Safety and Feasibility of Acute Percutaneous Septal Sinus Shortening: First-in-Human Experience

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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.

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