UNASSIGNED: Cryoballoon ablation for pulmonary vein isolation is a time-efficient procedure that can alleviate stress on electrophysiology lab resources. This analysis modeled the impact of cryoballoon ablation on electrophysiology lab operation using data from Latin America.
UNASSIGNED: Data from centers in Argentina, Mexico, Colombia, and Chile of the were used as inputs for an electrophysiology lab efficiency simulation model. The model used the assumption that either two (today\'s electrophysiology lab operations) or three (including electrophysiology lab operational changes) cryoballoon ablation procedures could be performed per day. The endpoints were the percentage of days that resulted in 1) overtime and 2) time left for an extra non-ablation electrophysiology procedure.
UNASSIGNED: Data from a total of 232 procedures from six Latin American centers were included in the analysis. The average electrophysiology lab occupancy time for all procedures in Latin America was 132 ± 62 minutes. In the Current Scenario (two procedures per day), 7.4% of simulated days resulted in overtime, and 81.4% had enough time for an extra electrophysiology procedure. In the Enhanced Productivity Scenario (three procedures per day), 16.4% of days used overtime, while 67.4% allowed time for an extra non-ablation electrophysiology procedure.
UNASSIGNED: Using real-world, Latin American-specific data, we found that with operational changes, three ablation procedures could feasibly be performed daily, leaving time for an extra electrophysiology procedure on more than half of days. Thus, use of cryoballoon ablation is an effective tool to enhance electrophysiology lab efficiency in resource-constrained regions such as Latin America.
UNASSIGNED: La ablación con criobalón para el aislamiento de venas pulmonares es un procedimiento que ahorra tiempo y puede ahorrar recursos del laboratorio de electrofisiología. Este análisis modeló el impacto de la ablación con criobalón en el funcionamiento del laboratorio de electrofisiología utilizando datos de América Latina.
UNASSIGNED: Los datos de los centros de Argentina, México, Colombia y Chile del se utilizaron como datos de entrada para un modelo de simulación de la eficiencia del laboratorio de electrofisiología. El modelo partió del supuesto de que se podían realizar dos (operaciones actuales del laboratorio de electrofisiología) o tres (incluidos los cambios operativos del laboratorio de electrofisiología) procedimientos de ablación con criobalón por día. Los criterios de valoración eran el porcentaje de días en los que se producían 1) horas extraordinarias y 2) tiempo restante para un procedimiento electrofisiológico adicional no relacionado con la ablación.
UNASSIGNED: Se incluyeron en el análisis los datos un total de 232 procedimientos de seis centros latinoamericanos. El tiempo medio de ocupación del laboratorio de electrofisiología para todos los procedimientos en Latinoamérica fue de 132 ± 62 minutos. En el escenario actual (dos procedimientos por día), el 7,4% de los días simulados resultaron en horas extras, y el 81,4% tuvo tiempo suficiente para un procedimiento de electrofisiología adicional. En el escenario de productividad mejorada (tres procedimientos por día), el 16,4% de los días utilizó horas extraordinarias, mientras que el 67,4% dispuso de tiempo suficiente para un procedimiento electrofisiológico extra sin ablación.
UNASSIGNED: Utilizando datos del mundo real específicos de América Latina, descubrimos que, aplicando cambios operativos, es factible realizar tres procedimientos de ablación al día, lo que deja tiempo para un procedimiento de electrofisiología adicional en más de la mitad de los días. Por lo tanto, el uso de la ablación con criobalón es una herramienta eficaz para mejorar la eficiencia de los laboratorios de electrofisiología en regiones con recursos limitados como América Latina.

UNASSIGNED: Pulmonary vein isolation (PVI) ablation is the established gold standard therapy for patients with symptomatic drug refractory atrial fibrillation (AF). Advancements in radiofrequency (RF) ablation, have led to the development of the novel contact force-sensing temperature-controlled very high-power short-duration (vHPSD) RF ablation. This setting delivers 90 W for up to 4 seconds with a constant irrigation flow rate of 8 mL/min. The aim of this study was to compare procedural outcomes and safety with conventional radiofrequency ablation.
UNASSIGNED: An observational study was conducted with patients who underwent first time PVI ablation between August 2020 and January 2022. The cohort was divided into: (1) vHPSD ablation; (2) High-power short duration (HPSD) ablation; (3) THERMOCOOL SMARTTOUCH™ SF (STSF). The vHPSD ablation group was prospectively recruited while the HPSD and STSF group were retrospectively collected. Primary outcomes were procedural success, PVI duration, ablation duration and incidence of perioperative adverse events. Secondary outcomes were intraprocedural morphine and midazolam requirement.
UNASSIGNED: A total of 175 patients were included in the study with 100, 30 and 45 patients in the vHPSD, HPSD and STSF group, respectively. PVI was successfully attained in all vHPSD patients. vHPSD demonstrated significantly reduced time required for PVI and total energy application in comparison to the HPSD and STSF groups (67.7 ± 29.7 vs. 92.9 ± 25.7 vs. 93.6 ± 29.1 min, p < 0.0001; 9.87 ± 4.16 vs. 33.9 ± 7.49 vs. 36.0 ± 10.5 min, p < 0.0001, respectively). Intravenous morphine and midazolam requirement was lower in the vHPSD group compared to the HPSD and STSF groups (10.2 ± 3.43 vs. 16.1 ± 4.58 vs. 15.3 ± 3.94 mg, p < 0.0001; 4.04 ± 3.24 vs. 8.63 ± 5.22 vs. 8.58 ± 4.72 mg, p < 0.0001). One cardiac tamponade was observed in both the vHPSD and HPSD groups while the STSF group exhibited an embolic stoke and two pericardial effusions that did not require drainage.
UNASSIGNED: In this study, vHPSD demonstrated a comparable safety profile to the other treatment arms. Procedural duration and energy application time was substantially reduced along with sedation requirement notwithstanding the limitations of observational study design, these preliminary findings are promising with respect to periprocedural outcomes and safety of vHPSD however longitudinal outcomes will be essential to assessing the overall efficacy of this novel technology.

BACKGROUND: Cryoballoon ablation for treatment of atrial fibrillation (AF) reduces procedure times, but limited data is available about its impact on electrophysiology (EP) lab efficiency in Central and Eastern Europe (CEE). Using CEE-specific procedure data, the present study modeled cryoballoon ablation procedures on EP lab resource consumption to improve efficiency.
METHODS: A discrete event simulation model was developed to assess EP efficiency with cryoballoon ablation. Model inputs were taken from CEE sites within the Cryo Global Registry, namely Czech Republic, Hungary, Poland, Serbia, and Slovakia. The main endpoints were percentage of days that resulted in overtime and percentage of days with time for one extra simple EP procedure. Use of the \'figure of 8\' (Fo8) closure technique to reduce procedure time was also examined.
RESULTS: The mean lab occupancy time across all CEE sites was 133 ± 47 minutes (min: 104 minutes, max:181 minutes). Cryoballoon ablation in the base-case scenario resulted in 14.6% of days with overtime and 64.8% of days with time for an extra simple EP procedure. Use of the Fo8 closure technique enhanced these values to 5.5% and 85.3%, respectively. Model endpoints were most sensitive to changes in lab occupancy times and overtime start time.
CONCLUSIONS: In this CEE-specific analysis of EP lab efficiency it was found that 3 cryoballoon ablation procedures could be performed in 1 lab day, leaving time for a 4th simple EP procedure on most days. As such, use cryoballoon ablation for PVI is an effective way to improve EP lab efficiency.

UNASSIGNED: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy.
UNASSIGNED: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF.
UNASSIGNED: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients.
UNASSIGNED: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes.
UNASSIGNED: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.

BACKGROUND: There remains an imperative need to accurately map the left atrium in the setting of atrial fibrillation. While the pulmonary vein segmental ostial isolation plays a significant role in atrial fibrillation, clinical attempts to selectively ablate near the pulmonary vein myocardial sleeves have demonstrated a higher recurrence rate of arrhythmia given less precise mapping modalities. However, novel omnipolar mapping technology coupled with Advisor™ HD Grid Mapping Catheter may provide an advantageous profile to map and selectively ablate near the myocardial sleeves.
METHODS: This retrospective cohort underwent ablation targeting the pulmonary vein myocardial sleeves with the use of omnipolar mapping technology and later wide area circumferential ablation (WACA) was performed.
RESULTS: The findings of this study demonstrated a few number of lesions were required to achieve all PVI targeting PVMS at 36 (95% CI 32-41) compared to WACA at 81 (95% CI 73-90). PVMS radiofrequency time was shorter at 314 s (95% CI 278-350 s) compared to 799 s (95% CI 692-906 s) for WACA. Mean procedure time to complete PVMS was 59 min (95% CI 53-65) and to complete WACA was 90 min (95% CI 80-100).
CONCLUSIONS: Precision ablation near PVMS coupled with omnipolar technology may provide a superior profile in reducing procedure time and number of ablative lesions compared to WACA in the setting of atrial fibrillation with possible similar results. Future investigation using randomized controlled trials can help further support these findings.

