State government investment expands use of pulsed-field ablation in atrial fibrillation

MedTech & Diagnostics News: Major public hospitals in Queensland are set to expand access to an innovative procedure for one of Australia’s most prevalent cardiac disorders, atrial fibrillation (AF), affecting around 600,000 individuals.

A $1.7 million investment by the QLD state government means more patients will gain access to Boston Scientific’s Farapulse pulsed-field ablation (PFA) system, indicated for the treatment of paroxysmal AF.

Conventional thermal treatments for AF such as radiofrequency or cryoablation have been used to heat or freeze the abnormally firing tissue in the left atrium that triggers AF episodes. This causes it to become scar tissue – rendering it electrically inert. However, these procedures can involve the patient being under general anaesthetic for up to two hours.

“It’s been a fairly effective treatment over the years, although rendering all of the tissue inert is quite challenging and you often have to go back and do multiple procedures over a period of time, to get that complete electrical isolation,” said Dr Tomos Walters, cardiologist at St Vincent’s Private Hospital Northside in Queensland.

He added “Also, there’s a danger that in making the tissue around the left atrium inert, there’s the potential to damage the oesophagus and nerves that lead to the diaphragm. In the most extreme cases – again which is rare – it can be fatal.”

Cardiologist A/Professor Haris Haqqani, St Vincent’s Private Hospital Northside and Prince Charles Hospital in Queensland, said “This technology is worth its weight in gold and it’s fair to say it’s quite revolutionary. It is clear that it is safer and more efficient for the patient.”

A/Professor Haris Haqqani noted the importance of not having the patient under anaesthetic for a significant period, especially given that most of the patients who need this procedure are aged in their 60s, 70s and some in their 80s

“The actual ablation time with PFA is only around 15 minutes or less. With thermal ablation procedures you typically would only do one or two procedures in a session, but due to the greater efficiency and faster workflow of PFA, many more patients should be able to be treated in that time,” he commented.

A/Professor Haqqani did the first PFA procedure in Australia and the first outside Europe at Prince Charles Hospital in 2022.

“This will have an enormous positive impact on reducing surgical waiting times, particularly of course in the public system – which has waiting times of around two to three years in some hospitals, but also in the private hospital system,” he added.

The approval of the Farapulse system was backed by data from the ADVENT trial, the first randomised study comparing PFA technology to thermal ablation. Results demonstrated noninferior safety and efficacy at one year, with considerably shorter procedural and ablation times.

Moreover, real-world data of more than 17,000 patients from the MANIFEST-17K registry showcased a low rate of major complications associated with the Farapulse system.

“While it’s not a paradigm shift in what we’re trying to achieve, it’s fair to say it’s a paradigm shift in how that’s being achieved,” noted Dr Walters. “The data supports its safety and efficacy.”

Additional data regarding the Farapulse system is expected to emerge from the ADVANTAGE AF trial. This trial aims to assess the efficacy of the Farapulse system in patients suffering from drug-refractory, symptomatic, persistent AF. Furthermore, it will investigate the application of the Farapoint PFA catheter for cavotricuspid isthmus ablation to address atrial flutter. Concurrently, the ongoing AVANT GUARD trial is exploring the potential of PFA as an initial treatment option for persistent AF compared to anti-arrhythmic drugs.

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