TERMINATE AF results

Medtronic summary

Abstract

Objective: Concomitant surgical ablation of atrial fibrillation (AF) improves AF-free survival, decreases stroke risk, and improves quality of life (QOL). This clinical trial evaluated the efficacy and safety of irrigated radiofrequency (iRF) ablation and cryoablation for the treatment of nonparoxysmal AF (NPAF).

Methods: In this prospective, multicenter study, a Cox-Maze IV lesion set using iRF and cryoablation with the Cardioblate™ iRF bipolar clamps and the Cardioblate™ CryoFlex™ cryoablation probes was performed to treat NPAF in patients undergoing concomitant cardiac surgery. Pulmonary vein isolation (PVI) was assessed intraoperatively. The primary efficacy endpoint was freedom from atrial tachyarrhythmias (ATAs; ie, AF/atrial flutter/atrial tachycardia) of ≥30 seconds after a 90-day washout from antiarrhythmic drugs (AADs) through 12 months. The primary safety endpoint was the rate of major adverse events (MAEs) at 30 days/discharge. MAEs and rhythm assessments were adjudicated independently.

Results: Among the 94 treated patients, the mean age was 69 ± 7 years, and 61 (65%) were male. Fifty-one patients (54%) had persistent AF, and 43 (46%) had long-standing persistent AF. PVI was confirmed in 100% of patients tested (65 of 65). Freedom from ATAs through 12 months was 76.2% (64 of 84; 95% Bayesian credible interval [BCI], 66.0%-84.0%). Using the Kaplan-Meier method, freedom from ATAs and AADs at 12 months was 80% (95% CI, 70%–87%). Seven of 93 patients (7.5%; 95% BCI, 3.7%–14.7%) had 10 MAEs through 30 days. The ≤30-day mortality rate was 4.3% (95% BCI, 1.7%–10.5%). QOL scores at 12 months (n = 81) improved significantly from baseline (P < .001).

Source: Damiano RJ, Philpott JM, Moront MG, et al. A prospective, multicenter trial of irrigated radiofrequency ablation and cryoablation to treat nonparoxysmal atrial fibrillation. J Thorac Cardiovasc Surg. Published online May 4, 2026. doi:10.1016/j.jtcvs.2026.04.010.

Disclosure: The Cardioblate™ LP irrigated RF surgical ablation device, Cardioblate™ BP2 irrigated RF surgical ablation device, and Cardioblate™ CryoFlex™ surgical ablation probe have not been approved by FDA for the treatment of nonparoxysmal atrial fibrillation (NPAF), and the safety and effectiveness for this off-label use have not been established.

Considerations associated with the use of the Cardioblate™ LP irrigated RF surgical ablation device and the use of the Cardioblate™ BP2 irrigated RF surgical ablation device for the treatment of NPAF

Indications

The Cardioblate™ LP surgical ablation device and the Cardioblate™ BP2 surgical ablation device are intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate™ LP surgical ablation device and the Cardioblate™ BP2 surgical ablation device should not be used for:

• Patients that have active endocarditis at the time of surgery
• Ablation in a pool of blood (e.g., through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)

Warnings and precautions

• Do not activate the device if saline is not flowing freely. Applying radiofrequency energy without irrigation can result in charring, tissue desiccation, or insufficient ablation.
• Remove the device from the patient before defibrillation.
• The device may be damaged before or during the procedure by improper handling or other intervening acts. If damaged, the device may fail to function properly, and may result in the following medical complications including, but not limited to:
  • Damage to the physiological conduction system
  • Peripheral tissue ablation due to breach of insulation covering
• No representation or warranty is made that failure or cessation of function of the device will not result in an adverse event, or that medical complications (including perforation of cardiac tissue) will not follow the procedure, or that the use of the device will in all cases restore adequate cardiac function.
• This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Multiple uses can result in the occlusion of the irrigation openings and affect the performance of the device. The energy platform has functionality to prevent the reuse of the device.
• It is the responsibility of the hospital to ensure that the individuals assigned to operate this device are well-trained in the operation of the device and alert to potential problems.
• Do not modify the device.
• Do not use the device in the presence of flammable anesthetics, oxidizing gases, or flammable materials used for cleaning or disinfecting, as explosion may occur.
• Use the device with caution in the presence of pacemakers or other active implanted devices. Interference produced by electrosurgical devices can affect the operation of the active implanted device or cause permanent damage to the active implanted device. Consult the active implanted device manufacturer or the responsible hospital department before using electrosurgical devices in patients with active implanted devices.
• Use caution to avoid trauma to tissues not within the intended area of ablation.
• Maximum storage temperature: 25°C (77°F)
• Storage relative humidity: 5% to 85%, noncondensing
• It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital procedures.
• Applicable to products with phthalates identified on the product label: This product contains phthalates.
• Inspect the device and device cable for breaks, cracks, nicks, and other damage before using the device. Do not use the device if any damage is found.
• The use of smoke evacuation equipment is recommended. Smoke generated by electrosurgical devices is potentially harmful to patients and users.

