Cardiac Implantable Devices Research Articles

The axillary vein puncture for implantable cardiac defibrillator implantation: 14 years of experience. Analysis of the results

BackgroundAxillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients.A simplified AVP technique is described. MethodsAll the patients who consecutively underwent “de novo” ICD implantation, from March 2006 to December 2020 at the University of Verona, were considered.Leads insertion was routinely performed through an AVP, according to a simplified technique. Outcome and complications have been retrospectively analyzed. ResultsThe study population consisted of 1711 consecutive patients. Out of 1711 patients, 38 (2.2%) were excluded because they were implanted with Medtronic Sprint Fidelis lead.Out of 1673 ICD implantations, 963 (57.6%) were ICD plus cardiac resynchronization therapy, 434 (25.9%) were dual-chamber defibrillators, and 276 (16.5%) were single-chamber defibrillators, for a total of 3879 implanted leads. The AVP success rate was 99.4%. Acute complications occurred in 7/1673 (0.42%) patients. Lead failure (LF) occurred in 20/1673 (1.19%) patients. Comparing the group of patients with lead failure with the group without LF, the presence of three leads inside the vein was significantly associated with LF, and the multivariate analysis confirmed three leads in place as an independent predictor of LF. ConclusionAVP, according to our simplified technique, is safe, effective, has a high success rate, and a very low complication rate. The incidence of LF was exceptionally low.The advantages of AVP are maintained over time in a population of ICD recipients.

Novel Medical Treatments and Devices for the Management of Heart Failure with Reduced Ejection Fraction.

Heart failure (HF) is a growing issue in developed countries; it is often the result of underlying processes such as ischemia, hypertension, infiltrative diseases or even genetic abnormalities. The great majority of the affected patients present a reduced ejection fraction (≤40%), thereby falling under the name of "heart failure with reduced ejection fraction" (HFrEF). This condition represents a major threat for patients: it significantly affects life quality and carries an enormous burden on the whole healthcare system due to its high management costs. In the last decade, new medical treatments and devices have been developed in order to reduce HF hospitalizations and improve prognosis while reducing the overall mortality rate. Pharmacological therapy has significantly changed our perspective of this disease thanks to its ability of restoring ventricular function and reducing symptom severity, even in some dramatic contexts with an extensively diseased myocardium. Notably, medical therapy can sometimes be ineffective, and a tailored integration with device technologies is of pivotal importance. Not by chance, in recent years, cardiac implantable devices witnessed a significant improvement, thereby providing an irreplaceable resource for the management of HF. Some devices have the ability of assessing (CardioMEMS) or treating (ultrafiltration) fluid retention, while others recognize and treat life-threatening arrhythmias, even for a limited time frame (wearable cardioverter defibrillator). The present review article gives a comprehensive overview of the most recent and important findings that need to be considered in patients affected by HFrEF. Both novel medical treatments and devices are presented and discussed.

Risk of infection and vascular complications with cardiac implantable electronic device implantation in patients with a history of mastectomy

Risk of infection and vascular complications with cardiac implantable electronic device implantation in patients with a history of mastectomy

Juxtaposed Atrial Appendages: Implications for Cardiac Electronic Device Implants

Juxtaposed Atrial Appendages: Implications for Cardiac Electronic Device Implants

Management of atrial arrhythmias identified by cardiac devices.

Implantable cardiac devices have shown that atrial fibrillation (AF) is more frequent than previously assumed, with subclinical, asymptomatic, self-limiting manifestations called atrial high-rate events (AHREs) or subclinical AF. The clinical significance and correct therapeutic management of these episodes of subclinical AF is less well defined than in the case of clinically manifest AF. Two important randomized studies on the topic have recently been published, NOAH-AFNET 6 and ARTESIA, which, however, have not definitively clarified the topic. In patients with AHRE or subclinical AF, the average thrombo-embolic risk is lower than that in patients with clinically manifest AF and is ∼1%. For this reason, in these patients, the possibility that the benefit of anticoagulant therapy is overshadowed by the risk of bleeding is very high. Therefore, while waiting for new tools that allow a better stratification of low-risk patients, we must rely on individual clinical evaluation and overcome the qualitative dichotomy (AHRE yes vs. AHRE no), preferring instead an approach that is as quantitative as possible and takes into account the number of episodes, their duration, and the patient's CHADSVASC score, before deciding, in each individual case, whether or not to use anticoagulant therapy.

