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Treating Sleep Apnea With CPAP Therapy Lowers the Risk of Heart Problems, COVID-19
Data presented at the virtual Sleep 2021 meeting by the Annual American Academy of Sleep Medicine suggests treating sleep apnea or obstructive sleep apnea is important for heart health and better prevents chances of COVID-19. Recent studies by Kaiser Permanente in Southern California show patients with untreated, moderate to severe obstructive sleep apnea (OSA) had a higher risk of experiencing cardiovascular issues and COVID-19 infection. However, the risk of these health issues were decreased in those who used CPAP therapy. According to the American Academy of Sleep Medicine, nearly 30 million adults in the U.S. have obstructive sleep apnea. In patients who experience heart failure, stroke or other cardiovascular issues, results from one of the studies show they were 71% more likely to face these issues if they have moderate to severe sleep apnea and no record of CPAP use than those without sleep apnea. Compared with the risk of heart problems in people with untreated sleep apnea, the risk of experiencing a cardiovascular event was 32% lower in patients with any severity of sleep apnea who used CPAP therapy, and it was 44% lower in those with moderate to severe sleep apnea who used CPAP. Lead author of the study and Assistant Professor in the division of medical informatics in the department of internal medicine at the University of Kansas Medical Center, Diego R. Mazzotti, Ph.D., said in a release effects of CPAP found were “stronger in patients with moderate to severe sleep apnea, as well as in patients who used CPAP, on average, greater than 4 hours per night.” Researchers analyzed the electronic health records of patients who received a sleep study between January 2018 and September 2020 through Kaiser Permanente. The sample was made of 11,145 people without sleep apnea, 13,898 patients with sleep apnea and a record of any CPAP use, and 20,884 patients with sleep apnea and no record of CPAP use. In an additional study by Kaiser from 2015 to 2020, it was stated patients with obstructive sleep apnea who have received CPAP therapy can avoid higher risks of getting COVID-19. The data showed a dose-response association of OSA severity on infection rate with patients with untreated mild OSA with a 2% rate of COVID-19 infection, while patients with severe untreated OSA had a COVID-19 infection rate of 2.4%, which was significantly higher than those treated with PAP at 1.4%. Patients who engaged in PAP therapy with good adherence had lower COVID-19 infection rates at 1.3% rather than patients without OSA resulting at 1.7%. The study also identified obesity, other chronic illnesses, and being on Medicaid to higher COVID-19 infection rates. Black and Hispanic patients also had higher COVID-19 infection rates, according to the study. “These findings demonstrate the critical importance for people with OSA to receive and stay on PAP therapy,” said ResMed’s Chief Medical Officer, Carlos M. Nunez, M.D., in a release. “In addition to COVID-19, OSA can increase a person’s risk for an array of chronic diseases, so it’s necessary for healthcare providers to educate patients on the importance of proper CPAP use so they can get optimal sleep, which may help keep their immune systems healthy.” This study collected data on nearly 82,000 U.S. patients who were evaluated for sleep disorders at Kaiser Permanente’s sleep clinic. Of those, 1,493 tested positive for COVID-19 infection. The data collected includes patients’ electronic health records, sleep study findings, and remotely collected data on PAP therapy.
Learn moreSleep Professionals Scramble to Find Solutions for Sleep Apnea Patients Amidst Philips Device Recall
Last week’s announcement that Philips is recalling millions of its CPAPs, bilevel PAPs, and ventilators sent shock waves throughout the sleep medicine subspecialty, leading to a frenzy of sleep lab administrators and sleep clinicians looking for alternative sleep apnea therapies for their patients. Without enough devices, and with questions of how long it will take to replenish the supply, sleep professionals have had to quickly find solutions to handle the ongoing situation. The recall involves between 3 to 4 million devices globally, based on the company’s production and shipment data obtained by AARP. More than half of the machines were purchased in the United States, with the majority of them being first-generation DreamStation products. DreamStation 2 products are not impacted by the recall. According to clinicians interviewed by Sleep Review, the recall has become a major obstacle to providing care. Akhil Raghuram, MD, medical director of the Vancouver Sleep Center in Portland, Ore, says about 50% of his sleep apnea patients use Philips machines, and his team has launched an email campaign to alert them of the problem. For the new patients, the recall means delaying care because there are not enough machines to go around. How big of a problem is the recall? “It’s huge,” says Raghuram in a phone interview. He learned the news after waiting on a pending Philips CPAP machine order for the last two months. “I knew that something was brewing.” Then, on Monday morning an article online alerted him of the recall. According to Philips, the PE-PUR foam may pose a threat if it enters the CPAP machine’s air pathway, where it could then be ingested or inhaled by the patient. The foam may also off-gas certain chemicals. Though some clinicians have speculated that adding a particulate filter to the devices (such as the type designed to prevent CPAPs from aerosolizing viruses and bacteria) may help, Philips has not released information about whether these filters alleviate the problem. In its recall notice, Philips advised that the foam degradation may be worsened by certain “unapproved” cleaning methods, such as ozone. High heat and high humidity environments may also