Publications by authors named "Jan M M Heyligers"

26 Publications

  • Page 1 of 1

Nationwide experience with EVAS relining of previous open or endovascular AAA treatment in the Netherlands.

Ann Vasc Surg 2022 Jan 5. Epub 2022 Jan 5.

Department of Vascular Surgery, Maastricht University Medical Center and CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands. Electronic address:

Objective: Relining of a previously placed surgical graft or endograft for an abdominal aortic aneurysm (AAA) is a reintervention to treat progression of disease or failure of the primary (endo)graft. Endovascular Aneurysm Sealing (EVAS) relining is a technique with potential advantages due to the absence of a bifurcation, the possibility for a unilateral approach, and sealing concept of the endobags. The purpose of this study was to describe the nationwide experience with EVAS relining of previous AAA repair in the Netherlands.

Methods: A retrospective analysis of all patients who underwent EVAS relining in seven high volume vascular centres in the Netherlands between 2014 and 2019 was performed. Primary outcomes were technical and clinical success. Secondary outcomes were perioperative outcomes, complications and survival.

Results: Thirty-three patients underwent EVAS relining of open (n=10) or endovascular (n=23) repair. Twenty-six were elective cases, five were urgent and two were acute (ruptured). Mean time between primary treatment and EVAS relining was 99±74 months. Indications after open repair were proximal progression of disease (n=7) and graft defect (n=3). Indications after EVAR were type IA (n=10), type IB (n=3), type IIIA (n=4), type IIIB (n=3) endoleak, and endotension (n=3). Eighteen patients underwent regular EVAS, four unilateral EVAS and 11 chimney-EVAS. In-hospital mortality was 6% (both patients with rAAA). Technical success was achieved in 97%. Median follow-up after EVAS relining was 20 months (range 0-43). Freedom from reintervention at one-year and two-year were 83% and 61% and the estimated survival 79% and 71%, respectively. EVAS relining after open repair had a clinical success of 90% at one-year and of 70% at latest follow-up, while after EVAR clinical success rates were 70% and 52%, respectively.

Conclusion: EVAS relining of previous AAA repair is associated with high technical success, however with low clinical success at median follow-up of 20 months. Clinical success was higher in patients with EVAS relining after open repair than after EVAR. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated.
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http://dx.doi.org/10.1016/j.avsg.2021.12.077DOI Listing
January 2022

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

Comparison of segmentation software packages for in-hospital 3D print workflow.

J Med Imaging (Bellingham) 2021 May 30;8(3):034004. Epub 2021 Jun 30.

Elisabeth-Tweesteden Hospital, Department of Surgery, Tilburg, Noord-Brabant, The Netherlands.

In-hospital three-dimensional (3D) printing of patient-specific pathologies is increasingly being used in daily care. However, the efficiency of the current conversion from image to print is often obstructed due to limitations associated with segmentation software. Therefore, there is a need for comparison of several clinically available tools. A comparative study has been conducted to compare segmentation performance of Philips IntelliSpace Portal (PISP), Mimics Innovation Suite (MIS), and DICOM to PRINT (D2P). These tools were compared with respect to segmentation time and 3D mesh quality. The dataset consisted of three computed tomography (CT)-scans of acetabular fractures (ACs), three CT-scans of tibia plateau fractures (TPs), and three CTA-scans of abdominal aortic aneurysms (AAAs). Independent-samples -tests were performed to compare the measured segmentation times. Furthermore, 3D mesh quality was assessed and compared according to representativeness and usability for the surgeon. Statistically significant differences in segmentation time were found between PISP and MIS with respect to the segmentation of ACs ( ) and AAAs ( ). Furthermore, statistically significant differences in segmentation time were found between PISP and D2P for segmentations of AAAs ( ). There were no statistically significant differences in segmentation time for TPs. The accumulated mesh quality scores were highest for segmentations performed in MIS, followed by D2P. Based on segmentation time and mesh quality, MIS and D2P are capable of enhancing the in-hospital 3D print workflow. However, they should be integrated with the picture archiving and communication system to truly improve the workflow. In addition, these software packages are not open source and additional costs must be incurred.
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http://dx.doi.org/10.1117/1.JMI.8.3.034004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242153PMC
May 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.
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http://dx.doi.org/10.1016/j.ejvs.2021.04.006DOI Listing
August 2021

Physical Activity in Patients with Symptomatic Peripheral Artery Disease: Insights from the PORTRAIT Registry.

Eur J Vasc Endovasc Surg 2020 12 21;60(6):889-895. Epub 2020 Jul 21.

Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.

Objective: A physically active lifestyle reduces the risk of cardiovascular events and functional impairment in patients with peripheral artery disease (PAD). There are limited data on the patterns of physical activity in patients with PAD compared between countries.

Methods: Self reported physical activity (sedentary vs. not) was obtained at enrolment, 3, 6, and 12 months in the US and Netherlands' cohorts of the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry of patients with new or worsening claudication. Multivariable repeated measures using modified Poisson regression analysis compared the proportion of sedentary participants over time between countries to identify factors that attenuate intercountry differences.

Results: Of 1 098 participants, 743 (67.7%) and 355 (32.3%) were recruited from the USA and the Netherlands respectively. Compared with the Netherlands, participants from the US were older (mean age 68.6 vs. 65.3 years; p < .001), more obese (41.3% vs. 20.5%; p < .001), and more likely to be female (41.3% vs. 31.4%; p = .002). There were fewer current smokers (30.1% vs. 52.8%; p < .001) and supervised exercise referrals (1.6% vs. 63.9%; p < .001) in the US compared with the Netherlands. US participants were more sedentary at baseline (43.7% vs. 34.1%; p < .001). Sedentary behaviour decreased after three months in both countries, then diverged with an increase in sedentary participants in the USA. Risk of sedentary behaviour was significantly greater in the USA compared with the Netherlands at 12 months, after adjustment of sociodemographic, lifestyle factors, and comorbidities (relative risk [RR] 1.56, 95% confidence interval [CI] 1.08-2.25; p = .020) but was attenuated after accounting for referral to supervised exercise (RR 1.20, 95% CI 0.67-2.16; p = .54).

Conclusion: Referral to supervised exercise was key in explaining the observed difference in the physical activity levels between patients with PAD in the USA and the Netherlands. Further promotion of supervised exercise for PAD may improve physical activity in patients with PAD and modify cultural norms of inactivity in the US.
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http://dx.doi.org/10.1016/j.ejvs.2020.06.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749016PMC
December 2020

Eagle Syndrome: A Unique Cause of Carotid Bleeding.

JACC Case Rep 2020 Mar 18;2(3):449-453. Epub 2020 Mar 18.

Department of Vascular Surgery, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.

Eagle syndrome is a rare aggregate of symptoms caused by an elongated styloid process. We present the unique case of bilateral vascular Eagle syndrome in a patient who experienced a unilateral acute swelling due to bleeding at the level of the right internal carotid artery. This complication has never been described before. ().
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http://dx.doi.org/10.1016/j.jaccas.2019.12.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311603PMC
March 2020

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

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing.

J Endovasc Ther 2018 Dec 25;25(6):719-725. Epub 2018 Oct 25.

1 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU).

Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3).

Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690).

Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.
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http://dx.doi.org/10.1177/1526602818808296DOI Listing
December 2018

Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.

J Vasc Surg 2019 02 29;69(2):367-377.e1. Epub 2018 Jul 29.

Division of Vascular Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc.

Background: We report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

Methods: From 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years.

Results: GREAT patients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREAT patients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREAT patients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREAT patients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression.

Conclusions: Midterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.
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http://dx.doi.org/10.1016/j.jvs.2018.05.200DOI Listing
February 2019

Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck.

J Endovasc Ther 2018 Aug 22;25(4):428-434. Epub 2018 May 22.

1 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.

Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology.

Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 - Q1).

Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066).

Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.
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http://dx.doi.org/10.1177/1526602818777494DOI Listing
August 2018

Two-Year Outcomes of the Nellix EndoVascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms.

J Endovasc Ther 2018 Jun 29;25(3):270-281. Epub 2018 Mar 29.

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

Purpose: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU).

Methods: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version.

Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences.

Conclusion: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.
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http://dx.doi.org/10.1177/1526602818766864DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967009PMC
June 2018

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.

J Endovasc Ther 2017 Dec 10;24(6):783-792. Epub 2017 Aug 10.

2 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.

Purpose: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.

Methods: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.

Results: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.

Conclusion: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.
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http://dx.doi.org/10.1177/1526602817725062DOI Listing
December 2017

Patient-specific Rehearsal Before EVAR: Influence on Technical and Nontechnical Operative Performance. A Randomized Controlled Trial.

Ann Surg 2016 Nov;264(5):703-709

*Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium†Department of Vascular Surgery, Zurich University Hospital, Zurich, Switzerland‡Department of Vascular and Thoracic Surgery, St. Maarten Hospital, Duffel, Belgium§Department of Surgery and Cancer, Imperial College London, UK¶Department of Vascular Surgery, St. Elisabeth Hospital, Tilburg, The Netherlands||Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.

