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Background and Objectives: Leadless pacemakers provide an innovative alternative to traditional transvenous pacemakers for managing cardiac arrhythmias. The objective of this systematic review is to conduct a meta-analysis comparing acute complication and mortality rates associated with leadless pacemakers versus transvenous pacemaker placements using national-level data. Specifically, we aim to summarize the current evidence and calculate pooled odds ratios for acute overall complications, acute device-related complications, and acute mortality to assess the early safety outcomes of leadless pacemaker placement relative to traditional transvenous pacemakers. Materials and Methods: A systematic search of PubMed, Scopus, ScienceDirect, and Google Scholar was conducted by two independent researchers using a predefined search protocol. The search included articles published up to 10 October 2024, without limits on review depth. Studies were included if they provided national-level data comparing leadless pacemaker and traditional pacemaker recipients in terms of acute mortality, acute overall complications, and acute device-related complications. Outcomes were pooled to calculate odds ratios using a random-effects model in RStudio (version 2024.12.1+563). Results: A total of five studies met the eligibility criteria. The pooled odds ratio for acute mortality was 2.03 (95% CI: 0.65–6.34, I2 = 99%; p < 0.01), for acute overall complications was 1.08 (95% CI: 0.45–2.61, I2 = 99%; p < 0.01), and for acute device-related complications was 1.02 (95% CI: 0.23–4.44, I2 = 99%; p < 0.01). Conclusions: The reviewed studies suggest that leadless pacemakers offer a promising alternative to transvenous pacemakers, offering a comparable short-term safety profile. Ongoing technological advancements may further enhance their applicability in clinical practice.

Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

IntroductionTranscatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis across a range of risk profiles. Despite advances in valve technology and procedural technique, conduction disturbance remains a common complication, with some patients requiring permanent pacemaker (PPM) implantation post procedure. Identification of predictors of PPM insertion informs procedural planning, patient counselling, and post-discharge monitoring.MethodsPatients who underwent TAVI at St. James’s hospital between 01/01/2019 and 31/12/2024 were included in a retrospective analysis. Primary outcome was new PPM insertion within 30 days post-TAVI. Patient demographics, baseline and post-TAVI ECG findings and procedural characteristics were recorded. Categorical variables were analysed using Chi-square or Fisher’s exact test, while continuous variables were assessed using independent samples t-tests. A p-value <0.05 was considered statistically significant.ResultsOf the patients (n=592), 9.8% (n=58) underwent PPM insertion within 30 days and there was no significant variation in implant rates over the study period (figure 1). PPM requirement was associated with pre-existing RBBB (p=.028), male sex (p=.014). Patients who received larger valves (≥27 mm) had a significantly higher rate of new pacemaker implantation compared to those with smaller valves (47.3% vs. 29.6%, p=.019). Post-TAVI ECG changes were strong predictors, including 3rd-degree AV block (p<.001), 2nd-degree AV block (p<.001), and 1st-degree AV block (p=.004), while the absence of new ECG changes was protective (p<0.001)(table 1). Of the 592 patients, 468 (79.7%) received balloon-expandable valves, with no significant difference in PPM rates between valve types (p=0.187).ConclusionAmong our cohort, incidence of new PPM insertion within 30 days post-TAVI was 9.8%. As expected, PPM requirement was strongly associated with new post-TAVI conduction disturbances, particularly high-grade AV block. Pre-existing RBBB, larger valve size and male sex were also associated with PPM insertion. These findings may help identify high-risk patients and guide monitoring strategies post-TAVI.Abstract 65 Table 1Clinical and procedural variables associated with post-TAVI PPM insertion Variable Pacemaker group (N=58) No pacemaker group (N=534) p-value Post-TAVI: 2nd-degree AV block 13.8% 1.5% <.001 Post-TAVI: 3rd-degree AV block 39.7% 1.5% <.001 Post-TAVI: 1st-degree AV block 19.0% 6.9% .004 Post-TAVI: New RBBB 10.3% 3.2% .065 Valve size group – Small (≤23mm ) 20.0% 33.1% Valve size group – Medium (24– 26mm ) 32.7% 37.3% Valve size group – Large (≥27mm ) 47.3% 29.6% 0.019 Post-TAVI: No ECG change 10.3% 52.8% <.001 Age at time of TAVI 81.4 years 80 years .116 Post-dilatation 17.2% 24.9% .202 Device type (balloon-expandable) 63.8% 69.3% .187 Pre-TAVI 1st-degree AV block 6.9% 4.9% .299 Pre-TAVI LBBB 3.4% 5.6% .639 Pre-TAVI RBBB 22.4% 10.3% .028 Post-TAVI: New LBBB 6.9% 7.5% .831 Abbreviations: TAVI: Transcatheter aortic valve implantation; AV: Atrioventricular; RBBB: Right Bundle Branch Block; LBBB: Left Bundle Branch Block.Abstract 65 Figure 1Dual-axis line and bar graph showing TAVI and PPM procedure volumes (bars) with corresponding ppm insertion (line graph)[Image Omitted. See PDF.]

