Validation of the accuracy of contact force measurement by contemporary force-sensing ablation catheters.

INTRODUCTION: Contact force sensing catheters are widely used for ablation of cardiac arrhythmias. They allow quantification of catheter-to-tissue contact, which is an important determinant for lesion formation and may reduce the risk of complications. The accuracy of these sensors may vary across the measurement range, catheter-to-tissue angle, and amongst manufacturers. We aim to compare the accuracy and reproducibility of four different force sensing ablation catheters. METHODS: A measurement setup containing a heated saline water bath with an integrated force measurement unit was constructed and validated. Subsequently, we investigated four different catheter models, each equipped with a unique measurement technology: Tacticath Quartz (Abbott), AcQBlate Force (Biotronik/Acutus), Stablepoint (Boston Scientific), and Smarttouch SF (Biosense Webster). For each model, the accuracy of three different catheters was measured within the range of 0-60 g and at contact angles of 0°, 30°, 45°, 60°, and 90°. RESULTS: In total, 6685 measurements were performed using 4 × 3 catheters (median of 568, interquartile range: 511-606 measurements per catheter). Over the entire measurement-range, the force measured by the catheters deviated from the real force by the following absolute mean values: Tacticath 1.29 ± 0.99 g, AcQBlate Force 2.87 ± 2.37 g, Stablepoint 1.38 ± 1.29 g, and Smarttouch 2.26 ± 2.70 g. For some models, significant under- and overestimation of >10 g were observed at higher forces. Mean absolute errors of all models across the range of 10-40 g were <3 g. CONCLUSION: Contact measured by force-sensing catheters is accurate with 1-3 g deviation within the range of 10-40 g. Significant errors can occur at higher forces with potential clinical consequences.

Eliminating transseptal sheath exchange for pulsed field ablation procedures using a direct over-the-needle transseptal access with the Faradrive sheath.

AIMS: Pulsed field ablation (PFA) for pulmonary vein isolation (PVI) combines the benefits of high procedural efficacy and safety. Transseptal puncture (TSP) to obtain left atrial (LA) access during PVI remains an important source of complications during LA procedures. For PFA procedures, TSP is generally performed using a standard transseptal sheath that is then exchanged over the wire for a dedicated PFA sheath, which might be a potential source for air embolism. We aimed to prospectively evaluate the feasibility and safety of a simplified workflow using the PFA sheath (Faradrive, Boston Scientific) directly for TSP. METHODS AND RESULTS: We prospectively enrolled 100 patients undergoing PVI using PFA at two centres. TSP was performed using the PFA sheath and a standard 98 cm transseptal needle under fluoroscopic guidance. TSP via the PFA sheath was successfully performed in all patients and no complications occurred. The median time from the first groin puncture to the completed LA access was 12 min (IQR 8-16 min). CONCLUSION: An over-the-needle TSP directly with the PFA sheath proved feasible and safe in our study. This simplified workflow has the potential to reduce the risk of air embolism, to shorten procedure time, and to reduce cost.

Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures.

AIMS: To validate the performance of a multipolar pulsed-field ablation (PFA) catheter compared to a standard pentaspline 3D-mapping catheter for endpoint assessment of pulmonary vein isolation (PVI). PFA for PVI using single-shot devices combines the benefits of high procedural efficacy and safety. A newly available multipolar PFA catheter allows real-time recording of pulmonary vein (PV) signals during PVI. METHODS AND RESULTS: Patients undergoing first PVI using PFA with the standard ablation protocol (eight applications per PV) were studied. Entrance and exit block (10 V/2 ms) were assessed using the PFA catheter. Subsequently, a high-density 3D electroanatomical bipolar voltage map (3D-EAM) was constructed using a standard pentaspline 3D-mapping catheter. Additional PFA applications were delivered only after confirmation of residual PV connection by 3D-EAM. In 56 patients, 213 PVs were targeted for ablation. Acute PVI was achieved in 100% of PVs: in 199/213 (93%) PVs with the standard ablation protocol alone and in the remaining 14 PVs after additional PFA applications. The accuracy of PV assessment with the PFA catheter after the standard ablation protocol was 91% (194/213 veins). In 5/213 (2.3%) PVs, the PFA catheter incorrectly indicated PV-isolation. In 14/213 (6.6%), the PFA catheter incorrectly indicated residual PV-conduction due to high-output pace-capture. Lowering the output to 5 V/1 ms reduced this observation to 0.9% (2/213) and increased the overall accuracy to 97% (206/213). CONCLUSION: A novel multipolar PFA catheter allows reliable endpoint assessment for PVI. Due to its design, far-field sensing and high-output pace-capture can occur. Lowering the pacing output increases the accuracy from 91 to 97%.

Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome.

AIMS: The aim of the study was to compare the 1-year efficacy and safety of a novel cryoballoon (NCB) ablation system (POLARx; Boston Scientific) for pulmonary vein isolation (PVI) compared with the standard cryoballoon (SCB) system (Arctic Front, Medtronic). METHODS AND RESULTS: Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB at two centres were included. We report 1-year efficacy after 12 months, short-term safety and hospitalizations within the blanking period, and predictors for AF recurrence. In case of repeat procedures, pulmonary vein (PV) reconnection patterns were characterized. Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 39 ± 13 mL/m2, paroxysmal AF in 64%) were studied. After a single procedure and a follow-up of 12 months, 68% in the NCB group and 70% in the SCB group showed no recurrence of AF/atrial tachycardias (P = 0.422). One patient in the NCB group suffered a periprocedural stroke with full recovery. There were no differences regarding hospitalizations during follow-up between the groups. PV reconnection observed during 12 repeat procedures (4 NCB, 8 SCB) pattern was comparable between the groups with more reconnections in the right-sided compared with the left-sided PVs. CONCLUSION: In this multicentre study comparing two currently available cryoballoon ablation systems for PVI, no differences were observed in the efficacy and safety during a follow-up of 12 months.

Efficacy and safety of ethanol infusion into the vein of Marshall for mitral isthmus ablation.

INTRODUCTION: Chemical ablation by retrograde infusion of ethanol into the vein of Marshall (VOM-EI) can facilitate the achievement of mitral isthmus block. This study sought to describe the efficacy and safety of this technique. METHODS AND RESULTS: Twenty-two consecutive patients (14 males, median age 71 years) with attempted VOM-EI for mitral isthmus ablation were included in the study. VOM-EI was successfully performed with a median of 4 ml of 96% ethanol in 19 patients (86%) and the mitral isthmus was successfully blocked in all (100%). Touch up endocardial and/or epicardial ablation after VOM-EI was necessary for 12 patients (63%). Perimitral flutter was present in 12 patients (63%) during VOM-EI and terminated or slowed by VOM-EI in 4 and 3 patients, respectively. The low-voltage area of the mitral isthmus region increased from 3.1 cm2 (interquartile range [IQR] 0-7.9) before to 13.2 cm2 (IQR: 8.2-15.0) after VOM-EI and correlated significantly with the volume of ethanol injected (p = .03). Median high-sensitive cardiac troponin-T increased significantly from 330 ng/L (IQR: 221-516) the evening of the procedure to 598 ng/L (IQR: 382-769; p = .02) the following morning. A small pericardial effusion occurred in three patients (16%), mild pericarditis in one (5%), and uneventful VOM dissection in two (11%). After a median follow-up of 3.5 months (IQR: 3.0-11.0), 10 of 18 patients (56%) with VOM-EI and available follow-up had arrhythmia recurrence. Repeat ablation was performed in five patients (50%) and peri-mitral flutter diagnosed in three (60%). CONCLUSION: VOM-EI is feasible, safe, and effective to achieve acute mitral isthmus block.

Left atrial anatomy, atrial fibrillation burden, and P-wave duration-relationships and predictors for single-procedure success after pulmonary vein isolation.

Aims: Atrial fibrillation (AF) is associated with changes in left atrial (LA) volume, but the relationship between LA size, AF burden, and electrical conduction behaviour is still uncertain. The aim of this study was to quantify the association and impact of these parameters on the single-procedure outcome after circumferential antral ablation for pulmonary vein isolation. Methods and results: Left atrial assessment was performed in 129 consecutive patients using pre-procedural imaging in three dimensions (sphericity, indexed volume), two dimensions (diameters), and from echocardiography in one dimension (long axis). Atrial fibrillation burden was classified based on the clinical assessment as paroxysmal and persistent and based on a validated scoring system including frequency, duration of AF episodes, and number of cardioversions into four grades (minimal, mild, moderate, and severe). P-wave duration and PR interval was measured on the 12-lead electrocardiogram at the end of the procedure. Atrial fibrillation burden score (AFB) was minimal (2%), mild (75%), moderate (9%), and severe (14%) and 65% had paroxysmal and 35% had persistent AF. The recurrence rate was significantly higher in patients with persistent AF, with higher AFB, with prolonged P-wave, and with an indexed LA volume > 55 mL/m2. In multivariable analysis, AFB (hazard ratio: 2.018(1.383-2.945), P > 0.001) and a prolonged P-wave (hazard ratio: 2.612(1.248-5.466), P = 0.011) were identified as significant predictors for AF recurrence. Conclusions: In our cohort of patients with symptomatic AF, the AFB and the P-wave duration but none of the anatomical parameter revealed to be independent predictors for AF/AT recurrence after circumferential antral pulmonary vein isolation.

Reliability of luminal oesophageal temperature monitoring during radiofrequency ablation of atrial fibrillation: insights from probe visualization and oesophageal reconstruction using magnetic resonance imaging.

AIMS: A current concept to prevent atrio-oesophageal fistula during radiofrequency (RF) catheter ablation of atrial fibrillation is to monitor luminal oesophageal temperature (LET). The objective of this study was to describe the temporal course of LET and to assess the reliability of monitoring the maximal LET during pulmonary vein isolation (PVI) using irrigated multi-electrode (IMEA, nMARQTM) and focal ablation catheters. METHODS AND RESULTS: We studied 40 patients with LET monitoring during PVI (20 patients using the IMEA and 20 patients using the focal catheter). A linear probe was used and visualized in the 3D mapping system. Left atrial and oesophageal reconstructions from delayed enhanced magnetic resonance imaging were integrated. Analysing 745 temperature profiles, LET >38°C was observed in 48 of 296 (17%) and 44 of 449 (10%) ablations for the IMEA and the focal catheter, respectively (P = 0.012). Temporal latency after interruption of RF energy delivery was observed for both catheters. Time until LET baseline temperature was restored after an increase of >1°C was 100 and 86 s for the IMEA and the focal catheter, respectively (P = 0.183). Imprecise representation of the maximal LET was observed in 24 (60%) and 28 patients (70%) for the left and right PVs, respectively. CONCLUSION: Due to the unknown exact lateral position of the LET probe within the oesophagus, the measured temperature does not necessarily reflect the maximal LET. The absence of LET increase does not rule out significant temperature increase within the oesophagus. Consequently, the temperature information of the linear multipolar probe should be used with caution.

One-year follow-up after irrigated multi-electrode radiofrequency ablation of persistent atrial fibrillation.

AIMS: Irrigated multi-electrode ablation (IMEA) is a novel tool to perform pulmonary vein isolation (PVI). The aim was to compare IMEA with point-by-point radiofrequency (RF) ablation in patients with persistent atrial fibrillation (AF) undergoing PVI. METHODS AND RESULTS: Forty-nine patients (age 60 ± 9 years, 82% male) were studied. In 24 patients, the IMEA catheter was used in conjunction with an electroanatomic mapping system. Twenty-five patients undergoing RF point-by-point ablation (RF-PVI) served as a control group. Validation of PVI based on the IMEA catheter was performed using a standard circular mapping catheter. Ninety-two of 94 pulmonary veins (PVs) (98%) were isolated using IMEA alone. Procedure time was 125 ± 23 min in the IMEA group and 127 ± 31 min in the RF-PVI group (P = 0.79). Fluoroscopy time was 12.2 (11-16.1) min with IMEA compared with 5.2 (4.1-9.3) min in the RF-PVI group (P < 0.001). Net ablation time was 11.8 (10.2-15.4) min in the IMEA group compared with 33.6 (30.3-40.1) min in the RF-PVI group (P < 0.001). Of 94 PVs presumed to be isolated after IMEA ablation, validation using a standard circular mapping catheter showed persistent PV potentials in 33 PVs (35%), requiring additional IMEA ablation. At 12 months, 16 of 24 patients (67%) in the IMEA group compared with 17 of 25 patients (68%) in RF-PVI group were free from AF (P > 0.99). CONCLUSION: With similar total procedure duration, IMEA-PVI was associated with shorter net ablation time and longer fluoroscopy time. Irrigated multi-electrode ablation recordings were not sufficient to confirm isolation in 35% of PVs. Single-procedure efficacy after 12 months was similar between the two groups.

Effective reduction of fluoroscopy duration by using an advanced electroanatomic-mapping system and a standardized procedural protocol for ablation of atrial fibrillation: 'the unleaded study'.

AIMS: It is recommended to keep exposure to ionizing radiation as low as reasonably achievable. The aim of this study was to determine whether fluoroscopy-free mapping and ablation using a standardized procedural protocol is feasible in patients undergoing pulmonary vein isolation (PVI). METHODS AND RESULTS: Sixty consecutive patients were analysed: Thirty consecutive patients undergoing PVI using Carto3 were treated using a standardized procedural fluoroscopy protocol with X-ray being disabled after transseptal puncture (Group 1) and compared with a set of previous 30 consecutive patients undergoing PVI without a specific recommendation regarding the use of fluoroscopy (Group 2). The main outcome measures were the feasibility of fluoroscopy-free mapping and ablation, total fluoroscopy time, total dose area product (DAP), and procedure time. Sixty patients (age 60 ± 10 years, 73% male, ejection fraction 0.55 ± 0.09, left atrium 42 ± 8 mm) were included. In Group 1, total fluoroscopy time was 4.2 (2.6-5.6) min and mapping and ablation during PVI without using fluoroscopy was feasible in 29 of 30 patients (97%). In Group 2, total fluoroscopy time was 9.3 (6.4-13.9) min (P < 0.001). Total DAP was 13.2 (6.2-22.2) Gy*cm(2) in Group 1 compared with 17.5 (11.7-29.7) Gy*cm(2) in Group 2 (P = 0.036). Total procedure time did not differ between Groups 1 (133 ± 37 min) and 2 (134 ± 37 min, P = 0.884). CONCLUSION: Performing mapping and ablation guided by an electroanatomic-mapping system during PVI without using fluoroscopy after transseptal puncture using a standardized procedural protocol is feasible in almost all patients and is associated with markedly decreased total fluoroscopy duration and DAP.

Pulsed-field ablation for the treatment of left atrial reentry tachycardia.

BACKGROUND: We describe our initial experience using a multipolar pulsed-field ablation catheter for the treatment of left atrial (LA) reentry tachycardia. METHODS: We included all patients with LA reentry tachycardia treated with PFA at our institution between September 2021 and March 2022. The tachycardia mechanism was identified using 3D electro-anatomical mapping (3D-EAM). Subsequently, a roof line, anterior line, or mitral isthmus line was ablated as appropriate. Roof line ablation was always combined with LA posterior wall (LAPW) ablation. Positioning of the PFA catheter was guided by a 3D-EAM system and by fluoroscopy. Bidirectional block across lines was verified using standard criteria. Additional radiofrequency ablation (RFA) was used to achieve bidirectional block as necessary. RESULTS: Among 22 patients (median age 70 (59-75) years; 9 females), we identified 27 LA reentry tachycardia: seven roof dependent macro-reentries, one posterior-wall micro-reentry, twelve peri-mitral macro-reentries, and seven anterior-wall micro-reentries. We ablated a total of 20 roof lines, 13 anterior lines, and 6 mitral isthmus lines. Additional RFA was necessary for two anterior lines (15%) and three mitral isthmus lines (50%). Bidirectional block was achieved across all roof lines, 92% of anterior lines, and 83% of mitral isthmus lines. We observed no acute procedural complications. CONCLUSION: Ablation of a roof line and of the LAPW is feasible, effective, and safe using this multipolar PFA catheter. However, the catheter is less suited for ablation of the mitral isthmus and the anterior line. A focal pulsed-field ablation catheter may be more effective for ablation of these lines. This study shows the feasibility to ablate linear lesions with a multipolar pulsed-field ablation catheter. 27 left atrial reentry tachycardia were treated in 22 patients.

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation.

PURPOSE: The aim was to report procedural and technical differences of a novel cryoballoon (NCB) ablation catheter for pulmonary vein isolation (PVI) compared to the standard cryoballoon (SCB) catheter. METHODS: Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB were included. Procedural parameters, technical differences, acute efficacy, and safety are reported. RESULTS: Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 40 ± 6 ml/m2) were studied. With the NCB, 156 of 158 PVs (99%) were isolated compared to isolation of 159 of 159 PVs (100%) with the SCB. The median number of freezes in the NCB and the SCB group was 6 (IQR 5-8) and 5 (IQR 4-7), respectively (p = 0.051), with 73% and 71% of the PVs isolated with a single freeze, respectively. Nadir temperature and temperature at isolation were - 59 ± 6 °C and - 45 ± 17 °C in the NCB group and - 46 ± 7 °C and - 32 ± 23 °C in the SCB group, respectively (both p < 0.001) with no difference in time to isolation (TTI). Procedural differences were observed for the total procedure time (84 ± 29 min in the NCB group and 65 ± 17 min in the SCB group, p = 0.003). There was a peri-procedural stroke in one patient in the NCB group. Differences in catheter design were observed that may account for the differences in temperature recordings and ice cap formation. CONCLUSIONS: Acute efficacy and TTI were similar with the NCB compared to the SCB. Measured temperatures were lower with the NCB, most likely due to differences in catheter design.

Dexmedetomidine versus propofol for operator-directed nurse-administered procedural sedation during catheter ablation of atrial fibrillation: A randomized controlled study.

BACKGROUND: Operator-directed nurse-administered (ODNA) sedation with propofol (PRO) is the preferred sedation technique for catheter ablation of atrial fibrillation (AF) in many centers. OBJECTIVE: The purpose of this study was to investigate whether dexmedetomidine (DEX), an α2-adrenergic receptor agonist, is superior to propofol. METHODS: We randomized 160 consecutive patients undergoing first AF ablation to ODNA sedation by DEX (DEX group) vs PRO (PRO group), according to a standardized protocol. Patients were unaware of treatment allocation. The primary endpoint was a composite of inefficient sedation, termination/change of sedation protocol or procedure abortion, hypercapnia (transcutaneous CO2 >55 mm Hg), hypoxemia (SpO2 <90%) or intubation, prolonged hypotension (systolic blood pressure <80 mm Hg), and sustained bradycardia necessitating cardiac pacing. Secondary endpoints were the components of the primary endpoint and patient satisfaction with procedural sedation, as assessed by a standardized questionnaire given the day after ablation. RESULTS: The primary endpoint occurred in 15 DEX group and 25 PRO group patients (19% vs 31%; P = .068). Hypercapnia was significantly more frequent in PRO group patients (29% vs 10%; P = .003). There was no significant difference for the other components of the primary endpoint, and no procedure was aborted. Patient satisfaction was significantly better among PRO group patients (visual analogue scale 0-100; median 100 in PRO group vs median 93 in DEX group; P <.001). CONCLUSION: Efficacy of ODNA sedation with DEX was not different from that with PRO. Hypercapnia occurs less frequently with DEX, but patient satisfaction is better with PRO sedation. In selected patients, DEX may be used as an alternative to PRO for ODNA sedation during AF ablation.

First clinical experience of a dedicated irrigated-tip radiofrequency ablation catheter for the ablation of cavotricuspid isthmus-dependent atrial flutter.

BACKGROUND: Different types of irrigated-tip ablation catheters are available for ablation of atrial flutter (AFL). The aim of this study was to compare an established with a novel dedicated Gold irrigated-tip catheter for ablation of AFL. METHODS AND RESULTS: We compared consecutive patients undergoing ablation of AFL using a standard 3.5 mm irrigated-tip platinum-iridium (Pt-Ir) catheter (Thermocool, TC-group) and a 3.5 mm irrigated gold-tip catheter (Gold-group) specifically designed for cavotricuspid isthmus ablation (CTI). The primary endpoint was acute efficacy (net RF time) to achieve block across the CTI. Secondary endpoints included procedure time, fluoroscopy duration, complications, and recurrence of AFL.153 patients (age 68 ± 11 years, 74% male) were included. Net RF time to achieve CTI block was not different between the TC-group (793 ± 503 s) and the Gold-group (706 ± 422 s; p = 0.406). Total procedure time was not significantly different between the TC-group (70 ± 26 min) and the Gold-group (70 ± 27 min; p = 0.769). A significant difference between the groups was identified for the fluoroscopy duration (TC-group: 934 ± 537 s, Gold-group: 596 ± 362 s, p < 0.001). There were no major complications observed in the groups. Recurrence of AFL occurred in 3 of 66 (5%) in the TC-group and in 2 of 87 (2%) in the Gold-group (p = 0.652). CONCLUSIONS: In conclusion, acute and chronic efficacy of the irrigated Pt-Ir and gold-tip catheters were comparable. However, the dedicated catheter design was associated with decreased fluoroscopy duration.

Fluoroscopy-Free Pulmonary Vein Isolation in Patients with Atrial Fibrillation and a Patent Foramen Ovale Using Solely an Electroanatomic Mapping System.

INTRODUCTION: The advent of electroanatomical mapping (EAM) systems for pulmonary vein isolation (PVI) has dramatically decreased radiation exposure. However, the need for some fluoroscopy remains for obtaining left atrial (LA) access. The aim was to test the feasibility of fluoroscopy-free PVI in patients with atrial fibrillation (AF) and a patent foramen ovale (PFO) guided solely by an EAM system. METHODS: Consecutive patients with AF undergoing PVI and documented PFO were studied. An EAM-guided approach without fluoroscopy and ultrasound was used. After completing the map of the right atrium, the superior vena cava and the coronary sinus, a catheter pull-down to the PFO was performed allowing LA access. The map of the LA and subsequent PVI was also performed without fluoroscopy. RESULTS: 30 patients [age 61±12 years, 73% male, ejection fraction 0.64 (0.53-0.65), LA size in parasternal long axis 38±7 mm] undergoing PVI were included. The time required for right atrial mapping including transseptal crossing was 9±4 minutes. Total procedure time was 127±37 minutes. Fluoroscopy-free PVI was feasible in 26/30 (87%) patients. In four patients, fluoroscopy was needed to access (n = 3) or to re-access (n = 1) the LA. In these four patients, total fluoroscopy time was 5±3 min and the DAP was 14.9±13.4 Gy*cm2. Single-procedure success rate was 80% (24/30) after a median follow-up of 12 months. CONCLUSION: In patients with a documented PFO, completely fluoroscopy-free PVI is feasible in the vast majority of cases.