Contemporary quality control methods are often insufficient in predicting clinical outcomes after revascularization in lower extremity arterial disease (LEAD) patients. This study evaluates the... Show moreContemporary quality control methods are often insufficient in predicting clinical outcomes after revascularization in lower extremity arterial disease (LEAD) patients. This study evaluates the potential of near-infrared fluorescence imaging with indocyanine green to predict the clinical outcome following revascularization. Near-infrared fluorescence imaging was performed before and within 5 days following the revascularization procedure. Clinical improvement was defined as substantial improvement of pain free walking distance, reduction of rest- and/or nocturnal pain, or tendency toward wound healing. Time-intensity curves and 8 perfusion parameters were extracted from the dorsum of the treated foot. The quantified postinterventional perfusion improvement was compared within the clinical outcome groups. Successful near-infrared fluorescence imaging was performed in 72 patients (76 limbs, 52.6% claudication, 47.4% chronic limb-threatening ischemia) including 40 endovascular- and 36 surgical/hybrid revascularizations. Clinical improvement was observed in 61 patients. All perfusion parameters showed a significant postinterventional difference in the clinical improvement group (P-values <.001), while no significant differences were seen in the group without clinical improvement (P-values .168-.929). Four parameters demonstrated significant differences in percentage improvement comparing the outcome groups (P-values within .002-.006). Near-infrared fluorescence imaging has promising additional value besides clinical parameters for predicting the clinical outcome of revascularized LEAD patients. Show less
White, N.A.; Vrielink, T.J.C.O.; Bogt, K.E.A. van der; Cohen, A.F.; Rotmans, J.I.; Horeman, T. 2023
IntroductionThe recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a... Show moreIntroductionThe recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices. MethodsA structured approach to determining the requirements for the clinical development of high-risk medical devices is introduced, utilizing the question-based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question-based framework. ResultsThe result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks. ConclusionThe framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining 'known unknowns' that require answering in the post-market phase after sufficient benefit is established relative to the risks. Show less
Introduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous... Show moreIntroduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a significant proportion of fistulas either fail to mature or remain unused. In addition, long-term complications associated with arteriovenous grafts and central venous catheters may be less relevant when considering the limited life expectancy of these patients. Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients. Methods and analysis OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. Patients aged 70 years or older who are expected to initiate haemodialysis treatment in the next 6 months or who have started haemodialysis urgently with a catheter will be enrolled. To detect and exclude patients with an unusually long life expectancy, we will use a previously published mortality prediction model after external validation. Participants allocated to the usual care arm will be treated according to current guidelines on vascular access creation and will undergo fistula creation. Participants allocated to one of the two intervention arms will undergo graft placement or catheter insertion. The primary outcome is the number of access-related interventions required for each patient-year of haemodialysis treatment. We will enrol 195 patients to have sufficient statistical power to detect an absolute decrease of 0.80 interventions per year. Ethics and dissemination Because of clinical equipoise, we believe it is justified to randomly allocate elderly patients to the different vascular access strategies. The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines. Protocol version and date V.5, 25 February 2021. Show less
Wang, Y.M.; Snoep, J.D.; Hemmelder, M.H.; Bogt, K.E.A. van der; Bos, W.J.W.; Boog, P.J.M. van der; ... ; Meuleman, Y. 2021