IntroductionPhage therapy, initially theorised in 1920’s Soviet Union, was overlooked with the widespread introduction of antimicrobials, but is now making a comeback. We present a unique case of the administration of phage therapy in a 94-year-old male, who suffered with recurrent pseudomonas infections secondary to incomplete extraction of a pacemaker. Currently, the awareness of phage therapy is limited outside of clinical trials, with narrow insight into available applications within cardiology in the UK.BackgroundThe patient had a permanent pacemaker inserted for sinus node dysfunction in 2009. Following this, he had an elective generator change which was complicated by a pseudomonas infection. Attempted extraction of this was incomplete, with a residual pacing tip remaining in the right ventricle. After all options were exhausted, including further surgical intervention, he was referred for bacteriophage therapy in 2024.Bacteriophages are intracellular viruses that selectively target and infect bacterial cells by hijacking their genome, inducing lysis. Phage therapy targets drug resistant pathogens whilst retaining selective toxicity, ensuring protection of the hosts biome. Uniquely, their ability to penetrate bacterial biofilms, enhances their therapeutic potential.As phage is not manufactured, nor licensed in the UK, an array of logistical issues were encountered in this case, resulting in a delay of treatment by over 4 weeks. Despite these challenges, phage therapy was successfully commenced making this a pioneering case at the forefront of cardiology.The patient ultimately died of complications of clinical deconditioning and frailty. However, this case demonstrates the use of phage therapy and its potential as a promising alternative for those facing severe infections on a background of significant antibiotic resistance.ConclusionThe future of phage therapy is exciting and promising, however there are many hurdles yet to overcome.Given the significant clinical risk and logistical challenges often associated with long term IV antibiotic use, phage therapy has a vast scope for application in the UK. Cases like this highlight the potential for phage therapy as a treatment option within cardiology patients, where no other avenues remain available.

BackgroundComplete atrioventricular block is a rare, yet important complication that can be seen in some cases of NSTEMI, leading to multiple nefarious complications. Such patients often require permanent pacemaker(PPM) implantations and there is limited data on whether the outcomes are modified by the sex of the patients. We aim to study any sex-based differences in outcomes among non-revascularized NSTEMI patients who underwent PPM implantations after experiencing complete atrioventricular block.MethodsNSTEMI patients who did not undergo CABG or PCI and experienced complete AV block requiring permanent pacemaker implantation were studied using the 2016–2021 National Inpatient Sample. We excluded cases with prior PPM implants and younger than 18 years. Multivariable regression analyzes were derived to estimate differences in outcomes between Males and Females.ResultsWe evaluated 1935 cases that matched our selection criteria, consisting of 990(51.2%) Males and 945(48.8%) Females. Males were younger (median age 77.0 vs. 79.0, p<0.01), with no differences in median Charlson Comorbidity Index (CCI) scores(4.0vs. 4.0, p=0.062) or time from admission to procedure(3.0 vs. 3.0 days, p=0.481). Males expressed higher odds of sepsis(aOR 2.173 95% CI 1.336–3.535 p 0.002), need for cardiopulmonary resuscitation(aOR 3.25 95% CI 1.826–5.785 p <0.001), acute kidney injury(aOR 3.715 95% CI 1.203–11.474 p 0.023 ) requiring hemodialysis, and mechanical ventilation(aOR 1.65 95% CI 1.185–2.297 p 0.003), than females. Although their median lengths of stay (6.0 vs. 7.0 days, p=0.249), hospital charges ($113762 vs. $118430, p=0.062), odds of acute ischemic strokes(aOR 1.127 95% CI 0.7–1.815 p 0.623), cardiogenic shock(aOR 0.806 95% CI 0.585–1.11 p 0.187), and need for vasopressors(aOR 1.198 95% CI 0.667–2.153 p 0.546) did not differ, males were more likely to die(aOR 1.757 95% CI 1.048–2.947 p 0.033)(table 1).Abstract 2-018 Table 1(enter this manually) Outcomes in Males (vs. Females, reference) p-value aOR lower upper Death 0.0331.7571.0482.947Cardiogenic shock0.1870.8060.5851.11AIS0.6231.1270.71.815Mech vent0.0031.651.1852.297Aki req hd0.0233.7151.20311.474Cpr<.0013.251.8265.785Vasopressors0.5461.1980.6672.153Sepsis0.0022.1731.3363.535MajorBleeding0.1310.8480.6851.05ConclusionMales undergoing PPM implantation following complete AV block in NSTEMI events are associated with several poorer outcomes than females. This highlights the need for proper pre-operative risk stratification and the need to address post-operative complications promptly for optimal outcomes.

