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Pulmonary Artery Denervation for Residual Pulmonary Hypertension After Endarterectomy
Quick Takes
- Pulmonary artery denervation (PADN) is an exciting new adjunctive therapy for PAH.
- This trial, in conjunction with the recently published TROPHY1, suggests a role for PADN in PAH patients moving forward.
- Future work is needed before PADN can be used in routine clinical practice.
Study Questions:
What is the safety and efficacy of pulmonary artery denervation (PADN) using remote magnetic navigation in patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA) in a sham-controlled trial?
Methods:
Fifty patients with residual CTEPH despite medical therapy ≥6 months after PEA, who had mean pulmonary artery (PA) pressure of 25 mm Hg or pulmonary vascular resistance (PVR) >400 dyn‧s‧cm5 were randomized to treatment with PADN (n = 25) or sham procedure with continued medical therapy with riociguat (n = 25). The primary endpoint was PVR at 12 months and secondary endpoint included 6-minute walk distance (6MWD).
Results:
At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm5 in the PADN group versus 149 ± 73 dyn‧s‧cm5 in the sham group, mean between-group difference was 109 dyn‧s‧cm5 (95% confidence interval, 45-171; p < 0.001). 6MWD improved with PADN as well (470 ± 84 vs. 399 ± 16 m; p = 0.03). After the PADN procedure, two patients developed groin hematoma that resolved without any consequences. No other safety issues were noted.
Conclusions:
In CTEPH patients with residual PAH post-PEA, PADN resulted in substantial improvements in PVR and 6MWD at 12 months of follow-up.
Perspective:
Group 4 PAH (CTEPH) is a three-compartment disease: proximal compartment (main and lobar PA obstruction), distal compartment (segmental and subsegmental PA obstruction), and vasculopathy at the capillary level. PEA relieves proximal obstruction, balloon pulmonary angioplasty helps with distal obstruction, and vasodilator therapy (riociguat) helps with vasculopathy. These results propose a potential new interventional treatment for the vasculopathy compartment in such patients. These findings are in line with the recently published TROPHY1 trial. TROPHY1 reported similar improvements in PVR and 6MWD with PADN (using a different device) in group 1 PAH. It is possible there is a class effect of PADN in patients with PAH. Future work will be needed to establish device safety and the role of PADN in this highly complex and variable disease state.
Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Acute Heart Failure, Pulmonary Hypertension, Interventions and Vascular Medicine, Hypertension
Keywords: Angioplasty, Balloon, Cardiology Interventions, Denervation, Endarterectomy, Heart Failure, Hematoma, Hypertension, Pulmonary, Thromboembolism, Vascular Resistance, Vasodilator Agents
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