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ABSTRACT: OBJECTIVE: Since insight into the reason for filing claims after treatment of varicose veins of the lower extremity might help prevent future claims, we determined the incidence of and reasons for medical liability insurance claims after such treatments in the Netherlands. METHOD: We performed a retrospective review of all medical liability insurance claims after varicose vein treatment handled by MediRisk between January 1993 and December 2007. RESULTS: A total of 144 claims were filed of which 104 were closed by the end of the study period. Nerve injury (n = 28), skin necrosis following sclerotherapy (n = 17), deep vein injury (n = 11) and insufficient communication (n = 9) accounted for more than 60% of all claims. Claims were equally distributed among registrars and consultants. Some 41 of the 104 closed claims were accepted. In 27 of the accepted cases, the physician had obviously failed in providing the care as expected from a medical practitioner allowed to perform these treatments. The majority of these 27 claims were due to injury of nerves (n = 11) or deep veins (n = 9). CONCLUSION: The incidence of claims after treatment of varicose veins in the Netherlands is low. Proper knowledge of anatomy and adequate communication, along with the introduction of less invasive treatments might prevent future claims.
Phlebology 03/2013; · 2.07 Impact Factor
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ABSTRACT: Objective: Randomized comparison of endovascular repair (EVAR) with
open repair (OR) in patients with a ruptured abdominal aortic aneurysm
(RAAA).
Background: Despite advances in operative technique and perioperative management
RAAA remains fraught with a high rate of death and complications.
Outcome may improve with a minimally invasive surgical technique: EVAR.
Methods: All patients with a RAAA in the larger Amsterdam area were identified.
Logistics for RAAA patients was changed with centralization of care
in 3 trial centers. Patients both fit for EVAR and for OR were randomized to
either of the treatments. Nonrandomized patients were followed in a prospective
cohort. Primary endpoint of the study was the composite of death and
severe complications at 30 days.
Results: Between April 2004 and February 2011, we identified 520 patients
with a RAAA of which 116 could be randomized. The primary endpoint rate
for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) =
5.4%; 95% confidence interval (CI): −13% to +23%]. The 30-day mortality
was 21% in patients assigned to EVAR compared with 25% for OR (ARR =
4.4% 95% CI:−11% to+20%). Themortality of all surgically treated patients
in the nonrandomized cohort was 30% (95% CI: 26%–35%) and 26% (95%
CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by
OR at trial centers.
Conclusions: This trial did not show a significant difference in combined
death and severe complications between EVAR and OR. Mortality for OR
both in randomized patients and in cohort patients was lower than anticipated,
which may be explained by optimization of logistics, preoperative CT imaging,
and centralization of care in centers of expertise
Annals of Surgery 01/2013; · 7.49 Impact Factor
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M-C J M Schreinemachers,
F J Bemelman,
M M Idu,
K A M I van Donselaar-van der Pant,
P J E J van de Berg,
J B Reitsma, D A Legemate,
S Florquin,
I J M Ten Berge,
B M Doorschodt,
T M van Gulik
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ABSTRACT: In this study, we assessed the safety of the new organ preservation solution polysol solution in the clinical setting of living kidney transplantation. We conducted a prospective pilot study in nine adult donor-recipient couples using polysol solution for washout and cold storage of kidney grafts. Adverse reactions possibly related to the use of polysol solution as well as renal function at 1, 6, and 12 months after transplantation were monitored. All living kidney transplantation performed in adults in our center within 2002 to 2008 using the University of Winconsin solution served as controls (n = 190). The use of polysol solution was associated with a higher acute rejection rate compared to University of Wisconsin solution at all time points. Also, antibody-mediated rejection occurred more frequently in the polysol group. Renal function at all time points was also comparable between the groups. This pilot study in living kidney transplantation is the first clinical study on the use of polysol solution. Although the study was not powered on the endpoint rejection, we observed a high number of acute rejection and antibody-mediated rejection episodes in recipients of polysol solution preserved grafts as compared to University of Wisconsin solution controls. As a consequence the study was terminated prematurely.
