by Barbara J. drew , RN, Phd, FAHA
February 13, 2010
Cardiac arrest from a medication-induced heart rhythm problem is a rare but potentially catastrophic event in hospitalized patients, and hospital care providers need to be more aware of it according to a joint scientific statement from the American Heart Association and American College of Cardiology. The statement, published online in both Circulation: Journal of the American Heart Association and Journal of the American College of Cardiology, is also endorsed by the International Society for Computerized Electrocardiology and the American Association of Critical-Care Nurses.
The rhythm disturbance, called Torsades de Pointes (TdP), has a characteristic electrocardiogram pattern described as a “twisting” of points on the graphic recording. This abnormal rhythm can degenerate into an even more serious rhythm disturbance called ventricular fibrillation, which then causes sudden cardiac arrest.
“This scientific statement is particularly important for healthcare professionals who administer QT-prolonging drugs in hospital units where patients have continuous ECG monitoring such as intensive care and telemetry units. If the ECG warning signs of impending TdP are recognized by observing the patient’s cardiac monitor, then TdP and subsequent cardiac arrest should be avoidable,” said Dr. Drew, chair of the statement writing committee and Professor of Nursing and Cardiology at the University of California, San Francisco. An interview with the lead author about the scientific statement by the editor-in-chief of the Journal of the American College of Cardiology, Dr. Anthony DeMaria, can be viewed at:http://www.cardiosource.com/cvn/index.asp?videoID=1406
The key points made in the scientific statement are as follows:
- Drugs associated with TdP vary greatly in their risk for arrhythmia; an updated list can be found at www.qtdrugs.org.
- Risk factors for drug-induced TdP include older age, female sex, heart disease, electrolyte disorders (especially hypokalemia and hypomagnesemia), renal or hepatic dysfunction, bradycardia or rhythms with long pauses, treatment with more than one QT-prolonging drug, and genetic predisposition.
- The risk: benefit ratio should be assessed for each individual to determine whether the potential therapeutic benefit of a drug outweighs the risk for TdP.
- Following initiation of a drug associated with TdP, ECG signs indicative of risk for arrhythmia include an increase in QTC from pre-drug baseline of 60 ms, marked QTc interval prolongation >500 ms, T-U wave distortion that becomes more exaggerated in the beat following a pause, visible (macroscopic) T wave alternans, new onset ventricular ectopy, couplets and non-sustained polymorphic ventricular tachycardia initiated in the beat following a pause.
- In monitoring QT intervals in an individual before and after drug administration, a consistent method should be used (i.e., same recording device, ECG lead, measurement tool [automated or manual], heart rate correction formula).
- Recommended actions when ECG signs of impending TdP develop are to discontinue the offending drug, replace potassium, administer magnesium, consider temporary pacing to prevent bradycardia and long pauses, transfer the patient to a hospital unit with the highest level of ECG monitoring surveillance where immediate defibrillation is available.
The statement suggests continuous ECG monitoring for at-risk patients, lists the drugs and drug combinations most likely to cause TdP, and provides guidance for managing drug-induced long Q-T syndrome and immediate treatment for TdP.
Co-authors are Barbara J. Drew, R.N., Ph.D., (Chair); Michael J. Ackerman, M.D., Ph.D.; Marjorie Funk, R.N., Ph.D.; Brian Gibler, M.D.; Paul D. Kligfield, M.D.; Venugopal Menon, M.D.; George Philippides, M.D.; Dan M. Roden, M.D.; and Wojciech Zareba, M.D., Ph.D.
Addendum:
The Telemetric and Holter ECG Warehouse (THEW) Center for Quantitative Electrocardiography and Cardiac Safety at the University of Rochester Medical Center
hosts a database of TdP cases (continuous Holter ECGs with long QT syndrome and drug-induced TdPs) that scientists can access to validate ECG monitoring systems. Director of THEW, Dr. Jean-Philippe Couderc, invites you to learn more about this opportunity at: http://thew-project.org/Database/E-OTH-12-6-009.html .
[09/23/2010]: AstraZeneca joins the THEW to further cardiac safety inThe Medical News: here.
