RF electrode-tissue coverage significantly influences steam pop incidence and lesion size.

BACKGROUND: Steam pops are a rare complication associated with radiofrequency (RF) ablation and are hard to predict. The aim of this study was to assess the influence of coverage between the RF ablation electrode and cardiac tissue on steam pop incidence and lesion size. METHODS AND RESULTS: An ex vivo model using porcine cardiac preparations and contact force sensing catheters was designed to perform RF ablations at different coverage levels between the RF electrode and cardiac tissue. During coverage level I, only the distal part of the ablation electrode was in contact with tissue. During coverage level II half of the ablation electrode, and during coverage level III the entire ablation electrode was embedded in tissue. RF applications (n = 60) at different coverage levels I-III were systematically performed using the same standardized ablation protocol. Ablations during coverage level III resulted in a significantly higher rate of steam pops (100%) when compared to ablations during coverage level II (10%) and coverage level I (0%), log rank p < .001. Coverage level I ablations resulted in significantly smaller lesion depths, diameters, and impedance drops when compared to higher coverage level ablations, p < .001. In the controlled ex vivo model, there was no difference in applied contact force or energy between different coverage levels. CONCLUSIONS: The level of coverage between RF electrode, cardiac tissue, and the surrounding fluid significantly influenced the incidence of steam pops in an ex vivo setup. Larger coverage between RF electrode and tissue resulted in significantly larger lesion dimensions.

Early recurrence after pulmonary vein isolation is associated with inferior long-term outcomes: Insights from a retrospective cohort study.

AIMS: The aim of this retrospective cohort study was to assess the influence of early recurrence (ER) after pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) on long-term outcomes and to identify clinical variables associated with ER. METHODS: We retrospectively collected clinical and procedural data from 1285 patients with paroxysmal AF who underwent PVI from 2011 to 2016. Kaplan-Meier, receiver operating characteristic (ROC) curve, logistic and Cox regression analyses were performed to analyze the influence of ER on long-term outcomes. RESULTS: ER was observed in 13% of patients. Kaplan-Meier analyses showed significantly different outcomes in 1285 patients with and without ER (49% vs 74%, log rank P < .01) and in 286 patients in the subgroup that underwent reablation (44% vs 79%, log rank P < .01). The hazard ratio (HR) of ER was 1.7 within 48 hours (5% of patients), 2.7 within 1 month (5%), 3.0 within 2 months (2%), and 6.4 within 3 months (1%) for late recurrence (LR), P < .01. ROC analysis (area under the curve [AUC] = 0.79) resulted in 70.3% sensitivity and 74.2% specificity for a 14-day blanking period, and 53.1% sensitivity and 85.5% specificity for a 30-day blanking period. Female patients (odds ratio [OR] 1.69, P < .01) and those with diabetes (OR 1.95, P = .01) were at higher risk for ER. CONCLUSIONS: ER is observed in a substantial number of patients with paroxysmal AF after PVI and has a continuous direct effect on LR according to the timing of ER. Randomized trials are required to assess the safety and effects of reablations in a shortened blanking period on long-term outcomes.

Atrial fibrillation ablation in adults with congenital heart disease on uninterrupted oral anticoagulation is safe and efficient.

BACKGROUND: The prevalence of atrial fibrillation (AF) is significantly higher in adults with congenital heart disease (ACHD) compared to patients without congenital heart disease (CHD). As AF in ACHD patients might have significant hemodynamic consequences, rhythm control is particularly desirable but rarely achieved by antiarrhythmic drugs. The aim of this study was to investigate safety and long-term outcome of AF ablation in ACHD patients. METHODS: All ACHD patients (n = 46) that underwent AF ablation at our centre from 2013 to 2017 were included in the study. CHD was classified as simple (46%), moderate (41%) or complex (13%). The majority of patients (61%) suffered from persistent AF (paroxysmal AF 39%). Persistent AF was present in 57% of patients with simple, in 58% of patients with moderate and 83% of patients with complex CHD. All patients underwent radiofrequency (RF) ablation on uninterrupted oral anticoagulation. Pulmonary vein isolation (PVI) was performed in patients with paroxysmal AF, whereas patients with persistent AF underwent PVI and ablation of complex fractionated atrial electrograms (CFAE). RESULTS: No major complications occurred. Single-procedure success after 18 months off antiarrhythmic drugs was 61% for paroxysmal AF and 29% for persistent AF (p = 0.003). Multiple procedures (mean 2.1 ± 1.4) increased long-term success to 82% for paroxysmal AF and 48% for persistent AF (p = 0.05). Long-term ablation success was 64% for simple, 62% for moderate and 50% for complex CHD patients. CONCLUSIONS: AF ablation in ACHD patients is feasible and safe regardless of CHD complexity. Success rates in patients with paroxysmal AF are high and comparable to patients without CHD. In ACHD patients with persistent AF, success rates of ablation are markedly reduced which might be due to a different and/or more extensive (bi-)atrial substrate. In the cohort of complex ACHD patients with persistent AF as the dominant AF type, long-term success of AF ablation is limited.

Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) in patients with paroxysmal atrial fibrillation (PAF) is effective but hampered by pulmonary vein reconnection due to insufficient ablation lesions. High-power delivery over a short period of time (HPSD) in RFA is stated to create more efficient lesions. The aim of this study was to compare intraprocedural safety and outcome of HPSD ablation to conventional power settings in patients undergoing PVI for PAF. METHODS AND RESULTS: We included 197 patients with PAF that were scheduled for PVI. An ablation protocol with 70 W and a duration cut-off of 7 s at the anterior left atrium (LA) and 5 s at the posterior LA (HPSD group; n = 97) was compared to a conventional power protocol with 30-40 W for 20-40 s (standard group; n = 100) in terms of periprocedural complications and a 1-year outcome. The HPSD group showed significantly less arrhythmia recurrence during 1-year follow-up with 83.1% of patients free from atrial fibrillation compared to 65.1% in the standard group (P < 0.013). No pericardial tamponade, periprocedural thromboembolic complications, or atrio-oesophageal fistula occurred in either group. Mean radiofrequency time (12.4 ± 3.4 min vs. 35.6 ± 12.1 min) and procedural time (89.5 ± 23.9 min vs. 111.15 ± 27.9 min) were significantly shorter in the HPSD group compared to the standard group (both P < 0.001). CONCLUSION: High-power short-duration ablation demonstrated a comparable safety profile to conventional ablation. High-power short-duration ablation using 70 W for 5-7 s leads to significantly less arrhythmia recurrences after 1 year. Radiofrequency and procedural time were significantly shortened.

The incidence, indications and predictors of acute pacemaker implantation after ablation of persistent atrial fibrillation.

INTRODUCTION: Patients with persistent atrial fibrillation (AF) may additionally suffer from a concealed sinus node disease. We sought to determine the incidence, indications and predictors of acute pacemaker [PM] implantation within 1 week after the ablation of persistent AF. METHODS AND RESULTS: We performed a retrospective analysis of patients, who had had an ablation of persistent AF at our center. Between 01/2011 and 08/2016, 1234 patients (mean age 65 ± 10 years, 66.7% male) without prior PM implantation underwent an ablation of persistent AF. Pulmonary vein isolation (PVI) was performed in 1158 (93.8%), the additional ablation of complex fractionated atrial electrograms (CFAE) in 1109 (89.9%) and linear ablation in 524 (42.5%) patients. Temporary cardiac pacing was necessary in 27 (2.2%) patients. The temporary PM was removed in 15 patients (1.2%) because sinus node recovered after a median of 1.0 (minimum 0.1-maximum 2.0) day. The remaining 12 (1.0%) patients required the implantation of a permanent PM. Another 13 (1.1%) patients required permanent PM implantation without prior temporary pacing. In a multivariable regression model, age [OR 1.07 (1.02-1.12), p = 0.006], sinus pauses prior to ablation [OR 7.97 (2.36-26.88), p = 0.001] and atria with low voltage [OR 2.83 (1.31-6.11), p = 0.008] were identified as significant predictors for acute cardiac pacing. CONCLUSION: Acute cardiac pacing within 1 week after the ablation of persistent AF was necessary in 40 (3.2%) patients. Age, sinus pauses in history prior to ablation and the existence of low-voltage areas in the atria were identified as relevant risk factors.