contribute to foam degradation, the company said. Raghuram speculates that the age of the device may also play a role in how much particulate matter is released since many people do not replace their machines as often as they should. Even the smallest sleep facilities have been impacted. In Kentucky, a two-bed sleep lab has had to reschedule their upcoming titrations. Prior to the recall, the center was leasing Philips machines, but the lab is now working to get new devices from an alternative supplier, says Candace Martin, RRT, the cardiopulmonary manager at Caldwell Medical Center in Princeton, Ky. “My first response was that it wasn’t going to be that big of a deal, but then I realized how difficult it was going to be to get equipment to replace what we already have,” she says in a phone interview. Despite the news, Martin believes the risk is likely small and, as a sleep apnea patient herself, she is choosing to continue therapy with her Philips device at home. “I’m not going to quit using mine and I will continue to use it until it is replaced with something else,” she says. “It would be a big deal for me to quit using it.” Many labs have grappled with how to communicate with patients to alert them of the potential danger. Since the level of risk still remains largely unknown, some are still offering titrations with Philips machines and counseling patients on the potential risks. At Vanderbilt Medical Center, a risk management team is working to get a letter out via the patient portal to patients who were seen in the last 5 years, according to Beth Ann Malow, MD, professor of neurology and pediatrics and director of the Vanderbilt Sleep Division. Malow shared this information during an American Academy of Sleep Medicine (AASM) virtual event last week entitled “Impact of the Philips PAP Recall on Patient Care and Sleep Center Operations.” Sara Elizabeth Benjamin, MD, a neurologist and sleep specialist at Johns Hopkins Center for Sleep, says she is giving her patients the option to carry on with in-lab titrations. All patients who wish to proceed must sign a consent form making them aware of any potential harm. “If they are not comfortable with it, we can still do a base-line split or we can delay the titration portion of the study,” Benjamin said during the AASM event. To develop an informed consent protocol, the Hopkins medical directors from two labs developed the form and a risk management strategy. There are also plans to send out a letter, developed in partnership with the legal department, to disperse to patients through the center’s online chart system. The Hopkins sleep labs are also fitting the Philips devices with in-line particle filters. For some patients, the harm of discontinuing CPAP therapy may pose a greater threat than the particulate matter. “There are definitely risks associated with this that [Philips] Respironics has put out, but at least from my reading, the risks are actually quite unclear and they might actually be quite small,” said Najib Ayas, MD, who is a faculty member in the respiratory care at the University of British Columbia in Canada, during the AASM event. “There are very tangible risks to patients stopping CPAP or biPAP abruptly and especially since, I feel that it is going to take months, if not longer to get replacement machines from Philips,” says Ayas. “The last thing you want to happen is someone getting into a motor vehicle crash. So I think that we have to be more nuanced and say ‘what is the best thing for our patients.’” “I feel like the ground is shifting a lot as well, so I am hoping that over the next few weeks there may be more information available in terms of longer-term cancer risk.” During this time, many providers have turned to another major CPAP manufacturer, ResMed, to order new devices. Machines made by ResMed have not been affected by the recall and use a different material for noise abatement, says Jayme Rubenstein, public relations director at ResMed, via an email interview. Some clinicians have anecdotally reported that ResMed is experiencing a backlog in orders. But Rubenstein says the company continues to closely monitor demand. “Our most important priority is patients and making sure those who need treatment get it when they need it,” he says. Disruptions May Last for Months or Longer According to an email interview with Philips spokesman Mario Fante, Philips has developed a plan to work with consumers to replace the current sound abatement foam with a new material. Patients are being directed to fill out a form online, so the company can stay in touch with them regarding the next steps. The website also contains a list of impacted machines. “We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue,” Fante says. Still, aside from the disruption in care, there will be a significant financial cost to shoulder and it remains unclear if patients will be supplied with alternative therapy devices in the interim. In its press release about its first quarter 2021 earnings, Philips states, “Given the estimated scope of the intended precautionary actions on the installed base, Philips has taken a provision of EUR 250 million.” Thomas Heffron, senior director of marketing and communications at AASM, said during the AASM event, “The advocacy needs in the weeks and months ahead are going to be huge. The first issue we are looking at right now is contacting CMS and the private payors about trying to get some temporary waivers or some exceptions to some of their policies.” Patients who have devices that are less than five years old, Heffron explained, will not be able to get a new device covered by insurance under current policies. So if it is going to take months or up to a year to get a device through Philips registration process, that is going to become a problem. “They can’t be without treatment for that long,” he said. “So we are really petitioning the payors to add some flexibility.” Lisa Spear is associate editor of Sleep Review.
