Cardiac Implantation Research Articles

Temporary transvenous cardiac pacing in cathlab - myocardial infarction versus other causes - differences, complications, and prognosis. Data from a single-center retrospective analysis.

Transvenous temporary cardiac pacing (TTCP) is a lifesaving procedure, but the incidence of complications and prognosis depends on the underlying cause. The aim of this study was to compare the characteristics, complications, and prognosis in patients with myocardial infarction (MI) requiring TTCP vs. patients with TTCP due to other causes. The present analysis involved 244 cases in whom TTCP was performed between 2017 and 2021 in a high-volume cathlab. All the procedures were performed by an interventional cardiologist. MI constituted 46.3% of the patients (n = 113), including 63 ST-segment elevation MI patients (55.75%). Non-MI patients (control group) consisted of patients with any cause of bradycardia requiring TTCP. Myocardial infarction patients requiring TTCP are younger and have a higher prevalence of hypertension and heart failure. The pacing lead is more frequently inserted during asystole/resuscitation, and pacing was needed for a longer time. MI patients required cardiac implantable electronic device implantation less frequently than in other causes (22% vs. 82%, p < 0.01). The incidence of TTCP complications did not differ. The incidence of in-hospital death was 6.5-fold higher in TTCP patients with MI. Logistic regression showed MI to be a strong predictor of in-hospital death (odds ratio: 8.1; 95% confidence interval: 1.3-57.9). In-hospital mortality in MI patients requiring TTCP is 6.5-fold higher than in other patients with bradycardia. The complication rate of TTCP is similar in MI and non-MI patients. It is not TTCP but the severity of MI itself and the fact that a pacing lead is frequently implanted in asystole or during resuscitation that is responsible for the higher mortality rate.

A wire to guide: a complementary method for facilitating access during device lead implantation using a guidewire inserted through a peripheral vein.

In this short manuscript, we discuss the role and present the practical aspects of a guidewire inserted distally inthe ipsilateral arm in facilitating venous localization and access in the context of cardiac rhythm managementdevice implantation, reducing the risks for complications, such as pneumo- and hemothorax. We believe that thisnotion may encourage practicing device-implanting physicians to keep this approach in mind and as a fallbackstrategy during their cases.

Ultrasound-Guided Venous Axillary Access Versus Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI Randomized Trial

BackgroundAxillary vein puncture (AVP) and cephalic vein surgical cutdown are recommended in international guidelines because of their low risk of pneumothorax and chronic lead complications. Directly visualizing and puncturing the axillary vein under ultrasound guidance reduces radiation exposure, provides direct needle visualization, and lowers periprocedural complications. Our hypothesis is that ultrasound-guided axillary access is safer and more feasible than the standard fluoroscopic technique. ObjectivesThe purpose of this study was to assess the efficacy and safety of ultrasound-guided axillary venous access during cardiac lead implantation for pacemakers (PMs) and implantable cardioverter-defibrillator (ICD) implantations. MethodsPatients were randomized in a 1:1 fashion to either axillary venous access under fluoroscopic guidance or ultrasound-guided axillary venous access. The composite outcome, including pneumothorax, hemothorax, inadvertent arterial puncture, pocket hematoma, pocket infection, lead dislodgement, and death, was evaluated 30 days after implantation. ResultsWe randomized 270 patients into 2 groups: the standard group for fluoroguided AVP (n = 134) and the experimental group for ultrasound-guided AVP (n = 136). No disparities in baseline characteristics were observed between the groups. The median age of the patients was 81 years, with women comprising 41% of the population. The majority of patients received single- and dual-chamber PMs (87% vs 88%; P = 1.00), and slightly over 10% in both groups received ICDs (13% vs 12%; P = 0.85). In total, we placed 357 leads in PMs and 48 leads in ICDs. Among these, 295 leads were inserted via axillary vein access and 110 via cephalic vein access. Notably, the subclavian vein was never used as a vascular access. The composite outcome was lower in the ultrasound group according to intention-to-treat analysis (OR: 0.55; 95% CI: 0.31-0.99; P = 0.034). The main difference within the composite outcome was the lower incidence of inadvertent axillary arterial puncture in the experimental group (17% vs 6%; P = 0.004). The ultrasound group also exhibited lower total procedural x-ray exposure (10,344 μGy × cm2 vs 7,119 μGy × cm2; P = 0.002) while achieving the same rate of success at the first attempt (61% vs 69%; P = 0.375). ConclusionsUltrasound-guided AVP is safer than the fluoroscopy-guided approach because it achieves the same rate of acute success while maintaining low total procedural radiation exposure. Ultrasound AVP should be considered the optimal venous access method for cardiac lead implantation. (Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation [ZEROFLUOROAXI]; NCT05101720)

