The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Pulmonary Artery Denervation Using Catheter based Ultrasonic Energy.

EuroIntervention 2019; just accepted article published in May 2019. DOI: 10.4244/EIJ-D-18-01082

1. Infection, Immunity and Cardiovascular Disease, University of Sheffield, UK, UNITED KINGDOM; 2. Department of Cardiology, Kaplan Medical Center, Hebrew University School of Medicine, Rehovot, Israel; 3. Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer, Israel; 4. CBSET Inc, Lexington, MA, USA; 5. Center of Anatomy and Cell Biology, Medical University Vienna, Vienna, Austria; 6. SoniVie, Rosh Haayin, Israel; 7. Columbia University Medical Center, NY, USA; 8. Cardiovascular Research Foundation, NY, USA; 9. University of California, San Diego, CA, USA

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Aims: Pulmonary arterial hypertension is a devastating disease characterized by pulmonary vascular remodelling and right heart failure. Radio-frequency pulmonary artery denervation (PDN) improves pulmonary hemodynamics in pre-clinical and early clinical studies, however denervation depth is limited. High-frequency non-focused ultrasound can deliver energy to the vessel adventitia, sparing the intima and media. We therefore investigated the feasibility, safety and efficacy of ultrasound PDN.

Methods and results: Histological examination demonstrated that innervation of human pulmonary arteries are predominantly sympathetic (71%), with >40% of nerves at a depth of >4mm. Finite element analysis of ultrasound energy distribution and ex-vivo studies demonstrated generation of temperatures >47ºC to a depth of 10mm. In domestic swine PDN reduced mean pulmonary artery pressure induced by thromboxane A2 in comparison to sham. No adverse events were observed to 95-days. Histological examination identified structural and immunohistological alterations of nerves in PDN treated animals, with sparing of the intima and media and reduced tyrosine hydroxylase staining 95-days post-procedure indicating persistent alteration of the structure of sympathetic nerves.

Conclusions: Ultrasound PDN is safe and effective in the pre-clinical setting, with energy delivery to a depth that will permit targeting sympathetic nerves in humans.

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