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

J Cardiovasc Electrophysiol. 2019 May;30(5):792-799. doi: 10.1111/jce.13898. Epub 2019 Mar 18.

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.

Publication types

  • Randomized Controlled Trial
  • Video-Audio Media

MeSH terms

  • Diaphragm / innervation*
  • Electric Stimulation Therapy / adverse effects
  • Electric Stimulation Therapy / instrumentation*
  • Humans
  • Implantable Neurostimulators*
  • Operative Time
  • Phrenic Nerve / physiopathology*
  • Prosthesis Design
  • Prosthesis Implantation* / adverse effects
  • Respiration*
  • Sleep Apnea, Central / diagnosis
  • Sleep Apnea, Central / physiopathology
  • Sleep Apnea, Central / therapy*
  • Time Factors
  • Treatment Outcome