Hi all,
It's a question of quality vs. quantity when it comes to Surgeons performing the Linx procedure.
Some are great and experienced while others are just beginning and see it as a potential cash cow. I know that Torax is trying hard to bring the Linx to as many doctors as possible in order to increase their revenue. However, you also have to look at studies and read the threads in this forum of people that have had the Linx performed. Esophyx TIF was oringinally pitched like this and now it is basically in the garbage can.
Don't get me wrong. I have been a real fanboy of the Linx since it's inception, but I temper my enthusiasm with an abundance of caution. We need more long term data that is not planned and paid for by Torax Medical.
Most insurance carriers won't pay for the Linx procedure either.
Look in this GERD - Heartburn thread for other peoples experiences with the Linx procedure and think about it.
I feel that this would really help in making the best decision.
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The following is from The New England Journal of Medicine, dated February 21, 2013. Paid for by Torax Medical.
Due to restrictions, I cannot display more than this. Hope that you understand. Sorry.
Discussion:
The barrier function of the lower esophageal sphincter depends, in part, on its ability to resist effacement and opening when challenged by gastric distention. Failure to do so results in episodes of gastric juice refluxing into the esophagus, which can injure the esophageal mucosa and underlying muscle, causing permanent damage to the sphincter and leading to further loss of barrier function. Therefore, reducing esophageal exposure to gastric juice is an important goal of antireflux treatment. If reflux is not reduced, symptoms or mucosal injury often persist. Samelson et al. found that a loose ligature placed around the lower esophageal sphincter prevented the sphincter from yielding when challenged by gastric distention. The expandable magnetic device for augmentation of the sphincter builds on this observation by providing greater control of resistance to sphincter effacement and opening than is provided by previous devices, allowing expansion for the passage of food, belching, or vomiting.
Numerous studies have shown that reflux symptoms persist in up to 40% of patients who receive therapy with proton-pump inhibitors and that these symptoms have a negative effect on both quality of life and health care utilization. The results of the current study show that after magnetic sphincter augmentation, quality-of-life scores significantly improved, as compared with preoperative scores without or with proton-pump inhibitors. At 3 years, 87% of patients (72 of 83 patients) had completely eliminated the use of proton-pump inhibitors. These results suggest that sphincter augmentation may be helpful for patients with a partial response to proton-pump inhibitors.
The significant reduction in exposure to esophageal acid provides quantitative evidence that magnetic sphincter augmentation improves the ability of the sphincter to resist the reflux of gastric juice into the esophagus and is associated with sustained control of heartburn and regurgitation. The sustained control of regurgitation implies control of both acid and nonacid reflux. The procedure preserved the ability to belch and vomit in most patients. These outcomes were similar in academic centers and community centers, suggesting that the technique of implanting the device can be standardized. Although these findings are encouraging, we recognize that they are preliminary, given the small study population and the 3-year follow-up.
It has long been recognized that surgical alteration of the lower esophageal sphincter by means of fundoplication may result in dysphagia. Dysphagia also occurs after magnetic sphincter augmentation. In both situations, the postoperative dysphagia is most commonly mild to moderate and resolves with time. Our findings suggest that the risk of dysphagia and need for esophageal dilation after sphincter augmentation is similar to the risk after fundoplication. Most of the patients in our study who underwent dilation had improvement. We speculate that dilation disrupts scarring by actuating the beads, resulting in reduced dysphagia. After sphincter augmentation in this study, persistent dysphagia that led to the removal of the device developed in 3% of patients. This rate of persistent dysphagia is similar to that observed in the pilot study and in registries in the United States and Europe. Removal of the device was required in six patients within 21 days to 2.9 years after placement. The possibility of easy removal of the device after a longer interval is unknown.
The placement of a foreign body around a mobile muscular tube such as the esophagus raises concern about erosion and hence the safety of the device. The current study, along with the previously published pilot trial and the commercial registries in the United States and Europe, brings the worldwide clinical experience to 497 magnetic implants, with a median implant duration of 2.9 years. To date, no erosions or migrations have been reported. The risk over a longer period of follow-up is not known. The continued collection of data from the present study, existing registries, and current clinical use will allow assessment of the long-term risk of erosion.
The current study was designed so that the direct effects of the sphincter augmentation device on each patient's exposure to esophageal acid, use of proton-pump inhibitors, and symptom control could be measured before and after the implantation. This design is limited in that it does not allow direct comparisons with other forms of therapy. Prospective, randomized trials with appropriate controls are needed.
In conclusion, this single-group trial showed that a magnetic device designed to augment the lower esophageal sphincter can be implanted with the use of standard laparoscopic techniques. The device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients. Studies with larger samples and longer-term follow-up are needed to confirm these early results and assess longer-term safety.
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I just wanted to bring balance to the entire issue. Hope this helps.
Be well,
Gastricman 