Exclusion of left atrial thrombus by dual-source cardiac computed tomography prior to catheter ablation for atrial fibrillation.

OBJECTIVES: Thromboembolic complications during atrial fibrillation (AF) ablation due to mobilisation of a pre-existing thrombus formation (TF) in the left atrium (LA) are devastating. The gold standard to exclude LA TF is transesophageal echocardiography (TEE). The present study compares sensitivity and specificity of a dual-source cardiac-computed tomography (DS-CT) with TEE for TF exclusion prior to AF ablation. In addition, CT protocols with and without ECG synchronized were evaluated. METHODS: In 622 patients, DS-CT as well as TEE to exclude TF was performed less than 48 h prior to AF ablation. Mean age of patients was 60 ± 10 years (69% males, 61% paroxysmal AF). During DS-CT, 280 patients (45%) were in AF. An ECG-synchronized DS-CT was performed in 332 patients, whereas 290 patients underwent DS-CT without ECG synchronization. RESULTS: In all patients without suspected TF on DS-CT (n = 552; 88.7%), no thrombus was found on TEE. A TF was suspected on DS-CT in 70 patients, of whom only three patients showed TF on TEE. No TF was detected in the other 67 patients (Fig. 1). Overall, sensitivity for TF detection in DS-CT was 100% and specificity was 89.2% (positive predictive value 4.3%, negative predictive value 100%). The CT protocol (ECG-synchronized versus non-ECG-synchronized) had no significant influence on diagnostic accuracy. Mean dose length product during DS CT was 282 ± 287 mGy cm (synchronized) versus 136 ± 55 mGy cm (non-synchronized) with p < 0.0001. CONCLUSIONS: DS-CT is a highly sensitive method for LA thrombus detection in patients undergoing AF ablation. It delivers additional anatomic details of pulmonary veins and LA anatomy with an acceptable radiation exposure. Non-ECG-synchronized DS-CT showed a significantly lower radiation exposure, whereas diagnostic accuracy was comparable. Therefore, DS-CT might serve as primary method to exclude LA TF in patients undergoing AF ablation.

Safety of Uninterrupted Periprocedural Edoxaban Versus Phenprocoumon for Patients Who Underwent Left Atrial Catheter Ablation Procedures.

Data about the safety of edoxaban in patients who underwent left atrial (LA) radiofrequency (RF) ablation procedures are lacking. This study sought to compare the safety of uninterrupted edoxaban with uninterrupted phenprocoumon administration during LA RF ablation for atrial fibrillation and atrial tachycardia. In total, 231 patients (mean age 64 ± 11years, male 71%) who underwent LA RF ablation under continuous oral anticoagulation (OAC) with edoxaban or phenprocoumon were included in the study. Patients on uninterrupted edoxaban (60 mg or 30 mg/day for at least 4 weeks) were matched for gender, age and type of arrhythmia with 2 patients on uninterrupted phenprocoumon (international normalized ratio 2 to 3). We identified 77 consecutive patients on edoxaban and n = 154 patients on phenprocoumon. Heparin was administered periprocedurally to achieve an activated clotting time of 280 to 300 seconds. No protamine was administered periprocedurally. The primary end point was a composite of bleeding, thromboembolic events, and death. The primary end point was met in 9 patients in the edoxaban group and in 22 patients in the phenprocoumon group (p = 0.69). No patient in either group died or had a thromboembolic complication. No major bleeding complication was observed in the edoxaban group, whereas one was found in 1 patient in the phenprocoumon group (p ≥0.99). Minor bleeding complications occurred in 9 patients (12%) in the edoxaban group and in 21 patients (14%) in the phenprocoumon group (p = 0.84). Uninterrupted OAC with edoxaban appeared to be as safe as uninterrupted OAC with phenprocoumon in patients who underwent LA RF ablation procedures.

