Atos Provox ActiValve Manual Del Usuario página 12

Handling related
Problem: It is difficult to push the prosthesis forward in the tube.
Probable cause: The esophageal flange has not folded completely forward into the loading tube.
Solution: Interrupt the insertion and pull the prosthesis back out of the loading tube. Inspect the voice prosthesis. If the
voice prosthesis is damaged, discard the prosthesis! If the valve is undamaged reload and repeat the procedure as described
in section 2.3.
Problem: The prosthesis has been completely inserted into the esophagus (accidental overshooting).
Solution: Leave the safety strap attached to the inserter and follow the instructions in section 2.4.
Puncture related
Aspiration of the prosthesis or other components – Immediate symptoms may include coughing, choking or wheezing.
Solution: Partial airway obstruction or complete airway obstruction requires immediate intervention for removal of the
object. If the patient can breathe, coughing may remove the foreign body. As with any other foreign body, complications from
aspiration may cause obstruction or infection including pneumonia, atelectasis, bronchitis, lung abscess, bronchopulmonary
puncture and asthma.
If aspiration of the device is suspected, a CT scan of the lungs should be performed to confirm aspiration and locate the device.
If the CT scan confirms aspiration of the device, the device may be retrieved endoscopically using non-toothed grasping forceps.
The silicone housing of the Provox ActiValve can also be located endoscopically. On a CT scan and during endoscopy, the
device may appear as a circular shape with an opening in the middle with an outer diameter of about 14 mm (the flanges of
the device), or as a cufflink shape with a shaft length of 4.5, 6, 8, 10 or 12.5 mm, depending on the size of the device. During
endoscopy, reflections from the light source on the clear silicone rubber may be seen. Also, in prostheses that have been in
situ for some time, white or yellow appearing Candida deposits may be visible on the device.
Ingestion of the prosthesis or other components can cause symptoms that largely depend on size, location, degree of
obstruction (if any).
Solution: The object usually passes spontaneously into the stomach and subsequently through the intestinal tract. If bowel
obstruction, bleeding or perforation occurs, or the object fails to pass through the intestinal tract, surgical removal must
be considered. If the device has remained in the esophagus it can be removed endoscopically. Spontaneous passage of the
device may be awaited for 4-6 days. The patient should be instructed to observe the stools for the ingested device. If the
device does not pass spontaneously, or if there are signs of obstruction (fever, vomiting, abdominal pain) a gastroenterologist
should be consulted.
The silicone housing of the Provox ActiValve can be located and retrieved endoscopically. For details on endoscopic retrieval
see section above.
Hemorrhage/Bleeding of the puncture – Slight bleeding from the edges of the TE-puncture may occur during replacement
of the prosthesis and generally resolves spontaneously. Patients on anti-coagulant therapy, however, should be carefully
evaluated for the risk of hemorrhage prior to placement or replacement of the prosthesis.
Infection and/or edema of the TE-puncture may increase the length of the puncture tract (e.g during radio therapy).
This may cause the prosthesis to be drawn inward and under the tracheal or esophageal mucosa. Inflammation or overgrowth
of the esophageal mucosa may also cause the prosthesis to protrude from the puncture on the tracheal side.
Solution: Temporarily replace the prosthesis with a longer one. Treatment with antibiotics with or without corticosteroids
may also be considered. If the situation does not improve the prosthesis should be removed. Stenting the puncture with a
catheter might be considered.
Granulation around the TE-puncture.
Solution: Electrical, chemical, or laser cauterization of the area of granulation may be considered.
Hypertrophic scarring around the puncture with bulging of the tracheal mucosa over the tracheal flange may occur if the
prosthesis is relatively short.
Solution: The excess tissue may be removed by using a laser, or a prosthesis with a longer shaft can be inserted.
Protrusion and subsequent extrusion of the prosthesis is sometimes observed during infection of the TE-puncture.
Solution: Removal of the prosthesis is required to avoid dislodgement into the trachea. Repuncture may be necessary if the
puncture has closed.
Leakage around the prosthesis – Transient leakage may occur and can improve spontaneously.
Solution: The most common reason for persistent leakage around the voice prosthesis is that the device is too long. Replace
the prosthesis with a shorter one. If the leakage is indicated by an enlarged puncture, place a Provox XtraFlange over the voice
prosthesis' tracheal flange or replace it with a Provox Vega XtraSeal. Temporary removal of the prosthesis, a submucosal
purse string suture or insertion of a cuffed tracheal cannula and/or nasogastric feeding tube may also be considered to reduce
the size of the puncture. If the leakage persists, surgical closure of the puncture may be necessary.
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