Chronic Performance of a Leadless Cardiac Pacemaker

Knops, Reinoud E.; Tjong, Fleur V.Y.; Neužil, Petr; Sperzel, Johannes; Miller, Marc A.; Petrů, Jan; Šimon, J; Šedivá, Lucie; Groot, Joris R. de; Dukkipati, Srinivas R.; Koruth, Jacob S.; Wilde, Arthur A.M.; Kautzner, Josef; Reddy, Vivek Y.

doi:10.1016/j.jacc.2015.02.022

Cited by 104 publications

(30 citation statements)

References 19 publications

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“…Although (sub)acute LP retrieval has shown to be feasible, [1][2][3] the occurrence of pacemaker encapsulation in humans and the possibility of long-term retrieval after years of implantation remains unknown. We report the first postmortem histological evaluation of an intermediate-term LP implant that showed partial, ongoing myofibrocellular encapsulation of the LP.…”

Section: Discussionmentioning

confidence: 99%

Postmortem Histopathological Examination of a Leadless Pacemaker Shows Partial Encapsulation After 19 Months

Tjong

Stam

Wal

et al. 2015

Circ: Arrhythmia and Electrophysiology

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A n 80-year-old male, with a history of coronary artery disease (coronary artery bypass graft surgery) and bradytachy syndrome was referred for a recurring pacemaker pocket infection of his dual chamber pacemaker system. The infected system was explanted and the leads extracted using laser, followed by antibiotic treatment. As the patient only required infrequent pacing, the choice for a single chamber pacing system was made. In January 2013, a leadless pacemaker (LP; Nanostim, St. Jude Medical, MN) was successfully implanted in the right ventricular (RV) apex. Four months postimplant, a transesophageal echocardiographic examination reconfirmed correct deployment of the LP in the RV apex, and the distal end of the LP moving freely during myocardial contraction (Figure 1A and 1B; Data Supplement), touching the lateral RV wall but not interfering with the RV septum (Movie in the Data Supplement). The LP did not interfere with the RV outflow tract, pulmonary valve or tricuspid valve, and no mobile structures were identified on the LP. The patient was monitored in the pacemaker outpatient clinic until he died because of an irresectable cholangiocarcinoma 19 months postimplant, in August 2014. The LP performance was stable throughout the entire follow-up, no device-related adverse events were observed and there was no occurrence of pacemaker syndrome. The patient consented before his death for autopsy of the heart and lungs, and a postmortem computed tomographic scan. Postmortem computed tomographic scan and heart radiograph analysis confirmed the position of the LP in the RV apex (Figure 2A and 2B). A three-dimensional reconstruction of the computed tomographic scan is shown in Figure 2A and Data Supplement. AutopsyAt autopsy, the heart showed hypertrophy and slight dilatation of both ventricles (heart weight: 605 g). The coronary artery bypass grafts appeared calcified but patent. The tricuspid valve showed retraction and thickening of leaflet edges at multiple sites potentially caused by previous implantation and removal of the conventional pacemaker leads ( Figure 3A). The LP was located near the apex of the RV between trabeculae, adjacent to a layer of endocardial thickening, but not penetrating the myocardium (Figure 3 A and 3C). The LP was covered by a thin capsule (<1 mm thick), which was firm near the base of the LP and fragile at the top ( Figure 3B). Adjacent to the LP, the septal and free wall myocardium showed several focal fibroelastic patches, interpreted as lesions caused by the friction of consecutive pacemaker leads and LP touching the free RV wall.Microscopic analysis revealed that the LP was covered for ≈60% in a thin fibrous capsule containing many α-smooth muscle actin immunostainable myofibroblasts. There was no endothelial lining present, which was confirmed by immunohistochemical analysis (CD34−), and no inflammation or foreign body reaction was observed. The distal part of the LP was covered by a fragile, thin layer composed of fibrin/platelet thrombus ( Figure 3D and 3E). Throughout the thi...

