Local Coverage Article Response to Comments

Response to Comments: Select Minimally Invasive GERD Procedures

A55749

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Article ID
A55749
Article Title
Response to Comments: Select Minimally Invasive GERD Procedures
Article Type
Response to Comments
Original Effective Date
12/01/2017
Retirement Date
N/A
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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Select Minimally Invasive GERD Procedures LCD. The official notice period for the final LCD begins on October 16, 2017 and the final determination will become effective on December 1, 2017.

We received a reconsideration request on TIF coincident with the CAC draft comment cycle. The evidence presented is detailed in the final policy summary of evidence. Based on this reconsideration request and submitted evidence, limited coverage has been added for TIF as outlined in the “Coverage and Limitations” section of the final LCD.

Response To Comments

NumberCommentResponse
1

We received one comment stating endoscopic treatments for GERD require further testing and evaluation of long term results. The commenter also agrees that these are still procedures in progress and should not receive Medicare reimbursement until further studies are completed.

Thank you for sharing your opinion.

2

One commenter would not recommend coverage for Stretta®. Data is poor and it is not considered standard of care for GERD.

Thank you.  We appreciate your opinion.

3

One commenter shared a presentation on Transoral Incisionless Fundoplication (TIF®) Procedure with EsophyX™.

 

Thank you for your Power Point of your recent presentation on Transoral Incisionless Fundoplication (TIF®). While you did not submit any new medical articles indexed in PubMed of the US National Library of Medicine of the National Institutes of Health, most of those you alluded to have been previously reviewed and are in our bibliography.  You did mention cost savings.  Unfortunately, Federal law prohibits Medicare from using cost in determining coverage.

 

4

Seven commenters requested coverage for Stretta®, stating the following:  

"Stretta is a widely accepted option for patients who do not get complete relief from their GERD symptoms and would like to avoid anti-reflux surgery. Stretta has been studied extensively, is proven safe and effective, and is supported by medical societies. It is time for NGS to recognize all of the data and allow positive coverage for Stretta in appropriate patients.  The clinical evidence on Stretta is robust as well as consistent. Please consider the following in your review. 

A 2017 Meta-Analysis of 2,468 patients from 28 studies concluded that the Stretta procedure significantly improves both subjective and objective clinical endpoints and should be considered as a viable alternative in managing GERD. 

A 2017 Clinical Spotlight Review by the guidelines committee of the Society of Gastrointestinal and Endoscopic Surgeons (SAGES), used to GRADE system to evaluate the literature, resulting in a strong recommendation for Stretta. 

The American Society of Gastrointestinal endoscopists (ASGE) included Stretta in their guideline on “The Role of Endoscopy in the Management of GERD. Regarding Stretta the guidelines noted that “Adverse events were infrequent and typically minor.  The technique appears to durable relieve GERD symptoms for up to 10 years in the majority of patients.” They concluded that endoscopic antireflux therapy be considered for selected patients. 

More than 40 peer-reviewed studies agree that Stretta is effective and safe in the treatment of GERD.  These include three RCTs and multiple observational studies from different institutions that consistently report that the Stretta procedure is associated with improvement in both objective and subjective GERD outcomes. 

Studies with long-term follow-up extending up to 10 years demonstrate durable symptom relief, superseding any placebo effect. 

In summary the quality of Stretta data directly conflicts with NGS current policy statements: 

  • Both the quality and quantity of this data as well as relevant society support meets the NGS criteria of “substantial peer-reviewed evidence.”

  • The strong medical society support also directly contradicts the NGS statement that there is an “absence of wide acceptance.”

  • The Stretta data far exceeds the data reported for other endoscopic treatments of GERD and it is inappropriate to lump all endoscopic treatment of GERD together, several of which are no longer marketed.

  • It is time to look at the overall body of evidence supporting the Stretta procedure rather than focusing on individual studies

It is also important to understand where Stretta fits in the continuum of care for GERD.

