Periodic Reporting for period 1 - BARAT (Biomechancial Aneurysm Risk Assessment Trial)
Okres sprawozdawczy: 2015-03-01 do 2015-10-31
The formation of aortic aneurysms is the by far the most common aortic disease, such that for example in the UK almost 4000 new cases are identified every year. In order to prevent aneurysms from rupture, progressive treatment like open surgery or endovascular (EVAR) repair is required. Despite these are costly and intensive interventions, current clinical treatment indication is based on oversimplified criteria like the maximum transverse aortic diameter or the aortic expansion rate. The sensitivity and specificity of these criteria is poor and fails to provide patient-specific (individualized) treatment indication. This causes considerable overtreatment of aortic aneurysm patients - currently ten operations are performed to prevent one AAA from rupture. In contrast, VASCOPS’ A4clinics software went one step further, and provides, in addition to geometrical parameters, also biomechanical indices by processing Computer Tomography (CT) images. A4clincis output is based on biomechanical simulations and requires a set of input parameters, many of them are patient-specific, but some of them reflect the mean patient population or are simple “educated guesses”. In addition biomechanical simulations are always very complex and influenced by operator decisions, such that the simulation result needs to be thorough clinically validated with respect to its diagnostic value. So far A4clinics has only been validated against small retrospective studies. However, in order to convince clinicians and make the approach accessible for large scale commercialization a large-scale and prospective validation is required.
The specific objective of the Biomechancial Aneurysm Risk Assessment Trial (bARAT) phase 1 is to develop a clinical validation plan for A4clinics, which is tightly linked to its successful large-scale commercialization. That includes the identification of regional/national aneurysm repair processes, the definition of validation partners and strategy, and to optimize measures to build-up clinical awareness regarding the clinical availability of VASCOPS’ A4clinics software. In addition bARAT phase 1 should draw conclusions regarding an effective distribution of A4clinics and plan technical as well as financial realizations of its large-scale validation. Study results will be documented as a business plan for further exploitation.
The specific objective of the Biomechancial Aneurysm Risk Assessment Trial (bARAT) phase 1 is to develop a clinical validation plan for A4clinics, which is tightly linked to its successful large-scale commercialization. That includes the identification of regional/national aneurysm repair processes, the definition of validation partners and strategy, and to optimize measures to build-up clinical awareness regarding the clinical availability of VASCOPS’ A4clinics software. In addition bARAT phase 1 should draw conclusions regarding an effective distribution of A4clinics and plan technical as well as financial realizations of its large-scale validation. Study results will be documented as a business plan for further exploitation.
Work performed during the reporting period and main results achieved so far:
1. Identification of key aneurysm repair centers in Europe
Key aneurysm repair centers in Europe could be identified according to the aspects size, spectrum of AAA treatment, number of patients and in particular number of AAA patients per year, international role, research activities and publications. Items 5 and 6 provide further details.
2. Identification of guidelines and clinical practice of aortic repair including (plans for) screening
bARAT identified the state of screening programs, inclusion criteria and protocols throughout Europe. Sweden, England, Scotland, Wales and Northern Ireland have implemented nationwide AAA screening programs, or are in the process of doing so. In Germany the Federal Joint Committee commissioned to prove the benefit of AAA screening programs and VASCOPS already approached the institution in charge (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen - IQWiG). Finally, a less detailed assessment of AAA screening programs outside Europe has been performed.
3. Identification of communication platforms (national/international) of vascular clinicians
International and national communication platforms of vascular clinicians have been identified. Many of the foreseen clinical validation partners (see item 6) play key roles in vascular surgery associations (for example Arkadiusz Jawien is the President of the European Society of Vascular Surgery; Armando Mansilha is the Chairman of the Annual Conference of the European Society of Vascular Surgery; Matt Thompson is member of the Vascular Society, Hans-Henning is secretary of the Zeitschrift für vaskuläre und endovaskuläre Medizin and organizes the Munich Vascular Conference; Natzi Sakalihassan organizes the International Meeting of Aortic Disease; Dittmar Böckler organizes the Heidelberger Heisse Eisen). In addition all of the foreseen clinical validation partners are frequently invited speakers at key vascular surgery conferences and/or meetings. Further platforms and communication channels are continuously explored and assessed with respect to a targeted dissimilation of the bARAT validation study progress and results.
4. Identification of European’s key opinion leaders in aneurysms repair and their relation to medical device manufacturer
bARAT could list European’s key opinion leaders in aneurysms repair and their relation to medical device manufacturer like Gore Medical, Endologix, Maquet, TriVascular, Philips, Siemens, Lombard Medical, Aptus, Medtronic, Vascutek, Abbott Vascular and Cook. Endologix could be acquired to use A4clinics for trainings purposes and close contacts with Siemens were established to explore integrating A4clincis within their EVAR planning workstation.
