Atrioventricular synchronous leadless pacemaker: state of art and broadened indications

Mitacchione, Gianfranco; Schiavone, Marco; Gasperetti, Alessio; Viecca, Maurizio; Curnis, Antonio; Forleo, Giovanni B.

doi:10.31083/j.rcm2202045

Cited by 21 publications

(16 citation statements)

References 24 publications

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“…Possible mediators might be the reduced risk for device related infection and the missing need for abandoned lead extraction. To further improve factors like battery longevity which might have further impact on the increasing use of leadless pacing, several efforts are made so that evidence concerning differences in cardiac as well as psychological endpoints will grow in the next years possibly leading to first-line use of leadless pacing and subcutaneous ICD implantation [ 81 , 82 ]…”

Section: Discussionmentioning

confidence: 99%

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Willy

Ellermann

Reinke

et al. 2022

JCDD

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The implantation of cardiac devices significantly reduces morbidity and mortality in patients with cardiac arrhythmias. Arrhythmias as well as therapy delivered by the device may impact quality of life of patients concerned considerably. Therefore we aimed at conducting a systematic search and meta-analysis of trials examining the impact of the implantation of cardiac devices, namely implantable cardioverter-defibrillators (ICD), pacemakers and left-ventricular assist devices (LVAD) on quality of life. After pre-registering the trial with the PROSPERO database, we searched Medline, PsycINFO, Web of Science and the Cochrane databases for relevant publications. Study quality was assessed by two independent reviewers using standardized protocols. A total of 37 trials met our inclusion criteria. Of these, 31 trials were cohort trials while 6 trials used a randomized controlled design. We found large pre-post effect sizes for positive associations between quality of life and all types of devices. The effect sizes for LVAD, pacemaker and ICD patients were g = 1.64, g = 1.32 and g = 0.64, respectively. There was a lack of trials examining the effect of implantation on quality of life relative to control conditions. Trials assessing quality of life in patients with cardiac devices are still scarce. Yet, the existing data suggest beneficial effects of cardiac devices on quality of life. We recommend that clinical trials on cardiac devices routinely assess quality of life or other parameters of psychological well-being as a decisive study endpoint. Furthermore, improvements in psychological well-being should influence decisions about implantations of cardiac devices and be part of patient education and may impact shared decision-making.

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Section: Discussionmentioning

confidence: 99%

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Willy

Ellermann

Reinke

et al. 2022

JCDD

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“…The functions of such a device are quite similar to the proposed subcutaneous node with its own power source. Even more suitable is another, recently developed technology: a leadless pacemaker [86], where the whole device is implanted inside the cardiovascular system, like the proposed nano-gateway. Communication between such devices inside the body, using GHz interfaces, has also been already validated by in-vivo experiments based on phantoms and animals [45], [51].…”

Section: Technology Readiness Discussionmentioning

confidence: 99%

Bridging Nano and Body Area Networks: A Full Architecture for Cardiovascular Health Applications

Asorey-Cacheda

Correia

Garcia-Pardo

et al. 2023

IEEE Internet Things J.

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Cardiovascular events occurring in the bloodstream are responsible for about 40% of human deaths in developed countries. Motivated by this fact, we present a new global network architecture for a system for the diagnosis and treatment of cardiovascular events, focusing on problems related to pulmonary artery occlusion, i.e., situations of artery blockage by a blood clot. The proposed system is based on bio-sensors for detection of artery blockage and bio-actuators for releasing appropriate medicines, both types of devices being implanted in pulmonary arteries. The system can be used by a person leading an active life and provides bidirectional communication with medical personnel via nano-nodes circulating in the bloodstream constituting an in-body area network. We derive an analytical model for calculating the required number of nano-nodes to detect artery blockage and the probability of activating a bioactuator. We also analyze the performance of the body area component of the system in terms of path loss and of wireless links budget. Results show that the system can diagnose a blocked artery in about 3 hours and that after another 3 hours medicines can be released in the exact spot of the artery occlusion, while with current medical practices the average time for diagnosis varies between 5 to 9 days.

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“…Initially, the A1 and A2 signals were linked to ventricular events. Physicians could manually set appropriate blanking windows to reject the detection of the A1/A2 signals in the accelerometer and program a filtered and rectified accelerometer signal that exceeded the A3 threshold but was under the A4 threshold [ 17 ]. This allowed for the detection of the atrial contraction (A4) signal with an output of an atrial marker via telemetry.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Leadless Pacemakers for Atrioventricular Synchronous Pacing: A Systematic Review and Meta-Analysis

Jin

et al. 2023

JCM

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Leadless pacemakers with an atrioventricular synchrony algorithm represent a novel technology for patients qualified for VDD pacing. The current evidence of their performance is limited to several small-scale observational studies. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of this new technology. We systematically searched the PubMed, Embase, and Cochrane library databases from their inception to 12 September 2022. The primary efficacy outcome was atrioventricular synchrony after implantation, whereas the secondary efficacy outcome was the change in cardiac output represented by the left ventricular outflow tract velocity time integral (LVOT-VTI). The primary safety outcome was major complications related to the procedures and the algorithm. Means or mean differences with 95% confidence interval (95% CI) were combined using a random-effects model or a fixed-effects model. Finally, 8 published studies with 464 participants were included in the qualitative analysis. The pooled atrioventricular synchrony proportion was 78.9% (95% CI 71.9–86.0%), and a further meta-regression did not screen factors that contributed significantly to the heterogeneity. Additionally, a significant increase in atrioventricular synchrony of 11.3% (95% CI 7.0–15.7%, p < 0.01) was achieved in patients experiencing programming optimization. LVOT-VTI was significantly increased by 1.9 cm (95% CI 1.2–2.6, p < 0.01), compared with the VVI pacing mode. The overall incidence of complications was approximately 6.3%, with major complications related to the algorithm being extremely low. Overall, leadless pacemakers with atrioventricular synchronous pacing demonstrated favorable safety and efficacy. Future data on their long-term performance are required to facilitate their widespread adoption in clinical practice.

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Atrioventricular synchronous leadless pacemaker: state of art and broadened indications

Cited by 21 publications

References 24 publications

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Bridging Nano and Body Area Networks: A Full Architecture for Cardiovascular Health Applications

Efficacy and Safety of Leadless Pacemakers for Atrioventricular Synchronous Pacing: A Systematic Review and Meta-Analysis

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