Stretta is targeted to a specific subgroup of patients whose symptoms remain uncontrolled despite daily (and sometimes twice daily) PPI therapy and are unable or unwilling to undergo anti-reflux surgery. 

  • Without a non-surgical, endoscopic option like Stretta the options for this patient are limited to anti-reflux surgery. Surgery comes with a much higher cost and higher complication rate than Stretta.

  • Many patients would benefit from an in-between option, do not wish to be on a lifetime of medications, and would like to avoid surgery.

  • The Stretta approach allows me to customize a solution for my patient’s condition.

No significant complications have been associated with the Stretta procedure. In contrast, fundoplication requires hospitalization and is associated with significant complication (e.g., dysphagia and gas-bloat syndrome).

Stretta is also appropriate for patients who have already undergone anti-reflux or bariatric surgery and still have chronic GERD. In these patients it helps avoid expensive and complicated revisional surgery.

Symptom improvement is the key clinical outcome for GERD, superseding normalization of acid exposure; the lack of a consistent correlation between symptom improvement and acid exposure reflects a misconception of the pathophysiology of GERD.

In addition, other Medicare MAC jurisdictions cover Stretta."

 

We thank you gentlemen for your opinion and experience. Those publications that you allude to and discuss have previously been reviewed and are currently in the bibliography of our policy.

 

5

One commenter stated that their products include the trans-oral Stretta® catheter system and stated the following: "The FDA originally cleared Stretta for use in 2000 and issued an updated clearance for the RF Generator in 2011 and an update to the Stretta catheter in 2016. Over the years a large amount of peer-reviewed data has accumulated on Stretta that solidifies its critical place in the continuum of care for GERD as an option in between medications and surgery.

Consider the significant amount of clinical data supporting efficacy and safety. Substantial data exists on objective and subjective outcomes (symptom and quality of life improvement, reduction of PPIs, reduction of acid exposure, healing of esophagitis), along with long-term durability (4-8-10 years) and a <1% complication rate. 

More than 40 clinical studies including more than 3,000 patients have been published on Stretta.  

The mechanism of action has been scientifically proven in the following animal and human studies: 

In humans, clinical studies demonstrate that Stretta RF treatment results in significant reductions in tissue compliance (without fibrosis) and reductions in transient LES relaxations. Animal studies show increased LES muscle wall thickness, growth of smooth muscle in the treatment zone, and an improvement in collagen (Kim et al 2003, Arts et al 2011, Herman et al 2015, respectively). These mechanisms improve the barrier between the stomach and esophagus and have been shown to improve GERD. The most recent animal study (Herman et al 2015) was a double blind sham controlled study authored by both clinical and histopathology experts who evaluated changes at the cellular level after RF delivery. 

Stretta is designed for a specific patient population different than a PPI or Anti-Reflux Surgery candidate: 

The ideal candidate for Stretta is a GERD patient with a small (<2cm) hiatal hernia, who does not get complete relief from anti-reflux medications and would like to avoid invasive surgery. A randomized trial comparing Stretta to anti-reflux surgery is not feasible due to the ethical issue posed by such disparate modalities with dramatically different risks and safety profiles (Stretta is significantly safer and has a far shorter recovery period). 

Currently available data shows that Stretta effectively manages the patient who wishes to avoid expensive, complex inpatient surgery with a much higher complication rate. 

Recent Meta-Analysis by Dr. Ronnie Fass - one of the largest of its kind for GERD treatments was coauthored by a statistical expert Dr. Fred Cahn. The discussion in the Fass meta-analysis presents the rationale and offers statistical validity for including observational studies in a meta-analysis. 

This large meta-analysis of 2468 patients reported on 28 studies, including four randomized trials, 23 cohort studies, and one registry. The mean follow-up was 25.4 months (3 months – 120 months). 

