This website is intended for healthcare professionals only.

Newsletter          
Hospital Healthcare Europe
HOPE LOGO
Hospital Healthcare Europe

EuroPCR 2022 highlights

EuroPCR 2022 Report

For many, EuroPCR 2022 marked the return of face-to-face learning and discussions with peers from across the globe. Many interactive sessions were held across the week in May, with excellent presentations from top-class clinicians. This report summarises some key sessions on transcatheter aortic valve implantation (TAVI), valve-in-valve (ViV) interventions and optimisation of such procedures.

Key sessions

Valve-in-valve: the journey starts with the first prosthesis

  • To understand the impact of valve-in-valve interventions on lifetime management

  • To learn about clinical considerations and the procedural technique of TAVI-in-TAVI procedures

  • To appreciate the potential pitfalls of such procedures and how to mitigate them

Emerging indications for TAVI

  • To discuss remaining uncertainties in the diagnosis and management of aortic valve disease

  • To appreciate available and building evidence for patients with asymptomatic severe aortic stenosis (AS) and symptomatic moderate AS

  • To understand challenges and options for interventional treatment of pure native aortic regurgitation

Learnings from an optimised TAVI patient’s journey

  • To understand best practices related to referral and in-hospital patient pathways

  • To discover how an optimised TAVI care pathway offers excellent clinical safety and quality of life and leads to healthcare economics benefits

  • To learn how and which TAVI procedural aspects can be optimised for the greater good of the patient and the healthcare system

1. Valve-in-valve: the journey starts with the first prosthesis

Key takeaways

  • Occlusion of the coronary arteries is a risk of valve-in-valve (ViV) that must be mitigated by thorough procedural planning, with the first transcatheter heart valve (THV) having a large influence

  • For patients with longer life expectancy, the implantation of a second TAVI should be included in the planning of the first TAVI implementation

  • ViV procedure volumes are expected to grow in the future as we will see patients implanted with first generation bioprosthesis returning

Valve-in-valve: what does it mean for lifetime management?

The first talk of the session was from Dr. Radoslaw Parma (Interventional Cardiologist, Medical University of Silesia). 

A recent report from the German Heart Surgery Registry showed that the number of mechanical prostheses has reduced considerably over the last decade, and a shift towards biological implantation has been seen.1 Dr. Parma explained this is likely due to increasing comorbidities in patients, resulting in contraindications to anticoagulants, and further predicts that, in the majority of countries, the number of TAVI procedures will soon exceed those of surgical aortic valve replacement (SAVR).

From 2011 to 2019 there was a large change in the surgical risk scores for patients receiving TAVI, moving from higher/intermediate risk to low-risk patients.2 In low-risk patients receiving TAVI, there is a high chance of needing ViV TAVI in the future. ViV TAVI demonstrated better early outcomes, including reduced 30-day mortality, risk of bleeding, and hospital length of stay.3 On this basis, Dr. Parma suggested that the future for primary SAVR patients may be TAVI-in-SAVR instead of reoperation, meaning consideration of the initial valve type and its failure, in regard to the patient’s anatomy, is key.

Finally, Dr. Parma discussed the difficulties of future coronary artery disease (CAD) in younger, low-risk patients. The SOURCE 3 registry showed that >3% of patients required intervention due to CAD following TAVI; for most, successful coronary angiography was achieved, however successful percutaneous coronary intervention (PCI) was sometimes inhibited.4 5

TAVI-in-TAVI: What is important?

Prof. Giuseppe Tarantini (Interventional Cardiologist, University of Padua) was the next to speak in this session on reintervention for high-, intermediate-, and low-risk patients. 

