Standards drawn up for live case demos at meetings
Six cardiovascular societies from around the world published Sept. 21 a statement 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 (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).
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, according to the statement.
This collaborative document, written in consultation with the Accreditation Council for Continuing Medical Education (ACCME) and the patient advocacy group Mended Hearts, addresses these concerns and recommends appropriate procedures and policies to maintain the highest educational and ethical values during live case demonstrations.
The FDA supported the development of the 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.
"Along with the growth of live case demonstrations 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, MD, director of the cardiology division at Scott & White Healthcare in Temple, Texas, 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," he said.
Ultimately, the justification for live broadcast case demonstrations should be based on answers to three critical questions, according to the statement:
The statement outlines a code of conduct for successful and ethical live case demonstrations, including:
"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, MD, president of HRS.
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.
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.
The document, along with the FDA article, is published in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology and HeartRhythm Journal.
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).
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, according to the statement.
This collaborative document, written in consultation with the Accreditation Council for Continuing Medical Education (ACCME) and the patient advocacy group Mended Hearts, addresses these concerns and recommends appropriate procedures and policies to maintain the highest educational and ethical values during live case demonstrations.
The FDA supported the development of the 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.
"Along with the growth of live case demonstrations 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, MD, director of the cardiology division at Scott & White Healthcare in Temple, Texas, 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," he said.
Ultimately, the justification for live broadcast case demonstrations should be based on answers to three critical questions, according to the statement:
- What is the Educational Value of Live Case Demonstrations? – Although some aspects of interventional cardiology and electrophysiology can be acquired from reading or didactic teaching, critical aspects of procedures are difficult to learn without direct observation, explanation and ultimately, "hands-on" experience.
- Are There Alternatives to Live Case Demonstrations? – For teaching interventional and electrophysiology procedures, pure didactic modalities cannot substitute for an actual demonstration of the procedure—both live and videotaped presentation.
- What Are the Risks and Benefits to Patients Participating in Live Cases? – Support personnel wishing to not disrupt the live transmission could be less apt to inform the operator of changes in vital signs during the procedure.
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; and
- 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, MD, president of HRS.
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.
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.
The document, along with the FDA article, is published in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology and HeartRhythm Journal.