We appreciate the attention Ouriel et al. have dedicated to reviewing our work.
1However, their complete dismissal of our findings raises significant concerns for conscious or unconscious bias on their part, given their extensive industry ties,
- Weissler E.H.
- Hammill B.G.
- Armstrong J.L.
- et al.
Association between device type and Type IIIb endoleaks following thoracic endovascular aortic repair.
Eur J Vasc Endovasc Surg. 2023; 65: 112-119
2and furthermore runs counter to ongoing efforts to improve medical device safety. Specifically, we would like to address the following points.
- Lundh A.
- Lexchin J.
- Mintzes B.
- Schroll J.B.
- Bero L.
Industry sponsorship and research outcome.
Cochrane Database Syst Rev. 2017; 2MR000033
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- Association between device type and Type IIIb endoleaks following thoracic endovascular aortic repair.Eur J Vasc Endovasc Surg. 2023; 65: 112-119
- Industry sponsorship and research outcome.Cochrane Database Syst Rev. 2017; 2MR000033
- Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.Pharmacoepidemiol Drug Saf. 2001; 10: 483-486
Published online: February 14, 2023
Publication stageIn Press Corrected Proof
© 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
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- Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic RepairEuropean Journal of Vascular and Endovascular SurgeryVol. 65Issue 1
- PreviewEndoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices.
- Not So Fast, All Devices and Their Materials Are DifferentEuropean Journal of Vascular and Endovascular Surgery
- PreviewFabric defects causing type IIIb endoleaks (ELs) were first described > 20 years ago, and this issue has recently been found at a high rate in the Medtronic (MDT; Santa Rosa, CA) Valiant Navion (Navion) device.1–3 Reporting device failures is important, and we applaud Weissler et al. for their attempt to bring further scrutiny to Navion device failures.4 However, we are concerned that they have missed much of the important nuance required in this type of study.