OBJECTIVE: In this prospective, randomized, control study we compared performance of J-shaped (JL) and straight atrial leads (SL) with active (screw-in) fixation mechanism, over a 5-year follow-up period. SUBJECTS AND METHODS: A total of 208 consecutive patients were randomized for implantation with a Medtronic 4568 JL model (n = 103) versus a Medtronic 4068 SL model (n = 105), and all lead-related measurements and complications were recorded. RESULTS: Lead-related complications occurred in JL and SL with similar frequency (6% and 9%, respectively, P = 0.45). Lead dislodgment occurred in 8 (7.8%) cases in SL versus none in JL (P = 0.004). Lead malfunction and excessive pacing thresholds without macrodislodgment occurred more frequently in JL (11; 10.7%) than in SL (4; 3.8%), P = 0.055. Lead material failure (insulation break) occurred only once in SL at the 5-year checkup. Most complications occurred during the first year after implantation. Other events occurred in both leads with similar frequency and included: death in 39 and 35, loss of follow-up in 8 and 6, and development of atrial fibrillation in 9 and 15 patients, respectively. Of those who completed follow-up, lead impedance and pacing threshold increased significantly in both groups. P wave decreased in SL but not in JL. CONCLUSION: More dislocations occurred in SL, but were counterbalanced by more lead malfunctions and excessive pacing thresholds in the JL group. Both leads demonstrated minor deterioration in electrical measurements during follow-up, with only 1 case of lead material failure in SL. Overall, both groups demonstrated favorable lead performance throughout follow-up.
RCT Entities:
OBJECTIVE: In this prospective, randomized, control study we compared performance of J-shaped (JL) and straight atrial leads (SL) with active (screw-in) fixation mechanism, over a 5-year follow-up period. SUBJECTS AND METHODS: A total of 208 consecutive patients were randomized for implantation with a Medtronic 4568 JL model (n = 103) versus a Medtronic 4068 SL model (n = 105), and all lead-related measurements and complications were recorded. RESULTS: Lead-related complications occurred in JL and SL with similar frequency (6% and 9%, respectively, P = 0.45). Lead dislodgment occurred in 8 (7.8%) cases in SL versus none in JL (P = 0.004). Lead malfunction and excessive pacing thresholds without macrodislodgment occurred more frequently in JL (11; 10.7%) than in SL (4; 3.8%), P = 0.055. Lead material failure (insulation break) occurred only once in SL at the 5-year checkup. Most complications occurred during the first year after implantation. Other events occurred in both leads with similar frequency and included: death in 39 and 35, loss of follow-up in 8 and 6, and development of atrial fibrillation in 9 and 15 patients, respectively. Of those who completed follow-up, lead impedance and pacing threshold increased significantly in both groups. P wave decreased in SL but not in JL. CONCLUSION: More dislocations occurred in SL, but were counterbalanced by more lead malfunctions and excessive pacing thresholds in the JL group. Both leads demonstrated minor deterioration in electrical measurements during follow-up, with only 1 case of lead material failure in SL. Overall, both groups demonstrated favorable lead performance throughout follow-up.