Nanostim

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) has been demonstrated up to three years after implantation. Longer-term data is warranted to assess the net clinical benefit of leadless pacing. OBJECTIVE: To evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. METHODS: In this retrospective cohort study, all consecutive patients were included with a first LP implantation from December 21, 2012 to December 13, 2016 in six Dutch high-volume centers...

Transcatheter pacing systems are self-contained, leadless, devices that offer the potential benefits of avoiding complications related to pectoral pocket and upper extremity vascular access. These systems in preapproval trials demonstrated excellent safety profile with the incidence of device-related cardiac perforation as low as 1.6% with Micra™ (Medtronic) and 1.3% in Nanostim (Abbott). In post-approval registry of Micra™ TPS, the rate of major complications was even lower than in the investigational study ranging from 0...

The progressive loss of functional capacity due to aging is a serious problem that can compromise human locomotion capacity, requiring the help of an assistant and reducing independence. The NanoStim project aims to develop a system capable of performing treatment with electrostimulation at the patient's home, reducing the number of consultations. The knee angle is one of the essential attributes in this context, helping understand the patient's movement during the treatment session. This article presents a wearable system that recognizes the knee angle through IMU sensors...

The Aveir VR Leadless Pacemaker (Abbott, Chicago, IL) recently was approved by the US Food and Drug Administration, and joined the Micra (Medtronic, Minneapolis, MN) transcatheter pacing system in the realm of nontransvenous cardiovascular implantable devices. The Aveir VR offers design improvements over its predecessor, the Nanostim (St. Jude Medical). There are recommendations for the perioperative management of conventional transvenous pacemakers, but leadless pacemakers add a new layer of consideration...

BACKGROUND: The Nanostim leadless pacemaker (LP) was launched in 2012. However, the use of Nanostim LP was suspended due to safety. OBJECTIVE: The aim of this study was to report our experience with the management of malfunctioning Nanostim LPs, including premature battery depletion. METHODS: Fifty-one consecutive patients (age 83 ± 10, 65% male) who underwent Nanostim LP implantation between 2014 and 2016 at Isala Hospital s were identified...

BACKGROUND: Transvenous pacemakers have been shown to improve quality of life and mortality in patients with bradycardia and cardiac conduction blocks. However, they possess inevitable drawbacks as they have a relatively high incidence of lead and device pocket-related complications. Therefore, leadless pacemakers have emerged as a solution to reduce the complications seen with conventional pacemakers. However, there have been no clinical trials to date comparing transvenous to leadless pacemakers...

BACKGROUND: Leadless pacemakers (LPs) have proven safe and effective, but device revisions remain necessary. Either replacing the LP or implanting a new adjacent LP is feasible. Replacement seems more appealing, but encapsulation and tissue adhesions may hamper the safety and efficacy of LP retrieval. OBJECTIVE: We determined the incidence and cellular characteristics of tissue adherent to retrieved LPs and the potential implications for end-of-life strategy. METHODS: All 15 consecutive successful Nanostim LP retrievals in a tertiary center were included...

BACKGROUND: A new intracardiac leadless pacemaker (ILP) has been developed to ensure atrioventricular (AV) synchrony (AVS) during ventricular pacing (VP). Recent studies have shown the feasibility and safety of accelerometer-based atrial sensing and an improvement in AVS among patients with atrioventricular block implanted with the Micra AV ILP (Medtronic Inc., Minneapolis, MN, USA). However, no data exists about the benefits of a VDD ILP in patients wearing a still working VVI Nanostim ILP (St Jude Medical, St Paul, MN, USA)...

Leadless pacemakers (LPs) have revolutionized the field of pacing by miniaturizing pacemakers and rendering them completelty intracardiac, hence reducing complications related to pacemaker pockets and transvenous leads. However, first generation LPs appear to be associated with a higher rate of myocardial perforation as compared to transvenous pacemakers (TV-PPM). Currently, LPs are predominantly designed to pace the right ventricle with no LPs that provide atrial or biventricular pacing. In this article, we review the available data on LPs while advocating for the need for a randomized controlled trial comparing LPs to TV-PPMs...

Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta-analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman-Tukey double arcsine transformation...

OBJECTIVES: The authors report their single-center experience with the retrieval and replacement of long-term implanted leadless cardiac pacemakers (LPs) and the factors contributing to success. BACKGROUND: LPs are a clinically effective and safe alternative to standard transvenous pacemakers for single-chamber ventricular pacing. However, the feasibility of retrieving and replacing long-term implanted LPs is not well known. METHODS: A total of 34 patients with implanted Nanostim LPs (mean implantation duration 1,570 ± 479 days) subsequently underwent retrieval...

