Myocardial injury and inflammation following pulsed-field ablation and very high-power short-duration ablation for atrial fibrillation.

INTRODUCTION: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) is an established treatment strategy for atrial fibrillation (AF). To improve PVI efficacy and safety, high-power short-duration (HPSD) ablation and pulsed-field ablation (PFA) were recently introduced into clinical practice. This study aimed to determine the extent of myocardial injury and systemic inflammation following PFA, HPSD, and standard RFA using established biomarkers. METHODS: We included 179 patients with paroxysmal AF receiving first-time PVI with different ablation technologies: standard RFA (30-40 W/20-30 s, n = 52), power-controlled HPSD (70 W/5-7 s, n = 60), temperature-controlled HPSD (90 W/4 s, n = 32), and PFA (biphasic, bipolar waveform, n = 35). High-sensitivity cardiac troponin T (hs-cTnT), creatine kinase (CK), CK MB isoform (CK-MB), and white blood cell (WBC) count were determined before and after ablation. RESULTS: Baseline characteristics were well-balanced between groups (age 63.1 ± 10.3 years, 61.5% male). Postablation hs-cTnT release was significantly higher with PFA (1469.3 ± 495.0 ng/L), HPSD-70W (1322.3 ± 510.6 ng/L), and HPSD-90W (1441.2 ± 409.9 ng/L) than with standard RFA (1045.9 ± 369.7 ng/L; p < .001). CK and CK-MB release was increased with PFA by 3.4-fold and 5.8-fold, respectively, as compared to standard RFA (p < .001). PFA was associated with the lowest elevation in WBC (Δ1.5 ± 1.5 × 109 /L), as compared to standard RFA (Δ3.8 ± 2.5 × 109 /L, p < .001), HPSD-70W (Δ2.7 ± 1.7 × 109 /L, p = .037), and HPSD-90W (Δ3.6 ± 2.5 × 109 /L, p < .001). CONCLUSION: Among the four investigated ablation technologies, PFA was associated with the highest myocardial injury and the lowest inflammatory reaction.

First clinical data on artificial intelligence-guided catheter ablation in long-standing persistent atrial fibrillation.

INTRODUCTION: Despite advanced ablation strategies and major technological improvements, treatment of persistent atrial fibrillation (AF) remains challenging and the underlying pathophysiology is not fully understood. This study analyzed the multiple procedure outcome and safety of catheter ablation of spatiotemporal dispersions (DISPERS) detected by artificial intelligence (AI)-guided software in patients with long-standing persistent AF. METHODS AND RESULTS: The Volta VX1 software was used for 50 consecutive patients undergoing catheter ablation for persistent AF. First, high-density mapping (78% biatrial) with a multipolar mapping catheter was performed. In addition to pulmonary vein isolation (PVI), ablation of DISPERS was performed aiming at homogenizing, dissecting, isolating, or connecting DISPERS areas to nonconducting anatomical structures. Follow-up contained regular visits at our outpatient clinic at 1, 3, 6, and 12 months including 7-day Holter electrocardiograms. Patients were mainly suffering from long-standing persistent AF (mean AF duration 50.30 ± 54.28 months). Following PVI, ablation of left atrial and right atrial DISPERS areas led to AF cycle length prolongation (mean of 162.0 ± 16.6 to 202.2 ± 21.6 ms after) and AF termination to atrial tachycardia (AT) or sinus rhythm (SR) in 12 patients (24%). No stroke or pericardial effusion occurred; major groin complications (pseudoaneurysm n = 1, atrioventricular fistula n = 1) were detected in two patients. After a blanking period of 6 weeks, recurrence of any atrial arrhythmia was documented in 26 patients (52%). The majority of patients presented with organized AT (n = 15) while AF was present in n = 9 patients and AT/AF was observed in n = 2 patients. Twenty-two patients underwent reablation. During a mean follow-up of 363.14 ± 187.42 days and after an average of 1.46 ± 0.68 procedures, 82% of patients remained in stable SR. CONCLUSION: DISPERS-guided ablation using machine learning software (the Volta VX1 software) in addition to PVI in long-standing persistent AF ablation resulted in high long-term success rates regarding AF and AT elimination. Most arrhythmia recurrences were reentrant AT. After a total of 1.46 ± 0.68 procedures, freedom from AF/AT was 82%. Despite prolonged procedure times complication rates were low. Randomized studies are necessary to evaluate long-term efficacy of dispersion-guided ablation using AI.

Radiofrequency ablation-Real-time visualization of lesions and their correlation with underlying parameters.

