Pulmonary artery denervation improves exercise capacity, hemodynamics, and clinical outcomes in patients with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH), according to results from a clinical trial testing the safety and efficacy of the procedure, called PADN-CFDA.
“The PADN-CFDA results are very important because this was an adequately powered randomized controlled trial and what we clearly saw was that there was a lower rate of clinical worsening and a better satisfactory clinical response,” Gregg W. Stone, MD, chair of the trial’s steering committee, said in a press release.
Previous research has shown that pulmonary artery denervation reduces pulmonary arterial pressure in patients with PAH. However, the safety and effectiveness of the approach have not previously been tested in randomized clinical trials.
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The PADN-CFDA trial enrolled 128 patients with WHO Group 1 PAH who were randomly divided into 2 groups to either undergo pulmonary artery denervation and receive a phosphodiesterase-5 inhibitor or undergo a sham procedure and receive the phosphodiesterase-5 inhibitor.
Read more about the clinical classification of PAH
The primary outcome measure of the trial was any change in 6-minute walk distance from baseline to 6 months.
The results showed that patients treated with pulmonary artery denervation had a greater improvement in the 6-minute walk distance than those who underwent the sham procedure. Moreover, the reduction in pulmonary vascular resistance was greater in patients treated with pulmonary artery denervation. Finally, pulmonary artery denervation improved right ventricular function, reduced tricuspid regurgitation, and decreased levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), a biomarker of heart failure.
During the 6-month follow-up, patients who underwent pulmonary artery denervation had less clinical worsening and a more satisfactory clinical response than those who underwent the sham procedure.
Pulmonary artery denervation is a catheter-based ablation technique. It targets the afferent and efferent fibers of a baroreceptor reflex in the main pulmonary artery trunk and its bifurcation, which is involved in the elevation in pulmonary arterial pressure that occurs in PAH.
References
Pulnovo Medical released results from PADN-CFDA pivotal trial for the treatment of pulmonary arterial hypertension (PAH). News release. Pulnovo Medical; September 20, 2022.
Zhang H, Wei Y, Zhang C, et al. Pulmonary artery denervation for pulmonary arterial hypertension: a sham-controlled randomized trial. JACC Cardiovasc Interv. Published online September 18, 2022. doi:10.1016/j.jcin.2022.09.013
Safety and efficacy of pulmonary artery denervation in patients with pulmonary arterial hypertension (PADN-CFDA). ClinicalTrials.gov. September 13, 2017. Updated March 29, 2022. Accessed September 21, 2022.