IntroductionThe development of Transcatheter Aortic Valve Replacement (TAVR) has provided an alternative to surgical valve replacement in high-risk population. Post-procedural length of stay is one of the main cost components after TAVR and is significantly influenced by prolonged monitoring for new conduction disturbances. Occurrence of advanced conduction delays, if left untreated, can be responsible for sudden cardiac death after discharge.ObjectiveWe aimed to determine the electrocardiographic predictors of advanced conduction disturbance that required a permanent pacemaker implantation (PPM) after TAVR.MethodsAll consecutive patients who underwent TAVR between January 2016 to July 2019 were identified from by a retrospective review of TAVR database at this centre.ResultsA total of 77 patients underwent TAVR within the study period and 7 patients were excluded as they had a pre-existing pacemaker/implanted cardiac defibrillator and 2 patients were excluded due to insufficient data. 36 of the patients were males (52%) with an average age of 82.1 years. The average BMI was 26.8 and 62 patients (91.1%) were symptomatic with New York Heart Association class 3 or above.All 68 patients had self-expanding Medtronic CoreValveTM. 10 (14.7%) patients required a PPM within an average of 5.3 days for an indication of either complete heart block or intermittent complete heart block. Of the 10 patients who had a PPM inserted,3 patients had a Right Bundle Branch Block (RBBB) at baseline. These patients were all pacing-dependent (>80% pacing when lower rate was programmed at 60 beats/min) at 6 weeks post-implantation follow-up. 4 out of 7 patients (57%) who had a non-RBBB pattern (i.e. LBBB or normal QRS complex) at baseline had an average pacing requirement of <2% at 6 weeks post implant follow-up. In the non-PPM group, 3 patients had a RBBB pattern and 15 had a LBBB pattern at baseline. Patients who had a baseline RBBB were more likely to require a PPM post TAVI (p-value = 0.02).ConclusionBaseline RBBB ECG pre-TAVR is a significant predictor of delayed advanced AV block. Our study validates previous suggestions that patients with baseline RBBB should not be considered for early discharge and may require prolonged monitoring to detect delayed AV conduction abnormalities. These patients are less likely to recover from their conduction disturbances as suggested by their pacing requirement at 6 week post-implantation follow-up.

A modular leadless pacemaker in wireless communication with a subcutaneous implantable cardioverter–defibrillator was shown to be safe and exceeded performance goals for communication between the pacemaker and ICD.

IntroductionCardiac devices play a crucial role in managing multiple cardiac conditions. This review evaluates the spectrum of Cardiac Implantable Electronic Device procedures performed by a single operator over 11 years, focusing on post-operative complications and their trends over time.MethodsRetrospective analysis was performed on 1,597 patients who underwent a device-related procedure between October 2013 and November 2024 by a single operator. Data assessed was collected prospectively.Results1,597 patients (1,098 male, 499 female) were included. Mean age was 73.2. Mean BMI was 26. 517 had a history of heart failure. 961 procedures were elective, 548 urgent, and 88 emergency. The cephalic vein alone was used 325 times as an access route, subclavian/axillary veins alone 696 times, and both cephalic and subclavian/axillary veins 156 times. Insertion of a new device occurred in 985 cases; the remainder were revisions (208), box changes (339), explants (27), and other procedures (25). 484 dual-chamber pacemakers were implanted, making it the most common device, with cardiac resynchronisation therapy-defibrillator (CRT-D) second most common (267) and single-chamber pacemakers (245) third (table 1). The most common complications within 1 year included atrial-lead displacement (17), wound infections requiring re-operation (15), and right-ventricular-lead displacement (12) (figure 1). Table 2 outlines the specific complication rate of each device (those not included did not account for any of the 94 complications). Emergency procedures had the highest setting-specific complication rate (8%), compared with 6% of urgent cases and 5.5% of elective procedures. Figure 2 demonstrates the procedure complication rate per year, with years 9 and 11 having the lowest rate (3%) and year 3 the highest (8%).Conclusion1,597 device-related procedures were performed by a single operator over 11 years. CRT-D and DDD-ICD had the highest complication rate, 9% and 8.5% respectively. Overall, complication rates declined with increasing operator experience.Abstract 56 Table 1Type of device[Image Omitted. See PDF.]Abstract 56 Table 2Device-specific complication rate[Image Omitted. See PDF.]Abstract 56 Figure 1Complications[Image Omitted. See PDF.]Abstract 56 Figure 2Combination rate by year[Image Omitted. See PDF.]