Graft function and patient survival are traditionally the most used parameters to assess the objective benefits of kidney transplantation. Monitoring graft function, along with therapeutic drug... Show moreGraft function and patient survival are traditionally the most used parameters to assess the objective benefits of kidney transplantation. Monitoring graft function, along with therapeutic drug concentrations and transplant complications, comprises the essence of outpatient management in kidney transplant recipients (KTRs). However, the patient's perspective is not always included in this process. Patients' perspectives on their health after kidney transplantation, albeit subjective, are increasingly acknowledged as valuable healthcare outcomes and should be considered in order to provide patient-centred healthcare. Such outcomes are known as patient-reported outcomes (PROs; e.g. health-related quality of life and symptom burden) and are captured using PRO measures (PROMS). So far, PROMS have not been routinely used in clinical care for KTRs. In this review we will introduce PROMS and their potential application and value in the field of kidney transplantation, describe commonly used PROMS in KTRs and discuss structural PROMS implementation into kidney transplantation care. Show less
Tummers, F.H.M.P.; Huizinga, C.R.H.; Pampus, M.G. van; Stockmann, H.B.A.C.; Cohen, A.F.; Bogt, K.E.A. van der; Fit Perform Collaborators 2021
BackgroundThe field of obstetrics and gynecology requires complex decision-making and skills because of unexpected high-risk situations. These skills are influenced by alertness, reaction time, and... Show moreBackgroundThe field of obstetrics and gynecology requires complex decision-making and skills because of unexpected high-risk situations. These skills are influenced by alertness, reaction time, and concentration. Night shifts result in sleep deprivation, which might impair these functions, although it is still unclear to what extent.ObjectiveThis study aimed to investigate whether a night shift routinely impairs the obstetrics and gynecology consultants’ and residents’ fitness to perform and whether this reaches a critical limit compared with relevant frames of reference.Study DesignResidents (n=33) and consultants (n=46) in obstetrics and gynecology conducted multiple measurements (n=415) at precall, postcall, and noncall moments with the fitness to perform self-test. The self-test consists of an adaptive pursuit tracking task that is able to objectively measure alertness, reaction time, concentration, and hand-eye coordination and Visual Analog Scale tests to subjectively score alertness. The test is validated with a sociolegal reference of a 0.06% ethanol blood concentration (the peak level after 2 units of alcohol, the legal driving limit). This equals −1.37% on the objective score and −8.17 points on subjective alertness. Linear mixed models were used to analyze the difference within subjects over a night shift, integrating repeated measures over time.ResultsThe overnight objective difference between postcall and precall measurements was −0.62 (P<.05) for residents and 0.28 (P=NS) for consultants, both not exceeding the sociolegal reference as a group. Objective impairment exceeded the reference for 31% of the residents and 28% of the consultants. Subjective alertness decreased in residents (−18.26; P<.001) and consultants (−10.85; P<.001), both exceeding the reference. No residents had to continue work postcall versus 7.8% of the consultants. None of the consultants that had to continue work were in an objective critically impaired state.ConclusionThis study provides insight and awareness of individual performance after night shifts with clear frames of reference. The performance of residents is negatively and significantly affected by night shifts; therefore, a scheduled day off after a night shift is justified. Consultants showed no overall impairment; however, a quarter did exceed the alcohol limit reference after their night shift. If not logistically feasible to schedule a protected day off after a night shift, our group recommends safe shift scheduling, including options to transfer care after a demanding night shift to prevent working in a compromised state. Show less
Goncalves, L.N.; Hoven, P. van den; Schaik, J. van; Leeuwenburgh, L.; Hendricks, C.H.F.; Verduijn, P.S.; ... ; Vorst, J.R. van der 2021
