Risk assessment of plaque rupture and future cardiovascular events (CVENT) by multi-spectral photoacoustic imaging

Project Information

CVENT

Grant agreement ID: 731771

DOI

10.3030/731771

Project closed

EC signature date 3 November 2016

Start date 1 November 2016

End date 30 April 2020

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost

€ 4 697 377,50

EU contribution

€ 4 260 790,00

Coordinated by

ESAOTE EUROPE B.V.
Netherlands

Periodic Reporting for period 2 - CVENT (Risk assessment of plaque rupture and future cardiovascular events (CVENT) by multi-spectral photoacoustic imaging)

Reporting period: 2018-05-01 to 2020-04-30

Summary of the context and overall objectives of the project

The focus of the CVENT consortium is on the translation (and advancement) of photoacoustic imaging (PAI) from a research-based image modality to a low-cost portable multi wavelength combined PAI system for vulnerable plaque imaging. Cardiovascular disease (CVD), more specifically, vulnerable plaque rupture, remains the major cause of death for people at middle age. In the carotid arteries feeding the brain, vulnerable plaque rupture initiates cerebrovascular ischemic attacks. Consequently, there is a worldwide unmet and urgent clinical need for functional information to enable in-depth diagnosis of carotid plaque vulnerability, avoiding cardiovascular events (CVENT). The CVENT project addresses this unmet clinical need by introducing a diagnostic method to assess plaque vulnerability.

The strategy of the CVENT consortium is to show that photoacoustic imaging (PAI) can deliver morphological information of carotid plaques that are known risk factors for plaque rupture (intraplaque haemorrhages), and to develop an economical feasible PAI add-on for a point-of-care US system that results in a simple diagnostic device that can indicate the risk of plaque rupture.

The workflow requested by physicians is: 1) to start with an US image to show the presences and size of a plaque and 2) to use the PAI add-on to get the morphological information on plaque rupture. The information of main interest is the presence of intraplaque haemorrhage Augmenting this functional information over the plaque in the US image will inform the physician about the risk of plaque rupture (presences of haemorrhage).

The main objective of the consortium is the development of a portable PAI system with a PAI add-on for the assessment of plaque composition and structure. To achieve this objective the CVENT consortium will focus on the following R&D objectives:

• PAI system engineering
• Advanced PAI signal processing
• PAI system verification and validation

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project has ended. All the objectives are implemented, tested and the pre-clinical pilot study validation has been conducted. In conclusion:
• The final prototype of the PA/US probe was finalized and installed at the different sites. The final system consists of multi-wavelength diode laser beam sources with ultra-high pulse power short pulse duration, and efficient diode laser drives. A hybrid front-end for US and PA data beam-forming has been developed. A full test of the PAI system and PA probes has been carried out.
• Advanced PAI signal processing methods have been developed in CVENT, including clutter suppression, singular-value decomposition, speed-of-sound correction, and motion correction. All software has been tested in silico, phantoms, and in-vivo datasets, and has distributed over the partners.
• The pre-clinical studies have been conducted in patients suffering from plaques, comparing non-invasive and intra-operative measurements to gold standard data (histology and MRI).
• The resulting system, signal processing methods and preclinical results are the result of the excellent motivation and cooperation in the team.
• Results have been presented to the public and have been reviewed by the Medical Resonance Board.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

With an emphasis on a cost effective, multimodality PAI system for screening, diagnosis and monitoring of carotid plaque vulnerability using innovative (optical) technology, the CVENT research and development has always been fully dedicated to create a beyond state-of-the-art change in healthcare delivery. The new probe is one in its kind and opens the doors for frequent clinical use of PAI for different applications. The CVENT consortium has shown to be able to create and translate new innovative technology and imaging methods all the way from the bench (development phase, experimental testing) to the bedsite, i.e. first clinical pilot studies in patients suffering from a plaque.

The CVENT strategy intertwines beyond-state-of-the-art R&D with strong stakeholder involvement and clear exploitation paths by the industrial partners. A cost-efficient point-of-care PAI system, able to provide morphological information about carotid plaque vulnerability, is highly innovative and will give ESAOTE a global top position in the vascular market. The strong industrial participation in the CVENT consortium is possible because each of the necessary optical and related components for the development of the PAI add-on have an intrinsic unique selling point. Specifically, these are: ultra-high-power pulsed diode laser (LUMIBIRD), highly efficient diode laser drivers (BrightLoop) and advanced diode laser diffractive optical beamforming (SILIOS). These components are pushed to the limits necessary to achieve our common goal on economical feasible simple plaque rupture detection. The intrinsic unique selling points open – next to the PAI add-on for ultrasound – new and profitable markets for each of the CVENT industrial partners. The same holds for the developments in signal processing, aimed at improving PAI quality. Speed-of-sound measurements and motion-compensated US are advances that will also be of interest for other US applications beyond PA.

The CVENT PAI system as an “US-system PAI add-on” can provide a revolutionary diagnostic approach for monitoring of carotid plaque vulnerability. As a result, it will fulfil an unmet clinical need and will be a unique selling point that will open additional markets on vascular ultrasound, but also on skin disease, burn wounds, and muscle imaging. Hence, there is in our CVENT consortium - next to the close involvement of vascular physicians - a strong cooperation with industrial and research partners to push PAI components and PAI signal processing to the limits of what is technically feasible and bring it into clinical application.

Illustration of the CVENT project