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* From the Sleep Disorders Center, Pulmonary and Critical Care Medicine Service, Virginia Mason Medical Center, Seattle, WA.
Correspondence to: Daniel I. Loube, MD, FCCP, Medical Director, Sleep Disorders Center (H10-SDC), Virginia Mason Medical Center, P.O. Box 1930, 925 Seneca St, Seattle, WA 98111; e-mail: sdcdil{at}vmmc.org
Abstract
Among adult patients with obstructive sleep apnea syndrome (OSAS), adherence to continuous positive airway pressure (CPAP) treatment is approximately 40%, according to recent well-designed studies that evaluated outcomes other than adherence as a primary end point. This finding suggests the need for the improvement of the adult OSAS treatment approach, either by improving adherence to CPAP treatment or by developing effective alternatives to CPAP. Technologic advances have allowed for the development of new treatments for OSAS that include automatic CPAP and innovative airway procedures. Studies evaluating the application of these new technologies are reviewed. These technologic advances can be viewed as possible improvements over the existing treatment approach only if the risks and benefits of each new treatment are well understood by OSAS patients and their physicians.
Key Words: automatic continuous positive airway pressure hypoglossal nerve stimulator obstructive sleep apnea syndrome upper airway resistance syndrome uvulopalatopharyngoplasty
The prevalence of obstructive sleep apnea syndrome OSAS) in the United States is 2 to 4% in middle-aged adults,1 which is similar in magnitude to the prevalence of some diseases considered to be major public health issues, such as diabetes mellitus or asthma. Preliminary studies suggest an association between untreated OSAS and an increased risk for cardiovascular disease, especially hypertension.2 The Sleep Heart Health Study and other ongoing cardiovascular outcome studies should provide guidance on the strength of these associations and determine whether OSAS contributes an independent risk.3 In lieu of these pending data, the most important and well-established consequences of untreated OSAS include impaired vigilance,4 decreased quality of life,5 and increased risk for motor vehicle accidents.6 The future treatment approach to adult OSAS will be tempered by the results of these ongoing cardiovascular outcomes studies with respect to the appropriateness of more complex and expensive treatment options, including those discussed in this review article: automatic continuous positive airway pressure (CPAP) and innovative upper airway procedures.
Recent randomized, controlled trials of CPAP vs placebo7 or conservative treatment8 of OSAS demonstrate improvement of daytime sleepiness and quality-of-life measures in the CPAP-treated cohorts. However, these CPAP treatment trials also determined that adherence to this therapy is approximately 40%, suggesting that there is a need to improve CPAP therapy or develop effective treatment alternatives. This review scrutinizes (1) the innovations in OSAS treatment, including automatic CPAP, that could allow for improved CPAP adherence, and (2) pharyngeal surgeries and nerve stimulators, which might provide an effective alternative to CPAP. The mechanics, efficacy, side-effect profile, and cost considerations are discussed for each of these treatment modalities.
Automatic CPAP
Mechanisms
During the last decade, at least eight self-adjusting CPAP systems
have been developed and utilized to treat adult OSAS patients, either
for the unattended titration of CPAP or for long-term variable pressure
treatment. Because these systems function by recognizing obstructive
respiratory events or surrogate measures of them, the systems have an
inherent diagnostic capability. The accuracy of the diagnostic
capabilities, as well as the characteristics of the internal algorithms
for pressure adjustment, are key components of the efficacy and patient
acceptability of these systems. The level of technical sophistication
and associated monetary costs of these systems may vary greatly, and
each system requires individualized and careful evaluation before use
in OSAS patients is advocated or discouraged.
Parameters monitored by the various systems include those derived from airflow, pressure, or snoring and other airway sounds. One example of an automatic CPAP system, AutoAdjust (DeVilbiss Health Care, Inc; Somerset, PA), uses a pneumotachometer to measure airflow and calculates a running average by either machine default or user-specified event definitions based on time and percentage of flow decrement.9 AutoSet (ResMed; San Diego, CA) increases mask pressure in response to apneas, breath-to-breath flattening of inspiratory airflow waveform contour, or snoring (Fig 1 ).10 Morphèe Plus (Pierre Medical; Verrieres le Buisson Cedex, France) utilizes a user-specified reference pressure, and the effective pressure varies on the basis of peak inspiratory and expiratory airflow based on machine compressor speed.11 Virtuoso (Respironics Inc; Murrysville, PA) increases mask pressure in response to airway vibration patterns as sensed by a pressure transducer.12
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Titration
The majority of peer-reviewed studies on the various commercially
available automatic CPAP systems suggest that OSAS treatment in the
sleep laboratory environment results in final CPAP settings comparable
to those obtained in technician-titrated studies with
PSG.17
18
19
20
21
This finding may have economic value in
allowing for a decrease in the technician-to-patient ratio in the sleep
laboratory and thereby reducing costs.22
However, it has
not been established that unattended automatic CPAP titration is safe
without a previous diagnostic PSG to establish the diagnosis of OSAS
and exclude patients with additional overlap or non-OSAS nocturnal
breathing disorders. Non-OSAS nocturnal breathing disorders include
central sleep apnea or chronic hypoventilation due to emphysema or
other diseases. A single case report documents the occurrence of
iatrogenic central sleep apnea induced by automatic CPAP in an OSAS
patient.23
Another potential hazard is unrecognized
arrhythmia during CPAP titration, although its occurrence has been
documented in only a single case series.24
Future versions
of automatic positive airway pressure systems may allow for the
recognition and appropriate treatment of non-OSAS breathing
disorders25
or arrhythmia, but these systems are not yet
developed or available clinically.
Without a technician in attendance, OSAS patients are at risk for intermittent or continuous mask leak during a titration study, which may lead to increased variability of CPAP pressures and associated arousals. This risk may be decreased by close attention to mask fit and by educating the patient about mask self-adjustment techniques prior to the titration study.26 Whether an accurate final CPAP prescription can be obtained with automatic CPAP in a home environment has not been well studied. Because some automatic CPAP systems may allow for the measurement and recording of mask leak, inadequate airflow or pressure signals, and other sources of artifact, inadequate titration can be recognized and the appropriate adjustments made to allow for repeat home titration or technician-supervised titration. The effect of home automatic CPAP titration on treatment acceptance and adherence are unknown, but considering the well-documented poor adherence rates for CPAP when OSAS patients are not closely supervised and intensively educated,7 8 there is significant risk for even further decrease in adherence rates if physician and technician contact are minimized.
Compensation issues may be critical to the clinical utilization of new technologies including automatic CPAP. In the United States, Medicare and most third-party payers currently will not reimburse for either attended or unattended automatic CPAP titration studies. The future trend may be for the automatic CPAP manufacturers to add additional diagnostic recording capabilities to these systems to allow for compensation as an attended cardiorespiratory (four-channel) study monitoring airflow, respiratory effort, oxygen saturation, and heart rate. Expanding the diagnostic capabilities of automatic CPAP titration systems could allow for effective home titration of CPAP with continuous technician monitoring and intervention through a centralized hub. A feasibility study by Coppola and Lawee27 determined that 11 closely followed OSAS patients could self-titrate CPAP at home without complication. A number of managed-care organizations have implemented programs using screening algorithms and nocturnal cardiorespiratory monitoring to diagnose OSAS, followed by unattended, home CPAP titration studies for those who screen positive.28 Widespread application of this approach cannot be advocated without systematic, peer-reviewed studies that demonstrate acceptable diagnostic accuracy of this approach compared with the gold standard, PSG, and assess treatment efficacy utilizing objectively measured outcomes such as machine-monitored CPAP adherence.
Variable Pressure
For severe OSAS patients identified by prior PSG, the home use of
a number of the automatic CPAP systems in the variable-pressure mode
result in lower overnight cumulative CPAP levels compared with CPAP at
a preset, fixed level.26
Studies of the
AutoAdjust,9
AutoSet,29
and Morphèe
Plus11
demonstrate that use of variable-pressure CPAP
resulted in decreases in the AHI that were the same as those attained
with technician-titrated CPAP. Preliminary data suggest that specific
automatic CPAP systems may vary with respect to efficacy in the
reduction of AHI for OSAS treatment.30
Only one
preliminary study evaluated automatic CPAP treatment in adult upper
airway resistance syndrome, which is defined by increased inspiratory
driving pressure detected by esophageal manometry during sleep without
evidence of airflow limitation by oronasal thermistor.31
This study determined that the AutoSet reduced the number of
respiratory effortrelated arousals (38.3 ± 20/h pretreatment vs
7.1 ± 4.8/h posttreatment; p = 0.005), but that the residual
driving pressure was increased in OSAS patients treated with the
Autoset compared with matched patients treated with technician-titrated
CPAP.32
A comparison of sleep architecture in the home environment for variable pressure and conventional CPAP has not been done, but in-laboratory comparisons suggest that there are no consistent differences for any specific system.33 Few studies have evaluated long-term adherence (> 2 months) with automatic CPAP, although Konermann et al,20 in a crossover study of 50 OSAS patients, found an increase in the mean treatment nights per week but no increase in the mean hours of usage per night. Whether the added expense of a variable CPAP capability is justified with respect to patient comfort and adherence benefits remains to be determined by future studies. Subgroups of OSAS patients who are more or less likely to benefit from automatic CPAP have not been identified. Automatic CPAP is more expensive than fixed-pressure CPAP. The added cost varies for each system, but some systems may cost less than $500 more than fixed-pressure CPAP systems. Currently, few third-party payers in the United States routinely authorize reimbursement for the added cost of automatic CPAP for home use.
