By Stacy Lawrence, Staff Writer
Once patients with severe chronic obstructive pulmonary disease (COPD) are hospitalized with a life-threatening event, it's common for them to be readmitted or even die within the following weeks and months after their initial release.
The results of a trial backed by Amsterdam-based Royal Philips NV show that adding noninvasive ventilation, a form of which is a common sleep apnea treatment, in addition to oxygen at home extended the median time to readmission or death for these patients by almost three months.
The five-year data were published in the latest issue of the Journal of the American Medical Association (JAMA) after being presented at the American Thoracic Society International Conference in Washington.
"It's a breakthrough study. We do not have enough of this kind of data: prospective, randomized, controlled trial for noninvasive ventilation in COPD. It's gratifying that so many patients find it helpful," Teofilo Lee-Chiong Jr., the chief medical liaison at Philips, told Medical Device Daily.
"In today's world of government funding and payers, they are always looking at mortality as if it's the only important thing. It is very important to add years to one's life, but it is also equally important to add life to one's years," he added.
He noted that the current standard-of-care for COPD patients after a life-threatening hospitalization event varies, but that some combination of oxygen and medication is typically used in an effort to stabilize them enough to continue along at home.
This seven-year study was designed to examine a very specific subset of patients, those with persistent COPD after they return home from a hospital stay necessitated after a life-threatening event. These patients have persistent hypercapnia, which means they had excessive carbon dioxide in their bloodstream caused by their poorly controlled COPD.
The trial screened more than 2,000 COPD patients in the five-year data to find the 116 enrolled patients in order to eliminate potentially confounding, but highly prevalent, conditions such as obesity, sleep apnea and cardiovascular conditions that are also improved with the use of noninvasive ventilation (NIV).
"It was a very tough subset of patients to find, those with pure COPD. And we want persistent patients; many patients when they are ill, normalize when they return home. We want to see the subset of patients who are severe and that remains high despite optimized treatment," Lee-Chiong said.
In the study at St. Thomas' Hospital in London, the results found that the addition of at-home noninvasive ventilation to oxygen prolonged readmission or death to 4.3 months after an initial hospitalization as compared to 1.4 months for the oxygen-only control group.
In the initial group, 57 were in the treatment group, while 59 were in the control group. A total of 36 patients in the treatment group and 28 patients in the control group completed the 12-month study period with many of the control group receiving noninvasive ventilation after an earlier primary outcome on readmission was reached.
"Patients with severe COPD and persistent hypercapnia have historically had limited therapy options available to them and outcomes have generally been poor," said a study author Nicholas Hart, professor and clinical director of Lane Fox Respiratory Service at St. Thomas' Hospital.
"The trial suggests that combining home oxygen and home noninvasive ventilation therapy can reduce hospital readmissions while maintaining patients' quality of life, which will drastically change the way we approach COPD treatment worldwide. We are looking forward to hopefully decreasing the mortality and readmission rates that result from severe COPD with further research," he added.
Seconded Lee-Chiong, "There are many studies looking at noninvasive ventilation for COPD, but they are just for readmission. We also measure mortality, quality of life, activity and how many people get back to work or require less medication."
Up next, researchers expect to do an economic analysis based on the data that would demonstrate the potential financial benefit to payers and hospitals of including noninvasive ventilation in at-home, post-treatment COPD patient care. There's also another similar ongoing study in the U.K. that's almost complete.
Follow-up studies are likely also to examine how well the addition of noninvasive ventilation will work in other settings such as smaller hospitals and academic centers to better understand how generalizable the results are and how much providers will need to adapt. In addition, they will likely examine additional, modified regimens to find the most useful that can be standardized across this patient population, as well as to determine which of various approaches is the most cost effective.
Lee-Chiong underscores the usefulness of connectivity and tracking this patient population at home.
"It depends on the setting, but connected care, I think, is essential. You follow the patient when they are discharged to their home, you can follow their condition and address it promptly and effectively," he said.
"There should be multiple options for patients to chose how they want to be connected. A smartphone, a personal phone call, we should provide all that; we don't want to impose one program on everyone," he noted.
He noted that earlier studies have indicated that a specific kind of noninvasive ventilation technology known as bi-level will prolong life, but worsen quality of life, for this specific patient group. The study used two NIV devices: Philips Respironics' Harmony 2 ventilator as well as the VPAP IIISTa ventilator from Resmed Inc.
At-home and connected care are a major theme for Philips, which dedicated itself to focusing solely on health technology in 2014.
Philips acquired noninvasive ventilation player Respironics for more than $5 billion in 2008. Via its Respironics group, Philips offers various NIV products including the Dreamstation BiPAP AVAPS and S/T, BiPAP A40 (ex-U.S. only) and Trilogy. It's focused on expanding use of its connected device, Trilogy, along with its connectivity platform Care Orchestrator.
Last quarter, Philips reported high-single digit growth in its Personal Health business, which includes sleep and respiratory health, while its Connected Care business had an uptick of 1 percent as compared to the same period a year earlier.