Sunday, April 07, 2024

UK
Pfizer accused of ‘bringing discredit’ on pharmaceutical industry after Covid social media posts


Camilla Turner
Sat, 6 April 2024 

Complaint centred around a tweet shared by medical director of company that watchdog ruled had 'limited' information - MARK LENNIHAN/AP

Pfizer has been accused by the UK’s pharmaceutical watchdog of “bringing discredit” on the industry after senior executives used social media to promote an “unlicensed” Covid vaccine.

The company has been found to have breached the regulatory code five times, which also includes making misleading claims, failing to maintain high standards and promoting unlicensed medicines.


A ruling by the pharmaceutical watchdog, the Prescription Medicines Code of Practice Authority (PMCPA), relates to a complaint about a message posted on X, formerly known as Twitter, in November 2020 by senior Pfizer employees.

The complaint raised concern about Pfizer’s “misuse of social media to misleadingly and illegally promote their Covid vaccine”, according to the ruling.

They claimed that such “misbehaviour” on social media was “even more widespread” than they had thought and “extended right to the top of their UK operation”.
‘Unlicensed medicine proactively disseminated’

The complaint centred on a social media post on X by Dr Berkeley Phillips, the medical director of Pfizer UK. He shared a post from an employee of Pfizer in the US which said: “Our vaccine candidate is 95 per cent effective in preventing Covid-19, and 94 per cent effective in people over 65 years old. We will file all of our data with health authorities within days. Thank you to every volunteer in our trial, and to all who are tirelessly fighting this pandemic.”

Four other Pfizer employees, including one “senior” colleague, published the same message

The PMCPA ruling noted that this message contained “limited” information about the vaccine’s efficacy, no safety information and no reference to adverse events.

It went on to say that the social media post resulted in an “unlicensed medicine being proactively disseminated on Twitter to health professions and members of the public in the UK”.

A Pfizer UK spokesman said that the company “fully recognises and accepts the issues highlighted by this PMCPA ruling”, adding that it is “deeply sorry”.

They said: “Pfizer UK has a comprehensive policy on personal use of social media in relation to Pfizer’s business which prohibits colleagues from interacting with any social media related to Pfizer’s medicines and vaccines – backed by staff briefings and training.

“The personal use of social media by UK pharmaceutical industry employees in relation to company business is a challenging area for pharmaceutical companies, in which we continue to take all of the appropriate steps that are reasonably expected of a pharmaceutical company.”

As part of their response to the ruling, Pfizer said it had launched a review into its employees’ use of social media platforms to ensure compliance with their own rules as well as the regulatory code.
‘Accidental and unintentional’

It is the sixth time Pfizer has been reprimanded by the regulator over its promotion of the Covid-19 vaccine.

One ruling by the watchdog, from November 2022, found that Pfizer’s chief executive made “misleading” statements about children’s vaccines.

Following a complaint from the campaign group UsForThem, the PMCPA found that Pfizer had misled the public, made unsubstantiated claims and failed to present information in a balanced way.

Three of the other Pfizer cases related to LinkedIn posts, one related one was about claims made in a press release and one was about posts on X.

For the most recent series of breaches, Pfizer was charged administrative costs of £34,800.

Ben Kingsley, the head of legal affairs at UsForThem, said: “It’s astonishing how many times Pfizer’s senior executives have been found guilty of serious regulatory offences – in this case including the most serious offence of all under the UK Code of Practice.

“Yet the consequences for Pfizer and the individuals concerned continue to be derisory. This hopeless system of regulation for a multi-billion dollar life and death industry has become a sham, in dire need of reform.”

Dr Phillips, the UK country medical director for Pfizer, said the social media post was “accidental and unintentional” adding: “That said, we immediately accepted the case ruling and do everything we can to ensure that our employees adhere to our strict social media policy and the industry Code of Practice when using their personal social media.”

David Watson of the Association of the British Pharmaceutical Industry (ABPI) said that the code of practice, which is overseen by the PMCPA, sets “high standards for companies that reflect and go beyond UK law”.

He added that cases that are found to have brought discredit on the industry are advertised in the medical, pharmaceutical, and nursing press.

UK Covid support scheme fraud has cost taxpayer over £10bn


Will Hazell
Sat, 6 April 2024 

According to a report, the total level of fraud and error in Covid support schemes amounted to an estimated £10.3bn - Christopher Furlong/Getty Images

The British taxpayer has lost more than £10 billion on Covid support schemes as a result of fraud and error, figures released by the Government show.

Labour accused ministers of attempting to “bury bad news” about public sector fraud losses totalling more than £50 billion by publishing the figures in a mass data dump.

Last month, the Public Sector Fraud Authority (PSFA) released a report on the “cross-Government fraud landscape”. According to the report, the total level of fraud and error in Covid support schemes amounted to an estimated £10.3 billion.

Outside Covid schemes, the PSFA estimated that total fraud and error in 2021-22 came to between £39.8 billion and £58.5 billion.

The revelations follow criticism of the Government’s commitment to tackling fraud. In 2022, Lord Agnew, the then anti-fraud minister, resigned during a Lords debate in which he accused the Treasury of having “no knowledge of, or little interest in, the consequences of fraud” and making “schoolboy errors” in relation to Covid loans.

Labour questioned the Government’s decision to quietly release the report on the final Thursday before Parliament’s Easter recess as one of more than 120 “transparency” documents. The data dump has been described as “take out the trash day” amid claims that it is used by ministers to try to conceal bad news.

Darren Jones, the shadow chief secretary to the Treasury, said: “The Conservatives tried their best to bury these figures under a mountain of other trash – but they cannot hide the truth that warnings were ignored and billions of pounds of public money was handed out to fraudsters.

“Instead of working tirelessly to recover that money on behalf of the British taxpayer, Rishi Sunak wants to hush it up and write it off.

“The public are sick of the rampant waste under the Conservatives while all our public services crumble and taxes overall continue to rise. That is why a Labour government will appoint a Covid corruption commissioner to chase down fraudsters, go through the dodgy contracts and clawback every pound we can.”

However, the Government disputed Labour’s claims. A spokesman said: “This is a wilful mischaracterisation of the Government’s commitment to transparency and our ongoing efforts to improve how we detect and crack down on public sector fraud and error.

“Since autumn 2021, we have invested more than £1 billion to take action, including launching the PSFA – which has saved taxpayers hundreds of millions of pounds in its first year alone – and have upgraded our AI fraud detection tool so it can flag suspicious networks and activity much earlier than before.”



Heathrow sale at risk of collapse after Australian investment giant pulls out

Luke Barr
Sat, 6 April 2024 

heathrow airport

The £6bn sale of Heathrow Airport is at risk of collapse after the Australian investment giant Macquarie ruled out buying a stake in the business.

Macquarie’s withdrawal has exposed a dearth of prospective buyers in Heathrow, largely because of the high price set by Saudi Arabia’s Public Investment Fund (PIF).

PIF triggered a battle for control of Heathrow late last year after it teamed up with the private equity firm Ardian to buy a 25pc stake in Britain’s biggest airport for £2.4bn from Ferrovial, the Spanish construction company.

However, other shareholders subsequently triggered so-called tag-along rights, with three others seeking to cash in on the lucrative offer.


They are the Canadian pension fund CDPQ, Singapore’s sovereign wealth fund GIC and the UK’s Universities Superannuation Scheme – meaning a 60pc threshold must be met to complete the sale.

The Telegraph revealed last month that Macquarie was plotting a bid to acquire the remaining 35pc stake, but the investor subsequently scrapped acquisition plans last week.

An investment fund backed by Sheikh Mansour bin Zayed Al Nahyan had reportedly shown an interest in buying a stake in Heathrow - UAE PRESIDENTIAL COURT/via REUTERS

Sources close to the deal have claimed there are no other bidders immediately apparent to support PIF and Ardian, with the latter unsuccessfully leading a charm offensive to identify another investor to raise funds.

This revelation also effectively rules out Abu Dhabi’s Mubadala investment fund, backed by Sheikh Mansour bin Zayed Al Nahyan, which had reportedly shown an interest earlier this year.

It is thought both PIF and Ardian could increase their bids but by nowhere enough to reach £6bn. They have currently agreed to take 10pc and 15pc respectively.

It comes amid a looming deadline to reach an agreement with Heathrow’s shareholders.

A significant hurdle in reaching a deal is the price attached to Heathrow, as the £2.4bn bid for a 25pc stake signed off by PIF and Ardian last year raised eyebrows in the City by valuing the airport at £9.5bn.

Any investor must be willing to take an active role in the running of the airport, which has been beset by strike action and disruption in recent years.

An alternative to the deal collapsing could be an agreement between the shareholders in which they accept selling smaller stakes in return for a lower sum.

However, a source close to the talks said this could leave some investors dissatisfied.

Another option could be for shareholders to abandon tag-along rights altogether, meaning Spain’s Ferrovial can offload its shares having spent 17 years as Heathrow’s largest investor.

The issue of Heathrow’s ownership has been hanging over the airport for months, at a time when new chief executive Thomas Woldbye is attempting to overhaul the business.

Since the rebound in travel post-pandemic, the issue of capacity has been thrust back onto the agenda at Heathrow – raising renewed questions over the airport’s plans for a third runway.

Restrictions relating to its expansion have led to high-profile industry chiefs arguing that Heathrow has lost its status as a global transport hub.

Paul Griffiths, former managing director of Gatwick Airports and current boss of Dubai Airports, said Heathrow has suffered from its “shortage in capacity”.

Current shareholders in Heathrow have also previously been criticised for starving the company of investment, with scrutiny placed on £4bn of dividends extracted before the pandemic. Since then, debts in the business have ballooned to almost £20bn.

Heathrow and Ardian declined to comment.

Train drivers strike for third time in four days

Sky News
Sun, 7 April 2024




Passengers on some of the UK's busiest rail routes will face travel chaos on Monday as train drivers are set to strike for the third time in four days.

Members of Aslef will walk out resulting in significant reductions in services, especially in East Anglia and the South East.

Aslef is embroiled in a near two-year long dispute over pay, with no sign of a breakthrough and no talks planned.


