Pacemaker Group Research Articles

Incidence, predictors and outcomes associated with pacemaker implantation in transthyretin cardiac amyloidosis

Abstract Background Arrhythmias are poorly tolerated by patients with transthyretin cardiac amyloidosis (ATTR). The occurrence rate of pacemaker (PM) implantation among ATTR, along with its predictors and impact on outcomes has not been extensively investigated. Our objective was to analyze the patterns of permanent PM implantation and to identify predictors for future PM placement in ATTR patients. Methods Consecutive patients with wild-type ATTR diagnosed in one single center between 2016-2022 were included. The primary outcome of the study was PM implantation. Patients with pre-existing PM (n = 31) were excluded. The study population included 160 patients, 88% male, median age 82 (76, 85) years. Clinical, laboratory, electrocardiography (ECG) and comprehensive echocardiography data were analysed. Results During a median follow-up of 30.5 months, 37 (23.1%) patients underwent PM implantation. The main indications for PM implantation were complete atrioventricular (AV) block (9 patients, 24.3%) and advanced conduction impairment (9 patients, 24.3%). ECG demonstrated a more prolonged PR interval and increased QRS duration (both p<0.001) with higher rate of first-degree AV block and right bundle branch block (both p=0.003) in patients requiring PM implantation. The echocardiogram showed greater wall thickness, a more dilated left atrium, along with biventricular dysfunction in the PM group. At multivariable analysis, first-degree AV block (HR=2.96, p=0.012), interventricular septum (IVS) thickness (HR=1.27, p=0.001) and biomarker-based staging system (HR= 2.43, p=0.008) were independently associated with PM implantation. PM implantation was associated with increased mortality or HF hospitalization. Conclusions In our cohort of ATTR patients, 23.1% required a pacemaker, primarily due to conduction system disease. Independent predictors for new pacemaker implantation included first-degree AV block, increased IVS thickness, and the biomarker-based staging system.

Health-related quality of life in a large cohort of patients with cardiac implantable electronic devices A registry-based study

Aim The association of cardiac implantable electronic devices (CIED), namely pacemaker (PM), implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy with (CRT-D) or without defibrillator (CRT-P) with health-related quality of life (HRQoL) is lacking. Methods and results Data from the Swedish Pacemaker and ICD Registry collected from January 2019 to February 2022 was used to analyze the responses to the European Quality of Life-5 Dimension questionnaire (EQ-5D) before and after one year of the CIED implant. Descriptive analysis was performed using Pearson’s chi-square test, the analysis of variance ANOVA, the Kruskal-Wallis test and Wilcoxon signed-rank test when appropriate. A multivariable regression analysis was used to compare the EQ-5D index and EQ-VAS variation after 1 year. Of 1,479 who completed the EQ-5D, 80% had a PM, 10% an ICD, 5% a CRT-P and 6% a CRT-D. The median age was 77 years with females constituting 38% of the PM group and 17% of the ICD group. The EQ-VAS and the EQ-5D index significantly increased after one year from the PM and CRT-P implant (EQ-VAS +2.8, standard deviations (SD) 23 and +5.8, SD 24.9; EQ-5D index +0.019, SD 0.114 and +0.051, SD 0.125) while only the EQ-5D index increased after one year from the ICD implant (+0.002, SD 0.104). After adjusting for age, sex and HRQoL at baseline, the presence of defibrillator was associated with lower EQ-VAS (ICD EQ-VAS variation: -3.4, 95% confidence intervals (CI) -6.7; -0.1 and CRT-D EQ-VAS variation -4.8, 95% CI -8.8;-0.7) and EQ-5D index (ICD EQ-5D index variation: -0.018, 95% CI -0.035; -0.0003 and CRT-D EQ-5D index variation -0.025 95% CI 0.046;0.004) after one year compared to PM. Conclusion These findings, showing the HRQoL associated with CIED, are important to support physicians’ and pacemaker nurses’ care after device implantation by embracing the patients’ perspectives.

Dual-chamber vs. single-chamber pacemaker in patients in sinus rhythm with an atrioventricular block: a nationwide cohort study.

