Transplant Trial Watch

Portable Normothermic Cardiac Perfusion System in Donation After Cardiocirculatory Death: A Health Technology Assessment.

Ontario Health

Ontario Health Technology Assessment Series 2020; 20(3): 1-90.


Aims
The primary objective of this study was to assess a portable normothermic cardiac perfusion system in preserving and transporting hearts that were donated after cardiocirculatory death (DCD) in terms of effectiveness, safety, budget impact, value for money as well as patient values and preferences.

Interventions
Electronic databases, including Ovid MEDLINE, Embase, the Cochrane Database of Systematic Reviews, the National Health Service Economic Evaluation Database (NHS EED), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Centre for Reviews and Dissemination (CRD) Health Technology Assessment database, were searched on April 3, 2018 and April 4, 2018 to retrieve studies published since January 1, 1998. The screening and selection of studies was carried out by a single reviewer. The Newcastle-Ottawa Scale for Cohort Studies was used to determine the risk of bias of nonrandomized studies.

Participants
A total of 4 studies were included in the review.

Outcomes
The clinical outcomes of interest were symptoms, quality of life, graft survival, graft failure, acute rejection, recipient survival, adverse events, infections and malignancies, device-related complications, ischemic time, duration of stay in intensive care unit, detection of hidden pathology, death count on waitlist pre and postimplementation, incidence of hearts declined for transplants because of functional or technical issues, and the heart transplant count pre and postimplementation. The economic outcomes of interest included incremental costs, incremental effectiveness, incremental cost

Follow-up
N/A

CET Conclusions
This is a well-written report of a thorough systematic review. The protocol was registered in advance and detailed searches were made in multiple relevant databases. A single reviewer screened titles and abstracts, examined full texts and extracted data. Unfortunately only 3 studies could be included: one cohort study with matched controls, a case series of 3 patients and a case series of 2 patients. The quality of the included evidence is very low to low, and the authors acknowledge this, declaring that they have low confidence in the effect estimates. Overall the outcomes for recipients of DCD hearts preserved using a portable normothermic cardiac perfusion system appear to be similar to outcomes for recipients of DBD hearts. The available data did not permit a cost-effectiveness analysis. One criticism of the methods is that databases were not searched and screened in duplicate by two independent reviewers. Nor was data extraction done in duplicate.

Quality notes
SR-QA not applicable

Trial registration
CRD42018095927

Funding source
Not reported