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Introduction <p>Heart transplantation is indicated for advanced heart failure but its widespread application is limited by the lack of donors. The Organ Care System (OCS™) is a medical device that preserves the donor’s heart in an almost physiological state. Our institution requested a Hospital-Based Health Technology Assessment to enlighten their decision on the purchase request of this device.</p> Methods <p>A pragmatic review was conducted on the efficacy of the OCS™ and ongoing clinical studies were listed. Economic aspects were objectified by a local Budget Impact Analysis. Organizational aspects were evaluated at a local level. Patients were involved in this evaluation to ensure that their views on this technology are taken into account.</p> Results <p>Scientific evidence showed a similar efficacy between OCS™ and standard cold storage on survival and duration of hospital stays, and a storage time superior with OCS™. The local budget impact analysis showed that 6&#xa0;additional heart transplants are needed to offset additional costs incurred by OCS™. The organizational evaluation highlighted the need to recruit an additional perfusionist. Patients were in favor of acquiring this device as it promises a possible increase of heart transplantations.</p> Conclusion <p>The OCS™ Heart system is a breakthrough innovation that seems promising for patients with advanced heart failure scheduled for heart transplant. More randomized clinical trials on OCS™ are needed to assess its long-term clinical and economic impact. Institutions that will acquire this device should take into account the significant economic impact.</p>

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Decision-making to implement an ex-vivo perfusion system for donor hearts in a French university hospital: a hospital-based health technology assessment

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月28日

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  • P. Guerre,
  • J. Berthiller,
  • M. Pozzi,
  • J. F. Obadia,
  • L. Huot

摘要

Introduction

Heart transplantation is indicated for advanced heart failure but its widespread application is limited by the lack of donors. The Organ Care System (OCS™) is a medical device that preserves the donor’s heart in an almost physiological state. Our institution requested a Hospital-Based Health Technology Assessment to enlighten their decision on the purchase request of this device.

Methods

A pragmatic review was conducted on the efficacy of the OCS™ and ongoing clinical studies were listed. Economic aspects were objectified by a local Budget Impact Analysis. Organizational aspects were evaluated at a local level. Patients were involved in this evaluation to ensure that their views on this technology are taken into account.

Results

Scientific evidence showed a similar efficacy between OCS™ and standard cold storage on survival and duration of hospital stays, and a storage time superior with OCS™. The local budget impact analysis showed that 6 additional heart transplants are needed to offset additional costs incurred by OCS™. The organizational evaluation highlighted the need to recruit an additional perfusionist. Patients were in favor of acquiring this device as it promises a possible increase of heart transplantations.

Conclusion

The OCS™ Heart system is a breakthrough innovation that seems promising for patients with advanced heart failure scheduled for heart transplant. More randomized clinical trials on OCS™ are needed to assess its long-term clinical and economic impact. Institutions that will acquire this device should take into account the significant economic impact.