Vocal Fold Augmentation with Calcium Hydroxylapatite

Peter C. Belafsky, Gregory N. Postma

Introduction

Synthetic calcium hydroxylapatite (CaHA; Radiesse, BioForm, Franksville, Wis.) was approved for vocal fold augmentation by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health in January 2002. Calcium hydroxylapatite is the primary mineral constituent of bone and teeth. The substance has a proven track record of being highly biocompatible [1-6]. The laryngeal implant is created by suspending CaHA spherules in a gel carrier composed primarily of glycerin and water. The gel is reabsorbed and eventually replaced by soft tissue in-growth. The CaHA remains at the site of injection and has the potential for long-standing augmentation. Since its approval by the FDA, we have injected over 100 vocal folds with CaHA and have achieved excellent results [7]. Theoretical complications include implant migration, granuloma formation, vocal fold mucosal wave irregularities, allergic reaction, infection, and ectopic calcification. None of these complications have been reported as a consequence of vocal fold CaHA injection [7-10]. This chapter reviews the concepts necessary for successful vocal fold augmentation with CaHA.

Injection augmentation is best reserved for persons with a small (1 mm) or medium-sized (2-3 mm) glottal gap. Individuals with a large gap (>4 mm) may be better served with a me-dialization laryngoplasty and arytenoid repositioning if indicated. The majority of the vocal folds that we have injected with CaHA (61%)

Table 8.4.1. Indications for injection augmentation with calcium hydroxylapatite have been mobile (e.g., vocal fold paresis/senile atrophy). We routinely inject both vocal folds at the same time, if necessary. Even when injecting a paralyzed vocal fold, we often inject a mobile contralateral vocal fold if it is bowed and atrophic. Our indications for injection augmentation with CaHA are presented in Table 8.4.1. We have performed bilateral injections in 13 individuals with glottal insufficiency secondary to Parkinson's hypophonia. Our results have been extremely positive and appear to be similar to the degree of improvement reported by other investigators with collagen augmentation [11,12].

Technique of Injection Augmentation with CaHA

Each package of Radiesse includes 1 cc of implant in a Luer-Lok syringe (Fig. 8.4.1). A 25-G laryngeal injection needle is now available (BioForm, Franksville, Wis.). The needle is 25 cm long and has a laser marked band 5 mm from the tip to help gauge injection depth. There are several possible techniques of CaHA injection. These techniques are categorized into in-office and operating-room-based procedures.

Indicationsfor Vocal Fold Augmentation with CaHA

Table 8.4.1. Indications for injection augmentation with calcium hydroxylapatite

Indication

%

Unilateral vocal fold paralysis

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