In complete atrioventricular block (AVB) with underlying sinus rhythm, it is recommended to implant a dual-chamber pacemaker rather than a single-chamber pacemaker. However, no large-scale study has been able to demonstrate the superiority of this choice on hard clinical criteria such as morbimortality. This retrospective observational study included all patients who received a primary pacemaker implantation in the indication of complete AVB with underlying sinus rhythm in France, based on the national administrative database between January 2013 and December 2022. After propensity score matching, we obtained two groups containing 19 219 patients each. The incidence of all-cause mortality was 9.22%/year for the dual-chamber pacemaker group, compared with 11.48%/year for the single-chamber pacemaker group (hazard ratio (HR) 0.807, P < 0.0001]. Similarly, there was a lower incidence of cardiovascular mortality (HR 0.766, P < 0.0001), heart failure (HR 0.908, P < 0.0001), atrial fibrillation (HR 0.778, P < 0.0001), and ischaemic stroke (HR 0.873, P = 0.008) in the dual-chamber pacemaker group than in the single-chamber pacemaker group. Regarding re-interventions and complications, there were fewer upgrades (addition of atrial lead or left ventricular lead) in the dual-chamber group (HR 0.210, P < 0.0001), but more haematomas (HR 1.179, P = 0.006) and lead repositioning (HR 1.123, P = 0.04). In the indication of complete AVB with underlying sinus rhythm, our results are consistent with current recommendations to prefer implantation of a dual-chamber pacemaker rather than a single-chamber pacemaker for these patients. Implantation of a dual-chamber pacemaker is associated with a lower risk of mortality, heart failure, atrial fibrillation, and stroke during follow-up.

Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia–bradycardia syndrome patients: a prospective, randomized trial

BackgroundClinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for the tachycardia–bradycardia syndrome (TBS) has not been evaluated adequately. We tried to compare the efficacy and safety outcomes of CA and PM implantation as an initial treatment option for TBS in paroxysmal atrial fibrillation (AF) patients.MethodsSixty-eight patients with paroxysmal AF and TBS (mean 63.7 years, 63.2% male) were randomized, and received CA (n = 35) or PM (n = 33) as initial treatments. The primary outcomes were unexpected emergency room visits or hospitalizations attributed to cardiovascular causes.ResultsIn the intention-to-treatment analysis, the rates of primary outcomes were not significantly different between the two groups at the 2-year follow-up (19.8% vs. 25.9%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.25–2.20, P = 0.584), irrespective of whether the results were adjusted for age (HR 1.12, 95% CI 0.34–3.64, P = 0.852). The 2-year rate of recurrent AF was significantly lower in the CA group compared to the PM group (33.9% vs. 56.8%, P = 0.038). Four patients (11.4%) in the CA group finally received PMs after CA owing to recurrent syncope episodes. The rate of major or minor procedure related complications was not significantly different between the two groups.ConclusionCA had a similar efficacy and safety profile with that of PM and a higher sinus rhythm maintenance rate. CA could be considered as a preferable initial treatment option over PM implantation in patients with paroxysmal AF and TBS.Trial registrationKCT0000155.

Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Impact of Cardiac Pacemaker Implantation in Patients With Acute Traumatic Cervical Spinal Cord Injury.

Cardiac pacemaker implantation may be indicated in patients with refractory bradycardia following a cervical spinal cord injury (CSCI). However, evidence about the impact of this procedure on outcomes is lacking. We planned a study to assess whether the implantation of a pacemaker would decrease mortality and hospital resource utilization in patients with CSCI. Adult patients with CSCI in the Trauma Quality Improvement Program (TQIP) database between 2016 and 2019 were retrospectively analyzed. Patients were divided into "pacemaker" and "non-pacemaker" groups, and their baseline characteristics and clinical outcomes were analyzed. A total of 6774 cases were analyzed. The pacemaker group showed higher in-hospital rates of cardiac arrest, myocardial infarction, and longer duration of mechanical ventilation and ICU stay than the non-pacemaker group. Nevertheless, pacemaker placement was associated with a significant decrease in mortality (4.2% vs 26.0%, P < .01). Patients with CSCI requiring a pacemaker placement had better survival than those treated without a pacemaker. Pacemaker implantation should be highly considered in patients who develop refractory bradycardia after CSCI.

Single-Chamber and Dual-Chamber Pacemaker Devices in Adults with Moderate and Complex Congenital Heart Disease: A Single Tertiary Referral Center Experience.

