The Laryngoscope V C 2012 The American Laryngological, Rhinological and Otological Society, Inc. Four-Year Outcomes of Palatal Implants for Primary Snoring Treatment: A Prospective Longitudinal Study Brian W. Rotenberg, MD, MPH; Kimberly Luu, BASc Objectives/Hypothesis: The objective of this study was to evaluate the long-term effectiveness of palatal implants as the treatment of primary snoring. Study Design: Prospective longitudinal cohort study. Methods: This study compared snoring outcomes before and after soft palate implantation for patients diagnosed with primary snoring (no sleep apnea). Snoring severity was obtained by the subjects’ sleep partners on a 10-point Likert scale. A paired Student t test compared the mean scale values preoperatively at week 52 and at the current 4-year follow-up. Body mass index for each patient was also compared to evaluate for any significant confounders. Results: Data were obtained from 23 patients out of 26 who were followed for the full study term. The follow-up time was on average 4 years following palatal implantation. A statistically (P < .016) and clinically significant improvement in the snoring scale was noted when comparing snoring severity between the preoperative and 4-year period and between the 52- week and 4-year scores. Although statistically significant improvement was found between the preoperative period and 52 weeks, there was a clinical deterioration in snoring scale scores between 52 weeks and 4 years. The mean (standard devia- tion) preoperative score was 9.5 (0.5), mean week-52 score was 5.0 (1.6), and mean 4-year score was 7.0 (1.8). Body mass index did not change through the observation interval. Conclusions: Soft palate implantation is a possible surgical technique with which to attempt to achieve subjective improvement of primary snoring severity. Subjective improvement, however, deteriorates significantly over time, and is only minimally sustained at 4 years postoperatively. This study provides new information on long-term palatal implant effectiveness. Key Words: Snoring, sleep apnea, palate implant, palatoplasty, evidence based medicine. Level of Evidence: 2b. Laryngoscope, 122:696–699, 2012 INTRODUCTION Primary snoring, defined as snoring without sleep- disordered breathing, affects over 20% of the popula- tion. 1,2 Snoring can cause severe social embarrassment and sleep-partner discord, and frequently leads patients to seek treatment from healthcare professionals. The sound of snoring is created by vibrating structures in the upper airway (most commonly the soft palate), there- fore treatment focuses on reducing these vibrations. The ideal treatment would maximally alleviate the social dis- turbances of snoring while minimizing risk and harm to the patient. Noninvasive techniques, such as lifestyle modification or the use of oral devices to manipulate the position of the mandible, have demonstrated modest suc- cess. 3,4 Continuous positive airway pressure (CPAP) is highly effective, however the intrusiveness of treatment makes users hesitate to adopt it, and those who do so purely for snoring have a generally poor adherence rate. 5,6 Operative procedures such as uvulopalatophar- yngoplasty (UPPP) are associated with higher risk and pain. 7,8 Thus, there currently is no optimal treatment for primary snoring that can achieve long-term effective- ness while being minimally invasive. Palatal implants (Pillar System; Xomed-Medtronic, Jacksonville, FL) work by inducing fibrosis and scarring through the introduction of a foreign body to the soft palate. This scarring is theorized to stiffen the palate, decreasing palatal flutter and thus snoring. 9,10 Initial effectiveness of the implants has been demonstrated in several studies as measured in patient quality-of-life ques- tionnaires, apnea-hypopnea (AHI) scores, snoring sounds per hour, or sleep-partner rating. However, all of these studies demonstrated only short-term effectiveness, up to a maximum of 18 months following implantation in one study, with the remainder being of far shorter duration (<1 year). 11–15 Prospective long-term outcome data are thus lacking from the literature, and without such data it is not possible to counsel patients regarding the proce- dure’s anticipated success rates. The purpose of this study was therefore to evaluate the multiyear effectiveness of palatal implants as the treatment of primary snoring. MATERIALS AND METHODS The study was designed as a prospective longitudinal study. The study was approved by the research ethics board at From the Department of Otolaryngology–Head and Neck Surgery, University of Western Ontario, London, Ontario, Canada. Editor’s Note: This Manuscript was accepted for publication November 22, 2011. The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Brian W. Rotenberg, MD, 268 Grosvenor St., London, Ontario, Canada N6A 4V2. E-mail: brian.rotenberg@sjhc.london.on.ca DOI: 10.1002/lary.22510 Laryngoscope 122: March 2012 Rotenberg and Luu: Long-Term Outcome of Implants for Snoring 696