Alexander R Mattson1,2,3,4, Jorge D Zhingre Sanchez1,2,3, Paul A Iaizzo1,2,3. 1. Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA. 2. Department of Surgery, University of Minnesota, Minneapolis, MN, USA. 3. Institute for Engineering in Medicine, University of Minnesota, Minneapolis, MN, USA. 4. Medtronic, Mounds View, MN, USA.
Abstract
BACKGROUND: Today, there is no manufacturer-supplied retrieval tool for the Micra™ pacemaker (Medtronic, Minneapolis, MN, USA); therefore, off-the-shelf catheters have been employed for retrievals. The proximal retrieval feature of the Micra™ can be snared and the device is then retracted from the myocardium, pulling the device through the tricuspid valve. This study characterizes the potential risks of Micra™ nitinol tine engagement with the tricuspid sub-valvular apparatus. METHODS: Fresh human hearts nonviable for transplant (n = 10) were obtained from our regional organ procurement agency (LifeSource, Minneapolis, MN, USA). Micra™ fixation tines were affixed to a linear force transducer. Tines were then engaged in tricuspid chordae tendineae to conduct a constant velocity tensile test. Each test was run until tines disengaged from the chordae tendineae or until they released from the valve apparatus. Subsequently, biomechanical failure properties of the valve apparatus and isolated chordae tendineae were determined using a series of uniaxial tensile tests. RESULTS: There were no chordal ruptures observed during our Micra™ tine extraction testing. Chordal failure required 15.0 times the force of extracting a single engaged tine, and 9.0 times the force of extracting two engaged tines. The uniaxial stresses required for isolated chordal failure averaged 17.4 N/mm2 ; failure strains exceeded 150% resting chordal length. CONCLUSIONS: The forces required to rupture tricuspid chordae tendineae significantly exceeded the forces potentially imposed on the chordae during Micra™ device retrievals. We conclude that the fixation tines of the Micra™ device are unlikely to damage the tricuspid apparatus during either implant or retrieval.
BACKGROUND: Today, there is no manufacturer-supplied retrieval tool for the Micra™ pacemaker (Medtronic, Minneapolis, MN, USA); therefore, off-the-shelf catheters have been employed for retrievals. The proximal retrieval feature of the Micra™ can be snared and the device is then retracted from the myocardium, pulling the device through the tricuspid valve. This study characterizes the potential risks of Micra™ nitinol tine engagement with the tricuspid sub-valvular apparatus. METHODS: Fresh human hearts nonviable for transplant (n = 10) were obtained from our regional organ procurement agency (LifeSource, Minneapolis, MN, USA). Micra™ fixation tines were affixed to a linear force transducer. Tines were then engaged in tricuspid chordae tendineae to conduct a constant velocity tensile test. Each test was run until tines disengaged from the chordae tendineae or until they released from the valve apparatus. Subsequently, biomechanical failure properties of the valve apparatus and isolated chordae tendineae were determined using a series of uniaxial tensile tests. RESULTS: There were no chordal ruptures observed during our Micra™ tine extraction testing. Chordal failure required 15.0 times the force of extracting a single engaged tine, and 9.0 times the force of extracting two engaged tines. The uniaxial stresses required for isolated chordal failure averaged 17.4 N/mm2 ; failure strains exceeded 150% resting chordal length. CONCLUSIONS: The forces required to rupture tricuspid chordae tendineae significantly exceeded the forces potentially imposed on the chordae during Micra™ device retrievals. We conclude that the fixation tines of the Micra™ device are unlikely to damage the tricuspid apparatus during either implant or retrieval.