Skip to main content

Advertisement

SpringerLink
Log in

Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Background

Patients with gastroesophageal reflux disease (GERD) often seek alternative therapy for inadequate symptom control, with over 40 % not responding to medical treatment. We evaluated the long-term safety, efficacy, and durability of response to radiofrequency treatment of the lower esophageal sphincter (Stretta).

Methods

Using an intent-to-treat analysis, we prospectively assessed 217 patients with medically refractory GERD before and after Stretta. There was no concurrent control group in the study. Primary outcome measure was normalization of GERD-health-related quality of life (GERD-HRQL) in 70 % or greater of patients at 10 years. Secondary outcomes were 50 % reduction or elimination of proton pump inhibitors (PPIs) and 60 % or greater improvement in satisfaction at 10 years. Successful treatment was defined as achievement of secondary outcomes in a minimum of 50 % of patients. Complications and effect on existing comorbidities were evaluated. The results of a 10-year study are reported.

Results

The primary outcome was achieved in 72 % of patients (95 % confidence interval 65–79). For secondary outcomes, a 50 % or greater reduction in PPI use occurred in 64 % of patients, (41 % eliminating PPIs entirely), and a 60 % or greater increase in satisfaction occurred in 54 % of patients. Both secondary endpoints were achieved. The most common side effect was short-term chest pain (50 %). Pre-existing Barrett’s metaplasia regressed in 85 % of biopsied patients. No cases of esophageal cancer occurred.

Conclusions

In this single-group evaluation of 217 patients before and after Stretta, GERD-HRQL scores, satisfaction, and PPI use significantly improved and results were immediate and durable at 10 years.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Wiklund I (2004) Review of the quality of life and burden of illness in gastroesophageal reflux disease. Dig Dis 22:108–114

    Article  PubMed  Google Scholar 

  2. Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ (2012) Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology 143:1179–1187

    Article  PubMed Central  PubMed  Google Scholar 

  3. Miwa H, Kondo T, Oshima T, Fukui H, Tomita T, Watari J (2010) Esophageal sensation and esophageal hypersensitivity—overview from bench to bedside. J Neurogastroenterol Motil 16:353–362

    Article  PubMed Central  PubMed  Google Scholar 

  4. Livstone EM, Sheahan DG, Behar J (1977) Studies of esophageal epithelial cell proliferation in patients with reflux esophagitis. Gastroenterology 73:1315–1319

    CAS  PubMed  Google Scholar 

  5. Harnett KM, Rieder F, Behar J, Biancani P (2010) Viewpoints on acid-induced inflammatory mediators in esophageal mucosa. J Neurogastroenterol Motil 16:374–388

    Article  PubMed Central  PubMed  Google Scholar 

  6. Souza RF, Huo X, Mittal V, Schuler CM, Carmack SW, Zhang HY, Zhang X, Yu C, Hormi-Carver K, Genta RM, Spechler SJ (2009) Gastroesophageal reflux might cause esophagitis through cytokine-mediated mechanism rather than caustic acid injury. Gastroenterology 137:1776–1784

    Article  CAS  PubMed  Google Scholar 

  7. Yiangou Y, Facer P, Dyer NH, Chan CL, Knowles C, Williams NS, Anand P (2001) Vanilloid receptor 1 immunoreactivity in inflamed human bowel. Lancet 357:1338–1339

    Article  CAS  PubMed  Google Scholar 

  8. Veronesi B, Carter JD, Devlin RB, Simon SA, Oortgiesen M (1999) Neuropeptides and capsaicin stimulate the release of inflammatory cytokines in a human bronchial epithelial cell line. Neuropeptides 33:447–456

    Article  CAS  PubMed  Google Scholar 

  9. Cheng L, Cao W, Behar J, Fiocchi C, Biancani P, Harnett KM (2006) Acid-induced release of platelet-activating factor by human esophageal mucosa induces inflammatory mediators in circular smooth muscle. J Pharmacol Exp Ther 319:117–126

