Atrial Pacing Improves Mitochondrial Function in Peripheral Blood Mononuclear Cells in Patients with Cardiac Implantable Electronic Devices.

Mitochondrial dysfunction contributes significantly to the development of atrial fibrillation (AF). Conflicting data regarding the atrial pacing and the risk of AF existed and the impact of atrial pacing on mitochondrial function remains unknown. Therefore, we sought to examine the association between atrial pacing percentage and mitochondrial function in patients with cardiovascular implantable electronic devices (CIED) with atrial pacing capability. This is a cross-sectional study involving 183 patients with CIED with atrial pacing capability. The oxidative stress and mitochondrial function were determined in peripheral blood mononuclear cells (PBMCs). Among 183 patients, 55.7% had permanent pacemakers, 7.7% had defibrillators and 36.6% had cardiac resynchronization therapy. Mean age was 67.5±14.7 years with 51% being male. Mean left ventricular ejection fraction (LVEF) was 53.9 ± 16.8%. We demonstrated that the presence of atrial pacing above 50% correlated with higher levels of mitochondrial spared respiratory capacity (P=0.043) and coupling efficiency (P=0.045). After adjusting with multiple linear regression for age, sex, LVEF, history of AF, sick sinus syndrome, co-morbidities, eGFR, CRT, and percentage of ventricular pacing, our findings revealed a statistically significant association between a higher percentage of atrial pacing and increased spared respiratory capacity (ß 0.217, P=0.046), lower non-mitochondrial respiration (ß -0.230, P=0.023) and proton leak (ß -0.247, P=0.022). We demonstrated that atrial pacing enhances mitochondrial performance in PBMCs and left ventricular contractile performance in patients with CIED. This observation may serve as additional support for the preventive effect of atrial pacing in the prevention of atrial arrhythmia.

Atrial High-Rate Episodes and Subclinical Atrial Fibrillation: State of the Art and Clinical Questions with Complex Solutions.

Atrial high-rate episodes (AHREs) and subclinical atrial fibrillation (AF) are frequently registered in asymptomatic patients with cardiac implantable electronic devices (CIEDs) and insertable cardiac monitors (ICMs). While an increased risk of thromboembolic events (e.g., stroke) and benefits from anticoagulation have been widely assessed in the setting of clinical AF, concerns persist about optimal clinical management of subclinical AF/AHREs. As a matter of fact, an optimal threshold of subclinical episodes' duration to predict stroke risk is still lacking and recently published randomized clinical trials assessing the impact of anticoagulation on thromboembolic events in this specific setting have shown contrasting results. The aim of this review is to summarize current evidence regarding classification and clinical impact of subclinical AF/AHREs and to discuss the latest evidence regarding the potential benefit of anticoagulation in this setting, highlighting which clinical questions are still unanswered.

Remote monitoring of cardiac implantable electronic devices to predict acute clinical decompensation events.

BACKGROUND: Heart failure (HF) patients are at constant risk of decompensation, and urgent hospital admissions can be life-threatening events. Monitoring biological variables has been proved to be an important mechanism to anticipate decompensations. TriageHF is a validated diagnostic algorithm tool available on Medtronic® cardiac implantable electronic devices that combines physiological data to stratify a patient's risk of HF hospitalization in the following 30 days in low, medium or high risk. We aimed to evaluate the utility of TriageHF algorithm to predict the occurrence of acute clinical decompensation events (ACDE), including HF and non-HF cardiovascular events, within a 30-day period in a population of HF patients with reduced ejection fraction. METHODS: We reviewed the transmissions received by the Medtronic® Carelink™ Network between August 2022 and July 2023. The heart failure risk status (HFRS) and the device parameters contributing to that risk, from the previous 30 days, were collected, along with the occurrence of ACDEs within 30 days. RESULTS: We retrospectively assessed 207 transmissions from the 64 patients included in the study. Among the 93 medium HFRS transmissions, 16 (17.2%) resulted in ACDEs. For the 21 high HFRS transmissions, 10 (47.6%) resulted in ACDEs. Considering the ACDEs, 60.7% were preceded by an alarm-initiated transmission. Except for heart rate variability, each diagnostic parameter demonstrated effectiveness in stratifying risk for ACDEs. Optivol® and the Combined Heart Rhythm showed independent association with ACDEs (p < .001). Patients with medium and high HFRS were, respectively, 8.6 and 29.1 times more likely to experience an ACDE in the next 30 days than low risk patients. A medium-high HFRS conferred a sensitivity of 92.9% and a NPV of 97.8% for an ACDE. CONCLUSION: TriageHF is a useful method for predicting ACDEs and has the potential to trigger medical actions to prevent hospitalizations.

