Candy-plug: Failure to launch.

Abstract

Dr. Miles and colleagues describe an initial series of 6 cases using the “candy plug” technique to induce false lumen thrombosis after TEVAR for TBAD.1Dr. Daniel Miles et al. Initial Experience with a Modified “Candy-Plug” Technique for False Lumen Embolization in Chronic Type B Aortic Dissection. J Vasc Surg Cases Innov Tech. 20XX, 1(1), XX-XX. doi: XXXX.Google Scholar They report good initial technical success with very limited follow up, in accordance with other similar case series. While this initial result appears promising, the safety and effectiveness of this technique remain poorly understood. My reservations about the technique are founded on the following:1.Failure to launch. The technique was first described 10 years ago yet there remain no larger published series demonstrating safety or effectiveness.2Kolbel T. Lohrenz C. Kieback A. Diener H. Debus E.S. Larena-Avellaneda A. Distal false lumen occlusion in aortic dissection with a homemade extra-large vascular plug: the candy-plug technique.J Endovasc Ther. 2013; 30: 484-489Crossref Scopus (117) Google Scholar This technique is readily available to any provider in a contemporary aortic practice. Why has no one published follow up data beyond 1 year?2.Publication bias. In personal communications, I have heard of several “candy plug” procedures resulting in early aortic rupture. Surgeons rarely share such experiences in a public forum and even more rarely publish them. This publication bias skews the publicly available data to over-report positive results. The lack of larger series or longer-term outcomes suggest this bias is occurring with this specific technique. Furthermore, efforts to overcome the limitations of single center reports, such as meta-analysis will also fail to overcome publication bias and may, in fact, enhance it.3.Natural history of TBAD after TEVAR. It remains very unclear to me that “candy plug” changes the natural history in comparison with TEVAR alone. In one retrospective review from our own institution, 80% of patients undergoing TEVAR for TBAD were free from revision aortic surgery by 3-year follow up.3Nathan DP, Shalhub S, Tang GL, Sweet MP, Verrier ED, Tran NT, Aldea GS, Starnes BW. Outcomes after stent graft therapy for dissection-related aneurysmal degeneration in the descending thoracic aorta. J Vasc Surg 2-5;61:1200-1207.Google Scholar This real-world cohort shows that TEVAR alone is safe and reasonably effective in the short to medium term, an experience shared by innumerable other aortic specialists throughout the world.4.Lack of standardization. There are no clear and specific sizing guidelines to optimize how best to do this procedure. Like parallel grafting, this technique creates gutters and has competing stents within an aneurysmal aorta. This begs several important technical questions. Without standardization in case planning, the variability in how the operation is conducted renders quantitative assessment of the outcomes difficult and reproducibility impossible. In order to support the increased use of this and other “false lumen management” techniques, we must first demonstrate that they are safe and then demonstrate that they are effective. Safety is demonstrated when larger cohorts of consecutive cases are reported along with procedural complications and short-term data on aortic expansion or rupture. Effectiveness, on the other hand, will only be clear when medium to longer term (e.g. 3-5 year) data demonstrate reduced incidence of aortic expansion and need for aortic reintervention in comparison to patients treated with TEVAR alone. Clear and specific technical guidance about the sizing strategies are required both to ensure consistency in procedural conduct as well as to facilitate broader utilization that might expect similar results. The SVS reporting standards specifically request reporting of these strategies in future publications.4Lomardi J.V. et al.Society for Vascular Surgery and Society of Thoracic Surgeons reporting standards for type B aortic dissections.J Vasc Surg. 2020; 71: 723-747Abstract Full Text Full Text PDF Scopus (176) Google Scholar Until such data are available, these efforts remain nice demonstrations of technical capability, but they cannot be confused with meaningful improvement in the care of patients with TBAD and should be used with caution. Initial Experience with a Modified “Candy-Plug” Technique for False Lumen Embolization in Chronic Type B Aortic DissectionJournal of Vascular Surgery Cases, Innovations and TechniquesPreviewPersistent distal false lumen (FL) perfusion after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) can lead to aneurysmal degeneration and increased risk of rupture. We present our initial experience using a modified “Candy-Plug” (CP) technique for FL embolization. Full-Text PDF Open Access