Abstract 20107: Randomized Comparison of Personalized versus Standardized Substrate Modification During Catheter Ablation for Symptomatic Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Simon Kircher ◽  
Arash Arya ◽  
David Altmann ◽  
Sascha Rolf ◽  
Andreas Bollmann ◽  
...  

Introduction: Pulmonary vein (PV) isolation forms the cornerstone of any ablation procedure for atrial fibrillation (AF). There is, however, no uniform strategy how to detect and target left atrial (LA) arrhythmogenic substrate outside the PV antra. Fibrosis that corresponds well to LA low-voltage areas (LVAs) seems to play a key role in AF arrhythmogenesis and might therefore be a suitable target for additional substrate modification (SM). Objective: The purpose of this prospective randomized study was to compare a novel technique for SM based on ablation of potentially arrhythmogenic LA LVAs with a standard approach consisting of empiric LA linear ablation. Methods: Patients (pts) with symptomatic paroxysmal or persistent AF were randomized to standard (group 1) or personalized (group 2) SM. Circumferential PV isolation was the primary step in both groups. In group 1, pre-defined linear lesions were applied at the LA roof and bottom, respectively, and at the mitral isthmus only in pts with persistent AF. In group 2, targets for SM (i.e. LVAs) were identified by detailed bipolar voltage mapping (BVM) during sinus rhythm irrespective of AF type. Peak-to-peak electrogram amplitudes were defined as “normal” (> 0.5 mV), as “low voltages” (0.2 to 0.5 mV), or as “scar” (< 0.2 mV). LVAs were targeted by tissue homogenization and / or strategic linear lesions. The primary endpoint was freedom from any atrial arrhythmia (i.e. AF, atrial flutter, or atrial tachycardia) > 30 seconds off antiarrhythmic drugs on serial 7-d-Holter ECG recordings after a follow-up period of 12 months. Results: In total, 124 ablation-naïve pts (mean age 63 ± 9 years, 62 % male, 49 % with persistent AF) were enrolled in this study. LVAs were present in 18 % of pts with paroxysmal and in 41 % of pts with persistent AF (p<0.05). At the end of the follow-up period, 25 out of 59 pts (42 %) in the conventional group were free from arrhythmia recurrence as compared to 40 out of 59 pts (68 %) in the BVM-guided group (unadjusted log rank p = 0.003). Conclusion: Personalized SM guided by endocardial BVM is associated with a higher success rate compared to a conventional approach applying empirical SM based on AF phenotype.

2003 ◽  
Vol 61 (3A) ◽  
pp. 566-573 ◽  
Author(s):  
Tânia A.M.O. Cardoso ◽  
Fernando Cendes ◽  
Carlos A.M. Guerreiro

OBJECTIVE: To investigate the value of leaving seizure-free patients on low-dose medication. METHOD: This was an exploratory prospective randomized study conducted at our University Hospital. We evaluated the frequency of seizure recurrence and its risk factors following complete or partial antiepileptic drug (AED) withdrawal in seizure free patients for at least two years with focal, secondarily generalized and undetermined generalized epilepsies. For this reason, patients were divided into two groups: Group 1 (complete AED withdrawal), and Group 2 (partial AED withdrawal). Partial AED withdrawal was established as a reduction of 50% of the initial dose. Medication was tapered off slowly on both groups. Follow-up period was 24 months. RESULTS: Ninety-four patients were followed up: 45 were assigned to complete (Group 1) AED withdrawal and 49 to partial (Group 2) AED withdrawal. Seizure recurrence frequency after two years follow-up were 34.04% in group 1 and 32.69% in Group 2. Survival analysis showed that the probability of remaining seizure free at 6, 12, 18 and 24 months after randomization did not differ between the two groups (p = 0.8). Group 1: 0.89, 0.80, 0.71 and 0.69; group 2: 0.86, 0.82, 0.75 and 0.71. The analysis of risk factors for seizure recurrence showed that more than 10 seizures prior to seizure control was a significant predictive factor for recurrence after AED withdrawal (hazard ratio = 2.73). CONCLUSION: Leaving seizure free patients on low AED dose did not reduce the risk for seizure recurrence. That is, once the decision of AED withdrawal has been established, it should be complete.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Weiss ◽  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
...  