The number of device implantation procedures has increased in adult patients with congenital heart disease (ACHD). Despite significant improvements in materials and implantation techniques, these patients are exposed to higher risk of device related complications than general population. Herein, we describe our single tertiary referral center experience on transvenous pacemaker (PM) implantation and follow-up in adult patients with moderate and complex congenital heart disease (CHD) as limited data are available on long-term outcome. We considered all adults with moderate and complex CHD aged more than 16 years who underwent transvenous single-chamber and dual-chamber PM implant for sinus node dysfunction or atrioventricular block between January 2013 to December 2022 at our Unit. Seventy-one ACHD patients were included in the study (mean age 38.6 ± 15.2 years, 64% with moderate CHD, 36% with complex CHD). Among 32 patients implanted with a dual chamber PM (DDD PM), 4 devices were reprogrammed in VDD mode, 3 in VVI and 2 in AAI mode during follow-up because of lead dysfunction or permanent atrial arrhythmia. In addition, 26 patients had a single chamber PM (AAI or VVI PM) and 13 patients had single-lead pacing system with a free-floating atrial electrode pair (VDD PM). Just one of 13 single-lead VDD PM was reprogrammed in VVI mode due to a low atrial sensing. In DDD PM group, 10 re-interventions were needed due to lead dysfunction (8 cases) and lead-related infective endocarditis (2 cases). Only 3 patients in the single-lead PM group developed lead dysfunction with 2 re-interventions needed, but no infective endocarditis was reported. The rate of long-term complications is high in moderate and complex ACHD with transvenous PM devices, and it is mainly lead-related. In our experience, the less leads implanted, the less complications will occur. Considering the heterogeneity of the ACHD population, transvenous single-chamber or dual-chamber PM device implantation should always be tailored on the single patient, balancing risks and benefits in this complex population.

Transvenous Compared With Leadless Pacemakers: A meta-analysis comparing TP versus LP.

This study aims to compare the effectiveness of leadless pacemakers (LPs) and transvenous pacemakers and to examine the safety of both methods. We included patients undergoing single-chamber pacemaker implantation, either LP or TVP. Our outcomes were successful implantation rate, major complication, vascular injury, tamponade, and pneumothorax. We performed a double-arm analysis comparing LP versus TVP, with risk ratio (RR) and 95% confidence interval. A total of 10 studies were included in this meta-analysis. Regarding efficacy endpoints, RR revealed no significant difference between the LP and transvenous pacemaker groups in terms of successful rate of implantation (RR = 1.00; P = 0.77). Regarding safety outcomes, LP experienced lower incidence of major complications (RR = 0.47; P = 0.01), infection (RR = 0.24; P = 0.001), and tamponade (RR = 0.36; P = 0.01). There was no significant difference between both groups regarding pneumothorax (RR = 0.35; P = 0.22) and vascular injury (RR = 1.55; P = 0.25). The study findings suggest that both LPs and TVPs have similar effectiveness. Moreover, the incidences of pneumothorax, vascular injuries, and major complications were found to be comparable between the 2 methods. However, LPs were found to have lower rates of infection and tamponade.

Predictors for new-onset conduction block in patients with pure native aortic regurgitation after transcatheter aortic valve replacement with a new-generation self-expanding valve (VitaFlow Liberty™): a retrospective cohort study

BackgroundNew-generation self-expanding valves can improve the success rate of transcatheter aortic valve replacement (TAVR) for severe pure native aortic regurgitation (PNAR). However, predictors of new-onset conduction block post-TAVR using new-generation self-expanding valves in patients with PNAR remain to be established. Therefore, this study aimed to identify predictors of new-onset conduction block post-TAVR using new-generation self-expanding valves (VitaFlow Liberty™) in patients with PNAR.MethodsIn this retrospective cohort study, patients were categorized into pacemaker and non-pacemaker groups based on their need for new postoperative permanent pacemaker implantation (PPI). Based on the postoperative presence of either new-onset complete left bundle branch block (cLBBB) or high-grade atrioventricular block (AVB), patients were further classified into conduction disorder and non-conduction disorder groups. Laboratory, echocardiographic, computed tomography, preoperative and postoperative electrocardiography, and procedural and clinical data were collected immediately after TAVR and during hospitalization and compared between the groups. Multivariate logistic regression analysis was performed incorporating the significant variables from the univariate analyses.ResultsThis study examined 68 consecutive patients with severe PNAR who underwent TAVR. In 20 patients, a permanent pacemaker was fitted postoperatively. Multivariate logistic regression analysis revealed an association between the need for postoperative PPI and preoperative complete right bundle branch block (cRBBB) or first-degree AVB, as well as a non-tubular left ventricular outflow tract (LVOT). In addition, valve implantation depth and angle of aortic root were independent predictors of new-onset cLBBB or high-grade AVB developing post-TAVR. The predictive value of valve implantation depth and angle of aortic root was further supported by receiver operating characteristic curve analysis results.ConclusionsIn patients with PNAR undergoing TAVR using self-expanding valves, preoperative cRBBB or first-degree AVB and a non-tubular LVOT were indicators of a higher likelihood of PPI requirement. Moreover, deeper valve implantation depth and greater angle of aortic root may be independent risk factors for new-onset cLBBB or high-grade AVB post-TAVR. Valve implantation depth and angle of aortic root values may be used to predict the possibility of new cLBBB or high-grade AVB post-TAVR.

