NHS0017

 

Written evidence submitted by Edwards Lifesciences

 

About Edwards

Edwards Lifesciences is a leading medical devices company providing lifechanging technologies to people with structural heart conditions and providing best-in-class monitoring technology in the operating room and intensive care units. Our heart treatment technologies provide curative and restorative treatment to people suffering from heart valve disease (HVD)a progressive, severe and debilitating condition with a high risk of mortality without treatment.

Response

Edwards Lifesciences welcomes this timely inquiry. In our response, we highlight the impact of the elective backlog on cardiac patients, and the specific acute impact on those with HVD. We identify policy means to best expedite the recovery of the backlog and reduce CVD deaths in the community.

 

The backlog continues to rise and present a growing problem for the NHS and social care services, with pressure on staff, lacking bed space, and progressive diseases causing worse outcomes for patients. Cardiac patients make up a large proportion of the overall elective care backlog. Recent NHSE data confirms that the cardiac care waiting list has grown for the 27th consecutive month, with an estimated 349,090 cardiac patients now on the waiting list[1] over 100,000 more than were reported in May 2021.[2] Waiting times for these patients also remain at high levels with over 125,983 people waiting over four months and over 7,000 people waiting over a year as of September.[3]

 

Immediate action to tackle these long waits and growing waiting lists is vital, both to ensure good outcomes for all patients and prevent thousands of deaths.

Overall burden of HVD and the backlog

Heart valve disease (HVD) patients make up a significant portion of the cardiac waiting list. HVD affects an estimated 1.5 million people in the UK, becoming more prevalent with age; with demographic ageing, this figure is set to double by 2046.[4] HVD is a progressive disease and if left untreated, has a critical prognosis; for severe aortic stenosis (a form of HVD), without treatment patients have a two-year survival rate of 50 per cent and a five-year survival rate of just 20 per cent after symptom onset.[5]

Capacity-enhancing innovations in cardiac elective care in national recovery plans

National recovery plans recognise the risk of mortality CVDs like heart valve disease pose without treatment, accordingly prioritising their treatment, but do not prioritise the most efficient means of treatment. Since 2020, research into the impact of different treatment regimens on patient recovery, elective throughput and deaths on waiting lists has evidenced the transformative, capacity-enhancing benefits of therapeutic innovations; conversion of traditional surgery to capacity-enhancing therapeutic innovations for eligible patients has been found to be essential for clearing the backlog.[6]

 

The referenced paper by Stickels et al, on aortic stenosis treatment and mortality, namely found that clearing the backlog by returning to pre-COVID-19 elective capacity and arrangements is not possible. Aortic stenosis is traditionally treated through surgical aortic valve replacement (SAVR; open heart surgery) or transcatheter aortic valve implantation (TAVI), a minimally invasive, transfemoral treatment. In the UK, SAVR is the default treatment mode and typically offered to younger patients, while TAVI is prioritised for older, frail patients unable to undergo open heart surgery.

 

Minimally invasive surgery options such as TAVI has been proven to be beneficial for patients. Such options can require shorter hospital stays and lead to less hospital-based follow-up care – while recovery from open heart surgery requires a lengthy hospital stay, up to several weeks, with TAVI, patients can be treated in day-case procedures and typically be released home after 48 hours, relieving nursing and support staff for other duties and relieving capacity and resources. With cross-training of staff made easier with minimally invasive treatment options, more practitioners can provide treatments, mitigating workforce capacity issues.

 

Maintaining usual service arrangements, Stickels et al found deaths from aortic stenosis would total over 2,500, with the backlog recovery taking nearly 4 years. Converting 50% of SAVR to TAVI procedures, the backlog would be cleared within 2 years, saving over 1,000 deaths. This estimation has been supported recently by the BHF, who have found that increasing waiting lists have contributed to just over 30,000 excess deaths involving heart disease since the start of the pandemic.[7]

 

The Stickels paper highlights the need to re-evaluate government backlog targets and prioritise access to capacity-enhancing minimally invasive options for all suitable patients awaiting CVD treatment. Operative and recovery speed are vital in preventing deaths and must hold primacy in elective recovery planning.

Need for improved detection and diagnostics

Due to obstacles to primary detective and diagnostic services, many HVD patients go undetected or late diagnosis, leading to worsened complications and more complicated treatment. Due to limited use of stethoscopes in GP appointments to detect characteristic heart murmurs, approximately a half of patients with heart valve disease are not diagnosed until significant valve disease has developed.[8]

 

Heart diseases are currently mostly diagnosed in hospitals despite 40% of patients having symptoms which should have triggered an earlier assessment.[9] This means that by the time the patient presents, it is likely that the heart has become compromised (heart failure), which can cause significant problems, admissions to hospital, and loss of independence, and it is likely that an operative intervention would be necessary at this stage.

 

While national recovery plans have pledged ‘£350 million in 2021-22 and £2.3 billion more between 2022-23 and 2024-25 to increase diagnostic capacity,’ which has successfully been used to establish around 90 community diagnostic centres (CDCs) to date, government policy has failed to address the issues in detection services across community and primary care services.

 

The lacking GP workforce and underutilisation of other primary care services, such as pharmacies, means that many patients are still not being picked up early in their disease progression and are presenting at a severe stage of the disease in hospitals. Addressing these shortcomings through routinised checks will be vital to capture ‘missing’ heart valve disease patients and ensure that elective care services are not overburdened with severe cases.

November 2022

 


[1] NHS England, September 2022. Statistical Press Notice NHS referral to treatment (RTT) waiting times data.

[2] NHS, July 2021. Statistical Press Notice NHS referral to treatment (RTT) waiting times data May 2021. Can be viewed at May21-RTT-SPN-publication-69343.pdf (england.nhs.uk)

[3] NHS England, September 2022, Statistical Press Notice NHS referral to treatment (RTT) waiting times data.

[4] BHF (July 2018). Heart valve disease facing diagnosis crisis over next 40 years.

[5] Heart Valve Voice (2016) Towards a Heart Healthy Future. A 2020 Vision for Heart Valve Disease. Available at: https://www.heartvalvevoice.com/application/files/9514/7792/7992/Heart_Healthy_Future_Report.pdf

[6] Stickels et al, ‘Aortic stenosis post-COVID-19: a mathematical model on waiting lists and mortality’, BMJ Open 2022.

[7] BHF (November 2022). Extreme heart care disruption linked to 30,000 excess deaths involving heart disease. Available here: https://www.bhf.org.uk/what-we-do/news-from-the-bhf/news-archive/2022/november/extreme-heart-care-disruption-linked-to-excess-deaths-involving-heart-disease

[8] NHS Long Term Plan, p.g 62. Bottle, A., Kim, D., Aylin, P., Cowie, M., Majeed, A. & Hayhoe, B. (2018) Routes to diagnosis of heart failure: observational study using linked data in England. Heart. 104 (7), 600-605. Available from: https://doi.org/10.1136/heartjnl-2017-312183

[9] d'Arcy JL, Coffey S, Loudon MA, et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE population cohort study.