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

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.

Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes

“…The median ESS at baseline and 5-years were 9 [5,14] and 6 [4,11], respectively (Table 2), demonstrating a consistent and clinically meaningful ≥3 point reduction 18,19…”

“…9,10 The TPNS system (Supplement Figure 1) is an implantable neurostimulation device consisting of a pulse generator implanted in the pectoral region, a stimulation lead placed in either the left pericardiophrenic or right brachiocephalic vein, and an optional sensing lead placed in the azygos vein. 11 The TPNS device automatically delivers therapy, continuously throughout the night during the scheduled time when the patient is in a sleeping position and at rest, without requiring patients to manually activate therapy. 12 As a condition of FDA approval, the Post Approval Study (PAS) collected evidence regarding long-term safety and effectiveness in adult subjects with moderate to severe CSA.…”

First interventional exchange of a left transvenous phrenic nerve stimulation lead from the novel remedē system

“…A Biotronik Lumax 340 CRTD device was implanted 32 months before the TPNS device in the left pectoral region with transvenously placed right atrial, right ventricular dual shock coil, and bipolar coronary sinus leads. The initial TPNS device implantation was performed in the right pectoral area as previously described 7 . TPNS stimulation lead (respistim LQS, Model 4055; Respicardia Inc.) was positioned within the left PPV (Figure 1) and electrical testing revealed desired and effective phrenic nerve stimulation.…”

“…From this transvenous position, the phrenic nerve can be stimulated 6,9 . Recently, Fox et al 6‐8,10 demonstrated long‐term efficacy and safety of TPNS 3 years postimplant.…”

“…The novel remedē system® (Respicardia Inc.) was developed as a fully implantable transvenous phrenic nerve stimulation (TPNS) device to specifically treat moderate to severe CSA in adult patients 6 . It consists of an impulse generator (IPG) and a stimulation lead, typically placed into the pericardiophrenic vein (PPV) that adjacently accompanies the left‐sided phrenic nerve 7,8 . From this transvenous position, the phrenic nerve can be stimulated 6,9 .…”