Objective: To evaluate the effectiveness of primary stapes surgery with and without a vein graft in patients with otosclerosis and to determine the differences in the postoperative gain in air-bone gap (ABG) and air-conduction (AC).
Study design: A nonrandomized multicenter clinical evaluation.
Setting: Two tertiary referral centers in The Netherlands and France.
Patients: Otosclerosis patients that underwent primary stapedotomy surgery.
Intervention: Primary stapedotomy surgery without a vein graft (n = 939, first center) compared with primary stapedotomy surgery with a vein graft (n = 3691, second center).
Main outcome measures: Preoperative and postoperative audiometric results were compared. An analysis of variance was performed to evaluate differences in postoperative ABG and AC gains between surgeries with and without a vein graft, adjusted for potential confounders.
Results: The postoperative ABG was 10 dB or lesser in 72.1% of the patients without a vein graft and in 93.2% of patients with a vein graft. After adjustments for differences at baseline, the mean gain in ABG was 18.6 dB (95% CI, 18.1-19.1) in the group without vein graft, compared with 24.2 dB (95% CI, 23.9-24.6) in the group with vein graft (mean difference, 5.6 dB; 95% CI, 5.0-6.2). The mean gain in AC was 19.5 dB (95% CI, 18.7-20.3) in the group without vein graft, compared with 24.3 dB (95% CI, 23.7-24.7) in the group with vein graft (mean difference, 4.8 dB; 95% CI, 3.8-5.7).
Conclusion: Patients with otosclerosis undergoing primary stapes surgery may benefit more from a vein graft interposition.
Level of evidence: 2B.