Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Residual Pulmonary Hypertension after Pulmonary Thromboembolism and Surgical Thrombendarterectomy (first-in-man study)

Purpose. To study the safety and effectiveness of simplicity denervation system in lowering pulmonary artery pressure in patients with pulmonary hypertention.

Methods. We analyzed the 3-months results of 12 procedures of pulmonary artery denervation with simplicity denervation system. The primary endpoints were the change of pulmonary artery pressure and 6 minutes walking test at 3 months follow-up.

Results. The procedure of pulmonary artery denervation was performed at the ostium of the right and left pulmonary arteries using the electrode from Simplicity denervation system. Using the coronary guiding technique, the tip of electrode was placed at the ostium of the pulmonary artery, then the radiofrequency energy was applied (temperature >50°C, energy = 12 W, and time = 120), rotating the tip with pace of 2 mm at the ostium of each pulmonary artery. The properly position of the electrode (tight contact with the vessel wall) was checked automatically by resistance monitoring and manual tracking. At 3 months follow-up the reduction of mean pulmonary artery pressure was 25 ± 4 mm Hg (p < 0.01) and improvement of the 6 minutes walking test from 321 ± 19 m to 487 ± 29 m (p < 0.01) was observed.

Conclusion. The simplicity denervation system is proven to be safe and effective for pulmonary artery denervation. Further randomized study is needed to confirm the clinical benefit of this procedures in patients with pulmonary hypertension.