In the absence of availability of less invasive alternatives such as Stretta, GERD patients are often referred to anti-reflux surgery, a far more expensive and invasive option with a significantly higher complication rate. There is a need for less-invasive, safer and less costly approach such as Stretta. As evidenced by the recently published Budget Impact Model (Gregory et al, Managed Care, May 2016), which indicates that by shifting 2% of GERD procedures to Stretta from PPI use or surgery, savings of 37 cents per member per month (PMPM) were seen. The analysis also noted: 

  • Patients with chronic refractory GERD symptoms continue to consume health care resources; and

  • These recurring health care costs go down following a Stretta procedure. 

The medical necessity of Stretta is demonstrated via wide acceptance by the physician community. Both the ASGE guidelines in 2015 and new SAGES guidelines support Stretta. Significantly, the SAGES Guidelines Committee recently published a second literature review of endoluminal techniques for treating GERD. The Stretta procedure received a strong grade recommendation in both versions. 

These specialty society recommendations contradict the NGS statement, “the preponderance of reviewers remain equivocal in their support and have called for randomized controlled trials with long-term follow-ups”. These published guidelines reflect the expert opinion of major medical societies and exceed the evidence requirement of “substantial peer-reviewed literature.” 

Because Stretta is delivered endoscopically, and does not alter the anatomy, it has become an important tool in patients who have previously had either bariatric surgery or a Nissen fundoplication, but still have GERD symptoms. These patients can have a Stretta to resolve their GERD and avoid a risky revisional surgery. Stretta data shows effectiveness in both post-Nissen and post-bariatric patients. 

In addition to the data, Stretta is a widely accepted standard of care for GERD as further evidenced by: 

  • In 2016 there were more than 2,500 Stretta procedures performed.

  • Since inception more than 25,000 patients have benefitted from Stretta therapy.

  • More than 3,000 Stretta patients have been enrolled in studies and followed for up to 10 years.

  • There are 190 practicing Stretta providers in the U.S.

  • Stretta has an 80% customer re-order rate.

  • Stretta is used at top academic medical centers in the USA (Harvard, Yale, Penn State, Cleveland Clinic, Stanford, Houston Methodist, Duke, Brigham & Womens, Montefiore, NYU, Mount Sinai, Ochsner Clinic, Vanderbilt, Johns Hopkins, Emory, etc.)

  • Stretta has been studied at many major academic institutions in the USA.

  • Stretta is covered by Medicare plans in 15 states

  • Stretta is covered by the BCBS plans: Carefirst, Highmark, NEPA, and Louisiana.

  • Stretta has been proven over time with robust evidence from more than 40 studies.

  • Stretta use is endorsed by two major medical societies: SAGES and ASGE.

  • Stretta is covered by all private insurers in the United Kingdom, and has NICE guidance.

  • Finally, effective 10/1/16, Novitas, a large MAC with jurisdiction in a dozen states in the South/Southwest and Northeast, published Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic) (L35350), a positive LCD. Medicare beneficiaries, particularly those in the same geographic region covered by NGS, should have access to this less invasive treatment for GERD."

 

Thank you for your letter.   We appreciate you commenting that the Stretta® device never actually was FDA approved.  While you did not submit any new medical articles indexed in PubMed of the US National Library of Medicine of the National Institutes of Health, most of those you alluded to have been previously reviewed and are in our bibliography.  You mention the savings if the Stretta® procedure were used.  Unfortunately, Federal law prohibits Medicare from using cost in determining coverage.

 

6

One commenter indicated that "since the device was FDA (PMA) approved in 2012, the level of evidence reporting on LINX has been steadily growing. At the October 2015 AMA CPT editorial panel meeting, LINX was assigned a category 1 CPT codes. Effective January 1, 2017, CPT codes 0392T and 0393T were deleted and replaced by 43284 and 43285 (Esophageal Sphincter Augmentation placement/removal). This decision was based on the quality of evidence validating the efficacy, durability and safety of LINX. In addition, the application process resulted in 6 specialty societies, 3 surgical and 3 Gastroenterological, self-identifying as supporting a category 1 code for LINX. Their support underscores the desire of clinicians that LINX be a treatment option for patients with recalcitrant GERD. The following publications were offered as support: 

