Aims Third-space endoscopy (TSE) procedures are hampered by a significant rate of intra-procedural
bleeding, affecting their duration and feasibility. The narrow field of endoscopic
view and the imperfect hemostatic power of TSE devices limit effective intra-procedural
hemostasis. Thus, large vessels (i.e., larger than the tip of the knife) usually required
coagulation with dedicated coagulation forceps, before the subsequent dissection with
the TSE knife. However, this requires device exchanges, slowing the TSE procedure
and consequently increasing the risk of adverse events and the overall costs. To overcome
these limits, we introduced a new technique of saline immersion (SI) vessel pre-sealing
with the same knife and the same electrosurgical setting. In this study, we present
the early results.
Methods This single-center historically prospective observational study was conducted by
recruiting consecutive patients treated with Peroral Endoscopic Myotomy (POEM) for
esophageal achalasia. They were compared with a historical cohort treated with the
standard hemostatic methods. The SI vessel pre-sealing method consists of the application
of electrocautery coagulation with the tip of the knife under saline solution, which
prevents the dissection effect, until the vessel is completely sealed, using a Hybrid-knife
(HK) with Swift Coag E3 (89W) coagulation setting (Erbe Elektromedizin GmbH, Tübingen,
Germany). The primary outcome was the rate of bleeding needing a re-intervention after
a first coagulation attempt, with secondary outcomes focused on the rate of complete
vessel coagulation, procedural length, use of dedicated hemostatic devices and adverse
events (AEs).
Results A total of 21 patients were treated with the pre-sealing technique and compared with
22 standard technique additional patients. During the submucosal dissection phase
of POEM were coagulated with the HK 195 blood vessels with a diameter greater than
1.2 mm (86 standard technique and 109 SI technique). Overall, no patients in the pre-sealing
group required the need of coagulation forceps, while 6 patients required the use
of this hemostatic device in the standard arm due to the size of the vessels or to
treat a bleeding vessel (0/21 vs. 6/22; P-value=0.02). In addition, the SI pre-sealing
coagulation significantly decreased intra-procedural bleeding events needing re-treatment,
demonstrating a 21% relative risk (RR) reduction: effective coagulation was indeed
significantly higher in this group compared to the conventional arm (91.74% vs 73.26%)
(P=0.0006). No significant differences were observed in total procedural time or safety
profiles between the two techniques.
Conclusions The SI pre-sealing technique reduced the need for vessel coagulation retreatment
compared to current practice. This technique also resulted in a significant reduction
in the use of dedicated hemostatic devices, showcasing potential better cost-effectiveness.
Procedural length and safety profile were not changed by the use of this novel mean
of coagulation, and it can be therefore suggested a potentially beneficial adoption
even by less experienced endoscopists.