Objective: To assess the effect of patient-specific virtual reality rehearsal (PsR) before endovascular infrarenal aneurysm repair (EVAR) on technical performance and procedural errors.

Background: Endovascular procedures, including EVAR, are executed in a complex multidisciplinary environment, often treating high-risk patients. Consequently, this may lead to patient harm and procedural inefficiency. PsR enables the endovascular team to evaluate and practice the case in a virtual environment before treating the real patient.

Methods: A multicenter, prospective, randomized controlled trial recruited 100 patients with a nonruptured infrarenal aortic or iliac aneurysm between September 2012 and June 2014. Cases were randomized to preoperative PsR or standard care (no PsR). Primary outcome measures were errors during the real procedure and technical operative metrics (total endovascular and fluoroscopy time, contrast volume, number of angiograms, and radiation dose).

Results: There was a 26% [95% confidence interval (CI) 9%-40%, P = 0.004) reduction in minor errors, a 76% (95% CI 30%-92%, P = 0.009) reduction in major errors, and a 27% (95% CI 8.2%-42%, P = 0.007) reduction in errors causing procedural delay in the PsR group. The number of angiograms performed to visualize proximal and distal landing zones was 23% (95% CI 8%-36%, P = 0.005) and 21% (95% CI 7%-32%, P = 0.004) lower in the PsR group.

Conclusions: PsR before EVAR can be used in different hospital settings by teams with various EVAR experience. It reduces perioperative errors and the number of angiograms required to deploy the stent graft, thereby reducing delays. Ultimately, it may improve patient safety and procedural efficiency.
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http://dx.doi.org/10.1097/SLA.0000000000001871DOI Listing
November 2016

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

J Vasc Surg 2016 Jun;63(6):1451-7

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

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.
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http://dx.doi.org/10.1016/j.jvs.2016.01.021DOI Listing
June 2016

Vascular access outcome in the elderly dialysis patient in combination with the quality of life.

Vasc Endovascular Surg 2013 Aug 12;47(6):444-8. Epub 2013 Jul 12.

Department of Surgery, Amphia Hospital, Breda, The Netherlands.

Purpose: We performed a retrospective study on hemodialysis fistulae in patients aged 75 years and older.

Methods: Dialysis records of 2 hospitals were searched for patients of 75 years and older who had primary autologous radiocephalic arteriovenous fistulae (RCAVFs) and brachiocephalic arteriovenous fistulae (BCAVFs). Outcome measures were primary, primary-assisted, and secondary patency rates. Also, quality of life (QOL) was measured.

Results: A total of 107 fistulae were placed in 90 patients; 65 (61%) RCAVFs and 42 (39%) BCAVFs were created. The primary patency rate (P = .026) and the primary-assisted patency rate (P = .016) of BCAVFs were significantly higher than that of RCAVFs. Secondary patency rates at 1 year (P = .01) and 2 years (P = .035) were higher in BCAVFs than in RCAVFs.

Conclusions: The BCAVFs give significantly higher primary and primary-assisted patency rates and also significantly higher secondary patency rates at 1 and 2 years. Therefore, we suggest the placement of elbow fistulae in the elderly patients. The QOL was surprisingly high in this population despite a high mortality rate.
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http://dx.doi.org/10.1177/1538574413495464DOI Listing
August 2013

Randomized trial of Legflow(®) paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial.

Trials 2013 Mar 28;14:87. Epub 2013 Mar 28.

Department of Vascular Surgery, St. Antonius Hospital, PO box 2500, Nieuwegein, EM 3430, The Netherlands.

Background: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.

Methods/design: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.

Discussion: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.

Trial Registration: ISRCTN47846578.
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http://dx.doi.org/10.1186/1745-6215-14-87DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3651710PMC
March 2013

Report of two in situ reconstructions with a saphenous spiral vein graft of Coxiella burnetii-infected aneurysms of the abdominal aorta.

J Vasc Surg 2013 Jan 20;57(1):234-7. Epub 2012 Nov 20.

Department of Vascular Surgery, St Elisabeth Hospital, Tilburg, The Netherlands.

Coxiella burnetii is a rare cause of vascular infections. Yet, Q fever is endemic in the southern part of The Netherlands. This report describes two patients--from the southern part of The Netherlands--with infected aneurysms of the abdominal aorta caused by Coxiella burnetii. Both patients underwent surgical debridement, in situ reconstruction with a great saphenous vein spiral graft, and a transmesenteric omentumplasty. One patient fully recovered, while the other died due to ischemic complications. A multidisciplinary work-up approach to treat infected abdominal aneurysms is proposed, including adequate surgical treatment and long-term antibiotic administration.
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http://dx.doi.org/10.1016/j.jvs.2012.08.042DOI Listing
January 2013

Accidental introduction of a peel-away sheath during endovascular repair of an infrarenal abdominal aortic aneurysm.