High/intermediate/low risk (>75 years old) High/intermediate risk (<75 years old) Low risk (<75 years old)
Life expectancy following SAVR 5.7-8.2 years 6 5.6-8.4 years 6 12.5-16.2 years 6,7

In 80-year-old patients, TAVI explantation has 30-day and 1-year mortality risk of 12.3% and 20.8%, respectively.9 While in 72-year-old patients, TAVI explantation has 30-day and 1-day mortality risk of 13.1% and 28.5%, respectively.10 

Prof. Tarantini went on to explain the importance of THV orientation and commissural alignment in regard to patient’s anatomy. Without needing any commissural alignment, the SAPIEN 3 valve achieved 95% of selective coronary access, whereas it was 71% for aligned supra-annular THVs and 46% for misaligned supra-annular THVs (P<0.001).11

Prof. Tarantini identified four factors to consider for coronary obstruction in redo-TAVI:

  • Risk plane

  • Valve to aorta (VTA) distance

  • Sinus sequestration

  • Commissural alignment

To finish the session, Prof. Christian Hengstenberg (Interventional Cardiologist, Medical University of Vienna) showed a case presentation of a TAVI-in-TAVI in his hospital. This Live-in-a-box case illustrated the concepts described by the Faculty (thorough planning including maintaining access to coronaries): a SAPIEN 3 valve was successfully implanted into another SAPIEN 3 valve, with frame alignment, decreasing the mean gradient from 44 mmHg to 8 mmHg without any complications.

2. Emerging indications for TAVI

Key takeaways

  • Aortic stenosis (AS) is a disease continuum and can be classified by many forms and degrees

  • Grading AS patients by extent of cardiac damage (e.g., left ventricular damage), instead of mild, moderate and severe may be a more objective way to classify patients

  • There are also intervention options for pure AR, despite being a challenging patient population

Aortic valve stenosis of uncertain severity

Prof. Lars Sondergaard (Consultant Cardiologist, Rigshospitalet) began the first session, presenting a symptomatic case of a 79-year-old female showing very borderline severe AS on several diagnostic tests, including echocardiography, invasive coronary angiography, and computed tomography (CT). 

The key takeaway from this case was the importance of diligently assessing the patient baseline characteristics and perform a fully comprehensive assessment. Even with borderline grade (moderate to severe AS) anatomy, it is important to consider that the patient is highly symptomatic so relieving this should be a priority when deciding to intervene. 

Truly asymptomatic severe AS

Next, Dr. Philippe Généreux (Interventional Cardiologist, Morristown Medical Centre) presented a case of a 78-year-old male with clear severe AS and suitable anatomy for both TAVI and SAVR, including a highly calcified tricuspid valve; yet he was asymptomatic. 

Dr. Généreux estimated that there was a 20 – 30% chance of this patient needing intervention within a year and a low risk of sudden death yet suggested that early intervention before onset of symptoms can prevent mortality and left ventricle (LV) dysfunction. The panel consensus was that patient preference is key here; CT scan should be performed early to ascertain the complexity of the intervention to ensure both efficacy and safety.

Symptomatic moderate AS

Dr. Nicole Karam (Interventional Cardiologist, Hôpital Européen Georges-Pompidou) presented a case of an 85-year-old male who has moderate AS, but is highly symptomatic.

Dr. Généreux explained a new method to classify patients with AS. In addition to grading by mild, moderate, and severe, this can be done by extent of cardiac damage.12 These included Stage 1 with LV damage, up to Stage 4 with right ventricular (RV) damage; these stages were seen to correlate with risk of mortality.12 

When comparing this stage system with the traditional grades, Dr Généreux emphasised that there are two interesting categories of patients:

  • Severe AS who classed as stage 0 (no cardiac damage)

  • Moderate AS who classed as stage 0 up to stage 4

Dr. Généreux suggested this may be a more objective way to classify patients and to alleviate the need to specify symptoms. So, in the future it may be stage of cardiac damage that could be incorporated into future recommendations for risk stratification.