Optimizing Patient Selection for Physiological Pacing in Bradyarrhythmia: Factors Associated With High Ventricular Pacing Burden.

Right ventricular (RV) pacing is established as the most common ventricular pacing (VP) strategy for patients with symptomatic bradyarrhythmia. Some patients with high VP burden suffer deterioration of left ventricular (LV) function, termed pacing-induced cardiomyopathy (PICM). Patients who pace > 20% of the time from the RV apex are at increased risk of PICM, but independent predictors of increased RV pacing burden have not been elucidated in those who have a permanent pacemaker (PPM) inserted for bradyarrhythmia. We aimed to identify factors that are associated with increased VP burden > 20%, hence determining those at risk for resultant PICM. In this retrospective cohort study, we identified the most recent 300 consecutive cardiac implantable electronic device (CIED) implants in our center and collected past medical history, electrocardiogram (ECG), echo, medication and pacemaker check data. A total of 236 individuals met inclusion criteria. Of the patients, 35% had RV pacing burden < 20%, while 65% had VP burden ≥ 20%; 96.2% of patients with complete heart block (CHB) paced > 20% (P = 0.002). Utilization of DDD or VVI (75.2% and 89.2% of patients, respectively) without mode switch algorithms was associated with VP > 20% (P < 0.001). Male or previous coronary artery bypass grafting (CABG) patients also statistically paced > 20%. Other factors trending towards significance included prolonged PR interval, atrial fibrillation or more advanced age. High-grade atrioventricular (AV) block was associated with an RV pacing burden > 20% over 3 years but this was not consistent in patients with only transient episodes of high-grade AV block. We found a significant association between high VP% and male sex, previous CABG and the absence of mode switching algorithms.

Assessment of the Impact of Cardiac Implantable Electronic Devices on Patients' Quality of Life.

Assessing the quality of life serves as a crucial metric during various therapeutic or surgical procedures. The rise in cardiac electronic device implantations in recent years underscores the significance of evaluating the quality of life among such patients. We conducted a study focusing on the quality of life of 438 patients with cardiac implantable electronic devices (cardiac pacemakers, cardioverter-defibrillators, cardiac resynchronization therapy devices). These patients were diagnosed with sick sinus syndrome, high-degree atrioventricular (AV) block, or severe heart failure (New York Heart Association (NYHA) classes III- IV (NYHA III-IV)), with left ventricular ejection fraction (LVEF) ≤ 35%, with/without complete left bundle branch block (QRS ≥ 130 μs), or with a history of ventricular tachycardia/ventricular fibrillation. The study utilized the EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire and the EQ visual analog scale, which patients completed both prior to cardiac device implantation and during six post-implantation follow-up visits. The analysis of the research findings was conducted using the IBM SPSS Statistics software program (Armonk, NY). Cardiac pacemaker implantation in patients with sick sinus syndrome and high-grade AV block demonstrated significant and highly reliable positive effects on quality of life concerning mobility, self-care, and usual activity. Similarly, cardiac resynchronization device implantation in individuals with severe heart failure with reduced LVEF and wide QRS showed significant positive effects in these areas. However, cardioverter-defibrillator implantation did not yield positive effects on these modules.Regarding pain/discomfort, neither pacemaker nor cardiac resynchronization device implantation resulted in improved quality of life, while there was a somewhat positive effect observed in the cardioverter-defibrillator group. In terms of anxiety/depression, pacemaker implantation in patients with sick sinus syndrome and high-degree AV block had a significant and highly reliable positive impact on quality of life. Additionally, relatively positive impacts were noted at various periods following cardioverter-defibrillator and cardiac resynchronization device implantations. Cardiac implantable electronic devices play a crucial role not only in saving lives but also in positively impacting the quality of life of patients when appropriately selected.