Incidence and risk factors for permanent pacemaker implantation in patients undergoing tricuspid valve surgery

Abstract Background Bradyarrhythmias requiring permanent pacemaker (PPM) implantation are commonly described after cardiac surgeries. Numerous studies evaluated the demographic and clinical risk factors for PPM placement following aortic and mitral valve surgeries. However, a paucity of data exists when it comes to tricuspid valve surgery (TVS). Purpose Our study aimed to evaluate the incidence of PPM placement after TVS and investigate the demographic, clinical, and procedural risk factors associated with the need for a PPM. Methods We included 13 294 patients from the Medicare database who underwent isolated TV repair (N=1319 (10%)), isolated TV replacement (N=2123 (16%)), or concomitant TV repair or replacement with different combinations of surgical aortic valve replacement (SAVR), mitral valve repair or replacement (MVR), and coronary artery bypass graft (CABG). Patients who underwent TV surgery for endocarditis were excluded. The primary exposure of interest for the study was new pacemaker placement after TV surgery and before discharge, or within 30 days from discharge date. Each patient from the pacemaker group was matched to up to 3 controls from the no pacemaker group. Results Among the included patients, 2518 (18.9%) required a PPM placement after TVS. In the logistic regression including patients’ variables, subjects who needed PPM implantation were more likely to be women (64.4% vs. 57.6%, P&amp;lt;0.001) and had a higher prevalence of prior sternotomy (P=0.01), chronic kidney disease (P=0.03), heart failure (P=0.04) and tumor (P=0.02). Patients who underwent isolated TV replacement and TV replacement with concomitant surgeries had a significantly higher risk of PPM implantation when compared to isolated TV repair and TV repair with concomitant surgeries (P&amp;lt;0.0001) (Table). Conclusion Post-procedural PPM implantation is a very frequent complication of TVS, especially in TV replacement with or without concomitant left-sided heart surgeries. Numerous demographic and clinical factors are associated with an increased risk of PPM placement. Adequate risk stratification and counseling of patients before surgery decision is essential.Demographic &amp; Surgical Risk Factors

Outcomes following permanent pacemaker implantation in patients undergoing tricuspid valve surgery

Abstract Background PPM implantation are commonly described after cardiac surgeries and notably after tricuspid valve surgery (TVS). Purpose Our study aimed to compare outcomes in patients who underwent PPM placement versus patients who did not following TVS. Methods We included 13 294 patients from the Medicare database who underwent isolated TV repair (N=1319 (10%)), isolated TV replacement (N=2123 (16%)), or concomitant TV repair or replacement with different combinations of surgical aortic valve replacement (SAVR), mitral valve repair or replacement (MVR), and coronary artery bypass graft (CABG). Patients who underwent TV surgery for endocarditis were excluded. The primary exposure of interest for the study was new pacemaker placement after TV surgery and before discharge, or within 30 days from discharge date. Each patient from the pacemaker group was matched to up to 3 controls from the no pacemaker group. The primary study outcome was all-cause mortality in follow-up in patients who underwent pacemaker placement after TV surgery versus patients who did not. The study’s secondary outcomes included 1-year mortality and the risk of hospital readmission with a diagnosis of endocarditis or heart failure (HF) in follow-up. Results Among the included patients, 2518 (18.9%) required a PPM placement after surgery. PPM placement was associated with a longer length of hospital stay (median 12 days (IQR 8-19 days) vs. 10 (7-17 days), P&amp;lt;0.001). It was not associated with a difference in risk of 1-year mortality (18.9% vs. 20.7%, OR 0.90, 95% CI 0.79-1.03, P=0.1). After a median follow-up of 3.1 years (IQR 1-5.5 years), PPM placement was also not associated with a significant increase in the risk of mortality in comparison to patients who did not require PPM (HR 1.02, 95% CI 0.93-1.12, P=0.7) (Figure 1). However, it was associated with a higher risk of HF readmission in follow-up (HR 1.28, 95% CI 1.14-1.43, P&amp;lt;0.001) when compared to no PPM (Figure 2). Finally, PPM was not associated with any difference in risk of endocarditis in follow-up (HR 1.03, 95% CI 0.74-1.45, P=0.8). Conclusion Post-procedural PPM implantation is a frequent complication of TVS. While mortality is not increased, PPM placement leads to higher HF hospitalization rates. Adequate risk stratification and counseling of patients before surgery decision is essential.Survival after TVSHeart Failure after TVS

