June 2021

Remodeling of Abdominal Aortic Angulation and Curvature After Endovascular Aneurysm Repair in Patients With vs Without Late Type Ia Endoleak or Endograft Migration.

J Endovasc Ther 2021 Apr 4;28(2):342-351. Epub 2021 Mar 4.

Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, the Netherlands.

Purpose: To investigate aortic remodeling of the supra- and infrarenal aorta from preoperative to 1 month and midterm follow-up after endovascular aneurysm repair (EVAR) by analyzing changes in angulation and curvature in patients with vs without late type Ia endoleak or device migration.

Materials And Methods: From a multicenter database, 35 patients (mean age 76±5 years; 31 men) were identified with late (>1 year) type Ia endoleak or endograft migration (≥10 mm) and defined as the complication group. The control group consisted of 53 patients (mean age 75±7 years; 48 men) with >1-year computed tomography angiography (CTA) follow-up and no evidence of endoleaks. Suprarenal and infrarenal angles were measured on centerline reconstructions of the preoperative, 1-month, and midterm CTA scans. The value and location relative to baseline of maximum suprarenal and infrarenal curvature were determined semiautomatically using dedicated software. Changes were determined at 1 month compared with the preoperative CTA and at midterm compared with 1 month.

Results: Preoperative suprarenal angulation was significantly greater in the complication group compared to the controls (34°±18° vs 24°±17°, p=0.008). It decreased significantly at 1 month in the complication group (29°±16°, p=0.011) and at midterm follow-up in the controls (20°±19°, p<0.001). Preoperative infrarenal angulation was not significantly different (57°±15° vs 49°±24°, p=0.114). This measurement increased significantly through midterm follow-up in the complication group (63°±23°, p<0.001) but remained stable in the controls (46°±22°). Preoperative suprarenal curvature was not significantly different (38±22 m vs 29±25 m, p=0.115). This variable increased significantly through midterm follow-up in the complication group (44±22 m) but remained constant in the controls (28±22 m). Preoperative infrarenal curvature was significantly greater in the complication group (77±29 m vs 65±28 m, p=0.047) and decreased significantly in both groups during midterm follow-up (50±17 m vs 41±19 m p=0.033). The location of the maximum curvature with regard to baseline shifted significantly distally in the complication group (54±43 to 72±41 mm, p<0.001), while it remained stable in the controls (46±33 to 48±31 mm).

Conclusion: At midterm follow-up, significant differences in supra- and infrarenal angulation and curvature were observed between patients with vs without type Ia endoleak or migration. The location of the maximum curvature shifted distally in patients with complications. The aortic morphology is more stable during midterm follow-up in the patients without endoleaks.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1526602821995831DOI Listing
April 2021

Embolization of the false lumen using IMPEDE-FX embolization plugs as part of treatment of an infrarenal post-dissection aneurysm: a case report.

CVIR Endovasc 2020 Dec 4;3(1):91. Epub 2020 Dec 4.

Department of Surgery, Rijnstate, P.O. Box 9555, 6800, TA, Arnhem, The Netherlands.

Background: This case report demonstrates the value of IMPEDE-FX plugs in an embolization procedure of a false lumen of an infrarenal post-dissection aneurysm.

Case Presentation: A 69-year-old patient was treated with mitral valve replacement, complicated by a Stanford type-A dissection. After 9 years he presented with an enlarging infrarenal post-dissection aneurysm. The false lumen was embolized using multiple IMPEDE-FX plugs as part of the treatment in addition to embolization of the inferior mesenteric artery and overstenting of the re-entry in the right iliac artery. At 15 months the CTA showed a fully thrombosed false lumen and remodeling of the true lumen.

Conclusions: The false lumen of an infrarenal post-dissection aneurysm can successfully be embolized using IMPEDE-FX embolization plugs as part of the treatment strategy. Prospective trials on patients with non-thrombosed false lumina are indicated.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s42155-020-00183-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718367PMC
December 2020

Carotid plaque stenosis, metabolism and flow dynamics: Important determinants of atherosclerotic risk?

J Nucl Cardiol 2020 Sep 10. Epub 2020 Sep 10.