J Vasc Surg 2012 Sep;56(3):833

Department of Vascular Surgery, St Elisabeth Hospital, Tilburg, The Netherlands.

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http://dx.doi.org/10.1016/j.jvs.2012.04.043DOI Listing
September 2012

Infected abdominal aneurysm due to Salmonella sepsis: report of a unique case treated using the superficial femoral vein.

Ann Vasc Surg 2012 Feb;26(2):279.e5-7

Department of Vascular Surgery, St. Elisabeth Hospital, Tilburg, The Netherlands.

We describe a 61-year-old patient with an infected aneurysm of the abdominal aorta due to Salmonella sepsis. Treatment was successful and included aneurysm resection, extensive debridement, and reconstruction of the abdominal aorta using the superficial femoral vein, combined with long-term antibiotic therapy.
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http://dx.doi.org/10.1016/j.avsg.2011.06.013DOI Listing
February 2012

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

J Vasc Surg 2011 Jun 5;53(6):1738-41. Epub 2011 Feb 5.

Department of Surgery, St. Elisabeth Hospital, Tilburg, The Netherlands.

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.
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http://dx.doi.org/10.1016/j.jvs.2010.11.108DOI Listing
June 2011

[Treatment of acute aortic dissection type B].

Ned Tijdschr Geneeskd 2010 ;154:B460

Universitair Medisch Centrum Utrecht, Afd. Heelkunde, Utrecht, The Netherlands.

Four patients presented with an acute type B aortic dissection. All were managed medically. However, three of the four patients needed additional invasive treatment. A 67-year-old patient was given a spinal catheter because of neurological symptoms. A 57-year-old patient underwent endovascular fenestration of the right renal artery and stenting of the iliac arteries to treat acute ischemia. In a 71-year-old patient an endograft was placed in the distal aortic arch to close a tear in the aortic wall, and two stents were placed in the right renal artery for stenosis. Currently, medical management is the preferred treatment for uncomplicated type B aortic dissection. In complicated type B aortic dissection, endovascular grafting seems to be a useful solution with a high primary success percentage.
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March 2010

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

J Vasc Surg 2008 Feb;47(2):324-9; discussion 329

Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.

Objectives: Almost 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).

Methods: The 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.

Results: No 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.

Conclusions: No 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.
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http://dx.doi.org/10.1016/j.jvs.2007.10.005DOI Listing
February 2008

Endothelial progenitor cell-seeded grafts: rash and risky.

Can J Cardiol 2006 Nov;22(13):1113-6

Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.

The patency of prosthetic vascular grafts is impaired by intimal hyperplasia (IH) near the anastomotic regions. The absence of a functional endothelial monolayer on the prosthetic grafts is an important stimulus for IH. To improve the outcome of synthetic vascular bypass surgery, cell seeding is a promising concept that has been extensively investigated and is still evolving. In the present paper, the concept of prosthetic graft cell seeding is discussed, with emphasis on its newest era: seeding with endothelial progenitor cells. Although experimental studies on prosthetic graft seeding using endothelial progenitor cells have shown excellent results on graft endothelialization, none of these studies reported favourable effects on the more clinically relevant end points such as IH or graft patency.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2569057PMC
http://dx.doi.org/10.1016/s0828-282x(06)70946-1DOI Listing
November 2006

Endothelial progenitor cell-seeded grafts: rash and risky.

Can J Cardiol 2006 Sep;22(11):929-32

Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.

The patency of prosthetic vascular grafts is impaired by intimal hyperplasia (IH) near the anastomotic regions. The absence of a functional endothelial monolayer on the prosthetic grafts is an important stimulus for IH. To improve the outcome of synthetic vascular bypass surgery, cell seeding is a promising concept that has been extensively investigated and is still evolving. In the present paper, the concept of prosthetic graft cell seeding is discussed, with emphasis on its newest era: seeding with endothelial progenitor cells. Although experimental studies on prosthetic graft seeding using endothelial progenitor cells have shown excellent results on graft endothelialization, none of these studies reported favourable effects on the more clinically relevant end points such as IH or graft patency.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2570241PMC
http://dx.doi.org/10.1016/s0828-282x(06)70311-7DOI Listing
September 2006

Heparin immobilization reduces thrombogenicity of small-caliber expanded polytetrafluoroethylene grafts.

