Leadless pacemakers reduce risk of device-related infection: Review of the potential mechanisms

El‐Chami, Mikhael F.; Bonner, Matthew; Holbrook, Reece; Stromberg, Kurt; Mayotte, Jane; Molan, Amy; Sohail, M. Rizwan; Epstein, Laurence M.

doi:10.1016/j.hrthm.2020.03.019

Cited by 98 publications

(86 citation statements)

References 43 publications

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“…These results were further replicated in the Micra post‐approval study that showed a 99% implant success rate and a 63% reduction in complications as compared to traditional TV‐PPM 3 . Recent data also suggest that an additional advantage of this new technology is a very low infection risk 4–7 …”

Section: Introductionmentioning

confidence: 79%

“…Previous reports have demonstrated the feasibility of using the Micra TPS as a bridge in patients who underwent device extraction from systemic infections 20 . Potential mechanisms of infection resistance inherent to the design of the leadless mechanism have been postulated 4 . First, the surface area of the Micra is considerably smaller (∼616 mm 2 ) than a conventional transvenous pacing lead (∼3500 mm 2 ) 4 .…”

Section: Discussionmentioning

confidence: 99%

“…Potential mechanisms of infection resistance inherent to the design of the leadless mechanism have been postulated 4 . First, the surface area of the Micra is considerably smaller (∼616 mm 2 ) than a conventional transvenous pacing lead (∼3500 mm 2 ) 4 . In addition, device encapsulation might be protective against bacterial infiltration.…”

Section: Discussionmentioning

confidence: 99%

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Life cycle management of Micra transcatheter pacing system: Data from a high‐volume center

Kiani

Merchant

Delurgio

et al. 2020

Cardiovasc electrophysiol

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Background Data on the management of Micra transcatheter pacing system (TPS) at the time of an upgrade or during battery depletion is limited. Objective We sought to evaluate the management patterns of patients implanted with a Micra TPS during long‐term follow‐up. Methods We retrospectively identified patients who underwent Micra implantation from April 2014 to November 2019. We identified patients who underwent extraction (n = 11) or had an abandoned Micra (n = 12). Results We identified 302 patients who received a Micra during the period of the study. Mean age was 72.7 ± 15.4 years, 54.6% were men, and left ventricular ejection fraction was 51.9 ± 5.2%. Mean follow‐up was 1105.5 ± 529.3 days. Procedural complications included pericardial tamponade (n = 1) treated with pericardiocentesis, significant rise in thresholds (n = 6) treated with reimplantation (n = 4), and major groin complications (n = 2). Indications for extraction included an upgrade to cardiac resynchronization therapy (CRT) device (n = 3), bridging after extraction of an infected transvenous system (n = 3), elevated thresholds (n = 3), and non‐Micra‐related bacteremia (n = 2). The median time from implantation to extraction was 78 days (interquartile range: 14–113 days), with the longest extraction occurring at 1442 days. All extractions were successful, with no procedural or long‐term complications. Indications for abandonment included the need for CRT (n = 6), battery depletion (n = 2), increasing thresholds/failure to capture (n = 3), and pacemaker syndrome (n = 1). All procedures were successful, with no procedural or long‐term complications. Conclusion In this large single‐center study, 6% of patients implanted with a Micra required a system modification during long‐term follow‐up, most commonly due to the requirement for CRT pacing. These patients were managed successfully with extraction or abandonment.

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Section: Introductionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Life cycle management of Micra transcatheter pacing system: Data from a high‐volume center

Kiani

Merchant

Delurgio

et al. 2020

Cardiovasc electrophysiol

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“…1,2 The LP is particularly useful in patients with high risk of infection (for instance, those on dialysis or with a history of endocarditis), pacemaker-dependent patients with bacteremia at the time of a transvenous lead extraction, or those with occluded upper extremity venous vasculature. [3][4][5] The Micra-transcatheter pacing system (Micra-TPS; Medtronic Inc.) is the only commercially available LP.…”

Section: Introductionmentioning

confidence: 99%

“…They avoid the complications inherent to transvenous devices, including pocket hematomas, device infections, pneumothoraces, lead failures, chronic venous occlusions, and tricuspid valve regurgitation 1,2 . The LP is particularly useful in patients with high risk of infection (for instance, those on dialysis or with a history of endocarditis), pacemaker‐dependent patients with bacteremia at the time of a transvenous lead extraction, or those with occluded upper extremity venous vasculature 3‐5 . The Micra‐transcatheter pacing system (Micra‐TPS; Medtronic Inc.) is the only commercially available LP.…”

Section: Introductionmentioning

confidence: 99%

Implantation of leadless pacemakers via inferior vena cava filters is feasible and safe: Insights from a multicenter experience

