PMID- 16305636
OWN - NLM
STAT- MEDLINE
DCOM- 20060413
LR  - 20071115
IS  - 0886-0440 (Print)
IS  - 0886-0440 (Linking)
VI  - 20
IP  - 6
DP  - 2005 Nov-Dec
TI  - Initial safety and feasibility clinical trial of the myosplint device.
PG  - S43-7
AB  - 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). 
      AIM: 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.
FAU - Fukamachi, Kiyotaka
AU  - Fukamachi K
AD  - Department of Biomedical Engineering, Lerner Research Institute, The Cleveland 
      Clinic Foundation, Cleveland, Ohio 44195, USA. fukamak@ccf.org
FAU - McCarthy, Patrick M
AU  - McCarthy PM
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Card Surg
JT  - Journal of cardiac surgery
JID - 8908809
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cardiac Surgical Procedures/instrumentation
MH  - Equipment Design/instrumentation
MH  - Equipment Failure
MH  - Equipment Safety/instrumentation
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/physiopathology/surgery
MH  - Heart Valve Prosthesis/adverse effects
MH  - *Heart-Assist Devices/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve Insufficiency/physiopathology/surgery
MH  - Stroke Volume
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2005/11/25 09:00
MHDA- 2006/04/14 09:00
CRDT- 2005/11/25 09:00
PHST- 2005/11/25 09:00 [pubmed]
PHST- 2006/04/14 09:00 [medline]
PHST- 2005/11/25 09:00 [entrez]
AID - JCS157 [pii]
AID - 10.1111/j.1540-8191.2005.00157.x [doi]
PST - ppublish
SO  - J Card Surg. 2005 Nov-Dec;20(6):S43-7. doi: 10.1111/j.1540-8191.2005.00157.x.