Cleveland Clinic study reveals leadless pacemakers cut patient complications

Patients who received leadless pacemakers experienced fewer short-term and mid-term complications overall than those who had traditional transvenous pacemakers, a Cleveland Clinic-led research study found.

Seven things to know:

1. Traditional pacemakers have wires, or leads, that stretch from the shoulder vein and attach to the heart. Previous research revealed these wires and the surgical implantation are the most common source of complications, occurring in up to 12 percent of device recipients.

But leadless pacemakers do not require wires and are about 10 percent of the size of a traditional pacemaker. Leadless pacemakers are placed directly into the heart using a catheter that goes through the femoral vein in the leg.

2. To see how the pacemakers compared, the study authors examined short- and mid-term complications between 718 patients receiving a leadless pacemaker and 1,436 patients with conventional (transvenous) pacemakers.

3. At one month, the study found patients receiving one type of leadless pacemaker (Nanostim) had fewer complications overall (5.8 percent versus 9.4 percent). The leadless pacemakers eliminated lead and pocket complications, including infection.

4. Among traditional pacemaker recipients, the study authors found lead complications (3.62 percent), pocket complications (0.42 percent) and infection (1.74 percent).

5. Leadless pacemaker recipients had an increased risk of developing pericardial effusion, or bleeding between the heart and the sac that surrounds the heart (1.53 percent versus 0.35 percent), the study found. Although these complications were uncommon, they required surgery in some cases.

6. The study found that beyond one month and up to 18 months of follow-up, leadless patients continued to experience overall fewer complications than transvenous patients (0.56 percent vs. 4.94 percent). Conventional pacemaker recipients saw several complications not present in the leadless group, including lead-related complications, electrode dislodgement, infection and pocket complications.

7. "The data from this study is encouraging, and we expect complications from leadless pacemakers to continue to decline as the technology improves and physicians gain experience implanting these devices," said lead study author Daniel Cantillon, MD.

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