Adaptive Servo-Ventilation Therapy for Patients With Chronic Heart Failure in a Confirmatory, Multicenter, Randomized, Controlled Study

Q: What question did this study set out to answer?

To confirm whether adaptive servo-ventilation (ASV) therapy combined with standard treatment improves cardiac function and clinical outcomes in patients with chronic heart failure.

Shin‐ichi Momomura; Yoshihiko Seino; Yasuki Kihara; Hitoshi Adachi; Yoshio Yasumura; Hiroyuki Yokoyama; Hiroshi Wada; Takayuki Ise; Kōichi Tanaka

doi:10.1253/circj.cj-15-0221

January 1, 2015Circulation JournalOpen Access

Adaptive Servo-Ventilation Therapy for Patients With Chronic Heart Failure in a Confirmatory, Multicenter, Randomized, Controlled Study

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Why the study?

Does adaptive servo-ventilation (ASV) added to guideline-directed medical therapy improve left ventricular ejection fraction in outpatients with chronic heart failure (LVEF <40%, NYHA class ≥II)?

Key Points

To confirm whether adaptive servo-ventilation (ASV) therapy combined with standard treatment improves cardiac function and clinical outcomes in patients with chronic heart failure.
A 24-week, open-label, multicenter, randomized controlled study conducted across 39 institutions enrolled 213 outpatients with chronic heart failure (LVEF <40%, NYHA class ≥II).
Participants were randomized to receive either ASV plus guideline-directed medical therapy (n=102) or guideline-directed medical therapy alone (n=103).
The primary endpoint was change in LVEF; secondary endpoints included heart failure deterioration, BNP levels, and clinical composite response (CCR).
LVEF and BNP improved significantly from baseline in both groups, but changes did not differ significantly between the ASV and control arms.
The ASV group demonstrated significant improvement in clinical composite response compared with controls, driven by significant enhancements in NYHA functional class and activities of daily living.

Structured PICO

Does adaptive servo-ventilation (ASV) added to guideline-directed medical therapy improve left ventricular ejection fraction in outpatients with chronic heart failure (LVEF <40%, NYHA class ≥II)?

P

Population

213 outpatients with chronic heart failure (LVEF <40%, NYHA class ≥II) on guideline-directed medical therapy, mean age 63.3 years, 165 males, based in 39 institutions in Japan.

I

Intervention

Adaptive servo-ventilation (ASV) added to guideline-directed medical therapy (GDMT) for 24 weeks.

C

Comparator

Guideline-directed medical therapy (GDMT) only for 24 weeks.

O

Outcome

Left ventricular ejection fraction (LVEF) measured according to the biplane Simpson's method at 24 weeks.surrogate

Adaptive servo-ventilation added to guideline-directed medical therapy did not significantly improve left ventricular ejection fraction compared to medical therapy alone in patients with chronic heart failure, though it did improve clinical composite response.

Limitations

Conducted in real-world settings where the clinical status of the patient undergoing GDMT was not necessarily stable
Open-label design allowing the possibility of biases (e.g., selection bias, evaluator bias, and participant expectation bias)
True endpoint (patient prognosis) was assessed indirectly by surrogate markers (e.g., LV remodeling and BNP)

Implication

ASV adds no LVEF benefit beyond GDMT in chronic HF; confirms absence of incremental echocardiographic effect.

Discussion

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Cite This Study

Momomura et al. (2015) studied this question.

synapsesocial.com/papers/6a7e4e133376ac4793f715c8 https://doi.org/10.1253/circj.cj-15-0221

Topics

HFrEF treatment

Heart failure

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Adaptive Servo-Ventilation Therapy for Patients With Chronic Heart Failure in a Confirmatory, Multicenter, Randomized, Controlled Study

Key Points

Structured PICO

Limitations

Implication

Discussion

Cite This Study

Topics

Adaptive Servo-Ventilation Therapy for Patients With Chronic Heart Failure in a Confirmatory, Multicenter, Randomized, Controlled Study

Key Points

Structured PICO

Limitations

Implication

Discussion

Cite This Study

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Topics

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