Potential adverse effects

The following known adverse effects are associated with the use of the product: Abrasion, Arrhythmia or EKG/ECG changes, Burn, Electrical shock, Infection, Ischemia, Organ dysfunction (cardiac), Perforation, Tissue damage

The following are possible adverse effects related to the ablation of cardiac tissue in combination with open heart surgery: Atrial lead dislodgement, Atrioesophageal fistula, Bleeding, Cardiac perforation/tamponade, Conduction disturbances (SA or AV node), Esophageal injury, Extension of extracorporeal bypass, Major complication (death), Mediastinitis, Myocardial infarction in the context of cardiac ablation, Pericarditis, Phrenic nerve paralysis, Pleural effusion, Pulmonary vein stenosis, Stroke or transient ischemic attack (TIA) post-ablation, Vagal nerve injury, Valve leaflet damage

FDA Approved Labeling for the Cardioblate™ LP surgical ablation device

FDA Approved Labeling for The Cardioblate™ BP2 surgical ablation device

Considerations associated with the use of the Cardioblate™ CryoFlex™ surgical ablation probe for the treatment of NPAF

Indications

The Cardioblate™ CryoFlex™ surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate™ CryoFlex™ 7-cm, 10-cm, and 10-S probes plus the CryoFlex™ clamp and CryoFlex™ surgical ablation console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications

The Cardioblate CryoFlex™ surgical ablation probe is not designed for use inside a beating heart.

Warnings and precautions

• Do not insert the Surgical Ablation Probe inside a beating heart. If a breach occurs in the probe inside a beating heart, this may result in severe injury or death to the patient.
• Do not pull on the Surgical Ablation Probe or console while its ablation segment is frozen to tissue as this could lead to inadvertent tissue damage.
• Do not use excessive application force when using the Surgical Ablation Probe in order to avoid tissue damage.
• Surgical probe procedures may mechanically induce arrhythmias.
• The Surgical Ablation Probe should be positioned correctly and the placement of the ablation segment confirmed prior to cryoablation. Ensure that tissue adjacent to the probe or below the targeted zone that is not intended to be ablated is protected from freezing. This avoids inadvertent lesion creation.
• Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury.
• The Surgical Ablation Probe contains pressurized refrigerant during operation. Discontinue treatment immediately if a breach in the probe is suspected, as this may result in release of pressurized gas and injury to the patient or the user.
• If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze button on the control panel.
• If you are unable to stop the injection, turn the system off by pressing the power switch on the side of the control panel or by disconnecting the power cord.
• Do not attempt to disconnect the probe during operation in the freeze mode as the sudden release of pressure may cause the probe to recoil, which may injure the operator.
• If the injection of refrigerant spontaneously stops before the preset time on the control panel has elapsed, replace the probe.
• Do not store the Surgical Ablation Probe below 0°C (32°F).
• Only appropriately trained personnel in a fully equipped facility should perform cardiac cryoablation procedures.
• This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness, or death.
• Discard all used Surgical Ablation Probes in accordance with hospital procedures. Reuse may affect product function.
• Prior to removing the Surgical Ablation Probe from its packaging, inspect the packaging to verify the integrity of the seal. Use sterile techniques when handling the product.
• Ensure that equipment used with the Surgical Ablation System is electrically safe and does not expose the patient to hazards.
• Ensure that all pressure and regulator lines are securely connected.
• Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure is safely vented.
• Perform a test injection before placing the Surgical Ablation Probe on tissue to be ablated.
• Do not use Surgical Ablation Probes that are damaged in any way.
• Do not expose the probe, accessories, or electrical connectors to cleaning fluids or solvents.
• Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
• Do not disconnect the probe from the console until the procedure is finished unless the probe needs to be replaced.

Potential adverse effects

Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following: bleeding, reoperation, extension of extracorporeal bypass, heart rhythm disturbances (atrial and/or ventricular), pericardial effusion, pericarditis, cardiac tamponade, pleural effusion, mediastinitis, conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation, low cardiac output, stroke, renal, gastrointestinal, or respiratory complications, sepsis, adjacent structural damage, death

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.

FDA Approved Labeling for the Cardioblate CryoFlex™ surgical ablation probe