The strike will hit c2c, Gatwick Express, Greater Anglia, Southeastern, Southern, South Western Railway, Great Northern and Thameslink.

The union says the dispute has cost the industry over £2bn, far more than it would have cost to resolve the conflict.

Aslef members at 16 train companies are also banning overtime on Monday and Tuesday which will further disrupt services.

Picket lines will be mounted outside the railway stations of operators affected by the strike.

Aslef general secretary Mick Whelan said his members remained solidly behind the industrial action and criticised the government and rail companies for the lack of contact over the past year.

The government introduced a new law last year aimed at ensuring minimum levels of service during strikes, but none of the train companies have opted to use it.

A Rail Delivery Group spokesperson said: "Train companies are working through plans to manage the unnecessary disruption to our passengers caused by this damaging industrial action.

"Minimum service levels are one potential tool for that but they are not a silver bullet.

"In the meantime, we remain committed to resolving this dispute and our offer, which would take average driver salaries to £65,000 for a four-day week without overtime, remains on the table."

A Department for Transport spokesperson said: "Aslef is the only rail union continuing to strike, targeting passengers and preventing their own members from voting on the pay offer that remains on the table.

"Having resolved disputes with all other rail unions, the transport secretary and rail minister have ensured that a pay offer is on the table - taking train drivers' average salaries from £60,000 up to £65,000."

UK Train drivers mount picket lines outside railway stations as strikes continue


Alan Jones, PA Industrial Correspondent
Sat, 6 April 2024 



Train drivers mounted picket lines outside railway stations on Saturday as strikes continued in a long-running pay dispute.

Aslef said the 22-month-long row had cost the industry £2 billion, much more than it would have cost to resolve the conflict.

Rail passengers suffered more travel disruption when six operators were hit by strikes.


Some areas of the country will have no services all day on Saturday.


Chiltern, TransPennine Express and Northern will not run any trains, while there will be reduced services on Great Western Railway, LNER and Heathrow Express.

LNER said it plans to run 35 services between London, Edinburgh and West Yorkshire, while no Heathrow Express trains will run before 7.25am or after 7pm.

GWR said services will be reduced, with many parts of its network having no trains all day.

Engineering work means there will be no trains between London Paddington and Reading.

The strikes follow walkouts at Avanti West Coast, East Midlands Railway, West Midlands Railway, CrossCountry and London NorthWestern on Friday, which crippled services.

Several train operators, including those serving busy commuter routes in the South East, will be hit by a strike on Monday.

A ban on overtime on Saturday, Monday and Tuesday at 16 train companies is also leading to cancellations and disruption.

Aslef says it wants to meet with train companies and ministers to try to break the deadlock, claiming that the Government does not want to resolve the row.

No meetings have been held between the union and the Rail Delivery Group (RDG) for a year, or with Transport Secretary Mark Harper since December 2022.

Aslef general secretary Mick Whelan said: “We’ve done 17 pay deals in the last 12 months across all sectors, nations and regions – freight, open-access, Elizabeth line, and Tube.

“And yet we only have a problem with one place and the place we have a problem with is the Westminster Government, who are interfering with our pay deals with the private companies we work for.”

A new law was introduced last year aimed at ensuring minimum levels of service during strikes, but none of the train operators have applied to use it.

A Department for Transport spokesperson said: “Aslef is the only rail union continuing to strike, targeting passengers and preventing their own members from voting on the pay offer that remains on the table.”

A spokesperson for the RDG said: “Minimum service level legislation is one of many useful tools for managing strike disruption, but it is not a silver bullet.”

 

New evidence links passive smoking with dangerous heart rhythm disorder




EUROPEAN SOCIETY OF CARDIOLOGY





Berlin, Germany – 7 April 2024:  Exposure to secondhand smoke – even at small amounts – is linked with greater risk of a serious heart rhythm disorder, according to research presented at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).1 The likelihood of atrial fibrillation increased as the duration of passive smoking lengthened. 

“The dangers of secondhand smoke were significant regardless of whether individuals were at home, outdoors, or at work, indicating that exposure universally elevates the risk of atrial fibrillation,” said study author Dr. Kyung-Yeon Lee of Seoul National University Hospital, Seoul, Republic of Korea. “We should all make every effort to avoid spending time in smoky environments. The findings should also drive policymakers to further curb smoking in public areas and support smoking cessation programmes to improve public health.” 

Atrial fibrillation is the most common heart rhythm disorder worldwide.2 Symptoms include palpitations, shortness of breath, fatigue, and difficulty sleeping. It is estimated that one in three Europeans will develop the condition during their lifetime. People with atrial fibrillation are five times more likely to have a stroke than their healthy peers. 2 

It is well established that passive smoking is linked to coronary artery disease and premature death.3-8 However, the links between secondhand smoke and atrial fibrillation have been unclear. This study examined the association between secondhand smoke exposure and the long-term risk of incident atrial fibrillation. The study included adults aged 40 to 69 years who had used the UK National Health Service (NHS) for any reason and were enrolled in the UK Biobank. Current smokers and those with atrial fibrillation at baseline were excluded from the study. 

