Search Results (23)

Background: Cardiac implantable electronic device (CIED) infections necessitate extraction and subsequent pacing interventions. Conventional methods after removing the infected CIED system involve temporary or semi-permanent pacing followed by delayed permanent pacemaker (PPM) implantation. Leadless pacemakers (LPs) may offer an alternative, allowing immediate PPM implantation without increasing infection risks. Our objective is to evaluate the safety and cost-effectiveness of LP implantation during the same procedure of CIED extraction, compared to conventional two-stage approaches. Methods: Pacemaker-dependent patients with systemic or pocket infection undergoing device extraction and LP implantation during the same procedure at Sheba Medical Center, Israel, were compared to a historical group of patients undergoing a semi-permanent (SP) pacemaker implantation during the procedure, followed by a permanent pacemaker implantation. Results: The cohort included 87 patients, 45 undergoing LP implantation and 42 SP implantation during the extraction procedure. The LP group demonstrated shorter intensive care unit stay (1 ± 3 days vs. 7 ± 12 days, p < 0.001) and overall hospital days (11 ± 24 days vs. 17 ± 17 days, p < 0.001). Rates of infection relapse and one-year mortality were comparable between groups. Economic analysis revealed comparable total costs, despite the higher initial expense of LPs. Conclusions: LP implantation during CIED extraction offers significant clinical and logistical advantages, including reduced hospital stays and streamlined treatment, with comparable safety and cost-effectiveness to conventional approaches. Full article

Background and Objectives: Leadless pacemakers provide an innovative alternative to traditional transvenous pacemakers for managing cardiac arrhythmias. The objective of this systematic review is to conduct a meta-analysis comparing acute complication and mortality rates associated with leadless pacemakers versus transvenous pacemaker placements using national-level data. Specifically, we aim to summarize the current evidence and calculate pooled odds ratios for acute overall complications, acute device-related complications, and acute mortality to assess the early safety outcomes of leadless pacemaker placement relative to traditional transvenous pacemakers. Materials and Methods: A systematic search of PubMed, Scopus, ScienceDirect, and Google Scholar was conducted by two independent researchers using a predefined search protocol. The search included articles published up to 10 October 2024, without limits on review depth. Studies were included if they provided national-level data comparing leadless pacemaker and traditional pacemaker recipients in terms of acute mortality, acute overall complications, and acute device-related complications. Outcomes were pooled to calculate odds ratios using a random-effects model in RStudio (version 2024.12.1+563). Results: A total of five studies met the eligibility criteria. The pooled odds ratio for acute mortality was 2.03 (95% CI: 0.65–6.34, I² = 99%; p < 0.01), for acute overall complications was 1.08 (95% CI: 0.45–2.61, I² = 99%; p < 0.01), and for acute device-related complications was 1.02 (95% CI: 0.23–4.44, I² = 99%; p < 0.01). Conclusions: The reviewed studies suggest that leadless pacemakers offer a promising alternative to transvenous pacemakers, offering a comparable short-term safety profile. Ongoing technological advancements may further enhance their applicability in clinical practice. Full article

Adult congenital heart disease (ACHD) represents a significant portion of congenital anomalies, and with improved treatments leading to an increased life expectancy, its prevalence has been increasing over the past few decades. Nonetheless, a considerable number of patients with ACHD require cardiac rhythm management devices during their lifetime. Traditionally, transvenous pacemaker placement has been the standard mode of treatment for these patients. However, some patients with ACHD have anatomical barriers that obscure this mode of treatment. Leadless pacing systems (LPSs) have changed the field of pacing. Currently, two different LPSs are available. In a real-world setting, implanting an LPS in patients after tricuspid valve (TV) surgery seems to be a straightforward procedure with a low risk of complications, with patients showing no valvular dysfunction after the intervention. LPS implantation is an option to avoid device-related complications in patients with previous TV surgery. Moreover, it has been demonstrated that even the jugular approach seems as safe as the femoral approach and could be considered an alternative implantation method for LPSs. The Aveir VR leadless pacemaker is a helix LPS with unique features, such as its capacity as a dual-chamber leadless pacemaker, the ability to map electrical parameters before releasing the device, and its possibility of being retrievable. Hereby, we present the case of Ebstein’s anomaly, atrial septal defect closure, and previous TV surgery with symptomatic intermittent advanced atrioventricular block. This case illustrates that a transjugular approach for LPSs is also feasible in patients with ACHD. Full article

