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European Society of Cardiology – Updated valvular heart disease guidelines 2021

In August, new guidelines were released as part of the ESC Congress 2021 for the management of valvular heart disease. Included in these guidelines are updated recommendations for the treatment of patients with aortic stenosis.

Updates to treatment recommendations1

  1. TAVI is now recommended for patients >75 years, regardless of increased surgical risk
  2. TAVI is recommended for those who are <75 years and of surgical high risk or if deemed inoperable
  3. The Heart Team is central to the decision-making process: evaluating clinical, anatomical, and procedural factors
  4. Patients should be encouraged to make an informed treatment choice following the Heart
    Team’s decision
  5. Asymptomatic patients are now considered for intervention in treatment guidelines

Summary of recommendations for the treatment of aortic stenosis with TF-TAVI

Patient eligibility

ESC Guidelines have adopted an age-based approach over a risk-based approach for patients who are
>75 years of age.1 For these patients, transfemoral (TF)-TAVI is now considered the standard of care, irrespective of surgical risk score.1 Furthermore, TF-TAVI is also recommended for patients who are <75 years of age and considered to be of increased risk or inoperable for surgery.1

Empirical evidence suggests that the average age of patients undergoing TAVI remains 80 years of age,2 and it is expected that these new guidelines will increase the referral of patients who are
>75 years of age for TAVI, likely reducing the mean age of patients undergoing the procedure and increasing the TAVI population.  

Pivotal role of the Heart Team

In the updated guidelines, more weight is given to the collaborative role of the Heart Team, placing it at the centre of every treatment decision for patients with aortic stenosis.1 The updated guidelines recommend that the choice between surgical or transcatheter intervention must be carefully evaluated by the Heart Team factoring in clinical, anatomical and procedural risks for every patient.1

The Heart Team fosters collaboration across medical specialities to offer optimal patient-centred care and has been shown to improve outcomes in TAVI procedures.3 Alongside making treatment decisions, the Heart Team guides patient selection, optimises patients’ pre-procedure status, facilitates early discharge and provides continuity of care.4,5

Patients’ choice is paramount

Once a decision has been made by the Heart Team, it is now recommended that this is discussed with the patient, allowing the patient to make an informed treatment choice.1

This will renew the focus on incorporating patient values and preferences in a shared decision-making approach.6 Patient-centred goals may inform selection of treatment options aligned with patient preferences. The most reported patient-defined goals in valvular disease are ones that will lead to a better quality of life. In elderly populations with ssAS, patient treatment goals favour quality of life outcomes over survival, and patient-defined goals include maintaining independence, reducing symptoms, and increasing functional ability – all of which favour TAVI over SAVR.7,8

Asymptomatic aortic stenosis

New to this version of the guidelines is recommendations for intervention for asymptomatic patients. Intervention is recommended in case of LV dysfunction or with symptoms on exercise testing.1

Historically, the treatment approach for patients with asymptomatic aortic stenosis has been one of close observation until symptom development.9 Implicit in this approach is the concept that asymptomatic patients have a good prognosis and will not benefit from intervention – instead exposing them to undue risks by undergoing intervention.9 However, more recently, it has been evidenced that long-term prognosis of these patients may not be as favourable as once thought.9 Therefore, the balance of risk vs prognostic benefit has shifted with the belief that some patients who are asymptomatic may benefit from early intervention for prognostic reasons.9

What impact will this have on your organisation?

Increase in TAVI eligibility

It is expected that the uptake of TAVI across the EU is expected to increase to as much as 177,000 with major implications for healthcare resource planning.10 These updated guidelines are anticipated to increase the patient population considered for, or undergoing, TAVI.  

In Europe, one million people >75 years of age have aortic stenosis, a disease burden that is increasing with an ageing population.11 Currently, only two-thirds of those with AS receive an intervention11 – and it is hoped that these updated guidelines make the referral for TAVI clear to understand, allowing more patients to undergo intervention as well as the possibility that asymptomatic patients with aortic stenosis can now be considered for early intervention.

Maximising capacity and reducing waiting lists by adapting to a growing TAVI need

Demand for TAVI may already exceed the capacity of service provision, and patients face increased waiting list times – which, translate to increased patient mortality.12 A delay of up to 6 months could lead to 24% of patients dying on the waiting list.12

Advances in technology as well as minimalist practices have led to the TAVI procedure being streamlined.12 Many studies have consolidated best practices to develop, implement and evaluate a standardised clinical pathway to facilitate safe discharge home at the earliest time after TAVI.13-15

Benefits of TAVI

Consolidating TAVI organisational efficiencies, it has been demonstrated that a minimalist, streamlined TAVI pathway, with rapid remobilisation, allows for next-day discharge home, with reproducible, excellent safety and efficiency outcomes.Next-day discharge and 48h discharge was achieved in 80% and 90% of TAVI patients, respectively, and amid concerns that a minimalist approach may affect safety or clinical efficacy, the composite primary endpoint of all-cause mortality or stroke by 30 days occurred in 2.9% of TAVI patients.14


References

  1. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Available from: https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/2021-Valvular-Heart-Disease
  2. Chakos A, et al. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg 2017;6:432–43.
  3. Walters DL, et al. Position Statement for the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program. Heart, Lung and Circulation 2014;1–5.
  4. Clarke S, et al. Using clinical decision support and dashboard tech to improve heart team efficiency and accuracy in TAVI program. Nursing Informatics 2016; doi:10.3233/978-1-61499-658-3-98.
  5. Hawkey MC, et al. Transcatheter aortic valve replacement program development. Catheterization and Cardiovascular Interventions 2014;84:859–67.
  6. Coylewright M, et al. TAVR in Low-Risk Patients: FDA Approval, the New NCD, and Shared Decision-Making. J Am Coll Cardiol 2020;75:1208-1211.
  7. Coylewright M, et al. Patient‐defined goals for the treatment of severe aortic stenosis: a qualitative analysis. Health Expect 2015;19:1036-43.
  8. Marsh K, et al. Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Research 2021;8:394.
  9. Bing R, et al. Management of asymptomatic severe aortic stenosis: check or all in? Heart 2020;0:1-9.
  10. Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J 2018;0:1–8.
  11. Thoenes M, et al. Patient screening for early detection of aortic stenosis (AS)—review of current practice and future perspectives. J Thorac Dis. 2018;10:5584-94.
  12. Ali N, et al. Valve for Life’: tackling the deficit in transcatheter treatment of heart valve disease in the UK. Open Heart 2021;8:e001547. doi: 10.1136/openhrt-2020-001547.
  13. Lauck SB, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway. Minimalist Approach, Standardised Care, and Discharge Criteria to Reduce Length of Stay. Circ Cardiovasc Qual Outcomes 2016;9:312–21.
  14. Wood DA, et al. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home of Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centres. JACC Cardiovasc Interv 2019;12:459–69.
  15. Barbanti M, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. Euro Intervention 2019;15:147–54.

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