Prospective trial - cohort 1 without and cohort 2 with upgrade and addition of lead
Major complications occurred in 4% of 1031 cohort 1 patients. and 15.3% of 713 cohort 2 patients.
In both cohorts complications were highest with ICD compared with PPM generator replacements.
Complications were highest in patients who had an upgrade to a CR device (18.7%)
The 6-month infection rate were 1.4% for cohort 1 and 1.1% for cohort 2