Multi-Modality Medical Imaging Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s12350-020-02311-0DOI Listing
September 2020

Migration After Endovasclar Aneurysm Sealing in Conjunction With Chimney Grafts.

J Endovasc Ther 2021 Feb 10;28(1):165-172. Epub 2020 Sep 10.

Department of Interventional Radiology and Vascular Surgery, Auckland City Hospital, Auckland, New Zealand.

Purpose: To assess the incidence of migration after endovascular aneurysm sealing (EVAS) in conjunction with chimney grafts (chEVAS) for repair of abdominal aortic aneurysms (AAAs).

Materials And Methods: A retrospective, observational cohort study was conducted of 31 patients (mean age 75.7 years; 27 men) treated for juxtarenal AAA between April 2013 and December 2018 at single centers in New Zealand and the Netherlands. The majority of patients received >1 chimney graft (13 single, 13 double, and 5 triple) during chEVAS. Six patients had only the first postoperative scan, so the migration analysis was based on 25 patients.

Results: Median seal length assessed on the first postoperative computed tomography scan was 36.5 mm. The assisted technical success rate was 93.5% with 2 technical failures. Median time to final imaging follow-up was 17 months in 25 patients. At the latest follow-up, there were no cases of caudal migration >10 mm. Freedom from caudal movement of 5 to 9 mm was estimated as 86.1% at 1 year and 73.9% at 2 years; freedom from clinically relevant migration (movement requiring reintervention) was 100% at both time intervals. However, at 3 years there were 2 cases of caudal movement of 5 to 9 mm and a type Ia endoleak warranting reintervention. No correlation between migration and aneurysm growth (p=0.851), endoleak (p=0.562), or the number of chimney grafts (p=0.728) was found. During follow-up, 2 patients (7%) had aneurysm rupture and 10 (33%) had reinterventions. Eight patients (27%) died; 2 were aneurysm-related (7%) and due to the consequences of a reintervention.

Conclusion: In the 2 years following chEVAS, there was no caudal migration >10 mm, but nearly a quarter of patients had caudal movement of 5 to 9 mm. A trend was observed toward ongoing migration that required intervention at 3-year follow-up. chEVAS is technically challenging and should be considered only for patients with no viable alternative treatment option.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1526602820957279DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816544PMC
February 2021

A Late Post-EVAR Rupture in a 102-Year-Old Patient Related to a Type II Endoleak.

Vasc Endovascular Surg 2020 Nov 25;54(8):729-733. Epub 2020 Aug 25.

Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Monterrey, México.

Purpose: Endovascular abdominal aortic aneurysm repair (EVAR) is progressively being applied in the elderly population. Type II endoleaks are common and mostly benign, but they are related to more aneurysm sac expansion after EVAR. They may lead to rupture in <1% of cases. We present a case of a centenarian with a post-EVAR rupture, related to type II endoleak, and discuss the use of EVAR on the management of this type of endoleak in an extremely old patient.

Case Presentation: A 102-year-old man with a history of EVAR 12 years earlier, presented to the emergency department with a drop of consciousness. A computed tomography revealed a ruptured abdominal aortic aneurysm. Angiography showed a type II endoleak related to patent lumbar arteries deriving from collateral branches of the right internal iliac artery. Embolization was not successful and subsequently the ostium of the iliolumbar artery was overstented, obliterating the feeding branch. The postoperative course was complicated by a deterioration of chronic obstructive pulmonary disease and patient was discharged home on the seventh postprocedural day; nonetheless, he died on postoperative day sixteenth due to respiratory complications.

Conclusion: Complications following EVAR are a real threat and emphasize the need for follow-up. The current case report shows that age per se should not be a contraindication for EVAR nor for follow-up. Also, late ruptures due to type II endoleaks could be treated in the very elderly population although larger series are required for robust conclusions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1538574420945447DOI Listing
November 2020

Endograft Conformability in Fenestrated Endovascular Aneurysm Repair for Complex Abdominal Aortic Aneurysms.

J Endovasc Ther 2020 10 22;27(5):848-856. Epub 2020 Jun 22.

Department of Surgery, Rijnstate, Arnhem, the Netherlands.

