Pharyngeal Electrical Stimulation Shows Promise in Post-Stroke Dysphagia

By Will Boggs MD

September 18, 2018

NEW YORK (Reuters Health) - Pharyngeal electrical stimulation (PES) allows successful decannulation in patients with stroke and subsequent tracheotomy, according to results from the PHAST-TRAC randomized trial.

"This study supports the notion to use PES in tracheotomized stroke patients as early as possible to help wean them from the tracheal cannula," Dr. Rainer Dziewas from University Hospital Muenster, in Germany, told Reuters Health by email.

As many as 2% of all patients with stroke and 25% of patients with stroke treated in the intensive care unit require a tracheotomy due to severe dysphagia with prolonged insufficient airway protection or the need for long-term ventilation. In many patients, severe dysphagia is the main reason why decannulation cannot be done for months after stroke.

Following on the heels of a successful pilot study, Dr. Dziewas and colleagues from nine sites in Germany, Austria and Italy assessed readiness for decannulation 24 to 72 hours after PES or sham treatment in 69 patients with stroke who required a tracheotomy, were successfully weaned from mechanical ventilation and could not be decannulated because of severe dysphagia.

After the masked first part of the study, 49% (17/35) of patients in the PES group were judged to be ready for decannulation, compared to 9% (3/34) of patients in the sham group.

After the decision to decannulate, 14 patients (82%) in the PES group were decannulated and none of these patients required recannulation over the next 48 hours or during their follow-up period up to hospital discharge, the researchers report in The Lancet Neurology, online August 28.

In the second part of the study, 15 patients originally assigned to PES who did not achieve readiness for decannulation and 30 patients originally assigned to sham treatment underwent PES, which resulted in 27% (4/15) of retreated patients and 53% (16/30) of newly treated patients being deemed ready for decannulation after three days of PES.

There were no serious adverse events related to PES treatment.

The median length of stay was significantly shorter among PES responders (14 days) than among nonresponders (36 days).

Earlier treatment was associated with better responses to PES.

"So far there are no firmly established treatment options in the given clinical scenario," Dr. Dziewas said. "Therefore, PES may indeed be an option to treat dysphagia in the most severely affected stroke patients."

"I think it is worth mentioning that, although in very few patients there were problems with catheter placement, in the majority of them treatment was applied without any difficulties," he said. "Therefore, one could conclude that treatment may indeed be efficacious, safe, and sufficiently easy to apply."

"Unfortunately, despite apparently encouraging results, this trial does not provide generalizable evidence that the device facilitates earlier tube removal," writes Dr. Martin Dennis from the University of Edinburgh, U.K., in an accompanying editorial. "The trial was stopped early before it had reached its prespecified maximum sample size - a factor that has previously been associated with overestimation of treatment effects."

"While these results do not support the introduction of the device into routine management of patients with post-stroke dysphagia, or even that of the small subset of patients with stroke who are intubated, the data are encouraging enough to support larger multicenter randomized controlled trials to help identify which, if any, subgroups of patients with stroke derive clinically important benefits from this treatment," he said.

Phagenesis Ltd., which made the stimulation device used in the study, funded the research and had various ties to all of the authors.

SOURCE: https://bit.ly/2wODtN7 and https://bit.ly/2CwzwTe

Lancet Neurol 2018.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....