Safety and feasibility of acute percutaneous septal sinus shortening: first-in-human experience

Catheter Cardiovasc Interv. 2007 Mar 1;69(4):513-8. doi: 10.1002/ccd.21070.


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.

Publication types

  • Evaluation Study

MeSH terms

  • Aortic Valve Insufficiency / complications
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Coronary Angiography
  • Coronary Artery Bypass
  • Coronary Artery Disease / surgery
  • Echocardiography
  • Equipment Safety
  • Feasibility Studies
  • Female
  • Heart Atria / surgery
  • Heart Septum / surgery*
  • Heart Valve Prosthesis Implantation
  • Humans
  • Hypertrophy, Left Ventricular / complications
  • Male
  • Middle Aged
  • Mitral Valve Insufficiency / diagnostic imaging
  • Mitral Valve Insufficiency / etiology
  • Mitral Valve Insufficiency / surgery
  • Mitral Valve Insufficiency / therapy*
  • Myocardial Infarction / surgery
  • Pilot Projects
  • Research Design
  • Severity of Illness Index
  • Treatment Outcome