Global Substrate Mapping and Targeted Ablation with Novel Gold-tip Catheter in De Novo Persistent AF.
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ABSTRACT:
SUBMITTER: Pope MT
PROVIDER: S-EPMC9204651 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimsLong-standing persistent atrial fibrillation (LSPAF) is challenging to treat with suboptimal catheter ablation (CA) outcomes. Thoracoscopic surgical ablation (SA) has shown promising efficacy in atrial fibrillation (AF). This multicentre randomized controlled trial tested whether SA was superior to CA as the first interventional strategy in de novo LSPAF.Methods and resultsWe randomized 120 LSPAF patients to SA or CA. All patients underwent predetermined lesion sets and implantable loop recorder insertion. Primary outcome was single procedure freedom from AF/atrial tachycardia (AT) ≥30 s without anti-arrhythmic drugs at 12 months. Secondary outcomes included clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness. At 12 months, freedom from AF/AT was recorded in 26% (14/54) of patients in SA vs. 28% (17/60) in the CA group [OR 1.128, 95% CI (0.46-2.83), P = 0.83]. Reduction in AF/AT burden ≥75% was recorded in 67% (36/54) vs. 77% (46/60) [OR 1.13, 95% CI (0.67-4.08), P = 0.3] in SA and CA groups, respectively. Procedure-related serious adverse events within 30 days of intervention were reported in 15% (8/55) of patients in SA vs. 10% (6/60) in CA, P = 0.46. One death was reported after SA. Improvements in AF symptoms were greater following CA. Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02).ConclusionSingle procedure thoracoscopic SA is not superior to CA in treating LSPAF. Catheter ablation provided greater improvements in symptoms and accrued significantly more QALYs during follow-up than SA.Clinical trial registrationISRCTN18250790 and ClinicalTrials.gov: NCT02755688.
| S-EPMC7767634 | biostudies-literature
Project description:BackgroundSuccess rates with conventional transvenous endocardial pulmonary vein isolation in patients with persistent and longstanding persistent atrial fibrillation (AF) are variable due to advanced electrical and structural remodeling of the atria. As a consequence, more extensive endocardial lesions, minimally invasive thoracoscopic surgical techniques, and hybrid ablation (combining thoracoscopic epicardial surgical and endocardial catheter ablation) have been developed.HypothesisThe HARTCAP-AF trial hypothesizes that hybrid AF ablation is more effective than (repeated) transvenous endocardial catheter ablation in (longstanding) persistent AF, without increasing the number of associated major adverse events.MethodsThis randomized controlled trial will include 40 patients with persistent or longstanding persistent AF who will be 1:1 randomized to either hybrid ablation or (repeated) catheter ablation. The procedures and follow-up are conducted according to the guidelines. The primary effectiveness endpoint is freedom from any supraventricular arrhythmia lasting longer than 5 min without the use of Vaughan-Williams class I or III antiarrhythmic drugs through 12 months of follow-up after the last procedure. In the catheter ablation arm, a second procedure planned within 6 months after the index procedure is allowed for obtaining the primary endpoint. Additionally, adverse events, cost-effectiveness, and quality of life data will be recorded.Trial registrationClinicalTrials.gov, NCT02441738 . Registered on 12 May 2015.
| S-EPMC6585003 | biostudies-literature
Project description:AimsAtrial fibrillation (AF) symptom relief is a primary indication for catheter ablation, but AF symptom resolution is not well characterized. The study objective was to describe AF symptom documentation in electronic health records (EHRs) pre- and post-ablation and identify correlates of post-ablation symptoms.Methods and resultsWe conducted a retrospective cohort study using EHRs of patients with AF (n = 1293), undergoing ablation in a large, urban health system from 2010 to 2020. We extracted symptom data from clinical notes using a natural language processing algorithm (F score: 0.81). We used Cochran's Q tests with post-hoc McNemar's tests to determine differences in symptom prevalence pre- and post-ablation. We used logistic regression models to estimate the adjusted odds of symptom resolution by personal or clinical characteristics at 6 and 12 months post-ablation. In fully adjusted models, at 12 months post-ablation patients, patients with heart failure had significantly lower odds of dyspnoea resolution [odds ratio (OR) 0.38, 95% confidence interval (CI) 0.25-0.57], oedema resolution (OR 0.37, 95% CI 0.25-0.56), and fatigue resolution (OR 0.54, 95% CI 0.34-0.85), but higher odds of palpitations resolution (OR 1.90, 95% CI 1.25-2.89) compared with those without heart failure. Age 65 and older, female sex, Black or African American race, smoking history, and antiarrhythmic use were also associated with lower odds of resolution of specific symptoms at 6 and 12 months.ConclusionThe post-ablation symptom patterns are heterogeneous. Findings warrant confirmation with larger, more representative data sets, which may be informative for patients whose primary goal for undergoing an ablation is symptom relief.
