Tympanic membrane regeneration therapy was associated with shorter operative time, greater hearing improvement, and higher patient satisfaction than conventional tympanoplasty among patients with chronic otitis media and tympanic membrane perforation.
The investigators retrospectively compared 154 patients with 166 affected ears treated at two institutions in Japan. Tympanic membrane regeneration therapy (TMRT) was performed in 101 patients (112 ears), while conventional tympanoplasty (CTP) was performed in 53 patients (54 ears). The TMRT group was treated following the therapy’s introduction into Japan’s National Health Insurance system in November 2019, whereas the CTP group underwent surgery from December 2018 to November 2019. The analysis included patients who did not require mastoidectomy or ossicular reconstruction; patients with cholesteatoma were excluded from the TMRT group.
TMRT was generally performed endoscopically under local anesthesia and involved creating a fresh wound around the perforation, removing middle-ear lesions, performing high-pressure saline irrigation, and placing a gelatin sponge impregnated with basic fibroblast growth factor and covering it with fibrin glue to promote tympanic membrane regeneration. CTP involved elevation of a tympanomeatal flap, cleaning of the tympanic cavity, and reconstruction of the membrane using autologous tissue. Researchers assessed membrane closure, hearing improvement, air-bone gap, operative time, patient satisfaction, adverse events, and reperforation.
Overall tympanic membrane closure occurred in 96% of ears treated with TMRT vs 89% treated with CTP, with no statistically significant difference between groups. About 80% of ears in each group achieved closure following one procedure, and more than 90% of ears in the TMRT group achieved closure following no more than two treatments.
Operative time averaged approximately 35 minutes with TMRT vs 112 minutes with CTP. Average air-conduction hearing improvement at 0.5, 1, and 2 kHz was 11.8 dB with TMRT vs 7.7 dB with CTP, and the postoperative air-bone gap averaged 5.4 dB vs 11.3 dB, respectively.
Across the individual frequencies evaluated, the TMRT group had statistically significant preoperative-to-postoperative hearing improvement at all frequencies. The CTP group had statistically significant improvement at 0.25, 0.5, and 1 kHz, but not at 2 or 4 kHz. At 4 kHz, the air-bone gap decreased from 11.7 dB to 6.7 dB with TMRT, while no improvement was observed with CTP.
Patient satisfaction was 94% with TMRT vs 74% with CTP. Additionally, 79% of patients who underwent TMRT reported being very satisfied compared with 34% who underwent CTP. No patients in the TMRT group reported being dissatisfied or very dissatisfied, compared with 9% and 6%, respectively, in the CTP group.
Adverse events occurred in 10% of TMRT-treated ears vs 19% of CTP-treated ears, although the difference was not statistically significant. Tympanic membrane cholesteatoma was the most common adverse event following TMRT, occurring in five of 112 ears, followed by membrane retraction in 4 ears and persistent otorrhea in 2 ears. Researchers characterized all adverse events in the TMRT group as minor. In the CTP group, adverse events included decreased bone conduction in two patients and taste disturbance in one patient, as well as membrane thickening, cholesteatoma, retraction, and thinning.
Reperforation occurred within 1 year following surgery in both groups, affecting 2% of ears treated with TMRT vs 8% treated with CTP; the difference was not statistically significant. Both reperforations in the TMRT group were pinhole-sized. In the CTP group, reperforations included one pinhole and one each of grade I, II, and III perforations.
The study had several limitations. It was a retrospective chart review conducted at only two institutions, and the treatment groups differed in symptom duration and follow-up. The authors also noted the relatively small sample size. Separately, baseline characteristics differed between groups: patients in the TMRT group were older, had a longer average disease duration, and had somewhat better mastoid air-cell development than those in the CTP group. The researchers noted that the relatively small sample of 154 patients warranted confirmation of the findings in a larger, multicenter prospective study.
Taken together, the findings showed that TMRT maintained a high tympanic membrane closure rate while being associated with shorter operative time, greater hearing improvement, and higher patient satisfaction than CTP in the population studied. Closure, adverse event, and reperforation rates did not differ significantly between groups.
“TM regeneration therapy is considered an effective treatment” for simple tympanic membrane perforations as well as more severe chronic otitis media accompanied by perforation, wrote lead study author Shin-ichi Kanemaru, of the Hearing Disturbance and Eardrum Regeneration Center at Kitano Hospital, and colleagues.
Disclosures: Kanemaru reported receiving patent royalties/licensing fees from Nobelpharma; the other authors reported no conflicts of interest.
Source: The Laryngoscope