The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial.

A novel non-contact system for remote parameter testing and reprogramming offers an alternative method for assessing device parameters during cardiac implantable electronic devices (CIEDs) implantation without the need for physical contact with the manufacturer's clinical service technician. The safety and feasibility of using this system in CIEDs implantation procedures remains to be determined. Evaluate the safety and feasibility of remote parameter testing in CIEDs implantation procedures. A single center, randomized, open-label, non-inferiority trial (ChiCTR2200057587) was conducted to compare the two approaches for interrogating CIEDs during implantation procedures: routine interrogation performed by on-site technicians or remote interrogation performed by technicians using the 5G-Cloud Technology Platform. Patients aged ≥18 years and elected to receive CIEDs were eligible for inclusion. The primary endpoint was the completion rate of the parameter test. Safety and efficiency were evaluated in all randomly assigned participants. A total of 480 patients were finally enrolled and were randomly assigned to routine group (n = 240) or remote group (n = 240). The primary endpoint was achieved by 100% in both groups (P = 0.0060 for noninferiority). The parameters of sensing, threshold, and impedance regarding the right atrium, right ventricle, and left ventricle had no statistical significance between the two groups (P > 0.05). Procedure time, parameter testing time, and both duration and dose of x-ray irradiation were not significantly different between the two groups (P > 0.05). Shut-open door frequency was significantly higher in the routine group than the remote group [6.00 (4.00, 8.00) vs. 0, P < 0.0001]. Notably, no clinical or technical complications were observed in the remote group. Remote parameter testing is safe and feasible across various devices implantation procedures. The utilization of remote parameter testing and reprogramming could represent an innovative approach to improve healthcare accessibility and unlock the full potential of secondary centers in managing CIEDs. ChiCTR2200057587.

Cardiac Magnetic Resonance and Cardiac Implantable Electronic Devices: Are They Truly Still "Enemies"?

The application of cardiac magnetic resonance (CMR) imaging in clinical practice has grown due to technological advancements and expanded clinical indications, highlighting its superior capabilities when compared to echocardiography for the assessment of myocardial tissue. Similarly, the utilization of implantable cardiac electronic devices (CIEDs) has significantly increased in cardiac arrhythmia management, and the requirements of CMR examinations in patients with CIEDs has become more common. However, this type of exam often presents challenges due to safety concerns and image artifacts. Until a few years ago, the presence of CIED was considered an absolute contraindication to CMR. To address these challenges, various technical improvements in CIED technology, like the reduction of the ferromagnetic components, and in CMR examinations, such as the introduction of new sequences, have been developed. Moreover, a rigorous protocol involving multidisciplinary collaboration is recommended for safe CMR examinations in patients with CIEDs, emphasizing risk assessment, careful monitoring during CMR, and post-scan device evaluation. Alternative methods to CMR, such as computed tomography coronary angiography with tissue characterization techniques like dual-energy and photon-counting, offer alternative potential solutions, although their diagnostic accuracy and availability do limit their use. Despite technological advancements, close collaboration and specialized staff training remain crucial for obtaining safe diagnostic CMR images in patients with CIEDs, thus justifying the presence of specialized centers that are equipped to handle these type of exams.

Risk of infections related to endovascular catheters and cardiac implantable devices in hemodialysis patients.

