Transvenous phrenic nerve stimulation for central sleep apnea is safe and effective in patients with concomitant cardiac devices

Hemal M. Nayak, Raj Patel, Scott McKane, Kristofer J. James, Timothy E. Meyer, Robin E. Germany, Christoph Stellbrink, Maria Rosa Costanzo, Ralph Augostini

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs). Objective: To report the safety and efficacy of TPNS in patients with concomitant CIEDs. Methods: In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics, and efficacy of TPNS. Safety was assessed using incidence of adverse events and device–device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life. Results: Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to 1 inappropriate defibrillator shock and delivery of antitachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥50% reduction in AHI and quality-of-life improvement. Conclusion: Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not seem to impact implant metrics, implantation success, and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device–device interaction.

Original languageEnglish (US)
Pages (from-to)2029-2036
Number of pages8
JournalHeart Rhythm
Volume17
Issue number12
DOIs
StatePublished - Dec 2020
Externally publishedYes

Keywords

  • Cardiovascular implantable electronic device
  • Central sleep apnea
  • Device–device interaction
  • Heart failure with reduced ejection fraction
  • Phrenic nerve stimulation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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