Skip to main content
Top
Published in: Surgical Endoscopy 7/2017

01-07-2017

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort

Authors: Mark Noar, Patrick Squires, Sulman Khan

Published in: Surgical Endoscopy | Issue 7/2017

Login to get access

Abstract

Background

Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF.

Methods

We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements.

Results

The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p < 0.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (p < 0.001), satisfaction increased from 1 to 4 (p < 0.001), and medication score decreased from 7 to 6 (p = 0.040). Nine patients decreased medication use by half at 10 years. No significant differences existed between refractory LNF and standard refractory GERD subsets at any follow-up time point ≥6 months to 10 years (p > 0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events.

Conclusion

Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.
Literature
1.
go back to reference Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC (1996) A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 223:673–685 (discussion 685–677) CrossRefPubMedPubMedCentral Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC (1996) A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 223:673–685 (discussion 685–677) CrossRefPubMedPubMedCentral
2.
go back to reference Kelly JJ, Watson DI, Chin KF, Devitt PG, Game PA, Jamieson GG (2007) Laparoscopic Nissen fundoplication: clinical outcomes at 10 years. J Am Coll Surg 205(4):570–575CrossRefPubMed Kelly JJ, Watson DI, Chin KF, Devitt PG, Game PA, Jamieson GG (2007) Laparoscopic Nissen fundoplication: clinical outcomes at 10 years. J Am Coll Surg 205(4):570–575CrossRefPubMed
3.
go back to reference Awais O, Luketich JD, Schuchert MJ, Morse CR, Wilson J, Gooding WE, Landreneau RJ, Pennathur A (2011) Reoperative antireflux surgery for failed fundoplication: an analysis of outcomes in 275 patients. Ann Thorac Surg 92:1083–1089 (discussion 1089–1090) CrossRefPubMed Awais O, Luketich JD, Schuchert MJ, Morse CR, Wilson J, Gooding WE, Landreneau RJ, Pennathur A (2011) Reoperative antireflux surgery for failed fundoplication: an analysis of outcomes in 275 patients. Ann Thorac Surg 92:1083–1089 (discussion 1089–1090) CrossRefPubMed
4.
go back to reference Broeders JA, De Rijnhart jong HG, Draaisma WA, Bredenoord AJ, Smout AJ, Gooszen HG (2009) Ten-year outcome of laparoscopic and conventional Nissen fundoplication: randomized clinical trial. Ann Surg 250(5):698–706CrossRefPubMed Broeders JA, De Rijnhart jong HG, Draaisma WA, Bredenoord AJ, Smout AJ, Gooszen HG (2009) Ten-year outcome of laparoscopic and conventional Nissen fundoplication: randomized clinical trial. Ann Surg 250(5):698–706CrossRefPubMed
5.
go back to reference Zhou T, Harnsberger C, Broderick R, Fuchs H, Talamini M, Jacobsen G, Horgan S, Chang D, Sandler B (2015) Reoperation rates after laparoscopic fundoplication. Surg Endosc 29:510–514CrossRefPubMed Zhou T, Harnsberger C, Broderick R, Fuchs H, Talamini M, Jacobsen G, Horgan S, Chang D, Sandler B (2015) Reoperation rates after laparoscopic fundoplication. Surg Endosc 29:510–514CrossRefPubMed
6.
go back to reference Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM (2003) Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 125:668–676CrossRefPubMed Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM (2003) Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 125:668–676CrossRefPubMed
7.
go back to reference Arts J, Bisschops R, Blondeau K, Farre 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 107:222–230CrossRefPubMed Arts J, Bisschops R, Blondeau K, Farre 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 107:222–230CrossRefPubMed
8.
go back to reference Herman RM, Berho M, Murawski M, Nowakowski M, Rys J, Schwarz T, Wojtysiak D, Wexner SD (2015) Defining the histopathological changes induced by nonablative radiofrequency treatment of faecal incontinence—a blinded assessment in an animal model. Colorectal Dis 17:433–440CrossRefPubMed Herman RM, Berho M, Murawski M, Nowakowski M, Rys J, Schwarz T, Wojtysiak D, Wexner SD (2015) Defining the histopathological changes induced by nonablative radiofrequency treatment of faecal incontinence—a blinded assessment in an animal model. Colorectal Dis 17:433–440CrossRefPubMed
9.
go back to reference 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 65:361–366CrossRefPubMed 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 65:361–366CrossRefPubMed
10.
go back to reference 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 65:367–372CrossRefPubMed 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 65:367–372CrossRefPubMed
11.
go back to reference Dughera L, Rotondano G, De Cento M, Cassolino P, Cisaro F (2014) Durability of Stretta radiofrequency treatment for GERD: results of an 8-year follow-up. Gastroenterol Res Pract 2014:531907CrossRefPubMedPubMedCentral Dughera L, Rotondano G, De Cento M, Cassolino P, Cisaro F (2014) Durability of Stretta radiofrequency treatment for GERD: results of an 8-year follow-up. Gastroenterol Res Pract 2014:531907CrossRefPubMedPubMedCentral
12.
go back to reference Noar M, Squires P, Noar E, Lee M (2014) Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc 28(8):2323–2333CrossRefPubMed Noar M, Squires P, Noar E, Lee M (2014) Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc 28(8):2323–2333CrossRefPubMed
13.
go back to reference McClusky DA 3rd, Khaitan L, Swafford VA, Smith CD (2007) Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) in patients with recurrent reflux after antireflux surgery: can surgery be avoided? Surg Endosc 21:1207–1211CrossRefPubMed McClusky DA 3rd, Khaitan L, Swafford VA, Smith CD (2007) Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) in patients with recurrent reflux after antireflux surgery: can surgery be avoided? Surg Endosc 21:1207–1211CrossRefPubMed
14.
go back to reference Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20:130–134CrossRefPubMed Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20:130–134CrossRefPubMed
15.
go back to reference Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS (2002) The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the US open label trial. Gastrointest Endosc 55:149–156CrossRefPubMed Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS (2002) The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the US open label trial. Gastrointest Endosc 55:149–156CrossRefPubMed
16.
go back to reference van Beek DB, Auyang ED, Soper NJ (2011) A comprehensive review of laparoscopic redo fundoplication. Surg Endosc 25:706–712CrossRefPubMed van Beek DB, Auyang ED, Soper NJ (2011) A comprehensive review of laparoscopic redo fundoplication. Surg Endosc 25:706–712CrossRefPubMed
17.
go back to reference Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG (2008) Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg 247(1):38–42CrossRefPubMed Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG (2008) Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg 247(1):38–42CrossRefPubMed
18.
go back to reference Neuvonen P, Iivonen M, Rantanen T (2014) Endoscopic evaluation of laparoscopic Nissen fundoplication: 89 % success rate 10 years after surgery. World J Surg 38(4):882–889CrossRefPubMed Neuvonen P, Iivonen M, Rantanen T (2014) Endoscopic evaluation of laparoscopic Nissen fundoplication: 89 % success rate 10 years after surgery. World J Surg 38(4):882–889CrossRefPubMed
19.
go back to reference Cai W, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG (2008) Ten-year clinical outcome of a prospective randomized clinical trial of laparoscopic Nissen versus anterior 180(degrees) partial fundoplication. Br J Surg 95(12):1501–1505CrossRefPubMed Cai W, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG (2008) Ten-year clinical outcome of a prospective randomized clinical trial of laparoscopic Nissen versus anterior 180(degrees) partial fundoplication. Br J Surg 95(12):1501–1505CrossRefPubMed
20.
go back to reference Ruiz-tovar J, Diez-tabernilla M, Chames A, Morales V, Sanjuanbenito A, Martinez-molina E (2010) Clinical outcome at ten years after laparoscopic fundoplication: Nissen versus Toupet. Am Surg 76(12):1408–1411PubMed Ruiz-tovar J, Diez-tabernilla M, Chames A, Morales V, Sanjuanbenito A, Martinez-molina E (2010) Clinical outcome at ten years after laparoscopic fundoplication: Nissen versus Toupet. Am Surg 76(12):1408–1411PubMed