Assessment of Psychological Implications and Quality of Life After Different Cardiac Device Implantation in Saudi Arabia.

Cardiac device therapy is likely to affect different aspects of patients' psychological well-being, such as their quality of life. The aim of this study was to examine the mental health status, specifically the conditions of depression and anxiety regarding implantable cardiac device patients. A cross-sectional retrospective study was conducted in January 2022. This study was conducted at King Abdul-Aziz University Hospital in Jeddah, Saudi Arabia. All patients aged more than 18 years old who underwent heart device implantation for six months or more formed the study population. A total of 30 implantable cardioverter defibrillator (ICD) subtypes were used in our patients (45.8%), including cardiac resynchronization therapy device (CRT-D) in seven patients (14.6%) and one subcutaneous ICD (2.1%). A pacemaker was used in 18 patients (37.5%).Binary logistic regression analysis was conducted to identify the association between type of cardiac implantation device and the likelihood of having abnormal depression and anxiety score. A total of 48 patients participated in this study. Hypertension was the most frequently associated risk factor in our sample (64.6%; n=31). In comparison between ICD users and pacemaker users in terms of the SF-36 general health survey, a marginally significant difference was noted in the role of limitations due to emotional health (63 ± 28.6) for ICD patients compared to pacemaker patients (81.8 ± 28.1), (p=0.050). However, pacemaker patients showed a significant favourable social functioning score (90.1 ± 17.7) compared to ICD patients (71.5 ± 19), (p=0.001). There is no significant difference noted regarding the other domains. Binary logistic regression analysis identified that patients who are using ICD were seven times more likely to have abnormal anxiety score (odds ratio: 7.00 (95% confidence interval: 1.36-35.9) (p=0.020). This study identified a potentialassociation between cardiac devices and the anxiety and quality of life of patients. Nonetheless, further investigation is warranted to assess the psychological and physiological effects of cardiac device therapy on patients, in addition to examining the effects of implantation and follow-up on cardiac function and cardiacsymptoms.

Role of routine investigations post cardiac devices implants in detecting peri-procedural complications: A retrospective analysis from a tertiary UK center.

Peri-procedural complications associated with cardiac implantable electronic devices are not uncommon. European Society of Cardiology guidelines recommend device checks of all devices within 72h of implant. European Heart Rhythm Association expert practical guide on Cardiac implantable electronic devices (CIEDs) recommend that a chest x-ray (CXR) should be performed within 24h to rule out pneumothorax and document lead positions. First, the rate of peri-procedural complications associated with CIED implants at our center, as well as patient and/or procedural-related factors that are associated with higher rates of complications, is analyzed. Second, the yield of the guideline-recommended measures in the early detection of peri-procedural complications is examined. Consecutive de novo transvenous device implants at our center in 2019 were retrospectively analyzed. Patients' demographics, types and indications for device therapy, procedural reports, device checks, and CXRs were obtained from the hospital electronic records. A total of 578 patients (Age 74±16 years, 68% male) were included. All patients had routine post-procedure CXRs and device checks. There were 16 (2.8%) complications; 7 (1.2%) pneumothoraxes, 6 (1%) pericardial effusions, and 3 (0.5%) lead displacements. Procedure time correlated significantly with complications; in uncomplicated cases it was 99±43 min versus 127±50 min in procedures associated with complications (p=.02). Routine post CIED implantation CXRs can detect early peri-procedural complications, while repeat post mobilization device checks has low yield of detection of complications. The only statistically significant predictor of peri-procedural complications is the duration of the procedure; longer procedures were associated with higher rates of complications.

