TACAIRE - The project

The Proyect

Abstract

Cardiac arrhythmias, a group of conditions in which the heartbeat is abnormal, are among the most recurrent cardiovascular diseases with an important impact in the quality of life of patients (atrial fibrillation is predicted to affect 17.9 million patients in Europe by 2060). When drug therapy fails in the correct management of these diseases, ablation, the selective damage of small regions of the cardiac tissue, is used instead. Current ablation techniques use thermal energy to destroy the target areas with success rates up to 70 %. However, there are complications, such as severe oesophageal or phrenic nerve injury or vascular stenosis, that current thermal treatments cannot overcome.

The TACAIRE project is focused on the development of new technological tools and methods for the non-thermal ablation of cardiac arrhythmias. In particular, the explored technique will be Irreversible Electroporation (IRE), also called Pulsed Field Ablation (PFA), which consists in the application of short and high intensity electric field pulses to kill the cells of the target tissue region. The present action will develop the necessary technologies to study in silico, in vitro and in vivo the potential clinical use of novel electric field waveforms and applicators for cardiac IRE. The present project is extremely timely because PFA is an emerging technique in the field of cardiac ablation with very promising expectations of becoming the leading technique in the near future.

The project involves the host institution, the Biomedical Electronics Research Group (http://berg.upf.edu/) at Universitat Pompeu Fabra (UPF, Barcelona, Spain) and a secondment partner of cardiologists (Research Institute of the Hospital de la Santa Creu i Sant Pau (HSCSP-IR), Barcelona, Spain).

PFA vs Thermal-based ablation

The current standard ablation technology is based on heating the target tissue with adiofrequency (RF) energy to provoke necrosis. Alternatively, cryoablation, a process that uses extreme cold to destroy tissue is used as an alternative. Despite the remarkable successful results of radiofrequency ablation, there are still some cases where recurrent disease cannot be correctly managed, or some complications occur.

The comparison between thermal and electroporation-based cardiac ablation provided the figure below summarizes the potential reduced number of risks and complications of PFA, and highlights the still open questions to be solved.

Compasion of Thermal ablation and Irreversible electroporation-based (PFA) ablation.

Scientific activities

Development of equipment:

During the project, some equipment elements will be developed. As a part of these activities, for example, new designs for catheter electrodes will be studied and implemented. Additional equipment for performing electrical impedance measurements or temperature measurements will be developed.

Development of numerical models:

During the course of the project, finite element models (FEM) will be implemented to predict the tissue damage caused by PFA integrating also thermal calculations for the specific case of IRE in the heart. To feed the model and assign realistic tissue properties different measurements and experiments will be performed in vivo and in vitro.A constant two-way optimization of the model from the experimental results and vice versa will be performed along the action

Experiments (in vitro)/(in vivo):

Basic in vitro experimental data studying the effects of different parameters of the electric field such as waveform shape, frequency, amplitude and duration will be acquired at the Barcelona Biomedical Research Park (PRBB) facilities. In vitro experiments will include more realistic models of primary cardiomyocytes. Specific aspects such as the different cell death mechanisms involved in PFA will be studied.

During the secondment planned in the present action, experiments in swine will be performed as a preclinical model. Following the 3 R’s rule, the animal experiments will allow to study and validate in a realistic model different aspects of the technique.

Other activities

Development of management/organizational skills:

During the project, the fellow will have the opportunity to enhance his leading and scientific administration skills participating in the financial management of the project and personal. Also, he will work in the establishment and consolidation of a network of collaborators

Intelectual property:

Due to the preclinical approach at the end of the project, there will be potentially patentable results concerning new equipment and treatment methods. The fellow will have also the opportunity to learn about regulatory aspects for market access.

Teaching and supervising:

The fellow will develop mentorship and supervision skills of graduate and PhD students. He will also participate in teaching activities of the Biomedical Engineering courses (e.g. Bioelectromagnetism).

Communication:

Presentation and communication skills will be improved through the participation in group meetings, dissemination activities and international conferences, where the fellow will have the opportunity to communicate the results to different audience levels.

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