Edwin M. Valladares, MS, RPSGT, RST
The implants have landed! The long awaited alternative therapies for sleep apnea have arrived. On Oct. 10, 2017, Respicardia, Inc announced the U.S. Food and Drug Administration (FDA)'s approval of the remedē® System for the treatment of central sleep apnea (CSA).1 This is the second implantable device approved for the treatment of sleep disordered breathing in the last couple of years. The first implantable device, the Inspire® Upper Airway Stimulation therapy, was approved by the FDA in 2014.2 The remedē System becomes available in a time when Adaptive Servo Ventilation (ASV) has been contraindicated in a subsection of CSA patient population.3 The remedē System stimulates the phrenic nerve unilaterally, usually the left phrenic nerve, and treats patients automatically and continuously throughout the entire night without patient adherence. The remedē System provides negative pressure to move air into the lungs, similar to normal breathing.
How does the remedē® System work?
The remedē System is composed of a stimulator with 1 monitoring lead and 1 stimulating lead emanating from it to provide coordinated stimulation through its proprietary algorithm. The stimulator lead is placed in the left pericardiophrenic vein or right brachiocephalic vein to stimulate the phrenic nerve and produce breathing. The sensing lead is placed in the azygos vein to monitor breathing and provides information back to the stimulator. A computer tablet with an electronic wand serves as the interface unit, which is used to interrogate the implanted device and make setting changes.4
The remedē System is implanted by a Cardiologist who is an Electrophysiologist experienced in cardiac resynchronization therapy (CRT). The device is titrated after 1 month post-implant in the Sleep Lab and it is programmed to turn on and off at set times across the night according to the patient’s usual sleep schedule. However, the device does not actively stimulate if the patient is upright, regardless of clock time. It also provides a pause time when changing position during the night. 4
Remedē® System Pivotal Trial Study
The remedē System Pivotal Trial evaluated the effectiveness and safety of the therapy. These data were used to apply for FDA approval. The study was a prospective, multicenter, randomized controlled trial, where clinical investigators across the USA and Europe implanted 151 patients with the remedē System. The study showed that 35 (51%) of 68 treatment patients achieved a 50% or more reduction in their AHI at the 6-month mark. Ninety-one percent of patients did not have any serious-related adverse events at 12-months.5
What This Means for the Field
This is a major step for the field of sleep medicine, because the remedē System provides another therapy for CSA patients. In addition, this therapy contributes to the role evolution for sleep technologists and sleep physicians. In an era where less complicated patients are being diagnosed using Home Sleep Apnea Testing (HSAT) units, and more complicated patients are being tested in the sleep lab, the role of the sleep technologists is increasingly leading to more training. The remedē System also provides sleep physicians another weapon in their arsenal against sleep disordered breathing, resulting in an even more specialized role. Furthermore, the increase in available therapies is also paving the way for more personalized care as researchers identify which therapies will maximize efficacy and efficiency for individual patients. In the end, patients win, and we are living yet another monumental change in our field!
Valladares is manager and senior technologist, Keck Medical Center of USC, USC Sleep Disorders Center Lecturer, Keck School of Medicine of USC, Div. of Pulmonary Critical Care and Sleep Medicine.
- Respicardia, Inc. Respicardia’s Remede System Receives FDA Approval. Press release, Minnetonka, MN: October 10, 2017.
- Inspire Medical Systems, Inc. FDA Approves Inspire® Upper Airway Stimulation (UAS) Therapy for Obstructive Sleep Apnea. Press release, Minneapolis, MN: May 1, 2014.
- Cowie MR, Woehrle H, Wegscheider K, et al. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. NEJM 2015; 373(12):1095-1105.
- Costanzo MR, Augostini R, Goldberg LR, et al. Design of the remede System Pivotal Trial: a prospective, randomized study in the use of respiratory rhythm management to treat central sleep apnea. J Card Fail 2015; 21: 892-902.
- Costanzo MR, Ponikowski P, Javaheri S, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. Lancet 2016; 388:974-82.