Complex Endovascular Aneurysm Repair: Patient Benefit or a Waste of Money?

Abstract

Over recent years, endovascular aneurysm repair (EVAR) has become the mainstay for the treatment of abdominal aortic aneurysms (AAA).1Budtz-Lilly J. Venermo M. Debus S. Behrendt C.A. Altreuther M. Beiles B. et al.Editor's choice - Assessment of international outcomes of intact abdominal aortic aneurysm repair over 9 Years.Eur J Vasc Endovasc Surg. 2017; 54: 13-20Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar The preference for EVAR is based on the knowledge that EVAR results in better early survival than open repair in intact aneurysms. Despite this survival benefit, the cost-effectiveness of EVAR versus open repair is still questionable.2Epstein D. Sculpher M.J. Powell J.T. Thompson S.G. Brown L.C. Greenhalgh R.M. Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials.Br J Surg. 2014; 101: 623-631Crossref PubMed Scopus (64) Google Scholar However, patient preference for a minimally invasive procedure with lower peri-operative risk has clearly pushed the broad application of EVAR internationally, despite the lack of convincing health economic cost-effectiveness.3Faggioli G. Scalone L. Mantovani L.G. Borghetti F. Stella A. Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study.Eur J Vasc Endovasc Surg. 2011; 42: 26-34Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar Para-/juxtarenal and thoraco-abdominal aortic aneurysms (TAAA) are clearly more challenging to manage, irrespective of the surgical technique used for their treatment. Various complex endovascular techniques for treatment of these aneurysms have been developed over the years,4Pecoraro F. Veith F.J. Puippe G. Amman-Vesti B. Bettex D. Rancic Z. et al.Mid- and longer-term follow up of chimney and/or periscope grafts and risk factors for failure.Eur J Vasc Endovasc Surg. 2016; 51: 664-673Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar, 5Schanzer A. Simons J.P. Flahive J. Durgin J. Aiello F.A. Doucet D. et al.Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.J Vasc Surg. 2017; 66: 687-694Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar with the most established method being use of custom made fenestrated and branched endografts. As with standard EVAR, fenestrated and branched EVAR (f/b EVAR) was initially reserved for patients judged to be high risk for open surgical repair and was only used at dedicated centres. Over time, however, f/b EVAR has increasingly become the modality of choice for treatment of complex aneurysms at many institutions.6Verhoeven E.L. Katsargyris A. Oikonomou K. Kouvelos G. Renner H. Ritter W. Fenestrated endovascular aortic aneurysm repair as a first line treatment option to treat short necked, juxtarenal, and suprarenal aneurysms.Eur J Vasc Endovasc Surg. 2016; 51: 775-781Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar, 7Budtz-Lilly J. Wanhainen A. Eriksson J. Mani K. Adapting to a total endovascular approach for complex aortic aneurysm repair: outcomes after fenestrated and branched endovascular aortic repair.J Vasc Surg. 2017; 66: 1349-1356Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar In contrast to infrarenal AAA repair, the benefit of f/b EVAR over open repair of complex aneurysms has not been established in any randomised trial. While some reports have indicated low peri-operative mortality and morbidity after endovascular repair, these studies are hampered by the risks associated with retrospective analyses, and a mixture of patients with various extents of pathology.8Tshomba Y. Leopardi M. Ferrer C. Cao P. De Rango P. Verzini F. et al.Aneurysms of the thoraco-abdominal aorta: a comparison with propensity score between endovascular repair and open surgery.Ann Vasc Surg. 2017; 38: e16-e17Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 9Rao R. Lane T.R. Franklin I.J. Davies A.H. Open repair versus fenestrated endovascular aneurysm repair of juxtarenal aneurysms.J Vasc Surg. 2015; 61: 242-255Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar In complex aortic repair, outcome varies depending on the extent of disease. In Crawford's original publication, the risk of paraplegia was 15%, 31%, 7%, and 4%, respectively, in type I, II, III, and IV TAAAs, underlining the fact that comparison of patients with TAAA of different extents was like comparing apples with oranges.10Svensson L.G. Crawford E.S. Hess K.R. Coselli J.S. Safi H.J. Experience with 1509 patients undergoing thoracoabdominal aortic operations.J Vasc Surg. 1993; 17: 357-368Abstract Full Text Full Text PDF PubMed Scopus (1101) Google Scholar In 2016, Coselli et al. published their experience with 3309 TAAA repairs performed between 1991 and 2014; paraplegia rates were 1.1%, 4.3%, 3.6%, and 0.6%, respectively, in type I, II, III, and IV TAAAs.11Coselli J.S. LeMaire S.A. Preventza O. de la Cruz K.I. Cooley D.A. Price M.D. et al.Outcomes of 3309 thoracoabdominal aortic aneurysm repairs.J Thorac Cardiovasc Surg. 2016; 151: 1323-1337Abstract Full Text Full Text PDF PubMed Scopus (350) Google Scholar Three decades of surgical advancements reduced this devastating complication to almost one tenth, but there was still a sevenfold difference between patients with type II and IV. Clearly, the apples and oranges story still applies, and if you try to include juxta-/pararenal aneurysms and even infrarenal aneurysms with a short neck in the equation, it is evident that speaking of heterogeneity is, at best, an understatement. The endovascular era complicated the situation significantly because, unlike open surgery, the extent of aorta that needs to be sacrificed is variable and much greater than the diseased one.12Bertoglio L. Cambiaghi T. Ferrer C. Baccellieri D. Verzini F. Melissano G. et al.Comparison of sacrificed healthy aorta during thoracoabdominal aortic aneurysm repair using off-the-shelf endovascular branched devices and open surgery.J Vasc Surg. 2018; 67: 695-702Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar In this issue, Michel et al. present a study of the 2 year cost-effectiveness of f/b EVAR versus open surgery in patients with complex aortic aneurysms.13Michel M. Becquemin J.