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Press Releases

Take a look at a selection of our recent media coverage:

‘Valve for Life’: tackling the deficit in transcatheter treatment of heart valve disease in the UK

10th August 2021

Impact of COVID-19 on TAVI and the management of patients with severe symptomatic aortic stenosis

Aortic stenosis and a backlog of care

COVID‐19 has had an unprecedented impact on the management of patients with aortic valve disease since non-urgent cardiovascular diagnostics and interventions were deferred.1–3 Delays in treatment are leading to a growing number of patients waiting for treatment with longer wait times.2,4 The consequences of such delays include death within the perioperative period and poor operative outcomes.1,4–7 It is estimated that as much as 50% of cancelled or delayed procedures may result in significant harm;6 therefore, delays in elective procedures to treat severe symptomatic aortic stenosis (ssAS) contribute to a hidden mortality rate of COVID-19.8 This is creating a wave of pressure on healthcare resources and personnel;4 reconsideration of these patients for transcatheter aortic valve implantation (TAVI) may help to prevent such complications as well as offering patient and organisational benefits1

Diverting ssAS patients to TAVI during COVID-19

COVID-19 has had a significant impact on therapeutic options for ssAS patients undergoing aortic valve replacement (AVR).3

During the pandemic, hospitals have initiated protocols that favour management options that minimise the use of (a) anaesthesiologists, (b) ventilators, (c) operating rooms, and (d) intensive care unit beds. While  surgical AVR (SAVR) require all these elements, TAVI does not1,6—using widely described ‘minimalist’ methodology.6,9–11 Guidelines for ssAS patients during the COVID-19 pandemic have, therefore, included the principle that patients who may have been accepted for sAVR could be ‘diverted’ to TAVI under the guidance of the Heart Team.1,2 SAVR has been the treatment choice in AS for decades, nevertheless, TAVI and especially TAVI with transfemoral access, has become a reliable and effective treatment option.1 This has formed a cornerstone of recommendations for TAVI practice during COVID-19.12

The adoption of a minimalist TAVI approach as the preferred default strategy is an imperative to promote access to care in the ‘new normal’ as COVID-19 continues to dictate the priorities of care.4 Perek et al. report that, from their hospital experience, in the years preceding the pandemic (2018 and 2019), approximately 50% of patients underwent SAVR; this rate dropped to 34% during COVID-19 (2020), demonstrating a shift in procedure from SAVR to minimally invasive TAVI.3 Alongside this shift, Joseph et al. report that there was a significant increase in the proportion of SAPIEN 3™ valves inserted (34 vs 68%, p = 0.001).12 During 2020, patients with AS were younger and had a lower calcification burden compared with pre-pandemic practice, making these patients more suitable for the SAPIEN 3™ valve, accounting for the increase in the use of the SAPIEN 3™ valve.12

Improved organisational and patient benefits of TAVI during COVID-19

COVID-19 cardiology guidelines were based on the accumulation of scientific evidence from clinical trials evidencing that minimally invasive TAVI is a safe and efficacious procedure with low complication rates, shorter length of hospital stay, reduced mortality and minimal stroke rate at 30 days, compared with SAVR.3,9–11 TAVI enables patients to rapidly derive significantly improved quantity and quality of life, regardless of surgical risk profile.2,4 From the patient’s standpoint, TAVI is preferable to SAVR, given shorter hospitalisation and consequent exposure of patients to COVID-19 in hospital and rehabilitation centers.8 This is also true from an organisational viewpoint, undoubtedly conserving resources relative to SAVR.8

Joseph et al. report that TAVI can be undertaken safely during the COVID-19 pandemic with 30-day event rates similar with published clinical trials and international registries.12 No statistically significant difference was noted in peri-procedural complications and 30-day outcomes, while post-operative length of stay was significantly reduced (2 vs 3 days, p < 0.0001) when compared with pre-COVID-19 practice.12

COVID-19 expedited a trend that is expected to continue

The rapid onset of halting referrals and procedures to create capacity to manage the COVID-19 pandemic will be followed by the resumption of access to care under drastically different circumstances, as the world emerges from the pandemic into a ‘new normal’.4 Addressing the escalating needs of patients with cardiovascular disease who are awaiting treatment presents the next challenge for healthcare systems across regions.4 Along with an understanding of the dynamic constraints on healthcare systems, minimalist TAVI can potentially help to further reduce post-care utilisation of resources and allow early patient recovery at home.5

