BACKGROUND: Implementation of the Atrial fibrillation Better Care (ABC) pathway is recommended by guidelines on atrial fibrillation (AF), but the impact of adherence to ABC pathway in patients with cancer is unknown. OBJECTIVES: To investigate the adherence to ABC pathway and its impact on adverse outcomes in AF patients with cancer. METHODS: Patients enrolled in the EORP-AF General Long-Term Registry were analyzed according to (i) No Cancer; and (ii) Prior or active cancer and stratified in relation to adherence to the ABC pathway. The composite Net Clinical Outcome (NCO) of all-cause death, major adverse cardiovascular events and major bleeding was the primary endpoint. RESULTS: Among 6550 patients (median age 69 years, females 40.1%), 6005 (91.7%) had no cancer, while 545 (8.3%) had a diagnosis of active or prior cancer at baseline, with the proportions of full adherence to ABC pathway of 30.6% and 25.7%, respectively. Adherence to the ABC pathway was associated with a significantly lower occurrence of the primary outcome vs. non-adherence, both in 'no cancer' and 'cancer' patients [adjusted Hazard Ratio (aHR) 0.78, 95% confidence interval (CI): 0.66-0.92 and aHR 0.59, 95% CI 0.37-0.96, respectively]. Adherence to a higher number of ABC criteria was associated with a lower risk of the primary outcome, being lowest when 3 ABC criteria were fulfilled (no cancer: aHR 0.54, 95%CI: 0.36-0.81; with cancer: aHR 0.32, 95% CI 0.13-0.78). CONCLUSION: In AF patients with cancer enrolled in the EORP-AF General Long-Term Registry, adherence to ABC pathway was sub-optimal. Full adherence to ABC-pathway was associated with a lower risk of adverse events.
- MeSH
- Anticoagulants adverse effects MeSH
- Stroke * epidemiology MeSH
- Atrial Fibrillation * epidemiology MeSH
- Hemorrhage chemically induced MeSH
- Humans MeSH
- Neoplasms * complications MeSH
- Registries MeSH
- Risk Factors MeSH
- Aged MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (P=0.012). There were no Moderato device- or CNT-related adverse events. Conclusions CNT significantly reduced 24-hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02837445.
- MeSH
- Time Factors MeSH
- Double-Blind Method MeSH
- Ventricular Function, Left MeSH
- Hypertension diagnosis physiopathology therapy MeSH
- Cardiac Pacing, Artificial * adverse effects MeSH
- Pacemaker, Artificial * MeSH
- Blood Pressure * MeSH
- Humans MeSH
- Pilot Projects MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart innervation MeSH
- Heart Rate * MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Europe MeSH
AIM: The purpose of this study was to compare sex differences of atrial fibrillation (AF) catheter ablation (CA) and to analyse the opportunities for improved outcomes. METHODS AND RESULTS: All data were collected from the Atrial Fibrillation Ablation Long-Term registry, a prospective, multinational study conducted by the ESC-EORP European Heart Rhythm Association (EHRA) under the EURObservational Research Programme (ESC-EORP). A total of 104 centres in 27 European countries participated. Of 3593 included patients, 1146 (31.9%) were female. Female patients were older (61.0 vs. 56.4 years; P < 0.001), had more comorbidities (hypertension, diabetes, and obesity), more episodes of arrhythmias per month (6.9 vs. 6.2; P < 0.001), and a higher average EHRA score (2.6 vs. 2.4; P < 0.001). The duration of the procedure was shorter in females (160.1 min vs. 167.9 min; P < 0.001), irrespective of additional ablation lesions added to pulmonary vein isolation. Overall cardiovascular complications were more frequent in women than in men (5.7% vs. 3.4%; P < 0.001). Furthermore, cardiac perforations (3.8% vs. 1.3%; P = 0.011) and neurological complications (2.2% vs. 0.3%; P = 0.004) were found in females in less experienced centres than in experienced ones. On a final note, at 12 months, AF recurrence rate was similar in females and males (34.4% vs. 34.2%; P = 0.897), but more females were still on antiarrhythmic drugs (50.6% vs. 44.1%; P < 0.001) when compared with men. CONCLUSION: Females underwent CA procedures for AF less frequently than males throughout Europe, despite more recurrent symptoms. With the same success rate, severe acute complications remained considerable in females, especially in less experienced centres.
- MeSH
- Atrial Fibrillation * diagnosis epidemiology surgery MeSH
- Catheter Ablation * adverse effects MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Hospitals MeSH
- Sex Characteristics MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Registries MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Europe MeSH
OBJECTIVES: The ASD2 (Acute Extravascular Defibrillation, Pacing, and Electrogram) study evaluated the ability to adequately sense, pace, and defibrillate patients with a novel implantable cardioverter-defibrillator (ICD) lead implanted in the substernal space. BACKGROUND: Subcutaneous ICDs are an alternative to a transvenous defibrillator system when transvenous implantation is not possible or desired. An alternative extravascular system placing a lead under the sternum has the potential to reduce defibrillation energy and the ability to deliver pacing therapies. METHODS: An investigational lead was inserted into the substernal space via a minimally invasive subxiphoid access, and a cutaneous defibrillation patch or subcutaneous active can emulator was placed on the left mid-axillary line. Pacing thresholds and extracardiac stimulation were evaluated. Up to 2 episodes of ventricular fibrillation were induced to test defibrillation efficacy. RESULTS: The substernal lead was implanted in 79 patients, with a median implantation time of 12.0 ± 9.0 min. Ventricular pacing was successful in at least 1 vector in 76 of 78 patients (97.4%), and 72 of 78 (92.3%) patients had capture in ≥1 vector with no extracardiac stimulation. A 30-J shock successfully terminated 104 of 128 episodes (81.3%) of ventricular fibrillation in 69 patients. There were 7 adverse events in 6 patients causally (n = 5) or possibly (n = 2) related to the ASD2 procedure. CONCLUSIONS: The ASD2 study demonstrated the ability to pace, sense, and defibrillate using a lead designed specifically for the substernal space.
- MeSH
- Defibrillators, Implantable * adverse effects statistics & numerical data MeSH
- Electrocardiography MeSH
- Prosthesis Implantation adverse effects methods mortality statistics & numerical data MeSH
- Cardiac Pacing, Artificial * adverse effects statistics & numerical data MeSH
- Middle Aged MeSH
- Humans MeSH
- Mediastinum surgery MeSH
- Prospective Studies MeSH
- Aged MeSH
- Arrhythmias, Cardiac therapy MeSH
- Sternum surgery MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Study MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
Hybridní ablace (hybrid ablation, HABL) fibrilace síní jako kombinace endoskopické, minimálně invazivní, epikardiální ablace při zavřeném hrudníku spolu s přesností endokardiální metody vedené systémem CARTO byla zavedena ve snaze překonat limitace současných možností léčby pacientů s perzistující fibrilací síní (persistent atrial firbrillation, PSAF) a dlouhodobě perzistující fibrilací síní (long-standing persistent atrial fibrillation, LSPAF). Smyslem toho monocentrického, prospektivního klinického registru bylo zhodnotit bezpečnost a proveditelnost i účinnost HABL u pacientů s PSAF a LSPAF jeden rok po výkonu. V období od července 2009 do prosince 2014 byla HABL provedena celkem u devadesáti (n = 90) pacientů (PSAF, n = 39 a LSPAF, n = 51). Průměrná délka incidence fibrilace síní byla 4,5 ± 3,7 roku. Šest měsíců po ablaci bylo 78 % pacientů v sinusovém rytmu. Dvanáct měsíců po výkonu bylo v sinusovém rytmu 86 % pacientů a 62,3 % v sinusovém rytmu bez podávání antiarytmik skupin I/III. Na základě těchto výsledků lze usuzovat, že u pacientů s perzistující a dlouhodobě perzistující fibrilací síní je třeba uvažovat o kombinaci epikardiální a endokardiální radiofrekvenční ablace, protože se jedná a bezpečnou a účinnou metodu obnovy sinusového rytmu.
The hybrid ablation (HABL) of atrial fibrillation which combines endoscopic, minimally invasive, closed chest epicardial ablation with endocardial CARTO-guided accuracy was introduced to overcome limitations of current therapeutic options for patients with persistent (PSAF) and long-standing persistent atrial fibrillation (LSPAF). The purpose of this single-centre, prospective clinical registry was to evaluate procedural safety and feasibility as well as effectiveness of the HABL in patients with PSAF and LSPAF 1-year post-procedure. From July 2009 to December 2014, ninety (n = 90) patients with PSAF (n = 39) and LSPAF (n = 51) underwent HABL. Mean AF duration was 4.5 ± 3.7 years. At 6 months post-procedure 78% patients were in SR. At 12 months post-procedure 86% patients were in SR and 62.3% in SR and of class I/III AADs. These results suggest that combination of epicardial and endocardial RF ablation should be considered as a treatment option for patients with persistent and long-standing persistent atrial fibrillation as it is safe and effective in restoring sinus rhythm.
- MeSH
- Ablation Techniques methods MeSH
- Atrial Fibrillation * surgery MeSH
- Cardiovascular Surgical Procedures methods MeSH
- Catheter Ablation methods instrumentation MeSH
- Combined Modality Therapy methods MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures methods MeSH
- Prospective Studies MeSH
- Severity of Illness Index MeSH
- Pulmonary Veins surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse how centres assess in routine clinical practice the success of the procedure and to evaluate the success rate and long-term safety/complications. METHODS AND RESULTS: Seventy-two centres in 10 European countries were asked to enrol 20 consecutive patients undergoing a first AFib ablation procedure. A web-based case report form captured information on pre-procedural, procedural, and 1-year follow-up data. Between October 2010 and May 2011, 1410 patients were included and 1391 underwent an AFib ablation (98.7%). A total of 1300 patients (93.5%) completed a follow-up control 367 ± 42 days after the procedure. Arrhythmia documentation was done by an electrocardiogram in 76%, Holter-monitoring in 52%, transtelephonic monitoring in 8%, and/or implanted systems in 4.5%. Over 50% became asymptomatic. Twenty-one per cent were re-admitted due to post-ablation arrhythmias. Success without antiarrhythmic drugs was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib in a real-world setting. The methods used to assess the success of the procedure appeared at least suboptimal. Even in this context, the 12-month success rate appears to be somewhat lower to the one reported clinical trials.
- MeSH
- Anti-Arrhythmia Agents therapeutic use MeSH
- Electrocardiography MeSH
- Atrial Fibrillation diagnosis mortality surgery MeSH
- Kaplan-Meier Estimate MeSH
- Catheter Ablation methods mortality MeSH
- Humans MeSH
- Pilot Projects MeSH
- Postoperative Care methods mortality MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Treatment Outcome MeSH
- Patient Readmission statistics & numerical data MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
