Abraham R.Tzafriri. ‘Procedural and Anatomical Determinants of Multi-Electrode Renal Denervation: Preclinical Versus Clinical.’
Summary: The failure of the prospective, randomized, sham-controlled SYMPLICITY HTN-3 trial to show significant difference in reduction of systolic BP (SBP) in patients with resistant hypertension 6 months after RDN compared to controls was attributed in part to procedural limitations in first generation devices. The confirmation of BP lowering in 3 recent randomized, sham-controlled feasibility and proof of concept studies of multi-electrode RF and ultrasound RDN in patients with and without concomitant antihypertensive medication supports this interpretation. This is notable as our preclinical evaluation of radiofrequency RDN catheters predicted the clinical trends and high rates of variability.
The acceleration of regulatory evaluation of medical therapies obliges us to manage preclinical research to support robust translation of their innovation.
Invited presentation at: CRT 2020, Feb 22-25; National Harbor, MD.