Cardiac implantable electronic devices in Bulgaria: results from the electronic registry BG-Pace for 2022

The current study analyses the activity on cardiac pacing in Bulgaria in 2022 based on data derived from a national registry of patients with cardiac implantable electronic devices (CIEDs).&amp;nbsp;Materials and methods.&amp;nbsp;Data from the national registry BG-Pace for 2022 was studied retrospectively. Demographic data, procedure and device type, pacing mode, etiology, symptoms, preimplantation ECG, number of implantations, and centre and operator volumes were analyzed.&amp;nbsp;Results:&amp;nbsp;Four thousand seven hundred seventy devices were implanted by 45 operators in 30 centers. Median age was 76 (IQR 69-82, 14-98) years, and male patients were 2843 (59,6%). The most significant number of implantations were carried out in the age group 70-79 years. The most commonly implanted CIEDs were antibradycardia devices - 578,8/million. Of them, conduction system pacing was used in 111 (2.3%). Implanted cardioverter-defibrillators demonstrated a growth compared to previous periods and reached 31.9/million. Cardiac resynchronization defibrillators implantations also shown a growth to 15.9/million. A considerable increase was found with implantable loop-recorders, which reached 8.8/million. Number of implantations per center was 115.5 (IQR 53-261.,3, 3-546), and 76,5 (IQR 36,8-154,8, 3-364) devices per operator. Dual chamber devices were most commonly implanted with a share of 83.1% in AVB I and II degrees, 72.5% in complete AVB, 82.6% in intraventricular conduction disturbances, and in 66.8% in patients with sick sinus syndrome. Pacing modes allowing for atrial sensing were most frequently implanted &amp;ndash; 62.4% of all implantations for conduction disturbances. There was a significant increase in the use of VVI mode with increasing age (P&lt;0.001).&amp;nbsp;Conclusion:&amp;nbsp;The national registry BG-Pace includes systematic clinical, demographical, and procedural&amp;nbsp;data for CIED implantations in Bulgaria. There is a growth in the implantation rates compared to previous periods, but they remain lower than the average number for Europe.

“Not much room for mushrooms” in the heart: knowns and unknowns of fungal infective endocarditis

Fungal infective endocarditis is a rare but highly lethal condition. Its diagnosis is often delayed due to nonspecific symptoms, inconclusive medical imaging, and negative blood cultures. Recent reviews of cases and series over the last 5 years indicate that the condition remains rare and lethal. If fungi are identified as the causative agents in more than 5% of patient cases with infective endocarditis, it is likely that risk factors such as immune suppression or cardiac implants are probably involved. A series derived from recent case reports indicates that Candida and Aspergillus are still the main causative infectious agents, with. C parapsilosis on the rise. From these cases, diagnostic clues (frequent embolisms, ophthalmic involvement, large, mobile and friable vegetation, non-valvular cardiac manifestations) are pointing towards fungal IE. These reports, however, are not standardized and a publication bias towards rare microorganisms or towards a favorable outcome might exist. Complications might be underreported, and important data such as diagnostic delay are absent or difficult to retrieve. Pharmacologic treatment is not fully standardized. Knowledge of resistant strains in this respect is important. Statistical analysis for the effect of complications and treatment modalities on outcome shows that any result should be treated cautiously. The current series is by no means a valid substitute for a well-designed series of fungal endocarditis. However, the better outcome with Candida and patients treated with surgery confirm earlier results. An international multicentric standardized registry of cases with fungal endocarditis in order to improve the outcome of this disease is highly needed. The effect of diagnostic delay on outcome remains elusive and should be resolved.

The role of early cardiac resynchronization therapy implantation in dilated cardiomyopathy patients with narrow QRS carrying lamin A/C mutation

The role of early cardiac resynchronization therapy implantation in dilated cardiomyopathy patients with narrow QRS carrying lamin A/C mutation

Prognostic Evaluation of Chagasic and Non-Chagasic Patients Undergoing Pacemaker Implantation and Cardiac Resynchronization in a Tertiary Center.

