Pulmonary Vein Ablation Catheter Research Articles

Predictors of class IC antiarrhythmic drugs efficacy in patients with paroxysmal form of atrial fibrillation

Background. Class IC antiarrhythmic drugs (IC-AADs) are recommended as first-line therapy in treatment of lone paroxysmal atrial fibrillation (AF) along with catheter ablation of pulmonary veins. Despite previous attempts to identify predictors of IC-AADs` efficacy, the choice between IC-AADs agents is still most often carried out using empirical approach.
 Aim. To determine the predictors of IC-AADs ` efficacy in patients with paroxysmal AF in the absence of structural heart disease.
 Materials and methods. Seventy four patients (22 men, 52 women, average age 65 [57; 70] years) were treated with IC-AADs: 26 patients were prescribed lappaconitine hydrobromide (Al) (allapinin at a dosage of 75 mg/day or allaforte 50–100 mg/day), 25 patients were prescribed propafenone (P) 450–600 mg/day, 23 patients – diethylaminopropionylethoxycarbonylaminophenothiazine hydrochloride (ethacizine, E) 150 mg/day. The average frequency of AF paroxysms was 2 [0.4; 6.25] per month. Patients were divided into 2 groups depending on the effect of AADs.
 Results. Over a 12 months follow-up IC-AADs therapy was effective in 28 (37.8%) patients (Eff+ group), in the remaining 46 (62.2%) patients AF recurrences or side effects demanding AADs withdrawal were registered (Eff-group). A DC value greater or equal to 5 ms predicted the effectiveness of IC-AADs therapy with 79% sensitivity and 77% specificity (OR 12, 95% CI 3.07–49.5, p0.0001). In the Al group the deceleration capacity (DC) value greater or equal to 5.25 ms allowed predicting therapy effectiveness with 86% sensitivity and 100% specificity (OR 7, 95% CI 1.14; 43; p=0.002). In the E group, the DC index was characterized by high sensitivity (80%) and specificity (85%) for a threshold value of 5.9 ms. In case of DC above this value, the probability of E therapy efficacy increased by 22-times (OR 22, 95% CI 1.5; 314; p=0.009). In group P, the DC medians in the Eff+ and Eff- groups did not differ significantly (p=0.821). However, at low DC values (less than 4 ms) P turned out to be the most effective compared to other two IC-AADs: its effectiveness was 50%, which was significantly higher compared to E (0%) and Al (0%) (p=0.046).
 Conclusion. Estimation of the DC level before starting IC-AADs can make it easier to choose a specific drug from this group and improve treatment results: at DC above 5.2 ms, it is advisable to use Al, at DC≥6 ms – Al or E, at DC less than 4 ms – P.

Ablation therapies for paroxysmal atrial fibrillation: A systematic review and patient-level network meta-analysis

Despite promising trials, catheter ablation is still regarded as an adjunct to antiarrhythmic drugs (AADs) in the treatment of paroxysmal atrial fibrillation (PAF). This study aimed to compare the effectiveness of various ablation therapies and AADs. Randomised controlled trials or propensity score-matched studies comparing atrial tachyarrhythmia recurrence among any combination of ablation modalities or AAD were retrieved. Kaplan-Meier curves and risk tables for this outcome were graphically reconstructed to extract patient-level data. Frequentist network meta-analysis (NMA) using derived hazard ratios (HRs), as well as 2 restricted mean survival time (RMST) NMAs, were conducted. Treatment strategies were ranked using P-scores. Across 24 studies comparing 6 ablation therapies (5,132 patients), Frequentist NMA-derived HRs of atrial fibrillation recurrence compared to AAD were 0.35 (95% confidence interval [CI]=0.25-0.48) for cryoballoon ablation (CBA), 0.34 (95% CI=0.25-0.47) for radiofrequency ablation (RFA), 0.14 (95% CI=0.07-0.30) for combined CBA and RFA, 0.20 (95% CI=0.10-0.41) for hot-balloon ablation, 0.43 (95% CI=0.15-1.26) for laser-balloon ablation (LBA), and 0.33 (95% CI=0.18-0.62) for pulmonary vein ablation catheter. RMST-based NMAs similarly showed significant benefit of all ablation therapies over AAD. The combination of CBA + RFA showed promising long-term superiority over CBA and RFA, while LBA showed favourable short-term efficacy. The advantage of ablation therapies over AAD in preventing atrial tachyarrhythmia recurrence suggests that ablation should be considered as the first-line treatment for PAF in patients fit for the procedure. The promising nature of several specific therapies warrants further trials to elicit their long-term efficacy and perform a cost-benefit analysis.