Long-term stability of atrial sensing in implantable cardioverter-defibrillators with floating atrial dipole leads

Abstract Introduction To maintain the advantages of having atrial sensing without the need to implant an additional lead, a single-lead ICD system with a floating atrial dipole (VDD DX ICD, Biotronik) with active fixation to the right ventricle has been developed. In this generation of ICDs, specially filtered atrial signs may be high enough to allow early detection of atrial arrhythmias and improve discrimination between atrial and ventricular tachycardias. However, maintaining reliable and stable atrial sensing via the floating dipole could be a concern regarding this technology. We aimed to determine the long-term stability of atrial sensing in patients (P) with this type of device. Methods All P implanted with ICDs with an active fixation DX lead at our centre between 2013 and 2021 were included. Atrial sensing and ventricular or supraventricular arrhythmic events were recorded during follow-up. We retrospectively analysed the atrial sensing evolution and compared it with a control group that had been implanted with a VDD pacemaker (PM). Results Seventy DX ICD P (82.9% males, age 69±14 years [between 19 and 86], 81.4% implanted as primary prevention) with &amp;gt; 1-year follow-up were included. The control group included 52P (age 82±6.3 years) who underwent PM implantation due to an advanced atrioventricular block. The mean P-wave amplitude at implantation was 4.85±2.44 mV in the DX ICD group and 1.54±0.89 mV in the VDD PM group. At one year after implantation, P-wave amplitude was 4.26±2.68 mV in the DX ICD group and 1.20±1.16 mV in the control group. From the control group, 7P (15,6%) lost atrial sensing after one year of follow-up, having their PM programmed as VVI after that. None of the P in the ICD group had lost atrial sensing in the same time period. After one year of follow-up, the P-wave amplitude had a mean reduction of 41.3% in the DX ICD group and of 65% in the control group (P=0.05). Conclusions Atrial signals can be reliably sensed by the floating dipole rings of a DX ICD in a long-term follow-up. This technology resulted in a higher stability of atrial sensing when compared with that obtained in P with a VDD PM. Additionally, a noteworthy number of P with a VDD PM lost atrial sensing, which did not happen in the group with the DX ICD.Results

Abstract 15691: Permanent Pacemaker Implantation After Aortic Valve Surgery for Infective Endocarditis Was Associated With an Increased Risk of Heart Failure

Background Surgery for infective endocarditis (IE) is associated with a high risk of receiving a new permanent pacemaker. The clinical impact of permanent pacemaker implantation in these patients is unknown. Research question Does permanent pacemaker implantation after aortic valve surgery for IE affect long-term clinical outcomes? Aims To analyze the risk of mortality, heart failure hospitalization, and prosthetic valve endocarditis in patients who received a permanent pacemaker within 30 days of aortic valve surgery for IE. Methods: In this nationwide, population-based, observational cohort study based on the SWEDEHEART register, we included all patients who underwent primary aortic valve replacement for IE in Sweden from 1997 to 2022. Patients with a preoperative cardiac implantable electronic device were excluded. The primary outcome was all-cause mortality. Secondary outcomes were heart failure hospitalization and prosthetic valve endocarditis. Follow-up was complete. Inverse probability of treatment weighting was used to account for intergroup differences and flexible parametric models were used to estimate cause-specific hazards and cumulative incidences. Results: Among 2110 patients, 131 patients (6%) received a new permanent pacemaker, and 1979 patients (94%) did not. The mean age was 59 years, and 433 patients (21%) were female. During a mean follow-up time of 8.5 years (maximum 26 years), 873 patients (41%) died. The cumulative incidence of all-cause mortality and heart failure hospitalization at 20 years was 66% (95% CI 46%-79%) versus 61% (95% CI 58%-64%) and 45% (95% CI 33%-58%) versus 32% (95% CI 29%-34%) in the pacemaker versus the non-pacemaker group, respectively. After adjustment, there was no difference in the risk of mortality (HR 1.14, 95% CI: 0.82-1.59) or reinfection (HR 1.00, 95% CI 0.63-1.59), but the risk of heart failure was increased in the pacemaker group (HR 1.67, 95% CI: 1.11-2.52). Conclusion Permanent pacemaker implantation after aortic valve surgery for IE was associated with an increased risk of heart failure, but there was no difference in the risk of long-term mortality or prosthetic valve endocarditis. These results suggest that patients who receive a pacemaker after surgery for IE warrant careful observation.