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), and available routine care data have so far broadly confirmed the safety of different NOACs in routine practice. However, such data for edoxaban are scarce, especially in extremely low and high body weight (BW). These extreme BWs may affect the bioavailability, distribution, and half-life of NOACs and, consequently, outcomes of treatment. Methods We analysed outcomes in normal-weight (BMI 18.5–25) vs overweight (BMI 25–30) and obese (BMI >30) patients enrolled into the ETNA-AF-Europe observational study (NCT02944019) collecting information on patients treated with edoxaban in 825 sites in 10 European countries. This snapshot analysis set includes data of 7,672 patients (56.3% of all enrolled patients) which have completed their 1-year follow-up visit (mean follow-up: 343.5 days). Results Median patient age was 74 years for all patients, 76 years for patients with a BMI 18.5–25 (group 1), 75 years for patients with BMI 25–30 (group 2), and 72 for patients with a BMI >30 (group 3). CrCl was 64 mL/min for patients with a BMI 18.5–25, 68 mL/min for patients with BMI 25–30, and 72 mL/min for patients with a BMI >30. The CHA2DS2-VASc (mean 3.1±1.38) and HAS-BLED (mean 2.5±1.10) score did not differ significantly between groups. As expected, diabetes and hypertension were significantly less prevalent in leaner patients and - accordingly - inversely correlated to age. There was no correlation between body weight and life-threatening bleeding (group 1: 0.28%; group 2: 0.40%; group 3: 0.14%). Also, stroke rates (group 1: 0.74%; group 2: 0.81%; group 3: 0.76%) did not differ between groups. Conclusion BMI, within the range here assessed, does not affect 1-year outcomes in European AF patients treated with edoxaban. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany


2003 ◽  
Vol 13 (3) ◽  
pp. 142-147 ◽  
Author(s):  
K.G. Freund ◽  
S. Houshian ◽  
P. Riegels-Nielsen

The aim of this prospective and randomised study was to test the ability of two different femoral plugs to seal off the femoral canal to prevent cement leakage, displacement of the restrictor and early aseptic loosening. Seventy patients, 35 in each of two groups, were included. There were 31 men and 39 women. The average age was 70 years; the follow-up was two years. In group 1 (the Exeter plug) there were four cases with cement leakage and in group 2 there were three (the DePuy plug). There were four cases with failures in group 1, due to technical failure peroperatively, and none in group 2. Two cases with early mechanical loosening were found in group 1 and none in group 2. Both restrictors were found equivalent in their ability to occlude the femoral canal but peroperatively there seem to be technical difficulties with the Exeter restrictor.


2021 ◽  
Vol 8 ◽  
Author(s):  
Zi-liang Song ◽  
Shao-hui Wu ◽  
Dao-liang Zhang ◽  
Wei-feng Jiang ◽  
Mu Qin ◽  
...  

Objectives: To evaluate the clinical safety and efficacy of radiofrequency catheter ablation for atrial fibrillation patients with a history of stroke.Methods and Results: A total of 116 symptomatic, drug-refractory AF patients with a history of stroke, and 1:2 matched patients without a history of stroke were enrolled. Of these, 28 cases occurred stroke within 3 months (Group 1), 88 cases with stroke history longer than 3 months (Group 2), and 232 cases without stroke (Group 3). PVI was performed in all patients, extended to ablation of linear lesions ablation. The periprocedural stroke rates and other procedure-related in-hospital complications did not differ significantly among the three groups. The maintenance rate of SR after the procedure showed no significant difference (p = 0.333), 52.7, 66.4, and 70.7% in Group 1, 2, and 3, respectively. Furthermore, the comparison between a history of stroke and those without it were also shown no significant difference (p = 0.351).Conclusions: Radiofrequency ablation for AF patients occurred stroke, even within 3 months is safe and effective, without higher periprocedural complication rate and recurrence rate.


2020 ◽  
Vol 27 (1) ◽  
pp. 30-33
Author(s):  
S. A. Vachev ◽  
S. V. Koroljov ◽  
A. S. Zotov ◽  
R. I. Khabazov ◽  
R. I. Troitsky

Objective. To improve the results of treatment for the patients with non-paroxysmal atrial fibrillation (AF) in combination with isthmus-dependent (typical) atrial flutter (AFL) by determining the optimal surgical tactics.Material and methods. The research based on the study of treatment results for 37 patients who are consequentially underwent thoracoscopic radiofrequency fragmentation (TRF) of the left atrium (LA) in the period from April 2017 to December 2019. All of the patients suffered from a combination of 2 types of arrhythmias: non-paroxysmal AF and AFL. Depending on history of catheter ablation (CA) of cavotricuspid isthmus (CTI) before TRF, all patients divided into 2 groups: group 1 - there was anamnesis of CA of CTI before TRF (N = 16; 43%); group 2 - there was no CA of CTI before TRF of the LA (N = 21; 57%). In the postoperative period, all patients underwent examination and interviewed regarding cardiac arrhythmias. At the time of April 1, 2020, information about heart rhythm and its disorders during follow-up period was received from 100% of patients. The duration of the follow-up period after TRF was 17 (3; 35) months.Results. There was no supraventricular tachyarrhythmias (SVT) during all follow-up period after TRF among the patients of group 1. There was 8 patients (38%) of group 2 with AFL, which is developed in the period from 1 to 6 months after TRF. All these patients underwent a CA of CTI after the end of a “blanking” period. There was 2 of 8 patients with developing of SVT after CA of CTI. The source of new rhythm disorder was the ablation line formed during TRF on the roof of the LA.Conclusion. In order to achieve long-term freedom from SVT requiring surgical intervention in patients suffering from a non-paroxysmal AF in combination with a typical AFL it is reasonable to perform catheter radiofrequency ablation of CTI at the first stage before TFR of the LA.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4045-4045
Author(s):  
Patricia Casais

