Associate Prof. PhD Serhii S. Pavlov, Attorney in Medical Law
Abstract
An article titled “Reproductive health after thoracic transplantation: An ISHLT expert consensus statement” was published in The Journal of Heart and Lung Transplantation, Vol 42, No 3, March 2023.[1] The team of authors, in the form of a consensus statement, reviewed current evidence on the feasibility of pregnancy following successful thoracic organ transplantation, specifically the lungs and heart. They also provided recommendations regarding preconception counseling, risk assessment for the patient, medical management, maternal and fetal outcomes, obstetric management, and pharmacological considerations.
The authors highlight that most data on pregnancy in thoracic transplant recipients are based on the experience of small, single-center, or voluntary registries. Although TPRI has gathered information in this field, participation is not mandatory. Unfortunately, national and international registries such as UNOS and ISHLT do not record pregnancy data, which could serve as a foundation for guidelines and recommendations.[2]
Indeed, the lack of a sufficient volume of standardized data complicates the process of developing official guidelines and recommendations for managing pregnancy in patients after thoracic transplantation. This circumstance has justified the need for writing this article, as the lack of information may affect the quality and safety of medical care, which, in turn, could lead to legal consequences related to medical liability in cases of complications or adverse outcomes.
In this article, we examine the regulatory mechanisms by which major national and international registries, such as UNOS (United Network for Organ Sharing) and ISHLT (International Society for Heart and Lung Transplantation), allow the incompleteness of pregnancy data in transplant recipients.
The conclusions will outline practical recommendations for improving legal regulation and data recording on pregnancy, which could serve as a basis for developing guidelines and recommendations for ensuring reproductive health after thoracic transplantation.
[1] Kittleson, M. M., DeFilippis, E. M., Bhagra, C. J., Casale, J. P., Cauldwell, M., Coscia, L. A., D’Souza, R., Gaffney, N., Gerovasili, V., Ging, P., Horsley, K., Macera, F., Mastrobattista, J. M., Paraskeva, M. A., Punnoose, L. R., Rasmusson, K. D., Reynaud, Q., Ross, H. J., Thakrar, M. V., & Walsh, M. N. (2023). Reproductive health after thoracic transplantation: An ISHLT expert consensus statement. The Journal of Heart and Lung Transplantation, 42(3). https://www.jhltonline.org/article/S1053-2498(22)02177-5/fulltext#seccesectitle0090
[2] Kittleson et al., 2023
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