Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control

El‐Chami, Mikhael F.; Alsamadi, Faisal; Clementy, N; Garweg, Christophe; Martínez‐Sande, José Luis; Piccini, Jonathan P.; Iacopino, Saverio; Lloyd, Michael S.; Prat, Xavier Viñolas; Jacobsen, Mia Ravn; Ritter, Philippe; Johansen, Jens Brock; Tondo, Claudio; Liu, Fang; Fagan, Dedra H.; Eakley, Alyssa K.; Roberts, Paul R.

doi:10.1016/j.hrthm.2018.08.005

Cited by 281 publications

(309 citation statements)

References 12 publications

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“…Six major complications occurred in four patients that were related to the Micra procedure or system (Table ). These complications have been reported previously …”

Section: Resultssupporting

confidence: 69%

“…The design and rationale for of the Micra PAR study (ClinicalTrials.gov identifier: NCT02536118) have been reported previously . Briefly, the aim of the Micra PAR is to further evaluate short‐ and long‐term safety and performance of the Micra transcatheter pacing system (TPS) when used in the “real‐world” setting following commercial release.…”

Section: Methodsmentioning

confidence: 99%

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Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

El‐Chami

Johansen

Zaidi

et al. 2019

Cardiovasc electrophysiol

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114

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IntroductionLeadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt.Methods and ResultsPatients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT‐D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow‐up duration was 8.5 ± 7.1 months (range 0‐28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1‐7). During follow‐up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection.ConclusionImplantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

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“…Six major complications occurred in four patients that were related to the Micra procedure or system (Table ). These complications have been reported previously …”

Section: Resultssupporting

confidence: 69%

Section: Methodsmentioning

confidence: 99%

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

El‐Chami

Johansen

Zaidi

et al. 2019

Cardiovasc electrophysiol

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114

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“…So far, there is a single published case report of a Micra transcatheter pacemaker infection in a patient with prior urinary tract infection and multiple hospitalizations. However, recent prospective studies of this novel leadless pacing technology resulted in the observation of no device‐involved infections despite 2,521 implanted devices followed for 12 months or more 8,10 . This study provides evidence that the coating material for the Micra transcatheter pacemaker, parylene, is more resistant to adhesion by common pathogens that cause pacemaker infections compared to titanium or polyurethane.…”

Section: Discussionmentioning

confidence: 76%

“…Leadless pacemakers eliminate the need for a subcutaneous pocket and associated generator pocket infections. Interestingly, no cases of hematogenous device infections were seen either in any of the leadless pacemaker clinical trials 7–10 . Recently, a provocative clinical observation derived from the Micra transcatheter pacemaker IDE trial showed the absence of device infection in the setting of documented bacteremia or endocarditis 11 .…”

Section: Introductionmentioning

confidence: 99%

Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers

El‐Chami

Mayotte

Bonner

et al. 2020

Cardiovasc electrophysiol

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Introduction Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. Methods Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. Results The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P < .001] and 5.51 ± 0.27 and 6.08 ± 0.11 log[CFU/mL] respectively for P. aeruginosa [P < .001]), and for parylene coated titanium versus polyurethane samples (4.27 ± 0.42 and 5.40 ± 0.49 log[CFU/mL] respectively for S. aureus [P < .001] and 4.23 ± 0.42 and 4.84 ± 0.32 log[CFU/mL] respectively for P. aeruginosa [P = .006]). Parylene coated titanium samples had a higher contact angle compared with bare titanium, but lower compared with polyurethane (mean contact angle 87.5 ± 3.1 degrees parylene, 73.3 ± 3.7 degrees titanium [P < .001 vs parylene], and 94.8 ± 3.7 degrees polyurethane [P = .002 vs parylene]). Conclusions Parylene coating significantly reduced the ability of bacteria to grow in colony count assays suggesting that this could contribute to the reduction of bacterial infections of Micra transcatheter pacemakers.

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“…Improvements in battery technology and advanced electrical circuitry brought about leadless pacemakers, miniaturized self-contained intracardiac single-chamber pacemakers delivered in the right ventricle through a percutaneous transfemoral catheter based approach [9, 10]. Two systems have been clinically available now for several years and showed clinical efficacy and safety [9–13]. However, existing leadless pacing systems and the S‑ICD are only available for patients requiring single-chamber right ventricular (RV) pacing or shock-only defibrillation therapy, respectively.…”

Section: Introductionmentioning

confidence: 99%

The modular cardiac rhythm management system: the EMPOWER leadless pacemaker and the EMBLEM subcutaneous ICD

Tjong

Koop

2018

Herzschr Elektrophys

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Cardiac implantable electronic devices have been successfully treating patients with brady- and tachyarrhythmias for decades. However, there are still significant complications related to this therapy modality, many related to the transvenous lead. Paradigm-shifting technologies, such as the subcutaneous implantable cardioverter–defibrillator (S-ICD) and leadless cardiac pacemakers (LCP), have emerged to address these complications. The novel modular cardiac rhythm management (mCRM) system, consisting of a communicating antitachycardia pacing-enabled LCP and S‑ICD, is the first system to integrate wireless intrabody communication between devices to allow for coordination of leadless pacing and defibrillator therapy delivery. In this review, the design and concept of the mCRM system are presented and available evidence is summarized.

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Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control

Abstract: Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.

Cited by 281 publications

References 12 publications

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers

The modular cardiac rhythm management system: the EMPOWER leadless pacemaker and the EMBLEM subcutaneous ICD

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