Endobronchial Valves
DESCRIPTION
Endobronchial valves are synthetic devices that are deployed with bronchoscopy into ventilatory airways of the lung for the purpose of controlling airflow. They have been investigated for use in individuals who have prolonged broncho-pleural air leaks, as well as an alternative to lung volume reduction surgery (LVRS) in individuals with lobar hyperinflation from severe emphysema.
Proper lung functioning is dependent upon a separation between the air-containing parts of the lung and the small vacuum-containing space around the lung called the pleural space. When air leaks into the pleural space the lung is unable to inflate resulting in hypoventilation and hypoxemia; this condition is known as a pneumothorax. A pneumothorax can result from a variety of processes including trauma, high airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs or bullae which may be congenital or a result of chronic obstructive pulmonary disease (COPD).
Although an air leak from the lung into the pleural space may seal spontaneously, it often requires intervention. Techniques currently employed to attempt air leak closure include the following:
Inserting a chest tube (tube thoracostomy) and employing a water seal or one-way valve to evacuate air collected in the pleural space and prevent it from reaccumulating,
Lowering airway pressures by adjusting the mechanical ventilator,
Using autologous blood patches,
Performing a thoracotomy with mechanical or chemical pleurodesis.
An endobronchial valve is a device that permits one-way air movement. During inhalation the valve is closed preventing air flow to the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. When used to treat persistent air leak from the lung into the pleural space, the endobronchial valve theoretically permits less air flow across the diseased portion of the lung during inhalation aiding in air leak closure. The valve may be placed, and subsequently removed, by bronchoscopy.
Endobronchial valves have also been investigated for use in severe emphysematous COPD. In emphysematous COPD peripheral lung tissue may form bullae. These diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. They also may rupture, causing a pneumothorax. Use of an endobronchial valve is thought to prevent hyperinflation of these bullae.
Consideration for the use of endobronchial valves in COPD is based on the improvement observed in patients who have undergone lung volume reduction surgery (LVRS). LVRS involves excision of peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism of clinical improvement for patients undergoing lung volume reduction has not been firmly established. However, it is believed that elastic recoil and diaphragmatic function are improved by reducing the volume of diseased lung. The procedure is designed to relieve dyspnea and improve functional lung capacity and quality of life; it is not curative. Endobronchial valves have been investigated as a non-surgical alternative to LVRS.
POLICY
Endobronchial valves as a treatment of prolonged air leaks, chronic obstructive pulmonary disease, emphysema or any other condition/disease is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
The only available data on endobronchial valves for treating air leaks are uncontrolled trials with small numbers of heterogenous individuals. Data on the FDA-approved endobronchial valve device are particularly limited. Case series and a single unblinded RCT on endobronchial valves for the off-label treatment of individuals with advanced emphysema provide insufficient evidence that the technology improves the net health outcome. In this trial, there were marginal benefits that may not be clinically meaningful and the adverse events experienced by individuals who received endobronchial valves raise concerns about the safety of the treatment.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2010). Endobronchial valves (7.10.128). Retrieved January 12, 2011 from BlueWeb. (9 articles and / or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/24/2011
MOST RECENT REVIEW DATE: 4/24/2011
ID_EBA
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