Learn morePulse Rate Variability May Predict Stroke in Obstructive Sleep Apnea
Pulse rate variability as detected by pulse oximetry could serve as a useful biomarker for stroke risk stratification in patients with obstructive sleep apnea (OSA), according to the results of a recent study published in the American Journal of Respiratory Critical Care Medicine. Researchers measured pulse rate variability via overnight oximetry during diagnostic sleep studies in patients with OSA having 5 or more events per hour. The primary study outcome was first episode of stroke. Standard deviation of normal-to-normal beat intervals and successive normal-to-normal differences were used to retrospectively correlate pulse rate variability to health outcomes. Among the 6075 stroke-free patients with OSA, the mean age was 62 years and the average apnea-hypopnea index was 28 events per hour. A total of 2536 patients were correctly treated via positive airway pressure and 3539 patients were nonadherent to positive airway pressure or did not receive any active OSA therapy. After the median follow-up of 6.5 years, 459 patients had died, and 177 patients had received a diagnosis of stroke. Overall, patients with lower sympathetic/parasympathetic tone (LF/HF ratio) were at higher risk for stroke. The association appeared to be stronger in patients with severe OSA. “Individuals with OSA, particularly those with severe disease, who demonstrate low sympathovagal balance (LF/HF) are at increased risk [for] stroke,” the study authors wrote. “[Pulse rate variability] indices derived from pulse oximetry data, readily available in routine sleep recordings, might provide a useful biomarker for stroke risk stratification.” Reference Sabil A, Gervès-Pinquié C, Blanchard M, et al; on behalf of the ERMES Study Group. Overnight oximetry-derived pulse-rate variability predicts stroke risk in patients with obstructive sleep apnea. Am J Respir Crit Care Med. Published online April 9, 2021. doi:10.1164/rccm.202101-0109LE
Learn moreRoundtable Discussion with Sovereign Medical and Acute/Hospital CPAP Experts
Personal PAP at the hospital, is it allowed? According to a recent survey by Sovereign Medical and Bleep, LLC, we were surprised to hear that 50% of hospitals/acute care facilities surveyed area allowing patients to bring in their own mask. There are strict rules for when/where personal device can be used including post-surgery treatment as well as upon admission to the hospital, and typically only allowed for use in individual patient rooms (admitted). 25% of those surveyed allow home CPAP mask to be used in Post Anesthesia Care Unit and 25% do not allow mask or other home equipment due to liability and cleanliness concerns. Focus has been on pleasing the patient vs. cost/time savings for the hospital/acute care center. So, what is the impact on the staff? Pap set-ups are predominantly the respiratory division although some systems do use nurses. When patients utilize their own mask, the respiratory therapist is often tasked with evaluating the equipment for safety risk and re-visits to patients to address leaks. 100% of participants agreed that the biggest issue for the hospital is patient compliance. Non-compliant/untreated OSA patients have a 2-7x increase for in-patient hospital stay and a 3x increase in Emergency Department visits. The cost to the healthcare system for non-complaint OSA patients is over $14,000 per patient according to economic healthcare models. Repeat visits not only cost patient and providers, but also decrease treatment center patient satisfaction scores. OSA CPAP Treatment Improvements: Lower A1c Lower Blood Pressure Decrease risk of diabetic retinopathy Decrease risk of Afib Increase Energy (lifecycle changes) Improved Mental Health Decrease Healthcare cost What drives patient noncompliance? Comfort is critical. Behind the comfort level, mask leak and pressure wound are the 2nd and 3rd reason. Recent studies show that “The average 300-bed acute facility with a 2.4% incidence rate spends $14 million a year on pressure ulcer prevention and treatment1.” First time users struggle with the restrictions of traditional mask, “You have to coach the patient and your technique is initially the focus. It is a combination of claustrophobia, air pressure, (leaked air) blowing air in their eye(s) and skin integrity.” Masks leak which creates a time challenge (refitting) for the respiratory and nursing team. Lack of proper fit is the #1 reason for respiratory/nurse call back. The typically solution is tightening (headgear) which can lead to pressure wound and discomfort. DreamPort® by Bleep can be a perfect solution. Easy to apply. Zero headgear and nothing in the nares eliminates pressure injury; it is the only clinically proven not to leak solution, single SKU, and the only CPAP compliant with Made in USA laws. Recent head-to-head studies show that 100% found the lack of head straps more comfortable; 80% found that their sleep was less interrupted with no nightly wakeups for leak/readjustment; 15% had a lower AHI (85% found it about the same). 100% had no incidents of claustrophobia. Bleep’s DreamPort® may be the solution to refitting costs, provider time, and patient satisfaction. Visit your Sovereign Medical representative or BleepSleep.com for more information.
