Esta revisão sistemática e a meta-análise que lhe acompanha sugerem que as técnicas cirúrgicas comparadas tiveram um efeito significativo no sentido da redução do índice de apneia e hipopneia (IAH), embora o efeito geral do tratamento tenha sido maior nos estudos de avanço maxilo-mandibular (AMM). Cabe salientar que a falta de uniformidade metodológica dos estudos não permitiu a comparação de variáveis igualmente importantes como o índice de massa corpórea, a gravidade da SAHOS, o grau de deformidade dentofacial e os níveis de saturação de oxigênio para cada uma das amostras. Assim, considerando-se a redução do IAH como único desfecho de interesse e medida de eficácia, a técnica de avanço do músculo genioglosso (AMG) parece ser menos eficaz que o AMM no tratamento de pacientes com a síndrome de apneia e hipopneia obstrutiva do sono (SAHOS).
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Fatores Avaliação Comentários Tipo de estudo
1. O estudo está descrito como ensaio clínico (randomizado ou não)? Sim Indefinido Não
Participantes
2. Os participantes têm diagnóstico de SAHOS através de exame clínico e PSG e
indicação para AMM e AMG? Sim Indefinido Não
3. Ausência de anomalias, síndromes craniofaciais ou DTM? Sim Indefinido Não
4. Os participantes têm entre 20 e 65 anos? Sim Indefinido Não subgrupos?Existem
Intervenção
5. Os participantes foram tratados com AMM ou AMG em pelo menos um dos
grupos-teste ou no grupo controle? Sim Indefinido Não
Desfecho
6. O estudo contempla os desfechos IAH (AHI ou RDI em inglês) e Saturação de
O2? Sim Indefinido Não
Decisão Final Incluir Indefinido Excluir
EFFECTIVENESS OF THE GENIOGLOSSUS MUSCLE ADVANCEMENT COMPARED TO THE MAXILLO-MANDIBULAR ADVANCEMENT IN THE TREATMENT OF THE SYNDROME OF APNEA AND OBSTRUCTIVE SLEEP APNEA
HYPOPNEA SYNDROME: A SYSTEMATIC REVIEW WITH METHANALYSIS
Djalma Carmo da Silva Júnior1 , André Luiz Oliveira Nascimento1 , Vinícius Lima de Almeida2 , Sheila Schneiberg Valença Dias3 , Luiz Renato Paranhos1,2, Paulo Henrique Luiz de Freitas1,2
Keywords: Obstructive Sleep Apnea, Genioglossus advancement, Maxillomandibular
advancement, Surgery success, Review
Corresponding author:
Paulo Henrique Luiz de Freitas, D.D.S, Ph.D. Department of Dentistry, Federal University of Sergipe at Lagarto Avenida Governador Marcelo Déda, nº 13 Centro ZIP Code 49.400-000
Lagarto – SE, Brazil Phone: +55 79 3631-4401
E-mail: paulo@bucomaxiloaracaju.com.br
ABSTRACT
The Syndrome of apnea and Obstructive sleep apnea hypopnea syndrome (OSAHS) is characterized by repeated episodes of interrupting the flow of inspired air during sleep due to the obstruction of upper airways. The criteria for the indication of surgical treatment of OSAHS, as well as the evidences about the effectiveness and safety of surgical techniques that impact the upper airways still deserve additional scientific exploration. Objective: to evaluate, through a systematic review, the effectiveness of the genioglossus advancement (GA) compared to the maxillo-mandibular advancement (MMA) in the treatment of patients with OSAHS. Method: One electronic search system was performed in the Lilacs, PubMed and SciELO databases in order to identify studies with patients undergoing surgery for GA and MMA for the treatment of OSAHS. The methodology followed the guidelines from the PRISMA statement. Results: A systematic search of the literature resulted in 889 records and six studies were included in this review. Conclusion: GA demonstrated inferior efficacy compared to the MMA, which was evidenced through the apnea-hypopnea index recorded using polysomnographys. The results of the meta-analysis show that the MMA offers superior efficacy to that of the GA in the context of the surgical treatment of OSAHS.
