Preliminary Recommendations on ICDs/Pacemakers

June 3, 2007
Rebekah McCallister

Internal Medicine World Report, June 2006, Volume 0, Issue 0

From the Heart Rhythm Society

IMWR

WASHINGTON, DC?The Heart Rhythm Society (HRS) released a draft of their comprehensive guidelines for the surveillance, analysis, and performance of pacemakers and implantable cardioverter defibrillators (ICDs) at a press conference on April 26, 2006. The recommendations, which have been expected since last year (see , November 2005), offer physicians and patients clearer, timelier, and more consistent information about the recall and advisory process.

"While lifesaving benefits of pacemakers and ICDs have been confirmed by numerous clinical trials, recent events have raised questions about the effectiveness of the current systems and processes used for postmarket surveillance and analysis of these cardiac devices," said Anne Curtis, MD, president of the HRS and chief, Division of Cardiology, University of South Florida, Tampa. "Industry communications to physicians and patients about the performance of these devices have also been called into question," she said.

The draft guidelines call for:

? Greater transparency in postmarketing surveillance, analysis, and reporting of information

? The establishment of new systems to identify malfunctioning devices more quickly

? Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified.

The recommendations cover 6 areas.

Device Performance

"Overall, device performance depends not only on the characteristics of the device, but on the skill of the implanting physician, the expertise of the physician and other caregivers following the device, and the ability of the patient to comply with recommendations," Dr Curtis said.

The HRS recommends that manufacturers establish standards of performance for their devices and develop biannual standardized device performance reports. It is suggested that physicians inform their patients not only about the benefits and risks of devices but also about their overall expected performance, including potential malfunction rates.

Surveillance

Postmarketing surveillance as currently configured is designed primarily to identify uncommon but potentially serious device-related adverse events, according to Dr Curtis. "We recommend that manufacturers use wireless and remote monitoring technologies to identify abnormal devices earlier and more quickly to determine the cause of malfunctions," she said.

In addition, the HRS suggests that the FDA enhance the Manufacturer And User Experience Database, known as MAUDE, to more readily identify devices that may pose a danger; recommends modifying the national cardiology data registry administered by the HRS and the American College of Cardiology to collect data on device performance and adverse events and include data on the cause of patients' deaths; and advises physicians to return malfunctioning devices to the manufacturer for analysis, whether the replacement is routine or because of a device malfunction.

Analysis of Data

The current system used to analyze data on ICD and pacemaker performance depends heavily on industry to detect and report problems, Dr Curtis explained. The industry analyzes device performance data and initially determines when a malfunction is likely to be recurrent, the potential frequency of the recurrent malfunction, and the likelihood that the malfunction could harm the patient.

"Physicians are not involved systematically in determining if and when a device safety concern exists or the response to a safety concern," she said.

As a result, the HRS is recommending that manufacturers establish independent standing committees of outside experts to analyze device performance and recommend appropriate action, and that the FDA establish standard postmarketing advisory committees to analyze data on device performance and suggest actions to address device malfunction.

Terminology

The different terms used by manufacturers and by the FDA have contributed to misunderstandings among physicians and patients regarding the actions that should be taken to alleviate a device malfunction.

"The term ?recall' suggests to patients and physicians that a device should be removed, when this may not be the case," Dr Curtis said. "The absence of clear guidelines regarding the circumstances that trigger notification of physicians and patients of device malfunction creates uncertainty."

Therefore, the HRS is recommending that manufacturers and the FDA use identical terminology when classifying device malfunctions. The HRS is also suggesting that the FDA eliminates the term "recall" and changes the term "class I recall" to "class I notification" or "class I safety alert."

Communication

The HRS is recommending that in addition to the "dear doctor" letters that the industry sends out when there is a device malfunction, a standardized Physician Device Advisory Notice form also be used. Physicians should use the standardized notification form to objectively assess the FDA advisories.

Clinician Practices

Although there are risks associated with device reimplantation, replacement of the device should be strongly considered if malfunction could result in death or serious harm to the patient, and if the risk of replacement is not substantially greater than the risk of device failure, according to Dr Curtis.

"Observation is recommended in situations of low patient risk," she said. "Alternatives to reimplantation that may mitigate the consequences of device malfunction and decrease patient risk should also be considered."

Heart Rhythm Journal

The guidelines are expected to be published in the October 2006 issue of the . Highlights from Heart Rhythm 2006

BOSTON?Reports presented at Heart Rhythm 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions, included a range of studies with important clinical implications for physicians who treat patients with cardiovascular (CV) conditions. The following 2 studies are among key topics discussed.

