Potential Risks & Complications of Spiration Valve Therapy
Valve therapy is a minimally invasive procedure that is well tolerated by most patients, but is not without risks. Please discuss these potential risks with your doctor. Call your doctor immediately if you have any discomfort, pain or any other concerns after your procedure.
- The Spiration Valve System should not be used for patients who have active asthma, bronchitis or clinically significant bronchiectasis.
- If you have swelling of airways (active asthma), inflammation of lung tissue (bronchitis), or airways that have gotten larger and/or infected (bronchiectasis), you should not have Spiration Valves placed in your lungs.
- You will be given drugs to make you unaware of pain during the procedure. These will make you sleepy (sedation) or unconscious (anesthesia). Talk with your doctor about the problems that can occur with sedation or anesthesia.
- The Spiration Valves are MR-conditional, which means that you can have an MRI procedure (a method for taking pictures of your internal organs) under certain conditions while the valves are implanted in your lungs. You will be given an information card to carry in your wallet. Show this card to a health care professional if you require an MRI.
- Although rare, as with all drugs and devices, it is possible that you may have an allergic reaction to the materials used in the Spiration Valve System.
Potential complications that may be associated with bronchoscopy and/or valve placement include, but are not limited to, the following:
- Altered arterial blood gas
- Anesthesia complications
- Arrhythmia (irregular heartbeat)
- Atelectasis (collapse of the lung)
- Bronchial injury
- Bronchospasm (tightening of the airways)
- Chest pain
- Chronic Obstructive Pulmonary Disease (COPD) exacerbation
- Dyspnea (shortness of breath)
- Empyema/lung abscess
- Hemoptysis (or bleeding)
- Hemothorax (blood collects between your lungs and chest wall)
- Hypoxemia (below-normal level of oxygen in the blood)
- Iatrogenic injuries
- Migration of a valve out of the lung or within the lung
- Myocardial infarction (heart attack)
- Persistent cough
- Pleural effusion (water on the lungs)
- Pneumothorax (air leak in the lungs)
- Pneumonia (lung infection)
- Respiratory failure
- Sore throat
- Thoracic pain
- Tissue hyperplasia or other reaction at valve site (abnormal increase in volume of lung tissue)
- Valve fracture
- Vocal cord injury
- Other procedure-related adverse events may occur