Upper respiratory tract surgical techniques for the treatment of patients with obstructive Sleep Apnea Syndrome

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A; ROMANO, M

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Obstructive Sleep Apnea Syndrome (OSAS) involves the onset of recurrent episodes in which air flow is limited during sleep as a consequence of an anatomic-functional alteration in the upper respiratory tract which produces its collapse, thus causing oxygen-hemoglobin dessaturation and micro-arousals which cause poor sleep, excessive day somnolence, neuropsychiatric, respiratory and cardiac disorders. It affects between 4-6% of men and 2-4% of women in the general adult middle age population. First line treatment for patients with moderate to severe OSAS is continuous positive airway pressure (CPAP), generally associated with changes in behavior, sleep hygiene (avoid supine-decubitus position and benzodiazepines), tobacco smoking and alcohol consumption quitting, weight loss and other specific therapies, such as mandibular advancement device use and upper respiratory tract surgery. Long-term patient compliance to CPAP therapy is poor , consequently other therapeutic alternatives such as upper respiratory tract surgery for patients who can not tolerate CPAP are proposed.TechnologyAmong the upper respiratory tract surgical techniques are uvulopalatopharyngoplasty (UPPP), uvulopatoplasty (UPP), laser-assisted uvulopalatopharyngoplasty (LAUP) and radiofrequency palate ablation (RFA). The purpose of UPPP is to reduce redundant tissue in the oropharynx (soft palate and tonsil pillars). When the pharynx is not operated on, the procedure is called UPP. LAUP and RFA are variations of UPPP which use a laser device or radiofrequency, respectively, instead of a scalpel.PurposeTo assess the available evidence on the efficacy, safety and coverage policy related aspect on the use of uvulopalatopharyngoplasty, uvulopatoplasty, laser-assisted uvulopalatopharyngoplasty and radiofrequency palate ablation for patients with OSAS.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems.ResultsTwo systematic reviews (SR), 4 clinical practice guidelines (CPG), 5 health technology evaluations and 8 coverage policies were selected.One SR published in 2009, evaluated surgical techniques for OSAS or snoring. It included four RCTs about the benefits, two with LAUP (74 patients) and two with RFA (86 patients) and 45 studies for the adverse effects (from 16 to 3,130 patients, mostly retrospective studies and case series). No significant differences were found when day somnolence and quality of life were evaluated between the surgical and control groups. The sleep Apnea-hypopnea Index (AHI) and snoring decreased in a clinical trial after LAUP, but no in the other study. Persistent post-surgical adverse effects were observed in approximately half of the patients; being the most common difficulty to swallow, changes in sensitivity and voice.The other SR included for UPPP intervention, 15 studies (n=950 patients), two of which were RCTs (n=70). Patient follow-up was between 3 months and 1 year and different diagnostic devices were used for follow-up. A 33% overall decrease was observed in the AHI (95% CI: 23% to 42%) although residual post-surgical AHI was still severe (it decreased from a mean of 40.3/hour to 29.8/hour). One of the results included reported 1-2% serious adverse effects and 0.2% post-surgical mortality. For LAUP intervention, 2 RCTs (n=70) and 6 observational studies were included which showed a 32% reduction in AHI; it went down from a mean of 18.6/h (pre-surgery) to 14.7/h post-LAUP. This is statistically significant, but of little clinical impact. For RFA, 1 RCT and 6 observational studies were included with a total of 175 patients. No valid conclusions could be drawn due to the poor quality of the studies.The CPGs recommend CPAP as first line treatment for the patients that can not tolerate UPPP and RFA could be an alternative. LAUP is not recommended.The health technology assessments consulted highlight that there is not enough evidence to assess the efficacy of the surgical interventions for OSAS treatment.In the 8 U.S. coverage policies consulted, there is consensus to cover UPPP for patients with OSAS diagnosis with poor CPAP compliance. LAUP and RFA are not covered.ConclusionsThe evidence found is of moderate quality. Based on 2 SR, which included a few number of randomized trials with few patients and the observational studies with heterogeneous interventions and results about the usefulness of the different surgical techniques (UPPP, UPP, LAUP and RFA), no benefit was observed on long-term mortality and other clinically relevant results. The benefits found are slight to moderate in interim results with a questionable clinical impact. It is also important to highlight that the adverse effects persist in more than half of the patients who underwent surgery. Therefore, there is not enough evidence to recommend these interventions as routine to improve day somnolence and quality of life in patients with OSAS.The CPGs and coverage policies consider UPPP use in patients with OSAS diagnosis and upper respiratory tract obstruction who can not tolerate or have poor compliance with CPAP.