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Stretta Therapy – a first line option for GERD
Gastroesophageal Reflux Disease (GERD) is estimated to affect 20% of the population in the USA1, this equates to approximately 65 million people from a population of 320 million people. Most patients manage reflux disease through medications (eg proton pump inhibitor) or in extreme cases surgery (Nissen fundoplication). According to Dr Mark Noar from The Heartburn and Reflux Study Center, Towson, MD, patients who are not responding to medication and are considered candidates for surgery, should consider another treatment option – Stretta Therapy.
“Reflux is a chronic, degenerative disease of the low oesophageal sphincter (LES), although it is actually a dual sphincter complex,” began Dr Noar. “There is an internal and external sphincter - the internal sphincter is part of the wall of the oesophagus and is the muscular portion or muscularis propria, and the external sphincter called the crura of the diaphragm around the oesophagus.”
He explained that in reflux, some patients may have internal sphincter defects and so their LES is too loose leading to reflux. Others may have an external problem which means they have a hiatal hernia and due to the loosening of the ligaments of the crura, and some patients have a mix of both. When both sphincters – independently or at the same time – begin to degenerate due to chronic inflammation there is an increase in reflux, and crucially, less and less muscularis propria to hold back the reflux.
The causes of GERD are well known (smoking, alcohol, caffeine, stress, medications are known to loosen the LES and/or increase gastric acids) – overeating, eating food with a high fat content and obesity in particular increases the pressure in the abdomen and may weaken the muscles at the bottom of the oesophagus. Over time this damages the LES and as symptoms persist may lead to further degeneration of the LES. However, there are some people who are predisposed to reflux despite maintaining a healthy lifestyle, exercising, not smoking and eating healthy foods.
According to Dr Noar, the current treatment strategies for reflux try to alleviate the symptoms without really attempting to address the underlying causes. For example, he said that some medications try to reduce the acid content of the stomach, whilst others try to improve the motility and gastric emptying of the stomach. Although these treatments may alleviate symptoms, none of them prevent the degeneration of the LES.
“I believe that there needs to be a change of focus to treating the LES. Medications are band-aids and they do not affect the cause of the disease. So we need to ask, ‘how can we treat the LES to help alleviate symptoms so we no longer need medications?’ That is the important question.”
Stretta Therapy (Mederi Therapeutics) was FDA cleared in the late-1990’s and entered clinical use in 2000, when Dr Noar was one of the first to perform the procedure. Stretta Therapy uses low energy radiofrequency (RF) waves to stimulate the water molecules in the muscles fibres so the molecules vibrate. In turn, this creates a very low energy (5 watts) and low-level heat (approximately 65-85°C) reaction in the muscle layer tissue. This temperature is insufficient to damage blood vessels or nerves, but it is sufficient to stimulate the muscle, and the muscle begins to grow.
“Clinical data has shown that the muscle continues to grow for up to 12 months after the procedure and the muscle becomes thicker, longer and stronger. This means that there will be a reduced tendency for the muscle to relax.”
Typically, Stretta Therapy is performed as an out-patient procedure and the actual treatment time usually takes about 20-30 minutes, under moderate sedation. Patients usually return home within a couple of hours and can resume their working and leisure activities within 24 hours.
“If we know the cause and the type of reflux, we can more accurately predict when the patients’ symptoms will subside. For example, if the patient has standard reflux with typical symptoms such as heart burn, difficulty swallowing or regurgitation, usually within about two months there are significant improvements to their symptoms after Stretta therapy. For patients who present with laryngeal type reflux it is a different mechanism of causation, and it is not so much the acid but the pepsin that affects the voice box and the bronchi. In these patients, it may take up to six months to see consistent results, because you need more muscles to hold back gas, than fluid.”
According to Dr Noar, the procedure is typically performed by a gastroenterologist or a surgeon who has a good subset of skills to perform upper-endoscopy, and as with any procedure there is a learning curve, but after four or five procedures most operators are proficient.
Patients must be surgical candidates to be eligible to receive Stretta Therapy and must not have a hiatal hernia larger than 3cm, as these patients are better candidates for surgery and need treatment for their external sphincter. Another contraindication is achalasia; this is the reverse condition when the LES is too tight, as well as pregnancy, gastric or oesophageal varices, severe scleroderma, oesophageal bleeding, endocarditis risk etc.
Regarding complications from Stretta Therapy, he said that there have been some complications reported in the literature and these usual arise within the first six hours of the procedure and include chest pain that usually lasts a couple of hours or days. Some patients may feel bloated and have a loss of appetite that may last as long as 2 weeks. There have been a couple of episodes of post-procedure bleeding, however, this was the result of patients stopping their medication prematurely. There have been some rare and transient episodes of gastroparesis reported.
