Terumo Interventional Systems
TRI-HERO Challenge
(TransRadial Intervention – HEmostasis pROtocol)
Participation Rules

Publishing date: March 20th 2024 (version 2.0)

1. Organizer

This Challenge is organised by:
Terumo Europe N.V. (Terumo Interventional Systems division)
Interleuvenlaan 40
3001 Leuven, BELGIUM

Contact person:

Thomas BAR
EMEA Marketing Manager Closure
Email: Thomas.Bar@terumo-europe.com
 

2. Eligibility

2.1     TRI-HERO Challenge (TransRadial Intervention – HEmostasis pROtocol) (the “Challenge”) is open to teams of:

  • Interventional cardiologists, interventional radiologists, nurses, and other operators involved in interventional procedures through radial access. 
  • with strong experience with radial access and closure management, and a focus on achieving patent hemostasis. 
  • using Terumo’s TR Band™ within its instructions for use in their daily practice for over a year, without additional device that could prevent visibility of the puncture site such gauze or hemostatic patch.
  • based in the following regions: Europe, Middle East, Africa, Asia and Pacific region. Participants from North or West America are not eligible.

2.2    Employees, affiliates, and immediate family members of Terumo employees are not eligible to participate.

3. ENTRY REQUIREMENTS

3.1 To participate, teams must: 

  • Log in or sign up to the https://www.tri-hero.com/ platform
  • Create a team profile, providing all required information, including the name of the protocol and select the category they wish to make a submission to:
    • Category 1: Diagnostic Procedures only 
    • Category 2: Intervention Procedures (+/- Diagnostic) 
  • Submit their Radial Access & Patent Hemostasis Protocol (the “Protocol”), following the online template on  https://www.tri-hero.com/ . Each Protocol should cover the following topics: 
    • Radial Access Protocol.
    • Patent Hemostasis Protocol (including application, deflation & removal of TR Band™). 
    • Tips & tricks that improved its radial practice & daily workload. 
  • Submit their 50 to 100 case reports (“Case Reports”), using the Excel template available on https://www.tri-hero.com/ 
    Each case report should include the results of 3 parameters: 
    • Number of TR Band™ deflations, after initial haemostasis is achieved
    • Time to Hemostasis, from sheath removal to TR Band™ removal 
    • Evidence of RAO following completion of Hemostasis (assessed by reverse barbeau test with use of pulse oximetry* ) 

*As recommended by  Bernat Ivo et al. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246.
 Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper

Case Reports must not contain any personally identifiable information of patients, such as names, initials, birth dates or other.

  • Choose a cover image for their submission, to help it stand out. Such a cover image can be (non limitative list):
    • a picture of the team (provided everyone appearing on the picture has given their consent),
    • a logo of the team’s hospital (provided appropriate authorizations have been received),
    • a picture taken during a Protocol (provided no patient is identifiable)

No other format or supporting documentation will be considered.

3.2 By participating to this challenge, each participating team accepts that its Protocol and Case Reports: 

  • will be displayed online for all healthcare professional interested by this challenge on https://www.tri-hero.com/
  • will be assessed by their peers, who will be able to vote for the protocol(s) of their choice. 
  • will be assessed by a panel of experienced operators.

3.3 Each participant is allowed to submit up to one Protocol and Case Reports for each category ( “Diagnostic Procedures only” or “Intervention Procedures (+/- Diagnostic)”), if the Protocol and Case Reports are specific to the dedicated category. The same protocol cannot be submitted in both categories.

3.4 Protocol submission may be rejected by Terumo for the following reasons: 

  • Use of another device than or in combination with TR Band™ to achieve hemostasis.
  • Off label use of TR Band™ evidenced in the Protocol. The TR Band™ is intended to be used for temporary hemostasis at the puncture site after catheterization via the radial artery.
  • Partial and/or incorrect compliance with the device’s instructions for use.
  • Incomplete data submission or incorrect format/template used
     

4. SUBMISSION DEADLINE

4.1 All entries must be submitted by June 20th 12.00AM.

4.2 Late entries will not be considered.
 

5. INTELLECTUAL PROPERTY

5.1 Participants retain the intellectual property rights to their submissions.

5.2 By joining this initiative, participants grant Terumo a non-exclusive, royalty-free license to use, reproduce, and distribute their submissions for promotional purposes.

