Is the new Micra-leadless pacemaker entirely safe?

Costa, Antoine Da; Romeyer‐Bouchard, Cécile; Guichard, Jean-Baptiste; Gerbay, Antoine; Isaaz, Karl

doi:10.1016/j.ijcard.2016.03.065

Cited by 14 publications

(16 citation statements)

References 6 publications

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“…4,5 Interestingly, we proceeded with more conservative management unlike the reported cases. [3][4][5] We agree with Amin et al 4 that myocardial local irritation as a result of multiple repositions might play a role in VAs, which in turn might explain a higher impedance and longer paced QTc. Despite the underlying mechanism remains a mystery, the relationship between inflammation and ventricular arrhythmias due to cytokine-mediated myocardial remodeling has been previously published and could justify the efficacy of a conservative strategy.…”

supporting

confidence: 89%

“…Our hypothesis was that long QT was acquired due to myocardial inflammatory damage and intravenous steroids and overstimulation were empirically used in the treatment leading to a resolution of repolarization abnormalities and premature ventricular contractions ( Figure 1C).The association of Micra implantation with the development of malignant VAs has been reported in three cases to the date, as summarized in supplementary table-1. [3][4][5] In all cases, a temporal connection between the leadless PM implantation and the development of the VAs was established, as patients did not suffer before from either premature ventricular contractions or ventricular tachycardia, and in all of the cases the paced beat played a key role in their development. 4,5 Interestingly, we proceeded with more conservative management unlike the reported cases.…”

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confidence: 95%

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Ventricular arrhythmias after leadless pacemaker implantation, a case report and systematic review of the literature

Alonso

Sandín‐Fuentes

García‐Granja

et al. 2019

Cardiovasc electrophysiol

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Disclosures: Dr. J. Rubio has served as a proctor for Medtronic. Other authors: No disclosures.Leadless pacemakers emerged as a means to decrease the incidence of lead and device-related complications of traditional PMs. Micra is the leadless PM most used worldwide. Its safety was addressed on the Micra transcatheter pacing study trial with a reported success rate of 100% and has been recently confirmed in an updated of the performance of Micra in the real-world setting. 1,2 However, in the first report in 2015 among 30 adverse events in 26 patients there were two ventricular tachycardia and one ventricular fibrillation, none of them resulting in death or reoperation. Furthermore, in the update in a real-world setting, there were 13 sudden cardiac deaths among 1801 implants during a mean follow-up of 6.8 ± 6.9 months. 1,2 No consistent explanation has been proposed but ventricular arrhythmias (VA) may have a causal relationship.In the basis of our experience we present a case of an aborted sudden cardiac death due to polymorphic ventricular tachycardia (PVMT) after Micra implant in the face of an acquired long QT ( Figure 1A), telemetry showed that the mechanism of the PMVT was an "R-on-T" phenomenon after a short-long-short sequence triggered by premature ventricular contractions ( Figure 1B). Our hypothesis was that long QT was acquired due to myocardial inflammatory damage and intravenous steroids and overstimulation were empirically used in the treatment leading to a resolution of repolarization abnormalities and premature ventricular contractions ( Figure 1C).The association of Micra implantation with the development of malignant VAs has been reported in three cases to the date, as summarized in supplementary table-1. [3][4][5] In all cases, a temporal connection between the leadless PM implantation and the development of the VAs was established, as patients did not suffer before from either premature ventricular contractions or ventricular tachycardia, and in all of the cases the paced beat played a key role in their development. 4,5 Interestingly, we proceeded with more conservative management unlike the reported cases. [3][4][5] We agree with Amin et al 4 that myocardial local irritation as a result of multiple repositions might play a role in VAs, which in turn might explain a higher impedance and longer paced QTc. Despite the underlying mechanism remains a mystery, the relationship between inflammation and ventricular arrhythmias due to cytokine-mediated myocardial remodeling has been previously published and could justify the efficacy of a conservative strategy. 6 On the basis of the facts address above, we would like to underline the possible proarrhythmic effect of leadless PM implant due to traumatic myocardial inflammation. The case and the systematic review highlight how immediate ECG and short term monitoring after the procedure could be a simple strategy to early identify high-risk repolarization abnormalities that may benefit from conservative management due to its transitory nature. Long-term ...