In May 2016, Dr Noar reported ten-year data at the Digestive Disease Week in San Diego, in three specific types of non-classical GERD patients: those with high BMI, those with respiratory symptoms of GERD or LPR, and those suffering from recurring GERD after anti-reflux surgery. The data demonstrated that each of these patient populations achieved the primary outcomes of long-term symptom relief, reduced medication use, and patient satisfaction.
Stretta and BMI
Many of the anti-reflux procedures have weight limits in terms of their success and whether they are allowed to be performed. Typically patients with an elevated weight will undergo a Nissen fundoplication. Noar and his colleagues wanted to examine the outcomes of Stretta Therapy in patients based on their body mass index (BMI). They looked at the ten-year outcomes in 99 patients comprising three subpopulations of BMI - normal, overweight and obese. They found that at ten-year follow-up, independent of BMI, all parameters demonstrated statistically significant improvement.
They also looked at the outcomes in Stretta patients with laryngopharyngeal reflux (LPR) and compared them with Stretta patients who did not have LPR symptoms. Some 99 patients were included in the study and at ten-year follow-up they reported that there was an equally robust response with all parameters demonstrating a statistically significant improvement across the entire respondent cohort.
The third subset of patients reported at the DDW meeting, were patients with refractory GERD after a laparoscopic Nissen fundoplication (LNF). A total of 18 refractory LNF patients and 81 standard refractory GERD patients were assessed. They reported that Stretta resulted in sustained improvement with near equivalence and slightly better outcomes than the non-LNF cohort. At ten-year follow-up, both patient subsets demonstrated statistically significant improvement in primary outcomes.
“What is truly encouraging about this last set of results is that if you have had prior surgery for GERD, you are limited in your future treatment options and the risk of complications in very high when trying to re-operate in these patients. It is my belief that this data demonstrated that Stretta therapy should now be seen at the procedure of choice in patients who have had prior surgery but their reflux has returned.”
“It is also clear that patients who undergo a gastric bypass or sleeve gastrectomy can often see an increase or worsening of their reflux, and again, Stretta therapy has demonstrated to be effective. Like LNF patients, bariatric patients have limited options for treating reflux disease and Stretta therapy appears to be the only treatment that effectively treats their reflux. For the bariatric surgeon, Stretta really is the only option to treat reflux after bariatric surgery.”
Dr Noar said that one of the most important considerations for a gastroenterologist or a surgeon who is going to adopt this procedure is to closely follow the prescribed technique. A second important consideration is patient selection and to make sure the patient is refluxing and does not have some other problem or condition such as achalasia.
“If patients are selected carefully and the procedure is followed with military precision, it is exceedingly safe and effective with no reported long-term complications associated with the procedure.”
Dr Noar said that at the end of the first year following Stretta Therapy, the literature shows that about 90-92% of patients are asymptomatic and off medication, at years three and four approximately 78-86% are asymptomatic and at ten years 72% of patients are free of symptoms. He added that the long-term effectiveness has not only been confirmed in his own data, but also by Dr Dughera’s team from Italy.2
“It is wonderful to think that by regenerating the tissue during a 20-30 minute procedure, we can eliminate reflux in more than 70% of patients out to ten years,” he added.
Dr Noar explained that some patients will return after Stretta therapy at varying intervals with a recurrence of symptoms and more often than not, these are LPR patients as this condition is more difficult to control. He explained there is some evidence to suggest a correlation between muscle size and the long-term efficacy of the procedure - and although Stretta therapy results in an increase the size of the muscle, if the muscle is thin to begin with this does limit the long-term outcome of the procedure.
Mederi Therapeutics recently launched the third generation Stretta RFT3 system. The new system includes new aesthetic, functional and material improvements that further facilitate ease of use and optimal delivery of Stretta treatment. These improvements include a new, slightly firmer catheter that allows more precise treatment placement and ease of use for the operator.
“Anyone who has reflux symptoms needs to adhere to lifestyle and behavioural changes, as well as medication to try and alleviate their symptoms,” concluded Dr Noar. “However, if their symptoms persist then they are not responding to medication, it is my opinion that at this point, Stretta becomes the first line therapy. Not only because it has demonstrated long-term effectiveness, but it stops patients taking medications over many years and the additional health problems that can cause.”
- El-Serag HB, et al. Gastroesophageal reflux among different racial groups in the United States. Gastroenterology. 2004;126:1692–1699
- Dughera L, Durability of Stretta Radiofrequency Treatment for GERD: Results of an 8-Year Follow-Up. Gastroenterol Res Pract. 2014;2014