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Table 1 Summary of the included studies

From: Efficacy and safety of paranasal sinus balloon catheter dilation in pediatric chronic rhinosinusitis: a systematic review

Study

Design

nd

Mean Age (Age range), years

Sinuses dilated via balloon

Inclusion

Adjunct procedure(s)

Follow-up time

Efficacy (by SN-5)

Mean (SD)

Efficacy (by others)

Mean (SD)

Revision, antibiotics use and AEs

Ramadan HH et al. 2010a [35]

Prospective interventional non-randomized

30 (55 sinuses)

6.6 (2–11)

48 Maxillary 2 Frontal 5 Sphenoid

Chronic sinusitis (> 3 months or 6 episodes per year) AND 2 failed courses of antibiotics AND positive CT scan

Adenoidectomy (n = 17)

52 weeks

Preop: 4.2, Postop: 3;

24 (80%) improveda

NR

Second intervention by ESS (2);

AEs: NR

Ramadan HH et al. 2010b [36]

Prospective single arm cohort

24 (56 sinuses)

6.5 (2–11)

50 Maxillary 2 Frontal 4 Sphenoid

Refractory CRS which failed medical treatment AND evidence of CRS on CT scan

Adenoidectomy (n = 15); Ethmoidectomy (n = 6)

52 weeks

Preop: 4.9 (1.14), Postop: 2.95 (1.35);

21 improveda

NR

AEs: None

Ramadan HH et al. 2012 [28]

Prospective single arm cohort

26 (33 sinuses)

7.7 (4–12)

33 Maxillary

Chronic sinusitis (> 3 months or 6 episodes per year) after failed adenoidectomy AND positive CT findings.

Ethmoidectomy (n = 4); Maxillary antrostomy (n = 3); Revision adenoidectomy (n = 2)

52 weeks

Preop: 4.6 (0.9), Postop: 3 (1.2);

21 (81%) improveda

NR

AEs: None

Thottam PJ et al. 2012 [30]

Retrospective, two group cohort blinded

15 (40 sinuses)

9.3 (3–17)

30 Maxillary 10 Frontal

Refractory CRS (at least 90 days despite medical therapy) AND CT confirmed uncomplicated CRS with the presence of maxillary +/− frontal sinus disease.

Ethmoidectomy

> 4 months (average of 37 weeks)

SN-5: NR;

12 (80.0%) Improvedb

NR

Second intervention by ESS (1);

Off Antibiotic: 11 (73.3%);

AEs: None

Wang F et al. 2015 [29]

Prospective interventional non-randomized controlled

42

9.3 (7–12)

Maxillary and Frontalc

Diagnosis of CRS according to EPOS 2012. Refractory CRS (defined as at least 2 years despite medical therapy)

Adenoidectomy

1 year

Preop: 4.3 (0.9), Postop: 2.9 (0.8);

39 (92.9%) improveda

VAS

Preop: 5.2 (1.4),

Postop: 3.1 (1.6)

AEs: periorbital swelling (1)

Thottam PJ et al. 2016 [31]

Retrospective, two group cohort

13 (34 sinuses)

9.3 (3–18)

26 Maxillary 8 Frontal

Refractory sinus symptoms despite medical treatments AND CT scan confirmed uncomplicated CRS and the presence of maxillary sinus disease with a Lund-Mackay score greater than 5.

Ethmoidectomy

2 years

SN-5: NR;

10 (76.9%) Improvedb

NR

Second intervention by ESS (1);

AEs: NR

Soler ZM et al. 2017 [24]

Prospective single arm cohort

33

6.6 (2–12)

Maxillary, Frontal and Sphenoidc

Diagnosis of CRS according to EPOS12, positive CT findings and disease resistant to medical treatments.

Adenoidectomy (n = 19); Inferior turbinate reduction (n = 6); Ethmoidectomy (n = 4); Tonsillectomy (n = 5); Others (n = 4)

6 months

Preop: 4.8 (1.2), Postop: 1.7 (0.8);

32 (97%) improveda

NR

Second intervention (0);

AEs: None

Liu J et al. 2017 [25]

Prospective single arm cohort

30 (61 sinuses)

10.2 (6–15)

38 Maxillary 9 Frontal 14 Sphenoid

Confirmed by positive Nasal endoscopy and CT scan AND failed Medical management for at least 3 months

None

12 months

Preop: 23.04 (12.47), Postop: 1.07 (2.11)

Lund-Mackay score Preop: 12.29 (6.23), Postop: 1.39 (2.47);

VAS Preop: 17.86 (7.59),

Postop: 0.57 (1.60);

Endoscopic score of Lund-kennedy preop: 6.69 (3.07),

postop: 0.36 (1.89)

AEs: synechia (3)

Gerber ME et al. 2018 [32]

Randomized controlled blinded study

12

7

Maxillaryc

CRS with at least 12 weeks of two symptoms AND refractory to medical treatments AND recurrence (4 or more episodes per year) AND evidence of rhinosinusitis on CT scan.

Adenoidectomy with maxillary sinus irrigation (all patients)

12–18 months

Preop: 3.62 (1.24), Postop: 2.40 (1.11)

NR

NR

Zalzal HG et al. 2019 [33]

Retrospective single arm cohort

38

6.76

Maxillaryc

CRS with at least 90 days of 2 or more of symptoms, or endoscopic signs AND failure of medical treatment defined by EPOS 2012 AND previous adenoidectomy AND Lund-Mackay score of at least 5 AND maxillary sinus involvement.

None

5 years

SN-5: NR

NR

Second intervention by ESS: 5 (13.1%);

Off antibiotic: 26 (68.4%)

  1. AEs Adverse events
  2. CRS Chronic rhinosinusitis
  3. CT Computed tomography
  4. ESS Endoscopic sinus surgery
  5. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012
  6. NR Not reported
  7. SN-5 Sino-Nasal 5 quality of life scale
  8. VAS Visual analogue scale
  9. a(0.5 decrease or more in SN-5 score) described by Kay and Rosenfeld
  10. bImprovement were defined as a decrease in the total complaint score of 1 or more symptoms. Symptoms are facial pain, sinus congestion, postnasal drip, rhinorrhea, headache, and low-grade fever
  11. cNumber of sinuses dilated via balloon sinuplasty was not specified in the included sample
  12. dNumber of children underwent balloon sinuplasty and included in the analysis of the respective study