A recent five-year study on the Remedē System has shown promising results confirming that this innovative implant maintains safety and effectiveness over an extended period.
This comprehensive research offers hope and reassurance to patients and healthcare providers alike. Demonstrating that the Remedē System improves sleep quality and delivers lasting benefits with minimal risks.
What is the Remedē System and How Does it Work?
The Remedē System is an innovative and highly specialized medical device designed to treat central sleep apnea (CSA). A condition distinct from the more commonly known obstructive sleep apnea (OSA).
CSA occurs when the brain fails to send the correct signals to the muscles responsible for breathing, leading to repeated pauses in breathing during sleep. These interruptions can severely impact sleep quality. Leading to significant health issues including cardiovascular problems and daytime fatigue.
The Remedē System stimulates the phrenic nerve, which controls the diaphragm—the primary muscle involved in breathing. It delivers small electrical pulses to this nerve. The device prompts the diaphragm to move, thereby initiating a breath. This process helps restore a normal breathing pattern during sleep, reducing episodes of apnea and improving overall sleep quality.
The system consists of three main components:
- Implantable Pulse Generator (IPG): This small device, similar in size to a pacemaker is implanted under the skin in the upper chest area. The IPG generates the electrical pulses that stimulate the phrenic nerve.
- Leads: These are thin insulated wires that connect the IPG to the phrenic nerve. The leads are carefully threaded through veins to position them accurately near the nerve.
- External Programmer: This handheld device allows healthcare providers to adjust the settings of the IPG to ensure it delivers the optimal level of stimulation for each patient. On top of that, patients can also use a simpler version of this programmer to manage their device and troubleshoot minor issues.
The Remedē System is designed to operate automatically once implanted, requiring minimal intervention from the patient during daily life. The IPG monitors the patient’s breathing patterns and delivers stimulation as needed to maintain regular breathing.
What Does the Five-Year Study Reveal About the Safety of the Remedē System?
Since its introduction, the Remedē System has been scrutinized. Researchers are keen to understand its long-term impact. A five-year study titled “Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes” provides valuable insights.
Background and Study Design
Initially, the remedē System Pivotal Trial aimed to demonstrate the safety and effectiveness of transvenous phrenic nerve stimulation (TPNS) therapy for treating central sleep apnea (CSA). Following promising results, the FDA approved the device in 2017. To gather long-term safety and effectiveness data, researchers conducted a Post Approval Study (PAS).
So the researchers invited patients from the original trial to participate in the PAS. Out of the 151 original participants, 53 agreed to continue, and 52 completed the five-year follow-up. The study involved sleep studies scored by a central laboratory, the Epworth Sleepiness Scale (ESS) to assess daytime sleepiness and a thorough safety assessment.
Key Findings
The findings were promising. Patients experienced sustained improvements in several critical areas:
- Apnea-Hypopnea Index (AHI) and Central-Apnea Index (CAI): Both AHI and CAI showed significant reductions. The AHI decreased from a median of 46 events per hour at baseline to 17 at five years. And the CAI saw an even more dramatic drop from 23 events per hour to just 1. Though residual hypopneas were still present, these improvements were substantial.
- Arousal Index and Oxygen Desaturation Index: These indices, important for understanding sleep quality also showed significant improvements. Signifying patients were waking up less frequently during the night and maintaining better oxygen levels.
- Sleep Architecture: The overall structure and quality of sleep improved. Indicating more restorative sleep.
- Epworth Sleepiness Scale (ESS): Daytime sleepiness, as measured by ESS showed a median reduction of 3 points. Meaning, patients felt less sleepy and more alert during the day.
Safety Profile
Similarly, safety was a major focus of the study. Here’s what they found:
- Serious Adverse Events: About 14% of patients experienced serious adverse events related to the implant procedure, the device itself, or the delivered therapy. Most notably, 16 patients (9%) needed a pulse generator reposition or lead revision primarily within the first year.
- No Long-Term Harm: Importantly, none of these adverse events caused long-term harm. Throughout the five-year period, there were no unanticipated adverse device effects or related deaths.
How is the Remedē System Implanted?
The implantation of the Remedē System is a minimally invasive, outpatient procedure performed by a specialized physician. Typically a cardiac electrophysiologist with experience in implantable devices such as implanting pacemakers, defibrillators, etc.. The procedure usually occurs in a hospital or surgical center and is performed under general anesthesia to ensure patient comfort.
Before the procedure patients undergo a thorough evaluation to determine their suitability for the Remedē System. This evaluation includes a comprehensive medical history review, physical examination and diagnostic tests such as sleep study to confirm the diagnosis of central sleep apnea.
Implantation Procedure
The implantation procedure is typically straightforward and can be completed within two to three hours under light sedation.
Pre-Procedure Preparation
Before the procedure the area of the chest where the device will be implanted is thoroughly cleaned with a special soap to reduce the risk of infection. Sterile towels are then placed over the area to maintain a sterile environment. The patient remains awake but drowsy throughout the procedure, ensuring minimal discomfort while allowing the medical team to monitor their status continuously.
Placement of Leads
The implantation involves placing two leads into blood vessels in the chest. The first lead is strategically positioned near the nerve that controls the diaphragm. As mentioned, it is the primary muscle involved in breathing. This lead’s role is important as it directly stimulates the nerve to regulate breathing patterns.