Ablation therapies for paroxysmal atrial fibrillation: a systematic review and patient-level network meta-analysis

Abstract Background Despite numerous promising trials, catheter ablation is still regarded as a second-line alternative to antiarrhythmic drugs (AAD) in the treatment of paroxysmal atrial fibrillation (PAF). There remains a role for a broad comparison of the effectiveness of various ablation therapies against each other, and versus AAD. Purpose To conduct a systematic review and network meta-analysis of ablation therapies and AAD in the treatment of PAF. Ablation therapies were hypothesized to be superior to AAD in preventing atrial fibrillation (AF) recurrence. Methods An electronic literature search was conducted to retrieve randomized controlled trials or propensity score-matched studies comparing freedom from AF recurrence among any combination of ablation modalities or AAD. Kaplan-Meier curves and risk tables for this outcome were graphically reconstructed to extract individual patient data (IPD). A Frequentist network meta-analysis (NMA) was performed using the derived hazard ratios (HRs) of each study to compare various ablation therapies and AAD. Two separate NMAs were also conducted with restricted mean survival time (RMST) analysis, using RMST absolute differences and ratios, in light of violation of the proportional-hazards assumption. Treatment strategies were ranked using P-scores. Pairwise comparisons were also performed between treatment pairs with three or more studies reporting direct comparisons. Results Across 24 studies comparing six ablation therapies, comprising 5274 patients, Frequentist NMA-derived HRs of AF recurrence compared to AAD were 0.35 (95% CI: 0.26–0.48) for cryoballoon ablation (CBA), 0.33 (95% CI: 0.25–0.45) for radiofrequency ablation (RFA), 0.21 (95% CI: 0.09–0.49) for combined CBA and RFA, 0.20 (95% CI: 0.11–0.39) for hot-balloon ablation (HBA), 0.44 (95% CI: 0.16–1.22) for laser-balloon ablation, and 0.33 (95% CI: 0.19–0.56) for pulmonary vein ablation catheter. RMST-based NMAs similarly showed a significant benefit of all ablation therapies over AAD in preventing AF recurrence. Although none of the HRs between pairs of ablation modalities were significant, P-scores for HBA and combined CBA and RFA were consistently higher than those of other treatments. Independent pairwise comparisons of RFA and CBA versus AAD were greatly in favor of ablation (shared-frailty HR=0.24, 95% CI: 0.19–0.31, p<0.001; shared-frailty HR=0.44, 95% CI: 0.35–0.56, p<0.001, respectively). Conclusions To our knowledge, this is the first network meta-analysis comparing a wide range of ablation therapies to AAD, synthesizing IPD from high-quality studies in three separate NMA models. The advantage of ablation therapies over AAD in preventing AF recurrence was consistently found across all three models. This strongly suggests that ablation should replace AAD as the first-line treatment for PAF in patients who are fit for the procedure. Moreover, the promising results of HBA underscore the need for more high-quality trials to be conducted. Funding Acknowledgement Type of funding sources: None.

Impact of open-irrigated radiofrequency catheter with contact force measurement on the efficacy and safety of atrial fibrillation ablation: a single-center direct comparison

BackgroundIn atrial fibrillation (AF) patients, catheter ablation of pulmonary veins (PVI) is the most effective therapeutic option to maintain sinus rhythm. To improve successful PVI, contact force–sensing (CF) catheters became routinely available. Previous studies did not clearly show superior clinical efficacy in comparison with non-CF catheters.MethodsWe investigated consecutive patients, who underwent index PVI for AF at our hospital between 2012 and 2018. Three hundred and fifty-four patients were ablated without CF. After availability of CF catheters in 2016, 317 patients were ablated using CF. In case of crossover between the groups, follow-up was censored. The primary endpoint was any documented atrial tachycardia (AT) or atrial fibrillation > 30 s after a 3-month blanking period. Secondary endpoints were procedural characteristics and periprocedural complications.ResultsThere was no significant difference between the groups at baseline except hyperlipidemia. After 365 days of follow-up, 67% of patients in the CF group remained free from AF/AT recurrence compared to 59% in non-CF group (P = 0.038). In multivariable Cox regression analysis, non-CF ablation was an independent risk factor for AF recurrence besides age and persistent AF. Total fluoroscopy time (15 ± 7.6 vs. 28 ± 15.9 min) and total procedure time (114 ± 29.6 vs. 136 ± 38.5 min) were significantly lower for CF-guided PVI (P < 0.001). Complication rates did not differ between groups (P = 0.661).ConclusionsIn our study, the AT/AF recurrence rate and pulmonary vein reconnection rate is lower after CF PVI with a similar complication rate but lower total procedure time and total fluoroscopy time compared to non-CF PVI.