A total of 400,493 adults were included in the analysis. The average age of participants was 56.5 years and 55.2% were women. A touchscreen questionnaire was used to ask participants the number of hours they had been exposed to other people’s smoke in a typical week over the past year at home and in other environments. Participants were categorised into the ‘exposed group’ if they had any contact with secondhand smoke and the ‘non-exposed group’ if they had no contact with secondhand smoke. Some 85,984 (21%) participants had been exposed to secondhand smoke in the previous year, with an average exposure of 2.2 hours per week. During a median follow-up of 12.5 years, atrial fibrillation developed in 23,471 (6%) participants. 

The researchers analysed the association between exposure to secondhand smoke and incident atrial fibrillation after adjusting for factors that could potentially affect the relationship, including age, sex, ethnicity, body mass index, daily alcohol consumption, moderate-to-vigorous physical activity, diabetes, high blood pressure, high blood lipids, socioeconomic status, and enrolment centre. The group exposed to secondhand smoke had a 6% higher risk of incident atrial fibrillation during follow-up compared with the non-exposed group after adjusting for the previously mentioned factors (hazard ratio 1.06, 95% confidence interval 1.03–1.10, p <0.001). 

A dose-dependent relationship was observed, whereby each increase in the duration of weekly passive smoking was linked with an even greater risk of atrial fibrillation. For example, 7.8 hours of passive smoking per week was associated with an 11% higher likelihood of the heart rhythm disorder compared with no passive smoking. The risk of atrial fibrillation for passive smokers was raised in homes, workplaces, and outside spaces. 

Dr. Lee said: “According to our study, once exposed to secondhand smoke, the likelihood of developing atrial fibrillation begins to increase, with the risk escalating significantly as the exposure time lengthens. The finding that passive smoking is harmful not only in enclosed indoor spaces but also outdoor environments underscores the importance of smoking bans to protect public health.” 

 

ENDS 

 

Authors: ESC Press Office  
Tel: +33 (0)489 872 075 

Email: press@escardio.org 

Follow us on X @ESCardioNews  

 

Notes to editor 

 

Funding: None. 

Disclosures: None. 

 

References and notes 

1The abstract ‘Secondhand tobacco smoke and risk of atrial fibrillation: an observational epidemiologic and gene-environment interaction analysis’ will be presented during the session ‘Atrial fibrillation: basic science - epidemiology’ which takes place on 7 April 2024 at 08:30 CEST at Moderated ePosters 1. 

2Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020;42:373-498. 

3Yankelevitz DF, Cham MD, Hecht H, et al. The association of secondhand tobacco smoke and CT angiography-verified coronary atherosclerosis. JACC Cardiovasc Imaging. 2017;10:652-659. 

4Yankelevitz DF, Henschke CI, Yip R, et al. Second-hand tobacco smoke in never smokers is a significant risk factor for coronary artery calcification. JACC Cardiovasc Imaging. 2013;6:651-657. 

5Peinemann F, Moebus S, Dragano N, et al. Secondhand smoke exposure and coronary artery calcification among nonsmoking participants of a population-based cohort. Environ Health Perspect. 2011;119:1556-1561. 

6Gallo V, Neasham D, Airoldi L, et al. Second-hand smoke, cotinine levels, and risk of circulatory mortality in a large cohort study of never-smokers. Epidemiology. 2010;21:207-214. 

7Glantz SA, Parmley WW. Passive smoking and heart disease. Epidemiology, physiology, and biochemistry. Circulation. 1991;83:1-12. 

8Lv X, Sun J, Bi Y, et al. Risk of all-cause mortality and cardiovascular disease associated with secondhand smoke exposure: a systematic review and meta-analysis. Int J Cardiol. 2015;199:106-115. 

 

About the European Heart Rhythm Association 

The European Heart Rhythm Association (EHRA) is a branch of the European Society of Cardiology (ESC). Its aim is to improve patients’ quality of life and reduce sudden cardiac death by limiting the impact of heart rhythm disturbances.  

 

About the EHRA Congress     #EHRA2024 

EHRA 2024 is the annual congress of the European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC). 

 

About the European Society of Cardiology  

The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives. 

 

Information for journalists about registration for EHRA 2024 

EHRA 2024 will be held 7 to 9 April at the CityCube Berlin, Germany, and online. Explore the scientific programme.

  • Free registration applies to accredited press

  • Credentials: A valid press card or appropriate letter of assignment with proof of three recent published articles. Read the ESC media and embargo policy

  • The ESC Press Office will verify the documents and confirm by email that your press accreditation is valid. 

  • The ESC Press Office decision is final regarding all press registration requests. 

 

Short-term incentives for exercise can lead to sustained increases in activity



NIH-supported study shows certain perks can spur long-term behavior change in adults with cardiovascular disease risks



NIH/NATIONAL HEART, LUNG AND BLOOD INSTITUTE





Short-term incentives for exercise can lead to sustained increases in activity
NIH-supported study shows certain perks can spur long-term behavior change in adults with cardiovascular disease risks
  
Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation. The findings were simultaneously presented as late-breaking research at the American College of Cardiology’s Annual Session.

