Medical Device Daily National Editor

BOSTON — If the performance of leads used to implant pacemakers and implantable cardioverter defibrillators (ICDs) is a large problem requiring consistent protocols and better data transparency, the extraction of these components – and the potential patient risks involved – may be an even more difficult issue requiring tracking and evaluation. It is, essentially, surgery, with all the attendant risks.

Besides issuing the first-ever comprehensive guidelines concerning lead performance to launch its 2009 scientific sessions here (Medical Device Daily, May 14, 2009), the Heart Rhythm Society (HRS; Washington) also unveiled new guidelines, of the updated type, on extracting these leads, if absolutely required.

The guidelines emphasize the need for greater consistency in these procedures, greater numbers of procedures by clinicians performing them, improved protocols in follow-up care, and pathways for future device development for these surgeries.

Rather burdened with the lengthy title "Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management," the guidelines were presented by Bruce Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic and an HRS officer, and Charles Love, MD, of the Division of Cardiovascular Medicine of Ohio State University (Columbus).

The presenters noted the increase in these extractions from just a very small number 20 to 30 years ago to an estimated 20,000 a year worldwide today, but a general scarcity of information concerning how many centers implanting CIDs (cardiovascular implantable devices) are well-equipped and having the necessary training and expertise to perform the lead extractions with good results.

The new statement updates a guideline issued by HRS in 2000, and Wilkoff said that it is a much more detailed attempt to outline the "tools, techniques and indications ... 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."

The presenters acknowledged that there is no good data concerning how many centers can do these extractions in an effective way, but Love told Medical Device Daily that his "ballpark" estimate of the U.S. centers well trained and prepared to perform these extractions would be "about 100." And he said that the guidelines should provide additional help not only to the prepared centers but also to those not well equipped to do extractions and so help them determine when a patient needs to be referred to qualified center.

The presenters also emphasized the need to begin building better registry information concerning the procedures.

They noted that Cook Medical (Bloomington, Indiana) some time ago had begun such a registry but discontinued the effort about 10 years ago. And Love said that Cook's efforts had been extremely helpful in pinpointing the various protocol areas required for developing the society's guidance documents.

Wilkoff said that the initial step in improving the broad understanding of how these procedures are being carried out should begin with documentation by individual facilities and local regions to provide "benchmarks" concerning the practice. And he said that "ultimately," national and international registries should be developed.

The presenters emphasized the need for clinician efficiency as the product of doing enough of these extractions and doing them frequently.

The document says that a research analysis of outcomes "suggests that the frequency of complete procedural success improves dramatically after the first 10-20 procedures have been performed. Even physicians with many years of experience have a reduced frequency of complete procedural success when 60 or fewer laser assisted lead extraction procedures were accomplished over the prior five years." And it notes "the steepest decline in complications over the first 30 cases."

Wilkoff, however, emphasized that these numbers are not hard-and-fast indicators of success in doing extractions, but instead that technical and clinical success should be defined by "outcomes."

He said, "Not all lead extractions are created equal," meaning that they vary greatly in complexity, and that "Volume is not the way you should measure this."

The key metric, he said, is where these procedures are done "repetitively ... but not hang our hats completely on a number."

Importantly, a primary recommendation of the guideline is 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."

Besides providing wording concerning the outcomes that define "technical and clinical success," the guideline addresses the following:

• Classification of complications.

• Personnel roles and responsibilities.

• Physician qualifications and training,

• Recommendations on minimum training volume, and 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.

The complete document guideline will be published in the July issue of HeartRhythm Journal, a publication of HRS.