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85th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery

German Society of Oto-Rhino-Laryngology, Head and Neck Surgery

28.05. - 01.06.2014, Dortmund

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The ReVent Medical Sleep Apnoea System for the treatment of obstructive sleep apnea (OSA): a feasibility study

Meeting Abstract

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  • corresponding author presenting/speaker Stefan Wenzel - Asklepios Klinik Harburg, Abt. HNO und KHC, Hamburg, Germany
  • author Thomas Verse - Asklepios Klinik Harburg, Abt. HNO und KHC, Hamburg, Germany
  • Ed Gillis - ReVent Medical, Inc., Cupertino, United States
  • Joachim Maurer - Universitäts HNO-Klinik Mannheim, Mannheim, Germany
  • Václav Pavelec - Chotoviny Klinik, Pilsen, Czech Republic
  • Brian Rotenberg - Department of Otolaryngology-Head and Neck Surgery, University of Western Ontario, London, Canada

German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. 85th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. Dortmund, 28.05.-01.06.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. Doc14hno20

doi: 10.3205/14hno20, urn:nbn:de:0183-14hno202

Published: July 24, 2014

© 2014 Wenzel et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Introduction: The ReVent system consists of implants that are implanted into the soft palate and the base of tongue in general anaestesia. After 4-6 weeks of healing the implants contract by resorption of the surrounding coiled mantle. Thus a collaps during sleep is to be avoided. The aim of this study is to determine the safety and efficacy of the ReVent system in treatment of OSA.

Patients and methods: 40 patients with OSA (AHI 15–40 in a polysomnography), BMI <32, age <65 years, CPAP incompliance and performed preoperative sleep induced endoscopy were provided each with two implants in the soft palate and the base of tongue. After a follow-up of 3-6 month polysomnographic data, data from the FOSQ-questionaire and from the Epworth sleepiness Scale (ESS), the length of surgery and postoperative pain-level were collected.

Results: 38 appeared to the 6-month foolw-up. The average length of surgery was 37 minutes. The FOSQ score increased from 15.7 to 17.8 (p=0.04) and the ESS decreased from 12.1 to 7.3 (p=0.08). In patients where the implants could be placed in a optimal manner (n=18) the median AHI decreased from 28.2 to 13.5. The surgical success rate (Sher) was 63%. Postoperative problems of speaking, swollowing or other complications were not observed.

Conclusion: The Implantation of each two implants into the soft palate and the base of tongue is a safe procedure and easy to perform. The first results are promising. The ReVent system has the potential of increasing the efficacy with a low morbidity by optimizing the implant position.