Device longevity of a leadless pacemaker family

Figure 1.. Projected longevity distributions for the Micra leadless pacemaker family of devices using Micra VR IDE patients and Micra AV patients on CareLink. Using pacing distributions from 644 patients as input, the device longevity model predicted a median estimated device longevity of 12.3 and 16.7 years for Micra VR and VR2, respectively. Using pacing distributions from 999 patients as input, the model predicted a median estimated device longevity of 10.8 and 15.6 years for Micra AV and AV2, respectively. IDE = investigational device exemption trial.

Figure 2.. Percentage of patients projected to need only one device for life. For Micra VR, 85% of patients would require only one device. For Micra VR2, 91% of patients would require only one device for life. Similarly, 70% of the Micra AV patients would require only one device and 80% of Micra AV2 patients would require only one device.

Figure 3.. Projected number of lifetime device replacements per 100 patients for each type of leadless pacemaker. Based on the percentage of patients that are served with one or two devices during their lifetime, the corresponding number of patients who require device replacement(s) was calculated for each type of leadless pacemaker. The cumulative number of device replacements was calculated per 100 pacemaker patients, and the incremental number of device replacements was assessed for Micra AV2 vs. Micra AV, and for Micra VR2 vs. Micra VR. Analyses estimating the number of devices avoided were also performed for the subset of pacemaker-dependent patients with greater than 90% ventricular pacing and were further stratified by age at index device implant (greater than 65 years and less than 65 years). AV = Micra AV; AV2 = Micra AV2; VR = Micra VR; VR2 = Micra VR2.