Catheter ablation is an established method to treat abnormal heart rhythms by restoring the heart’s normal electrical function. This approach uses energy to intentionally create microscopic scar tissue, which blocks the faulty electrical signals responsible for the arrhythmia. While standard ablation has been successful, the pursuit of greater safety, efficiency, and long-term effectiveness continues to drive new technological advancements. Advanced systems aim to maximize the creation of durable scar lines while minimizing the risk of damage to surrounding structures.
Atrial Arrhythmias and the Need for Precision Ablation
Atrial arrhythmias, most commonly Atrial Fibrillation (AFib), affect over 60 million people worldwide. AFib is characterized by a rapid, chaotic heart rhythm originating in the upper chambers, which increases the risk of stroke, heart failure, and mortality. The disease is often progressive, beginning as intermittent episodes (paroxysmal) and potentially advancing to persistent forms that are constantly present.
Conventional ablation techniques, such as standard radiofrequency ablation (RFA), rely on thermal energy to create lesions. This carries an inherent risk of collateral damage to adjacent non-cardiac tissues, such as the esophagus or the phrenic nerve, which controls the diaphragm. RFA requires a high degree of precision to create continuous, durable scar lines, a process that is often time-consuming and requires multiple point-by-point energy applications.
Defining the Affera System Technology
The Affera Mapping and Ablation System is an integrated platform designed to address the challenges of traditional ablation. At the center of this system is the Sphere-9™ catheter, which is capable of both high-density electroanatomic mapping and dual-energy ablation. This integration streamlines the procedural workflow by combining the functions of multiple traditional devices into a single catheter.
The Sphere-9 catheter features a unique, compressible, spheroid-shaped lattice electrode tip that expands to a 9-millimeter diameter upon deployment. This soft, cage-like tip is significantly larger than conventional focal ablation catheters, which are typically 3.5 to 4 millimeters. The expanded lattice contains nine mini-electrodes that function as thermocouples and sensors for ultra-high density mapping. This design provides a larger surface area for tissue contact and energy delivery, facilitating the creation of wider, more uniform lesions.
The Dual-Energy Lattice Tip Mechanism
The Affera system can switch instantly between two distinct energy sources: Radiofrequency (RF) and Pulsed Field (PF) energy, all through the same lattice-tipped catheter. This dual-energy capability allows the physician to tailor the ablation strategy based on the specific location, optimizing both effectiveness and safety. The system toggles seamlessly between the two modalities without the need to exchange catheters during the procedure.
Radiofrequency ablation uses heat to destroy the target tissue. The lattice tip’s large surface area is optimized for RF delivery, allowing a higher total current at a lower current density. This helps create deeper, more uniform thermal lesions while mitigating the risk of tissue overheating and steam pop formation. RF is useful for creating durable lines of scar tissue in areas where thermal risks are lower.
Pulsed Field Ablation (PFA) represents the nonthermal component. PFA delivers rapid, high-voltage electrical pulses that induce irreversible electroporation, causing microscopic pores in heart muscle cells (cardiomyocytes) to open permanently, leading to cell death. PFA offers a high degree of tissue selectivity; the electrical fields destroy cardiomyocytes while largely sparing non-cardiac structures. This tissue-specific effect is beneficial when ablating near vulnerable structures, such as the esophagus or the phrenic nerve, which are highly susceptible to thermal damage. Physicians can strategically use PFA in sensitive areas and switch to RF for other regions, leveraging the strengths of both energy types.
The Ablation Procedure and Recovery
The Affera ablation procedure begins with the insertion of the Sphere-9 catheter into a blood vessel, typically in the groin, and guiding it to the left atrium. The system’s integrated mapping technology provides real-time, detailed electrical maps, allowing for precise navigation and identification of the faulty signal sources. The use of the single, integrated catheter for both mapping and ablation streamlines the workflow, with many cases requiring only a single entry point.
Once the catheter is positioned, the dual energy is delivered to create the necessary scar tissue, most commonly to electrically isolate the pulmonary veins, which are frequent sources of AFib triggers. The procedure time using this advanced system is often shorter than with conventional radiofrequency ablation. Following the procedure, the patient is moved to a recovery area for close monitoring of their heart rhythm and vital signs.
Most patients are discharged from the hospital on the same day or the following morning. Patients may experience fatigue and soreness at the catheter insertion site for a few days. Patients are advised to avoid heavy lifting or vigorous exercise for about one week to ensure proper healing of the access site. Follow-up care involves monitoring for at least three months to confirm the long-term success of the ablation.