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2. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms

Author

van Schaik, Theodorus G., Yeung, Kak K., Verhagen, Hence J., de Bruin, Jorg L., van Sambeek, Marc R.H.M., Balm, Ron, Zeebregts, Clark J., van Herwaarden, Joost A., Blankensteijn, Jan D., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A.A., Buth, J., Pattynama, P. M., Verhoeven, E. L.G., van Voorthuisen, A. E., Balm, R., Cuypers, P. W.M., Prinssen, M., van Sambeek, M. R.H.M., Baas, A. F., Hunink, M. G., van Engelshoven, J. M., Jacobs, M. J.H.M., de Mol, B. A.J.M., van Bockel, J. H., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., de Bruin, J. L., Tielbeek, A. V., Reekers, J. A., Pattynama, P., Prins, T., van der Ham, A. C., van der Velden, J. J.I.M., van Sterkenburg, S. M.M., ten Haken, G. B., Bruijninckx, C. M.A., van Overhagen, H., Nolthenius, Tutein R.P., Hendriksz, T. R., Teijink, J. A.W., Odink, H. F., de Smet, A. A.E.A., Vroegindeweij, D., van Loenhout, R. M.M., Rutten, M. J., Hamming, J. F., Lampmann, L. E.H., Bender, M. H.M., Pasmans, H., Vahl, A. C., de Vries, C., Mackaay, A. J.C., van Dortmont, L. M.C., van der Vliet, A. J., Kool, Schultze L.J., Boomsma, J. H.B., van Dop, H. R., de Mol van Otterloo, J. C.A., de Rooij, T. P.W., Smits, T. M., Yilmaz, E. N., van den Berg, F. G., Visser, M. J.T., van der Linden, E., Schurink, G. W.H., de Haan, M., Smeets, H. J., Stabel, P., van Elst, F., Poniewierski, J., and Vermassen, F. E.G.

Published
2017
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4. Post-operative Surveillance and Long Term Outcome after Endovascular Aortic Aneurysm Repair in Patients with an Initial Post-operative Computed Tomography Angiogram Without Abnormalities: the Multicentre Retrospective ODYSSEUS Study

Author

Geraedts, Anna C.M., Mulay, Sana, Vahl, A. C., Verhagen, H. J.M., Wisselink, Willem, de Mik, Sylvana M.L., van Dieren, Susan, Koelemay, M. J.W., Balm, Ron, Balm, R., Elshof, J. W., Elsman, B. H.P., Hamming, J. F., Kropman, R. H.J., Poyck, P. P., Schurink, G. W.H., de Smet, A. A.E.A., van Sterkenburg, S. M., Ünlü, C., Vriens, P. W.H.E., de Vries, J. P.P.M., Wever, J. J., Wisselink, W., Zeebregts, C. J., ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Man, Biomaterials and Microbes (MBM), Surgery, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, Epidemiology and Data Science, ACS - Diabetes & metabolism, ACS - Heart failure & arrhythmias, APH - Health Behaviors & Chronic Diseases, Graduate School, Amsterdam Gastroenterology Endocrinology Metabolism, APH - Methodology, Cell biology, Erasmus School of Law, Neurology, and Child and Adolescent Psychiatry / Psychology

Subjects
Endoleak, Angiography, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Blood Vessel Prosthesis Implantation, Treatment Outcome, Risk Factors, Endovascular procedures, Vascular surgical procedures, Humans, Abdominal aortic aneurysm, Surgery, Prospective Studies, Cardiology and Cardiovascular Medicine, Tomography, X-Ray Computed, Aortic Aneurysm, Abdominal, Retrospective Studies
Abstract

