November 1, 2005
View Full PaperInitial Safety and Feasibility Clinical Trial of the Myosplint Device
Key Result
The Myosplint device was safe and feasible in 21 heart failure patients, with 0 serious device-related adverse events and an improvement in NYHA class from 3.0 to 2.1 at 6 months (p=0.001).
Study Design
Type
Observational (n=21)
Structured PICO
Is the Myosplint device safe and feasible for the treatment of heart failure?
P
Population
21 consecutive patients with heart failure
I
Intervention
Myosplint device implantation (9 received device alone, 12 received device plus mitral valve repair)
O
Outcome
Safety and feasibility (device-related adverse events and device failures)safety
The initial human experience with the Myosplint device demonstrates safety and feasibility, with improvements in NYHA class and LV ejection fraction in patients receiving the device alone.
Main Result
p-value: p=0.001
Limitations
- The device does not resolve mitral regurgitation, illustrating the need for a device that can simultaneously reduce or eliminate functional MR off-pump.
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). 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.