By: Dr François Bobin ENT, Reflux Specialist
Sleep Center Polyclinique de Poitiers (France)
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A 66-year-old male who worked as a retired school principal presented to the clinic. He is a non-smoker with a BMI = 24, who underwent laparoscopic Nissen fundoplication (anti-reflux surgery) in 1996. For several months following surgery he experienced digestive problems (including abdominal pain and diarrhea), pharyngeal irritation without dysphonia or oral burns, associated with frequent nocturnal awakening, and slight drowsiness (Epworth 8) without snoring.PPIs (esomeprazole, 40 mg once per day) were provided for two months as an initial treatment but proved ineffective.The patient’s RSS score upon presentation was 37 (8 + 29 + 0) with a significant LPR threshold > 131Upon visual inspection, larynx and pharynx appeared almost normal, though there was a small sliding 1 cm hiatal hernia demonstrated by digestive fibroscopy.
Many questions arose: Is this a case of Obstructive Sleep Apnea (OSA)? Is there a potential relationship with LPR or residual post-surgery GERD? Had the patient’s diet and lifestyle compromised his, initially promising, anti-reflux procedure over the intervening years?
MII-pH and polysomnography were performed simultaneously with Peptest.
• Peptest results were negative (one sample in the morning with an empty stomach <14 ng/ml, and one in the evening, after dinner, <14ng/ml).
• PSG showed a slight OSA (IAH 17/h).
• MII-pH (performed off PPI) showed frequent episodes of non-acid reflux, distal (pH between 5.7 –7.2) and proximal (pH between 6 –7.5), throughout the day and at the beginning of the nocturnal period.
Pure non-acid reflux is a very rare occurrence but may be related to Nissen surgery. A Restech Dx-pH test was performed off PPI to measure the presence of any acid or non-acid reflux in the pharynx. The test showed a very wide amplitude indicating daytime alkaline reflux, with pH ranging between 7–7.8, but was less marked at night. The RYAN Score was normal (0 for both upright and supine), confirming that no acid reflux was present.
An adapted treatment was implemented for a non-acid reflux regimen, using Sucralfate (bile chelator) three times a day, one hour after eating.
The symptomatology improved after a few days. The RSS score one month later was 13 (4 + 9 + 0), a decrease of 24 points.
Bile reflux was probable, according to the negative Peptest excluding pepsin as a cause of symptoms. Alkaline reflux was revealed using the MII-pH and Restech Dx-pH tests and confirmed as symptomatology quickly improved following the introduction of Sucralfate.
The clinical utility for Restech’s Dx-pH System in diagnosing alkaline reflux is demonstrated in this case. Otolaryngologists often find these patients more complex than conventional GERD or LPR patients as true alkaline reflux cases are comparatively rare and there are limited diagnostic tools available. With further refinement, it is clear that this patient community can be better served through a more extensive diagnostic framework incorporating the Restech Dx-pH.
After diagnosis, an adapted treatment was implemented for a non-acid reflux regimen. The patient halted their acid suppression medication and began taking Sucralfate (bile chelator) three times a day, one hour after each meal. The symptomatology improved rapidly with the patient reporting progress within a few days of the medication shift. After four weeks the RSS score was down to 13 (4 + 9 + 0) from a starting point of 37, a decrease of 24 points. Further follow-ups are anticipated to show continued improvement.
Bree has been an integral part of Restech from the very beginning. She holds a Masters in Public Health from George Washington University, a BFA from The University of Kansas in Visual Communications, and is a National Board Certified Health & Wellness Coach. Her command of marketing, public health/health delivery systems, and human health behavior change gives her a unique perspective in developing effective marketing strategies for the company.
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Thomas previously worked as a polysomnographic technologist in the Virginia Mason system, before moving into sales with Restech in 2007. After spending 9 years working with distributors across Europe, he was moved into an organizational role at the head office in Houston. In this capacity he works closely with sales and marketing to provide clinical support, manages clinical studies, and provides clinical perspectives on business development. In his spare time Thomas plays rugby for Houston Athletic Rugby Club.
Jeff has over 30 years of experience in the medical device industry and previously worked in sales at companies such as Encision Inc., Interventional Therapies, LLC, Boston Scientific, and United States Surgical Corporation. He has been working as the VP of Sales for Mederi Therapeutics since 2009 and now brings his extensive expertise to Restech. Jeff was part of the team that bridged the Mederi asset sale to Restech. His clinical knowledge of the Stretta and Secca technologies is invaluable. Jeff has three decades of physician relations experience that he brings to Restech as part of the leadership team.
Ray joined Restech in May 2018 as the Vice President for Sales. He has been in the medical device, and specifically in the GERD space for more than 18 years. Starting in sales at Sandhill Scientific pH diagnostics, he moved on to Curon Medical when Stretta and Secca were first introduced to the market. He then worked for Given Imaging when Curon closed operations. When Stretta was relaunced he joined Mederi as VP of Sales. Ray was instrumental in keeping Stretta alive and the customer based informed when Mederi ceased operation and assets were purchased by Restech. He is part of the leadership team directing all product sales for Restech. Ray graduated from Old Dominion University in Norfolk with a BS in Marketing and Business Administration.
Mark is a seasoned professional and Certified Public Accountant in Texas who brings a unique blend of creative vision and financial expertise to any leadership team. He worked as a Senior Executive for 15 years on a leadership team which grew a private equity backed cash logistics company performing at negative EBITDA on $100 million revenue into an international industry leader with superior profitability on revenue exceeding $1.5 billion. In addition, he spent 10 years as a Senior Manager at Price Waterhouse delivering results-oriented merger & acquisition, audit and strategic consulting services to middle market clientele including over 40 manufacturing, distribution, service, nonprofit and technology clients. Mark currently serves as a Chief Financial Officer and consulting CFO (seven years) providing in-house and outsourced CFO and transactional services to the middle market.
Larry is the CTO for Restech and holds a B.S. in Computer Science. He is a software architect specializing in remote patient monitoring, medical sensors, and clinical trial software. Larry holds a patent on massively distributed computing and has worked for a number of major software startup companies including Sybase, Oracle, and Teradata. Larry was also the co-founder of a startup to deliver advanced clinical pathways to patients using mobile devices and medical sensors. Larry is truly a pioneer and now a veteran in the deployment.
Jeff has a breadth of experience with over 25 years in engineering and executive positions within major fortune 100 healthcare companies. He also has proven success in startup medical technology companies. Jeff provides leadership in securing and managing Restech’s patent portfolio. He also built Restech’s compliance platform that established regulatory acceptance in 25+ countries worldwide. Jeff’s scientific support and in-depth understanding of the device industry set the foundation for current and future commercial innovations at Restech.
With nearly 30 years of working with physician thought leaders developing novel and emerging technologies, Leo has played a key role in the development and evolution of balloon angioplasty and stent technologies that revolutionized the therapy of cardiac disease. His experience was instrumental in the development of the patented platform technology which drives the Restech sensor. Leo provides a vision and passion for effecting change in the diagnosis and management of atypical reflux.
With over 20 years of executive experience in both the private and public sector, Debra brings a broad understanding of healthcare delivery system. With experience managing products aimed at wide scale disease and population management for 20 million subscribers, Debra has extensive experience in effectively and efficiently developing models of delivery that address specific health issues. Debra has also been involved in the legislative process and served as the elected President of the Independent Physician Association of California. Debra is dedicated to bringing tools to the healthcare market that improve and support the clinical process.