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

Igor F. Palacios, José A. Condado, Sergio Brandi, Victor Rodriguez, Fernando Bosch, Gaston Silva, Reginald Low, Jason H Rogers

Research output: Contribution to journalArticle

38 Citations (Scopus)

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 25 mm (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.

Original languageEnglish (US)
Pages (from-to)513-518
Number of pages6
JournalCatheterization and Cardiovascular Interventions
Volume69
Issue number4
DOIs
StatePublished - Mar 1 2007

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Safety
Mitral Valve Insufficiency
Equipment and Supplies
Feasibility Studies
Mitral Valve
Surgical Instruments
Thoracic Surgery
Animal Models
Clinical Trials
Therapeutics

Keywords

  • Catheters
  • Mitral valve
  • Percutaneous mitral valve repair
  • Regurgitation
  • Valves

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Safety and feasibility of acute percutaneous septal sinus shortening : First-in-human experience. / Palacios, Igor F.; Condado, José A.; Brandi, Sergio; Rodriguez, Victor; Bosch, Fernando; Silva, Gaston; Low, Reginald; Rogers, Jason H.

In: Catheterization and Cardiovascular Interventions, Vol. 69, No. 4, 01.03.2007, p. 513-518.

Research output: Contribution to journalArticle

Palacios, Igor F. ; Condado, José A. ; Brandi, Sergio ; Rodriguez, Victor ; Bosch, Fernando ; Silva, Gaston ; Low, Reginald ; Rogers, Jason H. / Safety and feasibility of acute percutaneous septal sinus shortening : First-in-human experience. In: Catheterization and Cardiovascular Interventions. 2007 ; Vol. 69, No. 4. pp. 513-518.
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