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confidence: 89%

mentioning

confidence: 95%

Ventricular arrhythmias after leadless pacemaker implantation, a case report and systematic review of the literature

Alonso

Sandín‐Fuentes

García‐Granja

et al. 2019

Cardiovasc electrophysiol

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“…Leadless pacemaker–facilitated ventricular arrhythmias have previously been reported with the Micra pacing system. 3 , 4 , 5 Da Costa and colleagues 3 reported a case of VF temporally associated to Micra insertion but without documenting the mechanism of initiation of tachycardia such that a causal relationship cannot be ascertained. More recently, Amin and colleagues 5 and Olsen and colleagues 4 each reported a case of Micra-facilitated sustained ventricular arrhythmias, the former managed with repositioning the Micra and the latter requiring deactivation of the Micra and implantation of a transvenous pacemaker.…”

Section: Discussionmentioning

confidence: 99%

“…Pacing-facilitated ventricular arrhythmias have previously been reported after Micra implantation. 3 , 4 , 5 Here, we report the first case of bradycardia-dependent polymorphic ventricular tachycardia (PMVT) caused by atrial undersensing in a patient implanted with the Micra AV leadless pacemaker.…”

Section: Introductionmentioning

confidence: 99%

Syncope after successful implantation of atrioventricular synchronous leadless pacemaker caused by polymorphic ventricular tachycardia

Halawa

Aguilar

Sweeney

et al. 2020

HeartRhythm Case Reports

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“…It is implanted in the right ventricle via a steerable transfemoral catheter delivery system using a 23 French introducer [5]. Due to its implantation into the myocardial wall via the femoral vein, the main sources of potential complications (e.g., subcutaneous pockets, permanent leads) are eliminated [6, 7]. …”

Section: Introductionmentioning

confidence: 99%

Visualization and appearance of artifacts of leadless pacemaker systems in cardiac MRI

Edlinger

Granitz

Paar

et al. 2018

Wien Klin Wochenschr

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SummaryBackgroundLeadless pacemaker systems are an important upcoming device in clinical rhythmology. Currently two different products are available with the Micra system (Medtronic) being the most used in the clinical setting to date. The possibility to perform magnetic resonance imaging (MRI) is an important feature of modern pacemaker devices. Even though the Micra system is suitable for MRI, little is yet known about its impact on artifacts within the images.ObjectiveThe aim of our ex vivo study was to perform cardiac MRI to quantify the artifacts and to evaluate if artifacts limit or inhibit the assessment of the surrounding myocardium.MethodsAfter ex vivo implantation of the leadless pacemaker (LP) in a porcine model, hearts were filled with saline solution and fixed on wooden sticks on a plastic container. The model was examined at 1.5 T and at 3 T using conventional sequences and T2 mapping sequences. In addition, conventional X‑rays and computed tomography (CT) scans were performed.ResultsCorrect implantation of the LP could be performed in all hearts. In almost all MRI sequences the right ventricle and the septal region surrounding the (LP) were altered by an artifact and therefore would sustain limited assessment; however, the rest of the myocardium remained free of artifacts and evaluable for common radiologic diagnoses. A characteristic shamrock-shaped artifact was generated which appeared to be even more intense in magnitude and brightness when using 3 T compared to 1.5 T.ConclusionThe use of the Micra system in cardiac MRI appeared to be feasible. In our opinion, it will still be possible to make important clinical cardiac MRI diagnoses (the detection of major ischemic areas or inflammatory processes) in patients using the Micra system. We suggest the use of 1.5 T as the preferred method in clinical practice.

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Is the new Micra-leadless pacemaker entirely safe?

Cited by 14 publications

References 6 publications

Ventricular arrhythmias after leadless pacemaker implantation, a case report and systematic review of the literature

Ventricular arrhythmias after leadless pacemaker implantation, a case report and systematic review of the literature

Syncope after successful implantation of atrioventricular synchronous leadless pacemaker caused by polymorphic ventricular tachycardia

Visualization and appearance of artifacts of leadless pacemaker systems in cardiac MRI

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