Introduction
An essential aspect of prosthetic vocal rehabilitation is that from time to time patients using (any) voice prostheses may experience problems that require special attention of their medical professional to ensure long-term use of their device. Since a voice prosthesis is not a permanent implant, it needs occasional replacement, either by the patient him/her self in case of a non-indwelling device, or by a medical professional in case of an indwelling prosthesis. The reasons to replace the voice prosthesis can be either device-related or fistula-related. The main reason for replacement is device-related, i.e. leakage through the voice prosthesis. Less frequent are fistula-related reasons, such as local infection, atrophy of the party wall, granulation or esophageal pouch formation. In this troubleshooting section will pay attention to all typical problems and adverse events that may interfere with optimal prosthetic voice rehabilitation. Proper attention for and solution of these issues will determine the ultimate success rate of this presently optimal method of vocal rehabilitation after total laryngectomy.
It is important to verify at each clinic visit the status of the prosthetic device, and if there are any problems, to establish their exact nature. The following list of 10 points should be kept in mind when a patient needs replacement of his/her Provox (2) device:
1. Determine the indication for replacement (leakage through or around, infection of the TE-fistula tract, etc.)
2. Determine the required length of the new prosthesis (never automatically replace the existing device with one of the same size)
3. Prepare the prosthesis for insertion (attaché the prosthesis to the inserter, fold the esophageal flange forward in the loading tube and advance the inserter to mark line 1)
4. Remove the old prosthesis with a non-toothed hemostat, and ask the patient to keep his/her mouth open (this prevents swallowing and thus aspiration) until the prosthesis is replaced
5. Insert the loading tube into the TE-fistula and advance the tube towards the posterior esophageal wall, making sure that the tip is inside the lumen of the esophagus
6. Advance the inserter until mark line 2 is level with the backside of the loading tube, using the thumb as a ‘stopper’
7. Pull back the inserter and the loading tube together, anchoring the esophageal flange on the anterior esophageal wall
8. Remove the loading tube, unfolding the tracheal flange (if necessary use one or two hemostats in case the tracheal flange is still in the TE-fistula, or in case of ‘overshooting’)
9. Ensure proper retention of the prosthesis by rotation and/or up and down movement of the prosthesis on the inserter
10. Cut the security string of the prosthesis and rotate the prosthesis into its optimal position with the cut edge pointing caudally.
Points 1 and 2 are important for any replacement procedure of any voice prosthesis, the other points are obviously relevant for Provox2 only. Nevertheless, the most common mistakes are made against Points 1 and 2. For instance, if the leakage problem is not identified as leakage around the prosthesis, simple replacement with a device of the same length is not helping much. If, due to a local infection and overgrowth of the mucosa in the esophageal lumen or esophageal pouch formation, the prosthesis is pushed outward/extruded, not identifying this problem and replacement with a shorter device will increase the problem. Fortunately, the problems and solutions discussed here are relatively rare and are mostly easily manageable, if recognized in time (1, 2).
Definition problems/adverse events: all ’fistula-related’ indications for replacements, except leakage around the prosthesis, if downsizing can solve this. (Subsiding of surgical edema and tissue reaction is a natural course of events, especially with indwelling voice prostheses, which are not handled by the patients themselves (little trauma to the fistula); this means that during follow-up often a shorter prosthesis is sufficient).
Problems or adverse events are mostly minor and their treatment is generally not too difficult. As a rule of thumb one can say, that in daily practice two-thirds of the patients have no problems what so ever, and they consume approximately one-third of the total time, spent on prosthetic voice rehabilitation. These patients only visit the outpatient clinic once in a while for replacement of the prosthesis when it becomes incompetent and shows mild leakage of fluids. The other one-third of the patients occasionally has problems, which need special attention and they consume the other two-thirds of the total time, spent on prosthetic voice rehabilitation. However, this concerns only 11% of the replacements, which means that the patients in this category usually have non-problematic replacements(2). If this one-third of the patients is treated properly, success rates up to 90% can be expected. It should be noted, that the influence of radiotherapy on the final outcome of the voice rehabilitation seems to be minor. There is no increase in immediate postoperative complications, but a temporary deterioration of the voice during postoperative irradiation must be reached. Furthermore, we found a decrease in device life and an increase in fistula-related complications in radiated patients, but these have rarely prevented the application of this prosthetic rehabilitation method in this patient category.
It is important to verify at each clinic visit the status of the prosthetic device, and if there are any problems, to establish their exact nature. The following list of 10 points should be kept in mind when a patient needs replacement of his/her Provox (2) device:
1. Determine the indication for replacement (leakage through or around, infection of the TE-fistula tract, etc.)
2. Determine the required length of the new prosthesis (never automatically replace the existing device with one of the same size)
3. Prepare the prosthesis for insertion (attaché the prosthesis to the inserter, fold the esophageal flange forward in the loading tube and advance the inserter to mark line 1)
4. Remove the old prosthesis with a non-toothed hemostat, and ask the patient to keep his/her mouth open (this prevents swallowing and thus aspiration) until the prosthesis is replaced
5. Insert the loading tube into the TE-fistula and advance the tube towards the posterior esophageal wall, making sure that the tip is inside the lumen of the esophagus
6. Advance the inserter until mark line 2 is level with the backside of the loading tube, using the thumb as a ‘stopper’
7. Pull back the inserter and the loading tube together, anchoring the esophageal flange on the anterior esophageal wall
8. Remove the loading tube, unfolding the tracheal flange (if necessary use one or two hemostats in case the tracheal flange is still in the TE-fistula, or in case of ‘overshooting’)
9. Ensure proper retention of the prosthesis by rotation and/or up and down movement of the prosthesis on the inserter
10. Cut the security string of the prosthesis and rotate the prosthesis into its optimal position with the cut edge pointing caudally.
Points 1 and 2 are important for any replacement procedure of any voice prosthesis, the other points are obviously relevant for Provox2 only. Nevertheless, the most common mistakes are made against Points 1 and 2. For instance, if the leakage problem is not identified as leakage around the prosthesis, simple replacement with a device of the same length is not helping much. If, due to a local infection and overgrowth of the mucosa in the esophageal lumen or esophageal pouch formation, the prosthesis is pushed outward/extruded, not identifying this problem and replacement with a shorter device will increase the problem. Fortunately, the problems and solutions discussed here are relatively rare and are mostly easily manageable, if recognized in time (1, 2).
Definition problems/adverse events: all ’fistula-related’ indications for replacements, except leakage around the prosthesis, if downsizing can solve this. (Subsiding of surgical edema and tissue reaction is a natural course of events, especially with indwelling voice prostheses, which are not handled by the patients themselves (little trauma to the fistula); this means that during follow-up often a shorter prosthesis is sufficient).
Problems or adverse events are mostly minor and their treatment is generally not too difficult. As a rule of thumb one can say, that in daily practice two-thirds of the patients have no problems what so ever, and they consume approximately one-third of the total time, spent on prosthetic voice rehabilitation. These patients only visit the outpatient clinic once in a while for replacement of the prosthesis when it becomes incompetent and shows mild leakage of fluids. The other one-third of the patients occasionally has problems, which need special attention and they consume the other two-thirds of the total time, spent on prosthetic voice rehabilitation. However, this concerns only 11% of the replacements, which means that the patients in this category usually have non-problematic replacements(2). If this one-third of the patients is treated properly, success rates up to 90% can be expected. It should be noted, that the influence of radiotherapy on the final outcome of the voice rehabilitation seems to be minor. There is no increase in immediate postoperative complications, but a temporary deterioration of the voice during postoperative irradiation must be reached. Furthermore, we found a decrease in device life and an increase in fistula-related complications in radiated patients, but these have rarely prevented the application of this prosthetic rehabilitation method in this patient category.
