temperature controlled radiofrequency ablation for osa · obstructive sleep apnea syndrome 2‐4 %...
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Temperature controlled radiofrequency ablation for OSA
Ridhwan Y. Baba, M.B.B.S.*1, V.V.S. Ramesh Metta, M.B.B.S.1, Arjun Mohan, M.B.B.S.2, M. Jeffery Mador, M.D.2
1 Department of Internal Medicine, University at Buffalo‐State University of Buffalo, Buffalo, NY
2 Division of Pulmonary, Critical care and Sleep medicine, Buffalo VA Medical Center, Buffalo, NY
• Conflict of Interest: none
• Financial disclosures: none
Obstructive Sleep Apnea
Apnea/ hypopnea index > 15 (AASM 1999, Young 1993)
4% women in USA 9 % men in USA
AHI > 5 24% men (Young 1993)
Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993)
Standard therapy
CPAP (Sullivan 1981)
poor tolerance CPAP: 20‐23% non compliant (McArdle 1999, Waldhorn 1990)
Sleepiness: 45%, Hypoxemia: 30%, both 11% (Rolfe 1991)
MAD: Acceptance rate 70% (Mohsenin 2003)
Surgical treatment
LAUP
Mandibular osteotomy & genioglossal
advancement w. hyoid myotomy
Temperature Controlled Radiofrequency Ablation
Radiofrequency ablation
Powell et al, 1999
Recent studies
Included papers with other surgeries (Nelson et al, 2001‐ UPPP with TCRFTA)
Socially disruptive snoring (Terris et al, 2002 ) Grouped patient populations Additional studies since 2006
Objective
Analyze available evidence for efficacy of TCRFTA in OSAS polysomnography data daytime sleepiness quality of life
Side effects and complications
Methods
Study design
Systematic review and meta‐analysis (RB, JM)
Included studies
Randomized controlled trials Clinical trials Comparative parallel group trials Case series
Inclusion criteria
Patient population with symptoms pre‐operative PSG demonstrative of RDI≥ 5
TCRFTA of the soft palate (SP), base of tongue (BoT) or both ‘stand‐alone procedure’
Exclusion criteria
Non‐apneic sleep disorders socially disruptive snoring upper airway resistance syndrome sleep disordered breathing
Radiofrequency technology for other interventions eg. uvulopalatoplasty, tonsillectomy
Search strategy
MEDLINE EMBASE Evidence Based Medicine Reviews
Search keywords
Catheter Ablation Diathermy Electrocoagulation
Limited search to humansMost recent search: April 2013
Sleep Apnea Syndrome Sleep Apnea, Obstructive Sleep disordered breathing
Selection process
Two independent authors (RB, RM)
Reference lists checked for additional citations (did not return in our initial search)
Disagreements resolved either by discussion or by a third reviewer (JM)
Data abstraction
Self‐developed standardized form Second reviewer verified data abstraction
Self‐developed standardized form
Analyzed outcomes: Objective
Polysomnography data: Respiratory distress index (RDI) Lowest oxygen saturation (LSAT, %)
Cephalometric radiography
Analyzed outcomes: Subjective Subjective somnolence Epworth sleepiness scale (ESS)
Level of snoring Visual analogue scale (VAS, 0 –10) snoring
OSAS specific quality of life Symptoms of Nocturnal Obstruction and Related Events (SNORE25)
Functional Outcomes of Sleep Questionnaire (FOSQ) General health status measured with SF‐36 Reaction time using the Psychomotor Vigilance Task (PVT‐192; Ambulatory Monitoring Inc, Ardsley, NY)
Methodological features
Selection bias Information bias Matching Blinding of outcome adjudicator Adjustment for confounding factors Confounding variables like prior surgery Incomplete data Withdrawals/ loss to follow‐up
Statistical analysis
RevMan Version 5.2 (Review Manager, Cochrane Collaboration 2012)
Excel 2011 (Microsoft, Redmond, WA, USA)
Statistical analysis
RoM = post‐TCRFTA mean/ pre‐TCRFTA mean Standard error calculated (Friedrich et al, 2011)
Standard equations for inverse variance weighting and random effects model (DerSimonian and Laird, 1986)
Heterogeneity (I2) (Higgins 2003) 0 to 50: low 50 to 80: moderate and worthy of investigation 80 to 100: severe and worthy of understanding 95 to 100: aggregate with major caution
Small number of studies were analyzed in each group, we considered a funnel plot unreliable to determine publication bias (Lau, 2006)