Chagas cardiomyopathy (ChCC) is one of the causes of the implantation of pacemakers (PM) in many patients and has been associated with an adverse prognosis. To compare the prognosis of the chagasic and non-chagasic populations undergoing PM and cardiac resynchronizer implantation. Observational, retrospective study, which analyzed a cohort of patients who underwent implantation of these devices, in a tertiary center, from October 2007 to December 2017, comparing the chagasic group with non-chagasic patients. The non-parametric Kaplan-Meier method was used to calculate patient survival. The significance level adopted in the statistical analysis was 5%. The primary outcome was mortality from any cause, while the secondary outcomes were the occurrence of hospitalization and the combination of hospitalization and death. A total of 911 patients were included, of which 23.4% had ChCC. In a Cox analysis adjusted for sex and age, Chagas disease (ChD) was not associated with an increased risk of death (HR: 1.14, CI:95%, 0.86-1.51, p=0.365), hospitalization (HR: 0.79, CI:95%, 0.61-1.04, p=0.09) or combined outcome of death and hospitalization (HR: 0.90, CI:95%, 0.72-1 .12, p=0.49). ChD was not associated with an increased risk of death, hospitalization, or combined outcome of death and hospitalization, even after adjustment for sex and age. These results contrast with those of previous studies and suggest changes in the quality of care of patients with cardiomyopathy.

A case of persistent left superior vena cava: an anatomical rarity with clinical implications

Persistent left superior vena cava (PLSVC) is a rare congenital anomaly characterised by the presence of a persistent left-sided SVC in addition to the normal right-sided SVC. This case report presents a unique instance of PLSVC in a 13-year-old male patient who was incidentally diagnosed during routine cardiac imaging for an unrelated condition. The diagnostic journey, including imaging modalities such as echocardiography and computed tomography, revealed the presence of this anatomical variation. Despite being asymptomatic, the case highlights the importance of recognising PLSVC, as it can have clinical implications in various medical and surgical scenarios, particularly in cardiac catheterization, pacemaker implantation, and central venous access procedures. This report discusses the clinical significance, diagnostic challenges, and management considerations associated with PLSVC, emphasising the need for increased awareness among healthcare professionals to ensure safe and effective patient care.

Itaconate and citrate releasing polymer attenuates foreign body response in biofabricated cardiac patches

Application of cardiac patches to the heart surface can be undertaken to provide support and facilitate regeneration of the damaged cardiac tissue following ischemic injury. Biomaterial composition is an important consideration in the design of cardiac patch materials as it governs host response to ultimately prevent the undesirable fibrotic response. Here, we investigate a novel patch material, poly (itaconate-co-citrate-co-octanediol) (PICO), in the context of cardiac implantation. Citric acid (CA) and itaconic acid (ITA), the molecular components of PICO, provided a level of protection for cardiac cells during ischemic reperfusion injury in vitro. Biofabricated PICO patches were shown to degrade in accelerated and hydrolytic conditions, with CA and ITA being released upon degradation. Furthermore, the host response to PICO patches after implantation on rat epicardium in vivo was explored and compared to two biocompatible cardiac patch materials, poly (octamethylene (anhydride) citrate) (POMaC) and poly (ethylene glycol) diacrylate (PEGDA). PICO patches resulted in less macrophage infiltration and lower foreign body giant cell reaction compared to the other materials, with corresponding reduction in smooth muscle actin-positive vessel infiltration into the implant region. Overall, this work demonstrates that PICO patches release CA and ITA upon degradation, both of which demonstrate cardioprotective effects on cardiac cells after ischemic injury, and that PICO patches generate a reduced inflammatory response upon implantation to the heart compared to other materials, signifying promise for use in cardiac patch applications.

Emerging Technologies for the Smallest Patients.

