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SAGES New Clinical Guideline

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Posted 2/18/2013 9:39 PM (GMT 0)
www.prnewswire.com/news-releases/stretta-therapy-for-gerd-receives-strongest-recommendation-in-sages-new-clinical-guideline-190664391.html


"The new Clinical Spotlight Review for endoluminal GERD therapies strongly supports the safety and effectiveness of Stretta as illustrated through the depth of clinical data. The body of data shows unequivocally that Stretta is a valuable minimally invasive tool for the treatment of GERD," stated Dr. Scott Melvin , current President of SAGES.
Posted 2/18/2013 9:44 PM (GMT 0)
"We are encouraged that insurance companies will take note of this guideline and update their coverage policies to make Stretta available to the many sufferers of GERD," stated Bill Reynolds , Mederi's VP of Reimbursement & Payer Strategy.



- I am surprised that SAGES is giving the Stretta procedure this kind of recommendation. Has anyone had success with the Stretta?

Post Edited (johnboy85) : 2/18/2013 10:32:48 PM (GMT-7)

Posted 2/18/2013 9:57 PM (GMT 0)
I asked this question on here myself a while back. I went to the website and it looks like there are not too many physicians trained in it, but it is definetly interesting. I am really hoping there will be insurance coverage for these less invasive procedures, I really do not want to live my life like this forever.
Posted 2/19/2013 2:19 AM (GMT 0)
Hi there.

Here is the actual SAGES link -

http://www.sages.org/publication/id/CSR1/

Keep in mind that this is just a brief discussion on Endoluminal Treatments for GERD.

In my opinion, you should stay away from the Stretta procedure as you would the plague. skull

I would also like to add the Esophyx TIF to this, as well.

Hope this helps.

Gastricman

P.S. ericapeace2000, what is the extent of your GERD? How are you living now? :)

Posted 2/19/2013 5:15 AM (GMT 0)
Summary of Recommendations

EsophyX
Long term data is not yet available for EsophyX. In short term follow-up, from 6 months to 2 years, EsophyX may be effective in patients with a hiatal hernia ? 2 cm with typical and atypical GERD. Further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety.

Quality of Evidence: (++). GRADE Recommendation: Weak

Stretta
Stretta is considered appropriate therapy for patients being treated for GERD who are 18 years of age or older, who have had symptoms of heartburn, regurgitation, or both for 6 months or more, who have been partially or completely responsive to anti-secretory pharmacologic therapy, and who have declined laparoscopic fundoplication.

Quality of Evidence: (++++). GRADE Recommendation: Strong

Post Edited (johnboy85) : 2/18/2013 10:32:07 PM (GMT-7)

Posted 2/19/2013 5:16 AM (GMT 0)
Wow the Esophyx received a terrible grade.

Here is the levels of Evidence/Definitions

Both the quality of the evidence and the strength of the recommendation for each of the guidelines were assessed according to the GRADE system. This uses a 4-tiered system for denoting the quality of evidence (very low (+), low (+ +), moderate (+ + +), or high (+ + + +)) and a 2-tiered system for strength of recommendation (weak, or strong) 1, 2.
Posted 2/19/2013 5:18 AM (GMT 0)
TIF Conclusions

The EsophyX device has been studied across a broad range of adult patient populations, and reported in one adolescent study. Numerous published series have reported significant untoward events, although the safety profile for the procedure appears to be evolving in parallel with the procedural technique. Results appear mixed with some series reporting disappointing outcomes, and others reporting promising short-term results; yet, there still is a significant gap in the literature. The majority of available literature is significantly underpowered, mostly observational studies with routinely brief follow-up periods. There has been a paucity of sham controlled trials and studies that directly compare TIF with laparoscopic anti-reflux surgery. The device has been modified through multiple revisions, and the technique of the procedure has evolved as well; long term data that will be available in the near future will most likely be based upon the first generation device and the TIF 1.0 technique. The creation of the EsophyX database and registry will aid in future research important to making more meaningful recommendations with respect to placement of TIF in the treatment of patients with GERD. Further study in the pediatric population will be necessary to consider TIF a treatment option for children.

