Non Clinical Study for Development of Multi-inflation Balloon Aortic Valvuloplasty Without Rapid Pacing

2022 Fiscal Year Final Research Report

• Project/Area Number: 21K16087
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 53020:Cardiology-related
• Research Institution: Kobe University
• Principal Investigator: Konishi Akihide 神戸大学, 医学部附属病院, 特命准教授 (90839888)
• Project Period (FY): 2021-04-01 – 2023-03-31
• Keywords: 心電図同期型 / バルーン大動脈弁形成術 / 重度大動脈弁狭窄症 / 非臨床試験 / 高頻脈ペーシング

Outline of Final Research Achievements

To accelerate the development of electrocardiogram-gated BAV, we made high-pressure driving machine which could inflate and deflate automatically without using rapid pacing to reduce cardiac output. The major complication of electrocardiogram-gated BAV is air embolism due to balloon rupture. Although the normal balloon is a single membrane, a electrocardiogram-gated BAV balloon requires a dual membrane to reduce the risk of air embolism. If the outer membrane ruptures, the driving machine is stopped due to the pressure change. At this time, air is not released because the inner membrane is not assumed to be injured. To evaluate the efficacy and safety of electrocardiogram-gated BAV including high-pressure driving machine and dual membrane balloon, a bench test was performed. The electrocardiogram-gated BAV device enabled multi-inflation stably without rapid pacing.

Free Research Field

循環器内科学分野

Academic Significance and Societal Importance of the Research Achievements

本医療機器の創出により、高頻脈ペーシングなしでも頻回拡張を実施できるため、患者の安全性が向上することに加えて、従来のBAVで問題であった手技の煩雑さを克服することが可能であるため、今まで治療できていなかった重度大動脈弁狭窄症患者に対して、広く治療を提供できる可能性がある。これにより、従来TAVIとBAVの治療には空白領域が存在していたが、本医療機器この空白領域を埋める新しい位置づけの治療法となりえる。