Since 2008, the Spiration® Valve System has been approved by the FDA as a Humanitarian Use Device for the control of prolonged air leaks following specified lung resections.*

The Procedure

How to Prepare for the Procedure

Before the procedure begins your doctor will give you medicine that will make you unaware of pain and will make you sleepy (sedation) or unconscious (anesthesia). If you know you are allergic to the drugs used to make you sleepy (sedatives) or unconscious (anesthesia), let your doctor know. If you have any concerns about sedation or anesthesia, talk with your doctor before the procedure. Your doctor will talk with you about the best type of sedation or anesthesia for you.

The narrow tube with a balloon at the end (balloon catheter) used to find the air leak and to measure the airways may be made of latex. (see Figures 1 a and b) If you are allergic to latex, let your doctor know and a non-latex balloon catheter will be used. A person who is highly allergic to latex can have an anaphylactic shock, a life threatening allergic reaction that may cause death.

Figures 1 a and b. The narrow, flexible tube with a camera (bronchoscope) is inserted into the lungs through the mouth or nose and directed to the location of the air leak; Inflation of a balloon in an airway to test for an air leak and to size the airway.


What to Expect During the Placement Procedure

The amount of time needed for the procedure will vary depending on the number and location of the air leaks. Based on use of the Spiration Valve System since June 2008, the average number of valves placed per patient is 3.

The first thing your doctor will do is insert a narrow, flexible tube with a camera on the end (bronchoscope, see Figure 1 a) through your mouth or nose. The camera helps your doctor see inside your airways. Next the doctor will put another narrow, flexible tube with a small balloon on the end (balloon catheter) through the bronchoscope and into your airways. The balloon does two things: (1) when it is inflated it will briefly block the airway to show if it leads to the leaking tissue (see Figure 1 b) and (2) it will measure the size of that airway. Your doctor will use this information to choose the best valve sizes to fit your airways. 

Next your doctor will place the correct size valve in the selected airway by putting the narrow, flexible tube (deployment catheter) that holds the valve through the bronchoscope (see Figure 2 a and b). Once the valve is placed, it will open like a small umbrella and block the flow of air into the leaking lung tissue. This will decrease the air flow, which can help the tissue around the air leak to heal naturally.

Figure 2 a and b. The Spiration Valve is delivered to the target location via a narrow, flexible tube (deployment catheter) that is passed through the bronchoscope.


What to Expect After the Placement Procedure

Following the procedure you will likely still have your chest tube(s) in place.  The reason for this is to let air in your chest escape and allow your doctor to measure the air leak. Depending on your overall health and how well your air leak is healing, your doctor will decide if you should stay in the hospital and how long your chest tube(s) should stay in place. Every air leak is different and the time it takes to heal can be very different from person to person. Therefore, it is important for you to talk to your doctor about your condition and the post-procedure plan.

If you are sent home with a chest tube(s), your doctor will give you instructions for your care at home. This will include information on caring for your chest tube(s), medicines, and follow-up visits. You will be given a card for your wallet that says you have one or more valves and where they are placed (see Figure 3). This card will have your doctor’s contact information. Call your doctor immediately if you have any discomfort, pain, or any other concerns after your procedure. Please keep this card with you at all times and show it to anyone who gives you medical care, including any emergency room medical staff.

Figure 3. The Spiration Valve Patient Card is your record of the procedure. An example of the front and back of the card are shown here.


What to Expect When the Spiration Valve is Removed

The valve will be removed when your doctor is confident that the air leak has stopped and there has been sufficient time for the tissue to heal. This should be about 2-6 weeks. Your doctor will check to see if the air leak has stopped by taking a picture of your lungs (using a chest x-ray or CT scans) or by bending/kinking your chest tube while it is attached to a device that measures and monitors air leaks (chest drainage system). 

Like valve placement, the valve removal procedure is done using sedation or anesthesia, but it usually takes less time. A narrow, flexible tube with a camera at the end (bronchoscope) will be used as it was during valve placement. The valve will be removed with a common medical tool (forceps) that helps doctors grab onto tissue and other objects in the body (see Figure 4 a and b).

Figure 4 a and b. Spiration Valve removal.


What happens if the Spiration Valve does not heal the air leak?

If your air leak does not decrease or stop after the procedure, your doctor will talk with you about your choices. These may include placing more valves in your airways or removing the valve(s) entirely. Your doctor may also decide that a different kind of procedure is needed.


Other treatments for patients with a prolonged air leak

The most common non-surgical treatment for prolonged air leaks is keeping a chest tube(s) in the body until the air leak is gone. It can take weeks and sometimes months for an air leak to heal using this method. In rare cases the leak may never heal using this method. Another option is a surgical procedure (pleurodesis) that causes the outside of the lung to stick to the inside of the rib cage; this prevents the lung from collapsing. As a last option, your doctor may decide the only way to stop your leak is to re-operate. Your doctor can give you more information about these treatment options.