The improvements, which also resulted in an extra 40 minutes of moderate exercise each week, correlated with a 6% reduced risk of premature death and a 10% reduced risk of cardiovascular-related deaths, compared to data from prior studies. The Department of Health and Human Services recommends that most adults should get at least 150 minutes of moderate aerobic exercise per week, such as brisk walking, or 75 minutes of vigorous exercise, like fast cycling, or a combination of the two, paired with twice-weekly strength sessions.

Researchers found that while a simple daily reminder was effective in helping people move more, offering financial incentives or point-based rewards, such as in a game, was even more effective. However, combining the two incentives proved most effective. Participants who got both were still logging improvements in activity levels six months after the rewards stopped.  

“Even moderate exercise can drastically reduce cardiovascular risk, so finding low-cost ways to get people moving and stay in a fitness program that they can do at home is a huge win for public health,” said Alison Brown, Ph.D., R.D., a program officer at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.

The study took place between 2019 and 2024. Researchers followed more than 1,000 adults at elevated risk for major cardiovascular events. All participants received a wearable fitness tracker, which connected to an online health portal and enabled researchers to count their baseline daily step count. Participants then set a goal to increase their daily steps by 33%, 40%, 50%, or any amount greater than 1,500 steps from their starting point. After they set their goals, participants were randomized into one of four groups.

Three groups offered incentives, including game-like rewards, financial rewards, or a combination of the two. In the game group, each participant received points every week and kept them by meeting their daily step goals. On days they failed to meet their goals they lost points. Participants with enough points moved up a level and participants who failed to meet goals moved down a level. A family member or friend could act as a participant’s “support crew” and receive weekly updates about their progress. At the end of the study, adults who reached the highest levels by meeting their daily step goals received trophies. In the financial group, each participant received $14 each week, but lost $2 a day if they did not meet their step targets. The third group received game-like and financial incentives.

The fourth group – a control group – received no incentives but got the fitness tracker, along with daily messages that noted their step count. Each intervention lasted for 12 months followed by a six-month follow-up period where all participants received the same information as controls.

Before the study began, participants in all groups logged an average of about 5,000 daily steps, or 2.4 miles. After 12 months, they increased their daily step count by more than 1,500, or three-fourths of a mile.

Compared to the control group, the game-incentive group walked an extra 538 steps from their baseline amount, while those who received financial incentives walked an extra 492. The group who received both incentives averaged 868 extra steps and maintained an average 576 more daily steps six months later. Adults in the single interventions kept their physical activity increases, but the gains didn’t differ significantly from the average 1,200 extra steps people in the control group took 18 months after the start of the study.

Still, “The interventions created immediate benefits for participants – and they worked,” said Alexander C. Fanaroff, M.D., a study author, an expert in behavior change, and an interventional cardiologist and assistant professor of medicine in the Division of Cardiology at the University of Pennsylvania, Philadelphia. “Research shows it’s easier to think about today instead of the future, whether it’s exercising more to support long-term heart health or saving for a future goal, like college or retirement.”

Researchers said people wanting to change their behavior, especially around exercise, can focus on the same principles used in the study, which created immediate benefits or rewards for movement. For example, there are exercise apps that provide daily reminders and rewards for meeting personal health goals, people could enlist family and friends for support, and even create scenarios where they lose money by giving it away if they don’t meet their targets. Healthcare systems and organizations could also use tactics in the study to help patients increase physical activity levels. The research was supported by NHLBI grant R61/R33HL141440.

Reference: Fanaroff AC, Patel MS, Chokshi N, et al. Effects of gamification, financial incentives, or both to increase physical activity among patients at high risk of cardiovascular events: The BE ACTIVE randomized controlled trial. Circ. 2024; doi: 0.1161/CIRCULATIONAHA.124.069531.
   
                                                                                  ###     

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit https://www.nhlbi.nih.gov/.              

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov/.         

                                               NIH...Turning Discovery Into Health


Successful “first in human” clinical trial of pioneering guidance for heart bypass surgery



University of Galway research at cutting edge of cardiovascular and coronary artery disease planning as trial shows non-invasive cardiac-CT, with AI-powered blood flow scanning, is safe and feasible


 NEWS RELEASE 
UNIVERSITY OF GALWAY

Professor Patrick W Serruys and Professor Yoshi Onuma in the CORRIB Core Lab at University of Galway 

IMAGE: 

PROFESSOR PATRICK W SERRUYS AND PROFESSOR YOSHI ONUMA IN THE CORRIB CORE LAB AT UNIVERSITY OF GALWAY.

view more 

CREDIT: UNIVERSITY OF GALWAY




A new approach to the guidance, planning and conduct of heart bypass surgery has been successfully tested on patients for the first time in a clinical trial coordinated by a research team at University of Galway.

The FAST TRACK CABG study, overseen by the University’s CORRIB Research Centre for Advanced Imaging and Core Lab, has seen heart surgeons plan and carry out coronary artery bypass grafting (CABG), based solely on non-invasive cardiac-CT scan images, with HeartFlow’s AI-powered blood flow analysis of the patient’s coronary arteries.

