Heart experts issue guidance on management on implantable cardiac
devices
22 May 2008
The Heart Rhythm Society and the European Heart Rhythm Association
have issued an 'expert consensus' on the monitoring of cardiovascular
implantable electronic devices to ensure that these life-saving devices
are managed properly and patients receive the best possible care [1].
The consensus statement was released last week at Heart Rhythm 2008,
the Society’s 29th Annual Scientific Sessions.
In 2007 alone, nearly one million patients in North America and more
than 800,000 in Europe received a CIED, such as a pacemaker, implantable
cardioverter defibrillator (ICD) or cardiac resynchronization therapy
(CRT) device. These devices provide ongoing therapy for patients, but
throughout the patient’s lifespan that therapy requires monitoring and
adjustments.
The number of follow-up visits for patients with a cardiovascular
implantable electronic device (CIED) exceeds 5.8 million visits each
year, and that number will continue to increase as more CIEDs are
implanted.
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.
“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.
“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 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:
- actors 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; and
- reimbursement issues.
“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, PhD, president-elect of EHRA, and 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.”
Reference1. Heart Rhythm Society and the European Heart Rhythm
Association Expert Consensus on the Monitoring of Cardiovascular
Implantable Electronic Devices (CIED): Description of Techniques,
Indications, Personnel, Frequency and Ethical Considerations.
EuroPace, The European Journal of Pacing, Arrhythmias and Cardiac
Electrophysiology of the European Heart Rhythm Association and the
Working Group on Cardiac Cellular Electrophysiology of the European
Society of Cardiology will be publishing the full text of the Consensus
Document in their June 2008 issue.