Methylxanthine Derivatives in the Treatment of Sinus Node Dysfunction: A Systematic Review.

While the chronotropic effects of theophylline and aminophylline are well-known, their clinical application in the treatment of sinus node dysfunction has not been established in a review. The purpose of this systematic review is to evaluate the efficacy and safety of methylxanthines in the treatment of bradyarrhythmias associated with sinus node dysfunction. A systematic review was conducted in accordance with PRISMA guidelines on Embase, PubMed, MEDLINE, Cochrane Central, Web of Science, SciELO, Korean Citation Index, Global Index Medicus, and CINAHL through June 2023. A total of 607 studies were identified through the literature search. After applying the inclusion and exclusion criteria, 14 studies were included in this review. The causes of bradyarrhythmias involving the sinoatrial node included acute cervical spinal cord injury, coronavirus disease of 2019, carotid sinus syncope, chronotropic incompetence, heart transplant, and chronic sinus node dysfunction. Theophylline and aminophylline were shown to be effective for increasing heart rate and reducing the reoccurrence of bradyarrhythmias. The data on symptom resolution was conflicting. While many case studies reported a resolution of symptoms, a randomized controlled trial reported no significant difference in symptom scores between the control, theophylline, and pacemaker groups in the treatment of sick sinus syndrome. The incidence of adverse effects was low across all study designs. The data suggests methylxanthines may be useful as an alternative or bridge to nonpharmacologic pacing; however, dosing has yet to be established for various indications. Overall, methylxanthines proved safe and effective as a pharmacologic therapy for bradyarrhythmic manifestations of sinus node dysfunction.

Comparison of Safety of Leadless Pacemakers and Transvenous Pacemakers: A Meta-Analysis.

Pacemakers have been accessible for six decades, and clearly defined criteria for pacemaker implantation have been established. Within the contemporary clinical practice, two dependable pacing platforms exist leadless pacemakers and transvenous pacemakers. The aim of this meta-analysis is to compare the safety of leadless pacemakers to transvenous pacemakers.This meta-analysis adhered to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 framework.A comprehensive and systematic search was conducted across various databases including Scopus, Cochrane Library, and EMBASE, spanning from inception to August 15, 2023.The primary outcomes assessed in this meta-analysis were total complications, all-cause mortality, and device-related complications. Furthermore, secondary outcomes evaluated encompassed the need for reintervention, occurrences of pneumothorax, pericardial effusion, endocarditis, hemothorax, and hematoma. Total 17 studies were included in this meta-analysis. The findings of this study showed that patients with leadless pacemakers had a lower risk of total complications, device-related complications, pneumothorax, and endocarditis. The risk of reintervention was significantly lower in the leadless pacemaker group. However, compared to a transvenous pacemaker, the risk of pericardial effusion was significantly higher in the leadless pacemaker group.It is important to acknowledge the limitations arising from the lack of extensive long-term follow-up data for leadless pacemakers. As technology evolves, continued research will be essential in uncovering the full spectrum of prolonged complications associated with these devices.

Ventricular arrhythmias and cardiac arrest in atrial fibrillation patients with pacemakers and implantable cardioverter-defibrillators

Atrial fibrillation (AF) has been linked to ventricular arrhythmias (VAs) and sudden death, but few studies have specifically explored this association. We investigated whether AF is associated with an increased risk of ventricular tachycardia (VT), ventricular fibrillation (VF) and cardiac arrests (CA) in patients with cardiac implantable electronic devices (CIEDs). All patients with pacemakers and implantable cardioverter-defibrillators (ICDs) hospitalised between 2010 and 2020 were identified from the French National database. Patients with a prior history of VT/VF/CA were excluded. 701,195 patients were identified initially. After excluding 55,688 patients, 581,781 (90.1%) and 63,726 (9.9%) remained in the pacemaker and ICD groups respectively. 248,046 (42.6%) pacemaker patients had AF and 333,735 (57.4%) had no AF, whereas in the ICD group 20,965 (32.9%) had AF and 42,761 (67.1%) had no AF. The incidence of VT/VF/CA was higher in AF patients compared to non-AF patients both in pacemaker (1.47%/year vs. 0.94%/year) and ICD (5.30%/year vs. 4.21%/year) groups. After multivariable analysis, AF was independently associated with an increased risk of VT/VF/CA in pacemaker (HR 1.236 [95% CI 1.198-1.276]) and ICD (HR 1.167 [95% CI 1.111-1.226]) patients. This risk was still significant in the 1:1 propensity score-matched analysis of the pacemaker (n=200,977 per subgroup) and ICD cohorts (n=18,349 per subgroup), HR 1.230 [95% CI 1.187-1.274] and HR 1.134 [95% CI 1.071-1.200] respectively and in the competing risk analysis (pacemaker: HR 1.195 (95% CI 1.154-1.238], ICD: HR 1.094 [95% CI 1.034-1.157]). CIED patients with AF have a higher risk of VT/VF/CA compared to CIED patients without AF.

