Effect of electrical stimulation therapy of the lower esophageal sphincter in GERD patients with ineffective esophageal motility

Matthias Paireder, Ivan Kristo, Reza Asari, Gerd Jomrich, Johannes Steindl, Erwin Rieder, Sebastian F Schoppmann, Matthias Paireder, Ivan Kristo, Reza Asari, Gerd Jomrich, Johannes Steindl, Erwin Rieder, Sebastian F Schoppmann

Abstract

Background: Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) is a novel technique in antireflux surgery. Due to the minimal alteration at the LES during surgery, LES-EST is meant to be ideal for patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM). The aim of this prospective trial (NCT03476265) is to evaluate health-related quality of life and esophageal acid exposure after LES-EST in patients with GERD and IEM.

Methods: This is a prospective non-randomized open-label study. Patients with GERD and IEM undergoing LES-EST were included. Follow-up (FUP) at 12 months after surgery included health-related quality of life (HRQL) assessment with standardized questionnaires (GERD-HRQL) and esophageal functional testing.

Results: According to the study protocol, 17 patients fulfilled eligibility criteria. HRQL score for heartburn and regurgitation improved from 21 (interquartile range (IQR) 15-27) to 7.5 (1.25-19), p = 0.001 and from 17 (11-23.5) to 4 (0-12), p = 0.003, respectively. There was neither significant improvement of esophageal acid exposure nor reduction of number of reflux events in pH impedance measurement. Distal contractile integral improved from 64 (11.5-301) to 115 (IQR 10-363) mmHg s cm, p = 0.249. None of the patients showed any sign of dysphagia after LES-EST. One patient needed re-do surgery and re-implantation of the LES-EST due to breaking of the lead after one year.

Conclusion: Although patient satisfaction improved significantly after surgery, this study fails to demonstrate normalization or significant improvement of acid exposure in the distal esophagus after LES-EST.

Keywords: Electrical stimulation therapy; Gastro esophageal reflux disease; Ineffective esophageal motility; Lower esophageal sphincter.

Conflict of interest statement

Drs. Matthias Paireder, Ivan Kristo, Reza Asari, Gerd Jomrich, Johannes Steindl, Erwin Rieder, and Sebastian F. Schoppmann have no conflicts of interest or financial ties to disclose. All authors meet the criteria for authorship as set forth in the Consensus Statement on Journal Authorship. Potential conflicts of interest or financial ties are stated further below. Sebastian Schoppmann received an unrestricted research grant from EndoStim.

© 2020. The Author(s).

Figures

Fig. 1
Fig. 1
Change in median (interquartile range—IQR) GERD health-related quality of life (HRQL) composite score. P = 0.003 versus baseline and 12-month follow-up
Fig. 2
Fig. 2
Change in median (interquartile range—IQR) GERD health-related quality of life (HRQL) heartburn score. P = 0.001 versus baseline and 12-month follow-up
Fig. 3
Fig. 3
Change in median (interquartile range—IQR) GERD health-related quality of life (HRQL) regurgitation score. P = 0.003 versus baseline and 12-month follow-up
Fig. 4
Fig. 4
Median (interquartile range – IQR) % of time 24-h distal esophageal pH at baseline and 12-month follow-up
Fig. 5
Fig. 5
Median (interquartile range – IQR) lower esophageal sphincter (LES) resting pressure at baseline and 12-month follow-up
Fig. 6
Fig. 6
Median (interquartile range – IQR) distal contractile integral (DCI) at baseline and 12-month follow-up

