A Medical Device Daily

More European countries need to embrace the remote monitoring of cardiovascular implantable devices, rather than offering face to face clinic visits, concluded a press briefing at the Europace 2009 meeting in Berlin, Germany.

"Moving to a more continuous follow-up approach would have the tremendous advantages of enhancing patient safety, decreasing physician and nurse work load, and allowing health staff to focus on medical emergencies," said Angelo Auricchio, MD, of the European Heart Rhythm Association (EHRA) and spokesperson of the European Society of Cardiology (ESC; both Sophia Antipolis, France), adding that such systems may have the additional advantage of being more cost effective for health care providers.

Currently only around 1% of patients in Europe with implantable cardiac devices are being monitored with remote devices. The vast majority are still being followed up by routine face-to-face clinic visits.

Despite wide availability of remote monitoring in many European countries, said Auricchio, few countries offer patients such systems. "Even in countries that have introduced remote monitoring there are widespread disparities between centers," he said.

Auricchio, who works at Cardiocentre Ticino (Lugano, Switzerland), said cardiovascular implantable electronic devices (CIEDs) — which include cardiac pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) devices, implantable cardiovascular monitors and implantable loop recorders — have now been developed with numerous programmable features allowing for storage of substantial amounts of diagnostic information.

The EHRA and Heart Rhythm Society (HRS; Washington) expert consensus on monitoring of cardiovascular electronic devices, published last year, estimated that in 2006 about 250,000 pacemakers and 50,000 ICDs were implanted in Europe. The numbers implanted are estimated to be increasing by 5% to 10 % per year.

What has become increasingly apparent, Auricchio said, is that once the device has been implanted, it needs to be followed up effectively to allow it to work efficiently.

"This means that more than 2 million follow-up encounters with device patients are now needed in Europe each year, which is pushing the health care system to breaking point," he said. "Services are so overstretched by routine follow-ups that they do not have much spare capacity to deal with emergencies when they come in."

The solution, suggests Auricchio, is to increase the number of devices that can be interrogated remotely. "Technology is available to download data related to device function, arrhythmia frequency, cardiovascular hemodynamic parameters and patient activity, from specific CIEDs and transmit the encrypted data using telephone technology to remote-secure monitoring centers," he said, adding, "Here healthcare staff can both identify errant device behaviour, as well as patients'physiological response to a multitude of programmable therapies."

EHRA said there are "many advantages" for remote devices. With the current face-to-face visit approach, physicians commonly first learn about critical device malfunctions and physiological changes when the patient returns to the clinic for a follow-up and manual device interrogation, which only takes place two to four times per year, depending on the patient status. With remote monitoring, problems can be identified immediately.

"Continuous control of the device will permit detection of possible device dysfunction at a very early stage which allows us to take immediate action, thus improving patient safety significantly." said Josep Brugada, MD, president of the EHRA.

The EHRA/HRS consensus document adds that payers and regulators need to improve their recognition of the importance of CIED follow-up and develop adequate reimbursement strategies. "There is no point investing in the device without comparable investment in the long-term follow-up and therapy," said the authors.

To understand the new models of reimbursement, EHRA in conjunction with Eucomed (Brussels, Belgium), plans to survey the costs involved with in hospital CIED follow-up throughout Europe. "We need to have a better idea of the baseline costs so that we can start to understand the cost efficiency of introducing remote monitoring," said Auricchio.

Recommendations for drivers with ICDs

Patients with an implantable cardioverter defibrillator (ICDs) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions are imposed making these recommendations an important guideline for patients.

A consensus statement with recommendations for drivers with ICDs was presented at a press conference at the Europace meeting, on Sunday.

A team of 12 experts from EHRA, the Council on Cardiovascular Nursing and Allied Professions within ESC and the Cardiac Rehabilitation section of the European Association of Cardiovascular Prevention and Rehabilitation reviewed the literature, assessed the risk and issued a consensus statement.

"Driving restrictions vary across different countries in Europe. We hope the document may serve as an instrument for European and National regulatory authorities to formulate uniform driving regulations," said Johan Vijgen, chairperson of the task force.

"Driving restrictions are perceived as difficult for patients and their family and have an immediate consequence for their lifestyle. In addition to the psychological and societal impact, the driving ban may also pose a considerable impact on employment and education and thereby economic status," he said.

The document presents recommendations for private driving and professional driving.

Many patients are currently implanted for primary prevention (treatment of patients at risk for life-threatening arrhythmias who have never had sustained ventricular arrhythmias). The risk for sudden incapacitation is lower in these patients. Therefore, the study group said driving restrictions should be less strict for these patients than for patients implanted for secondary prevention (those who have survived a life-threatening arrhythmia).

Sports participation can boost risks

While most people will enjoy the benefits and pleasures of exercise, there are a few for whom regular athletic training will increase the risk of cardiac arrhythmias and even sudden death, especially among those in middle-age or with pre-existing cardiac diseases.

"It's for this reason that sports medicine has focused on pre-participation screening in an attempt to detect any hidden heart disease," said Luis Mon, MD, of Hospital Cl nic de Barcelona in Spain.

On the other hand, disturbances in heart rhythm, particularly atrial fibrillation, which represent one of the major cardiovascular reasons for hospital admission, is more common among cyclists, marathon runners and other athletes with a long history of endurance training.

Mont reported that atrial fibrillation is more frequent in middle-aged individuals who formerly took part in competitive sports and continue to be active, or simply in those involved in regular endurance training without having actually participated in competitive sports. "So we have to look at the effects of endurance or athletic training with a more open view," he said.

Fighting against sudden cardiac death

Sudden cardiac death (SCD) is an unexpected death caused by a sudden loss of heart function. Every year, 400,000 adults die of SCD, making it one of the largest causes of death in Europe.

SCD begins with sudden cardiac arrest. Mostly this is caused by ventricular fibrillation. When this occurs, the heart will abruptly stop to pump blood. Consequently, the patient feels dizzy and faints. SCD occurs within minutes, if no resuscitation is immediately initiated.

"Many victims could survive if they were treated quickly and effectively with cardiopulmonary resuscitation (CPR), including defibrillation. If we could increase the actual rate of survival from 5% to 20%, 80,000 lives could be saved each year in Europe alone" said Dietrich Andresen, MD, local host to Europace 2009 and director of Vivantes-Klinikum Am Urban (Berlin).

"Waiting for emergency personal to arrive at the scene leads to delays in help and reduces the chance of survival by 10% each minute. Immediate intervention by trained laypersons could make a huge difference.

This is why the EHRA and the Lion's Club Intercontinental (LCI) in Berlin are supporting a program on basic CPR skills," Andresen said.

LCI) Berlin also assists programs for laypersons on how to use automatic external defibrillators, as well as supporting the placement of AEDs in targeted public areas such as sports arenas, office complexes or doctor's offices.