Transplantation Proceedings 01/2013; 45(1):38-45. · 1.00 Impact Factor
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ABSTRACT: Treatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear.
To compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction.
In a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year.
Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776).
European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 02/2012; 43(4):466-71. · 2.92 Impact Factor
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ABSTRACT: Assessment of postoperative mortality in patients undergoing elective surgery for asymptomatic abdominal aorta aneurysm (AAA) in the Academic Medical Center (AMC), Amsterdam, the Netherlands. This is compared with national statistical information and data in the literature.
Retrospective cohort study.
Retrospective analysis of all patients who underwent an elective open or endovascular intervention in connection with asymptomatic aneurysm of the infrarenal abdominal aorta ≥ 5.5 cm in the period 2004-2010.
In the study period 234 patients were electively operated for an abdominal aorta aneurysm (129 conventional and 104 endovascular interventions). In this period, 3 (1.3%) patients died in hospital or within 30 days of the intervention. Of the 73 patients ≥ 75 years of age, 2 (2.7%) died. None of the deceased patients were treated endovascularly.
The figures presented for elective aneurysm surgery in the AMC are favourable in comparison with the published national mortality statistics of over 10% morality in patients ≥ 75 years of age. Because of the lack of randomized trials for treatment of aneurysms ≥ 5.5 cm there are many uncertainties concerning survival benefit obtained by operation. It is important for each clinic to arrange the care for elective aneurysm surgery in such a way that mortality is minimal. Important factors to achieve this are a well-attuned treatment team and careful patient selection.
Nederlands tijdschrift voor geneeskunde 01/2012; 156(16):A4342.
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ABSTRACT: Prosthetic grafts have poor patency rates in peripheral arterial reconstructions. Glycerol (GL)-preserved grafts are an alternative. The aim of this study was to examine patency, graft morphology and function of GL-preserved allografts in a goat carotid artery animal model.
The first group (n = 7) underwent bilateral replacement of the carotid artery by a carotid allograft that was preserved in GL for 1 week. In the second group (n = 5), a carotid artery allograft that was preserved in University of Wisconsin solution (UW) for 48 h was used. In the third group (n = 5), the jugular vein (autologous vein, AU) was used. The follow-up was 3 months.
One UW graft and 1 GL graft occluded in the first 24 h postoperatively. Three-month primary patency rates for GL, UW and AU grafts were 93, 100 and 80%, respectively (p = 0.39). Graft diameter was increased in UW allografts (p < 0.005), whereas GL allografts remained unchanged. After explantation, GL allografts demonstrated contraction and relaxation capacity and lower intimal thickness (p < 0.001).
GL preservation has proven to be a feasible method for arterial allograft transplantation in a large animal model with decreased intimal hyperplasia and renewed functional capability.
European Surgical Research 12/2011; 48(2):64-72. · 0.93 Impact Factor
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ABSTRACT: The aim was to summarize the results of all randomized clinical trials (RCTs) comparing percutaneous transluminal angioplasty (PTA) with (supervised) exercise therapy ((S)ET) in patients with intermittent claudication (IC) to obtain the best estimates of their relative effectiveness.
A systematic review was performed of relevant RCTs identified from the MEDLINE, Embase and Cochrane Library databases. Eligible RCTs compared PTA with (S)ET, included patients with IC due to suspected or known aortoiliac and/or femoropopliteal artery disease, and compared their effectiveness in terms of functional outcome and/or quality of life (QoL).
Eleven of 258 articles identified (reporting data on eight randomized clinical trials) met the inclusion criteria. One trial included patients with isolated aortoiliac artery obstruction, three trials studied those with femoropopliteal artery obstruction and five included those with combined lesions. Two trials compared PTA with advice on ET, four PTA with SET, two PTA plus SET with SET and two PTA plus SET with PTA. Although the endpoints in most trials comprised walking distances and QoL, pooling of data was impossible owing to heterogeneity. Generally, the effectiveness of PTA and (S)ET was equivalent, although PTA plus (S)ET improved walking distance and some domains of QoL scales compared with (S)ET or PTA alone.
