Abstract
Background and purpose
Management of severe obstructive sleep apnea-hypopnea syndrome (OSAHS) is challenging and needs multidisciplinary cooperation. Ventilation is considered the gold standard of treatment in severe OSAHS. The aim of the study was to compare the therapeutical efficacy of a type of surgery (maxillomandibular advancement [MMA]) vs a ventilatory treatment modality (autotitrating positive airway pressure [APAP]).
Materials and methods
At the ENT Department of Forlì Hospital (University of Pavia), in strict cooperation with the Sleep Lab of the University of Bologna, a prospective randomized controlled trial was designed and performed. After fully informing them, 50 consecutive patients who have severe OSAHS were enrolled and randomized into a conservative (APAP) or surgical (MMA) section. Demographic, biometric, polysomnogram (PSG) and Epworth Sleepiness Scale profiles of the 2 groups were statistically not significantly different.
Results
One year after surgery or continuous APAP treatment, both groups showed a remarkable improvement of mean Apnea-Hypopnea Index (AHI) and Epworth Sleepiness Scale levels; the degree of improvement was not statistically different.
Conclusions
Given the relatively small sample of subjects studied and the relatively brief follow-up, MMA proved to be a valuable alternative therapeutical tool in our adult and severe OSAHS patient group, with a success rate not inferior to APAP.
1
Introduction
Sleep-disordered breathing (SDB) is a very common but greatly underestimated disorder. Between 2% and 4% of the adult population have significant obstructive sleep apnea-hypopnea syndrome (OSAHS) . Its prevalence may have increased along with the widespread and increasing obesity ‘epidemic’ . The impact of SDB on general health conditions may be impressive, and unfortunately, it is not completely understood. The consequences of SDB during the day are wide ranging and include excessive sleepiness, impaired cognitive performance, disturbed mood, and reduced quality of life . Furthermore, OSAHS is an independent factor for hypertension , myocardial infarction , and stroke . There is a clear, although not automatic, correlation between OSAHS severity, cardiovascular, and neurocognitive complications. From a therapeutical point of view, there are many options for patients with OSAHS. Continuous positive airway pressure (CPAP) via a nasal mask is considered the mainstay for treatment in moderate to severe Obstructive Sleep Apnea Syndrome (OSAS) . The Cochrane approach could demonstrate strong evidence of efficacy for this device. Unfortunately, some patients do not accept this treatment, it appears to be poorly tolerated in quite a number of subjects, and their compliance is especially important in long-term treatment, which must be accurately evaluated with an interview as well as with CPAP smart card analysis. Recent reports confirm that autotitrating positive airway pressure (APAP) is as effective as CPAP in OSAHS patient management . Among the alternative options proposed in the literature, surgery is a long-time acknowledged solution. To date, however, there is no clear scientific evidence that surgery can be considered a really effective option in OSAHS management. The results of the Cochrane review about the role of surgery in OSAHS management are poor, even if there were some important results when compared with sham surgery, but this effect proved to be inconsistent . Moreover, the efficacy of surgery seems to be inversely related to the severity of OSAHS, and for this reason, it is not recommendable for AHI values greater than 30. So far, the role of surgery in the treatment of OSAHS and the relative effectiveness of different interventions are controversial and not proven in a strictly scientific way. To date, there is no randomized controlled prospective study comparing the most effective procedure in the surgical area (maxillomandibular advancement [MMA]) and positive pressure ventilation. Based on this assumption, we have designed a randomized prospective study comparing MMA and a ventilatory device (APAP) to understand the real effectiveness of surgery.
2
Materials and methods
Fifty patients with PSG classified as severe OSAHS (AHI >30) were prospectively enrolled in a randomized trial that was previously approved by the Local Board of Ethics. A schematic diagram of the study design is given in Fig. 1 . Tables 1 and 2 list all the single cases, with their respective biometric, PSG and Epworth Sleepiness Scale (ESS) parameters, and their sex and age. All the patients were informed of the study, and they gave their consent. Blinding was not possible with this study design. All the patients were studied by means of analysis of level 3 unattended sleep study, both pre- and postoperative/APAP, according to the Associazione Italiana di Medicina del Sonno—Italian Association of Sleep Medicine (AIMS) Guidelines for the selection of PSG Studies . The unattended study was carried out with the use of a POLIMESAM DEVICE. Oral and nasal airflow, chest and abdominal wall movement, oxygen saturation, patient position, and electrocardiogram, as well as snoring and leg movements, were registered at home. The same doctor (S.F.), specially trained in Sleep Medicine (Fellowship in Sleep Medicine, Sleep Lab of the Neurological Clinic of Bologna University) evaluated all the pre- and posttreatment PSG recordings. Inclusion criteria included the presence of severe OSAHS (AHI >30), regardless of body mass index (BMI; which was usually abnormally high) and no formal contraindication for surgery according to the Stanford protocol (preexisting local and general medical conditions that could increase the risk of surgery or might compromise the final outcome, fear of surgery, concern over pain and discomfort, loss of work or income during convalescence, advancing age) and no formal contraindication for APAP Chronic Obstructive Pulmonary Disease (COPD), heart dysrhythmia, heart failure, restrictive lung disease, neuromuscular disease, previous surgery for SDB). The study was carried out at the Department of Special Surgery, ENT and Oral Surgery Unit, Morgagni-Pierantoni Hospital, University of Pavia in Forlì, Italy. All but 6 of the patients in the present study were referred from the Sleep Lab of the University Neurological Clinic of Bologna.
