EACTS Statement: Regarding TAVI

In Portugal, there is increased pressure to perform TAVI without on-site cardiac surgery. In response, we would like to reiterate the importance of the 2021 EACTS/ESC Valvular Heart Disease guidelines that require on-site cardiac surgery and cardiology departments at any valve centre performing TAVI. 

Read our full statement below.

To Whom It May Concern,

There is increasing pressure to perform transcatheter aortic valve implantation (TAVI) without on-site cardiac surgery. We would like to highlight the importance of the 2021 EACTS/ESC Valvular Heart Disease guidelines that require on-site cardiac surgery and cardiology departments at any valve centre performing TAVI. This letter is intended to clarify the reasons for this position.

The EACTS/ESC guidelines for the management of valvular heart disease state that valve interventions must be undertaken in Heart Valve Centres. The main purpose of these centres is to deliver optimal quality of care with a patient-centred approach. This requires established cardiology and cardiac surgery departments with 24-hr/7-day services. On-site cardiac surgery departments optimise TAVI care by enhancing:

• Patient selection and procedural planning
• Procedural performance
• Management of complications and post-procedural care.

TAVI has shown exponential growth around the world, surpassing surgical aortic valve replacement (SAVR) in numbers. Morbidity and mortality have been decreasing. However, major complications requiring extra-corporeal support and urgent cardiac surgery remain steady at 0.8-1%, and these urgent interventions carry a high mortality (10-30%).

Parallels between the development of PCI and TAVI have been made, with increasing calls to not require on-site cardiac surgery, as the outcomes of centres without on-site cardiac surgery are reported not to differ significantly from those with on-site cardiac surgery. It is important to note that TAVI differs in two distinct ways from PCI:

1. Urgent PCI in acute coronary syndromes saves muscle and lives. Having access to PCI without delay for transfer, to minimize door-to-balloon times, justifies having PCI units distributed within the population. TAVI is rarely, if ever, urgent. There is always time to stabilise and transfer a patient with severe symptomatic aortic stenosis.
2. Although major complications of TAVI are rare, they carry a very high mortality, and the results of high-volume, expert heart teams have shown that many of these patients can be saved. As we expand into low-risk patients and many more procedures, there will be an increasing number of patients who require urgent cardiac surgery, and who could have undergone elective SAVR. It is not ethical to propose TAVI without an institutional department of cardiac surgery.

Furthermore, there is evidence to support that the larger the volume, the better the outcomes in TAVI. Creating smaller, low volume units without on-site cardiac surgery risks splitting the TAVI volumes and affecting patient outcomes. In addition, it is unlikely that centres without on-site cardiac surgery have the same advanced critical care units required for cardiac surgery. As a result, these patients would not benefit from the same level of care being available.

In light of the information and evidence above, we would like to repeat the importance of a true Heart Team approach for the management of valvular heart disease, in accordance with our guideline recommendations.

Kindest regards.

Patrick Myers (Secretary General Elect)

Rafa Sádaba (Secretary General)

Friedhelm Beyersdorf (President)

Filip Casselman (Chair, Acquired Cardiac Disease Domain)

References

1. Beyersdorf F, Vahanian A, Milojevic M, Praz F, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Jüni P, Pierard L, Prendergast BD, Sádaba JR, Tribouilloy C, Wojakowski W, ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart diseaseDeveloped by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2021;60(4):727-800. doi: 10.1093/ejcts/ezab389.
2. Mylote D, Head SJ, Kappetein AP, Piazza N. TAVI at institutions without cardiovascular surgery departments: why? EuroIntervention 2014;10:539-541.
3. Smith CR. Emergency cardiac surgery following TAVI: implications for the future, European Heart Journal 2018;39(8):685-686.