    Article  CAS  PubMed  Google Scholar 

  10. Sampliner RE (1999) A population prevalence of Barrett’s esophagus: finally. Gastroenterology 116:277–285

    Article  Google Scholar 

  11. Hvid-Jensen F, Pedersen L, Drewes AM, Sorensen HT, Funch-Jensen P (2011) Incidence of adenocarcinoma among patients with Barrett’s esophagus. N Engl J Med 365:1375–1383

    Article  CAS  PubMed  Google Scholar 

  12. Kahrilas PJ (2011) The problems with surveillance of Barrett’s esophagus. N Engl J Med 365:1437–1438

    Article  CAS  PubMed  Google Scholar 

  13. Metz DC (2004) Managing gastroesophageal reflux disease for the lifetime of the patient: evaluating the long-term options. Am J Med 117(suppl 5A):49S–55S

    PubMed  Google Scholar 

  14. Chiba N, De Gara CJ, Wilkinson JM et al (1997) Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta analysis. Gastroenterology 112:1798–1810

    Article  CAS  PubMed  Google Scholar 

  15. Ali T, Roberts DN, Tierney WM (2009) Long-term safety concerns with proton pump inhibitors. Am J Med 122(10):896–903

    Article  CAS  PubMed  Google Scholar 

  16. Girgis CM, Sher D, Seibel MJ (2010) Atypical femoral fractures and bisphosphonate use. N Engl J Med 362:1848–1849

    Article  CAS  PubMed  Google Scholar 

  17. Aguirre C, Egurbide MV (2009) Gastroesophageal reflux disease. N Engl J Med 360:729

    Article  CAS  PubMed  Google Scholar 

  18. Heidelbaugh JJ, Goldberg KL, Inadomi JM (2009) Adverse risks associated with proton pump inhibitors. Gastroenterol Hepatol 5(10):725–734

    Google Scholar 

  19. Ghebremariam YT, Lependu P, Lee JC et al (2013) Unexpected effect of proton pump inhibitors: elevation of the cardiovascular risk factor asymmetric dimethylarginine. Circulation 128(8):845–853

    Article  CAS  PubMed  Google Scholar 

  20. Dean BB, Aguilar D, Crawley JA, Dubois RW (2003) Impact of gastroesophageal reflux disease on worker productivity in an employed U.S. population. Gastroenterology 124(4 Suppl 1):A505

    Article  Google Scholar 

  21. Crawley JA, Hamelin B, Gallagher E (2000) How satisfied are chronic heartburn sufferers with the results they get from prescription strength heartburn medication? Gastroenterology 118(4 Pt 1):A210

    Article  Google Scholar 

  22. Spechler SJ, Lee E, Ahnen D et al (2001) Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 285:2331–2338

    Article  CAS  PubMed  Google Scholar 

  23. Mahmood Z, McMahon BP, Arfin Q, Byrne PJ, Reynolds JV, Murphy EM, Weir DG (2003) Endocinch therapy for gastrooesophageal reflux disease: a 1 year prospective follow up. Gut 52:34–39

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  24. Deviere J, Costamagna G, Neuhaus H, Voderholzer W, Louis H, Tringali A, Marchese M, Fiedler T, Darb-Esfahani P, Schumacher B (2005) Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multi-center trial. Gastroenterology 128:532–540

    Article  PubMed  Google Scholar 

  25. Fockens P, Bruno MJ, Gabbrielli A, Odegaard S, Hatlebakk J, Allescher HD, Rosch T, Rhodes M, Bastid C, Rey J, Boyer J, Muehldorffer S, van den Hombergh U, Costamagna G (2004) Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the gatekeeper reflux repair system. Endoscopy 36:682–689

    Article  CAS  PubMed  Google Scholar 

  26. Donahue PE, Carvalho P, Yoshida J, Miidla I, Shen YJ, Bombeck CT, Nyhus LM (1989) Endoscopic sclerosis of the cardia affects gastroesophageal reflux. Surg Endosc 3(1):11–12

