This open-label, randomized trial assessed the safety of uninterrupted dabigatran versus warfarin in 635 patients undergoing ablation for atrial fibrillation. The incidence of major bleeding events ...was significantly lower with dabigatran than with warfarin (1.6% vs. 6.9%).
Catheter ablation of atrial fibrillation is a well-established treatment for symptomatic atrial fibrillation. Guidelines have incorporated catheter ablation of symptomatic atrial fibrillation as a class 1 or 2 indication, depending on previous antiarrhythmic treatment and type of atrial fibrillation.
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The most important complications associated with ablation of atrial fibrillation are periprocedural stroke or transient ischemic attack (TIA) and cardiac tamponade.
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Systemic anticoagulation before, during, and after ablation is important in reducing the risk of periprocedural cerebrovascular events.
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To minimize these risks, heparin should be administered during ablation to maintain an activated clotting time of more than 300 seconds. However, . . .
Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical ...trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications.
This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each).
In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.
Abstract
Aims
Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of ...catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines.
Methods
This prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries. Patients were randomized 1 : 1 to RF ablation or AAD treatment. The primary endpoint was the rate of persistent AF/atrial tachycardia (AT) at 3 years.
Results
After early study termination following slow enrolment, 255 (79%) of the planned 322 patients were enrolled (RF ablation, n = 128, AAD, n = 127); 36% of patients in the RF ablation group and 41% in the AAD group completed 3 years of follow-up. For the primary endpoint, the Kaplan–Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF ablation 2.4% (95% confidence interval (CI), 0.6–9.4%) than with AAD therapy 17.5% (95% CI, 10.7–27.9%); one-sided P = 0.0009. Patients ≥65 years were ∼4 times more likely to progress to persistent AF/AT than patients <65 years, suggesting RF ablation can delay disease progression hazard ratio: 3.87 (95% CI, 0.88–17.00); P = 0.0727. Primary adverse events were reported for eight patients in the RF ablation group.
Conclusions
Radiofrequency ablation is superior to guideline-directed AAD therapy in delaying the progression from paroxysmal to persistent AF.
Summary Background In patients with ventricular tachycardia (VT) and a history of myocardial infarction, intervention with an implantable cardioverter defibrillator (ICD) can prevent sudden cardiac ...death and thereby reduce total mortality. However, ICD shocks are painful and do not provide complete protection against sudden cardiac death. We assessed the potential benefit of catheter ablation before implantation of a cardioverter defibrillator. Methods The Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study was a prospective, open, randomised controlled trial, undertaken in 16 centres in four European countries. Patients aged 18–80 years were eligible for enrolment if they had stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction (LVEF; ≤50%). 110 patients were randomly allocated in a 1:1 ratio to receive catheter ablation and an ICD (ablation group, n=54) or ICD alone (control group, n=56). Randomisation was done by computer-generated randomly permuted blocks and stratified by centre and LVEF (≤30% or >30%). Patients were followed up for at least 1 year. The primary endpoint was the time to first recurrence of VT or ventricular fibrillation (VF). Analysis was by intention to treat (ITT). This study is registered with ClinicalTrials.gov , number NCT00919373. Findings 107 patients were included in the ITT population (ablation group, n=52; control group, n=55). Two patients (one in each group) withdrew consent immediately after randomisation without any follow-up data and one patient (ablation group) was excluded because of a protocol violaton. Mean follow-up was 22·5 months (SD 9·0). Time to recurrence of VT or VF was longer in the ablation group (median 18·6 months lower quartile 2·4, upper quartile not determinable) than in the control group (5·9 months IQR 0·8–26·7). At 2 years, estimates for survival free from VT or VF were 47% in the ablation group and 29% in the control group (hazard ratio 0·61; 95% CI 0·37–0·99; p=0·045). Complications related to the ablation procedure occurred in two patients; no deaths occurred within 30 days after ablation. 15 device-related complications requiring surgical intervention occurred in 13 patients (ablation group, four; control group, nine). Nine patients died during the study (ablation group, five; control group, four). Interpretation Prophylactic VT ablation before defibrillator implantation seemed to prolong time to recurrence of VT in patients with stable VT, previous myocardial infarction, and reduced LVEF. Prophylactic catheter ablation should therefore be considered before implantation of a cardioverter defibrillator in such patients. Funding St Jude Medical.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Stratification of patients with atrial fibrillation (AF) according to mechanistic and prognostic criteria may optimize the effectiveness and safety of catheter ablation. In women, AF is associated ...with more severe symptoms and worse prognosis.
