Search Results (155)

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

Tricuspid regurgitation (TR) is a well-recognized factor contributing to adverse outcomes and mortality. Recent developments in transcatheter valve repair techniques, with the emergence of tricuspid transcatheter edge-to-edge repair (TEER) devices, have altered the treatment algorithm of TR and now offer a safe and feasible alternative for the effective management of the disease and an improvement in patient symptoms. Evidence from large studies and registries showcases the benefit of tricuspid interventions in terms of heart failure hospitalization and quality of life; however, most studies do not report a significant benefit in terms of hard outcomes. Even though longer-term follow-up may be needed to identify such differences, it is important to also identify distinct patient phenotypes that would benefit the most from such interventions, moving from pure anatomical criteria to an overall assessment of the patient’s clinical status. Therefore, the aim of this review is to provide updates on potential moderators of the effect of tricuspid TEER, focusing on novel anatomical criteria, right cardiac function, and renal physiology, in order to guide patient selection and provide an insightful discussion on the optimal patient phenotype for future trial design. Full article

Background and Objectives: Implantation of cardiac implantable electronic devices (CIEDs) is increasingly performed in elderly and comorbid patients, for whom minimizing perioperative complications—including pain and systemic drug use—is critical. Traditional local infiltration often provides insufficient analgesia. The ultrasound-guided PECS II block, an interfascial regional technique, offers promising analgesic benefits in thoracic wall procedures but remains underutilized in cardiac electrophysiology. Materials and Methods: We conducted a prospective, controlled, non-randomized clinical study including 106 patients undergoing de novo CIED implantation. Patients were assigned to receive either a PECS II block (n = 53) or standard lidocaine-based local anesthesia (n = 53). Pain intensity was assessed using the numeric rating scale (NRS) intraoperatively and at 1, 6, and 12 h postoperatively. Secondary outcomes included the need for rescue analgesia, procedural duration, length of hospitalization, and patient satisfaction. Results: Patients in the PECS II group reported significantly lower NRS scores at all time points (mean intraoperative score: 2.1 ± 1.2 vs. 5.7 ± 1.6, p < 0.001; at 1 h: 2.5 ± 1.5 vs. 6.1 ± 1.7, p < 0.001). Rescue analgesia (metamizole sodium) was required in only four PECS II patients (7.5%) vs. 100% in the control group within 1 h. Hospital stay and procedural time were also modestly reduced in the PECS II group. Patient satisfaction scores were significantly higher in the intervention group. Conclusions: The ultrasound-guided PECS II block significantly reduces perioperative pain and the need for additional analgesia during CIED implantation, offering an effective, safe, and opioid-sparing alternative to conventional local infiltration. Its integration into clinical protocols for device implantation may enhance procedural comfort and recovery. Full article

Subclinical atrial fibrillation (SCAF) episodes are frequently detected in patients with cardiac implantable electronic devices (CIEDs). These asymptomatic arrhythmias are increasingly recognized as potential harbingers of clinical atrial fibrillation and thromboembolic events. However, the management of SCAF—particularly regarding the use of oral anticoagulation (OAC)—remains controversial. This literature review (Medline, Scopus, Goggle scholar, Embase) focuses on using current literature and clinical studies to guide decision-making regarding anticoagulation therapy and other treatment options that can limit complications for patients with SCAF. The decision to initiate anticoagulation in patients with atrial high-rate episodes (AHREs) should be individualized, balancing stroke risk against bleeding potential. Ongoing research and post hoc analyses will further clarify which subgroups may benefit most from therapy, informing future guideline recommendations. Full article