Results
Only abstracts in English:Guo et al, 2001Mu et al, 2007 Shao et al, 2008
TCRFTA: Base of tongue
TCRFTA: Base of tongueShort term follow up (< 12 months)
TCRFTA: Base of tongue (RDI)
TCRFTA: Base of tongue (LSAT)
Excluded studies:Friedman et al., 2008
TCRFTA: Base of tongue (ESS)
Excluded studies:Woodson et al, 2001Friedman et al., 2008
TCRFTA: Base of tongue (VAS snoring)
Excluded studies:Friedman et al., 2008
TCRFTA: Base of tongue (others)
TCRFTA: Base of tongueLong term follow up (> 12 months)
TCRFTA: Base of tongue
TCRFTA: Base of tongue Adverse events ulceration odynophagia pharyngodynia mild‐to‐severe tongue edema ecchymosis
oral thrush and post‐operative vasovagal reaction were relatively rare complications
8 cases of infection and 2 cases of tongue base abscess were reported by studies that did not use perioperative antibiotic prophylaxis (Powell et al, 1999, Stuck et al, 2002, Woodson et al, 2001)
hematoma transient neuralgia transient tongue deviation hypoglossal nerve injury
TCRFTA: Soft palate
TCRFTA: Soft palate
Excluded studies:Terris et al, 2002Atef et al, 2005Back et al, 2009
TCRFTA: Multi level
TCRFTA: Multi level (RDI1)
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Sub group analysis: Randomized vs. non randomized Level 1 vs. other PSG Inclusion/ Exclusion criteria Prior surgery or not
Bipolar vs. unipolar No of procedures Baseline AHI Geography
TCRFTA: Multi level (RDI2)
TCRFTA: Multi level (LSAT2)
TCRFTA: Multi level (ESS2)
TCRFTA: Multi level (VAS snoring)
TCRFTA: Multi level
TCRFTA: Multi level
Adverse events swelling ulceration hematoma formation cellulitis dysphagia or aspiration bleeding, and scarring at the surgical site One unilateral tonsillar abscess formation was also reported (Fischer et al., 2003)
Conclusion
TCRFTA is clinically effective in OSAS base of tongue multilevel procedure
RDI levels symptoms of sleepiness in patients
Local anesthesia, low morbidity, transient side effects , comparable efficacy when compared to other surgical treatments
Limitations
Multiple prior surgery in some studies Majority observational studies included Long term follow up limited Cure rate? Site of obstruction Surgical protocol variable Identification of OSAS
References American Academy of Sleep Medicine. International classification of sleep disorders,
2nd Edition: Diagnostic and coding manual. Westchester, IL: American Academy of Sleep Medicine; 2005
Young, T., et al., The occurrence of sleep‐disordered breathing among middle‐aged adults. N Engl J Med, 1993. 328(17): p. 1230‐5.
Sullivan CE, Issa FG, Berthon‐Jones M, Eves L. Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares. Lancet 1981;1: 862–865.
McArdle, N., et al., Long‐term Use of CPAP Therapy for Sleep Apnea/Hypopnea Syndrome. J. Am J Respir Crit Care Med 1999. 159:1108–1114.
Waldhorn RE, Herrick TW, Nguyen MC, et al. Long‐term compliance with nasal continuous positive airway pressure therapy of obstructive sleep apnea. Chest 1990;97:33–38.
Rolfe I, Olson LG, Saunders NA. Long‐term acceptance of continuous positive airway pressure in obstructive sleep apnea. Am Rev Respir Dis 1991;144:1130–1133.
Mohsenin N, Mostofi MT, Mohsenin V. The role of oral appliances in treating obstructive sleep apnea. J Am Dent Assoc 2003;134:442‐9.
References Powell, N. B., et al. "Radiofrequency tongue base reduction in sleep‐disordered
breathing: A pilot study." Otolaryngology ‐ Head & Neck Surgery 1999. 120(5): 656‐664. Farrar, J., et al. "Radiofrequency ablation for the treatment of obstructive sleep apnea:
a meta‐analysis." Laryngoscope 2008. 118(10): 1878‐1883. Friedrich, J.O., N.K. Adhikari, and J. Beyene, Ratio of means for analyzing continuous
outcomes in meta‐analysis performed as well as mean difference methods. J ClinEpidemiol, 2011. 64(5): 556‐64.
DerSimonian, R. and N. Laird, Meta‐analysis in clinical trials. Control Clin Trials, 1986. 7(3):177‐88.
Higgins, J.P., et al., Measuring inconsistency in meta‐analyses. BMJ, 2003. 327(7414):557‐60.
Lau, J., et al., The case of the misleading funnel plot. BMJ, 2006. 333(7568):597‐600.