Pectoral Nerve Block II for Cardiac Implantable Electronic Devices.

AIM: This study aimed to assess the feasibility and effectiveness of the pectoral nerves (PECS) II block in facilitating cardiac implantable electronic device (CIED) insertion in a sample of 120 patients, with a focus on the percentage of cases completed without additional intraoperative local anesthesia. METHODS: PECS II blocks were performed on the left side using ultrasound guidance in all 120 patients. Feasibility was assessed by the proportion of cases completed without the need for extra intraoperative local anesthetic. Secondary outcomes included the amount of additional local anesthetic used, intraoperative opioid requirements, postoperative pain scores, time to first postoperative analgesia, analgesic consumption, patient satisfaction, and block-related complications. RESULTS: Of the 120 patients, 78 (65%) required additional intraoperative local anesthetic, with a median volume of 8.2 mL (range 3-13 mL). Fifteen patients (12.5%) needed intraoperative opioid supplementation. Nine patients (7.5%) required postoperative tramadol for pain relief. In total, 98 patients (81.7%) reported high satisfaction levels with the procedure. CONCLUSIONS: The PECS II block, when combined with supplementary local anesthetic, provided effective postoperative analgesia for at least 24 h in 120 patients undergoing CIED insertion. While it did not completely replace surgical anesthesia in most cases, the PECS II block significantly contributed to a smoother intraoperative experience for patients.

Safety and Efficiency of Cephalic Vein Puncture by Modified Seldinger Technique Compared to Subclavian Vein Puncture for Cardiac Implantable Electronic Devices.

INTRODUCTION: The establishment of venous access is one of the driving factors for complications during implantation of pacemakers and defibrillators (cardiac implantable electronic devices [CIED]). Recently, a novel approach of accessing the cephalic vein for CIED by cephalic vein puncture (CVP) using a modified Seldinger technique has been described, promising high success rates and simplified handling with steeper learning curves. In this single-center registry, we analyzed the safety and efficiency of CVP to SVP access after defining CVP as the primary access route in our center. METHODS: A total of 229 consecutive patients receiving a CIED were included in the registry. Sixty-one patients were implanted by primary or bail-out SVP; 168 patients received primary cephalic preparation and CVP was performed when possible, using a hydrophilic transradial sheath. RESULTS: Implantation of at least one lead via CVP was successful in 151 of 168 patients (90%), and implantation of all leads was possible in 122 of 168 patients (72.6%). Total implantation times and fluoroscopy times and doses did not differ between CVP and SVP implantations. Pneumothorax occurred in 0/122 patients implanted via CVP alone, but 8/107 (7.5%) patients received at least one lead via SVP. CONCLUSION: Our data confirms high success rates of the CVP for CIED implantation. Moreover, this method can be used without significantly prolonging the total procedure time or applying fluoroscopy dose compared to the highly efficient SVP while showing lower overall complication rates.

Remote Monitoring of Cardiac Implantable Electronic Devices in Very Elderly Patients: Advantages and Specific Problems.

Cardiac implantable electronic devices (CIEDs) offer the benefit of remote monitoring and decision making and find particular applications in special populations such as the elderly. Less transportation, reduced costs, prompt diagnosis, a sense of security, and continuous real-time monitoring are the main advantages. On the other hand, less physician-patient interactions and the technology barrier in the elderly pose specific problems in remote monitoring. CIEDs nowadays are abundant and are mostly represented by rhythm control/monitoring devices, whereas hemodynamic remote monitoring devices are gaining popularity and are evolving and becoming refined. Future directions include the involvement of artificial intelligence, yet disparities of availability, lack of follow-up data, and insufficient patient education are still areas to be improved. This review aims to describe the role of CIED in the very elderly and highlight the merits and possible drawbacks.

Conduction System Pacing: Hope, Challenges, and the Journey Forward.

