Rapid Growth in Cardiovascular Implant Devices Spurs
New International Guidelines
Pacemakers, implantable cardioverter defibrillators,
cardiac resynchronization therapy (CRT) devices nearing 2 million in
U.S., Europe
May 15, 2008 - Approaching two million people in
the U.S. and Europe now live with cardiovascular implantable electronic
devices (CIED) and this number is expected to continue its rapid
increase. Doctors from both continents joined yesterday in releasing new
guidelines for the proper management of the devices, which include
pacemakers, implantable cardioverter defibrillators (ICD) or cardiac
resynchronization therapy (CRT) devices.
These devices provide ongoing therapy for patients,
but throughout the patient’s lifespan that therapy requires monitoring
and adjustments. The new consensus statement is the first to offer
guidance on the management of CIEDs from the time of implantation until
explantation or the patient’s death.
The Heart Rhythm Society and the European Heart
Rhythm Association, working together, prepared HRS/EHRA Expert
Consensus on the Monitoring of Cardiovascular Implantable Electronic
Devices (CIED): Description of Techniques, Indications, Personnel,
Frequency and Ethical Considerations. The consensus statement was
released yesterday at
Heart Rhythm 2008, the Heart
Rhythm Society’s 29th Annual Scientific Sessions.
Nearly one million patients in North America and
more than 800,000 in Europe have a CIED. The number of follow-up visits
for patients with a CIED exceeds 5.8 million visits each year, and that
number will continue to increase as more CIEDs are implanted.
“As the indications for implantation broaden and
the frequency of device utilization increases, the management of these
patients and their devices has become a complex medical service,” said
Bruce L. Wilkoff, MD, FHRS, chair of the Heart Rhythm Society’s Health
Policy Committee and Director of Cardiac Pacing and Tachyarrhythmia
Devices at the Cleveland Clinic Foundation.
“Until now, there has been little guidance for
practicing physicians, hospitals, regulatory agencies and insurance
agencies to provide the medically appropriate level of care for
patients.”
The Heart Rhythm Society and the European Heart
Rhythm Association brought together an international panel of experts in
order to comprehensively address all issues related to device management
and follow-up. The international panel agreed that device monitoring
should be handled by professionals specially trained in the field, and
also issued a call-to-action for the device industry, health care
institutions and physician practices to provide the necessary
infrastructure that will ensure patient care is safe and effective.
Experts also addressed how the Internet and wireless technology are
changing patient data management and data sharing.
The new consensus statement offers guidance on a
range of issues including:
● Factors that determine the type and frequency
of device follow-up
● Content requirements for both in person and
remote monitoring
● Data management considerations including
patient confidentiality and data security
● Remote management strategies
● Considerations for the development of a global
device registry
● Roles and responsibilities for physicians,
allied professionals, manufacturers and regulatory agencies
● Patient education and responsibilities
● Ethical considerations, including CIED
management in dying patients
“With the goal of increasing the length and quality
of the patient’s life, appropriate monitoring of device therapy can
enhance the likelihood that the patient can pursue their life with fewer
interruptions by hospital admissions and operative interventions,” said
Panos Vardas, MD, Ph.D., from Heraklion University Hospital in Heraklion-Crete,
Greece.
“Guidance provided by this consensus statement sets
an international benchmark for device management practices and will help
physicians provide better, safer and more consistent care for CIED
patients worldwide.”
The complete guidelines will be published in the
June issues of the HeartRhythm Journal, the official journal of
the Heart Rhythm Society, and Europace.
Editor's Notes:
About Heart Rhythm2008
Heart Rhythm 2008 takes place May 14-17 at the Moscone Convention
Center in San Francisco. The meeting is the most comprehensive
educational event on heart rhythm disorders, offering 250 educational
opportunities in multiple formats. The world’s most renowned scientists
and physicians will present a wide range of heart rhythm topics
including advances in statins, cardiac resynchronization therapy,
catheter ablation, cardiac pacing and heart failure and the latest
technology, including state-of-the-art pacemakers and defibrillators.
About EHRA
The European Heart Rhythm Association, as the leading organization in
the field of arrhythmias and electrophysiology in Europe attracts
physicians from all over the Europe and fosters the development of this
area of expertise. EHRA is a registered branch of the European Society
of Cardiology, based in Sophia Antipolis, France and currently numbers
over 2000 European professionals active in the fields of arrhythmias and
pacing. Further information is available at
www.escardio.org/EHRA.