Recommendation:
Long term data is not yet available for EsophyX. In short term follow-up, from 6 months to 2 years, EsophyX may be effective in patients with a hiatal hernia ? 2 cm with typical and atypical GERD. Further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety.
Quality of Evidence: (++). GRADE Recommendation: Weak

Post Edited (johnboy85) : 2/18/2013 10:33:26 PM (GMT-7)

Posted 2/19/2013 5:19 AM (GMT 0)
Stretta conclusions

More than 30 peer reviewed studies, including 4 adequately powered randomized, controlled studies, a comprehensive meta-analysis and multiple prospective clinical trials have documented the safety and efficacy of the Stretta procedure. Durable treatment outcomes to at least to 48 months also have been demonstrated in multiple studies, with significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores. Stretta may be recommended as an appropriate therapeutic option for patients with GERD who meet current indications and patient selection criteria and choose endoluminal therapy over laparoscopic fundoplication. Those criteria include:

Adult patients (age >=18) with symptoms of heartburn, regurgitation, or both for >= 6 months who have been partially or completely responsive to antisecretory pharmacologic therapy.

The procedure has not been studied and should not be applied in treating patients with severe esophagitis, hiatus hernias > 2 cm, long segment Barrett esophagus, dysphagia, or those with a history of autoimmune disease, collagen vascular disease, and/or coagulation disorders. Further studies are needed to evaluate the role of Stretta in children if it is to be considered a therapeutic option.

Recommendation:
Stretta is considered appropriate therapy for patients being treated for GERD who are 18 years of age or older, who have had symptoms of heartburn, regurgitation, or both for 6 months or more, who have been partially or completely responsive to anti-secretory pharmacologic therapy, and who have declined laparoscopic fundoplication.
Quality of Evidence: (++++). GRADE Recommendation: Strong

Post Edited (johnboy85) : 2/18/2013 10:33:40 PM (GMT-7)

Posted 2/19/2013 5:26 AM (GMT 0)
I am very surprised by this information; especially the quality of evidence grade given to the Stretta. I initially saw Dr. Smith at the Mayo clinic in Jacksonville to inquire about the Stretta procedure back in 2011 but he told me to hold off for the Linx.
Posted 2/19/2013 5:29 AM (GMT 0)
Looks like there are quite a few clinics offering the Stretta procedure.

www.mederitherapeutics.com/index.php?page=physician-finder
Posted 2/19/2013 8:00 PM (GMT 0)
Hi johnboy85,

I think that someone is being well compensated to give the Stretta procedure those grades. smhair

The Linx looks like the best option for those who do not wish to have an NF right now.

If it worked so well, why isn't everyone performing Stretta? It's been out for awhile.

Gastricman

Posted 2/19/2013 8:07 PM (GMT 0)
Gastric man:

MY GERD is mostly painful, I had a scope done and I had mild inflammation. But the pain is very bothersome and the diet is very restricting. I have to plan my whole life around food, especially if I have to attend a social event. My biggest complaint now (I say now because symptoms have changed) is this back pressure/pain after meals mostly. The pain is in between my shoulder blades and also into the middle of my back. I had an ultra sound of my abdomen and nothing was wrong. Chest X ray, nothing. Stomach emptying test, fine. Celiac, negative (I am on a gluten free diet as it helps). I take nexium which helps, but I still have this back pain. I also do not want to be on nexium forever either. I hope these doctors can come uip with some better alternatives.
Posted 2/19/2013 9:03 PM (GMT 0)
Hi erica,

What does your blood Ferritin level look like on the Nexium?

I had to be taken off of it since the Nexium brought it down into the single digits!

The next step "up" would be Protonix, which helped with the GERD and Ferritin.

However, I started to be very susceptible to various gastric infections and it lost it's effectiveness. So now I am on Dexilant, which is better, but not perfect. I can't even dine out unless I *know* that the food is prepared under very sanitary conditions. When I go to a restaurant, I actually make sure the the utensils are wrapped up in a napkin and glasses are clear. I totally understand what you are going through - seriously.

I am currently deciding between the Linx (not covered by my insurance) and the NF (which is.)

To be honest, it is the most difficult decision that I will have to make in my life.

The problem with treating GERD is that the LES is a sensitive, active component of your digestive system. It is not like having an apendectomy, with no future ill effects. Any way that I see it, I must go off these PPI's.

FWIW. Hope I'm not boring you. :)

Best,

Gastricman

Posted 2/20/2013 1:52 AM (GMT 0)
Just my 2 cents (without a full understanding of Stretta, I should add): It looks the return of pressure relies upon scarring post thermal injury to the LES. I am NOT a fan of injuring tissue to contract it - there will be some loss; what, I don't know.

Also, the mechanism (scarring and pullng together) seems to indicate a LAX LES as a prerequisite. For a majority of patients, LES prssures are usually normal.
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