In a multicenter study, 526 patients underwent implantation of a new leadless cardiac pacemaker. Among the first 300 patients who were followed for 6 months, the pacemaker met prespecified sensing ...and pacing requirements in 90%, and serious adverse events were observed in 6.7%.
Each year, nearly 1 million persons worldwide receive conventional transvenous cardiac pacemakers with active-fixation leads to treat bradycardia and heart block.
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Despite considerable technological advancements since the clinical introduction of these pacemakers six decades ago, pacemaker-related adverse events occur in 1 in 10 patients.
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These events are typically related to the transvenous lead, surgical pocket, or pulse generator.
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The leads are susceptible to dislodgement, fracture, or insulation failure and can also cause infection, cardiac perforation, venous occlusion, and tricuspid regurgitation. Pulse generators have been associated with infection, pocket hematoma, and skin erosion.
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A recently developed . . .
IMPORTANCE: The relative rates of detection of atrial fibrillation (AF) or atrial flutter from evaluating patients with prolonged electrocardiographic monitoring with an external loop recorder or ...implantable loop recorder after an ischemic stroke are unknown. OBJECTIVE: To determine, in patients with a recent ischemic stroke, whether 12 months of implantable loop recorder monitoring detects more occurrences of AF compared with conventional external loop recorder monitoring for 30 days. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, open-label, randomized clinical trial conducted at 2 university hospitals and 1 community hospital in Alberta, Canada, including 300 patients within 6 months of ischemic stroke and without known AF from May 2015 through November 2017; final follow-up was in December 2018. INTERVENTIONS: Participants were randomly assigned 1:1 to prolonged electrocardiographic monitoring with either an implantable loop recorder (n = 150) or an external loop recorder (n = 150) with follow-up visits at 30 days, 6 months, and 12 months. MAIN OUTCOMES AND MEASURES: The primary outcome was the development of definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization). There were 8 prespecified secondary outcomes including time to event analysis of new AF, recurrent ischemic stroke, intracerebral hemorrhage, death, and device-related serious adverse events within 12 months. RESULTS: Among the 300 patients who were randomized (median age, 64.1 years interquartile range, 56.1 to 73.7 years; 121 were women 40.3%; and 66.3% had a stroke of undetermined etiology with a median CHA2DS2-VASc congestive heart failure, hypertension, age ≥75 years, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category score of 4 interquartile range, 3 to 5), 273 (91.0%) completed cardiac monitoring lasting 24 hours or longer and 259 (86.3%) completed both the assigned monitoring and 12-month follow-up visit. The primary outcome was observed in 15.3% (23/150) of patients in the implantable loop recorder group and 4.7% (7/150) of patients in the external loop recorder group (between-group difference, 10.7% 95% CI, 4.0% to 17.3%; risk ratio, 3.29 95% CI, 1.45 to 7.42; P = .003). Of the 8 specified secondary outcomes, 6 were not significantly different. There were 5 patients (3.3%) in the implantable loop recorder group who had recurrent ischemic stroke vs 8 patients (5.3%) in the external loop recorder group (between-group difference, −2.0% 95% CI, −6.6% to 2.6%), 1 (0.7%) vs 1 (0.7%), respectively, who had intracerebral hemorrhage (between-group difference, 0% 95% CI, −1.8% to 1.8%), 3 (2.0%) vs 3 (2.0%) who died (between-group difference, 0% 95% CI, −3.2% to 3.2%), and 1 (0.7%) vs 0 (0%) who had device-related serious adverse events. CONCLUSIONS AND RELEVANCE: Among patients with ischemic stroke and no prior evidence of AF, implantable electrocardiographic monitoring for 12 months, compared with prolonged external monitoring for 30 days, resulted in a significantly greater proportion of patients with AF detected over 12 months. Further research is needed to compare clinical outcomes associated with these monitoring strategies and relative cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02428140
Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover ...trial of conventional versus incremental antibiotics.
This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.
In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.
Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures P, age A, depressed renal function D, immunocompromised I, and procedure type T) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.
This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial PADIT Pilot; NCT01002911)
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BACKGROUND:The optimal timing of catheter ablation for atrial fibrillation (AF) in reference to the time of diagnosis is unknown. We sought to assess the impact of the duration between first ...diagnosis of AF and ablation, or diagnosis-to-ablation time (DAT), on AF recurrence following catheter ablation.