There are number of ongoing randomised control trials assessing the efficacy of TAVI with the SAPIEN 3 valve for the aforementioned controversial patient cohorts. These include the Early TAVR trial focusing on asymptomatic patients with severe calcified AS, as well as the TAVR Unload trial and PROGRESS trial focusing on moderate AS patients.13–15

Anatomical and procedural challenges of patients with pure native aortic regurgitation

Dr. Nicolo Piazza (Interventional Cardiologist, McGill University Health Centre) presented the next session on aortic regurgitation (AR). AR is morphologically classified by 2 mechanisms (1) abnormal motion of the leaflets that are prolapsing or retracted, and (2) enlarged aortic root or ascending aorta.16 

Around 1 in 10 patients with any valvular heart disease has some severity of AR.17 For TAVI, the most common aetiologies are degenerative (50%), rheumatic (15%), and congenital (15%), whereas the most common indications were degenerative (63%), post-endocarditis (8%), and aortic aneurysm (11%).17,18

Dr. Piazza went on to explain that the challenges in performing TAVI for pure AR can lie with the patient, the device or the operator. 

Patient Device Operator
  • Lack of calcification
  • Dynamic annulus
  • High stroke volume
  • Many non-dedicated devices
  • Poor visualisation
  • Little experience

The little experience from the operator comes from a very low number of TAVIs being performed for AR. An average of only ~8 cases per centre per year were performed; even in centres performing >1000 TAVIs each year, a maximum of 17 TAVIs for pure AR was reported.18 

3. Learnings from an optimised TAVI patient’s journey

Key takeaways

  • Severe aortic stenosis (AS) prevalence is increasing, with many patients remaining undiagnosed or untreated

  • Delays in the patient pathway have a strong impact on morbidity and mortality

  • It is key that the Heart Team recommendation is discussed with the patient who can then make an informed decision

  • A streamlined evidence-based TAVI pathway, such as the Edwards Benchmark program, can provide excellent safety outcomes and conserved hospital resources, enabling more patients to access high-quality care

Today’s challenges

Dr. Mick Ozkor (Interventional Cardiologist, Barts Heart Centre) began the session by presenting data showing that, of 10,795 patients, 57% had an indication or potential indication for AVR, of whom only 48% received an AVR.19 The consequence of this delayed referral is increased mortality rates, particularly in those patients with impaired ejection fraction.19 Even if patients are referred, prolonged waiting time is associated with increased mortality.20

Refer better, treat faster

The UK performs significantly lower numbers of TAVI procedures compared with other European countries, likely due to commissioning constraints and significantly fewer implanting centres.21 This under-provision has resulted in geographical inequity, which, in turn, causes waiting times as long as 20 weeks from time of referral.21

In this section, Dr. Joanne Shannon (General Cardiologist, Frimley Park Hospital) discussed how she has optimised the TAVI pathway in her hospital.

Compared to the national median time from referral to TAVI of 20 weeks, Frimley Park referral time was 12 weeks as a result of this optimised pathway. Dr. Shannon suggested further improvements of:

  • Better access to CT imaging

  • Better access to catheter lab slots for angiography/PCI

  • Daily triaging of referrals

  • Weekly telephone reviews of all patients on the waiting list to pre-empt and initiate change in priority status

  • Regular meetings between local TAVI nurse and surgical centre TAVI coordinator

  • Better access to surgeons

  • Attendance of implanting cardiologists at all Heart Team meetings, where possible

  • Increasing catheter lab capacity or expand to non-surgical centres

Patient’s informed decision and expected outcomes

Prof. Eric Durand (Interventional Cardiologist, University Hospital of Rouen) explained that making an informed decision with a patient must include the clinical, anatomical, and procedural information as well as the life expectancy and relative risk of the procedure. The panel concluded that, for borderline patients, discussions should be with both an interventional cardiologist and a surgeon.