Learn moreBleep, LLC is pleased to announce sponsoring the first of a series of round table events with Sovereign Medical Inc.
Bleep, LLC is pleased to announce starting May 26, 2021 we are sponsoring the first of a series of round table events with Sovereign Medical Inc. “Understanding non-invasive PAP therapy in the Hospital Setting.”Please contact your local Sovereign Medical representative for more information on future events. Bleep, LLC can help decrease: care cost, pressure injury penalties, inventory, and eliminate PAP refitting time by respiratory team and RNs. The average 300-bed acute facility with a 2.4% incidence rate spends $14 million a year on pressure ulcer prevention and treatment,” per healthcarefinancenews.com Bleep, LLC is the only FDA cleared pap product to address the #1 reason PAP patients experience pressure ulcers. Eliminate re-fit time, dramatically reduce pressure ulcer risk, use the only “clinically proven not to leak” solution. Single SKU and the only solution fully made in the USA. Contact [email protected] for more information. Contact your Sovereign Medical Inc representative for information on future round table events.
Learn moreHelping Veterans with sleep apnea
Using telehealth to enhance treatment VA is working to help Veterans with Obstructive Sleep Apnea (OSA) sleep better at night – using telehealth. OSA is a condition in which a person’s airway sometimes narrows or closes while they sleep. OSA can disrupt sleep and decreased airflow can strain the heart, lungs, and other organs. The strain can lead to problems such as high blood pressure, heart attack and stroke. At the Edward Hines, Jr. VA Hospital in Hines, Illinois, Home Telehealth Lead Care Coordinator Nina Giustino, Pulmonary Nurse Practitioner Shireen Long, and Quality Coordinator Mary McCabe have launched a pilot program to improve care for Veterans with OSA. Veterans who have OSA breathe easier at night by using a Continuous Positive Airway Pressure (CPAP) machine prescribed by their VA providers. The CPAP machine is a small portable pump that sends air through a hose held over the nose and/or mouth by a mask. The mild air pressure widens the airway to relieve symptoms. But providers have found that Veterans don’t always use their CPAP machines on a regular basis. And they don’t always know how to recognize and troubleshoot issues such as an ill-fitting mask. Patients enrolled in remote monitoring program As a solution, Giustino, Long and McCabe developed the pilot program. Veterans were enrolled into the Remote Patient Monitoring – Home Telehealth (RPM-HT) program and assigned the Obstructive Sleep Apnea Disease Management Protocol (DMP) developed by Cognosante, one of the two RPM-HT vendors. DMP sessions transmit via RPM technology, which then transmits the information and data regarding their OSA. In addition, the pulmonary program has technology that captures CPAP machine data that is added to the Veteran’s medical record. This process then allows the RPM-HT care coordinator to review device compliance and trouble shoot barriers with Veterans as well provide education and feedback to the Veteran to help improve compliance and symptoms. Veterans with OSA often don’t have an in-person follow-up with their provider until three months after their CPAP treatment starts. If the care coordinator detects an issue, they can schedule a telehealth appointment with the Veteran between in-person appointments and coach them on how to use the CPAP machine. Disease gets worse with not enough oxygen “With sleep apnea patients, one of the challenges was not being able to have a more immediate response or follow-up to address issues with their CPAP machine,” said Long. “So we wanted to find a solution because, if a Veteran doesn’t use their device, the disease gets worse and there’s not enough oxygen in their bloodstream.” Giustino, Long and McCabe developed guidelines to educate nursing staff on OSA, CPAP machines and how to troubleshoot problems with device use. This training aids in early detection of a Veteran’s noncompliance to treatment and prevents worsening symptoms. The goal is for Veterans to use their CPAP machines for four or more hours per night for at least 21 nights over a 30-day period. With the addition of telehealth, VA providers at Hines have seen an increase in CPAP machine use. Over a 30-day period, CPAP machine use increased from 49% to 57%, and CPAP machine use for more than four hours per night increased from 28% to 41%. Thanks to the pilot program, RPM- HT nurses can solve device issues faster. Real reward is ability to provide better care for Veterans This innovative program was a semifinalist in the Veterans Health Administration’s Shark Tank competition. “The culture of innovation VA fosters enables us to come up with out-of-the-box solutions. And we’re grateful that this idea has been supported,” said Giustino. “As a nurse with prior experience working outside of VA, I think the support for innovative solutions within VA far surpasses what happens in the private sector.” The groups said that while it was nice having the competition recognize them, the real reward is the ability to provide better care to Veterans. Other VA facilities have reached out to learn how to add this offering for their patients too. “This whole project has been a collaborative effort at Hines,” McCabe said. “And we’re excited about the potential it has to expand to other facilities and improve care for more Veterans.” For more information on VA telehealth, visit the VA Telehealth Services website.
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