To compare the impact of 2 commercially available custom-made fenestrated endografts on patient anatomy. The records of 234 patients who underwent fenestrated endovascular aneurysm repair for abdominal aortic aneurysm from March 2002 to July 2016 in 2 hospitals were screened to identify those who had pre- and postoperative computed tomography angiography assessments with a slice thickness of ≤2 mm. The search identified 145 patients for further analysis: 110 patients (mean age 72.4±7.1 years; 94 men) who had been treated with the Zenith Fenestrated (ZF) endograft and 35 patients (mean age 72.3±7.3 years; 30 men) treated with the Fenestrated Anaconda (FA) endograft. Measurements included aortic diameters at the level of the superior mesenteric artery (SMA) and renal arteries, target vessel angles, target vessel clock positions, and the target vessel tortuosity index. Variables were tested for inter- and intraobserver agreement. There was a good agreement between observers in all tested variables. The native anatomy changed in both groups after endograft implantation. In the ZF group, changes were seen in the angles of the celiac artery (p=0.012), SMA (p=0.022), left renal artery (LRA) (p<0.001), and the right renal artery (RRA) (p<0.001); the aortic diameter at the SMA level (p<0.001); and the LRA (p<0.001) and RRA (p<0.001) clock positions. In the FA group, changes were seen in the angles of the LRA (p=0.001) and RRA (p<0.001) and in the SMA tortuosity index (p=0.044). Between group differences in changes were seen for the aortic diameters at the SMA and renal artery levels (p<0.001 for both) and the LRA clock position (p=0.019). Both custom-made fenestrated endografts altered vascular anatomy. The data suggest a higher conformability of the Fenestrated Anaconda endograft compared with the Zenith Fenestrated.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1526602820936185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536524PMC
October 2020

Physiological Appearance of Hybrid FDG-Positron Emission Tomography/Computed Tomography Imaging Following Uncomplicated Endovascular Aneurysm Sealing Using the Nellix Endoprosthesis.

J Endovasc Ther 2020 06 15;27(3):509-515. Epub 2020 Apr 15.

Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands.

To investigate the physiological uptake of hybrid fluorine-18-fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) before and after an uncomplicated endovascular aneurysm sealing (EVAS) procedure as a possible tool to diagnose EVAS graft infection and differentiate from postimplantation syndrome. Eight consecutive male patients (median age 78 years) scheduled for elective EVAS were included in the prospective study ( identifier NCT02349100). FDG-PET/CT scans were performed in all patients before the procedure and 6 weeks after EVAS. The abdominal aorta was analyzed in 4 regions: suprarenal, infrarenal neck, aneurysm sac, and iliac. The following parameters were obtained for each region: standard uptake value (SUV), tissue to background ratio (TBR), and visual examination of FDG uptake to ascertain its distribution. Demographic data were obtained from medical files and scored based on reporting standards. Visual examination showed no difference between pre- and postprocedure FDG uptake, which was homogenous. In the suprarenal region no significant pre- and postprocedure differences were observed for the SUV and TBR parameters. The infrarenal neck region showed a significant decrease in the SUV and no significant decrease in the TBR. The aneurysm sac and iliac regions both showed a significant decrease in SUV and TBR between the pre- and postprocedure scans. Physiological FDG uptake after EVAS was stable or decreased with regard to the preprocedure measurements. Future research is needed to assess the applicability and cutoff values of FDG-PET/CT scanning to detect endograft infection after EVAS.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1526602820913888DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288856PMC
June 2020

Electrocardiography-gated computed tomography angiography analysis of cardiac pulsatility-induced motion and deformation after endovascular aneurysm sealing with chimney grafts.

J Vasc Surg 2020 11 2;72(5):1743-1752.e5. Epub 2020 Apr 2.

Multimodality Medical Imaging M3i Group, Faculty of Science and Technology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands.

Objective: To evaluate the proximal stability of the chimney endovascular aneurysm sealing configuration (chEVAS) during the cardiac cycle by investigating the cardiac pulsatility-induced movement and deformation.

