TAVI outcomes in the spotlight of current trials

June 7, 2024

Prof. Ralph von Bardeleben

Aortic Highlights, 2024

Dr. Thourani

Edwards Lifesciences at EACTS 2022: Aortic valve disease: Patient centric management in elderly population

Prof. Sabine Bleiziffer

MVT Aortic course 2022, vol.2

Prof. Augusto D’Onofrio

MVT Aortic 2022, vol.2

– What’s less invasive than minimally-invasive surgery? Micro-invasive.

– The initial pros and cons of each approach are clear, but what about the outcomes?

– Don’t forget to implement Enhanced Recovery After cardiac Surgery (ERAS) protocols.

Prof. Marjan Jahangiri

MVT Aortic 2022, Vol.2

– Plan well, plan ahead, and keep the patient’s best interests in mind.

– Be sure you keep detailed notes during the first SAVR procedure.

– To avoid coronary artery obstruction, it may be worth avoiding SAVR valves where the leaflets are externally wrapped around the struts.

Dr. Vinod Thourani

Be courageous, be experienced, be ethical … according to the Guidelines!

Prof. Bart Meuris

Be courageous, be experienced, be ethical … according to the Guidelines!

With the publication of the 2021 update to ESC/EACTS guidelines for the management of valvular heart disease, new guidance should be considered when caring for patients with severe aortic stenosis.

Three key recommendations stand out:

Early intervention is recommended for asymptomatic patients with a LVEF below 55% without another cause

An emphasis on Heart Team collaboration to provide the optimal treatment while informing and involving patients in their decision-making

A clear age delineation that patients younger than 75 years of age with severe aortic stenosis receive SAVR, and patients older receive TAVI

It is established that the durability of modern surgical bioprosthetic valves is over 10 years,2 and in recent years there has been a trend towards a greater use of bioprosthetic valves.3 On the other hand, mechanical valves continue to be associated with bleeding risks because of the need for lifelong anticoagulation therapy, leading to lifestyle changes.4-6

Several large, long-term studies have demonstrated up to 20-year durability for the bioprosthetic Carpentier-Edwards PERIMOUNT
aortic valve.2,7,8

Carpentier-Edwards PERIMOUNT valve

 

Two ongoing trials, COMMENCE and EU Feasibility, are evaluating the longevity of bioprosthetic aortic valves with novel RESILIA tissue after five-year implantation. Five-year results from these studies have demonstrated a favourable safety profile and good haemodynamic performance.9,10

INSPIRIS RESILIA aortic valve

Another study found that the INSPIRIS RESILIA valve reduced the length of hospital stay compared with mechanical valves (6.6 days versus 10.3 days).11 Selecting the right treatment for the patient requires many considerations, most importantly the desire of the informed patient.

Additionally, the Heart Team needs to consider the age, estimated life expectancy, comorbidities, and anatomical and procedural characteristics of the patient; relative risks and long-term outcomes associated with SAVR or TAVI; prosthetic heart valve durability; feasibility of transfemoral TAVI; and local experience and outcome data to achieve optimal outcomes for patients.1

Recommended resources

References

1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021: doi:10.1093/eurheartj/ehab395.

2. Johnston DR, Soltesz EG, Vakil N et al. Long-term durability of bioprosthetic aortic valves: Implications from 12,569 implants. Ann Thorac Surg. 2015; 99: 1239–47

3. Bartus K, Sadowski J, Litwinowicz R et al. Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database. J Thorac Dis. 2019; 11: 2340–9.

4. Head SJ, Çelik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017; 38: 2183–91.

5. Reul RM, Ramchandani MK, Reardon MJ. Transcatheter aortic valve-in-valve procedure in patients with bioprosthetic structural valve deterioration. Methodist DeBakey Cardiovasc J. 2017; 13: 132.

6. Swinkels B, Ten Berg J, Kelder J et al. What can we learn from the past by means of very long-term follow-up after aortic valve replacement? J Clin Med. 2021; 10: 3925.

7. Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P et al.Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015; 99: 831–7.

8. Forcillo J, Pellerin M, Perrault LP et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013; 96: 486–93.

9. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardio-Thorac Surg. 2021; 59: 434–41.

10. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting 2021.

11. Meuris B. Innovation in anticalcification technology in heart valves leads to lower hospital stay in adults undergoing aortic valve replacement. Oral Presentation at HTAi 2021 virtual congress.

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

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.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, COMMENCE, INSPIRIS, INSPIRIS RESILIA, PERIMOUNT, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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

Prof. Michael Borger

Be courageous, be experienced, be ethical … according to the Guidelines!

Dr. Mark Hall

MVT Aortic 2021

Consequences of AVR on young Women