title: Initial safety and feasibility clinical trial of the myosplint device.
abstract: BACKGROUND
  The Myocor Myosplint device is a passive implantable device for the treatment of heart failure by changing the geometry of the left ventricle (LV).
  
  
  OBJECTIVE
  The purpose of this evaluation was to describe the first human experience with the Myosplint device to demonstrate safety and feasibility.
  
  
  METHODS
  Of the first consecutive 21 patients, 9 patients received a Myosplint device alone while 12 patients underwent a mitral valve repair as well. Safety and efficacy data were gathered at enrollment and during follow-up.
  
  
  RESULTS
  No serious device-related adverse events or device failures were observed. Three patients died during the follow-up period, and 2 patients underwent heart transplantation. There was a significant improvement in the New York Heart Association (NYHA) functional class from 3.0 +/- 0.3 at baseline to 2.1 +/- 0.7 at 6 months (p = 0.001). Both LV end-diastolic and end-systolic volumes had decreased at follow-up. The LV ejection fraction significantly increased in the Myosplint alone group (from 17.1 +/- 4.0% at baseline to 21.8 +/- 4.1% at 3 months and 23.1 +/- 7.2% at 6 months) but not in the Myosplint and mitral valve repair group. The mitral regurgitation (MR) grade had a significant (p = 0.002) linear relationship with the NYHA functional class.
  
  
  CONCLUSIONS
  The initial clinical experience of the Myosplint device demonstrated both safety and feasibility, validating the LV shape change concept in humans. A remodeling solution must, however, include MR resolution, to illustrate the need for a device that can simultaneously reduce or eliminate functional MR off-pump.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. fukamak@ccf.org
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
authors.forename: Patrick M
authors.initials: PM
authors.lastname: McCarthy
mesh_terms: D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000295:instrumentation; D004867:Equipment Design / Q000295:instrumentation; D004868:Equipment Failure; D004869:Equipment Safety / Q000295:instrumentation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000503:physiopathology / Q000601:surgery; D013318:Stroke Volume; D015996:Survival Rate; D016896:Treatment Outcome