| Patient | Age | Sex | BMI | AHI pre | AHI post | ESS pre | ESS post | Satisfaction ⁎ |
|---|---|---|---|---|---|---|---|---|
| 1 | 54 | F | 31.1 | 45 | 1 | 5 | 5 | 90 |
| 2 | 47 | M | 33.6 | 69 | 10 | 5 | 5 | 100 |
| 3 | 38 | M | 28 | 38 | 2 | 8 | 8 | 100 |
| 4 | 39 | M | 33.2 | 71 | 1 | 12 | 7 | 100 |
| 5 | 56 | M | 32.1 | 59 | 14 | 14 | 10 | 85 |
| 6 | 65 | M | 31 | 80 | 10 | 15 | 8 | 95 |
| 7 | 45 | M | 27.4 | 50 | 0 | 11 | 8 | 100 |
| 8 | 59 | F | 31.6 | 62 | 8 | 10 | 8 | 100 |
| 9 | 61 | M | 29 | 58 | 5 | 12 | 9 | 95 |
| 10 | 40 | M | 38 | 55 | 9 | 12 | 7 | 90 |
| 11 | 43 | M | 34.1 | 55 | 2 | 15 | 8 | 100 |
| 12 | 53 | M | 28 | 53 | 12 | 12 | 8 | 100 |
| 13 | 67 | M | 47.5 | 36 | 2 | 15 | 8 | 100 |
| 14 | 47 | M | 26.7 | 31 | 2 | 11 | 7 | 100 |
| 15 | 45 | M | 36 | 75 | 8 | 14 | 7 | 100 |
| 16 | 55 | M | 31 | 46 | 9 | 12 | 8 | 90 |
| 17 | 54 | M | 31.6 | 50 | 6 | 12 | 8 | 75 |
| 18 | 33 | M | 31.1 | 71 | 1 | 12 | 5 | 100 |
| 19 | 50 | M | 28 | 67 | 22 | 15 | 8 | 100 |
| 20 | 34 | M | 47.7 | 68 | 4 | 14 | 8 | 100 |
| 21 | 51 | M | 37.1 | 62 | 23 | 12 | 7 | 90 |
| 22 | 40 | M | 28.7 | 87 | 8 | 11 | 8 | 95 |
| 23 | 53 | M | 38.5 | 61 | 5 | 14 | 8 | 100 |
| 24 | 44 | M | 23 | 31 | 18 | 7 | 11 | 95 |
| 25 | 54 | M | 33.1 | 64 | 22 | 11 | 8 | 60 |
| Patient | Age | Sex | BMI | AHI pre | AHI post | ESS pre | ESS post | Satisfaction ⁎ |
|---|---|---|---|---|---|---|---|---|
| 1 | 62 | M | 25.5 | 34 | 4 | 11 | 6 | 90 |
| 2 | 53 | F | 31.25 | 58 | 5 | 7 | 6 | 80 |
| 3 | 52 | F | 34.7 | 65 | 5 | 16 | 7 | 95 |
| 4 | 37 | M | 28.9 | 45 | 9 | 9 | 7 | 90 |
| 5 | 42 | M | 29.9 | 60 | 9 | 12 | 6 | 90 |
| 6 | 39 | M | 33.2 | 71 | 7 | 12 | 7 | 30 |
| 7 | 45 | M | 38.1 | 62 | 4.5 | 12 | 5 | 100 |
| 8 | 50 | F | 30.4 | 43 | 9 | 10 | 4 | 100 |
| 9 | 56 | M | 26.5 | 56 | 6 | 6 | 6 | 80 |
| 10 | 39 | M | 25.3 | 60 | 9 | 11 | 7 | 80 |
| 11 | 38 | M | 28.2 | 47 | 9 | 13 | 5 | 70 |
| 12 | 51 | M | 29.6 | 44 | 6 | 8 | 7 | 90 |
| 13 | 48 | M | 30.3 | 55 | 3 | 11 | 3 | 90 |
| 14 | 51 | M | 28.8 | 30 | 6 | 9 | 9 | 70 |
| 15 | 42 | M | 28.3 | 42 | 6 | 10 | 4 | 90 |
| 16 | 33 | M | 31.1 | 71 | 7 | 12 | 5 | 40 |
| 17 | 76 | M | 32.7 | 35 | 7 | 13 | 7 | 100 |
| 18 | 68 | M | 27.2 | 45 | 2 | 11 | 7 | 100 |
| 19 | 34 | M | 47.7 | 68 | 5 | 14 | 8 | 30 |
| 20 | 44 | F | 28.4 | 35 | 6 | 13 | 6 | 80 |
| 21 | 53 | F | 27.3 | 56 | 7 | 8 | 6 | 80 |
| 22 | 63 | M | 26.9 | 40 | 9 | 12 | 3 | 90 |
| 23 | 39 | M | 29 | 60 | 7 | 18 | 4 | 100 |
| 24 | 54 | M | 29.0 | 41 | 5 | 10 | 8 | 80 |
| 25 | 48 | M | 27.9 | 36 | 6 | 12 | 4 | 95 |
2.1
Outcome assessment
Measurable parameters considered in this study included severity of OSAHS after the treatment (as measured by AHI), assessment of posttreatment daytime sleepiness (using the ESS) , and degree of subjective overall satisfaction (using a visual analogical scale [VAS], 0%–100%). Reduction and possible normalization of AHI and ESS were considered primary outcomes. As a secondary outcome, we evaluated the degree of subjective satisfaction. The type and rate of all the complications encountered in the 2 groups were also reported and analyzed.
2.2
Treatment
Irrespective of the randomization result, all patients were previously informed of all the alternative medical and/or surgical therapies available.