5.3 By joining this initiative, participants acknowledge and agree that Terumo reserves the right to reuse submissions for potential product improvement purposes, without the need for further consent or compensation from participants.  
 

6. AWARD CRITERIA

6.1 Submissions will be assessed by both (a) the audience and (b) a panel of expert operators, leading to the attribution of 4 team awards in total for the Initiative.

6.2 Team Awards attributed by Panel of Expert Operators 

6.2.1 The panel of expert operators (the “Panel”) will be composed as follows:

  • Prof. James Nolan, Interventional Cardiologist 
    Keele University, Staffordshire, United Kingdom 
  • Dr. Ivo Bernat, Interventional Cardiologist 
    University Hospital and Faculty of Medicine, Pilsen, Czech republic
  • Alison Dahlmann, Nurse
    Clinic Pasteur, Toulouse, France
  • David Rodrigues, Nurse 
    Santo António University Hospital Centre, Porto, Portugal

No Terumo personnel will form part of those panels. Members of the panel will be engaged by Terumo as consultants and remunerated for their time according to the principles of the Medtech Europe Code of Ethical Business Conduct.

6.2.2 After the submission deadline, a pre-selection of 20 protocols with the highest “case report” score will be done: 

  • 10 protocols for the Category 1: Diagnostic Procedures only
  • 10 protocols for the Category 2: Intervention Procedures (+/- Diagnostic) 

A maximum of 10 points will be awarded on the average results shared in the Case Reports, per criteria: 

  • Number of TR Band™ deflations (after initial hemostasis is achieved) will count for maximum 3 points.
  • Time to hemostasis (from sheath removal to TR Band™ removal) will count for maximum 3 points.
  • Evidence of RAO following completion of Hemostasis (assessed by reverse barbeau test with use pulse oximetry) for maximum 4 points.

More Information available on the scoring in Annex 1 “Background on this initiative”

6.2.3 The panel members will assess the pre-selected 20 Protocols and assign them a maximum of 10 points based on the panelists personal experience, with a focus on the feasibility and simplicity for the teams in charge of the success of the hemostasis protocol. The average score will determine the wining protocols. 

6.2.4 The Panel will attribute 2 awards to the participating teams that have received the highest score: 

  • one for the best protocol to preserve radial access after Diagnostic Procedures (Category 1)
  • one for the best protocol to preserve radial access after an Interventional Procedures (Category 2)

In the event of a tie between two protocols, the protocol with the highest “case report” score will win.

6.2.5 The decision of the Panel is final and binding.

6.2.6 In the event a participating team originates from the same medical center as one of the Panel member, this Panel memeber will be excluded from the assessment of that team’s Procotol.

6.3 Awards attributed by the peers 

6.3.1 Peers will be able to review and vote for the protocol(s) of their choice. Peers are described as healthcare professionals (Interventional cardiologists, interventional radiologists, nurses, and other operators involved in interventional procedures through radial access) who may or may not have submitted a protocol themselves. Employees, affiliates, and immediate family members of Terumo employees are not eligible to vote.

6.3.2 To vote, Peers must register on the https://www.tri-hero.com/. Only one vote per protocol and per Peer is allowed, but a Peer may vote for multiple protocols, with no limit in number. 

6.3.3 Peers’ Votes will be open from the beginning of the initiative until June 20th 12.00AM. 

6.2.4 The Peers’ Award will be attributed to 2 participating teams: 

  • The team with the most votes within the “Diagnostic Procedures only” category
  • The team with the most votes within the “Intervention Procedures (+/- Diagnostic)” category 

In the event of a tie between two protocols, the protocol with the highest “case report” score will win.
 

7. PRIZES

7.1 The 4 awarded teams will receive the following prizes:

7.1.1 One educational grant of a value of maximum three thousand euros (3000€) for the team, to access a single educational event of their choice.  The grant cannot be used for multiple events. The amount can be used to cover the following costs: registration, transportation, accommodation, meals, up to 3000€. The funds will be transferred to a bank account of the medical center where the winning team is practicing and in no event be paid on individual accounts. In case the maximum amount of 3000€ is not spent on one event, the remaining amount will not be paid out.

Terumo reserves the right to approve or refuse the chosen event(s), which must be submitted for review 5 weeks before the event using the attached form.

