Success of five stapes prostheses evaluated by Kaplan-Meier product-survival procedure.
OBJECTIVE
To determine if modifications to a first-generation Teflon-wire piston stapes prosthesis improve results over time.


METHODS
Retrospective chart review.


METHODS
Private practice.


METHODS
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.


METHODS
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).


METHODS
American Academy of Otolaryngology-Head and Neck Surgery guidelines including 4-frequency pure-tone average, success rate (gap </=10 dB), and Kaplan-Meier product-survival procedure.


RESULTS
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.


CONCLUSIONS
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.
Mangham
Charles A
CA
Seattle Ear Clinic, Seattle, Washington, USA. chasmangham21@msn.com
Neel
Jacqueline
J
Mangham
Hannah F
HF
D001301:Audiometry, Pure-Tone; D004867:Equipment Design; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D011138:Polytetrafluoroethylene; D019919:Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D012189:Retrospective Studies; D013201:Stapes Surgery / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
D011138:Polytetrafluoroethylene