First long-term outcome data for the MicraVR™ transcatheter pacing system: data from the largest prospective German cohort

Sultan, Arian; Scheurlen, Cornelia; Wörmann, Jonas; van den Bruck, Jan-Hendrik; Filipovic, Karlo; Erlhöfer, Susanne; Dittrich, Sebastian; Schipper, Jan-Hendrik; Lüker, Jakob; Sinning, Jan-Malte; Nguyen, Dinh Quang; Fischer, Sören; Steven, Daniel; Winter, Stefan

doi:10.1007/s00392-023-02286-1

Cited by 2 publications

(2 citation statements)

References 15 publications

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“…Device parameters were stable at follow-up with a small but clinically insignificant decline in impedance and trivial rise in threshold, which is consistent with previously published data regarding Micra. 6 The two major findings were that the pacing burden declined significantly in the follow-up period and that there was a significant reduction in the LVEF in this cohort.…”

Section: Introductionmentioning

confidence: 74%

“…5 LPs greatly outperform transvenous systems with respect to device related infections, as the rate of infection in LPs is trivial both short and long term. 5,6 The risk of pacing induced cardiomyopathy (LVEF drop ≥10%) in pacemaker dependent patients is suggested to be equivalent or lower in those implanted with an LP (3%) versus those with a transvenous system (~13%). 7 A major drawback to the use of LPs is their inability to provide atrial pacing, which typically limits their use to patients without sinus node dysfunction.…”

Section: Introductionmentioning

confidence: 99%

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Leadless pacemakers in postoperative patients: Is it time for the new to become the normal?

Rasmussen,

Powers

2023

Cardiovasc electrophysiol

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2223ability to program the device "off" obviates the safety issues that can arise in comparison to the unpredictable asynchronous behaviors of a transvenous system at EOL. Thus, LPs could be considered a bridge to AV conduction recovery with a minimal hardware footprint for many of these patients. | LIMITATIONSThe best predictor of drop in LVEF within the cohort was a history of heart failure with reduced ejection fraction. Half of the patients with a history of heart failure with reduced ejection fraction (11/22) experienced a drop in LVEF of 10% or more. Thus, these patients would likely be better served with CRT or conduction system pacing unless there is a contraindication to transvenous pacing. LPs could be considered in patients in whom LVEF is expected to recover, but accurate clinical prediction tools for LVEF recovery are lacking and caution should be used. In contrast, the AV MICRA group had a trend towards lower LVEF, but it was not clinically meaningful (56.1% vs. 54.6%). While limited, historical data have shown valve intervention may promote restoration of sinus rhythm. 11 Thus, based on the likely benefit of maintaining AV synchrony, we suggest preferential use of MICRA AV over MICRA VR unless compelling evidence for permanent atrial fibrillation.Overall, LPs performed well in this retrospective, single center study of postoperative patients with relatively low rates of reintervention and complications. However, the evidence for drop in LVEF suggests that this patient population would benefit from a prospective study to better understand the net clinical effect of LP versus transvenous pacemaker in this population.

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Section: Introductionmentioning

confidence: 74%

Section: Introductionmentioning

confidence: 99%

Leadless pacemakers in postoperative patients: Is it time for the new to become the normal?

Rasmussen,

Powers

2023

Cardiovasc electrophysiol

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Feasibility, timing and outcome of leadless cardiac pacemaker implantation in patients undergoing cardiac implantable electronic device extraction

Kiblboeck,

Blessberger,

Ebner

et al. 2024

Clin Res Cardiol

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Background Patients requiring extraction of infected or dysfunctional cardiac implantable electronic devices (CIED) have high morbidity and mortality. The Micra™ leadless cardiac pacemaker (LCP) may be beneficial for patients requiring permanent pacemaker therapy after CIED extraction. Methods This study aimed to assess the feasibility, timing and outcomes of LCP implantation in patients who underwent CIED extraction due to infection or dysfunction. The local Micra™ LCP registry was reviewed for LCP implantations and CIED extractions. Results Micra™ LCP implantation was scheduled for 48 consecutive patients (21 women, 44%) undergoing CIED extraction for infection (n = 38, 79%) or dysfunction (n = 10, 21%), and feasible in 47 (98%). Complete CIED removal was feasible in 44 patients (92%) and in 37/38 patients with infected CIED (97%). Overall, 32 LCP (67%) were implanted in a single procedure: 3 (6%) before and 13 (27%) after CIED extraction. LCP were implanted in a single procedure in 24/38 patients (63%) with infected CIED and in 8/10 patients (80%) with dysfunctional CIED. The in-hospital mortality rate was 6% (n = 3), and the survival rates at 30 days, 90 days and 1 year were 94% (n = 45/48), 90% (n = 43/48), and 85% (n = 41/48), respectively. No recurrent LCP-related mortality or infections occurred during a median follow-up of 15 (interquartile range, 12–41) months. Conclusion Two-thirds of LCPs could be implanted in a single procedure with CIED extraction; no recurrent infections were detected. Overall, Micra™ LCP implantation in patients requiring CIED extraction was feasible. Graphical Abstract

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First long-term outcome data for the MicraVR™ transcatheter pacing system: data from the largest prospective German cohort

Cited by 2 publications

References 15 publications

Leadless pacemakers in postoperative patients: Is it time for the new to become the normal?

Leadless pacemakers in postoperative patients: Is it time for the new to become the normal?

Feasibility, timing and outcome of leadless cardiac pacemaker implantation in patients undergoing cardiac implantable electronic device extraction

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