  • Ganz et al (2015), demonstrate that “Over the 5 year follow-up period, no device erosions, migrations, or malfunctions occurred.” The conclusion to the safety study is that “Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD.”
  • Lipham et al conducted an examination of the first 1000 patients treated with LINX. The reporting period covered more than 6 years and included 1,048 patients at 82 sites (US & OUS) with a median implant duration of 274 days. Overall rates include:
    • Perioperative complications – 0.1%
    • Readmissions – 1.3%
    • Dilations – 5.6%
    • Device Removals – 3.4%
    • Device Erosions – 0.1%
    • No device migrations or malfunctions 

Their conclusion is that “the MSAD has a low risk profile, and the overall device removal rates are relatively low. The hiatal and gastric anatomy is left undisturbed, thereby keeping the option for fundoplication if the device is removed. This safety analysis of the first 1000 patients underscores that the MSAD is a safe option for patients with uncomplicated GERD who are considering antireflux surgery.” 

  • In Gastroenterology; April 2016 Volume 150, Issue 4, Pages 1009-1018 “An Episode Payment Framework for Gastroesophageal Reflux Disease: Symptomatic Gastroesophageal Reflux Disease, Dysplastic and Nondysplastic Barrett’s Esophagus, and Anti-Reflux Surgical and Endoscopic Interventions” it was advised LINX be considered when entering into a value-based care agreement for GERD, “While the mainstay of surgical therapy for GERD is the laparoscopic fundoplication with hiatal hernia repair, an alternative procedure is the laparoscopic implantation of a ring of magnetic beads around the lower esophagus to augment the lower esophageal sphincter. One-, 3-, and 5-year results show that patients had significantly reduced esophageal acid exposure, improvement in GERD-related quality of life, and significant reduction in use of PPIs. Dysphagia was common in the first few months after implantation, but present in only 4% of patients at 3 years”.
  • Warren et al (2015) and Reynolds et al (2015) conducted propensity matched studies of LINX versus LNF and found similar outcomes between the matched groups. The authors of both propensity studies acknowledge the shortcomings of the respective studies with regard to selection bias and I acknowledge that issue as well. However, when looking at the results of all 9 studies, one can see a recognizable trend toward symptom resolution and improved quality of life versus the pre-surgical condition. The absence of a RCT does not create a problem for determining the benefit of LINX. The addition to the body of evidence of 2 propensity-matched studies comparing MSA to LNF by different authors, on different cohorts, showing similar results, adds to the strength of the data. Propensity matched studies have been used in over 40,000 different analyses. The goal of propensity matching is to statistically approximate the randomness that is found in an RCT. In the case of a single propensity study, one might be concerned with selection bias both with the cohort and the variable selection as well as the caliper. However, with 2 propensity matched studies, the goal of inducing randomness is enhanced. The Warren study had 5 covariates and the Reynolds study had 9 covariates; the caliper in the Warren study was .01 whereas in the Reynolds study it was .5. The variability between these covariates and the differences in the caliper as well as the different authors should help to create additional randomness from the standpoint of selection bias, leading to more believable outcomes individually and when compared to one another. 

The LINX procedure has been recognized and recommended by both the ACG (American College of Gastroenterology) and ASGE (American Society for Gastrointestinal Endoscopy) in a joint letter sent to Dr. Yao, at Anthem on September 2, 2016 requesting that LINX now be considered a covered benefit for their members. 

Of particular interest is the following statement: 

  • “Currently, the standard surgical therapy for GERD is laparoscopic fundoplication (LF). While LF can be effective in reducing symptoms, the lack of standardization (surgeon dependent) and the potential for adverse side effects detract from its potential advantages. Peer review has demonstrated the LINX procedure to be safe and effective in reducing the symptoms of acid reflux, while preserving gastric anatomy and minimizing adverse side effects.” 

Additionally, the following point is made regarding both organizations’ clinical guidelines regarding this technology: 

  • “Since the release of ACG and ASGE guidelines pertaining to LINX in 2013 and 2014 respectively, several peer reviewed publications have been released regarding the LINX procedure. These documents were not available, and, therefore not included in the review process for the specialty society guidelines.”