The research was published today in the European Heart Journal and is available at https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehae199

The key findings of this first-in-human study is the 99.1% feasibility, which means that heart bypass surgery without undergoing invasive diagnostic catheterisation is feasible and safe, driven by the good diagnostic accuracy of the cardiac CT scan and AI-powered blood flow analysis.

The trial was sponsored by University of Galway and funded by GE Healthcare (Chicago, USA) and HeartFlow, Inc. (Redwood City, California, USA).

In comparing the safety and effectiveness of heart bypass surgery, the trial had similar outcomes to recent surgical groups of patients who underwent conventional invasive angiogram investigations, which involves inserting a catheter through an artery in the wrist or groin to access diseased arteries and using dye to visualise blockages.

The findings of the FAST TRACK CABG trial suggest that the less invasive approach to heart bypass surgery offers comparable safety and efficacy to established methods. The research team noted that safety issues inherent to invasive investigation can be replaced by a non-invasive technique using CT scan imaging and AI-powered blood flow analysis.

Trial chairman Professor Patrick W Serruys, Established Professor of Interventional Medicine and Innovation at University of Galway, said: “The results of this trial have the potential to simplify the planning for patients undergoing heart bypass surgery. The trial and the central role played by the CORRIB Core Lab puts University of Galway on the frontline of cardiovascular diagnosis, planning and treatment of coronary artery disease.”

The study was carried out in leading cardiac care hospitals in Europe and the US and involved 114 patients who had severe blockages in multiple vessels, limiting blood flow to their heart.

The cardiac CT used in this study (Revolution CT, GE Healthcare) has a special resolution that makes the non-invasive images as good or even better than the images traditionally obtained by a direct injection of contrast dye in the artery of the heart through a catheter.

During the trial, the analysis of high resolution cardiovascular imagery and data was carried out by the CORRIB Core Lab team and shared by telemedicine with surgeons in trial hospitals.

The HeartFlowTM Analysis, which provides AI-powered blood flow analysis called Fractional Flow Reserve derived from CT (FFRCT), quantifies how poorly the narrowed vessel provides blood to the heart muscle, assisted the surgeon in clearly identifying which of the patient’s vessels should receive a bypass graft.

Professor Serruys added: “The potential for surgeons to address even the most intricate cases of coronary artery disease using only a non-invasive CT scan, and FFRCT represents a monumental shift in healthcare. Following the example of the surgeon, interventional cardiologists could similarly consider circumventing traditional invasive cineangiography and instead rely solely on CT scans for procedural planning. This approach not only alleviates the diagnostic burden in cath labs but also paves the way for transforming them into dedicated ‘interventional suites’- ultimately enhancing patient workflows.”

Dr Yoshi Onuma, Professor of Interventional Cardiology at University of Galway and the medical director of CORRIB Research Centre, said: “Exploring the potential for minimising diagnostic catheterisation procedures is important for several reasons- a catheterisation procedure is invasive and it is unpleasant for the patient. It is also costly for the health service. While there is a minimal risk associated with the procedure, it is not entirely risk free.

“CT scan analysis, FFRCT, and guidance from the team in Galway is a world first in bypass surgery. It may become a game-changer, altering the traditional relationship between GP, radiologist, cardiologist and cardio-thoracic surgeon for the benefit of the patient.”

Dr Saima Mushtaq, Director of Cardiovascular CT in Centro Cardiologico Monzino, Milan, Italy, said: “This is a historical trial that may change our approach for patients who are candidates for CABG revascularisation and with the FAST TRACK CABG trial we have been part of this revolution in which a CT scan is considered a tool to plan revascularisation skipping invasive coronary angiography.”

Dr John Puskas, Mount Sinai Morningside, New York and Professor of Cardiothoracic Surgery, Emory University Hospital Midtown, Atlanta, Georgia, said: “As the only North American surgeon, enrolling many patients in this trial, I have a unique perspective: I can conclusively state that there is no loss in diagnostic precision or accuracy nor any decrement in the quality of surgical planning or performance when the surgical team is guided solely by data from a latest-generation, non-invasive coronary CT scan. Once the surgeon is familiar with this new imaging modality, there are several ways in which it is actually a better guide than the historical invasive coronary angiogram.”

Professor Fidelma Dunne, Director of the Institute for Clinical Trials at University of Galway, said: “The outcomes of this inaugural human trial are highly promising, prompting further exploration of the advantages offered by this non-invasive methodology through an extensive randomised trial. At the Institute for Clinical Trials we are committed to conducting high-impact trials that have the potential to revolutionise patient care globally.”

The pioneering research of the CORRIB Core Lab at University of Galway into cardiovascular diagnosis and coronary artery disease will be further investigated in a large scale randomised trial. The research team is planning it will involve more than 2,500 patients from 80 hospitals across Europe.