EP radiofrequency generators: Significant offsets between selected and delivered power?

INTRODUCTION: For radiofrequency (RF) ablation, the EP Shuttle® (Stockert GmbH, Freiburg, Germany), Ampere® (St. Jude Medical, St. Paul, MN, USA), and SmartAblate® (Biosense Webster, Diamond Bar, CA, USA) generator models are most frequently used in clinical practice. The aim of this study was to assess the correlation between selected and delivered RF power for different generators. METHODS AND RESULTS: In an experimental setup, ablation catheters were connected to the EP Shuttle® , Ampere® , and SmartAblate® generators. The power delivered by the generators was measured using a current converter and an oscilloscope. The selected power displayed on the generator was compared to the actually delivered power measured by the experimental setup (n = 800 measurements). The offsets between selected and delivered power increased significantly with impedance (EP Shuttle® ). For example, at a selected power of 30 W, the delivered power was 40.3 W (EP Shuttle® ), 30.1 W (Ampere® ), and 28.1 W (SmartAblate® ) at an impedance of 200 Ω. In addition, ablation lesions (n = 80) were created in ex vivo porcine cardiac muscle preparations. The resulting ablation lesion size was calculated in caliper measurements. When the EP Shuttle® generator was operated at 200 Ω, the resulting lesion size was significantly larger than at 100 Ω. There were no significant offsets between power delivery and lesion size when using the Ampere® or SmartAblate® generators. CONCLUSIONS: The Ampere® and SmartAblate® generator models deliver accurate power as selected by the user. The power delivered by the EP Shuttle® generator exceeds the selected power by up to 40% depending on impedance. The findings were confirmed in ex vivo porcine heart experiments and should be considered in clinical practice.

Catheter ablation of left atrial arrhythmias on uninterrupted oral anticoagulation with vitamin K antagonists: What is the relationship between international normalized ratio, activated clotting time, and procedure-related complications?

BACKGROUND: Ablation of atrial fibrillation (AF) on uninterrupted phenprocoumon reduces periprocedural thromboembolic and bleeding complications. Heparin is administered intraprocedurally to achieve activated clotting times (ACT) of 300-400 seconds. We investigated the effect of international normalized ratio (INR) on ACT and intraprocedural heparin requirements. Moreover, safety of a target ACT of 250-300 seconds was investigated. METHODS AND RESULTS: We studied 949 patients referred for AF or left atrial tachycardia ablation. Patients were divided into Group 1 (n = 249) with an INR <2 and Group 2 (n = 700) with an INR ≥2. Mean INR was 1.7 ± 0.13 in Group 1 and 2.3 ± 0.25 in Group 2. Baseline, mean, minimum and maximum ACT were significantly lower in Group 1 (138 ± 17 seconds vs. 145 ± 21 seconds; 281 ± 28 seconds vs. 288 ± 29 seconds; 251 ± 36 seconds vs. 258 ± 34 seconds; 307 ± 32 seconds vs. 316 ± 40 seconds; P <0.05). Intraprocedural heparin requirements adjusted to body weight were lower in Group 1 (127 ± 41 U/kg vs. 122 ± 40 U/kg). Weak correlations between INR and baseline, mean, minimum and maximum ACT as well as intraprocedural heparin requirements were observed. No differences regarding major or minor complications were found. INR and periprocedural anticoagulation parameters had no influence on major complications. No thromboembolic complications were observed in both groups with a target ACT value of 250-300 seconds. CONCLUSIONS: There is only a weak correlation between INR, intraprocedural ACT, and intraprocedural heparin requirements. Periprocedural target ACT of 250-300 seconds seems safe and does not increase periprocedural bleeding and thromboembolic complications in patients undergoing RF ablation on uninterrupted phenprocoumon therapy.

