Temporary Pacing Leads - Scoping and Mitigating Environmental Impact

Lead Participant: CARDIAC-TECH LTD

Abstract

Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances that can lead to serious complications during recovery. Patients are therefore normally fitted with a temporary pacing system for 1-2 weeks after their procedure to ensure a near-normal rhythm is maintained.

Unlike permanent (implanted) pacing systems, temporary pacemakers sit externally at the patient's bedside and are connected to the heart with wires that are fitted during surgery and which pass through the chest. These wires are then connected to extension cables that interface with the pacing device.

Whereas temporary pacemakers are re-usable, temporary pacing wires and extension cables are typically incinerated after a single use. Although pacing wires are implanted, pacing extension cables are not and serve only to secure and shield the connection between the wires and pacemaker.

Since two sets of extension cables are normally required per procedure (one for each heart chamber) and around 34,000 cardiac surgical procedures are performed each year in the U.K., an estimated 68,000 cables are burned annually (representing over 3.6 metric tonnes of waste)\[1\]. In the U.S. and Europe, the number of procedures performed annually exceeds 1.4m., representing around 2.8m cables (or 150 tonnes of plastic waste)\[2\].

In addition to contributing to CO2 emissions, pacing cables are commonly formed from polyvinyl chloride (PVC), which produces hydrogen chloride and dioxins upon incineration - persistent organic toxins that are highly toxic.

Cardiac Tech has developed a novel medical device that is anticipated to revolutionise, temporary pacing (see IUK projects 10042881 and 10051092). Through this technology, the Company has the opportunity to disrupt the market for temporary pacing equipment, and plans to exploit this opportunity in a more sustainable manner.

In this project, Cardiac Tech will work with Pd-m International Ltd., a product design agency with a specialism in sustainability; regulators and stakeholders, to evaluate the product lifecycle and materials used in temporary pacing cables, and to identify and assess the appetite for more sustainable business models, practices and/or products. This will include assessing the barriers to cable reprocessing and re-sterilisation (including opportunities to change regulatory pathways), as well consideration of less environmentally impactful materials from which cables could be manufactured, such as plant-based plastics.

Throughout the project, the partners will include stakeholders in the design process to ensure that realistic and viable design or business model alternatives are proposed, and strong design foundations are established.

1\. https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf[][0]

2\. https://idataresearch.com/over-900000-cardiac-surgeries-performed-every-year-in-the-united-states/

[0]: https://www.nicor.org.uk/wp-content/uploads/2020/12/National-Adult-Cardiac-Surgery-Audit-NACSA-FINAL.pdf

Lead Participant

Project Cost

Grant Offer

CARDIAC-TECH LTD £17,410 £ 17,410
 

Participant

PDM INTERNATIONAL LIMITED £59,172 £ 59,172
KNOWLEDGE TRANSFER NETWORK LIMITED

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