Left atrial functional remodeling assessed by echocardiography in patients undergoing ablation for atrial fibrillation: correlation with the presence of fibrosis and invasive atrial pressure

Abstract Funding Acknowledgements Type of funding sources: None. Background Radiofrequency catheter ablation of pulmonary veins has become a common procedure for treatment of atrial fibrillation (AF). Nevertheless, the procedure is characterized by an extremely variable success rate, which reflects a great heterogeneity of factors implicated in AF recurrence and AF burden. Purpose We focused on the role of left atrium (LA) in patients with paroxysmal and persistent AF who underwent catheter pulmonary veins ablation procedure. In particular we paid attention to three factors: echocardiographic evaluation of LA function, LA scar evaluated by electroanatomic mapping and LA pressures (LAP) during ablation procedure. The aim of the study was to investigate the correlation between echocardiographic parameters indicating atrial dysfunction (LA volume indexed, E/E’, LAA contraction velocity, LA stiffness and LA longitudinal strain during reservoir phase (LASr)) and intraprocedural parameters (such as LAPpeak and the amount of fibrosis). Methods The study included 25 patients; mean age was 63 ± 8 years; nineteen patients (76%) had paroxysmal AF, eighteen patients (72%) were in sinus rhythm at the time of ablation. The population was divided into two subgroups according to the amount of fibrosis evaluated by electroanatomic mapping: patients with fibrosis ≥ 5% of the total LA volume were considered as having an atrial scar. All patients underwent a comprehensive transthoracic echocardiography and a transesophageal echocardiography before the ablation procedure. Intraprocedural data regarding LAPpeak and electroanatomic mapping were collected. Measurements were acquired during both sinus rhythm (SR) and AF. Results Patients with atrial scar had similar LA volume compared to patients without scar (44 ml vs 37.4 ml, p = 0.108) , but presented a trend towards higher LAPpeak (24.3 mmHg vs 15.9 mmHg, p = 0.053) and had higher E/E’ (11 vs 7, p = 0.037) and consequently increased LA stiffness (0.72 vs 0.23, p= 0.006). Still, they had lower LASr (16.6% vs 33.2%, p = 0.013) and tended to have reduced LAA contraction velocity (0.4 m/sec vs 0.7 m/sec, p= 0.005). Conclusions The present findings suggest that functional remodeling of the LA, more than morphological changes, are correlated with the presence of atrial fibrosis and elevated atrial pressure detected during ablation procedures. These parameters may represent potential criteria to guide patients’ selection for ablation procedure and deserve dedicated studies to be confirmed. Abstract Figure.

Pulmonary vein isolation for atrial fibrillation: Does ablation technique influence outcome?

BackgroundOver the last 20 years various techniques have been developed striving for safer and more durable pulmonary vein isolation (PVI). The three most commonly used tools are pulmonary vein ablation catheter (PVAC) and cryoballoon (‘single-shot’ techniques), and point-by-point (PBP) radiofrequency ablation using 3D electroanatomical mapping (EAM). ObjectiveEvaluate the safety and efficacy of the different techniques in an unselected population undergoing de-novo ablation for persistent or paroxysmal atrial fibrillation (AF) at Royal Papworth Hospital (RPH). MethodRetrospective, single-centre study of consecutive AF ablations at RPH between March 2017 and April 2018. Demographic, procedural and outcome data were analysed. ResultsOver the study period 329 first-time PVI procedures were performed. 37.4% were performed using PBP, 39.8% using cryoballoon and 22.8% using PVAC. There was no significant difference in age or sex between different ablation technique groups. 238 procedures were performed for paroxysmal AF and 91 for persistent AF. A higher proportion of the persistent cases were performed using point-by-point techniques compared to paroxysmal cases (58.2% vs 29.0%, p < 0.05).Procedural times were significantly longer in the group undergoing PBP ablation compared to cryoballoon or PVAC. However, there was no statistically significant difference in 12-month freedom from symptomatic AF or procedural complications between the groups. ConclusionsPBP, PVAC and cryoballoon AF ablation all appeared equally efficacious in an unselected population, though PVAC and cryoballoon procedures were shorter. All procedures were associated with a low adverse event rate. Prospective examination is required to substantiate this finding.