Upper Airway Procedures
Palatal Surgery
Surgery on the soft palate to treat OSAS has previously been
performed using a scalpel (uvulopalatopharyngoplasty
[UPPP]).34
More recently, procedures have involved with
CO2 or YAG lasers (laser-assisted
uvulopalatoplasty [LAUP]),35
cautery (cautery-assisted
palatal stiffening operation [CAPSO]),36
or
radiofrequency energy (Somnoplasty; Somnus; Mountainview,
CA).37
An advantage of LAUP, CAPSO, and Somnoplasty over
UPPP is that these procedures are performed with local anesthesia, and
thus are adaptable to an ambulatory setting.
The fundamental shortcoming of all palatal surgical procedures to date,
including the newer techniques, is that the majority of OSAS patients
are inadequately treated on the basis of reduction in the AHI. In a
study by Doghramji et al38
of 53 OSAS patients identified
by awake endoscopy as palatal obstructers on the basis of the Muller
manuever, only 32% of these severe OSAS patients (mean AHI, 46.5)
demonstrated a
50% decrease in AHI with UPPP. Results from LAUP
studies suggest even less clinical utility than UPPP for OSAS
treatment, although selection bias related to lack of posttreatment PSG
has resulted in a wide variance in changes in the AHI as reported in
the otolaryngology literature.39
40
41
The failure of LAUP
in the treatment of OSAS has been attributed to the limited resection
of pharyngeal tissue compared with UPPP. Modification of the LAUP
procedure to include more complete resection of the pharynx was
proposed by Mickelson and Ahuja42
in a recent study, in
which only 36 of 59 OSAS patients (61%) underwent posttreatment PSG.
These authors conclusion that a more aggressive LAUP procedure is
"an effective treatment for mild, moderate and severe" OSAS is
doubtful in view of the previously reported limited efficacy rate of
UPPP and potential selection bias in the current study.
Novel palatal stiffening procedures include CAPSO and Somnoplasty. Palatal tissue is not excised or ablated as with UPPP or LAUP, but rather, a midline soft palate scar forms within 1 to 2 months following CAPSO or Somnoplasty. With respect to the effect of these novel palatal procedures on AHI for OSAS patients, only data in abstract form are available for CAPSO,37 and a multicenter clinical trial is ongoing to evaluate palatal Somnoplasty. An advantage of Somnoplasty over other palatal procedures may be decreased pain due to the avoidance of mucosal tissue resection; however, repetition of the procedure is usually required before the optimal surgical effect is obtained, which leads to increased cost.43 Palatal mucosal tissue is excised from the midline with CAPSO, and although the procedure is of short duration and is inexpensive, postoperative pain is considerable and could preclude further study of this procedure.
In summary, palatal procedures alone are not likely to be effective for the majority of OSAS patients, no matter which technique is used. To date, no studies guide the selection of patients more likely to benefit from these procedures, except possibly for those with mild severity based on AHI. As discussed below, it is necessary that additional surgical procedures be available to allow for the salvaging of palatal surgery failures.
Tongue Base Procedures
Since 1981, Riley and Powell of Stanford University have developed
a stepwise approach to the surgical treatment of OSAS. Patients in whom
UPPP has failed may undergo subsequent surgery such as geniohyoid
advancement myotomy combined with hyoid resuspension and/or (in a
smaller subset of patients) maxillomandibular advancement. As with much
of the palatal surgery outcome literature, the Stanford surgical OSAS
treatment data are flawed by potential selection bias, with a 26% loss
to follow-up in a retrospective study of 415 adult OSAS patients
published in 1993.44
However, smaller studies of
consecutive patients receiving these procedures45
suggest
that surgical treatment of OSAS is more effective than palatal surgery
alone, especially with maxillomandibular advancement.46
Unfortunately, while palatal surgery is widely available, relatively
few surgeons perform these additional procedures for the treatment of
OSAS patients. Advanced surgical expertise is required to perform these
additional procedures, and prolonged hospitalization and high costs are
associated with such procedures, especially maxillomandibular
advancement. Although no studies have evaluated this issue, it is
assumed that high numbers of OSAS patients who fail palatal surgery
remain untreated.
