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Clinical TrialVolume 76, Issue 8, August 2020

JOURNAL：J Am Coll Cardiol. Article Link

Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy

A Romanov, A Cherniavskiy, N Novikova et al. Keywords: chronic thromboembolic pulmonary hypertension; pulmonary artery denervationpulmonary hypertension; remote magnetic navigation

ABSTRACT

BACKGROUND - Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA).


OBJECTIVES - This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA.


METHODS - Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm−5based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test.


RESULTS - After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm−5in the PADN group versus 149 ± 73 dyn‧s‧cm−5in the MED group, mean between-group difference was 109 dyn‧s‧cm−5(95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).


CONCLUSIONS - PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.


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