Key practices for optimisation – Kiel Centre’s experience 

This session went through the best practices associated with the Edwards Benchmark program. This includes some very important steps:

  • Structured screening programme

  • TAVI coordinator 

  • Minimalist TAVI practices, local anaesthesia

  • Early mobilisation

The ambitious safety goals include 30-day rates of 1% mortality, 1% stroke, 6% permanent pacemaker, 4% cardiac readmissions and 1% major vascular complications, as well as 80% next day discharge.22–24

Optimised peri- and post-TAVI procedural steps – Charité Centre’s experience

Prof. Henryk Dreger (Interventional Cardiologist, Charité Universitätsmedizin Berlin) went on to explain key pre-, peri-, and post-procedural steps which optimise TAVI in 2022. 

Pre-procedure Peri-procedure Post-procedure
  • Structured screening process
  • Multidisciplinary team (MDT) incorporates patient preference
  • Inclusion of patient, family and referring physician
  • TAVI coordinator
  • TTE only
  • Peripheral venous access
  • Local anaesthesia and conscious sedation
  • Ultrasound guided access
  • Pacing over the wire
  • Early nurse-led mobilisation
  • Consistent management of conduction disorders
  • Early mobilisation
  • Early discharge
  • 1 day on IMC

Prof. Dreger finished by presenting research supporting the safety of early discharge in France, Italy, the Netherlands, UK, and North America.22,25,26 In France, multicentre studies demonstrated lower or similar all-cause mortality post-TAVI up to 3 years following early discharge.25,26 In the FAST-TAVI trial performed in Italy, the Netherlands and the UK, patients appropriately discharged early had significantly lower risk of the primary endpoint (7% vs 26.4%, p<0.001), which was reflected in some of its components: stroke, permanent pacemaker implantation, major vascular complications and major/life-threatening bleeding.22 In North America, the 3M TAVI clinical pathway ensured early discharge with excellent outcomes.24

Closing statement

The sessions summarised in this report walk through some important considerations for TAVI for clinicians and hospital decision makers alike. With the indication for TAVI expanding beyond  patients at high surgical risk to those as intermediate and low risk, valve considerations based on future ViV TAVI, patient preference, and increasing capacity for TAVI are becoming increasingly important.  The ambitious goals of the Edwards Benchmark program can optimise the TAVI pathway and should be considered by hospitals across Europe.

References

Session references

1. Valve-in-valve: the journey starts with the first prosthesis. Presented at EuroPCR 2022 on 17th May.
2. Emerging indications for TAVI. Presented at EuroPCR 2022 on 17th May.
3. Learnings from an optimised TAVI patient’s journey. Presented at EuroPCR 2022 on 18th May.

Speaker references from sessions

References from speakers in ‘Valve-in-valve: the journey starts with the first prosthesis’

1. Beckmann A, Meyer R, Lewandowski J, Markewitz A, Gummert J. German Heart Surgery Report 2020: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2021;69(4):294-307. doi:10.1055/s-0041-1730374

2. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020;76(21):2492-2516. doi:10.1016/j.jacc.2020.09.595

3. Sá MPBO, van den Eynde J, Simonato M, et al. Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement. JACC Cardiovasc Interv. 2021;14(2):211-220. doi:10.1016/j.jcin.2020.10.020

4. Tarantini G, Nai Fovino L, le Prince P, et al. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020;13(7):e008972. doi:10.1161/CIRCINTERVENTIONS.120.008972

5. Tarantini G, Nai Fovino L. Lifetime Strategy of Patients With Aortic Stenosis: The First Cut Is the Deepest. JACC Cardiovasc Interv. 2021;14(15):1727-1730. doi:10.1016/j.jcin.2021.06.029

6. Martinsson A, Nielsen SJ, Milojevic M, et al. Life Expectancy After Surgical Aortic Valve Replacement. J Am Coll Cardiol. 2021;78(22):2147-2157. doi:10.1016/j.jacc.2021.09.861

7. Glaser N, Persson M, Jackson V, Holzmann MJ, Franco-Cereceda A, Sartipy U. Loss in Life Expectancy After Surgical Aortic Valve Replacement: SWEDEHEART Study. J Am Coll Cardiol. 2019;74(1):26-33. doi:10.1016/j.jacc.2019.04.053