| S-EPMC11008952 | biostudies-literature
Project description:ImportanceCatheter ablation for persistent atrial fibrillation (AF) has shown limited success.ObjectiveTo determine whether AF drivers could be accurately identified by periodicity and similarity (PRISM) mapping ablation results for persistent AF when added to pulmonary vein isolation (PVI).Design, setting, and participantsThis prospective randomized clinical trial was performed between June 1, 2019, and December 31, 2020, and included patients with persistent AF enrolled in 3 centers across Asia. Data were analyzed on October 1, 2022.InterventionPatients were assigned to the PRISM-guided approach (group 1) or the conventional approach (group 2) at a 1:1 ratio.Main outcomes and measuresThe primary outcome was freedom from AF or other atrial arrhythmia for longer than 30 seconds at 6 and 12 months.ResultsA total of 170 patients (mean [SD] age, 62.0 [12.3] years; 136 men [80.0%]) were enrolled (85 patients in group 1 and 85 patients in group 2). More group 1 patients achieved freedom from AF at 12 months compared with group 2 patients (60 [70.6%] vs 40 [47.1%]). Multivariate analysis indicated that the PRISM-guided approach was associated with freedom from the recurrence of atrial arrhythmia (hazard ratio, 0.53 [95% CI, 0.33-0.85]).Conclusions and relevanceThe waveform similarity and recurrence pattern derived from high-density mapping might provide an improved guiding approach for ablation of persistent AF. Compared with the conventional procedure, this novel specific substrate ablation strategy reduced the frequency of recurrent AF and increased the likelihood of maintenance of sinus rhythm.Trial registrationClinicalTrials.gov Identifier: NCT05333952.
| S-EPMC10665974 | biostudies-literature
Project description:BACKGROUND:Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. METHODS/DESIGN:Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n?=?120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ??30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. DISCUSSION:The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the comparative efficacy, safety and cost-effectiveness of thoracoscopic surgical ablation and conventional percutaneous catheter ablation for long-standing persistent atrial fibrillation. In addition, the results of the trial will provide information on the effects on patients' quality of life. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN18250790 . Registered on 24 April 2015.
| S-EPMC5819216 | biostudies-literature
Project description:BackgroundCatheter ablation (CA) is an effective treatment for patients with persistent atrial fibrillation (PsAF); however, little is known about its impact on health care utilization for patients with PsAF. The ThermoCool SmartTouch SF (STSF) catheter (Biosense Webster) incorporates an advanced porous tip and contact force-sensing technology.ObjectiveThe purpose of this study was to determine health care utilization among patients with PsAF who underwent ablation with the STSF catheter.MethodsA retrospective cohort study using the Premier Healthcare Database identified patients with PsAF undergoing CA with the STSF catheter in inpatient and outpatient settings. The proportion of patients experiencing AF-related inpatient admissions, outpatient admissions, emergency department (ED) visits, electrical cardioversion, and a composite outcome in the 12 months pre- vs postablation were compared using the McNemar test. Subanalyses were performed on study outcomes by race/ethnicity.ResultsThe final sample included 3077 patients (mean age 65.9 years; 31.7% female). Among patients with PsAF undergoing ablation with the STSF catheter, relative reductions in health care utilization in the 12 months post- vs preablation included 55.3% in AF-related inpatient admissions (P <.0001), 38.9% in outpatient admissions (P <.0001), 52.4% in ED visits (P <.0001), and 61.2% in electrical cardioversions (P <.0001). Composite outcome utilization in the 12 months post- vs preablation declined by 40.2% (P <.0001) for the overall cohort, 40.0% for White patients (P <.0001), 52.2% for Black patients (P <.0001), and 50.1% for Asian patients (P = .032).ConclusionSignificant improvements in health care utilization were observed among PsAF patients who underwent ablation using the STSF catheter. Improvements were particularly marked in underrepresented racial and ethnic groups.
