Safety And Efficacy of the Novel Ultraslim Bipolar with Microwave Energy Flexible Catheter for Per Oral Endoscopic Myotomy in Patients with Achalasia: A Single-center Case Series

Aims Achalasia treatments aim to reduce lower oesophagal sphincter (LES) pressure. Per-oral Endoscopic Myotomy (POEM) is a minimally invasive therapy for achalasia, which has demonstrated high technical and clinical success with lower adverse events than Heller myotomy. However, due to the LES myotomy and lack of anti-reflux procedures, this endoscopic treatment increases the risk of gastroesophageal reflux disease (GERD) (2,3). Although various tools have been developed for different steps of POEM procedure, some devices still require the exchange of accessories. To overcome this, the investigators aimed to evaluate a single multi-modal device that integrates features for all demands required for POEM. Besides that, this tool includes a super high-frequency microwave in its tip, which offers the ability to cut, dissect, inject and coagulate.

Methods A single-centre, prospective, interventional study included patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (incision, tunnelling and myotomy) were performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety were the primary endpoints; while post-procedure reflux symptoms and quality of life were assessed as secondary outcomes with reflux severity index (RSI) [1] [2] [3].

Results Nineteen patients (47,4% females; median age 48 years) with achalasia underwent POEM, whereas in 63.2% fundoplication was performed. Among these patients, achalasia was predominantly classified as type II (80%), 31.6% had previous treatment such as pneumatic dilations (5/6) and Heller myotomy (1/6). The median pre-procedural Eckardt score was 7. Anterior myotomy approaches in 84.2% of the cases. POEM was technically feasible in all patients, with a mean total procedural time of 84.6±26.9 minutes. Clinical success was assessed in 1-month follow-up. 73.7% of patients denied gastroesophageal reflux symptoms, reported with an IRS of 1. The median Eckardt score was 1. During the procedure, there was no mucosal tissue damage, and no immediate or delayed complications were reported post-POEM.

Conclusions Speedboat is a promising tool with bipolar and microwave energy capabilities for the management of achalasia, having substantial improvement in 74% of cases, perceived as no GERD symptomatology within the first month after the procedure. Advantages this tool holds are: (1) clear margins due to a lower voltage than standard monopolar devices, (2) deeper dissection and clear view of the muscle bed due to the protective hull, (3) the use of a single device for the procedure, and (4) reduced mucosal tissue damage. Longer follow-up time and larger studies are required to validate this novel technology.

Publikationsverlauf

Artikel online veröffentlicht:
27. März 2025

• References

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