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Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years

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Abstract

Background

Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE.

Methods

Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis).

Results

TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year.

Conclusion

TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases.

ClinicalTrials.Gov

ID: NCT03669874.

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Abbreviations

CI:

Confidence intervals

CT:

Computed tomography

DCI:

Distal contractile integral

GERD:

Gastro-esophageal reflux disease

GI:

Gastrointestinal

HRM:

High-resolution manometry

HRQL:

Health-related quality of life

ITT:

Intention to treat

LES:

Lower esophageal sphincter

MUSE:

Medigus ultrasonic surgical endostapler

NERD:

Non-erosive reflux disease

PEEP:

Positive end-expiratory pressure

PP:

Per protocol

PPI:

Proton pump inhibitor

RSI:

Reflux symptom index

TIF:

Transoral incisionless fundoplication

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Authors and Affiliations

  1. Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy

    Sabrina Gloria Giulia Testoni, Maria Bernadette Cilona, Lorella Fanti, Emanuela Ribichini, Giulia Martina Cavestro, Dario Esposito, Edi Viale, Chiara Notaristefano, Raffaella Alessia Zuppardo, Francesco Azzolini, Sandro Passaretti & Pier Alberto Testoni

  2. Division of Gastrointestinal Endoscopy, Treviglio-Caravaggio Hospital, ASST Bergamo Ovest, Treviglio, Italy

    Giorgia Mazzoleni

Authors
  1. Sabrina Gloria Giulia Testoni
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  2. Maria Bernadette Cilona
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  3. Giorgia Mazzoleni
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  4. Lorella Fanti
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  11. Francesco Azzolini
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Contributions

SGGT drafted the manuscript, performed statistical analysis, followed the endoscopic case series, and collected the endoscopic data; MBC clinically followed the patients and collected the clinical data; GM, ER, and SP performed functional analysis; GM clinically followed the patients and collected clinical and functional data; SP performed statistical analysis; LF and FA assisted in transoral incisionless fundoplication procedures; GMC, DE, EV, CN, and RAZ performed endoscopic controls; PAT designed the study protocol, performed transoral incisionless fundoplication procedures, provided scientific guidance, and supervised the scientific work.

Corresponding author

Correspondence to Pier Alberto Testoni.

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Disclosures

Sabrina Gloria Giulia Testoni, Maria Bernadette Cilona, Giorgia Mazzoleni, Lorella Fanti, Emanuela Ribichini, Giulia Martina Cavestro, Dario Esposito, Edi Viale, Chiara Notaristefano, Raffaella Alessia Zuppardo, Francesco Azzolini, Sandro Passaretti, and Pier Alberto Testoni have no conflict of interest or financial ties to disclose. All authors revised and approved the final version of this article.

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Testoni, S.G.G., Cilona, M.B., Mazzoleni, G. et al. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc 36, 5023–5031 (2022). https://doi.org/10.1007/s00464-021-08860-w

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