    Article  CAS  PubMed  Google Scholar 

  27. O’Connor KW, Lehman GA (1988) Endoscopic placement of collagen at the lower esophageal sphincter to inhibit gastroesophageal reflux: a pilot study of 10 medically intractable patients. Gastrointest Endosc 34:106–112

    Article  PubMed  Google Scholar 

  28. Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH (2002) The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the US open label trial. Gastrointest Endosc 55(2):149–156

    Article  PubMed  Google Scholar 

  29. Cadiere GB, Buset M, Muls V et al (2008) Antireflux trabsoral incisionless fundoplication using Esophyx: 12-month results of a prospective multicenter study. World J Surg 32:1676–1688

    Article  PubMed Central  PubMed  Google Scholar 

  30. Bonavina L, DeMeester TR, Ganz RA (2012) LINX Reflux Management System: magnetic sphincter augmentation in the treatment of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol 6:667–674

    Article  CAS  PubMed  Google Scholar 

  31. Rodríguez L, Rodriguez P, Gómez B, Ayala JC, Saba J, Perez-Castilla A, Galvao Neto M, Crowell MD (2012) Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial. Surg Endosc Surg Endosc 27(4):1083–1092

    Article  Google Scholar 

  32. Falk GW, Fennerty MB, Rothstein RI (2006) AGA Institute technical review on the use of endoscopic therapy for gastrooesophageal reflux disease. Gastroenterology 131:1315–1336

    Article  PubMed  Google Scholar 

  33. Fry LC, Mönkemüller K, Malfertheiner P (2007) Systematic review: endoluminal therapy for gastrooesophageal reflux disease: evidence from clinical trials. Eur J Gastroenterol Hepatol 19:1125–1139

    Article  PubMed  Google Scholar 

  34. Chen D, Barber C, McLoughlin P, Thavaneswaran P, Jamieson GG, Maddern GJ (2009) Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg 96:128–136

    Article  CAS  PubMed  Google Scholar 

  35. Corley DA, Katz P, Wo J, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM (2003) Temperature controlled radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD (the Stretta procedure): a randomized, double-blind, sham controlled, multi-center clinical trial. Gastroenterology 125:668–676

    Article  PubMed  Google Scholar 

  36. Arts J, Bisschops R, Blondeau K, Farré R, Vos R, Holvoet L, Caenepeel P, Lerut A, Tack J (2012) A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD. Am J Gastroenterol 107(2):222–230

    Article  CAS  PubMed  Google Scholar 

  37. Triadafilopoulos G (2004) Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc 18:1038–1044

    Article  CAS  PubMed  Google Scholar 

  38. Aziz AM, El-Khayat HR, Sadek A, Mattar SG, McNulty G, Kongkam P, Guda MF, Lehman GA (2010) A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease. Surg Endosc 24(4):818–825

    Article  PubMed  Google Scholar 

  39. Perry KA, Banerjee A, Melvin WS (2012) Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech 22(4):283–288

    Article  PubMed  Google Scholar 

  40. Noar MD, Lotfi-Emran S (2007) Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc 65:367–372

    Article  PubMed  Google Scholar 

  41. Velanovich V (1999) Comparison of symptomatic and quality of life outcomes of laparoscopic versus open antireflux surgery. Surgery 126:782–789

    Article  CAS  PubMed  Google Scholar 

  42. Velanovich V (1998) Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL), quality-of-life scales for gastroesophageal reflux disease. J Gastrointest Surg 2:141–145

    Article  CAS  PubMed  Google Scholar 

  43. Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20:130–134

    Article  CAS  PubMed  Google Scholar 

  44. Utley DS (2003) The Stretta procedure: device, technique, and pre-clinical study data. Gastrointest Endosc Clin North Am 13:135–145

