Summary Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring ...function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. Methods We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II–III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT00538356. Findings We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43–0·90). Ten versus 27 patients died during follow-up. Interpretation Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. Funding Biotronik SE & Co. KG.
The aim of this study was to assess the association between maximum daily atrial fibrillation (AF) burden and risk of ischaemic stroke.
Cardiac implanted electronic devices (CIEDs) enhance detection ...of AF, providing a comprehensive measure of AF burden.
A pooled analysis of individual patient data from five prospective studies was performed. Patients without permanent AF, previously implanted with CIEDs, were included if they had at least 3 months of follow-up. A total of 10 016 patients (median age 70 years) met these criteria. The risk of ischaemic stroke associated with pre-specified cut-off points of AF burden (5 min, 1, 6, 12, and 23 h, respectively) was assessed.
During a median follow-up of 24 months, 43% of 10 016 patients experienced at least 1 day with at least 5 min of AF burden and for them the median time to the maximum AF burden was 6 months (inter-quartile range: 1.3-14). A Cox regression analysis adjusted for the CHADS2 score and anticoagulants at baseline demonstrated that AF burden was an independent predictor of ischaemic stroke. Among the thresholds of AF burden that we evaluated, 1 h was associated with the highest hazard ratio (HR) for ischaemic stroke, i.e. 2.11 (95% CI: 1.22-3.64, P = 0.008).
Device-detected AF burden is associated with an increased risk of ischaemic stroke in a relatively unselected population of CIEDs patients. This finding may add to the basis for timely and clinically appropriate decision-making on anticoagulation treatment.
Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote ...monitoring system with daily transmissions Biotronik Home Monitoring (HM) demonstrated improved survival. We performed a patient-level analysis to verify this result with appropriate time-to-event statistics and to investigate further clinical endpoints.
Individual data of the TRUST, ECOST, and IN-TIME patients were pooled to calculate absolute risks of endpoints at 1-year follow-up for HM vs. conventional follow-up. All-cause mortality analysis involved all three trials (2405 patients). Other endpoints involved two trials, ECOST and IN-TIME (1078 patients), in which an independent blinded endpoint committee adjudicated the underlying causes of hospitalizations and deaths. The absolute risk of death at 1 year was reduced by 1.9% in the HM group (95% CI: 0.1-3.8%; P = 0.037), equivalent to a risk ratio of 0.62. Also the combined endpoint of all-cause mortality or hospitalization for worsening heart failure (WHF) was significantly reduced (by 5.6%; P = 0.007; risk ratio 0.64). The composite endpoint of all-cause mortality or cardiovascular (CV) hospitalization tended to be reduced by a similar degree (4.1%; P = 0.13; risk ratio 0.85) but without statistical significance.
In a pooled analysis of the three trials, HM reduced all-cause mortality and the composite endpoint of all-cause mortality or WHF hospitalization. The similar magnitudes of absolute risk reductions for WHF and CV endpoints suggest that the benefit of HM is driven by the prevention of heart failure exacerbation.
Stratification of patients with atrial fibrillation (AF) according to mechanistic and prognostic criteria may optimize the effectiveness and safety of catheter ablation. In women, AF is associated ...with more severe symptoms and worse prognosis.
We sought to assess sex-related differences in catheter ablation procedures and outcome in a large cohort of patients with AF.
A total of 3652 patients (1198 women 33%; 2454 men 67%) included in the German Ablation Registry were analyzed. Periprocedural parameters and outcome at 12-month follow-up were compared between male and female patients.
Women were older at the time of ablation (women: 63.6 years; men: 59.1 years; P < .0001) and exhibited a higher prevalence of paroxysmal AF (women: 72%; men: 61%; P < .0001). They were less often affected by cardiovascular disease and reduced left ventricular function. Energy application duration and overall procedure duration were shorter in women. Conversely, the rate of major inhospital complications was increased in female patients (1.9% vs 0.8%; P = .023) and mainly driven by major bleeding events. At follow-up, women experienced higher AF recurrence rates (women: 50%; men: 45%; P = .017) and more often received oral medication for rhythm and rate control. In addition, the rate of pacemaker implantation was higher in the female cohort. Women more frequently reported femoral access site complications (women: 6%; men: 3%; P < .001). Overall, male patients were more often free from AF-related symptoms and satisfied with the treatment.
Catheter ablation of AF was associated with a distinct sex-related outcome and complication profile that requires consideration in clinical practice.
Aims
This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA
2
DS
2
-VASc score parameters as ...predictors for clinical outcome.
Methods
Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily OD;
n
= 751) plus a P2Y
12
inhibitor for 12 months or a vitamin K antagonist VKA (
n
= 755) plus a P2Y
12
inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis.
Results
Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR 95% CI: 0.83 0.654–1.047). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR 95% CI): 1.06 0.711–1.587), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR (95% CI: 0.99 (0.730; 1.343). Increasing CHA
2
DS
2
-VASc score was associated with increased rates of all outcomes. CHA
2
DS
2
-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%,
p
= 0.0024).
Conclusion
After PCI in AF patients, increasing CHA
2
DS
2
-VASc score was associated with increased bleeding rates and CHA
2
DS
2
-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.
To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry.
Data from 12 566 patients who underwent catheter ablation of SVT ...between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution.
Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention.
The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of ...this therapy. Besides an assessment of the effectiveness of the therapy in specific patients groups, comparisons with pharmacological stroke prophylaxis, surgical approaches, and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies, and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.
(1) Background: Meteorological factors seem to exert various effects on human health, influencing the occurrence of diseases such as thromboembolic events and strokes. Low atmospheric pressure in ...summer may be associated with an increased likelihood of ischemic stroke. The aim of this study was to investigate the potential impact of meteorological conditions on left atrial appendage (LAA) thrombus formation. (2) Methods: A total of 131 patients were included, diagnosed with a first instance of thrombus via 3D transesophageal echocardiography (TEE) between February 2009 and February 2019. Months with frequent thrombus diagnoses of at least 10 thrombi per month were categorized as frequent months (F-months), while months with fewer than 10 thrombus diagnoses per month were labelled as non-frequent months (N-months). The analysis focused on differences in meteorological parameters in two-week and four-week periods before the diagnosis. (3) Results: F-months were predominantly observed in spring and summer (April, May, June, and July), as well as in February and November. During F-months, a higher absolute temperature difference, lower relative humidity, longer daily sunshine duration, and greater wind speed maximum were observed in the two- and four-week periods rather than for N-months. In the two-week period, average temperatures, equivalent temperatures, and temperature maxima were also significantly higher during F-months than N-months. (4) Conclusion: Thrombi in the left atrial appendage are more prevalent during periods characterized by high absolute temperature differences, low relative humidity, and long daily sunshine duration.
German Ablation Registry‐Different Energy Sources in AF Ablation
Background
Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been ...a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking.
Methods
Between January 2007 and August 2011, a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled. The cohort was divided into 2 groups according to the ablation energy source used: cryoballoon ablation (group 1, n = 905 24.0%, median age 63 years, 64.3% men) and RF ablation (group 2, n = 2870 76.0%, median age 63 years, 62.7% men). Comorbidities and baseline clinical characteristics were similar in both groups.
Results
Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo‐ (4.6%) and RF‐ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P < 0.001). Other complications were more common in RF compared to cryoablation (4.6% in RF vs 2.7% in cryo; P < 0.05).
Conclusion
RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate.
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