February 23, 2005

The Heart Rhythm Society (HRS) was encouraged by members, industry, and the Food Drug Administration (FDA) to comment on our responsibilities to patients when a potential product failure is identified. The Board of Trustees and the Health Policy Committee have approved the following statement.

The clinical community is most often made aware of device problems through either a product safety alert or a product recall. A medical device safety alert is issued in situations where a medical device may present an unreasonable risk of substantial harm to the public health. It may not be considered a recall because the device does not have to be corrected or removed. A recall is for devices that are defective. The FDA recall classifications are based on the level of risk that the defective device poses to patients. A class I designation implies a situation in which there is a reasonable probability that the device will cause serious adverse health consequences or death. However, a class I designation for implanted devices does not necessarily require that an implanted device be extracted. Explanting the device may create additional risks and cause more harm. Rather than explanting the device, a class I recall strategy may only require closer follow-up of the patient to monitor the device. A class I recall requires that the manufacturer verify that all people who should have been notified of the recall received the recall notification. The FDA conducts a thorough audit of a manufacturer’s class I recall to ensure that the appropriate people have been notified and that they understood and followed the recall instructions. For a class I recall, the FDA or the manufacturer may issue a press release to ensure prompt and effective notification about the recall.

When recalls are issued, one action the manufacturer may take is to notify physicians by issuing a “Dear Doctor” letter. This helps to ensure appropriate professional clinical insight about the device affected by the recall. The manufacturer should provide some guidance but the professional clinical management of patients is ultimately left to the physician. In deciding whether to replace a pacemaker or ICD, the physician must weigh the risk of a device failure against the risk of replacement. Heart Rhythm Society members were faced with a similar decision several years ago when the Telectronics Accufix lead had an increased failure rate. In this case, more patients died during an extraction procedure than due to lead failure. Our collective experience with the Telectronics Accufix lead exemplifies why the risks of an intervention should be weighed carefully.

Heart Rhythm Society physicians were recently surveyed for their opinions about the need to replace a pacemaker or ICD when an advisory is issued (Maisel WH. Physician management of pacemaker and implantable cardioverter defibrillator advisories. PACE 2004;27:437-442). The physician consensus (>70% agreement) from this survey is summarized below:

Consensus/Clinical Status Risk of Sudden Device Failure

Consensus: REPLACE ICD

• Implanted for any reason = 1.0%
• Implanted for Secondary Prevention or History of Appropriate ICD Therapy = 0.1%
• Underlying Rhythm 30 bpm = 1.0%
• No underlying rhythm = 0.1%

Consensus: NOT TO REPLACE ICD

• Implanted for ANY indication and No Prior Appropriate ICD Therapy = 0.01%
• Underlying Rhythm 30 bpm = 0.01%

NO Consensus on Advisory Management

• Implanted for ANY indication and No Prior Appropriate ICD Therapy >0.01% and < 1.0%
• Implanted for ANY indication and History of Appropriate ICD Therapy <0.1%
• Underlying Rhythm 30 bpm >0.1% and  <1.0%
• No underlying rhythm <0.1%

The results of this survey indicate that physicians are most likely to recommend replacement of an ICD if the patient is pacemaker dependent or has a history of spontaneous VT/VF. The frequency of arrhythmias and the incidence of device failure affect this judgment. Opinions are most diverse for patients who are not pacemaker dependent or who had an ICD implanted for primary prevention without any subsequent arrhythmias. While these results are not based on clinical trials, the survey represents the opinions of many Heart Rhythm Society members.

The Heart Rhythm Society feels that specific individual management decisions are best left to the patient in consultation with his or her physician. The care of patients with medical devices such as pacemakers and defibrillators does not stop after implantation. As physicians learn about the long-term performance of those devices, either through product performance reports or advisory letters, standard clinical practice should include:

• Device (lead and pulse generator) registration
• Keep/maintain patient contact information
• Know the facts about device performance
• Contact and counsel each patient
• Maintain the physician-patient relationship by treating each patient as an individual
• Exercise medical judgment in each case based upon all the available information

When the FDA issues safety alerts and recalls, no specific recommendations are applicable to all patients. The results of the published survey and clarification of FDA intent for recalls and safety alerts may help patients and physicians weigh the risk of a sudden device failure with the risk of replacing the ICD. This decision must take into account the risk of sudden death and infection (1-2%) or other operative complications that could be life-threatening. The need to replace the ICD may be clear for some patients. In other cases more intensive follow-up could provide a reasonable alternative.

If you have any questions about this issue, please contact Amy Melnick, Vice President, Health Policy at 202-464-3434 or amelnick@hrsonline.org.

Stephen C. Hammill, MD                           Bruce Lindsay, MD
President                                                      Chair, Health Policy Committee
Heart Rhythm Society                                 Heart Rhythm Society

On behalf of the Heart Rhythm Society Board of Trustees