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1. Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction

Author

Mark J.W. Koelemay, Nick S. van Reijen, Susan van Dieren, Franceline A. Frans, Erik J.G. Vermeulen, Hessel C.J.L. Buscher, Jim A. Reekers, M.G.W. Dijkgraaf, R.J. de Haan, R. Balm, M.M. Idu, J.D. Blankensteijn, A.W. Hoksbergen, A.P. Conijn, R. Met, D.A. Legemate, S. Bipat, K.P. van Lienden, O.M. van Delden, E.J. Zijlstra, R. Lely, R.H.H. Engelbert, M.A. van Egmond, A. Poelgeest, E. Geleijn, A.J. de Nie, M.A. Schreve, A. Kamphuis, R.H.J. Kropman, J. Wille, J.P.M.M. de Vries, R.H. van de Mortel, H.D. van de Pavoord, D.A. van den Heuvel, M. van Leersum, M.J. van Strijen, J.A. Vos, D. Nio, A. Rijbroek, G.J.M. Akkersdijk, R. Metz, B.J. van Kelckhoven, H.J. van de Rest, V.J. Leijdekkers, A.C. Vahl, R.C. van Nieuwenhuizen, J.G. Blomjous, A.D. Montauban van Swijndregt, P.P.C. Poyck, M. van der Jagt, J.A. van der Vliet, L.J. Schultze Kool, P.L. Klemm, H.W. Slis, M.C.M. Willems, L.C. Huisman, J.H.D. de Bruine, M.J. Mallant, L. Smeets, S.M. van Sterkenburg, M.M. Reijnen, P.B. Veendrick, M.H. van Werkum, J.A. van Ostayen, B.H.P. Elsman, L.G. van der Hem, R.B.M. van Tongeren, C.F.M. Klok, W.E. Hellings, J.C. Aarts, A.M. Wiersema, T.A. van den Broek, A. Moolhuijzen, J.A. Teijink, M.R. van Sambeek, B.P. Keller, G.A. Vos, J.C. Breek†, J. Gravendeel, R. Oosterhof-Berktas, N.A. Koedam, E.J. Hollander, T. Pels Rijcken, S.S. van der Voort, B. Honing, D.M. Scharn, M.S. Lemson, J. Seegers, R.M. Krol, C.J. Buskens, C.J. Zeebregts, R.A. de Bie, H. van Overhagen, Surgery, ACS - Atherosclerosis & ischemic syndromes, Graduate School, APH - Personalized Medicine, APH - Quality of Care, APH - Methodology, Radiology and Nuclear Medicine, Epidemiology and Data Science, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Amsterdam Cardiovascular Sciences, Rehabilitation medicine, AMS - Rehabilitation & Development, ARD - Amsterdam Reproduction and Development, ACS - Diabetes & metabolism, ACS - Heart failure & arrhythmias, APH - Health Behaviors & Chronic Diseases, VU University medical center, Radiology and nuclear medicine, Other Research, ACS - Microcirculation, Man, Biomaterials and Microbes (MBM), RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, and Epidemiologie

Subjects
Randomised controlled trial, Endovascular revascularisation, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Walking, Intermittent Claudication, Iliac Artery, Exercise Therapy, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Peripheral Arterial Disease, Treatment Outcome, Intermittent Claudication/etiology, Quality of Life, Humans, Peripheral Arterial Disease/complications, Surgery, Cardiology and Cardiovascular Medicine, Supervised exercise therapy
Abstract

Contains fulltext : 251517.pdf (Publisher’s version ) (Open Access) OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction. METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded. RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC. CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

Published
2022
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2. Editor's Choice – Nationwide Analysis of Patients Undergoing Iliac Artery Aneurysm Repair in the Netherlands