Methods: We retrospectively analyzed postoperative electrocardiogram-gated computed tomography angiography scans of 11 chEVAS cases (9 primary chEVAS plus 2 chEVAS-in-chEVAS). ChEVAS procedures were conducted between September 2013 and June 2016. Motion and deformation of the EVAS stents, the chimney grafts, and the stented branch vessels were evaluated during the cardiac cycle using an established combination of image registration and segmentation techniques.

Results: Electrocardiogram-gated computed tomography angiography scans of 11 chEVAS configurations including 22 EVAS stents and 20 chimney grafts were analyzed. The three-dimensional displacement was at most 1.7 mm for both the EVAS stents and the chimney grafts. The maximum change in distance between components was no more than 0.4 mm and did not differ between EVAS-to-EVAS stent and EVAS stent-to-chimney stent (0.2 ± 0.1 mm vs 0.2 ± 0.1 mm; P = .823). The mean change in chimney deflection angle was 1.2 ± 0.7°; the maximum change was greatest for the superior mesenteric artery (SMA) (2.6°). The EVAS stent-to-chimney angles for the left renal artery, right renal artery, and SMA varied on average by 0.7 ± 0.3° (range, 0.4°-1.3°), 1.0 ± 0.3° (range, 0.5°-1.7°), and 0.8 ± 0.4° (range, 0.3°-1.3°), respectively, during the cardiac cycle. The end-stent angles for the left renal artery, right renal artery, and SMA varied on average by 1.7 ± 0.9° (range, 0.5°-3.3°), 1.9 ± 0.8° (range, 0.7°-3.3°), and 1.3 ± 0.4° (range, 0.7°-1.6°), respectively, during the cardiac cycle. Overall, the end-stent angles varied on average by 1.7 ± 0.8° (range, 0.5°-3.3°).

Conclusions: The chEVAS configuration proved to be stable during the cardiac cycle, as demonstrated by minimal cyclical changes in distance between device components and angulation between the EVAS stents and the chimney grafts. The limited deflection angles of the chimney grafts decrease the risk of bending fatigue, but the more apparent change in end-stent angle distal to the chimney graft may raise concerns regarding late branch occlusion or stenosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2020.01.064DOI Listing
November 2020

A novel roller pump for physiological flow.

Artif Organs 2020 Aug 25;44(8):818-826. Epub 2020 Mar 25.

Multi-Modality Medical Imaging (M3I) Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

Having physiological correct flow waveforms is a key feature for experimental studies of blood flow, especially in the process of developing and testing a new medical device such as stent, mechanical heart valve, or any implantable medical device that involves circulation of blood through the device. It is also a critical part of a perfusion system for cardiopulmonary bypass and extracorporeal membrane oxygenation procedures. This study investigated the feasibility of a novel roller pump for use in experimental flow phantoms. Flow rates of carotid flow profile measured directly with the ultrasonic flow meter matched well with the reference flow rates programmed into the machine with similarity index of 0.97 and measured versus programmed flow rates at specific time-points of peak systolic velocity (PSV): 0.894 vs 0.880, end systolic velocity (ESV): 0.333 vs 0.319, and peak diastolic velocity (PDV): 0.514 vs 0.520 L/min. Flow rates derived from video analysis of the pump motion for carotid, suprarenal, and infrarenal flows also matched well with references with similarity indices of 0.99, 0.99, and 0.96, respectively. Measured flow rates (mean/standard deviation) at PSV, ESV, and PDV time-points for carotid: 0.883/0.016 vs 0.880, 0.342/0.007 vs 0.319, and 0.485/0.009 vs 0.520; suprarenal: 3.497/0.014 vs 3.500, 0.004/0.003 vs 0, and 1.656/0.073 vs 1.453; infrarenal: 4.179/0.024 vs 4.250, -1.147/0.015 vs -1.213, and 0.339/0.017 vs 0.391 L/min, respectively. The novel roller pump is suitable for benchtop testing of physiological flow.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/aor.13670DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496437PMC
August 2020

Outcomes after treatment of complex aortic abdominal aneurysms with the fenestrated Anaconda endograft.

J Vasc Surg 2020 07 9;72(1):25-35.e1. Epub 2019 Dec 9.