The COVID-19 pandemic has acted as a catalyst for change in healthcare systems worldwide. Resulting adaptations ought to be perceived as opportunities for sustained change and not as temporary disruptions to an often empirically derived TAVI service framework.12 For patients with severe aortic stenosis, efforts to bring treatment to patients amid this pandemic might lead to favoured use of catheter-based management using minimalist techniques.6 As the pandemic abates, TAVI programmes cannot expect a ‘flipping of the switch’ back to pre-pandemic status.4 TAVI programmes must facilitate access to care without compromising patient safety, enable hospitals to manage the competing demands created by COVID-19 and establish new processes to support patients living with valvular heart disease.4

Cost remains a significant barrier to the widespread adoption of TAVI by publicly-funded services outside the pandemic setting; however, incorporating minimalist TAVI has the potential to further improve the cost-effectiveness of a TAVI service.12 There is a compelling need to facilitate the rapid adoption of best practices adapted to the unique demands created by COVID-19 and leverage existing evidence to minimise healthcare resources, facilitate accelerated treatment of AS without compromising patient safety and ensure that patients return home to enjoy the benefits that TAVI affords.4


References

  1. Harky A, Seyedzenouzi G, Sanghavi R, et al. COVID‐19 and its implications on patient selection for TAVI and SAVR: Are we heading into a new era? J Card Surg 2021;36:265-267.
  2. Khialani B, MacCarthy P. Transcatheter management of severe aortic stenosis during the COVID-19 pandemic. Heart 2020;106:1183-1190.
  3. Perek B, Olasinska-Wisniewska A, Misterski M, et al. How the COVID-19 pandemic changed treatment of severe aortic stenosis: a single cardiac center experience. J Thorac Dis 2021;13:906-917.
  4. Lauck S, Forman J, Borregaard B, et al. Facilitating transcatheter aortic valve implantation in the era of COVID-19: Recommendations for programmes. European Journal of Cardiovascular Nursing 2020;19:537-544.
  5. Basman C, Kliger CA, Pirelli L, et al. Management of elective aortic valve replacement over the long term in the era of COVID-19. European Journal of Cardio-Thoracic Surgery 2020;57:1029-1031.
  6. Mehta JJ, Patel J, Ayoub B, et al. Caution regarding potential changes in AVR practices during the COVID‐19 pandemic. J Card Surg 2020;35:1168-1169.
  7. Ro R, Khera S, Tang GHL, et al. Characteristics and Outcomes of Patients Deferred for Transcatheter Aortic Valve Replacement Because of COVID-19. JAMA Netw Open 2020;3:e2019801.
  8. Sundt TM. Managing Aortic Stenosis in the Age of COVID-19: Preparing for the Second Wave. JAMA Netw Open 2020;3:e2020368.
  9. Wood D. The Vancouver 3M (multidisciplinary, multimodality but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers. JACC: Cardiovascular Interventions 2019;12:459-69.
  10. Barbanti M, van Mourik MS, Spence MS, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention 2019;15:147-154.
  11. Lauck SB, Wood DA, Baumbusch J, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay. Circ Cardiovasc Qual Outcomes 2016;9:312-321.
  12. Joseph J, Kotronias RA, Estrin-Serlui T, et al. Safety and operational efficiency of restructuring and redeploying a transcatheter aortic valve replacement service during the COVID-19 pandemic: The Oxford experience. Cardiovascular Revascularization Medicine 2020:S1553838920307855.

For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

©2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2599 v1.0

EuroPCR highlights (18-20 May) Part 3: The Edwards Benchmark™ program

7th July 2021

This year, the annual meeting of EuroPCR was held as a 3-day digital event, supplemented with on-demand content. EuroPCR historically covers a diverse range of topics in interventional cardiovascular medicine.

There were many sessions dedicated to the evolving changes of transcatheter aortic valve implantation (TAVI). This third and final part of the report details the conference highlights on benefits of the Edwards Benchmark™ program, including improved patient outcomes, organisational efficiencies, and program implementation.

Discussions on optimising TAVI procedures, leading to patient and organisational benefits and resource conservation were perceived as a contemporary concern as the world emerges from the pandemic into a ‘new normal’ post-COVID-19.