As IC is a common healthcare problem, defining the optimal treatment strategy is important. A combination of PTA and exercise (SET or ET advice) may be superior to exercise or PTA alone, but this needs to be confirmed.
British Journal of Surgery 09/2011; 99(1):16-28. · 4.61 Impact Factor
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D T Ubbink,
H Vermeulen,
A M Knops, D A Legemate,
K Oude Rengerink,
M J Heineman,
Y B Roos,
C J Fijnvandraat,
H S Heymans,
R Simons,
M Levi
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ABSTRACT: Evidence-based practice (EBP) is a generally accepted means to improve healthcare quality. However, not all healthcare professionals and managers apply EBP in daily practice. We investigated EBP attitudes, knowledge and the perceived barriers and facilitators to practising EBP , to define tailor-made interventions for improving evidence-based behaviour.
In this cross-sectional survey, doctors and nurses from five major specialities of a university hospital were invited to complete the McColl and Barriers questionnaires.
Response rates were 70% (305÷435) for doctors and 74% (396÷537) for nurses. They were welcoming towards EBP, but considered time constraints, knowledge gaps and poor availability of evidence as major barriers to implement EBP . They also mentioned contradicting results (75%) and flawed methodology (69%), while nurses frequently mentioned unawareness of (75%), or difficulty in reading and interpreting research papers (70%). Regarding EBP knowledge, 6/8 common EBP terms could be explained by 54% of doctors but by only 15% of nurses. Facilitating factors among doctors concerned the availability and accessibility of high-level evidence and communication of evidence during various clinical meetings and handovers for clinical decision making. Among nurses, promoting factors involved more teaching and instances to incorporate EBP in clinical practice. Both groups desired more managerial support in terms of motivation and opportunities.
Doctors and nurses have embraced the EBP paradigm as an important means to improve quality of clinical patient care, but its application is still cumbersome. This paper offers a tailored programme for implementation and managerial role-models.sustainment of EBP, corroborated by professional and managerial role-models.
The Netherlands Journal of Medicine 02/2011; 69(2):87-94. · 2.07 Impact Factor
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ABSTRACT: A patient with Streptococcus pneumoniae aortitis is presented. Because of nonspecific symptoms (fever and back pain) there was a long diagnostic delay. In addition, the aortitis was located near the renal arteries which severely hampered early surgical treatment. Although emergency surgery was performed when aortic rupture occurred, the patient did not survive. Infectious arteritis of large vessels is a diagnosis often made late and associated with high mortality.
The Netherlands Journal of Medicine 01/2011; 69(1):31-4. · 2.07 Impact Factor
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ABSTRACT: Ethical and legal aspects of biobanking continue to be a topic of concern. The String of Pearls Initiative (PSI) helped establish new norms for biobank governance in The Netherlands. This article gives an overview of issues that emerged from the medical-ethical review processes of PSI. The criteria applied to biobanking projects by Ethical Review Boards were derived from the legally prescribed criteria for medical research. However, these criteria were interpreted in radically diverging ways. Key issues included the legal status of prospective research-dedicated biobanks, informed consent, monitoring of the use of biobanks, and alignment of biobanking policies both within and between research departments. The article calls on all actors involved in biobanking to continue to strive for the harmonization of biobanking policies. A certain degree of central coordination is crucial in order to improve on collaborative biobanking initiatives.
Nederlands tijdschrift voor geneeskunde 01/2011; 155(26):A3557.
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D A Legemate
European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 10/2010; 40(4):442. · 2.92 Impact Factor
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ABSTRACT: Delayed graft function (DGF) has a negative effect on the results of living-donor kidney transplantation.
To investigate potential risk factors for DGF.
This prospective study included 200 consecutive living donors and their recipients between January 2002 and July 2007. Delayed graft function was defined as need for dialysis within the first postoperative week.