21.
go back to reference Salminen PT, Hiekkanen HI, Rantala AP, Ovaska JT (2007) Comparison of long-term outcome of laparoscopic and conventional Nissen fundoplication: a prospective randomized study with an 11-year follow-up. Ann Surg 246(2):201–206CrossRefPubMedPubMedCentral Salminen PT, Hiekkanen HI, Rantala AP, Ovaska JT (2007) Comparison of long-term outcome of laparoscopic and conventional Nissen fundoplication: a prospective randomized study with an 11-year follow-up. Ann Surg 246(2):201–206CrossRefPubMedPubMedCentral
22.
go back to reference Broeders JA, De Rijnhart jong HG, Draaisma WA, Bredenoord AJ, Smout AJ, Gooszen HG (2009) Ten-year outcome of laparoscopic and conventional Nissen fundoplication: randomized clinical trial. Ann Surg 250(5):698–706CrossRefPubMed Broeders JA, De Rijnhart jong HG, Draaisma WA, Bredenoord AJ, Smout AJ, Gooszen HG (2009) Ten-year outcome of laparoscopic and conventional Nissen fundoplication: randomized clinical trial. Ann Surg 250(5):698–706CrossRefPubMed
23.
go back to reference Yamamoto SR, Hoshino M, Nandipati KC, Lee TH, Mittal SK (2014) Long-term outcomes of reintervention for failed fundoplication: redo fundoplication versus Roux-en-Y reconstruction. Surg Endosc 28:42–48CrossRefPubMed Yamamoto SR, Hoshino M, Nandipati KC, Lee TH, Mittal SK (2014) Long-term outcomes of reintervention for failed fundoplication: redo fundoplication versus Roux-en-Y reconstruction. Surg Endosc 28:42–48CrossRefPubMed
24.
go back to reference Furnee EJ, Broeders JA, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJ, van Rijn PJ, Broeders IA (2010) Laparoscopic Nissen fundoplication after failed EsophyX fundoplication. Br J Surg 97:1051–1055CrossRefPubMed Furnee EJ, Broeders JA, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJ, van Rijn PJ, Broeders IA (2010) Laparoscopic Nissen fundoplication after failed EsophyX fundoplication. Br J Surg 97:1051–1055CrossRefPubMed
25.
go back to reference Toydemir T, Yerdel MA (2011) Laparoscopic antireflux surgery after failed endoscopic treatments for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech 21:17–19CrossRefPubMed Toydemir T, Yerdel MA (2011) Laparoscopic antireflux surgery after failed endoscopic treatments for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech 21:17–19CrossRefPubMed
26.
go back to reference Furnee EJ, Broeders JA, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJ, Broeders IA (2010) Symptomatic and objective results of laparoscopic Nissen fundoplication after failed EndoCinch gastroplication for gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol 22:1118–1122CrossRefPubMed Furnee EJ, Broeders JA, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJ, Broeders IA (2010) Symptomatic and objective results of laparoscopic Nissen fundoplication after failed EndoCinch gastroplication for gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol 22:1118–1122CrossRefPubMed
27.
go back to reference Islam S, Geiger JD, Coran AG, Teitelbaum DH (2004) Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg 39:282–286 (discussion 282–286) CrossRefPubMed Islam S, Geiger JD, Coran AG, Teitelbaum DH (2004) Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg 39:282–286 (discussion 282–286) CrossRefPubMed
28.
go back to reference Pennathur A, Awais O, Luketich JD (2010) Minimally invasive redo antireflux surgery: lessons learned. Ann Thorac Surg 89(6):S2174–S2179CrossRefPubMed Pennathur A, Awais O, Luketich JD (2010) Minimally invasive redo antireflux surgery: lessons learned. Ann Thorac Surg 89(6):S2174–S2179CrossRefPubMed
29.
go back to reference 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 24:818–825CrossRefPubMed 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 24:818–825CrossRefPubMed
Metadata
Title
Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort
Authors
Mark Noar
Patrick Squires
Sulman Khan
Publication date
01-07-2017
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 7/2017
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-016-5296-9

Other articles of this Issue 7/2017

Surgical Endoscopy 7/2017 Go to the issue