By: Müller DT, MD; Leers JM, MD; Bruns CJ, MD; Fuchs HF, MD
Department of General, Visceral, Cancer and Transplant Surgery, University of Cologne
53-year old male with a BMI of 24 kg/m2 presented with typical GERD symptoms such as severe bothersome heartburn every day, frequent belching, regurgitation especially after eating heavy meals, and occasional chest pain.
In addition, he reported atypical symptoms, mainly a chronic cough. His symptoms generally worsened after eating heavy meals, deep-fried foods, and alcohol consumption.
The patient presented at our Department of General, Visceral, Cancer and Transplant Surgery for further evaluation of his symptoms. Prior treatment included PPIs, however, sufficient symptom control was not achieved, and the patient sought alternative treatment options including surgery.
The patient was seen in our specialized surgical outpatient clinic. Prior to receiving a complete diagnostic work-up, the patient discontinued PPIs for 7 days. Upper GI endoscopy revealed mild LA Grade A esophagitis and a 2 cm Hiatal Hernia. Biopsies of the gastroesophageal junction were taken, and the pathology report confirmed reflux-associated esophagitis.
To determine the exact position of the lower esophageal sphincter (LES) and as part of our preoperative evaluation, we proceeded with high-resolution manometry. This demonstrated 100% peristaltic swallows, an LES resting pressure well within the normal range, and an overall good esophageal motility.
Contrast radiography (barium swallow) was performed in both upright and supine positions and using Valsalva’s maneuver and did not confirm any abnormal reflux.
In order to further evaluate abnormal esophageal and/or laryngopharyngeal acid exposure we then performed simultaneous 24-hour impedance pH-metry and laryngopharyngeal pH-metry using the Restech Dx-pH. The esophageal pH probe was placed 5 cm above the LES as previously determined by high-resolution manometry. A total of 56 reflux episodes were recorded, though the patient was only below a pH of 4 for 2.1% of the study.
Our patient showed a borderline abnormal composite DeMeester score of 10.4 with the threshold for abnormal being > 14.72. This result alone does not clearly prove abnormal esophageal acid exposure.
In contrast, results from the concurrently performed Restech Dx-pH measurement showed clearly abnormal laryngopharyngeal acid exposure. An upright RYAN score of 52.13 was calculated using DataView 4, which exceeds the previously established normal threshold of 9.41, (Ayazi et al.,2009). Supine position showed a normal RYAN score of 0.
Given the mainly typical GERD symptoms and chronic cough, the endoscopic proof of reflux-related esophagitis, the borderline abnormal esophageal pH measurement, and the abnormal upright RYAN score on the Restech Dx-pH, a diagnosis of GERD with associated atypical symptoms was made. Due to the good esophageal motility and the previous failure of long-term PPI therapy, our patient was considered a good candidate for minimally invasive antireflux surgery.
One month after the diagnostic evaluation, the patient underwent a laparoscopic Nissen fundoplication (360° fundoplication).
At his one-year postoperative follow-up, the patient reported no use of any PPIs or anti-acid medication and the GERD-HRQL, used for assessment of symptoms, showed a score of 2. The patient reported full symptom resolution, with no heartburn or cough and only mild dysphagia. In addition, the patient stated that he was very satisfied, his overall health had improved, and if he had to choose a treatment again, he would once more opt for surgery.
As shown in earlier research, Restech’s Dx-pH test and 24-hour esophageal pH tests do not necessarily need to correspond. With a borderline DeMeester score, a positive Restech examination helped to support the decision for antireflux surgery, in this case leading to full symptom resolution for our patient.
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.