NEW YORK (Reuters Health) – Percutaneous extraction of pacemaker or implantable cardioverter-defibrillator (ICD) leads is safe in patients with cardiac vegetations, investigators report. And as long as blood cultures remain sterile, permanent devices can be reimplanted within a week or two.
Eradication of device-related infection requires complete system removal, the authors note in the March 2nd Journal of the American College of Cardiology. Traditionally, patients with vegetations larger than 1 cm in diameter have had their leads removed via thoracotomy, in order to avoid septic emboli — but the surgery itself increases patients’ risks for serious complications and for prolonged recovery.
Senior author Dr. Steven P. Kutalek and associates at Drexel University College of Medicine, Philadelphia, studied 100 patients (mean age, 67 years) who had 1838 leads extracted percutaneously despite echocardiographic evidence of vegetations. This group accounted for roughly 10% of all the percutaneous lead extraction cases at the authors’ center between 1991 and 2007.
The vegetations ranged from 0.2 to 4.0 cm in largest diameter (mean 1.6 cm). Implants had been in place for an average of 51 months. The median extraction time (4 min per lead) was not significantly different from the median in a reference group consisting of all 66 patients without vegetations who underwent extraction in 2004.
Five patients had complications during lead extraction, including embolized vegetation in two. However, all 5 were discharged in stable condition and recovered uneventfully.
In 54 patients, surgeons reimplanted new devices during the same hospitalization, at a median of 7 days after extraction. None of these second devices had to be extracted due to relapsing infection.
Twenty-nine patients were lost to follow-up. In the remaining 71, the average follow-up was 438 days.
Nineteen patients died – 11 of persistent septicemia, 1 of sudden cardiac death, and the other 7 of unknown causes with no evidence of ongoing infection (including 4 who had received a new device).
Ten patients died within 30 days of lead extraction. “These unfortunate outcomes occurred in a critically ill subset of patients who often have extensive comorbidities,” the researchers note. They attribute the operative mortality to disease severity rather than the mode of lead extraction.
Also, “given the frequent ambiguity of initial culture data,” the authors recommend transesophageal ultrasonography before device extraction in order to identify patients at high risk for endocarditis.
This study demonstrates that “percutaneous lead extraction with vegetations of all sizes is possible and seemingly appropriate,” Dr. James D. Maloney at Heartland Spine and Specialty Hospital, Overland Park, Kansas, and Dr. James D. Maloney III at the University of Wisconsin, Madison, write in a related editorial.
Still, they’re concerned that residual infected inflammatory tissue needs to be debrided after the leads are removed.
“The question remains… if a nidus of chronic infection sometimes remains, does that cause refractory sepsis and congestive heart failure?” they ask. “Can and should it be removed surgically?”
J Am Coll Cardiol 2010;55:886-897.