5. Identification of clinical partners that would be most valuable validation partners
Potential clinical validation partners have been identified. Selection was based on their international reputation in AAA research, as well as their strategic value in performing the proposed European-wide bARAT validation study.
6. Approach and invitation of clinical partners to join the bARAT study
VASCOPS invited international leading clinical institutions all over Europe to join the bARAT validation study. The following institutions could be acquired successfully:
-Arkadiusz Jawien, Professor of Vascular Surgery, Chairman of the Department of Vascular Surgery and Angiology, University of Copernicus, Bydgoszcz, Poland
-Armando Mansilha, Professor of Vascular Surgery, CUF Porto Hospital, Portugal
-Christos Liapis, Professor of Vascular Surgery, University of Athens Medical School, Greece
-Dittmar Boeckler, Professor of Vascular Surgery, Heidelberg University Hospital, Germany
-Fabio Verzini, Professor of Vascular Surgery, Unit of Vascular and Endovascular Surgery, Perugia, Italy
-Hans-Henning Eckstein, Professor of Vascular and Endovascular Surgery, Department for Vascular and Endovascular Surgery/Vascular Center, Klinikum rechts der Isar, TUM, Germany
-Igor Koncar, Vascular Surgeon, Medical School, University of Belgrade, Serbia
-Jes Lindholt, Professor of Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, University Hospital of Odense, Danmark
-Joy Roy, Vascular Surgeon, Department of Molecular Medicine and Surgery, Karolinska Hospital Stockholm, Sweden
-Jürg Schmidli, Professor of Vascular Surgery, Bern University Hospital, Switzerland
-Marc van Sambeek, Vascular Surgeon, Catharina Hospital Eindhoven, The Netherlands
-Matt Thompson, Professor of Vascular Surgery, St George's Vascular Institute, London, UK
-Matthew Bown, Professor of Vascular Surgery, Department of Cardiovascular Sciences, University of Leicester, UK
-Natzi Sakalihasan, Professor of Vascular Surgery, Cardiovascular Surgery Department, University Hospital of Liège, Belgium
-Vincent Riambau, Professor and Chief of Vascular Surgery DivisionThorax Institute, Hospital Clinic University of Barcelona, Spain
7. Definition of an effective validation plan
Together with the clinical partners (see item 6) bARAT has developed a targeted validation plan, which addresses the following points:
- Retrospective and prospective study designs
- Cost estimates to implement the validation studies
- Binding statement and agreement for publication of validation results
8. Technical planning
bARAT has developed protocols to process and store the collected validation data.
1. Identification of key aneurysm repair centers in Europe
Key aneurysm repair centers in Europe could be identified according to the aspects size, spectrum of AAA treatment, number of patients and in particular number of AAA patients per year, international role, research activities and publications. Items 5 and 6 provide further details.
2. Identification of guidelines and clinical practice of aortic repair including (plans for) screening
bARAT identified the state of screening programs, inclusion criteria and protocols throughout Europe. Sweden, England, Scotland, Wales and Northern Ireland have implemented nationwide AAA screening programs, or are in the process of doing so. In Germany the Federal Joint Committee commissioned to prove the benefit of AAA screening programs and VASCOPS already approached the institution in charge (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen - IQWiG). Finally, a less detailed assessment of AAA screening programs outside Europe has been performed.
3. Identification of communication platforms (national/international) of vascular clinicians
International and national communication platforms of vascular clinicians have been identified. Many of the foreseen clinical validation partners (see item 6) play key roles in vascular surgery associations (for example Arkadiusz Jawien is the President of the European Society of Vascular Surgery; Armando Mansilha is the Chairman of the Annual Conference of the European Society of Vascular Surgery; Matt Thompson is member of the Vascular Society, Hans-Henning is secretary of the Zeitschrift für vaskuläre und endovaskuläre Medizin and organizes the Munich Vascular Conference; Natzi Sakalihassan organizes the International Meeting of Aortic Disease; Dittmar Böckler organizes the Heidelberger Heisse Eisen). In addition all of the foreseen clinical validation partners are frequently invited speakers at key vascular surgery conferences and/or meetings. Further platforms and communication channels are continuously explored and assessed with respect to a targeted dissimilation of the bARAT validation study progress and results.
4. Identification of European’s key opinion leaders in aneurysms repair and their relation to medical device manufacturer
bARAT could list European’s key opinion leaders in aneurysms repair and their relation to medical device manufacturer like Gore Medical, Endologix, Maquet, TriVascular, Philips, Siemens, Lombard Medical, Aptus, Medtronic, Vascutek, Abbott Vascular and Cook. Endologix could be acquired to use A4clinics for trainings purposes and close contacts with Siemens were established to explore integrating A4clincis within their EVAR planning workstation.