EuroPCR: relevant sessions attended
Session type Session title Speakers
  Livestream   TAVI: contemporary indications and techniques   Didier Tchetche, Hendrik Treede, Lars Sondergaard
  & Helene Eltchaninoff
  Livestream   Optimise your TAVI patient’s outcomes:
  implementing the Edwards Benchmark program
  Simon Kennon, Olivier Darremont, Helene Eltchaninoff,
  Derk Frank & Sandra Lauck Francesco Saia
  On-demand   Improving patient outcomes with
  Edwards Benchmark program
  Helene Eltchaninoff

Edwards Benchmark™ Program

The Edwards Benchmark™ program was introduced by Prof. Helene Eltchaninoff, Dr Sandra Lauck, Dr Olivier Darremont and Dr Francesco Saia; it was described as a multidisciplinary team-based and patient-centred quality improvement program that revisits historical practice and matches contemporary patient care to current TAVI techniques that are based on up-to-date empirical evidence.

An effective, evidence-based program to improve communication and to improve patient’s trajectory of care

Sandra Lauck

The research basis for the Edwards Benchmark™ program focuses on the latest empirical evidence for minimalist TAVI
pathways.1-3 Looking at best practice across the patient trajectory is essentially the spirit of the Benchmark™ program: standardised program processes with increased efficiency, resulting in a minimalist pathway with maximum safety and improved patient outcomes.

Patient outcomes

When polled on what they believed the benefit of an optimised TAVI pathway to be, 70% of the EuroPCR attendees selected ‘superior patient outcomes’, and 53% selected ‘continuous access to care’. With only 3% selecting ‘unclear benefits’, it is apparent that most of the audience believed that there is some benefit derived from optimising the TAVI procedure pathway – both Dr Francesco Saia and Dr Derk Frank agreed with the audience, commenting that it is great to see that most of the attendees perceive some benefit to optimising the TAVI procedure pathway. In Kiel, Dr Derk Frank is managing to achieve some great results in regard to the mean length of stay, since this has been reduced from 10 to 5 days through standardisation of the TAVI procedure.

Additionally, Dr Sandra Lauck described improved quality-of-life of TAVI was demonstrated from the 3M TAVI study, which took place from 2014 to 2017.1 With most patients deriving significant quality-of-life benefits by Week 2, this offered reassurance that next-day discharge home was well tolerated.

In Vancouver, Dr Sandra Lauck and team are achieving excellent procedural outcomes, 1 which are rounded to form three objectives of the Edwards Benchmark™ program,

  • 80% Next-day discharge
  • 1.5% 30-day major vascular complication
  • 6% 30-day new pacemaker

with the other three coming from the FAST-TAVI trial: 3

  • 1% 30-day mortality
  • 1% 30-day stroke
  • 4% 30-day cardiovascular readmission

Organisational benefits

Current variability in hospital length of stay is an opportunity to apply measures that will allow for quicker discharge. Early discharge decreases the overall cost of hospital stay/patient. The Edwards Benchmark™ program provides opportunities to implement measures for optimisation and resource conservation pre-, peri- and post-procedure. This can include shortening and simplifying each of the procedure steps and using protocols to avoid delays in discharge.

Edwards Benchmark™ program results from France and Germany

Germany (Derk Frank):
  • German mean length of stay is 10 days
  • Post implementing the Benchmark™ programme total length of stay reduced from 9 to 6 days
  • No reported safety complications
  • Numerically impressive differences in outcomes between conventional TAVI and Benchmark™ TAVI (3.4% to 0.9%)
France (Olivier Darremont):
  • In 2020, TAVI procedures numbered 452, back in 2017, this was 194
  • Length of stay was 5.3 days in 2020, and 7 days in 2017
  • Between Dec 2020 and Mar 2021:
    • 30-day mortality: 0%
    • 30-day stroke: 2.4%
    • Pacemaker implantation: 2.3%
    • Vascular bleeding 2.3%
    • Overall readmission: 9.3%
  • In 2021, length of stay is 4.2 days

In Germany, we recognised the need for a streamlined TAVI program with timely and safe discharge

Derk Frank

Barriers to Edwards Benchmark™ programme implementation

When polled, 43% of the audience identified ‘administration buy-in’ as the biggest barrier to implementing a TAVI efficiency program, such as the Edwards Benchmark™ program. This was closely followed by ‘additional capacity’, ‘TAVI coordinator’ and ‘discharge destination’, all ≥30%.

