LAS VEGAS — Not long ago, Dr. C. Daniel Smith showed a slide at an American College of Surgeons meeting that proclaimed endoluminal approaches to gastroesophageal reflux disease were “here to stay.”
A mere 2 years later, he's not so sure. “We're already reading obits for several of these procedures,” said Dr. Smith, chairman of surgery at the Mayo Clinic in Jacksonville, Fla., at the spring meeting of the ACS.
The curtain closed rapidly on several of the new stars in endoluminal GERD technology, sharply reducing the number of devices and procedures available for use in the United States.
Back in 2005, four devices had been approved and were being marketed for U.S. use and one—the Gatekeeper—appeared to be nearing Food and Drug Administration approval.
But in the interim between then and now, there have been several new developments:
▸ Medtronic Inc. withdrew its application for the Gatekeeper device because of concerns over efficacy.
▸ Boston Scientific Inc. voluntarily recalled the Enteryx liquid chemical polymer augmentation system in response to reports of serious adverse events, including deaths.
▸ Curon Medical Inc., maker of the Stretta device, declared bankruptcy, ending sales of that radiofrequency system, at least for now.
The endoluminal GERD device market now includes only the EndoCinch suturing system and the Plicator device, which uses jaws to create a “pleat” of tissue at the gastroesophageal junction.
For reasons that are both economic and practical, it would make sense to have a safe, predictable, and efficacious minimally invasive procedure for GERD, said Dr. Smith. Each year, 700,000 GERD-related endoscopies are performed and 200,000 patients are evaluated for possible antireflux surgery (although only about 70,000 patients undergo such a procedure).
But any endoluminal approach involves challenges, including the question of whether it would be reimbursed as an endoscopic procedure or as a more lucrative surgical procedure, which specialists would perform it, and whether it would prove truly efficacious in the long term.
The current state-of-the-art surgical alternative, laparoscopic Nissen fundoplication, “is a pretty good operation,” Dr. Smith said. “The gold standard … is going to have to be unseated before any of the endoluminal therapies gain acceptance.”
The EndoCinch suturing system by Bard Medical Inc., which cinches the lower esophageal sphincter, is not highly efficacious, according to Dr. Smith. Results of using the EndoCinch system at the Mayo Clinic parallel those of published studies, revealing that just 25%–38% of GERD patients are able to discontinue proton pump inhibitor (PPI) medications following the procedure.
The Plicator device from NDO Surgical Inc. has had better outcomes, with studies showing that more than half of patients can stop taking PPIs and experience significant improvements in their health-related quality of life after they have been treated with the jawlike device.
Results of Stretta trials were promising; although results were not seen after 6 months, outcomes were better at 12-month follow-up evaluations. This may be because, following the radiofrequency ablation to the deep submucosal space at the lower esophageal sphincter, collagen deposition needed time to mature.
Dr. Smith disclosed that he is on the scientific advisory committee for Endogastric Solutions Inc., manufacturer of the EsophyX device, currently available only in Europe. This device allows the operator to isolate the distal esophagus with suction.
The EsophyX then is advanced into the stomach, where it partially retroflexes to allow placement of fasteners around the circumference of the esophagus.
In one study of 84 patients treated using the EsophyX, 77 were no longer taking PPI medications 3 months after the procedure, he said.