(1) Background: Near-infrared fluorescence imaging is a technique capable of assessing tissue perfusion and has been adopted in various fields including plastic surgery, vascular surgery, coronary... Show more(1) Background: Near-infrared fluorescence imaging is a technique capable of assessing tissue perfusion and has been adopted in various fields including plastic surgery, vascular surgery, coronary arterial disease, and gastrointestinal surgery. While the usefulness of this technique has been broadly explored, there is a large variety in the calculation of perfusion parameters. In this systematic review, we aim to provide a detailed overview of current perfusion parameters, and determine the perfusion parameters with the most potential for application in near-infrared fluorescence imaging. (2) Methods: A comprehensive search of the literature was performed in Pubmed, Embase, Medline, and Cochrane Review. We included all clinical studies referencing near-infrared perfusion parameters. (3) Results: A total of 1511 articles were found, of which, 113 were suitable for review, with a final selection of 59 articles. Near-infrared fluorescence imaging parameters are heterogeneous in their correlation to perfusion. Time-related parameters appear superior to absolute intensity parameters in a clinical setting. (4) Conclusions: This literature review demonstrates the variety of parameters selected for the quantification of perfusion in near-infrared fluorescence imaging. Show less
Knops, E.; Schaik, J. van; Bogt, K.E.A. van der; Veger, H.T.C.; Putter, H.; Waasdorp, E.J.; Vorst, J.R. van der 2021
Introduction: An important step to reach a favorable outcome of abdominal endovascular aneurysm repair (EVAR) is preoperative sizing of the stent graft using computed tomography angiography (CTA)... Show moreIntroduction: An important step to reach a favorable outcome of abdominal endovascular aneurysm repair (EVAR) is preoperative sizing of the stent graft using computed tomography angiography (CTA) images of the abdominal aorta. A variety of costly image processing software options is available to obtain the necessary aortic measurements. A package that can be used for EVAR sizing is OsiriX Lite (R)-an open source, freely downloadable image processing option. This study assesses the concurrent validity of OsiriX Lite (R) when compared with commercially available 3Mensio Vascular (R) and Siemens Syngo.via (R).Methods: CTA scans of 20 patients that underwent EVAR for abdominal aneurysm were selected, 10 elective and 10 ruptured. For each scan, 6 observers determined 20 parameters needed for proper stent graft sizing, 2 using Osirix Lite (R), 3 using 3Mensio Vascular (R), and 1 using Siemens Syngo.via (R). For each parameter, an intraclass correlation coefficient (ICC) and a P-value were calculated. Interrater agreement was interpreted using the Koo and Li Guidelines. Time needed to perform EVAR planning was compared.Results: Overall interrater agreement between the 3 sizing options was found to be either "good" or "moderate" for 16 out of 20 parameters (80%). Time needed to perform EVAR planning was not significantly different for Osirix Lite (R) (568 sec) when compared with 3Mensio Vascular (R) (603 sec) or Siemens Syngo.via (R) (659 sec) with a P-value of 0.88.Conclusions: The authors conclude that Osirix Lite (R) is an accurate and time-effective image processing option for preoperative sizing of an EVAR stent graft when matched to 3Mensio Vascular (R) and Siemens Syngo.via (R). Show less
Voorzaat, B.M.; Bogt, K.E.A. van der; Bezhaeva, T.; Schaik, J. van; Eefting, D.; Putten, K. van der; ... ; Rotmans, J.I. 2020
The durability of prosthetic arteriovenous (AV) grafts for hemodialysis access is low, predominantly due to stenotic lesions in the venous outflow tract and infectious complications. Tissue... Show moreThe durability of prosthetic arteriovenous (AV) grafts for hemodialysis access is low, predominantly due to stenotic lesions in the venous outflow tract and infectious complications. Tissue engineered blood vessels (TEBVs) might offer a tailor-made autologous alternative for prosthetic grafts. We have designed a method in which TEBVs are grown in vivo, by utilizing the foreign body response to subcutaneously implanted polymeric rods in goats, resulting in the formation of an autologous fibrocellular tissue capsule (TC). One month after implantation, the polymeric rod is extracted, whereupon TCs (length 6 cm, diameter 6.8 mm) were grafted as arteriovenous conduit between the carotid artery and jugular vein of the same goats. At time of grafting, the TCs were shown to have sufficient mechanical strength in terms of bursting pressure (2382 +/- 129 mmHg), and suture retention strength (SRS: 1.97 +/- 0.49 N). The AV grafts were harvested at 1 or 2 months after grafting. In an ex vivo whole blood perfusion system, the lumen of the vascular grafts was shown to be less thrombogenic compared to the initial TCs and ePTFE grafts. At 8 weeks after grafting, the entire graft was covered with an endothelial layer and abundant elastin expression was present throughout the graft. Patency at 1 and 2 months was comparable with ePTFE AV-grafts. In conclusion, we demonstrate the remodeling capacity of cellularized in vivo engineered TEBVs, and their potential as autologous alternative for prosthetic vascular grafts. Show less
INTRODUCTION: Arteriovenous fistulas (AVFs) for hemodialysis (HD) are often associated with better outcomes than arteriovenous grafts (AVG). We aimed to investigate vascular access (VA) outcomes... Show moreINTRODUCTION: Arteriovenous fistulas (AVFs) for hemodialysis (HD) are often associated with better outcomes than arteriovenous grafts (AVG). We aimed to investigate vascular access (VA) outcomes and assessed if AVF non-maturation outweighs long-term complications of AVGs.METHODS: In this multicenter retrospective cohort-study in the Netherlands, one- and three-year primary, primary assisted, secondary and functional patency were calculated and the incidence of adverse events and procedures was assessed. Functional patency of RCAVFs, upper arm AVFs and AVGs was compared using Cox analyses.RESULTS: 1041 patients who received their first VA were included of which 863 successfully matured. These patients were analyzed with a median follow-up of 25 months. The one-year functional patency was 67 ± 2.0% for RCAVFs, 83 ± 2.0% for upper arm AVFs, and 85 ± 3.5% for AVGs, respectively. Three-year functional patency was 62 ± 2.0% for RCAVFs, 74 ± 2.0% for upper arm AVFs, and 69 ± 5% for AVGs, respectively. AVGs required more procedures per year (3.3/year) of functional patency when compared to upper arm AVFs (1.8/year).CONCLUSION: The functional patency of AVFs and AVGs is comparable, although AVGs required more interventions to maintain usability for hemodialysis. The choice of VA is a trade-off between short-term advantages, favoring AVGs and long-term advantages, favoring AVFs. Which VA is most appropriate depends on the patient’s prognosis and preferences. Show less
Nauta, L.; Voorzaat, B.M.; Rotmans, J.I.; Ghariq, E.; Urlings, T.; Bogt, K.E.A. van der; Linden, E. van der 2019
Background: Surgical skills and decision making are influenced by alertness, reaction time, eye-hand coordination, and concentration. Night shift might impair these functions but it is unclear to... Show moreBackground: Surgical skills and decision making are influenced by alertness, reaction time, eye-hand coordination, and concentration. Night shift might impair these functions but it is unclear to what extent. The aim of this study was to investigate whether a night shift routinely impairs the surgeon's fitness to perform and whether this reaches a critical limit as compared to relevant frames of reference.Methods: Consultants (n = 59) and residents (n = 103) conducted fitness to perform measurements at precall, postcall, and noncall moments. This validated self-test consists of an adaptive tracker that is able to objectively measure alertness, reaction time, concentration, and eye-hand coordination, and multiple visual analog scales to subjectively score alertness. Results are compared to sociolegal (ethanol) and professional (operative skills) frames of reference that refer to a decrease under the influence of 0.06% ethanol.Results: Residents spent 1.7 call hours asleep on average as compared to 5.4 for consultants. Subjective alertness decreased in residents after night shifts (-13, P < 0.001) but not in consultants (-1.2, P = NS). The overnight difference in tracker score was -1.17 (P < 0.001) for residents and 0.46 (P = NS) for surgeons. Postcall subjective alertness only correlated to objective alertness in consultants. For residents, hours slept on-call correlated to objective alertness. For consultants, subsequent night calls significantly correlated to objective alertness, with the third subsequent call related to performance below the reference.Conclusions: Consultants remain fit to perform after night call, but subsequent calls may compromise clinical activities. This study provides insight and awareness of individual performance with clear frames of reference. Show less
