What if a computer simulation model of the heart and blood vessel could reduce the need for human or animal data in clinical trials, while speeding up product development? Biotronik and their research partners are looking into exactly that question in the new EU-funded SIMCor project. One of the first likely developments from this partnership will be an implantable sensor to better manage heart failure.

More than 10 million people in Europe suffer from heart failure. Beyond its obvious impacts on patient quality of life, treating heart failure uses 1-2% of a developed country’s health budget every year, with two-thirds of that taken up by hospital stays. If we can help reduce hospital visits related to heart failure, we can both help heart failure patients live better lives and reduce overall healthcare costs. That’s just one reason why Biotronik is taking part in SIMCor, a three-year EU-funded project to develop an implantable pressure sensor that aims to help heart failure patients and physicians better manage their condition.

Along with Biotronik, SimCor includes 11 partners from eight countries, including Berlin’s Charité Hospital. By pooling resources and data, SIMCor’s goal is to speed up the development of this technology and achieve results as fast as possible.

Beyond a new and innovative technology to support heart failure patients, the SIMCor partnership also has the potential to provide even longer-lasting benefits. If successful, computer simulations of the heart-implant interaction could speed up product testing and regulatory approval, providing many patients with technology that can save and improve their lives in a more timely manner.

How the SIMCor partnership can speed up the development process

The SIMCor project focuses on developing computer simulation technology that can help test and validate medical devices. These computerized tests could replace the need for animal testing and help make clinical studies even safer for patients. If a large and high-quality dataset is available, researchers can simulate clinical interventions in virtual patient cohorts. Over the longer term, this could reduce clinical trial size by 25%, with 30% less time required to complete studies. In the end, this allows medical devices to be quickly approved to help patients. The US FDA has already noted the potential positive effects such modelling could have, and is encouraging the development of simulation technology. By working together, Biotronik and its SIMCor partners can conduct these simulations using far bigger datasets than would otherwise be available, yielding the sophisticated modelling required to simulate heart and blood vessels.

Dr. Torsten Luther, Director of Product Development for Delivery Tools, Leads & Accessories in R&D at Biotronik

“We need to demonstrate that implants perform well across the whole patient population. That’s a long and sometimes challenging process because patient anatomy can vary widely, especially due to diseases,” said Dr. Torsten Luther, Director of Product Development for Delivery Tools, Leads & Accessories in R&D at Biotronik. “Using a large data pool to simulate different parts of the cardiovascular system, such as the heart or pulmonary artery, allows us to test implant performance across a wide range of anatomies representing the whole patient population. We can then optimize our technology for everyone.”

Collaboration is an important driver for innovation

Research and development have always been a priority at Biotronik. Since developing the first German pacemaker in 1963, Biotronik has continued to pave the way for pioneering innovations. In its Berlin headquarters alone, one out of every five employees work in R&D, ensuring that medical technology keeps pace with the interests and needs of future patients and physicians.

By investing in clinical trials and initiating research projects, Biotronik seeks to address research gaps and offer practical treatment options.

Dr. Andreas Arndt, Team Lead R&D Sensors and SIMCor project coordinator at Biotronik

“The SimCor project is a great example of how we work together with like-minded partners from different industries as well as academic institutions across Europe. We profit from each other’s knowledge and together, we can make an impactful contribution to medical research. In this regard, I believe that collaboration can be a key driver for innovation,” said Dr. Andreas Arndt, Team Lead R&D Sensors and SIMCor project coordinator at Biotronik.

See a Computer Simulation of the Pulmonary Artery

YouTube: https://youtu.be/8YMsoXsH4P8

Australian study shows that savings made from shorter stays are double the cost of hiring more staff

A study across 55 hospitals in Queensland, Australia suggests that a recent state policy to introduce a minimum ratio of one nurse to four patients for day shifts has successfully improved patient care, with a 7% drop in the chance of death and readmission, and 3% reduction in length of stay for every one less patient a nurse has on their workload.

The study of more than 400,000 patients and 17,000 nurses in 27 hospitals that implemented the policy and 28 comparison hospitals is published in The Lancet. It is the first prospective evaluation of the health policy aimed at boosting nurse numbers in hospitals to ensure a minimum safe standard and suggests that savings made from shorter hospital stays and fewer readmissions were double the cost of hiring more staff.

Despite some evidence that more nurses in hospitals could benefit patient safety, similar policies have not been widely implemented across the globe, partly due to an absence of data on the long-term effects and costs, as well as limited resources. In recent years, Scotland, Wales, and Ireland have mandated numbers of patients per nurse, but strategies to improve nursing levels remains debated worldwide.

