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Clinical Trial
. 2024 May 2;26(5):euae118.
doi: 10.1093/europace/euae118.

Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study

Prashanthan Sanders  1 , Stewart Healy  2 , Mehrdad Emami  1 , Emily Kotschet  2 , Amber Miller  3 , Jonathan M Kalman  4
Affiliations
Clinical Trial

Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study

Prashanthan Sanders et al. Europace. .

Abstract

Aims: Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared with thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first-generation PFA systems. In this study, we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation.

Methods and results: The VOLT CE Mark Study is a pre-market, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA system for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest computed tomography, and cerebral magnetic resonance imaging. Study endpoints were the rate of primary serious adverse event within 7 days and acute procedural effectiveness. A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed a 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 min, respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or oesophageal lesions causally related to the PFA system and three subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events.

Conclusion: The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.

Keywords: Atrial fibrillation; Balloon; Basket; Pulsed field ablation; Single shot.

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Conflict of interest statement

Conflict of interest P.S. reports serving on the medical advisory board for Abbott, Medtronic, Boston-Scientific, CathRx, and Pacemate. The University of Adelaide has received on behalf of P.S. research funds from Boston-Scientific, Medtronic, Abbott, and Becton Dickenson. S.H. reports teaching and consulting honorariums for Medtronic, Boston Scientific, Biotronik, and Johnson and Johnson. S.H. also serves on the medical advisory boards for Biotronik and Boston Scientific. The Victorian Heart Hospital has also received research funds from Boston Scientific, Medtronic, and Abbott on behalf of S.H. The University of Adelaide has received advisory and/or consulting fees on behalf of M.E. from Medtronic and Biosense Webster. E.K. reports serving on the medical advisory boards for Medtronic, Boston-Scientific, and Biotronik. A.M. is employed by Abbott. J.M.K. reports research and fellowship support from Medtronic, Biosense Webster, Abbott, and Zoll.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
A procedural workflow for pulmonary vein isolation ablation with the Volt™ pulsed field ablation system. (A) A balloon-in-basket Volt™ pulsed field ablation catheter, Sensor Enabled™. (B). A fluoroscopic view of over-the-wire deployment of the balloon-in-basket system in the RSPV, assisted with the use of the sheath. (C) Integration of the Volt pulsed field ablation catheter with the Ensite™ X EP system. The integration demonstrates the impedance-based tissue proximity indicator displaying real-time electrode-tissue proximity and depicting proximity values via automarks after therapy delivery. An en face visualization in the left image allows accurate rotation to achieve contiguous lesions. The delivered application followed by an attenuation of pulmonary vein signals (arrow) is also seen in the accompanying electrograms.
Figure 2
Figure 2
Subject disposition and scheduled events. The presented results pertain to the feasibility sub-study and presents data to 30 days. Below the dotted line depicts the ongoing follow-up and remainder study visits as scheduled for the entire study cohort.
Figure 3
Figure 3
Pre-ablation (left) and post-ablation (right) voltage maps demonstrating the area of pulmonary vein isolation (in grey). Shown are a variety of pulmonary vein morphologies that have been successfully targeted in the feasibility sub-study, including (A) typical 4 vein anatomy, (B) Left common PV, and (C) a roof vein.
Figure 4
Figure 4
Remapping confirmed durable isolation after more than 60 days post-procedure. Voltage maps from pre-procedure, post-index procedure, and prior to repeat procedure for the single case of left atrial remapping that has been undertaken. This patient had a recurrence of AF. Remapping of the left atrium demonstrated persistent isolation of the pulmonary veins with no regression of the pulsed field ablation area (shown in grey). This patient was treated in the repeat procedure with an isolation of the SVC.
See this image and copyright information in PMC

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