An ingenious new non-surgical treatment promises relief from emphysema and COPD. We asked the manufacturer Pulmonx about the Zephyr Valve
• What conditions was the Zephyr® Valve created to address?
The Zephyr Valve is suitable for patients who have difficulty breathing due to severe emphysema – a form of COPD (chronic obstructive pulmonary disease). All other treatment options, such as medication, should have been tried first. Before you can be treated, your doctor will check whether a part of your lungs is suitable for the Zephyr Valve procedure.
• How common are these conditions and what are the causes?
COPD is the second most common lung disease in the UK. 115,000 people are diagnosed with COPD every year which is the equivalent of a new diagnosis every 5 minutes.
4.5% of all people aged over 40 live with diagnosed COPD. COPD is more prevalent in the North East and North West of England & Scotland.7
COPD develops because of long-term damage to your lungs from breathing in a harmful substance, usually cigarette smoke, as well as smoke from other sources and air pollution. If the damage to the bronchi is so well-advanced that it cannot be reversed, lung specialists talk of a permanent narrowing of the respiratory tract, i.e. COPD.
• How serious are these conditions?
Living with COPD can be extremely difficult and have a profound impact on daily life. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. Shortness of breath can be an extremely scarey experience for people that suffer from COPD. Doing even the most simple tasks such as brushing teeth and getting dressed often take twice as long. As daily activities become more challenging, people with COPD often describe their world as‚ becoming much smaller‘ and their burden on family and friends much greater.
• What are the drawbacks to conventional treatments for these conditions?
Conventional medical treatment often gives very modest and short-lived relief of the symptoms caused by COPD. Over time as the disease progresses, the impact of medical treatment often declines. As the progression continues patients may then require oxygen therapy to help with their breathing. Pulmonary rehabilitation (physiotherapy) has been show to help alleviate patients symptoms and is a prerequisite for alternative treatments open to a particular set of people that suffer with COPD.
• How does the Zephyr Valve work?
The Zephyr Valve is not another medicine, or surgery that requires cutting the skin. It is a procedure during which small valves are inserted into the airways, helping the healthier parts of the lungs to expand, thus reducing pressure on the diaphragm and making it easier for the patient to breathe.
• What is involved in patient assessment for the Zephyr Valve?
After the diagnosis of severe emphysema is being confirmed by a chest physician, the doctor will refer the patient to an experienced treatment centre. To determine whether surgical treatment options and/or the insertion of Zephyr Valves are possibilities, it may be necessary to conduct additional tests – e.g. a lung function test or a CT scan.
• How invasive is the fitting procedure and how long does it take?
The valves are a permanent implant designed to fit in the airways of the lungs. The valves are placed in selected airways during a bronchoscopy procedure (no incisions or cutting required) and are an alternative to the more invasive traditional lung volume reduction surgery.
In a procedure lasting 30-60 minutes, about four Zephyr Valves are placed in the airways leading to the damaged parts of the lung. This is done by bronchoscopy (through the nose or mouth) thus requiring no cutting of skin. The valves prevent air from entering the damaged parts of the lungs, thus reducing over-inflation.
• What are the main benefits of the Zephyr Valve?
The benefits of the Zephyr Valve have been clinically proven in several clinical studies. 2-6 In the current LIBERATE Study1, after one year, patients treated with the Zephyr Valve – compared to patients who received medication alone – experienced the following benefits:
• Patients could breathe more easily due to improved lung function
• They were able to do more physical activity and cover longer distances
• They could do more daily activities like going for a walk, taking a bath and gardening
• They had a better quality of life and more energy
• They were more confident when they left the house
• What studies have been made of the clinical benefits of the Zephyr Valve?
Results from multiple randomized clinical trials of the Zephyr® Valve have demonstrated clinically meaningful benefits in lung function, exercise capacity, and quality of life (QoL). Since 2007 more than 19,000 patients have been treated globally.
• What does UK national guidance say about the Zephyr Valve?
The National Institute for Health and Care Excellence (NICE) aims to improve outcomes for people using the NHS and public health and social care services. The Zephyr Valve is aligned with their guidance and therefore recommended as a standard of care.8
Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.
- Criner G et al. Am J Resp Crit Care Med.2018; 198(9), 1151-1164
- Sciurba FC et al. N Eng J Med 2010; 363:1233-1244 (includ. a supplemental annex)
- Davey C et al. Lancet 2015; 386: 1066-1073
- Klooster K et al. N Engl J Med 2015; 373(24): 2325-2335
- Valipour A et al, AJRCCM 2016. 194: 1073-1082
- Kemp S et al. Am J Respir Crit Care Med. 2017
- https://statistics.blf.org.uk/copd
- NICE (National Institute for Health and Care Excellence) Final Guidance on Endobronchial valve insertion to reduce lung volume in emphysema (https://www.nice.org.uk/guidance/ipg600), accessed Dec. 20, 2017.
The Zephyr® Endobronchial Valve is an implantable bronchial valve intended to control airflow in order to improve lung functions in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks. The Zephyr Valve is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated; Evidence of active pulmonary infection; Patients with known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium); Patients with known allergies to silicone; Patients who have not quit smoking. Use is restricted to a trained physician. Prior to use, please reference the Zephyr Endobronchial System Instructions for more information on indications, contraindications, warnings, all precautions, and adverse events.
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