Patients requiring dialysis are extremely vulnerable to infectious diseases. The high burden of comorbidities and weakened immune system due to uremia and previous immunosuppressive therapy expose the patient on dialysis to more infectious events than the general population. The infectious risk is further increased by the presence of endovascular catheters and implantable cardiologic devices. The former is generally placed as urgent vascular access for dialysis and in subjects requiring hemodialysis treatments without autogenous arteriovenous fistula. The high frequency of cardiovascular events also increases the likelihood of implanting indwelling implantable cardiac devices (CIED) such as pacemakers (PMs) and defibrillators (ICDs). The simultaneous presence of CVC and CIED yields an increased risk of developing severe prosthetic device-associated bloodstream infections often progressing to septicemia. Although, antibiotic therapy is the mainstay of prosthetic device-related infections, antibiotic resistance of biofilm-residing bacteria reduces the choice of infection eradication. In these cases, the resolution of the infection process relies on the removal of the prosthetic device. Compared to CVC removal, the extraction of leads is a more complex procedure and poses an increased risk of vessel tearing. As a result, the prevention of prosthetic device-related infection is of utmost importance in hemodialysis (HD) patients and relies principally on avoiding CVC as vascular access for HD and placement of a new class of wireless implantable medical devices. When the combination of CVC and CIED is inevitable, prevention of infection, mainly due translocation of skin bacteria, should be a mandatory priority for healthcare workers.

Impact of Chronotropic Incompetence and Correlation with Exercise Tolerance in Patients with Implantable Cardiac Devices Undergoing a Phase II Cardiac Rehabilitation Program Article Sidebar

Objective: Since patients with implantable cardiac devices tend to develop chronotropic incompetence (CI) associated with the effect of the device itself or the pharmacological effect of the underlying disease, CI could act as a limiting factor in improving exercise tolerance in patients undergoing cardiac rehabilitation program, since an increase in HR is a crucial part in improving cardiac output as a central component of oxygen consumption (VO2). However, it has been observed that there could be other factors contributing to the improvement in exercise tolerance in these patients regardless of the presence of CI. The aim of this research is to clarify the effect of chronotropic incompetence on the improvement in exercise capacity in patients with implantable cardiac devices after a phase II cardiac rehabilitation program (CRP). Methods: Quasi-experimental study applied to patients with implantable cardiac devices (ICDs, CRT, pacemakers) undergoing a supervised concurrent CRP, lasting 4-6 weeks, at an intensity between 65-80% of heart rate reserve (HRR), associated with kinesiotherapy sessions (with strength and endurance training and other biomotor qualities) and interdisciplinary intervention, education, and counseling. CI was calculated using the chronotropic response index, and METs-load measurement was performed at the beginning and at the end of the intervention. Results: Forty patients with a mean age of 61.4 years were included, mostly male (29) 72.5%, (23) 57.5% diagnosed with heart failure, and regarding the type of device, pacemakers (20) 50%, implantable cardioverter-defibrillator (ICD) (12) 30%, and cardiac resynchronization therapy with defibrillator (CRT-D) (20) 8%, of the total patients (35) 87.5% presented chronotropic incompetence and only (5) 12.5% with normal chronotropic response at the end of the intervention. A significant decrease in the chronotropic response index from 0.70 to 0.47 (p &lt;0.001) and a significant increase in METs-load from 5.47 to 9.35 (p &lt;0.001) were found. The value of the differential between initial and final METs (delta-METs) was obtained for both groups, observing a significant increase between initial and final METs in favor of patients with CI (3.8 Vs 3.5, p&lt;0.012) at the end of the intervention. A significant moderate negative correlation (r=-0.395, Spearman, p&lt;0.012) was determined between the degree of CI and final METs-load. Conclusions: It was observed that patients with implantable cardiac devices undergoing a CRP show an increase in exercise tolerance measured in METs, with an inversely proportional correlation to chronotropic incompetence.

How we do it: Cardiac implantable devices are not a contraindication to MRI: time for a paradigm shift.

Magnetic resonance imaging (MRI) is now an indispensable diagnostic tool in medicine due to its outstanding contrast resolution and absence of radiation exposure, enabling detailed tissue characterization and three-dimensional anatomical representation. This is especially important when evaluating individuals with congenital heart disease (CHD) who frequently require cardiac implantable electrical devices (CIEDs). While MRI safety issues have previously limited its use in patients with CIEDs, new advances have called these limitations into question. However, difficulties persist in the pediatric population due to the continued lack of specific safety data both related to imaging young children and the specific CIED devices they often require. This paper discusses MRI safety considerations related to imaging patients with CIEDs, investigates pediatric-specific problems, and describes thorough methods for safe MRI access, highlighting the significance of specialized institutional guidelines.