Professor Professor Patrick W [VIDEO] | 

Professor Professor Patrick W Serruys in the CORRIB Core Lab at University of Galway explaining the results and significance FAST TRACK CABG trial

Stopping aspirin one month after coronary stenting procedures significantly reduces bleeding complications in heart attack patients



THE MOUNT SINAI HOSPITAL / MOUNT SINAI SCHOOL OF MEDICINE
Primary efficacy and safety outcomes during follow-up between one-month and 12-months post-PCI 

IMAGE: 

THE PRIMARY EFFICACY ENDPOINT OF CLINICALLY-RELEVANT BLEEDING, DEFINED AS BARC TYPES 2, 3 OR 5 BLEEDING, WAS ASSESSED IN THE INTENTION-TO-TREAT POPULATION BETWEEN ONE-MONTH AND TWELVE-MONTHS POST-PCI IN PATIENTS WHO WERE EVENT-FREE AFTER ONE MONTH OF TICAGRELOR AND ASPIRIN. SWITCHING TO TICAGRELOR MONOTHERAPY AT ONE MONTH RESULTED IN A 55-PERCENT REDUCTION IN THE HAZARD OF CLINICALLY RELEVANT BLEEDING COMPARED WITH CONTINUING TICAGRELOR PLUS ASPIRIN OVER THE ENSUING 11 MONTHS.

view more 

CREDIT: MOUNT SINAI HEALTH SYSTEM




Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart patients and keeping them on ticagrelor alone safely improves outcomes and reduces major bleeding by more than half when compared to patients taking aspirin and ticagrelor combined (also known as dual antiplatelet therapy or DAPT), which is the current standard of care.

These are the results from the ULTIMATE-DAPT study announced during a late-breaking trial presentation at the American College of Cardiology Scientific Sessions on Sunday, April 7, and published in The Lancet.

This is the first and only trial to test high-risk patients with recent or threatened heart attack (acute coronary artery syndromes, or ACS) taking ticagrelor with a placebo starting one month after PCI, and compare them with ACS patients taking ticagrelor with aspirin over the same period. The significant findings could change the current guidelines for standard of care worldwide.

“Our study has demonstrated that withdrawing aspirin in patients with recent ACS one month after PCI is beneficial by reducing major and minor bleeding through one year by more than 50 percent. Moreover, there was no increase in adverse ischemic events, meaning continuing aspirin was causing harm without providing any benefit,” says Gregg W. Stone, MD, the study co-chair of ULTIMATE-DAPT, who presented the trial results.

“It is my belief that it’s time to change the guidelines and standard clinical practice such that we no longer treat most ACS patients with dual antiplatelet therapy beyond one month after a successful PCI procedure. Treating these high-risk patients with a single potent platelet inhibitor such as ticagrelor will improve prognosis,” adds Dr. Stone, who is Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai.

The study analyzed 3,400 patients with ACS at 58 centers in four countries between August 2019 and October 2022. All of the patients had undergone PCI, a non-surgical procedure in which interventional cardiologists use a catheter to place stents in the blocked coronary arteries to restore blood flow. The patients were stable one month after PCI and were on ticagrelor and aspirin. Researchers randomized the patients after one month, withdrawing aspirin in 1,700 patients and putting them on ticagrelor and a placebo, while leaving the other 1,700 patients on ticagrelor and aspirin. All patients were evaluated between 1 and 12 months after the procedure.

During the study period, 35 patients in the ticagrelor-placebo group had a major or minor bleeding event, compared to 78 patients in the ticagrelor-aspirin group, meaning that the incidence of overall bleeding incidents was reduced by 55 percent by withdrawing aspirin. The study also analyzed major adverse cardiac and cerebrovascular events including death, heart attack, stroke, bypass graft surgery, or repeat PCI. These events occurred in 61 patients in the ticagrelor-placebo group compared to 63 patients in the ticagrelor-aspirin group, and were not statistically significant - further demonstrating that removing aspirin did no harm and improved outcomes.

“It was previously believed that discontinuing dual antiplatelet therapy within one year after PCI in patients with ACS would increase the risk of heart attack and other ischemic complications, but the present study shows that is not the case, with contemporary drug-eluting stents now used in all PCI procedures. Discontinuing aspirin in patients with a recent or threatened heart attack who are stable one month after PCI is safe and, by decreasing serious bleeding, improves outcomes,” Dr. Stone adds. “This study extends the results of prior work that showed similar results but without the quality of using a placebo, which eliminates bias from the study.”

This trial was funded by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project.

 

Mount Sinai is a World Leader in Cardiology and Heart Surgery

Mount Sinai Fuster Heart Hospital at The Mount Sinai Hospital ranks No. 1 in New York and No. 4 globally according to Newsweek’s “The World’s Best Specialized Hospitals.” It also ranks No. 1 in New York for cardiology, heart, and vascular surgery, according to U.S. News & World Report®.  

It is part of Mount Sinai Health System, which is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report's® “Best Hospitals” Honor Roll for 2023-2024.

For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

  

CAPTION

The primary safety endpoint of MACCE, the composite cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically-driven target vessel revascularization, was assessed in the intention-to-treat population between one-month and 12-months post-PCI in patients who were event-free after one month of ticagrelor and aspirin. During the next eleven months patients treated with ticagrelor monotherapy had similar rates of adverse ischaemic events as patients who were maintained on ticagrelor plus aspirin.

