Periodic Reporting for period 2 - BEAT AF (Ground-BrEAking Electroporation-based inTervention for Atrial Fibrillation treatment (BEAT AF))
Período documentado: 2022-09-01 hasta 2024-02-29
Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of cardiovascular expenses, with over 10 million affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. This arrhythmia is characterized by abnormalities in electrical impulse formation and conduction within the heart.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.
During the second reporting period, BEAT AF hit cruising speed as the team gathered together to brainstorm and implement innovative solutions to remediate any regulatory delays experienced during RP1.The fruits of this can be seen in the major achievements since kick-off in March 2021.
Enrolment for the paroxysmal AF study was completed in mid-January 2024, meaning that 292 patients accepted to participate and we are very grateful to all of them. For the Persistent AF study, enrolment should be completed anytime soon. As of April 2024, only 3 patients are to be recruited. Most of the sub-studies have included enough patients to hopefully provide meaningful results. Furthermore, these ancillary studies provide BEAT AF with the opportunity to start a publishing cycle which will maintain high-interest in the action. Certain sub-studies such as SS1-oesophageal safety, SS2 - Brain MRI, SS3 – ANS study and SS5 – Atrial and ventricular imaging, are based on data that are viable a few days or months after the inclusion. Thanks to this, the team will be able to produce a publishing strategy to exploit those data earlier, without compromising the main study.
As for the main study, recent developments as-well-as most publications indicate that PFA is very likely to be safer than RF. We do believe that this will be demonstrated in a very solid way by BEAT AF as the trial has been constructed to be controlled and randomized. We therefore believe that we will have in the coming month some very solid demonstrations of PFA superiority in terms of esophageal safety and PV stenosis which we expect to be simply non-existing with this energy. We will have to wait for a little more than a year to get the data analysed in terms of superior efficacy with PFA which is the primary goal of this ambitious study.
In the meantime, BEAT AF has put an accent on public outreach, especially to the patients who are the heart of this clinical trial. Work during the last 18 months for the communication and dissemination team was focused on updating the communication roadmap in order to share results from the clinical trial with patients in a meaningful manner. To do this, expert patients were included in our first and second face-to-face meetings, culminating in a collaborative strategy to co-publish lay papers based of scientific publications produced by the action. The first of these is expected in Spring 2024.
Enrolment for the paroxysmal AF study was completed in mid-January 2024, meaning that 292 patients accepted to participate and we are very grateful to all of them. For the Persistent AF study, enrolment should be completed anytime soon. As of April 2024, only 3 patients are to be recruited. Most of the sub-studies have included enough patients to hopefully provide meaningful results. Furthermore, these ancillary studies provide BEAT AF with the opportunity to start a publishing cycle which will maintain high-interest in the action. Certain sub-studies such as SS1-oesophageal safety, SS2 - Brain MRI, SS3 – ANS study and SS5 – Atrial and ventricular imaging, are based on data that are viable a few days or months after the inclusion. Thanks to this, the team will be able to produce a publishing strategy to exploit those data earlier, without compromising the main study.
As for the main study, recent developments as-well-as most publications indicate that PFA is very likely to be safer than RF. We do believe that this will be demonstrated in a very solid way by BEAT AF as the trial has been constructed to be controlled and randomized. We therefore believe that we will have in the coming month some very solid demonstrations of PFA superiority in terms of esophageal safety and PV stenosis which we expect to be simply non-existing with this energy. We will have to wait for a little more than a year to get the data analysed in terms of superior efficacy with PFA which is the primary goal of this ambitious study.
In the meantime, BEAT AF has put an accent on public outreach, especially to the patients who are the heart of this clinical trial. Work during the last 18 months for the communication and dissemination team was focused on updating the communication roadmap in order to share results from the clinical trial with patients in a meaningful manner. To do this, expert patients were included in our first and second face-to-face meetings, culminating in a collaborative strategy to co-publish lay papers based of scientific publications produced by the action. The first of these is expected in Spring 2024.
BEAT AF addresses a widespread non-communicable, chronic medical condition that not only constitutes a significant burden on the health and quality of life for the concerned patients, but also poses significant pressure on healthcare system through:
a) long-term pharmacological treatment of AF, treatment of resulting co-morbidities and management of complications (e.g. hospitalizations, emergency care), and
b) costs and complexity of catheter ablation treatment.
By replacing routine thermal PVI with superior, safer and way easier to use PEF energy for cardiac ablation, BEAT AF implements an innovative and effective healthcare intervention providing superior care to more AF patients. Over the last 30 years, no new technology has reached this level of hope in the field. The BEAT AF partners are very excited to participate in a landmark effort!
BEAT AF trials aim at reporting improved hard outcomes, offering an ultra-rapid durable PVI with excellent durable safety to patients. We do believe that among other major clinical benefits, it will completely change patients’ experience and facilitate their decision process to undergo ablation, allowing for earlier ablation procedures.
BEAT AF will pave the way for widespread acceptance of the new technology and drive establishment of PEF ablation for AF in clinical practice within 3 to 4 years. Outcomes for patients and disease burden, both in terms of population access to PEF ablation for AF as well as disease progression and quality-of-life for the individual patient will be greatly improved.
One of BEAT AF’s goals is to establish PEF ablation for AF in medical guidelines for the treatment of these patients. To do so we will provide evidence-based medicine through our two clinical studies and preliminary findings on potential reduction in healthcare costs (e.g. all-cause rehospitalizations, cardiovascular rehospitalizations for AF related and non–AF related, redo procedures, time spent under anti-arrhythmic drugs). Ultimately, this will provide a safer, and more (cost-) effective way of treating patients with atrial fibrillation.
a) long-term pharmacological treatment of AF, treatment of resulting co-morbidities and management of complications (e.g. hospitalizations, emergency care), and
b) costs and complexity of catheter ablation treatment.
By replacing routine thermal PVI with superior, safer and way easier to use PEF energy for cardiac ablation, BEAT AF implements an innovative and effective healthcare intervention providing superior care to more AF patients. Over the last 30 years, no new technology has reached this level of hope in the field. The BEAT AF partners are very excited to participate in a landmark effort!
BEAT AF trials aim at reporting improved hard outcomes, offering an ultra-rapid durable PVI with excellent durable safety to patients. We do believe that among other major clinical benefits, it will completely change patients’ experience and facilitate their decision process to undergo ablation, allowing for earlier ablation procedures.
BEAT AF will pave the way for widespread acceptance of the new technology and drive establishment of PEF ablation for AF in clinical practice within 3 to 4 years. Outcomes for patients and disease burden, both in terms of population access to PEF ablation for AF as well as disease progression and quality-of-life for the individual patient will be greatly improved.
One of BEAT AF’s goals is to establish PEF ablation for AF in medical guidelines for the treatment of these patients. To do so we will provide evidence-based medicine through our two clinical studies and preliminary findings on potential reduction in healthcare costs (e.g. all-cause rehospitalizations, cardiovascular rehospitalizations for AF related and non–AF related, redo procedures, time spent under anti-arrhythmic drugs). Ultimately, this will provide a safer, and more (cost-) effective way of treating patients with atrial fibrillation.