Leadless Cardiac Pacemaker – Feasibility of a ‘Heavy’ Case

European Journal of Arrhythmia & Electrophysiology, 2016;2(2):66–8 DOI: https://doi.org/10.17925/EJAE.2016.02.02.66

Abstract:

The conventional pacing systems consist of a small size-battery, an electronic circuit and leads. Despite improvements in diagnostic and therapeutic features, transvenous leads remain the weakest link of the pacing system. Nowadays, two types of leadless cardiac pacemaker (LCP) exist leading stimulation from the right ventricle (RV) apex or low septum at the desired lower rate, with rate responsive algorithms. We report our experience with an LCP implant in a severely obese patient and demonstrate the feasibility of the procedure and the excellent telemetric (conductive) communication between the LCP and the programmer despite the critical mass of the patient.
Keywords: New technology; pacing, leadless cardiac pacemaker (LCP), obesity
Disclosure: Antonio Curnis, Francesca Vassanelli, Manuel Cerini, Lorenza Inama, Francesca Salghetti, Antonio D’Aloia and Luca Bontempi have nothing to disclose in relation to this article. No funding was received in the publication of this article.
Compliance with Ethics:All procedures were followed in accordance with the responsible committee on human experimentation and with the Helsinki Declaration of 1975 and subsequent revisions, and informed consent was received from the patient involved in this case study.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.
Received: March 29, 2016 Accepted December 13, 2016
Correspondence: Francesca Vassanelli, Piazzale Spedali Civili 1, 25100, Brescia, Italy. E: vassanella@gmail.com
Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit.

Case report
A 50-year-old man with a history of myocardial infarction (MI) in 2006 and arterial hypertension presented with episodes of paroxysmal atrio-ventricular block (AVB). He was also affected by severe obesity (353 kg) with a body mass index (BMI) of 121 kg/m2 and diabetes mellitus (Figure 1). He was transported from another hospital to our reference center in a special ambulance by the fire service. Since 2006 the patient had refused to take any medications. The poor-quality trans-thoracic echocardiogram (TT) showed a preserved left ejection fraction (LVEF), and normal sized right (RV) and left ventricles (LV) with an inferior wall akinesia. Despite the critical mass of the patient, taking into account the clinical situation and relatively young age, it was decided to consider the option of a percutaneous leadless pacemaker implant (Nanostim™ Leadless Pacemaker System [LCP], St. Jude Medical, Sylmar, CA, US). We required an extra-support for the operating bed, and for this reason it couldn’t be moved at all during the procedure. After local anesthestic was administered, puncture of the right femoral vein was performed under ultrasound guidance with pericardiocentesis needle (Easy Kit for pericardiocentesis, ab medica spa, Milan, Italy). After positioning a long guidewire (Amplatz Super Stiff™ J-Tip Guidewire, Boston Scientific, MA, US), the RV was reached with a Pig-Tail (Pig 5.2F Super Torque® Plus, Angiographic Catheter, Cordis®, Miami Lakes, Florida, US) and an angiography at the apex was performed (Figure 1). The delivery system (Nanostim™ Delivery System Catheter) with the LCP mounted on a deflectable tip was advanced under fluoroscopic guidance through the inferior vena cava to the right atrium and then RV. The pacemaker was successfully implanted in the RV low septum, screwing it with 1.25 turns. The tug test for stability was performed (Figure 3A and B). Before the complete release of the LCP, the telemetric communication between the LCP and the programmer (Merlin™ Patient Care System, St. Jude Medical, Sylmar, CA, US, equipped with S1LINK module) was tested. Intraoperative tests were satisfactory: R-wave amplitude of 4.5 mV, lead impedance of 630 ohms and pacing threshold of 1.0 V x 0.4 msec. At the end of the implantation, a manual compression of the femoral vein was performed in order to achieve hemostasis at the puncture site. The total procedural time was 21 minutes, with a fluoroscopic time of 6 minutes. There were no intra or peri-procedural complications and the patient was discharged the day after. Parameters remained stable and acceptable at 3- and 6-month follow-up appointments (Figure 4).

Discussion
Since the first idea to use ‘electricity’ for heart stimulation in 1774 and the first complete implant of a pacing system in 1959,1 the technology of cardiac devices has evolved considerably to treat bradyarrhythmia and tachyarrhythmias. Nowadays, the conventional pacing systems consist of a small size-battery, an electronic circuit and leads. Despite improvements in diagnostic and therapeutic features, transvenous leads remain the weakest link of the pacing system. There are 65,000 lead failures annually in more than 4 million implanted systems worldwide2. Insulation defects due to abrasion and traction, metal ion oxidation, and conductor fracture are all reported and result in lead malfunction3, one of the most feared complications alongside infection.

By 1970 the concept of a totally intracardiac self-contained pacemaker with miniaturised batteries and electronic circuits4 had already emerged, but, until 2012 there were no implants in humans. Nowadays, two types of LPM exist: Nanostim™ Leadless Pacemaker System and Micra™ Transcatheter Pacing System (Medtronic, Minneapolis, MN, USA), both of which lead stimulation from the RV apex or low septum at the desired lower rate, with rate responsive algorithms. They involve two different types of engage: screw fixation for the Nanostim™ with a steroid-eluting tip, and passive fixation for Micra™. Both systems allow the absence of a surgical pocket and transvenous leads. The leadless PM were designed to be retrieved and although some data are available regarding acute repositioning, no data exist for the removal of chronic implanted systems.

The currently available intracardiac pacemakers are suitable for patients who have an indication for single chamber (VVI/VVIR) pacing pacing (Class I and II of the current guidelines), as an alternative to conventional transvenous pacemakers (PM).

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Keywords: New technology; pacing, leadless cardiac pacemaker (LCP), obesity