Department of Surgery, Rijnstate, Arnhem, The Netherlands; Multimodality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, The Netherlands. Electronic address:

Objective: To date, information on the fenestrated Anaconda endograft is limited to case series with a small sample size. This study was performed to assess the technical and clinical outcome of this device in a large international case series.

Methods: All worldwide centers having treated more than 15 complex abdominal aortic aneurysms (AAA) or type IV thoracoabdominal aortic aneurysm patients with the fenestrated Anaconda endograft were approached. Main outcome parameters were procedural technical success, postoperative and follow-up clinical outcome for endoleaks, target vessel patency, reintervention rate, and patient survival.

Results: Three hundred thirty-five consecutive cases treated between June 2010 and May 2018 in 11 sites were included. Patients were treated for a short neck infrarenal (n = 98), juxtarenal (n = 191), suprarenal AAA (n = 27), or type IV thoracoabdominal aortic aneurysm (n = 19). Mean age was 73.6 ± 4.6 years (292 male). Endografts contained a total of 920 fenestrations, with a mean of 2.7 ± 0.8 fenestrations per case. Technical success was 88.4% (primary, 82.7%; assisted primary 5.7%). In 6.9% of cases, a procedural type IA endoleak was observed, spontaneously disappearing in 82.6% during early follow-up. The development of a type IA endoleak was associated with greater neck angulation (odds ratio [OR], 0.94; P = .01), three fenestrations (OR, 42.7; P = .01) and the presence of augmented proximal rings (OR, 0.17; P = .03). Median follow-up was 1.2 years (interquartile range, 0.4-2.6). The mean estimated glomerular filtration rate deteriorated from 67.6 ± 19.3 mL/min/1.73 m preoperatively to 59.3 ± 22.7 mL/min/1.73 m at latest follow-up (P = .00). The freedom from AAA growth were 97.9 ± 0.9% (n = 190) and 86.4 ± 3.0% (n = 68), with a freedom from AAA rupture of 99.7 ± 0.3% (n = 191) and 99.1 ± 0.7% (n = 68), at 1 and 3 years, respectively. The endoleak-free survival, excluding spontaneously resolved procedural endoleaks, at 1 and 3 years was 73.4 ± 2.6 (n = 143) and 65.6 ± 3.4% (n = 45), respectively. The target vessel patency at one and three years were 96.4 ± 0.7% (n = 493) and 92.7 ± 1.4% (n = 156), respectively. A total of 75 reinterventions were done in 64 cases (19.1%), of which 25 cases for an endoleak. The reintervention-free survival at 1 and 3 years were 83.6 ± 2.2% (n = 190) and 71.0 ± 3.7% (n = 68), respectively. No deaths during procedure, extending within 24 hours postoperatively, were observed. Within 30 days 14 patients (4.2%) died and during follow-up another 39 patients (11.6%) died. Three deaths were considered AAA related (one rupture, one endograft infection, and one bilateral renal artery occlusion). The estimated cumulative survival at 1 and 3 years were 89.8 ± 1.8% (n = 191) and 79.2 ± 3.0% (n = 68), respectively.

Conclusions: The custom-made fenestrated Anaconda endograft is a valuable option for the treatment of a complex AAA. A procedural type IA endoleak is seen relatively frequently, but spontaneously resolves in most cases.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2019.08.283DOI Listing
July 2020

Quantitative Stent Graft Motion in ECG Gated CT by Image Registration and Segmentation: In Vitro Validation and Preliminary Clinical Results.

Eur J Vasc Endovasc Surg 2019 Nov 20;58(5):746-755. Epub 2019 Sep 20.

Multi-modality Medical Imaging (M3I) group, Faculty of Science and Technology, Technical Medical Centre, University of Twente, Enschede, the Netherlands; Department of Vascular Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.

Objectives: The dynamic endovascular environment of stent grafts may influence long term outcome after endovascular aneurysm repair (EVAR). The sealing and fixation of a stent graft to the aortic wall is challenged at every heartbeat, yet knowledge of the cardiac induced dynamics of stent grafts is sparse. Understanding the stent-artery interaction is crucial for device development and may aid the prediction of failure in the individual patient. The aim of this work was to establish quantitative stent graft motion in multiphasic electrocardiogram (ECG) gated computed tomography (CT) by image registration and segmentation techniques.

