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.
Insights from the clinical research investigating INSPIRIS RESILIA and Carpentier-Edwards Magna Ease valves
Francesco Onorati
Prof. Augusto D’Onofrio
MVT Aortic 2022, vol.1
– Not only about hemodynamics, this lecture provides comparisons among three bioprostheses
– Similar clinical outcomes, better hemodynamic results, and shorter ICU stays for rapid deployment valves… but newer bioprosthesis tissue technology may raise the bar even higher
Prof. Michael Borger
MVT Aortic 2022, vol.1
-The “aortic size paradox”: an interesting paradox, indeed
-Length? Diameter? Which should we pay more attention to?
-Be sure to pay attention to genetics, biomarkers, abnormal flow, other risk factors, and more
Prof. Marco Di Eusanio
MVT Aortic 2022, vol.1
Prof. Bart Meuris
MVT Aortic 2022, vol.1
- Shorter hospital stays, less anticoagulation, long-term financial savings? Hear about the data of an expert’s personal experience.
- With advanced anti-calcification treatment, the future of bioprostheses is promising not only for patient outcomes, but even from a financial perspective
Dr. Douglas Johnston
STS annual meeting 202
Prof. D’Onofrio – EACTS 2021
Prof. Kocher – EACTS 2021
The recently updated ESC/EACTS Guidelines contain two key changes in the recommendations for prosthetic valve selection:1
- A new Class IIb recommendation for bioprostheses in patients already on long-term NOACs
- An upgraded Class I recommendation for bioprostheses in patients for whom good-quality anticoagulation is unlikely or contraindicated, and in patients whose life-expectancy is lower than the presumed durability of the valve
Importantly, the desire of the informed patient remains central to prosthetic valve selection. Valve durability in young patients is an important consideration, but long-term data on bioprosthetic SAVR have been limited.
INDURE registry
INDURE is a prospective, open-label, multicentre registry that is tackling this issue head-on. INDURE has enrolled over 400 patients aged up to 60 years who are undergoing SAVR with the INSPIRIS RESILIA valve in 21 sites across Europe and Canada. Patients are being followed up for five years, with echocardiograms analysed by Echo Core Laboratory at years one and five.2,3
One-year results from the first 435 patients were reported at the 2021 EACTS Annual Meeting. Younger patients (up to 50 years old) in the registry were more likely to have a bicuspid aortic valve or aortic valve regurgitation at baseline than patients aged 51–60 years, but were less likely to have aortic stenosis, hypertension or diabetes.3
Excellent haemodynamic outcomes at 1 year
The excellent haemodynamic outcomes were comparable in the younger and older patient groups.
Plus, preliminary safety outcomes demonstrated low all-cause mortality and no confirmed cases of valve-related mortality up to one year. Rates of endocarditis and stroke were low (<1%). There were no cases of stage 3 SVD.
The INDURE registry will continue to provide clinical evidence on the use of the INSPIRIS RESILIA valve in young patients for the next 5 years.
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2021.
2. Meuris B, Borger MA, Bourguignon T et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020; 15: 119.
3. De Paulis R. Surgical aortic valve replacement in patients under 60 years old: A prospective, multicentre real-world registry in Europe and Canada. EACTS 2021.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for Use (consult eifi.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, INSPIRIS, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-3060 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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.
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.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2948 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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.1
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.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2950 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Ai L et al. Innovations. 2017; 12: 338–45. DOI: 10.1097/imi.0000000000000407
Aim
To develop a clinically relevant aortic root model, and then compare the haemodynamic function of the EDWARDS INTUITY valve (a rapid deployment valve) with the Carpentier- Edwards PERIMOUNT Magna Ease valve (a conventional bioprosthetic valve), in vitro.
Background Information
Many trials have shown the short-term safety and efficacy of sutureless rapid deployment aortic valves, but direct comparisons of the haemodynamic performance of these new valves with conventional bioprosthetic valves are lacking.
Methods
Model development
Multi-slice computed tomography reconstructions in patients with aortic stenosis were used to generate a 3D printed model of an aortic root.
Effective diameter of the aortic annulus was 21 mm, effective area was 3.38 cm2 and LVOT area was 3.01 cm2.
Valve Deployment
For measurement of haemodynamic parameters (EOA, TPG and LVOT geometry), Magna Ease valves were sutured to the model’s annulus, with and without the use of pledgets, and EDWARDS INTUITY valves were secured by balloon inflation. EDWARDS INTUITY
valves were further tested with frames expanded
to 22, 23, 24 and 25 mm.
Figure 1: EDWARDS INTUITY and Magna Ease valves in the aortic root model and cadaver heart
A: EDWARDS INTUITY valve in the model;
B: Magna Ease valve in the model without pledgets;
C: Magna Ease valve in the model, with pledgets;
D: Outflow view of the aortic root model; E: EDWARDS INTUITY valve in the cadaver heart;
F: Magna Ease valve without pledgets in the cadaver heart.
Reproduced from Ai L et al, 2017. © 2017 Wolters Kluwer Health, Inc. Reproduced with permission LVOT in the rubber gasket aortic root model and in the cadaver heart.
Results
Hemodynamic Performance
The EDWARDS INTUITY valve had both a greater EOA and a lower TPG than the Magna Ease valve, irrespective of pledget use (Figure 1). EOA
and TPG were also significantly different between Magna Ease valves with and without pledgets (all p<0.002 or 0.001).
LVOT Performance
Expanding the EDWARDS INTUITY valve frame diameter from 22 to 25 mm increased the average LVOT area index stepwise from 1.07 to 1.34: this minimally affected EOA or TPG (Table 1).
