One patient could only walk 15 to 20 steps before needing to get back on her oxygen, making it difficult to find motivation to engage in daily activities. Another patient struggled with severe breathlessness that limited even basic tasks like standing for long periods or holding a conversation without becoming out of breath, despite following a strict medication regimen. These are some of the common challenges for people with advanced COPD/emphysema, where breathlessness can become so debilitating that it impacts nearly every aspect of daily life.
Emphysema, a type of chronic obstructive pulmonary disease (COPD) is a chronic lung disease that makes breathing difficult. Emphysema occurs when the air sacs in the lungs, called alveoli, are damaged or destroyed. This causes the alveoli to rupture and trap air, resulting in hyperinflation of the lungs making breathing difficult and impacting supply of oxygen through the body. The debilitating symptoms resulting from such hyperinflation can be improved by reducing the degree of hyperinflation by removal of the most diseased part of the lungs.
For patients with this condition in whom medication alone is no longer adequately controlling their breathlessness, endobronchial valves (EBV) offer a new treatment option. The devices are about the size of a pencil eraser and are bronchoscopically placed in the most diseased part of the lung.
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Typically placed under general anesthesia without any cutting, the one-way valves allow trapped air to escape during exhalation but prevent new air from entering during inhalation. This helps to deflate the damaged area of the lung and enable healthier parts of the lung to function more effectively, which can improve patients’ breathing and increase their activity levels. The procedure, which is reversible, i.e., the valves can be readily removed, has been proven safe and effective, typically requiring only a short hospital stay.
The valves are indicated for patients who have received optimal medical management (smoking cessation, pulmonary rehabilitation, medications and if appropriate oxygen supplementation) but still remain symptomatic. These patients are typically limited in what they can do because of their shortness of breath e.g., have trouble climbing stairs, doing everyday errands, maybe even walking around their yard. By making breathing easier, lung valves allow patients to have a better quality of life and limit the potential need for more invasive treatment such as lung volume reduction surgery or lung transplantation.
Though a new concept to many patients, lung volume reduction with valves is now a guideline recommended standard of care procedure, having undergone five randomized controlled trials, received regulatory approval, delivered positive real-world evidence, and secured insurance approval. Busy physicians are discovering their potential for meaningful clinical outcomes; for patients, stairs, strolls, and chores become possible again.
The referral process: ‘Don’t overthink it’
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Given their efficacy, medical professionals are working to ensure candidates for the valves have every chance to benefit. General pulmonologists are working to better understand who qualifies for referral to an EBV specialist and how that is determined. A fair amount of workup is required: prospective candidates must undergo pulmonary function tests, CT scan, arterial blood gas test, six-minute walk test, and an echocardiogram, in addition to pulmonary rehabilitation.
In general terms, however, the valves are recommended for advanced COPD/emphysema patients who have been optimally medially managed and are still breathless (have a forced expiratory volume, or FEV, of less than 50% of predicted normal volume). Patients have to quit smoking to qualify and physicians report that the opportunity to have this procedure has been a strong motivator to quit smoking.
Interventional pulmonologists who place the valves urge general pulmonologists to refer patients for the valves sooner rather than later, and whenever the procedure is a realistic possibility. Rather than waiting until a patient meets every qualification, referring a patient who may be close to eligibility helps ensure that those who could benefit have the opportunity to be evaluated.
Education and collaboration
The more often general pulmonologists refer patients, the more familiar they will be with patients’ likely suitability for lung valves and the more often they will raise the procedure as an option. Specialists urge physicians to simplify referral criteria in their minds and focus on the 50% FEV1 threshold.
General pulmonologists are also establishing partnerships and referral channels with interventional pulmonologists to coordinate appointments and diagnostic tests and share the experiences of patients with the valves.
Now, patients who were previously facing challenges like needing oxygen after just a few steps or struggling with breathlessness from simple movements are finding new possibilities for daily life. With improved breathing, many have been able to participate in activities they once thought were lost to them, from everyday tasks like taking out the trash to traveling with family to enjoying hobbies – experiences that allow them to live more freely and independently.
Photo: Kobus Louw, Getty Images
Narinder Singh Shargill, PhD, is Vice President of Global Medical Affairs at Pulmonx, a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. Narinder has 30+ years of experience taking medical devices through clinical development, regulatory approvals, and post-approval support through Medical Affairs’ activities, including 20+ years in interventional pulmonology. He led execution of key clinical trials leading to FDA approval of the Zephyr Valves in the US. Before Pulmonx, Narinder was Vice President, Clinical Strategy and Medical Affairs–Pulmonary at Boston Scientific and played a key global role supporting the Alair® Bronchial Thermoplasty System. Previously, he was Vice President, Clinical Affairs at Asthmatx, where his efforts led to the first therapeutic device approval in interventional pulmonology. Narinder also worked with Baxter following its acquisition of Fusion Medical Technologies, Nycomed Salutar, and Scios Inc. He holds a PhD in Nutrition/Biochemistry from the University of Southampton and completed post-doctoral training at the University of Southern California School of Medicine and School of Pharmacy.
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