Success of five stapes prostheses evaluated by Kaplan-Meier product-survival procedure

To determine if modifications to a first-generation Teflon-wire piston stapes prosthesis improve results over time.

Retrospective chart review.

Private practice.

Three hundred eleven ears in 277 consecutive patients who had primary stapedotomies with reconstruction to an open fenestra during 1989 to 2000 and in 2005 to 2006.

The devices were examined sequentially as follows: Schuknecht piston (50), De La Cruz piston (30), Mangham piston (179), titanium CliP piston (32), and Teflon Robinson prosthesis (20).

American Academy of Otolaryngology-Head and Neck Surgery guidelines including 4-frequency pure-tone average, success rate (gap

When success was defined as an air-bone gap of 10 dB or less and no revision surgery for other reasons, patients with Schuknecht, De La Cruz, and Mangham pistons had comparable results; both at 1 year (87-96%) and in the long term (about 80% at 15 yr). The estimated median duration of success was 24 years. Success over time was significantly poorer for the Robinson prosthesis (76% at 1 year) and CliP piston, 68% at 30 months (p < 0.05). Of 18 patients with crimpable pistons who had revision surgery, two-thirds had a finding of necrosis on the vestibular side of the incus. All 3 of the CliP piston patients with revisions had an unstable connection to the incus.

Four second-generation prostheses-De La Cruz, Mangham, CliP, and Teflon-Robinson-all failed to improve on the success of a first-generation Schuknecht piston. The findings may apply only to the technique of sealing the fenestra after placing the prosthesis.