 

We appreciate the comments.   The paper “Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant” is a compilation of self-reported incidents to Manufacturer and User Facility Device Experience (MAUDE) database.  This is a problem for evaluating safety since it depends on physicians to voluntarily adding to this data base.  In addition, the median (but not the mean) implant duration was only 1.4 years.  Typically mean, not median is used in studies.  This does not address the clinical results of the device, but rather the self-reported mechanical complications.

 

7

Another commenter stated that "LINX provides consistent, reproducible clinical benefits that have borne out across multiple studies directed by diverse groups of investigators. Two comparative effectiveness studies reporting on 328 patients comparing LINX and LNF showed outcomes for LINX patients to be as good as or better than LNF patients, while preserving the gastric anatomy and demonstrating a much better side-effect profile (ability to belch and vomit). Preliminary results from Level I RCT data presented at 2017 DOW comparing LINX vs. double dose PPI (150 pts) showed that 92.6% of patients treated with LINX achieved the primary endpoint success criteria versus 8.6% of patients treated with twice a day omeprazole, coupled with significant improvement in quality of life (88.9% of patients treated with LINX versus 6.8% of patients treated with twice a day omeprazole). Of the nearly 6500 LINX procedures that have been performed in the U.S., there have been 169 explants (2.6%) and 14· erosions (.22%), which compares favorably to the re-surgery rate of LNF, 12.3% at 5 years. 

This technology has been available to patients for nearly 10 years, and in the hands of qualified surgeons for properly selected patients offers an option that is not only SAFER than the current gold standard, but also MORE EFFECTIVE than the current gold standard."

 

Thank you for sharing your opinion on the LINX® procedure.

 

8

One commenter stated that "aggressive surgical approaches to GERD are underutilized. Such procedures could save money to insurers over what is currently offered as years of medical treatment. Too many patients and their insurance carriers spend far too much time and resources on a disease that has a route cause in anatomical variance and break down (weak LES, hiatal hernia); and it is a variance that can be cured with surgery. 

Fundoplication is an excellent treatment for GERD. There are some side effects with fundoplication that are quoted in the literature, but these side effects are of very small numbers in good surgical hands. 

The major problem with fundoplication is that it is a procedure that is very surgeon dependent (their training, skillset). 

The LINX procedure has potential advantages over current surgical fundoplication. The first is that is a simpler and more reproducible procedure than fundoplication. Therefore, it is at less risk for operator variance (skill, volume, and training). The second is that the valve created with the LINX is more of a "smart" valve. The artificial sphincter that is LINX can open and close by the actions of the magnets. 

Thereby it has the potential to produce less dysphagia from food boluses heading downward toward the stomach, and should allow more ability to relieve pressure from the stomach (gas and even vomitus) that currently may cause gas bloat or pain with fundoplication. Thirdly, it is a sphincter that won't lose strength over time as it what may happen years out with fundoplications. 

In reading the literature, I was an early adopter of LINX after the 3-year data published in NEJM (this has only been strengthened with recent 5-year update). I was convinced this procedure offered my patients distinct advantages over fundoplication. Unfortunately, I have only been able to place two LINX procedures in about three years due to insurance denials. Both patients are doing terrific, by the way, and I would have placed many more if it were not for denials. I feel there is even more long term favorable data now that would make this device appropriate to cover. I would welcome this option for GERD patients with typical symptomatology, history of PPI responsiveness, and positive pH probe analysis."

The commenter further stated that "they were not interested with or impressed with the TIF procedure at this time. It does not have much to offer other than representing and expensive short term natural tissue valve created by endoscopic means. The classic LES augmentation must happen by the laparoscopic approach either with fundoplication, or now with artificial sphincter augmentations. The TIF is just not a robust enough augmentation procedure in my opinion."

