Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Uvulopalatopharyngoplasty (UPPP)

Caples, 2010

SR and meta-analysis of RCT’s and non-randomized controlled trials, cohort studies and case-series.

Literature search up to June, 2008.

Inclusion criteria SR:

- Reporting of AHI before and after surgical intervention.

- sample size > 1

- published in English

Exclusion criteria:

- Papers that only reported surgical success without precise outcome data on individual study subjects

This broad search yielded 79 papers; 15 studies investigated UPPP, 13 had an observational study design, 2 were randomized trials.

Important patient characteristics at baseline:

N, Age range, % men, BMI

Total n=950

Mean age: 44y

Sex: 91,9% men

BMI: 29 kg/m2

AHI: 40.3

Intervention:

UPPP

Control:

- Pre-treatment measurement (13 studies)

- MRA (1 study)

- Lateral pharyngoplasty (1 study).

End-point of follow-up:

3-12 months

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

% reduction in AHI: 33% (95%CI 23 to 42).

Postoperative residual AHI was 29,8.

Complications

Post-operative bleeding (n=2);

No deaths were reported.

Quality of studies was very low.

‘Outcomes in women, some minorities, and those more than 50 years of age are lacking. Whether body

weight imparts influence on outcomes is not clearly evident  from the current dataset, though the suggestion by Friedman et

al. that a BMI > 40 kg/m2 is a marker of poorer outcomes is notable and could serve as a model for future research. ‘

Stuck, 2017

Unpublished data

(individual study characteristics deduced from (1st author,

year of publication

))

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCT’s and non-randomized controlled trials, cohort studies, retrospective studies and case series or reports.

Literature search up to 4^th of February 2016

Study design:

Prospective design (k=53, four studies were RCT’s);

Retrospective design (k=36);

Case reports (k=3);

Control group (k=18)

Setting and Country:

Not reported for the individual studies. Review was written in the Netherlands

Source of funding:

Inclusion criteria SR:

- Adult patients with OSA diagnosed via PSG or comparable objective measure

- isolated ‘standard’ UPPP

Exclusion criteria SR:

- significant surgical variations or modifications of the UPPP-procedure (lateral pharyngoplasty, palatal advancement, Z-pharyngoplasty etc).

- concomitant surgery (e.g. septoplasty or tracheostomy)

92 studies included.

Two studies were included in the meta-analyses (RCT’s)

Important patient characteristics at baseline:

N ranged from 1-1570 (58.6 ±163.1).

Mean age ranged from 29-57 years (weighted mean age was 46.8 y)

Mean BMI ranged from 25-37 kg/m2 (weighted mean BMI was 29.3 kg/m2)

Intervention:

Isolated ‘standard’ UPPP (consisting of resection of

excessive mucosa of the soft palate with or without tonsillectomy combined with a reconfiguration of the soft palate with sutures involving the anterior and posterior pillar).

Control:

Pre-treatment measurements.

18 studies used a control group:

- other surgical techniques (k=7)

- MADs (k=5)

- CPAP (k=5)

- not receiving an intervention (k=5)

- healthy controls (k=3)

End-point of follow-up:

Follow-up ranged from early postoperative period to 15.75 years.

Follow-up <1 months: k=2

Follow-up 1-3 months: k=22

Follow-up 3-12 months: k=33

Follow-up >1 year: k=14

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

UPPP versus control (k=2)

Pooled effect (random effects model), mean difference -18.59 (95%CI -34.14, -3.04)

SDM: -1.03 (95%CI -1.45, -0.60)

Before and after UPPP (k=3 RCT’s):

Baseline: 35.4

Follow-up (median 7.2 months): 17.9

Pooled effect (random effects model), mean difference: -20.31 (95%CI -32.65, -7.97).

SDM: -1.48 (-1.80, -1.15)

Outcome measure-2: ESS

UPPP versus control (k=2)

Pooled effect (fixed effects model), mean difference:

-5.37 (95%CI -7.03, -3.72);

SDM: -1.13 (95%CI -1.56, -0.69)

Before and after UPPP (k=7)

Baseline, weighted mean: 12.1 (range 10.2 – 14.7)

After: 6.7 (range 2.9 – 9.1)

Outcome measure-3: ODI

Pooled effect (fixed effects model), mean difference (95%CI)

Outcome measure-4: FOSQ

-

Risk of bias was evaluated using Cochrane Collaboration ‘Risk of bias’ tool.

New palate techniques (e.g. lateral pharyngoplasty, expansion sphinxter pharyngoplasty, reposition pharynfoplasty)

Volner, 2016

SR and meta-analysis of retrospective case-series.

Literature search up to April 2016

A: Zhang, 2014

B: Shine, 2009

C: Woodson, 2005

D: Woodson, 1997

E: Woodson and Toohil, 1993

Study design: RCT (parallel / cross-over), cohort (prospective / retrospective), case-control

Setting and Country:

A: China

B: Australia, Scotland

C: USA

D: USA

E: USA

Source of funding:

No financial or material support for this study was received.

Inclusion criteria SR:

- transpalatal advancement pharyngoplasty was performed as treatment for obstructive sleep apnea;

- no other surgeries addressing other levels of obstruction were performed at the same time (if performed, tonsillectomy is considered a part of the procedure, similar to traditional UPPP);

- polysomnography and/or sleepiness data was reported before and after surgery.

Exclusion criteria SR:

Not reported

Five studies included

Important patient characteristics at baseline:

Total patients: n=199.

N, Mean age, BMI

A: N=119; 39.1 ± 7.8 yrs; 28.0 ± 3.0 kg/m2

B: N=60, 47.4 ± 9.7 yrs; 29.5 ± 3.1 kg/m2

C: N= 10; 48.3 ±8.3 yrs; NR

D: N=4; 46 ± 6.4 yrs; 31.6 ± 3.4 kg/m2

E: N=6;, 56 ± 12.7 yrs; 41.3 ± 6.6 kg/m2

Groups comparable at baseline? NA

Intervention:

Isolated transpalatal advancement pharyngoplasty

Control:

Pre-treatment

End-point of follow-up:

The review did not mention study duration or when follow-up measurements were done.

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

Grand mean (95%CI)

Pre-op AHI: 54.6 (51.4, 57.8)

Post-op AHI: 19.2 (16.9, 21.5)

Mean change was: -36.25 (-48.45, -24.05) (relative reduction 64.8%);

Heterogeneity (I²): 85%

Outcome measure-3: Oxygen saturation

Defined as lowest oxygen saturation, Grand mean (95%CI):

Pre-op: 81.9 (80.0, 83.8)

Post-op: 85.4 (83.8, 87.0).

Mean change: 3.55 (0.33-7.44);

Heterogeneity (I²): 22%.

Most common complication was oronasal fistulae. Other complications that were mentioned, were:

velopalatine insufficiency, tonsillar bleeding requiring surgical intervention, an associated case of serous otitis media, and one instance of airway obstruction requiring an emergency tracheostomy.

Authors conclusions: TPAP improves AHI and oxygen saturation, but the number of studies is limited, even as the retrospective designs. 

Research comparing TPAP to pharyngoplasty procedures without palatal advancement would help determine the optimal role for this procedure.

NICE quality assessment

A: 4

B:  4

C: 3b

D: 4

E: 3b

Pang, 2015

SR and meta-analysis of case-series  and clinical trials

Literature search up to March 2015

A: Pang, 2007

B: Sorrenti, 2012

C: Vicini, 2014

D: Carrasco, 2015

Study design:

A: Clinical trial

B: Case series

C: Clinical trial

D:  Clinical trial

Setting and Country:

A: China

B: Italy

C: Italy

D: Spain

Source of funding:

Not reported

Inclusion criteria SR:

- have some form of comparison with traditional treatment method for OSA

- published in English

- adult and paediatric studies

5 studies included, but we excluded the one study that was done in children.