Author

Hamid Jalalzadeh, Reza Indrakusuma, Mark J.W. Koelemay, Ron Balm, L.H. Van den Akker, P.J. Van den Akker, G.J. Akkersdijk, G.P. Akkersdijk, W.L. Akkersdijk, M.G. van Andringa de Kempenaer, C.H. Arts, J.A. Avontuur, J.G. Baal, O.J. Bakker, R. Balm, W.B. Barendregt, M.H. Bender, B.L. Bendermacher, M. van den Berg, P. Berger, R.J. Beuk, J.D. Blankensteijn, R.J. Bleker, J.H. Bockel, M.E. Bodegom, K.E. Bogt, A.P. Boll, M.H. Booster, B.L. Borger van der Burg, G.J. de Borst, W.T. Bos-van Rossum, J. Bosma, J.M. Botman, L.H. Bouwman, J.C. Breek, V. Brehm, M.J. Brinckman, T.H. van den Broek, H.L. Brom, M.T. de Bruijn, J.L. de Bruin, P. Brummel, J.P. van Brussel, S.E. Buijk, M.G. Buimer, D.H. Burger, H.C. Buscher, G. den Butter, E. Cancrinus, P.H. Castenmiller, G. Cazander, H.M. Coveliers, P.H. Cuypers, J.H. Daemen, I. Dawson, A.F. Derom, A.R. Dijkema, J. Diks, M.K. Dinkelman, M. Dirven, D.E. Dolmans, R.C. van Doorn, L.M. van Dortmont, M.M. van der Eb, D. Eefting, G.J. van Eijck, J.W. Elshof, B.H. Elsman, A. van der Elst, M.I. van Engeland, R.G. van Eps, M.J. Faber, W.M. de Fijter, B. Fioole, W.M. Fritschy, R.H. Geelkerken, W.B. van Gent, G.J. Glade, B. Govaert, R.P. Groenendijk, H.G. de Groot, R.F. van den Haak, E.F. de Haan, G.F. Hajer, J.F. Hamming, E.S. van Hattum, C.E. Hazenberg, P.P. Hedeman Joosten, J.N. Helleman, L.G. van der Hem, J.M. Hendriks, J.A. van Herwaarden, J.M. Heyligers, J.W. Hinnen, R.J. Hissink, G.H. Ho, P.T. den Hoed, M.T. Hoedt, F. van Hoek, R. Hoencamp, W.H. Hoffmann, A.W. Hoksbergen, E.J. Hollander, L.C. Huisman, R.G. Hulsebos, K.M. Huntjens, M.M. Idu, M.J. Jacobs, M.F. van der Jagt, J.R. Jansbeken, R.J. Janssen, H.H. Jiang, S.C. de Jong, V. Jongkind, M.R. Kapma, B.P. Keller, A. Khodadade Jahrome, J.K. Kievit, P.L. Klemm, P. Klinkert, B. Knippenberg, N.A. Koedam, M.J. Koelemay, J.L. Kolkert, G.G. Koning, O.H. Koning, A.G. Krasznai, R.M. Krol, R.H. Kropman, R.R. Kruse, L. van der Laan, M.J. van der Laan, J.H. van Laanen, J.H. Lardenoye, J.A. Lawson, D.A. Legemate, V.J. Leijdekkers, M.S. Lemson, M.M. Lensvelt, M.A. Lijkwan, R.C. Lind, F.T. van der Linden, P.F. Liqui Lung, M.J. Loos, M.C. Loubert, D.E. Mahmoud, C.G. Manshanden, E.C. Mattens, R. Meerwaldt, B.M. Mees, R. Metz, R.C. Minnee, J.C. de Mol van Otterloo, F.L. Moll, Y.C. Montauban van Swijndregt, M.J. Morak, R.H. van de Mortel, W. Mulder, S.K. Nagesser, C.C. Naves, J.H. Nederhoed, A.M. Nevenzel-Putters, A.J. de Nie, D.H. Nieuwenhuis, J. Nieuwenhuizen, R.C. van Nieuwenhuizen, D. Nio, A.P. Oomen, B.I. Oranen, J. Oskam, H.W. Palamba, A.G. Peppelenbosch, A.S. van Petersen, T.F. Peterson, B.J. Petri, M.E. Pierie, A.J. Ploeg, R.A. Pol, E.D. Ponfoort, P.P. Poyck, A. Prent, S. ten