Why the study?
To compare complication rates and CRT response between patients implanted with a novel two-lead CRT-DX system and those implanted with a standard three-lead CRT-D system.
Does a two-lead CRT-DX system improve complication-free survival compared to a standard three-lead CRT-D system in patients requiring cardiac resynchronization therapy?
Population
240 subjects selected into 120 matched pairs from a postapproval study
Comparison
Two-lead CRT-DX system vs standard three-lead CRT-D system
Design
Matched-pair cohort subanalysis
Follow-up
Mean follow-up of 1.3 and 1.4 years
Key result
The two-lead CRT-DX system resulted in a higher complication-free survival rate compared to a standard three-lead CRT-D system (92.5% vs 85.0%; 95% CI 0.1-14.9%; P=0.0495).
Authors
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May support two-lead CRT-DX to reduce complications in CRT candidates; leaves open need for randomized confirmation.
Cohort (n=240)
Does a two-lead CRT-DX system improve complication-free survival compared to a standard three-lead CRT-D system in patients requiring cardiac resynchronization therapy?
Absolute Event Rate: 92.5% vs 85%
p-value: p=0.0495
A two-lead CRT-DX system provides similar clinical responses with significantly fewer complications and inappropriate shocks compared to a conventional three-lead CRT-D system.
Shaik et al. (2020) conducted a cohort in Heart failure requiring cardiac resynchronization therapy (n=240). Two-lead CRT-DX system vs. Standard three-lead CRT-D system was evaluated on Complication-free rate (95% CI 0.1-14.9, p=0.0495). The two-lead CRT-DX system resulted in a higher complication-free survival rate compared to a standard three-lead CRT-D system (92.5% vs 85.0%; 95% CI 0.1-14.9%; P=0.0495).
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