EDWARDS INTUITY valves resulted in more circular LVOTs than Magna Ease valves, although increasing ellipticity did not impact EOA or TPG.
Average maximum flow velocity was lower across the EDWARDS INTUITY valve than the Magna Ease valve without pledgets (p<0.003), as were maximum turbulent shear stress (p<0.02) and turbulent kinetic
energy (p<0.002).
| EDWARDS INTUITY valve (n=4) | Magna Ease valve (n=4) | Magna Ease valve with pledgets (n=4) | |
| EOA, cm2 | 1.85 ± 0.06 | 1.56 ± 0.01 | 1.21 ± 0.08 |
| Mean gradient, mmHg |
16.8 ± 1.3 | 23.4 ± 0.51 | 1.21 ± 0.08 |
EOA: effective orifice area
Table 1: TPG and EOA of models with an EDWARDS INTUITY valve or a Magna Ease valve (with or without pledgets)
Limitations
- Such a model, isolated from the left ventricle, cannot replicate all physiological mechanical properties.
- Pathological changes and normal physiological variations can affect valve performance in vivo: these were not modelled here.
- The use of saline, rather than blood or a substitute, may have affected simulated valve performance.
Conclusions
- Haemodynamic performance was superior for the EDWARDS INTUITY valve than the Magna Ease valve with increased EOA and reduced mean gradient.
- Pledgets worsened Magna Ease valve performance.
- Maximum velocity, turbulent shear stress and kinetic energy were all lower across the EDWARDS INTUITY valve than the Magna Ease valve.
- Haemodynamic advantages may account for the superior clinical performance of rapid deployment valves over conventional surgical valves
Important safety information:
Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances,
which may require a permanent cardiac pacemaker implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite
valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported
for surgical aortic valves. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to
implantation. See instructions for use for additional information.
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, EDWARDS INTUITY, EDWARDS INTUITY Elite, Magna, Magna Ease, PERI, PERIMOUNT and PERIMOUNT Magna are trademarks are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2350 v1.0
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.
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, 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.
© 2021 Edwards Lifesciences Corporation. All rights reserved.
PP–EU-1734 V1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
MVT Fundamentals Course
Dr. Paolo Berretta, Italy
Keywords: aortic stenosis; aortic valve replacement; transvalvular pressure gradients; valve haemodynamics
Rapid deployment valves requiring minimal sutures are an alternative to conventional surgical valves. In addition to facilitating minimally invasive surgery, rapid deployment valves are associated with improved haemodynamic outcomes compared with conventional surgical valves. The mechanism behind these haemodynamic outcomes is unknown.
Sadri et al. present the first in-vitro study that compares a conventional valve with a rapid deployment valve in the same surrounding physiology. PERIMOUNT Magna Ease and EDWARDS INTUITY Elite valves were sequentially implanted in a donor heart, and μ-computerised tomography used to develop 3D-printed flow models for each valve. Sadri et al. explain how the EDWARDS INTUITY Elite, a rapid deployment valve, may increase effective orifice area and lower transvalvular pressure gradients, peak velocities and patient─prosthesis mismatch.
Click on the link below to see how two different valves perform in the same heart.
Click here to access the full publication
Important safety information:
Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances, which may require a permanent cardiac pacemaker implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported for surgical aortic valves. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation. See instructions for use for additional information.
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, EDWARDS INTUITY, EDWARDS INTUITY Elite, Magna, Magna Ease, PERI, PERIMOUNT, and PERIMOUNT Magna Ease are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2020 Edwards Lifesciences Corporation. All rights reserved.
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Keywords: aortic stenosis; aortic valve replacement; patient–prosthesis mismatch; rapid-deployment aortic valves
Severe aortic stenosis in low- and intermediate-risk patients is currently treated by surgical aortic valve replacement (SAVR). However, SAVR can cause patient–prosthesis mismatch (PPM), a condition where a patient’s body surface area is too big compared with the effective orifice area of the implant. This mismatch results in higher transvalvular pressure gradients and is associated with a higher risk of adverse outcomes. There is a potential risk of PPM in patients who undergo SAVR due to higher transvalvular pressure gradients, especially if they have a small aortic root.
Coti et al. studied patients with a small aortic root who underwent SAVR with the EDWARDS INTUITY valve. This single-centre cohort analysis provides useful insights by analysing haemodynamic parameters, survival rates, functional class improvements and PPM incidence.
Click on the link below to see the outcomes of the EDWARDS INTUITY valve transplant in at-risk patients.
Click here to access the full publication
Important safety information:
Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances, which may require a permanent cardiac pacemaker implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported for surgical aortic valves. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation. See instructions for use for additional information.
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, EDWARDS INTUITY, and EDWARDS INTUITY Elite are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2020 Edwards Lifesciences Corporation. All rights reserved.
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Keywords: aortic bioprostheses; aortic stenosis; aortic valve replacement
Surgical aortic valve replacement (SAVR) is still offered to elderly populations despite the potential for structural valve degeneration. Currently, however, there is limited comparative data on the long-term durability of different SAVR prostheses.
Reporting outcomes including repeat aortic valve replacement, prosthetic valve endocarditis and late all-cause mortality, Biancari et al. present key results from a retrospective, non-randomised, propensity-matched comparative analysis of the Trifecta and Carpentier-Edwards PERIMOUNT Magna Ease valves. The authors compared the outcomes of 2,216 patients who had undergone the procedure to implant one of the two SAVR prostheses.
Click the link below for an update on the latest research in aortic valve replacement.
Click here to access the full publication
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, Magna, Magna Ease, PERI, PERIMOUNT and PERIMOUNT Magna are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.