BACKGROUND: Lesion durability and transmurality are crucial for successful radiofrequency (RF) ablation. This study provides a model of real-time RF lesion visualization and insights into the role of underlying parameters, as local impedance (LI). METHODS: A force-sensing, LI-sensing catheter was used for lesion creation in an ex vivo model involving cross-sections of porcine cardiac preparations. During 60 s of RF application, one measurement per second was performed regarding lesion size and available ablation parameters. In total, 1847 measurements from n = 36 lesions were performed. Power (20-50 W) and contact force (1-5 g, 10-15 g, 20-25 g) were systematically alternated. RESULTS: Lesion formation was most prominent in the first seconds of RF application during which nonlinear lesion growth was observed (max. 1.08 mm/s for lesion depth and 2.71 mm/s for lesion diameter). Power levels determined the extent of lesion formation in the early phase. After 20 s, lesion size growth velocity approaches 0.1 mm/s at all power levels. LI changes were also highest in the first seconds (up to - 12 Ω/s) and decreased to less than - 0.1Ω/s after prolonged application. CONCLUSION: Lesion formation in irrigated RF ablation is a nonlinear process. Final lesion size resulting from an RF application is mainly influenced by high rates of lesion growth in the first seconds of ablation. LI seems to be a good surrogate for differentiating changes in lesion formation.

Safety profile and long-term efficacy of very high-power short-duration (60-70 W) catheter ablation for atrial fibrillation: results of a large comparative analysis.

AIMS: This retrospective study sought to compare complication rates and efficacy of power-controlled very high-power short-duration (vHPSD) and conventional catheter ablation in a large cohort of patients with atrial fibrillation (AF). METHODS AND RESULTS: We analyzed 1115 consecutive patients with AF (38.7% paroxysmal, 61.3% persistent) who received first-time catheter ablation at our centre from 2015 to 2021. Circumferential pulmonary vein isolation ± additional substrate ablation using an irrigated-tip catheter was performed with vHPSD (70 W/5-7 s or 60 W/7-10 s) in 574 patients and with conventional power (30-35 W/15-30 s) in 541 patients. Baseline characteristics were well-balanced between groups (mean age 65.1 ± 11.2 years, 63.4% male). The 30-day incidence of cardiac tamponade [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598], pericardial effusion ≥ 10 mm [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598] and transient ischaemic attack [1/574 (0.17%) vs. 2/541 (0.37%), P = 0.529] was not significantly different between vHPSD and conventional ablation. No stroke, atrio-esophageal fistula, cardiac arrest or death occurred. Procedure (122.2 ± 46.8 min vs. 155.0 ± 50.5 min, P < 0.001), radiofrequency (22.4 ± 19.3 min vs. 52.9 ± 22.0 min, P < 0.001), and fluoroscopy (8.1 ± 7.2 vs. 9.2 ± 7.4, P = 0.016) duration were significantly shorter in the vHPSD group. At 12 months follow-up, freedom of any atrial arrhythmia was 44.1% vs. 34.2% (P = 0.010) in persistent AF and 78.1% vs. 70.2% in paroxysmal AF (P = 0.068). CONCLUSION: vHPSD ablation is as safe as conventional ablation and is associated with an improved long-term efficacy in persistent AF.

High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?

AIMS: Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new 'high-power' charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. METHODS AND RESULTS: A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350 kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%-2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%-0.6%). The effective magnetic field along the charging cable was 38.65 µT and at the charging station was 77.9 µT. CONCLUSIONS: The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.

The influence of electrode-tissue-coverage on RF lesion formation and local impedance: Insights from an ex vivo model.

BACKGROUND: The influence of power, duration and contact force (CF) on radiofrequency (RF) lesion formation is well known, whereas data on local impedance (LI) and electrode-tissue-coverage (ETC) is scarce. The objective was to investigate their effect on lesion formation in an ex vivo model. METHODS AND RESULTS: An ex vivo model was developed utilizing cross-sections of porcine heart preparations and a force-sensing, LI-measuring catheter. N = 72 lesion were created systematically varying ETC (minor/full), CF (1-5 g, 10-15 g, 20-25 g) and power (20 W, 30 W, 40 W, 50 W). In minor ETC, the distal tip of the catheter was in electric contact with the tissue, in full ETC the whole catheter tip was embedded within the tissue. Lesion size and all parameters were measured once per second (n = 3320). LI correlated strongly with lesion depth (r = -0.742 for ΔLI; r = 0.781 for %LI-drop). Lesions in full ETC were significantly wider and deeper compared to minor ETC (p < .001) and steam pops were more likely. Baseline LI, ΔLI, and %LI-drop were significantly higher in full ETC (p < .001). In lesions resulting in steam pops, baseline LI, and ΔLI were significantly higher. The influence of CF on lesion size was higher in minor ETC than in full ETC. CONCLUSIONS: ETC is a main determinant of lesion size and occurrence of steam pops. Baseline LI and LI-drop are useful surrogate parameters for real-time assessment of ETC and ΔLI correlates strongly with lesion size.

Bipolar ablation of therapy-refractory ventricular arrhythmias: application of a dedicated approach.

AIMS: Bipolar radiofrequency ablation (B-RFA) has been reported as a bail-out strategy for the treatment of therapy refractory ventricular arrhythmias (VA). Currently, existing setups have not been standardized for B-RFA, while the impact of conventional B-RFA approaches on lesion formation remains unclear. METHODS AND RESULTS: (i) In a multicentre observational study, patients undergoing B-RFA for previously therapy-refractory VA using a dedicated B-RFA setup were retrospectively analysed. (ii) Additionally, in an ex vivo model lesion formation during B-RFA was evaluated using porcine hearts. In a total of 26 procedures (24 patients), acute success was achieved in all 14 ventricular tachycardia (VT) procedures and 7/12 procedures with premature ventricular contractions (PVC), with major complications occurring in 1 procedure (atrioventricular block). During a median follow-up of 211 days in 21 patients, 6/11 patients (VT) and 5/10 patients (PVC) remained arrhythmia-free. Lesion formation in the ex vivo model during energy titration from 30 to 50 W led to similar lesion volumes compared with initial high-power 50 W B-RFA. Lesion size significantly increased when combining sequential unipolar and B-RFA (1429 mm3 vs. titration 501 mm3 vs. B-RFA 50 W 423 mm3, P < 0.001), an approach used in overall 58% of procedures and more frequently applied in procedures without VA recurrence (92% vs. 36%, P = 0.009). Adipose tissue severely limited lesion formation during B-RFA. CONCLUSION: Using a dedicated device for B-RFA for therapy-refractory VA appears feasible and safe. While some patients need repeat ablation, success rates were encouraging. Sequential unipolar and B-RFA may be favourable for lesion formation.

Feasibility and safety of left atrial access for ablation of atrial fibrillation in patients with persistent left superior vena cava.

BACKGROUND: In patients with persistent left superior vena cava (PLSVC) ablation procedures can be challenging. We sought to determine the feasibility and safety of left atrial ablations in patients with PLSVC, especially when PLSVC is unknown prior to the ablation procedure. METHODS AND RESULTS: In this retrospective analysis 15 adult patients (mean age 64.6 ± 14.5 years, 53.3% male) with PLSVC undergoing 27 ablation procedures for atrial fibrillation or left atrial flutter were included. In 5 (33.3%) patients PLSVC was only discovered during the procedure. Transseptal puncture (TSP) was declared "difficult" by the ablating physician in 13 of 27 (48.2%) procedures and was not successfully completed in the first attempt in two patients with known PLSVC. Once TSP was successfully completed, all relevant structures were reached both during mapping and ablation in all procedures independent of whether PLSVC was known prior to the procedure. One major complication (3.7%) occurred in 27 procedures in a patient with known PLSVC. In the patients with unknown PLSVC no complication occurred. CONCLUSION: In experienced hands, left atrial access and ablation in patients with PLSVC is feasible and safe, particularly with regard to patients in whom the PLSVC is unknown prior to the ablation procedure.

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.

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.

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.

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.

Correlation between atrial fibrillation driver locations and complex fractionated atrial electrograms in patients with persistent atrial fibrillation.

INTRODUCTION: The aim of this study was to evaluate a spatial correlation between active atrial fibrillation (AF) drivers measured by electrocardiographic imaging and complex fractionated atrial electrograms (CFAEs) in patients with persistent AF. METHODS: Sixteen patients with persistent AF were included. A biatrial geometry relative to an array of 252-body-surface-electrodes was obtained from a noncontrast computed tomography scan. The reconstructed unipolar AF electrograms were signal-processed (ECVUE™, CardioInsight Technologies Inc., Cleveland, OH, USA) to identify AF drivers. Before driver ablation, a biatrial mapping using the NavX system (St. Jude Medical, St. Paul, MN, USA) was performed to identify CFAEs. CFAE and driver regions were then quantified and compared. RESULTS: AF was terminated by driver ablation in 11/16 (70%) patients. The mean number of ablated driver regions was 4 ± 1 per patient. The most frequent driver locations were the inferior left atrium and coronary sinus, the right pulmonary veins, and the right atrium. In 49/63 (78%) of the driver locations, more than 75% of the driver site showed CFAEs. The mean ablated driver area was 58 ± 24 cm2 (19 ± 11% of total surface area). The mean CFAE area was 178 ± 59 cm2 (49 ± 16%). The percentage of non-ablated CFAE area was 76 ± 13% of total CFAEs. In 9/11 patients with AF termination, the termination site showed CFAEs. CONCLUSIONS: There is a significant overlap between AF driver regions identified by the ECVUE™ system and CFAE areas identified by the NavX system. AF driver regions are smaller and mostly embedded in larger CFAE areas. Selective ablation of drivers in CFAE areas seems sufficient to terminate persistent AF in the majority of patients.

Ablation of Complex Fractionated Electrograms With or Without ADditional LINEar Lesions for Persistent Atrial Fibrillation (The ADLINE Trial).

BACKGROUND: For persistent atrial fibrillation (AF) ablation, different strategies including complex fractionated atrial electrograms (CFAE) ablation and linear lesions (LL) have been used in addition to pulmonary vein isolation (PVI). However, it is still a matter of debate if extended substrate modification improves long-term outcome. The aim of this study was to determine the benefit of LL in addition to PVI and CFAE ablation regarding freedom from arrhythmia recurrence in patients with persistent AF. METHODS: The study was a prospective randomized trial including 90 patients with persistent and longstanding persistent AF. All patients underwent PVI and CFAE ablation. If AF did not terminate to atrial tachycardia (AT) or sinus rhythm, patients were randomized to direct current cardioversion (Group 1; n = 45) or LL (Group 2; n = 45). Primary endpoint was freedom from any atrial arrhythmia off antiarrhythmic drugs at 12 months. (NCT02059369) RESULTS: Baseline characteristics were similar between the two groups with more than half of the patients having structural heart disease. The primary endpoint was reached in 37% in Group 1 (G1) and 16% in Group 2 (G2; P = 0.03). After a total number of 1.4 ± 0.5 (G1) versus 1.7 ± 0.4 (G2; P = 0.01) procedures, freedom from any arrhythmia was reached in 54% in G1 and 65% in G2 (P = 0.35). CONCLUSION: In persistent AF ablation, LL in addition to PVI and CFAE show a significantly lower success rate after a single procedure compared to PVI and CFAE. Following LL, significantly more patients needed a reablation to reach a similar success rate during a 12-month follow-up.

Fiberoptic Contact-Force Sensing Electrophysiological Catheters: How Precise Is the Technology?

BACKGROUND: Contact-force (CF) sensing catheters are increasingly used in electrophysiological procedures due to their efficacy and safety profile. As data about the accuracy of fiberoptic CF technology are scarce, we sought to quantify it using in vitro experiments. METHODS AND RESULTS: A force sensor was built with a flexible membrane to allow exact reference force measurements for each set of experiments. A TactiCath Quartz (TCQ) ablation catheter was brought in contact with the force sensor membrane in order to compare the TCQ force measurements to sensor reference force measurements. Measurements were performed at different tip angles (0°/perpendicular contact, 45°, 90°/parallel contact), with fluid irrigation, different degrees of catheter deflection, and using a sheath. The accuracy of the TCQ force measurements was 0.9 ± 0.9 g (0°), 0.8 ± 0.8 g (45°) and 1.2 ± 1.3 g (90°), 0.8 ± 0.7 g (irrigation), 0.8 ± 0.8 g (deflection), and 0.8 ± 0.9 g (sheath); this was not significantly different among all experimental conditions. The precision was ≤3.8%. CONCLUSION: CF measurements using a fiberoptic sensing technology show a high level of accuracy and precision, without being significantly influenced by tip angle, fluid irrigation, catheter deflection or use of a sheath.

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.

Irrigated-tip catheters for radiofrequency ablation of right-sided accessory pathways in adolescents.

BACKGROUND: Catheter ablation of right-sided accessory pathways (APs) has lower success and higher recurrence rates compared to left-sided substrates. Irrigated-tip catheter (ITC) ablation might offer an advantage in this setting but data about its use in patients below 18 years are scarce. The aim of this study was to compare an ITC approach to conventional catheter ablation. METHODS: A retrospective analysis of all patients <18 years undergoing radiofrequency ablation (RFA) for right-sided APs from 2004 to 2014 at our institution was performed. Patients either underwent an ITC approach in combination with 3-D mapping (Group 1; n  =  53) or a conventional non-ITC approach (Group 2; n  =  52). Study endpoints were acute procedural success, safety, and recurrence rate. A total of 105 mostly adolescent patients (56.2% male; median age 14 years) with 107 right-sided APs were included. RESULTS: The prevailing anatomic AP locations were right posteroseptal (44.9%), right anterior/anterolateral (24.3%), and right lateral (13.1%). Acute success (94.3% vs 94.2%) did not differ between the groups. One major complication (pericardial effusion) occurred in the non-ITC group. Overall, freedom from AP recurrence was 94% at 4 years in the ITC group, and 81% at 4 years in the non-ITC group (P  =  0.04). CONCLUSIONS: The use of ITCs in combination with 3-D mapping system for ablation of right-sided APs in adolescents has a high acute success rate, is safe, and associated with a significantly reduced recurrence rate compared to a non-ITC/conventional approach. It might be considered as alternative approach in this age group.

Transseptal Puncture Guided by CT-Derived 3D-Augmented Fluoroscopy.

BACKGROUND: Transseptal puncture for left atrial (LA) access is still mainly performed using fluoroscopy and transesophageal or intracardiac echocardiography. We present an easily applicable approach for the guidance of transseptal puncture that uses the combination of a 3D-mapping system and CT-derived 3D-overlayed anatomy. METHODS AND RESULTS: A computer tomographic (CT) LA-angiography was performed in n = 65 patients prior to a scheduled atrial fibrillation ablation procedure. The CARTO3 (Biosense Webster, Diamond Bar, CA, USA) segmentation tool was used to create a 3D-reconstruction of cardiac anatomy and the spine. The CARTO UNIVU module was then used to overlay and register the segmented 3D-anatomy onto fluoroscopy. The 3D-reconstructed spine and cardiac anatomy were congruently aligned to their fluoroscopic counterparts in fluoroscopic views. The feasibility of the technique, its safety, and accuracy (assessed as contour offsets between 3D-overlay and angiographic LA anatomy) were evaluated. Overlay registration accuracy was analyzed by CARTO3 registration matrices. Transseptal puncture was feasible without complications in all 65 patients using the new 3D-overlay technique. Three-dimensional-overlay contour offsets were 1.6 ± 1.2 mm in left PV, 1.7 ± 1.2 mm in right PV, and 1.3 ± 1.0 mm in the LA roof region. Overlay registration accuracy was 4.9 ± 2.7 mm. The average time needed for anatomy segmentation was 204 ± 61 seconds, time needed for overlay registration was 18 ± 8 seconds. CONCLUSIONS: Three-dimensional-augmented fluoroscopy is feasible, safe, and easy to apply as guidance for transseptal puncture and demonstrates a high level of accuracy.

Electromagnetic Contact-Force Sensing Electrophysiological Catheters: How Accurate is the Technology?

BACKGROUND: Contact-force (CF) sensing catheters are increasingly used in clinical electrophysiological practice due to their efficacy and safety profile. As data about the accuracy of this technology are scarce, we sought to quantify accuracy based on in vitro experiments. METHODS AND RESULTS: A custom-made force sensor was constructed that allowed exact force reference measurements registered via a flexible membrane. A Smarttouch Surround Flow (ST SF) ablation catheter (Biosense Webster, Diamond Bar, CA, USA) was brought in contact with the membrane of the force sensor in order to compare the ST SF force measurements to force sensor reference measurements. ST SF force sensing technology is based on deflection registration between the distal and proximal catheter tip. The experiment was repeated for n = 10 ST SF catheters, which showed no significant difference in accuracy levels. A series of measurements (n = 1200) was carried out for different angles of force acting to the catheter tip (0°/perpendicular contact, 30°, 60°, 90°/parallel contact). The mean absolute differences between reference and ST SF measurements were 1.7 ± 1.8 g (0°), 1.6 ± 1.2 g (30°), 1.4 ± 1.3 g (60°), and 6.6 ± 5.9 g (90°). Measurement accuracy was significantly higher in non-parallel contact when compared with parallel contact (P < 0.01). CONCLUSIONS: Catheter force measurements using the ST SF catheters show a high level of accuracy regarding differences to reference measurements and reproducibility. The reduced accuracy in measurements of 90° acting forces (parallel contact) might be clinically important when creating, for example, linear lesions.

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures.

AIMS: This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. METHODS AND RESULTS: From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose-area products were 877.9 ± 624.7 µGym² (n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² (n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² (n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² (n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min (P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min (P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min (P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min (P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups (P = 1.0). CONCLUSION: The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures.