First-in-Man Transcervical Surgical Aortic Valve Replacement Using the CoreVista System

Area of Science:

• Cardiovascular Surgery
• Minimally Invasive Procedures
• Medical Device Innovation

Background:

• Surgical aortic valve replacement (SAVR) typically involves a sternotomy, leading to significant patient recovery burdens.
• A novel transcervical access approach aims to reduce invasiveness for SAVR.
• This study evaluates a new device system designed for this less invasive surgical aortic valve replacement (SAVR) approach.

Observation:

• A novel device system was developed for retraction, illumination, and visualization during transcervical SAVR.
• Feasibility was assessed through cadaver studies and risk analysis, followed by training.
• The first-in-man case involved a 63-year-old female with severe aortic stenosis undergoing SAVR via a short transverse neck incision.

Findings:

• The novel device facilitated successful access, delivery, and deployment of a sutureless aortic valve prosthesis.
• The implanted valve demonstrated optimal performance with a mean gradient of 6 mm Hg and an aortic valve area of 2.5 cm².
• No moderate or severe paravalvular regurgitation was observed, confirming device success.

Implications:

• Transcervical SAVR using this novel system is feasible and offers a less invasive alternative.
• This approach holds potential for shorter hospital stays and reduced complications compared to traditional SAVR.
• Further clinical studies are warranted to validate the long-term benefits of this innovative surgical aortic valve replacement (SAVR) technique.