    Article  Google Scholar 

  45. Reymunde A, Santiago N (2007) Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc 65:361–366

    Article  PubMed  Google Scholar 

  46. Dughera L, Navino M, Cassolino P, De Cento M, Cacciotella L, Cisarò F, Chiaverina M (2011) Long-term results of radiofrequency energy delivery for the treatment of GERD: results of a prospective 48-month study. Diagn Ther Endosc 2011:507157

    Article  PubMed Central  PubMed  Google Scholar 

  47. Fass R, Shapiro M, Dekel R, Sewell J (2005) Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease where next? Aliment Pharmacol Ther 22(2):79–94

    Article  CAS  PubMed  Google Scholar 

  48. Fass R (2012) Alternative therapeutic approaches to chronic proton pump inhibitor treatment. Clin Gastroenterol Hepatol 10(4):338–345

    Article  CAS  PubMed  Google Scholar 

  49. Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW (2003) Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg 237(5):638–647

    PubMed Central  PubMed  Google Scholar 

  50. Hunter JG, Smith CD, Branum GD, Waring JP, Trus TL, Cornwell M, Galloway K (1999) Laparoscopic fundoplication failures: patterns of failure and response to fundoplication revision. Ann Surg 230:595–606

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  51. Soper NJ, Dunnegan D (1999) Anatomic fundoplication failure after laparoscopic antireflux surgery. Ann Surg 229:669–677

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  52. Dent J, Dodds WJ, Friedman RH, Sekiguchi T, Hogan WJ, Arndorfer RC, Petrie DJ (1980) Mechanism of gastroesophageal reflux in recumbent asymptomatic human subjects. J Clin Invest 65:256–267

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  53. Chan CL, Facer P, Davis JB, Smith GD, Egerton J, Bountra C, Williams NS, Anand P (2003) Sensory fibres expressing capsaicin receptor TRPV1 in patients with rectal hypersensitivity and faecal urgency. Lancet 361:385–391

    Article  CAS  PubMed  Google Scholar 

  54. Matthews PJ, Aziz Q, Facer P, Davis JB, Thompson DG, Anand P (2004) Increased capsaicin receptor TRPV1 nerve fibres in the inflamed human oesophagus. Eur J Gastroenterol Hepatol 16:897–902

    Article  CAS  PubMed  Google Scholar 

  55. Guarino MP, Cheng L, Ma J, Harnett K, Biancani P, Altomare A, Panzera F, Behar J, Cicala M (2010) Increased TRPV1 gene expression in esophageal mucosa of patients with non-erosive and erosive reflux disease. Neurogastroenterol Motil 22(746–751):e219

    Google Scholar 

  56. Cao W, Cheng L, Behar J, Fiocchi C, Biancani P, Harnett KM (2004) Proinflammatory cytokines alter/reduce esophageal circular muscle contraction in experimental cat esophagitis. Am J Physiol Gastrointest Liver Physiol 287:G1131–G1139

    Article  CAS  PubMed  Google Scholar 

  57. Cheng L, Cao W, Fiocchi C, Behar J, Biancani P, Harnett KM (2005) In vitro model of acute esophagitis in the cat. Am J Physiol Gastrointest Liver Physiol 289:G860–G869

    Article  CAS  PubMed  Google Scholar 

  58. Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ (2002) Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut 50:451–459

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  59. Isomoto H, Wang A, Mizuta Y, Akazawa Y, Ohba K, Omagari K, Miyazaki M, Murase K, Hayashi T, Inoue K, Murata I, Kohno S (2003) Elevated levels of chemokines in esophageal mucosa of patients with reflux esophagitis. Am J Gastroenterol 98:551–556

    Article  CAS  PubMed  Google Scholar 

  60. Yoshida N, Uchiyama K, Kuroda M, Sakuma K, Kokura S, Ichikawa H, Naito Y, Takemura T, Yoshikawa T, Okanoue T (2004) Interleukin-8 expression in the esophageal mucosa of patients with gastroesophageal reflux disease. Scand J Gastroenterol 39:816–822

