OBJECTIVE: Percutaneous endocardial cardiac surgical procedures are hindered by limited stability and control within the heart. A novel technology, which enables transcatheter devices to shift between flexible and firm states, creates a stable endovascular base to precisely access and intervene upon high-value cardiac structures. METHODS: A uniquely designed endocardial system provides distinctly stable and precise access to the heart chambers, valves, and great vessels. This system enters the heart in a flexible, relaxed state, conforming to the intracardiac anatomy with minimal cardiac distortion. When desired, the operator shifts the endocardial system into a stable fixed state, whereby the system becomes firm while preserving optimal cardiac anatomy, pathway, and position. Left heart applications were studied in the living porcine model and human cadavers. In addition, preclinical evaluation culminated in Food and Drug Administration Investigational Device Exemption approval for a right heart application (pulmonary embolectomy). RESULTS: In living porcine hearts, sutures were successfully placed in the mitral valve annulus using a steerable, inner suture delivery device supported by this endocardial system. Cardiac hemodynamics remained stable with limited distortion of the right ventricular anatomy. For right-heart applications, 10 patients across the United States and Europe have undergone acute pulmonary embolectomy in the SPIRARE I trial with no device-related adverse events reported. CONCLUSIONS: This innovative technology provides a stable base for precise and controlled repetitive access to difficult-to-reach targets, enabling percutaneous access for endocardial procedures traditionally performed via cardiotomy. Early clinical results of the SPIRARE trial demonstrate feasibility and patient safety.
Andy C. Kiser (Mon,) studied this question.