Descriptors: Apnea and hypopnea syndrome; surgical treatment; genioglossus advancement;
INTRODUCTION
Obstructive sleep apnea (OSA) is prevalent chronic condition marked by snoring, unrestful sleep with consequent excessive daytime sleepiness, and fatigue1 . Its serious long-term effects include neurocognitive deficit, headaches, erectile dysfunction, as well as higher morbidity and mortality rates related to cardiovascular and cerebrovascular diseases compared to the general population, not to mention the decline in the quality of life2-4 . In fact, untreated OSA patients may experience a mortality rate as high as 30% in just 15 years5 . The presence and severity of OSA is determined by means of the apnea-hyponea index calculated from polysomnography (PSG) data, which is also the primary metric to evaluate the effectiveness of therapies for OSA treatments 6 . Considering the skeletal surgical procedures used to treat moderate to severe OSA, maxillomandibular advancement (MMA) ranks among the most effective and well documented7 . Still, major surgery in the usually obese, hypertensive and dyslipidemic OSA patient8 often brings about complications such as atelectasis, pulmonary embolism, myocardial infarction, and the most feared of all - death9, 10 . Indeed, a recent study by Passeri et al11 matched OSA patients treated with MMA to patients with dentofacial deformities (DFD) who underwent similar maxillofacial procedures and found the relative risk of perioperative complications in OSA patients to be three times that of DFD patients. Fortunately and as expected, there were no deaths in either group of their cohort. Considering the above, the search for a less morbid, alternative procedure that addresses the treatment needs of OSA patients comes naturally for surgeons providing that level of care. Genioglossus advancement with hyoid myotomy (GA) has shown promising long-term results in the treatment of OSA patients, particular when regular follow-up visits with relevant weight control information are instituted12. Still, it has not been determined how GA compares to MMA in terms of surgical effectiveness for OSA treatment. To investigate how a simpler procedure such as GA would compare to the more invasive MMA, we performed a systematic review of non-randomized clinical studies, followed by a meta- analysis, which probed into each procedure’s effectiveness in terms of absolute changes in the apnea hypopnea index (AHI).
METHODS
This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement13 . Literature search An electronic search of the PubMed, SciELO and LILACS online databases was conducted from their respective dates of inception to March 2016, without language restrictions. The PICOS criteria for the study are presented in Table 1. Free text words and Medical Subject Heading terms were used. Among others, headings such as “airway obstruction”, ”sleep apnea”, “orthognathic surgery”, “maxillomandibular advancement” were combined through Boolean operators ('OR' and 'AND'). Search strategies for each database are detailed in Table 2. Clinical studies were sought that included adult patients who required GA or MMA to treat moderate to severe OSA. Hits obtained were exported to the Mendeley desktop 1.13.3 software (Mendeley Ltd., London, England) for verification of duplicity. Study selection Titles and abstracts identified were screened without time restrictions, resulting in a number of seemingly relevant studies for the systematic review. The following exclusion criteria were applied: 1) case reports, 2) technical reports, 3) animal or in vitro studies, 4) review papers, 5) studies that did not report data (mean and standard deviation) required to perform a meta-analysis for the outcome of interest, and 6) publications presenting data already published by the same research group. The authors carefully assessed the eligibility of all studies; from those included in the final analysis, the following data were extracted: authorship, year of publication, study design, sample size, mean age in years, pre- and postoperative apnea-hypopnea index (AHI), follow-up period, criteria for success and rate of surgical success. Data extraction was carried out in a standardized fashion using a protocol adapted from Parmar et al14 . Analysis of selected studies: methodological quality, meta- analysis and heterogeneity For analyzing the methodological quality of the included studies, two authors (DCSJ and ALON) independently assessed the texts through a list of questions based on the Critical Appraisal Skills Programme (CASP) for cohort studies15. A third author (PHLF) resolved any inconsistencies between the first two evaluators. The following questions were used to assess the quality of the included studies: 1) Did the study address a clearly focused issue? 2) Was the cohort or sample recruited in an acceptable way? 3) Was the outcome accurately measured to minimize bias? 4) Was the follow up of subjects complete enough? and 5) How precise are the results? Since the studies were considered similar in
Forest plots were constructed with the pre- and post-surgery mean difference with a 95% CI interval for the continuous variable AHI. The data were analyzed using the statistical software Review Manager 5.2.6 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark, 2012). The Z test was used to determine the statistical significance of the treatment effect. The Chi2 test was used to test the null hypothesis of absence of statistically significant heterogeneity. The heterogeneity index I2 was also calculated. It indicates absence of heterogeneity among the studies when close to 0%. When close to 25%, 50% and 75%, I 2 indicates low, moderate and high heterogeneity, respectively16. In addition, the Tau2 was used to test the statistical heterogeneity in spite of its low value.
