BACKGROUND: Some operators routinely extract chronically implanted transvenous leads from a femoral, whereas others prefer a superior approach. This prospective study compared the safety and effectiveness of laser sheaths versus femoral snare extractions. METHODS AND RESULTS: The single-center study comprised 101 patients referred for unequivocal indications to extract > or =1 transvenous lead(s). Patients were >4 years of age and were randomly assigned to extractions with a laser sheath (group 1: n=50) versus a snare via femoral approach (group 2: n=51). The multicenter study comprised 358 patients who underwent extraction of old transvenous leads using laser sheaths (n=218, group 3) in 3 centers and from a femoral approach (n=138, group 4) in 3 other centers. In the single-center study, the success and complications rates were similar in groups 1 and 2. No patient died of a periprocedural complication. The procedural duration (51+/-22 versus 86+/-51 minutes) and duration of total fluoroscopic exposure (7+/-7 versus 21+/-17 minutes) were significantly shorter (each P<0.01) in group I than in group 2. In the multicenter study, we observed 2 procedure-associated deaths in group 3 versus 1 in group 4. Major procedural complications were observed in 3% of patients in group 3, versus 3% in group 4 (P=NS). The rates of complete, partial, and unsuccessful extractions were similar in groups 3 and 4. CONCLUSIONS: Old transvenous leads were extracted with similar success and complication rates by the femoral and laser approaches. However, the femoral approach was associated with longer procedures and a longer duration of fluoroscopic exposure.
RCT Entities:
BACKGROUND: Some operators routinely extract chronically implanted transvenous leads from a femoral, whereas others prefer a superior approach. This prospective study compared the safety and effectiveness of laser sheaths versus femoral snare extractions. METHODS AND RESULTS: The single-center study comprised 101 patients referred for unequivocal indications to extract > or =1 transvenous lead(s). Patients were >4 years of age and were randomly assigned to extractions with a laser sheath (group 1: n=50) versus a snare via femoral approach (group 2: n=51). The multicenter study comprised 358 patients who underwent extraction of old transvenous leads using laser sheaths (n=218, group 3) in 3 centers and from a femoral approach (n=138, group 4) in 3 other centers. In the single-center study, the success and complications rates were similar in groups 1 and 2. No patient died of a periprocedural complication. The procedural duration (51+/-22 versus 86+/-51 minutes) and duration of total fluoroscopic exposure (7+/-7 versus 21+/-17 minutes) were significantly shorter (each P<0.01) in group I than in group 2. In the multicenter study, we observed 2 procedure-associated deaths in group 3 versus 1 in group 4. Major procedural complications were observed in 3% of patients in group 3, versus 3% in group 4 (P=NS). The rates of complete, partial, and unsuccessful extractions were similar in groups 3 and 4. CONCLUSIONS: Old transvenous leads were extracted with similar success and complication rates by the femoral and laser approaches. However, the femoral approach was associated with longer procedures and a longer duration of fluoroscopic exposure.
Authors: Seth Sheldon; Paul A Friedman; David L Hayes; Michael J Osborn; Yong-Mei Cha; Robert F Rea; Samuel J Asirvatham Journal: J Interv Card Electrophysiol Date: 2012-05-15 Impact factor: 1.900
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