Raa, J.T. Raymakers, M. Reichart, B.L. Reichmann, M.M. Reijnen, A. Rijbroek, M.J. van Rijn, R.A. de Roo, E.V. Rouwet, C.G. Rupert, B.R. Saleem, M.R. van Sambeek, M.G. Samyn, H.P. van ’t Sant, J. van Schaik, P.M. van Schaik, D.M. Scharn, M.R. Scheltinga, A. Schepers, P.M. Schlejen, F.J. Schlosser, F.P. Schol, O. Schouten, M.H. Schreinemacher, M.A. Schreve, G.W. Schurink, C.J. Sikkink, M.P. Siroen, A. te Slaa, H.J. Smeets, L. Smeets, A.A. de Smet, P. de Smit, P.C. Smit, T.M. Smits, M.G. Snoeijs, A.O. Sondakh, T.J. van der Steenhoven, S.M. van Sterkenburg, D.A. Stigter, H. Stigter, R.P. Strating, G.N. Stultiëns, J.E. Sybrandy, J.A. Teijink, B.J. Telgenkamp, M.J. Testroote, R.M. The, W.J. Thijsse, I.F. Tielliu, R.B. van Tongeren, R.J. Toorop, J.H. Tordoir, E. Tournoij, M. Truijers, K. Türkcan, R.P. Tutein Nolthenius, Ç. Ünlü, A.A. Vafi, A.C. Vahl, E.J. Veen, H.T. Veger, M.G. Veldman, H.J. Verhagen, B.A. Verhoeven, C.F. Vermeulen, E.G. Vermeulen, B.P. Vierhout, M.J. Visser, J.A. van der Vliet, C.J. Vlijmen - van Keulen, H.G. Voesten, R. Voorhoeve, A.W. Vos, B. de Vos, G.A. Vos, B.H. Vriens, P.W. Vriens, A.C. de Vries, J.P. de Vries, M. de Vries, C. van der Waal, E.J. Waasdorp, B.M. Wallis de Vries, L.A. van Walraven, J.L. van Wanroij, M.C. Warlé, V. van Weel, A.M. van Well, G.M. Welten, R.J. Welten, J.J. Wever, A.M. Wiersema, O.R. Wikkeling, W.I. Willaert, J. Wille, M.C. Willems, E.M. Willigendael, W. Wisselink, M.E. Witte, C.H. Wittens, I.C. Wolf-de Jonge, O. Yazar, C.J. Zeebregts, M.L. van Zeeland, Surgery, ACS - Atherosclerosis & ischemic syndromes, Pathology, VU University medical center, Pediatrics, Dermatology, ACS - Microcirculation, ACS - Diabetes & metabolism, Graduate School, 02 Surgical specialisms, ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Neurology, Erasmus MC other, Molecular Genetics, Erasmus School of Economics, Socio-Medical Sciences (SMS), Cell biology, Gynecological Oncology, Research & Education, Child and Adolescent Psychiatry / Psychology, Cardiology, Urology, Erasmus School of Health Policy & Management, Erasmus School of Social and Behavioural Sciences, Erasmus School of Law, Department of History, Department of Psychology, Education and Child Studies, Obstetrics & Gynecology, Department of Finance, General Practice, Applied Economics, Pediatric Surgery, Department of Business-Society Management, Commercial Law and Financial Law, Radiology & Nuclear Medicine, Business Economics, Neurosurgery, Public Health, Anesthesiology, Internal Medicine, Hematology, Intensive Care, Psychiatry, WP ESPhil, and Gastroenterology & Hepatology