Background: In total, 6.6% to 11% of patients with an initially implanted implantable cardioverter-defibrillator (ICD) will develop significant bradycardia and the need for pacing in subsequent years. As the leadless pacemaker (LP) and subcutaneous implantable cardioverter-defibrillator (S-ICD) population comorbidities are often similar, both groups would benefit from a hybrid solution. Unfortunately, currently, there is no commercially available and sufficiently validated interconnected set of S-ICD and LP. Methods: In this single-center, prospective observational study, 32 pacing-dependent patients after implantation of a Micra LP were screened for S-ICD on the left and right sides of the sternum using the EMBLEM Automated Screening Tool. At least one positive, both in the supine and standing positions, was considered a positive screening. The impact of various clinical variables and morphology of paced QRS on screening results was assessed. Moreover, the function of the tricuspid valve was evaluated before and after LP implantation to consider whether there is a relationship between paced QRS and worsening tricuspid regurgitation. Results: Patients with paced heart rhythm were divided into two groups based on screening results for S-ICD. The positive screening outcome was achieved in 10 patients (31.25%). No correlation between any clinical variable and screening results was found. However, right axis deviation [RAD] of paced QRS seems to be a strong predictor of positive S-ICD screening (RAD in 9/32 patients, sensitivity 90%, specificity 100%, PPV 100%, NPV 96% for passing screening), and negative polarity of paced QRS in inferior leads predicts negative screening results (positive polarity in II, III, and aVF in 12/32 patients, sensitivity 100%, specificity 90%, PPV 83%, NPV 100% for passing screening). Conclusions: Right axis deviation of the paced rhythm, positive QRS polarity of leads II, III, and aVF, and negative QRS polarity in leads I and aVL seem to predict a positive screening result for S-ICD. Such a position of LP does not seem to worsen tricuspid regurgitation. Full article

The widespread use of Cardiac Implantable Electronic Devices (CIEDs) has transformed the management of cardiac arrhythmias, improving survival and quality of life for millions. However, this progress has introduced a range of device-related complications, which can significantly impact patient outcomes. This review examines “new diseases” linked to CIEDs, categorizing them into physical (e.g., infections, venous obstruction, lead failure, and device recalls) and functional complications (e.g., arrhythmias, pacemaker syndrome, and left ventricular dysfunction). Prevention and management strategies are emphasized. Emerging technologies, such as leadless devices, quadripolar leads, and remote monitoring systems, hold promise in reducing risks and enhancing patient care. Future directions include integrating artificial intelligence for real-time monitoring, improving device durability, and exploring novel materials to minimize infections and mechanical failures. Understanding CIED-related complications is essential for healthcare providers to balance the benefits and risks of these life-saving technologies. Full article

Cardiac Resynchronization Therapy (CRT) has been established as a major component of heart failure management, resulting in a significant reduction in patient morbidity and death for patients with increased QRS duration, low left ventricular ejection fraction (LVEF), and high risk of arrhythmias. The ability to synchronize both ventricles, lower heart failure hospitalizations, and optimize clinical outcomes are some of the attractive characteristics of biventricular pacing, or CRT. However, the high rate of CRT non-responders has led to the development of new modalities including leadless CRT pacemakers (CRT-P) and devices focused on conduction system pacing (CSP). This comprehensive review aims to present recent findings from CRT clinical trials and systematic reviews that have been published that will likely guide future directions in patient care. Full article

Although significant strides have been made in cardiac pacing, the field is still evolving. While transvenous permanent pacing is highly effective in the management of bradyarrhythmias, it is not risk free and may result in significant morbidity and, rarely, mortality. Transvenous leads are often the weakest link in a pacing system. They may dislodge, fracture, or suffer breaches in their insulation. This review was undertaken to clarify leadless risks, benefits, and alternatives to transvenous cardiac pacing for bradyarrhythmias and heart failure management. In order to clarify the role(s) of leadless pacing, this narrative review was undertaken by searching MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and review articles, as well as other clinically relevant reports and studies. The search was limited to English-language reports published between 1932 and 2024. Leadless pacing was searched using the terms Micra™, Nanostim™, AVEIR™, single-chamber leadless pacemaker, dual-chamber leadless pacemaker, cardiac resynchronization therapy (CRT), cardiac physiological pacing (CPP) and biventricular pacing (BiV). Google and Google Scholar, as well as bibliographies of identified articles were also reviewed for additional references. The advantages and limitations of leadless pacing as well as options that are under investigation are discussed in detail. Full article