Efficacy and safety of the GOLD FORCE multicentre randomized clinical trial: multielectrode phased radiofrequency vs. irrigated radiofrequency single-tip catheter with contact force ablation for treatment of symptomatic paroxysmal atrial fibrillation.

Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF. The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782). In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times.

Long Term outcomes of percutaneous atrial fibrillation ablation in patients with continuous monitoring.

There is limited data using continuous monitoring to assess outcomes of atrial fibrillation (AF) ablation. This study assessed long-term outcomes of AF ablation in patients with implantable cardiac devices. 207 patients (mean age 68.1 ± 9.5, 50.3% men) undergoing ablation for symptomatic AF were followed up for a mean period of 924.5 ± 636.7 days. Techniques included The Pulmonary Vein AblationCatheter (PVAC) (59.4%), cryoablation (17.4%), point by point (14.0%) and The Novel Irrigated Multipolar RadiofrequencyAblationCatheter (nMARQ) (9.2%). 130 (62.8%) patients had paroxysmal AF (PAF) and 77 (37.2%) persistent AF. First ablation and repeat ablation reduced AF burden significantly (relative risk 0.91, [95% CI 0.89 to 0.94]; P <0.0001 and 0.90, [95% CI, 0.86-0.94]; P <0.0001). Median AF burden in PAF patients reduced from 1.05% (interquartile range [IQR], 0.1%-8.70%) to 0.10% ([IQR], 0%-2.28%) at one year and this was maintained out to four-years. Persistent AF burden reduced from 99.9% ([IQR], 51.53%-100%) to 0.30% ([IQR], 0%-77.25%) at one year increasing to 87.3% ([IQR], 4.25%-100%) after four years. If a second ablation was required, point-by-point ablation achieved greater reduction in AF burden (relative risk, 0.77 [95% CI, 0.65-0.91]; P <0.01). Ablation reduces AF burden both acutely and in the long-term. If a second ablation was required the point-by-point technique achieved greater reductions in AF burden than "single-shot" technologies. Persistent AF burden increased to near pre ablation levels by year 4 suggesting a different mechanism from PAF patients where this increase did not occur.

Pulmonary vein isolation for AF: does technique influence outcome?

Abstract Funding Acknowledgements Type of funding sources: None. Background Over the last 20 years various techniques have been developed striving for safer and more durable pulmonary vein isolation (PVI). The three most commonly used tools are pulmonary vein ablation catheter (PVAC) and cryoballoon (‘single-shot’ techniques), and point-by-point (PBP) radiofrequency ablation using 3D electroanatomical mapping (EAM). Objective Evaluate the safety and efficacy of the different techniques in an unselected population undergoing de-novo ablation for persistent or paroxysmal atrial fibrillation (AF) at a single high-throughput centre. Method Retrospective, single-centre study of consecutive AF ablations between March 2017 and April 2018. Demographic, procedural and outcome data were analysed. Results Over the study period 329 first-time PVI procedures were performed. 37.4% were performed using PBP, 39.8% using cryoballoon and 22.8% using PVAC. There was no significant difference in age or sex between different ablation technique groups. 238 procedures were performed for paroxysmal AF and 91 for persistent AF. A higher proportion of the persistent cases were performed using point-by-point techniques compared to paroxysmal cases (58.2% vs 29.0%, p &amp;lt; 0.05). Procedural times were significantly longer in the group undergoing PBP ablation compared to cryoballoon or PVAC. However, there was no statistically significant difference in 12-month freedom from symptomatic AF or procedural complications between the groups. Conclusions PBP, PVAC and cryoballoon AF ablation all appeared equally efficacious in an unselected population, though PVAC and cryoballoon procedures were shorter. All procedures were associated with a low adverse event rate. Prospective examination is required to substantiate this finding. Table 1CARTOn= 123Cryoballoonn= 131PVACn = 75p-valueAge/years61.7 ± 9.259.5 ± 10.661.7 ± 9.70.14Male92 (74.8)88 (67.2)49 (61.3)0.80Paroxysmal AF70 (56.9)106 (78.6)62 (82.7)0.14Cardiovascular risk factors Hypertension Diabetes Ischaemic heart disease Cerebrovascular disease Heart failure Dyslipidaemia73 (59.3)23 (18.7)40 (32.5)2 (1.6)0 (0) 12 (9.8)79 (60.3)19 (14.5)45 (34.4)0 (0)1 (0.8)16 (12.2)43 (57.3)16 (21.3)22 (29.3)1 (1.3)0 (0)10 (13.3) 0.58 0.24 0.62 - - 0.71Left atrial diameter/cm4.2 ± 0.74.1 ± 0.73.9 ± 1.00.69Procedure time/mins191.3 ± 39126.7 ± 24117.4 ± 30&amp;lt;0.056 month success Paroxysmal Persistent50/66 (75.8)32/51 (62.7)78/103 (75.7)18/24 (75.0)48/61 (78.6)10/12 (83.3) 0.99 0.80Complications9 (7.3)3 (2.3)1 (1.3)0.07Patient demographics, procedural characteristics and outcomes for Carto, cryoballoon and PVAC cases. Values presented as mean ± SD or n (%)Abstract Figure. Time to arrhythmia recurrence