Pacemaker Implantation following Heart Transplantation: Analysis of a Nation-Wide Database.

The 2018 United-Network-for-Organ-Sharing (UNOS) allocation-system changes resulted in greater recognition of mechanical circulatory support (MCS), leading to more heart transplantations (HTx) in patients with MCS. We aimed to investigate the effect of the new UNOS allocation system on the need for a permanent pacemaker and associated complications following HTx. The UNOS Registry was questioned, to identify patients that received HTx in the US between 2000 and 2021. The primary objectives were to identify risk factors for the need for a pacemaker implantation following HTx. 49,529 HTx patients were identified, 1421 (2.9%) requiring a pacemaker post-HTx. Patients who required a pacemaker were older (53.9 ± 11.5 vs. 52.6 ± 12.8 years, p < 0.001), more frequently white (73% vs. 67%; p < 0.001) and less frequently black (18% vs. 20%; p < 0.001). In the pacemaker group, UNOS status 1A (46% vs. 41%; p < 0.001) and 1B (31% vs. 27%; p < 0.001) were more prevalent, and donor age was higher (34.4 ± 12.4 vs. 31.8 ± 11.5 years; p < 0.001). One-year survival was no different between the groups (HR: 1.08; 95% CI: 0.85, 1.37; p = 0.515). An era effect was observed (per year: OR: 0.97; 95% CI: 0.96, 0.98; p = 0.003), while ECMO pre-transplant was associated with lower risk of a pacemaker (OR: 0.41; 95% CI: 0.19, 0.86; p < 0.001). While associated with various patient and transplant characteristics, pacemaker implantation does not seem to impact one-year survival after HTx. The need for pacemaker implantation was lower in the more recent era and in patients who required ECMO pre-transplant, a finding explained by recent advances in perioperative care.

Ventricular Functional Analysis in Congenital Complete Heart Block Using Speckle Tracking: Left Ventricular Epicardial Compared to Right Ventricular Septal Pacing.

Chronic right ventricular (RV) apical pacing in patients with congenital complete atrioventricular block (CCAVB) is associated with left ventricle (LV) dyssynchrony and dysfunction. Hence, alternative pacing sites are advocated. The aim of this study was to compare LV function using STE in selected patients with LV epicardial pacing (LVEp) vs. RV transvenous pacing (RVSp). This was a single-center, retrospective study in patients with CCAVB who underwent permanent pacemaker implant at age ≤ 18years. Age- and gender-matched patients with a normal heart anatomy and function served as the control group. LV function was comprehensively assessed by conventional 2D Echocardiography and speckle-tracking echocardiography (STE). We included 24 patients in the pacemaker group [27.6% male, mean age of 17.1 at last follow-up, follow-up duration of 8.7years, RVSp (n = 9; 62.5%)] compared to 48 matched healthy controls. Shortening fraction (SF) and ejection fraction (EF) were normal and similar between cases and controls. However, STE detected abnormal LV function in the pacemaker group compared to controls. The former demonstrated lower/abnormal, Peak Longitudinal Strain myocardial (PLS Myo) [- 12.0 ± 3.3 vs. - 18.1 ± 1.9, p < 0.001] and Peak Longitudinal Strain endocardial (PLS endo) [- 16.1 ± 4.1 vs. 1.7 ± 1.7, p < 0.001]. STE parameters of LV function were significantly more abnormal in LVEp vs. RVSp subgroup as demonstrated by lower values for PLS Myo (- 10.1 ± 3.2 vs. - 13.1 ± 2.9, p = 0.03) and PLS Endo (- 13.8 ± 4.4 vs. - 17.5 ± 3.3, p = 0.03). STE was more sensitive in detecting subtle differences in LV function relative to standard conventional 2D echocardiography (SF and EF) in selected patients with CCAVB and a permanent pacemaker. Furthermore, STE demonstrated that transvenous RV septal pacing was associated with better LV systolic function preservation than LV epicardial pacing for comparable post-implant intervals.