Important patient characteristics at baseline:

N; Mean age; BMI

A: 45; 42.1 yrs; 28.7 kg/m2

B: 85; 42.7 yrs; NR-

C: 24; 54.2 yrs; 27.2 kg/m2

D: 53; 43.9 yrs; 27.5 kg/m2

Intervention:

Expansion Sphincter Pharyngoplasty (ESP) (‘’basically a bilateral tonsillectomy, palatopharyngeus muscle rotation flap that is antero-supero-laterally rotated with a figure 8 suture, through the muscle bulk itself, with a vicryl 4/0 round body needle. This palatopharyngeus

muscle is isolated and left with its posterior surface partially attached to the posterior horizontal superior pharyngeal

constrictor muscles. Sufficient muscle has to be isolated to mobilize the muscle and allow the suturing of the muscle with the vicryl suture.’’)

Control:

A: UPPP

B: pre-operative values

C: TORS/UPPP

D: UPPP

End-point of follow-up:

A: 6 months

B: average follow-up tome was 6 months

C: 9 months

D: 6.9 months

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

Success rate: 50 % reduction from the pre-operative AHI and an AHI less than 20: between 80 and 90%.

A: Pre-op AHI: 44.2 ± 10.2

Post-op AHI: 12 ± 6.6

Success rate: 82.6%

B:  Pre-op AHI: 33.3

Post-op AHI: 11.7

Success rate: 89.2%

C: Pre-op AHI: 38.5 ± 14.3

Post-op AHI: 9.9 ± 8.6

D: Pre-op AHI: 27.7 ± 7.5

Post-op AHI: 6.5 ± 5.2

Success rate: 90%

Pooled effect (random effect:

-27.19 (-35.20, -19.18; I2=92%

ESP versus UPPP:

Mean difference post-operative:

A:  -7.60 (-11.86, -3.34), favouring ESP

C: -9.90 (-19.24, -0.56), favouring ESP

D: -11.90 (-18.30, -5.50), favouring ESP

Pooled effect (ReviewManager):

-9.5 (-12.36, -5.73) favouring ESP

No quality assessment of the included studies.

Authors conclusions: The expansion pharyngoplasty in this meta-analysis has

been shown to have significantly better clinical and statistical

outcome compared to the traditional methods of

treating OSA in both adults and children.

In the conclusion the authors mention that there are minimal complications

Caples, 2010

SR and meta-analysis of RCT’s and non-randomized controlled trials, cohort studies and case-series.

Literature search up to June, 2008.

A: Cahali, 2004*

Inclusion criteria SR:

- Reporting of AHI before and after surgical intervention.

- sample size > 1

- published in English

Exclusion criteria:

- Papers that only reported surgical success without precise outcome data on individual study subjects

This broad search yielded 79 papers; one/two papers investigated lateral pharyngoplasty.

Important patient characteristics at baseline:

N, Age range, % men, BMI

Intervention:

15, 43-59 yrs, 80% men, 29.3 kg/m2.

Control:

N=12, BMI 30.1 ± 2.4

Intervention:

Lateral pharyngoplasty

Control:

UPPP

End-point of follow-up:

Not reported

For how many participants were no complete outcome data available?

Outcome measure-1: AHI

Lateral pharyngoplasty:

Pre-op AHI: 41.6

Post-op AHI: 15.5

UPPP:

Pre-op AHI: 34.6 ± 16.3

Post-op AHI: 30 ± 21.6

Ratio of mean pre and post-operative: 0.87 (95%CI 0.53, 1.41)

Quality of studies was very low (for all UPPP studies).

Tongue-volume reducing surgery (e.g. Transoral robotic surgery (TORS), CELL, SMILE

Meccariello, 2016

SR and meta-analysis of case-series /cohorts

Literature search up to November 2015.

A: Thaler, 2015

B: Mudderis, 2014

C: Toh, 2014

D: Hoff, 2014

E: Hoff, 2014b

F: Lin, 2014

G: Vicini, 2014

H: Friedman, 2012

Study design, setting and country:

A: Prospective

B: retrospective

C: retrospective

D: Multicentre retrospective

E: Retrospective

F: Case series

G: Multicentre retrospective

H: retrospective

Source of funding:

Financial disclosures: None

Inclusion criteria SR:

- available information on outcome data

- data concerning surgical treatment

- pre- and post-operative data on AHI, BMI, SpO2, ESS, complications.

Exclusion criteria SR:

- use of TORS for other pathologies

- case reports without significant outcome data

- reports on surgical techniques without significant outcome data

8 studies included

Important patient characteristics at baseline:

Total N=830

Mean age: 49 ± 3.3 yrs

Mean BMI: 29.9 ± 2.4 kg/m2

Previous sleep apnea surgery: n=285

Intervention:

Transoral robotic surgery (TORS):

UPPP (71.3%), expansion sphincter pharyngoplasty (15.3%). Epiglottoplasty was performed in association with robotic tongue base reduction (48.5%). Four papers report on TORS as part of a multilevel setting, one study evaluates TORS as a stand-alone procedure.

Control:

Pre-operative measurements

End-point of follow-up:

Not reported

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

Pooled mean ± SD:

Pre-op AHI: 44.4 ± 9.8

Post-op AHI: 18.8 ± 7.8

P<0.01

Outcome measure-2: ESS

Pre-op ESS: 13.9 ± 1.3

Post-op ESS: 5.9 ± 0.7

P<0.01

Outcome measure-3: Oxygen saturation

Defined as lowest SpO2.

Pre-op SpO2: 78.2 ± 3.2

Post-op SpO2: 84.3 ± 1.4

P<0.01

Complications were reported by 21% of the patients, most of them classified as minor: Transient dysphagia (7.2%), bleeding 4.2%), post-operative pharyngeal edema (1%).

Authors conclusions:

TORS for the treatment of OSAHS appears to be a

promising and safe procedure for selected patients seeking

an alternative to continuous positive airway pressure (CPAP), although further researches are urgently needed.

Justin, 2016

SR and meta-analysis of retrospective and prospective studies

Literature search up to November 2015

Included studies:

Eesa, 2015

Friedman, 2012

Glazer, 2014

Hoff, 2015

Hoff, 2014

Lee, 2012

Lin, 2013

Lin, 2013

Muderris, 2015

Richmon, 2014

Thaler, 2016

Toh, 2014

Vicini, 2010

Vicini, 2012

Vicini, 2014

Vicini, 2014

Source of funding:

No funding source or sponsorship. The authors declared to have no conflicts of interest.

Inclusion criteria:

- articles that studies TORS for OSA

- all study designs, except case reports and small case series (n<5)

- both single and multilevel operations

- published in English

Exclusion criteria:

Not mentioned

16 studies included (2 prospective nonrandomized studies; 1 retrospective study with historical controls; 13 retrospective case series)

Important patient characteristics at baseline:

N, mean age

49.39 (range 48.3 to 54.6) yrs.

BMI: 30.44 (range 26.5 to 34.5) kg/m2

Sex: 74.25% men (range 25-90%)

Intervention:

TORS;

Wide variety in types of procedures:

TORS in base-of-tongue resection or lingual tonsillectomy, with or without performing additional sleep surgery.

Control:

Pre-operative measures

End-point of follow-up:

Mean follow-up ranged from 3-19 months.

For how many participants were no complete outcome data available?

Not described

Outcome-measure 1: AHI

(random effects model; 13 studies):

Summary estimate: 24.0 95%CI, 22.1, 25.8; p<.001, I2 = 99%)

Surgical success, defined as AHI <20 and 50% reduction: 48.2% (95%CI, 38.8-57.7%; P<0.001, I2 = 99%).

Outcome-measure 2: ESS

(Random effects model; 12 studies):

Summary estimate:

-7.2 (95%CI, -7.7, -6.6; P <0.001, I2 = 99%

Outcome-measure 3: Oxygen saturation

Lowest oxygen saturation percentage (LSAT; 9 studies)

Change: 5.3% (95%CI, 4.0-6.7%; P<0.001, I2 = 99%).

Quality of the studies was assessed nu the 2011 Oxford Centre for Evidence-Based Medicine Levels of Evidence table. All studies had level 4.

Ten studies were of moderate quality, six were of high quality.

