New insights from the CAT-HF trial present promise for subsets of sufferers who use adaptive servo-ventilation, however bigger research are wanted.
In 2015, when the outcomes of Adaptive Servo-Air flow for Central Sleep Apnea in Systolic Coronary heart Failure (SERVE-HF) trial had been launched, it despatched ripples by way of the sleep drugs world.
The medical trial that concerned 1,325 sufferers with coronary heart failure with diminished ejection fraction (HFrEF) and central sleep apnea confirmed that the sufferers who had been handled with adaptive servo-ventilation (ASV) had the next danger of all-cause mortality and cardiovascular mortality than those that had been handled with standard coronary heart failure administration.1 These findings led to security notices issued by the likes of the American Academy of Sleep Medication (AASM) and have made sleep suppliers cautious of prescribing ASV remedy to sufferers with coronary heart failure.
However latest insights from the Cardiovascular Enhancements with Minute Air flow-targeted Adaptive Servo-Air flow Remedy in Coronary heart-Failure (CAT-HF) trial counsel that ASV remedy might enhance cardiovascular outcomes for a subset of sufferers with moderate-to-severe sleep disordered respiration (both due to obstructive or central sleep apnea). Like SERVE-HF, CAT-HF was funded by ResMed, which markets an ASV gadget.
The CAT-HF trial appeared on the impact ASV remedy has on sufferers hospitalized for acute decompensated coronary heart failure and who’ve moderate-to-severe sleep apnea. Whereas the examine discovered that including ASV to optimized medical remedy didn’t enhance 6-month cardiovascular outcomes, it did discover that sufferers in a pre-specified subgroup—these with preserved ejection fraction—noticed constructive results of ASV remedy in bettering the situation of their sleep-disordered respiration.2 “There are not any degree of proof 1A guideline really helpful therapies particular for HFpEF [heart failure with preserved ejection fraction] sufferers, which accounts for half of all individuals dwelling with continual coronary heart failure,” says CAT-HF lead investigator and heart specialist Christopher M. O’Connor, MD, CEO of the Inova Coronary heart and Vascular Institute, in a launch. “These outcomes from CAT-HF counsel we have to additional examine the position of whether or not addressing sleep-disordered respiration may also help individuals who have coronary heart failure with preserved ejection fraction.”
A more moderen evaluation of information from the CAT-HF trial means that ASV therapy may additionally enhance diastolic perform—a risk primarily based on the substantial reductions seen in left atrial quantity amongst sufferers (each with diminished and preserved ejection fraction) receiving ASV that warrants additional examine.3
And a CAT-HF potential substudy of sufferers with pacemakers/defibrillators printed this 12 months gives proof of idea that ASV remedy might scale back atrial fibrillation burden in sufferers with coronary heart failure and sleep apnea.4
“If we have a look at the research total, we all know that the prevalence of sleep apnea each central and obstructive can vary from 50% to 75% of sufferers with coronary heart failure in addition to sufferers with coronary heart arrhythmias,” says Teofilo Lee-Chiong Jr., MD, who was not concerned within the research. Lee-Chiong is chief medical liaison for Philips Respironics, which markets an ASV gadget. “The problem is that sufferers might have each kinds of apneas, so there’s not a one-size-fits-all kind of strategy that matches all sufferers.”
Particularly in terms of sufferers with sleep apnea who even have comorbidities like coronary heart failure or atrial fibrillation, remedies want to regulate based on how their coronary heart circumstances are evolving. As an example, if a coronary heart failure affected person will get handled for his or her arrhythmia, then his or her therapy of sleep apnea may have adjustment as nicely.
“It’s anticipated that you simply alter your administration for sufferers like this, so ASV is actually solely a part of a mixture of therapies accessible for sufferers,” says Lee-Chiong, who can be a professor of drugs and pulmonologist at Nationwide Jewish Well being and creator or editor of greater than 20 books on sleep drugs and pulmonology.
ASV Over the Years
For physicians like Lee Surkin, MD, who’s board licensed in cardiology, nuclear cardiology, and sleep drugs, recommending ASV remedy to sufferers with coronary heart failure has posed challenges. After SERVE-HF outcomes had been launched, he really helpful that every one of his sufferers with diminished left ejection fraction (lower than or equal to 45%) stop ASV therapy. However he’s nonetheless had some sufferers insist on ASV remedy regardless of being warned of the dangers.
How do you make sense of two considerably conflicting realities that the SERVE-HF trial noticed elevated mortality danger amongst sufferers with diminished ejection fraction, however some sufferers with diminished ejection fraction have the real-world expertise that utilizing the remedy improves their high quality of life?
In response to this query, Surkin, who was not concerned within the research, says following follow pointers is essential. “That is the place affected person training is necessary in order that they perceive the implication of those medical trials—collaborating with sufferers to allow them to make a completely knowledgeable resolution is how I’ve practiced drugs for 22 years,” he says.
Whereas many agree that these findings are encouraging for sufferers, there’s additionally settlement that there’s a powerful want for a bigger medical examine that entails the next examine participant quantity. The AASM has not launched new follow pointers in response to the CAT-HF trial.
Proper now, there’s an ongoing trial often called ADVENT-HF that appears on the impact ASV has on survival and hospital admissions in coronary heart failure, which has the potential to offer further perception into the reason for mortality and the influence of improved ASV compliance.
“There’s clearly loads of work to be performed to refine and outline follow pointers on this enviornment and as suppliers, we have to migrate to a extra interdisciplinary strategy,” says Surkin, who based the American Academy of Cardiovascular Sleep Medication in an effort to extend collaboration amongst sleep drugs and cardiology suppliers.
What’s extra, based on Surkin and Lee-Chiong, extra conversations amongst suppliers from totally different disciplines and between sufferers and suppliers are wanted.
“We must always have a look at ASV as a part of the answer for the affected person and never only a single therapy,” says Lee-Chiong. “Previously, physicians have taken a prescriptive strategy to care however now the emphasis ought to be on taking much less of a fragmented strategy in treating sufferers as an entire and fascinating in additional of a steady dialogue with sufferers.”
Yoona Ha is a contract author and healthcare public relations skilled.
1. Cowie MR, Woehrle H, Wegscheider Okay, et al. Adaptive servo-ventilation for central sleep apnea in systolic coronary heart failure. N Engl J Med. 2015;373:1095-1105.
2. O’Connor CM, Whellan DJ, Fiuzat M, et al. Cardiovascular Outcomes with Minute Air flow-Focused Adaptive Servo-Air flow Remedy in Coronary heart Failure: The CAT-HF Trial. J Am Coll Cardiol. 2017 Mar 28;69(12):1577-87.
3. Daubert MA, Whellan DJ, Woehrle H, et al. Remedy of sleep-disordered inhaling coronary heart failure impacts cardiac transforming: Insights from the CAT-HF Trial. Am Coronary heart J. 2018 Jul;201:40-8.
4. Piccini JP, Pokorney SD, Anstrom KJ, et al. Adaptive servo-ventilation reduces atrial fibrillation burden in sufferers with coronary heart failure and sleep apnea. Coronary heart Rhythm. 2019 Jan;16(1):91-7.