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Treatment decisions in cardiovascular care: lessons from an Italian audit

The results of a national audit and quality improvement project looking to optimise cardiovascular treatment and care across Italy has recently been presented at the Italian National Association of Hospital Cardiologists conference. Here, Professor Furio Colivicchi speaks to Helen Quinn about the rationale for the audit study, the key findings and next steps, plus the team’s ambitions to widen the scope of the project to support more patients nationally and across Europe.

Cardiovascular diseases (CVDs) are the leading cause of death globally. Figures produced by the World Health Organization (WHO) estimate 17.9 million lives are lost each year as a result of CVDs, with four out of five of these deaths being a result of heart attacks and strokes.

Finding ways to reduce death and ill health related to CVD is a primary goal of many researchers around the globe, including Professor Furio Colivicchi.

After training in internal medicine, Professor Colivicchi moved to clinical cardiology and developed a particular interest in secondary cardiovascular prevention. He joined the San Filippo Neri Hospital in Rome in 1991, becoming its director of cardiology in 2013, and he’s also a professor of cardiovascular medicine at Tor Vergata University of Rome’s School of Medicine.

In Italy, the prevalence of CVD is nearly two-fold higher than the global rate, and Professor Colivicchi is working hard to improve best practice and patient outcomes. He is currently undertaking an audit of cardiovascular care across the country with the Italian National Association of Hospital Cardiologists (ANMCO) for which he is also immediate past president.

The audit analyses admissions and treatment pathways for CVD patients throughout the country and examines whether the guidelines for treatments are being adhered to and how to improve this likelihood.

Guidelines for clinical practice

Current guidelines from the European Society of Cardiology (ESC), published in 2019, advise the use of high-intensity statins and subsequently, ezetimibe and PCSK9 inhibitors to reduce low-density lipoprotein cholesterol (LDL-C) levels below 55 mg/dL within four weeks.

However, such combination therapy is not used as much as it should be in clinical practice, and Professor Colivicchi and his team suggest this is due to therapeutic inertia, where clinicians do not always consider the information contained in such guidelines.

‘There is a gap between what should be done according to the guidelines, what the scientific evidence is about the management of certain cardiovascular conditions and what is actually performed in clinical practice,’ Professor Colivicchi says.

According to the guidelines patients with recurrent cardiac events should be reaching lower LDL-C levels of 40mg/dL – a target Professor Colivicchi describes as ‘rather ambitious’.

‘We have evidence from several observational studies in Europe, the United States and Italy that these levels were not reached in clinical practice. Patients were not following a proper path to the reduction of cardiovascular risk, which is the reduction of ischemic recurrences in particular,’ he explains. ‘Our idea was to have a photo of what was going on and then give feedback to the institutions involved in the project.’

Auditing cardiovascular care

To begin the study, entitled ‘Optimisation of the pathways from hospital discharge to follow up: the APPRO-EVO AUDIT ACS Project’, Professor Colivicchi organised observations in over 50 hospitals throughout Italy, which involved around 500 cardiologists and more than 1,100 patients.

The clinicians involved in the study collected data over four weeks, describing the general management of their patients, the epidemiological features of this population, the kind of lipid-lowering treatment implemented and whether these patients could or could not reach the recommended targets as outlined in the ESC guidelines. The audit and feedback methodology aimed to improve the quality of healthcare given to high-risk patients.

Professor Colivicchi says: ‘This is the general idea about audit; it is a circle in which you have to check what you do, try to improve your practice, and then check again to see what has actually happened. If you close the gap, then there is always an improvement.’

After collecting and analysing the initial data, the researchers undertook a second audit involving more than 1,000 additional patients to see if anything had changed following the feedback from the first audit.

Professor Colivicchi found a ‘striking increase’ in the use of new drugs in the second audit, particularly PCSK9 inhibitors and monoclonal antibodies, to treat the most severe forms of hypercholesterolemia.

Optimising cardiovascular therapies and meeting targets

The results, which Professor Colivicchi presented at the recent ANMCO conference, show that in the first phase, just 60% of the patients were discharged from hospital with a combination therapy, including a statin plus ezetimibe. The remaining patients were discharged usually with only a statin.

Following the feedback from the first audit, the number of patients receiving combination therapy rose to 75%, and the use of PCSK9 inhibitors rose from 10% to 17% in the second audit. In addition, more than 80% of patients reached the recommended targets in the guidelines.

‘We were able to demonstrate that when there is a particular attention to clinical practice, the healthcare providers tend to improve their performance. Patients were followed more carefully because when you know that someone is observing you and assessing what you’re doing, there is specific care in what is actually done,’ says Professor Colivicchi.

The next stage is to expand the project from 50 to 200 and then 300 hospitals, including minor and community hospitals throughout Italy. Professor Colivicchi hopes that clinicians will perform the assessments every six months.

He adds: ‘When you implement a quality improvement procedure within every single hospital, you can improve the practice and reach the goals recommended by the guidelines. If you reach the target, you can expect to improve clinical outcomes over the medium to long term. So, this is the underlying logic: you need that feedback.’

Prevention through clinical improvement

Through the study, Professor Colivicchi notes that the CVD patients arriving at the hospital often showed many modifiable risk factors that had not been addressed. These included smoking, being diabetic with suboptimal control of glucose metabolism, hypertension without proper treatment, as well as high cholesterol. The findings from the study show that if antiplatelet therapy is appropriately managed to reduce LDL-C, cardiovascular recurrence events will also be reduced – even in high-risk populations.

‘Prevention is relevant. Secondary prevention is extremely relevant because the effectiveness of preventive procedures is more prevalent in those patients at high cardiac risk. So, you can reduce the number of the events that are recurrent in more than 50% of patients,’ Professor Colivicchi explains.

The team is sharing the data with the Italian Ministry of Health and the local health authorities to provide them with evidence that certain interventions are effective in improving clinical practice. The evidence from the audit allows clinicians to optimise the choice of treatments, ultimately promoting a higher quality of care in a safer and more efficient way.

Professor Colivicchi’s evidence showed that, overall, there was a better use of therapeutic resources in the at-risk population and thus an increased likelihood of achieving the therapeutic targets recommended by the current ESC guidelines.

‘This experience is just one step in the direction of quality improvement. We think we are always doing the best for our patients, but this is not necessarily true. We have to measure what we do every day, and then we must be accountable for what we do. This is an approach we can implement to have some objective evidence of our clinical practice and to improve it properly,’ Professor Colivicchi concludes.

Only time will tell just how extensive the improvements are to patient care throughout Italy as a result of the audit study, but the researchers hope the impact is even more widespread than that. Their process is likely to be applicable to other health services and can help to support the implementation of best practice around the world.






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