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Study Design

Key Result 1

Patients undergoing a straight forward CRM generator replacement (cohort 1), without plans to add or revise a lead, experienced a major complication rate of 4.0%, a major periprocedural event rate of 0.2%, a minor complication rate of 7.4%, and an infection rate of 1.4%.

Key Result 2

Patients undergoing a generator replacement with a plan to add or revise existing leads (cohort 2) experienced a major complication rate of 15.3%, a major periprocedure event rate of 2.4%, a minor complication rate of 7.6%, and an infection rate of 1.1%.

Key Result 3

In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%)

Clinical Relevance

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