Background: Leadless pacemakers offer a safe and effective alternative pacing strategy. However, limited data are available for patients with end stage renal disease (ESRD), a population of significant relevance. Methods: Using the Nationwide Readmission Database, we extracted data from all adult patients with ESRD who underwent traditional transvenous or leadless pacemaker implantation between 2016 and 2021. We compared in-hospital mortality, 30-day readmission rates, complication rates, and healthcare resource utilization between the two cohorts. Results: A total of 6384 (81.2%) patients were included in the transvenous pacemaker cohort, and 1481(18.8%) patients were included in the leadless pacemaker cohort. In patients with ESRD, leadless pacemaker implantation was linked to higher in-hospital complications when compared to transvenous pacemakers. These included the need for blood transfusion (aOR 1.85, 95% CI 1.32–2.60, p < 0.01), vascular complications (aOR 3.6, CI 1.40–9.26, p = 0.01), and cardiac complications (aOR 4.12, CI 1.70–9.98, p < 0.01). However, there were no differences between the two groups in terms of in-hospital mortality and 30-day readmission rates. The median length of stay was longer for leadless pacemaker implantation than transvenous pacemaker implantation (5 days vs. 4 days, p < 0.01). The total hospitalization charges were also higher ($139,826 vs. $93,919, p < 0.01). Conclusions: Although previous studies have demonstrated lower long-term complication rates with leadless pacemakers than transvenous pacemakers, our analysis shows a higher risk of short-term in-hospital complications in ESRD patients, though no differences in in-hospital mortality and 30-day readmissions. Full article

This paper studies the development of piezoelectric energy harvesting for self-powered leadless intracardiac pacemakers. The energy harvester fit inside the battery compartment, assuming that the energy harvester would replace the battery with a smaller rechargeable battery capacity. The power output analysis was derived from the three-dimensional finite element analysis and in vivo heart measurements. A Doppler laser at the anterior basal in the right ventricle directly measured the heart’s kinetic motion. Piezoceramics in the cantilevered configuration were studied. The heart motion was periodic but not harmonic and shock-based. This study found that energy can be harvested by applying periodic bio-movements (cardiac motion). The results also showed that the energy harvester can generate 1.1 V voltage. The effect of various geometrical parameters on power generation was studied. This approach offers potential for self-powered implantable medical devices, with the harvested energy used to power devices such as pacemakers. Full article

(1) Background: Leadless pacemakers (LPs) have been proposed as a reimplantation strategy in pacing-dependent patients undergoing cardiac implantable electronic device (CIED) extraction for infection. In this study, we analysed the risk of LP infection when this device is implanted before lead extraction. (2) Methods: This was a retrospective study including patients who underwent LP implantation between 2017 and 2022. Patients were divided in two groups according to whether LP was implanted following CIED extraction for infection (Group 1) or other indications (Group 2). The primary aim was to describe the risk of LP infection. (3) Results: We included in this study 49 patients with a median age of 81 [20–94] years, mostly males (36, 73%). In Group 1 patients, 17 cases (85%) showed systemic CIED infections, and 11 (55%) had positive lead cultures. Most Group 1 cases (n = 14, 70%) underwent one stage of LP implantation and CIED extraction. Mortality rate during follow-up was 20% (nine patients). Patients were followed up for a median of 927 [41–1925], days and no cases of definite or suspected LP infections were identified. (4) Conclusions: The risk of LP infection was extremely low. LP appears as a potential option for reimplantation in this setting and should be considered in pacing-dependent patients at a high risk of CIED infection recurrence. Full article

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. Full article

Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers. Full article

Modern cardiac pacemakers are equipped with a function that allows the heart rate to adapt to the current needs of the patient in situations of increased demand related to exercise and stress ("rate-response" function). This function may be based on a variety of mechanisms, such as a built-in accelerometer responding to increased chest movement or algorithms sensing metabolic demand for oxygen, analysis of intrathoracic impedance, and analysis of the heart rhythm (Q-T interval). The latest technologies in the field of rate-response functionality relate to the use of an accelerometer in leadless endocavitary pacemakers; in these devices, the accelerometer enables mapping of the mechanical wave of the heart’s work cycle, enabling the pacemaker to correctly sense native impulses and stimulate the ventricles in synchrony with the cycles of atria and heart valves. Another modern system for synchronizing pacing rate with the patient’s real-time needs requires a closed-loop system that continuously monitors changes in the dynamics of heart contractions. This article discusses the technical details of various solutions for detecting and responding to situations related to increased oxygen demand (e.g., exercise or stress) in implantable pacemakers, and reviews the results of clinical trials regarding the use of these algorithms. Full article

There are reports documenting that electromagnetic waves generated by deep brain stimulation devices can interfere with cardiac pacemakers. This might be even a life-threatening problem in cardiac pacemaker-dependent patients. Herein, we present a case report on a patient with bilaterally implanted deep brain stimulation devices, who concomitantly had the indications for permanent cardiac pacing. The report shows that a leadless AV pacemaker may be a safe and reasonable option in these cases. Full article