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 BuffaloState University of Buffalo, Buffalo, NY 2 Division of Pulmonary, Critical care and Sleep medicine, Buffalo VA Medical Center, Buffalo, NY

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Page 1: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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

Page 2: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

• Conflict of Interest: none

• Financial disclosures: none

Page 3: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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)

Page 4: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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)

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Surgical treatment

LAUP

Mandibular osteotomy & genioglossal

advancement w. hyoid myotomy

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Temperature Controlled Radiofrequency Ablation

Page 7: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

Radiofrequency ablation

Powell et al, 1999

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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

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Objective

Analyze available evidence for efficacy of TCRFTA in OSAS polysomnography data daytime sleepiness quality of life

Side effects and complications

Page 10: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

Methods

Page 11: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

Study design

Systematic review and meta‐analysis (RB, JM)

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Included studies

Randomized controlled trials Clinical trials Comparative parallel group trials Case series 

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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’

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Exclusion criteria

Non‐apneic sleep disorders socially disruptive snoring  upper airway resistance syndrome sleep disordered breathing 

Radiofrequency technology for other interventions eg. uvulopalatoplasty, tonsillectomy 

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Search strategy

MEDLINE EMBASE Evidence Based Medicine Reviews 

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Search keywords

Catheter Ablation Diathermy Electrocoagulation

Limited search to humansMost recent search: April 2013

Sleep Apnea Syndrome Sleep Apnea, Obstructive  Sleep disordered breathing 

Page 17: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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)

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Data abstraction

Self‐developed standardized form Second reviewer verified data abstraction 

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Self‐developed standardized form

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Analyzed outcomes: Objective

Polysomnography data: Respiratory distress index (RDI)  Lowest oxygen saturation (LSAT, %) 

Cephalometric radiography

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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)

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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

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Statistical analysis

RevMan Version 5.2 (Review Manager, Cochrane Collaboration 2012)

Excel 2011 (Microsoft, Redmond, WA, USA)

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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) 

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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)

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Results

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Only abstracts in English:Guo et al, 2001Mu et al, 2007 Shao et al, 2008

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TCRFTA: Base of tongue

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TCRFTA: Base of tongueShort term follow up (< 12 months)

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TCRFTA: Base of tongue (RDI)

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TCRFTA: Base of tongue (LSAT)

Excluded studies:Friedman et al., 2008

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TCRFTA: Base of tongue (ESS)

Excluded studies:Woodson et al, 2001Friedman et al., 2008

Page 33: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Base of tongue (VAS snoring)

Excluded studies:Friedman et al., 2008

Page 34: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Base of tongue (others)

Page 35: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Base of tongueLong term follow up (> 12 months)

Page 36: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Base of tongue

Page 37: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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

Page 38: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Soft palate

Page 39: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Soft palate

Excluded studies:Terris et al, 2002Atef et al, 2005Back et al, 2009 

Page 40: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level

Page 41: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level (RDI1)

________________________________________________________________________________________

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

Page 42: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level (RDI2)

Page 43: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level (LSAT2) 

Page 44: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level (ESS2)

Page 45: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level (VAS snoring)

Page 46: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

TCRFTA: Multi level 

Page 47: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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) 

Page 48: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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

Page 49: Temperature controlled radiofrequency ablation for OSA · Obstructive Sleep Apnea Syndrome 2‐4 % adults (Young 1993) Standard therapy ... Clinical trials Comparative parallel group

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 

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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.

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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.