GERD Concept stomach on fire blue background 1538 x 1254
Graphic source: Adobe Stock

Gastroesophageal reflux disease, also known as GERD, is common, costly, and often chronic. For some people, it may mean taking medications for long periods of time. For others, surgery may be required to get long-lasting relief.

What is GERD?

GERD occurs when the lower esophageal sphincter becomes lax and allows moderate to large amounts of acidic stomach contents to regurgitate (reflux) into the esophagus. This causes esophageal inflammation (esophagitis) and, sometimes, ulcerations, scarring (strictures), and a variety of non-gastrointestinal symptoms, such as a chronic cough and asthma.

It can also be associated with the development of Barrett’s esophagus, a condition where the lining of the esophagus responds to the chronic irritation by transforming its cell type to one that more closely resembles that of the lining of the intestine. The reason why this is important is that Barrett’s esophagus is considered a risk factor for the development of an uncommon, but potentially deadly form of cancer – esophageal adenocarcinoma.

Traditional approaches to treatment

Before we explore the pros and cons of incisionless surgery for GERD, here’s a quick review of traditional approaches to the treatment of the disease.

Lifestyle changes

Some people with GERD can control their symptoms with lifestyle changes, such as avoiding fried foods, alcohol, not going to sleep right after a big meal or losing weight. However, many will resort to medications – often proton pump inhibitors or PPIs.

PPIs

Although prescription or over-the-counter PPIs are often taken for very long periods of time, significant risks related to taking the medication for longer than it was originally intended have been reported in the medical literature. These include (amongst others):

    • Vitamin B12 deficiency[i]
    • Increased risk of C.difficile[ii]
    • Chronic kidney disease[iii]
    • Cardiovascular disease[iv]
    • Increased risk of osteoporosis fractures[v]
    • Dementia[vi]
    • Stroke[vii]

     

Further, although PPIs reduce the acidity of the regurgitated stomach contents, they do not address the underlying cause of the reflux – that is, the abnormally functioning lower esophageal sphincter (LES).

Surgery

Surgical correction of a lax LES has been an accepted alternative to treat chronic GERD for many years. However, whether done by an open procedure (Nissen fundoplication) or by laparoscopy (laparoscopic Nissen fundoplication), it is a big operation that may leave patients with some unpleasant symptoms, such the inability to belch or vomit, difficulty swallowing, bloating, and an increase in flatulence.

A Non-Medication, Non-Surgical Incisionless Alternative

I recently met with Skip Baldino, the President and CEO of EndoGastric Solutions. I wanted to learn about his company’s innovative non-medication, non-surgical incisionless alternative for the treatment of GERD. According to their literature, the company is “a medical device company focused on developing and commercializing innovative, evidence-based, non-invasive surgical technology for the treatment of GERD.”

Their product, the EsophyX device, is used with a standard endoscope (for direct visualization) and inserted through the mouth to rebuild the LES using traditional surgical principles. To understand how it works, we need to first review the principles of fundoplication.

What is a fundoplication?

Fundoplication is a surgical procedure that involves wrapping and then sewing the upper part of the stomach (called the fundus) around the lower esophagus in a way that causes the esophagus to pass through a small tunnel created out of stomach muscle. This strengthens the lax LES and makes it more difficult for acidic stomach contents to back up into the esophagus.

Nissen Fundoplication Surgery graphic 750 x 594
Photo source: Adobe Stock Photos

The open procedure (Nissen fundoplication) is done by making a large incision in either the abdomen or the chest. The laparoscopic technique (laparoscopic Nissen fundoplication) is performed without making large incisions. Instead, the surgeon inserts a camera and various instruments through small incisions in the abdomen.

Traditional Nissen procedures involved encircling the esophagus completely with the stomach fold. Unfortunately, this may create an LES that is too tight to allow the patient to belch or vomit. This is associated with an uncomfortable bloating sensation and an increase in embarrassing flatulence.

More recently a variety of procedures (e.g., Toupet, Dor) were developed that involved only a partial wrap – from 180 to 270 degrees or so. These have been associated with a reduction in the obstructive symptoms.

