Before the laser option became available, the only way to remove the leads from patients with pacemakers or ICDs involved pushing telescoping, metal sheaths over the lead and physically breaking the hold of the scar tissue at the end of the lead without damaging any tissues. “There was a pretty high risk of causing a tear in either one of the veins or the heart, and that’s a bad problem, because you can bleed to death internally in a couple of minutes,” Wool says.
Because of the danger, only infections merited the removal of leads. “If a patient’s lead wore out, you put a new one in alongside the old one,” Wool says, “which is not necessarily a good thing, since there’s more chance of infections.”
Even manufacturer recalls of bad leads or blocked veins did not warrant the risk of removal. “In the last few years, there’s been a lot of leads recalled. I probably had hundreds of patients with those bad leads,” Wools says.
Previously, in the case of a recalled lead, cardiologists could only cap the end to make it inert, though leaving it there increased the risk of a blocked vein.
The new laser-oriented procedure solves these problems. Instead of rigid steel, the flexible, polymer sheaths by Spectranetics contain fiber optics carrying a low-temperature excimer laser beam. “When you activate the sheath, it vaporizes the scar tissue as it goes through the vein along the lead,” Wool says. “that frees the lead from the heart tissue and you can pull it out through the hollow sheath.”
The now-empty laser sheath can serve as a hollow catheter right to the heart. “You put in the guide wire line and now you have the access to put in the new lead,” Wool says.
The laser’s ablating of scar tissue and the width of the sheath also mean any previously blocked vein is now opened to receive a new lead. “Probably at least 15 percent of the time veins become blocked around leads, so that made it impossible for a new lead to be inserted in the same vein with normal methods,” Wool says. “But in the process of extracting with a laser, you basically create a new channel, because the sheath is wider than the lead.”
The procedure itself remains basically the same. “But with the laser, it’s become a whole lot easier and safer, so that incidents have proliferated,” Wool says. “Infections did not happen often. I’d maybe send one or two a year to Birmingham for lead extractions. But now we can remove any useless lead. That’s the point.”
The physicality of the procedure remains, but is far less than with the metal sheaths. “The key thing in doing the procedure is maintaining counter traction on the lead,” Wool says. “If you just pull on it with your hands, you tear it apart.” So a tool called a locking device threads through the hollow passage in the center of the old lead and latches to the end.
“So you’re pulling really hard on that device, while you’re pushing on the laser sheath,” Wool says. “The pulling also helps straighten the lead out, because there’s actually lot of curves from outside of the body to that end of the lead in your heart, and when you straighten it out, it lowers the risk that the laser will go off center.”
Recovery also tends to be shorter with the laser method. “Patients are only in one night and some can be done as outpatient,” Wool says. “But the important thing about this procedure is for those who got pacemakers at 50, they don’t end up with six leads in them by the time they’re 70. Now we can take them out as they fail.”
Over his 25 years in practice, Wool estimates he’s put in 3,500 to 4,000 devices and only had one or two patients a year who faced infections. But with the safety of the laser method, he’ll be performing one or two lead extractions a week now. “I can’t emphasize enough that the big difference with this procedure is that indications have increased many orders of magnitude.”