Cocaine intoxication

? . Contrary to claims in the lay media, use of cocaine or even cocaine intoxication may actually protect against the life-threatening arrhythmias that can result from electrical stun guns, according to a study done on animals. The drug reduced a healthy heart's vulnerability to developing ventricular fibrillation by 1.5 to 2 times above the study's baseline safety margin. Lead investigator Dhanunjaya Lakkireddy, of the Cleveland Clinic Foundation in Ohio, and colleagues used a custom-built device to deliver a neuromuscular-incapacitating discharge to research animals that matched the waveform of commercially available stun guns (ie, Taser X-26). "There have been many news reports that tasers can increase the incidence of heart attacks in people on cocaine, but our findings show that these claims are unfounded and not based on science," said Dr Lakkireddy. He noted that more research is needed to determine the relationship between cocaine and tasers in patients with underlying heart conditions.

Omega-3 fatty acids

? . Although eating foods rich in omega-3 fatty acids may carry some cardiac benefits, it does not have beneficial effects on the heart's electrical function, according to a new analysis of data from almost 17,000 male physicians in the Physicians' Health Study, which found that eating fish more frequently was associated with a higher risk of developing atrial fibrillation (AF). After adjustment for multiple risk factors for AF, lifestyle factors, and other dietary factors, men who ate fish >5 times weekly were at a 61% increased risk of developing AF compared with men who ate fish only once monthly. Fish consumption was tallied in 1983; 15 years later the men reported if they had been diagnosed with AF. At the end of the follow-up period, 1257 (7.1%) of the physicians had developed AF. Coinvestigator Anthony Aizer, MD, of the Cardiology Division of New York University Department of Medicine, New York City, said, "It is important to recognize that within the same population as this current study, fish consumption was associated with lower risk of sudden cardiac death. The message of the study is not to stop eating fish. AF is a complex condition that requires the interaction of a number of risk factors to develop." Thus, additional investigation is needed to reach a more definitive answer about the multiple effects of omega-3 fatty acid on the heart's electrical function.

Highlights from Heart Rhythm 2006

BOSTON?Reports presented at Heart Rhythm 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions, included a range of studies with important clinical implications for physicians who treat patients with cardiovascular (CV) conditions. The following 2 studies are among key topics discussed.

? Cocaine intoxication. Contrary to claims in the lay media, use of cocaine or even cocaine intoxication may actually protect against the life-threatening arrhythmias that can result from electrical stun guns, according to a study done on animals. The drug reduced a healthy heart's vulnerability to developing ventricular fibrillation by 1.5 to 2 times above the study's baseline safety margin. Lead investigator Dhanunjaya Lakkireddy, of the Cleveland Clinic Foundation in Ohio, and colleagues used a custom-built device to deliver a neuromuscular-incapacitating discharge to research animals that matched the waveform of commercially available stun guns (ie, Taser X-26). "There have been many news reports that tasers can increase the incidence of heart attacks in people on cocaine, but our findings show that these claims are unfounded and not based on science," said Dr Lakkireddy. He noted that more research is needed to determine the relationship between cocaine and tasers in patients with underlying heart conditions.

? Omega-3 fatty acids. Although eating foods rich in omega-3 fatty acids may carry some cardiac benefits, it does not have beneficial effects on the heart's electrical function, according to a new analysis of data from almost 17,000 male physicians in the Physicians' Health Study, which found that eating fish more frequently was associated with a higher risk of developing atrial fibrillation (AF). After adjustment for multiple risk factors for AF, lifestyle factors, and other dietary factors, men who ate fish >5 times weekly were at a 61% increased risk of developing AF compared with men who ate fish only once monthly. Fish consumption was tallied in 1983; 15 years later the men reported if they had been diagnosed with AF. At the end of the follow-up period, 1257 (7.1%) of the physicians had developed AF. Coinvestigator Anthony Aizer, MD, of the Cardiology Division of New York University Department of Medicine, New York City, said, "It is important to recognize that within the same population as this current study, fish consumption was associated with lower risk of sudden cardiac death. The message of the study is not to stop eating fish. AF is a complex condition that requires the interaction of a number of risk factors to develop." Thus, additional investigation is needed to reach a more definitive answer about the multiple effects of omega-3 fatty acid on the heart's electrical function.

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