Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial

EP Europace ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. 1487-1494 ◽  
Author(s):  
Katharina Schoene ◽  
Arash Arya ◽  
Friederike Grashoff ◽  
Helge Knopp ◽  
Alexander Weber ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Energy Levels ◽  
Randomized Study ◽  
Posterior Wall ◽  
Drop Out ◽  
Peak Temperature ◽  
Drop Out Rate ◽  
Higher Power

Abstract Aims The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes. Methods and results Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA− group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA−. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA− (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA− required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3–13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541. Conclusion This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure.

scholarly journals High-power short-duration radiofrequency ablation for atrial fibrillation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
K Kassa ◽  
Z Nagy ◽  
B Kesoi ◽  
Z Som ◽  
C Foldesi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Short Duration ◽  
Contact Force ◽  
High Power ◽  
Posterior Wall ◽  
Pericardial Tamponade ◽  
Fluoroscopy Time ◽  
Control Group

Abstract Funding Acknowledgements Type of funding sources: None. Introduction In recent times, high-power short-duration (HPSD) radiofrequency ablation (RFA) has emerged as an alternative strategy for pulmonary vein isolation (PVI) in atrial fibrillation (AF). Purpose We aimed to compare HPSD approach and conventional, ablation-index (AI) guided PVI using contact force sensing ablation catheters in respect of efficacy, safety, procedural characteristics, and outcome. Methods A total of 184 consecutive AF patients with first PVI were enrolled (age: 60 ± 11 years, paroxysmal: 56.5%, persistent: 43.5%) between November 2016 and December 2019. An ablation protocol of 50W energy with 15-20 g contact force was used for a duration of 8-12 sec based on the loss of capture concept in the HPSD group (n = 91) meanwhile, PVI was achieved according to the conventional power settings (posterior wall 25W, AI: 400, anterior wall 35W, AI: 550 ) in the control group (n = 93). During 1-year follow-up, documented AF for more than 30 seconds was considered as recurrence. Results Radiofrequency time and procedural time were significantly shorter using HPSD ablation (26.0 ± 12.7 min vs. 42.9 ± 12.6 min, p < 0.001, and 91 ± 30.1 min vs. 105.3 ± 28 min, p < 0.001). The HPSD strategy significantly lowered fluoroscopy time and radiation dose (5.47 ± 4.07 min vs. 8.15 ± 10.04 min, p = 0.019, and 430.2 ± 534.06 cGycm2 vs. 604.2 ± 633.9 cGycm2, p = 0.046). The HPSD group showed significantly less arrhythmia recurrence during 1-year follow-up with 76.9% of patients free from AF compared to 66.7% in the control group (p = 0.037). No pericardial tamponade, periprocedural thromboembolic complication, or atrio-oesophageal fistula occurred in the HPSD group. We observed 2 pericardial tamponade and 1 periprocedural stroke in the control group. Conclusions HPSD RFA for AF was demonstrated to be safe, and lead to significantly improved 1-year outcome in our mixed patient population. HPSD protocol significantly shortened procedural and radiofrequency time with decreased fluoroscopy time and radiation exposure.

scholarly journals Interruzione del trattamento nei pazienti con schizofrenia che ricevono olanzapina o aripiprazolo: metanalisi degli studi clinici controllati

2005 ◽  
Vol 6 (1) ◽  
pp. 69-76
Author(s):  
Benedetta Santarlasci ◽  
Giovanni Biricolti ◽  
Cecilia Orsi
Keyword(s):  
Treatment Group ◽  
Literature Search ◽  
Drop Out ◽  
Inclusion Criteria ◽  
Antipsychotic Therapy ◽  
Therapy Discontinuation ◽  
Randomized Controlled ◽  
Drop Out Rate ◽  
Number Of Patients

BACKGROUND: In schizophrenia the drop-out rate can be used as proxy of effectiveness. The drop-out evaluation is also important considering the relevant economic impact for NHS of an antipsychotic therapy discontinuation in terms of patient hospitalization and other related healthcare resources consumption. OBJECTIVE: To analyze the differences in the rates of drop-out from clinical trials between olanzapine and aripiprazole. METHODS: Literature search was based on MEDLINE, on Iowa-IDIS and Drugdex databases (1966-Dec 2004). Analysis included 12 randomized controlled trials (3.778 patients), 8 for olanzapine (2.559 patients) and 4 for aripiprazole (1.219 patients). RCT inclusion criteria were: a) Patients affected by schizophrenia; b) Randomized assignment to olanzapine or aripiprazole treatment group; c) Number of patients included in the treatment group higher than 100; d) Drop-out frequency evaluation between 4th and 26th weeks of follow-up. RESULTS: The rate of treatment discontinuation was greater for aripiprazole than for olanzapine (42,2% vs. 31,6% respectively). The comparison between drop-out percentages is statistically significant (p

scholarly journals Radiofrequency Ablation versus Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation: A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Ali H. Hachem ◽  
Joseph E. Marine ◽  
Housam A. Tahboub ◽  
Sana Kamdar ◽  
Shaffi Kanjwal ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Meta Analysis ◽  
Fluoroscopy Time ◽  
Radiofrequency Energy ◽  
Cryoballoon Ablation ◽  
Complication Rates ◽  
Ablation Time ◽  
Significant Difference

