PEAK PlasmaBlade: Safer Option for EP Lead Procedures

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PEAK-PlasmaBlade-3.jpg - PEAK PlasmaBlade
Left: PEAK PlasmaBlade 40-170˚ C. Right: Traditional electrosurgery 350-450˚ C

In the current economic climate, providers need to make fiscally conservative choices about their inventory, but healthcare systems that focus on quality, such as North Shore-Long Island Jewish (NSLIJ) Health System* in New York, continue to keep patient safety at the forefront of that decision-making process, especially for complicated electrophysiology (EP) procedures.

Clinical considerations

LIJ Medical Center, a tertiary hospital within the NSLIJ Health system, has a high-volume EP lab, implanting approximately 640 devices and conducting 150 ablation procedures in 2010.

David J. Slotwiner, MD, a cardiac electrophysiologist at NSLIJ, learned about the PEAK PlasmaBlade (PEAK Surgical, Palo Alto, Calif.), a low-temperature, pulsed-plasma radiofrequency device designed for precision dissection with minimal thermal injury to adjacent tissue, approximately two years ago. He heard it was an improvement over scalpel and traditional electrosurgery (bovie), due to its non-traumatic effects to implantable device leads.

After a thorough assessment of the clinical need, as well as probable utilization and pricing, NSLIJ adopted the PEAK PlasmaBlade.

“Currently, we use the PlasmaBlade for any procedure in which a device is already implanted, including implant generator changes, lead extractions or pocket revisions,” Slotwiner says. “The clinical advantage is that it does not damage existing hardware.”

Avoiding damage to transvenous leads during such procedures can reduce the potential for adverse events, as well as cost. Research has found that commonly used polyurethane and copolymer materials have low thermal stability and are highly susceptible to thermal damage during cautery use (J Cardiovasc Electrophysiol 2009;20:429-435). Lead damage often requires additional surgical intervention which can lead to increased length of hospital stay or even death, costing between $5,000 and $20,000 per incident.

These procedures require meticulous detail. “When we undertake ICD or pacemaker generator replacement procedures, leads are wrapped around the device and encased in thick, fibrous tissue. Dissecting out those thin wires from the fibrous capsules can be tedious,” Slotwiner explains. “Therefore, patient risk with scalpel and traditional electrosurgery is not insignificant, and many patients require new leads when they simply came in for a generator replacement.”

In fact, Gould et al found that during ICD generator replacement procedures, 17.1 percent of 2,635 ICD advisory devices were replaced over a one-year follow-up (HeartRhythm 2008; 5[12]:1675-1681). There was a 9.1 percent complication rate, and two deaths.

“We haven’t had any lead damage since we adopted the PlasmaBlade,” Slotwiner says.  

Finally, lead extractions are traditionally problematic procedures. Based on the FDA’s MAUDE database, 57 deaths and 48 serious cardiovascular injuries were associated with device-assisted lead extraction between 1995 and 2008 (Europace 2010;12[3]:395-401). NSLIJ has had no adverse outcomes while using the PlasmaBlade.

PEAK practicality = quality care

“Even if the price point is slightly higher for a new device, our service line ultimately assesses the benefits to the patient,” says Patricia Farrell, RN, director of cardiac services at LIJ Medical Center. “In the case of the PlasmaBlade, the benefit of reduced adverse events also brings down the cost of the overall inpatient hospital stay.”

Also, the procedures are faster using the PlasmaBlade, “which means less sedation for the patient, a reduced risk of infection and bleeding, as well as a quicker recovery,” Slotwiner says. “Previously, the procedures involved a great deal of retracting and bending, which prolonged the procedures.”

“As a health system that has achieved the lowest cath lab mortality rate in New York state, NSLIJ’s focus is on patient safety and providing quality patient care,” Farrell explains. This should be the focus for all administrators when making inventory decisions.”

*NSLIJ has not received any funding related to this article.