Prof. Helene Eltchaninoff was intrigued by these results since hospital reimbursement for TAVI is based on patients’ length of stay. She recognises that there is a loss of reimbursement with early discharge, but there are stronger medical reasons to discharge early. Reduced hospitalisation equates to increased TAVI procedures, and Dr Francesco Saia added that in the wake of the pandemic, there is a strong need to increase optimisation, organisational efficiencies, and the number of procedures to reduce waiting lists and a backlog of care. Reimbursement, however, may be an issue in other organisations.

Facilitator Simon Kennon added, that in the UK, he does not believe administration buy-in to be a problem, but rather healthcare professional buy-in. He was very interested how this reflects multi-regional differences in healthcare systems.

Loss of reimbursement is trivial compared with increased capacity

Helene Elchaninoff

Ongoing studies

Dr Derk Frank had the opportunity to present the Edwards Benchmark™ Registry: an ongoing study to reduce hospital length of stay in patients undergoing TAVI and reducing the need for ICU resources. This study is taking place over 30 sites with the aim to recruit 2400 patients, 1500 of which will be prospective.

Looking ahead

It is very apparent that TAVI has come a long way since the first successful attempt in 2002.1 As EuroPCR 2021 draws to a close for another year, it is evident where we might expect the research and evolution of TAVI to continue in 2021: honing the patient selection criteria for TAVI to, as Dr Sandra Lauck described, get it right for every patient, first time.

Perhaps more importantly, as the world emerges from the pandemic into a ‘new normal’, there will be an expectation of improved organisational efficiencies to get through a backlog of care: TAVI is a procedure that is minimally invasive and whose pathway has been optimised and streamlined to deliver excellent patient outcomes and confer organisational benefits.


References

  1. Lauck SB, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway. Minimalist Approach, Standardised Care, and Discharge Criteria to Reduce Length of StayCirc Cardiovasc Qual Outcomes 2016;9:312–21.  
  2. 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. 
  3. 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

©2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2511 v1.0

EuroPCR highlights (18-20 May) Part 2: Optimising the TAVI procedure

This year, the annual meeting of EuroPCR was held as a 3-day digital event, supplemented with on-demand content. EuroPCR historically covers a diverse range of topics in interventional cardiovascular medicine.

There were many sessions dedicated to the evolving changes of transcatheter aortic valve implantation (TAVI). This second part of the report details conference highlights on optimising the TAVI procedure with a focus on pathway optimisation, early discharge, and the importance of the TAVI coordinator.

EuroPCR: relevant sessions attended
Session type Session title Speakers
  Livestream   TAVI: contemporary indications and techniques   Didier Tchetche, Hendrik Treede, Lars Sondergaard
  & Helene Eltchaninoff
  On-demand   Re-framing optimal implantation of the SAPIEN 3
  valve in TAVI
  Jonathan Mailey
  Poster: POS341   Predictors of early discharge after TAVR   Marco Angelillis, et al.

Objectives of TAVI optimisation

Dr Derk Frank, Dr Francesco Saia, and Dr Sandra Lauck outlined why optimising the TAVI procedure is needed, including new challenges presented with COVID-19, increased TAVI workload with an all-risk indication, and untreated patients. As the world emerges from the pandemic, optimising resources and increasing hospital capacity will become the biggest challenges according to Dr Francesco Saia. While Dr Sandra Lauck believes that the goals in contemporary TAVI should include a predictable patient trajectory of care, excellent patient outcomes and efficient and scalable processes of care.

Expectation in 2021: Getting it right, for every patient, at every touch point, every time

Sandra Lauck

TAVI pathway optimisation

Since the first TAVI procedure in 2002,1 it has been simplified, and contemporary TAVI is based on a minimalist pathway with maximum safety, leading to improved patient outcomes.2-4

With TAVI expanding into the low-risk patient cohort, the population available to undergo TAVI is growing. For many organisations, this will require optimisation of the procedure pathway to accommodate the increasing number needed to be treated. There is a need to streamline patient management to treat more patients without compromising patient safety.

