Restech’s pH system was the highlight of new research presented by Dr. Ezra Teitelbaum at the 2017 American College of Surgeons’session on Novel Endoscopic and Minimally Invasive Techniques for Esophageal Dysmotility and Reflux Disease. Dr. Teitelbaum (Assistant Professor of Surgery and Medical Education at Northwestern University) collaborated with Dr. Steven DeMeester (President and Executive Director of the Foundation for Research and Education in Esophageal and Foregut Disorders) on a study comparing the results of different pH monitoring tests in patients off antisecretory medications.
CURRENT DIAGNOSTIC PATHWAY FOR EXTRAESOPHAGEAL SYMPTOMS
THE VALUE OF pH MONITORING
The diagnosis of extraesophageal reflux can be quite complex because the symptoms are nonspecific. Physicians typically approach the diagnostic process by placing patients on empiric treatment with PPIs or performing pH monitoring.
pH monitoring helps to establish a definitive diagnosis, from which the physician can design a personalized treatment plan through dosing and timing medication, lifestyle modifications, and/or surgical intervention. Follow-up pH studies can be performed to assess the patient’s response to the prescribed therapy.
With all the different options available, how does one determine which method of pH monitoring should be used to diagnose extraesophageal symptoms?
This particular study looked at three options: the standard esophageal pH catheter, the Bravo esophageal pH capsule, and the Restech pharyngeal pH catheter.
1. ESOPHAGEAL CATHETER v. BRAVO
Conventional distal esophageal pH monitoring systems, like the esophageal catheter and Bravo capsule reflux system, were designed to evaluate esophageal pH to help physicians diagnose gastroesophageal reflux disease (GERD).
However, can we use an esophageal system as a proxy for what happens in the pharynx?
Patients in this study received either an esophageal catheter or Bravo test. The authors analyzed the two groups assuming that they were similar cohorts, but to their surprise found “the differences are striking. [In] the patients who underwent a Bravo, 71% had abnormal tests or evidence of GERD. Of the patients who had [esophageal] catheter studies, only 13% were abnormal.”
This low agreement suggests esophageal catheter pH monitoring produces a high number of false negatives and may be less sensitive in patients with extraesophageal symptoms.
2. ESOPHAGEAL CATHETER v. PHARYNGEAL CATHETER (RESTECH)
Similar to the variation seen between the Bravo and the esophageal catheter (measurements in the distal esophagus) the study also showed substantial variation between the esophageal and oropharyngeal catheters, with the oropharyngeal catheter demonstrating better agreement with the Bravo capsule.
3. BRAVO v. PHARYNGEAL CATHETER (RESTECH)
Finally, Bravo and Restech were studied simultaneously in patients with extraesophageal symptoms. The study found a 94% agreement between abnormal and normal studies in the two pH systems. The one divergent patient between the two devices demonstrated significant only on the second day of their Bravo test, with Restech tests limited to 24 hours during this study.
Restech was more comfortable and easier to use than other pH systems. This is because of Restech’s simple visual placement, whereas others require invasive manometry or endoscopy.
With greater patient comfort, minimally invasive placement in-office, and excellent specificity/sensitivity, Restech pharyngeal pH monitoring is suggested as a first line test for use in patients with extraesophageal symptoms.
WHY IS AN OBJECTIVE EVALUATION OF REFLUX SO IMPORTANT?
The value of pH monitoring in obtaining an objective diagnosis for extraesophageal symptoms makes it a crucial tool for identifying the cause of these symptoms. However, not all pH devices yield the same measure of specificity and sensitivity. Esophageal catheter pH monitoring presented with low sensitivity in patients with extraesophageal symptoms. This study found high agreement between simultaneous Restech and Bravo measurements, with significantly better sensitivity of 93% and a negative predictive value of 92%.
Teitelbaum recommends Restech or Bravo to test patients presenting with extraesophageal symptoms, but highlights that the Restech test may be an easier initial evaluation of reflux.
IS REFLUX THE CAUSE OF EXTRAESOPHAGEAL SYMPTOMS?
USE EVIDENCE-BASED TESTING TO FIND OUT.
If you’d like to learn more about Restech, we are happy to visit your office anytime!
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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.