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Randomized Controlled Trial
. 2019 May;30(5):792-799.
doi: 10.1111/jce.13898. Epub 2019 Mar 18.

How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

Ralph S Augostini  1 , Muhammad R Afzal  1 , Maria Rosa Costanzo  2 , Randy Westlund  3 , Christoph Stellbrink  4 , Klaus Gutleben  5 , Sanjaya Gupta  6 , Moeen Saleem  2 , Timothy W Smith  7 , Michael Peterson  8 , Michael Drucker  9 , Andrew Merliss  10 , John Hayes  11 , Christen Butter  12 , Matthew Hutchinson  13 , Dariusz Jagielski  14
Affiliations
Randomized Controlled Trial

How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

Ralph S Augostini et al. J Cardiovasc Electrophysiol. 2019 May.

Abstract

Background: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA.

Objective: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).

Methods: The remedē System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration.

Results: In the remedē System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months.

Conclusion: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.

Keywords: central sleep apnea; phrenic nerve; phrenic nerve stimulation; transvenous stimulation.

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Conflict of interest statement

Dr Augostini has relationships with commercial interests in the following areas: Consultant/Speaker Bureau – Respicardia; and Advisory Board Membership.

Figures

Figure 1
Figure 1
A, Guide catheter at the junction of the left brachiocephalic (LBC) vein and left subclavian veins. B, Nonselective venogram showing branches taking off from the LBC vein
Figure 2
Figure 2
A, Probing with the 0.014” coronary wire and cannulating the pericardiophrenic vein. B, Deploying the left stimulation leads to the level of the left atrium
Figure 3
Figure 3
A, Orientation of the coronary sinus right catheter in the superior vena cava to identify the azygos ostium. B, Contrast injection through an inner catheter revealing the azygos ostium and valve leaflets (left anterior oblique)
Figure 4
Figure 4
A, Venogram of the azygos vein revealing branch vein ostia. B, Cannulation of the branch vein using a 0.014” coronary wire
Figure 5
Figure 5
A, Venogram of the target branch off the azygos vein. B, Location of the sensing lead in the branch vein
Figure 6
Figure 6
A, Final position of the left stimulation and sensing leads. B, Placement of the right‐sided stimulation lead
See this image and copyright information in PMC

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