Device-based left ventricular geometry change for heart failure treatment: developmental work and current status

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Heart Failure Treatment

Background:

• Left ventricular (LV) geometry change is an innovative concept for heart failure management.
• The Myosplint device aims to reduce LV wall stress and enhance cardiac function by altering LV radius.
• This is achieved by implanting three devices to divide the LV into two smaller chambers.

Purpose of the Study:

• To evaluate the feasibility and safety of device-based LV geometry change using the Myosplint.
• To assess the impact of Myosplint implantation on LV wall stress, systolic and diastolic function, and myocardial energetics.
• To establish the clinical utility of the Myosplint in heart failure patients.

Main Methods:

• Extensive animal studies were conducted using a canine dilated cardiomyopathy model.
• An acute human feasibility study involved implanting the Myosplint in 5 patients during heart transplant surgery.
• Clinical safety studies with chronic implantation were initiated in Germany and the US, involving 21 patients.

Main Results:

• Animal studies demonstrated decreased LV wall stress, improved systolic function, maintained diastolic function, and enhanced myocardial energetics.
• The Myosplint was easily implanted in human patients on a beating heart without procedural complications.
• LV wall stress significantly decreased post-implantation, and chronic implantation in 21 patients showed no device-related adverse events.

Conclusions:

• Device-based LV geometry change with the Myosplint is a practical and effective treatment strategy.
• The Myosplint procedure has been demonstrated to be safe for patients with heart failure.
• This technology offers a promising new avenue for improving cardiac performance in heart failure management.