References

    1. Pauwels A, Boecxstaens V, Andrews CN, Attwood SE, Berrisford R, Bisschops R, Boeckxstaens GE, Bor S, Bredenoord AJ, Cicala M, Corsetti M, Fornari F, Gyawali CP, Hatlebakk J, Johnson SB, Lerut T, Lundell L, Mattioli S, Miwa H, Nafteux P, Omari T, Pandolfino J, Penagini R, Rice TW, Roelandt P, Rommel N, Savarino V, Sifrim D, Suzuki H, Tutuian R, Vanuytsel T, Vela MF, Watson DI, Zerbib F, Tack J. How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery) Gut. 2019;68(11):1928–1941. doi: 10.1136/gutjnl-2019-318260.
    1. Schwameis K, Oh D, Green KM, Lin B, Zehetner J, Lipham JC, Hagen JA, DeMeester SR. Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn. Dis Esophagus. 2020 doi: 10.1093/dote/doz099.
    1. Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE, International High Resolution Manometry Working G (2015) The Chicago classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil 27(2):160–174.
    1. Kristo I, Schwameis K, Paireder M, Jomrich G, Kainz A, Schoppmann SF. Dysphagia severity is related to the amplitude of distal contractile integral in patients with Jackhammer esophagus. Neurogastroenterol Motil. 2018;30(5):e13276. doi: 10.1111/nmo.13276.
    1. Pandolfino JE, Fox MR, Bredenoord AJ, Kahrilas PJ. High-resolution manometry in clinical practice: utilizing pressure topography to classify oesophageal motility abnormalities. Neurogastroenterol Motil. 2009;21(8):796–806. doi: 10.1111/j.1365-2982.2009.01311.x.
    1. Gyawali CP, Sifrim D, Carlson DA, Hawn M, Katzka DA, Pandolfino JE, Penagini R, Roman S, Savarino E, Tatum R, Vaezi M, Clarke JO, Triadafilopoulos G. Ineffective esophageal motility: Concepts, future directions, and conclusions from the Stanford 2018 symposium. Neurogastroenterol Motil. 2019;31(9):e13584. doi: 10.1111/nmo.13584.
    1. Hiestand M, Abdel Jalil A, Castell DO. Manometric subtypes of ineffective esophageal motility. Clin Transl Gastroenterol. 2017;8(3):e78. doi: 10.1038/ctg.2017.4.
    1. Novitsky YW, Wong J, Kercher KW, Litwin DE, Swanstrom LL, Heniford BT. Severely disordered esophageal peristalsis is not a contraindication to laparoscopic Nissen fundoplication. Surg Endosc. 2007;21(6):950–954. doi: 10.1007/s00464-006-9126-3.
    1. Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Saba J, Perez-Castilla A, Galvao Neto M, Crowell MD. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial. Surg Endosc. 2013;27(4):1083–1092. doi: 10.1007/s00464-012-2561-4.
    1. Rodriguez L, Rodriguez P, Neto MG, Ayala JC, Saba J, Berel D, Conklin J, Soffer E (2012) Short-term electrical stimulation of the lower esophageal sphincter increases sphincter pressure in patients with gastroesophageal reflux disease. Neurogastroenterol Motil 24(5):446–450, e213.
    1. Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Oxenberg D, Perez-Castilla A, Netto MG, Soffer E, Boscardin WJ, Crowell MD. Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease. Surgery. 2015;157(3):556–567. doi: 10.1016/j.surg.2014.10.012.
    1. Paireder M, Kristo I, Asari R, Jomrich G, Steindl J, Rieder E, Schoppmann SF. Electrical lower esophageal sphincter augmentation in patients with GERD and severe ineffective esophageal motility-a safety and efficacy study. Surg Endosc. 2019;33(11):3623–3628. doi: 10.1007/s00464-018-06649-y.
    1. 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(2):141–145
    1. Mellow MH, Pinkas H. Endoscopic therapy for esophageal carcinoma with Nd:YAG laser: prospective evaluation of efficacy, complications, and survival. Gastrointest Endosc. 1984;30(6):334–339. doi: 10.1016/S0016-5107(84)72448-5.
    1. Beecher HK. The powerful placebo. J Am Med Assoc. 1955;159(17):1602–1606. doi: 10.1001/jama.1955.02960340022006.
    1. Walach H, Sadaghiani C, Dehm C, Bierman D. The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials–a secondary analysis. BMC Med Res Methodol. 2005;5:26. doi: 10.1186/1471-2288-5-26.
    1. Kienle GS, Kiene H. The powerful placebo effect: fact or fiction? J Clin Epidemiol. 1997;50(12):1311–1318. doi: 10.1016/S0895-4356(97)00203-5.
    1. Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, Brindley D, Savulescu J, Beard DJ, Carr AJ. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348:g3253. doi: 10.1136/bmj.g3253.
    1. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ. 1995;311(7004):551–553. doi: 10.1136/bmj.311.7004.551.
    1. Dao HV, Matsumura T, Kaneko T, Takahashi S, Tokunaga M, Oura H, Ishikawa K, Akizue N, Kikuchi A, Fujie M, Saito K, Okimoto K, Maruoka D, Nakagawa T, Arai M, Kato J, Kato N. Impact of ineffective esophageal motility on chemical clearance in patients with gastroesophageal reflux symptoms. Dis Esophagus. 2020 doi: 10.1093/dote/doaa026.
    1. Oleynikov D, Eubanks TR, Oelschlager BK, Pellegrini CA. Total fundoplication is the operation of choice for patients with gastroesophageal reflux and defective peristalsis. Surg Endosc. 2002;16(6):909–913. doi: 10.1007/s00464-001-8327-z.
    1. Zhang X, Geboes K, Depoortere I, Tack J, Janssens J, Sifrim D. Effect of repeated cycles of acute esophagitis and healing on esophageal peristalsis, tone, and length. Am J Physiol Gastrointest Liver Physiol. 2005;288(6):G1339–1346. doi: 10.1152/ajpgi.00492.2004.
    1. Liebermann-Meffert D, Klaus D, Vosmeer S, Allgower M. Effect of intraesophageal bile and acid (HCl) perfusion on the action of the lower esophageal sphincter. Scand J Gastroenterol Suppl. 1984;92:237–241.
    1. Mello MD, Shriver AR, Li Y, Patel A, Gyawali CP. Ineffective esophageal motility phenotypes following fundoplication in gastroesophageal reflux disease. Neurogastroenterol Motil. 2016;28(2):292–298. doi: 10.1111/nmo.12728.
    1. Kapadia S, Osler T, Lee A, Borrazzo E. The role of preoperative high resolution manometry in predicting dysphagia after laparoscopic Nissen fundoplication. Surg Endosc. 2018;32(5):2365–2372. doi: 10.1007/s00464-017-5932-z.
    1. Furnee EJ, Draaisma WA, Gooszen HG, Hazebroek EJ, Smout AJ, Broeders IA. Tailored or routine addition of an antireflux fundoplication in laparoscopic large hiatal hernia repair: a comparative cohort study. World J Surg. 2011;35(1):78–84. doi: 10.1007/s00268-010-0814-8.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