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Section: Discussionmentioning

confidence: 99%

Postmortem Histopathological Examination of a Leadless Pacemaker Shows Partial Encapsulation After 19 Months

Tjong

Stam

Wal

et al. 2015

Circ: Arrhythmia and Electrophysiology

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“…Moreover, the risk of device embolization cannot be disregarded. The fixation part of the device is the key to "anchor" an LCP to the myocardium, so if this part is not strong enough to attach to the myocardium, the device will 'fly' away and obstruct the outflow tract or pulmonary arteries [3][4][5].…”

Section: Limitations Of Lcp Implantationmentioning

confidence: 99%

“…However, so far, LCP's limitations do not exceed its benefits. Essentially, the limitations outlined above can be avoided with advanced training and a higher level of interventional skills [5].…”

Section: Limitations Of Lcp Implantationmentioning

confidence: 99%

“…The benefit is that the encapsulation may lower the risk of infection in the existence of bacteraemia; whereas the risk is the retrievability of the device. It would be difficult to withdraw an LCP that is attached very tightly to the surrounding myocardium by this myofibrous capsule ( Figure 10) [5]. LEADLESS II trial reported that LCPs were successfully retrieved without any problem at 160±180 days (median=100, min=1, max=413) [25].…”

Section: Encapsulation Phenomenon In Long-term Lcp Implantationmentioning

confidence: 99%

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Leadless Cardiac Pacemaker as a Novel Intervention Modality for Atrioventricular Conduction Disturbance in Hypertrophic Cardiomyopathy

Sutanto

2017

J.ATAMIS

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Atrioventricular conduction disturbance is a common complication of cardiovascular diseases, such as hypertrophic cardiomyopathy. Moreover, the most common form of atrioventricular conduction disturbance is atrioventricular block. Until recently, cardiac pacing was considered to be the most reliable long-time management of atrioventricular block. However, cardiac pacemakers have several limitations and complications. When the first generation of leadless pacemakers was invented in the 1980s, it was multi-component. Nowadays, self-contained or single component leadless pacemakers have been developed and have become popular amongst cardiac electrophysiologists. In particular, in 2013, St. Jude Medical developed a novel design for a cardiac pacemaker called the NanostimTM Leadless Pacemaker. In 2015, Medtronic released a smaller leadless pacemaker called the MicraTM Transcatheter Pacing System.1,2 Although NanostimTM and MicraTM represent state of the art technology; a few studies have documented some of their limitations.3-6 More research is needed to confirm and solve these problems

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“…The device is delivered to the right ventricle at the end of a purpose-designed steerable percutaneous delivery catheter via the femoral vein. Initially, it was recommended that it was placed at the right ventricular apex but complications in the first tranche of implants lead to revision of the protocol advising implant on the apical septum [14,15]. The Nanostim is anchored with the use of a helical screw-in fixation electrode at the distal end of the device with a secondary fixation mechanism using nylon tines.…”

Section: Introductionmentioning

confidence: 99%

Leadless Pacemakers: practice and promise in congenital heart disease

Clarke

Zaidi

Clarke

2017

J Congenit Heart Dis

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The development of the implantable cardiac pacemaker nearly 60 years ago represented a paradigm shift in the control of potentially lethal heart rhythms and has revolutionized the lives of those at risk of sudden death from bradycardia. Subsequent technological developments have resulted in devices that offer additional benefits to patients, including defibrillation and resychronisation therapy. Previously, Cardiac Implantable Electronic Devices (CIEDs) relied on leads, either transvenous or epicardial, to transmit electronic impulses to the heart. The potential value of self-contained leadless intracardiac pacemaker devices has long be recognised with their potential to avoid intrinsic problems with traditional CIEDs, particularly device-related infection and lead failure. Two leadless devices have been introduced since 2012 which may offer a safe, long term alternative to leaded CIEDs with greater patient acceptability and greater flexibility, particularly for congenital heart disease patients where venous access problems may otherwise limit access to traditional transvenous systems. Here we examine the development of leadless pacemakers, the current state of affairs in clinical practice, and key considerations for future developments, with a focus on the usage of such devices in the setting of congenital heart disease.

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Chronic Performance of a Leadless Cardiac Pacemaker

Cited by 104 publications

References 19 publications

Postmortem Histopathological Examination of a Leadless Pacemaker Shows Partial Encapsulation After 19 Months

Postmortem Histopathological Examination of a Leadless Pacemaker Shows Partial Encapsulation After 19 Months

Leadless Cardiac Pacemaker as a Novel Intervention Modality for Atrioventricular Conduction Disturbance in Hypertrophic Cardiomyopathy

Leadless Pacemakers: practice and promise in congenital heart disease

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