5. Identification of clinical partners that would be most valuable validation partners
Potential clinical validation partners have been identified. Selection was based on their international reputation in AAA research, as well as their strategic value in performing the proposed European-wide bARAT validation study.
6. Approach and invitation of clinical partners to join the bARAT study
VASCOPS invited international leading clinical institutions all over Europe to join the bARAT validation study. The following institutions could be acquired successfully:
-Arkadiusz Jawien, Professor of Vascular Surgery, Chairman of the Department of Vascular Surgery and Angiology, University of Copernicus, Bydgoszcz, Poland
-Armando Mansilha, Professor of Vascular Surgery, CUF Porto Hospital, Portugal
-Christos Liapis, Professor of Vascular Surgery, University of Athens Medical School, Greece
-Dittmar Boeckler, Professor of Vascular Surgery, Heidelberg University Hospital, Germany
-Fabio Verzini, Professor of Vascular Surgery, Unit of Vascular and Endovascular Surgery, Perugia, Italy
-Hans-Henning Eckstein, Professor of Vascular and Endovascular Surgery, Department for Vascular and Endovascular Surgery/Vascular Center, Klinikum rechts der Isar, TUM, Germany
-Igor Koncar, Vascular Surgeon, Medical School, University of Belgrade, Serbia
-Jes Lindholt, Professor of Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, University Hospital of Odense, Danmark
-Joy Roy, Vascular Surgeon, Department of Molecular Medicine and Surgery, Karolinska Hospital Stockholm, Sweden
-Jürg Schmidli, Professor of Vascular Surgery, Bern University Hospital, Switzerland
-Marc van Sambeek, Vascular Surgeon, Catharina Hospital Eindhoven, The Netherlands
-Matt Thompson, Professor of Vascular Surgery, St George's Vascular Institute, London, UK
-Matthew Bown, Professor of Vascular Surgery, Department of Cardiovascular Sciences, University of Leicester, UK
-Natzi Sakalihasan, Professor of Vascular Surgery, Cardiovascular Surgery Department, University Hospital of Liège, Belgium
-Vincent Riambau, Professor and Chief of Vascular Surgery DivisionThorax Institute, Hospital Clinic University of Barcelona, Spain
7. Definition of an effective validation plan
Together with the clinical partners (see item 6) bARAT has developed a targeted validation plan, which addresses the following points:
- Retrospective and prospective study designs
- Cost estimates to implement the validation studies
- Binding statement and agreement for publication of validation results
8. Technical planning
bARAT has developed protocols to process and store the collected validation data.
The expected final results from bARAT phase 1 is a sound validation plan, which execution leads to results that convince vascular clinics and allows a large-scale commercial exploitation of A4clincis software. The diffuse AAA repair indication criteria used in current clinical practice implies that ten AAA repairs are needed to prevent a single case from rupture. In contrast implementing A4clinics in the daily clinical routine will help to prioritize patients for aneurysm repair according to their INDIVIDUAL risk for aortic rupture. Consequently, this individualized diagnostic information will landmark a significant break-through to optimize the health care of AAA patients.
Despite clear European guidelines for aneurysm repair significant regional/national variations are noticed. The very different national refunding schemas and partially implemented screening programs led to significant differences in patient work flows. bARAT phase 1 should provide enough insights into this diversity, such that implementation strategies for A4clinics can be designed fully respecting hospital constraints and needs.
So far bARAT could acquire 15 clinical partners willing join the validation study. All of them are respected figures in the clinical community and they will be of key importance to implemented A4clinics in the daily clinical routine. They will also help to promote the validation study to the wider clinical community and help building-up awareness of VASCOPS’s individualized AAA repair indication method. Specifically, bARAT will derive strategies how clinical partners should be exposed, and similarly, how stakeholder interests should be incorporated in general, to optimize the distribution of A4clinics software.
Finally, validating the A4clinics software without resources from the Horizon 2020 SME instrument program would be very difficult for VASCOPS and would cut down ongoing product development.
Despite clear European guidelines for aneurysm repair significant regional/national variations are noticed. The very different national refunding schemas and partially implemented screening programs led to significant differences in patient work flows. bARAT phase 1 should provide enough insights into this diversity, such that implementation strategies for A4clinics can be designed fully respecting hospital constraints and needs.
So far bARAT could acquire 15 clinical partners willing join the validation study. All of them are respected figures in the clinical community and they will be of key importance to implemented A4clinics in the daily clinical routine. They will also help to promote the validation study to the wider clinical community and help building-up awareness of VASCOPS’s individualized AAA repair indication method. Specifically, bARAT will derive strategies how clinical partners should be exposed, and similarly, how stakeholder interests should be incorporated in general, to optimize the distribution of A4clinics software.
Finally, validating the A4clinics software without resources from the Horizon 2020 SME instrument program would be very difficult for VASCOPS and would cut down ongoing product development.