Breaking news – The Swallow Expansion Device (SED) – a potential game changer for patients with profound oropharyngeal dysphagia. In early January 2015 the SED was implanted into Jeff Mauerman, a cancer survivor who is feeding tube dependent due to oropharyngeal dysphagia. This is the first FDA Approved Clinical Trial that allows a Medical Piercing to Control a Body Sphincter (Part 1 of 2)
Byline: Ed Steger, President, National Foundation of Swallowing Disorders
Disclosure: Dr. Peter Belafsky is the Medical Director of the National Foundation of Swallowing Disorders.
[Editor’s note. This story is based on an interview between Jeff Mauerman and Ed Steger that was conducted on February 4, 2015. This is five weeks after surgery and two months before he will know the extent, if at all, to which he will be able to swallow again.]
Like me, you may have many questions. Who’s Jeff Mauerman? What’s a sphincter? Why would one want to control a sphincter with a medicinal piercing? What does any of this that have to do with swallowing? FDA approved, really? We’ll begin with the question of who’s Jeff Mauerman.
Jeff spent 30 years as an electronics engineer; he is also an oral cancer survivor. Concerned about a lump in his neck, Jeff was diagnosed with stage three squamous cell carcinoma in 2000 after a fine needle biopsy revealed cancer in lymph nodes in his neck. Further examination revealed a tumor at the base of his tongue. He was treated with concurrent radiation and chemotherapy which concluded in March 2001. Due to concerns by his radiologist about his ability to maintain proper nutrition and hydration following his treatment, a feeding tube (percutaneous endoscopic gastrostomy (PEG)) tube was implanted in Jeff’s abdomen. The PEG tube was removed in June 2001 after Jeff had recovered enough to consume food and liquid orally and maintain his weight and hydration needs. Jeff did well for the next 10 years. In 2007 he had his first swallow study and the results showed a more or less normal swallow. Although the study results were unremarkable, Jeff felt food stuck in his throat just above his esophagus. An endoscopy confirmed this suspicion and the food was dislodged without incident.
New health issues began to escalate in 2011 with bouts of pneumonia, fatigue, and weight loss. His physicians suspected lung cancer due to spots on his lungs from a CT scan. Jeff underwent a lung biopsy. The good news, there was no evidence of cancer; the bad news, one of the suspected spots was food which Jeff had inhaled into his lungs while eating. That was the point at which his physicians recognized his pneumonia as aspiration pneumonia. At this time, a new PEG tube was inserted into Jeff’s stomach.
By 2013, Jeff’s swallowing became unsustainable. He had his second swallow study which confirmed aspiration. Aspiration in this case is where food and liquid enters the lungs. He met with a speech-language pathologist who prescribed a set of oral exercises. When those failed, he went through an 8 week VitalStim therapy program. A swallow study following the exercise and VitalStim therapy showed no sign of improvement.
In mid-2014, a friend of a friend mentioned success he had had in treatment of a similar swallowing issue that had been treated by Dr. Peter Belafsky at the Center for Voice and Swallowing at UC Davis. In August 2014, Jeff had a swallow study that revealed esophageal stenosis. He subsequently underwent a dilation. In layman’s terms, this procedure involves the insertion of a long deflated balloon into the esophagus where it then is inflated to help break up fibrosis and stretch the esophagus with the intent of allowing food to more easily pass down the esophagus. This procedure did not improve Jeff’s swallow enough to allow Jeff to resume eating by mouth and the PEG tube remained in place.
At this point, Jeff had lost hope that he would ever be able to eat food again. The PEG tube would become part of him forever. A call in late 2014 changed all that. Dr. Belafsky called and offered Jeff the opportunity to consider a recently approved phase I clinical trial. If he agreed, he would be Patient One.
What’s a sphincter?
A sphincter is a valve that maintains constriction of a natural body passage or orifice and which relaxes as required by normal physiological functioning. Sphincters are found in over 60 places in the body.
What does a sphincter have to do with swallowing?
One of those 60 plus sphincters in the human body is the Upper Esophageal Sphincter (UES). As its name implies, it is located at the top of the esophagus. During a normal swallow, it relaxes and allows food to pass from the pharynx (throat) to the esophagus in a normal manner without aspirating. The pharynx sits between one’s oral cavity and esophagus. When the UES is compromised, due to radiation, injury, neurologic damage, or other causes, it blocks the natural opening of the esophagus and can cause food and liquids to back up in the throat and enter the trachea (airway). This exposes one to aspiration (food and liquid entering the lungs). Each individual is different, but varying degrees of aspiration can cause pneumonia and even death.
The swallow expansion device (SED) is a small titanium implant that is planted on the voice box through a small incision in the neck. The procedure to place the implant takes less than 15 minutes and is performed without the need for sedation. The implant has a small post (piercing) that protrudes through the skin. When a person swallows, the patient pulls the device forward and the upper esophageal sphincter opens to super-physiologic (greater than normal) proportions and allows food to pass. The procedure requires the patient to allow 8 weeks for the surgical site to heal and for the SED to integrate before attempting to use the device.
An FDA approved clinical trial
In June of 2014, the FDA approved a clinical trial (ClinicalTrials.gov Identifier: NCT02296528) – Safety and Efficacy of the Swallow Expansion Device (SED). This is a Phase I trial that is open to 5 patients with profound feeding tube dependent oropharyngeal dysphagia. The primary outcome measures are improvement in UES opening and swallowing safety as measured via fluoroscopy. If swallowing is improved and there is no aspiration, the patient will be taught how to coordinate pulling the SED with the correct amount of force at the appropriate time during swallowing. This training will be performed under the guidance of a speech and language pathologist.
There is some fascinating history behind this invention that is explained near the bottom of the clinical trial documentation. Click on NCT02296528 to read more about this trial on ClinicalTrials.gov.
Back to Jeff Mauerman
In early January 2015, Dr. Belafsky and his team at UC Davis placed the SED in Jeff Mauerman. It was done under a local anesthetic through a small 1.5 inch incision. The skin was lifted, the device inserted onto the cartilage, the post was pierced through the skin; the site was then sutured, cleaned, and bandaged. It took about 30 minutes start to finish.
I asked Jeff how he felt about being the “first” patient. He said there was a mixture of excitement at the prospect of being able to eat socially with the anxiety of being that first “trial” patient. The anxiety dissipated after a few days; now there is excitement tempered with the reality of, “will this really work? “ To find out, Jeff will need to wait the eight weeks from the time of the procedure to allow the site to heal properly and the device to integrate. After that there will be a prolonged training period for him to learn how to effectively use the device during meals. Jeff remains optimistic, but also realistic. In his own words, “if this works, I and my family are beyond fortunate; if it doesn’t, I haven’t lost anything.”
The NFOSD will report back on Jeff’s progress in April. Stay tuned!
Ed Steger would like to thank both the Mauerman’s and Dr. Belafsky for their courage in sharing their story mid way through patient #1 in a small phase 1 clinical trial with an outcome that will not be known until the April 2015 time frame.