Contains fulltext : 252341.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Lifelong imaging surveillance is recommended following endovascular aneurysm repair (EVAR). This study aimed to examine the association between adherence to post-operative surveillance and survival and secondary interventions in patients with an initial post-operative computed tomography angiogram (CTA) without abnormalities. METHODS: All consecutive patients undergoing EVAR for intact abdominal aortic aneurysm (AAA) in 16 hospitals between 2007 and 2012 were identified retrospectively, with follow up until December 2018. Patients were included if the initial post-operative CTA showed no types I - III endoleak, kinking, infection, or limb occlusion. Discontinued follow up was defined as at least one 16 month period in which no imaging surveillance was performed. Primary outcomes were aneurysm related mortality and secondary interventions, and secondary outcome all cause mortality. Kaplan-Meier analysis was used to estimate survival, and Cox regression analyses to identify the association between independent variables and outcome. Sensitivity analyses were performed by varying the definition of continued yearly follow up. The study protocol was published (bmjopen-2019-033584). RESULTS: 1 596 patients (552 continued, 1 044 discontinued follow up) were included with a median (interquartile range) follow up of 89.1 months (52.6). Cumulative aneurysm related, overall, and intervention free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at 1, 5, and 10 years, respectively. American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR] 3.810, 95% confidence interval [CI] 1.296 - 11.198), increase in AAA diameter (HR 3.299, 95% CI 1.408 - 7.729), and continued follow up (HR 3.611, 95% CI 1.780 - 7.323) were independently associated with aneurysm related mortality. The same variables and age (HR 1.063 per year, 95% CI 1.052 - 1.074) were significantly associated with all cause mortality. No difference in secondary interventions was observed between patients with continued vs. discontinued follow up (89/552; 16% vs. 136/1044; 13%; p = .091). Sensitivity analyses showed worse aneurysm related and overall survival in patients with continued follow up. CONCLUSION: Discontinued follow up is not associated with poor outcomes. Future prospective studies are indicated to determine in which patients imaging follow up can be safely reduced.

Published
2022

5. A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

Author

Lam, Yee Lai, Alozai, Tamana, Schreve, Michiel A., de Smet, André A.E.A., Vahl, Anco C., Nagtzaam, Ivo, Lawson, James A., Nieman, Fred H.M., Wittens, Cees H.A., Lam, Yee Lai, Alozai, Tamana, Schreve, Michiel A., de Smet, André A.E.A., Vahl, Anco C., Nagtzaam, Ivo, Lawson, James A., Nieman, Fred H.M., and Wittens, Cees H.A.

Abstract

Background: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). Methods: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. Results: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). Conclusions: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow

Published
2022

6. Analysis of Outcomes After Endovascular Abdominal Aortic Aneurysm Repair in Patients With Abnormal Findings on the First Postoperative Computed Tomography Angiography

Author

Geraedts, Anna C.M., Mulay, Sana, van Dieren, Susan, Koelemay, M. J.W., Balm, R., Elshof, J. W., Elsman, B. H.P., Hamming, J. F., Kropman, R. H.J., Poyck, P. P., Schurink, G. W.H., de Smet, A. A.E.A., van Sterkenburg, S. M., Ünlü, C., Vahl, A. C., Verhagen, H. J.M., Vriens, P. W.H.E., de Vries, J. P.P.M., Wever, J. J., Wisselink, W., Zeebregts, C. J., Geraedts, Anna C.M., Mulay, Sana, van Dieren, Susan, Koelemay, M. J.W., Balm, R., Elshof, J. W., Elsman, B. H.P., Hamming, J. F., Kropman, R. H.J., Poyck, P. P., Schurink, G. W.H., de Smet, A. A.E.A., van Sterkenburg, S. M., Ünlü, C., Vahl, A. C., Verhagen, H. J.M., Vriens, P. W.H.E., de Vries, J. P.P.M., Wever, J. J., Wisselink, W., and Zeebregts, C. J.

Abstract

Purpose: Lifelong follow-up after endovascular abdominal aortic aneurysm repair (EVAR) is recommended due to a continued risk of complications, especially if the first postoperative imaging shows abnormal findings. We studied the long-term outcomes in patients with abnormalities on the first postoperative computed tomography angiography (CTA) following EVAR. Materials and Methods: This is a retrospective study of all consecutive patients who underwent elective EVAR for nonruptured abdominal aortic aneurysm (AAA) between January 2007 and January 2012 in 16 Dutch hospitals with follow-up until December 2018. Patients were included if the first postoperative CTA showed one of the following abnormal findings: endoleak type I–IV, endograft kinking, infection, or limb occlusion. AAA diameter, complications, and secondary interventions during follow-up were registered. Primary endpoint was overall survival, and other endpoints were secondary interventions and intervention-free survival. Kaplan-Meier analyses were used to estimate overall and intervention-free survival. Cox regression analyses were used to identify the association of independent determinants with survival and secondary interventions. Results: A total of 502 patients had abnormal findings on the first postoperative CTA after EVAR and had a median follow-up (interquartile range IQR) of 83.0 months (59.0). The estimated overall survival rate at 1, 5, and 10 years was 84.7%, 51.0%, and 30.8%, respectively. Age [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.05 to 1.10] and American Society of Anesthesiologists (ASA) classification (ASA IV HR 3.20, 95% CI 1.99 to 5.15) were significantly associated with all-cause mortality. Overall, 167 of the 502 patients (33.3%) underwent 238 secondary interventions in total. Fifty-eight patients (12%) underwent an intervention based on a finding on the first postoperative CTA. Overall survival was 38.4% for patients with secondary interventions and 44.5% for patien

