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Safety and feasibility of acute percutaneous septal sinus shortening: First‐in‐human experience
Author(s) -
Palacios Igor F.,
Condado José A.,
Brandi Sergio,
Rodriguez Victor,
Bosch Fernando,
Silva Gaston,
Low Reginald I.,
Rogers Jason H.
Publication year - 2007
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21070
Subject(s) - medicine , percutaneous , mitral regurgitation , cardiology , surgery
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 [PS 3 ] 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 PS 3 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 PS 3 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 PS 3 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 PS 3 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. © 2007 Wiley‐Liss, Inc.