Benefit And Risk Of Endomyocardial Biopsy For Heart Transplant Patients In The Contemporary Era

Background: The reference standard of detecting acute rejection (AR) in adult heart transplant (HTx) patients is an endomyocardial biopsy (EMB). The majority of EMBs are performed in asymptomatic patients. However, the benefit of diagnosing and treating AR compared to the risk of EMB complications has not been compared in the contemporary era (2010-current). Objectives: This study compared treated AR and EMB complications in HTx patients. Methods: The authors retrospectively analyzed 2,769 EMB obtained in 326 consecutive HTx patients between August 2019 and August 2022. Variables included surveillance versus for cause indication, recipient and donor characteristics, EMB procedural data and pathologic grades, treatment for AR, and clinical outcomes. Results: The overall EMB complication rate was 1.6%. EMBs performed within 1 month after HTx compared to after 1 month HTx showed significantly increased complications (OR = 12.74, p < 0.001). The treated AR rate was 14.2% in the for cause EMBs and 1.2% in the surveillance EMBs. We found the benefit/risk ratio was significantly lower in the surveillance compared to the for cause EMB group (OR = 0.05, p < 0.001). Conclusions: The yield of surveillance EMBs has declined in the contemporary era, while for cause EMBs continued to demonstrate a high benefit/risk ratio. The risk of EMB complications was highest within 1 month after HTx. Surveillance EMB protocols in HTx patients may need to be re-evaluated. ### Competing Interest Statement Dr. Paul Kim has disclosed receiving payments from CareDx and Natera for consulting and working at an institution that received research payments from CareDx and Natera. There are no other potential conflicts of interest by the other co-authors. Neither CareDx nor Natera were involved in the conceptualization of the study, data collection and analysis, manuscript preparation, and editing of the final manuscript ### Funding Statement Dr. Paul Kim has disclosed receiving payments from CareDx and Natera for consulting and working at an institution that received research payments from CareDx and Natera. There are no other potential conflicts of interest by the other co-authors. Neither CareDx nor Natera were involved in the conceptualization of the study, data collection and analysis, manuscript preparation, and editing of the final manuscript. No other funding was received. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The IRB of University of California San Diego gave ethical approval for this work Their contact info is: IRB@ucsd.edu 858-246-4777 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study will be uploaded to Mendeley, and the link will be updated when it is available