Effectively managing CRM device leads, lead failure and infection were highly discussed topics at the recent Heart Rhythm Society annual meeting in Denver. More than 35 sessions were dedicated to the topic. A day-long Lead Management Summit with a dozen and a half sessions by world-renowned experts focused on practical advice for physicians, administrators and patients. One central message prevailed: Successful lead management begins with careful implantation planning.
“The history of lead development runs hand in hand with lead failure,” said Andrew Epstein, MD, of the University of Pennsylvania. "Almost as long as we’ve had leads, we’ve had registries to manage them safely and efficiently, dating back to 1974. And despite the lessons learned from lead failures, they persist.”
|Lead Placement/Replacement: Achieving a Low Complication Rate|
– Neil F. Strathmore, MBBS, FHRS, CCDS, Royal Melbourne (Australia) Hospital
“We can’t think this way: Put it in and let the next person worry about taking it out if there is a problem,” said Charles J. Love, MD, FHRS, CCDS, of Ohio State University. “[Instead think] how do we prevent the need for lead extraction?”
Citing 10-year ICD failure rates of 20 percent and the dangers of death and infection from lead extraction, Epstein urged physicians to always be mindful of the consequences of lead extraction. Vigilance also is key in monitoring leads over time as failures are not often sudden; there’s an increase in peaks and change can occur very gradually. Remote monitoring is the best tool for watching performance over time. Physicians also should heed vendor advisories but “avoid the dark side of advisories and risk over reaction…and the significant number of major complications that can come with lead extraction… [in favor of] stepping back a bit to decide how do I want to reach this decision [for and with each patient],” Epstein shared.
Overall, Epstein and others stressed that all leads have a finite life expectancy. The goal of zero failure rate is unattainable; resolution is in how failures are managed. The cardiology community needs to watch performance of implanted leads and closely assess trends. “We need post-marketing surveillance, not the absence of approval of new technology by acquiring long-term follow-ups before approval,” he said. Physicians play a key role in vigilance, too—having a “huge responsibility” as they always need to return explanted hardware to the vendor and communicate problems. And when in need, reference the well-defined FDA and CMS processes and standards for issuing and managing recalls.
By the numbers
|Complications for Implantable Cardiac Devices|
– Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators. Circulation. 2007;116:1349-9
Approximately 400,000 patients receive ICDs every year in the U.S., and more than 3 million patients in the U.S. currently have ICDs. (Circulation 2011;123:e378-380) The number of devices implanted continues to increase while the population receiving them is often sicker. Studies show these factors can lead to additional complications for implant, lead management and extraction when necessary, noted Jeffrey A. Brinker, MD, of Johns Hopkins Hospital.
Performance data abound about successes and failures. The Danish Pacemaker Registry (1997-2008; 28,860 patients), for one, estimates that about 5.4 percent of patients have some kind of complication within three months of implantation, while 3.6 percent have lead complications, according to Neil F. Strathmore, MBBS, FHRS, CCDS, Royal Melbourne (Australia) Hospital. Figures from other studies and registries show acute and early lead dysfunctions, including displacement, occurring in 2.1 to 2.5 percent of patients. Bleeding complications are rare (0.4 percent) but most often are brought on by heparin bridging (2 percent) and dual antiplatelet therapy (1.9 percent).
Infection rates among cardiac rhythm management device implants are a more common concern, with one 2010 U.S. study by Voigt et al. in PACE