Valves for Emphysema

New Study on Endobronchial Valves as Treatment for Emphysema

The results of a new study evaluating placement of valves inside the lung – called bronchoscopic lung volume reduction – was published in the December 10, 2015, issue of the New England Journal of Medicine.

Diagram of scope passed thru mouth into the lungs (called bronchoscopy)

Diagram of scope passed thru mouth into the lungs (called bronchoscopy)

Background: With bronchoscopic lung volume reduction, valves are placed into the breathing tubes to block the flow of air out of the specific area of the lung. This collapses part of the “bad” lung which is not functioning and allows the “good lung” to expand.  This allows the diaphragm (the main breathing muscle) to work more effectively. Ideally, this will improve lung function and make it easier to breathe.  A diagram of how bronchoscopy is done is shown on the left below; a view of one of the valves used in the study is shown on the right below.

Zephyr valve used in the study

Zephyr valve used in the study

 

 

 

Zephyr valve prevents air from entering the lung. Air can only move out of the lung,  resulting in collapse of emphysema lung.

Zephyr valve prevents air from entering the lung. Air can only move out of the lung, resulting in collapse of emphysema lung.

 

 

 

 

 

 

 

 

Unfortunately, this procedure does not work for everyone who has emphysema. Researchers around the world are trying to find out the best candidates for this treatment. One reason that bronchoscopic lung volume reduction may not work is if someone has a hole or defect in the fissure that separates lobes in the lung. A brief anatomy lesson will help to explain this concern. There are 3 lobes or discrete parts in the right lung and 2 lobes or discrete parts in the left lung. In the figure below, fissures are shown by black curves.

Diagram showing 3 lobes in the right Lung and 2 lobes in the Left Lung. The black curves are fissures which separate the lobes. If there is a defect in a fissure, putting in a valve into one breathing tube will not collapse the desired part of the lung.

Diagram showing 3 lobes in the right Lung and 2 lobes in the Left Lung. The black curves are fissures which separate the lobes. If there is a defect or hole in a fissure, putting in a valve into one breathing tube will not collapse the desired part of the lung.

 

In some individuals, small openings or pores allow air to flow across the fissure from one lobe to another. This flow is called collateral ventilation.  However, this is not beneficial if the goal is to collapse a part of “bad” lung. The collateral ventilation allows air to bypass the lung blocked by the valves, just like a bypass road allows you to drive around or bypass a city.

Study: Klooster and colleagues at the University Medical Center in Groningen, Netherlands, were able to measure whether someone had collateral ventilation or not. In those who did not have collateral ventilation, 34 patients received endobronchial valves and 34 patients were the control group and treated with standard medical therapy.

Findings at 6 months: There were significant increases in breathing tests [by 140 ml in how much air can be exhaled in one second (FEV1) and by 347 ml in vital capacity (FVC)] and in the distance walked in 6 minutes (by 74 meters) in the valve group compared with the control group.  There were 23 serious adverse events in the valve group and 5 in the control group. One person who received valves died. Some individuals required removal of the valves (15%) or replacement of the valves (12%).

My Comment: These findings make sense. If you are going to have valves placed inside of your breathing tubes to collapse areas damaged by emphysema, the treatment team should make sure that you do not have collateral ventilation. This should lead to better overall benefits of bronchoscopic lung volume reduction.

Although the authors had patients report on their quality of life, I am disappointed that the researchers did not have the participants rate their shortness of breath with a valid questionnaire. Those with emphysema are bothered most by their breathing difficulty, and being able to breathe easier is one of the key goals of treatment.

Like another study that I summarized in September 2015 under COPD News, there are risks with the procedure and you need to weigh possible benefits and possible risks. Certainly, you should discuss these with you doctor and the specialists who perform this procedure.

 

 

Use of Valves To Treat Advanced Emphysema

Valve Study Shows Some Benefits and Some Risks

Over the past year, I have been asked by a few patients with COPD in my practice, “What else can you do to help my breathing get better?” Each of these individuals is taking available long-acting inhaled bronchodilators, is participating in pulmonary rehabilitation program, and is on oxygen.

In response to the question, I describe the possibility of a research study where a doctor passes a flexible scope thru the mouth and then into the breathing tubes to look inside the lungs (called bronchoscopy).

Diagram of scope passed thru mouth into the lungs (called bronchoscopy)

Diagram of scope passed thru mouth into the lungs (called bronchoscopy)

Umbrella-like valves are attached to the end of the scope and then placed into the breathing tubes to collapse part of the lung which is not functioning.This allows the “good lung” to expand and allows the diaphragm (the main breathing muscle) to work more effectively. Ideally, this will improve lung function and make it easier to breathe.  The procedure is called bronchoscopic lung volume reduction.

 

Photo of umbrella device taken from inside a breathing tube. The umbrella will block air from entering the lung leading to collapse.

Photo of umbrella device taken from inside a breathing tube. The umbrella will block air from entering the lung leading to collapse.

 

View of umbrella valves positioned into breathing tubes that block entry of air and collapse the lung

View of umbrella valves positioned into breathing tubes that block entry of air and collapse the lung

 

 

 

 

 

 

 

 

In the United States, this procedure is considered investigational which means additional studies are required to evaluate benefits and risks before approval by the Food and Drug Administration.