Educational Request Application

7.1.2 Each awarded team will be able to present their winning protocol during the award ceremony: an online webinar aiming to disseminate the best protocols to the audience. This event will take place in September (exact date to be communicated soon). It will be available on replay on https://www.tri-hero.com/ and on Terumo’s website(s)

7.1.3 Each team will also be interviewed remotely, to enable them to further highlight their experience and share their best practices with their peers. This interview will be available on replay on https://www.tri-hero.com/and on Terumo’s website(s)

For the avoidance of doubt, awarded teams will not be compensated for their participation in the award-winning ceremony or the interviews.

7.2 Prizes are non-transferable, and no cash alternatives will be offered.

7.3 Due to local legal and industry code restrictions, awarded teams practicing in the following countries will not be eligible for an Educational Grant as prize:

  • Belgium
  • France
  • The Netherlands

For countries in the Asia-Pacific region, please contact us to confirm your eligibility to receive such a grant.

Awarded teams from those countries will be provided with the prizes described in point 7.1.2 and 7.1.3. No alternative or compensation will be provided.


8. Winner Notification

8.1 Awarded teams will be notified by email within end of June (exact date to be communicated soon) after the jury and peer assessment is completed.

8.2 If an Awarded team does not respond within a week, the prize may be forfeited, and the team with the next highest score/number of votes selected.


9. Privacy

Terumo Europe NV, as the data controller, is committed to protecting and respecting the privacy and personal data of the participants. If you have any questions with regards your privacy you can contact the Terumo Privacy Office at privacy@terumo-europe.com.

To participate in the TRI-HERO Challenge, the Participant has to register on the TRI-HERO.com platform. Terumo and Radcliffe Cardiology have entered into a Data Processing Agreement by which both Parties commit to the respect of applicable Privacy legislation, including the implementation of appropriate security measures and the respect of privacy rights of the participants. 
When registering, you will be requested to provide the following data: 

  • Title
  • First name & Last name
  • Country
  • Name of your Hospital or orgnanisation
  • Job title
  • Confirmation to be a healthcare professional 
  • Primary area of interest

Terumo will use this data for the only purpose of managing the contest and the prizes, based on the contractual need to manage the contest. Additionally, and only if you consent to it, Terumo will also provide you with marketing communications based on your interests. You can withdraw your consent at any time in our marketing platform or by sending an email to privacy@terumo-europe.com.

The people eligible to vote will not have access to your personal data. They will only be able to see the name of your institution, department and country (if provided), which is not enough to identify you. 

If you are one of the winners, Terumo will announce your award on the https://www.tri-hero.com/ platform and following personal data may be published or mentioned during the closing webinar: the names of the team members and their specialty, institution, department and country.

We will keep your data for the time necessary to fulfil the purposes described above. The data of the participants that were not selected, will be retained for 12 months after prizes have been awarded. The data of the winners will be retained for the period required to demonstrate compliance with local legislation in the awarding and handling of the prize.

Participants have the right to access their personal data, the right to rectify them, if necessary, and/or to restrict its processing or erase them, if applicable. Participants are also entitled to object to the processing and or withdraw the consent, where applicable. 
If you would like to exercise your rights, you can send an email to privacy@terumo-europe.com

If you would like to know more about how Terumo process personal data, you can consult the full Privacy Notice at www.terumo-europe.com.


10. Disqualification


10.1 Terumo reserves the right to disqualify any participant who violates the rules or engages in fraudulent or inappropriate conduct.

10.2 Decisions regarding disqualification are at the sole discretion of Terumo.

11. Changes to the rules

11.1 Terumo reserves the right to make changes to the present rules at any time.

11.2 Participants are responsible for regularly reviewing the rules to stay informed about any updates.

12. Governing Law

12.1 The Initiative and these rules are governed by the laws of Belgium.

By joining the initiative, participants agree to abide by these rules and the decisions of Terumo Interventional Systems, which are final and binding in all matters related to the Initiative.

 

Annex 1 "Background on this initiative"

Radial access has become standard practice in cardiology across the globe1,2 and is rising as a safe access with improved clinical outcome for endovascular interventions3.

Preventing Radial Artery Occlusion (RAO), the most frequent post procedural complication of radial access, is crucial to keep the radial artery open for future interventions4. 

One of the key measures to prevent RAO is to achieve non occlusive or patent hemostasis.