| S-EPMC9626894 | biostudies-literature
Project description:AimsThe GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF).Methods and resultsGOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively.ConclusionPhased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.
| S-EPMC7273334 | biostudies-literature
Project description:Patients with atrial fibrillation (AF) are at increased risk of thrombotic events despite oral anticoagulation (OAC). Radiofrequency catheter ablation (RFCA) can restore and maintain sinus rhythm (SR) in patients with AF. To assess whether RFCA improves thrombotic status. 80 patients (71% male, 64 ± 12y) with recently diagnosed AF, on OAC and scheduled to undergo RFCA or DC cardioversion (DCCV) were recruited. Thrombotic status was assessed using the point-of-care global thrombosis test (GTT), before, and 4-6 weeks after DCCV and 3 months after RFCA. The GTT first measures the time taken for occlusive thrombus formation (occlusion time, OT), while the second phase of the test measures the time taken to spontaneously dissolve this clot through endogenous thrombolysis (lysis time, LT). 3 months after RFCA, there was a significant reduction in LT (1994s [1560; 2475] vs. 1477s [1015; 1878]) in those who maintained SR, but not in those who reverted to AF. At follow-up, LT was longer in those in AF compared to those in SR (AF 2966s [2038; 3879] vs. SR 1477s [1015; 1878]). RFCA resulted in no change in OT value, irrespective of rhythm outcome. Similarly, there was no change in OT or LT in response to DCCV, irrespective of whether SR was restored. Successful restoration and maintenance of SR following RFCA of AF is associated with improved global thrombotic status with enhanced fibrinolysis. Larger studies are required to confirm these early results and investigate whether improved thrombotic status translates into fewer thromboembolic events.
| S-EPMC5658452 | biostudies-literature
Project description:Background: Extra-pulmonary vein triggers can play a significant role in atrial fibrillation recurrence after catheter ablation. We explored the characteristics of the extra-pulmonary vein (PV) triggers in de novo and repeat atrial fibrillation (AF) catheter ablation (AFCA). Methods: We included 2,118 patients who underwent a de novo AFCA (women 27.6%, 59.2 ± 10.9 years old, paroxysmal AF 65.9%) and 227 of them conducted repeat procedures. All included patients underwent isoproterenol provocation tests at the end of the procedure, and then we analyzed extra-PV triggers-related factors. Results: Extra-PV triggers were documented in 11.7% of patients undergoing de novo AFCA (1.22 ± 0.46 foci per patient) and 28.6% undergoing repeat AFCA (1.49 ± 0.73 foci per patient). Older age and higher LA volume index in de novo procedures and women, diabetes, and higher parasympathetic nerve activity (heart rate variability) in repeat-AFCA were independently associated with the existence of extra-PV triggers. The septum (19.9%), coronary sinus (14.7%), and superior vena cava (11.2%) were common extra-PV foci. Among 46 patients who were newly found to have mappable extra-PV triggers upon repeat procedures, 15 (32.6%) matched with the previous focal or empirical extra-PV ablation sites. The rate of AF recurrence was significantly higher in patients with extra-PV triggers than in those without after de novo (HR 1.91, 95% CI 1.54-2.38, p < 0.001) and repeat procedures (HR 2.68, 95% CI 1.63-4.42, p < 0.001). Conclusions: Extra-PV triggers were commonly found in AF patients with significant remodeling and previous empirical extra-PV ablation. The existence of extra-PV triggers was independently associated with poorer rhythm outcomes after the de novo and repeat AFCA.
| S-EPMC8600078 | biostudies-literature
Project description:Ablation of AF through electrical isolation of the pulmonary veins is a well-established technique and a cornerstone in the ablation of AF, although there are a variety of techniques and ablation strategies now available. However, high numbers of patients are returning to hospital after ablation procedures such as pulmonary vein isolation (PVI). Scar tissue (as identified by contact voltage mapping) is found to be present in many of these patients, especially those with persistent AF and even those with paroxysmal AF. This scarring is associated with poor outcomes after PVI. Cardiac mapping is necessary to locate triggers and substrate so that an ablation strategy can be optimised. Multipolar mapping catheters offer more information regarding the status of the tissue than standard ablation catheters. A patient-tailored catheter ablation approach, targeting the patient-specific low voltage/fibrotic substrate can lead to improved outcomes.
| S-EPMC6528045 | biostudies-literature