How Pulsed Ablation Systems Compare for Treating Cardiac Arrhythmia?

Cardiac arrhythmia is a condition where the heart beats irregularly, either too fast or too slow. It can cause symptoms such as palpitations, dizziness, chest pain, and shortness of breath. It can also increase the risk of stroke and heart failure. One of the treatments for cardiac arrhythmia is ablation, a procedure that destroys the abnormal tissue that causes the irregular heartbeat.

Ablation can be done using different energy sources, such as heat (radiofrequency), cold (cryoablation), or electricity (pulsed-field ablation). In this article, we will compare the different types of pulsed ablation systems that are available or under development for treating cardiac arrhythmia.

What is pulsed-field ablation?

Pulsed-field ablation (PFA) is a novel technique that uses electrical pulses to create tiny holes in the membranes of heart muscle cells. This causes the targeted cells that contribute to irregular heart rhythms to die without altering the overall structure of the tissue or affecting other cell types.

PFA has several advantages over thermal ablation, which uses heat or cold to create scars in the heart tissue. Thermal ablation carries the risk of damaging other nearby tissues and structures, such as the esophagus and nerves. PFA, on the other hand, is more selective and precise, as it only affects cardiomyocytes and not surrounding tissues, which have much higher thresholds for damage from electroporation.

PFA also allows ablation procedures to be performed in less time and with less radiation exposure than thermal ablation, as it does not require temperature monitoring or mapping of the tissue. PFA may also have better durability and lower recurrence rates than thermal ablation, as it creates more uniform and transmural lesions.

What are the different types of pulsed ablation systems?

There are currently two pulsed ablation systems that have been approved or are under investigation for treating cardiac arrhythmia: PulseSelect (Medtronic) and FARAPULSE (Boston Scientific).

PulseSelect

PulseSelect is the first PFA system that has been approved by the FDA for the treatment of paroxysmal and persistent atrial fibrillation (AF), a common type of cardiac arrhythmia that affects the upper chambers of the heart. It was previously approved in Europe and is expected to be commercially available in the U.S. soon.

PulseSelect uses a catheter with four electrodes that deliver rapid, high-voltage pulsed electrical fields to the tissue around the pulmonary veins, which are often the source of AF triggers. The system has a generator that controls the voltage, duration, and frequency of the pulses, as well as a console that displays real-time feedback on lesion formation and tissue contact.

The safety and efficacy of PulseSelect have been demonstrated in several clinical trials, such as PULSED AF, QDOT-FAST, and PULSED AF LEADLESS. These trials showed that PulseSelect was able to achieve pulmonary vein isolation (PVI), which is the goal of AF ablation, in shorter procedure times and with lower fluoroscopy times than thermal ablation. They also showed that PulseSelect had low rates of complications, such as esophageal injury, phrenic nerve palsy, and cardiac tamponade.

FARAPULSE

FARAPULSE is another PFA system that is currently under investigation for treating AF. It uses a catheter with eight electrodes that deliver bipolar electrical pulses to create lesions around the pulmonary veins. The system has a generator that controls the pulse parameters and a console that displays real-time feedback on lesion formation and tissue contact.

The safety and efficacy of FARAPULSE are being evaluated in several clinical trials, such as FARAPULSE Pivotal, AVANT GUARD, and ADVENT-HF. These trials aim to compare FARAPULSE with anti-arrhythmic drug therapy or thermal ablation for first-line or second-line treatment of paroxysmal or persistent AF. They also aim to assess the impact of FARAPULSE on quality of life, stroke prevention, and heart failure outcomes.

Conclusion

Pulsed-field ablation is a new, highly selective catheter ablation method for cardiac arrhythmia that offers several advantages over thermal ablation, such as faster procedure times, less risk to adjacent structures, and better durability. Two pulsed ablation systems are available or under development for treating AF: PulseSelect and FARAPULSE. Both systems have shown promising results in clinical trials and may soon become widely adopted in the field of electrophysiology.

: [Pulsed-Field Ablation: A New, Highly Selective Catheter Ablation Method for Heart Arrhythmias – Consult QD](https://consultqd.clevelandclinic.org/pulsed-field-ablation-a-new-highly-selective-catheter-ablation-method-for-heart-arrhythmias/)

: [New Ablation Technology Found Safe, Effective for Atrial Fibrillation - American College of Cardiology](https://www.acc.org/About-ACC/Press-Releases/2023/03/06/14/01/New-Ablation-Technology-Found-Safe-Effective-for-AFib)

: [Ablation for Cardiac Arrhythmia - Cardiovascular Disorders - Merck Manuals Professional Edition](https://www.merckmanuals.com/professional/cardiovascular-disorders/overview-of-arrhythmias-and-conduction-disorders/ablation-for-cardiac-arrhythmia)

: [Pulsed Field Ablation for Paroxysmal Atrial Fibrillation (QDOT-FAST) - Full Text View - ClinicalTrials.gov](https://clinicaltrials.gov/ct2/show/NCT03787038)

: [Pulsed Field Ablation Using the Medtronic PulseSelect? System in Paroxysmal Atrial Fibrillation (PULSED AF LEADLESS) - Full-Text View - ClinicalTrials.gov](https://clinicaltrials.gov/ct2/show/NCT04155981)

: [FARAPULSE Pivotal Trial for the Treatment of Paroxysmal Atrial Fibrillation (FARAPULSE Pivotal) - Full-Text View - ClinicalTrials.gov](https://clinicaltrials.gov/ct2/show/NCT04093166)

: [Atrial Fibrillation and Determinants of Ventricular Dysfunction (ADVENT-HF) - Full Text View - ClinicalTrials.gov](https://clinicaltrials.gov/ct2/show/NCT04649531)