[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[01/10/2012] Department of Physiological Nursing, University of California, San Francisco, CA, USA
The Mission of the Department of Physiological Nursing prevention of UCSF is to study the prevention, measurement, and treatment of physiological and biobehavioral responses to health, illness/disease and aging. Psycho-physiological interrelationships and interventions also are studied. Research spans all phases of the health/illness trajectory including people who are healthy, critically ill, living with a chronic illness, and those at the end of life.
[01/03/2012] University of Bologna (HST-ICIR) , Bologna, Italy
The University of Bologna was probably the first University in the western world. Its history is one of great thinkers in science and the humanities, making it an indispensable point of reference in the panorama of European culture. Bologna has thus been called upon to forge relationships with institutions in the most advanced countries to modernise and expand its activity. Among the many challenges which it has met with success, Bologna committed itself to the European dimension which has now led to adoption of the new university system.
[11/08/2011] Long Beach Memorial Medical Center, Long Beach, CA, USA
Long Beach Memorial Medical Center has been recognized as a major regional provider of medical and surgical services. Long Beach Memorial consistently achieves national accolades for its quality care, including being named as one of the U.S. top 125 hospitals by Consumers CHECKBOOK; named Top 100 Hospitals Cardiovascular by Thomson Reuters; and named one of Americas Best Hospitals for Orthopedics by U.S. News and World Report magazine.
[11/08/2011] University of Ljubjana, Ljubjana Slovenia
The university of Ljubjana was founded in 1919 on the basis of centuries of educational tradition, remaining the only Slovenian university for half a century.The very beginnings of medical education in Slovenia began in 1653 with the establishment ACEDEMIAE Operosorum in Ljubljana, where the medical component led by M. Gerbec (Gerbecius) by the first full description of symptoms and signs of atrio-ventricular block, disturbance, which was only possible to objectively define the development of electrocardiography several centuries later.
[11/02/2011] University of Adelaide, Adelaide, Australia
School of Electrical and Electronic Engineering: The School of Electrical and Electronic Engineering of University of Adelaide was formally founded in 1946, however courses were run in conjunction with other schools for a number of years before that. Over the years the curriculum has retained its essential nature as a broad curriculum founded on a strong basis of science, maths and technology principles.
[10/24/2011] Philips Heathcare-AARC, Andover, MA. USA
The Advanced Algorithm Research Center(AARC)is a Philips-sponsored professional organization established in late 2000, the AARC is devoted to advanced research and development in all areas of ECG analysis, including diagnostic electrocardiography, arrhythmia analysis, stress testing, patient monitoring and resuscitation.
[07/18/2011] University of Utah, Salt Lake City, UT. USA
The Department of Internal Medicine is the single largest department on the University of Utah campus, and has 14 subspecialty divisions. Its education program is nationally recognized for excellence. And, despite the small size relative to other institutions, this group is one of the top research departments in the United States, with numerous multi-year awards.
[06/28/2011] Medial Research, Ramot-Hashavim Israel
Medial Research is a private research institute established with the purpose of making research as well as application breakthroughs in personalized medicine. Medial aspires that the results of its findings will allow patients to benefit from personalized medical treatment adapted to each patient's specific clinical, physiological and demographical parameters.
[06/27/2011] Universidad Favaloro, CABA Argentina
The Favaloro University (Spanish: Universidad Favaloro) is an Buenos Aires Argentine, private university in the city of Buenos Aires. It was founded by surgeon Rene Favaloro in 1998. Research at the Favaloro University is distributed between the Faculty of Medical Sciences, the Faculty of Engineering and Exact and Natural Sciences and the Institute of Cardiology and Cardiovascular Surgery.
[05/23/2011] FDA-NCTR, Jefferson, AR. USA
The National Center for Toxicological Research (NCTR), FDA internationally recognized research center, plays a critical role in the FDA mission. NCTR-in partnership with researchers from elsewhere in FDA, other government agencies, academia, and industry-provides innovative technology, methods development, vital scientific training, and technical expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.
[02/28/2011] Johns Hopkins University School of Medicine, Baltimore, MD. USA
World-renowned for its medical research and advances, Johns Hopkins Medicine includes a variety of Core Facilities. Designed to encourage and enable cutting-edge research in the areas of basic science, genetics, medicine and others.
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
[12/13/2009]:The University of Rochester and the NHLBI enabled the creation of a "Center for Quantitative Electrocardiography and Cardiac Safety" (CES). Read more...
[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...