TABLE 1.
Summary of included publications from PubMed and Ovid Embase literature search with adverse events reported.
| Authors | No. of patients | No. of ears | Patient age, in y (mean) | Study design | Risk of bias | Balloon manufacturer | Average follow‐up (in months) | No. of complications (%) | Complications (n) | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Abdel‐Aziz et al. (2014) | 284 | 510 | Unknown | Retrospective case series | Good | Spiggle and theiss | 2.00 | 3 (1%) | Hypoglossal Paresis (1), Subcutaneous emphysema (2) |
|
2 |
Ashry et al. (2017) | 48 | 67 | 50 | Retrospective cohort study | Good | Acclarent | 15.60 | 1 (2%) | Patulous ET (1) |
| 3 | Bowles et al. (2017) | 39 | 55 | 45.5 | Prospective cohort study | Good | Acclarent | 6.00 | 0 | NRAE |
|
4 |
Catalano, Peter et al. (2012) | 70 | 100 | 45 | Retrospective cohort study | Good | Acclarent | 7.58 | 1 (1%) | Subcutaneous Emphysema (1) |
|
5 |
Chen, Nina et al. (2022) | 35 | 49 | 38.4 | Retrospective cohort study | Poor | Unknown | 36.00 | 0 | NRAE |
|
6 |
Chen et al. (2020) | 49 | 25 | 10.2 | Retrospective cohort study | Good | Spiggle and theiss | 18.00 | 3 (6%) | Epistaxis (3) |
|
7 |
Cheng et al. (2021) | 62 | 96 | 47.3 | Retrospective cohort study | Good | Spiggle and theiss | 10.00 | 0 | NRAE |
| 8 | Choi et al. (2021) | 31 | 38 | 44.7 | Randomized controlled trial | Good | Mega medical | 1.50 | 0 | NRAE |
| 9 | Cutler et al. (2019) | 47 | 83 | 52.5 | Randomized controlled trial | Good | Entellus | 29.40 | 0 | NRAE |
|
10 |
Dai et al. (2016) | 8 | 12 | 53.1 | Retrospective case series | Fair | Spiggle and theiss | 6.40 | 0 | NRAE |
| 11 | Dalchow et al. (2016) | 217 | 342 | 45.58 | Prospective cohort study | Good | Spiggle and theiss | 7.50 | 0 | NRAE |
| 12 | Dean (2019) | 33 | 43 | Unknown | Retrospective cohort study | Fair | Acclarent | 1.50 | 0 | NRAE |
| 13 | Demir and Batman (2020) | 62 | 55 | 7 | Retrospective cohort study | Good | Spiggle and theiss | 12.00 | 4 (6%) | Hemotympanum (2), OME (2) |
| 14 | Giunta et al. (2019) | 20 | 21 | Unknown | Retrospective cohort study | Good | Spiggle and theiss | 34.80 | 4 (20%) | AOM (1), Tinnitus (1), SNHL (1), Subcutaneous Emphysema (1) |
| 15 | Gürtler et al. (2015) | 21 | 21 | 37.5 | Retrospective cohort study | Good | Spiggle and theiss | 26.00 | 1 (5%) | Epistaxis (1) |
| 16 | Howard et al. (2021) | 43 | 81 | 12.4 | Retrospective cohort study | Good | Acclarent | 0.96 | 2 (5%) | Epistaxis (1), Vertigo (1) |
| 17 | Jenckel et al. (2015) | 33 | 56 | 11 | Retrospective cohort study | Fair | Spiggle and theiss | 6.00 | 0 | NRAE |
| 18 | Jurkiewicz et al. (2013) | 4 | 7 | 45.75 | Prospective case series | Fair | Spiggle and theiss | 1.50 | 0 | NRAE |
| 19 | Kapadia and Tarabichi (2018) | 40 | 40 | 30 | Retrospective case series | Good | Foley catheter | 16.50 | 4 (10%) | Tinnitus (1), SNHL (1), Vertigo (2) |
| 20 | Kim et al. (2018) | 10 | 10 | 52.2 | Prospective case series | Good | Acclarent | 3.00 | 1 (10%) | Mucosal Laceration (1) |
| 21 | Kim et al. (2022) | 1 | 2 | 22 | Retrospective case report | N/a | Unknown | 0.75 | 1 (100%) | Perilymph Fistula (1) |
| 22 | Lee et al. (2020) | 1 | 2 | 55 | Retrospective case report | N/a | Acclarent | 12 | 1 (100%) | Nasopharyngeal Mucocele (1) |
| 23 | Leichtle et al. (2017) | 52 | 97 | 7 | Retrospective cohort study | Good | Spiggle and theiss | 5.18 | 4 (8%) |
Epistaxis (3), Hemotympanum (1) |
| 24 | Liang et al. (2016) | 90 | 90 | 36 | Randomized controlled trial | Good | Spiggle and theiss | 6 | 0 | NRAE |
| 25 | Long et al. (2021) | 1 | 2 | 51 | Retrospective case report | N/a | Entellus | Unknown | 2 (100%) | Epistaxis (1), Pneumomediastinum (1) |
| 26 | Luukkainen et al. (2018) | 34 | 52 | 41 | Retrospective cohort study | Fair | Acclarent | 37.20 | 0 | NRAE |
| 27 | Luukkainen et al. (2019) | 18 | 27 | 39.5 | Prospective case series | Good | Spiggle and theiss | Unknown | 0 | NRAE |
| 28 | McCoul and Anand (2012) | 22 | 35 | 55.1 | Prospective cohort study | Good | Acclarent | 10.00 | 1 (5%) | Hemotympanum (1) |
