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Background: The aim of this study was to investigate whether transvenous lead removal is safe and effective in patients with lead vegetations greater than 1 cm in size. Methods: From 1991 to 2005, a total of 53 patients underwent pacemaker or ICD lead removal for vegetations. Transvenous lead removal using locking stylets and sheaths was performed in 30 patients (56.6%) and was found to be effective in 29 of those patients. In 1 patient, due to rupture of the lead, open heart removal of the ventricular lead remnant and tricuspid valve repair had to be performed due to persistent infection. In 23 of these patients, transesophageal echocardiography (TEE) verified vegetations greater than 1 cm in size. The remaining patients underwent primary lead removal using sternotomy and extracorporeal circulation (ECC). Pacemaker pocket infection was found in 16 patients (55.2%) of the transvenous study group and in 11 patients (45.8%) of the ECC group (P = 0.72). Results: Perioperative mortality was 5.7% (3 patients); all of them underwent primary ECC removal and had severe endocarditis of the tricuspid valve. None of the patients who underwent transvenous lead removal died and there were no further complications such as pericardial tamponade or major pulmonary embolism requiring further interventions, even in patients demonstrating large vegetations. Conclusions: This study demonstrates that transvenous lead removal is a safe and highly effective procedure for the removal of infected pacemaker and ICD leads, even in patients with large vegetations. Embolism to the lung proceeds mainly without further complications; however, patients with vegetations that might obstruct a main stem of the pulmonary artery should undergo ECC removal. [ABSTRACT FROM AUTHOR]