Abstract 152 A novel zero-exchange approach for left atrial access in pulmonary vein isolation with pulsed field ablation

Background

Pulsed field ablation (PFA) emerged as a novel, promising non-thermal method for achieving durable pulmonary vein isolation (PVI) and is currently being intensively studied. To perform the PVI, the 12 F over-the-wire PFA ablation catheter (Farawave) must be introduced via the Faradrive steerable sheath (13.8 F inner and 16.8F outer diameter, Boston Scientific).

In most cases before introducing the Faradrive sheath into the left atrium, a single transseptal puncture with a standard 8.5 F sheath (steerable or non-steerable) is performed followed by an exchange to the Faradrive sheath into the left atrium.

Purpose

This study aimed to describe the safety and feasibility of direct TSP using the Faradrive steerable sheath before performing PVI with PFA.

Methods

We prospectively enrolled 120 consecutive patients undergoing PVI with PFA at our institution since July 2022. Patients with paroxysmal or persistent AF refractory to antiarrhythmic treatment (class I and III antiarrhythmics) were considered eligible if they were older than 18 years of age, and provided informed consent before inclusion. TSP was performed in all cases with transesophageal echocardiography (TEE) guidance, using the Faradrive sheath and a 98 cm matched Brockenbrough needle.

Comorbidities, medications, and epidemiological data were recorded and analyzed. The primary end-point was the occurrence of pericardial tamponade during or within the first 24 hours after the procedure, the secondary end-point was the occurrence of every major complication (stroke, groin complication, phrenic nerve injury).

Results

All 120 patients were included into the final analysis (57% male): 55% of patients had paroxysmal AF and 45% persistent AF. The patients were 6811 years old, had a median EHRA class 3, and a median CHA2DS2VAsc score of 3 points. The body mass index was 28+/-6 kg/m2 and the left atrial volume index (LAVI) was 33+/-14 ml/m2.

The mean duration of the procedure was 65 minutes, median time to TSP was 15 minutes and the median fluoroscopy dose was 595 cGy*cm2. There was no need for advanced transseptal puncture techniques, i.e., radiofrequency needle or SafeSept wire. One major complication occurred periprocedurally: a non-TSP related pericardial tamponade, which was successfully managed with pericardial puncture. The mechanism of the pericardial tamponade was most likely an atrial wall perforation with the guiding wire of the PFA catheter during PVI. No further complications occurred during the first 24 hours after the procedure.

Conclusion

The TSP with the use of the Faradrive sheath and a matched-length needle for PVI with PFA was safe and feasible in all patients without the need for advanced transseptal puncture techniques. Further studies with more patients investigated are necessary to verify this modified workflow.

Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02302-4
A novel zero-exchange approach for left atrial access in pulmonary vein isolation with pulsed field ablation
A. G. Bejinariu¹, M. Spieker¹, N. Augustin¹, D. Glöckner¹, J. Schmidt¹, M. Kelm¹, O. R. Rana¹
¹Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf;
Background Pulsed field ablation (PFA) emerged as a novel, promising non-thermal method for achieving durable pulmonary vein isolation (PVI) and is currently being intensively studied. To perform the PVI, the 12 F over-the-wire PFA ablation catheter (Farawave) must be introduced via the Faradrive steerable sheath (13.8 F inner and 16.8F outer diameter, Boston Scientific). In most cases before introducing the Faradrive sheath into the left atrium, a single transseptal puncture with a standard 8.5 F sheath (steerable or non-steerable) is performed followed by an exchange to the Faradrive sheath into the left atrium. Purpose This study aimed to describe the safety and feasibility of direct TSP using the Faradrive steerable sheath before performing PVI with PFA. Methods We prospectively enrolled 120 consecutive patients undergoing PVI with PFA at our institution since July 2022. Patients with paroxysmal or persistent AF refractory to antiarrhythmic treatment (class I and III antiarrhythmics) were considered eligible if they were older than 18 years of age, and provided informed consent before inclusion. TSP was performed in all cases with transesophageal echocardiography (TEE) guidance, using the Faradrive sheath and a 98 cm matched Brockenbrough needle. Comorbidities, medications, and epidemiological data were recorded and analyzed. The primary end-point was the occurrence of pericardial tamponade during or within the first 24 hours after the procedure, the secondary end-point was the occurrence of every major complication (stroke, groin complication, phrenic nerve injury). Results All 120 patients were included into the final analysis (57% male): 55% of patients had paroxysmal AF and 45% persistent AF. The patients were 6811 years old, had a median EHRA class 3, and a median CHA2DS2VAsc score of 3 points. The body mass index was 28+/-6 kg/m2 and the left atrial volume index (LAVI) was 33+/-14 ml/m2. The mean duration of the procedure was 65 minutes, median time to TSP was 15 minutes and the median fluoroscopy dose was 595 cGy*cm2. There was no need for advanced transseptal puncture techniques, i.e., radiofrequency needle or SafeSept wire. One major complication occurred periprocedurally: a non-TSP related pericardial tamponade, which was successfully managed with pericardial puncture. The mechanism of the pericardial tamponade was most likely an atrial wall perforation with the guiding wire of the PFA catheter during PVI. No further complications occurred during the first 24 hours after the procedure. Conclusion The TSP with the use of the Faradrive sheath and a matched-length needle for PVI with PFA was safe and feasible in all patients without the need for advanced transseptal puncture techniques. Further studies with more patients investigated are necessary to verify this modified workflow.
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