Myocardial morphological changes and pulmonary vein catheter ablation efficacy in patients with atrial fibrillation

Aim. To study the association between morphological changes and comorbidities and atrial fibrillation (AF) catheter ablation efficacy, and to evaluate morphological predictors of AF recurrence in patients with durable pulmonary vein isolation (PVI) after catheter intervention.Material and methods. Fifty-four patients with paroxysmal/persistent AF without severe structural heart disease were enrolled in this study who underwent primary pulmonary vein cryoballoon ablation (CBA) with simultaneous implantation of an electrocardiogram loop recorder (Medtronic Reveal XT) and interatrial/interventricular septum biopsy. The follow-up duration was 12 months with scheduled 3, 6 and 12 month visits. Patients with recurrent AF were referred for redo procedure, where the PVI durability was assessed. The follow-up duration after the second procedure was also 12 months. The patients were divided into two groups: patients without recurrent AF and patients with recurrent AF after two catheter interventions.Results. In interventricular septum biopsy samples we found the morphological criteria of myocarditis in 70% of the patients (n=34). Individual morphological changes were detected in all patients. The most common types were cardiomyocyte hypertrophy — 98,1% (n= 52), overcrossing of cardiomyocytes — 77,4% (n=41) and lymphohistiocytic infiltration of the interstitium by more than 14 cells — 75,5% (n=40). Patients with persistent AF were significantly more likely to have endothelial cell swelling (55% vs 45%, p=0,022). Interstitial tissue edema was the only morphological parameter significantly associated with AF recurrence (p=0,03).Conclusion. In patients with AF and no structural heart disease who underwent drug-resistant AF cryoballoon ablation, morphological changes in the myocardium of the atria and ventricles are detected in 100% of cases. The predominant biopsy diagnosis is myocarditis. Morphological signs of the inflammatory process activity, as interstitial tissue edema are associated with the high incidence of non-venous AF. Further preoperative evaluation is needed to identify patients with non-venous atrial fibrillation, which will increase the effectiveness of interventional approach.

Current Drug Treatment Strategies for Atrial Fibrillation and TASK-1 Inhibition as an Emerging Novel Therapy Option.

