Search Results (286)

Biofilms are structured communities of microorganisms encased in a self-produced extracellular matrix, and they represent one of the most widespread forms of microbial life on Earth. Their presence poses serious challenges in both environmental and clinical settings. In natural and industrial systems, biofilms contribute to water contamination, pipeline corrosion, and biofouling. Clinically, biofilm-associated infections are responsible for approximately 80% of all microbial infections, including endocarditis, osteomyelitis, cystic fibrosis, and chronic sinusitis. A particularly critical concern is their colonization of medical devices, where biofilms can lead to chronic infections, implant failure, and increased mortality. Implantable devices, such as orthopedic implants, cardiac pacemakers, cochlear implants, urinary catheters, and hernia meshes, are highly susceptible to microbial attachment and biofilm development. These infections are often recalcitrant to conventional antibiotics and frequently necessitate surgical revision. In the United States, over 500,000 biofilm-related implant infections occur annually, with prosthetic joint infections alone projected to incur revision surgery costs exceeding USD 500 million per year—a figure expected to rise to USD 1.62 billion by 2030. To address these challenges, surface modification of medical devices has emerged as a promising strategy to prevent bacterial adhesion and biofilm formation. This review focuses on recent advances in chemical surface functionalization using non-antibiotic agents, such as enzymes, chelating agents, quorum sensing quenching factors, biosurfactants, oxidizing compounds and nanoparticles, designed to enhance antifouling and mature biofilm eradication properties. These approaches aim not only to prevent device-associated infections but also to reduce dependence on antibiotics and mitigate the development of antimicrobial resistance. Full article

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

Cardiac arrhythmias remain a major source of morbidity and mortality, often stemming from molecular and structural abnormalities that are insufficiently addressed by current pharmacologic and interventional therapies. Gene therapy has emerged as a transformative approach, offering precise and durable interventions that directly target the arrhythmogenic substrate. Across the spectrum of inherited and acquired arrhythmias—including long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, atrial fibrillation, and post-infarction ventricular tachycardia—gene-based strategies such as allele-specific silencing, gene replacement, CRISPR-mediated editing, and suppression-and-replacement constructs are showing growing translational potential. Advances in delivery platforms, including cardiotropic viral vectors, lipid nanoparticle-encapsulated mRNA, and non-viral reprogramming tools, have further enhanced the specificity and safety of these approaches. Additionally, innovative applications such as biological pacemaker development and mutation-agnostic therapies underscore the versatility of genetic modulation. Nonetheless, significant challenges remain, including vector tropism, immune responses, payload limitations, and the translational gap between preclinical models and human electrophysiology. Integration of patient-derived cardiomyocytes, computational simulations, and large-animal studies is expected to accelerate clinical translation. This review provides a comprehensive synthesis of the mechanistic rationale, therapeutic strategies, delivery platforms, and translational frontiers of gene therapy for cardiac arrhythmias. Full article

Background/Objectives: Single-dose pre-operative antibiotic prophylaxis for cardiac-device implantation is recommended but extending antibiotic prophylaxis is common. Locally, 50–60% of patients had extended prophylaxis after pacemaker insertion or generator change. Our antimicrobial stewardship programme (ASP) incorporated behavioural change strategies in implementing a multi-pronged intervention bundle to address this and evaluated its effectiveness and safety. Methods: This single-centre, retrospective cohort study included patients aged 21 years old or older, undergoing uncomplicated pacemaker insertion or generator change at Singapore General Hospital (SGH) from October 2022 to March 2025. To improve antibiotic use, ASP interventions incorporating behaviour change strategies were implemented, namely (1) data-driven feedback, (2) targeted education, (3) identification and engagement of ASP champion, and (4) clinical pathway revision. Results: There were 779 patients evaluated; 380 (48.8%) received standard prophylaxis while 399 (51.2%) received extended prophylaxis with oral antibiotics (mean duration, 3.3 ± 0.8 days). Following ASP interventions, the practice of extended prophylaxis declined significantly from 43.8% to 24.0% (p < 0.01). The incidence of surgical site infections was low and similar in both groups (0.8%, p = 1.000); all infections were superficial. There was also significant reduction in the proportion of patients on all antibiotics from 20.7% to 16.3% (p < 0.01). Identification and engagement of ASP champion proved pivotal in changing prescribing behaviour through peer influence and credibility. Conclusions: The bundled ASP interventions, incorporating behavioural change strategies, have effectively and safely reduced the use of extended prophylaxis post-cardiac device implantation. Behavioural change interventions are essential to achieve sustained stewardship success. Full article