GERD surgery without incisions

Transoral incisionless fundoplication or TIF is exactly what its name implies. It is a way to perform a partial fundoplication by inserting a specialized device into the stomach via an endoscope instead via a surgical incision.

EsophyX-Z-model-device-with-close-up 750 x 433
The EsophyX Z Device
Photo source: Endogastric Solutions

The device, the EsophyX Z, has a flexible end that the endoscopist can manipulate in order to fold the anterior curve of the stomach partway around the end of the esophagus. It also is able to deliver fasteners, known as SerosaFuse “H” fasteners to fix the folds in place.

TIF procedure graphic 750 x 579
Graphic source: Gastroenterology 2015 148, 324-333.e5DOI: (10.1053/j.gastro.2014.10.009) Copyright © 2015 AGA Institute (courtesy of EndoGastric Solutions)

What type of GERD patients should consider fundoplication?

Not everyone with GERD should have this type of procedure – whether surgical or incisionless. Prior to the procedure, GERD fundoplication patients are evaluated by a gastroenterologist or a foregut surgeon who performs endoscopy, often with biopsies, to determine the severity or grade of the esophagitis. 

In general, some of the indications for a procedure (surgery or TIF) include:

  • Continued symptoms despite optimal medical management
  • Patients unable or unwilling to follow recommended therapy including taking PPIs as prescribed
  • Need for long-term medical therapy
  • Complications of GERD (eg, Barrett esophagus or peptic stricture but without severe changes -dysplasia- or carcinoma).
  • Extraesophageal manifestations (eg, asthma, hoarseness, cough, chest pain, aspiration).
Barrett’s esophagitis must be evaluated for the presence of high-grade neoplasia or cancer before proceeding with a fundoplication.

Who is eligible for a TIF procedure? 

Patients with typical GERD symptoms and no or only low-grade esophagitis and no or only a small hiatal hernia are good candidates for TIF. According to EndoGastric Solution’s criteria, TIF is contraindicated in patients with the following:

  • BMI ≥ 35
  • Esophagitis (Los Angeles C/D)
  • Barrett’s Esophagitis
  • Esophageal ulcer
  • Fixed esophageal stricture or narrowing
  • Portal hypertension and/or varices
  • History of any of these procedures in the past: previous resective gastric or esophageal surgery, cervical spine fusion, Zenker’s diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, > 2 dilations for esophageal stricture, or cirrhosis
  • Active esophageal, gastric, or duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if the patient complains of postprandial satiety during the assessment

Incisionless is good, but does it work?

In medicine, the best measure of whether something actually achieves the outcomes doctors and patients want is the publication of a well-designed, carefully controlled clinical trials that has been subjected to peer-review.

To date, EndoGastric Solutions notes that over 22,000 global procedures (most in the U.S.) have been performed. They also tell me that there are more than 1500 uniquely studied patients in over 100 peer-reviewed publications from more than 75 centers. These studies examined different aspects of the procedure, including the safety of the procedure, the durability of the outcomes, and the impact on symptoms, healing of esophagitis, and PPI use.

One of the most important of these studies is the 5-year multi-center TEMPO study that was published in 2018. It compared the TIF procedure to PPI use in what is called a cross-over study. That means that patients in the group assigned to take PPIs had the TIF surgery once the initial phase of the study was completed. Here are the conclusions of the study:

“The quality and durability of the long-term symptomatic outcomes achieved in this study set apart the TIF 2.0 procedure from these earlier GERD treatment modalities. These results were achieved without unwanted SAE [serious adverse events] and post-fundoplication side effects. Importantly, the elimination of regurgitation, atypical symptoms, and heartburn, as evaluated by validated, disease-specific questionnaires (RDQ, RSI, GERD-HRQL)*, was maintained without significant deterioration over time. Therefore, this study establishes the ability of the TIF 2.0 procedure to provide long-term and durable resolution of troublesome GERD symptoms, improvement of the quality of life, and reduction in PPI utilization in well-selected chronic GERD patients.“**

*These questionnaires are explained in the text of the study

**Emphasis is mine

How much does it cost?