In Dr Francesco Saia’s experience, protocols help to prepare the patient before they arrive at the hospital. These protocols allow for safe transfer to the ward and a continuity of care. The use of protocols allows for standardisation and there exists protocols for every step along the patient’s trajectory of care: from entry to discharge. Deviation from the pathway should be limited and discussed with the heart team.
Key features of minimalist TAVI:
  • Use of protocols and standardisation of processes
  • Transfemoral access
  • Local anaesthesia
  • Minimally invasive
  • No ICU admission > admit direct to ward
  • Immediate removal of pacing

Minimalist TAVI is maximal planning

Francesco Saia

Early discharge

Dr Sandra Lauck, Dr Francesco Saia and Dr Olivier Darremont discussed how early discharge contributes to optimisation of the TAVI procedure, conserving resources and delivering improved patient outcomes. With an expected backlog of care and delays to treatment as the pandemic abates, reducing the length of stay is mandatory to increase capacity and allow the possibility of treating more patients. Fast-track 24h protocols make use of risk criteria for early discharge to limit unexpected complications. Early mobilisation post-procedure contributes to early discharge, and the MobiTAVI5 trial has demonstrated the feasibility, safety and efficacy of early discharge, with early mobilisation, conferring additional organisational and patient benefits.

The MobiTAVI trial:3
  • Immobilisation post-TAVI may prevent post-operative complications such as delirium and infection
  • Early ambulation after transfemoral TAVI was investigated
  • 150 patients from 2016 to 2018 were prospectively assessed
  • Time to mobilisation in the early group was 4h49 ± 31 min vs in the regular group 20h7 ± 3h6
  • No major vascular complications occurred and minor complications were similar
  • Numerically lower incidence for all outcomes were reported in the early group
  • Early ambulation 4-6h post-TAVI is feasible and safe
    • Early ambulation decreases the combined incidence of delirium, infections, pain and unplanned catheter use

Dr Marco Angelillis, et al. presented a poster on the predictors of early discharge in TAVI. Patients were categorised as either fast track (<3 days) or slow track (>3 days) based on length of stay. Patients whose length of stay was >3 days were analysed for possible predictors of increased length of stay, including procedural complications or clinical and electrographic characteristics. New onset or worsening of conduction disturbances and major or life-threatening bleeding were independently associated with increased length of stay (>3 days). Therefore, it was concluded that only patients with bleeding complications or major conduction disturbance should be monitored >48h. Early discharge of <3 days did not adversely affect 30-day safety patient outcomes.

With TAVI moving into the low-risk patient indications, empirical evidence shows 80% of patients early discharged (<3 days) to home, and that early discharge is both feasible and safe across all-risk patients; however, the goal should not be day-1 discharge but rather early discharge based on patient status, according to Prof. Helene Eltchaninoff.

Role of the TAVI coordinator

The TAVI coordinator has been described as the cornerstone for a successful TAVI program. Sandra Lauck explained how the TAVI program coordinator is responsible for coordination with all relevant parties to achieve improved patient outcomes. Derk Frank expanded that this provides a seamless continuation of care. The program coordinator is pivotal in ensuring that healthcare professionals along the patient’s trajectory are aligned on the objectives of care.

The pivotal responsibilities of a TAVI coordinator include leading the program, facilitating patient-focused processes and improving communication. Dr Derk Frank emphasised the importance of the TAVI coordinator by highlighting how the immediate impact can be measured when their TAVI coordinator is on annual leave: in these instances, the mean length of stay increases by 1 day. He described that it is ideal to have 1 coordinator per 100 TAVI procedures performed/year.

Responsibilities of the TAVI coordinator:
  • Coordinates the program
  • Facilitates patient-focused processes of care
  • Fosters communication among heart team members
  • Provides expertise in cardiovascular and geriatric care
  • Clinical assessment skills
  • Patient, family and staff education

Role of the TAVI coordinator has become an essential indicator of TAVI programs across multiple regions

Sandra Lauck

Looking ahead

As the world emerges from the pandemic into a ‘new normal’, there will be an expectation of improved organisational efficiencies to get through a backlog of care: TAVI is a procedure that is minimally invasive and whose pathway has been optimised and streamlined to deliver excellent patient outcomes and confer organisational benefits.

Read the third part of this report here.


References

1. Cribier A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case descriptionCirculation 2002;106:3006–3008. 

2. Lauck SB, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway. Minimalist Approach, Standardised Care, and Discharge Criteria to Reduce Length of StayCirc Cardiovasc Qual Outcomes 2016;9:312–21.  

3. 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. 

4. 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

5. Vendrik J, et al. Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial. Neth Heart J 2020;28:240-8

For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable) Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.


 [MP1]Added

© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2467 v1.0

EuroPCR highlights Part 1: Evolving eligible patient population for TAVI (18-20 May 2021)

This year, the annual meeting of EuroPCR was held as a 3-day digital event, supplemented with on-demand content. EuroPCR historically covers a diverse range of topics in interventional cardiovascular medicine.

