Effectiveness of barbed repositioning pharyngoplasty for the treatment of obstructive sleep apnea (OSA): a prospective r

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ENT • ORIGINAL ARTICLE

Effectiveness of barbed repositioning pharyngoplasty for the treatment of obstructive sleep apnea (OSA): a prospective randomized trial Claudio Vicini 1,2 & Giuseppe Meccariello 1 & Filippo Montevecchi 1 & Andrea De Vito 1 & Sabrina Frassineti 1 & Riccardo Gobbi 1 & Stefano Pelucchi 2 & Giannicola Iannella 3 & Giuseppe Magliulo 3 & Giovanni Cammaroto 1,4 Received: 13 January 2019 / Revised: 7 October 2019 / Accepted: 9 October 2019 # Springer Nature Switzerland AG 2019

Abstract Purpose The aim of our randomized clinical trial is to produce stronger evidence supporting barbed repositioning pharyngoplasty (BRP) as a therapeutic option for the treatment of obstructive sleep apnea (OSA). Methods The trial was a single-center prospective controlled trial with two parallel arms (group A: BRP; group B: observation) and randomization. Baseline and 6-month polygraphy evaluating the apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS) were performed. To test the differences among groups of Student’s t test, the role of each factor (univariate analysis) and their independent effect (multivariate analysis) was explored using logistic regression model as appropriate. Linear regression was also conducted. Results A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group. BRP showed to be more effective than observation. Logistic regression showed that preoperative AHI is related significantly to postoperative AHI within the BRP group. A linear regression showed that higher baseline AHI predicts more significant postoperative absolute AHI reduction. Conclusions BRP appears to be a promising technique and might be included within the surgical armamentarium of a sleep surgeon. Patients affected by severe OSA may benefit from this surgery with more significant reduction of AHI values. Keywords Barbed repositioning pharyngoplasty . OSA . Sleep surgery . OSAS . Outcome

Introduction Obstructive sleep apnea (OSA) is a frequent sleep disorder affecting a significant number of patients with a consistent psychological and physiological impact. The prevalence of individuals with an apnea-hypopnea index (AHI) ≥ 5 stands around 9–38%, being higher in males [1].

* Giovanni Cammaroto [email protected] 1

Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy

2

Unit of Otolaryngology, University of Ferrara, Ferrara, Italy

3

Unit of Otolaryngology, La Sapienza University, Rome, Italy

4

Unit of Otolaryngology, University of Messina, Messina, Italy

OSA has been strongly associated to several neurobehavioral conditions and to certain cardiopulmonary pathologies, such as stroke and cardiac ischemia, which might potentially reduce patients’ survival [2]. Continuous positive airway pressure (CPAP) is still considered the most efficient therapy for OSA. However, a significant number of patients seem not able to tolerate CPAP masks and high air pressure ventilation and therefore requires other forms