Nutritional Status Predicts the Length of Stay and Mortality in Patients Undergoing Electrotherapy Procedures.

(1) Background: Nutritional status is a factor that impacts the patients' outcomes in various medical conditions including cardiovascular patients or surgical procedures. However, there is limited available information about its impact on the short-term outcomes of cardiac implantable electronic device (CIED) implantations. This study aimed to assess the relationship between nutritional status, complications, mortality risk, and length of stay at the hospital in patients undergoing CIED implantations. (2) Material and Methods: 588 patients who underwent CIED implantation in 2022 and 2023 were included in the retrospective analysis. The nutritional status assessment was performed using NRS 2002 and BMI. The implanted devices were single-chamber pacemakers (n = 82), dual-chamber pacemakers (n = 329), one-chamber ICDs (n = 83), dual-chamber ICDs (n = 19), CRT-P (n = 19), and CRT-D (n = 56). (3) Results: The regression analysis showed that the NRS 2002 score predicted the length of stay (age-adjusted: β = 1.02, p = 0.001) among the CIED-implanted patients. The CRT-D subgroup was particularly responsible for this relationship (β = 4.05, p = 0.003 after age adjustment). The analysis also revealed significant differences between the NRS 2002 score in the in-hospital death subgroups (1.75 ± 1.00 points for deaths vs. 1.00 ± 1.00 points for survivors; p = 0.04). There were no significant differences in nutritional status parameters regarding early complications subgroups. (4) Conclusions: This study showed that nutritional risk assessed with NRS 2002 is a predictor of length of stay (particularly for CRT-D) and mortality among patients undergoing CIED implantations. The results of the analysis point out the impact of patients' nutritional status on short-term outcomes of CIED implantations, particularly in CRT-D implants where 1 NRS 2002 point was a predictor of a mean 4.05 days (77.2%) longer hospitalization.

Mortality and Costs of Cardiac Implantable Electronic Device (CIED) Infections According to the Therapeutic Approach: A Single-Center Cohort Study.

Background: Cardiac device infections are serious adverse events associated with considerable morbidity and mortality, significant costs, and increased healthcare utilization. The aim of this study is to calculate the costs of treatment of cardiac implantable electrostimulation device (CIED)-related infections for different types of infection (local or systemic) and therapeutic approaches. Patients and Methods: Single-center cohort (1985-2018). The costs of the CIED-related infections were analyzed according to initial treatment (antimicrobial treatment exclusively, local approach, or transvenous lead extraction (TLE)). Total costs (including those for hospitalization stay, drugs, extraction material, and newly implanted devices) were assigned to each case until its final resolution. Results: A total of 380 cases (233 local and 147 systemic infections) were analyzed. The average cost of systemic infection was EUR 34,086, mainly due to hospitalization (78.5%; mean: 24 ± 14 days), with a mortality rate of 10.8%. Local infection had a mortality rate of 2.5% (mainly related to the extraction procedure) and an average cost of EUR 21,790, which was higher in patients with resynchronization therapy devices and defibrillators (46% of total costs). Surgical procedures limited to the pocket for local infections resulted in a high rate of recurrence (87%), evolved to systemic infections in 48 patients, and had a higher cost compared to TLE (EUR 42,978 vs. EUR 24,699; p < 0.01). Conclusions: The costs of treating CIED-related infections are high and mainly related to the type of treatment and length of hospitalization. Complete device removal is always the most effective approach and is a cost-saving strategy.

Long-term outcome and cardiac function after anatomic repair of congenitally corrected transposition.

