Stretta found to be effective in more GERD patient sub-sets: Q&A with Dr. Mark Noar on his follow-up to 10-year patient data.
Stretta, a non-ablative radiofrequency treatment for gastroesophageal reflux disease, is a safe and effective treatment. Numerous studies have confirmed this, including 10-year patient data released in 2014. Mederi Therapeutics launched RFT3, the third generation of Stretta technology, at Digestive Disease Week 2016 in San Diego.
"The Stretta procedure is a low-energy, low-temperature electrical stimulation of the lower esophageal sphincter muscle that results in net growth of the muscle," says Mark Noar, MD, director of The Heartburn and Reflux Study Center in Towson, Md. "It's purely a regenerative medicine-type procedure as it increases the thickness and size of the muscle."
At DDW, Dr. Noar also discussed 10-year follow-up data on Stretta from studies he conducted. Here, he lays out his findings as well as their significance in the GERD treatment.
Q. What are some of the highlights of the follow-up to the 10-year patient data that has been collected on Stretta therapy?
MN: We looked at all different sub-sets of reflux patients and how they would respond to Stretta therapy. We looked at three specific groups. The first sub-set was patients who underwent Nissen fundoplication that failed. The second sub-set included patients with different body weights ranging from normal to obese. The last sub-set was laryngopharyngeal reflux, or LPR, patients.
We found that Stretta therapy outcomes in the LPR group were as good as among standard refluxing patients. This is significant because Stretta was found to be the only other procedure, outside of the Nissen surgical procedure that worked for this sub-set.
Stretta was also found to be effective among the patients with different body weights. The procedure was equally effective across all groups. The only other procedure that was effective for this sub-set was Nissen fundoplication. This gives bariatric patients another great option, especially because the Nissen procedure is not [extremely] effective in the very obese patient.
For the group of patients who underwent Stretta with a failed Nissen fundoplication, Stretta was as effective as it was among patients who had not undergone the Nissen procedure. Thus, for the failed Nissen fundoplication group, considering the high complication rate or [rate of] re-doing the surgery and mounting evidence against chronic proton-pump inhibitor use, Stretta should be considered first line therapy.
Over the 10 years of follow up after Stretta therapy, no patient developed cancer of the esophagus. This could mean that a procedure like Stretta could help protect against esophageal cancer, but more data is needed on that.
Q. What are some of the biggest challenges for people suffering from GERD?
MN: The biggest challenge is that since GERD is a chronic degenerative disease, it doesn't stop progressing. It is not like the common cold, where if you wait a few days and it gets better. GERD sufferers need to remain diligent about dietary recommendations, including not eating right before dinnertime and not eating certain foods. Whether or not you undergo a procedure for GERD, you need to be diligent for the rest of your life.
Also, we are increasingly seeing new complications or side effects from the chronic use of proton-pump inhibitor therapy. As a result, people are looking for alternatives and Stretta may be right for these patients.
Q. Why are the study findings significant for GERD sufferers?
MN: These findings are significant because they demonstrate, in a peer-reviewed study, that there is a larger group of GERD patients who can undergo Stretta therapy safely. We now know it works for more groups of GERD sufferers and that it produces long-term results.
Q. How is the 3rd generation of Stretta different from earlier generations?
MN: Mederi Therapeutics did a nice job continuing to respond to physicians' suggestions, and the new generation of Stretta is easier and more comfortable to use. In Gen 3, we see that a lot of the processes that used to be under the manual control of the physician have been automated. It looks more like an endoscope and includes additional measurement markings. The control screen includes screen prompts that help the physician during the procedure. Taken in total, these changes result in an easier more comfortable procedure experience for the physician and patient.