Abstract Introduction: Our objectives were to investigate if aging is an independent risk factor for major bleeding during oral anticoagulant treatment (OAT) for atrial fibrillation (AF). Patients and Methods: An inception cohort study was designed to include patients (pts) referred to our Department to initiate OAT due to AF from July 2000 to July 2007. Inclusion criteria: no prior OAT, AF being the only reason to OAT, follow-up at our Institution, and signed informed consent. Exclusion criteria: concomitant reason for OAT, and pts refusal to participate. Pts were followed until OAT was stopped by the patient’s cardiologist or until July 2007. Patients who underwent a successful electric cardioversion and were followed up only for 4 weeks were not included unless they presented a bleeding episode. Epidemiological and clinical data were documented for all patients. Major bleeding episodes, age, time on OAT, and INR at the bleeding event were recorded. Deaths were registered and classified as “related” or “not related” to OAT. For the analysis, the inception cohort was divided into three groups according to the age of beginning and ending of OAT. Group 1 included patients younger than 77 at the end of OAT. Group 2 was constituted by the patients that initiated therapy before 80 and were followed after that age. Patients starting after 80 years of age were the group 3. Time in therapeutic range and INR variability were calculated. Incidence rate and relative risk (RR) of major hemorrhage (MH) was estimated. Results: During the study period, 2.971 patients were referred for initiation of OAT, 40% (1.172) had AF, and 671 met the exclusion criteria (138 patients had a prior OAT, 111 were not going to go on control OAT at the Institution, and 422 had a concomitant reason for OAT (mitral estenosis, heart valve prostheses, venous thrombosis, coronary artery by-pass, etc.) Five-hundred and one patients were included in the study, 68 (13.5%) were lost for follow-up after inclusion or had less than 4 weeks after initiation, and 433 had complete follow-up. Patients’ characteristics and MH are shown in Table 1. Time within therapeutic range was similar in all age-groups (65.0%, 62.8%, and 65.4% for group 1, 2 and 3, respectively). There were 28 MH in 23 pts during the study period. In group 3, the rate of MH was 3.39/100 patient-years while in group 1 it was 0.85/100 patient-years. The RR was 3.0 (1.2–7.6 95%CI) in group 3 compared to group 1(p= 0.02). Among patients in group 2, the RR of bleeding increased to 5.8 (2.27–14.95) after the age of 80. The likelihood ratio of MH with increasing age was 14.1 (p= 0.001). INR variability tended to be higher in Group 3 and in bleeding patients regardless their age. Aspirin, number of concomitant medications and CHADS2 score were not associated with the risk of MH. There were 10 deaths, all in pts older than 80. In 9/10 the cause of death was documented and was unrelated to OAT. One patient died after a non-characterized stroke, it was considered hemorrhagic. Rate of death related to bleeding after age of 80 (groups 2 and 3) was 0.54%. Conclusions: This long-term follow up cohort study shows that aging is an independent risk factor for MH; this observation might have clinical implications for the management of elderly pts. Table 1: Patients’ characteristics Group 1 Group 2 Group 3 N 249 55 129 * 8/9 events after the age of 80. Sex Female (%)&#x2028; Male (%) 55 (49.5)&#x2028; 56 (50.0) 29 (54)&#x2028; 25 (46) 69 (55)&#x2028; 57 (45) Age at beginning OAT mean± SD 63.9±8.4 74.9 ± 2.0 82.8 ± 2.7 Age at ending OAT mean± SD 68.7±7.9 81.3 ± 1.4 85.7 ± 3.1 Follow-up (years) mean± SD 5.2±0.2 4.5 ±0.3 2.5 ± 0.1 Prior ischemic stroke N (%) 15 (13.5) 9 (17) 28 (22) Deaths N (%) 0 1 (2) 9 (7%) Major hemorrhages Events (pts) 8 (7) 9 (8)* 11 (8) Mean age (years) 68.4 ± 2.6 79.7 ± 0.5 83.0 ± 0.8 Mean Time on OAT (weeks± SE) 32.1±8 142.2 ± 28.6 77.8 ± 22.5 Mean INR ±SE at 3.9 ± 0.7 3.5 ± 1.0 3.6 ± 0.5 1st event (range) (2.6–8.2) (2.0–10.8) (1.6–6.0)