Pediatric and congenital heart disease patients may require cardiac implantable electronic device implantation, inclusive of pacemaker, ICD, and implantable cardiac monitor, for a variety of etiologies. While leads, generators, and monitors have decreased in size over the years, they remain less ideal for the smallest patients. The potential for a miniature pacemaker, fetal micropacemaker, improving leadless technology, and rechargeable devices creates hope that the development of pediatric-focused devices will increase. Further, alternative approaches that avoid the need for a transvenous or surgical approach may add more options to the toolbox for the pediatric and congenital electrophysiologist.

Prevalence and Predictors of Venous Stenosis Following First Transvenous Cardiac Implantable Electronic Device Implantation.

Very few studies have been done on Venous stenosis following the first transvenous cardiac device implantation. We aimed to assess the prevalence and predictors of Venous stenosis/Occlusion following the first transvenous cardiac device implantation with venous angiography at one year of follow-up. This study was a single-center prospective, observational study. Demographic, clinical, procedural, and device data was collected. All patients underwent a preimplant contrast and repeated venography at twelve months to look for upper limb venous anatomy, obstruction, or collaterals. A total of 146 patients were included in the final analysis. 60 (41 %) patients developed some degree of venous stenosis. Most patients had mild to moderate stenosis, and almost all were asymptomatic. Among patient-related factors increasing age (64.66 ± 10.07 vs 60.91 ± 11.94 years p = 0.04), presence of hypertension (50.5 % vs 19.6 % p = 0.0004), diabetes (73 % vs 29.6 % p = 0.000) and dyslipidemia (66.7 % vs 36.3 p = 0.009) were significantly associated with Venous stenosis/occlusion. Among procedure-related factors, larger total lead diameter (3.88 ± 1.09 vs. 3.50 ± 1.03 mm p = 0.03) and implantation of biventricular devices (p = 0.0037) seem to be significantly associated with venous obstruction. In logistic regression analysis, hypertension (p = 0.018), total lead diameter (p = 0.024), and use of CRT-P/CRTD/ICD (p = 0.03) remained significant predictors of severe venous stenosis. Our study demonstrates venous obstruction in 40 % of cardiac implantable electronic device patients at one-year follow-up. Most patients have mild to moderate stenosis, and almost all are asymptomatic. Increasing age, hypertension, diabetes, dyslipidemia, larger total lead diameter, and implantation of biventricular devices are significantly associated with venous obstruction.

Progress of biodegradable polymer application in cardiac occluders.

Cardiac septal defect is the most prevalent congenital heart disease and is typically treated with open-heart surgery under cardiopulmonary bypass. Since the 1990s, with the advancement of interventional techniques and minimally invasive transthoracic closure techniques, cardiac occluder implantation represented by the Amplazter products has been the preferred treatment option. Currently, most occlusion devices used in clinical settings are primarily composed of Nitinol as the skeleton. Nevertheless, long-term follow-up studies have revealed various complications related to metal skeletons, including hemolysis, thrombus, metal allergy, cardiac erosion, and even severe atrioventricular block. Thus, occlusion devices made of biodegradable materials have become the focus of research. Over the past two decades, several bioabsorbable cardiac occluders for ventricular septal defect and atrial septal defect have been designed and trialed on animals or humans. This review summarizes the research progress of bioabsorbable cardiac occluders, the advantages and disadvantages of different biodegradable polymers used to fabricate occluders, and discusses future research directions concerning the structures and materials of bioabsorbable cardiac occluders.

Zero to minimal fluoroscopy for cardiac electronic device implantation: A systematic review and meta-analysis.