Methods: Experimental validation was performed by evaluating a series of ECG gated CT scans of a stent graft moving at different amplitudes of displacement at different virtual heart rates using a motion generating device with synchronised ECG triggering. The methodology was further tested on clinical data of patients treated with EVAR devices with different stent graft designs. Displacement during the cardiac cycle was analysed for points on the fixating stent rings, the branches or fenestrations, and the spine.

Results: Errors for the amplitude of displacement measured in vitro at individual points on the wire frame were at most 0.3 mm. In situ cardiac induced displacement of the devices was found to differ per location and also depended on the type of stent graft. Displacement during the cardiac cycle was greatest in a fenestrated device and smallest in a chimney graft sac anchoring endosystem, with maximum displacement varying from 0.0 to 1.4 mm. There was no substantial displacement measurable in the spine.

Conclusions: A novel methodology to quantify and visualise stent graft motion in multiphasic ECG gated CT has been validated in vitro and tested in vivo. This methodology enables further exploration of in situ motion of different stent grafts and branch stents and their interaction with native vessels.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejvs.2019.03.009DOI Listing
November 2019

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data.

J Vasc Surg 2020 03 20;71(3):780-789. Epub 2019 Aug 20.

the Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands; Multimodality Imaging Group, Faculty of Science and Technology, University of Twente, Enschede, The Netherlands.

Objective: The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date.

Methods: Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak.

Results: Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up.

Conclusions: In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2019.04.486DOI Listing
March 2020

[Cystic adventitial degeneration of the radial artery: wrist swelling of unexpected origin].

Ned Tijdschr Geneeskd 2019 08 19;163. Epub 2019 Aug 19.

Rijnstate ziekenhuis, afd. Heelkunde, Arnhem.

BACKGROUND Cystic adventitial degeneration (CAD) of an artery is a rare disease in which a mucinous cyst is formed in the adventitia. The condition usually occurs in the popliteal artery, but in rarer cases in arteries of the forearm, where it may lead to symptoms caused by local swelling or arterial occlusion. CASE DESCRIPTION A 54-year-old woman was referred by her general practitioner for a wrist swelling. This was initially thought to be caused by a ganglion but after ultrasound and MRI, it was found to be CAD of the radial artery. The symptoms recurred after transcutaneous aspiration of the cyst. This was followed by surgical resection with venous graft reconstruction. CONCLUSION In rare cases, swelling of the wrist is caused by CAD. Ultrasound and, if necessary, MRI will lead to a reliable diagnosis. Treatment consists of transcutaneous aspiration and, in case of recurrence, surgical resection.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2019

Haemodynamics in Different Flow Lumen Configurations of Customised Aortic Repair for Infrarenal Aortic Aneurysms.

Eur J Vasc Endovasc Surg 2019 05 15;57(5):709-718. Epub 2019 Apr 15.

Multimodality Medical Imaging M3i Group, Technical Medical Centre, University of Twente, the Netherlands.

Objective: Customised aortic repair (CAR) is a new and minimally invasive technique for the endovascular treatment of abdominal aortic aneurysms (AAAs). The aneurysm is completely sealed with a non-contained, non-cross linked polymer, while a new flow lumen is created with balloons. For CAR, the haemodynamically most favourable balloon and flow lumen configuration has not been established before; therefore, four flow parameters were assessed in an in vitro model.

Methods: Three in vitro balloon configurations were implanted in an in vitro AAA model; a configuration with crossing balloons (CC) and two parallel configurations (PC1 and PC2). These three models were consecutively placed in a flow system that mimics physiological flow conditions. Laser particle imaging velocimetry (PIV) was used to resolve spatial and temporal flow patterns during the cardiac cycle. In house built algorithms were used to analyse the PIV data for the computing of (i) flow velocity; (ii) vorticity; (iii) wall shear stress (WSS); and (iv) time averaged wall shear stress (TAWSS).