The TRI-HERO (TransRadial Intervention HEmostasis pROtocol) Challenge is a joined effort of Terumo Interventional Systems and Radial experts with a clear objective: support best practice sharing to achieve patent hemostasis and preserve radial access.

By sharing your protocol, you will contribute to increase both awareness & knowledge on the best way to achieve successful patent hemostasis, inspiring other teams across the globe to improve their practice

Your peers & a Panel of Radial Experts will assess the protocol to identify the best protocols for diagnostic procedures and for interventional procedures.

More details on the Panels selection criteria.

The Panel of experts will select the top 20 protocols based on the average results shared in the Case Reports, per criteria: 

  • Criteria #1 Number of TR Band™ deflations, after initial haemostasis is achieved
  • Criteria #2 Time to Hemostasis, from sheath removal to TR Band™ removal 
  • Criteria #3 Evidence of RAO following completion of Hemostasis (assessed by reverse barbeau test with use pulse oximetry)

Criteria #1:   Number of TR Band™ deflations, after initial haemostasis is achieved

  • Context: with the shortage of staff, and increased workload, fewer deflation may lead to reduced workload while maintaining patient outcome 
  • Description of “Number of TR Band™ deflations“: 
    • Once TR Band™ is placed, sheath is removed and initial haemostasis is achieved, the “number of TR Band™ deflations” corresponds to how many times the device is deflated before full deflation and device removal
    • If bleeding occurs, additional inflation of air will be required, leading to additional deflation(s) that must accounted for 
  • Baseline: Average of 4 deflations based on TR Band™ Instructions for Use (IFU) and Terumo's application guidelines
    • IFU: TR Band™ Nominal pressure is 13mL
    • Terumo's application guidelines: removing 3-5mL every 10-15 minutes per deflation
  • Score scale : up to 3 points 

Criteria #2:   Time to Hemostasis

  • Context: the CRASOC I, II& III studies5 demonstrated the benefits of a shorter compression time to reduce Radial Artery Occlusion rates
  • Description of “Time to Hemostasis” criterion: this means the time in minute between the application of TR Band™ and full deflation AND  Removal of TR Band™
  • Baseline: based on nominal Pressure of TR band™ & Terumo's application guidelines, without rebleeding
    • Low heparin intervention, mainly Diagnostic procedures = 120min, 60min before deflation protocol then 4 deflations every 15min
    • High heparin intervention mainly Interventional procedures = 180min, based on 120min before deflation protocol then 4 deflations every 15min
  • Score scale: up to 3 points

Criteria #3:   Evidence of RAO following completion of Hemostasis  

  • Context: RAO remains the most frequent postprocedural complication of transradial access, restricting the use of the same radial artery for future procedures. Real-world reported incidence of RAO remains high, with wide variability in the uptake of RAO prevention strategies4.
  • Description of “Evidence of RAO following completion of Hemostasis“ criterion: assessed by Reverse Barbeau test with use of pulse oximetry4 once hemostasis protocol is successfully finished.
  • Baseline: the International Consensus Paper4 led by Ivo Bernat in 2019 defined simple and effective methods to achieve an institutional rate of RAO <5%
  • Score scale: up to 4 points

Once identified, each panel member will assess the pre-selected 20 Protocols and assign them a maximum of 10 points based on the panelists personal experience, with a focus on the feasibility and simplicity for the teams in charge of the success of the hemostasis protocol. The average score will determine the wining protocols.

The Panel will attribute 2 awards to the participating teams that have received the highest score:

  • one for the best protocol to preserve radial access after Diagnostic Procedures (Category 1)
  • one for the best protocol to preserve radial access after an Interventional Procedures (Category 2)

References :

  1. Ibanez B et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2018;39:119–77.
  2. Lawton J.S. et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):197-215.
  3. Nanjundappa A. et al. Transradial Access for Peripheral Endovascular Interventions: A Leap Toward Improved Patient Safety and Improved Clinical Outcomes. J Soc Cardiovasc Angiogr Interv. 2023 .101179
  4. Bernat I.et al. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention - An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12:2235-2246
  5. Dangoise V. et al. Usefulness of a Gentle and Short Hemostasis Using the Transradial Band Device after Transradial Access for Percutaneous Coronary Angiography and Interventions to Reduce the Radial Artery Occlusion Rate (from the Prospective and Randomized CRASOC I, II, and III Studies) Am J Cardiol. 2017 Aug 1;120:374-379