Miles et al1 described an initial series of six cases using the “candy plug” technique to induce false lumen thrombosis after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). They reported good initial technical success with very limited follow-up, in accordance with other similar case series. Although their initial results appeared 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; however, no larger reported series have demonstrated the safety or effectiveness.2 This technique is readily available to any provider in a contemporary aortic practice. Why has no one reported the 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 have rarely shared such experiences in a public forum and have even more rarely reported them. This publication bias has skewed the publicly available data to the overreporting of positive results. The lack of larger series or longer term outcomes suggest that this bias has been occurring with this specific technique. Furthermore, efforts to overcome the limitations of single-center reports, such as meta-analyses, will also fail to overcome the publication bias and might, in fact, enhance it.

• 3.

  The natural history of TBAD after TEVAR: it has remained very unclear to me that the “candy plug” technique changes the natural history compared with TEVAR alone. In one retrospective review from our own institution, 80% of patients who had undergone TEVAR for TBAD were free from revision aortic surgery by the 3-year follow-up.3 This real-world cohort has shown 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: no clear and specific sizing guidelines have been developed to optimize how best to do this procedure. Similar to 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.

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 will be demonstrated when larger cohorts of consecutive cases with the procedural complications and short-term data on aortic expansion or rupture have been reported. In contrast, effectiveness will only be clear when the medium to longer term (eg, 3 to 5-year) data have demonstrated a reduced incidence of aortic expansion and need for aortic reintervention compared with patients treated with TEVAR alone. Clear and specific technical guidance regarding the sizing strategies are required both to ensure consistency in the procedural conduct and to facilitate broader usage that might expect similar results. The Society for Vascular Surgery reporting standards have specifically requested reporting of these strategies in future publications.4

Until such data are available, these efforts will remain nice demonstrations of technical capability but should not be confused with meaningful improvement in the care of patients with TBAD and should be used with caution.

The opinions or views expressed in this commentary are those of the author and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery.