OBJECTIVE: Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans. PATIENTS AND METHODS: A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period. RESULTS: Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report. CONCLUSION: Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.

Department of Otolaryngology Head and Neck Surgery Western University London ON Canada

Department of Otorhinolaryngology Head and Neck Surgery Asklepios Klinikum Harburg Hamburg Germany

Department of Otorhinolaryngology Head and Neck Surgery University Medicine Mannheim Mannheim Germany

LENTE Clinic Plzeň Czech Republic; Faculty of Health Studies of West Bohemia University Plzeň Czech Republic

ReVENT Medical Inc Newark CA USA

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Teschler H, Randerath W. Sleep-related breathing disorders – historical development, current status, future prospects. Pneumologie. 2010;64(9):583–589. PubMed

Green DE, Schulman DA. Obstructive sleep apnea and cardiovascular disease. Curr Treat Options Cardiovasc Med. 2010;12(4):342–354. PubMed

Peker Y, Hedner J, Kraiczi H, Loth S. Respiratory disturbance index: an independent predictor of mortality in coronary artery disease. Am J Respir Crit Care Med. 2000;162(1):81–86. PubMed

Young T, Finn L, Peppard PE, et al. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008;31(8):1071–1078. PubMed PMC

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993;328(17):1230–1235. PubMed

Jenkinson C, Davies RJ, Mullins R, Stradling JR. Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial. Lancet. 1999;353(9170):2100–2105. PubMed

Hack M, Davies RJ, Mullins R, et al. Randomised prospective parallel trial of therapeutic versus subtherapeutic nasal continuous positive airway pressure on simulated steering performance in patients with obstructive sleep apnoea. Thorax. 2000;55(3):224–231. PubMed PMC

Calhoun DA, Harding SM. Sleep and hypertension. Chest. 2010;138(2):434–443. PubMed PMC

Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010;182(2):269–277. PubMed PMC

Gottlieb DJ, Whitney CW, Bonekat WH, et al. Relation of sleepiness to respiratory disturbance index: the Sleep Heart Health Study. Am J Respir Crit Care Med. 1999;159(2):502–507. PubMed

Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005;353(19):2034–2041. PubMed

Punjabi NM, Caffo BS, Goodwin JL, et al. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med. 2009;6(8):e1000132. PubMed PMC

Ram S, Seirawan H, Kumar SK, Clark GT. Prevalence and impact of sleep disorders and sleep habits in the United States. Sleep Breath. 2010;14(1):63–70. PubMed

Kapur VK, Alfonso-Cristancho R. Just a good deal or truly a steal? Medical cost savings and the impact on the cost-effectiveness of treating sleep apnea. Sleep. 2009;32(2):135–136. PubMed PMC

Rama AN, Tekwani SH, Kushida CA. Sites of obstruction in obstructive sleep apnea. Chest. 2002;122(4):1139–1147. PubMed

Buchner NJ, Sanner BM, Borgel J, Rump LC. Continuous positive airway pressure treatment of mild to moderate obstructive sleep apnea reduces cardiovascular risk. Am J Respir Crit Care Med. 2007;176(12):1274–1280. PubMed

Grote L, Hedner J, Grunstein R, Kraiczi H. Therapy with nCPAP: incomplete elimination of sleep related breathing disorder. Eur Respir J. 2000;16(5):921–927. PubMed

Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008;5(2):173–178. PubMed PMC

Kribbs NB, Pack AI, Kline LR, et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993;147(4):887–895. PubMed

Phillips CL, Grunstein RR, Darendeliler MA, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013;187(8):879–887. PubMed

Walker-Engstrom M-L, Tegelberg A, Wilhelmsson B, Ringqvist I. 4-year follow-up of treatment with dental appliance or uvulopalatopharyngoplasty in patients with obstructive sleep apnea: a randomized study. Chest. 2002;121:739–746. PubMed

Maurer JT. Surgical treatment of obstructive sleep apnea: standard and emerging techniques. Curr Opin Pulm Med. 2010;16(6):552–558. PubMed

Kezirian EJ. Hypopharyngeal surgery in obstructive sleep apnea: an evidence-based medicine review. JAMA Otolaryngol Head Neck Surg. 2006;132(2):206–213. PubMed

Baradaranfar MH, Edalatkhah M, Dadgarnia MH, et al. The effect of uvulopalatopharyngoplasty with tonsillectomy in patients with obstructive sleep apnea. Indian J Otolaryngol Head Neck Surg. 2015;67(suppl 1):29–33. PubMed PMC

Friedman M, Schalch P, Lin HC, Kakodkar KA, Joseph NJ, Mazloom N. Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2008;138(2):209–216. PubMed