Right ventricular apex (RVA) pacing has historically been the default approach for cardiac pacing; however, it is associated with the development of progressive left ventricular dysfunction and heart failure (HF), particularly in patients with high pacing burdens. While advances in device programming and modern algorithms have sought to mitigate these effects, preserving physiological activation has proven to be more critical than reducing ventricular pacing. Conduction system pacing (CSP) techniques—namely, His-bundle pacing (HBP) and particularly left bundle branch area pacing (LBBAP)—have emerged as superior alternatives, enabling improved left ventricular function and reduced rates of pacing-induced cardiomyopathy (PICM). Nevertheless, despite the clinical advantages of these procedures over RVA, they face limitations including variable implantation success rates, increased pacing thresholds and lead revision rates, technical challenges, and occasional procedure prolongation. Thus, while CSP approaches represent the future of physiological pacing, RVA pacing continues to provide a necessary and reliable option in the current clinical practice. Full article

Background/Objectives: We aimed to identify the factors associated with clinically important changes in quality of life (QoL) of real-world heart failure (HF) patients. Methods: This is a single-centre, prospective cohort study including 419 patients at an HF clinic between January 2013 and February 2020. QoL was assessed regularly using Minnesota Living with Heart Failure Questionnaire (MLHFQ). We used five nested linear mixed-effects models to account for QoL measurements between patients and within-patient. Models were adjusted for time, sociodemographic factors, comorbidities, self-care adherence, and HF severity factors. Results: Median age was 78 years, 54.4% of patients were female, and 49.6% had left ventricle ejection fraction ≥ 50%. At baseline, 62.5% of patients were New York Heart Association (NYHA) class II. Median N-terminal-pro-B type natriuretic peptide level was 1454 pg/mL. Mean MLHFQ total score at baseline was 25 points (95%CI: 22.97–27.60). Having an implanted cardiac resynchronization therapy-pacemaker (CRT-P) was associated with moderate to large improvement in QoL (−13.55 points, 95%CI: −22.45–−4.65). NYHA class II and estimated glomerular filtration rate < 30 mL/min/1.73 m² were associated with small to moderate QoL deterioration (9.74 points, 95%CI: 6.74–12.75 and 5.82 points, 95%CI: 1.17–10.47, respectively). NYHA classes III or IV and a recent HF hospitalization were associated with large to very large QoL deterioration (28.39 points, 95%CI: 23.82–32.96; 60.59 points, 95%CI: 34.46–86.72; and 26.91 points, 95%CI: 21.80–32.03, respectively). Conclusions: CRT-P implantation, NYHA class and HF hospitalization are associated with the most clinically important QoL changes. Full article

Background and Clinical Significance: Evaluating wide complex rhythms in patients with permanent pacemakers can be a diagnostic challenge, particularly when the rhythm is irregular. While pacemaker-mediated rhythms are typically regular and predictable, the appearance of wide complex irregular rhythms raises concerns ranging from lead malfunction to life-threatening arrhythmias, such as ventricular tachycardia. Understanding the interplay between intrinsic cardiac activity and device function is crucial for timely and accurate diagnosis in this increasingly common clinical scenario. Case presentation: We report on a 74-year-old female with a VVI pacemaker implanted for binodal disease, who presented with intermittent palpitations and an irregular rhythm. The patient has a recent history of falling on her right shoulder, which is also the site of the device implantation. We used a clinical step-by-step approach to rule out pacemaker malfunction and to establish the need for an unscheduled device interrogation. Conclusions: This case presentation highlights the important role of clinical reasoning and the approach to such a patient, especially when a key method of pacemaker evaluation, such as device interrogation, is not readily available. Full article

Bradyarrhythmia is associated with an increased risk of falls, syncope, and sudden cardiac arrest in Parkinson’s disease (PD). However, studies investigating bradyarrhythmia in PA have been scarce. Therefore, we aimed to assess trends, prevalence, and risk factors of bradyarrhythmia and pacemaker implantation in PD patients. The National Inpatient Sample was utilized to identify patients’ data with primary and secondary diagnoses of Parkinson’s disease (PD) from 2016 to 2020. A total of 333,242 patients had a PD diagnosis; of these, 5092 (1.5%) had comorbid diagnoses of bradyarrhythmia. The prevalence of bradyarrhythmia in patients with PD was 351.9 per 10,000 hospitalizations (3.5%), with an increase from 291.9 to 463.8 per 10,000. However, the trends remained relatively stable. The overall prevalence of pacemaker implantation in patients with PD was 79.9 per 10,000 hospitalizations (0.8%). The overall trend of pacemaker implantation was stable in patients with PD. Age ≥ 65, male sex, and comorbidities (atrial fibrillation, coronary artery disease, heart failure, hypertension, liver failure, obesity, peripheral vascular disease, renal failure) were associated with a higher likelihood of bradyarrhythmia in patients with PD. This study’s findings revealed an increase in the prevalence of bradyarrhythmia. However, the prevalence of pacemaker implantation remained relatively stable over the study period. Full article