Because TORS was often one part of a multilevel surgery, it is difficult to specify what the exact effect of TORS is.

Tong-positieveranderdende chirurgie (e.g. Hyoid-Thyroid-pexie)

Song, 2016

SR and meta-analysis of retrospective and prospective studies

Literature search up to September 2015

Included studies:

Hamans, 2013

Mickelson, 2012

Gilespie, 2011

Holzl, 2006

Bowden, 2005

Den Herder, 2005

Stuck, 2005

Riley, 1994

Kaya, 1984

Source of funding:

The authors have no funding, relationships or conflicts of interest to disclose.

Inclusion criteria:

- Adults (≥ 18 yrs) who have OSA

- isolated hyoid surgery as intervention

- quantitative data on pre- and post-hyoid surgery, on AHI, AI, RDI, ODI, LSAT, general outcomes, sleepiness, complications

- any designs

Exclusion criteria:

- studies with additional surgeries

- patients with central sleep apnea

Nine studies included (two case reports, seven case series)

Important patient characteristics at baseline:

N, mean age

N=101 in total

Mean age ± SD: 47.3 ± 12.4 yrs

Mean BMI ± SD: 27.5 ± 3.8 kg/m2

Intervention:

hyoid surgery only

Control:

Pre-operative measurements

End-point of follow-up:

Follow-up ranged from 6 weeks to 1 year.

For how many participants were no complete outcome data available?

Not reported

Outcome measure-1: AHI

Isolated hyoid surgery (mean ± SD):

Pre-op AHI: 37.3 ± 21.1 (95%CI 33.1, 41.5)

Post-op AHI: 23.0 ± 18.6 (95%CI 19.3, 26.7)

Reduction of 38.3% (p<0.0001)

Outcome measure-2: ESS

(two studies, n=39)

Pre-op ESS: 10.3 ± 4.9 (95%CI 8.8, 11.8)

Post-op ESS: 7.1 ± 4.2 (95%CI 5.8, 8.4); P=0.0027

Outcome measure-3: Oxygen saturation

Defined as ODI (1 study)

Pre-op ODI: 23.6 ± 18.0

Post-op ODI: 15.6 ± 8.3; p=0.29

Defined as LSAT (2 studies, n=40)

Pre-op LSAT: 80.8 ± 7.4

Post-op LSAT: 82.6 ± 6.5; p=0.25

NICE criteria were used to assess quality of the studies. Most studies met between four and seven (of the eight) criteria).

Authors conclusions;

Isolated hyoid surgery has reduced OSA severity and improved sleepiness in adults. Hyothyroidopexy provided a 50.7% reduction in AHI, followed by hyoid myotomy with suspension (38.3% reduction in AHI) and hyoid expansion (7.1% reduction in AHI).

Handler, 2014

SR and meta-analysis of retrospective and prospective studies

Literature search up to October, 2012

Included studies:

DeRowe, 2000

Woodson, 2000

Woodson, 2001

Kuhnel, 2005

Fibbi, 2009

Sezen, 2011

Miller, 2002

Terris, 2002

Sorrenti, 2003

Thomas, 2003

Omur, 2005

Vicente, 2006

Fernandez, 2009

Sezen, 2011

Source of funding:

Philips (E.HAMANS); ApniCure (A.N.G.); Siesta Medical

(E.HANDLER, A.N.G., S.M.). The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Inclusion criteria:

- tongue suspension as stand-alone therapy

- tongue suspension as part of a multilevel approach

- genioglossus advancement with UPPP, or genioglossus with hyoid suspension

Exclusion criteria:

- letters or comments

- a tongue suspension procedure was not performed as part of

the methods.

- an additional airway surgery was performed along with the

tongue suspension.

- clinical indication was unrelated to OSA and/or snoring

A total of 27  studies were included, of which six investigated tongue suspension as stand-alone therapy, eight investigated tongue suspension with UPPP, and 18 publications investigated  genioglossus advancement with UPPP, of genioglossus with hyoid suspension (not included in this review)

Important patient characteristics at baseline:

Tongue suspension:

N=82 in total

Mean age ± SD:

Mean BMI: 29.4 kg/m2

Tongue suspension with UPPP:

N=167 in total

Mean age ± SD:

Mean BMI: 29.9 kg/m2

- Tongue suspension as stand-alone therapy (6 studies)

- Tongue suspension with UPPP (8 studies)

Pre-operative measurements

End-point of follow-up:

Tongue suspension:

Follow-up ranged from 2 months to 2 years

Tongue suspension with UPPP:

Follow-up ranged from 3 months to 3 years

For how many participants were no complete outcome data available?

Outcome measure-1: AHI

Tongue suspension as stand-alone therapy (6 studies)

Pre-op AHI: 32.0

Post-op AHI: 18.8

41.1% reduction.

Surgical success, defined as ≥50% reduction in AHI and an AHI <20, was 36.6%

Tongue suspension with UPPP (8 studies)

Pre-op AHI: 44.0

Post-op AHI: 16.6

622.3% reduction.

Surgical success, defined as ≥50% reduction in AHI and an AHI <20, was 62.3%

Quality of the studies was assessed nu the Oxford Centre for Evidence-based Medicine (1=high evidence, 5=low).

Tongue suspension as stand-alone therapy (6 studies)

One article had level 2 evidence, five articles had level 4 evidence.

Complications: removal of the tongue suspension structure was needed in three patients because  of infection and pain

Tongue suspension with UPPP (8 studies)

Two articles had level 2 evidence, six articles had level 4 evidence.

Complications: extrusion of the suture, broken suture, persistent globus sensation (resolved with suture removal)

Radiofrequency thermotherapy

Baba, 2015

SR and meta-analysis of case-series /cohorts / clinical trials/ RCT’s about the temperature controlled radiofrequency tissue ablation (TCRFTA).

Literature search up to April 2013

BoT:

Powell, 1999

Stuck, 2002

Woodson, 2001

Li,

Stuck, 2002

Riley, 2003

Blumen, 2006

Den herder, 2006

Friedman,

Fibbi, 2009

Soft palate:

Brown,

Blumen,

Terris,

Atef,

Back

Multilevel:

Woodson, 2003

Fischer, 2003

Steward, 2004

Steward, 2004a

Stuck, 2004

Steward, 2004

Neruntarat, ..

Uloza, 2009

Ceylan, 2009

Uloza, 2009

De Vito, 2012

Study design: RCT (parallel / cross-over), cohort (prospective / retrospective), case-control

Source of funding:

The authors declared none financial disclosures or conflicts of interest.

Inclusion criteria SR:

- Subjects with OSA confirmed by clinical symptoms and a PSG demonstrated RDI≥5;

- treatment with TCRFTA of the soft palate, base of the tongue or both as a stand-alone procedure;

- published in English

Exclusion criteria SR:

- TCRFTA was used with other surgical interventions such as uvulopalatopharyngoplasty;

- TCRFTA was used for treatment of socially disruptive snoring or upper airway resistance syndrome.

A total of 20 studies was included.

Important patient characteristics at baseline:

Base of tongue:

Number of participants ranges from: 11 -96.

Mean age ranged from: 44.9 – 57.9

Soft palate:

Number of participants ranges from: 12 -78.

Mean age ranged from: 45 – 52.8

Multilevel:

Number of participants ranges from: 16 - 72

Mean age ranged from: 35.8  – 56.0

Intervention:

1) TCRFTA of the base of tongue (BoT): three non-randomized, parallel group trials, and seven prospective case series

2) TCRFTA of the soft palate: five studies, of which two non-randomized, prospective case series,

3) TCRFTA in multilevel approach: 11 studies (9 were included in the meta-analysis): one RCT, two non-randomized comparative parallel group trials, five prospective case series, and one retrospective case series.

Control

1) CPAP (n=1), submucosal minimally invasive lingual excision (SMILE, n=1), or lingual suspension (n=2)

End-point of follow-up:

BoT: Follow-up ranged from 12 weeks – 28 months

SP: Follow-up ranged from 6 weeks – 18 months

Multilevel: Follow-up ranged from 8 weeks – 23 months

For how many participants were no complete outcome data available?

