Therapy of bilateral vocal fold paralysis: Real world data of an international multi-center registry

Abstract

Purpose: To collect data on diagnosis, treatment, patient's management, and quality of life in patient with bilateral vocal fold paralysis (BVFP).

Methods: A retrospective, observational, multicenter registry study was performed. Medical records of 326 adults with permanent BVFP (median age: 61 years; 70% female, 60% after thyroid surgery) generated between 2010 and 2017.

Results: Median time between BVFP onset and inclusion was 1.2 years. Median post-treatment follow-up was 2 months (range: 0-42). Surgery was treatment of choice in 61.7% of the cases, with a 2-year revision rate of 32.4%. Prior to inclusion, 40.2% of the patients underwent at least one surgery. For tracheotomized patients, decannulation rate was 33.8%. Non-surgical treatments included voice therapy and botulinum toxin injection. Corticosteroid application was the most frequent treatment for post-treatment complications (18%; 1-month after surgery). Older age was an independent predictor for dyspnea (Hazard ratio [HR] = 1.041; CI = 1.005 to 1.079; p = 0.026) and the need for oxygen treatment (HR = 1.098; CI = 1.009 to 1.196; p = 0.031). Current alcohol consumption (HR = 2.565; CI = 1.232 to 5.342; p = 0.012) and a cancer-related etiology (HR = 4.767; CI = 1.615 to 14.067; p = 0.005) were independent factors of higher revision risk.

Conclusions: Surgery for BVFP is currently not standardized but highly variable. Postoperative and BVFP-related complications and revision surgery are frequent. Complications are linked to patients' alcohol drinking habits and BVFP etiology. These results shall be confirmed by the upcoming evaluation of the prospective data of this registry.

Fig 1. Relative amount of patients with surgery, non-surgical treatment and complications from baseline to 25 months later.

A: Percentage of patients undergoing scheduled surgical vs. non-surgical BVFP treatment and of patients requiring no BVFP-related treatment from the baseline to the last follow-up visit (max. 25 months after baseline). B: Evaluation of the changes in the BVFP symptomology and need of symptom medical treatment from the baseline to the last follow-up visit. C: Changes in the detection of BVFP- vs. BVFP treatment-related complications from the baseline to the last follow-up visit. The percentage of patients was always calculated on the total number of patients for which medical acts were available at the respective check-point.

Fig 2. Probability of decannulation.

Decannulation rate (Y-axis) of 97 patients, who underwent tracheostomy before or at baseline. Considering the pre-baseline period, the patients were followed up for a maximum of 60 months (X-axis). The Kaplan-Meier curve shows that this rate decreased with time and reached a plateau about 24 months after tracheostomy.

Fig 3. Revision surgery rate for patients who underwent a surgery at baseline.

The period considered for analysis is comprised between baseline and the last follow-up visit (max. 25 months after baseline). The revision need probability was calculated by means of the Kaplan-Meier curve. A: When all 326 patients were considered for analysis, the probability that a revision is needed increased with time and reached a plateau after 18 months from the first surgery. B: Patients regularly drinking alcohol showed a significantly (p = 0.019) increased need of revision surgeries compared with patients who do not drink it. C: Patients for whom the BVFP onset is due to a cancer showed a significantly (p = 0.015) increased need of revision surgeries compared with patients who do not drink it.