Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines

Lead Performance Policies and Guidelines Multimedia: View the webcast presentation of "Challenging Times in Lead Management: From Implant to Extraction or Abandonment" (10/13/09)featuring a moderated panel discussion concerning the various approaches to lead management as they relate to a given patient's situation. Updated 7/1/09: Interview between Kenneth A. Ellenbogen, MD, FHRS and Robert G. Hauser, MD, FHRS, CCDS on the importance of the Society’s lead performance policies and guidelines document — watch and listen now    » View webcast presentation (10:32) of Lead Performance and Communication of Lead Performance by Stephen C. Hammill, MD, FHRS, presented May 14, 2009 at Heart Rhythm 2009    » Listen to highlights of the Lead Performance Panel discussion from Heart Rhythm 2009

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, the Heart Rhythm Society has released the first comprehensive guidance document on lead performance (PDF, 189K). The document was released on Wednesday, May 13, 2009 during the Society’s 30th Annual Scientific Sessions.

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.”

Download Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines (PDF, 189K) » Download Clinical Document Overview Slides (Microsoft PowerPoint, 2.1M)

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.”

Recommendations for Clinicians

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
• Clinician responsibilities for reporting suspected or definite lead related problems

The complete document was published in the June issue of the HeartRhythm Journal, the official journal of the Heart Rhythm Society.

Lead Performance Panel Discussion from Heart Rhythm 2009

At the Heart Rhythm Society’s 2009 Annual Scientific Sessions, an expert panel of clinicians, industry, and the U.S. Food and Drug Administration convened to discuss the Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines clinical document. Listen to highlights from the interview:

• What the Society as an organization needs to do in the future regarding lead performance
  
• Keys to implementing the recommendations of the document and potential roadblocks
• The importance and role of benchmarks as outlined in the clinical document
• How this report has changed the physician's approach to patients
• The structure of changes in the FDA to monitor device performance
• The FDA approval process for post market study of leads
• The FDA's recommendation to develop a guidance document on what constitutes new and / or iteration of a device
• Helping those who are not coming into the EP clinic to get the devices they may need and concluding remarks

Panelists

N.A. Mark Estes, III, MD, FHRS
Mark D. Carlson, MD, FHRS
Robert G. Hauser, MD, FHRS
William H. Maisel, MD, FHRS
Megan Moynahan, MS