We sought to assess sex-related differences in catheter ablation procedures and outcome in a large cohort of patients with AF.
A total of 3652 patients (1198 women 33%; 2454 men 67%) included in the German Ablation Registry were analyzed. Periprocedural parameters and outcome at 12-month follow-up were compared between male and female patients.
Women were older at the time of ablation (women: 63.6 years; men: 59.1 years; P < .0001) and exhibited a higher prevalence of paroxysmal AF (women: 72%; men: 61%; P < .0001). They were less often affected by cardiovascular disease and reduced left ventricular function. Energy application duration and overall procedure duration were shorter in women. Conversely, the rate of major inhospital complications was increased in female patients (1.9% vs 0.8%; P = .023) and mainly driven by major bleeding events. At follow-up, women experienced higher AF recurrence rates (women: 50%; men: 45%; P = .017) and more often received oral medication for rhythm and rate control. In addition, the rate of pacemaker implantation was higher in the female cohort. Women more frequently reported femoral access site complications (women: 6%; men: 3%; P < .001). Overall, male patients were more often free from AF-related symptoms and satisfied with the treatment.
Catheter ablation of AF was associated with a distinct sex-related outcome and complication profile that requires consideration in clinical practice.
To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry.
Data from 12 566 patients who underwent catheter ablation of SVT ...between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution.
Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention.
Summary Background Catheter ablation is increasingly used to manage atrial fibrillation, but arrhythmia recurrences are common. Adenosine might identify pulmonary veins at risk of reconnection by ...unmasking dormant conduction, and thereby guide additional ablation to improve arrhythmia-free survival. We assessed whether adenosine-guided pulmonary vein isolation could prevent arrhythmia recurrence in patients undergoing radiofrequency catheter ablation for paroxysmal atrial fibrillation. Methods We did this randomised trial at 18 hospitals in Australia, Europe, and North America. We enrolled patients aged older than 18 years who had had at least three symptomatic atrial fibrillation episodes in the past 6 months, and for whom treatment with an antiarrhythmic drug failed. After pulmonary vein isolation, intravenous adenosine was administered. If dormant conduction was present, patients were randomly assigned (1:1) to additional adenosine-guided ablation to abolish dormant conduction or to no further ablation. If no dormant conduction was revealed, randomly selected patients were included in a registry. Patients were masked to treatment allocation and outcomes were assessed by a masked adjudicating committee. Patients were followed up for 1 year. The primary outcome was time to symptomatic atrial tachyarrhythmia after a single procedure in the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT01058980. Findings Adenosine unmasked dormant pulmonary vein conduction in 284 (53%) of 534 patients. 102 (69·4%) of 147 patients with additional adenosine-guided ablation were free from symptomatic atrial tachyarrhythmia compared with 58 (42·3%) of 137 patients with no further ablation, corresponding to an absolute risk reduction of 27·1% (95% CI 15·9–38·2; p<0·0001) and a hazard ratio of 0·44 (95% CI 0·31–0·64; p<0·0001). Of 115 patients without dormant pulmonary vein conduction, 64 (55·7%) remained free from symptomatic atrial tachyarrhythmia (p=0·0191 vs dormant conduction with no further ablation). Occurrences of serious adverse events were similar in each group. One death (massive stroke) was deemed probably related to ablation in a patient included in the registry. Interpretation Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation. This approach should be considered for incorporation into routine clinical practice. Funding Canadian Institutes of Health Research, St Jude Medical, Biosense-Webster, and M Lachapelle (Montreal Heart Institute Foundation).
