To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker

Grubman, Eric; Ritter, Philippe; Ellis, Christopher R.; Giocondo, Michael J; Augostini, Ralph; Neužil, Petr; Ravindran, Bipin; Patel, Ankit; Omdahl, Pamela; Pieper, Karen S.; Stromberg, Kurt; Hudnall, J. Harrison; Reynolds, Dwight

doi:10.1016/j.hrthm.2017.07.015

Cited by 66 publications

(60 citation statements)

References 16 publications

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“…Here, we use the term “retrieval” to discuss any acute or short‐term device removal, and “extraction” to discuss encapsulated, chronic implants. Notably, there is a relatively modest, but growing, volume of knowledge surrounding acute retrieval and/or chronic extraction of tined leadless pacemakers, such as the Medtronic Micra™ (Medtronic, Minneapolis, MN, USA) …”

Section: Introductionmentioning

confidence: 99%

The fixation tines of the Micra™ leadless pacemaker are atraumatic to the tricuspid valve

Mattson

Sanchez

Iaizzo

2018

Pacing Clinical Electrophis

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Background: Today, there is no manufacturer-supplied retrieval tool for the Micra TM pacemaker (Medtronic, Minneapolis, MN, USA); therefore, off-the-shelf catheters have been employed for retrievals. The proximal retrieval feature of the Micra TM can be snared and the device is then retracted from the myocardium, pulling the device through the tricuspid valve. This study characterizes the potential risks of Micra TM nitinol tine engagement with the tricuspid sub-valvular apparatus.Methods: Fresh human hearts nonviable for transplant (n = 10) were obtained from our regional organ procurement agency (LifeSource, Minneapolis, MN, USA). Micra TM fixation tines were affixed to a linear force transducer. Tines were then engaged in tricuspid chordae tendineae to conduct a constant velocity tensile test. Each test was run until tines disengaged from the chordae tendineae or until they released from the valve apparatus. Subsequently, biomechanical failure properties of the valve apparatus and isolated chordae tendineae were determined using a series of uniaxial tensile tests.Results: There were no chordal ruptures observed during our Micra TM tine extraction testing.Chordal failure required 15.0 times the force of extracting a single engaged tine, and 9.0 times the force of extracting two engaged tines. The uniaxial stresses required for isolated chordal failure averaged 17.4 N/mm 2 ; failure strains exceeded 150% resting chordal length. Conclusions:The forces required to rupture tricuspid chordae tendineae significantly exceeded the forces potentially imposed on the chordae during Micra TM device retrievals. We conclude that the fixation tines of the Micra TM device are unlikely to damage the tricuspid apparatus during either implant or retrieval. K E Y W O R D Sbiomechanical failure properties, cardiac anatomy, extraction, Micra pacemaker, retrieval, tricuspid valve device interactions

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Section: Introductionmentioning

confidence: 99%

The fixation tines of the Micra™ leadless pacemaker are atraumatic to the tricuspid valve

Mattson

Sanchez

Iaizzo

2018

Pacing Clinical Electrophis

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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%

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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“…The Micra transcatheter pacing system (Medtronic Micra TPS) offers potential advantages over conventional pacing systems by decreasing the rate of complications such as lead dislodgement or fracture, pocket haematoma, lead infection, and tricuspid valve impairment. 1 However, protocols to manage these systems once the battery runs out are not standardized. Since implanted devices are expected to become encapsulated over time, the longer the length of implantation the greater the risks involved with percutaneous retrieval.…”

Section: Introductionmentioning

confidence: 99%

Safety and usefulness of a second Micra transcatheter pacemaker implantation after battery depletion

et al. 2019

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To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker

Abstract: The overall system revision rate for patients with TPS at 24 months was 1.4%, 75% lower than that for patients with TVPs. TPS was disabled and left in situ in 64% of revisions, and percutaneous retrieval was successful as late as 14 months postimplant.

Cited by 66 publications

References 16 publications

The fixation tines of the Micra™ leadless pacemaker are atraumatic to the tricuspid valve

The fixation tines of the Micra™ leadless pacemaker are atraumatic to the tricuspid valve

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

Safety and usefulness of a second Micra transcatheter pacemaker implantation after battery depletion

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