PURPOSE OF THE REVIEW: Cardiac pacing has evolved in recent years currently culminating in the specific stimulation of the cardiac conduction system (conduction system pacing, CSP). This review aims to provide a comprehensive overview of the available literature on CSP, focusing on a critical classification of studies comparing CSP with standard treatment in the two fields of pacing for bradycardia and cardiac resynchronization therapy in patients with heart failure. The article will also elaborate specific benefits and limitations associated with CSP modalities of His bundle pacing (HBP) and left bundle branch area pacing (LBBAP). RECENT FINDINGS: Based on a growing number of observational studies for different indications of pacing therapy, both CSP modalities investigated are advantageous over standard treatment in terms of narrowing the paced QRS complex and preserving or improving left ventricular systolic function. Less consistent evidence exists with regard to the improvement of heart failure-related rehospitalization rates or mortality, and effect sizes vary between HBP and LBBAP. LBBAP is superior over HBP in terms of lead measurements and procedural duration. With regard to all reported outcomes, evidence from large scale randomized controlled clinical trials (RCT) is still scarce. CSP has the potential to sustainably improve patient care in cardiac pacing therapy if patients are appropriately selected and limitations are considered. With this review, we offer not only a summary of existing data, but also an outlook on probable future developments in the field, as well as a detailed summary of upcoming RCTs that provide insights into how the journey of CSP continues.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool.

BACKGROUND AND AIMS: The rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. METHODS: This was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. RESULTS: A total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. CONCLUSIONS: Systemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Determinants of global cardiac implantable electrical device remote monitoring utilization - Results from an international survey.

Background: Despite near-global availability of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED), there is a high geographical variability in the uptake and use of RM. The underlying reasons for this geographic disparity remain largely unknown. Objectives: To study the determinants of worldwide RM utilization and identify locoregional barriers of RM uptake. Methods: An international survey was administered to all CIED clinic personnel using the Heart Rhythm Society global network collecting demographic information, as well as information on the use of RM, the organization of the CIED clinic, and details on local reimbursement and clinic funding. The most complete response from each center was included in the current analysis. Stepwise forward multivariate linear regression was performed to identify determinants of the percentage of patients with a CIED on RM. Results: A total of 302 responses from 47 different countries were included, 61.3% by physicians and 62.3% from hospital-based CIED clinics. The median percentage of CIED patients on RM was 80% (interquartile range, 40-90). Predictors of RM use were gross national income per capita (0.76% per US$1000, 95% CI 0.72-1.00, P < .001), office-based clinics (7.48%, 95% CI 1.53-13.44, P = .014), and presence of clinic funding (per-patient payment model 7.90% [95% CI 0.63-15.17, P = .033); global budget 3.56% (95% CI -6.14 to 13.25, P = .471]). Conclusion: The high variability in RM utilization can partly be explained by economic and structural barriers that may warrant specific efforts by all stakeholders to increase RM utilization.

Cumulative radiation dose from medical imaging in paediatric congenital heart disease patients with epicardial cardiac implantable electronic devices.

Aims: To determine whether paediatric congenital heart disease (CHD) patients with epicardial cardiac implantable electronic devices (CIEDs) receive high cumulative effective doses (CEDs) of ionizing radiation from medical imaging tests. Methods and results: We compared 28 paediatric CHD patients with epicardial CIEDs (cases) against 40 patients with no CIED matched by age at operation, sex, surgical era, and CHD diagnosis (controls). We performed a retrospective review of radiation exposure from medical imaging exams between 2006 and 2022. Radiation dose from computed tomography (CT) and X-ray radiography was calculated using the National Cancer Institute Radiation Dosimetry Tool. We performed univariate analysis to compare the CED between the two groups. In the case subgroup, we convened experts' review to adjudicate the prevalence of CT exams that should have been performed with magnetic resonance imaging (MRI) in the absence of a CIED. Children (median age 2.5 years at implant) with CIEDs received significantly higher median CED compared with matched controls (6.90 vs. 1.72 mSv, P = 0.0018). In cases, expert adjudication showed that 80% of the CT exams would have been performed with MRI in the absence of a CIED. This resulted, on average, a five-fold increase in the effective dose (ED) from post-lead implant CTs. Conclusion: Paediatric CHD patients with CIED received four times higher CED than matched controls. Improved access to medical imaging tests without ionizing radiation, such as MRI, could potentially reduce the ED in CIED patients by up to five times.

Management of anesthesia for procedures in the cardiac electrophysiology laboratory.

