BOSTON, May 13, 2009 — Safe and effective management of patients with cardiovascular implantable devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators (ICDs) is a complex and evolving issue. To ensure that physicians and facilities are adequately prepared to determine if and when lead extraction is necessary and to give patients the best possible care during these procedures, the Heart Rhythm Society has developed Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus Statement on Facilities, Training, Indications and Patient Management.The consensus statement was released today at Heart Rhythm 2009, the Society’s 30th Annual Scientific Sessions.
The Heart Rhythm Society brought together a panel of international experts who specialize in device implantation and extraction to update guidance originally published in April 2000. With the overall goal of continuous quality improvement, the updated guidance provides standards for health care professionals and institutions involved in the care of patients with CIEDs.
“As technology evolves and the number of patients with CIEDs increases, effective and consistent lead management strategies and lead extraction protocols must be utilized,” said Bruce L. Wilkoff, MD, FHRS, second-vice president of the Heart Rhythm Society and Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic. “This new document outlines tools, techniques and indications for lead extraction that will prepare physicians, medical teams and facilities to determine the most effective lead management solution for their patients and deliver the best possible care.”
Given the technical challenges and risk of complications involved in lead extraction, the writing panel recommends that physicians should only seek training and hospitals should only provide service when there is an ongoing commitment to a procedural volume adequate to maintain the skills of the physician and team. A sustained commitment to track outcomes of both device implantation and lead extraction is also essential. The new document addresses a range of issues to prepare both physicians and facilities including:
- Outcomes defining technical and clinical success
- Classification of complications
- Personnel roles and responsibilities
- Physician qualifications and training
- Recommendations on minimum training volume
- Facility and equipment requirements
- Patient and procedure preparation
- Indications for lead removal and transvenous lead extraction
- Technical and clinical evaluation of new techniques and tools
- Recommendations for clinical evaluation of lead extraction devices
Lead Management Registry
The expert panel also calls for physicians, hospitals, manufacturers and national regulatory bodies to support the development of a lead management registry to benchmark local, national and international outcomes. The web based data collection tool would be accessible to all committed lead management centers and collect core data for the evaluation of technologies and advance standards for quality measures.
“The fundamental step towards providing quality care first requires the measurement of patient and procedural outcomes,” adds Dr. Wilkoff.