Experts Debate Apnea Treatment Vacuum After SERVE-HF

Kate Johnson

October 27, 2015

MONTREAL — The treatment of central sleep apnea in heart failure patients was in the spotlight here at CHEST 2015, as experts debated whether or not to completely reject the use of adaptive servo ventilation in this patient population in light of recent findings from the SERVE-HF trial.

In that trial, all-cause mortality was 28% higher in the ventilation group than in the placebo group, and cardiovascular mortality was 34% higher, as previously reported by Medscape Medical News.

"I do think a lot of good has come out of this trial because now at least we have the best data to show that what we thought was beneficial is actually harmful," said panel chair Neil Freedman, MD, from Northshore University Health System in Bannockburn, Illinois.

The current recommendation from the American Academy of Sleep Medicine (AASM) is to "not start anybody on adaptive servo ventilation who would have qualified for this trial," Dr Freedman told Medscape Medical News.

"You won't see any heart failure patients with an ejection fraction of less than 45% and a central sleep apnea index of 15 or more being started on adaptive servo ventilation," he said.

 
The findings of the research study are statistically significant and of urgent concern.
 

As for patients who are currently being treated with adaptive servo ventilation, whether or not they are benefiting symptomatically, the AASM recommends the discontinuation of the therapy, he added. That means actually tracking down old patients, he pointed out.

"The findings of the research study are statistically significant and of urgent concern," according to the website of the American Association of Sleep Technologists.

Now What?

Clinicians now know what to avoid, but the course of treatment is less clear.

"Is there a threshold ejection fraction at which it would be safe to use adaptive servo ventilation?" Dr Freedman asked. The data suggest that "patients with better ejection fractions would be less likely to be harmed," he said.

"You don't want to change your management of heart failure patients who do not fit the classic criteria in the study," said panelist Virend Somers, MD, director of the cardiovascular facility and the sleep facility at the Mayo Clinic in Rochester, Minnesota, who was involved in the SERVE-HF study.

"But someone with unstable heart failure and an ejection fraction of 30% — I don't care what kind of apnea they have — you can treat them with whatever you think is the best option," he explained.

At the moment, the focus should be on confirming the diagnosis and ensuring optimal medical management with agents such as beta blockers, angiotensin-converting-enzyme inhibitors, and angiotensin receptor blockers, said Dr Freedman.

"It is possible that people who had central sleep apnea on their initial sleep study were not maximally medically managed. With better medication, they may not need adaptive servo ventilation," he said. "Or maybe now they have more obstructive sleep apnea, and may benefit more from continuous positive airway pressure, which is not contraindicated."

Choosing Ventilation

For patients who fit the exact SERVE-HF profile, there are still options, said panelist Atul Malhotra, MD, director of sleep medicine at the University of California, San Diego.

"I ask them if they're optimized medically, and then afterward it is a conversation about risk versus benefit. Many patients choose to stay on it; that's a personal decision they have to make," he explained.

Dr Freedman said he agrees. "In the end, it's up to the physician and the patient to have a conversation," he pointed out. "As long as patients are making an educated decision, if they want to continue on therapy, it's not unreasonable as long as they understand the potential risks."

Despite the SERVE-HF results, making people feel better should be an important consideration, said panelist Peter Gay, MD, a pulmonary and critical care expert at the Mayo Clinic in Rochester.

"I don't think you can say, unconditionally, that this is a bad device," he argued. "People are going to come in your door with sleep problems and, at the end of the day, if it makes people feel better and they're informed, I don't think we can just say, 'Well, this study says you're killing yourself.' Maybe they just feel better, and that's alright."

But even when central sleep apnea symptoms improved in the SERVE-HF study, there was no improvement in quality of life, said Dr Somers.

All the panelists agreed that the reason for the increase in mortality in the SERVE-HF patients who were treated with adaptive servo ventilation remains unclear.

Sudden Death

"If it was something about the hardware of the machine, you would have expected the deaths to occur at night, while patients were using the machine. But that does not seem to be the case," Dr Somers explained. "The deaths that were statistically different in the ventilation group were sudden deaths," he added.

It has been suggested that there is something protective about Cheyne–Stokes respiration, which adaptive servo ventilation negates, but this theory has been hotly contested.

"I don't believe central sleep apnea is good for patients," said panelist Shahrokh Javaheri, MD, from the VA Medical Center in Cincinnati.

"The consequences of central sleep apnea and obstructive sleep apnea are very similar," he pointed out. "If the consequences of obstructive sleep apnea in the general population are bad, then the consequences of central sleep apnea in the context of heart failure are also bad," he said.

CHEST 2015: American College of Chest Physicians Meeting. Session 400. Presented October 26, 2015.

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