 

Thank you for your comments.  Medicare is not allowed by law to use cost in making coverage decisions.  We do appreciated you sharing your experience with us concerning the LINX® procedure.   We also appreciate your professional opinion that this is superior to the TIF procedure.  We thank you for pointing out that you have found that private insurers typically will not cover.

 

9

Another commenter stated that "the MSA procedure is safe and effective in treating GERD for patients who would otherwise be considered appropriate for laparoscopic Nissen fundoplication. Furthermore, MSA offers important clinical advantages over fundoplication in indicated patients with respect to the side effect profile and the fact that it is a reversible procedure. MSA is becoming an established treatment option in their institution and is not considered “investigational” by them or by leading medical societies such as the American Gastroenterological Association (AGA): “While mainstay of surgical therapy for GERD is the laparoscopic fundoplication with hiatal hernia repair, an alternative procedure is the laparoscopic implantation of a ring of magnetic beads around the lower esophagus to augment the lower esophageal sphincter.” 

The commenter fully respects and appreciates the desire of a payer to have the most rigorous evidence possible, non-coverage due to lack of a randomized clinical trial is not appropriate given the already established clinical benefits of MSA and the ethical considerations of randomizing patients to a non-reversible procedure such as surgical fundoplication. Six clinical studies have compared MSA to surgical fundoplication in more than 1,000 patients. Three of the six studies used propensity score matching analyses. This statistical method provides robust data from which conclusions can be drawn. Reflux control was found to be comparable between the treatments and consistent across all studies but bothersome side effects associated with surgical fundoplication, such as gas bloat syndrome and inability to belch or vomit, occurred less frequently after MSA as compared to fundoplication. 

Additionally, MSA achieves reflux control without requiring major alterations to the patient's gastric anatomy. Since clinical determinations about the risk-benefit of L\NX compared to Nissen fundoplication can reasonably be made from the available clinical evidence. Our team waited for 5 year safety data before deciding to start implementing MSA as part of our clinical treatment plan and our review has allowed us to comfortably recommend this approach as a substitute for Nissen Fundoplication. We hold firm that subjecting patients to randomization of a surgical procedure at this stage would not materially add to our clinical understanding of MSA and is needlessly burdensome. 

Furthermore, enrolling an RCT of MSA vs. surgical fundoplication would not be feasible as patients would be unwilling to allow a randomization process to determine which anti-reflux procedure they receive. We have attempted to perform randomized trials between surgical procedures here at Northwestern and recruitment is impossible with most patients opting to not enroll and undergo the procedure they have chosen before the referral. 

With this said, I would like to bring your attention to preliminary results from the CALIBER trial reported at Digestive Disease Week (DOW) on May 9th 2017. The CALIBER Trial is a 150 patient multicenter RCT comparing MSA to acid suppression medication (omeprazole) in patients with troublesome regurgitation. All patients had a diagnosis of GERO as confirmed by abnormal acid exposure time and moderate to severe regurgitation despite taking once-daily omeprazole. Patients were randomized to treatment with twice a day omeprazole or MSA. The primary endpoint of the trial was elimination of moderate to severe regurgitation at 6 months after treatment. Preliminary results showed: 

  • 92.6% of patients treated with LINX achieved the primary endpoint success criteria versus 8.6% of patients treated with twice a day omeprazole.
  • Significant improvement in quality of life was achieved in 88.9% of patients treated with LINX versus 6.8% of patients treated with twice a day omeprazole
  • Normal levels of reflux were restored in 92% of patients treated with LINX compared to 36% of patients treated with twice a day omeprazole. 

In closing, as a clinician dedicated to providing my patients with proven treatment options for GERO, non-coverage of MSA puts me and patients in a difficult position. MSA is regularly indicated for the treatment of patients with GERO, but it has been largely inaccessible to patients covered by NGS. 

Regrettably, the draft LCD considers MSA to be not "reasonable and necessary" and "not covered". This status is outdated and not aligned with the current clinical evidence and medical community experts in the management of GERO. There is a reasonable expectation that proven and medically necessary treatments - like MSA - will be a covered benefit by Medicare. The best way for NGS to fulfill its commitment to Medicare beneficiaries (our patients) is by recognizing MSA as medically necessary and a proven benefit for patients indicated for anti-reflux surgery."

