RITMOCORE Common Challenge

RITMOCORE deals with the technological evolution in the treatment of patients with arrhythmias. The general principle is to shift the focus from the conventional purchasing of pacemakers to a provision of innovative services for the multi-professional management of the patient before and after implantation. The RITMOCORE approach promotes a comprehensive model of care that could include:

  • the remote monitoring of pacemakers and use of wearable sensors, Apps and innovative devices;
  • the mediation of a support centre, to reinforce the contacts with the patient, pre-process the data from remote devices and triage the patient’s needs.
  • the patient education on healthy lifestyles and disease management, leading to an effective self-management (also with the help of the caregiver);
  • the involvement of GPs and integration of care pathways through adequate information sharing;

RITMOCORE is planning a joint procurement. The critical mass from procurers offers the means to motivate the industry to change its current business model and value chain for a better alignment of interests. RITMOCORE uses an instrument called Public Procurement of Innovation (PPI). Public procurement of innovation will help foster market uptake of innovative products and services, increase the quality of public services in markets where the public sector is a significant purchaser, support access to markets for businesses – especially small and medium-sized enterprises (SMEs) – and help address major societal challenges. PPI aims to ‘close the gap’ between cutting-edge technology and processes and the public sector customers or users who can benefit from them.

The ageing population impact is already tangible in the electro cardiology departments, who faces a steadily growth of patients using or in need of a pacemaker. At the same time, the budgetary restrictions imposed by the last financial crisis are there to stay and there is no budget increase from one year to another.
A patient implanted with a pacemaker should be monitored three months after the implant and then after, at least, yearly. When the battery starts to deplete, the monitoring frequency is increased to avoid emergency replacement, which implies a higher risk and inconveniences for the patient and a significant increase in cost.
A proper follow-up guarantees optimal programming of the PM and on-time battery replacement in a programmed consultation. For those patients very senior, or living far from Hospital, the follow-up visit could be highly inconvenient and informal carers need a family leave for the occasion, sometimes it is also needed an ambulance to do the trip.
The increase in demand and the constraint in resources is starting to challenge the proper follow up of patients implanted with a pacemaker, according to the clinical guidelines, due to the constrain in available time from clinicians.
The implantable devices industry is highly innovative. There is a continuous evolution of devices that allows better quality of life of patients, and also, PMs are able to continuously measure and load valuable bio-parameters, useful for preventing strokes or detect abnormal behaviours, for instance. The trend is a continuous increase of prices for those more innovative devices.
In this context, the current budget constrains have promoted the reduction of PM costs by aggregating purchases. The approach has significantly reduced the prize per unit but has also limited the diversity of models on hand of clinicians and make not available for the patients most innovative or just most adequate PMs.
Low end pacemakers are bigger in size, have shorter battery duration, less diagnostic yield of device dysfunction, less diagnostic yield of extracardiac conditions, less automated algorithms, are not compatible with magnetic resonance imaging nor with remote monitoring.
During the follow-up visits only 15% of patients need a re-programming or further attention. This means that up to 85% of follow-up visits have no actual added value since no action is required from the clinicians. However, a periodic control of the patient and the device is required. Patients not complying with their follow-up get out the control of the electrocardiography unit, with high risk of urgency battery replacement, mostly inconvenient both for the patients and the hospital.
The average age of these patients is around 75 years old, frequently with multiple co-morbidities. Frequently GPs have no access to the information related with the patient PM, the care pathways are fragmented and this is a constrain for a proper comprehensive view of the patient condition.
Furthermore, patients implanted with a pacemaker receive a remarkable psychological impact, mostly unattended. Patients feel unable to identify properly the symptoms of any malfunctioning and are frequently in panic.

Most pacemakers currently in the market (except the very low end) offer remote monitoring capacity with just a monitoring device at home or at primary care premises. Remote monitoring allows the clinicians to control the status of the patients and the PM remotely, thus decreasing unproductive visits and increasing the focus on those patients with complications and/or re-programing needs.
Remote monitoring could be done with increased frequency, compared to face-to-face visits, and that reduces the time to detect complications and increases the benefits for the patient.
Remote monitoring also enables the use of the bio-data collected by the PM in prevention and patient coaching. These advance services need further cooperation among big players, SMEs and researchers.
To really improve the patient experience and quality of life all of the above must be done in a context of a continuity of care and patient empowerment. The coordination of care is necessary to allow the GP, accessing to all relevant information, to give full support to the patient. In addition, increasing the feeling of safety and self-control of the condition implies to activate the patient and their family. To reduce stress and increase quality of life for patients and their informal carers they need to be empowered. Patient activation includes well known resources with a high potential impact on better quality of life.

A variety of factors influence the fact that solution are not in place yet:

  • Remote monitoring and high-performance pacemakers are out of budget in the current purchasing models with the current budgetary restrictions.
  • Full exploitation of the benefits of remote monitoring requires an improvement in relation to coordinating care and enhancement in ICT infrastructures.
  • Coordinated care needs information sharing and support from policy/decision makers. Investments in this area have a strong potential impact and most advance health systems are working on it, but it is still not feasible when using non-interoperable Health Information Systems.
  • Patient activation should be supported by: educational content, information, monitoring, supporting networks and coaching. This implies human resources, again limited by budget restriction, and support from policy/decision makers.

RITMOCORE plans to enable the availability of high performance pacemakers, remote monitoring, coordinated care and patient activation by a risk sharing model, fostered by the PPI procedure.
A deep change in the purchasing procedure will create an alignment of interests among industry, clinicians and financial officers that will create the conditions for a restructuration of care path processes, including the necessary resources in a service model contract. Further cooperation within industrial big players and SMEs will be fostered. The combination of all these ingredients will substantially increase the patient experience and quality of life looking for the long-term sustainability of the health care system.