Hang Zhang1, Juan Zhang1, Mengxuan Chen2, Du-Jiang Xie3, Jing Kan1, Wande Yu3, Xiao-Bo Li3, Tian Xu3, Yue Gu1, Jianzeng Dong4, Hong Gu4, Yaling Han5, Shao-Liang Chen6. 1. Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 2. Mailman School of Health, Columbia University, New York, New York. 3. Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China. 4. Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China. 5. Division of Cardiology, Shenyang Northern Hospital, Shenyang, China. 6. Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.
Abstract
OBJECTIVES: The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial. BACKGROUND: PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown. METHODS:Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism. RESULTS: At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism. CONCLUSIONS: PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).
RCT Entities:
OBJECTIVES: The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial. BACKGROUND: PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown. METHODS: Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism. RESULTS: At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism. CONCLUSIONS: PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).
Authors: Anna Klinke; Torben Schubert; Marion Müller; Ekaterina Legchenko; Jason G E Zelt; Tsukasa Shimauchi; L Christian Napp; Alexander M K Rothman; Sébastien Bonnet; Duncan J Stewart; Georg Hansmann; Volker Rudolph Journal: Cardiovasc Diagn Ther Date: 2020-10
Authors: Chakradhari Inampudi; Daniel Silverman; Marc A Simon; Peter J Leary; Kavita Sharma; Brian A Houston; Jean-Luc Vachiéry; Francois Haddad; Ryan J Tedford Journal: Chest Date: 2021-08-12 Impact factor: 9.410
Authors: M Riccardi; M Pagnesi; E Sciatti; C M Lombardi; R M Inciardi; M Metra; E Vizzardi Journal: Heart Fail Rev Date: 2022-06-01 Impact factor: 4.214
Authors: Natalia S Goncharova; Olga M Moiseeva; Heber Ivan Condori Leandro; Irina S Zlobina; Aelita V Berezina; Kirill N Malikov; Dmitry M Tashkhanov; Dmitry S Lebedev; Evgeny N Mikhaylov Journal: Biomed Res Int Date: 2020-02-17 Impact factor: 3.411