According to a study recently issued in the journal JAMA, implanting coils in the lungs can improve exercise aptitude at six months in patients with severe emphysema — a critical component of chronic obstructive pulmonary disease (COPD) — but the study cautioned the expense may be considered too high for some countries.
Emphysema is generally characterized by the hyperinflation and inelasticity of lung tissue, leading to exercise limitation, shortness of breath (dyspnea), and poor quality of life. Managing severe emphysema can be a challenge due to the restricted efficacy of the current available treatments.
A procedure which has confirmed clinical benefits in emphysema patients is lung volume reduction surgery, although it is still associated with considerable disease and fatality rates. The surgery uses nitinol (a metallic alloy) coils in a bronchoscopic intervention (through the use of a flexible, thin, endoscope) to reduce the volume and restore lung retreat.
The clinical trial study (REVOLENS), conducted at 10 different university hospitals in France, was led by Gaetan Deslee, M.D., Ph.D., from the Hospital Universitaire de Reims in France. Deslee and his team randomly distributed patients with severe emphysema to bilateral coil treatment (50 patients; standard of care and additional treatment where almost 10 coils were placed per lobe in two procedures) or standard of care (50 patients; received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen).
The primary measure outcome was the improvement of at least 54 meters, or 59 yards, during a six-minute walk test at six months after the intervention, which was observed in 18 patients (36 percent) in the coil group, and nine patients (18 percent) in the standard-of-care group. The coil treatment was linked to a noteworthy decrease in lung hyperinflation, and gradually allowed improvements in the patient’s quality of life.
On average, the total one-year per-patient cost disparity between groups neared $48,000. “This cost-effectiveness ratio at one year and modeled to three years would not be considered efficient enough to warrant adopting the technology by most countries. Implementation of this technique in a large-scale emphysema population is likely to require this additional data given the high per-patient cost in the short run and the uncertain effect on total healthcare expenditures,” the research team wrote in a news release.
In fact, the quality-adjusted life-years (QALYs) gain could be sustained for up to three years with similar follow-up costs in both groups, as the incremental ratio of cost-effectiveness would be around $270,000 QALY, nearing the incremental cost-effectiveness ratio reported for lung-volume reduction surgery in the U.S., but the authors emphasized that “further investigation is needed to assess durability of benefit and long-term cost implications.”
One of Deslee’s colleagues, Frank C. Sciurba, M.D., from the University of Pittsburgh, wrote in an accompanying editorial to the research article, “As further refinements in radiologic and clinical characterization progress, clinicians could expect to be able to offer even greater clinically based ‘precision medicine’ in matching a given technologic intervention to specific patient characteristics. Even though this approach may ultimately result in fewer patients eligible for treatment, those who receive treatment will be likely to have a more predictable therapeutic response.”
And, Sciurba added, “this improved efficiency could serve to translate into greater cost-effectiveness. Should the emerging data from larger pivotal trials support the meaningful clinical, albeit palliative, responses observed in preliminary trials, physicians caring for patients with COPD should not delay in providing evidence-based interventions that offer realistic hope to patients with few other choices to relieve their symptoms and improve their quality of life.”