Novel score predicts heart failure following atrial fibrillation ablation

A SCORE BASED ON FOUR clinical and imaging parameters identifies the heart failure patients who benefit most from atrial fibrillation (AF) ablation, late-breaking data presented at EHRA 2023 have shown.

Medium-sized randomised trials have produced mixed evidence on the benefit of ablation in patients with heart failure, with outcomes depending on the selection and characteristics of patients. Therefore, there is uncertainty about which heart failure patients should be referred for ablation.

The European Society for Cardiology (ESC) Guidelines on AF recommend the procedure to reverse left ventricular dysfunction in AF patients when tachycardia-induced cardiomyopathy is highly probable. In addition, catheter ablation should be considered in selected AF patients with heart failure and reduced ejection fraction to improve survival and reduce heart failure hospitalisation.

“The tools to help clinicians determine who exactly these selected patients are and which patients have tachycardia-mediated cardiomyopathy are elusive and often subjective,” said study investigator Marco Bergonti

(Istituto Cardiocentro Ticino, Lugano, Switzerland). “Further evidence is needed to help stratify and identify those patients who will most likely benefit from AF ablation. The Antwerp score was developed to predict the response to ablation in heart failure patients with impaired (below 50%) ejection fraction.”

The score is based on four parameters: QRS width above 120 milliseconds (two points), known aetiology (two points), paroxysmal AF (one point) and severe atrial dilation (one point). Scores range from zero to six, with zero indicating a greater likelihood of recovery. A previous single-centre study showed that the score estimated the probability of left ventricular ejection fraction (LVEF) recovery after ablation.

The latest study aimed to externally validate the Antwerp score in a large European multicentre cohort. The researchers retrospectively identified patients with heart failure, impaired LVEF and AF who had an ablation procedure at eight centres in Europe. Participants underwent echocardiography to assess LVEF before ablation and 12 months

0.98) and a 15% reduced risk of transient ischaemic attack (HR 0.85; 95% CI 0.80–0.90).

The researchers also found that long-term statin use was associated with greater protection than shortterm use. Compared to those taking the medication for between three months and two years, patients using statins for six years or longer had a 43% lower risk of ischaemic stroke or systemic embolism (HR 0.57; 95% CI 0.54–0.61), 44% reduced likelihood of haemorrhagic stroke (HR 0.56; 95% CI 0.53–0.60) and 42% reduced risk of transient ischaemic attack (HR 0.58; 95% CI 0.52–0.64). These associations were consistent regardless of whether or not patients used anticoagulant medication and the type of anticoagulant.

Huang said: “These data support the use of statins to prevent stroke and transient ischaemic attack in patients with new-onset AF. The findings have important clinical implications particularly given afterwards. The primary endpoint was sufficient improvement in ejection fraction at the 12-month echocardiography to be considered a “responder” to treatment. Responders were defined according to the 2021 universal definition of heart failure in patients with a baseline LVEF of 40–50%, an LVEF increase to 50% or more, in those with a baseline LVEF of 40% or below, an increase in LVEF at least 10% from baseline, and a second measurement of LVEF above 40%.

The study included 605 patients, some 427 of whom (70%) were classified as responders and more likely to have positive ventricular remodelling (odds ratio [OR] 8.9, p<0.001), fewer heart failure hospitalisations (OR 0.09, p<0.001) and lower mortality (OR 0.11, p<0.001) compared to non-responders. The Antwerp score predicted LVEF improvement after ablation with an area under the curve of 0.86 (95% confidence interval [CI] 0.82–0.89; p<0.001). For total scores of zero, one, two, three, four, and five to six, the proportion of responders was 94%, 92%, 82%, 51%, 40% and 17%, respectively.

Bergonti said: “Based on our findings, patients with a low score (two or less) may benefit from early referral for catheter ablation, with a more than 90% chance of recovery. Patients with a high score (five or higher) have a very low expected recovery rate (below 20%) and hence may benefit more from alternative strategies such as aggressive rate control. Those in the intermediate zone (score three to four, expected recovery rate 47%) may benefit from further diagnostic tests such as cardiac magnetic resonance to improve their diagnostic assessment, as the presence of late gadolinium enhancement has been associated with less LVEF improvement.”

Judges of the CX 2023 Dragon’s Den-style contest—the finale of the Charing Cross (CX) Symposium (25–27 April, London, UK) Innovation Showcase programme—described the field of entrants to this year’s edition of the competition as the strongest line-up in its history.

