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Infection is a known complication of the placement of cardiac implantable electronic devices. In this randomized, controlled trial involving 6983 patients undergoing cardiac-device placement, an antibacterial envelope was studied to determine infection prevention. The envelope reduced infection by 40%.

In this trial, patients with atrioventricular block and systolic dysfunction were randomly assigned to receive biventricular or right ventricular pacing. Clinical outcomes were superior with biventricular pacing. These data may extend the use of this pacing mode. Trials of cardiac-resynchronization therapy (CRT) have included patients with advanced systolic heart failure and prolonged QRS duration. 1 These trials have specifically excluded patients with a moderate-to-high degree of atrioventricular block who require ventricular pacing in order to evaluate the effects of CRT independently of the potentially confounding detrimental effects of right ventricular pacing. Whereas right ventricular pacing achieves the primary goal of restoring an adequate heart rate in patients with atrioventricular block, studies suggest that right ventricular apical pacing may lead to progressive left ventricular dysfunction and heart failure in patients with preexisting left ventricular dysfunction, 2 , 3 presumably owing to . . .

The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics. We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers. Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs. Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions. ClinicalTrials.gov NCT02237404.

BackgroundThe avascular capsule around the generator of the cardiac implantable electronic device (CIED) could be susceptible to bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence.MethodsThis prospective randomized trial, conducted from December 2013 to December 2019, included 195 patients divided equally into two groups. In the intervention group (n = 97), capsule removal was performed on the floor of the pocket, while it was not performed in the control group (n = 98). In both groups, swab culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision.ResultsA total of 195 patients were included (mean age 70.2 ± 13.6 years, 55.4% women), with an average follow-up period of 54.3 ± 28.9 months. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, and Staphylococcus species were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs. 1.0%, p = 0.606). Hematoma has occurred in 10 patients (3.1% vs. 7.1%, p = 0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection (HR 13.6, 95% CI 1.02–181.15, p = 0.048).ConclusionsIn this long-term prospective study, capsulectomy during the replacement of the generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.

Cardiac resynchronization improves left ventricular function and functional status in patients who have left ventricular systolic dysfunction and interventricular dyssynchrony due to a conduction delay. In a randomized trial comparing medical therapy alone with medical therapy plus cardiac resynchronization, combined therapy was associated with a significant reduction in the risk of death from any cause. In a randomized trial comparing medical therapy alone with medical therapy plus cardiac resynchronization, combined therapy was associated with a significant reduction in the risk of death from any cause. Despite improvements in pharmacologic treatment, many patients with heart failure have severe and persistent symptoms, and their prognosis remains poor. 1 , 2 Such patients commonly have regions of delayed myocardial activation and contraction, leading to cardiac dyssynchrony. In a series of trials lasting up to six months, cardiac resynchronization decreased symptoms and improved exercise capacity, the quality of life, and ventricular function. 3 – 7 The Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial showed that cardiac-resynchronization therapy alone or combined with an implantable defibrillator reduced the composite end point of death from any cause or hospitalization during a . . .

Pocket hematoma is a common and serious complication following cardiac implantable electronic device (CIED) implantation, contributing to significant morbidity and mortality. This study aimed to evaluate the efficacy of a novel pocket compression device in reducing pocket hematoma occurrence. We enrolled 242 patients undergoing CIED implantation, randomly assigning them to receive either the novel compression vest with a pressure cuff or conventional sandbag compression. Pocket hematomas were categorized as grade 1 (mild), grade 2 (moderate), or grade 3 (severe, requiring intervention or prolonged hospitalization). The primary endpoint, incidence of pocket hematoma 24 h post-procedure, did not significantly differ between the two groups (26.7% vs. 19.7%, p  = 0.224). Rates of grade 2 hematoma were similarly low and comparable (2.5% vs. 0.8%, p  = 0.368), with no grade 3 hematomas observed. Skin reactions and patient comfort were similar between groups. The sole predictor for hematoma occurrence was current oral anticoagulation use. In conclusion, our study found a low incidence of clinically significant pocket hematomas. The novel pocket compression device showed comparable efficacy to conventional methods, suggesting it as a viable alternative for reducing post-procedural complications without additional adverse effects. Trial registration number : The study was registered in the Thai Clinical Trials Registry (TCTR) at https://www.thaiclinicaltrials.org/ , with the identification number TCTR20230913005, date of first trial registration 13/09/2023.

