The Newbreez® Intralaryngeal Endoprosthesis For Laryngeal Dysfunction After Partial Laryngectomy
Corresponding author: Dr. Luca D’Ascanio, Department of Otolaryngology, Head & Neck Surgery, Carlo Poma Strada Lago Paiolo, 10-46100 ,Civil Hospital of Mantova, Italy, Tel: +39-3283186967; Fax: +39 0376201624; E-mail:firstname.lastname@example.org
Keywords: laryngeal cancer; prosthesis; partial laryngectomy; quality of life
The aim of partial laryngeal surgery is to perform a radical removal of cancer, reconstructing the anatomical crossing of the respiratory and digestive tracts with preservation of laryngeal function. [1-5] Despite usual favorable results, postoperative functional impairment may persist. In such cases, dysphagia and dyspnea are the most important complications and may cause recurrent aspiration pneumonia, hyponutrition, and cachexia. [1-6] The reasons for impaired swallowing recovery in partial laryngectomies can be incorrect surgery (excessive resections, loose pexies, nerve lesions), worsening of general conditions, reduced patient’s compliance, and unfavorable local healing.  In addition to logaoedic therapy, several surgical rehabilitation procedures (cricopharyngeal myotomies, botulinum toxin injections, collagen or Polydimethylsiloxane injections, laryngeal prosthesis, etc) have been proposed to solve such problems. However, the results of these procedures are variable and persistent dysphagia/dyspnea may require permanent gastrostomy-tracheostomy or total laryngectomy, with negative functional, aesthetic, and psychological consequences for the patient. [6,7]
In case of functional failure of partial laryngectomy, we propose the use of an intralaryngeal prosthesis (NewBreez® Protip Medical, France). The NewBreez® is an intralaryngeal implantable device, designed to limit the clinical consequences of a dysfunctional larynx. It is composed of a medical silicone tube-body and a titanium cap (Figure 1). The silicone body of the NewBreez® is designed to passively fix the device in the larynx, which means no surgical attachment to surrounding tissue is necessary and the device can be easily removed if required. In addition, the tube-body preserves the patency of laryngeal lumen, thus representing an efficient treatment of postoperative laryngeal stenosis. The obvious drawback of such placement is a reduced adduction movement of the residual laryngeal structures, with consequent worsening of voice quality. The prosthesis cap protects the body lumen (thus preventing inhalation) and allows, at the same time, air passage and breathing. This valve-based system consists of an armature, fitted with a ring and connected with the silicone body, and a cap which rises after air overpressure produced during expiration and falls as a result of low pressure created during inhalation. The device is routinely used for the treatment of laryngeal dysfunction in patients affected by neurological disorders (amyotrophic lateral sclerosis, cerebral ischemia, etc). The insertion procedure lasts few seconds and is easily carried out transorally thanks to the prosthesis specific introducer, under general anesthesia. The NewBreez® is available in three different sizes of body diameter (14, 16, 18 mm). The prosthesis size is exactly selected on the basis of postoperative laryngeal diameter assessed by computed tomography/magnetic resonance imaging. The accurate selection of prosthesis size reduces the risk of its dislodgement into the trachea. Such risk is further lowered by the peculiar shape of NewBreez® intralaryngeal prosthesis: its silicone tube-body has a horizontal carved groove in which the cricoid ring can rest, thus fixing the prosthesis in place and preventing possible migrations. However, even in case of vertical migration towards the trachea, the resistance of the prosthesis silicone tube-body would guarantee airway patency, thus preventing dyspnea or breathing impairment. In neurologic subjects, no prosthesis dislodgement and/or significant patient’s discomfort have been reported so far. Despite such findings, since the prosthesis (though biocompatible) is a “foreign” body within the larynx, the patient should be informed about the potential risk of migration or local inflammation caused by the prosthesis in the preoperative informed consent.
Figure 1. Lateral view showing the NewBreez® endolaryngeal prosthesis in place. Notice the inferior silicone tube-body, allowing air passage, and the superior titanium cap, preventing inhalation.
Before prosthesis implantation, possible tumor recurrence should be ruled out. This obvious prerequisite is usually respected considering the proposed timing for prosthesis insertion: in case of postoperative inhalation or laryngeal stenosis, patients are usually submitted to other treatments (i.e. multiple logaoedic rehabilitations, local injections, transoral laser resections, gastrostomy), which require long periods of time (months/years).  During this period, a regular (endoscopy/imaging) oncologic follow-up is carried out. In case of symptoms’ persistence after those treatments, the patient is candidate to prosthesis insertion. After NewBreez® placement, the oncologic follow-up is carried out by imaging alone, since mucosal surface may be hidden by the prosthesis.
In particular MRI and PET have proved to be effective in the follow-up of patients submitted to local injections after laryngeal surgery , therefore they may be used also after NewBreez® insertion. In addition, in case of doubt about possible tumor recurrence at imaging exams, the prosthesis can be easily removed and biopsies can be performed. Severe restrictions of neck extension, relevant limitation of mouth-opening, cognitive impairment, and severe cervical hyperostosis are contraindications to NewBreez® insertion. Even though several endolaryngeal prosthesis have beendescribed,  we propose the use of the NewBreez® device in laryngeal dysfunction following partial laryngectomy and/ or radiotherapy for laryngeal cancer thanks to the good results obtained in neurological patients suffering from permanent inhalation (unpublished data). A multicenter long-term study is advisable to assess the prosthesis ability to attain ab-ingestisprevention and tracheostomy closure in patients affected by inhalation/dyspnea after partial laryngectomy and/orradiotherapy.
6.Bergamini G, Alicandri-Ciufelli M, Molteni G, De Siati DR, Luppi MP et al. Rehabilitation of swallowing with polydimethylsiloxane injections in patients who underwent partial laryngectomy. Head Neck. 2009, 31(8): 1022- 1030.