Fluoroscopy is conventionally performed for cardiac implantable electronic device (CIED) therapy and carries radiation drawback for both patients and medical workers. Recently, zero to minimal fluoroscopy (ZMF) approach is introduced to reduce radiation exposure of fluoroscopy. This study compares the feasibility and safety of ZMF approach to fluoroscopy for CIEDs therapy in adults. A systematic literature search was conducted on PubMed, ScienceDirect, and Web of Science in March 2023. All observational or experimental studies comparing ZMF approach to fluoroscopy for adult CIEDs therapy were included. Reviews, case report/series, animal studies, and non-English articles were excluded. The success rate, procedural time, fluoroscopy time, radiation dose, and complications rate were compared for each approach. Seven articles for permanent and three articles for temporary CIEDs were included for analysis. The success rate of ZMF for permanent CIEDs was similar to fluoroscopy method (OR: 0.77, 95% CI: 0.33-4.15). The procedural time of ZMF was similar to fluoroscopy for both permanent and temporary CIEDs (standardized mean difference [SMD]: 0.10, 95% CI: -0.35 to 0.55 and SMD: -0.71, 95% CI: -1.87-0.44, respectively). However, ZMF approach markedly reduced the fluoroscopy time and radiation exposure for permanent CIEDs (SMD: -1.80, 95% CI: -2.49 to -1.12 and SMD: -1.26, 95% CI: -2.24 to -0.29). The complication rate was similar for permanent CIEDs (OR: 1.08, 95% CI: 0.41-2.84), yet lowered for temporary CIEDs (OR: 0.34, 95% CI: 0.20-0.59). ZMF had similar success rate, procedural time, and sum complication rate for permanent CIEDs implantation with a significant reduction of fluoroscopy time and radiation exposure.

Impact of clinical frailty on the outcome of pacing for bradyarrhythmias in a district general hospital population

Abstract Background and Aims There is good evidence for mortality with increasing age, heart disease, peripheral vascular disease, pulmonary disease and renal disease in implantable cardiac defibrillators. And while multimorbid states and fragility are considered in decision to offer for more complex cardiac electronic device implants1,2 we aimed to characterise how much frailty and co-morbidities impact mortality in patients receiving simple bradyarrhythmia cardiac pacing device implants. Methods Retrospective examination of 700 consecutive novel standard bradyarrhythmia cardiac device implants (DDD, VVI, AAI) at Walsall Manor Hospital between 01/01/2016 to 28/02/2021 was undertaken through the electronic patient record. Patients’ frailty was calculated with Rockwood Frailty Score (RFS) and comorbidities at the time of implant recorded.3 Prospective follow up until 14/02/2023 was conducted, allowing at least a 2 year follow-up for all surviving patients. Results were analysed with Kaplan-Meier survival curves and Hazard Ratios (HR) and Risk Ratios (RR). Results Mean age of implant was 78.4±10.3 with mortality rate of 87/700 (12.4%) at one year and total 282/700 (40.3%). Overall, a RFS of 5 or more was associated with death overall HR 2.05 (95% CI 1.61-2.60) and 3.42 (95% CI 2.23-5.24) within 1 year (Fig. 1). Heart failure (OR 2.38, 95% CI 1.59-3.57), valvular heart disease (OR 3.19, 95% CI 2.08-4.89), atrial fibrillation/flutter (OR 1.44, 95% CI 1.09-1.91), chronic kidney disease (OR 1.89, 95% CI 1.296-1.72), malignancy (OR 1.91, 95% CI 1.08-3.36) were important co-morbidities of death within one year of implant. Ischemic heart disease and cognitive impairment including dementia demonstrated a trend towards worse mortality but did not reach significance (Fig. 2). Conclusion High frailty score as well as comorbidities including heart failure, valvular heart disease, atrial fibrillation, chronic kidney disease and malignancy indicate increased risk of early death after novel implant of bradycardia cardiac pacing device implants. Although advanced age alone is not a barrier to offer pacing, consideration should be given to advanced frailty and multimorbid states which may detract from any perceived benefit bradyarrhythmia correction may offer. These data have impacted our shared decision making during the consent process with our patients and in our multidisciplinary team discussions.Figure 1Figure 2

Thoracic ultrasound versus chest X-ray for early detection of mechanical early complications of cardiac device implantation procedures

