Safety and feasibility of acute percutaneous septal sinus shortening: First‐in‐human experience

Abstract

Background: Multiple percutaneous therapies for the treatment of functional and ischemic mitral regurgitation (FMR/IMR) are under development. We previously reported a novel percutaneous technique, the percutaneous septal sinus shortening [PS³] System™, which was effective in ameliorating FMR in an animal model. We herein report results from the first‐in‐human safety and feasibility pilot study involving the PS³ System. Methods and Results: The primary objective of this first‐in‐human study was to evaluate the safety and feasibility of acute percutaneous septal‐lateral shortening by using the PS³ System in patients immediately prior to clinically‐indicated surgical mitral valve repair. Two patients were enrolled. Patient One had severe aortic insufficiency with moderate functional mitral regurgitation. The PS³ System reduced the MR grade from 2+ to 1+ with a decrease in the mean septal‐lateral systolic (SLS) dimension from 38 to 27 mm (29% reduction). Patient Two had severe ischemic mitral regurgitation in the setting of severe multi‐vessel disease and prior infero‐posterior infarct. MR grade was reduced from 3+ to 1+ with a decrease in the mean SLS dimension from 36 to 25mm (31% reduction). There were no procedural complications and both patients proceeded to pre‐planned cardiac surgery, where the devices were explanted under direct visualization. Conclusions: The PS³ System has been safely translated from the preclinical setting to first‐in‐human implantation. Both patients studied experienced a reduction in MR after device implantation, with significant SLS shortening. Further clinical trials will be needed to assess long‐term efficacy and durability.