Antistolling en atrium fibrilleren: Consequenties voor de kwetsbare oudere, en de valrisicomythe

Atrium fibrilleren (AF) is de meest voorkomende ritmestoornis bij de mens. Incidentie neemt toe met de leeftijd, het aantal ischemische beroertes als gevolg van AF disproportioneel meer. Antistolling is om die reden een van de hoekstenen van behandeling. Gepercipieerde ernst van bloedingsrisico’s van antistolling maken echter juist dat de groep met hoogste risico, de bejaarde populatie, relatief wordt onderbehandeld. Dit artikel belicht beide risico’s voor de traditionele vitamine K antagonisten, alsook de nieuwe orale anti- coagulantia uit de families directe thrombine antagonisten en factor Xa antagonisten

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

The value of remote care in the reduction of healthcare utilization in implantable cardioverter-defibrillator patients

Background: Minimal evidence is available of the reduction in healthcare utilization of remote care in ICD patients over a longer period of follow-up. Objectives: This study compared healthcare utilization up to 3 year follow-up in implantable cardioverter-defibrillator (ICD) patients with remote care compared to conventional care. Methods: We conducted a retrospective cohort study of patients who received a single or dual-chamber ICD or cardiac resynchronization therapy-defibrillator (CRT-D) between 2016 and 2018. Patients with remote care and patients were compared with patients with received conventional care (control group). The primary endpoint was a composite of cardiac follow-up visits, ICD follow-up visits, telephone consultations, emergency department (ED) visits and hospital admissions and was defined as total healthcare utilization. The secondary endpoints were the individual care activities and one-year all-cause mortality. Results: A total of 497 patients were included in the study, of which 299 patients were allocated to the remote care and 198 patients to the control group. Mean follow-up was 815 ± 279 days. Remote care was associated with a significantly lower rate of adjusted total healthcare utilization in comparison to the control group that sustained for 3 subsequent follow-up years (IRR = 0.78, 95% CI [0.67 to 0.92], p &lt;.01). One-year all-cause mortality was similar between the remote care and control group (respectively 3.0% vs. 5.5%, p =.29). Conclusions: Compared to the standard follow-up of in-office care, a remote care program was associated with a sustained lower rate of planned and unplanned healthcare utilization up to 3 subsequent years after ICD/CRT-D implantation.</p

Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation for paroxysmal atrial fibrillation

Background - Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation. Methods and Results - Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA 2 DS 2 -VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months. Conclusions - In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times

Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation for paroxysmal atrial fibrillation

\u3cp\u3eBackground - Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation. Methods and Results - Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA 2 DS 2 -VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P&lt;0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P=0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA (P&lt;0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing &gt;50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months. Conclusions - In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times.\u3c/p\u3

New image processing and noise reduction technology allows reduction of radiation exposure in complex electrophysiologic interventions while maintaining optimal image quality : a randomized clinical trial

Background Despite their carcinogenic potential, X-rays remain indispensable for electrophysiologic (EP) procedures. Objective The purpose of this study was to evaluate the dose reduction and image quality of a novel X-ray technology using advanced image processing and dose reduction technology in an EP laboratory. Methods In this single-center, randomized, unblinded, parallel controlled trial, consecutive patients undergoing catheter ablation for complex arrhythmias were eligible. The Philips Allura FD20 system allows switching between the reference (Allura Xper) and the novel X-ray imaging technology (Allura Clarity). Primary end-point was overall procedural patient dose, expressed in dose area product (DAP) and air kerma (AK). Operator dose, procedural success, and necessity to switch to higher dose settings were secondary end-points. Results A total of 136 patients were randomly assigned to the novel imaging group (n = 68) or the reference group (n = 68). Baseline characteristics were similar, except patients in the novel imaging group were younger (58 vs 65 years,

Health insurance outcome-based purchasing:the case of hospital contracting for cardiac interventions in the Netherlands

\u3cp\u3eInnovative forms of value-based purchasing contracts, based on outcome instead of volume, are imperative to face the imminent cost crisis in health care. The objective of this study was to design and implement a model for an outcome-based purchasing contract between a hospital and a health insurance company. The model was implemented in 2015. A study cohort (n = 14,944) from patients with coronary artery disease or atrial fibrillation treated in 2014 was compared to a historical reference cohort from patients treated between 2010 and 2013. The outcome measures and the model are based on Porter's value-based healthcare principles. Improvements in outcomes were observed, leading to a financial incentive to be spent on further quality improvement. Implementation of this model is a first step towards enabling inclusion of patient-relevant outcomes in purchasing for healthcare. It aligns the focus of health insurance companies and hospitals on patient value.\u3c/p\u3

The Prognostic Role of Global Longitudinal Strain and NT-proBNP in Heart Failure Patients Receiving Cardiac Resynchronization Therapy

Background: We aimed to evaluate whether baseline GLS (global longitudinal strain), NT-proBNP, and changes in these after cardiac resynchronization therapy (CRT) can predict long-term clinical outcomes and the echocardiographic-based response to CRT (defined by 15% relative reduction in left ventricular end-systolic volume). Methods: We enrolled 143 patients with stable ischemic heart failure (HF) undergoing CRT-D implantation. NT-proBNP and echocardiography were obtained before and 6 months after. The patients were followed up (median: 58 months) for HF-related deaths and/or HF hospitalizations (primary endpoint) or HF-related deaths (secondary endpoint). Results: A total of 84 patients achieved the primary and 53 the secondary endpoint, while 104 patients were considered CRT responders and 39 non-responders. At baseline, event-free patients had higher absolute GLS values (p p p = 0.002) was beneficially associated with lower primary endpoint incidence, while baseline NT-proBNP levels (HR = 1.55; 95% CI, 1.43–2.01; p = 0.002) and diabetes presence (HR = 1.27; 95% CI, 1.12–1.98; p = 0.003) were related to higher primary endpoint incidence. Conclusions: In HF patients undergoing CRT-D, baseline GLS and NT-proBNP concentrations may serve as prognostic factors, while they may predict the echocardiographic-based response to CRT

Performance of idarucizumab as antidote of dabigatran in daily clinical practice

AIMS: Because practice-based data on the usage of idarucizumab for urgent dabigatran reversal is unavailable, we evaluated the appropriateness of idarucizumab usage, its haemostatic effectiveness and clinical outcomes. METHODS AND RESULTS: An observational cohort study was performed including consecutive patients who were treated with idarucizumab between 2016 and 2018. Appropriate usage was assessed with predefined criteria. Post-reversal effectiveness was evaluated according to International Society on Thrombosis and Haemostasis (ISTH) recommendations. Patients were followed for 90 days for occurrence of thromboembolism, (re-)bleeding and death. Idarucizumab was used in 88 patients, of whom 53 (60%) presented with severe bleeding (20 gastrointestinal and 18 intracranial) and 35 (40%) requiring urgent surgical intervention. Use of idarucizumab was judged inappropriate in 25 patients (28%). Effective haemostasis was achieved in 32 of 48 (67%) bleeding patients in whom assessment was possible. Seven of 16 patients with major bleeding who did not achieve effective haemostasis (five intracranial) died, compared with two of 32 patients with effective haemostasis (relative risk 7.0, 95% confidence interval 1.6-30). Four patients (4.2%) developed thromboembolism [2 (2.1%) within 30 days] and four patients (4.2%) re-bleeding, all within 10 days. Seventeen patients (19%) died; 10 (11%) within 5 days. CONCLUSION: In this practice-based cohort, idarucizumab use was considered inappropriate in 28% of patients. Effective haemostasis was achieved in two-third of bleeding patients and was associated with lower mortality risk. Clinical outcomes were similar to those observed in the RE-VERSE AD trial, comprising re-bleeds and thromboembolism, and a high-mortality rate