| 29 | McMurran et al. (2020) | 25 | 36 | 44 | Prospective cohort study | Good | Spiggle and theiss | 28 | 2 (8%) |
Subcutaneous Emphysema (1), TM Perforation (1) |
| 30 | Meyer et al. (2018) | 60 | 91 | 49.4 | Randomized controlled trial | Good | Entellus | 10.92 | 0 | NRAE |
| 31 | Ockermann et al. (2010) | 8 | 13 | 44.1 | Quasi‐experimental study | Good | Spiggle and theiss | 2.00 | 0 | NRAE |
| 32 | Park et al. (2022) | 1 | 1 | 63 | Prospective case report | N/a | Mega medical | 12.00 | 1 (100%) | Patulous ET (1) |
| 33 | Poe et al. (2011) | 11 | 11 | 51.8 | Quasi‐experimental study | Good | Acclarent | 9.12 | 5 (45%) | Mucosal Laceration (5) |
| 34 | Poe et al. (2018) | 296 | 444 | 55.6 | Randomized controlled trial | Good | Acclarent | 1.50 | 0 | NRAE |
| 35 | Ramakrishnan and Kadambi (2020) | 10 | 15 | 32 | Retrospective cohort study | Good | Eustacare | 2.00 | 0 | NRAE |
| 36 | Satmis and van der Torn (2018) | 42 | 66 | 43 | Retrospective cohort study | Good | Spiggle and theiss | 3.00 | 5 (12%) | Epistaxis (1), Otalgia (2), Patulous ET (1), TM Perforation (1) |
| 37 | Schmitt et al. (2018) | 38 | 45 | 49.9 | Retrospective cohort study | Good | Spiggle and theiss | 14.27 | 2 (5%) | Rhinitis (1), Tongue dysesthesia (1) |
| 38 | Schroder et al. (2015) | 622 | 1076 | Unknown | Retrospective cohort study | Good | Spiggle and theiss | Unknown | 3 (0.5%) | Subcutaneous Emphysema (3) |
| 39 | Shah et al. (2018) | 1 | 1 | 28 | Retrospective case report | N/a | Entellus | Unknown | 2 (100%) |
Subcutaneous emphysema (1), Pneumomediastinum (1) |
| 40 | Si et al. (2018) | 200 | 200 | 41.02 | Retrospective cohort study | Good | Spiggle and theiss | 11.09 | 1 (0.5%) | Patulous ET (1) |
| 41 | Si et al. (2019) | 120 | 120 | 43 | Randomized controlled trial | Good | 24.00 | 2 (1.7%) | Patulous ET (2) | |
| 42 | Silvola et al. (2014) | 41 | 41 | 48 | Prospective cohort study | Good | Acclarent | 30.00 | 0 | NRAE |
| 43 | Singh et al. (2017) | 11 | 13 | 42.5 | Prospective cohort study | Fair | Spiggle and theiss | Unknown | 0 | NRAE |
|
44 |
Skevas et al. (2018) | 2272 | 3670 | Unknown | Retrospective cohort study | Good | Spiggle and theiss | Unknown | >18 (0.8%) | AOM (1), Epistaxis (?), a Patulous ET (1), Pneumomediastinum (3), Subcutaneous emphysema (10), Tinnitus (3) |
| 45 | Standring et al. (2021) | 169 | 309 | 52.4 | Prospective cohort study | Good | Stryker | 6.00 | 3 (2%) | AOM (1), OME (1), Otalgia (1) |
| 46 | Sun et al. (2020) | 58 | 74 | 50.1 | Retrospective cohort study | Good | Unknown | 24.00 | 0 | NRAE |
| 47 | Swain et al. (2020) | 21 | 25 | 44.9 | Retrospective cohort study | Fair | Spiggle and theiss | 2.00 | 3 (14%) | AOM (1), Mucosal Laceration (2) |
| 48 | Tisch et al. (2017) | 94 | 90 | 9.6 | Retrospective cohort study | Good | Spiggle and theiss | 11.73 | 5 (5%) | AOM (3), Epistaxis (2) |
| 49 | Todt et al. (2021) | 1547 | 2614 | Unknown | Retrospective case series | Good | Spiggle and theiss | Unknown | 7 (0.5%) | SNHL (7) |
| 50 | Toivonen et al. (2021) | 26 | 46 | 12.5 | Retrospective cohort study | Good | Acclarent | 27.60 | 2 (8%) | Patulous ET (2) |
| 51 | Utz et al. (2020) | 15 | 26 | 31.3 | Retrospective cohort study | Good | Acclarent | 9.50 | 0 | NRAE |
| 52 | Utz and Wise (2019) | 1 | 1 | 20 | Retrospective case report | N/a | Acclarent | 12.00 | 0 | NRAE |
| 53 | Wanscher and Svane‐Knudsen (2014) | 34 | 50 | 45 | Prospective cohort study | Fair | Spiggle and theiss | 2.00 | 4 (12%) | AOM (4) |
| 54 | Williams et al. (2016) | 18 | 25 | 40.6 | Retrospective cohort study | Good | Spiggle and theiss | 7.10 | 0 | NRAE |
| 55 | Wong and Prepageran (2021). | 12 | 14 | 39.5 | Prospective cohort study | Good | Entellus | 6.00 | 0 | NRAE |
Abbreviations: AOM, acute otitis media; ET, eustachian tube; OME, otitis media with effusion; SNHL, sensorineural hearing loss; TM, tympanic membrane.
a
Publication by Skevas et al. (2018) did not specify the number of epistaxis episodes after BDET.