2.2.1
MMA group treatment protocol
All the surgical procedures were performed under general anesthesia after routine fiberoptic orotracheal intubation. Temporary tracheotomy was routinely carried out to avoid possible episodes of dyspnea in the first 24 to 48 hours after surgery and to facilitate the possibility of having to suction mucous secretion. As a first step, a sagittal split ramus mandibulae osteotomy according to Obwegeser-Dal Pont was performed with a powered reciprocating saw and a Lindemann cutting burr (in the ramus inner cortex area). The fixed amount of advancement, 11 mm for all the cases, was checked by means of a customized intermediated splint. To stabilize the achieved advancement, we inserted 3 to 4 bicortical screws. In 3 cases, a titanium plate was added on each side to improve stabilization. As a second step, a low Le Fort I maxillary osteotomy was carried out step by step using a powered reciprocating saw and different kinds of special osteotomes. The final position of the maxilla was stabilized by 4 titanium screwed plates. The surgical team leader for all the procedures was always the same (C.V.), assisted by 2 surgeons. All the patients were postoperatively managed in the ENT ward with continuous monitoring of pulse rate, blood pressure, and p o 2 during the first 24 hours. Elastomeric release of morphine hydrochloride was the routine choice for pain relief. The rigid intermaxillary fixation was removed after 24 hours, and oral intake of food was immediately encouraged. The tracheotomy was removed usually on the fourth/fifth day. Discharge was possible within 1 week for all the patients.
2.2.2
The APAP group treatment protocol
The patients enrolled in the conservative section of the present study were submitted to automatic APAP application (Vivisol SOMNO smart2, BREAS, MedicAir) with a nasal mask, held in position with an elastic headgear and attached to a flow generator by elephant tubing. The APAPs were administered according to the AIMS-AIPO guidelines (Commissione AIPO-AIMS, 2001) . This APAP is able to detect 3 different parameters for pressure autotitration: (1) forced oscillation, (2) flow limitation, (3) snoring. The patients were requested to continue using the Auto-CPAP only after a successful test period, usually 1 week, checked by interview and smart card evaluation (the smart card records the true time of utilization and different operative parameters). We routinely recalled all the patients every 3 weeks to check the effectiveness and the use of the Auto-CPAP. A complete smart card check was scheduled after an interval of 2 months. Patient counseling and management were both handled by the same physician (A.D.V.), specifically trained in Sleep Medicine (Fellowship in Sleep Medicine, Sleep Lab of University of Bologna).
2.3
Statistical analysis
A Mann-Whitney test was used to compare the difference between preoperative and postoperative AHI and ESS mean scores within the 2 groups. The test was also used to determine if there were any differences between the 2 treatment groups with respect to age, preoperative weight, AHI, and ESS.
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