Cardiac pacemakers are standard implantable medical devices that regulate and treat heart rhythm disorders, primarily aiming to improve patient health outcomes. This study presents the systematic design, implementation, and simulation-based validation of a novel fuzzy-immune adaptive Fractional-Order Linear Quadratic Integral (FO-LQI) control strategy for heart rate (HR) regulation using cardiac pacemakers. Unlike the conventional LQI controller, the proposed approach replaces the integer-order integrator with a fractional-order integral operator to enhance the controller’s design flexibility and dynamic response. To address the implementation challenges of fixed fractional exponents, a fuzzy-immune adaptation mechanism is introduced to modulate the fractional order in real time. This adaptive scheme improves the controller’s robustness across varying physiological states, enabling more responsive HR adaptation to the patient’s metabolic demands. The proposed controller is modeled and simulated in MATLAB/Simulink using physiologically relevant test cases. Comparative simulation results show that the fuzzy-immune adaptive FO-LQI controller outperforms the baseline LQI and fixed FO-LQI controllers in achieving time-optimal HR regulation. These findings validate the reliability and enhanced robustness of the proposed control scheme for simulating cardiac behavior under diverse physiological conditions. Full article

Background: The increasing use of technologies operating between 10 and 200 kHz, such as RFID, wireless power transfer systems, and induction cooktops, raises concerns about electromagnetic interference (EMI) with cardiac implantable electronic devices (CIEDs). The mechanisms of interaction within this frequency range have been only partially addressed by both the scientific and regulatory communities. Methods: A physical twin of a pacemaker/implantable defibrillator (PM/ICD) was developed to experimentally assess voltages induced at the input stage by low-to-mid-frequency magnetic fields. The setup simulates the two sensing modalities programmable in PMs/ICDs and allows for the analysis of different implant configurations, lead geometries, and positions within a human body phantom. Results: Characterization of the physical twin demonstrated its capability to reliably measure induced voltages in the range of 5 mV to 1.5 V. Its application enabled the identification of factors beyond the implant’s induction area that contribute to the induced voltage, such as the electrode-tissue interface and body-induced currents. Conclusions: This physical twin represents a valuable tool for experimentally validating the mechanisms of EMI in CIEDs, providing insights beyond current standards. The data obtained can serve as a reference for the validation of numerical models and patient-specific digital twins. Moreover, it offers valuable information to guide future updates and revisions of international electromagnetic compatibility standards for CIEDs. Full article

Background/Objectives: After years of work in the field of aortic arch surgery, the technique has evolved, making this procedure relatively safe, with lasting results. Due to the increasing long-term survival and overall aging of the patient population, more patients require aortic arch reoperation. In the present study, the safety of aortic arch reoperations was analyzed in the long term, focusing on risk factors for mortality. Methods: Between 1999 and 2023, 108 patients were included in our study who underwent reoperation on aortic arch after prior operation on the aorta, the aortic valve, or a combination of both. The exclusion criteria were being aged under 18 years and transcatheter aortic valve implantation as a previous intervention. The principal outcome was the incidence of mortality, and additional outcomes of interest included cardiac re-reoperation, bleeding, a new aortic type B dissection, infective endocarditis, readmission due to a cardiac cause, coronary intervention and neurovascular complications, pacemaker implantation, and temporary mechanical circulatory support. Results: The mean age was 56 ± 14 years, and 75% (81/108) of patients were male. In our study, we found age (p ≤ 0.01) and history of coronary artery disease (p = 0.01) to be preoperative risk factors for adverse outcomes. The mean time between the index operation and reoperation was 6.84 years (1.61–14.94). Indications for reoperation included dilatation (HR = 0.49, p = 0.05), rupture or false aneurysm (HR = 2.08, p= 0.08), dissection (HR = 1.41, p = 0.30), and endocarditis (HR = 1.49, p = 0.41). A main risk factor was the need for a salvage reoperation (p ≤ 0.01). Also, a longer operation (p = 0.04), cardiopulmonary bypass (p ≤ 0.01), and ventilation time (p ≤ 0.01), bleeding complications (p ≤ 0.01), and requiring temporary mechanical circulatory support (p = 0.04) were linked to higher mortality. The overall survival was 82% after 1 year, 73% after 5 years, and 56% after 10 years. In the multivariate Cox regression analysis, age (HR = 1.04, p ≤ 0.01), the need for a salvage operation (HR = 5.38, p = 0.01), a prolonged ventilation time (HR = 1.08, p = 0.04), and bleeding complications (HR = 3.76, p = 0.03) were associated with higher mortality. In the ROC analysis, an age over 57.5 years was associated with significantly lower overall survival (p ≤ 0.01). Conclusions: Aortic arch reoperations can be performed with acceptable long-term outcomes, but perioperative factors significantly influence early mortality. Salvage operations, bleeding complications, and prolonged ventilation were strong predictors of adverse outcomes. Older age, particularly >57.5 years, was independently associated with increased mortality risk. Full article