Delayed graft function was diagnosed in 12 patients (6%). Intraoperative complications occurred in 10 donors (5%), and postoperative complications in 24 donors (13.5%). One-year kidney graft survival with vs without DGF was 52% and 98%, respectively (P < .002). In donors, 2 univariate risk factors for DGF identified were lower counts per second at peak activity during scintigraphy, and multiple renal veins. In recipients, only 2 or more kidney transplantations and occurrence of an acute rejection episode were important factors. At multivariate analysis, increased risk of DGF was associated with the presence of multiple renal veins (odds ratio, 151.57; 95% confidence interval, 2.53-9093.86) and an acute rejection episode (odds ratio, 78.87; 95% confidence interval, 3.17-1959.62).
Hand-assisted laparoscopic donor nephrectomy is a safe procedure. The presence of multiple renal veins and occurrence of an acute rejection episode are independent risk factors for DGF.
Transplantation Proceedings 09/2010; 42(7):2422-6. · 1.00 Impact Factor
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ABSTRACT: To explore what kind of information surgeons communicate with patients diagnosed with an abdominal aortic aneurysm, and if the information provided regarding the disorder and treatment options available complies with legal requirements.
Dutch vascular surgeons sound-recorded consultations with their patients. Recordings were scored using a checklist based on ethical considerations and five statutory categories of information on: (1) the disorder, (2) procedure and aim of surgery, (3) consequences and risks of surgery, (4) watchful observation and (5) individual prognosis regarding state of health. Each category was represented by several information items, which were scored dichotomously ('not mentioned' or 'mentioned'). A category was considered sufficiently addressed if at least one of its items was mentioned.
Thirty-five consultations were recorded (13 patients with aneurysmal diameter <5.5 cm and 22 with diameter >or=5.5 cm). In a minority of recordings, all five categories were addressed: 1/13 (8%) and 9/22 (41%), respectively. None of the information items was discussed consistently in every recording. Although most patients were informed about the proposed treatment option (11/13; 85% and 19/22; 86%), the alternative treatment option was mentioned only occasionally (4/13; 31% and 14/22; 64%).
Patients with an abdominal aneurysm are informed inconsistently about their disorder and treatment options. Information is often less than that legally required. This may hinder shared decision making.
European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 03/2010; 39(6):708-13. · 2.92 Impact Factor
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ABSTRACT: Regarding the preoperative informed consent procedure (ICP), a considerable gap exists between legal requirements and current clinical practice. Although it is often thought that the ICP just has a legal background, the ICP is also important for shared decision making. Physicians are insufficiently trained to complete the different stages of the ICP and standardization of the given information is far from optimal. What the patient really needs and wants to know, besides the legal framework, needs better formulation e.g. in guidelines. The limited health literacy of patients often prevents an adequate ICP. Therefore physicians should learn to check the patient's level of literacy and to adapt the information accordingly. Patients do not always realize the importance of informed consent and there is a need for improved patient empowerment.
Nederlands tijdschrift voor geneeskunde 01/2010; 154(41):A2492.
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European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 04/2009; 37(6):740-1; author reply 741-2. · 2.92 Impact Factor
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ABSTRACT: Vascular transplantation has become an alternative for prosthetic grafts. Suitable storage methods for vascular allografts are therefore necessary. For small caliber arterial allografts, cryopreservation and cold storage showed discouraging results. Since glycerol preservation proved effective for the storage of skin allografts, this preservation method was investigated for vascular allografts using a rat aortic transplantation model.
Glycerol-preserved allografts (GA) were transplanted to the infrarenal aorta (n = 18) in Wistar rats. A control group (n = 18) underwent immediate autotransplantation (AU) of an equal length of aorta.
Cumulative graft patency at 90 days' follow-up was 93% for AU and 78% for GA (ns). No aneurysm formation was detected in both groups. Intraluminal endothelial cell coverage, integrity of the media and smooth muscle cell repopulation were comparable in both groups. Intimal thickness was less in GA than in AU and inflammatory reaction in the adventitia was diminished in GA.