Implantable cardiac devices are critical in improving patients’ quality of life through precise and continuous interaction between the device and pathological cardiac tissue. Due to the inherently rigid nature of conventional devices, several complications arise when interacting with soft cardiac tissue, caused by a mechanical mismatch between the device and myocardium. This leads to the excessive formation of fibrous tissue around the implanted device, ultimately compromising both device functionality and tissue health. To address these challenges, flexible electronics based on polymers and elastomers significantly softer than conventional rigid metals and silicon have been explored. The epicardial approach enables the device to conform to the curved myocardial surface and deform synchronously with cardiac motion, thereby improving mechanical compatibility. However, modulus mismatches between soft polymers and cardiac tissue can still lead to mechanical instability and non-uniform adhesion, potentially affecting long-term performance. This review comprehensively summarizes recent research advancements in epicardial patch electronics based on bioadhesive and conductive hydrogels. We emphasize current research directions, highlighting the potential of hydrogels in epicardial electronics applications. Critical discussion includes recent trends, ongoing challenges, and emerging strategies aimed at improving the properties of hydrogel-based epicardial patches. Future research directions to facilitate clinical translation are also outlined. Full article

Background: Subcutaneous pocket infection is a common morbidity associated with the integration of cardiac implantable electronic devices (CIEDs). A new antibiotic-eluting CIED bioenvelope has been developed as a prophylactic measure to mitigate infection and skin erosion caused by device migration. This study investigated the envelope’s regulatory properties in scar formation and vascularization. Methods: Fibroblasts were seeded on either plastic (n = 6) or small intestine submucosal extracellular matrix (SIS-ECM) (n = 6) for 24 h. The culture media were analyzed for proangiogenic and proinflammatory proteins with multiplex. Sham (n = 8) or SIS-ECM (n = 8) was randomly implanted into the dorsal subcutaneous pocket of mice. The implants were excised on day 7, cultured for 24 h, and the media analyzed. Rabbit models were implanted with either synthetic polymer HDPE (n = 12) or SIS-ECM (n = 11). The treatments were excised at weeks 2, 10, and 26 and then stained for analysis. Results: SIS-ECM significantly increased the fibroblasts’ paracrine release of proangiogenic and proinflammatory factors like VEGF-A (p < 0.05) and IL-6 (p < 0.05) compared with plastic. The murine tissue interacting with SIS-ECM released significantly more angiogenic proteins like VEGF-A (p < 0.05) than the sham. The histology analysis of rabbit subcutaneous tissue revealed a decreasing level of inflammation and fibrosis over time with SIS-ECM. Conclusions: The CIED bioenvelope elicited proangiogenic paracrine signaling and reduced fibrotic response in fibroblasts and animal models. Clinical translation of the CIED bioenvelope as an adjunct to regular prophylactic practice may be warranted in the future. 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

Despite ongoing concerns about electromagnetic interference affecting cardiac implantable electronic devices (CIEDs) in the electrical industry workplaces, no study has experimentally assessed induced voltages in CIEDs under exposure to power-frequency magnetic fields. This study addresses this gap by quantifying such interference using a dedicated experimental setup to reproduce high intensity magnetic fields and to measure voltages induced on CIEDs under exposure. A thorough analysis was carried out in comparison with formula-based and simulation approaches applied in previous studies. The induced voltages on CIEDs were measured across varying configurations, including sensing mode, implantation method, exposure frequency, and magnetic field orientation. Our findings reveal the induced voltage levels under exposure from a statistical perspective and highlight correlations between susceptibility and the impact factors, with unipolar configurations and left pectoral implants exhibiting the highest susceptibility. This work provides insights into electromagnetic interference risks for CIED carriers and supports the development of individual protection strategies to enhance occupational safety. Full article