There were many sessions dedicated to the evolving changes of transcatheter aortic valve implantation (TAVI). This first part of the report details conference highlights on the evolving eligible aortic stenosis patient populations for TAVI such as young, low-risk patients and bicuspid aortic stenosis, along with contemporary challenges.

EuroPCR: relevant sessions attended
Session type Session title Speakers
  Livestream   TAVI in bicuspid aortic valve   Bernard Prendergast, Simon Redwood,
  Darren Mylotte & Raj Makkar
  Livestream   TAVI in bicuspid aortic valve patients, SAPIEN 3™
  platform, a safe and efficient option
  Radoslaw Parma, Didier Tchetche, Jörg Kempfert &
  Christoph Klein
  Livestream   TAVI: contemporary indications and techniques   Didier Tchetche, Hendrik Treede, Lars Sondergaard &
  Helene Eltchaninoff
  On-demand   TAVI for bicuspid aortic valve stenosis in
  low surgical risk population
  Raj Makkar
  Poster: POS295   Five-year results of balloon-expandable TAVI   Olaf Wendler, et al.

Patient selection

Discussions on appropriate patient selection for TAVI took place with Dr Hendrik Treede, Dr Didier Tchetche, and Prof. Lars Sondergaard. As TAVI is now approved for all-age patients, regardless of the surgical risk profile, categorising patients by surgical risk category may be an outdated process, according to Dr Didier Tchetche. It is far more important to categorise patients based on age, comorbidities, life expectancy, valve anatomy and extent of calcification. Dr Hendrik Treede agreed, adding that, after good results in low-risk trials, even age for TAVI may not be a factor. There is no defined age cut-off for TAVI vs surgical aortic valve replacement (SAVR), but a ‘cut-off’ around 65 years of age might be considered based on life expectancy and valve durability.

The definition of acceptable outcomes has changed based on increased life expectancy

Nicolas Dumonteil

Valve durability

Dr Didier Tchetche explained that most experts agree on a cut-off age of 65 years because of valve durability concerns. With TAVI indications expanding into the low-risk surgical patient population, valve durability becomes one of the biggest contemporary challenges. The younger patient cohort along with increased life expectancy means that patients are expected to outlive their device, and some structural valve deterioration is expected. However, there is a paucity of long-term data on outcomes.

5-year outcomes from the SOURCE 3 registry were reported by Prof. Olaf Wendler, et al. The SOURCE 3 registry included 1947 patients from 80 centres in 10 countries, enrolled between July 2014 and October 2015, who underwent TAVI with the SAPIEN 3™ valve.¹ The results showed that over time, non-cardiovascular causes of deaths increased in the elderly cohort of patients with an infrequent need for re-intervention: only 22 re-interventions were needed. Looking at the 5-year outcomes, it was concluded that the SAPIEN 3 device provides a safe and effective treatment for patients with severe, symptomatic aortic stenosis.

TAVI for bicuspid aortic valve

TAVI for bicuspid valve aortic stenosis was a hot topic at this year’s EuroPCR – with the evolution of TAVI into these patients who have previously been excluded from clinical trials based on their anatomy. Bicuspid aortic valve discussions were held with Prof. Bernard Prendergast, Prof. Simon Redwood, Dr Darren Mylotte, Dr Raj Makkar, Dr Didier Tchetche, and Dr Jörg Kempfert.

Bicuspid aortic valve disease is the most common congenital heart disorder in adults, affecting 1-2% of the population, and can be complicated by aortic stenosis. Traditionally, SAVR has been the treatment of choice for symptomatic bicuspid aortic stenosis because of their challenging anatomy: up to 50% of patients undergoing SAVR for AS have bicuspid valves.1 Patients with bicuspid aortic valves are frequently observed in younger patients who undergo SAVR; it has been reported that as many as 41.7% of those who are 70 years of age who undergo SAVR have a bicuspid aortic valve.1 As TAVI expands into the intermediate- and low-risk patient cohorts, this has critical implications for TAVI and valve anatomy.1

In such patients, the heart team conduct a thorough assessment, and the patient’s age, severity and distribution of calcification and surgical risk are key factors in the decision-making process.