The complexity of cardiac electrophysiology procedures has increased significantly during the past 3 decades. Anesthesia requirements of these procedures can differ on the basis of patient- and procedure-specific factors. This manuscript outlines various anesthesia strategies for cardiac implantable electronic devices and electrophysiology procedures, including preprocedural, procedural, and postprocedural management. A team-based approach with collaboration between cardiac electrophysiologists and anesthesiologists is required with careful preprocedural and intraprocedural planning. Given the recent advances in electrophysiology, there is a need for specialized cardiac electrophysiology anesthesia care to improve the efficacy and safety of the procedures.

Association of Atrial Fibrillation Burden and Mortality Among Patients With Cardiac Implantable Electronic Devices.

BACKGROUND: Current estimates of atrial fibrillation (AF)-associated mortality rely on claims- or clinical-derived diagnoses of AF, limit AF to a binary entity, or are confounded by comorbidities. The objective of the present study is to assess the association between device-recognized AF and mortality among patients with cardiac implantable electronic devices capable of sensitive and continuous atrial arrhythmia detection. Secondary outcomes include relative mortality among cohorts with no AF, paroxysmal AF, persistent AF, and permanent AF. METHODS: Using the deidentified Optum Clinformatics US claims database (2015 to 2020) linked to the Medtronic CareLink database, we identified individuals with a cardiac implantable electronic device who transmitted data ≥6 months after implantation. AF burden was assessed during the first 6 months after implantation (baseline period). Subsequent mortality, assessed from claims data, was compared between patients with and without AF, with adjustment for age, geographic region, insurance type, Charlson Comorbidity Index, and implantation year. RESULTS: Of 21 391 patients (age, 72.9±10.9 years; 56.3% male) analyzed, 7798 (36.5%) had device-recognized AF. During a mean of 22.4±12.9 months (median, 20.1 [12.8-29.7] months) of follow-up, the overall incidence of mortality was 13.5%. Patients with AF had higher adjusted all-cause mortality than patients without AF (hazard ratio, 1.29 [95% CI, 1.20-1.39]; P<0.001). Among those with AF, patients with nonparoxysmal AF had the greatest risk of mortality (persistent AF versus paroxysmal AF: hazard ratio, 1.36 [95% CI, 1.18-1.58]; P<.001; permanent AF versus paroxysmal AF: hazard ratio, 1.23 [95% CI, 1.14-1.34]; P<.001). CONCLUSIONS: After adjustment for potential confounding factors, the presence of AF was associated with higher mortality in our cohort of patients with cardiac implantable electronic devices. Among those with AF, nonparoxysmal AF was associated with the greatest risk of mortality.

Infectious mass debulking in lead-associated endocarditis with a percutaneous aspiration system.

AIMS: Debulking of infective mass to reduce the burden if infective material is a fundamental principle in the surgical management of infection. The aim of this study was to investigate the validity of this principle in patients undergoing transvenous lead extraction in the context of bloodstream infection (BSI). METHODS AND RESULTS: We performed an observational single-centre study on patients that underwent transvenous lead extraction due to a BSI, with or without lead-associated vegetations, in combination with a percutaneous aspiration system during the study period 2015-22. One hundred thirty-seven patients were included in the final analysis. In patients with an active BSI at the time of intervention, the use of a percutaneous aspiration system had a significant impact on survival (log-rank: P = 0.0082), while for patients with a suppressed BSI at the time of intervention, the use of a percutaneous aspiration system had no significant impact on survival (log-rank: P = 0.25). CONCLUSION: A reduction of the infective burden by percutaneous debulking of lead vegetations might improve survival in patients with an active BSI.

Infections of cardiac implantable electronic devices and how to improve transvenous lead extraction by the virtual reality.

