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Heart recipient outcomes following transplantation of donor hearts with impaired versus normal function: a study
Rana Doueh1, Göran Dellgren2, Lisa Ternström2
1Anesthesiology and Intensive Care Medicine, University of Gothenburg Institute of Clinical Sciences, Gothenburg, Sweden rana.doueh@vgregion.se.
Insights
The IMPROVED Heart study evaluates using donor hearts with temporary dysfunction for transplantation. This research aims to increase heart transplants by assessing if these hearts yield comparable outcomes to healthy ones.
Area of Science:
- Cardiology
- Transplantation Medicine
- Organ Donor Research
Background:
- Cardiac transplantation is limited by donor organ shortage.
- Neurogenic stunned myocardium causes temporary left ventricular dysfunction in donors, often with rapid recovery.
- Expanding donor criteria can increase heart availability.
Purpose of the Study:
- To determine if donor hearts with regional wall motion abnormalities or mild/moderate left ventricular dysfunction offer comparable outcomes to those with normal function.
- To increase the utilization of donor hearts through systematic evaluation of function.
Main Methods:
- Prospective, multicenter observational study (IMPROVED Heart).
- Systematic assessment of donor heart function using echocardiography, biomarkers, and clinical data.
- Enrollment of 445 heart transplant recipients, including at least 89 with impaired function, starting in 2022.
Main Results:
- Primary objective is to compare outcomes between recipients of donor hearts with and without impaired function.
- Non-inferiority statistical analysis planned.
- Study commenced enrollment in 2022.
Conclusions:
- The study will provide crucial data on the viability of using donor hearts with temporary dysfunction.
- Findings may expand donor acceptance criteria, potentially increasing heart transplant numbers.
- Results will be disseminated through scientific meetings and peer-reviewed publications.
Background:
Cardiac transplantation remains the most effective treatment for patients with end-stage heart failure, but its use is limited by donor organ shortage. Expanding donor acceptance criteria may increase the availability of transplantable hearts. Left ventricular dysfunction due to neurogenic stunned myocardium is common among organ donors and is characterised by rapid functional and structural recovery. The IMPROVED Heart (IMPact of donor heart function on Recipient Outcomes: a prospectiVE observational study to increase the utilisation of Donor Hearts) study aims to increase the number of heart transplantations by systematically evaluating and using donor hearts with temporarily impaired function.
Methods And Analysis:
IMPROVED Heart is a prospective, multicentre observational study. The primary objective is to determine whether recipients of donor hearts with regional wall motion abnormalities and/or mild to moderate global left ventricular dysfunction have outcomes comparable to recipients of hearts with normal function. Cardiac function in potential heart donors is assessed systematically using repeated echocardiography in addition to cardiac biomarkers and clinical data. Heart transplant recipients are managed according to routine clinical practice. Based on a non-inferiority power calculation, 445 transplanted hearts-including at least 89 with impaired function-are required. The study started enrolling in 2022.
Ethics And Dissemination:
The study was approved by the Swedish Ethical Review Authority in March 2020 (Dnr 2019-06229). Study findings will be presented at scientific meetings and published in international peer-reviewed journals.
Trial Registration Number:
NCT04393181.