According to CEO Skip Baldino, the EsophyX device costs “north of $4,000.” It is a one-time use only device (a throwaway) for a variety of reasons including issues related to manufacturing and fear of contamination. The cost of the device is included in the overall costs of the procedure.

The out-of-pocket cost to the patient will vary depending on their insurance status. Reimbursement is covered in all 50 states by Medicare and TIF is covered by ~120M covered lives in total. There is a dedicated procedure (CPT) Code (43210) for this procedure. The company also offers a pre-approval service for patients not currently covered.

It is important to note that not all commercial insurers cover the procedure. And of course, if covered, a patient’s out-of-pocket costs depends on their deductible, co-payment or co-insurance levels.

From the Insurer/Payer’s perspective, the 2018 TEMPO study reported the following:

  • “Medicare data suggest that the average reimbursement for a TIF procedure ($4, 510.81) is about half the rate for a laparoscopic Nissen fundoplication (LNF) ($8, 573.99).
  • A simulation applying these reimbursement rates to the 60 TEMPO patients (who were candidates for either procedure) reveals a potential procedure-related savings of $238 543.40 for performing TIF 2.0 instead of LNF. 
  • Out of the 63 patients enrolled in this study and who underwent the TIF procedure, 5% had corrective surgery within 5 years, leaving 95% of patients who underwent a less-invasive procedure, with virtually no side effects and at significant overall cost savings compared with more invasive GERD surgery.”

The study authors concluded that “the TIF 2.0 procedure appears to be cost-effective.

The bottom line

The TIF procedure offers an attractive, cost-effective alternative for the treatment of chronic GERD for patients who are unwilling to take PPI’s for a prolonged duration of time or prefer an endoscopic procedure to surgery – if they meet the criteria for the procedure.

References


[i]  Lam JR. JAMA. 2013 Dec 11;310(22):2435-42. doi: 10.1001/jama.2013.280490.

[ii]  Trifan, Anca, et al. World J Gastroenterol. 2017 Sep 21; 23(35): 6500–6515.

[iii]  Lazarus B, Chen Y et al. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193.

[iv] Shiraev TP, Bullen A. Heart Lung Circ. 2018 Apr;27(4):443-450. doi: 10.1016/j.hlc.2017.10.020. Epub 2017 Nov 20

[v] https://onlinelibrary.wiley.com/doi/abs/10.1111/1756-185X.12866

[vi] Gomm V, von Holt K. JAMA Neurol. 2016 Apr;73(4):410-6. doi: 10.1001/jamaneurol.2015.4791.

[vii] https://www.ahajournals.org/doi/abs/10.1161/circ.134.suppl_1.18462 

 

3 COMMENTS

  1. Thank you Dr. Salber @docweighsin! You are correct that anyone like Deanna can research on GERDHelp.com to both find a physician and to get an answer to this frequently asked question (https://www.gerdhelp.com/faqs/) “I have a hiatal hernia. Can I still get a TIF procedure?”
    Yes. Clinical data indicates that the TIF procedure can “reduce” hiatal hernias under 2cm. If you have a hiatal hernia larger than 2cm, your TIF trained physician will repair the hernia before your TIF procedure. Both procedures can be performed during the same anesthesia session. While in this case you will have incisions as a result of the hernia repair, you still benefit from the superior performance of the TIF procedure compared to traditional fundoplication.
    (Abstract of Clinical Data referenced above — https://www.gerdhelp.com/blog/references/revision-of-failed-traditional-fundoplication-using-esophyx-transoral-fundoplication/

  2. Is there any help for people in the Southeast GA? Is this treatment available to people who have had a Lap Niesen 10 or so years ago?

    • I believe it is available all over the U.S., but the best way to find out where you can find doctors doing the procedure is via the EndoGastric Solutions’ consumer site: https://www.gerdhelp.com/find-a-physician/ I don’t know the answer to your question about whether you can have this procedure 10 years after a Lap Nissen, but I do think that you might be able to find the answer on the gerdhelp.com site. I always urge people to get more than one opinion from a health professional before undertaking anything as serious as a medical procedure.

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