Netherlands Trial Registry Identifier: NTR2249.
H.J.M. Verhagen is a consultant to Medtronic and WL Gore & Associates and received an unrestricted educational grant from Abbott. MGM Hunink receives Royalties from Cambridge University Press for her textbook on Medical Decision Making, reimbursement of expenses from the European Society of Radiology (ESR) for work on the ESR guidelines for imaging referrals, reimbursement of expenses from the European Institute for Biomedical Imaging Research (EIBIR) for membership of the Scientific Advisory Board, and research funding from the American Diabetes Association, the Netherlands Organization for Health Research and Development, the German Innovation Fund, Netherlands Educational Grant ("Studie Voorschot Middelen"), and the Gordon and Betty Moore Foundation. Authors contribution: Sanne Klaphake, MD, contribution to the concept and design of the ERASE study acquisition of data analysis an interpretation of data participate in drafting the article and revising it critically give final approval of the version to be published Farzin Fakhry, MD, contribution to the concept and design of the ERASE study acquisition of data analysis an interpretation of data participate in drafting the article and revising it critically give final approval of the version to be published EllenV. Rouwet, MD, PhD, contribution to the concept and design of the ERASE study acquisition of data analysis an interpretation of data participate in drafting the article and revising it critically give final approval of the version to be published Lijckle van der Laan, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Jan J. Wever, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Joep A. W. Teijink, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Wolter H. Hoffmann, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Andre S. van Petersen, MD, acquisition of data participate in revising it critically give final approval of the version to be published Jerome P. van Brussel, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Guido N. M. Stultiens, MD, acquisition of data participate in revising it critically give final approval of the version to be published Alex Derom, MD, acquisition of data participate in revising it critically give final approval of the version to be published P. Ted den Hoed, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Gwan H. Ho, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Lukas C. van Dijk, MD, PhD, acquisition of data participate in revising it critically give final approval of the version to be published Nicole Verhofstad, PhD, acquisition of data parti...
Background: The ERASE (Endovascular Revascularization and Supervised Exercise) study showed that a combination therapy of endovascular revascularization followed by supervised exercise resulted in greater improvement in walking ability and quality of life as compared with supervised exercise only (standard care) in patients with intermittent claudication. The cost-effectiveness of the combination therapy as compared with supervised exercise is not well defined. In this report, the cost-effectiveness analysis of the ERASE study is presented. Methods: Two hundred twelve patients were randomly assigned to the combination therapy (n=106) or supervised exercise only (n=106) and were followed for 12 months. Cumulative costs per patient were collected using the in-hospital resource utilization data and cost-questionnaires. Quality-adjusted life years were estimated using the EuroQol-5D questionnaire. Incremental cost-effectiveness ratios were calculated from both the health care and societal perspective. The associated uncertainty was determined using bootstrap techniques and acceptability curves. Results: As compared with supervised exercise only, the combination therapy cost an additional €1.462 (99% CI, 388 to 3862) from the health care perspective and €161 (99% CI, −2286 to 3106) from the societal perspective. Accumulated quality-adjusted life- years during 1 year follow-up were 0.042 (99% CI, −0.009 to 0.118) higher in the combination therapy group. The incremental cost-effectiveness ratio was €34.810 from the health care perspective and €3.833 from the societal perspective. Compared with supervised exercise, at a willingness-to-pay threshold of €80.000 per quality-adjusted life-year, the combination therapy had a probability of 87% and 95% of being cost-effective from the health care and societal perspective, respectively. Conclusions: Combination therapy of endovascular revascularization followed by supervised exercise is clinically and economically a more attractive approach than supervised exercise only for intermittent claudication up to 12-month follow-up. Yet, the long-term cost- and clinical effectiveness of both strategies for specific patient groups remains to be defined. REGISTRATION: URL: https://www.trialregister.nl ; Unique identifier: NTR2249.
REPLYIn a recent article in the Annals of Vascular Surgery, Duffy et al. 1 reviewed the management of and the clinical success of minimal invasive surgery in median arcuate ligament (MAL) syndrome. The existence of the MAL syndrome, also known as the celiac artery compression syndrome (CACS), was open for debate because many reasoned that an isolated respiration-dependent celiac artery stenosis could not result in symptoms. Duffy et al. clearly describe in their review article the clinical presentation, the work-up, and treatment (minimal invasive) for CACS. They reviewed the results of laparoscopy for the treatment of CACS from several case reports. To complete their review, we would like to highlight the three larger studies 2-4 that describe the laparoscopic and endoscopic release in CACS, published several months before the publication of Duffy et al. We realize that the article by Duffy et al. was probably accepted for publication just before the publication of these large trials.The clinical and angiographic results after laparoscopic and endoscopic release in CACS were described in three separate studies (n ¼ 77; follow-up between 20 and 44 months). The conversion rate to open surgery varied between 13-27% in the transabdominal laparoscopic group, 2,3 as compared with 2% in the retroperitoneal endoscopic release group. 4 The main reason for conversion was intraoperative bleeding. In the largest series, 4 after retroperitoneal endoscopic release, unimpeded vessel anatomy during respiration was observed on angiography in 78%. Six patients with persisting intraluminal stenoses after release underwent supplementary endovascular angioplasty resulting in a primary-assisted anatomic patency of 89%. It is crucial to ensure that the release is complete. Angioplasty can be used to determine the presence of residual ligament compression. The patients-freefrom-symptoms rates where 89%, 4 93%, 2 and 100% 3 after a median follow-up of 20, 44, and 28 months, respectively.Duffy et al., on the basis of their experience, state that the operation should divide all fibrous bands of the MAL, including the celiac ganglion fibers around the celiac artery, leaving the celiac trunk completely free circumferentially. However, in our endoscopic approach, 4 only the left crus was divided and therefore the right branches of the plexus and the right crus were kept intact. We have shown that this is strongly associated with restoration of blood flow, disappearance of ischemia, and resolution of symptoms. 4,5 An advantage of this approach is that it minimizes the occurrence of gastroesophageal reflux disease (GERD). We observed GERD in 9% after open CACS release as opposed to 0% in the retroperitoneal approach. 4,5 Furthermore, Duffy et al. mentioned peroperative assessment of the artery by laparoscopic ultrasound imaging after decompression. It is arguable whether general anesthetic with muscle relaxation makes it possible to assess respiration-dependent flow changes. For this reason, we perform a digital subtraction angiography and if ...
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