Spate of implantable devices leads to monitoring guidelines

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The Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) have developed a set of comprehensive monitoring guidelines that addresses solutions to data management, patient privacy and ethical issues. The guidelines were released at the 2008 HRS meeting in San Francisco last week.

Nearly one million patients in North America and more than 800,000 in Europe have a cardiovascular implantable electronic device (CIED), such as a pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device.

The devices provide ongoing therapy for patients, but throughout the patient’s lifespan require 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.

“We concentrate most of our energy in implanting devices and very little in the follow-up over time,” said lead author Bruce L. Wilkoff, MD, chair of the HRS Health Policy Committee. “It’s not buying the car that makes the difference but driving it.”

The international panel of experts agreed that device monitoring should be handled by professionals specially trained in the field. The societies also issued a call-to-action for the device industry, healthcare institutions and physician practices to provide the necessary infrastructure to ensure patient care is safe and effective. The 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; 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 panel member Panos Vardas, MD, PhD, from Heraklion University Hospital in Heraklion-Crete, Greece.

In a related study, Cleveland Clinic researchers reported at the HRS meeting that home monitoring of devices via wireless technology is increasingly being embraced by patients. The study is the first to show how the rapidly evolving technology can increase the number of patient evaluations without directly increasing demands on clinic staff time and resources, according to the researchers.

Elizabeth Ching, RN, and colleagues tracked ongoing ICD device follow-up patient visits over a four year period. Each ICD patient was offered the option of in-person device follow-up or device follow-up supplemented with remote monitoring.

Between 2003 and 2007, the total number of ICD evaluations increased by 164 percent, allowing for improvements in time management and overall utilization of in-clinic resources. During the study, remote evaluations increased dramatically from 94 to more than 5,000 patients, according to Ching.

“We increased our total number of patient evaluations over the past five years, without as much strain as seeing all of the patients in clinic,” Ching said. “This growth is a direct result of the clinic’s incorporation of ICD follow-up through remote monitoring evaluations, allowing for better time management and overall improvements in resource allocation.”