Choi JH, Kim S-N, Cho JH. Efficacy of the pillar implant in the treatment of snoring and mild-to-moderate obstructive sleep apnea: a meta-analysis. Laryngoscope. 2013;123(1):269–276. PubMed

Hamans E, Boudewyns A, Stuck BA, et al. Adjustable tongue advancement for obstructive sleep apnea: a pilot study. Ann Otol Rhinol Laryngol. 2008;117(11):815–823. PubMed

Woodson BT, Steward DL, Mickelson S, Huntley T, Goldberg A. Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2010;143(4):585–590. PubMed

van Maanen JP, Witte BI, de Vries N. Theoretical approach towards increasing effectiveness of palatal surgery in obstructive sleep apnea: role for concomitant positional therapy? Sleep Breath. 2014;18:341–349. PubMed

Tan KB, Toh ST, Guilleminault C, Holty J-EC. A cost-effectiveness analysis of surgery for middle-aged men with severe obstructive sleep apnea intolerant of CPAP. J Clin Sleep Med. 2015;11(5):525–535. PubMed PMC

Boyd SB, Walters AS, Song Y, Wang L. Comparative effectiveness of maxillomandibular advancement and uvulopalatopharyngoplasty for the treatment of moderate to severe obstructive sleep apnea. J Oral Maxillofac Surg. 2013;71(4):743–751. PubMed PMC

Handler E, Hamans E, Goldberg AN, Mickelson S. Tongue suspension: an evidence-based review and comparison to hypopharyngeal surgery for OSA. Laryngoscope. 2014;124:329–336. PubMed

Caples SM, Rowley JA, Prinsell JR, et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep. 2010;33(10):1396–1407. PubMed PMC

Baba RY, Mohan A, Metta VV, Mador MJ. Temperature controlled radiofrequency ablation at different sites for treatment of obstructive sleep apnea syndrome: a systematic review and meta-analysis. Sleep Breath. 2015;19:891–910. PubMed

Franklin KA, Anttila H, Axelsson S, et al. Effects and side-effects of surgery for snoring and obstructive sleep apnea – a systematic review. Sleep. 2009;32(1):27–36. PubMed PMC

Sundaram S, Lim J, Lasserson TJ, Bridgman SA. Surgery for obstructive sleep apnea. Cochrane Database Syst Rev. 2005;19(4):CD001004. PubMed

Pang KP, Siow JK, Tseng P. Safety of multilevel surgery in obstructive sleep apnea: a review of 487 cases. Arch Otolaryngol Head Neck Surg. 2012;138(4):353–357. PubMed

Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative complications in obstructive sleep apnea patients undergoing surgery: a review of the legal literature. Anesth Analg. 2016;122(1):145–151. PubMed

Nelson RE, Carter JM, Anand AG. Hypopharyngeal airway surgery for obstructive sleep apnea: morbidity in the early postoperative period. Otolaryngol Head Neck Surg. 2014;151(1 suppl):260–261. PubMed

Li KK, Riley RW, Powell NB, Gervacio L, Troell RJ, Minault C. Obstructive sleep apnea surgery: patient perspective and polysomnographic results. Otolaryngol Head Neck Surg. 2000;123:572–575. PubMed

Gillis E, Rampersaud C, Pease E, Buscemi P. A novel implantable device for a minimally invasive surgical treatment of obstructive sleep apnea: design and preclinical safety assessment. Nat Sci Sleep PubMed PMC

Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004;291(16):2013–2016. PubMed

Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnea. Lancet. 2014;383(9918):736–747. PubMed PMC

Blumen MB, Chalumeau F, Gauthier A, Bobin S, Coste A, Chabolle F. Comparative study of four radiofrequency generators for the treatment of snoring. Otolaryngol Head Neck Surg. 2008;138:294–299. PubMed

Bostanci A, Turhan M. A systematic review of tongue base suspension techniques as an isolated procedure or combined with uvulopalatopharyngoplasty in obstructive sleep apnea. Eur Arch Otorhinolaryngol. 2015 Oct 27; Epub. PubMed

Pavelec V, Hamans E, Stuck BA. A study of the new generation of the advance system tongue implants: three- and six-month effects of tongue to mandible tethering for obstructive sleep apnea. Laryngoscope. 2011;121:2487–2493. PubMed

Aurora RN, Casey KR, Kristo D, et al. American Academy of Sleep Medicine Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010;33(10):1408–1413. PubMed PMC

Stuck BA, Sauter A, Hormann K, Verse T, Maurer JT. Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial. Sleep. 2005;28(7):847–850. PubMed

Friedman M, Vidyasagar R, Bliznikas D, Joseph NJ. Patient selection and efficacy of pillar implant technique for treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2006;134:187–196. PubMed