METHODS:We conducted a systematic electronic search for observational studies reporting the outcomes associated with catheter ablation for atrial fibrillation stratified by diagnosis-to-ablation time. The primary meta-analysis using a random effects model assessed AF recurrence stratified by DAT ≤1 year versus >1 year. A secondary analysis assessed outcomes stratified by DAT ≤3 years versus >3 years.
RESULTS:Of the 632 screened studies, 6 studies met inclusion criteria for a total of 4950 participants undergoing AF ablation for symptomatic AF. A shorter DAT ≤1 year was associated with a lower relative risk of AF recurrence compared with DAT >1 year (relative risk, 0.73 95% CI, 0.65–0.82; P<0.001). Heterogeneity was moderate (I=51%). When excluding the one study consisting of only patients with persistent AF, the heterogeneity improved substantially (I=0%, Cochran’s Q P=0.55) with a similar estimate of effect (relative risk, 0.78 95% CI, 0.71–0.85; P<0.001).
CONCLUSIONS:Shorter duration between time of first AF diagnosis and AF ablation is associated with an increased likelihood of ablation procedural success. Additional study is required to confirm these results and to explore implementation of earlier catheter AF ablation and patient outcomes within the current AF care pathway.
Left ventricular (LV) dysfunction may be sustained or aggravated during the convalescent months following an acute myocardial infarction (MI) and is difficult to predict. We sought to determine ...current practice patterns of LV ejection fraction (LVEF) reassessment during the months following MI and evaluate the predictors and clinical significance of LVEF change in a prospective post-MI patient cohort.
Patients with an acute MI between June 2010 and August 2014 were identified using the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Patients with initial LV dysfunction (LVEF <40% with first MI or <45% with multiple MI events) underwent a protocol-driven repeat LVEF assessment in follow-up if routine LVEF reassessment was not performed.
Of 5,964 MI patients, follow-up LVEF assessments were attained for 442 of the 695 patients who had significant LV dysfunction. A sizable proportion (25%) had either no increase or a decline in LVEF. Adverse remodeling was associated with an anterior MI location, a greater peak serum troponin T, and a higher baseline LVEF at time of MI. Adverse LV remodeling conferred a 3-fold risk of death (hazard ratio 3.0, 95% CI 1.6-5.7, P=.001) adjusted for baseline LVEF, anterior MI location, and medication use.
Current practice of LVEF reassessment during the convalescent months post-MI is suboptimal despite a sizeable proportion of patients that undergo adverse LV remodeling. Targeting processes affecting low rates of LVEF reassessment may reduce missed care opportunities and ensure that patients consistently receive appropriate evidence-based and guideline-recommended care.
This study hypothesizes that a lack of left ventricular ejection fraction (LVEF) recovery after myocardial infarction (MI) would be associated with a poor outcome.
A reduced LVEF early after MI ...identifies patients at risk of adverse outcomes. Whether the change in LVEF in the weeks to months following MI provides additional information on prognosis is less certain.
Change in LVEF between the early (2 to 7 days) and later (2 to 12 weeks) post-MI periods in patients with a first MI was assessed in 3 independent cohorts (REFINE Risk Estimation Following Infarction Noninvasive Evaluation; CARISMA Cardiac Arrhythmia and Risk Stratification after Myocardial Infarction; ISAR Improved Stratification of Autonomy Regulation). Patients were categorized as having no recovery (Δ ≤0%), a modest increase (Δ 1% to 9%), or a large increase (Δ ≥10%) in LVEF. The relationship between change in LVEF and risk of sudden cardiac arrest (SCA) and all-cause mortality were assessed in Cox multivariable models.
In REFINE, patients with no LVEF recovery had a higher risk of sudden cardiac arrest (hazard ratio: 5.8; 95% confidence interval: 2.1 to 16.6; p = 0.001) and death (hazard ratio: 3.9; 95% confidence interval: 1.5 to 10.1; p < 0.001), independent of revascularization, baseline LVEF, and medical therapy compared with patients with recovery. Similar findings were observed in the other cohorts. LVEF reassessments beyond 6 weeks post-MI were more predictive of outcome than were earlier reassessments.
The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death.
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BACKGROUND AND PURPOSE:Management of cryptogenic stroke involves the identification of modifiable risk factors, such as atrial fibrillation (AF). Extended rhythm monitoring increases AF detection ...rates but at an increased device cost compared with conventional Holter monitoring. The objective of the study was to identify and synthesize the existing literature on the cost-effectiveness of prolonged rhythm monitoring devices for AF detection in cryptogenic stroke.