The aim of this retrospective cohort study was to provide a single-center clinical audit of complications for single chamber permanent pacemaker implantation (PPI) techniques and determine if the clinical parameters, PPI technique or complications were associated with outcome. The electronic medical records were searched for dogs treated for bradyarrhythmia with PPI. Data related to presenting complaint, signalment of the dog, ECG diagnosis, echocardiographic findings, PPI technique, and programing of the pacemaker were recorded. Survival length (days) was recorded as the last veterinary visit; if the dog was dead the reason was documented. Cumulative survival of each pacemaker was examined by a Kaplan-Meier survival curve and the two techniques compared with a logrank test. Chi-square was used to determine the association between major complications and death. A total of 66 dogs with 52 transvenous and 30 epicardial PPIs were included. All epicardial pacemakers were implanted via transdiaphragmatic approach. A total of 31 life-threatening complications were reported. There were nine deaths related to major complications (13.6% of the study sample). The median follow-up period was 366 days, with a median survival of 255 days, and a significant difference in cumulative survival of each pacemaker (P = 0.01) between epicardial (93 days, range 0–1882 days) and transvenous (334 days, range 0–2745) PPIs but no significant difference in cumulative survival between the two techniques when only the first pacemaker was considered (p = 0.07). The presence of a major complications had a significant association with death due to pacemaker complications (P<0.001). The decision to perform epicardial PPI in failed transvenous PPI patients may have skewed the cumulative survival as was evident in the lack of significant difference in survival when only first PPI were examined. Major complication rates between the two techniques were similar and the authors consider both techniques equally reliable to manage symptomatic bradycardia in dogs.

ObjectiveMany patients undergoing transcatheter aortic valve implantation (TAVI) have a pre-existing, permanent pacemaker (PPM) or receive one as a consequence of the procedure. We hypothesised that chronic pacing may have adverse effects on TAVI outcomes.Methods and resultsFour groups of patients undergoing TAVI in the Placement of Aortic Transcatheter Valves (PARTNER) trial and registries were compared: prior PPM (n=586), new PPM (n=173), no PPM (n=1612), and left bundle branch block (LBBB)/no PPM (n=160). At 1 year, prior PPM, new PPM and LBBB/no PPM had higher all-cause mortality than no PPM (27.4%, 26.3%, 27.7% and 20.0%, p<0.05), and prior PPM or new PPM had higher rehospitalisation or mortality/rehospitalisation (p<0.04). By Cox regression analysis, new PPM (HR 1.38, 1.00 to 1.89, p=0.05) and prior PPM (HR 1.31, 1.08 to 1.60, p=0.006) were independently associated with 1-year mortality. Surviving prior PPM, new PPM and LBBB/no PPM patients had lower LVEF at 1 year relative to no PPM (50.5%, 55.4%, 48.9% and 57.6%, p<0.01). Prior PPM had worsened recovery of LVEF after TAVI (Δ=10.0 prior vs 19.7% no PPM for baseline LVEF <35%, p<0.0001; Δ=4.1 prior vs 7.4% no PPM for baseline LVEF 35–50%, p=0.006). Paced ECGs displayed a high prevalence of RV pacing (>88%).ConclusionsIn the PARTNER trial, prior PPM, along with new PPM and chronic LBBB patients, had worsened clinical and echocardiographic outcomes relative to no PPM patients, and the presence of a PPM was independently associated with 1-year mortality. Ventricular dyssynchrony due to chronic RV pacing may be mechanistically responsible for these findings.Trial registration number(ClinicalTrials.gov NCT00530894).

Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes. A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity. Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m2 [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]). Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients. ClinicalTrials.gov identifier: NCT03627585.

This report describes a special programming of pacemakers to reduce the risk of atrial fibrillation in patients with symptomatic bradycardia due to sinus-node disease. The pacing algorithm was designed to minimize the extent of ventricular paced beats in order to reduce ventricular desynchronization. The approach successfully reduced the risk of atrial fibrillation and provides a clinically useful alternative to standard pacing. This report describes a special programming of pacemakers in patients with symptomatic bradycardia to minimize the extent of ventricular paced beats. The approach successfully reduced the risk of atrial fibrillation and provides a clinically useful alternative to standard pacing. Despite nearly 20 years of clinical research involving thousands of patients, the optimal pacing strategy for patients with symptomatic bradycardia due to sinus-node disease has yet to be defined. Atrial pacing is associated with a reduced incidence of atrial fibrillation, as compared with ventricular pacing, 1 but atrioventricular block may occur even in carefully selected patients. 2 , 3 Conventional dual-chamber pacing maintains a coordinated atrioventricular relationship by synchronizing ventricular paced beats to atrial activity, prevents syncope during atrioventricular block, and slightly reduces the risk of atrial fibrillation as compared with ventricular pacing. Dual-chamber pacing, however, does not reduce mortality and has a . . .