Patients who’ve received leadless pacemakers experience fewer complications than traditional pacers, according to a new study from the Cleveland Clinic.
Results from the study were published in the journal Heart Rhythm.
Investigators in the multi-center study compared short and mid-term complications between 718 patients who received Abbott‘s (NYSE:ABT) Nanostim leadless pacer and 1,436 patients who received conventional pacers, Cleveland Clinic reports.
Data from the Nanostim patients were taken from Abbott’s Leadless II trial, while transvenous patient data were acquired from the Truven Health MarketScan claims databases for patients with single-chamber pacers from between April 2010 and March 2014.
Results indicated that at one month, patients who received the leadless Nanostim experienced fewer complications, at 5.8% as compared to 9.4% of patients who received traditional pacers.
Patients who received leadless pacemakers were free from lead and pocket complications, including infection, which occurred in 3.6% and 0.4% of traditional pacer recipients, respectively. The rate of infection amongst traditional pacemaker patients was 1.7%.
No significant differences between groups were reported in relation to vascular complications, electrode dislodgment or generator complications.
In contrast, patients receiving leadless pacers were reported to be at higher risk of developing pericardial effusions, at approximately 1.5% versus 0.4% in those receiving traditional pacers, according to the Cleveland Clinic.
Results indicated that leadless patients experienced fewer complications out to 18 months when compared to transvenous patients, at approximately 0.6% and 4.9%, respectively.
“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. While this research shows benefit for leadless pacing, we must keep in mind that the field is still too young to compare the long-term results of this technology, the implications of which will not be fully understood for at least another decade,” study author Dr. Daniel Cantillon of the Cleveland Clinic said in a press release.
In February, Abbott’s Nanostim pacer was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign.