The Heart Rhythm Society (HRS) released the first comprehensive guidance document on lead performance in pacemakers and implantable cardioverter defibrillators (ICDs), recognizing that lead malfunction is crucial to patient safety, and asserting that physicians and patients must have timely and accurate data when malfunctions occur. The document was released Wednesday at the 30th annual HRS scientific sessions.
"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, a cardiologist at Beth Israel Deaconess Medical Center in Boston, and co-chair of the HRS 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."
The task force provides a 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."
The guidance recommends that physicians who care for patients with cardiovascular implantable devices have several important clinical responsibilities related to lead performance. New clinician recommendations will help prevent misunderstandings, eliminate unwarranted patient anxiety and fear, and minimize inappropriate, unsafe responses to malfunctions that have low risks to patient safety.
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; and
* Clinician responsibilities for reporting suspected or definite lead related problems.
The complete document will be published in the June issue of the journal Heart Rhythm.