2017
DOI: 10.1016/j.hrthm.2017.05.017
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A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Abstract: Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99.6%) of implant success and low rate (1.51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.

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Cited by 275 publications
(263 citation statements)
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“…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%
See 1 more Smart Citation
“…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%
“…Leadless pacemakers eliminate pocket‐related infections and have the potential to reduce lead‐related endocarditis. In the Micra leadless pacemaker investigational device exemption (IDE) study and post approval registry (PAR) no Micra device‐related infections or any infections requiring device removal were observed . Hence, Micra in the setting of device infection might be an appealing pacing alternative after CIED removal.…”
Section: Introductionmentioning
confidence: 99%
“…During the initial experience, the device has been preferentially deployed in the right ventricular (RV) apex . Thereafter, the implantation of the device in a septal position has been associated with a reduction of major complications including cardiac perforation and effusion . Recently, two reports have confirmed the safety and the favorable long‐term electrical performance of the mid‐septal implantation of the device in high‐risk population .…”
Section: Introductionmentioning
confidence: 99%
“…In a comparison between historical controls and leadless pacing implants, the relative risk of major complications was reduced by 48% with the leadless technology [73]. The data of the ‘real world’ MICRA leadless pacemaker have recently confirmed the short-term reliability of this type of device implant [74,75]. The major drawback of this technology is the limitation of single-chamber pacing, as well as the high cost.…”
Section: The Future Of Electrical Therapies In Laminopathiesmentioning
confidence: 99%
“…The major drawback of this technology is the limitation of single-chamber pacing, as well as the high cost. The single chamber pacemaker is a device that can be proposed for 15–20% % of patients with bradyarrhythmias [72,74]. In patients with neuromuscular disorder (such as Emery-Dreifuss muscular dystrophy) with atrial fibrillation or atrial standstill, who do not present indications for a defibrillator, implant of a leadless pacemaker could represent an emerging option in appropriately selected cases.…”
Section: The Future Of Electrical Therapies In Laminopathiesmentioning
confidence: 99%