Pulmonary Artery Denervation Studied to Treat Pulmonary Arterial Hypertension

September 18, 2022—A new sham-controlled clinical evaluation of pulmonary artery denervation (PADN) for patients with pulmonary arterial hypertension (PAH) found that in addition to increasing exercise capacity, PADN improved hemodynamics and clinical outcomes during 6-month follow-up.

Previous observational studies have demonstrated that PADN improves hemodynamic and exercise capacity in patients with PAH but has not yet been studied in a randomized trial, noted the study investigators.

The findings were reported at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts, and simultaneously published online by Hang Zhang, MD, et al in JACC: Cardiovascular Interventions.

As summarized in the TCT press release, the investigators randomized 128 PAH patients to PADN (n = 63) or a sham procedure (n = 65) at 11 centers in China between January 2018 and June 2021. Patients not taking PAH-specific drugs for at least 30 days were enrolled.

Both PADN and sham procedure patients received a phosphodiesterase-5 inhibitor (PDE-5i). For the sham procedure, the PADN catheter was positioned at the target site, but ablation was not performed. Measurement of N-terminal-pro brain natriuretic peptide (NT-proBNP), a 6-minute walk test (6MWD), and transthoracic echocardiography were performed at baseline and at 7, 30, and 180 days using standardized procedures.

The primary endpoint was the between-group difference in the change in 6MWD from baseline to 6 months.

The investigators found that 6MWD improved in both groups during follow-up, with the between-group difference becoming significant by 30 days. The median change from baseline to 6 months was 61.0 m (12.0-92.0 m) in the PADN group and 18.0 m (-9.0 to 66.0 m) in the sham group (P = .004). The adjusted between-group mean difference in the change of 6MWD from baseline to 6 months was 33.8 m (95% CI, 16.7-50.9; P < .001).

At 6 months, pulmonary vascular resistance was reduced by -3.0 ± 0.3 Wood units after PADN and -1.9 ± 0.3 Wood units after sham (adjusted difference -1.4; 95% CI, -2.6 to -0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation, and decreased NT-proBNP. Clinical worsening was also less (1.6% vs 13.8%; odds ratio [OR], 0.11; 95% CI, 0.01-0.87) and a satisfactory clinical response was greater (57.1% vs 32.3%; OR, 2.79; 95% CI, 1.37-5.82) with PADN treatment, reported the investigators in the TCT press release.

“This study clearly demonstrates that treatment with PADN plus a PDE-5i was safe and resulted in improved exercise capacity at 6 months compared with PDE-5i treatment alone,” commented senior investigator Shao-Liang Chen, MD, in the TCT press release. “In addition, we found significant improvements in hemodynamics as well as a reduction in clinical worsening with PADN. Larger randomized trials are needed to demonstrate the incremental benefits of PADN in patients on combination pharmacotherapy.”

Dr. Chen is Director of Cardiology and Cath Lab, Nanjing First Hospital in Nanjing, China, as well as Vice President of Nanjing First Hospital, Nanjing Medical University and Professor of Internal Medicine and Cardiology, Nanjing Medical University.

The study was granted by the National Scientific Foundation of China and funded by Nanjing First Hospital. Pulnovo Medical (Wuxi) Co., Ltd. provided all PADN catheters through the study period, noted the TCT press release.