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ALERTA: Increased Risk of Cardiovascular Death with Adaptive Servo-Ventilation (ASV) Therapy

07-09-2017

7 de setembro de 2017

De interés de todos los Neumólogos de Latinoamérica.
Recibido este Alerta gracias a la gentileza del Departamento de Sueño ALAT, Dra. Ma. Angélica Bazurto.

Dear Key Opinion Leaders of Latin America.

Increased Risk of Cardiovascular Death with Adaptive Servo-Ventilation (ASV) Therapy for Patients with Predominant Central Sleep Apnea and Symptomatic Chronic Heart Failure with Reduced Ejection Fraction

The attached urgent [Field Safety Notification] has been issued as a result of the SERVE-HF clinical study. We are writing to make you aware that we are sending this notification to Physicians and Distributors / Suppliers of Medical Devices.
Physicians managing patients with symptomatic chronic heart failure with reduced ejection fraction and predominant central sleep apnea who are using ResMed ASV devices should contact their patients to discuss discontinuation of treatment.
Distributors / Suppliers of Medical Devices are being notified and asked to provide the [Field Safety Notification] to their prescribing physicians and health care facilities which have purchased identified products.
A serious safety concern has been identified during the preliminary primary data analysis from the SERVE-HF clinical trial. This trial investigated the effect of Adaptive Servo Ventilation (ASV) therapy on the hospitalization and mortality rate of patients with symptomatic, chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea (AHI ≥ 15, ≥ 50% central events, cAI ≥ 10).
The [Field Safety Notification] requires that all patients on ASV therapy with symptomatic chronic heart failure with reduced ejection fraction ≤ 45% be reassessed and advised of the increased risk of Cardiovascular Death with the aim of stopping ASV therapy. In addition, the indications and contraindications for ASV therapy for new patients have been amended as result of this scientific study.

Patient safety is ResMed’s most important priority.

If you would like to contact your members directly, we are available to assist.

With your assistance, we intend to act quickly to reduce the risk of patients using our ASV. The reasons for these unexpected results regarding ASV therapy are still under investigation and additional information about the SERVE-HF study will be published and posted as it becomes available on ResMed’s website at www.resmed.com.

Healthcare providers and patients who have questions or would like more information are encouraged to call (US) +1-800-478-9010 and visit www.SERVE-HFFAQs.com.

Best regards

Dr Adam Benjafield
Vice President, Medical Affairs
D +1 858 836 6782 M +1 619 405 6657
ResMed Corp 9001 Spectrum Center Blvd San Diego CA 92123, USA



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