Pulmonary artery denervation (PADN) in patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy was associated with improved hemodynamics and clinical and functional status compared with medical therapy, according to a published study in the Journal of the American College of Cardiology.
A total of 50 patients with residual CTEPH despite receiving medical therapy for at least 6 months after pulmonary endarterectomy, and with mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) >400 dyn.s.cm-5 based on right heart catheterization were enrolled in the study. Patients were randomly assigned to receive PADN (n=25; mean age, 48±14 years; 48% men) using remote magnetic navigation for ablation, or medical therapy with riociguat (MED group; n=25; mean age, 47±14; 52% men).
The median time after pulmonary endarterectomy before randomization was 26 months in the PADN group and 32 months in the MED group. A sham procedure with mapping but no ablation was performed in the MED group. The primary end point was PVR, 12 months after randomization, and secondary end points included performance in the 6-min walk test.
The mean PVR reduction was 258±135 dyn.s.cm-5 in the PADN group compared with 149±73 dyn.s.cm-5 in the MED group at 12 months (mean between-group difference, 109 dyn.s.cm-5; 95% CI, 45-171; P = .001). Distance on the 6-min walk test significantly increased in the PADN vs MED group (470±84 m vs 399±116 m, respectively; P =.03).
This study was designed as a pilot program to test the concept of PADN in residual CTEPH after surgery, and they could not perform so that a sample size calculation was not feasible due to absence of data for this population at the time of the study. In addition, this was a single-center study with a relatively small number of patients.
“PADN in patients with CTEPH after pulmonary endarterectomy was safe and effective, and resulted in substantial reduction of PVR and pulmonary artery pressure during 12 months of follow-up, accompanied by improved 6-min walk test and reduced need for hospitalization,” concluded the study authors.
Disclosures: This study received funding from a medical device company.
Romanov A, Cherniavskiy A, Novikova N, et al. Pulmonary artery denervation for patients with residual pulmonary hypertension after pulmonary endarterectomy. J Am Coll Cardiol. 2020;76:916-926.