Atrial fibrillation (AF) is the most common sustained arrhythmia with a prevalence of up to 4% and an upwards trend due to demographic changes. It is associated with an increase in mortality and stroke incidences. While stroke risk can be significantly reduced through anticoagulant therapy, adequate treatment of other AF related symptoms remains an unmet medical need in many cases. Two main treatment strategies are available: rate control that modulates ventricular heart rate and prevents tachymyopathy as well as rhythm control that aims to restore and sustain sinus rhythm. Rate control can be achieved through drugs or ablation of the atrioventricular node, rendering the patient pacemaker-dependent. For rhythm control electrical cardioversion and pharmacological cardioversion can be used. While electrical cardioversion requires fasting and sedation of the patient, antiarrhythmic drugs have other limitations. Most antiarrhythmic drugs carry a risk for pro-arrhythmic effects and are contraindicated in patients with structural heart diseases. Furthermore, catheter ablation of pulmonary veins can be performed with its risk of intraprocedural complications and varying success. In recent years TASK-1 has been introduced as a new target for AF therapy. Upregulation of TASK-1 in AF patients contributes to prolongation of the action potential duration. In a porcine model of AF, TASK-1 inhibition by gene therapy or pharmacological compounds induced cardioversion to sinus rhythm. The DOxapram Conversion TO Sinus rhythm (DOCTOS)-Trial will reveal whether doxapram, a potent TASK-1 inhibitor, can be used for acute cardioversion of persistent and paroxysmal AF in patients, potentially leading to a new treatment option for AF.

Variation of P-wave indices in paroxysmal atrial fibrillation patients before and after catheter ablation

The effects of pulmonary vein isolation in the surface electrocardiogram of patients with paroxysmal atrial fibrillation are analyzed in this paper using non-invasive markers for early detection of the arrhythmia recurrences.Several features have been extracted on P-waves of V1 lead for paroxysmal atrial fibrillation patients who underwent catheter ablation of pulmonary veins for restoring sinus rhythm permanently. Surface ECG was simultaneously recorded along with intracardiac recordings starting from the beginning of the intervention until half an hour after the catheter ablation successfully ended. Significant difference between the means before and after catheter ablation have been observed for the cross-correlation index, kurtosis and amplitude dispersion of P-waves.A logistic regression has been applied to all the descriptors and pointed to the amplitude dispersion index, as well as the minimum gradient joint with kurtosis of P-waves prior to catheter ablation as good predictors of recurrence of atrial fibrillation (78% accuracy). It is important to note how using a few descriptors good classification results are achieved. This study opens a door to early detection of atrial fibrillation recurrences using markers obtained by non-invasive methods.

Smart Touch Radiofrequency Catheter Ablation versus Cryoballoon Ablation of Pulmonary Veins in Patients with Paroxysmal Atrial Fibrillation

AIM: Evaluation of the safety and efficacy of pulmonary veins isolation in patients with paroxysmal atrial fibrillation (AF) using two new different technologies, cryoballoon (CB) ablation and radiofrequency ablation with contact force (CF)-sensing catheters.&#x0D; METHODS: Prospective single-center evaluation, carried out from January 2016 to June 2018 in Critical Care Medicine Department – Cairo University, comparing CF radiofrequency (Thermocool® SmartTouch, Biosense Webster, Inc.) (CF group) with CB ablation (Arctic Front Advance 28 mm CB, Medtronic, Inc.) (CB group), in regards to procedural safety and efficacy, as well as recurrence at 12 months. Overall, 50 consecutive patients were enrolled (25 in each group).&#x0D; RESULTS: The characteristics of patients of both the groups were similar (46.9 ± 11.2 years, the proportion of women 36%, mean documented AF duration 3 ± 2.3 years, mean CHA2DS2-VASc score 1.4 ± 1.3, and mean HAS-BLED 1.4 ± 0.6). Duration of the procedure was significantly lower in the CB group (171.7 ± 15.24 vs. 199.3 ± 18.94 min, p = 0.002), with a longer duration of fluoroscopy and X-ray exposure in the CB group than the CF group but statistically non-significant difference (58.60 ± 11.57 vs. 48.7 ± 13.86 min and 6273 ± 4934 cGy cm² vs. 6853 ± 5069 cGy cm², p = 0.1 and p = 0.2, respectively). Overall complication rate was similar in both groups: 2 (8%) in each group. At 12 months, AF recurrence occurred in 7 patients (28%) in the CF group and in 9 patients (36%) in the CB group (log rank p = 0.682).&#x0D; CONCLUSION: Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 12 months with similar overall complication rate.

Systematic review and network meta-analysis of atrial fibrillation percutaneous catheter ablation technologies using randomized controlled trials.

