Dr. Paolo Berretta, Italy

What to know in 2020

Consequences of AVR on young Women

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 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.

Keywords: bioprosthesis; aortic valve replacement; long-term outcomes; reintervention; mortality

Bioprostheses are the most common valve type used for aortic valve replacement (AVR) in the UK. Early structural valve degeneration of 19- to 21-mm Sorin Mitroflow LX valves led the UK Medicine and Healthcare products Regulatory Agency to issue a Medical Device Alert in 2017.

This summary presents key data from a single-centre, retrospective study comparing outcomes for the Mitroflow valve and the Carpentier-Edwards PERIMOUNT Magna valve. Theologou et al. analysed data from 2,608 patients, assessing aortic valve reintervention and mortality rates up to 10 years.

Download below to keep up to date with the latest research in AVR.

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 meet the requirements for bearing the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Magna, 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.

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.

Keywords: aortic bioprostheses; aortic valve replacement; structural valve degeneration

Long-term durability is a key concern for bioprosthetic valves, but measuring structural valve degeneration (SVD) has been complicated by different SVD definitions. The RESILIENCE trial is the first prospective study to use both clinical and imaging SVD definitions to assess long-term valve durability.

This summary describes the design of this multicentre, prospective trial. The trial will investigate predictors of durability and time to failure in RESILIA tissue valves, which are treated to minimise free aldehydes and preserve the tissue.

The trial will include up to 250 adults from up to 15 centres. The primary endpoint is time to valve failure due to SVD, while the secondary endpoints are valve leaflet calcification volume and SVD stage 2 or 3. Non‑contrast computed tomography and transthoracic echocardiography will be carried out at 5, 7, 9 and 11 years after valve implantation to assess valve morphology and haemodynamics.

Download below to keep up to date with 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 meet the requirements for bearing the CE marking of conformity.

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