J Vasc Surg 2006 Mar;43(3):587-91

Department of Vascular Surgery, University Medical Center, Utrecht, The Netherlands.

Objective: The patency of small-diameter expanded polytetrafluoroethylene (ePTFE) grafts for vascular reconstruction is impaired by acute thrombotic occlusion. Prosthetic materials are thrombogenic and cause platelet adhesion and activation of the coagulation cascade. Heparin is a potent anticoagulant drug widely used to prevent and treat thrombosis. A new ePTFE graft with long-term bonding of heparin is now commercially available in several European countries, but a basic analysis of its mechanism of action in humans has never been performed. This study was performed to evaluate the thrombogenicity of heparin-bonded ePTFE grafts compared with standard ePTFE in a newly developed human ex vivo model.

Methods: Nonanticoagulated blood was drawn from antecubital veins of 10 healthy donors with a 19-gauge needle. The proximal end of a 60-cm ePTFE vascular graft with a diameter of 3 mm was connected to the needle while the distal end was connected to a syringe, which was placed in a syringe pump. Every volunteer served as his or her own control by using a heparin-bonded ePTFE graft on one arm and a standard ePTFE graft on the other arm. The perfusions were performed over 6 minutes with a flow rate of 20 mL/min, corresponding to a shear rate of 74/s. Serial samples were taken at the distal end of the graft for determination of prothrombin fragment 1 + 2, fibrinopeptide A, and P-selectin expression on perfused platelets. Fibrin deposition and platelet deposition were studied by using scanning electronic microscopy.

Results: Fibrinopeptide A production over time was significantly reduced on the heparin-bonded ePTFE grafts compared with standard ePTFE grafts (P < .05). There was no increase in the production of prothrombin fragment 1 + 2 or P selectin over time on either type of graft. Scanning electronic microscopy scanning showed platelet deposition and fibrin formation on standard ePTFE grafts, whereas no platelets or fibrin were observed on heparin-bonded ePTFE grafts.

Conclusions: Heparin immobilization substantially reduces the thrombogenicity of small-diameter ePTFE in a newly developed human ex vivo model. In this study, we provide evidence that the mechanism of action of the heparin bonding is due not only to anticoagulant but also to antiplatelet effects. Heparin bonding may be an important improvement of ePTFE, resulting in better patency rates for vascular reconstructions.
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http://dx.doi.org/10.1016/j.jvs.2005.10.038DOI Listing
March 2006

In vivo cell seeding with anti-CD34 antibodies successfully accelerates endothelialization but stimulates intimal hyperplasia in porcine arteriovenous expanded polytetrafluoroethylene grafts.

Circulation 2005 Jul 27;112(1):12-8. Epub 2005 Jun 27.

Laboratory of Experimental Cardiology, University Medical Center, Utrecht, The Netherlands.

Background: The patency of AV expanded polytetrafluoroethylene (ePTFE) grafts for hemodialysis is impaired by intimal hyperplasia (IH) at the venous outflow tract. The absence of a functional endothelial monolayer on the prosthetic grafts is an important stimulus for IH. In the present study, we evaluated the feasibility of capturing endothelial progenitor cells in vivo using anti-CD34 antibodies on ePTFE grafts to inhibit IH in porcine AV ePTFE grafts.

Methods And Results: In 11 pigs, anti-CD34-coated ePTFE grafts were implanted between the carotid artery and internal jugular vein. Bare ePTFE grafts were implanted at the contralateral side. After 3 (n=2) or 28 (n=9) days, the pigs were terminated, and the AV grafts were excised for histological analysis and SEM. At 3 and 28 days after implantation, 95% and 85% of the coated graft surface was covered by endothelial cells. In contrast, no cell coverage was observed in the bare graft at 3 days, whereas at 28 days, bare grafts were partly covered with endothelial cells (32%; P=0.04). Twenty-eight days after implantation, IH at the venous anastomosis was strongly increased in anti-CD34-coated grafts (5.96+/-1.9 mm2) compared with bare grafts (1.70+/-0.4 mm2; P=0.03). This increase in IH coincided with enhanced cellular proliferation at the venous anastomosis.

Conclusions: Autoseeding with anti-CD34 antibodies results in rapid endothelialization within 72 hours. Despite persistent endothelial graft coverage, IH at the outflow tract is increased profoundly at 4 weeks after implantation. Further modifications are required to stimulate the protective effects of trapped endothelial cells.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.104.504407DOI Listing
July 2005
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