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
Cardiac-Tech is a UK-based SME that is developing a novel safety monitoring system for temporary pacemakers which will lead to a higher standard of care.
Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances during their recovery which can lead to serious complications. Cardiac surgical patients are therefore normally fitted with a temporary pacing device after their procedure to ensure a near-normal rhythm is maintained.
Unlike permanent (implanted) pacing systems, temporary pacemakers sit externally by the patient's bedside and are connected to the heart with wires that pass through the chest. The contact of these wires with the heart can degenerate from scar tissue formation or the patient's own movement; for example, when coughing.
At present, temporary pacemakers are relatively unsophisticated and are unable to detect changes in the patient's parameters. They rely on periodic checks at the bedside, where dangerous changes can go unnoticed for hours. This can lead to overcompensation with medication that has unpleasant side effects and an extended recovery period. In the most extreme circumstances, inappropriate programming of the temporary pacemaker can lead the device to cause cardiac arrest.
The U.S. Food and Drug Administration (FDA) holds a database on reported safety issues, where around 1,500 dangerous incidents related to temporary pacing are recorded yearly in the U.S. alone (_MAUDE website_). However, it is recognised that this number is potentially just 'the tip of the iceberg', as identifying the temporary pacemaker as the problem relies on expertise present at the time.
To overcome these issues, Cardiac Tech Ltd. has developed a unique Temporary Pacing Safety Monitor (known as the Pace-Protect) that can analyse the pacemaker and patient's electrical signals and alert the relevant medical team whenever a problem with the pacemaker's programming is identified.
In this project, Cardiac Tech Ltd. intends to work with two UK-based subcontractors, L2S2 Ltd and Control Developments (UK) Ltd., to develop a web platform and communications interface that will allow the remote monitoring of multiple networked Pace-Protect devices.
The connection of Cardiac-Tech's pacemaker monitoring technology with a digital platform will allow alerts to be delivered to cardiologists and physiologists whenever pacing issues are identified and will ensure pacing expertise is on hand, wherever it is required.
The system will reduce the opportunity for human error, ensure that patients in post-cardiac surgical care experience a safe and stable recovery and reduce stress levels for nursing staff.
Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances during recovery which can lead to serious complications. Cardiac surgical patients are therefore normally fitted with a temporary pacing system 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 pass through the chest. The contact of these wires with the heart can often degenerate from scar tissue formation or the patient's own movement; for example, when coughing.
At present, temporary pacemakers are relatively unsophisticated and are unable to detect changes in the patient's parameters. They rely on periodic checks, where dangerous changes can go unnoticed for hours. The associated issues and mis-identification of cause can lead to overcompensation with medication that has unpleasant side-effects and is associated with an extended recovery period. In the most extreme circumstances, inappropriate programming of the temporary pacemaker can lead the device to cause cardiac arrest.
The FDA holds a database (MAUDE) on reported safety issues, where around 1,500 dangerous incidents related to temporary pacing are recorded yearly in the US alone, and this is potentially just the tip of the iceberg - since identifying the temporary pacemaker as the problem relies on expertise present at the time. Cardiac Tech have polled over 100 cardiologists, cardiac physiologists and nurses in the U.K. and 75% either agree or strongly agree that there are serious safety issues in temporary pacing.
To overcome these issues, Cardiac Tech is developing a unique temporary pacing safety device that will monitor the pacemaker and patient's electrical signals and timings. The device uses sophisticated software to instantly alert medical staff to dangerous changes in pacing function in order to make sure that patients get the best treatment and the correct medication and can be discharged sooner. The device will reduce the opportunity for human error and ensure that patients in post-cardiac surgical care experience a safe and stable period of recovery.
Cardiac Tech have built a fully functioning prototype of their device that proves the technology works. In this project, the company plans to work with an award winning design consultancy to develop a bespoke ergonomic casing and intuitive user interface that will allow surgeons, doctors and nursing staff to easily fit the device to current pacemakers and monitor their patients 24/7 in the clinical environment.