Beyond the learning curve: How operator experience affects pulsed-field ablation outcomes.

Area of Science:

• Electrophysiology
• Cardiovascular Ablation Technologies
• Medical Device Learning Curves

Background:

• Pulmonary vein isolation (PVI) using single-shot pulsed-field ablation (PFA) is a novel technique.
• The learning curve for PFA is presumed to be short.
• 3D electro-anatomical mapping (3D-EAM) may offer benefits in shortening the learning curve and enhancing lesion durability.

Purpose of the Study:

• To evaluate procedural performance markers over time for PVI utilizing PFA.
• To assess the impact of 3D-EAM on PVI outcomes.
• To analyze the learning curve associated with PFA for PVI.

Main Methods:

• 1008 patients undergoing PVI with PFA were analyzed.
• 3D-EAM was employed selectively based on operator experience and planned lesion sets.
• Patients were followed for arrhythmia recurrence at 3, 6, and 12 months post-procedure.

Main Results:

• The learning curve for procedure and fluoroscopy time was estimated at 18 and 8 procedures, respectively.
• 12-month freedom from arrhythmia recurrence was similar during (65%) and after (68%) the learning curve (20 cases).
• PVI durability significantly improved after 60 procedures per operator (61% vs. 73%).

Conclusions:

• The learning curve for single-shot PFA is approximately 20 cases per operator, based on procedural efficiency.
• Significant improvements in long-term PVI durability are noted beyond 60 cases.
• Neither the learning curve phase nor the use of 3D-EAM impacted freedom from arrhythmia recurrence.