In June 2015, Dr. Davey and her colleagues published the results of a study (in the journal  Lancet, volume 386) involving 50 patients with severe emphysema. In Group 1 (25 patients), valves were placed by a bronchoscope (a scope passed thru mouth into breathing tubes) to cause collapse of one lobe of the lung. Group 2 (25 patients) was considered as a control group as individuals had the same bronchoscope passed into the breathing tubes to mimic the first group, but no valves were place (sham or fake).

The study was performed at the Royal Brompton and Imperial College in London, United Kingdom, a leading respiratory research institute. The study was not sponsored by a commercial company.

The study had several very specific requirements for individuals to enter the study:

  1. general emphysema with a lobe in one lung as a target to collapse (we all have 3 lobes in the right lung and 2 lobes in the left lung)
  2. an intact interlobar fissure on CT scan of the chest (this means that air should not be able to pass from an open lobe to the collapsed lobe after the valve has been placed)
  3. the key breathing test result – forced expiratory volume in one second (FEV1) – less than 50% of predicted
  4. low exercise capacity (unable to walk more than 450 meters (492 yards) in six minutes
  5. the need to stop because of shortness of breath after walking 100 yards or after a few minutes on the level

RESULTS at 3 months after procedure: 

Outcome                                                   Group 1          Group 2 (control group)        Signficant

Change in FEV1                                      + 8.8%                       + 2.9%                                      Yes

Change in 6 min walk                           + 27 yards                + 3 yards                                  Yes

Change in exercise time on cycle      + 25 sec                    – 11 sec                                     Yes

Quality of life                                           – 4.4 units                – 3.6 units                                No

(the lower the score the better quality of life)

RISKS: Two patients in Group 1 died within 90 days of the procedure. One patient in Group 2 was too sick to return for follow-up testing.  Two patients in Group 1 had a pneumothorax (air in the space around the lung due to rupture) which occurred at 3 days and at 12 days after the procedure). Both patients who had a pneumothorax needed a tube placed between the ribs in order to remove the air and allow the hole to heal. Four patients coughed out a valve before 3 months.

MY COMMENT: As often seen in studies, some individuals improved a lot after the procedure while others did not improve at all. Any treatment including placement of valves into the lung requires the individual to consider both benefits and possible risks. In the northeast, the closest research site in the study is Beth Isreal-Deaconess Medical Center in Boston.

 

Will Lung Volume Reduction Surgery Help Me?

Dear Dr. Mahler:

I have been reading about lung volume reduction clinical trials. Is this procedure for people with emphysema that is diffuse?
Thank you.

Karen from Cranston, Rhode Island

Dear Karen:

Lung volume reduction surgery (abbreviated LVRS) is an operation to remove about 20 – 30% of damaged lung for those with severe emphysema. By removing some areas of the lung that are not working normally, the remaining lung can expand and be more efficient. The operation is performed either by a large incision in the chest (called thoracotomy) or by several small incisions using a scope to do the surgery (called video-assisted thorascopic surgery and abbreviated VATS).

The evaluation process is extensive to determine whether you are a “good candidate” for LVRS. It includes a medical history and physical examination, tests of how your heart and lungs function, an exercise test, and a CT scan of your chest. In one study, it was shown that those with the emphysema mainly in the upper parts of the lung and with low exercise tolerance benefited the most by having less breathing difficulty, a better quality of life, and improved ability to exercise after LVRS. You will be expected to join a pulmonary rehabilitation program for 6 – 8 weeks before surgery so that you are in the best possible shape. The surgeon will review with you the risks with this operation.

Karen, by your question it sounds like you were told that you have diffuse emphysema on a CT scan. This means that the damage is throughout your lungs rather than predominantly in the upper lungs as is preferred for best results with LVRS. If this is the case, you may wish to consider another approach IF you continue to have breathing difficulty despite being treated with the best available medications for COPD and having completed pulmonary rehabilitation program.

At certain medical centers, small devices such as coils or umbrellas are placed through a bronchoscope (small flexible tube) into an airway (breathing tube) that leads to an emphysema area. The purpose of the coil or umbrella is to collapse damaged lung so that the remaining lung can expand and function more normally. The procedure is called bronchoscopic lung volume reduction. At the present time, the placement of coil or umbrella devices has not been approved by the Food and Drug Administration (FDA) and is therefore investigational. This means you would need to be part of a study to evaluate the benefits and risks of placement of a coil or umbrella into your airway.

Photo of umbrella device taken from inside a breathing tube.  The umbrella will block air from entering the lung leading to collapse.

Photo of umbrella device taken from inside a breathing tube. The umbrella will block air from entering the lung leading to collapse.


View of umbrella devices positioned into breathing tubes that block entry of air into the lung tissue.

View of umbrella devices positioned into breathing tubes that block entry of air into the lung tissue.

I practice in New Hampshire and have referred interested patients with advanced emphysema to Dr. Adnan Majid, Director of the Emphysema Clinic at Beth Isreal Deaconess Medical Center in Boston, Massachusetts. Dr. Mahid and his team are participating in different FDA-approved clinical trials to learn about the benefits and safety of bronchoscopic lung volume reduction with the Nitinol coil (called the RENEW study) and the IBV umbrella valve (called the EMPROVE study). If you are interested, you should discuss this with your doctor, and possibly ask her/him to refer you to this medical center as it is close to where you live in Rhode Island.