Multicenter, randomized comparison between magnetically navigated and manually guided radiofrequency ablation of atrioventricular nodal reentrant tachycardia (the MagMa-AVNRT-trial).

BACKGROUND: Remote magnetic navigation (RMN) is attributed to diminish radiation exposure for both patient and operator performing catheter ablation for different arrhythmia substrates. The purpose of this prospective, randomized study was to compare RMN with manually guided catheter ablation for AV nodal reentrant tachycardia (AVNRT) regarding fluoroscopy time/dosage, acute and long-term efficacy as well as safety. METHODS AND RESULTS: A total of 218 patients with AVNRT undergoing catheter ablation at three centers (male 34%, mean age 50 ± 17 years) were randomized to a manual approach (n = 113) or RMN (n = 105) using the Niobe® magnetic navigation system. The primary study endpoint was total fluoroscopy time/dosage for patient and operator at the end of the procedure. Secondary endpoints included acute success, procedure duration, complications and success rate after 6 months. Fluoroscopy time and dosage for the patient were significantly reduced in the RMN group compared to the manual group (6 ± 6 vs. 11 ± 10 min; p < 0.001 and 425 ± 558 vs. 751 ± 900 cGycm2, p = 0.002). A reduction in fluoroscopy time/dose also applied to the operator (3 ± 5 vs. 7 ± 9 min 209 ± 444 vs. 482 ± 689 cGycm2, p < 0.001). Procedure duration was significantly longer in the RMN group (88 ± 29 vs. 79 ± 29 min; p = 0.03) and crossover from the RMN group to manual ablation occurred in 7.6% of patients (7.6 vs. 0.1%; p = 0.02). Acute success was achieved in 100% of patients in both groups. Midterm success after 6 months was 97 vs. 98% (p = 0.67). No complications occurred in both groups. CONCLUSION: The use of RMN for catheter ablation of AVNRT compared to a manual approach results in a reduction of fluoroscopy time and dosage of about 50% for both patients and physicians. Acute and midterm success and safety are comparable. RMN is a good alternative to a manual approach for AVNRT ablation.

Safety and Feasibility of Subcutaneous Purse-String Suture of the Femoral Vein After Electrophysiological Procedures on Uninterrupted Oral Anticoagulation.

The aim of this study was to compare safety and feasibility of a subcutaneous purse-string suture (PSS) with manual compression (MC) to gain hemostasis in patients after multiple femoral venous punctures undergoing electrophysiological procedures on uninterrupted oral anticoagulation (OAK). A total of 784 patients who underwent catheter ablation for atrial fibrillation (n = 564) or (a)typical atrial flutter (n = 220) were assessed. Four hundred sixty-two patients received PSS (58.9%) and 322 patients (41.1%) received MC to gain hemostasis. All patients were on uninterrupted full-dose OAK. During the procedure, weight-adapted heparin was applied. Venous sheath diameter were 8Fr (n = 2)/11.5Fr (n = 1) for left atrial or 8Fr (n = 1)/6Fr (n = 2) for right atrial procedures. No protamine was administered at the end of the procedure. After PSS, patients' had 6 hours of bed rest compared with 10 hours after MC (sheath removal after 4 hours followed by a bandage for 6 hours). PSS was removed the following day. All patients underwent duplex sonography of the access site the following day. Using the PSS, hemostasis was achieved in 453 of 462 patients (98%). MC leads to hemostasis in all 322 patients. No difference was found between the 2 approaches regarding hematomas (<5 cm or >5 cm), arterio-venous fistulas, or pseudoaneurysms. No major complication such as ipsilateral leg ischemia, the need of vascular surgery, or deep vein thrombosis occurred. In conclusion, PSS is a safe and effective way to gain immediate hemostasis after multiple punctures of the femoral vein in patients undergoing catheter ablation on OAK. PSS avoids MC and leads to shorter patient immobilization.

