A large footprint focal catheter toggling between pulsed field and radiofrequency energy: first clinical experience for ventricular tachycardia ablation
Key result
Ventricular tachycardia ablation using a novel lattice-tip catheter toggling between pulsed field and radiofrequency energy was feasible and safe in 4 patients, with no recurrences at 5 months.
Why the study?
Pre-clinical studies of a novel lattice-tip catheter toggling between pulsed field and radiofrequency energy showed promising results for ventricular tissue, but clinical studies for ventricular tachycardia ablation were lacking.
Population
Four consecutive patients undergoing VT ablation
Comparison
Ventricular tachycardia ablation using a lattice-tip catheter toggling between pulsed field and radiofrequency energy
Design
Prospective single-arm case series
Follow-up
Median of 5 months
Authors
Discussion
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Implication
First-in-human VT ablation experience with lattice-tip PF/RF catheter; hypothesis-generating and leaves open comparative efficacy versus standard tools.
Key Points
- Evaluate the initial clinical feasibility and acute safety of a focal lattice-tip catheter toggling between pulsed field and radiofrequency energy for ventricular tachycardia ablation.
- Prospective compassionate-use series evaluating N=4 male patients (mean age 55.8 ± 18.8 years; three with prior failed ablations) undergoing ventricular tachycardia ablation.
- Conducted electroanatomical activation and substrate mapping using the Sphere-9 catheter and Affera system under general anesthesia, employing PF-first delivery in the right ventricle and RF-first in the left ventricle.
- Radiofrequency applications averaged 15.0 ± 23.3 applications (4.8 ± 7.8 min) and pulsed field ablation averaged 45 ± 29.6 applications (92.2 ± 122.0 s) across treated patients.
- Dense scar area (<0.5 mV) expanded from 7.5 ± 5.5 cm² to 20.3 ± 12 cm², and low-voltage area (<1 mV) expanded from 10.4 ± 4.6 cm² to 27.5 ± 11.5 cm² post-ablation.
- Achieved acute procedural endpoints including arrhythmia non-inducibility and local non-capture with zero acute complications and zero recurrences at a median follow-up of 5 months.
Study Design
Type
Case Report (n=4)
Structured PICO
P
Population
4 male patients with ventricular tachycardia undergoing ablation with a novel lattice-tip catheter, followed for a median of 5 months.
I
Intervention
Ventricular tachycardia ablation using a novel mapping and ablation lattice-tip catheter (Sphere-9) that toggles between pulsed field (PF) and radiofrequency (RF) energy.
O
Outcome
Procedural feasibility, safety (complications), and acute efficacy (non-inducibility of VT, PVC suppression, local non-capture).safety
The first clinical experience using a novel lattice-tip catheter toggling between pulsed field and radiofrequency energy for VT ablation demonstrated feasibility, safety, and promising acute efficacy.
Limitations
- Further studies are needed to clarify the optimal ablation endpoints and confirm our findings.
- Small sample size (n=4)
- Exploratory first-in-human clinical experience
Cite This Study
Pannone et al. (2024) conducted a case report in Ventricular tachycardia (n=4). Lattice-tip catheter (Sphere-9) toggling between pulsed field and radiofrequency energy was evaluated on Feasibility, safety, and acute results (non-inducibility of VT, PVC suppression). Ventricular tachycardia ablation using a novel lattice-tip catheter toggling between pulsed field and radiofrequency energy was feasible and safe in 4 patients, with no recurrences at 5 months.