Percutaneous heart valves; past, present and future.

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Interventional Cardiology

Background:

• Percutaneous heart valves (PHVs) represent a significant advancement for patients with severe valve disease who are unsuitable for traditional surgery.
• Over 50 PHV designs have emerged since their inception over a decade ago, with notable examples like the CoreValve and Edwards SAPIEN valves undergoing extensive clinical evaluation.
• The Edwards SAPIEN valve has received FDA approval for inoperable patients, highlighting progress in transcatheter valve technology.

Purpose of the Study:

• To review the historical development and current status of percutaneous heart valves.
• To identify key design considerations crucial for advancing PHV technology.
• To assess the potential for PHVs to become a standard treatment option for a broader patient population.

Main Methods:

• Literature review of percutaneous heart valve development, clinical trials, and FDA approvals.
• Analysis of current complications associated with PHV implantation.
• Discussion of engineering and clinical factors influencing PHV design and application.

Main Results:

• Significant progress has been made in PHV technology, with specific valves gaining regulatory approval for high-risk patients.
• Major complications, including vascular bleeding and stroke, currently limit the widespread adoption of PHVs in operable patients.
• The review highlights the evolution of valve designs and the ongoing need for refinement.

Conclusions:

• Percutaneous heart valves have demonstrated considerable promise, particularly for inoperable patients.
• Further advancements in valve design and increased clinical experience are necessary to overcome current limitations.
• PHV replacement may eventually be a feasible option for lower-risk patients currently undergoing conventional surgery.