Then the second lead is placed near the ribs serving to measure the patient’s breathing. Both leads are essential for the remedē System to monitor and correct breathing irregularities effectively.
Device Implantation
Once the leads are correctly positioned, they are attached to the main device. The device itself is then implanted just below the skin on either the right or left side of the chest. This placement is chosen for optimal functionality and patient comfort. The incision made to insert the device is usually closed with stitches. Ensuring that it heals properly and minimizes scarring.
Verification with Imaging
The doctor will use a type of x-ray with a contrast dye to place the leads accurately. So this imaging technique provides real-time visuals. This allow the physician to confirm the correct positioning of the leads. And helps avoid complications and ensures that the device will function correctly once activated.
Post-Procedure Recovery
After the procedure, patients typically stay in the hospital for observation, usually for one day. The duration of the hospital stay can vary based on individual health conditions, how well the patient tolerates the procedure and their recovery speed. During this time, healthcare providers monitor the patient to ensure there are no immediate complications and that the device is functioning as expected.
What Happens After the Implantation?
Following the implantation of the Remedē System, patients enter an important phase of adjustment: fine-tuning to ensure the device is delivering optimal therapy, regular follow-up visits with their healthcare provider, and continuous monitoring of the device’s performance and the patient’s response.
Initial Activation and Adjustment Period
In the weeks following implantation, patients will have several appointments with their sleep specialist. The implant is typically activated approximately 6 weeks after the implantation procedure to allow for adequate healing. These subsequent follow up appointments will fine-tune the device settings. The provider can adjust the level and timing of the electrical pulses in addition to a multitude of other parameters. The goal is to minimize central apnea events, maximize comfort and improve sleep quality.
Follow-Up Visits
Regular follow-up visits are essential to ensure the long-term success of the Remedē System. During these visits, the healthcare provider will:
- Review the Patient’s Sleep Patterns: This involves assessing the number of apnea events, sleep quality and any changes in daytime symptoms such as fatigue or sleepiness.
- Adjust Device Settings: The provider may make further adjustments to the device settings. This is to enhance its effectiveness based on the data collected. Additionally the patient’s feedback will be considered.
- Monitor for Complications: The provider will check for any signs of complications. Such as infection at the implant site or issues with the leads or IPG.
Fine Tune Sleep Study
After approximately three months of clinic-based adjustments on the programming of the Remedē and demonstration of both objective and subjective improvements by the implant download data and patient reports then a full night sleep laboratory sleep study will be performed with a Remedē representative being present the full night with our sleep technician to make fine tune adjustments to the programming while the patient is asleep.
Patient Education and Support
Patients are educated on how to manage certain aspects of their implant which is programmed internally within the device itself. The system is easy to use as it is automatically programmed to turn on and off, pause, and restart, etc. There is no manual operation of the Remedē system by the patient.
Long-Term Management
Long-term management of the Remedē System involves periodic check-ups, usually every six months to a year, to ensure the device continues to function correctly and the patient remains free of significant apnea events. The IPG has a battery life of approximately five years.
How Can the Insomnia and Sleep Institute of Arizona Help You Determine if the Remedē System is Right for You?
The Insomnia and Sleep Institute of Arizona is here to guide you every step of the way.
Starting with the Right Diagnosis
First things first: An accurate diagnosis is important. We’ll begin with comprehensive evaluations to confirm that you have moderate-to-severe central sleep apnea (CSA). This typically involves sleep studies and thorough assessments of your symptoms and medical history. If CSA is confirmed, we initially recommend trying ASV therapy as long as you do not have contraindications to ASV therapy, as it’s often the first line of treatment.
Moving to the Next Step
But what if ASV doesn’t work for you? That’s where the Remedē System comes in. If ASV therapy isn’t effective, we’ll discuss the possibility of the Remedē System implant. This isn’t just any implant. It’s a sophisticated device designed to address CSA by stimulating the phrenic nerve to regulate your breathing during sleep.
Getting the Right Specialist
The implantation procedure differs slightly from obstructive sleep apnea treatments (OSA). Instead of an ENT surgeon, a cardiac electrophysiologist performs the implant. Don’t worry. We’ve got you covered. We’ll refer you to the best specialists in the field to ensure you’re in capable hands.
Ongoing Care and Monitoring
Once the device is implanted, our job isn’t over. We’ll be with you through the entire post-implantation process. Regular follow-ups will ensure that the device works correctly and that your therapy is optimized. We’ll monitor your progress, make any necessary adjustments and provide support to help you get the best possible results.
Ready to Take the Next Step?
Reach out to The Insomnia and Sleep Institute of Arizona today. Simply complete our online form to get started.
References:
Maria Rosa Costanzo, Javaheri, S., Piotr Ponikowski, Oldenburg, O., Augostini, R., Goldberg, L. R., Christoph Stellbrink, Fox, H., Schwartz, A. R., Gupta, S., McKane, S., Meyer, T. E., & Abraham, W. T. (2021). Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. Nature and Science of Sleep, Volume 13, 515–526. https://doi.org/10.2147/nss.s300713
remedē System. (2024, April 2). Remedē® System. https://remede.zoll.com/remede-system/
remedē ® System Patient Manual. (n.d.). Retrieved July 16, 2024, from https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160039d.pdf
