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Those game-changing innovations of the year: Congress casts its vote

ESC Congress News 2015 - London

Congress participants cast their vote yesterday on the most game-changing innovations or clinical trial results of the year. From 3D printing to ear stimulation, the list of contenders covered a wide range. Six specialists first provided an overview of those shortlisted. Each gave a ten minute presentation to the audience in which they built the case for their nominated ‘game-changer’ and outlined why it should win. The audience was then asked to vote. The winner was PARADIGM-HF, the largest ever study of a heart failure treatment. The trial was a breakthrough after identifying a new therapy which made a genuine difference to survival in heart failure.



Paradigm-HF trial in heart failure

Cecilia Linde from the Karolinska Institute in Sweden proposed that the Paradigm-HF study makes a strong case that the angiotensin receptor inhibitor/neprilysin inhibitor LCZ696 (valsartan/sacubitril) should be used as first line treatment in patients with heart failure and reduced ejection fraction. ‘This is the first new drug to show an impact on HF mortality and morbidity for years,’ said Linde.

The experimental drug, she added, was now a reality which should become widely available to patients in the near future.  The Paradigm study showed at a median follow-up of 27 months in comparison to enalapril, LCZ696  reduced the risk of death by 16%, cardiovascular death by 20%, and hospitalisation by 21% (N Engl J Med 2014, 371: 993-1004). The treatment group had higher proportions of patients with hypotension and non-serious angioedema, but lower proportions with renal impairment, hyperkalemia and cough.

The reason neprilysin inhibition is valuable, Linde explained, is that neprilysin degrades vasoactive peptides that are beneficial in HF.

Troponin assay in acute cardiac care

A novel algorithm using high-sensitivity cardiac troponin T measurement can accelerate the management of suspected acute MI. Maddalena Lettino, director of the clinical cardiology unit at Humanitas Research Hospital in Milan, Italy, said this new grading system can save hospitals money, reduce pressure on emergency departments and save patients the anxiety of a delayed diagnosis. The concept allows safe rule-out as well as accurate rule-in of acute MI in the majority of patients within one hour. This innovative approach to acute MI diagnosis has already been validated by the TRAPID-AMI trial. Results showed that the assay allowed rule-in or rule-out of MI within this time frame in about three-quarters of patients.

It should now be incorporated into European guidelines, urged Lettino, and be made generally available. She said this would help ensure that ‘not too many people are using emergency departments’ - because doctors could confidently discharge patients with non-life threatening disease.

HCM score in cardiovascular risk prevention

An innovative scoring system could reduce the high rate of false positives for hypertrophic cardiomyopathy (HCM) among athletes. This approach refines current screening parameters and could increase the accuracy of ECG interpretation, said Professor Joep Perk from Linnaeus University in Sweden.

HCM is the leading cause of sudden cardiac death in young sportsmen and women. Screening guidelines were published after the death in 2003 of footballer Marc-Vivien Foe. However, overlap exists between physiological and pathological ECG patterns, resulting in high rates of false positives. ECG abnormalities occur in one in five white athletes and one in two black athletes.

These errors can result in elite players - including footballers - being disqualified from competing, said Perk, adding that ‘this does a lot of psychological harm’ because athletes fear something is wrong with their heart.

The new scoring system was devised following an analysis of more than 5000 ECG results and combines nine ESC parameters with two from the Seattle heart failure risk calculator.

Ear stimulation in electrophysiology

Sabine Ernst, an electrophysiologist from the National Heart and Lung Institute, London, made a strong case for neuromodulation of the vagus nerve as a novel therapy for atrial fibrillation. While AF is traditionally treated by invasive ablation strategies, such as isolation of the pulmonary veins, the autonomic nervous system is known to play a major role in its aetiology. ‘But the anatomy of the sympathetic nervous system is very complex with multiple fibres that are hard to identify,’ said Ernst.

A recent study suggests that the tragus nerve, located at the front of the ear canal, can be used to access the vagus nerve non-invasively (JACC 2015, 65: 867-75). The study, which randomised 40 patients with paroxysmal AF to low level electrical stimulation of metal clips attached to the tragus nerve externally or a sham treatment, found both AF and inflammatory cytokines were suppressed in the active group. ‘You can start to dream that one day we will be able to add non-invasive treatments for AF to hearing aids or smart phone head sets,’ said Ernst. ‘We are moving away from destroying the myocardium in patients in arrhythmias.’

3D printing in cardiovascular imaging

Three dimensional printing, said Luigi Badano, is a game changing innovation in cardiovascular imaging with the potential to allow the bio-printing of tissues - and ultimately entire organs. In 3D printing objects are being created by laying down one thin layer of material which bonds to another thin layer derived from such imaging modalities as computerised tomography, cardiac magnetic resonance and 3D echocardiography. ‘We can use 3D printers to understand complex anatomy . . . to hold the physical structure of the heart in our hands,’ said Badano, from Padua, Italy. ‘We can use it to teach anatomy to medical students, plan surgical interventions and communicate with patients, showing them exact structures revolutionising the concept of informed consent.’

One recent study comparing identical cardiac surgical procedures performed with and without 3D printing showed that 3D printing shaved 30 minutes off the time taken.

Using bio-ink and bio-paper, which acts as a temporary scaffold, bioprinting takes 3D printing one step further, allowing live endothelial cells to be formed into structures. ‘This provides an opportunity to design valves that will fit the exact body size of your patient,’ said Badano.

Recently the Wake Forest Baptist Medical Center Institute in the US  modified adult human skin cells into functional heart cells with the ability to generate a beat. Such cells, Badano said, might eventually be used by 3D printers to create functional hearts.

More DAPT data in coronary intervention

How long to treat patients with dual anti-platelet therapy (DAPT) after stenting is a hot topic right now, with experts divided over whether shorter or longer duration times are best.

A new study, scheduled for publication next month, is expected to advance knowledge in this debate, said Philippe Garot from the Institut Cardiovasculaire Paris Sud, France. The LEADERS FREE trial is the world’s first prospective, randomised double-blind clinical trial using a one-month course of DAPT after implantation of an active stent.

Garot said that the trial is focused on patients at high risk of bleeding who have until now not been considered suitable for DAPT. The study has been designed to examine safety and efficacy outcomes in patients receiving treatment with the BioFreedom stent, a new generation of drug coated stent. The study, said Garot, has compared the BioFreedom stent with an early generation bare metal stent (BMS) in patients who cannot be treated for more than a month with DAPT. The hope is, he added, that this study will address the current ‘unmet need’ for improved care among this patient group.

‘There are still unmet needs in interventional cardiology, especially in high risk patients,’ he said, and we need further data on this population.’