It is now believed that TAVI is a reasonable alternative to surgery in carefully selected low-risk bicuspid aortic stenosis patients

Raj Makkar

Dr Raj Makkar presented registry results that examined outcomes of TAVI in bicuspid valvular aortic stenosis.³ 160,000 low-risk patients underwent TAVI with SAPIEN 3™ and SAPIEN 3 Ultra™ valves: of these, 3,243 had bicuspid valves with a mean age of 69 years. Procedural and in-hospital outcomes were reported to be excellent with all-cause mortality reported as 0.6% vs 0.4% in bicuspid and tricuspid valves, respectively. The primary endpoint of stroke was 1.1% vs 0.9% in bicuspid and tricuspid valves, respectively. Despite concerns that surround the use of TAVI in bicuspid anatomy, procedural success rate was high and intraprocedural complications were low. The rates of death and/or stroke at 30 days and 1 year were found to be favourable in low surgical risk patients undergoing TAVI for bicuspid aortic stenosis and similar to tricuspid aortic stenosis. These results suggest that TAVI may be a reasonable treatment option in carefully selected patients with bicuspid aortic stenosis who are of low surgical risk.

Looking ahead

It is very apparent that TAVI has come a long way since the first successful attempt in 2002. As EuroPCR 2021 draws to a close for another year, it is evident where we might expect the research and evolution of TAVI to continue in 2021: honing the patient selection criteria for TAVI to, as Dr Sandra Lauck described, get it right for every patient, first time. Long-awaited long-term data on valve durability is highly anticipated and will guide TAVI treatment decisions and finally, following such promising early results, there is an expectation of more research with promising outcomes in performing TAVI in a before-now excluded patient group for TAVI: the bicuspid aortic stenosis patient.

Read the second part of this report here.


References

  1. Wendler O, et al. SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve. Circulation 2017, 135(12), 1123–1132.
  2. Makkar R, et al. Transcatheter aortic valve replacement for bicuspid aortic stenosis: are we ready for the challenge? JACC 2016;68:1206-8.
  3. Edwards Lifesciences (2021, May 18). Real-World Data Confirm Excellent Results For Bicuspid Patients Treated With Edwards SAPIEN 3 TAVR [Press release]. https://www.edwards.com/ch-en/news-releases/real-world-data-confirm-excellent-results-for-bicuspid-patients-treated-with-edwards-sapien-3-tavr/

For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable). Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2467 v1.0

Transcatheter aortic valve implantation efficiency programs: Optimised TAVI pathways

2nd July 2021

Rapid expansion in the use of TAVI has led to continuing improvements in techniques and clinical outcomes, but this has also presented a new problem: treating a larger cohort of patients in a more efficient way with shorter procedures and shorter hospital stays, while maintaining excellent outcomes.1 Minimalist TAVI approaches have been shown to have distinct advantages without compromising patient safety.2-4 Consequently, there is an increasing need to simplify the TAVI procedure, and practice recommendations have been adopted to support the patient’s journey from referral to discharge.1

An optimised TAVI pathway embodies efficient patient screening, a minimalist peri-procedure approach and early discharge – eliminating complication risks and without compromising patient outcomes.1

Establishing a multidisciplinary heart team 

International guidelines recommend establishing a multidisciplinary heart team to screen patients for TAVI;5 this collaborative process has been deemed essential in establishing a successful TAVI efficiency programme.6,7 The heart team fosters collaboration across medical specialities to offer optimal patient-centered care,8 and has been shown to improve outcomes in TAVI procedures, making use of diverse competencies. The heart team guides patient selection, optimises patients’ pre-procedure status, facilitates early discharge and provides continuity of care.6,7

The multidisciplinary team includes any of interventional cardiologists, cardiothoracic surgeons, imaging specialists, nurses, anaesthesiologists, occupational therapists, social workers, and administrative staff.6-8 A key team member is the clinician who leads the coordination and streamlining of the TAVI programme, facilitating patient-focused processes of care for both out- and in-patient settings, and fostering communication: the TAVI co-ordinator.6,9

Members of the heart team work collaboratively and should be co-located at heart valve centres: centres of excellence for diagnostics and treatment of valvular heart disease.10 Many centres of excellence that have implemented a TAVI efficiency programme include dedicated TAVI teams that incorporate the concept of the heart team.2 These TAVI teams will have expertise in TAVI along with basic peripheral vascular intervention skills.6

Peri- and post-procedure

A TAVI efficiency programme focuses on avoiding inessential treatment steps and minimising human resource needs during the procedure.1 Transfemoral TAVI is used in >90% of cases,1 and maximising transfemoral access is important when trying to maximally exploit the benefits of a minimalist TAVI approach.1-3