Outcome measure 1: RDI

TCRFTA of BoT (7 studies): ratio of means (RoM) = 0.60 (95%CI 0.47–0.76), p<0.0001, I2=51 %

TCRFTA of SP:

ROM = 0.67 (95%CI 0.43–1.03), p=0.07, I2=83 %)

TCRFTA in multilevel:

RoM (7 observational studies) = 0.59 (95%CI 0.45–0.79), p=0.0003, I2=93 %

RoM (1 RCT) = 0.79 (95%CI 0.54–1.15), p=0.21

Outcome measure 2: ESS

TCRFTA of BoT (6 studies):

RoM = 0.59 (95%CI 0.51–0.67), p<0.00001, I2=0

TCRFTA of SP (2 studies):

RoM = 0.85 (95%CI 0.63–1.15), p=0.29, I2=0 %

TCRFTA in multilevel:

RoM (4 observational studies) = 0.78 (95%CI 0.69–0.89), p=0.0001, I2=0 %

RoM (1 RCT) = 0.82 (95%CI 0.67–1.02), p=0.08

Outcome measure 3: Oxygen saturation

Defined as Lowest oxygen saturation (LSAT %)

TCRFTA of BoT (4 studies):

RoM =1.05 (95%CI 1.01–1.10), p=0.02, I2=37%

TCRFTA in multilevel:

RoM (3 observational studies) = 1.03 (95%CI 1.00–1.06), p=0.08, I2=73%

RoM (1 RCT) = 0.99 (95%CI 0.95–1.03), p=0.73

Outcome measure 4: QoL

Defined as VAS-snoring

TCRFTA of BoT (3 studies):

RoM = 0.48 (%CI 0.37–0.62), p<0.00001, I2=0

SF-36: significant effects on physical, bodily pain, vitality, and social functioning.

TCRFTA of SP (5 studies):

RoM = 0.39 (95%CI 0.30–0.50), p<0.00001, I2=0 %

TCRFTA in multilevel:

RoM (3 observational studies) = 0.54, (95%CI 0.41–0.70), p<0.00001, I2=59%

Conclusion of the authors: TCRFTA seems to be clinically effective in reducing RDI levels and symptoms of sleepiness in patients with OSA syndrome

when directed at the base of tongue or as a multilevel

procedure.

Adverse effects

TCRFTA of BoT: ulceration of the tongue base mucosa, odynophagia,

pharyngodynia, mild-to-severe tongue edema, ecchymosis,

hematoma, transient neuralgia, transient tongue deviation,

and hypoglossal nerve injury. Eight cases of infection and

two cases of tongue base abscess were reported by studies that

did not use perioperative antibiotic prophylaxis

Caples, 2010

SR and meta-analysis of case-series /cohorts

Literature search up to June 2008.

Bot:

Den Herder, 2006

Riley, 2003

Stuck, 2005

Soft palate:

Bassiouny, 2007

Blumen, 2002

Wassmuth, 2000

Mixed:

Fisher, 2003

Stuck, 2004

Woodson, 2003

Source of funding:

The study was not industry supported. Dr. Caples has received research support from ResMed and Ventus Medical.

Inclusion criteria SR:

- surgical treatment of OSA

- randomized and non-randomized trials, cohort studies and case series (n<1)

- reporting AHI before and after surgical intervention

Exclusion criteria SR:

- publications of isolated nasal procedures, isolated tonsillectomy, and tracheostomy

- studies that only reported surgical success without precise outcomes data on individual subjects

The broad search revealed 79 studies, of which nine studies of RFA: one RCT (Woodson, 2003), 8 observational studies.

Important patient characteristics at baseline:

Not reported

Groups comparable at baseline?

NA

Intervention:

- RFT of the soft palate: three studies

- RFT of the tongue base: three studies

- RFT of multiple levels: 1 RCT and 2 observational studies

Control:

Pre-operative measurements.

The control group in the RCT received sham surgery and CPAP.

End-point of follow-up:

not mentioned

For how many participants were no complete outcome data available?

Outcome measure-1: AHI

Ratio of Means (7 observational studies and 1 RCT): 0.66 (95%CI 0.54, 0.81). I2: 38%.

RCT: RoM: 0.79 (95%CI 0.55- 1.14)

Observational studies: 0.64 (95%CI 0.50- 0.80). Change in mean AHI from 23.4 to 14.2.

Outcome measure 2: ESS

ESS in the observational studies changed from 9.7 to 6.7, significance unknown.

Farrar, 2008

SR and meta-analysis of case-series /cohorts / RCT’s

Literature search up to 2008 (?)

BoT:

Powel, 1999

Nelson, 2001

Woodson, 2001

Stuck, 2002

Li, 2002

Riley, 2003

Den Herder 2006

Blumen, 2006

Soft palate:

Terris, 2002

Blumen, 2002

Mixed:

Fischer, 2003

Woodson, 2003

Steward, 2004

Steward, 2004

Stuck, 2004

Steward, 2005

Source of funding:

Inclusion criteria SR:

- patients diagnosed with OSA  on the basis of symptoms and a preoperative PSG (RDI ≥5)

- treatment consisting of RFA of the palate, tongue base, or both as a stand-alone procedure

- reporting at least one the following outcomes: pre- and postoperative treatment RDT, ESS, or lowest oxygen saturation.

16 studies were included (three randomized, 13 non-randomized)

Important patient characteristics at baseline:

Number of participants ranged from 9-56.

BMI, mean ± SD = 28.5 ± 3.8

Radiofrequency ablation (RFA)

Base of tongue: 8 studies

Soft palate: 2 studies

Mixed: 6 studies

Pre-operative measurements?

Follow-up time

Follow-up time ranged from 6 weeks to 28 months

Outcome measure 1: RDI

OR=0.69 (95%CI 0.61-0.77)

Long term (24 months)

OR= 0.55 (95%CI 0.45-0.72)

Outcome measure 2: ESS

OR=0.69 (95%CI 0.63-0.75) (14 studies)

Long term (24 months):

OR=0.68 (95%CI 0.43-0.73)

Outcome measure 3: Oxygen saturation

Defined as lowest oxygen saturation.

OR=1.02 (95%CI 0.88-1.20) (9 studies)

Complications

Soft palate RFA (144 patients):

Mucosal ulceration (2.4%)

Palate perforation (1.2%)

Peritonsillar abscess (0.3%)

Tongue base RFA (252 patients):

Floor of mouth hematoma (0.7%)

Tongue cellulitis w/o abscess (0.6%)

Tongue edema requiring hospitalization (0.6%)

Mucosal ulceration (0.6%)

Tongue base abscess (0.3%)

Hypoglossal nerve paresis (0.3%)

Lingual nerve hypesthesia (0.1%)

Vasovagal syncope (0.1%)

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control I ³

Follow-up

Outcome measures and effect size ⁴

Comments

Lateral pharyngoplasty

Mantovani, 2016

Type of study:

Case series

Country: Italy

Source of funding:

No financial support was received for the study

Inclusion criteria

- adult patients with severe OSAS (AHI ≥30) due to retro-palatal obstruction

- who had undergone tonsillectomy

- refused CPAP treatment

Exclusion criteria:

- chronic lower airway disease

- chronic systemic disease

- craniofacial, neuromuscular, psychiatric, syndromic or defined genetic disorders

- drug or alcohol addiction

- previous OSAS surgery

- BMI>30 kg/m2

- no variation in BMI of >0.2 during the follow-up period

- follow-up of <6 months

N total at baseline:

N=32

Important prognostic factors²:

Age, mean ± SD: 47.3 ± 8.6 yrs

Sex: 75% men

BMI, mean ± SD: 27.4 ± 0.8 kg/m2

Barbed Roman blinds Technique (BRBT)

Pre-operative measurements

Length of follow-up:

Mean follow-up time was 12.1 ± 2.0 months

Outcome measure-1: AHI

Pre-op: 36.9 ± 4.5

Post-op: 13.7 ± 4.5

P<0.001

Success rate, defined as a reduction in AHI of ≥50% and/or a post-operative AHI of <20/hour: 84%

Outcome measure-2: ESS

Pre-op: 15.3 ± 4.4

Post-op: 5.7 ± 2.9

P<0.0014

Outcome measure-3: Oxygen saturation

Defined as time with <90% )2 saturation

Pre-op; 12.5 ± 6.7

Post-op: 3.5 ± 4.2

P<0.001

Outcome measure-4: QoL

Defined as VAS (tolerability): 4.3 ± 0.7

Complications:

No significant complications (i.e. dyspnea, dysphagia, swallowing disturbances, bleeding).

