A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Roberts, Paul R.; Clémenty, Nicolas; Samadi, Faisal Al; Garweg, Christophe; Martínez‐Sande, José Luis; Iacopino, Saverio; Johansen, Jens Brock; Prat, Xavier Viñolas; Kowal, Robert C.; Klug, Didier; Mont, Lluís; Steffel, Jan; Li, Shelby; Osch, Dirk van; El‐Chami, Mikhael F.

doi:10.1016/j.hrthm.2017.05.017

Cited by 264 publications

(247 citation statements)

References 9 publications

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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%

“…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%

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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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103

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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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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

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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103

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“…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%

Leadless pacing with Micra TPS: A comparison between right ventricular outflow tract, mid‐septal, and apical implant sites

Garweg

Vandenberk

Foulon

et al. 2019

Cardiovasc electrophysiol

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Background With its steerable transcatheter delivery system, the Micra can be deployed in nonapical positions within the right ventricle, potentially allowing reduction of the paced QRS width. We sought to evaluate the safety and long‐term performance of the right ventricular outflow tract (RVOT) pacing using the Micra transcatheter pacing system (TPS). We also compared the paced QRS between RVOT, mid‐septal, and apical implant positions. Methods All patients who underwent a Micra TPS implantation at the University Hospitals of Leuven were enrolled in this observational study. Right ventricular (RV) position of the device was assessed on per‐procedural ventriculography. Paced QRS was analyzed and follow‐up completed at 1 month and then every 6 months. Results Among the 133 patients included (mean follow‐up: 13 ± 11 months), 45 were implanted in the RVOT, 58 midseptally, and 30 at the apex. All implant procedures were successful and no pericardial effusion was encountered within the 30 days post‐implant. Two major complications were reported with devices implanted at the apex. Pacing impedance was significantly higher in the RVOT compared to the mid‐septal and apical position (P < .001). Pacing threshold and R‐wave amplitude did not differ over time in either position. The median narrowest paced QRS duration was observed in the RVOT (142 ms) compared to mid‐septal (159 ms; P < .001), and apical position (181 ms; P < .001). Conclusion Implantation of the Micra TPS in the RVOT is safe and feasible. Electrical performance over time was comparable to mid‐septal and apical positions. The narrowest paced QRS complexes is achieved with RVOT pacing.

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“…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%

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

Boriani

Biagini

Ziacchi

et al. 2018

Nucleus

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Lamin A/C gene mutations can be associated with cardiac diseases, usually referred to as ‘cardiolaminopathies’ characterized by arrhythmic disorders and/or left ventricular or biventricular dysfunction up to an overt picture of heart failure. The phenotypic cardiac manifestations of laminopathies are frequently mixed in complex clinical patterns and specifically may include bradyarrhythmias (sinus node disease or atrioventricular blocks), atrial arrhythmias (atrial fibrillation, atrial flutter, atrial standstill), ventricular tachyarrhythmias and heart failure of variable degrees of severity. Family history, physical examination, laboratory findings (specifically serum creatine phosphokinase values) and ECG findings are often important ‘red flags’ in diagnosing a ‘cardiolaminopathy’. Sudden arrhythmic death, thromboembolic events or stroke and severe heart failure requiring heart transplantation are the most dramatic complications of the evolution of cardiolaminopathies and appropriate risk stratification is clinically needed combined with clinical follow-up. Treatment with cardiac electrical implantable devices is indicated in case of bradyarrhythmias (implant of a device with pacemaker functions), risk of life-threatening ventricular tachyarrhythmias (implant of an ICD) or in case of heart failure with wide QRS interval (implant of a device for cardiac resynchronization). New technologies introduced in the last 5 years can help physicians to reduce device-related complications, thanks to the extension of device longevity and availability of leadless pacemakers or defibrillators, to be implanted in appropriately selected patients. An improved knowledge of the complex pathophysiological pathways involved in cardiolaminopathies and in the determinants of their progression to more severe forms will help to improve clinical management and to better target pharmacological and non-pharmacological treatments.

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A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Cited by 264 publications

References 9 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

Leadless pacing with Micra TPS: A comparison between right ventricular outflow tract, mid‐septal, and apical implant sites

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

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