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Iliac Aneurysm/epidemiology, Patient characteristics, Netherlands/epidemiology, 030204 cardiovascular system & hematology, 030230 surgery, Iliac Artery/pathology, Endovascular aneurysm repair, Iliac Artery, 03 medical and health sciences, 0302 clinical medicine, Aneurysm, Sex Factors, medicine, 80 and over, Humans, EVAR, Registries, Iliac artery aneurysm, Aged, Netherlands, Retrospective Studies, Surgical repair, Aged, 80 and over, business.industry, Open repair, Endovascular Procedures, Retrospective cohort study, Guideline, Vascular surgery, medicine.disease, Guideline Adherence/statistics & numerical data, Surgery, Endovascular Procedures/methods, Aneurysm repair, Treatment Outcome, Iliac Aneurysm, Female, Guideline Adherence, Cardiology and Cardiovascular Medicine, business
Abstract

OBJECTIVE: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR).METHODS: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests.RESULTS: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38-50) mm and 68 (IQR 58-85) mm, respectively. Mortality was 1.3% (95% CI 0.7-2.4) after eIAA repair and 25.5% (95% CI 18.0-34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively).CONCLUSION: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair.

Published
2020
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3. Randomised Clinical Trial of Supervised Exercise Therapy vs Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study

Author

M.J.W. Koelemay, N.S. van Reijen, S. van Dieren, F.A. Frans, E.J.G. Vermeulen, H.C.J.L. Buscher, J.A. Reekers, M.G.W. Dijkgraaf, R.J. de Haan, R. Balm, M.M. Idu, J.D. Blankensteijn, A.W. Hoksbergen, A.P. Conijn, R. Met, D.A. Legemate, S. Bipat, K.P. van Lienden, O.M. van Delden, E.J. Zijlstra, R. Lely, R.H.H. Engelbert, M.A. van Egmond, A. Poelgeest, E. Geleijn, A.J. de Nie, M.A. Schreve, A. Kamphuis, R.H.J. Kropman, J. Wille, J.P.M.M. de Vries, R.H. van de Mortel, H.D. van de Pavoord, D.A. van den Heuvel, M. van Leersum, M.J. van Strijen, J.A. Vos, D. Nio, A. Rijbroek, G.J.M. Akkersdijk, R. Metz, B.J. van Kelckhoven, H.J. van de Rest, V.J. Leijdekkers, A.C. Vahl, R.C. van Nieuwenhuizen, J.G. Blomjous, A.D. Montauban van Swijndregt, P.P.C. Poyck, M. van der Jagt, J.A. van der Vliet, L.J. Schultze Kool, P.L. Klemm, H.W. Slis, M.C.M. Willems, L.C. Huisman, J.H.D. de Bruine, M.J. Mallant, L. Smeets, S.M. van Sterkenburg, M.M. Reijnen, P.B. Veendrick, M.H. van Werkum, J.A. van Ostayen, B.H.P. Elsman, L.G. van der Hem, R.B.M. van Tongeren, C.F.M. Klok, W.E. Hellings, J.C. Aarts, A.M. Wiersema, T.A. van den Broek, A. Moolhuijzen, J.A. Teijink, M.R. van Sambeek, B.P. Keller, G.A. Vos, J.C. Breek†, J. Gravendeel, R. Oosterhof-Berktas, N.A. Koedam, E.J. Hollander, T. Pels Rijcken, S.S. van der Voort, B. Honing, D.M. Scharn, M.S. Lemson, J. Seegers, and R.M. Krol

Subjects
Surgery, Cardiology and Cardiovascular Medicine
Published
2022
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4. Long-term Results of Percutaneous Transluminal Angioplasty for Symptomatic Iliac In-stent Stenosis

Author

M. Bemelman, Rogier H.J. Kropman, J.P.P.M. de Vries, H.D.W.M. van de Pavoordt, J.C. van den Berg, Jan Albert Vos, R.H. van de Mortel, and F.L. Moll

Subjects
Male, medicine.medical_specialty, Percutaneous, Time Factors, medicine.medical_treatment, Iliac artery, Arterial Occlusive Diseases, Duplex scanning, Medicine, Humans, Local anesthesia, Vascular Patency, Retrospective Studies, Medicine(all), medicine.diagnostic_test, business.industry, Graft Occlusion, Vascular, Stent, Percutaneous transluminal angioplasty, Middle Aged, medicine.disease, Intermittent claudication, Surgery, Radiography, Stenosis, Treatment Outcome, In-stent obstruction, Angiography, Retreatment, Female, Stents, Radiology, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Complication, Angioplasty, Balloon, Follow-Up Studies
Abstract

Objective This study describes the long-term results of endoluminal therapy for iliac in-stent obstructions. Design This is a retrospective study. Materials and methods From 1992 to 2005, 68 patients (22 women), with a mean age of 61 ± 13 years and 16 bi-iliac in-stent obstructions, underwent 84 endovascular interventions for focal iliac in-stent stenoses (n = 61) or occlusions (n = 23). Primarily, only uncovered stents were placed. All patients were symptomatic: 70% had disabling intermittent claudication, 23% had resting pain, and 7% had trophic changes. All had in-stent diameter reduction exceeding 50% that was confirmed by duplex scanning and angiography. Procedures were performed under local anesthesia via the femoral route. Results All interventions were initially technically successful, with a minor complication of pneumonia in one patient (2%). Initial clinical success was achieved in 86% of patients. PTA alone was used to treat 72 (86%) in-stent obstructions, the other 12 (14%) had PTA and renewed stent placement. The 30-day mortality rate was 0%. Mean follow-up was 35 months (range, 3 months to 10 years) and included duplex scanning. Primary clinical patency was 88% at 1 year, 62% at 3 years, and 38% at 5 years follow-up. During follow-up, 28 (33%) of 84 extremities required secondary reinterventions because of symptomatic renewed in-stent stenosis, and 11 were treated successfully with repeated endovascular interventions. Secondary patency at 1 year was 94%, 78% at 3 years, and 63% at 5 years. Surgical intervention was eventually needed in 17 (20%) of the 84 extremities. Conclusions Endoluminal therapy for iliac focal in-stent obstructive disease seems to be a safe technique with acceptable long-term outcome and therefore a true alternative to primary surgical reconstruction.

Published
2006
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