Dissociated pulmonary vein activity after pulmonary vein isolation for paroxysmal atrial fibrillation: a predictor for recurrence?

BACKGROUND: The role of dissociated pulmonary vein (DPV) activity after pulmonary vein isolation (PVI) is still poorly defined. We evaluated electrophysiological features and clinical impact on long-term outcome of DPV activity. METHODS: A total of 243 patients (mean age 63 ± 11 years; 63% males) undergoing PVI for paroxysmal atrial fibrillation (AF) were included. DPV activity was defined as a residual low frequency irregular PV rhythm. Patients were divided into Group 1 (presence of DPV activity; n = 65) or Group 2 (absence of DPV activity; n = 178). RESULTS: Of 936 isolated PVs, 112 PVs (12%) showed DPV activity. DPV activity was observed more frequently in PVs identified as AF triggers (P = 0.026). During follow-up (mean 12 ± 7 months), 15 of 65 patients of Group 1 (23%) and 57 of 178 patients of Group 2 (32%) had an arrhythmia recurrence (P = 0.23). At linear regression analysis, no independent predictor for clinical recurrence was identified. During the repeat ablation, 62 of 72 patients (86%) showed a recovered PV conduction without difference between the 2 groups. Clinically, all patients of Group 1 with PV reconnection (n = 13/15) had a recurrence of paroxysmal AF. In Group 2, 5 of 52 patients with reconnected PV developed non-PV related arrhythmias. CONCLUSION: DPV activity occurred in 12% of PVs after PVI and was observed more frequently in PVs identified as AF triggers. DPV activity was not predictive for AF recurrence during follow-up. PV-left atrium reconnection involving PVs with DPV activity leads to AF.

Pre-differentiated human committed T-lymphoid progenitors promote peripheral T-cell re-constitution after stem cell transplantation in immunodeficient mice.

T-cell re-constitution after allogeneic stem cell transplantation (alloSCT) is often dampened by the slow differentiation of human peripheral blood CD34(+) (huCD34(+) ) hematopoietic stem cells (HSCs) into mature T cells. This process may be accelerated by the co-transfer of in vitro-pre-differentiated committed T/NK-lymphoid progenitors (CTLPs). Here, we analysed the developmental potential of huCD34(+) HSCs compared with CTLPs from a third-party donor in a murine NOD-scid IL2Rγ(null) model of humanised chimeric haematopoiesis. CTLPs (CD34(+) lin(-) CD45RA(+) CD7(+) ) could be generated in vitro within 10 days upon co-culture of huCD34(+) or cord blood CD34(+) (CB-CD34) HSCs on murine OP9/N-DLL-1 stroma cells but not in a novel 3-D cell-culture matrix with DLL-1(low) human stroma cells. In both in vitro systems, huCD34(+) and CB-CD34(+) HSCs did not give rise to mature T cells. Upon transfer into 6-wk-old immune-deficient mice, CTLPs alone did not engraft. However, transplantation of CTLPs together with huCD34(+) HSCs resulted in rapid T-cell engraftment in spleen, bone marrow and thymus at day 28. Strikingly, at this early time point mature T cells originated exclusively from CTLPs, whereas descendants of huCD34(+) HSCs still expressed a T-cell-precursor phenotype (CD7(+) CD5(+) CD1a(+/-) ). This strategy to enhance early T-cell re-constitution with ex vivo-pre-differentiated T-lymphoid progenitors could bridge the gap until full T-cell recovery in severely immunocompromised patients after allogeneic stem cell transplantation.