    Article  CAS  PubMed  Google Scholar 

  61. Wardlaw AJ, Moqbel R, Cromwell O, Kay AB (1986) Platelet-activating factor. A potent chemotactic and chemokinetic factor for human eosinophils. J Clin Invest 78:1701–1706

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  62. Tam WC, Schoeman MN, Zhang Q, Dent J, Rigda R, Utley D, Holloway RH (2003) Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease. Gut 52(4):479–485

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  63. Herman R, Berho M, Murawski M, Nowakowski M, Rys J, Schwarz T, Wojtysiak D, Herman RB, Wexner SD (2013) Non-ablative radiofrequency (RF) application to smooth muscle of internal anal sphincter (IAS): a tissue study. Surg Endosc 27:S305

    Article  Google Scholar 

  64. Go MR, Dundon JM, Karlowicz DJ, Domingo CB, Muscarella P, Melvin WS (2004) Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery 136:786–794

    Article  PubMed  Google Scholar 

  65. Arts J, Sifrim D, Rutgeerts P, Lerut A, Janssens J, Tack J (2007) Influence of radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) on symptoms, acid exposure, and esophageal sensitivity to acid perfusion in gastroesophagal reflux disease. Dig Dis Sci 52(9):2170–2177

    Article  CAS  PubMed  Google Scholar 

  66. Utley DS, Kim M, Vierra MA, Triadafilopoulos G (2000) Augmentation of lower esophageal sphincter pressure and gastric yield pressure after radiofrequency energy delivery to the gastroesophageal junction: a porcine model. Gastrointest Endosc 52(1):81–86

    Article  CAS  PubMed  Google Scholar 

  67. Noar MD, Noar E (2008) Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction. Surg Endosc 22(11):2440–2444

    Article  PubMed  Google Scholar 

  68. Noar MD, Xu L, Koch KL (2003) Effect of radiofrequency ablation on gastric dysrhythmias in patients with gastroesophageal reflux disease (GERD) and functional dyspepsia. Gastroenterology 124(4 Suppl 1):A98

    Article  Google Scholar 

  69. Kahrilas P (2003) Radiofrequency energy treatment of GERD. Gastroenterology 125:970–973

    Article  PubMed  Google Scholar 

  70. Louis H (2013) Endoscopic full-thickness plication for the treatment of GERD: is there a future? Gastrointest Endosc 77(1):15–17

    Article  PubMed  Google Scholar 

  71. Coron E, Sebille V, Cadiot G, Zerbib F, Ducrotte P, Ducrot F, Pouderoux P, Arts J, Le Rhun M, Piche T, Bruley des Varannes S, Galmiche JP (2008) Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro–oesophageal reflux disease patients. Aliment Pharmacol Ther 28(9):1147–1158

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

This work was supported by an unrestricted grant from the Digestive Health Education Foundation (DHEF00036).

Disclosure

M. D. Noar has served as a member of the clinical advisory board and has received honoraria for speaking and training for Mederi Therapeutics Inc., and has no other conflicts of interest or financial ties to disclose. P. J. Squires, E. N. Noar, and M. L. Lee have no conflicts of interest or financial ties to disclose.

Author information

Authors and Affiliations

  1. Heartburn & Reflux Study Center, Endoscopic Microsurgery Associates PA, 7402 York Road 100, Towson, MD, 21204, USA

    Mark Noar

  2. School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA

    Patrick Squires

  3. School of Medicine, Tulane University, 1430 Tulane Ave, New Orleans, LA, 70118, USA

    Emmanuelle Noar

  4. School of Public Health, UCLA, 640 Charles E Young Dr S, Los Angeles, CA, 90095, USA

    Martin Lee

Authors
  1. Mark Noar
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Patrick Squires
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Emmanuelle Noar
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Martin Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mark Noar.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Noar, M., Squires, P., Noar, E. et al. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc 28, 2323–2333 (2014). https://doi.org/10.1007/s00464-014-3461-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-014-3461-6

Keywords

Search

Navigation