Surgical Solution for Controlled, Debris-Free Removal of Implanted Heart Valves
This Transcatheter Aortic Valve Replacement (TAVR) extraction device enables the more efficient removal of a replaced cardiac valve. Valvular heart disease, and subsequent replacement, occurs when one or more of the four heart valves (aortic, mitral, tricuspid, or pulmonary) is damaged and not functioning properly. Many deaths attributed to valvular heart disease are due to diseases of the aortic valve. Significant valve disease is treated with mechanical or bioprosthetic valve replacement operations, in which a valve is implanted to replicate the function of the native valve. This is done via a surgical (SAVR) or transcatheter (TAVR) aortic valve replacement.
Transcatheter Aortic Valve Replacements (TAVR) became the standard intervention for high-risk patients with aortic stenosis. Traditionally, TAVRs are elected for older patients assessed as not able to reliably survive open heart surgery. TAVR usage is expanding rapidly to younger and lower-risk populations. As implant rates rise, the need for effective removal of failed TAVR valves-- after approximately 10 years-- is increasing, making explant procedures one of the fastest growing and most technically demanding areas in cardiothoracic surgery. Existing removal methods rely on manual cutting and grasping of scar tissue and the valve, creating excessive force on the valve annulus, increasing tissue damage, and prolonging operative times. Additionally, there is the ever-present risk of debris falling into the left ventricular cavity during dissection and becoming a risk to embolize if it is not all identified and removed. This highlights a major clinical need for a safer, faster, and more delicately controlled approach to remove failed TAVR valves while minimizing aortic annulus injury and stroke risk.
Researchers at the University of Florida have developed a Transcatheter Aortic Valve Replacement (TAVR) extraction and debris containment device that enables controlled, circumferential inward collapse of the implanted valve to streamline removal and preserve tissue integrity and capture dissection debris. This technology directly addresses limitations by enabling controlled, minimally traumatic extraction of failed TAVR implants.
Application
Single-use surgical device designed to safely and efficiently collapse and enable easier removal of failed transcatheter aortic (TAVR) and other valves and capture dissection debris during open-heart procedures
Advantages
- Controlled inward compression of the implanted valve, minimizing trauma to the aortic annulus and surrounding tissue
- Hook-based actuation system ensures precise and predictable valve engagement, reducing procedure time
- Integrated debris catcher mechanism traps dislodged calcium and tissue, lowering stroke and embolization risk
- Streamlines explant procedure
Technology
The device features an outer housing and an inner shaft equipped with multiple circumferential hooks that transition between deployed and retracted positions via a ratchet-actuated handle. During use, the distal tip is inserted into the failed valve, and the hooks are deployed in an outward direction to engage the valve frame at multiple points. Ratcheting inward mechanical retraction of the hooks collapses the valve inward, enabling controlled extraction with minimal force on surrounding tissue. A debris catcher, consisting of a flexible tube, filament, and an expandable sack, is deployed distally to capture calcium and tissue fragments generated during valve compression and dissection. The entire mechanism is engineered for single-handed operation and is disposable, enabling the surgeon to efficiently remove the valve and associated debris in a streamlined, reproducible process.
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