The judging panel of physician-innovators selected HeartEye, a Netherlands-based developer of handheld electrocardiogram (ECG) devices, as the overall winner of the innovation prize, which comes with a £1,000 award. Honourable mention was given to four other entrants from the field of 12.

Peter Doevendans (UMC Utrecht, Utrecht, The Netherlands) gave an overview of the HeartEye technology in a short presentation entitled ‘ECG anytime, anywhere in 60 seconds’, describing it as a “digital transformation” for ECG acquisition. HeartEye is a pocket-sized device that can take clinical-standard ECG readings wirelessly, negating the need for a large, stationary ECG unit.

The technology, which has been developed with the support of an Innovative Medical Devices Initiative (IMDI) grant from the Netherlands Organisation for Health Research and Development (ZonMw) is patented, and could be marketed to healthcare providers or direct to consumers within two years, Doevendans explained.

“We have been doing this for a number of years, and this was the toughest by far,” said judging panellist Robert Mitchell (Park City, USA), before the announcement of HeartEye as the winner of the prize. Euphrates Vascular, the developer a nano-scale endovascular system to address microvascular occlusion and no reflow, was among those singled out by the judges as being of particular interest. Presenter David Deaton (Medstar Georgetown University

The European Union’s (EU) Council of Ministers has adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).

PRODUCERS OF MEDICAL devices will have until 31 December 2027 for higher-risk devices and until 31 December 2028 for medium and lower-risk devices to meet the legal requirements.

The extension of the transition period will be granted under certain conditions, ensuring that only devices that are safe and that only manufacturers have already started the certification procedure will benefit from the additional time.

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic. However, challenges in the implementation of the legislation led to concerns about a potential shortfall in the availability of certain devices, which prompted a rethink in the timetable for the regulation as proposed by the European Commission in December.

Adoption of the resolution by EU Council members, comprising ministers from each of the EU’s member states, means that the decision to extend the implementation period will enter into force on the day of its publication in the Official Journal of the EU.

“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” Acko Ankarberg Johansson, Sweden’s minister for healthcare, was quoted as saying when the changes were confirmed in March.

Hospital, Washington, DC, USA) told the judges that the Pulse NanoMed device extends the reach of current therapies, and has been given approval to begin a US Food and Drug Administration (FDA) investigational device exemption (IDE) trial in patients with acute ischaemic stroke.

Tilo Kölbel (University of Hamburg, Hamburg, Germany) introduced Mokita Medical, which has developed a technology to address air embolisation during procedures such as thoracic endovascular aneurysm repair (TEVAR) and transcatheter aortic valve implantation (TAVI), a cause of stroke and cognitive decline. The Mokita technology uses a gas-soluble fluid to eliminate air from devices, and is being developed into a disposable device that can be connected to the delivery system for a transcatheter procedure. The company is planning a first-in-man study for 2024, and anticipates commercialisation from 2026 onwards.

Mitchell praised Kölbel’s work in this area as being “really important and impactful”, and said that the entry had been one of the strongly considered options for the prize.

Another technology featured in the session included a non-invasive, wearable monitoring system for arteriovenous fistulas (AVFs), intended to aid early identification of failing AVFs. The innovation, presented by Ali Kordzadeh (Anglia Ruskin University, Braintree, UK) is worn like a wristwatch by patients to monitor venous outflow. Novel device coating materials were also exhibited, with Tony Simula (Mawson Lakes, Australia) detailing Bioinvisible, a drug-free polymer coating that could replace existing drug coatings in devices such as stents, vascular grafts and heart valves.

MedTech Europe, which represents the continent’s device manufacturers, has welcomed the adoption of the amended transitional provisions, which it said will help mitigate the immediate risk that medical devices across all areas of medicine, which are still on the EU market, would no longer be available after May 2024.

“The amendment of the Medical Devices Regulations’ transitional provisions is a needed step forward to help ensure that more medical devices remain available to patients and healthcare systems across Europe.

This decision grants Notified Bodies more time to complete certification of more than 500.000 medical devices and accelerates efforts to certify innovative devices in the pipeline,” says Oliver Bisazza, CEO of MedTech Europe.

As soon as the amendment comes into force, MedTech Europe said that alongside its members it will work toward its implementation according to the new provisions and extended deadlines.

“In that regard, it is important that all stakeholders have an aligned and clear interpretation of the amendment, including the process for submitting applications to Notified Bodies, and how the extended validity of certificates can be concretely demonstrated,” the organisation’s statement adds.