There is limited information on long-term outcomes and trajectories of ventricular and valvular functions in patients with congenitally corrected transposition of the great arteries after anatomic repair according to the operative strategy with a median follow-up period of more than 10 years. Twenty-nine patients who underwent anatomic repair in Okayama University Hospital between January 1994 and December 2020 were reviewed. Outcomes were compared between patients who underwent a double switch operation (DS group) and patients with an atrial switch with a Rastelli operation (Rastelli-Senning/Mustard group). Fifteen (52%) were in the DS group and 14 (48%) were in the Rastelli-Senning/Mustard group. The median follow-up period after anatomic repair was 12.7 (interquartile range 4.2-18.8) years. There were 3 (10%) early deaths and 3 (10%) late deaths. Survival rates for the entire cohort at 10 and 20 years were 86% and 71%, respectively, and were not different between the 2 groups. Using competing risk analysis, risks of heart failure, cardiac rhythm device implantation and atrial arrhythmia showed no significant differences between the 2 groups, whereas risk of reoperation was higher in the Rastelli-Senning/Mustard group than that in the DS group. Four patients after a DS operation and 1 patient after a Rastelli technique developed more than moderate aortic regurgitation. During a median follow-up period of more than 10 years, mortality rate and ventricular and valvular functions after anatomic repair were acceptable, though the incidences of late complications were relatively high, especially in the Rastelli-Senning/Mustard group.

Effects of envelopes on cardiac implantable electronic device pocket healing: A head-to-head preclinical evaluation

BackgroundThe healing response to cardiac implantable electronic device (CIED) implantation results in inflammation that can lead to fibrous pocket formation, which may disrupt pocket healing or complicate future interventions. ObjectiveThe purpose of this study was to assess CIED pocket healing with use of the second-generation TYRX absorbable antibacterial envelope (T2), the next-generation (NG) TYRX absorbable antibacterial envelope under development, and the CanGaroo® extracellular matrix envelope (ECM) compared to no envelope. MethodsA total of 110 CIEDs were implanted in an ovine model, either with (T2, NG, or ECM) or without envelopes. Histopathologic and morphometric analyses were completed at several timepoints after implant (3 days, 7 days, 4 weeks, 12 weeks, 24 weeks). An independent pathologist completed a blinded histopathology assessment of the pockets. ResultsTYRX (T2/NG) pockets showed similar inflammatory and healing profiles to controls with more rapid provisional matrix formation compared to controls and ECM. ECM pockets exhibited increased acute (3 and 7 days) and chronic (24 weeks) inflammation. T2/NG had almost complete (T2) or complete (NG) absorption by week 12. ECM remained present at week 24 and was associated with significantly thicker capsules (ECM 0.80 ± 0.14 mm; NG 0.37 ± 0.10 mm; control 0.56 ± 0.17 mm). ConclusionCompared to ECM, pockets with TYRX showed less inflammation, more rapid provisional matrix formation, faster absorption, and thinner capsules. TYRX pockets had low inflammation comparable to controls with accelerated provisional matrix deposition and tissue adhesion. The healing response to CIEDs used with TYRX fosters the formation of a well-healed pocket, which may bring patient benefit beyond its proven infection reduction.

Optimal hospital discharge time after cardiac implantable electronic device implantation: A retrospective study from a tertiary electrotherapy center.

Optimal hospital discharge time after cardiac implantable electronic device implantation: A retrospective study from a tertiary electrotherapy center.

Cardiac Implantable Electronic Device (CIED) Infections, Associated Risk Factors and Optimization in Reducing CIED Infections; An Experience of Tertiary Care Hospital of Pakistan