Introduction: Infections in cardiac implantable electronic devices (CIED) are increasing over time and associated with substantially mortality and healthcare costs. The best approach is the complete removal of the system by transvenous lead extraction (TLE). However, when leads are more than 10 years old, this technique requires considerable expertise and failures with the result of abandoned leads or serious complications may occur. The aim of this study is to describe our experience using virtual and mixed reality in the preoperative planning of complex cases. Patients and methods: Consecutive patients from a referral centre with CIED infections in which TLE was judged difficult. Synchronized computed tomography (CT) scan images were processed and transferred to a fully immersive virtual reality room and also to the operative room (mixed reality) for better guidance during the extracting procedure. Results: Ten patients (seven with local and three with systemic infections) were preoperative evaluated. Processed images and virtual reality showed intense adherences of the leads to the veins, right ventricle, and right atrium endocardium and between them that preclude a difficult extraction and required a carefully planning and sometimes a different technical approach. The anticipated difficulty was confirmed by the higher times of fluoroscopy. All leads were extracted and no complications were registered. Conclusions: Preoperative planning is essential for evaluation of TLE difficulty and prevention of unexpected situations. Virtual reality seems an estimable aid for operators in planning difficult cases and also an excellent tool for teaching. Supplementary information: The online version contains supplementary material available at 10.1007/s12055-023-01663-9.

Contemporary Management of Cardiac Implantable Electronic Device Infection: The American College of Cardiology COGNITO Survey.

Background: Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges. Objectives: The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers. Methods: An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios. Results: Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment. Conclusions: There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes.

Remote monitoring of cardiac implantable electronic devices using smart device interface versus radiofrequency-based interface: A systematic review.

Background: Guidelines recommended remote monitoring (RM) in managing patients with Cardiac Implantable Electronic Devices. In recent years, smart device (phone or tablet) monitoring-based RM (SM-RM) was introduced. This study aims to systematically review SM-RM versus bedside monitor RM (BM-RM) using radiofrequency in terms of compliance, connectivity, and episode transmission time. Methods: We conducted a systematic review, searching three international databases from inception until July 2023 for studies comparing SM-RM (intervention group) versus BM-RM (control group). Results: Two matched studies (21 978 patients) were retrieved (SM-RM arm: 9642 patients, BM-RM arm: 12 336 patients). There is significantly higher compliance among SM-RM patients compared with BM-RM patients in both pacemaker and defibrillator patients. Manyam et al. found that more SM-RM patients than BM-RM patients transmitted at least once (98.1% vs. 94.3%, p < .001), and Tarakji et al. showed that SM-RM patients have higher success rates of scheduled transmissions than traditional BM-RM methods (SM-RM: 94.6%, pacemaker manual: 56.3%, pacemaker wireless: 77.0%, defibrillator wireless: 87.1%). There were higher enrolment rates, completed scheduled and patient-initiated transmissions, shorter episode transmission time, and higher connectivity among SM-RM patients compared to BM-RM patients. Younger patients (aged <75) had more patient-initiated transmissions, and a higher proportion had ≥10 transmissions compared with older patients (aged ≥75) in both SM-RM and BM-RM groups. Conclusion: SM-RM is a step in the right direction, with good compliance, connectivity, and shorter episode transmission time, empowering patients to be in control of their health. Further research on cost-effectiveness and long-term clinical outcomes can be carried out.

Safety of magnetic resonance imaging in patients with cardiac implantable electronic devices and abandoned or epicardial leads: a systematic review and meta-analysis.

AIMS: Persistent reluctance to perform magnetic resonance imaging (MRI) in patients with abandoned and/or epicardial leads of cardiac implantable electronic devices is related to in vitro studies reporting tip heating. While there is a plethora of data on the safety of MRI in conditional and non-conditional implantable devices, there is a clear lack of safety data in patients with abandoned and/or epicardial leads. METHODS AND RESULTS: Relevant literature was identified in Medline and CINAHL using the key terms 'magnetic resonance imaging' AND 'abandoned leads' OR 'epicardial leads'. Secondary literature and cross-references were supplemented. For reporting guidance, the Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 was used. International Prospective Register of Systematic Reviews (PROSPERO) registration number 465530. Twenty-one publications with a total of 656 patients with 854 abandoned and/or epicardial leads and 929 MRI scans of different anatomical regions were included. No scan-related major adverse cardiac event was documented, although the possibility of under-reporting of critical events in the literature should be considered. Furthermore, no severe device dysfunction or severe arrhythmia was reported. Mainly transient lead parameter changes were observed in 2.8% in the subgroup of patients with functional epicardial leads. As a possible correlate of myocardial affection, subjective sensations occurred mainly in the subgroup with abandoned epicardial leads (4.0%), but no change in myocardial biomarkers was observed. CONCLUSION: Existing publications did not report any relevant adverse events for MRI in patients with abandoned and/or epicardial leads if performed according to strict safety guidelines. However, a more rigorous risk-benefit calculation should be made for patients with epicardial leads.