Priorities of post-procedure care include vigilant monitoring of recovery, facilitating the rapid return of patients to baseline status and preventing complications.3,4 Discharge inside of 72h has been reported in >70% of patients when a minimalist TAVI approach has been adopted.3,4 Adequate patient follow-up ensures comprehensive patient management and decreased complication rates.3 It has been reported that early ambulation (6h post-procedure) results in early discharge, which helps to ensure adequate turnover of uncomplicated patients.1

Optimised TAVI pathways: Partnering with Industry

While TAVI has been found to have higher procedural costs compared with SAVR, driven primarily by the costs associated with the valve, this is offset by a decrease in healthcare resource utilisation. The overall costs (initial procedure and hospitalisation) have been reported to be lower for TAVI than for SAVR: this makes TAVI dominant compared with SAVR from a health economic perspective.11

As such, metrics for a TAVI efficiency programme encompass patients’ quality of life, clinical outcomes, length of stay, resource utilisation, and cost-effectiveness.6,7 TAVI efficiency leads to reduced procedural time, shorter ICU and hospital stay, lower resource use and hospital costs, and increased volume of TAVI procedures – conferring an overall cost-saving for TAVI compared with SAVR.1,11

When it comes to TAVI efficiency programmes, it is suggested that stakeholders collaboratively devise a plan for evaluating the success and sustainability of the programme,6,8 since inefficiencies, practice variation and imprecise decisions in Heart Teams are inevitable. Several heart centres around the world have high volume TAVI workloads and provide training and subsequent proctoring services.12 One such service is the Edwards Benchmark ProgramTM, provided by Edwards Lifesciences.

The Edwards Benchmark ProgramTM consolidates clinical best practices into an educational transformation pathway for hospitals and adopts the minimalist TAVI pathway to improve patient outcomes and access to TAVI procedures.13 The Benchmark program™ is a standardised care pathway to achieve consistently excellent outcomes; it is a reproducible and scalable programme designed to optimise the patient pathway from admission to discharge.13

Objectives of the Benchmark ProgramTM include <1% 30-day mortality and stroke, >80% next-day discharge home and <4% 30-day cardiovascular readmissions.13 Many European centres have been successfully enrolled into the Benchmark Program™, with consistent reduction in average length of stay and increases in the number of TAVI cases performed per day.13 As evidence-based practice becomes increasingly important, the Edwards Benchmark ProgramTM will help to make the patient journey from referral to discharge more efficient and more importantly, confer cost-savings to organisations by reducing healthcare resource utilisation.


References:

  1. Tchetche D, et al. How to make the TAVI pathway more efficient. Interv Cardiol 2019;14:31–33. 
  2. Lauck SB, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway. Minimalist Approach, Standardised Care, and Discharge Criteria to Reduce Length of StayCirc Cardiovasc Qual Outcomes 2016;9:312–21.  
  3. 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. 
  4. 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. 
  5. ESC/EACTS guidelines. European Heart Journal 2017;38:2739-91.
  6. Hawkey MC, et al. Transcatheter aortic valve replacement program development: recommendations for best practice. Catheterization and Cardiovascular Interventions 2014;84:859–67.
  7. 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.
  8. 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.
  9. Derk Frank, Insights into the Edwards Benchmark program, PCR London Valves 2019. 
  10. ESC. TAVI 2018: from guidelines to practice. Available from: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-15/TAVI-2018-from-guidelines-to-practice. Accessed April 2021.
  11. Zhou J, et al. Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population. 2019;139:877-88.
  12. Vallely MP, et al. How to set up a successful TAVI program 2012; doi: 10.3978/j.issn.2225-319X.2012.06.04.

Facilitating transcatheter aortic valve implantation in the era of COVID-19: Recommendations for programmes

30th June 2021

Watch how a UK IC and General Manager manage aortic stenosis patients in the Covid-19 age

2nd June 2021

Watch Prof. Anthony Mathur from Barts Health NHS Trust and Sophie Nicholls from Bristol Heart Institute share their experiences with TAVI from different perspectives.

The cost-effectiveness of TAVR in low surgical risk patients with severe aortic stenosis

Watch how the Frankfurt team has benefitted from TAVI during these unprecedented times

PD Dr. Mariuca Vasa-Nicotera and Maria Zisiopoulou from University Hospital FrankfurtGermany, explore their experiences on the benefits of TAVI for their hospital during these unprecedented times.