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Seliutskii ◽  
N Savina ◽  
A Chapurnykh

Abstract Background radiofrequency ablation (RFA) is considered to be one of the most preferred treatments for atrial fibrillation (AFib) in patients with heart failure (HF). Objective to study the effectiveness of AFib RFA in patients with HF, to compare the effectiveness of the procedure in patients with paroxysmal (PaAFib) and persistent (PeAFib) AFib. Materials and methods 65 patients with AF and HF with LVEF &lt; 50%, who underwent RFA were included in a prospective study. All patients underwent transthoracic echocardiography and quality of life assessment using the SF-36 questionnaire before RFA and after 12 months. AFib was recorded in 42 (65%) of patients, AFL in 23 (35%). Thirty (46%) patients had PaAfib (Group 1), and 35 (54%) PeAFib (Group 2). Results In 45 (69%) patients sinus rhythm (SR) was restored during RFA, in 15 (23%) SR was restored by electrical cardioversion. In 5 (8%) patients with PaAFib revealed SR at the time of RFA. Twelve month follow-up period revealed 49 (75%) patients who were free from AFib: 23 (77%) patients with PaAFib and 26 (74%) with PeAFib. After 12 month follow-up we revealed the improvement in LVEF (p &lt; 0.001 in both groups), decrease of anteroposterior size of left atrium (LA) (p &lt; 0.001 in both groups) and LA volume (p &lt; 0.001 in both groups), improvement in the mental (p = 0.008 in Group 1; p = 0.006 in Group 2) and physical component of health according to the SF-36 questionnaire (p = 0.036 in Group 1; p = 0.049 in Group 2). There were no significant differences between two groups of follow-up period. Conclusions AFib RFA significantly improves the course of heart failure and the quality of life of patients, leads to decrease of left atrium size and increase of LVEF. The effectiveness of RFA does not depend on the type of arrhythmia in  HF patients.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Ikeda ◽  
M Iguchi ◽  
H Ogawa ◽  
K Ishigami ◽  
Y Aono ◽  
...  

Abstract Background Previous studies have suggested that proteinuria is independently associated with clinical outcomes in diabetic patients, irrespective of the presence of renal dysfunction. However, data regarding the impact of proteinuria on clinical outcomes in diabetic patients with atrial fibrillation (AF) are limited. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city in Japan. Follow-up data were available in 4,454 patients, and 634 diabetic patients with available data of proteinuria and estimated glomerular filtration rate (eGFR) were examined. We compared the clinical background and outcomes between patients with proteinuria (n=251) and those without (n=383). Then, we divided the patients into 4 subgroups according to the presence of proteinuria and renal dysfunction, and compared the clinical outcomes between groups; group 1 (without proteinuria, eGFR ≥60 ml/min/1.73 m2; n=203), group 2 (with proteinuria, eGFR ≥60; n=96), group 3 (without proteinuria, eGFR <60; n=180), group 4 (with proteinuria, eGFR <60; n=155). Results Age was comparable between patients with or without proteinuria. Patients with proteinuria had higher prevalences of previous heart failure (HF), stroke/systemic embolism, hypertension and renal dysfunction. The prevalences of previous myocardial infarction, and major bleeding were similar between two groups. During the median follow-up of 1,505 days, the incidence rates of HF hospitalization (4.1/100 person-years vs. 2.5/100 person-years; p<0.01) and cardiovascular death (1.8/100 person-years vs. 0.4/100 person-years; p<0.01) were higher in patients with proteinuria. When we divided patients into 4 subgroups, the incidences of HF hospitalization (group 1: 1.8/100 person-years vs. group 2: 3.4/100 person-years vs. group 3: 3.8/100 person-years vs. group 4: 4.9/100 person-years; p<0.01) and cardiovascular death (group 1: 0.3/100 person-years vs. group 2: 1.8/100 person-years vs. group 3: 0.5/100 person-years vs. group 4: 2.2/100 person-years; p<0.01) tended to be higher in not only group 3 and group 4 but also group 2 than group 1 (Figure). Multivariate Cox proportional hazards regression analysis including female gender, age (≥75 years), hypertension, pre-existing HF, renal dysfunction (eGFR <60),low left ventricular ejection fraction (<40%) and proteinuria revealed that proteinuria was an independent determinant of both of HF hospitalization (adjusted hazard ratio [HR]: 1.57, 95% confidence interval [CI]: 1.05–2.34) and cardiovascular death (HR: 3.76, 95% CI: 1.59–8.88). Figure 1 Conclusion In Japanese diabetic patients with AF, proteinuria was associated with higher incidences of HF hospitalization and cardiovascular death, irrespective of the presence of renal dysfunction.


