PERISOC (solution de cardioplégie / solution pour conservation d’organe)

Opinions on drugs - Posted on Oct 04 2021

Reason for request

Inscription

Key points

Favourable opinion for reimbursement:

  • in cardioplegia during cardiac surgery;
  • in the protection of organs during surgical procedures in a bloodless field (heart, kidney, liver);
  • for the preservation of donor organs for transplantation: perfusion and cold preservation (heart, kidney, liver, pancreas).

What therapeutic improvement?

No clinical added value in the therapeutic strategy in each of the indications.

Role in the care pathway?

Cardioplegia during cardiac surgery

The choice of cardioplegia solution used during cardiac surgery depends on two main factors: the type of surgery performed (in particular, the clamping time associated with the surgery), as well as the centre’s practices and the local protocols in place. Practices vary from one cardiac surgery unit to another.

For crystalloid cardioplegia, the choice of solution depends primarily on the clamping time.

The use of cardioplegia techniques with blood or a crystalloid solution such as PLEGISOL requires re-administration every 20 to 30 minutes.

Role of the medicinal product in the care pathway

Like certain crystalloid or blood cardioplegia solutions, PERISOC can be used as a first-line option for cardioplegia. The benefit of PERISOC lies in its single-dose administration. This benefit can be useful for complex and/or lengthy cardiac surgery procedures. The aortic clamping time can thus be prolonged without the need to repeat the cardioplegia injection.

Protection of organs during surgical procedures in a bloodless field (heart, kidney, liver)

There are no guidelines concerning the protection of organs during surgical procedures in a bloodless field. However, in the surgical context, organ protection is essential.

Role of the medicinal product in the care pathway

In the same way as solutions for organ preservation, the role of organ protection solutions like PERISOC is to maintain the viability of the organ ex vivo, in the best condition possible, throughout the surgical procedure. Like the other solutions, PERISOC is a first-line medicinal product.

Preservation of donor organs for transplant: perfusion and cold preservation (heart, kidney, liver, pancreas)

In the transplantation context, organ preservation is a critical phase. The role of solutions for organ preservation is to maintain the viability of the organ ex vivo, in the best possible condition, during transportation from the donor to the recipient, with a view to ensuring optimal transplantation success.

The 2020 European kidney transplantation guidelines indicate that University of Wisconsin and HTK solution are equally effective and are standard for multi-organ or single kidney harvesting procedures.

According to these guidelines, “the characteristics of HTK are its low viscosity, low potassium concentration and low cost. University of Wisconsin solution has been the standard static cold preservation solution for the procurement of liver, kidney, pancreas, and intestine. […]. HTK and UW retained a greater capacity to preserve endothelial structure and pH buffering function during warm ischaemia in comparison to MHCS and Celsior, especially in DCD donors.”

Role of the medicinal product in the care pathway

Like University of Wisconsin solution, PERISOC should be used as a first-line option to protect donor organs for transplantation.

 

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of PERISOC is substantial in the protection of organs during surgical procedures in a bloodless field (heart, kidney, liver).


Clinical Added Value

no clinical added value

Considering:

  • the absence of robust data demonstrating an advantage of PERISOC in terms of efficacy and safety compared to the alternatives;
  • the medical need met by the medicinal and non-medicinal alternatives currently available, including BRETSCHNEIDER with the same qualitative and quantitative composition as PERISOC;

the Transparency Committee considers that PERISOC provides no clinical added value (CAV V) in the current care pathway for cardioplegia.


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