P ulmonary vein (PV) isolation is an effective therapy to alleviate symptoms and restore sinus rhythm in patients with atrial fibrillation (AF).1 However, recent reports have shown that ablation in the left atrium (LA) is associated with new asymptomatic cerebral emboli (ACE) visible on postprocedural diffusion-weighted cerebral MRI.2 The largest such study reported an ACE incidence of 14.2% using openirrigation radiofrequency (RF) catheters.3 Although no patient parameters were correlated with ACE, procedural parameters, such as cardioversion and activated clotting time (ACT) level, were associated with new silent lesions. Smaller subsequent reports with rates ranging from 7% to 12% have similarly implicated procedural factors to increasing ACE incidence, including concomitant diagnostic coronary angiography, 4 total RF duration, 5 and non-PV ablation.6 Editorial see p 827 Clinical Perspective on p 842Two nonrandomized studies found that use of multielectrode RF (MER) ablation was associated with elevated ACE incidence compared with irrigated RF and cryoablation, with a rate as high as 38%. 7,8 Subsequent animal studies showed that both gaseous and solid emboli were generated during both irrigated and MER ablation in the swine LA. 9 Specifically with the circular MER catheter, increased gas emboli were observed during catheter insertion into transseptal sheaths while both embolic and gaseous © 2013 American Heart Association, Inc. Original Article Circ Arrhythm ElectrophysiolBackground-This prospective, multicenter study sought to evaluate the incidence of asymptomatic cerebral emboli (ACE) during ablation of atrial fibrillation (AF) using a multielectrode radiofrequency (MER) system when specific procedural changes were applied. Methods and Results-Sixty subjects (age 60±10 years; 87% paroxysmal; CHADS 2 score, 0.6±0.7) undergoing AF ablation with a circular MER catheter were studied. Three procedural changes were specified: (1) ablation was performed under therapeutic vitamin K antagonist and heparin to maintain activated clotting time >350 seconds; (2) submerged loading of the catheter into the introducer before sheath insertion to minimize air ingress; and (3) either the distal or proximal electrode of the circular MER catheter was deactivated to prevent inadvertent bipolar radiofrequency interaction. MRI was performed <7 days preablation and 2 days postablation. Subjects with new cerebral findings after ablation underwent repeat MRI after 1 month. An acute ACE lesion was defined by a new hyperintensity on diffusion-weighted and fluidattenuated inversion recovery cerebral MRI sequences. Neurological function was evaluated at baseline, postablation, and 1 month. All target pulmonary veins were isolated. In 60% (36/60) of patients, pre-existing cerebral lesions were seen on the preprocedure MRI (8 lesions per subject; interquartile range, 3-22). New postprocedural ACE occurred in only 1/60 patients (incidence, 1.7%; 95% confidence interval, 0.04-8.9), which was no longer visible on MRI after 1 month. Conclusi...
BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
Background Biatrial, extensive, and complex ablation strategies have been published for the treatment of neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block. We have developed a less extensive and more specific approach compared with previously published cardioneuroablation strategies, called cardio-neuromodulation. It is based on tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus, preferentially through a right-sided approach. Methods Patients with syncope were enrolled between December 2016 and December 2017. They were assigned to group A if they had a positive head-up tilt test and to group B if they presented with a pause ≥3 seconds. The area to target during cardio-neuromodulation was designed offline on a computed tomographic scan. Slow heart rates and pauses were compared during 24-hour rhythm registration at baseline, at 1-month follow-up, and 6-month follow-up. Syncope burden was assessed before the procedure and at 3- and 6-month follow-up. Results Twenty patients underwent cardio-neuromodulation through a right-sided approach (12 in group A, 8 in group B). The first application of radiofrequency energy led to a P-P interval shortening >120 ms in all 20 patients. After a mean±SD ablation time of 7±4 minutes and mean ablated surface area of 11±6 mm 2 , the P-P interval shortened by 219±160 ms ( P <0.001). The number of beats <50/min during 24-hour rhythm registration was reduced by a median of 100% at 6-month follow-up ( P <0.001). Syncope burden was reduced by 95% at 6-month follow-up ( P <0.001). Conclusions These data indicate that cardio-neuromodulation, through a right-sided and computed tomographic–guided procedure, is safe, fast, and highly reproducible in preventing inappropriate functional sinus bradycardia and syncope recurrence.
AimsDuty-cycled radiofrequency ablation (RFA) has been used for atrial fibrillation (AF) for around 5 years, but large-scale data are scarce. The purpose of this survey was to report the outcome of the technique.Methods and resultsA survey was conducted among 20 centres from seven European countries including 2748 patients (2128 with paroxysmal and 620 with persistent AF). In paroxysmal AF an overall success rate of 82% [median 80%, interquartile range (IQR) 74–90%], a first procedure success rate of 72% [median 74% (IQR 59–83%)], and a success of antiarrhythmic medication of 59% [median 60% (IQR 39–72%)] was reported. In persistent AF, success rates were significantly lower with 70% [median 74% (IQR 60–92%)]; P = 0.05) as well as the first procedure success rate of 58% [median 55% (IQR 47–81%)]; P = 0.001). The overall success rate was similar among higher and lower volume centres and were not dependent on the duration of experience with duty-cycled RFA (r = −0.08, P = 0.72). Complications were observed in 108 (3.9%) patients, including 31 (1.1%) with symptomatic transient ischaemic attack or stroke, which had the same incidence in paroxysmal and persistent AF (1.1 vs. 1.1%) and was unrelated to the case load (r = 0.24, P = 0.15), bridging anticoagulation to low molecular heparin, routine administration of heparin over the long sheath, whether a transoesophageal echocardiogram was performed in every patient or not and average procedure times.ConclusionDuty-cycled RFA has a self-reported success and complication rate similar to conventional RFA. After technical modifications a prospective registry with controlled data monitoring should be conducted to assess outcome.
Background— Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation. Methods and Results— Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA 2 DS 2 –VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P <0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P =0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA ( P <0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months. Conclusions— In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times. Clinical Trial Registration— URL: www.clinicaltrials.gov ; Unique identifier: NCT01696136.
Syncope is frequently neurally mediated and can seriously affect quality of life. Different ablation strategies have been successfully performed. These approaches have not gained wide acceptance and are quite extensive and complex, exposing patients to significant risks. This article reports the case of a 16-year-old girl who was severely affected by frequent and prolonged episodes of syncope and was treated by tailored ablation of the anterior right ganglionated plexus with a multielectrode irrigated catheter. She had fainted >30 times in the 5 years preceding treatment, experiencing approximately 10 severe episodes of syncope in the previous 12 months. After 3 minutes of ablation, the P-P interval was reduced by >400 milliseconds. Syncope disappeared and the patient has remained completely asymptomatic over a follow-up of 22 months. The "reset" basal P-P interval has remained unchanged (follow-up electrocardiogram at 16 months). At 6 months, there was no residual heart rate activity <50 bpm. On 24-hour rhythm registration, P-P intervals ≥1,000 milliseconds (corresponding to a heart rate of ≤60 bpm) were reduced by >16,000 beats. We believe that this case report is original for several reasons: the unusual clinical presentation; the unique structure targeted; the very limited ablation, implying much lower risks for the patient; the anatomical approach; and the different endpoint. This new "cardio-neuromodulation" approach could be useful for the treatment of patients with neurally mediated syncope.
The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.
Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.
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