Background. Pulmonary vein isolation is commonly performed using radiofrequency energy with cryoablation gaining acceptance. We performed a meta-analysis of randomized controlled trials which compared radiofrequency versus cryoablation for patients with atrial fibrillation. Methods. A systematic search strategy identified both published and unpublished articles from inception to November 10, 2016, in multiple databases. The primary outcomes for this meta-analysis were long-term freedom from atrial fibrillation at 12-month follow-up and overall postoperative complication rates. For all included studies, the methodological quality was assessed through the Cochrane Collaboration’s tool for risk of bias. Results. A total of 247 articles were identified with eight being included in this review as they satisfied the prespecified inclusion criteria. Overall, there was no significant difference in freedom from atrial fibrillation at ≥12-month follow-up between those receiving cryoballoon and radiofrequency ablation, respectively (OR = 0.98, CI = 0.67–1.43, I2 = 56%, p=0.90). Additionally, the secondary outcomes of duration of ablation, fluoroscopy time, and ablation time failed to reach significance. Cryoballoon ablation had significantly greater odds of postoperative phrenic nerve injury at 12-month follow-up. Conclusions. Our meta-analysis suggests that cryoballoon ablation provides comparable benefits with regard to freedom from atrial fibrillation at medium-term follow-up, fluoroscopy time, ablation time, operative duration, and overall complication rate in comparison to radiofrequency ablation.

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 ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Low Voltage ◽  
Randomized Study ◽  
Standard Group ◽  
Linear Lesions ◽  
Substrate Modification ◽  
Arrhythmogenic Substrate ◽  
Group 2 ◽  
Group 1

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.

Life After Capo

1983 ◽  
Vol 3 (3_suppl) ◽  
pp. 51-53
Author(s):  
Clair C. Williams
Keyword(s):  
Peritoneal Dialysis ◽  
Treatment Options ◽  
Drop Out ◽  
Advanced Age ◽  
Dialysis Modality ◽  
Short History ◽  
Drop Out Rate ◽  
Stage Renal Disease ◽  
End Stage

Of 508 patients trained for CAPD during the first five years, 115 (22.6%) were transferred to an alternative dialysis modality. Of these 87% were transferred to centre dialysis programs, equally divided between hemodialysis and intermittent peritoneal dialysis. Advanced age favoured transfer to intermittent peritoneal dialysis and failure due to peritonitis, transfer to hemodialysis. Three year survival after transfer from CAPD was 38%. The presence of diabetes and advanced age adversely affected survival after transfer. Dialysis modality and peritonitis as the cause of CAPD failure did not affect survival. Other treatment options are available to patients who fail CAPD. A relatively high drop-out is therefore acceptable and preferable to continuing CAPD in patients encountering complications which might ultimately influence their survival. Since its introduction in Toronto in 1977, continuous ambulatory peritoneal dialysis (CAPD) has achieved increasing prominence in the management of end-stage renal disease. Throughout its comparatively short history, one of the major criticisms of this technique has been the relatively high drop-out rate. This report provides a follow-up of patients transferred from CAPD to alternative dialysis modalities.

scholarly journals Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial

EP Europace ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. 1645-1652
Author(s):  
Mattias Duytschaever ◽  
Johan Vijgen ◽  
Tom De Potter ◽  
Daniel Scherr ◽  
Hugo Van Herendael ◽  
...  
Keyword(s):  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Randomized Study ◽  
Standard Of Care ◽  
Posterior Wall ◽  
Anterior Wall ◽  
Atrial Arrhythmia ◽  
Clinical Trial Registration ◽  
First Pass

Abstract Aims To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. Methods and results This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4–86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8–82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8–87.0%). Freedom fromrepeat ablations by the Kaplan–Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9–6.3%). Conclusions The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres. Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.

scholarly journals Risk of stroke after radiofrequency ablation of atrial fibrillation: 10-year follow-up of Danish nationwide cohort

2013 ◽  
Vol 34 (suppl 1) ◽  
pp. 1606-1606
Author(s):  
D. Karasoy ◽  
C. Torp-Pedersen ◽  
G. Gislason ◽  
J. Hansen ◽  
A. Johannessen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation

P3793Spironolactone in patients with permanent atrial fibrillation, possible heart failure protective potential

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Dabrowski ◽  
T Chwyczko ◽  
I Kowalik ◽  
E Smolis-Bak ◽  
A Borowiec ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Beta Blocker ◽  
Interstitial Fibrosis ◽  
Randomized Study ◽  
Treated Group ◽  
Control Treatment ◽  
Permanent Atrial Fibrillation ◽  
Minute Walk

