Managing the Epidemic of Obstructive and Central Sleep Apnea in Cardiology Webinar Q&A

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Webinar Q&A

A1: Both mild obstructive sleep disordered breathing episodes and periodic limb movements will have a reciprocal pattern, which will be indistinguishable from one another.  The main difference is that the sleep disordered breathing episodes will also be characterized by some degree of oxyhemoglobin desaturation and/or an abrupt change in snoring intensity, which will coincide with the reciprocal pattern (arousal from the event).

A2: A HSAT cannot formally diagnose central sleep apnea, but WatchPAT with central plus can identify those patients that need to go to the PSG as 25% of HF patients will have primary central sleep apnea.
A3: WatchPAT uses two signals, PAT and HR as a proxy for sympathetic activation, which is called a reciprocal pattern, i.e. PAT or blood vessels vasoconstrict and HR accelerates paroxysmally. This is a part of the negative feedback loop mediated by the ANS to maintain homeostasis from the increasing CO2 and decreasing O2. In other words, the reciprocal pattern is a surrogate for respiratory arousals.
A4: The autonomic arousals in the reciprocal pattern (peripheral vasoconstriction and pulse rate acceleration) are different in PLMS than respiratory arousals. On the report and raw data, there will typically be an elevated RDI that is less prominent in REM sleep and also goes away in the last 1/2 of the study.
A5: Yes, WatchPAT is FDA cleared for children 12 and above
A6: No – it is just delivered via telemedicine instruction or via the phone with an instruction guide either in the app or in the carrying case with step by step instructions.
A7: A recent validation study by Pillar et al publish in 2019 the sensitivity in Heart Failure and Atrial Fib patients was .71 and the specificity was .98 during simultaneous synchronized PSG for central sleep apnea. WatchPAT is indicated by the FDA for central and obstructive sleep apnea detection in HF and AF patients.
A8: An important feature of the PAT technology is that the clamping effect increases as the pressure is raised in the PAT probe, in contrast, open ended cuffs applied over the fingertip increasingly tend to expel the finger as pressure is raised.
A9: WatchPAT’s algorithm automatically generates an auto-scored report; however, recently a large cohort at Johns Hopkins which recently published a paper in JCSM provides a framework to allow the qualified technologists and physician to manually review and edit the raw data. It is a requirement of the AASM that all sleep studies raw data are both reviewable and editable.
A10: The snore and body position sensor has a 3 axis accelerometer that we derive a chest movement.
A11: WatchPAT’s sleep staging is clinically validated and it reports sleep efficiency, sleep latency and REM latency on top of sleep stages. WatchPAT has 88.6% overall agreement against PSG on detecting light/deep and REM sleep.
A12: Based on WatchPAT’s PAT technology and detecting True Sleep Time, WatchPAT is eligible to use 95800 code which has higher reimbursement rate vs airflow base devices. Also due to ease of use, 3 points of contact, WatchPAT has 98% study success rate and does not require long times from clinic to clean and prepare the device. Overall, cost of ownership of WatchPAT is very low.
A14: CSA must be formally diagnosed by PSG; however, the use of WP allows the clinician to accurately mine for those patients within the cardiology practice patients and then prioritize them for the PSG sleep center.
A15: Sometimes it is an issue though there are some prominent sleep physicians that will eat the DRG costs to risk stratify the patient prior to discharge especially when readmission penalties are a focus (COPD, CHF).
A17: If they have a device of their own, we ask their family to bring in. We have a clunky, huge BiPAP machine that we use in the hospital. We will have the auto-titrating CPAP machine delivered to the bedside if they test positive for OSA before discharge. This way they can try it with help. We do not always get this luxury, but we try.
A18: OSA, OSA-CSA, and CSA were found in 29%, 40%, and 31% of patients, respectively; 41% showed periodic breathing in the registry.
A19: There have been some reports of vitamin C and E being helpful but I do not know of any controlled studies of dietary supplements. We do not recommend any supplements for sleep apnea, but we do recommend weight loss, a heart healthy diet and regular cardiovascular exercise (150 minutes/week as the goal)
A21: We partner with our sleep colleagues to refer patients for mandibular advancement devices and we do have some success with this. We manage it like CPAP asking about compliance at each visit. We have had some patients complain about insurance coverage in our area.
A22: We wait for them to be near the end of the admission – diuresed and on somewhat stable meds. It is usually a day or 2 before discharge. Volume overload can make OSA and CSA appear worse.
A23: Yes. It is a chicken or egg question. The two diseases are intertwined and drive each other.
A24: Yes. There are some studies with mandibular advancement devices improving sleep apnea in patients with heart failure (Swed Dent J. 2004;28(4):155-63. PMID: 15779492) with a reduction in sympathetic activity. I am not sure if there are any outcome studies. We recommend MAD for patients with OSA and inability or unwillingness to use CPAP.
A25: Respicardia studied patients who presented with predominant CSA during a diagnostic (no therapy) sleep study. Patients with treatment emergent sleep apnea were not included, as remede is not designed for patients where airway obstruction is the primary issue.

