WASHINGTON, DC, September 21, 2010 — Six cardiovascular societies from around the world today published a statement on live case demonstrations at cardiovascular meetings. The statement is the result of a collaborative effort by the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), Heart Rhythm Society (HRS), European Society of Cardiology (ESC), Sociedad Latinoamericana de Cardiología Intervencionista (SOLACI) and Asian-Pacific Society of Interventional Cardiology (APSIC). The document 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 document is published in the HeartRhythm Journal, Catheterization and Cardiovascular Interventions, and Journal of the American College of Cardiology.
The writing committee was comprised of experts with varying degrees of live broadcast experience who consulted with legal, bioethical and patient advocacy groups, ensuring the inclusion of multiple perspectives.
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 (ACCME) 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 written a companion article reinforcing the FDA’s role in approving or disapproving the use of investigational devices in live cases based on whether the live presentation is appropriate. The FDA document also outlines regulations and protocols that practitioners and institutions must follow before, during and after any live demonstration that uses an investigational device.
“Interventional cardiology procedures are very technical and cannot be learned simply by reading a book or manuscript. 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,” said SCAI Past President Gregory J. Dehmer, M.D., FSCAI, FACC, professor of medicine, Texas A & M University Health Science Center College of Medicine, director, cardiology division, Scott & White Healthcare, and writing committee chair. “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.”
“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,” notes the statement. 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.
“Live case demonstrations can be incredibly effective educational tools and should always be conducted safely and ethically,” said Ralph Brindis, M.D., M.P.H., president of the American College of Cardiology. “We are proud to partner on this important document that recommends standards for performing and broadcasting live cases at medical meetings.”
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 who 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, CME 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 following 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 panel’s recommended code of conduct for live case demonstrations will help to ensure that the safety and comfort of our patients remains the cardiovascular community’s number one priority, while still allowing physicians, allied professionals and other medical personnel an opportunity to collaborate and demonstrate best practices for cardiovascular device implantation techniques and complex-ablation procedures,” said Douglas L. Packer, M.D., FHRS, president of the Heart Rhythm Society.
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 as their needs are considerably different than for adults.