# Analysis by sex of safety and effectiveness of transvenous phrenic nerve stimulation

## TL;DR

This study found that transvenous phrenic nerve stimulation is equally safe and effective for treating central sleep apnea in women and men, with women reporting greater quality of life improvements.

## Contribution

The study provides evidence that TPNS is safe and effective for women with central sleep apnea, a group historically underrepresented in clinical trials.

## Key findings

- Women experienced comparable improvements in CSA metrics and sleep quality to men after TPNS.
- Women reported a 25-percentage point greater improvement in quality of life compared to men after 12 months of TPNS.
- TPNS was safe for women with no serious adverse events, while men had a 10% rate of such events.

## Abstract

Little is known about sex differences in the treatment of central sleep apnea (CSA). Our post hoc analysis of the remedē System Pivotal Trial aimed to determine sex-specific differences in the safety and effectiveness of treating moderate to severe CSA in adults with transvenous phrenic nerve stimulation (TPNS).

Men and women enrolled in the remedē System Pivotal Trial were included in this post hoc analysis of the effect of TPNS on polysomnographic measures, Epworth Sleepiness Scale, and patient global assessment for quality of life.

Women (n = 16) experienced improvement in CSA metrics that were comparable to the benefits experienced by men (n = 135), with central apneas being practically eliminated post TPNS. Women experienced improvement in sleep quality and architecture that was comparable to men post TPNS. While women had lower baseline apnea hypopnea index than men, their quality of life was worse at baseline. Additionally, women reported a 25-percentage point greater improvement in quality of life compared to men after 12 months of TPNS therapy. TPNS was found to be safe in women, with no related serious adverse events through 12 months post-implant, while men had a low rate of 10%.

Although women had less prevalent and less severe CSA than men, they were more likely to report reduced quality of life. Transvenous phrenic nerve stimulation may be a safe and effective tool in the treatment of moderate to severe CSA in women. Larger studies of women with CSA are needed to confirm our findings.

ClinicalTrials.gov NCT01816776; March 22, 2013.