The role of endomyocardial biopsy in the management of cardiovascular disease: A Scientific Statement from the American Heart Association, the American College of Cardiology, and the European Society of Cardiology Endorsed by the Heart Failure Society of America and the Heart Failure Association of the European Society of Cardiology

Abstract

The role of endomyocardial biopsy (EMB) in the diagnosis and treatment of adult and pediatric cardiovascular disease remains controversial, and the practice varies widely even among cardiovascular centers of excellence. A need for EMB exists because specific myocardial disorders that have unique prognoses and treatment are seldom diagnosed by noninvasive testing.1 Informed clinical decision making that weighs the risks of EMB against the incremental diagnostic, prognostic, and therapeutic value of the procedure is especially challenging for nonspecialists because the relevant published literature is usually cited according to specific cardiac diseases, which are only diagnosed after EMB. To define the current role of EMB in the management of cardiovascular disease, a multidisciplinary group of experts in cardiomyopathies and cardiovascular pathology was convened by the American Heart Association (AHA), the American College of Cardiology (ACC), and the European Society of Cardiology (ESC). The present Writing Group was charged with reviewing the published literature on the role of EMB in cardiovascular diseases, summarizing this information, and making useful recommendations for clinical practice with classifications of recommendations and levels of evidence. The Writing Group identified 14 clinical scenarios in which the incremental diagnostic, prognostic, and therapeutic value of EMB could be estimated and compared with the procedural risks. The recommendations contained in the present joint Scientific Statement are derived from a comprehensive review of the published literature on specific cardiomyopathies, arrhythmias, and cardiac tumors and are categorized according to presenting clinical syndrome rather than pathologically confirmed disease. The ultimate intent of this document is to provide an understanding of the range of acceptable approaches for the use of EMB while recognizing that individual patient care decisions depend on factors not well reflected in the published literature, such as local availability of specialized facilities, cardiovascular pathology expertise, and operator experience. The use of EMB in the posttransplantation setting is beyond the scope of this document. This Scientific Statement was approved for publication by the governing bodies of the American Heart Association, the American College of Cardiology, and the European Society of Cardiology and has been officially endorsed by the Heart Failure Society of America and the Heart Failure Association of the European Society of Cardiology. The classifications of recommendations used in this document are The levels of evidence are Class I: conditions for which there is evidence or there is general agreement that a given procedure is beneficial, useful, and effective; Class II: conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment; Class IIa: conditions for which the weight of evidence/opinion is in favor of usefulness/efficacy; Class IIb: conditions for which usefulness/efficacy is less well established by evidence/opinion; and Class III: conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful. Level A (highest): multiple randomized clinical trials; Level B (intermediate): limited number of randomized trials, nonrandomized studies, and registries; and Level C (lowest): primarily expert consensus. The first nonsurgical techniques for heart biopsy were reported in 1958.2 In the 1960s the safety of heart biopsy improved, with vascular access through the right external or internal jugular vein, sampling of the right interventricular septum, and designation of the heart borders by right heart catheterization before biopsy.3 Sakakibara and Konno4 introduced the use of a flexible bioptome with sharpened cusps that allowed EMB by a pinching as opposed to a cutting technique. Caves et al.5 modified the Konno biopsy forceps (Stanford Caves-Shulz bioptome) to allow percutaneous biopsies through the right internal jugular vein with only local anesthesia and rapid tissue removal. The reusable Stanford-Caves bioptome and its subsequent modifications became the standard device for EMB for approximately 2 decades.6,7 Single-use bioptomes and sheaths allow access through the right and left jugular or subclavian veins, right and left femoral veins, and right and left femoral arteries and may be associated with lower risk of pyrogen reaction and transmission of infection than reusable bioptomes. The right internal jugular vein is the most common percutaneous access site for right ventricular EMB in the United States. In Germany and Italy, the femoral vein is commonly used for percutaneous access.8 Sonographic techniques to identify the location, size, and respirophasic variation in size of the internal jugular vein decrease the duration of the procedure and complications.9,1