 

Thank you for your comments.  We appreciate your experience with this device.  We appreciate you summarizing selective literature.  Unfortunately, no new medical articles indexed in PubMed of the US National Library of Medicine of the National Institutes of Health were submitted.

 

10

A board certified general surgeon stated that "the LINX procedure is head-and-shoulders better than the Nissen Fundiplication.  It is more effective, has a better side effect profile and the surgery is technically easier.  All in all this is a tremendous win for patients.  It also helps to remove the long term cost of ongoing pharmaceutical proton pump inhibitor use (Prilosec etc…).  The “Lap Nissen” works well to control reflux, but has some undesirable side effects.   Patients and their families did NOT want to have a Nissen surgery due to both real and PERCEIVED problems with the surgery.  Everyone had heard about their neighbor or distant aunt who could NOT vomit!   This is a result of the Nissen.  

The scientific data on the LINX procedure is now 10 years out.  Over 1000 implants all over the world have proven solidly that the LINX works, has an excellent safety profile and the patients do very well.  

Also, the literature has shown that the laparoscopic Nissen is NOT SO GREAT after all!  Going head to head LINX vs. Nissen over 5 years, the efficacy of the Nissen fades while the control of reflux after a LINX holds steady after the same 5 years.   

Again, in summary, this LINX surgery is considerably better than the Nissen.  It is technically easier (and will have fewer side effects), it takes less anesthesia time (the patients will go home same day, rather than overnight stay), and the patients are happier and do better in the long run.  This has been PROVEN in the literature."

 

Thank you for your comments.  We appreciate your experience with your performance of eight (8) patients with the LINX® procedure since December 2016, as well as experience with the Nissen procedure. 

 

11

Another surgeon stated the following in favor of the LINX® procedure. "There is a growing need for more than one method of treating the spectrum of gastro-esophageal reflux from a surgical prospective. There is no question that Laparoscopic Nissen fundoplication is an excellent treatment option to prolonged treatment with PPIs and for those patient who break through PPI control, but it does have complications that we as surgeons would like to avoid.   

There is a need for an effective operative treatment of patients with uncomplicated gastro-esophageal reflux, for those patients who develop complication of PPI therapy, or are worried about developing PPI complications, and for those patients, particularly the young, who need lifetime PPI treatment at considerable treatment costs over their lifetime.  

There have been several unsuccessful efforts to bridge the gap between PPI treatment and laparoscopic Nissen fundoplication, particularly for those without a significant hiatus hernia, complicated GERD or for patients who are likely to require PPIs for many years.  Stretta has been tried but was not successful. Currently there is a vogue for TIF (Transoral Incisionless Fundoplication), however this is not proving to be successful in the long run. The concept of TIF is to recreate the angle of His using an endoscopic approach is an excellent idea, however the technique has problems. The concept of securing the serosal surface of the fundus of the stomach to the serosal surface of the esophagus with T-fasteners is not well thought out. Firstly serosa does not adhere to serosa well, and T-fasteners erode through the stomach and esophageal walls pulling out with the result that the new flap valve, that was created falls apart with the recurrence of reflux symptoms. There is also an incidence of perforation due to the T-fasteners pulling out requiring abdominal exploration.  

The most exciting technique that has good results, which are sustained over time, is the LINX procedure of placing the circle of magnetic beads around the lower esophagus. The procedure of the laparoscopic of LINX collar of magnetic beads takes about an hour, compared to 2 or more hours for a laparoscopic Nissen fundoplication. There is also less disruption of the normal anatomic planes compared with dissection required for a Nissen fundoplication.  The recovery for the procedure is superior to that of laparoscopic Nissen fundoplication.  

