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How does partnering with Industry benefit your organisation? Implementing TAVI best practices

Implementing change

Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3TM valve has been granted the CE mark for all-risk patients with severe symptomatic aortic stenosis (ssAS).1

Switching ssAS patients from other treatment methods to the less-invasive TAVI procedure will pave the way to improved hospital efficiency, including shortening waiting lists and length of stay (LOS) and lowering re-hospitalisation rates, which is of paramount importance during and post-COVID-19,2 as hospitals face tackling the backlog of patients whose care have been placed on hold while hospital resources have been restructured during the pandemic.3

Streamlining the TAVI pathway

Many studies have consolidated best practices to develop, implement and evaluate a standardized clinical pathway to facilitate safe discharge home at the earliest time after TAVI. These studies aimed to create clinical pathway protocols that supplement the TAVI procedure with the SAPIEN 3TM valve.4-6

Opportunities were first identified to adopt minimalist practices, standardizing post-procedure care, decreasing patients’ length of stay and facilitating safe discharge to home.4 An expanded multidisciplinary heart team designed a comprehensive TAVI clinical pathway that followed the patients’ journey from admission to discharge; the role of the multidisciplinary heart team is invaluable in implementing quality innovation that entails minimalist peri-procedure practices and facilitates early discharge home for patients with ssAS.4 The risk-stratified criteria that was identified informed the development of the multimodality, multidisciplinary but minimalist TAVR (3M TAVR) study.4,5

The barriers to implementing the TAVI clinical pathway were challenging and grounded in historical practices, the complexity and disciplines engaged in the care of TAVI patients, the adoption of length of stay as a programme quality indicator and the operational challenges of implementing peri-procedure practices.5 These barriers were addressed by an expanded multidisciplinary heart team approach that captured the patient’s journey from admission to discharge, in the form of a TAVI Care Team.

This multidisciplinary Care Team enabled communication and discussion of all operational and practice issues related to the clinical pathway initiative; identification of educational initiatives for members of the team; engagement and support of all multidisciplinary stakeholders, all of whom were focused and aligned on the adaptation of new processes, improved outcomes and reduced demand on health service resources; and implementation of practice changes involving the transition to minimalist care.

Consolidating TAVI organisational efficiencies, the results demonstrated that a minimalist, streamlined TAVI pathway with the Edwards Lifesciences SAPIEN 3TM valve, 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.5

This minimalist clinical pathway that utilised pre-specified risk criteria to allow a safe and timely discharge of patients with ssAS undergoing TAVI, was validated by the European FAST-TAVI trial in 2019. The trial found that the 30-day complication risk did not increase when pre-specified risk criteria was used.6   

                                                                                                                                   Figure from Wood et al. (2019)5

Partnering with industry

There are three key areas on which collaboration between Industry and hospitals might be based: evidence, tracking and technology. (Cogora, in-house data

There is a significant body of TAVI literature that illustrates pre-, peri- and post-procedure processes that positively impact on the safety and efficiency of partnering with Industry. However, these processes can vary from site-to-site and operator-to-operator. 

In Edwards Lifesciences, hospitals have a partner that has further consolidated these examples of best practice to create the Edwards BenchmarkTM Programme: an educational standardised care pathway (from admission to discharge) that optimises the TAVI clinical pathway with a programme designed to deliver good, reproducible patient outcomes and access, and improved institutional capacity driven by proven best practice.7


References

  1. Whooley S. Edwards’ Sapien 3 TAVI wins expanded approval in Europe. 2019. Available at: https://www.massdevice.com/edwards-sapien-3-tavi-wins-expanded-approval-in-europe/. Accessed April 2021.
  2. ESC. ESC Guidance for the Diagnosis and Management of CV Disease during the COVID-19 Pandemic. 2020. Available from: https://www.escardio.org/static_file/Escardio/Education-General/Topic%20pages/Covid-19/ESC%20Guidance%20Document/ESC-Guidance-COVID-19-Pandemic.pdf. Accessed April 2021.
  3. The Health Foundation. Elective care in England: Assessing the impact of Covid-19 and where next. 2020. Available at: https://www.health.org.uk/publications/long-reads/elective-care-in-england-assessing-the-impact-of-covid-19-and-where-next. Accessed April 2021.
  4. 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.
  5. 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.
  6. 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.
  7. Derk F, Insights into the Edwards Benchmark program, PCR London Valves 2019.

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