Novel procedures for OSAS that persists after palatal surgery address obstruction at the base of tongue; options include suture suspension with the Repose System (Influence Corp; San Francisco, CA) and Somnoplasty. The results of prior attempts at scalpel or laser resection of the tongue base in OSAS treatment have not been good enough to recommend continued application of these procedures. In a 1997 study by Mickelson and Rosenthal,47 only 3 of 12 patients who received laser tongue base resection had a posttreatment AHI of < 20. Although no intraoperative complications were reported, the mean hospital stay after this procedure was 3.6 days, and 50% of the patients required temporary tracheotomy. It is likely that the Repose and Somnoplasty base-of-tongue procedures offer an advantage over prior base-of-tongue resection and other nonpalatal procedures in that these newer procedures are easier to perform and are associated with shorter or no hospital stays.
The Repose procedure is performed under general anesthesia, and a screw
is inserted at the base of the mandible. The screw contains attachments
for polypropylene suture that is passed through the tongue base,
allowing for anterior support (Fig 2 ). Tightness of the tongue suspension is determined digitally, and
caution must be exercised to prevent tissue ischemia, pain, and edema.
In a study of 16 carefully selected OSAS patients who had not undergone
palatal surgery, PSG 3 months after treatment demonstrated a decrease
in the AHI from 35 ± 8 to 17 ± 8 (p = 0.001).48
Only 1 of 15 patients (7%) demonstrated a posttreatment AHI of
10
and a > 50% reduction from the pretreatment AHI (Fig 3
). Two patients had postoperative pain and local soft tissue infection
requiring removal of the tongue base suture and exclusion from the
treatment data analysis. An additional patient developed a
floor-of-mouth cyst requiring marsupialization. Another case series
evaluated this procedure in 72 OSAS patients with prior palatal
surgery49
; approximately 10% of patients were not
evaluated postoperatively with PSG. Hyoid suspension and myotomy were
concomitantly performed in 24 of the 72 patients, but the selection
criteria for this additional procedure were not specified. With the
Repose procedure alone, the AHI decreased from 65 ± 21 to 45 ± 17
(31%); in combination with hyoid surgery, the AHI decreased more
markedly, from 74 ± 19 to 30 ± 16 (59%). Short-term
complications included temporary odynophagia and dysphagia, but all
patients were able to tolerate liquids and a soft diet by time of
discharge after a mean hospital stay of 1.2 days; the base-of-tongue
suture was not removed in any patient.
|
|
10 and a > 50% reduction
from the pretreatment AHI (Fig 4
). MRI demonstrated a 17% reduction in tongue volume after the series
of procedures were complete. Three patients experienced adverse events,
including a superficial tongue ulceration and a soft tissue infection
that required incision and drainage under general anesthesia and a
temporary tracheotomy. Costs for this technique are increased by the
need for multiple procedures: the current version of the radiofrequency
needle and handle assemblage are not reusable.
|
Conclusion
It is hoped that these novel technologies and procedures will lead to the improved efficacy and tolerability of OSAS treatment. However, caution is advised because, despite the preliminary nature of much of the related research, the relative ease of applying some of these technologies and performing some of these novel procedures may result in widespread use. Evaluation of some of the specific OSAS technologies or procedures in the past has been problematic because of study selection bias and a lack of control or comparison groups. More systematic research efforts in the future should allow for accurate assessments of innovative treatments and optimize their refinement and integration into the clinical management of OSAS.
Footnotes
Abbreviations: AHI = apnea-hypopnea index; CAPSO = cautery-assisted palatal stiffening operation; CPAP =continuous positive airway pressure; LAUP = laser-assisted uvulopalatoplasty; OSAS = obstructive sleep apnea syndrome; PSG = nocturnal polysomnography
References
This article has been cited by other articles:
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P. B. Yoo and D. M. Durand Effects of selective hypoglossal nerve stimulation on canine upper airway mechanics J Appl Physiol, September 1, 2005; 99(3): 937 - 943. [Abstract] [Full Text] [PDF] |
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F. Abdenbi, B. Chambille, and P. Escourrou Bench testing of auto-adjusting positive airway pressure devices Eur. Respir. J., October 1, 2004; 24(4): 649 - 658. [Abstract] [Full Text] [PDF] |
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