METHODS:We conducted a systematic review of available economic evaluations of prolonged ECG monitoring for AF detection following cryptogenic stroke compared with standard care.
RESULTS:Of the 530 unique citations, 8 studies assessed the cost-utility of prolonged ECG monitoring compared with standard care following cryptogenic stroke. The prolonged ECG monitoring strategies included 7-day ambulatory monitoring, 30-day external loop recorders or intermittent ECG monitoring, and implantable loop recorders. The majority of cost-utility analyses reported incremental cost-effectiveness ratios below $50 000 per QALY gained; and two studies reported a cost-savings.
CONCLUSIONS:There is limited economic literature on the cost-effectiveness of extended ECG monitoring devices for detection of atrial fibrillation in cryptogenic stroke. In patients with cryptogenic stroke, extended ECG monitoring for AF detection may be economically attractive when traditional willingness-to-pay thresholds are adopted. However, there was substantial variation in the reported ICERs. The direct comparison of cost-effectiveness across technologies is limited by heterogeneity in modeling assumptions.
Whether the benefits observed with cardiac resynchronization therapy (CRT) are similar in patients with versus those without atrial fibrillation (AF) is unclear. Furthermore, whether patients with AF ...receiving CRT should undergo atrioventricular nodal (AVN) ablation remains uncertain.
The purpose of this study was to compare outcomes in patients with and those without AF receiving CRT and to evaluate the influence of AVN ablation on outcomes in patients with AF.
A systematic review and meta-analysis was performed. Outcomes included death, CRT nonresponse, and changes in left ventricular (LV) remodeling, quality of life (QoL), and 6-minute hall walk distance (6MWD).
Twenty-three observational studies were included and followed a total of 7,495 CRT recipients, 25.5% with AF, for a mean of 33 months. AF was associated with an increased risk of nonresponse to CRT (34.5% vs 26.7%; pooled relative risk RR 1.32; 95% confidence interval CI 1.12, 1.55; P = .001)) and all-cause mortality (10.8% vs 7.1% per year, pooled RR 1.50, 95% CI 1.08, 2.09; P = .015). The presence of AF was also associated with less improvement in QoL, 6-minute hall walk distance, and LV end-systolic volume but not LV ejection fraction. Among patients with AF, AVN ablation appeared favorable with a lower risk of clinical nonresponse (RR 0.40; 95% CI 0.28, 0.58; P <.001) and a reduced risk of death.
The benefits of CRT appear to be attenuated in patients with AF. The presence of AF is associated with an increased risk of clinical nonresponse and death than in patients without AF. AVN ablation may improve CRT outcomes in patients with AF.
A Dual-Chamber Leadless Pacemaker Knops, Reinoud E.; Reddy, Vivek Y.; Ip, James E. ...
The New England journal of medicine,
06/2023, Letnik:
388, Številka:
25
Journal Article
Recenzirano
In this study involving 300 patients with an indication for a dual-chamber pacemaker, a leadless system provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation.
Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant ...gram-positive organisms, which are common pathogens in device infections.
This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection.
The authors performed a cluster randomized crossover trial with 4 randomly assigned 6-month periods, during which centers used either conventional or incremental periprocedural antibiotics for all cardiac implantable electronic device procedures as standard procedure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin. The primary outcome was 1-year hospitalization for device infection in the high-risk group, analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects.
Device procedures were performed in 28 centers in 19,603 patients, of whom 12,842 were high risk. Infection occurred in 99 patients (1.03%) receiving conventional treatment, and in 78 (0.78%) receiving incremental treatment (odds ratio: 0.77; 95% confidence interval: 0.56 to 1.05; p = 0.10). In high-risk patients, hospitalization for infection occurred in 77 patients (1.23%) receiving conventional antibiotics and in 66 (1.01%) receiving incremental antibiotics (odds ratio: 0.82; 95% confidence interval: 0.59 to 1.15; p = 0.26). Subgroup analysis did not identify relevant patient or site characteristics with significant benefit from incremental therapy.
The cluster crossover design efficiently tested clinical effectiveness of incremental antibiotics to reduce device infection. Device infection rates were low. The observed difference in infection rates was not statistically significant. (Prevention of Arrhythmia Device Infection Trial PADIT Pilot PADIT; NCT01002911).
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