Complications of botulinum toxin injections for treatment of esophageal motility disorders†

Abstract

In achalasia and spastic esophageal motility disorders, botulinum toxin (botox) injection is considered an effective and low-risk procedure for short-term symptom relief. It is mainly offered to medically high-risk patients. However, no analysis of risks of botox injections has been performed. To determine the incidence and risk factors of procedure-related complications after esophageal botox injections, we analyzed the records of all patients undergoing botox injection therapy for esophageal motility disorders at four university hospitals in Europe and North America between 2008 and 2014. Complications were assigned grades according to the Clavien-Dindo classification. In 386 patients, 661 botox treatments were performed. Main indications were achalasia (51%) and distal esophageal spasm (DES) (30%). In total, 52 (7.9%) mild complications (Clavien-Dindo grade I) were reported by 48 patients, the majority consisting of chest pain or heartburn (29 procedures) or epigastric pain (5 procedures). No ulceration, perforation, pneumothorax, or abscess were reported. One patient died after developing acute mediastinitis (Clavien-Dindo grade V) following injections in the body of the esophagus. In univariate logistic regression, younger age was associated with an increased risk of complications (OR 1.43, 95%CI 1.03-1.96). Treatment for DES, injections into the esophageal body, more injections per procedure, more previous treatments and larger amount of injected botulinum toxin were no risk factors for complications. Esophageal botox injection seems particularly appropriate for high-risk patients due to low complication rate. However, it should not be considered completely safe, as it is associated with rare side effects that cannot be predicted.

Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double‐blind randomized sham‐controlled study

“…15 As the literature is scarce on the subject, with only one ran- mediastinitis must be known by the physician and agreed by the patient before starting with this therapy. 16 Our randomized double-blind sham-controlled study yielded results somewhat different from the study reported by Vanuytsel et al 14 .…”

“…It was decided to perform a sham procedure in the control group (no injection) rather than saline injection because of a hypothetical infectious risk of substrate injection in the esophageal wall. Although no significant complication occurred in this series of patients, either after one or two injections of botulinum toxin, we believe that the risks of side effects (such as chest pain or heartburn), and the possibility of severe complication such as acute mediastinitis must be known by the physician and agreed by the patient before starting with this therapy …”

“…Indeed, several open‐labeled studies have suggested a good efficacy of botulinum toxin to treat esophageal spasms or hypercontractile esophagus and one randomized controlled study showed a significant short‐term effect of botulinum toxin on dysphagia associated with diffuse esophageal spasms and nutcracker esophagus . However, although the injection of botulinum toxin in digestive sphincters is considered to be a safe procedure, there may be adverse events including death . The evaluation of its efficacy and safety thus remains an important concern …”

“…14 However, although the injection of botulinum toxin in digestive sphincters is considered to be a safe procedure, there may be adverse events including death. 15,16 The evaluation of its efficacy and safety thus remains an important concern. 17 The aim of our study was to evaluate the efficacy of the botulinum toxin injection in the lower esophageal sphincter and the distal part of the esophageal body in patients with symptoms associated with hypercontractile esophagus as described by the Chicago classification v3.0.…”

Management of achalasia cardia: Expert consensus statements

“…No ulceration, perforation, pneumothorax, or abscess were reported. Deaths is reported from acute mediastinitis following BT injection into body …”