Author + information
- Received August 22, 2018
- Revision received September 5, 2018
- Accepted September 13, 2018
- Published online February 4, 2019.
- Hang Zhang, MDa,∗,
- Juan Zhang, MDa,∗,
- Mengxuan Chen, MDb,∗,
- Du-Jiang Xie, MDc,∗,
- Jing Kan, MBBSa,
- Wande Yu, MDc,
- Xiao-Bo Li, MDc,
- Tian Xu, MBBSc,
- Yue Gu, PhDa,
- Jianzeng Dong, MDd,
- Hong Gu, MDd,
- Yaling Han, MDe and
- Shao-Liang Chen, MDa,∗ ()
- aDivision of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- bMailman School of Health, Columbia University, New York, New York
- cDivision of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China
- dDivision of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China
- eDivision of Cardiology, Shenyang Northern Hospital, Shenyang, China
- ↵∗Address for correspondence:
Dr. Shao-Liang Chen, Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.
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)
↵∗ The first 4 authors equally contributed to this work.
This study was funded by grants from Nanjing Healthy Bureau and the National Science Foundation of China (Funding numbers NSFC 91639303 and NSFC 81770441). Dr. S.-L. Chen is the inventor of patents for PADN but not the owner. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 22, 2018.
- Revision received September 5, 2018.
- Accepted September 13, 2018.
- 2019 American College of Cardiology Foundation
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