The results of the LINX procedure are excellent and compares favorably with that of laparoscopic Nissen fundoplication. The percentage of patients completely off PPIs, is the same as for those patients after a Nissen fundoplication, 82% and 63% respectively, and the QOL scores are the same for the two procedures (Riegler M, et al Surg Endosc August 2014). Over time the LINX results have been shown to hold up with 80% of LINX patients having complete session of PPIs at 4 years (Lipham J, et al Surg Endosc April 2012). The incidence of the gas bloat syndrome is less after a LINX procedure than after Nissen fundoplication, and the patients can burp, and can vomit more easily then with a Nissen fundoplication.  

As GI laparoscopic surgeons treating gastro-esophageal reflux disease we are being asked about the LINX procedure, as the patients have heard about its good results. The fact that such a good procedure is not covered by insurance is very disappointing for patients and for surgeons who would like the availability of a low reliable risk procedure."

 

Thank you for your comments and describing your surgical experiences.  However, the Riegler M, et al Surg Endosc August 2014 and the Lipham J, et al Surg Endosc April 2012 that you reference are currently in our listed references.  We do note that you also are a surgeon who feels that the TIF procedure is unproven we appreciate your details in the problems associated with it.

 

12

Another surgeon stated that "an open Nissen Fundoplication was considered the “gold standard” for the treatment of reflux. Although “successful” in eliminating reflux, most patients then suffered significant side effects of dysphagia and bloating. These side effects were usually long term and this discouraged many patients from even considering surgery because of the new problems that it caused. A Laparoscopic Fundoplication today is a shorter and looser wrap than was the open repair. Although patients today have a better ability to belch and vomit compared to patients 30 years ago, patient satisfaction is still low. There is also a significant variation in technique from one surgeon to another and this leads to a wider range of outcomes.  It is a fixed wrap that doesn’t allow any normal, physiologic reflux. I have never been fully satisfied with the outcomes of a Nissen Fundoplication because of these side effects. I have followed with great interest, over the years, newer technologies to treat reflux with fewer post-operative side effects. The Stretta procedure seemed promising initially but the results have been disappointing in my opinion. I did train for the TIF procedure but have never performed a procedure. I didn’t like permanent polypropylene fixators placed at the GE junction and then have them become a permanent intraluminal foreign body. This procedure also does not address a hiatal hernia at all. We now know that surgical control of reflux involves both fixing the LES as well as closing a hiatal defect and keeping the GE junction in the abdominal cavity. It is not surprising that the outcomes of the TIF procedure have been unimpressive. 

The lower esophageal sphincter augmentation (Linx) procedure is a completely different technology and approach to GERD. The surgical procedure is now performed in a very standard method by all surgeons certified by Torax Medical. This results in very similar results in all centers. The amount of dissection and disruption of the anatomy in the lower esophagus and upper stomach is less than that of a fundoplication. The esophageal hiatus can be addressed and closed in every patient. Precise surgical sizing and multiple sizes of the device will ensure an exact fit in every patient.  Most importantly, the results of a properly implanted Linx device gives similar outcomes to a fundoplication in the control of GERD without the same short and long term side effects of a fundoplication. 85 % of patients stop their prescription medications and a 94% patient satisfaction rate is incredible. Concerns about late erosions have not been observed and there has not been a single death in the worldwide literature. The few patients who haven’t tolerated the Linx device (about 1%) have been able to have the device removed laparoscopically.  

As a surgeon, I want to be able to offer my GERD patients the best and latest technology to improve their quality of life and, perhaps, even lower the risk of developing esophageal cancer. Surgery is always changing. I don’t treat reflux the way I did during my surgical training 30 years ago.  Treatment has changed for almost all medical conditions over that time. The Linx device is the most exciting development in reflux surgery in the last 25 years. It has been proven to be very safe, effective, and has very similar outcomes compared to a fundoplication without the unwanted side effects of a fundoplication.  I strongly recommend that this procedure be available for your patients who have objectively documented GERD that desire treatment other than life long prescription medications and lifestyle change."

 

We appreciate your opinions on the LINX® device and Stretta® procedure and your disappointing results in the latter despite initial promise.

 

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