Objective: To determine the frequency of infections in cardiac implantable Electronic device patients, identify risk factors, and look for optimization in reducing Cardiac Implantable Electronic Device infections, with a resultant decrease in mortality and morbidity, decrease in hospital stay, and total expenditure. Study Design: Cross-sectional study. Place and Duration of Study: Electrophysiology Department of National Institute of Cardiovascular Diseases, Karachi Pakistan, from Jul 2019 to Jun 2020. Methodology: The study was conducted on the patients with cardiac implantable devices. Adult patients of either genderwith cardiac implantable Electronic device and infection were included. Epicardial leads and surgical site infections within six weeks were excluded. Results: One thousand and forty-six (1046) patients were enrolled in the study. There were 596(57%) male patients. 385(36.8%) patients were implanted with single chamber pacemakers, 390(37.3%) with dual chamber pacemakers, 146(14%) single chamber ICD (implantable cardiac defibrillator), 67(6.4%) dual-chamber cardiac implantable Electronic device, 46(4.4%) CRT-D, 12(1.1%) TPM, 134(12.8%) Re-do, 114(10.9%), 114(10.9%) generator change, 20(1.9%) leads revision, 26(2.5%) patients had extraction. The rate of CIED infection was 34(2.1%). The association of the study parameters with infection rate revealed that type of device (p=0.002), extraction, suture type, and post-procedure hematoma (p&lt;0.001) had a statistically significant relationship with infection rate.Conclusion: The Cardiac Implantable Electronic Device infection rate was 2.1%. Hypertension and diabetes were common risk factors, and left ventricular dysfunction was common in high-energy devices with multiple leads and repeated procedures.

Prevention of complications during implantation of devices in arrhythmology, past, present and future

Infections associated with cardiac implantable electronic devices (CIED) pose a serious risk to the patient’s health due to the high mortality rate of this type of complications. This literature review presents risk factors, microbiology and pathogenesis, as well as the rationale and evidence for the use of antibiotic-releasing envelopes in patients with an increased risk of infectious complications. As a preventive measure, envelopes for implantable cardiac devices with antimicrobial impregnation are used, which have been developed to reliably hold devices in place, provide a stable environment and reduce the risk of infectious complications. Since it is believed that most infections occur during cardiac devices implantation, these covers have become an effective method of prevention. New technologies of the envelopes promise to reduce the CIED pocket infection rate. Preclinical and clinical data confirm the effectiveness of local antibiotic delivery through synthetic shells or ICS shells based on intracellular matrix, eluting rifampicin/minocycline and gentamicin, respectively. Moreover, the shell of the extracellular matrix usually stimulates tissue remodeling and angiogenesis, thereby minimizing inflammation and promoting bacterial clearance. Given the continued growth in the implantation of cardiac devices and the associated infectious complications, innovative approaches to infection prevention during the implantation of arrhythmological devices are crucial.

Rate of cardiovascular events up to 8 years after uncomplicated myocarditis: a nationwide cohort study.

While prognosis of acute myocarditis with uncomplicated presentation is perceived as benign, data on long-term outcomes are scarce. We evaluated rates of myocarditis-associated cardiovascular events after a first-time hospitalization with uncomplicated acute myocarditis in patients without known heart disease. In this retrospective nationwide population-based cohort study from 2013 to 2020, hospitalized patients with uncomplicated acute myocarditis but without known heart disease were 1:1 propensity score-matched with surgical controls hospitalized for laparoscopic appendectomy. As assessed in time-to-event analyses, the primary outcome was a composite of rehospitalization for myocarditis, pericardial disease, heart failure and its complications, arrhythmias, implantation of cardiac devices, and heart transplant. After matching, we identified 1439 patients with uncomplicated acute myocarditis (median age of 35 years, 74.0% male) and 1439 surgical controls (median age of 36 years, 74.4% male). Over a median follow-up of 39 months, compared with surgical controls, the hazard ratio for the primary composite outcome was 42.3 [95% confidence interval (CI) 17.4-102.8], corresponding to an incidence rate of 43.7 vs. 0.9 per 1000 patient-years (py) and an incidence rate difference of 42.7 (95% CI 36.7-48.8) per 1000 py. Patients hospitalized with uncomplicated acute myocarditis and no known prior heart disease were associated with substantial risk for cardiovascular events over a follow-up of up to 8 years. This calls for a more efficient therapeutic management of this population of patients.