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

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. 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. 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. 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.