Abstract Background In the immediate postoperative of cardiac implantable electronic devices (CIED) implantation, the use of chest radiography (CXR) is the gold standard diagnostic tool for early complications, accompanied by electrical parameters testing for diagnostic of early catheter dislodgement. However, the ability to detect thoracic complications using CXR is limited, and it requires radiation exposure. Thoracic ultrasound (TUS) is an easy and highly appropriate technique to detect thoracic pathologies, although its use in cardiac stimulation is not yet widespread. Purpose To compare the diagnostic power of the CXR and TUS alone and in association with electrical parameters testing in detecting early complications after CIED implantation. Methods 397 patients who underwent CIED implantation or upgrade at four large arrhythmia referral centres were prospectively enrolled from November 1, 2021, to September 30, 2022. Following surgery, all patients underwent CXR and TUS at the bedside and the electrical parameters were tested with the device programmer. The primary endpoint was the rate of mechanical complications, defined as a composite or pneumothorax, haemothorax and pericardial effusion. The secondary endpoint was the composite of mechanical complications + electrical complications (lead macro- and micro-dislodgments). Results Total mechanical complications were 21 (5.3%), of which the most common were pneumothorax (3.3%) and pericardial effusion (2%). No cases of hemothorax were observed. The diagnosis of mechanical complication was made by TUS alone in 18 cases (86%), by CXR alone in 2 (9.5%) and in 1 case (4.8%) by both. TUS demonstrated a diagnostic sensitivity for mechanical complications of 90% and for total complications of 87% (associated with electrical control) compared to CXR which had a sensitivity of 20% and 57% respectively. Both methods did not differ in terms of specificity (100%). Conclusions In our experience, TUS has a diagnostic power superior to CXR to detect early mechanical complications. Our results suggest TUS may be used as the primary technique in association with standard electrical control to search for postoperative complications after CIED implantation.

Factors associated with early and late Staphylococcus aureus bacteraemia after first cardiac implantable electronic device implantation a Danish nationwide cohort study

Abstract Background Staphylococcus aureus bacteraemia (SAB) is a serious condition with high morbidity and mortality. Patients with a cardiac implantable electronic device (CIED) and SAB carries a risk of up to 50 % for device related infection. Yet, little is known about risk factors for early and late SAB in CIED patients in real-world clinical practice. Purpose We aimed to identify risk factors associated with first-time early and late SAB following de novo CIED implantation among adult Danish patients. Methods Using the Danish Pacemaker and ICD Register, we identified all Danish patients aged 18 to 99 years with a first CIED implantation between 2000 and 2020. The primary outcome of first-time post-CIED implantation SAB was identified from The National Danish Staphylococcus Aureus Bacteriemia Database. Early SAB was defined as SAB ≤ 6 months from CIED implantation. Late SAB was defined as first-time SAB after CIED, occurring &amp;gt; 6 months from CIED implantation. Multivariable Cox regression with backward elimination was used to identify factors associated with increased risk of developing early and late SAB. Age, sex, device type, implantation year, preexisting co-morbidity, procedure related factors and prior surgery (thoracic, abdominal, orthopedic, gynecologic, or urologic) was evaluated. Statistically significant variables were fitted to the final models to obtain hazard ratios with 95% confidence intervals. Results We identified 87,216 patients with first-time CIED implantation within the study period: PM n = 66,151 (75.8%); Implantable Cardioverter Defibrillator (ICD) n = 13,498 (15.5%); Cardiac resynchronization therapy PM (CRT-P) n = 3,491 (4.0 %); Cardiac resynchronization therapy with defibrillator (CRT-D) n = 4,076 (4.7 %). Median age across the population was 75 years (IQR 66-82) and 62.6% were males. Median time to SAB in the early SAB group was 46 days (IQR 18-105) and 2,9 years (IQR 1.5-5.1) in the late SAB group. Post implantation SAB was observed in 1,399 (1.6%) patients; with 363 (25.9%) early SAB events and 1,036 (74.1%) late SAB events. Factors associated with early SAB included previous SAB, renal dialysis, COPD, surgery 1 year prior to CIED implantation, liver disease, diabetes, and congestive heart failure (Figure 1). Male sex, increasing age, previous SAB, congestive heart failure, aortic valve disease, diabetes, renal dialysis, COPD, cancer, liver disease and the use of systemic corticosteroids were associated with an increased risk of late SAB. Conclusions Renal dialysis, previous SAB, diabetes, congestive heart failure, COPD and liver disease were associated with an increased risk of both early and late SAB. Increasing age, male sex, aortic valve disease and cancer were associated with an increased risk of late SAB, while surgery within 1 year prior to CIED implantation was associated with early SAB. Most of the identified factors were non-modifiable and comparable to known risk factors for SAB in non-CIED patients.Figure 1

Quadruple therapy for heart failure before and after electronic cardiac device implantation - are we hitting our targets?