BRBT seems to like a minimally invasive, safe and effective surgery method to treat OSAS.

Vicini, 2015

Type of study:

Case series

Setting:

Country: Italy

Source of funding:

Not reported.

The authors report no conflicts of interest

Inclusion criteria:

- patients diagnosed with mild to severe OSA (AHI ≥5)

- having the main site of obstruction at the retropalatal level with or without retrolingual obstruction

- patients not accepting or unwilling to use CPAP

- failures of previous surgery

- age between 21-70

BMI ≤ 35 kg/m2

- Patients fit for general anaesthesia

Exclusion criteria:

- severe medical illness

- significant craniofacial anomalies affecting airways

- limited mouth opening

N total at baseline:

N=10

Important prognostic factors²:

Age, mean ± SD: 53.4 ± 12.4 (range 30-70) yrs

100% men

BMI, mean ± SD: 28.5 ± 3.6

Groups comparable at baseline? NA

Barbed Reposition Pharyngoplasty (BRP); as a step in a multisite procedure. BRP in combination with TORS (n=3); hyoid suspension (n=6); nasal surgery (n=9); tonsillectomy (n=9).

Pre-operative measurements

Length of follow-up:

6 months

Loss-to-follow-up:

N=0

Incomplete outcome data:

N=0

Outcome-measure 1: AHI:

Pre-op: 43.65 ± 26.83

Post-op: 13.57 ± 15.41; p=0.007.

Success rate, defined as post-operative AHI < 20 with a reduction of <50%: 90%.

Outcome-measure 2: ESS:

Pre-op: 11.6 ± 4.9

Post-op: 4.3 ± 2; p<0.01.

Outcome-measure 3: ODI

Pre-op: 44.7 ± 27.3 

Post-op: 12.9 ± 16.3; p=0.004.

Complications: foreign body sensation at the palate, but spontaneously disappeared.

BRP was presented as a step in a multilevel ithuania

Chi, 2015

Type of study:

Randomized controlled trial:

Country: Taiwan

Source of funding:

Not reported.

The authors report no conflicts of interest

Inclusion criteria:

- history of CPAP intolerance

- narrowing retropalatal and retroglossal space by Muller’s maneuver

- low Friedman tongue base grade (Grade I, Iia, Iib, III)

- larger tonsils size (grade 2, 3, 4)

Exclusion criteria:

- history of previous oropharyngeal surgery

- BMI > 40 kg/m2

- presence of uncontrolled hypothyroidism

- gross craniofacial anomalies

- cleft palate and lip

N total at baseline:

UPPP + LP: N=30

UPPP: N=30

Important prognostic factors²:

Age, mean ± SD, % men, BMI:

UPPP + LP: 43.7 ± 9.9 yrs, 84%, 27.0 ± 4.6 kg/2

UPPP: 36.4 ± 10.5 yrs, 76%, 28.4 ± 5.7 kg/m2

Groups comparable at baseline? Yes

Intervention:

UPPP + lateral pharyngoplasty

Control:

UPPP

Length of follow-up:

4-6 months after the surgery

Loss-to-follow-up:

UPPP + LP: n=5

UPPP: N=1

Reasons: not reported

Incomplete outcome data:

UPPP + LP: n=5

UPPP: N=1

Reasons: not reported

Outcome-measure 1: AHI

UPPP + LP:

pre-op: 34.1 / post-op: 17.3

UPPP:

Pre-op: 30.6 / post-op: 21.3;

P=0.088.

Outcome-measure 2: ESS

UPPP + LP:

pre-op: 10.5 / post-op: 7.7

UPPP:

Pre-op: 11.2/ post-op: 9.9;

P=0.91.

Outcome-measure 3: oxygen saturation

Defined as mean SpO2

UPPP + LP:

pre-op: 93.1 / post-op: 94.5

UPPP:

Pre-op: 93.4/ post-op: 95.1;

P=0.83.

In patients with moderate severity (n=12), a significant effect was observed in AHI, favouring UPPP+LP.

Emara, 2016

Type of study:

Prospective study

Country: Egypt

Source of funding: None

The authors declared to have no competing interests.

Inclusion criteria

- nocturnal polysomnography diagnostic of OSA

- body mass index <30 kg/m2

- small tonsils or previous tonsillectomy

- Friedman stage II or III, type I Fujita

- inability to tolerate nasal CPAP or failed CPAP-therapy

- retropalatal and lateral pharyngeal collapse

- diagnosis with flexible nasoendoscopy during a Müller’s maneuver based on a 5-point scale.

Exclusion criteria

Patients with retroglossal airway collapse

N total at baseline:

N=41

Important prognostic factors²:

Age, range: 27-54

76% men

BMI mean ± SD: 27.5±1.1 kg/m2

Mild OSA n=8; moderate n=22; severe n=8

Intervention:

Anterolateral Advancement Pharyngoplasty

(‘’to advance and fix the palatopharyngeus muscle with the superior pharyngeus constrictor muscle without transecting any of their fascicules anterolateral to the pterygomandibular raphe and anterosuperior to the levator veli palatine muscle.’’)

Control:

Preoperative measurements

Length of follow-up:

6 months

Loss-to-follow-up:

N=3

Reasons: not mentioned

Incomplete outcome data:

N=3

Reasons: not mentioned

Outcome-measure 1: AHI

Pre-op AHI: 42.1 ± 16.3

Post-op AHI: 16.3 ± 10.3; p≤0.001 (95%CI 18.2, 31.1)

Surgical success was 86.6%, defined as a 50% reduction in AHI and AHI<20.

33 patients (of the 38; 87%)

Achieved surgical success (AHI <20 and a 50% decrease in AHI)

Outcome-measure 2: ESS

Pre-op: 16.3 ± 2.1

Post-op: 8.1 ± 2.8

P≤0.001 (95%CI 3.56, 7.58)

Outcome-measure 3: Oxygen saturation

Pre-op: 79.9 ± 14.8

Post-op: 89.3 ± 11.1;

p≤0.05 (95%CI -13.5, -3.5)

Complications: There was no postoperative bleeding, velopharyngeal insufficiency, speech alternations, or taste loss. 

Authors conclusions: Anterolateral advancement pharyngoplasty appears to be an effective technique with a high surgical success rate in the treatment of OSA patients with lateral pharyngeal wall collapse.

Kim, 2013

Type of study:

Retrospective study

Country:

South-Korea

Source of funding:

The authors declared to have no conflicts of interests.

Inclusion criteria

- patients with OSAS

- age ≥20 yrs

N total at baseline:

N=92

Important prognostic factors²:

Age mean ± SD: 47.0 ± 11.8

BMI, mean ± SD: 25.6 ± 3.2 kg/m2

Sex: 75% men

Modified uvulopalatal flap with lateral pharyngoplasty.

Concomitant tonsillectomy was performed in 85 patients, turbinate or nasal septal surgery was performed in 61 patients.

Pre-operative measurements

Length of follow-up:

6 months

Loss-to-follow-up:

Not reported, but probably none.

Incomplete outcome data:

Not reported, but probably none.

Outcome-measure 1: AHI

Pre-op AHI: 39.1 ± 21.6

Post-op AHI: 7.9 ± 5.6; p<0.001

Surgical success was 78.3%, defined as a 50% reduction in AHI and AHI<20.

