During open-heart surgery, cardioplegia solution plays a pivotal role in myocardial protection and extending cardiac arrest time during cardiopulmonary bypass. Widely used cardioplegia solutions include Plegisol® and Custodiol® HTK Solution. Plegisol® requires multiple infusions due to its short duration, while Custodiol® HTK offers longer protection but comes at a high cost and demands stringent storage conditions.

Another option, del Nido Solution, is the preferred choice for most cardiac surgeries in the U.S. due to its extended protective duration and superior myocardial protection. However, its limited stability poses significant challenges, making the selection of cardioplegia solutions a practical dilemma for clinicians.

A Breakthrough in Stable Cardioplegia Solution: Prolonged Protection and Simplified Workflow

To address these issues, a team led by pharmacist Lin, Mei-Hsing from National Taiwan University Hospital successfully developed an innovative stable cardioplegia solution. This new formulation retains the high-potassium composition and excellent myocardial protection of del Nido Solution while overcoming its instability issues.

The key innovation lies in the use of THAM (tromethamine) as a substitute for traditional sodium bicarbonate, enabling the solution to remain stable at room temperature. Unlike del Nido Solution, which requires complex on-site preparation, the new product is ready-to-use and can be stored at room temperature for at least one year. This significantly simplifies clinical workflows, enhances safety, and improves convenience for medical professionals.

In addition, the new stable cardioplegia solution offers significant cost advantages. While Custodiol® HTK is expensive and requires cold-chain transport and storage, this innovative solution provides a more economical alternative for hospitals and can be used across a broader range of medical facilities. Compared to the frequent infusions required with Plegisol®, the long-lasting protective effect of the new product reduces intraoperative interruptions, minimizing patient risks and improving overall surgical efficiency.

Technological Breakthroughs and Future Prospects: Unlocking Global Market Potential

Pharmacist Lin emphasized that this stable cardioplegia solution not only resolves the stability challenges of traditional products but also introduces greater ease of use and safety. It is expected to gain rapid market acceptance, particularly in regions with high demand for cardiac surgeries such as the U.S. and Europe. Lin further noted that the introduction of this product will significantly enhance clinical efficiency and safety in cardiac surgeries, offering highly effective and economical solutions to cardiac surgical centers worldwide.

The commercialization prospects for this product are vast, especially in emerging markets where economic growth and improved healthcare infrastructure are driving demand for high-quality medical products. Lin revealed that the team is already in discussions with domestic and international pharmaceutical companies for collaborations and plans to expand market penetration following the acquisition of a U.S. patent. With support from regulatory bodies such as the U.S. FDA and TFDA, this innovative product is poised to quickly enter the international market and establish a significant presence in the field of cardiac surgery.

Resource: 「開」心為重 創新麻痺液安全護心肌！