Abstract Background Quadruple therapy is currently recommended pharmacological treatment for heart failure with reduced ejection fraction (HFrEF). It consists of beta-blockers, mineralocorticoid receptor antagonists (MRA), angiotensin converting enzyme inhibitors (ACE-I) – recently suggested to be replaced with angiotensin receptor/neprilysin inhibitor (ARNI), and sodium-glucose cotransporter-2 inhibitors (SGLT2-I). Patients eligible for implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) implantation should have therapy titrated to evidence-based target doses prior to the procedure, whenever tolerable. Compliance with guidelines as well as distinction in prescription practice before and after device implantation in the era of quadruple HFrEF therapy has not yet been fully researched. Purpose The purpose of this study is to evaluate the use of disease-modifying drugs in corresponding target doses in patients with HFrEF eligible for ICD or CRT implantation, prior to and after the procedure. Methods This is a retrospective observational study which included patients with HFrEF hospitalized for ICD or CRT implantation in a single tertiary centre from January 2021 to January 2023. Data was collected through patients' medical history and phone calls. Results We collected data on a total of 107 patients with HFrEF and ICD or CRT implantation. Most patients received all four classes of guideline-directed therapy before ICD or CRT implantation: beta-blockers (91,6%), MRA (86,0%), ACE-I (31,8%) or ARNI (59,8%) and SGLT2-I (59,8%). Evidence-based target doses were reached for 10,2%, 52,2%, 11,8%, 32,8% and 100% patients receiving beta-blockers, MRA, ACE-I, ARNI and SGLT2i respectively. After hospitalization for device implantation, results pointed to an increase in prescription of beta-blockers (99,1%), MRA (97,2%), and most notably SGLT2-I (87,9%), while more ACE-I (19,6%) were replaced with ARNI (75,7%). Target doses were reached for 19,8%, 72,1%, 28,6%, 37,0%, and 100% patients receiving beta-blockers, MRA, ACE-I, ARNI, and SGLT2-I respectively. Conclusions Most of the examined patients have been receiving all four drug classes prior to device implantation. We noticed a rising trend in recruiting novel heart failure drugs, ARNI and SGLT2-I, after the procedure. However, drug titration was non-compliant with guidelines. There was a slight improvement in up-titration of therapy after the procedure, which could be explained by more common medication adjustments by electrophysiologists during device control sessions as well as better drug tolerability after device implantation. Regardless, a minority of patients received ACE-I, ARNI and beta blockers in target doses. Despite several objective obstacles to adequate administration of disease-modifying drugs, including intolerability and patients’ non-adherence, further effort in up-titrating guideline-directed medical therapy should be applied.Therapy administration practice

Contact allergy to medical devices

Abstract Background Medical devices are not subject to any legal obligation to declare ingredients. With an increasing number of available medical devices, increasing reports of contact allergies to these devices result in a more difficult, delayed or lack of diagnosis of the trigger. Methods Elaborate chemical methods, such as gas chromatography–mass spectroscopy, were able to detect novel contact allergens in medical devices. Results Diabetic patients requiring insulin benefit from sophisticated glucose sensor measurement systems and insulin pump systems, but are limited in their choices by the development of contact allergy. Potential contact allergens in medical adhesives, plasters, and wound dressings require extensive diagnostic testing. Contact allergic reactions to cardiac electronic implants are rare. The potential relevance of a contact allergic reaction to endoluminal stents to restenosis of the treated vascular territory is discussed. Contact dermatitis to medical gloves is usually due to the vulcanization accelerators. Mouth–nose protective or FFP2 mask-associated eczema is often irritant, very rarely allergic in origin. Conclusion With continued development of medical devices, new contact allergens are introduced. The declaration of their ingredients is necessary for rapid diagnosis and future prevention.