Durability: An even more important factor in valve selection

October 8, 2021

The 2021 update of the ESC/EACTS Guidelines for the management of valvular heart disease, recommends treating patients with severe aortic stenosis younger than 75 years and low risk with surgical aortic valve replacement (SAVR), simplifying the initial patient treatment pathway and preferred mode of intervention. The implication is that valve durability is now even more important because of younger patients’ greater longevity.

Edwards Lifesciences has two ongoing trials, COMMENCE and EU Feasibility, that are evaluating the longevity of a bioprosthetic valve with novel RESILIA tissue. Both trials have demonstrated a favourable safety profile and good haemodynamic performance at 5 years, with additional follow-up to be conducted up to 10 years.^1,2

The COMMENCE trial

Safety endpoints, probability event-free:

COMMENCE is an FDA pivotal trial designed to evaluate the safety and effectiveness of the INSPIRIS bioprosthetic aortic valve with the novel RESILIA tissue.¹ The 5-year data are now available:

· All-cause mortality 89.2%

· Major paravalvular leak 99.5%

· Endocarditis 97.8%

Improved haemodynamic performance from baseline

The absence of structural valve deterioration through 5 years* and the presence of stable gradients, plus freedom from regurgitation support durability over the observational period.

*One case of structural valve deterioration was diagnosed at postoperative Day 1,848.

At 5 years, COMMENCE results indicate a favourable safety profile and stable haemodynamic performance of a bioprosthetic valve with RESILIA tissue. Ten-year data in an extended follow-up cohort and the RESILIENCE trial with 11-year follow-up are forthcoming.

The RESILIA EU Feasibility study

The RESILIA EU Feasibility study has investigated the safety and performance in aortic valve replacement patients of the bioprosthesis with the novel RESILIA tissue at 5 years.² Here, we summarise the results at 5 years:

Stable haemodynamic performance:

Mean gradient was 14.8 ± 7.6 mmHg
Average effective orifice area was 1.4 ± 0.5 cm²

Zero structural valve deterioration events and stable transvalvular gradients were observed at 5 years.

At 5-years, results from the EU Feasibility study represent the longest follow-up of aortic valve replacement patients with RESILIA tissue and demonstrate excellent haemodynamic performance and safety outcomes.¹

Recommended resources

https://edwardseducation.com/edwardsmasters/the-latest-tissue-valve-technology-responding-to-the-unmet-needs-in-avr/

References

1. 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, January 29-31, 2021.

2. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg 2020; 59: 434–41.

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

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

Leon, Martin B., et al., Journal of the American College of Cardiology (2021) DOI:10.1016/j.jacc.2020.12.052

Aim

Report 2-year findings from PARTNER 3, emphasizing the clinical outcomes from 1 to 2 years and using new standardized definitions of hemodynamic valve deterioration and bioprosthetic valve failure

Methods

1000 patients randomly assigned (1:1) to transfemoral TAVR with SAPIEN 3 vs. SAVR
Mean STS score: 1.9%; mean age: 73 years
Primary endpoint: composite of death from any cause, all stroke or cardiovascular rehospitalization at 1 year

Results

Overall, complete primary endpoint follow-up through 2 years of 96.5% (TAVR 99%, SAVR 93.8%)
Functional status, as measured with KCCQ-OS, remained superior for TAVR at 2 years
Mean gradients were slightly higher after TAVR vs. SAVR (13.6 vs. 11.8 mmHg, p = 0.06; n = 495 and 453 for TAVR and SAVR, respectively) Bioprosthetic valve durability determined using VARC 3 criteria was similar for the 2 groups

Conclusions

The 2-year follow-up from the PARTNER 3 low-risk trial showed continued superiority of the primary endpoint favoring TAVR versus surgery, but more frequent deaths, strokes, and valve thrombosis events in the TAVR group between 1 and 2 years

Disease-specific health status at 2 years was better after TAVR than surgery

Echocardiographic findings through 2 years indicated stable valve hemodynamics and no differences in valve durability parameters

Key
talking points

Is there a trend for similar outcomes after TAVR and surgery?
Primary endpoint remained significantly lower with TAVR vs. SAVR, yet the differences in death and stroke have greatly diminished at 2 years. It must be noted that 3 of the 7 deaths occurring between 1- and 2-year follow-up in the TAVR arm were of noncardiac origin (cancer, suicide and sepsis), and 3 of the 6 strokes were disabling. This more granular data points to similar rates of event between year 1 and2 for TAVR and SAVR.

Why was valve thrombosis higher in TAVR patients?
75% of the patients with clinical events committee-adjudicated valve thrombosis were asymptomatic. A computed tomography substudy is running in parallel with the PARTNER 3 trial, increasing awareness on hemodynamic changes and inflating the frequency of valve thrombosis events. The consequences at long term remain uncertain.

Is TAVR the treatment of choice in low-risk patients?
Results of the PARTNER 3 trial are not applicable to all patients at low surgical risk. Exclusion criteria such as bicuspid aortic valves, severe coronary artery disease, concomitant valve disease or vascular disease precluding transfemoral access limit application of these results in these cohorts. Longer follow-up is also needed to assess valve’s durability in younger patients with severe AS.

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

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