8. Tarantini G, Nai Fovino L, le Prince P, et al. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020;13(7):e008972. doi:10.1161/CIRCINTERVENTIONS.120.008972

9. Percy ED, Harloff MT, Hirji S, et al. Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services. JACC Cardiovasc Interv. 2021;14(15):1717-1726. doi:10.1016/j.jcin.2021.06.011

10. Bapat VN, Zaid S, Fukuhara S, et al. Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry. JACC Cardiovasc Interv. 2021;14(18):1978-1991. doi:10.1016/j.jcin.2021.07.015

11. Tarantini G, Nai Fovino L, Scotti A, et al. Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study. Circ Cardiovasc Interv. 2022;15(2). doi:10.1161/CIRCINTERVENTIONS.121.011045

References from speakers in ‘Emerging indications for TAVI’

12. Généreux P, Pibarot P, Redfors B, et al. Staging classification of aortic stenosis based on the extent of cardiac damage. Eur Heart J. 2017;38(45):3351-3358. doi:10.1093/eurheartj/ehx381

13. ClinicalTrials.gov. EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (EARLY TAVR). Published 2022. Accessed July 26, 2022. https://clinicaltrials.gov/ct2/show/NCT03042104

14. ClinicalTrials.gov. Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD). Published November 1, 2021. Accessed July 26, 2022. https://clinicaltrials.gov/ct2/show/NCT02661451

15. ClinicalTrials.gov. PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS). Published July 8, 2022. Accessed July 26, 2022. https://clinicaltrials.gov/ct2/show/NCT04889872

16. Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017;30(4):303-371. doi:10.1016/j.echo.2017.01.007

17. Iung B. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231-1243. doi:10.1016/S0195-668X(03)00201-X

18. Sawaya FJ, Deutsch MA, Seiffert M, et al. Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC Cardiovasc Interv. 2017;10(10):1048-1056. doi:10.1016/j.jcin.2017.03.004

References from speakers in ‘Learnings from an optimised TAVI patient’s journey’

19. Li SX, Patel NK, Flannery LD, et al. Trends in Utilization of Aortic Valve Replacement for Severe Aortic Stenosis. J Am Coll Cardiol. 2022;79(9):864-877. doi:10.1016/j.jacc.2021.11.060

20. Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. 2014;98(5):1564-1570; discussion 1570-1. doi:10.1016/j.athoracsur.2014.06.040

21. Ali N, Faour A, Rawlins J, et al. “Valve for Life”: tackling the deficit in transcatheter treatment of heart valve disease in the UK. Open Heart. 2021;8(1). doi:10.1136/openhrt-2020-001547

22. 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(2):147-154. doi:10.4244/EIJ-D-18-01197

23. 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(3):312-321. doi:10.1161/CIRCOUTCOMES.115.002541

24. Wood DA, Lauck SB, Cairns JA, et al. 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: The 3M TAVR Study. JACC Cardiovasc Interv. 2019;12(5):459-469. doi:10.1016/j.jcin.2018.12.020

25. Durand E, le Breton H, Lefevre T, et al. Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial. Arch Cardiovasc Dis. 2020;113(6-7):391-400. doi:10.1016/j.acvd.2019.11.010

26. Durand E, Avinée G, Tron C, et al. Analysis of Length of Hospital Stay after Transfemoral Transcatheter Aortic Valve Implantation: Results from the FRANCE TAVI (FRench Transcatheter Aortic Valve Implantation) Registry. Structural Heart. 2019;3:204. doi:10.1080/24748706.2019.1588542

Medical device 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, Edwards Lifesciences, SAPIEN, SAPIEN 3, and Edwards Benchmark are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

© 2022 Edwards Lifesciences Corporation. All rights reserved. PP–EU-4713 v1.0

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland  • edwards.com