RESULTS

That Deliver Confidence

CSA PATIENT IDENTIFICATION & TESTING

Identifying and treating Central Sleep Apnea (CSA) is critical to improving patient quality of life and preventing the cardiovascular decline caused by the disease.* CSA symptoms can be subtle and often overlap with co-existing symptoms that occur from other causes such as chronic heart failure, atrial fibrillation, and stroke. It is important to maintain a high index of suspicion for CSA in patients at risk.1

 

 

Common Risk Factors Associated with CSA1-3

  • Recent heart failure (HF) hospitalization or symptomatic HF
  • Frequent hospitalizations
  • Atrial or ventricular arrhythmias
  • Witnessed apneas
  • Male
  • Low ejection fraction
  • Nocturia (> 2 per night)

CSA Testing

CSA is diagnosed via a home or in-lab sleep study that is prescribed by a physician to determine if a patient has sleep apnea and if their primary type of apnea is CSA or obstructive sleep apnea (OSA).

During the sleep study, the number of apneic and hypopneic (abnormal shallow breathing) events per hour are counted and reported as the Apnea Hypopnea Index (AHI), the most common measure of severity of sleep apnea.

Home Sleep Apnea Test
(HSAT, Polygram, PG)

Completed at home

Measures oxygen, air flow
and movement of the chest and
abdomen**

In-Lab Sleep Study
(Polysomnogram, PSG)

Assesses sleep stage and other sleep
disorders in addition to sleep apnea

Requires overnight monitoring in a
sleep lab

Sleep testing metrics include:4

Apnea-Hypopnea Index (AHI)4

Number of apneas and hypopneas per hour of sleep

Mild (5 – 14 events/hour),
Moderate (AHI of 15 > to < 30 events/hour), and
Severe (AHI ≥ 30 events/hour)

Central apnea

≥10 second cessation of airflow, without effort

Obstructive apnea

≥10 second cessation of airflow, while effort continues

Arousal Index

Number of arousals per hour of sleep

Hypopnea

30% or more reduction in airflow for 10 seconds with a 3% or 4% fall in oxygen saturation

Oxygen Desaturation Index (ODI) 3% or 4%

Number of times oxygen saturation drops by 3% or 4% or more per hour

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*remedē is not intended to prevent cardiovascular disease.
**Required to distinguish the type of sleep apnea

  1. Costanzo MR, Khayat R, Ponikowski P, et al. State-of-the-art review: Mechanisms and clinical consequences of untreated central sleep apnea in heart failure. J Am Coll Cardiol 2015;65:72-84.
  2. Khayat R, Jarjoura D, Porter K, et al. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. Eur Heart J 2015;36(23):1463-9.
  3. Bitter T, Westerheide N, Prinz C, et al. Cheyne-Stokes respiration and obstructive sleep apnoea are independent risk factors for malignant ventricular arrhythmias requiring appropriate cardioverter-defibrillator therapies in patients with congestive heart failure. Eur Heart J 2011;32:61-74.
  4. Iber C, Ancoli-Israel S, Chesson AL Jr., et al., for the American Academy of Sleep Medicine. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications. Westchester, IL: American Academy of Sleep Medicine, 2007.
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For Clinicians

IMPORTANT SAFETY INFORMATION

Indications for Use
The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.

Contraindications
The remedē System is contraindicated for the following:

Warnings

Precautions
It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device. Use remedē System therapy with caution in pacemaker-dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing. The safety and effectiveness of the remedē System during pregnancy has not been established.

See the Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Adverse Effects
Possible adverse events which may be associated with the use implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.