Temperature controlled radiofrequency ablation for OSA

Transcription

1 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

2 Conflict of Interest: none Financial disclosures: none

3 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)

4 Standard therapy CPAP (Sullivan 1981) poor tolerance CPAP: MAD: 20 23% non compliant (McArdle 1999, Waldhorn 1990) Sleepiness: 45%, Hypoxemia: 30%, both 11% (Rolfe 1991) Acceptance rate 70% (Mohsenin 2003)

5 Surgical treatment LAUP Mandibular osteotomy & genioglossal advancement w. hyoid myotomy

6 Temperature Controlled Radiofrequency Ablation

7 Radiofrequency ablation Powell et al, 1999

8 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

9 Objective Analyze available evidence for efficacy of TCRFTA in OSAS polysomnography data daytime sleepiness quality of life Side effects and complications

10 Methods

11 Study design Systematic review and meta analysis (RB, JM)

12 Included studies Randomized controlled trials Clinical trials Comparative parallel group trials Case series

13 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

14 Exclusion criteria Non apneic sleep disorders socially disruptive snoring upper airway resistance syndrome sleep disordered breathing Radiofrequency technology for other interventions eg. uvulopalatoplasty, tonsillectomy

15 Search strategy MEDLINE EMBASE Evidence Based Medicine Reviews

16 Search keywords Catheter Ablation Diathermy Electrocoagulation Sleep Apnea Syndrome Sleep Apnea, Obstructive Sleep disordered breathing Limited search to humans Most recent search: April 2013

17 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)

18 Data abstraction Self developed standardized form Second reviewer verified data abstraction

19 Self developed standardized form

20 Analyzed outcomes: Objective Polysomnography data: Respiratory distress index (RDI) Lowest oxygen saturation (LSAT, %) Cephalometric radiography

21 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)

22 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

23 Statistical analysis RevMan Version 5.2 (Review Manager, Cochrane Collaboration 2012) Excel 2011 (Microsoft, Redmond, WA, USA)

24 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)

25 Heterogeneity (I 2 ) (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)

26 Results

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

28 TCRFTA: Base of tongue

29 TCRFTA: Base of tongue Short term follow up (< 12 months)

30 TCRFTA: Base of tongue (RDI)

31 TCRFTA: Base of tongue (LSAT) Excluded studies: Friedman et al., 2008

32 TCRFTA: Base of tongue (ESS) Excluded studies: Woodson et al, 2001 Friedman et al., 2008

33 TCRFTA: Base of tongue (VAS snoring) Excluded studies: Friedman et al., 2008

34 TCRFTA: Base of tongue (others)

35 TCRFTA: Base of tongue Long term follow up (> 12 months)

36 TCRFTA: Base of tongue

37 TCRFTA: Base of tongue Adverse events ulceration odynophagia pharyngodynia mild to severe tongue edema ecchymosis hematoma transient neuralgia transient tongue deviation hypoglossal nerve injury 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)

38 TCRFTA: Soft palate

39 Excluded studies: Terris et al, 2002 Atef et al, 2005 Back et al, 2009 TCRFTA: Soft palate

40 TCRFTA: Multi level

41 TCRFTA: Multi level (RDI 1 ) 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

42 TCRFTA: Multi level (RDI 2 )

43 TCRFTA: Multi level (LSAT 2 )

44 TCRFTA: Multi level (ESS 2 )

45 TCRFTA: Multi level (VAS snoring)

46 TCRFTA: Multi level

47 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)

48 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

49 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

50 References American Academy of Sleep Medicine. International classification of sleep disorders, 2 nd 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, (17): p 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: McArdle, N., et al., Long term Use of CPAP Therapy for Sleep Apnea/Hypopnea Syndrome. J. Am J Respir Crit Care Med : 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: Rolfe I, Olson LG, Saunders NA. Long term acceptance of continuous positive airway pressure in obstructive sleep apnea. Am Rev Respir Dis 1991;144: Mohsenin N, Mostofi MT, Mohsenin V. The role of oral appliances in treating obstructive sleep apnea. J Am Dent Assoc 2003;134:442 9.

51 References Powell, N. B., et al. "Radiofrequency tongue base reduction in sleep disordered breathing: A pilot study." Otolaryngology Head & Neck Surgery (5): Farrar, J., et al. "Radiofrequency ablation for the treatment of obstructive sleep apnea: a meta analysis." Laryngoscope (10): 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 Clin Epidemiol, (5): DerSimonian, R. and N. Laird, Meta analysis in clinical trials. Control Clin Trials, (3): Higgins, J.P., et al., Measuring inconsistency in meta analyses. BMJ, (7414): Lau, J., et al., The case of the misleading funnel plot. BMJ, (7568):