RESULTS
Six studies12, 17-21 that enrolled 116 patients were identified for inclusion in the review. The search of Pubmed, LILACS and SciELO databases provided a total of 889 citations. After adjusting for duplicates 827 remained. Of these, 786 studies were discarded because after reviewing the abstracts it appeared that these papers clearly did not meet the criteria. The full text of the remaining 41 citations was examined in detail, and 35 studies did not meet the inclusion criteria as described. No “grey literature” relevant studies were obtained, nor were other papers retrieved through hand searching or checking the references of included studies. The flowchart for study selection according to the chosen criteria is presented in Figure 1.
Description of the included studies
Out of the six studies included, five were published in English and one in Portuguese. They were conducted in Italy19, Czech Republic18, Thailand12, France17, the Netherlands20, and Brazil21. All studies were published between 2003 and 2014. The summary concerning the studies and the interventions is shown in Table 3.
Clinical outcomes of the included studies
Description of the outcomes for the individual studies is presented in Table 4. While criteria for determining surgical success varied among studies, those reporting data on surgical success showed that it ranged from 70.1% to 74% for GA and 63% to 80% for MMA. Quality
recruited in an acceptable manner and had their results presented in a relatively precise manner. All studies included showed moderate quality, but none was considered as being entirely free of biases. Table 5 shows results for the quality assessment of the individual studies.
Results of the meta-analysis
Four studies17, 19-21 including 39 patients treated with MMA presented sufficient preand postoperative data on AHI (figure 2). The meta-analysis of data from these studies showed that MMA caused a statistically significant (P < 0.00001) effect on the reduction of AHI (random effect: MD = 42.91, 95% CI, 35.87-49.95). Heterogeneity among MMA studies was considered irrelevant (Tau2 = 0.0; Chi2 = 1.13, df = 3, P = 0.68; I 2 = 0%). Two studies12, 18 including 77 patients treated with GA presented sufficient pre- and postoperative data on AHI (figure 3). Data extracted from these studies was subjected to meta-analysis and revealed that GA caused a reduction of AHI (random effect: MD = 22.18, 95% CI, -0.47-44.88), but the difference did not reach statistical significance (P = 0.05). Heterogeneity among GA studies was high (Tau2 = 263.02; Chi2 = 62.9, df = 1, P < 0.00001; I 2 = 98%).
DISCUSSION
The purpose of this study was to determine whether a less invasive procedure such as advancement (GA) could be considered a similarly effective alternative to maxillomandibular advancement (MMA) for the treatment of obstructive sleep apnea (OSA). The outcome of interest of the meta-analysis - which is also the measure of effectiveness in the context of treatments for OSA6 - was the change in the apneahypopnea index (AHI). In face of the results and minding the limitations inherent to a systematic review, it appears that GA is less effective than MMA in terms of reducing AHI in OSA patients. The main difference between the two procedures is the extent of surgery: while MMA is a major operation that requires in average more than three days of hospitalization after surgery7 , GA is a relatively less invasive procedure that is associated with fewer complications and low morbidity12, 22 . Since OSA patients are often systemically compromised8 and appear to be more prone to perioperative unwanted events9-11, it is fair to say that if minor surgery could match major procedures in terms of effectiveness, expert surgeons managing OSA patients would
treatment for moderate and severe OSA7, 23. The degree of mandible advancement is the determining factor for therapeutic success, since the greater the advancement, the greater the widening of the upper airways22 . While no deaths were reported after MMA for OSA treatment and major complications were relatively uncommon7, 11, the procedure is still seen as being “highly morbid” by non-surgical physicians because the operation is lengthy and carries the risk of postoperative distress due to pharyngeal edema24. Thus, MMA – although recognized as an effective treatment – is either rarely presented as an option for OSA patients or offered only after several unsuccessful non-surgical approaches24 . On the other hand, GA is a less invasive surgical procedure marked by its low morbidity22 . The rationale for using GA as a treatment for OSA rests on the fact that anterior repositioning of the genial tubercle and genioglossus muscle stabilizes the hypopharyngeal airway, which in turn stretches the base of tongue and decreases the risk of its prolapse into the posterior airway space during sleep25 . Even when hyoid procedures are associated, operating in the anterior mandible and in the superficial neck planes seems much less of a surgical challenge than that posed by