Houmsse

Karki

Gabriels

et al. 2020

Cardiovasc electrophysiol

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Background: The leadless Micra transcatheter-pacing system (Micra-TPS) is implanted via a femoral approach using a 27-French introducer sheath. The Micra Transcutaneous Pacing Study excluded patients with inferior vena cava (IVC) filters. Objective: To examine the feasibility and safety of Micra-TPS implantation through an IVC filter. Methods: This multicenter retrospective study included patients with an IVC filter who underwent a Micra-TPS implantation. Data for clinical and IVC filter characteristics, preprocedure imaging, and procedural interventions were collected. The primary outcome was a successful leadless pacemaker (LP) implantation via a femoral approach in the presence of an IVC filter. Periprocedural and delayed clinical complications were also evaluated. Results: Of the 1528 Micra-TPS implants attempted, 23 patients (1.5%) had IVC filters. The majority (69.6%) of IVC filters were permanent. Six (26.1%) patients underwent preprocedural imaging to assess for filter patency. One patient's filter was retrieved before LP implantation. The primary outcome was achieved in 21 of 22 patients (95.5%) with an existing IVC filter. An occluded IVC precluded LP implantation in one patient. Difficulty advancing the stiff guidewire or the 27-Fr sheath was encountered in five patients. These cases required repositioning of the wire (n = 2), gradual sheath upsizing (n = 2), or balloon dilation of the filter (n = 1). Postprocedure fluoroscopy revealed intact filters in all cases. During a median 6-month follow-up, there were no clinical complications related to the filter or the Micra-TPS.

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Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

et al. 2021

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IMPORTANCEThe safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined. OBJECTIVE To compare patient characteristics and complications among patients implanted with leadless VVI and transvenous VVI pacemakers. DESIGN, SETTING, PARTICIPANTS The Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted between March 9, 2017, and December 1, 2018, were identified and included. All Medicare patients implanted with leadless VVI and transvenous VVI pacemakers during the study period were enrolled. Patients with less than 12 months of continuous enrollment in Medicare prior to leadless VVI or transvenous VVI implant and with evidence of a prior cardiovascular implantable electronic device were excluded, leaving 5746 patients with leadless VVI pacemakers and 9662 patients with transvenous VVI pacemakers. Data were analyzed from May 2018 to April 2021. EXPOSURES Medicare patients implanted with leadless VVI pacemakers or transvenous VVI pacemakers. MAIN OUTCOMES AND MEASURESThe main outcomes were acute (30-day) complications and 6-month complications. RESULTSOf 15 408 patients, 6701 (43.5%) were female, and the mean (SD) age was 81.0 (8.7) years. Compared with patients with transvenous VVI pacemakers, patients with leadless VVI pacemakers were more likely to have end-stage kidney disease (690 [12.0%] vs 226 [2.3%]; P < .001) and a higher mean (SD) Charlson Comorbidity Index score (5.1 [3.4] vs 4.6 [3.0]; P < .001). The unadjusted acute complication rate was higher in patients with leadless VVI pacemakers relative to transvenous VVI pacemakers (484 of 5746 [8.4%] vs 707 of 9662 [7.3%]; P = .02). However, there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%; risk difference, 0.3; 95% CI, −0.6 to 1.3; P = .49). Pericardial effusion and/or perforation within 30 days was significantly higher among patients with leadless VVI pacemakers compared with patients with transvenous VVI pacemakers in both unadjusted and adjusted models (unadjusted, 47 of 5746 [0.8%] vs 38 of 9662 [0.4%]; P < .001; adjusted, 0.8% vs 0.4%; risk difference, 0.4; 95% CI, 0.1 to 0.7; P = .004). Patients implanted with leadless VVI pacemakers had a lower rate of 6-month complications compared with patients implanted with transvenous VVI pacemakers (unadjusted hazard ratio, 0.84; 95% CI, 0.68-1.03; P = .10; adjusted hazard ratio, 0.77; 95% CI, 0.62-0.96; P = .02). CONCLUSIONS AND RELEVANCEIn this study, despite significant differences in patient characteristics, patients in whom a leadless pacemaker was implanted were observed to have higher rates of pericardial effusion and/or perforation but lower rates...

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Leadless pacemakers reduce risk of device-related infection: Review of the potential mechanisms

Cited by 98 publications

References 43 publications

Life cycle management of Micra transcatheter pacing system: Data from a high‐volume center

Life cycle management of Micra transcatheter pacing system: Data from a high‐volume center

Implantation of leadless pacemakers via inferior vena cava filters is feasible and safe: Insights from a multicenter experience

Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

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