GA were successfully grafted with acceptable patency rates compared to autografts, while intima hyperplasia and adventitial inflammatory reaction were less.
European Surgical Research 01/2009; 42(2):78-86. · 0.93 Impact Factor
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ABSTRACT: The results of the recently published PeriOperative ISchemic Evaluation (POISE) trial show that perioperative use of metoprolol in patients with atherosclerosis undergoing major non-cardiac surgery reduces the risk of cardiovascular complications. This effect was primarily produced by a 1.5% reduction in non-fatal myocardial infarction (MI), but this advantage was outweighed by a 0.8% increase in total mortality and a 0.5% increase in nonfatal stroke. These results, combined with previous meta-analyses, confirm that non-fatal MI is reduced at the cost of a statistically significant increase in stroke rate and a near significant increase in mortality. It is likely that the increase in complications is due to a high dose of metoprolol being given too shortly before the operation. These findings call for judicious perioperative use of adrenergic beta-antagonists in cardiac-high-risk patients undergoing high risk non-cardiac surgery. Dosage should be lower and administration should be implemented longer before the operation.
Nederlands tijdschrift voor geneeskunde 12/2008; 152(48):2603-5.
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ABSTRACT: To assess the mortality of patients with ruptured abdominal aortic aneurysms undergoing open surgery and examine changes in mortality over time.
Literature databases were searched for relevant articles published between 1991 and 2006. Two reviewers independently performed study inclusion and data extraction. Primary outcome measure was 30 day or in-hospital mortality. Subgroup analyses were performed examining the effect of population- and hospital-based studies, hospital volume and type of surgeon.
From a total of 1419 identified studies, 145 observational studies met the inclusion criteria of which 116 were included in the systematic review comprising 60,822 patients. Overall mortality was 48.5% (95% CI: 48.1-48.9%) and did not change significantly over the years. Age increased over the years. For overall mortality a trend was seen in favour of high-volume hospitals.
This meta-analysis suggests that mortality of patients with RAAA treated by open surgery has not changed over the past 15 years. This could be explained by increased age of patients undergoing RAAA repair.
European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 06/2008; 35(5):558-70. · 2.92 Impact Factor
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ABSTRACT: Cost-effectiveness analysis of three diagnostic imaging strategies for the assessment of aortoiliac and femoropopliteal arteries in patients with peripheral arterial occlusive disease. The strategies were: angiography as the reference strategy, duplex scanning (DS) plus supplementary angiography (S1) and DS plus confirmative angiography (S2).
A decision model was built with sensitivity and specificity data from literature, supplemented with prospective hospital cost data in Euro (euro). The probability of correctly identifying the status of a lesion was taken as the primary outcome. We compared strategies by assessing the extra costs per additional correctly identified case.
Assuming no false positive or false negative results, angiography is the most effective strategy if the prevalence of significant obstructive lesions in the aortoiliac and femoropopliteal tract exceeds 70%, or if the sensitivity of duplex scanning is lower than 83%. In case of lower prevalence, strategy S1 becomes equally or even more effective than angiography. At a prevalence of 75%, performing angiography costs euro 8443 per extra correctly identified case compared with strategy S1.
In most situations angiography is more effective than diagnostic strategy S1. However, if society is unwilling to pay more than euro 8443 for knowing a patient's disease status, diagnostic strategy S1 is a cost-effective alternative to angiography, especially at lower prevalence values.
European Journal of Radiology 05/2008; 66(1):142-8. · 2.61 Impact Factor
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D A Legemate
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ABSTRACT: The neurovascular costoclavicular compression syndrome is rare. Physicians generally have little experience with this syndrome. It is difficult to provide evidence based on sound clinical science that proves the existence of the syndrome in relation to diagnosis and treatment. Nevertheless there are reasons to assume that this syndrome exists on the basis of clinical experience, particularly that of vascular surgeons.
Nederlands tijdschrift voor geneeskunde 04/2008; 152(9):502.