Feasibility and safety of bridge therapy with active fixed electrodes connected to external permanent pacemakers for patients with infective endocarditis after lead removal and before permanent pacemaker implantation

Objective: To analyze the feasibility and safety of bridge therapy with active fixed electrodes connected to external permanent pacemakers (AFLEP) for patients with infective endocarditis after lead removal and before permanent pacemaker implantation. Methods: A total of 44 pacemaker-dependent patients, who underwent lead removal due to infective endocarditis in our center from January 2015 to January 2020, were included. According to AFLEP or temporary pacemaker option during the transition period, patients were divided into AFLEP group or temporary pacemaker group. Information including age, sex, comorbidities, indications and types of cardial implantable electionic device (CIED) implantation, lead age, duration of temporary pacemaker or AFLEP use, and perioperative complications were collected through Haitai Medical Record System. The incidence of pacemaker perception, abnormal pacing function, lead perforation, lead dislocation, lead vegetation, cardiac tamponade, pulmonary embolism, death and newly infection of implanted pacemaker were compared between the two groups. Pneumothorax, hematoma and the incidence of deep vein thrombosis were also analyzed. Results: Among the 44 patients, 24 were in the AFLEP group and 20 in the temporary pacemaker group. Age was younger in the AFLEP group than in the temporary pacemaker group (57.5(45.5, 66.0) years vs. 67.0(57.3, 71.8) years, P=0.023). Male, prevalence of hypertension, diabetes mellitus, chronic renal dysfunction and old myocardial infarction were similar between the two groups (all P>0.05). Lead duration was 11.0(8.0,13.0) years in the AFLEP group and 8.5(7.0,13.0) years in the temporary pacemaker group(P=0.292). Lead vegetation diameter was (8.2±2.4)mm in the AFLEP group and (9.1±3.0)mm in the temporary pacemaker group. Lead removal was successful in all patients. The follow-up time in the AFLEP group was 23.0(20.5, 25.5) months, and the temporary pacemaker group was 17.0(14.5, 18.5) months. In the temporary pacemaker group, there were 2 cases (10.0%) of lead dislocation, 2 cases (10.0%) of sensory dysfunction, 2 cases (10.0%) of pacing dysfunction, and 2 cases (10.0%) of death. In the AFLEP group, there were 2 cases of abnormal pacing function, which improved after adjusting the output voltage of the pacemaker, there was no lead dislocation, abnormal perception and death. Femoral vein access was used in 8 patients (40.0%) in the temporary pacemaker group, and 4 patients developed lower extremity deep venous thrombosis. There was no deep venous thrombosis in the AFLEP group. The transition treatment time was significantly longer in the AFLEP group than in the temporary pacemaker group (19.5(16.0, 25.8) days vs. 14.0(12.0, 16.8) days, P=0.001). During the follow-up period, there were no reinfections with newly implanted pacemakers in the AFLEP group, and reinfection occurred in 2 patients (10.0%) in the temporary pacemaker group. Conclusions: Bridge therapy with AFLEP for patients with infective endocarditis after lead removal and before permanent pacemaker implantation is feasible and safe. Compared with temporary pacemaker, AFLEP is safer in the implantation process and more stable with lower lead dislocation rate, less sensory and pacing dysfunction.

Symptoms of Depression, Anxiety, and Posttraumatic Stress among Patients with Cardiac Pacemakers

Despite being a prerequisite for tailoring specific therapeutic interventions, knowledge of pattern and prevalence of clinically significant psychiatric symptomatology among patients with cardiac pacemakers (PMs), especially of symptoms of posttraumatic stress, is limited. We studied symptoms of depression, anxiety, and posttraumatic stress among PM patients (PM due to syncope or presyncope) compared to participants of (i) a cardiac, (ii) a chronic disease, and (iii) a healthy control group. Symptoms of depression, anxiety and posttraumatic stress were measured by validated self-report scales at least 6 months after implantation of the PM (PM group; n = 38), percutaneous coronary intervention (PCI; PCI control group; n = 23), and first dialysis (Dialysis control group; n = 17). Blood donors constituted the Healthy control group (n = 42). Both PM, PCI, and dialysis patients reported depressive symptoms above clinical cut-off more frequently than the healthy controls (16.2, 26.1, 41.2, and 0%, respectively; p < 0.001). Self-report of symptoms of anxiety and posttraumatic stress did not differ significantly across study groups. However, a non-negligible proportion of PM patients reported on symptoms of posttraumatic stress of anticipated clinical relevance. Identification and treatment of depression deserves attention in clinical routine in all three patient populations. Further study of posttraumatic stress in PM patients seems advisable.