Minimising permanent pacemaker implantation (PPI) after TAVI

Increased demand for transcatheter aortic valve implantation (TAVI) procedures for patients with severe aortic stenosis has not been matched with a proportional increase in available resources in recent years. This article highlights the importance of developing integrated care pathways for TAVI, which incorporate standardised protocols for permanent pacemaker implantation (PPI) to ensure best practice, increase service efficiency and reduce rates of PPI post-TAVI.

Introduction

Severe aortic stenosis (AS) is the most common degenerative heart valve disease (HVD).¹ There are growing numbers of patients with AS who are waiting for transcatheter aortic valve implantation (TAVI), as rates of degenerative HVD rise. Around 1.5 million people in the UK currently have moderate-to-severe HVD, and numbers are expected to rise to 2.7 million by 2040.² Figure 1 shows the level of undiagnosed patients across all age groups with severe symptomatic AS.³ A significant proportion of patients who are receiving TAVI are aged 75 to 90 years, an increasing demographic in the National Health Service (NHS) as the population ages. The demand will have increased during the COVID-19 pandemic due to delays in undertaking elective procedures.

One of the most common issues following TAVI is the onset of new atrioventricular conduction disturbance, which requires permanent pacemaker implantation (PPI). Data suggest that the need for pacing is higher with the new-generation transcatheter valves.⁴ The approach to pacing within the TAVI patient journey warrants careful consideration because PPI post-TAVI is associated with longer hospital length of stay (LOS) and potential complications (table 1).⁵ In addition, the longer-term outcome is worse after PPI post-TAVI. Improving this aspect of TAVI care through early identification and treatment would improve patient outcomes and reduce demand on stretched resources.

Variation

There is no standardised approach in the UK for patient management and technology choice for TAVI, neither is there clarity on criteria for patient eligibility and timing of procedure. Both hospital episode statistics (HES)⁵ and National Institute for Cardiovascular Outcomes Research (NICOR) data⁶ point to very wide variation in rates of post-TAVI pacing between centres. Between 2016/17 and 2018/19, HES data in England show PPI implantation rates ranging from 1.1% to 12.1% of the TAVI population.⁵ A number of possible clinical factors underlie the wide variation in PPI rate:

• Valve choice
• Patient demographics, particularly patient age 
• Presence and severity of annular calcification and comorbid conditions
• Service issues:
  • Centres have different care pathway protocols, with variability in funding across commissioning organisations
  • Patient referral times from district general hospitals (DGHs) to specialist centres is variable, as is the individual hospital recovery set-up within each specialist centre
  • Timing of the procedure can also influence outcomes, for instance, if the procedure is performed on a Friday there may be a lack of weekend provision if a temporary pacemaker needs to be removed and replaced by a PPI.

Such a variation raises the question as to whether some centres may be implanting pacemakers unnecessarily, and some not enough, in managing the wide-ranging degrees of conduction problems.

It is evident that entry onto a TAVI care pathway is not consistent, and likewise there is no nationally agreed protocol for PPI following TAVI. A unified strategy is required to ensure that patients receive a consistent level of care, with the aim of reducing waiting times for access, reducing PPI where possible and optimising patient outcomes. It should be remembered that although PPI is a problem more commonly associated with TAVI, it is also an issue following surgical aortic valve replacement (SAVR) and with rapid-deployment surgical bioprostheses, therefore, any strategy would benefit from including these procedures.

Challenges to consistency

Developing consistent care pathways across geographical areas is challenging. Clinic arrangements and procedure days vary, and importantly, bed availability between centres differs, which often drives decisions about immediate post-procedure care. Nevertheless, clear guidelines on indication and timing of pacing are overdue.

PPI post-TAVI increases the hospital mean LOS,⁵ which impacts on capacity, especially in light of the COVID-19 pandemic, so it is important that a clearly defined and integrated ‘best practice TAVI pathway’ is developed with a standardised protocol for PPI embedded within it. Such guidelines would ideally incorporate clear definitions, a pre-implantation risk score for conduction disturbance such as annular anatomy/calcification, TAVI sizing and type, implantation technique, as well as management recommendations.

Patient age

Pacing among younger patients is controversial, since evidence suggests that PPI decreases short-term mortality,^7-9 but increases longer-term mortality.⁴ TAVI operators are also concerned about PPI in younger patients, as the patient’s longer life-expectancy may result in the need for further pacemaker replacement, with potential morbidity. Despite these concerns, figure 2 shows a considerable number of TAVI patients under 75 years are receiving PPI in England.⁵ A standardised post-TAVI PPI protocol should include a definition of when pacing is warranted in this younger patient population.

Pacing is an important issue, particularly in the changing risk profile of TAVI patients, yet there is wide variation in practice across the UK for many aspects of the TAVI pathway, and no standardised pacing protocol. This is an area that requires further discussion to agree best practice guidelines for clinicians in order to minimise rates of PPI post-TAVI, and to allow patients to have an informed choice about their treatment plan. There is a particular need for more data to understand how PPI impacts patient outcomes over the long term, and to help guide both case and device selection, especially among younger patients.

Priorities

Key priorities for patients undergoing TAVI:

• There should be no residual haemodynamic valve problem
• How this is achieved depends on patient characteristics (e.g. native valve anatomy, calcification, etc.)
• Valve choice should be made by clinicians in a multi-disciplinary team (MDT) setting, taking into account multiple patient factors
• Valve choice may be influenced by pre-existing conduction disease seen on the electrocardiogram (ECG)
• In younger, lower-risk patients, the risk of PPI is increasingly important in valve choice.

These points must underpin the care pathway for TAVI. End-to-end integrated care pathways are central to the NHS Long Term Plan (2019),¹⁰ both to enhance patient outcomes and to improve throughput of patients in secondary care. For TAVI this needs to encompass all aspects of care, including better HVD detection and referral in the community. True integrated care for TAVI patients offers an attractive opportunity to increase capacity for procedures. This could significantly improve referral pathways for patients and increase the efficiency of tertiary centre MDTs – a more pressing concern than ever in the wake of the global pandemic.

Key messages

• With end-to-end integrated care pathways now central to the NHS, there is an opportunity for true integration for transcatheter aortic valve implantation (TAVI) patients both to enhance patient outcomes and to improve throughput of patients in secondary care, but this needs to encompass all aspects of care, including better heart valve disease (HVD) detection and referral in the community
• A unified strategy for TAVI would improve the efficiency of specialist multi-disciplinary team (MDT) meetings to assess whether patients get TAVI or surigical aortic valve replacement (SAVR)
• Valve choice should be made by clinicians in a MDT setting, taking into account multiple patient factors
• In younger, lower-risk patients, the risk of permanent pacemaker implantation (PPI) is increasingly important in valve choice

Conflicts of interest

PM is a Procedural Proctor for Edwards Lifesciences, has received an educational grant from Edwards Lifesciences and research support from Boston Scientific. NU is Proctor for Edwards Lifesciences. JC is Proctor for Boston Scientific. DS is Proctor for Abbott and has received speaker fees from Edwards Lifesciences. DM is Proctor for Edwards Lifesciences and Abbott Vascular. AZ, SD, IM, MO, SS: none declared.

Funding

This project is managed as an independent programme developed by an expert clinical panel, led by Professor Philip MacCarthy, with the support of Wilmington Healthcare Ltd., and fully funded by Edwards Lifesciences plc. All content is independent of, and not influenced by, Edwards Lifesciences plc.

Acknowledgement

Sarah Mehta (Wilmington Healthcare, London, UK) participated in writing or technical editing of the manuscript.

References

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