PCI denotes percutaneous coronary intervention; BARC denotes Bleeding Academic Research Consortium; MACCE, major adverse cardiovascular or cerebrovascular events; HR, hazard ratio; CI, confidence interval.

CREDIT

Mount Sinai Health System

SOCK NOT SHOCK

Electronic sock detects unhealthy walking style


EUROPEAN SOCIETY OF CARDIOLOGY





Berlin, Germany – 7 April 2024:  An electronic sock that detects an unhealthy walking style linked with diabetes and poor circulation shows promise for preventing foot ulcers and amputation. The novel research is set to benefit the many patients with diabetes who have clogged arteries in the legs and is presented for the first time at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).1 

Study author Dr. Ki Hong Lee of Chonnam National University Hospital, Gwangju, Republic of Korea said: “Diabetes can affect the way people walk, also known as their gait. Patients with diabetes tend to put pressure on the metatarsal area of the foot, rather than the heel. This way of walking encourages ulcers, which can become infected and lead to amputation. Identifying walking issues early using an electronic sock would enable patients to learn a healthy walking style and prevent serious foot problems.” 

Around 1 in 10 people – 537 million in total – have diabetes worldwide,2 putting them at a two- to four-fold higher risk of coronary artery disease, stroke, heart failure, atrial fibrillation and peripheral artery disease compared to their healthy peers.3 Foot problems are common in diabetes. High blood sugar damages the nerves and blood vessels, with symptoms including numbness, tingling, pain, and loss of feeling. The symptoms can be difficult to detect in the early stages, meaning that cuts and ulcers may develop and become infected. The combination of an infection and poor blood flow makes healing difficult and can lead to gangrene and, ultimately, amputation. 

This study examined whether a sock fitted with a ballistocardiogram (BCG) sensor could distinguish between healthy people and patients with diabetes. A BCG detects body motion as the heart ejects blood, and could potentially be used to measure heart rate and pressure exerted on the feet when walking. 

The study enrolled 20 patients with diabetes and 20 controls without diabetes. All participants wore the BCG sock for 40 seconds while standing and 40 seconds while walking to measure heart rate and to assess pressure distribution on the foot. At the same time as wearing the sock, participants had an electrocardiogram (ECG) assessment of heart rate using a small patch attached to the wrist and a single electrode adhered to the chest. ECG is the gold standard tool in cardiology for measuring heart rate. 

The purpose of the heart rate measurement was to assess the accuracy of the BCG sock as a measurement tool relative to ECG, the gold standard method. For this analysis, ECG values in each study participant (patients and controls) were compared with BCG values in the same participant. The researchers found that the heart rate measurements by the BCG sock and ECG were almost same, with a correlation coefficient of 0.99 (95% confidence interval 0.99-1.00). 

The foot pressure distribution measurements were performed to discover whether the BCG sock could 1) detect differences between patients with diabetes and healthy controls, and 2) detect differences between patients with diabetes according to whether or not they had damage to the nerves or blood vessels. Nerve damage was classified using the Michigan Neuropathy Screening Instrument (MNSI), while blood vessel damage was classified using the ankle-brachial index (ABI). 

Regarding the BCG comparison between patients and healthy controls, this showed that patients with diabetes exerted higher pressure in the metatarsal area of the foot while walking compared to participants without diabetes. For the BCG comparison between patients with diabetes, the researchers found that compared to patients without blood vessel damage (ABI score of 0.9 or higher), those with blood vessel damage (ABI score less than 0.9) exerted significantly greater pressure on the metatarsal area of the foot during walking and less pressure on the heel. There was no significant difference in foot pressure distribution measurements between patients with or without nerve damage. 

Dr. Lee said: “The novel BCG sock produced accurate measurements of heart rate as indicated by the nearly identical values as ECG. The pressure measurements showed that the sock could identify patients with diabetes, and could also pinpoint patients with diabetes and poor circulation. Taken together, the results suggest that the electronic sock could be an easy, non-invasive way to find patients with diabetes who could benefit from gait training to prevent foot complications.” 

 

ENDS 

 

Authors: ESC Press Office  
Tel: +33 (0)489 872 075 

Email: press@escardio.org 

Follow us on X @ESCardioNews  

 

Notes to editor 

Funding: This study was supported by a CNUH-GIST research collaboration grant funded by the Chonnam National University Hospital Biomedical Research Institute. 


References and notes 

1The abstract ‘Wearable self-powered ballistic signal detectors with ferroelectric composites arrays for cardiovascular and diabetic complication’ will be presented during the session ‘Basic Science 1’ which takes place on 7 April 2024 at 17:30 CEST at Moderated ePosters 1. 

2International Diabetes Federation. IDF Diabetes Atlas: https://diabetesatlas.org/

3Marx N, Federici M, Schütt K et al. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023;44:4043–4140. 

 

About the European Heart Rhythm Association 

The European Heart Rhythm Association (EHRA) is a branch of the European Society of Cardiology (ESC). Its aim is to improve patients’ quality of life and reduce sudden cardiac death by limiting the impact of heart rhythm disturbances.  

 

About the EHRA Congress     #EHRA2024 

EHRA 2024 is the annual congress of the European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC). 

 

About the European Society of Cardiology  

The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.