Background/Objectives: Remote telemedical management (RTM) in heart failure (HF) patients with cardiac implantable electronic devices (CIED) is a reliable approach to follow device-specific and heart failure-related parameters. However, while some positive outcome data is available, results are inconclusive. We aimed to assess the benefits of continuous remote telemonitoring (RTM) compared to the in-person visit (IPV) in reducing all-cause mortality, heart failure hospitalizations (HFH), cardiovascular (CV) deaths, and the occurrence of inappropriate therapy. Methods: The study comprised a systematic review and meta-analysis of randomized controlled trials (RCTs) testing RTM (device-related or other non-invasive telemonitoring systems) vs. IPV for the management of HF patients. The main endpoints were all-cause and CV mortality. Risk of bias and level of evidence were assessed. Hazard ratios (HRs), odds ratios (ORs) and 95% confidence intervals (CI) were calculated. CENTRAL, EMBASE and MEDLINE were searched, and only randomized controlled studies were included. Results: Sixteen RCTs were identified, comprising a total of 11,232 enrolled patients. Seven studies evaluated all-cause mortality, resulting in an OR 0.83 (95% CI 0.72 to 0.96). When CV mortality was assessed, the RTM group showed a significant benefit compared to the IPV group (OR 0.81, 95% CI 0.67 to 0.97). The risk of bias ranged from “low” to “some concerns” for most outcomes, and the certainty was low to moderate depending on the specific outcomes. Conclusions: RTM proved to be superior in reducing all-cause and CV mortality compared to IPV; however, there is a clear need to have standardized alert actions to achieve the mortality benefit. Full article

Background—Percutaneous left atrial appendage (LAA) closure (LAAC) offers a valid alternative to oral anticoagulation in patients with atrial fibrillation (AF) at high risk of bleeding. However, its impact on AF burden and device function in patients with cardiac implantable electronic devices (CIEDs) remains largely unexplored. Methods—From our prospective LAAC registry (clinicaltrial.gov—NCT04628078), which includes all consecutive LAAC procedures performed at our institution, we identified patients with a CIED and retrospectively analyzed procedural and follow-up data. The primary endpoint was defined as a composite of death, TIA/stroke, systemic or pulmonary embolism and major bleeding (BARC 3-5) within 7 days of the procedure. The secondary endpoint was CIED lead dislodgement. Additionally, AF burden was compared before and after LAAC. Results—Of the 586 LAAC procedures performed between August 2015 and January 2023, 36 patients (6%) had a CIED. The median CHA₂DS₂-VASC and HAS-BLED scores were 4.0 and 3.0, respectively. The primary endpoint occurred in one (3%) patient, and no patient experienced CIED lead dislodgement. AF burden data before and after LAAC were available in 20 patients. The mean AF burden increased from 6% to 31% following LAAC (p = 0.064). Conclusions—A CIED was present in 6% of LAAC procedures, and LAAC appears feasible and safe in this patient population. Larger, prospective studies are warranted to further evaluate the impact of LAAC on AF burden. Full article

Background: Atrial fibrillation (AF) is the most common supraventricular arrhythmia and is associated with an impaired prognosis. Studies using implantable cardiac monitors suggest that this association is closely linked to AF burden, defined as the percentage of time spent in AF. Consequently, there is a growing need for affordable and comfortable alternative devices, such as wearables, capable of reliably monitoring AF burden in patients with AF. Methods: Major electronic databases were searched for studies comparing AF burden quantification using wearables and reference ECG monitoring methods. A Bayesian approach was adopted for the final analysis. Results: Six studies, including a total of 448 patients and 36,978 h of valid simultaneous recordings, were analyzed. Bayesian analysis revealed no statistically significant differences between wearables and reference methods in AF burden quantification. The mean error was 1% (95% CrIs: −4% to 7%). Similar findings were observed in the subgroup analysis of studies assessing only smartwatches. Between-study heterogeneity was low, and no evidence of publication bias was detected. Conclusion: Our analysis suggests that AF burden quantification using wearables is comparable to reference ECG monitoring methods. These findings support the potential role of wearables in clinical practice, particularly for research and prognostic purposes. However, more studies are needed to determine whether the observed statistical equivalence translates to clinical significance, thereby supporting the widespread use of wearables in the assessment of rhythm control therapeutic strategies. Full article