We sought out to make comparisons between all atrial fibrillation (AF) catheter ablation technologies using randomized controlled trial data. Our comparisons were freedom from AF, procedural duration, and fluoroscopy duration. Searches were made of EMBASE, MEDLINE, and CENTRAL databases, and studies were selected which had cryoballoon, conventional radiofrequency (RF), multipolar RF catheters, and laser technology as an arm in the study and were identified as randomized controlled trials (RCTs). These studies were analyzed for direct comparisons using conventional meta-analysis and a combination of indirect and direct comparisons via a network meta-analysis (NMA). With respect to freedom from AF both direct comparisons and NMA did not demonstrate any significant difference. However in analysis of procedural and fluoroscopy duration (minutes) for the pulmonary vein ablation catheter (PVAC), both conventional analysis and NMA revealed significantly shorter procedure times, RF vs PVAC (conventional: 61.99 [38.03-85.94], P <.00001; NMA: 54.76 [36.64-72.88], P < .0001) and fluoroscopy times, RF vs PVAC (conventional: 12.96 [6.40-19.53], P = .0001; NMA: 8.89 [3.27-14.51], P < .01). The procedural duration was also shorter for the cryoballoon with NMA, RF vs CRYO (20.56 [3.47-37.65], P = .02). Our analysis demonstrated that while there was no difference in the efficacy of the individual catheter technologies, there are significant differences in the procedural duration for the PVAC and the cryoballoon. While they may seem an attractive solution for high-volume centers, further RCTs of next-generation technologies should be examined.

1247Similar rate of thermal esophageal lesions are found in patients alternatively assigned to high power short duration (70W, 8s) vs. lesion index guided (35W) ablation for atrial fibrillation

Abstract Background wide antral pulmonary vein (PV) catheter ablation (CA) in patients with atrial fibrillation (AF) is safe and effective when permanent trans-mural lesions are achieved without causing harm to surrounding anatomical structures. Atrio-esophageal fistula, due to its high mortality, is the most dreadful complication related to CA for AF, therefore alternative radiofrequency (RF) approaches to reduce or eliminate this complication are currently studied. The shallower but wider lesions of high power short duration (HPSD) ablation might represent a safe alternative. Purpose to compare the rate of thermal esophageal lesions in patients with paroxysmal and persistent AF undergoing CA assigned to the 2 different RF modality. Methods one-hundred patients with paroxysmal and 100 with persistent AF will be alternatively assigned to undergo CA with the FlexAbility™ (HPSD group: 70W, 41°, 8 seconds) or the TactiCath™ (LSI-group: 35W, 41°, LSI: 5-5.5 posterior wall, up to 6 anywhere else) catheter. A 3-D mapping system, a steerable sheath and adenosine-test (30mg) were used in all patients. Posterior wall (PW) isolation in addition to PV isolation was performed in all, and patients with persistent AF were additionally treated with mitral and cavotricuspid isthmus ablation. Insertion of an esophageal probe was always attempted, and all patients underwent upper endoscopy 24 to 48 hours after CA. Results between June and October 2019, 71 patients (68 ± 10 years old, 32 (45%) female, 44 (60%) paroxysmal AF, AF duration 58 ± 81 months) were alternatively assigned to HPSD (36, 51%) or LSI-guided (35, 49%) ablation. No differences in clinical characteristics were found between groups. After 45 ± 18min and 30 ± 14 min of procedural and RF time, all PVs were isolated, and all spontaneous and adenosine-induced reconnections treated. Successful PW isolation was achieved with an additional 8 ± 3 and 7 ± 3 min of procedural and RF time. When HPSD and LSI-guided groups are compared, a similar rate of clinically non-relevant and self-healing thermal lesions at endoscopy was found (10, 27.8% vs. 10, 28.6%). Independent of the treatment group, a higher peak temperature identified patients with esophageal lesions (43.2° vs. 42°; P=.0065). A peak temperature value of 43.1° best identify patients most likely to develop thermal lesions (AUC 0.71, SE 84%, SP 39%). Interestingly, none of the 11 patients in whom esophageal probe insertion was not possible or attempted developed thermal lesions in comparison to 20 (33%) patients who underwent esophageal temperature monitoring (P=.0046). Conclusions: no difference in thermal induced esophageal lesions were found when the two different RF approach (HPSD vs. LSI guided) were compared. Interestingly, lack of temperature monitoring with an esophageal probe is associated with no thermal lesions at endoscopy.

Pulmonary vein isolation using second-generation single-shot devices: not all the same?

Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI. Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold. In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs. In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7mm). During a mean follow up of 13.2 ± 3.6months, success was 54% in PVAC Gold patients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups. Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.

