Aortic valve replacement with minimally invasive approach, with the EDWARDS INTUITY Elite valve
Prof. Günter Laufer
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. Sabine Bleiziffer
MVT Aortic 2022, vol.1
– A comprehensive lecture about the indications, technical aspects, and results of the rare but challenging procedure of TAVI explantation
– When looking at long-term data, acknowledge the high mortality rates and think about which era the original valves were implanted (technology and overall know-how)
– Be sure to totally familiarize yourself with the technology, implantation method, material, and design of the originally implanted valve
Prof. Ruggero De Paulis
MVT Aortic 2022, vol.1
– Many surgical options, very comprehensive, and very unbiased
– A redo-SAVR is not as simple as just “redoing” the procedure: beware of higher risk and more complex procedures
– Very clear 7-step removal process of the original valve prosthesis
-Pros and cons of different pledgets, suture techniques, valve positioning, valve sizing, and more
Prof. Bart Meuris
MVT Aortic 2022, vol.1
-Cosmesis vs clinical benefit? Cross-clamp times? Extra costs? Have you thought about these aspects before?
-What about less pain? Less blood loss? Shorter ICU stays? Lower rates of atrial fibrillation? Remember, there are always pros and cons.
-If combined procedures are necessary, minimally invasive can be a choice in experienced centers
Prof. Augusto d’Onofrio
MVT Aortic 2022, vol.1
– Valve-in-valve, TAVI in TAVI, SAVR after TAVI… familiarize yourself with the mid-to-long-term data for each valve type combination, and transparently inform the patients of not only the benefits but also the risks
– Even the experts say, extracting an infected TAVI is extremely difficult, so be sure to choose the original valve wisely
Prof. D’Onofrio – EACTS 2021
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
Dr. Mark Hall
MVT Aortic 2021
Dr. Marco Solinas
MVT Aortic 2021
Dr. Paolo Berretta, Italy
Dr. Torsten Christ, Germany
Dr. Martin Andreas
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; bundle branch block; conduction disturbances
Rapid-deployment aortic valve replacement (RD-AVR) may cause conduction disturbances in the heart and lead to permanent pacemaker implantation.
This real-world, prospective study presents data from 700 consecutive patients, who underwent RD-AVR with an EDWARDS INTUITY valve. Coti et al. analysed postoperative, 3-month and 1-, 3- and 5-year follow-up data to assess the incidence of new conduction disturbances and pacemaker implantation rates. The authors also identified preoperative predictors for new pacemaker requirement. This study highlights how inclusion criteria and concomitant interventions can affect cardiac conductions after RD-AVR.
Download the summary below to find out more about conduction disturbances following RD-AVR.
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 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 valve replacement; permanent pacemaker implantation; rapid deployment prosthesis
In recent years, rapid deployment and transcatheter valves have reduced the invasiveness of aortic valve replacement. However, both of these types of prosthesis have been associated with conduction disturbances and subsequent postoperative permanent pacemaker implantation (PPI).
This summary highlights key results from a single-centre, observational study assessing the factors associated with PPI following the implantation of EDWARDS INTUITY or EDWARDS INTUITY Elite valves. Arribas et al. analysed data for 71 patients followed up for an average of 33 months, and assessed the incidence, reasons for and impact of PPI.
Download below to keep up to date with the latest research in aortic valve replacement.
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 meet the requirements for bearing the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY, and EDWARDS INTUITY Elite are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.
