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

Ralph S Augostini,Randy Westlund,Michael Peterson,Maria Rosa Costanzo,Sanjaya Gupta,Andrew Merliss,John Hayes,Dariusz Jagielski,Muhammad R Afzal,Michael Drucker,Christen Butter,Matthew Hutchinson,Moeen Saleem,Klaus Gutleben,Timothy W Smith,Christoph Stellbrink

doi:10.1111/jce.13898

Abstract

BackgroundCentral 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.ObjectiveTo describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).MethodsThe 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.ResultsIn 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.ConclusionIn 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.

Highlights

Central sleep apnea (CSA) is a breathing disorder characterized by periods of apnea or absence of airflow caused by absent central respiratory drive because of increased sensitivity to the partial pressure of CO2.1 CSA commonly presents as Cheyne‐ Stokes breathing, characterized by cycles of deep, rapid, crescendo decrescendo breathing, followed by slower, shallower breathing, or no breathing without respiratory effort from the diaphragm.[1]
Of the 151 randomized patients enrolled in the remedē System Pivotal Trial, 147 (97%) were successfully implanted on the first attempt
The percentage of patients free from serious adverse events associated with the implant procedure, the system, or the delivered therapy through the 12‐month visit was 91% (95% confidence interval [86%, 95%]).[9]

Summary

Introduction

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). A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). 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. A well‐established relationship exists between Cheyne‐Stokes respirations and increased mortality in patients with heart failure.[4-6]. Treatment options for CSA have been limited, especially in patients with heart failure and reduced left ventricular function where mask‐based therapies may, lead to an increase in mortality (SERVE‐HF).[7,8] In addition to increased mortality, the recurring hypoxemia and neurohormonal activation associated with CSA lead to systemic and pulmonary hypertension, arrhythmias, and increased cardiovascular burden.[5,6] To date, treatment options for CSA have been limited, especially in patients with heart failure and reduced left ventricular function where mask‐based therapies may, lead to an increase in mortality (SERVE‐HF).[7,8]

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