Ultrasound Pulmonary Artery Denervation Promising in PAH

By David Douglas

May 14, 2020

NEW YORK (Reuters Health) - Therapeutic intravascular ultrasound pulmonary-artery denervation is safe and reduces pulmonary vascular resistance (PVR) in certain patients with pulmonary arterial hypertension (PAH), according to a small open-label trial.

The study "demonstrated a good safety profile and suggested a positive effect on hemodynamics, exercise tolerance and daily activity on top of current best medical therapy," Dr. Alexander M. K. Rothman of the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, in the UK, told Reuters Health by email.

In a paper in JACC: Cardiovascular Interventions, Dr. Rothman and colleagues note that catheter-based renal denervation offers "the opportunity to modulate sympathetic activity through targeted denervation of the pulmonary vasculature, potentially avoiding the adverse effects of systemically active therapies."

"Current guidelines indicate that patients with PAH and high-risk indicators should be treated with 2 disease-specific therapies," the researchers write. "As such, the effect of pulmonary artery denervation (PDN) in patients on best medical therapy is unknown, as is the feasibility of ultrasound energy delivery for PDN."

To investigate, the team studied 23 patients (18 women) who underwent PDN using the TIVUS system from SoniVie, which funded the study. At enrollment, all patients were receiving dual oral therapy, and seven were also using an inhaled prostanoid or an oral prostacyclin agonist.

Patients were given an average of 10 ultrasound activations, and all received the pre-specified minimal number of activations (two right, one left and two main). The mean duration of the denervation procedure was 32.0 minutes. Mean fluoroscopy time was 8.1 minutes.

There were no procedure-related adverse events. At four- or six-month follow-up, hemodynamic and functional endpoints had improved significantly, with a 17.8% reduction in PVR and a 42-meter increase in six-minute walk distance. There were also significant improvements in mean pulmonary-artery pressure, right-atrial pressure and pulmonary-arterial compliance.

The team calls for further studies to evaluate the efficacy, durability, safety and long-term clinical impact of PDN in patients with pulmonary hypertension of various forms.

However, "If further studies are positive," concluded Dr. Rothman, "this may provide an exciting new therapy for patients with PAH."

In an accompanying editorial, Dr. Marc Pritzker of the University of Minnesota, in Rochester, observes, "As is frequently the case with small studies and positive results, the outcomes are provocative and raise more questions and opportunities."

Particularly, he told Reuters Health by email, the research "provides further evidence that mechanical therapies when added to medications provide additive therapeutic value and are safe."

Dr. Rothman and several coauthors disclose financial ties to SoniVie.

SOURCE: https://bit.ly/3fGk3Qe and https://bit.ly/2LdGPRu https://bit.ly/2LdGPRu, JACC: Cardiovascular Interventions, online April 27, 2020.

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