BACKGROUND: Leadless pacemakers preclude the need for permanent leads to pace endocardium. However, it is yet to be determined whether a leadless pacemaker of a similar design to those manufactured for the right ventricle (RV) fits within the left ventricle (LV), without interfering with intracardiac structures. METHODS: Cardiac computed tomography scans were obtained from 30 patients indicated for cardiac resynchronisation therapy upgrade. The mitral valve annulus, chordae tendineae, papillary muscles and LV endocardial wall were marked in the end-diastolic frame...

Granules of calcium/phosphate biomaterials are used to fill small bone defects in oral and maxilla-facial surgery. Granules of natural (e.g., trabecular bone, coral) or synthetic biomaterials are provided by industry. Small granules can also form of putty. The 3D geometry of granules creates a macroporosity allowing invasion of vascular and bone cells when pores are larger than 300 μm. We analyzed the 3D-porosity of 11 different stacks of biomaterials: Osteopure®, CopiOs®, Bio-Oss®, TCP Dental HP®, KeraOs®, TCH®, Biocoral®, EthOss® and Nanostim®...

PURPOSE: Leadless pacemaker (LP) extraction is a relatively new field with limited operator experience. We sought to report a comparison of retrieval process for Nanostim vs Micra transcatheter LPs. METHODS: The list of retrievals for the Micra transcatheter pacemaker system (TPS) was obtained from Medtronic whereas Nanostim data was obtained from centers that participated in the Leadless II study. Details of retrieval such as indication, days post implantation, complications, and post procedure device management were obtained from the manufacturer database for each site, and any missing details were obtained from individual operators...

PURPOSE: The leadless pacemaker (LP) is a promising new technology in pacing therapy that avoids a generator pocket and transvenous lead-related complications. However, extraction experience with simultaneous re-implant of a leadless device remains limited. We sought to study the outcomes of Nanostim LP retrieval and simultaneous reimplantation of Micra LP. METHODS: Patients undergoing retrieval of the Nanostim LP and receiving a Micra LP implant between 2016 and 2018 at Mayo Clinic (Rochester, MN) were studied...

BACKGROUND AND OBJECTIVES: The success rate of leadless cardiac pacemaker (LP) retrieval remains a major concern for this disruptive technology. The present paper performed a systematic review of the safety and feasibility of the retrieval of LPs. METHODS: Primary publications that performed LP retrieval were collected and included five animal experiments and two worldwide retrieval experiences in human. The procedural details, such as indication, days post implantation, extraction success rate, and complications, were described...

BACKGROUND: Endocardial pacemaker leads and right ventricular (RV) pacing are well-known causes of tricuspid valve, mitral valve, and cardiac dysfunction. Lead-related adverse consequences can potentially be mitigated by leadless pacemaker (LP) therapy by eliminating the presence of a transvalvular lead. This study assessed the impact of LP placement on cardiac and valvular structure and function. METHODS: Echocardiographic studies before and 12±1 months after LP implantation were performed between January 2013 and May 2018 at our center and compared with age- and sex-matched controls of dual-chamber transvenous pacemaker recipients...

BACKGROUND: Leadless cardiac pacing (LCP) has emerged as a new modality for permanent pacing. We sought to describe comparative outcomes between LCP and transvenous pacemakers. METHODS: Patients receiving LCP (Micra [Medtronic, Minneapolis, MN, USA] and Nanostim [St. Jude Medical/Abbott Laboratories, Chicago, IL, USA]) between 2014 and 2017 at the Mayo Clinic Heart Rhythm Enterprise practice (Rochester, MN, USA; Jacksonville, FL, USA; and Scottsdale, AZ, USA) were identified...

Conventional transvenous pacemaker and ICD-therapy is associated with significant lead- and pocket-related problems. Leadless pacemaker and subcutaneous ICD (S-ICD) therapies are innovative technologies, that avoid these complications. To date two leadless pacemaker systems have been implanted percutaneously for isolated right ventricular pacing, the Nanostim™ and the Micra™ device. The S-ICD represents an alternative to the transvenous ICD for primary and secondary prevention of sudden cardiac death. New multicomponent leadless pacemakers, as well as the combination of leadless pacemaker and S-ICD, are promising therapeutic options in the future...

Nanostim™ (St. Jude Medical Inc., Saint Paul, MN, USA; now Abbott Medical Inc. Abbott Park, IL, USA) was the first self-contained intracardiac pacemaker to be implanted in a human patient. A total of 1423 Nanostim devices were implanted worldwide between 2013 and 2016 and three clinical trials were initiated. Although the device was recalled in 2016 owing to rare but serious battery failures, the concept of leadless pacing has gained widespread acceptance and is expanding beyond the initial single-chamber devices to dual-chamber systems, biventricular pacing, and combinations with defibrillators...