Results: Suprarenal flow patterns were similar in all models. The CC showed a higher infrarenal velocity than PC1 and PC2 (38 cm/s vs. 23 cm/s vs. 23 cm/s), and a higher vorticity at the crossing of the lumens (CC: 337/s; PC1 127/s; PC2: 112/s). The lowest vorticity was observed in PC2, especially in the infrarenal neck (CC: 200/s; PC1 164/s; PC2: 98/s). Although WSS and TAWSS varied between configurations, values were in the within non-pathological range.

Conclusion: The flow lumens created by three balloon configurations used in an in vitro model of CAR have been studied, and resulted in different haemodynamics. The differences in velocity and lower vorticity, especially at the crossing section of the two balloons, showed that PC2 has favourable haemodynamics compared with the CC and PC1. Future research will be focused on the clinical applicability of CAR based on the PC2 design.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejvs.2018.11.012DOI Listing
May 2019

Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial).

J Vasc Surg Venous Lymphat Disord 2019 05;7(3):364-374

Department of Surgery, Rijnstate, Arnhem, The Netherlands. Electronic address:

Objective: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear.

Methods: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended.

Results: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae.

Conclusions: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvsv.2018.12.014DOI Listing
May 2019

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

J Vasc Surg 2019 10 29;70(4):1099-1106. Epub 2019 Mar 29.

Department of Vascular Surgery, Rijnstate Hospital, Arnhem, The Netherlands.

Background: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA).

Methods: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand.

Results: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions.

Conclusions: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2019.01.044DOI Listing
October 2019

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study.

J Endovasc Ther 2019 06 1;26(3):305-315. Epub 2019 Apr 1.

1 Department of Vascular Surgery, Rijnstate, Arnhem, the Netherlands.

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296).

Materials And Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI).

Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups.

Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1526602819839044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6628633PMC
June 2019

Geometric changes over time in bridging stents after branched and fenestrated endovascular repair for thoracoabdominal aneurysm.

J Vasc Surg 2019 Sep 2;70(3):702-709. Epub 2019 Mar 2.

Division of Vascular Surgery, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Objective: The objective of this study was to assess long-term durability of bridging stents in branched and combined branched and fenestrated endovascular aneurysm repair (B/F-EVAR) for thoracoabdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm.

Methods: A retrospective database analysis was performed of patients treated by B/F-EVAR for TAAA. Computed tomography angiography images were analyzed to assess patency, bridging stent angulation and migration, aneurysm diameter, and migration of the endograft.

Results: Twenty-eight patients with a median age of 70 years (interquartile range [IQR], 67-77 years) were included. Assisted technical success was 89%. Within 30 days postoperatively, five patients died. In the remaining 23 patients, median follow-up was 5.3 years (IQR, 2.9-7.2 years), and 1-, 3-, and 5-year estimated overall survival was 69%, 65%, and 44%, respectively. During follow-up, 12 of 47 (26%) branches occluded and 5 of 47 (11%) branches developed a 70% to 99% stenosis. The 1-, 3-, and 5-year estimated freedom from adverse events was 78%, 76%, and 59% for branch stents and 100%, 96%, and 90% for fenestration stents, respectively. The median distal bridging stent migration was 0.5 mm (IQR, -1.9 to 1.4; P > .05 mm). In 10 branches, migration >10 mm was seen, ranging from 14.1 mm sliding in to 23.0 mm sliding out. The angulation between branch and stent became 4 degrees more angulated (IQR, -14 to +2 degrees). In 23 branches, the angulation changed 10 degrees or more, leading to an occlusion in 7 branches, a 70% to 99% stenosis in 3 branches, and a 50% to 70% stenosis in 4 branches. In three cases, the endograft migrated >5 mm caudally, with a breach in a fenestration stent in one and a breach in a branch stent in another.

Conclusions: The anatomic configuration of branches in B/F-EVAR of TAAAs and pararenal abdominal aortic aneurysms changes over time. The change in angle of branches and the bridging stent influences the likelihood of stenosis and occlusion. Follow-up of B/F-EVAR should include computed tomography angiography measurements of aortic diameter, endograft migration, target vessel stent length, and angulation to detect disconnection, stenosis, and occlusion.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jvs.2018.12.023DOI Listing
September 2019
-->