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For combined pre- and post-capillary pulmonary hypertension (CpcPH), pulmonary artery denervation (PADN) appeared to improve clinical and hemodynamic results in a randomized, sham-controlled trial.
Mean 6-minute walk distance was increased 83 m in the PADN study arm versus 15 m in a sildenafil (Revatio, Viagra) arm at 6-month follow-up (P<0.001), Shao-Liang Chen, MD, of Nanjing Medical University in Nanjing, China, reported here at the Transcatheter Cardiovascular Therapeutics meeting and .
The researchers also noted a change in pulmonary vascular resistance (PVR). Treatment with PADN was connected to lower PVR than in the sildenafil group (P=0.001).
"The present randomized sham-controlled study is the first to report the safety and efficacy of PADN for patients with CpcPH," Chen and co-authors wrote.
"We found that after a 6-month follow-up, PADN resulted in a significant increase in the 6MWD, consistent with the significant improvements in PVR, other hemodynamic parameters, and cardiac function," the investigators continued.
Treating patients with pulmonary hypertension can be challenging and they have increased risk of mortality over time, so efforts should be made to assess therapies that can improve these patients' outcomes as this study does, noted B. Hadley Wilson, MD, of The Sanger Heart & Vascular Institute in Charlotte, North Carolina.
The researchers selected 98 CpcPH patients who all had mean pulmonary vascular resistance (PVR) >3.0 Woods Units, an average pulmonary arterial pressure greater than or equal to 25 mm Hg, and pulmonary capillary wedge pressure greater than 15 mm Hg. Patients were then assigned to either PADN or sildenafil; from there, they received standard heart failure treatment.
Secondary endpoints showed that PADN treatment was tied to significantly lower PVR than in the sildenafil group (P=0.001). From baseline to 6-month follow-up, the average reduction of PVR was 29.8% in the PADN group versus 3.4% in the sildenafil group.
Safety findings at 6-month follow-up included two fatal pulmonary embolisms -- within 36 days for one sildenafil patient and 72 days for a PADN patient. There were seven deaths overall, of which five were in the sildenafil group.
"So there's at least a couple of parameters there where patients are doing better with this pulmonary artery denervation versus just the standard medical therapies, so it definitely has a lot of merit for further, larger studies," Wilson said.
Some of the study limitations include the small number of patients and included a post-hoc analysis, noted Wilson.
"Further studies are warranted to define its precise role in the treatment of this patient population," Chen and co-authors concluded.
Disclosures
This study was funded by Nanjing Healthy Bureau and the National Science Foundation of China.
Chen reported being listed as inventor on patents related to PADN but is not the owner.
Primary Source
JACC: Interventions
Zhang H, et al "Pulmonary artery denervation significantly increases 6-minute walk distance for patients with combined pre- and post-capillary pulmonary hypertension associated with the left heart failure: PADN-5 Study" JACC Cardiovasc Intervent 2018; DOI: 10.1016/j.jcin.2018.09.021.