Original Investigation
Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy

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Abstract

Background

Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA).

Objectives

This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA.

Methods

Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm−5 based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test.

Results

After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm−5 in the PADN group versus 149 ± 73 dyn‧s‧cm−5 in the MED group, mean between-group difference was 109 dyn‧s‧cm−5 (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).

Conclusions

PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.

Key Words

chronic thromboembolic pulmonary hypertension
pulmonary artery denervation
pulmonary hypertension
remote magnetic navigation

Abbreviations and Acronyms

3D
3-dimensional
6MWT
6-min walk test
CI
confidence interval
CTEPH
chronic thromboembolic pulmonary hypertension
MED
medical therapy with riociguat
PA
pulmonary artery
PADN
pulmonary artery denervation
PAP
pulmonary artery pressure
PEA
pulmonary endarterectomy
PH
pulmonary hypertension
PVR
pulmonary vascular resistance
RF
radiofrequency
RHC
right heart catheterization
RMN
remote magnetic navigation
RVOT
right ventricular outflow tract

Cited by (0)

This study was partially supported by a grant from Biosense Webster (investigator-initiated study BWI-IIS-423). The funding sources had no influence on the study design, data analysis and results interpretation. Dr. Romanov as a principal investigator received a grant from Biosense Webster (investigator-initiated study BWI-IIS-423), which was provided to E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation. The current study was partially supported by this grant. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.

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