Leadless pacemaker confers similar complications, survival at 30 days as transvenous device
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Patients who received a leadless pacemaker had similar rates of acute complications and survival at 30 days as those who received a transvenous VVI pacemaker, according to data presented at the virtual Heart Rhythm Society Annual Scientific Sessions.
In addition, patients who received the leadless pacemaker (Micra transcatheter pacing system, Medtronic) had fewer complications at 6 months compared with the transvenous VVI pacemaker, according to the presentation.
“The Micra leadless pacemaker is associated with a two-thirds reduction in complications at 6 months with no difference in survival or complications at 30 days,” Cardiology Today Editorial Board Member Jonathan P. Piccini, MD, MHS, FHRS, associate professor of medicine and director of cardiac electrophysiology at Duke University Medical Center, said during a press conference.
Medicare claims data
In this study, researchers analyzed Medicare claims data from patients who were undergoing de novo VVI pacemaker implantation between March 2017 and December 2018 and had 12 months of data before device implantation. Patients received Micra implants (n = 5,746; mean age, 79 years; 44% women) or transvenous VVI pacemakers (n = 9,662; mean age, 82 years; 43% women).
“The Micra [Coverage with Evidence Development] study ... had three main objectives: to assess the rate of complications between Micra and transvenous pacemakers at 30 days and 6 months, to evaluate the need for device revision and also to assess all-cause mortality,” Piccini said during the press conference.
The Micra group was more likely to have higher Charlson comorbidity index scores (5.1 vs. 4.6; P < .0001) and end-stage renal disease (12% vs. 2.3%; P < .0001) compared with the transvenous VVI pacemaker group.
At 30 days, there were no significant differences in overall acute complications in the Micra and transvenous VVI pacemaker groups (7.7% vs. 7.4%, respectively). Patients implanted with the Micra had lower rates of device-related complications (1.4% vs. 2.5%; P < .05) and higher rates of cardiac effusions/perforations (0.8% vs. 0.4%; P < .05) and events at the puncture site (1.2% vs. 0.3%; P < .05) compared with those treated with transvenous VVI pacemakers.
Complications were also assessed at 6 months, during which overall complications were lower in the Micra group vs. the transvenous VVI pacemaker group (3.3% vs. 9.4%). This group also had fewer device-related complications compared with patients implanted with transvenous VVI pacemakers (1.7% vs. 3.4%).
Patients in the Micra group had a 66% reduction in the risk for complications through 6 months compared with those in the transvenous VVI pacemaker group (HR = 0.34; 95% CI, 0.28-0.43). The Micra group also had a lower rate of system revision compared with the transvenous group, although it was not statistically significant (2.8% vs. 1.7%; HR = 0.63; 95% CI, 0.36-1.12).
The Micra and transvenous VVI pacemaker groups had similar rates of mortality at 30 days and 6 months (HR = 1; 95% CI, 0.89-1.12).
Impact on conducting studies
“This study also demonstrates that we can use data from real-world evidence for comparative effectiveness studies without the need for in-person visits to supplement effectiveness data in the general population with respect to new electrophysiologic interventions such as leadless pacing,” Piccini said during the press conference. – by Darlene Dobkowski
Reference:
Piccini JP, et al. LBCT04-01. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).
Disclosures: The study was funded by Medtronic. Piccini reports he receives support from the NHLBI; receives grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific and Philips; and consults for Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, MyoKardia, Philips, Sanofi and UpToDate.
Perspective
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Jodie L. Hurwitz, MD, FHRS
Some important take-home messages are that leadless pacing in appropriate patient populations is available and here to stay. This study shows in a large real-world population that leadless pacemakers have the ability to eliminate the risks seen with device leads.
There is a patient population where leadless pacemakers should be considered rather than transvenous pacemakers. The worry that these leadless pacemakers are not as effective or have more complications is not supported when real-world data are evaluated.
It would be interesting to see results of a randomized trial of leadless vs. transvenous single-chamber ventricular pacing. It will also be interesting to see studies looking to minimize access problems and evaluate learning curves.
Leadless pacing is the way of the future. Leads are a major problem with available transvenous devices. Keep your eye out for devices that sense in both the atrium and ventricle.
Collapse
Piccini JP, et al. LBCT04-01. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).
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