OBJECTIVE: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach.
RESULTS: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37).
CONCLUSIONS: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.

OBJECTIVE: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.
RESULTS: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.
CONCLUSIONS: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05114954.

Pulmonary vein isolation (PVI) stands as a widely practiced cardiac ablation procedure on a global scale, conventionally guided by fluoroscopy. The concurrent application of electroanatomical mapping systems (EAMS) and intracardiac echocardiography offers a means to curtail radiation exposure. This study aimed to compare procedural outcomes between conventional and our initial zero-fluoroscopy cases in patients with paroxysmal or persistent atrial fibrillation (AF), undergoing point-by-point PVI. Our prospective observational study included 100 consecutive patients with AF who underwent point-by-point radiofrequency PVI. The standard technique was used in the first 50 cases (Standard group), while the fluoroless technique was used in the subsequent 50 patients (Zero group). The zero-fluoroscopy approach exhibited significantly shorter procedural time (59.6 ± 10.7 min vs. 74.6 ± 13.2 min, p < 0.0001), attributed to a reduced access time (17 [16; 20] min vs. 31 [23; 34.5] min, p < 0.001). Comparable results were found for the number of RF applications, total ablation energy, and left atrial dwelling time. In the Zero group, all procedures were achieved without fluoroscopy, resulting in significantly lower fluoroscopy time (0 [0; 0] sec vs. 132 [100; 160] sec, p < 0.0001) and dose (0 [0; 0] mGy vs. 4.8 [4.1; 8.2] mGy, p < 0.0001). The acute success rate was 100%, with no major complications. Zero-fluoroscopy PVI is feasible, safe, and associated with shorter procedure times compared to the standard approach, even in cases without prior experience in zero-fluoroscopy PVI.

OBJECTIVE: Pulsed field ablation (PFA) is a novel, non-thermal, cardiac tissue-selective ablation modality. To date, radiofrequency (RF)-guided high-power short-duration (HPSD) ablation represents the gold standard besides cryo-ablation for pulmonary vein isolation (PVI). This single-centre, retrospective study investigated the efficacy of PFA-PVI vs. HPSD-RF PVI in terms of single-procedure arrhythmia-free outcome and safety in a real-world setting.
RESULTS: Consecutive, paroxysmal atrial fibrillation (AF) patients who underwent PVI using PFA or HPSD-RF were enrolled. In group PFA, PVI was performed using a pentaspline PFA catheter. The ablation procedure in group HPSD-RF was performed with RF energy (45 W, ablation index). A total of 410 patients (group PFA, 201; group HPSD-RF, 209) were included. There was no difference between both groups regarding age, gender, and CHA2DS2-VASc score. The procedure time was significantly shorter in group PFA [61 (44-103) vs. 125 (105-143) min; P < 0.001]; fluoroscopy time and dose area product were significantly higher in group PFA [16 (13-20) vs. 4 (2-5) min; P < 0.01 and 412 (270-739) vs. 129 (58-265) μGym2; P < 0.01]. The overall complication rates were 2.9% in group PFA and 6.2% in group HPSD (P = 0.158). There was one fatal stroke in the PFA group. The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 85% with PFA and 79% with HPSD-RF (log-rank P = 0.160). In 56 repeat ablation procedures, the PV reconnection rate was 30% after PFA and 38% after HPSD-RF (P = 0.372).
CONCLUSIONS: Both PFA and HPSD-RF were highly efficient and effective in achieving PVI in paroxysmal AF patients. The arrhythmia-free survival is comparable. The PV reconnection rate was not different.

OBJECTIVE: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach.
RESULTS: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37).
CONCLUSIONS: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.