Summary

  • The U.S. commercial Affera™ mapping and ablation system and ablation settings (PULSE3, RF-ANT, and RF-MI) with the Sphere-9™ mapping and ablation catheter were designed and approved for atrial tissue. Reports of cases, in literature or conferences, demonstrating the use of the Affera™ system to treat ventricular arrhythmias were performed on systems that are different from what was approved by the FDA and commercially available in the United States.​
  • Through preclinical research, ventricular settings (PULSE3V and longer modified radiofrequency [RF]) have been created and are actively being studied in an ongoing feasibility study with a pivotal trial to follow.​
  • FDA-approved “compassionate use“ provides a pathway to access the investigational ventricular settings.

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Articles of interest

Considerations associated with the use of the Sphere-9™ catheter for the treatment of VT

Indications

The FDA-approved use for the Sphere-9™ catheter is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than one year), and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera™ mapping system.​

The Affera™ mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system’s display screen.

Contraindications

  • In coronary vessels with diameter smaller than the expandable ablation electrode, as the catheter may damage the coronary vessels
  • In patients with prosthetic valves, as the catheter may damage the prosthesis
  • Using the retrograde approach in patients who have had aortic valve replacement

Warning and precautions

  • Cardiac ablation may induce intentional or unintentional life-threatening cardiac arrhythmias. Defibrillation equipment must be available for immediate use in the case of a life-threatening arrhythmia.
  • Carefully observe the recommended settings in the instructions for use to reduce the risk of delivering excessive energy causing excessive heating or collateral damage. Excessive ablation duration may also lead to excessive heating or collateral damage.
  • PF ablation in areas adjacent to coronary arteries may lead to coronary artery spasm.

Potential adverse events

  • Hemodynamic decompensation/cardiogenic shock
  • Epicardial access complications (e.g., inadvertent right ventricular puncture, diaphragmatic puncture, hemopericardium, pneumopericardium, vascular puncture)
  • Esophageal fistula