Acute success and safety of the second-generation PVAC GOLD phased RF ablation catheter for atrial fibrillation

PurposeThe second-generation multi-electrode catheter, pulmonary vein ablation catheter (PVAC) GOLD, was designed to improve the delivery of phased radiofrequency energy and reduce procedure times using a ‘single-shot’ approach for pulmonary vein isolation (PVI), while retaining efficacy and safety. This large registry presents acute success rates and safety outcomes in a daily practice setting.MethodsA total of 1017 patients undergoing first-time ablation for atrial fibrillation (AF) using PVAC GOLD were included, 644 patients with paroxysmal AF and 373 patients with non-paroxysmal AF, divided into 175 patients receiving PVI only and 198 patients receiving PVI with additional substrate modification.ResultsHigh and comparable percentages of successful PVI could be achieved in all groups (98%, 95% and 99%; p = 0.108). The median total procedure time for all groups was 90 min [70–100]. As expected, the total procedure, ablation and fluoroscopy time were significantly longer in the PVI + substrate modification group compared with the PVI-only cases (all p < 0.001), but not between the PVI-only groups (p = 0.306, p = 0.088, p = 0.233, respectively). A total of 44 complications were observed in 43 patients (4.2%). Major complications were seen in 19 patients (1.87%) and non-major procedure–related complications were seen in 25 patients (2.46%). Complications leaving permanent sequelae were rare and occurred in only four patients (0.39%). Complications did not differ between groups (p = 0.199, p = 0.438, p = 0.240 and p = 0.465 respectively).ConclusionPVAC GOLD performs successful PVI, while reducing procedure times and retaining safety for paroxysmal, persistent and long-standing persistent AF. Safety was unaffected by additional substrate modification.

Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.

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.

Intracardiac Fibrinolysis and Endothelium Activation Related to Atrial Fibrillation Ablation with Different Techniques.

Objective The effect of pulmonary vein isolation (PVI) on fibrinolytic and endothelial activation with currently applied periprocedural anticoagulation has not been explored. We measured markers of fibrinolysis and endothelium activation before and after PVI with the second-generation cryoballoon (Cryo), pulmonary vein ablation catheter (PVAC-Gold), and irrigated radiofrequency (IRF). Methods Markers of fibrinolysis and endothelium activation in left atrial (LA) blood samples were measured in 31 patients before and after PVI (Cryo:10, PVAC-Gold: 7, IRF: 14). Periprocedural anticoagulation included uninterrupted vitamin K antagonist and iv heparin (ACT≥300 sec) during LA dwelling. Results Levels of D-dimer (median; interquartile range, mgFEU/L) increased with all techniques (PVAC: 0.34; 0.24–0.50 versus 0.70; 0.61–1.31; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; PAP complex level (ng/ml) increased after Cryo (247.3, 199.9–331.6 versus 270.9, 227.9–346.7; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; PAI-1 activity (%) decreased with the PVAC (1.931; 0.508–3.859 versus 0.735, 0.240–2.707; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; VWF antigen levels and FVIII activity increased after PVI with all the 3 techniques. The levels of soluble VCAM-1 (ng/ml) did not change after PVAC procedures, but increased after Cryo (542, 6; 428.5–753.1 versus 619.2; 499.8–799.0; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; p=0.0313, Cryo: 0.33; 0.28–0.49 versus 0.79; 0.65–0.93; Conclusion PVI with contemporary ablation techniques and periprocedural antithrombotic treatment induces coagulation and endothelium activation of similar magnitude with different ablation methods.

Novel videoendoscopy demonstrating irregular, pulsatile GI bleeding from left atrium through an esophageal fistula after pulmonary vein isolation and catheter ablation for atrial fibrillation (with video)

A 63-year-old woman was seen with hematemesis, melena, acute decline in hemoglobin level (from 13.9 to 10.9 g/dL), profound tachycardia (122 beats per minute, irregularly irregular pulse), and blood pressure of 140/72 mm Hg 1 month after pulmonary vein isolation and catheter ablation (performed for sotalol-refractory paroxysmal atrial fibrillation) with the use of extremely high ablative energy because of complex electrophysiologic anatomy with failure to convert to sinus rhythm. The patient was administered long-term dabigatran (she was allergic to warfarin) for atrial fibrillation.