Background/Objectives:Pacing treatment of bradyarrhythmias is both to reduce symptoms and to prevent syncope and sudden cardiac death. The aim of our study was to analyze left bundle branch area pacing (LBBAP) in the prevention of new-onset AF and the improvement of echocardiographic parameters in patients with mildly reduced left ventricular ejection fraction (LVEF) compared to patients with bradyarrhythmias but preserved LVEF who underwent mid-septal right ventricular pacing. Methods: This research was structured as a retrospective observational cohort study that included 186 patients with LBBAP and 186 patients with RVP, enrolled for 3 years until March 2024 with a follow-up time of 1 year. The primary endpoint of our study was new-onset atrial fibrillation after pacemaker implantation. The secondary endpoint was the improvement of echocardiographic parameters. Results: We observed in the LBBAP group a mean QRS complex duration of 108.7 ± 8.83 ms (after pacemaker implantation), compared to a much longer duration in the RVP group (143.8 ± 9.851 ms, p = <0.0001). At 1 year of follow-up, 22 (11.82%) patients in the RVP group were diagnosed with new-onset atrial fibrillation, compared to 6 (3.22%) patients out of 186 included in the LBBAP group (p = 0.0017). Regarding LVEF, at follow-up, RVP patients had a decrease in LVEF compared to those in the LBBAP group who had an improved LVEF (54.54 ± 3.77%, p < 0.0001). Conclusions: LBBAP both prevents the onset of atrial fibrillation and improves echocardiographic parameters, especially left ventricular ejection fraction, thus contributing to significantly reducing the risk of developing/worsening advanced heart failure through pacing-induced cardiomyopathy. Full article

Background/Objectives: Surgical aortic valve replacement effectively relieves left ventricular afterload and promotes reverse remodeling in patients with severe aortic stenosis. The Perceval prosthesis offers a hybrid approach, combining complete annular decalcification with sutureless deployment. This design allows for reduced operative times and potentially larger effective orifice areas. However, comparative data with conventional stented bioprosthetic valves remain limited, particularly regarding reverse remodeling, hemodynamic performance, and long-term clinical outcomes. Methods: In this retrospective cohort study, 115 patients underwent aortic valve replacement with either the Perceval valve (n = 44) or conventional stented bovine pericardial valves (n = 71). Results: The Perceval group showed a 100% procedural success rate with no in-hospital mortality, significantly shorter cardiopulmonary bypass and cross-clamp times, larger effective orifice areas, and a lower incidence of patient–prosthesis mismatch. Both groups demonstrated favorable left ventricular mass regression and reverse remodeling. The rates of paravalvular leakage, permanent pacemaker implantation, and redo aortic valve replacement were comparable between groups. Multivariate Cox regression identified the follow-up indexed left ventricular mass as an independent predictor of major adverse cardiac and cerebral events. Conclusions: In this study, the Perceval valve was associated with promising hemodynamic characteristics and procedural efficiencies, particularly in cases with small aortic annuli and during minimally invasive procedures. The valve was associated with reverse ventricular remodeling and clinical outcomes that appeared similar to those of conventional stented bioprostheses. These observations suggest it may represent a potential alternative option for surgical aortic valve replacement in appropriate clinical scenarios. However, randomized control trials are needed to confirm these associations. 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

Background: Salmonella enterica serovar Infantis (S. Infantis) is a widespread pathogen in agriculture, causing epidemics in chicken flocks. Despite being primarily an animal pathogen, it may pose significant health risks to immunocompromised individuals. Methods: This report describes the first known case of cardiac device-related infective endocarditis (CDRIE) attributed to S. Infantis, highlighting its emerging pathogenic potential. It also reviews the literature for microbiologic and epidemiologic perspectives. Results: A 61-year-old male with a history of high-grade multiple myeloma presented with nonspecific symptoms, including low-grade fever and exertional dyspnoea. Blood cultures identified a pure culture of S. Infantis, and transoesophageal echocardiography revealed vegetations on pacing leads. Following pacemaker extraction and appropriate antimicrobial therapy, the patient’s condition temporary improved, but later deteriorated due to the progression of underlying malignancy. Conclusions: This case underscores the importance of considering S. Infantis in the differential diagnosis of endocarditis in immunocompromised patients, along with the critical need for stringent food safety measures to mitigate infection risks from contaminated poultry products. Full article