Join this in-depth discussion on the Affera mapping and ablation system’s unique intracardiac signal collection and analysis features, including real-world case examples from Prof Andrea Sarkozy.
Speakers:
Prof Andrea Sarkozy
Dr Khaldoun Tarakji
Brian Stewart
Learning Objectives:
Understand how intracardiac electrograms are collected using Close-Unipolar™ mapping technology
Explore the clinical utility of the unique capabilities of the Affera mapping and ablation system
See real-world examples of this technology in complex cases
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Q&A Responses:
1. What is meant by “bipolar blindness"?
Bipolar blindness is a term commonly used to describe bipolar electrogram sensitivity to wavefront direction.1
2. How do you know the Sphere-9™ catheter accurately displays electrograms (EGMs)?
Close-Unipolar™ signals will look different than bipolar EGMs because only one electrode is touching tissue in the recording pair. This results in a clearer, easier-to-annotate signal, as signals are not merged over multiple tissue-contacting electrodes (false fractionation).1 When the mini electrode records a complex signal, you can trust that this is due to substrate complexity, as it is occurring at the mini electrode.
3. What is the recommended learning curve for an operator familiar with traditional mapping systems? What real-time safety markers does the system offer to prevent esophageal injury during AF ablation? How can electrogram recording be optimized in the software for final procedure documentation?
A sub-analysis of the SPHERE Per-AF IDE trial showed effectiveness increased to 80% when the operator completed ≥ 10 cases.2 In terms of safety features, when the energy mode is switched to radiofrequency (RF), the mapping system displays a posterior mask of stripes on the model indicating where RF should not be delivered. The plan view in the superior aspect of both mapping windows highlights the posterior aspect of the model in bright pink.
4. In what specific situations is it recommended to switch from pulsed field (PFA) to radiofrequency (RF) energy using the same catheter? (The system is dual-energy; understanding when to use each maximizes therapy.)
PFA should always be used on the posterior wall, and in the U.S., the catheter is approved for CTI-dependent flutter with RF energy. Many operators choose to use PF for the entire PVI and will use RF near the valve for anterior and lateral mitral isthmus lines.
5. How should the impedance indicator be interpreted to confirm proper contact before a pulsed field (PFA) pulse? What recommendations are there for catheter stabilization in hard-to-reach areas such as the left atrial roof?
There is a lot of built-in redundancy within the mapping system user interface to display increased local impedance. The electrodes on the catheter graphic will grow brighter white as local impedance increases. The corresponding electrograms from those electrodes will be highlighted in the signal annotation viewer on the right side of the screen. The electrodes will also glow on the sensor globe in the center of the screen, as well. At the top of screen, there is a green global impedance indicator that will increase in height as local impedance increases. The catheter’s conformable nitinol lattice enhances stability compared to small tip focal ablation catheters in difficult anatomic locations.3
6. What is the learning curve for operators transitioning from RF/cryo to PFA?
In the IDE trial, there was a sub analysis that showed effectiveness increased to 80% when the operator had ≥10 cases under their belt.2
7. What differentiates the Sphere-9 catheter from other PFA catheters?
The Sphere-9 catheter is the only true all-in-one, wide area focal tool on the market. The Sphere-9 catheter allows for HD mapping, PF ablation, and RF ablation all in one tool.3 On top of that, the wide area focal design is flexible, allowing the operator to complete linear lesion sets, without compromising on efficiency.
See risk information.
Product usage represented may not be approved or cleared in all markets.
1. de Bakker JMT. Pacing Clin Electrophysiol. 2019;42:1503-1516.
2. Kiehl E, et al. OPERATOR LEARNING CURVE WITH A NOVEL DUAL-ENERGY LATTICE-TIP ABLATION SYSTEM. In: Asia-Pacific Heart Rhythm Society; September 26-28, 2024; Sydney, Australia.
3. Barkagan M, et al. Expandable lattice electrode ablation catheter. Circ Arrhythm Electrophysiol 2019;12:e007090.