2019 ◽  
Vol 2019 ◽  
pp. 1-10
Author(s):  
Xue-Rong Sun ◽  
Ying Tian ◽  
Ashok Shah ◽  
Xian-Dong Yin ◽  
Liang Shi ◽  
...  

Background. In patients with persistent atrial fibrillation (AF), the procedural and clinical outcomes of ablation combined with infusion of antiarrhythmic drug are unknown. Objectives. To determine the impact of low-dose ibutilide after circumferential pulmonary vein isolation (CPVI) and/or left atrial (LA) substrate modification on acute procedural and clinical outcome of persistent AF. Methods. In a prospective cohort of 135 consecutive patients with persistent AF, intravenous 0.25 mg ibutilide was administered 3 days before the procedure and intraprocedurally, if required, after CPVI and/or additional LA substrate modification of sites with continuous, rapid or fractionated, and low-voltage (0.05–0.3 mv) atrial activity. Results. Persistent AF was terminated by CPVI alone (n=15) or CPVI + ibutilide (n=32) in 47 (34.8%) patients (CPVI responders). Additional LA substrate modification without (n=33) or with subsequent administration of 0.25 mg ibutilide (n=19) terminated AF in another 52 (38.5%) patients (substrate modification responders). Sinus rhythm was restored by electrical cardioversion in the remaining 36 (26.7%) patients (nonresponders). The mean LA substrate ablation time was 14 ± 6 minutes. At follow-up of 24 ± 10 months, the rates of freedom from atrial tachyarrhythmias among the responders in CPVI and substrate modification groups were mutually comparable (66.0% and 69.2%) and higher than among the nonresponders (36.1%; P<0.01). Among the responders, there was no difference in clinical outcome between patients whose persistent AF was terminated without or with low-dose ibutilide. Conclusion. Administration of low-dose ibutilide during ablation of persistent AF may allow select patients wherein substrate ablation is not or minimally required to optimize procedural and clinical outcomes.


2021 ◽  
Vol 20 (3) ◽  
pp. 2714
Author(s):  
M. A. Kirgizova ◽  
G. M. Savenkova ◽  
I. O. Kurlov ◽  
S. N. Krivolapov ◽  
R. E. Batalov ◽  
...  

Aim. To study the efficacy and safety of direct oral anticoagulant (DOAC) therapy after implantation of cardiac resynchronization therapy (CRT) devices in atrial fibrillation (AF) patients with coronary artery disease (CAD) and dilated cardiomyopathy (DCM).Material and methods. The study included 93 patients followed up from 2014 to 2016 (71 men and 22 women) aged 33-85 years (59,7±10,6) with stable CAD (group 1, n=44) and DCM (group 2, n=49). All patients were diagnosed with AF. The left ventricular ejection fraction (LVEF) was 30,6±3,8%; the left ventricular end-diastolic dimension was 230,9±60,8 mm. All patients received anticoagulants for the prevention of thromboembolic events: a vitamin K antagonist (warfarin) or DOAC. The analysis of medical records, as well as ECG records, echocardiographic, 24-hour ECG monitoring data and information from implanted device was carried out. The follow-up period lasted 24 months.Results. After 24-month follow-up, positive dynamics was noted in all patients — LVEF increased from 30,6±3,7% to 39,5±5,8%). In patients with DCM, a more pronounced increase in myocardial contractile function was noted. Stroke within time interval from 12 to 24 months developed in two patients taking warfarin, from different groups. Transient ischemic attacks were observed in 6 patients: in one patient from group 1 during the period from inclusion and 12-month visit, and in 5 patients from 12 to 24 months. Out of 5 patients, two belonged to group 1 and three — to group 2, while one patient took aspirin and the other 4 — warfarin. One patient from group 1 with persistent AF and vitamin K antagonist therapy had left atrial appendage thrombosis. Hemorrhagic strokes and major bleeding have not been reported.Conclusion. Among patients taking DOAC, regardless of the underlying disease (CAD or DCM) and response to CRT, bleeding events were less often recorded, and there were no thromboembolic events.


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