Author + information
- Received August 22, 2018
- Revision received September 5, 2018
- Accepted September 13, 2018
- Published online September 23, 2018.
- Hang Zhang, MD†,
- Juan Zhang, MD†,
- Mengxuan Chen, MD‡,
- Dujiang Xie, MD¶,
- Jing Kan, MBBS†,
- Wande Yu, MD¶,
- Xiaobo Li, MD¶,
- Tian Xu, MBBS¶,
- Yue Gu, PhD†,
- Jianzeng Dong, MD#,
- Hong Gu, MD#,
- Yaling Han, MD§ and
- Shao-Liang Chen, MD†∗ ()
- †Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- ‡Mailman School of Health, Columbia University, New York, US
- ¶Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China
- #Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China
- §Division of Cardiology, Shenyang Northern Hospital, Shenyang, China
- ↵∗Address for Correspondence: Shao-Liang Chen, MD Division of Cardiology Nanjing First Hospital Nanjing Medical University 68 Changle Road Nanjing 210006, China Phone and Fax: +86-25-52208048.
Background Pulmonary artery denervation (PADN) has been shown to improve hemodynamics of pulmonary arterial hypertension (PAH) in a series of patients. Additionally, benefits of targeted medical therapy for patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) secondary to left sided heart failure are unknown.
Objectives We sought to assess the benefits of PADN among CpcPH patients in a prospective, randomized sham-controlled trial.
Methods Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mmHg, pulmonary capillary wedge pressure >15 mmHg, and pulmonary vascular resistance (PVR] > 3.0 Woods Units, 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-minute walk distance (6MWD) 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 6MWD 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; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 vs. 6.1 ± 2.9 Wood Units, p = 0.001). Clinical worsening was less frequent in the PADN group compared to 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.
*The first four authors equally contributed to this manuscript
This study was funded by grants from Nanjing Healthy Bureau and the National Science Foundation of China (Funding number: NSFC 91639303 and NSFC 81770441).
Dr. Shao-Liang Chen is the inventor of patents for PADN but not the owner.
All the remaining authors have no any relevant disclosures.
- Received August 22, 2018.
- Revision received September 5, 2018.
- Accepted September 13, 2018.
- 2018 American College of Cardiology Foundation