Abstract Background Atrial fibrillation (AF) promotes electrical, neurohormonal and structural remodeling of atria and ventricles. Long lasting AF leads to atrial interstitial fibrosis, apoptosis, loss of myofibrils and finally to heart failure (HF). Purpose The aim of the study was impact of aldosterone antagonist, spironolactone, on exercise tolerance and neurohormonal activity in patients with permanent AF without symptoms of HF. Methods In prospective, randomized study patients with permanent AF at least for 1 year, no signs and symptoms of HF and stable clinical condition were included. Patients were randomized to: beta-blocker plus spironolactone (dose: 25 mg) treatment and rate-control treatment with only beta-blocker. Propranolol, metoprolol and bisoprolol were used, doses were adjusted to achieve resting heart rate 60–80/min. Ergospirometry (CPX) and 6-minute walk (6-MWT) tests were performed during separate days. Results Study group consisted of 49 patients, 69% men, mean age 62.1±9.6 without structural and chronic active diseases, mean time of arrhythmia was 5.5 years, Q1: 2, Q3: 8 years. Follow-up was 11.2 months. All patients were treated with beta-blockers, 27 patients were treated with 25 mg spironolactone. Surprisingly physical capacity in 6-minute walk test (6-MWT) in studied patients was not significantly reduced in comparison with values ranges for healthy volunteers. After 11.2 months follow-up significantly longer exercise time (433±113 vs. 367±162 sec, p<0.05) and lower maximal HR (159±25 vs. 165±22 beats/min, p<0.0550) were observed in spironolactone treated group. Other CPX variables did not differ significantly between groups after 11,2 months: VO2: 20.7±5.1 vs. 20.1±4.8 [ml/kg/min]; VO2 as % of normal value: 78.4±15.2 vs. 76.8±15.2; O2 pulse: 12±2.8 vs. 12.7±3.6 [ml/beat]; AT: 1.4±0.3, 1.6±0.5 [L/min]; VE: 74.9±20.0, 72.6±17.9 [L/min]. All spirometric variables worsened after 11.2 months: VC: 4.3±1.1 vs. 3.8±0.8 [L], p<0.0005, FVC: 4.2±1.1 vs. 3.8±1.0 p<0.005 [L], FEV1: 3.1±0.8 vs. 2.8±0.7 [L], p<0.01. In spironolactone treated group after 11.2 months BNP concentrations were significantly lower: Q1: 54, Q2: 83, Q3: 100 vs. Q1: 42, Q2: 93; Q3: 184 ng/L (p=0.025) and aldosterone levels were markedly increased: Q1: 216, Q2: 266; Q3:443 vs. Q1: 169; Q2: 228; Q3:294 ng/dL (p=0.0007). Conclusions In patients with permanent atrial fibrillation cardiopulmonary exercise responses were markedly abnormal, but exercise capacity was increased after spironolactone treatment. Deterioration of spirometry results might be due to beta-blocker treatment. In spironolactone treated group BNP levels were significantly lower what may correspond to its heart failure protective activity.

P421Efficacy of radiofrequency ablation and drug therapy of atrial fibrillation in patients with heart failure

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Seliutskii ◽  
N Savina ◽  
A Chapurnykh
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Drug Therapy ◽  
Radiofrequency Ablation ◽  
Therapy Group ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Sf 36

Abstract Objective to compare the efficacy of radiofrequency ablation (RFA) and drug therapy in patients with atrial fibrillation (AFib) and heart failure (HF) within 12-month follow-up. Materials and methods 130 patients (men-75%, average age-62.8 ± 11.8 years) with AFib and HF with left ventricular ejection fraction (LVEF)&lt;50% were included in a prospective study. In 107 (82%) of the included patients, intermediate LVEF was detected (40-49%). At the time of inclusion, paroxysmal AFib (PaAFib) was recorded in 60 (46%) of patients and persistent AFib (PeAFib) in 70 (54%). AFib RFA was performed in 65 patients, 65 patients continued to receive optimal antiarrhythmic therapy. Prior to the intervention and after 12 months, all patients underwent transthoracic echocardiography and quality of life (QoL) assessment using the SF-36 questionnaire. Results the freedom from AFib within 12 months follow-up period was registred in 49 (75%) of patients in the RFA group and 26 (40%) in the drug therapy group. After 12 month follow-up period we revealed increase of LVEF (p &lt; 0.001), decrease of anteroposterior size (p &lt;0.001) and volume (p &lt; 0.001) of left atrium (LA), improvement of mental (p = 0.008) and physical (p = 0.048) health components according to the SF-36 questionnaire in the RFA group. In the group of drug rhythm control, after 12 months there was only the improvement of mental (p = 0.006) and physical p = 0.016) health components and it was much less than in RFA group (р&lt;0.001). Similar results were received in patients who were free from Afib within 12 months in both groups. Conclusions in patients with AFib and HF with LVEF &lt; 50%, restoration and maintenance of sinus rhythm using RFA was accompanied by an increase in LVEF, decrease of  LA size, and an improvement of QoL. In the group of drug therapy, there was a lower freedom from AFib and there was the slight improvement only in QoL.

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