Mayo Clinic proceedings · 2000
Randomized comparison of J-shaped and straight atrial screw-in pacing leads.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Glikson M, Yaacoby E, Feldman S, Bar-Lev D S, Yaroslavtzev S, Granit C, Rotstein Z, Kaplinsky E, Eldar M
Аннотация
OBJECTIVE: To study the importance of a J shape in atrial pacing leads.
PATIENTS AND METHODS: We compared in a randomized controlled study acute and chronic results with 2 steroid-eluting, polyurethane, screw-in atrial lead models that differ only in shape. A total of 208 patients were randomized to have implantation of either a straight atrial lead (n = 105) or a J-shaped atrial lead (n = 103). Patients were followed up for 1 year.
RESULTS: On implantation, there were no significant differences between leads in rates of failure to implant, implant measurements, number of attempts to achieve an acceptable position, and fluoroscopy times. Before discharge and at 3-month and 1-year follow-up, electrical measurements showed no statistical differences between leads. During the first year after implantation, there were 2.9% early dislodgments (< 1 week after implantation) and 2.9% late dislodgments in the straight lead group (5.9% rate of all dislodgments) vs no dislodgments in the J-shaped lead group (P = .01). There was a trend toward higher rates of exit block and lead malfunction in the J-shaped lead group. Rates of pericardial complications, subclavian/axillary thrombosis, and chronic atrial fibrillation were the same in both groups.
CONCLUSIONS: Both leads appear to have an equally favorable performance profile for 1 year of follow-up. The J-shaped lead seems to be more stable and have fewer dislodgments, although it may have a somewhat higher malfunction rate.
PATIENTS AND METHODS: We compared in a randomized controlled study acute and chronic results with 2 steroid-eluting, polyurethane, screw-in atrial lead models that differ only in shape. A total of 208 patients were randomized to have implantation of either a straight atrial lead (n = 105) or a J-shaped atrial lead (n = 103). Patients were followed up for 1 year.
RESULTS: On implantation, there were no significant differences between leads in rates of failure to implant, implant measurements, number of attempts to achieve an acceptable position, and fluoroscopy times. Before discharge and at 3-month and 1-year follow-up, electrical measurements showed no statistical differences between leads. During the first year after implantation, there were 2.9% early dislodgments (< 1 week after implantation) and 2.9% late dislodgments in the straight lead group (5.9% rate of all dislodgments) vs no dislodgments in the J-shaped lead group (P = .01). There was a trend toward higher rates of exit block and lead malfunction in the J-shaped lead group. Rates of pericardial complications, subclavian/axillary thrombosis, and chronic atrial fibrillation were the same in both groups.
CONCLUSIONS: Both leads appear to have an equally favorable performance profile for 1 year of follow-up. The J-shaped lead seems to be more stable and have fewer dislodgments, although it may have a somewhat higher malfunction rate.