Dr. Bruce L. Wilkoff. Image Source: Cleveland Clinic

BOSTON—Laser-assisted lead removal demonstrated safety and efficacy, based on initial data from the four-year, retrospective LExICon study presented today at the 30th annual scientific sessions of the Heart Rhythm Society (HRS). However, principal investigator Bruce Wilkoff told Cardiovascular Business News that the greatest differentiator in success rates and patient outcomes depends on operator experience.

The LExICon (Lead Extraction in Contemporary Settings) was a multicenter, observational, retrospective trial, which examined laser-assisted lead removal, using the Spectranetics laser sheath, of 2,405 leads (from both pacemakers and defibrillators) in 1,449 patients at 13 centers in the U.S. and Canada between January 2004 and December 2007.

Wilkoff, director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, noted that all of the centers were "experienced with experienced physicians." In fact, the physicians had a mean experience level of approximately 11.4 years with lead extraction and about 7.9 years with laser-assisted lead extraction.

LExICon's endpoints were to assess the safety and efficacy of lead extraction, along with the net patient outcomes. They evaluated the demographics of procedural-related complications and patient complications after the procedures during the hospitalization.

Wilkoff and colleagues found a 97.7 percent clinical success rate and a 96.5 percent complete lead removal success rate with laser-assisted lead extraction in the 13 centers.

During the study period, the researchers discovered a 1.4 percent major adverse event rate for events directly related to the lead extraction, which represents a 26 percent relative reduction, compared to a previous multicenter study evaluating the original laser sheath. Wilkoff said they defined major adverse events as infections or internal bleeding, which could "potentially prolong hospitalizations." He noted that patients of "smaller to normal size" had a decreased rate of complications.

While 1.7 percent of the patients died during their hospitalization, only 0.27 percent died as a direct result of the lead extraction, which represents more than a 50 percent relative reduction, compared to a previous multicenter study evaluating the original laser sheath. "Lead extraction is a significant intervention that has some mortality risk, but these patients are quite sick, and they have other complications, which resulted in their unfortunate deaths," Wilkoff said.

To explain the improvement in patient outcomes, Wilkoff said that previous studies took place in the early stages of lead extraction. "While the tools have changed and improved slightly, operators are far more experienced. Also, while the physicians in this trial have more experience, previous trials also represent a less homogenous understanding of the proper way to perform lead extraction in the earlier eras," he explained. "For instance, in the previous era of lead extraction, if a patient had a pocket infection, mortality rates were raised to 1.7 percent, and if a patient had a pocket infection, along with a fever and positive blood cultures, then the mortality rate went up to 4.3 percent during hospitalization. And, an indication of diabetes bumped the mortality rate to more than 12 percent."

Wilkoff acknowledged that there is "a learning curve" associated with success rates of operators. He noted that in LExICon, even though these physicians have been "performing lead extractions for years, not everyone has been performing the procedure with the same frequency."

As a result, they divided the operators into three groups: those who had performed 60 or less during the proceeding four years; those who had performed 60 and 130 during the proceeding four years; and those who had performed more than 130 during the same time period. "We found that high volume rates lower complication rates, but do not necessarily impact mortality rates," he noted. "While it is important to become experienced, you need to keep it up--the more you perform, the better the outcomes."

"The real dilemma is to get people enough training and experience to maintain their confidence," Wilkoff said.

Overall, Wilkoff said this procedure is integral in managing patients with implanted leads. "Patients are living longer, but leads don't last forever. Transvenous lead extraction, when done by experienced operators, can be the best way to manage device infections, veins with blockages or lead malfunctions," he noted.

"These are skills that can be performed in any electrophysiology lab, which is willing to commit to a team of physicians, nurses and support staff. You need a lot of support for these procedures," he concluded. "But, that investment could transform a practice, and changes the way you approach patients, elevating what you can accomplish at a center. It's worth the investment. The problem remains in getting experienced operators to those who need their help."

The Colorado Springs, Colo.-based Spectranetics, which manufactures and markets the Excimer laser system, supported the study.