Published
2021

11. Quality of Life after Endovascular and Open AAA Repair. Results of a Randomised Triala

Author

Prinssen, M., Buskens, E., Blankensteijn, Jan D., Buth, J., Tielbeek, A. V., Verhoeven, E. L.G., Prins, T., Hamming, J. F., Lampmann, L. E.H., Schurink, G. W.H., de Haan, M., Balm, R., Reekers, J. A., Bender, M. H.M., Pasmans, H., Visser, M. J.T., van der Linden, E., Blankensteijn, J. D., de Smet, A. A.E.A., Vroegindeweij, D., van Sterkenburg, S. M.M., ten Haken, G. B., Boomsma, J. B.B., van Dop, H. R., de Mol van Otterloo, J. C.A., de Rooij, T. P.W., van Sambreek, M. R.H.M., Pattynama, P., Bruijninckx, C. M.A., van Overhagen, H., van der Ham, A. C., van der Velden, J. J.I.M., Wisselink, W., van den Berg, F. G., Tutein Nolthenius, R. P., Hendriksz, T. R., Vahl, A. C., de Vries, C., Mackaay, A. J.C., Smeets, H. J., van Dortmont, L. M.C., Elsman, B. H.P., Smits, T. M., van Loenhout, R. M.M., Rutten, M. J., Teijink, J. A.W., Odink, H. F., Yilmaz, E. N., den Butter, G., Poniewierski, J., Vermassen, F. E.G., Stabel, P., van Elst, F., Epidemiology and Data Science, Pathology, Surgery, ACS - Atherosclerosis & ischemic syndromes, and Radiology and nuclear medicine

Subjects
Male, Quality of life, medicine.medical_specialty, Time Factors, Health Status, Population, law.invention, Aortic aneurysm, Aneurysm, Randomized controlled trial, law, Surveys and Questionnaires, medicine, Humans, EVAR, Postoperative Period, education, Heart, lung and circulation [UMCN 2.1], Aged, Medicine(all), education.field_of_study, business.industry, Open AAA repair, Recovery of Function, medicine.disease, Abdominal aortic aneurysm, humanities, Surgery, Clinical trial, Randomised trail, Female, Cardiology and Cardiovascular Medicine, business, Vascular Surgical Procedures, Abdominal surgery, Aortic Aneurysm, Abdominal, DREAM-trial
Abstract

Contains fulltext : 57956.pdf (Publisher’s version ) (Closed access) AIM: To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. METHODS: In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated to EVAR or OR. QoL questionnaires (SF-36 and EuroQoL-5D) were sent to all patients preoperatively (PREOP) and at five time points in the first postoperative year (3W, 6W, 3M, 6M and 12M). Between November 1999 and August 2002, 153 patients (141 male; 12 female) were randomised (78 EVAR and 75 OR; one crossover from OR to EVAR). The EuroQoL-5D scores and the eight domains of the SF-36 for the two groups were compared using the Mann-Whitney test. Changes over time were analysed using the Wilcoxon sign test. RESULTS: There were no statistically significant differences in baseline characteristics (age, gender and SVS risk factors). The preoperative QoL scores of the study group were similar to the QoL scores of the general population of the same age. After 3W the OR group showed a significant decrease on the EuroQol-5D (p=0.022) and in six of the eight SF-36 domains. The EVAR group also showed a significant decrease on the EuroQol-5D (p=0.004) and in 5 of the 8 domains of the SF-36. At 6W the EuroQol-5D had recovered to baseline in the OR group and the decreased domains of the SF-36 had partially recovered. In the EVAR group the EuroQol-5D and three of the five decreased SF-36 domains, had returned to baseline. From 6M on, the OR group reported a significantly higher score on the EuroQoL-5D than the EVAR group (p=0.045 (6M) and p=0.001 (12M)). CONCLUSION: In the early postoperative period there is a small, yet significant QoL advantage for EVAR compared to OR. At 6 months and beyond, patients reported better QoL after OR than after EVAR.

Published
2004
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