Cardiovascular Societies Publish Collaborative Statement on Live

September 21, 2010—A joint statement from major cardiovascular societies was published that outlines first-of-its-kind standards for institutions and medical practitioners to consider when performing and broadcasting live cardiovascular case demonstrations at medical meetings.

The statement is the result of a collaborative effort by the Society for Cardiovascular Angiography and Interventions, American College of Cardiology, Heart Rhythm Society, European Society of Cardiology, Sociedad Latinoamericana de Cardiología Intervencionista, and Asian-Pacific Society of Interventional Cardiology. Gregory J. Dehmer, MD, et al were the authors of the live case statement, which was published in Catheterization and Cardiovascular Interventions (2010;76:E111–E125); Journal of the American College of Cardiology (2010;56:1267–1282); and HeartRhythm Journal (2010;7;1522-1535). The statement provides sample patient consent forms.

According to the statement, “Patient-based teaching has been used since the earliest days of medical education and continues to be used today for educating medical students, physicians, nurses, and other medical personnel. Patient demonstrations have evolved from bedside teaching, to the surgical amphitheater, to recorded medical procedures, and finally to broadcast live case demonstrations.” It further asserts that live cases are an effective educational tool, especially for new technical procedures that cannot be learned by self-study or didactic presentations. Additionally, live cases are well-attended sessions at professional medical meetings and are an integral educational component for medical education. The statement outlines a code of conduct for successful and ethical live case demonstrations, including:

• A program committee blinded to industry sponsors and financial relationships, that will determine the program topics, speakers, demonstration cases, case operators, moderators, and panelists
• Use of two experienced operators so one can focus on the patient and the procedure while the other focuses on the teaching aspects of the case
• A production team familiar with working in a sterile environment
• Full disclosure of any financial interest or relationship with an industry sponsor by the host institution, continuing medical education provider, production company, and/or physician
• No excessive branding or marketing by the host institution
• Termination of the live demonstration in the event of a life-threatening complication, followed by a formal case review after the procedure
• Off-label use of devices is permitted if considered reasonable for standard practice, but should be identified as off-label and should not serve as a forum to promote off-label use

The statement also provides recommendations for conducting pediatric and congenital heart disease broadcasts, as the ethics surrounding live procedures on children have been questioned. Special considerations are necessary for the pediatric age group because their needs are considerably different than needs of adults.

According to the societies, the writing committee was composed of experts with varying degrees of live broadcast experience, who consulted with legal, bioethical, and patient advocacy groups, ensuring the inclusion of multiple perspectives.

The societies stated that, until now, few recommendations have existed in the cardiology community to address appropriate procedures and behaviors during live case demonstrations. With their growing popularity, concerns have been raised about patient safety, the value of live case demonstrations as an educational tool, and the ethics of performing live procedures.

This collaborative statement, written in consultation with the Accreditation Council for Continuing Medical Education and the patient advocacy group Mended Hearts Inc., addresses these concerns and recommends appropriate procedures and policies to maintain the highest educational and ethical values during live case demonstrations.

The Food and Drug Administration (FDA) supported the development of this document and has contributed a companion article reinforcing the agency's role in approving or disapproving the use of investigational devices in live cases based on whether the live presentation is appropriate. It also outlines regulations and protocols that practitioners and institutions must follow before, during, and after any live demonstration that uses an investigational device. The FDA's Andrew Farb, MD, et al published the article in Catheterization and Cardiovascular Interventions (2010;76:E126–E129); Journal of the American College of Cardiology (2010; 56:1283-1285); and HeartRhythm Journal (2010;7:e1–e3).


“Interventional cardiology procedures are very technical and cannot be learned simply by reading a book or manuscript,” commented Dr. Dehmer, the writing committee chair and past president of the Society for Cardiovascular and Angiographic Interventions.

According to Dr. Dehmer, “Live case demonstrations were pioneered by Dr. Andreas Gruentzig, the ‘founding father' of interventional cardiology, more than 30 years ago and have grown in their scope ever since. However, along with that growth have been concerns that live cases have deviated from their primary purpose of education and have become too much of an entertainment spectacle. With the rapid growth in live demonstrations, the cardiovascular community identified a need for expert recommendations to ensure live case demonstrations are always conducted appropriately and ethically while continuing to provide educational value to physicians and optimal care to patients.”