A26: The remede System can be programmed to accommodate travel between time zones, but there are some limitations that should be considered. First, therapy can be programmed during a clinic visit to switch time zones on a specified date. The limitation is that only two future time zones can be programmed (e.g. change from time zone A to B, then later change from B back to A).
If traveling through multiple time zones or on an irregular schedule, an alternative approach may be possible. remede begins delivering therapy when 3 conditions are met a) within the specified therapy time, b) patient is reclined, c) patient activity is low. If a patient has a need to regularly change schedules, criteria a) can be relaxed. This allows therapy to be delivered any time the patient is in a reclined position and activity is low. The downside implication of this is that the patient may begin therapy inadvertently if conditions b) and c) are met during the day (e.g. lying down by a swimming pool in the middle of the day). At any time, therapy can be paused by increasing the patient’s incline or rolling over. We understand the above scenarios may require some additional clarification based on an individual patient’s needs. We would be happy to discuss further if you have specific patients in mind.

A27: remede is FDA approved for moderate to severe CSA in adults and does not require attempting/failing any other therapies. From an insurance standpoint, only Aetna currently has a policy that calls out the need for other therapies to be attempted first, though other private insurers may be more likely to prior authorize the procedure if other therapies have been considered.
A28: Like a cardiac pacemaker, when the battery of the device nears expiration an electrophysiologist would replace the implanted pulse generator, requiring the previously implanted device to be extracted—a common, routine procedure. Occasionally, one or more of the leads also need to be replaced. While the experience and implant duration here is limited, we have thus far seen almost all extracted leads come out safely with simple traction. A small number required extraction techniques and instrumentation similar to cardiac pacemaker leads. Patients typically go home the morning after the extraction procedure.
A29: remede is contraindicated for patients with a known need for MRI. If a need for imaging does arise in the future, the provider will need to determine whether alternative forms of imaging can be used.
Q30: To date, there is no evidence that the remede system causes a cough. Is there a reason you suspect this would be an issue? Some clinicians were initially concerned that remede could cause abrupt contraction of the diaphragm (often described as a “hiccup”). This fear arose from unintentional stimulation of the diaphragm during implant of cardiac devices. However, the remede system is programed to deliver slow, smooth stimulation of the diaphragm that approximates a normal breath.
A31: remede is designed to treat central sleep apnea, and there is no evidence indicating a benefit in treating obstructive events. That said, most patients – including those with predominant CSA – tend to have some amount of OSA as well. Patients studied during the pivotal trial did not use any adjunctive therapy, and therefore data represent the benefit of remede alone. Following commercial launch, we have seen some instances of clinicians using low dose CPAP in conjunction with remede to treat residual obstructive events that did not resolve with remede.
A32: Patients with predominant CSA tend to have some amount of obstructive sleep apnea as well. In the pivotal trial, entry criteria limited participants to obstructive apneas < 20% of all apneas. Pivotal trial patients did have some degree of OSA/unscored events, with the median obstructive apnea index at baseline XX and the median hypopnea (unscored) index at baseline YY.

A32: Patients with predominant CSA tend to have some amount of obstructive sleep apnea as well. In the pivotal trial, entry criteria limited participants to obstructive apneas < 20% of all apneas. Pivotal trial patients did have some degree of OSA/unscored events, with the median obstructive apnea index at baseline XX and the median hypopnea (unscored) index at baseline YY.

Patients studied during the pivotal trial did not use any adjunctive therapy, and therefore data represent the benefit of remede alone. Following commercial launch, we have seen some instances of clinicians using low dose CPAP in conjunction with remede to treat residual obstructive events that did not resolve with remede.

A33: remede is designed to minimize the risk of nerve fatigue, and to date there have been no signals of nerve fatigue. Nerve fatigue can be an issue in neurostimulation therapies that physically come into contact with the nerve. The remede leads sit inside the vein that runs next to the lead, and therfore do not touch the lead.
A34: remede is FDA approved for moderate to severe CSA in adults, which is typically defined as over half of the apneas being central. However, a patient with this profile may warrant extra consideration because it is possible a substantial degree of OSA would remain after receiving remede therapy.

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