Outcome-measure-2: ESS

Pre-op ESS: 11.1 ± 5.1

Post-op ESS: 6.6 ± 3.7; p<0.001

Outcome-measure-3: Oxygen saturation

Defined as minimal oxygen saturation

Pre-op: 77.0 ± 10.8

Post-op: 86.4 ± 11.3; p=0.001

Outcome-measure-4: QoL

Defined as Visual analogue scale for snoring, scaled by the bed-partner or observer. à niet meenemen

Pre-op: 7.9 ± 2.5

Post-op: 3.6 ± 2.4; p<0.00

Postoperative complications included transient nasal

regurgitation, bleeding, dysphagia and foreign-body sensation. These were self-limited and resolved in a few months.

No major postoperative complication, such as velopharyngeal insufficiency, was observed in any patient.

Transoral robotic surgery

Li, 2016

Title: Efficacy of Coblation Endoscopic Lingual Lightening in Multilevel Surgery for Obstructive Sleep Apnea.

Type of study:

Retrospective case-control study

Country:

Taiwan/China

Source of funding: non- commercial (ministery of science and technology; Chang Gung Memorial hospital)

Inclusion criteria:

- Adults with OSA, with AHI>20

- chief symptoms of snoring or daytime sleepiness

- Friedman stage III (tongue position III and tonsil size I-II).

- enlarged lingual tonsils or tongue base on flexible nasopharynogoscopy

- intolerance of or unwillingness to use CPAP

Exclusion criteria:

- lack of follow-up PSG

- history of OSA surgical treatment to the soft palate or tongue

N total at baseline:

N= 90

Intervention: n=30

Control: n=60

Important prognostic factors²:

Intervention:

Age, mean ± SD: 41.5 ± 9.4 yrs

Sex: 90 % men

BMI, mean ± SD: 26.4 ± 3.0

Control:

Age, mean ± SD: 40.3 ± 9.2 yrs

Sex: 98 % men

BMI, mean ± SD: 26.6 ± 2.8

Groups comparable at baseline? Yes

Groups were matched by age, sex, BMI, baseline AHI.

Intervention:

Coblation endoscopic lingual lightening (CELL) and relocation pharyngoplasy

Control:

Relocation pharyngoplasy alone

Length of follow-up:

Six months

Loss-to-follow-up:

Intervention: 0 (not described, but as it is a retrospective study, it would probably zero. 

Control:

Intervention: 0 (not described, but as it is a retrospective study, it would probably zero.

Incomplete outcome data:

See above

Outcome-measure 1: AHI

Intervention:

Pre-op AHI: 48.4 ± 16.9

Post-op AHI: 16.5 ± 11.2;

Reduction: -65.5± 20.5%, P<0.001.

Control:

Pre-op AHI: 44.2 ± 19.3

Post-op AHI: 20.1 ± 15.6; -Reduction: 59.1±30.3%, P<0.001.

Change in % was significantly higher in the intervention group than in the control group; p=0.047

Surgical response rate was also greater in the intervention group (73%) than in the control group (50%); p=0.04.

Outcome measure-2: ESS

Intervention:

Pre-op ESS: 10.9±4.7

Post-op ESS: 8.7±3.9

Reduction: -17.1±38.4, p=0.004

Control:

Pre-op ESS: 11.4±5.0

Post-op ESS: 7.8±3.7

Reduction: -20.2±74.5, p<0.001

Groups did not differ.

Outcome measure-3: Oxygen saturation

Defined as lowest oxygen saturation (%)

Pre-op: 76.4±8.5

Post-op: 82.4±5.4

Reduction: 8.6±9.6, p<0.001

Control:

Pre-op: 77.5±7.9

Post-op: 81.8±8.5

Reduction: 5.9±9.9, p<0.001

Groups did not differ.

Combined CELL and relocation pharyngoplasty had better AHI outcomes than relocation pharyngoplasty alone. On other outcome measures, there were no differences in effect shown.

Li, 2016b

Title: Coblation endoscopic lingual lightening (CELL) for obstructive sleep apneu

Type of study:

Retrospective case series

Country:

Taiwan, China

Source of funding:

Inclusion criteria:

- adults ≥18 yrs

- significant OSA symptoms of daytime sleepiness or snoring

- Friedman tongue position III

- mouth opening ≥ 3 finger bradths

- tongue base touching or pushing epiglottis during Mullers maneuver in flexible nasopharungoscopy

- moderate to severe OSA (AHI>15)

- poor response to conservative measures either intolerance or unwilling to accept CPAP or MAD 

Exclusion criteria:

- pregnant women

N total at baseline:

N=25 moderate to severe OSA

Important prognostic factors²:

Age, mean ± SD: 42±9 yrs

Sex: 80% men

BMI: 26.5±3.0 kg/m2

80% had severe OSA

Groups comparable at baseline? NA

Intervention:

Coblation endoscopic lingual lightening (CELL) surgery in combination with modified uvulopalatopharyngoplasty (known as relocation pharyngoplasty)

Control:

Pre-operative measurements

Length of follow-up:

Six months after the surgery (range 6-8 months)

Loss-to-follow-up:

N=0; patients were already selected on complete outcome data.

Control:

N (%)

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome-measure 1: AHI

Pre-op AHI: 45.7 ± 21.7

Post-op AHI: 12.8 ± 8.2

P<0.001

Postoperative AHI<15: 72%

Overall response rate, defined as Ahi<20 and at least a reduction in AHI of 50%, was 80%.

Outcome measure-2: ESS

Pre-op ESS: 9.6 ± 4.9

Post-op ESS: 7.5 ± 4.3

P=0.023

Outcome measure-3: oxygen saturation

Defined as lowest oxygen saturation

Pre-op: 77.1± 10.5

Post-op: 83.3±5.6

P=0.001

Conclusions of the authors:

CELL is feasible, safe and effective in treating tongue base obstruction in OSA patients who underwent simultaneous relocation pharyngoplasty.

Complications:

‘’One postoperative bleeding case involving the left tongue base that was re-treated by coblation in the operation theatre’’

Temporary decreased taste: 20%; taste disturbance at 1 year after surgery: 4%. No incidences of airway compromise, paralyzed tongue or speech dysfunction..

Arora, 2015

Type of study:

Prospective case series

Country: Brazil

Source of funding: no funding was received.

The authors declared that they have no competing interests.

Inclusion criteria:

- moderate-to-severe OSA confirmed by sleep study (AHI ≥15/h)

- failure to tolerate or comply with other OSA treatment modalities including CPAP and MAD

- BMI<35 kg/m2

- predominant BOT collapse with or without epiglottic collapse evaluated by DISE

Exclusion criteria:

- contraindications to elective surgery due to severe comorbidities, limited mouth opening and a failure to attend post-operative follow-up for a minimum period of 12 months

N total at baseline:

N=14

Important prognostic factors²:

Age, mean ± SD: 54.3 ± 14.6 yrs

Sex: 93% men

BMI, mean ± SD: 28.7 ± 2.8 kg/m2

Patients undergone previous surgery for OSA: 64%

Groups comparable at baseline? N.a.

Intervention:

Transoral robotic surgery (TORS) of the tongue base with (n=10) or without epiglottoplasty (n=4)

Control:

Pre-operative measurements

Length of follow-up:

Follow-up measurements were done after six months. QoL measures were repeated at 2 weeks, 3, 6, 12, 18 and 24 months.

Median follow-up time was 24 months (mean 18.9, Sd 6.2, range 12-24).

Loss-to-follow-up:

N (%): 3 (21%)

Reasons: refused a  post-operative sleep study because they reported feeling significantly better.

Incomplete outcome data:

N (%): 3 (21%)

Reasons: refused a  post-operative sleep study because they reported feeling significantly better.

Outcome-measure 1: AHI

(n=11)

Pre-op AHI: 36.3 ± 21.4

Post-op AHI: 21.2 ± 24.6,

Reduction: 51%, p=0.03.

Success rate: 64% (defined as AHI<20 and ESS<10 and at least 50% reduction in AHI.)

Cure rate: 36% (defined as AHI<5 and ESS<10 and at least 50% reduction in AHI.

