Sustained 12 Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea

Abstract

Transvenous phrenic nerve stimulation improved sleep metrics and quality of life after 6 months versus control in the remedē System Pivotal Trial. This analysis explored the effectiveness of phrenic nerve stimulation in patients with central sleep apnea after 12 months of therapy. Reproducibility of treatment effect was assessed in the former control group in whom the implanted device was initially inactive for the sixth month and subsequently activated when the randomized control assessments were complete. Patients with moderate-to-severe central sleep apnea implanted with the remedē System were randomized to therapy activation at 1 month (treatment) or after 6 months (control). Sleep indices were assessed from baseline to 12 months in the treatment group and from 6 to 12 months in former controls. In the treatment group, a ≥50% reduction in apnea-hypopnea index occurred in 60% of patients at 6 months (95% confidence interval [CI] 47% to 64%) and 67% (95% CI 53% to 78%) at 12 months. After 6 months of therapy, 55% of former controls (95% CI 43% to 67%) achieved ≥50%reduction in apnea-hypopnea index. Patient Global Assessment was markedly ormoderately improved at 6 and 12 months in 60% of treatment patients.Improvements persisted at 12 months. A serious adverse event within 12 months occurred in 13 patients (9%). Phrenic nerve stimulation produced sustained improvements in sleep indices and quality of life to at least 12 months in patients with central sleep apnea. The similar improvement of former controls after 6 months of active therapy confirms benefits are reproducible and reliable.

First report of concomitant subcutaneous defibrillator and phrenic nerve stimulator implantation in a patient with severe central sleep apnea and left ventricular systolic dysfunction

“…10 PNS with the remed e system has been shown to improve symptoms and reduce central apneas and is currently indicated for patients diagnosed with moderateto-severe CSA. 11,12 Both sensing and pacing leads of the remed e system are programmable. The quadripolar left lead can be programmed in multipolar pacing configuration to deliver output between 0.1 and 10 mA at a pulse width of 60-300 microseconds.…”

Stymulacja nerwu przeponowego w leczeniu centralnego bezdechu sennego u chorych z niewydolnością serca

“…Możliwe jest zaprogramowanie stymulacji w trybie unipolarnym bądź bipolarnym. Wymuszone zaprogramowanym trybem stymulacji skurcze przepony przywracają regularność toru oddechowego, wykorzystując do tego wytworzone ujemne ciśnienie w klatce piersiowej, co zbliża mechanizm działania systemu remedē do fizjologicznego oddychania [20]. Stymulacja nerwu przeponowego zmniejsza lub znosi epizody bezdechu nocnego (ryc.…”

“…Średni czas zabiegu wyniósł 2,7 ± 0,8 h, a całkowity czas fluoroskopii 43,0 ± 22,5 min. Pozytywne efekty tego badania udokumentowano również w przedłużonej do 12 miesięcy obserwacji zarówno w zakresie parametrów oddechowych, jak i oceny jakości życia [20]. Ponadto stwierdzono niewielką, ale narastającą poprawę parametrów echokardiograficznych, między innymi LVEF, zarówno po 6 (wzrost z 38,6% ± 0.4 do 39,8 ± 0,4; p = 0,03), jak i po 12 miesiącach (wzrost z 38,6% ± 0,4 do 41,4 ± 0,4; p < 0,001).…”

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

“…The IPG is a programmable device that provides an electrical stimulus to the left or right phrenic nerve and monitors the patient's respiration using transthoracic impedance. Stimulation of the left or right phrenic nerve causes the diaphragm to contract, thereby developing negative intrathoracic pressure and restoring regular breathing pattern …”

“…Stimulation of the left or right phrenic nerve causes the diaphragm to contract, thereby developing negative intrathoracic pressure and restoring regular breathing pattern. 10 Because of the lack of therapeutic options available for patients with CSA and the morbidity associated with the disease, phrenic nerve stimulation is an important treatment, especially for patients with concomitant heart failure. The remedē System Pivotal Trial demonstrated significant improvements in the number of sleep apnea events, sleep architecture, hypoxia, and arousals (all P < 0.001).…”