The new guidance outlines recommendations for clinicians on issues including:

Informed consent

Monitoring of device performance

Clinical presentation of abnormal lead performance

Clinical management when abnormal lead performance is suspected

Special considerations for pediatric patients

Clinician responsibilities for reporting suspected or definite lead related problems

Millions of patients have benefitted from the life-saving technology that pacemakers and implantable cardioverter defibrillators (ICDs) provide. However, the significant performance expectations placed on these devices and the lead wires within them, present surveillance and monitoring challenges. The recognition of lead malfunction is crucial to patient safety, and to ensure physicians and patients have timely, accurate and understandable information when lead malfunctions occur.

Monitoring of lead performance poses unique challenges for physicians, patients, regulators and members of the industry. Pacemaker and ICD leads must deliver reliable life-sustaining therapy to the heart and convey electrical information while withstanding the hostile environment of the body. A lead may experience more than 500,000,000 repetitive cardiac cycles during its lifetime and although substantial scientific and engineering efforts have improved their performance, leads occasionally malfunction.

“The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance,” said William H. Maisel, MD, MPH a cardiologist at Beth Israel Deaconess Medical Center and co-chair of the Heart Rhythm Society’s Task Force on Lead Performance. “Guidance provided in this document will help set standard practices for evaluation, analysis and communication of lead performance issues moving forward.”

Key Recommendations

The task force provides a wide range of recommendations on issues including communication of lead performance, pre-market evaluation of leads, post-market monitoring of lead performance, threshold for action and communication after abnormal lead performance is identified and clinical recommendations for physicians. Emerging modalities for lead surveillance including remote monitoring and the use of the NCDR ICD Registry™ as a post-market surveillance tool are also addressed. In addition, the task force encourages the FDA to provide guidance that explains when and how manufacturers can legally use terms other than “recall” in their product advisory notifications.

“When lead malfunctions are communicated to physicians, patients and the public, the language should be crafted to avoid unnecessary anxiety or inappropriate interventions,” said task force co-chair Robert G. Hauser, MD of the Minneapolis Heart Institute. “For example, the term ‘recall’ should not be used because it falsely implies that the lead should be removed and returned to the manufacturer.”