Outcome measure-2: ESS

Pre-op: 14.9 ± 5

Post-op: not reported

All patients had normal ESS at 6 months (Reduction p=0.002)

Outcome measure-3: Oxygen saturation

Defined as mean oxygen saturation  levels:

Pre-op: 92.9 ± 1.8 

Post-op: 94.3 ± 2.5; p=0.005

Outcome measure-4: QoL

Measured with EQ-5D VAS

EQ-5D significantly improved in all patients from 3 months forward.

Complications:

One patient had a minor secondary bleed (21 days following surgery); one patient developed dysgeusie; two patients reported persistent odynophagia to solids. These symptoms were temporary and resolved within 6 weeks.

Friedman, 2008

Evaluation of submucosal minimally invasive lingual excision technique for treatment of obstructive sleep apnea/hypopnea syndrome

Type of study:

Historical cohort with planned data collection

Setting: tertiary care center

Country:

Source of funding:

Inclusion criteria:

- signs and symptoms of OSAHS

- abnormal PSG

- intolerance or failure of CPAP

Exclusion criteria:

N total at baseline:

SMILE: n=48

RFBOT: n=48

Important prognostic factors²:

Age, mean ± SD, sex, BMI:

SMILE: 44.0 ± 9.1 yrs; 83% men; 30.6 ± 5.2 kg/m2

RFBOT: 46.1 ± 11.7 yrs; 81.3% men; 29.0 ±4.4 kg/m2

Groups comparable at baseline?

Yes

Intervention:

Submucosal minimally invasive lingual excision (SMILE)

Control:

- Radiofrequency base of tongue reduction (RFBOT)

Length of follow-up:

Average follow-up time was 6.4 months, with a range of 3 to 18 months

Loss-to-follow-up:

None reported, probably because it is a retrospective study

Incomplete outcome data:

See above

Outcome-measure 1: AHI

% change in AHI

SMILE: -54.4 ± 26.7%

RFBOT: -44.1 ± 28.6%

NS

Outcome-measure 2: ESS

% change in ESS

SMILE: -32.0 ± 28.0

RFBOT: -23.5 ± 25.7

NS

Outcome measure-3: Oxygen saturation

%change in min SaO2

SMILE: 4.8 ± 15.8

RFBOT: 3.9 ± 11.6

NS

Outcome measure-4: QoL

Defined as VAS pain severity score

SMILE: 3.6 ± 2.5

RFBOT: 2.4 ± 2.3

P=0.014

Complications:

RFBOT: no significant bleeding; one patient developed partial hypoglossal nerve paralysis that resolved within a month; no airway complications; no significant edema.

SMILE: bleeding was minimal in 46 (of the 48) patients. Two patients had significant bleeding. Four patients developed temporary hypoglossal paralysis that resolved within 2 months. One patient had permanent unilateral hypoglossal paralysis. Seix patients had significant edema (impaired tongue mobility, swallowing and speech for 1-3 days).

SMILE had a higher overall success rate than RFBOT, but resulted in higher morbidity rates.

Hyoid-Thyroid-pexie

Canzi, 2013

Type of study:

Retrospective study

Country: Italy

Source of funding:

Not reported.

The authors declared that they did not have conflict of interests.

Inclusion criteria:

- adult patients with OSAS and no other sleep-disordered breathing

- CPAP use had failed or patients refused it

- multilevel pharyngeal obstruction

Exclusion criteria:

-

N total at baseline:

N=140

Important prognostic factors²:

Age, mean: 50.7, range 32-76

Sex: 91% men

BMI, median: 27.8 kg/m2

Mild OSAS (AHI: 5-15): 15%

Moderate OSAS (AHI: 16-30): 33%

Severe OSAS (AHI >30): 52%.

Groups comparable at baseline?

NA

Intervention:

Hyoid suspension type II, in multilevel OSAS surgery

Control:

Pre-treatment measurements

Length of follow-up:

Follow-up ranged from 6-18 months

Loss-to-follow-up:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measure-1: AHI

Pre-op AHI, median (IQR): 31 (21 –44) events/h

Post-op AHI, median (IQR): 12 (6-25) events/h

Difference: -19, p<0.05

Responders (AHI<20): 67%

Outcome measure-2: ESS

Pre-op ESS, median (IQR): 10 (8-12)

Post-op ESS, median (IQR): 8 (6-9)

Difference: -2, p<0.05

Authors conclusions;

‘’Hyoid suspension in multilevel treatment is effective when short-term results are considered.’’

‘’No intraoperative adverse events or major complications occurred.’’ Two patients reported neck seroma, one patient reported hyoid fracture, and one keloid scar development. No further significant effects. 

Piccin, 2013

Type of study:

Case series

Country: Italy

Source of funding:

None

Competing interests:

None

Inclusion criteria:

- Patients with OSAS that underwent hyoid suspension

Exclusion criteria:

N total at baseline:

N=25 / 27

Important prognostic factors²:

Age, mean ± SD: 46 ± 11.8 yrs

Sex: 100% men

BMI, mean ± SD: 28.8 ± 3.7 kg/m2

Groups comparable at baseline? NA

Intervention:

Hyoid suspension using a modified Hörman technique

Control:

Pre-operative measurements

Length of follow-up:

At least 4 months of follow-up. Mean follow-up time was 6.5 months (range 4-10 months)

Loss-to-follow-up:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measure-1: AHI

Pre-op AHI, mean ± SD: 43.1 ± 25.1

Post-op AHI: 10.9 ± 5.8;

P<0.001

AHI decreased by 74.8%.

Surgical success, defined as AHI <20 with a decrease ≥ 50%, was 76%.

Outcome measure-2: ESS

Pre-op ESS, mean ± SD: 16 ± 6

Post-op ESS: 7.4 ± 3.2;

P<0.001

Outcome measure-3: Oxygen saturation

Defined as ODI:

Pre-op ODI, mean ± SD: 43.5 ± 28.2

Post-op ODI: 13.3 ± 6.9;

P<0.001

Defined as Lowest oxygen saturation:

Pre-op, mean ± SD: 72.9 ± 15.2

Post-op: 89.2 ± 5.1;

P=0.002

Patients with a BMI ≤30 kg/m2 had a greater reduction in AHI compared to patients with a BMI > 30 kg/m2.

Age was a predictor for success or failure of this kind of surgery.

No complications related to this modification were noted.

Radiofrequency thermotherapy of the tongue base

Balsevičius, 2015

Type of study:

Prospective, nonrandomized single center case study

Country:

Lithuania

Source of

funding:

Inclusion criteria:

- Age 18-65 years

- BMI ≤35 kg/m2

- AHI 5-30 /h

- Mallamati⁰ I⁰-II⁰

- Friedmand⁰ 0⁰-2⁰

- Obstruction of III⁰ and IV⁰ at the retro-palatal level measures during the Mueller maneuver

Exclusion criteria:

- allergies

- pregnancy

- psychiatric and neurological disorder

Previous palatal/tongue base surgery

Speech/swallowing disorders

- Bleeding disorders

Severe nasal obstruction

Excessive mucosa at the posterior palatal arch, elongated uvula

- Obstruction of III⁰ and IV⁰ at the retro-lingual level measured during Mueller maneuver

- Significant hypertrophy of the lingual tonsil

N total at baseline:

N=35

Important prognostic factors²:

Age, mean ± SD: 42.7 ± 12.2 yrs

Sex: : 64% M

BMI, mean ± SD: 28.0 ± 3.7 kg/m2

Intervention:

Radiofrequency ablation of the soft palate, nine lesions; two sessions

Control:

Pre-operative measurements

Length of follow-up:

At least after three months after the procedure. Mean follow-up time was 118 days (SD 21).

Loss-to-follow-up:

N=7:

N=2 stopped after first RFT session

N=5 declined to participate in posttreatment evaluation

Incomplete outcome data:

N=7:

N=2 stopped after first RFT session

N=5 declined to participate in posttreatment evaluation

Outcome measure 1: AHI

Pre-operative: 13.7±5.9 Postoperative: 8.3±4.9 (p<0.001).

