Indications
A voice prosthesis is not a permanent implant, and needs periodic replacement. Indications for replacement can be divided in ‘prosthesis-related’, and ‘fistula-related’.
Prosthesis-related indications are leakage through the valve and obstruction. The most common indication (74%) for replacement of the Provox (1) and Provox2 voice prostheses is prosthesis-related, i.e. incompetence of the valve due to candida overgrowth, causing leakage of fluids through the valve. Obstruction of the prosthesis, leading to total blockage of the prosthesis and/or excessive pressure to obtain adequate speech, is a rare prosthesis-related indication for replacement (3%). If obstruction occurs, cleaning of the prosthesis by suction, preferably under endoscopic control, should be tried before replacement is undertaken. Inspection of the prosthesis can easily be carried out with a rigid 30o nasopharyngoscope or a flexible laryngoscope. In this way, inspection of the valve is possible and cleaning of distinct areas of the prosthesis is feasible. This often solves the problem without the need for replacement.
Fistula-related indications comprise of leakage around the prosthesis, hypertrophy and/or infection of the fistula, or spontaneous loss of the device. These indications form less than a quarter of the reasons for replacement. The majority of these indications are formed by leakage around the device, where a too long prosthesis causes a pistoning effect, by which fluids are squeezed around the device during drinking. In most cases, downsizing the prosthesis by inserting a shorter device solves this problem. It should be realized, that subsiding of surgical edema and tissue reaction is a natural course of events, especially with indwelling prostheses, which are not handled by the patients themselves (less trauma to the fistula); this means that during follow-up often a shorter prosthesis is sufficient.
This phenomenon is not considered to be an adverse event, in contrast to all other fistula-related indications, which will be discussed in the Troubleshoot section below.
The mean device life of the Provox (1) and Provox2 voice prostheses in the Netherlands is approximately 5 months, but individual variations can be considerable. Shorter (4-6 weeks) and much longer durations of use (up to 10 years) have been observed. This has resulted in the Netherlands Cancer Institute in a median device life of 3 months.
For a complete overview of the long-term aspects of prosthetic vocal rehabilitation using the Provox System, we refer to the following paper: OpdeCoul B, Hilgers FJM, Balm AJM, Tan IB, van Tinteren H, van den Hoogen FJA. A decade of postlaryngectomy vocal rehabilitation in 318 patients: a single institution’sexperience with consistent application of indwelling voice prostheses (Provox). Arch Otolaryngol Head Neck Surg 2000; 126: 1320-1328.
Prosthesis-related indications are leakage through the valve and obstruction. The most common indication (74%) for replacement of the Provox (1) and Provox2 voice prostheses is prosthesis-related, i.e. incompetence of the valve due to candida overgrowth, causing leakage of fluids through the valve. Obstruction of the prosthesis, leading to total blockage of the prosthesis and/or excessive pressure to obtain adequate speech, is a rare prosthesis-related indication for replacement (3%). If obstruction occurs, cleaning of the prosthesis by suction, preferably under endoscopic control, should be tried before replacement is undertaken. Inspection of the prosthesis can easily be carried out with a rigid 30o nasopharyngoscope or a flexible laryngoscope. In this way, inspection of the valve is possible and cleaning of distinct areas of the prosthesis is feasible. This often solves the problem without the need for replacement.
Fistula-related indications comprise of leakage around the prosthesis, hypertrophy and/or infection of the fistula, or spontaneous loss of the device. These indications form less than a quarter of the reasons for replacement. The majority of these indications are formed by leakage around the device, where a too long prosthesis causes a pistoning effect, by which fluids are squeezed around the device during drinking. In most cases, downsizing the prosthesis by inserting a shorter device solves this problem. It should be realized, that subsiding of surgical edema and tissue reaction is a natural course of events, especially with indwelling prostheses, which are not handled by the patients themselves (less trauma to the fistula); this means that during follow-up often a shorter prosthesis is sufficient.
This phenomenon is not considered to be an adverse event, in contrast to all other fistula-related indications, which will be discussed in the Troubleshoot section below.
The mean device life of the Provox (1) and Provox2 voice prostheses in the Netherlands is approximately 5 months, but individual variations can be considerable. Shorter (4-6 weeks) and much longer durations of use (up to 10 years) have been observed. This has resulted in the Netherlands Cancer Institute in a median device life of 3 months.
For a complete overview of the long-term aspects of prosthetic vocal rehabilitation using the Provox System, we refer to the following paper: OpdeCoul B, Hilgers FJM, Balm AJM, Tan IB, van Tinteren H, van den Hoogen FJA. A decade of postlaryngectomy vocal rehabilitation in 318 patients: a single institution’sexperience with consistent application of indwelling voice prostheses (Provox). Arch Otolaryngol Head Neck Surg 2000; 126: 1320-1328.