Study fills data gap

“Our findings plug a crucial data gap that has delayed a widespread roll-out of nurse staffing mandates. Opponents of these policies often raise concerns that there is no clear evaluation of policy, so we hope that our data convinces people of the need for minimum nurse-to-patient ratios by clearly demonstrating that quality nursing is vital to patient safety and care,” says lead author, Professor Matthew McHugh of the University of Pennsylvania School of Nursing, USA.

In 2016, 27 public hospitals in Queensland were required to instate a minimum of one dedicated nurse for every four patients during day shifts and one for every seven patients for night shifts on medical-surgical wards.

The research team collected data from those 27 Queensland hospitals that instated ratios and from 28 other hospitals in the state that did not, at baseline in 2016 and at follow-up in 2018 (two years after the policy was implemented). Only nurses in direct contact with adult patients in medical-surgical wards were included – data from patients in birthing suites and psychiatric units were not assessed in the study.

Researchers used patient data to assess demographics, diagnoses, and discharge details for patients, as well as length of hospital stay. These data were then linked to death records for 30 days following discharge, and to readmissions within seven days of discharge.

The researchers sent an email survey to nurses in each hospital to ask about the numbers of bedside nurses and patients on their most recent shift. The responses were used to establish the numbers of nurses per patient and then averaged across wards and hospitals. Responses were received from 8,732 nurses (of a possible 26,871) at baseline in 2016, and 8,278 (of a possible 30,658) in 2018.

The study includes baseline data for 231,902 patients (142,986 in hospitals that implemented the policy and 88,916 in comparison hospitals), and for 257,253 patients (160,167 in hospitals that implemented the policy and 97,086 in comparison hospitals) after the policy was brought in.

Comparison hospitals had no change in staffing, with six patients per nurse in 2016 and the same ratio (1:6) in the follow-up period in 2018. Intervention hospitals averaged five patients per nurse at baseline in 2016, with a reduction to four per nurse after the policy implementation.

Patient deaths

To compare the changes in outcomes in the intervention and comparison hospitals over time, the researchers estimated the odds of dying within 30 days of admission and of being readmitted within seven days of discharge, and the additional length of stay, after adjusting for factors such as patient age, sex, existing health conditions and hospital size. They found that the chance of death rose between 2016 and 2018 by 7% in hospitals that did not implement the policy, and fell by 11% in hospitals that did implement the policy.

Readmissions

The chances of being readmitted increased by 6% in the comparison hospitals over time, but stayed the same in hospitals that implemented the policy. Between 2016 and 2018, the length of stay fell by 5% in the hospitals that did not implement the policy, and by 9% in hospitals that did.

Nurse workloads

Further analyses found that when nurse workloads improved by one less patient per nurse, the chance of death and readmissions fell by 7%, and the length of hospital stay dropped by 3%.

Using their modelling to predict figures that would have been expected without the policy in place, the researchers estimated that there could have been 145 more deaths, 255 more readmissions and 29,222 additional days in hospital in the 27 hospitals that implemented the policy between 2016 and 2018.

Financial impact of employing more nurses

To calculate the financial impact of the staffing policy, the researchers used state data to estimate the cost of funding the 167 extra staff needed to reduce workload by one patient per nurse at approximately $33,000,000 (AUD) in the first two years. Based on Australian health economic data, they further estimated that preventing readmissions and reducing lengths of stay resulted in an approximate saving of $69,150,858 in the 27 hospitals across the two years following the mandate.

“Part of the reluctance to bring in a minimum nurse-patient ratio mandate from some policy-makers is the expected rise in costs from increased staffing. Our findings suggest that this is short-sighted and that the savings created by preventing readmissions and reducing length of stay were more than twice the cost of employing the additional nurses needed to meet the required staffing levels – a clear return on investment. Often, policy-makers are concerned about whether they can afford to implement such a policy. We would encourage governments to look at these figures and consider if they can afford not to,” says Professor Patsy Yates of the Queensland University of Technology School of Nursing, Australia.

Study limitations

The authors note that there are a number of limitations associated with the study. Hospitals in the research were not randomly assigned to comparison or intervention groups, as only 27 hospitals in the state were mandated to follow the policy. Furthermore, the hospitals included in both groups were not matched for size or patient demographics and health conditions, although this is accounted for in adjusted analyses.

Access the study: Effects of nurse-to-patient ratio legislation on nurse staffing and patient mortality, readmissions, and length of stay: a prospective study in a panel of hospitals. The Lancet. May 11, 2021. https://doi.org/10.1016/S0140-6736(21)00768-6