Adding pulmonary-artery denervation to guideline-directed medical therapy (GDMT) reduced clinical worsening in patients with pulmonary hypertension associated with left heart disease and heart failure, results from a Chinese randomized trial have shown.
Study Findings
The estimated 2-year incidence of clinical worsening — a composite of death, heart or lung transplantation, hospitalization for heart failure, outpatient worsening of heart failure requiring intravenous diuresis, or a decline in the 6-minute walk distance — was just 25.7% for those randomized to denervation plus GDMT as compared with 51.5% for the group receiving GDMT only (HR 0.49, 95% CI 0.30-0.82, P=0.006).
Similar results were seen in a secondary analysis that excluded the 6-minute walk test component of the composite endpoint, reported Dr. Shao-Liang Chen from Nanjing Medical University at the European Society of Cardiology Congress (ESC) in Munich.
Chen noted several limitations of the PADN-HF-PH trial, including that it was open-label, had a relatively short follow-up of about a year, and was conducted only in one country.
Need for Further Research
However, the generalizability and the impact of blinding are being assessed in the ongoing international sham-controlled PULSE-LHD trial, Chen added.
Pulmonary hypertension caused by left heart disease and associated with heart failure may be driven by sympathetic overactivation, leading to increased pulmonary vascular resistance, right ventricular dysfunction, and poor outcomes. Pulmonary-artery denervation interrupts the sympathetic nerves innervating the pulmonary artery, reducing sympathetic activity, which may, in turn, improve outcomes.
Dr. Felix Mahfoud from University Hospital Basel highlighted the PADN-HF-PH results as “quite promising” but raised concerns regarding the open-label design.
He pointed out that while there is a compelling efficacy signal with concordant physiological and patient-centered signals, no significant changes in morbidity and mortality were observed. He noted that the lack of a sham control was a major limitation.
Trial Details
The PADN-HF-PH trial was a multicenter, open-label, randomized trial conducted in China, involving 264 patients with pulmonary hypertension associated with left heart disease and heart failure. Patients were randomly assigned to receive either pulmonary-artery denervation plus GDMT or GDMT alone, with a median follow-up for the primary analysis of 338 days.
The procedure was successful in all 134 patients, with minimal discomfort reported — only 1.5% required additional analgesia. After pulmonary-artery denervation, 88% of patients saw a reduction of at least 1% in mean pulmonary artery pressure, while 53% experienced a decrease of at least 10%.
Additionally, acute reductions in pulmonary vascular resistance and pulmonary-artery wedge pressure were observed, along with increased cardiac output.
Access-site hematomas occurred in two patients in the denervation group and one in the control group, with adverse events reported at similar frequencies between the groups.
Disclaimer
The information provided is for educational purposes only and should not be taken as medical advice. Always consult a healthcare professional for any medical concerns or before undergoing any medical treatment.
Fuente: https://www.medpagetoday.com/meetingcoverage/esc/122861
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