Artikel
The ReVENT Medical Sleep Apnea System for treatment of persistent tongue base obstruction after previous surgeries. A pilot study
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Autoren
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Thomas Verse
- Asklepios Klinik Harburg, Hamburg, Germany
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Stefan Wenzel
- Asklepios Klinik Harburg, Hamburg, Germany
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Ed Gillis
- ReVent Medical, Newark, United States
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Johannes Brus
- Asklepios Klinik Harburg, Hamburg, Germany
| Veröffentlicht: | 24. Juli 2014 |
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Gliederung
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Introduction: Tongue base obstruction in patients with obstructive sleep apnea (OSA) is usually treated be invasive surgical techniques like hyoid suspension, or laser-assisted resection of lingual tonsils.These surgeries produce significant morbidity within the first days after surgery.
The ReVent system consists of silicone tongue implants, that are held in an extended shape by bioabsorbable polymer coils. 4 implants are implanted via a single small submental skin incision. The ReVent implants have a loop on each end of the implant. During the healing process, scar tissue grows into the loops fixing the end of the implant to the surrounding tongue tissue.
After 4–6 weeks post implantation, the bioabsorbable polymer coils resorb. This allows the implants to contract about one third of their original length to support and stabilize the tongue in order to prevent apneas.
A first study using two implants in the tongue and two in the soft palate in 40 patients showed significantly reduced postoperative morbidity as compared to other surgeries.
The aim of this study was to assess patient`s morbidity after implantation of 4 ReVent implants into the tongue.
Methods: All together 7 patients (AHI= 38,8±26,6) with persistent tongue base obstruction after previous multi-level surgery were included. All patients received 4 implants placed in their tongue.
One day one after surgery a flexible nasopharyngoscopy was performed. On day 10 an MRI scan was done to evaluate implant placement. Postoperative pain was recorded for 10 days using a visual analogue scale (0–10).
Results: The duration of surgery ranged from 20 to 43 minutes. There were no severe or persisting complications or adverse events. In total two implants were removed due to exposure into the hypopharynx at day one post surgery. Pain-levels averaged 4.1 on day 1, falling to to 2.0 on day 6 and to 1.2 on day 10. All patients were satisfied with the subjective outcome of their ReVent treatment.
Conclusion: The implantation of 4 ReVent implants into the tongue is safe and easy to perform. The postoperative morbidity observed was much lower compared to other tongue surgeries. Sleep studies are being performed to evaluate objective success in terms of AHI.