Background: Preventing infections associated with cardiac implantable electronic devices (CIED) and neurostimulators is essential to optimizing patient outcomes. This study aimed to evaluate the antimicrobial performance of a biologic CIED envelope incorporating a bioabsorbable disc infused with rifampin and minocycline. Methods: The antimicrobial activity was evaluated in a rabbit model and in vitro elution tests. Based on in vivo–in vitro correlation studies, a modified AATCC-100 method was used to quantitatively assess antibacterial activity across seven bacterial strains relevant to CIED infections. Results: Pharmacokinetic analysis showed a biphasic elution profile, with rapid initial release followed by more gradual elution over 14 days. The AATCC results showed no bacterial recovery for any tested species, with complete eradication in all replicates. Conclusions: These results support the use of antibiotic-eluting bioenvelopes as an effective strategy for preventing bacterial infections associated with CIED. The modified AATCC-100 test and in vivo–in vitro correlation studies provide new tools for the evaluation of the antibiotic activity of implantable biomaterials. Full article

Background/Objectives: PRKAG2 syndrome (PS) is a rare genocopy of hypertrophic cardiomyopathy (HCM). Our goal was to expand knowledge about PS by analyzing patient clinical, imaging, and follow-up data. Methods: The study included carriers of likely pathogenic or pathogenic PRKAG2 variants identified in the years 2011–2022. Cardiac involvement was assessed by electrocardiography, echocardiography, cardiac magnetic resonance imaging, and endomyocardial biopsy (EMB). We recorded concomitant diseases and cardiac events, including the implantation of electronic cardiac devices, arrhythmia, heart failure (HF), and death. Results: Seven patients from four families (median age 43 years) with PRKAG2 variants: Phe293Leu, Val336Leu, Arg302Gln, and His530Arg were included. At the first evaluation, 3 carriers were in New York Heart Association (NYHA) functional class II–III, while the remaining were in NYHA class I. Left ventricular hypertrophy (LVH) was present in 5 patients; 2 had ventricular pre-excitation, one was in atrial flutter and pacemaker-dependent; 2 had bradycardia. Two female carriers had concomitant chronic renal disease. In the EMB of one of the patients, staining for glycogen deposits was positive. Furthermore, we provide a link between the Val336Leu PRKAG2 variant and autophagy identified on EMB. After a median follow-up of 13.1 years, 6 carriers had LVH, 3 required admission for HF, and 1 had sustained ventricular tachycardia with subsequent cardioverter defibrillator implantation, and despite this, died suddenly; there were two de novo pacemaker implantations due to symptomatic bradycardia. Conclusions: PR is a distinctive disorder with an early onset of arrhythmic events, often leading to HF. Full article

Infective endocarditis (IE) is a relatively rare but potentially life-threatening disease characterized by substantial mortality and long-term sequelae among the survivors. In recent decades, a dramatic change in the profile of patients diagnosed with IE has been observed primarily in developed countries, most likely due to an aging population and a recent increase in invasive medical procedures. Nowadays, the typical IE patient is usually older, with complex comorbidities, and a history significant for cardiac disease, including degenerative heart valve disease, prosthetic valves, or cardiovascular implantable electronic devices (CIEDs). Moreover, as patient risk factors change, predisposing them to more healthcare-associated IE, the microbiology of IE is also shifting; there are growing concerns regarding the rise in the incidence of IE caused by difficult-to-treat resistance (DTR) bacteria in at-risk patients with frequent healthcare contact. The present review aims to explore the evolving landscape of IE and summarize the current knowledge on novel diagnostics to ensure timely diagnosis and outline optimal therapy for DTR bacterial IE. Full article

Cardiac implantable electronic devices (CIEDs) are commonly used for a number of cardiac-related conditions, and it is estimated that over 300,000 CIEDs are placed annually in the US. With advances in technology surrounding these devices and expanding indications, CIEDs can remain implanted in patients for long periods of time. Although the safety profile of these devices has improved over time, both the incidence and prevalence of long-term complications are expected to increase. This review highlights pertinent long-term complications of CIEDs, including lead-related issues, device-related arrhythmias, inappropriate device therapies, and device-related infections. We also explore key clinical aspects of each complication, including common presentations, patient-specific and non-modifiable risk factors, diagnostic evaluation, and recommended management strategies. Our goal is to help spread awareness of CIED-related complications and to empower physicians to manage them effectively. Full article