-P. Marzelle J. Quelen C. Durand-Zaleski I. on behalf of the WINDOW Trial participantsEditor's Choice – A study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.Eur J Vasc Endovasc Surg. 2018; 56: 15-21Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar This study, the early results of which have been reported previously,14Michel M. Becquemin J.P. Clement M.C. Marzelle J. Quelen C. Durand-Zaleski I. et al.Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms.Eur J Vasc Endovasc Surg. 2015; 50: 189-196Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar compared high risk patients receiving f/b EVAR for para-/juxta-renal AAAs and infra- and supra-diaphragmatic TAAAs with a control group of patients treated by open surgery. The study confirms that there was no difference in mortality, but costs were higher with f/b EVAR in all subgroups except supra-diaphragmatic TAAA. The new study added that f/b EVAR patients had more readmissions on average and that at 2 years hospital costs were even higher in the f/b EVAR group, except in the supra-diaphragmatic TAAA subgroup. From a health economic perspective, the cost of f/b EVAR is significantly higher than a standard EVAR procedure. The French WINDOW trial is one of the few to assess cost-effectiveness of f/b EVAR versus open repair. As the study does not show any survival benefit for the f/b EVAR group versus patients treated by open repair, f/b EVAR is either more expensive and less effective (in patients with para-/juxtarenal aneurysms or infra-diaphragmatic TAAA), or prohibitively cost-ineffective (in patients with supra-diaphragmatic TAAA). Michel et al. have acknowledged many limitations of their study.13Michel M. Becquemin J.-P. Marzelle J. Quelen C. Durand-Zaleski I. on behalf of the WINDOW Trial participantsEditor's Choice – A study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.Eur J Vasc Endovasc Surg. 2018; 56: 15-21Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar In particular, it should be noted that while the patients in the endovascular group were enrolled in a French multicentre prospective registry (WINDOW), the data that were actually used came from the national discharge database for both groups as “the two databases were not fully concordant”. Cost calculations are based on local data, and may not be valid in other circumstances; generally, cost-effectiveness analyses are always affected by the methodology used and should be interpreted with caution.15Mani K. Lundkvist J. Holmberg L. Wanhainen A. Challenges in analysis and interpretation of cost data in vascular surgery.J Vasc Surg. 2010; 51: 148-154Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar Additionally, the French WINDOW trial, upon which the evaluation of f/b EVAR is based in this study, actively selected patients regarded as being at high risk of open surgical repair to f/b EVAR treatment. However, when analysing the data, no differences in the Charlson index were observed and only selective differences were noted regarding age and other comorbidities. Only a few of the significantly different comorbidities were those predictive of mortality in open TAAA repair, such as type II extension, age, renal failure, diabetes, and symptomatic aneurysms.16Coselli J.S. LeMaire S.A. Miller 3rd, C.C. Schmittling Z.C. Koksoy C. Pagan J. et al.Mortality and paraplegia after thoracoabdominal aortic aneurysm repair: a risk factor analysis.Ann Thorac Surg. 2000; 69: 409-414Abstract Full Text Full Text PDF PubMed Scopus (288) Google Scholar This issue should be considered when analysing the results of the TAAA cohort because the cost-effectiveness analysis and results might have been quite different in truly high versus low risk candidates. In addition, this kind of patient selection fails to replicate real life scenarios where, nowadays, open surgery for supra-diaphragmatic TAAA is often offered to younger patients with connective tissue disease, patients with complex post-dissection aneurysms, or patients with previous failed TEVAR or disease progression after TEVAR. Despite these caveats, the paper by Michel et al. is the best currently available evidence for evaluation of cost-effectiveness of f/b EVAR versus open repair for complex aneurysms, and the impressive cost disparity shown between f/b EVAR and open repair for complex aneurysms cannot be ignored. There is clearly a mismatch between the results of this cost-effectiveness evaluation of f/b EVAR, and the increasing use of complex endovascular techniques for treatment of suprarenal aneurysms. The trend can easily be recognised from the era of expansion of standard EVAR for infrarenal AAA. This expansion also occurred despite lack of evidence for cost-effectiveness of EVAR. The thought provoking paper by Michel et al. indicates the need for further scientific evaluation of modern endovascular techniques for treatment of complex aneurysms, from a clinical, as well as health economic, perspective. The results presented by Michel et al. underline the need for further discussion regarding the sanity of the current pricing for f/b EVAR devices.13Michel M. Becquemin J.-P. Marzelle J. Quelen C. Durand-Zaleski I. on behalf of the WINDOW Trial participantsEditor's Choice – A study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.Eur J Vasc Endovasc Surg. 2018; 56: 15-21Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar Currently, the market competition for these devices remains limited. If the price of these endovascular devices is not adjusted to a reasonable level within the short term, there is an imminent risk that their use will be limited by healthcare payer institutions, who will then circumvent clinical decision making. Surely, this would not be of benefit either to patients, clinicians or industry.