Alexander Romanov1, Alexander Cherniavskiy2, Nataliya Novikova2, Alexander Edemskiy2, Dmitry Ponomarev2, Vitaliy Shabanov2, Denis Losik2, Dmitry Elesin2, Ilya Stenin2, Igor Mikheenko2, Roman Zhizhov2, Evgeny Kretov2, Evgeny Pokushalov3, Sunny S Po4, Tamila V Martynyuk5, Jonathan S Steinberg6. 1. Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation. Electronic address: abromanov@mail.ru. 2. Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation. 3. Russian Scientific Society of Clinical Electrophysiology, Arrhythmology, and Cardiac Pacing, Moscow, Russian Federation. 4. Heart Rhythm Institute, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma. 5. A.L. Myasnikov Institute of Clinical Cardiology, Russian Cardiology Research and Production Complex, Ministry of Health of the Russian Federation, Moscow, Russian Federation. 6. Clinical Cardiovascular Research Center, University of Rochester School of Medicine and Dentistry, Rochester, New York.
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-5 based 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-5 in the PADN group versus 149 ± 73 dyn‧s‧cm-5 in 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 ± 84m 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.
RCT Entities:
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-5 based 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-5 in the PADN group versus 149 ± 73 dyn‧s‧cm-5 in 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.
Authors: Matus Niznansky; Jan Kavan; Petra Zemankova; Tomas Prskavec; David Ambroz; Pavel Jansa; Jaroslav Lindner Journal: J Int Med Res Date: 2021-03 Impact factor: 1.671
Authors: Natalia S Goncharova; Heber Ivan Condori Leandro; Aleksandr D Vakhrushev; Elena G Koshevaya; Yury A Skorik; Lubov B Mitrofanova; Lada A Murashova; Lev E Korobchenko; Elizaveta M Andreeva; Dmitry S Lebedev; Olga M Moiseeva; Evgeny N Mikhaylov Journal: BMC Pulm Med Date: 2021-12-18 Impact factor: 3.317