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BACKGROUND—In the meantime, catheter ablation is widely used for the treatment of persistent atrial fibrillation (AF). There is a paucity of data about long-term outcomes. This study evaluates (1) ...5-year single and multiple procedure success and (2) prognostic factors for arrhythmia recurrences after catheter ablation of persistent AF using the stepwise approach aiming at AF termination.
METHODS AND RESULTS—A total of 549 patients with persistent AF underwent de novo catheter ablation using the stepwise approach (2007–2009). A total of 493 patients were included (Holter ECGs ≥every 6 months). Mean follow-up was 59±16 months with 2.1±1.1 procedures per patient. Single and multiple procedure success rates were 20.1% and 55.9%, respectively (80% off antiarrhythmic drug). Antiarrhythmic drug–free multiple procedure success was 46%. Long-term recurrences (n=171) were paroxysmal AF in 48 patients (28%) and persistent AF/atrial tachycardia in 123 patients (72%). Multivariable recurrent event analysis revealed the following factors favoring arrhythmia recurrencefailure to terminate AF during index procedure (hazard ratio HR, 1.279; 95% confidence interval CI, 1.093–1.497; P=0.002), number of procedures (HR, 1.154; 95% CI, 1.051–1.267; P=0.003), female sex (HR, 1.263; 95% CI, 1.027–1.553; P=0.027), and the presence of structural heart disease (HR, 1.236; 95% CI, 1.003–1.524; P=0.047). AF termination was correlated with a higher rate of consecutive procedures because of atrial tachycardia recurrences (P=0.003; HR, 1.71; 95% CI, 1.20–2.43).
CONCLUSIONS—Catheter ablation of persistent AF using the stepwise approach provides limited long-term freedom of arrhythmias often requiring multiple procedures. AF termination, the number of procedures, sex, and the presence of structural heart disease correlate with outcome success. AF termination is associated with consecutive atrial tachycardia procedures.
BACKGROUND:Cardiac repolarization abnormalities in drug-induced and genetic long-QT syndrome may lead to afterdepolarizations and life-threatening ventricular arrhythmias. Human induced pluripotent ...stem cell–derived cardiomyocytes (hiPSC-CMs) should help to overcome the limitations of animal models based on species differences in repolarization reserve. Here, we compared head-to-head the contribution of IKs (long QT1) and IKr (long QT2) on action potentials (APs) in human left ventricular (LV) tissue and hiPSC-CM–derived engineered heart tissue (EHT).
METHODS:APs were measured with sharp microelectrodes in EHT from 3 different control hiPSC-CM lines and in tissue preparations from failing LV.
RESULTS:EHT from hiPSC-CMs showed spontaneous diastolic depolarization and AP generation that were sensitive to low concentrations of ivabradine. IKr block by E-4031 prolonged AP duration at 90% repolarization with similar half-effective concentration in EHT and LV but larger effect size in EHT (+281 versus +110 ms in LV). Although IKr block alone evoked early afterdepolarizations and triggered activity in 50% of EHTs, slow pacing, reduced extracellular K, and blocking of IKr, IKs, and IK1 were necessary to induce early afterdepolarizations in LV. In accordance with their clinical safety, moxifloxacin and verapamil did not induce early afterdepolarizations in EHT. In both EHT and LV, IKs block by HMR-1556 prolonged AP duration at 90% repolarization slightly in the combined presence of E-4031 and isoprenaline.
CONCLUSIONS:EHT from hiPSC-CMs shows a lower repolarization reserve than human LV working myocardium and could thereby serve as a sensitive and specific human-based model for repolarization studies and arrhythmia, similar to Purkinje fibers. In both human LV and EHT, IKs only contributed to repolarization under adrenergic stimulation.
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