Objective: In the diagnosis of peripheral artery disease (PAD), the ankle-brachial index plays an important role. However, results of the ankle-brachial index are unreliable in patients with severe... Show moreObjective: In the diagnosis of peripheral artery disease (PAD), the ankle-brachial index plays an important role. However, results of the ankle-brachial index are unreliable in patients with severe media sclerosis. Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) can provide information about tissue perfusion and has already been studied in oncologic, reconstructive, and cardiac surgery. For patients with PAD, this technique might give insight into skin perfusion and thereby guide treatment. We performed a systematic review of the literature on the use of NIR fluorescence imaging in patients with PAD.Methods: PubMed, MEDLINE, Embase, and Cochrane were searched for articles and abstracts on the application of NIR fluorescence imaging using ICG as fluorescent dye in patients with PAD. Our search strategy combined the terms "fluorescence," "ICG," or synonyms and "peripheral artery disease" or synonyms. The extracted data included fluorescence parameters and test characteristics for diagnosis of PAD.Results: Twenty-three articles were found eligible for this review using 18 different parameters for evaluation of the fluorescence signal intensity. NIR fluorescence imaging was used for four main indications: diagnosis, quality control in revascularization, guidance in amputation surgery, and visualization of vascular structures. For the diagnosis of PAD, NIR fluorescence imaging yields a sensitivity ranging from 67% to 100% and a specificity varying between 72% and 100%. Significant increases in multiple fluorescence parameters were found in comparing patients before and after revascularization.Conclusions: NIR fluorescence imaging can be used for several indications in patients with PAD. NIR fluorescence imaging seems promising in diagnosis of PAD and guidance of surgeons in treatment, especially in patients in whom current diagnostic methods are not applicable. Further standardization is needed to reliably use this modality in patients with PAD. Show less
Oevelen, M. van; Abrahams, A.C.; Weijmer, M.C.; Nagtegaal, T.; Dekker, F.W.; Rotmans, J.I.; ... ; DUCATHO Study Grp 2019
OBJECTIVE:Arteriovenous fistulas for hemodialysis vascular access are a burden for the cardiovascular system. After successful kidney transplantation, prophylactic arteriovenous fistula ligation... Show moreOBJECTIVE:Arteriovenous fistulas for hemodialysis vascular access are a burden for the cardiovascular system. After successful kidney transplantation, prophylactic arteriovenous fistula ligation may improve cardiac outcomes; however, evidence is scarce. This survey investigates physicians' preference for management of arteriovenous fistulas and identifies the factors associated with preference for either arteriovenous fistula ligation or maintenance.MATERIALS AND METHODS:A survey was sent to members of eight national and international Nephrology and Vascular Surgery societies. The survey comprised eight case vignettes of asymptomatic patients with a functioning arteriovenous fistula after kidney transplantation. Characteristics possibly associated with treatment preferences were arteriovenous fistula flow, left ventricular ejection fraction, and patient age. Respondents were asked to state preference to maintain or ligate the arteriovenous fistula. Linear mixed-effects models were used to investigate the association of treatment preference with case characteristics.RESULTS:A total of 585 surveys were returned. A reduced left ventricular ejection fraction of 30% (beta 0.60, 95% confidence interval 0.55; 0.65) and a high flow of 2500 mL/min (beta 0.46, 95% confidence interval 0.41; 0.51) were associated with a higher preference for arteriovenous fistula ligation. Disagreement among respondents was considerable, as in four out of eight cases less than 70% of respondents agreed on the arteriovenous fistula management strategy.CONCLUSION:Although respondents recognize a reduced left ventricular ejection fraction and a high flow as the risk factors, the high disagreement on management preferences suggests that evidence is inconclusive to recommend arteriovenous fistula ligation or maintenance after kidney transplantation. More research is needed to determine optimal arteriovenous fistula management after successful kidney transplantation. Show less
Wilschut, E.D.; Rotmans, J.I.; Bos, E.J.; Zoest, D. van; Eefting, D.; Hamming, J.F.; Bogt, K.E.A. van der 2018
