A decade of postlaryngectomy vocal rehabilitation in 318 patients: A single institution's experience with consistent application of Provox indwelling voice prostheses

Objective: To assess long-term results with consistent use of indwelling voice prostheses (Provox; Atos Medical AB, Horby, Sweden) for vocal rehabilitation after total laryngectomy. Design: Retrospective clinical analysis. Setting: Comprehensive national cancer center. Patients: Three hundred eighteen patients (261 men and 57 women; mean age, 62 years) from November 1988, through May 1999. Intervention: Standard wide-field total laryngectomy (287 patients) or total laryngectomy with circumferential pharyngeal resection (31 patients), and 2700 prosthesis replacements. Prostheses remained in situ during 364339 days (1000 patient-years). Main Outcome Measures: Device lifetime, indications for replacement (device or fistula related), adverse events, and voice quality. Results: Median patient-device follow-up was 67 months. Mean actuarial device lifetime for all indications for replacement was 163 days (median, 89 days). Main indications for replacement were device-related, ie, leakage through the prosthesis (73%) and obstruction (4%), or fistula-related, ie, leakage around the prosthesis (13%), and hypertrophyand/or infection of the fistula (7%). Adverse events occurred in 11% of all replacements in one third of the patients, mostly solvable by a shrinkage period, or adequate sizing and/or antibiotic treatment. Definitive closure of the tracheoesophageal fistula tract occurred in 5% of the patients. Significant clinical factors for increased device lifetime were no radiotherapy (P = .03), and age older than 70 years (P < .02). Success rate with respect to voice quality (ie, fair to excellent rating) was 88%, which was significantly influenced by the extent of surgery (P < .001). Conclusion: The consistent use of indwelling voice prostheses shows a high success rate of prosthetic vocal rehabilitation, in terms of the percentage of long-term users (95%), and of a fair-to-excellent voice quality (88% of patients).