60.7% of the patients improved their AHI by at least 50%.

Outcome measure 2: ESS

Pre-operative: 8.5 ± 4.1

Post-operative: 6.7 ± 3.7

P<0.01

Outcomes measures 4: QoL

Defined as Lithuanian version of the sleep apneu quality of life index

Pre-operative: 4.7±0.9

Postoperative: 5.3±0.8

Conclusions of the authors: Results of the present study suggest that RFT protocol with

nine lesions to the soft palate seems to be an effective and safe

treatment modality associated with low morbidity in selected

mild to moderate OSAHS patients.

No major complications (paralysis of the soft palate,

velopharyngeal insufficiency, palatal fistula, or perforation) were noted after the RFT. Seven patients developed mucosal

blanching of the soft palate, which was resolved spontaneously

within 1 month.

Sonsuwan, 2015

Type of study:

Prospective case series

Country: Thailand

Source of funding:

The authors declared to have no conflicts of interest.

Inclusion criteria:

- diagnosis of mild to moderate OSA (AHI 5-29 times/hour)

- patients presented with snoring

Exclusion criteria:

- BMI > 30 kg/m2

- presence of nasal or supraglottic obstruction

- coexisting sleep disorders

such as insomnia, periodic limb movement disorders, pregnancy or pregnancy plan

- comorbid diseases that may

affect wound healing processes such as diabetes, cardiovascular

diseases, coagulopathy, and incomplete clinical data.

N total at baseline:

N=51

Important prognostic factors²:

Posttreatment AHI≥5 (N=35)

Age, median (range): 52 (21-64) yrs

BMI, median (range): 25.6 (22.5-30.0) kg/m2

Sex: 77.1% men

Posttreatment AHI<5 (n=16)

Age, median (range): 49 (31-64) yrs

BMI, median (range): 25.2 (22.5-29.0) kg/m2

Sex: 68.8% men

Radiofrequency ablation (RFA) of the soft palate (three points). They used the Ellman device (Ellman Surgitron model EMC Ellman International).

Frequency used: 3.8 MHz in the coagulation mode with power at 3.5 which produced a current of 58 Watts.

Pre-operative measurements

Length of follow-up:

Three months

Loss-to-follow-up:

Not reported, but probably none.

Incomplete outcome data:

Not reported, but probably none.

Outcome measurement 1: AHI

Mean ± SD

Pre-operative: 15.57 ± 7.33

Post-operative: 7.94 ± 5.69

P<0.001

31.37% of the patients had an AHI < 5/h

Outcome measure-2: ESS

Mean ± SD

Pre-operative: 10.14 ± 6.24

Post-operative: 5.51 ± 3.57

P<0.001

Outcome measure-3; Oxygen saturation

Minimal saturation, Mean ± SD

Pre-operative: 79.90 ± 4.51

Post-operative: 85.10 ± 3.93

P<0.001

RFA seems to be a beneficial treatment for mild to moderate OSA.

Baseline AHI seems to be correlated with preferable outcome.

Complication: Self-limited mucosal ulcer: n=3

Study

Appropriate and clearly focused question? ¹

Comprehensive and systematic literature search?²

Description of included and excluded studies³

Description of relevant characteristics of included studies?⁴

Appropriate adjustment for potential confounders in observational studies? ⁵

Assessment of scientific quality of included studies? ⁶

Enough similarities between studies to make combining them reasonable? ⁷

Potential risk of publication bias taken into account? ⁸

Potential conflicts of interest reported?⁹

First author, year

Yes/no/unclear

Yes/no/unclear

Yes/no/unclear

Yes/no/unclear

Yes/no/unclear/ not applicable

Yes/no/unclear

Yes/no/unclear

Yes/no/unclear

Yes/no/unclear

UPPP

Caples, 2010

Unclear, very broad question

Yes

No

Unclear

Not applicable

Yes; per type of surgery

Not applicable; only one study

No

No

Stuck, 2017

Yes

Yes

No

No

No/not applicable

Unclear, only of the RCT’s

Unclear; only data from three RCT’s were pooled. Observational studies were not pooled

No

No

New palate techniques (e.g. lateral pharyngoplasty, expansion sphinxter pharyngoplasty, reposition pharynfoplasty)

Volner, 2016

Yes

Yes

No

No (no follow-up time, design)

Not applicable

Yes: NICE criteria

Unclear; heterogeneity was quite high

No

No; not for the included studies.

Pang, 2015

Yes

Yes

No

Yes; age, BMI, follow-up, intervention

Not applicable

No

Unclear; heterogeneity was quite high

No

No

Caples, 2010

Unclear, very broad question

Yes

No

Unclear

Not applicable

Yes; per type of surgery

Not applicable; only one study

No

No

Tongue-volume reducing surgery (e.g. Transoral robotic surgery (TORS), CELL, SMILE

Meccariello, 2016

Yes

Yes

No

Unclear; no follow-up time reported

Not applicable

Yes;  QUADAS-2 method

Uncleas

Yes; funnel plot

no

Justin, 2016

Yes

Yes

No

Yes

Not applicable

Yes; 2011 Oxford Centre for vidence-Based Medicine Levels of Evidence table

Unclear; results were combined but heterogeneity was very high.

Unclear; a funnel plot was examined, but the results were not reported

No

Tong-positieveranderdende chirurgie (e.g. Hyoid-Thyroid-pexie)

Song, 2016

Yes

Yes

No

Yes

Not applicable

Yes; NICE criteria

Yes

No; because there were less than 10 studies, the results of a funnel plot would have been unreliable

No

Handler, 2014

Yes

Unclear

No

Yes, but  no age or sex reported

Not applicable

Yes; Oxford Centre for vidence-Based Medicine Levels of Evidence table

Unclear; data were pooled, but no size of heterogeneity was reported

No

No

Radiofrequency thermotherapy

Baba, 2015

Yes

Yes

Yes

Yes

Not applicable

Yes; GRADE

Unclear

Yes; funnel plots were considered as unreliable because of the low number of studies

No

Farrar, 2008

Yes

Yes

No

Yes, but no age reported

Not applicable

No

Yes

No

No

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?¹

(unlikely/likely/unclear)

Bias due to  insufficiently long, or   incomplete follow-up, or differences in follow-up between treatment groups?²

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?³

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all  important prognostic factors?⁴

(unlikely/likely/unclear)

Montovani, 2016

Unclear; patients with CPAP failure

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made (case series)

Vicini, 2015

Unlikely

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made (case series)

Emara, 2016

Unclear; patients with CPAP failure

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made (case series)

Kim, 2013

Unlikely

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made (case series)

Li, 2016

Unclear; retrospective case-control study

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made

Li, 2016b

Unclear; retrospective study

Unlikely

Likely; no blinding mentioned

Unlikely; no adjustments were made (case series)

Arora, 2016

Unclear; patients with CPAP failure

Likely; 20% of the patients did not have a follow-up measurement

Likely; no blinding

Unlikely; no adjustments were made (case series)

Friedman, 2008

Unlikely; retrospective cohort-study

Likely, follow-up time ranger from 3 to 18 months

Likely; no blinding mentioned

Unlikely; no adjustments were made

Canzi, 2013

Unlikely

Likely; follow-up time had a large range

Likely; no blinding

Unlikely; no adjustments were made (case series)

Piccin, 2013

Unlikely

Likely; follow-up time had a large range

Likely; no blinding

Unlikely; no adjustments were made (case series)

Balsevičius, 2015

Unlikely

Unclear; follow-up was rather short (118 days)

Likely; no blinding

Unlikely; no adjustments were made (case series)

Sonsuwan, 2015

Unlikely

Unclear; follow-up was rather short (118 days)

Likely; no blinding

Unlikely; no adjustments were made (case series)

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate  concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Chi, 2015

To stratify the groups

preoperatively, patients were categorized as suffering from either mild, moderate, or severe OSAS.

No clear method of randomization was described.

Unclear

Unclear; both groups received surgery

Likely

Likely

Unlikely

Unlikely

Likely