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


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.
Palacios
Igor F
IF
Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. ipalacios@partners.org
Condado
José A
JA
Brandi
Sergio
S
Rodriguez
Victor
V
Bosch
Fernando
F
Silva
Gaston
G
Low
Reginald I
RI
Rogers
Jason H
JH
D001022:Aortic Valve Insufficiency / Q000150:complications; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000601:surgery; D004452:Echocardiography; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D006325:Heart Atria / Q000601:surgery; D006346:Heart Septum / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000150:complications; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery / Q000628:therapy*; D009203:Myocardial Infarction / Q000601:surgery; D010865:Pilot Projects; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome