Evolut r

Manufactured by Medtronic

Sourced in United States, Ireland

The Evolut R is a self-expanding transcatheter aortic valve replacement (TAVR) system designed for the treatment of severe aortic stenosis. It features a dynamic sealing skirt and a recapturable, repositionable design to allow for optimal valve placement.

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Lab products found in correlation

Corevalve, by Medtronic (35 mentions) Evolut pro, by Medtronic (26 mentions) Sapien 3, by Edwards Lifesciences (26 mentions) Sapien xt, by Edwards Lifesciences (16 mentions) Acurate neo, by Boston Scientific (8 mentions) Evolut r pro, by Medtronic (5 mentions) Edwards sapien xt, by Edwards Lifesciences (4 mentions) Evlolut pro, by Medtronic (4 mentions) Sapien 3 ultra, by Edwards Lifesciences (3 mentions) Sapien, by Edwards Lifesciences (3 mentions) Evolut pro plus, by Medtronic (2 mentions) Lotus valve, by Boston Scientific (2 mentions) Accurate neo, by Boston Scientific (2 mentions) Lotus edge, by Boston Scientific (2 mentions) Edwards sapien xt or s3 prosthesis, by Edwards Lifesciences (2 mentions) Evolut series, by Medtronic (2 mentions) Mimics v18, by Materialise (1 mentions) Boston lotus, by Boston Scientific (1 mentions) Sapien xt, by Medtronic (1 mentions) Sapien 3, by Medtronic (1 mentions)

Spelling variants of this product

CoreValve Evolut R (23 citations) Evolut R Pro (11 citations) CoreValve Evolut R/PRO (4 citations) Evolut R valve (3 citations) Medtronic CoreValve/Evolut R Revolving System (3 citations) CoreValve Evolut R/ Pro/Pro + (2 citations) Evolut R and Pro (2 citations)

72 protocols using evolut r

Finite Element Modeling of Transcatheter Heart Valves

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Finite element models of the CoreValve, Evolut R, Evolut PRO (Medtronic, Minneapolis, MN), and Lotus (Boston Scientific, Marlborough, MA) THVs, which had been previously developed, were used. 8 (link) In brief, frame morphology was derived from micro-CT scanning (30-μm resolution). Strut width was obtained from optical microscopy or based on data shared by the device manufacturer. Mechanical properties of the nickel titanium (Nitinol) frames were obtained though in vitro radial compression testing at body temperature, recording radial force throughout the compression cycle.
Patient-specific finite element models of the aortic root were constructed from preprocedural CT scans (Mimics v18.0; Materialise, Leuven, Belgium). The aortic wall, leaflets, and calcium were modeled with differing mechanical properties, as described previously. 10 The finite element model of the implanted THV was positioned within the aortic root model. Finite element analysis was performed using Abaqus/Explicit (v6.12; Dassault Systèmes, Vélizy-Villacoublay, France; available from https:// www.3ds.com). All steps of the procedure, including pre-and postdilatation were modeled.

Dowling C., Bavo A.M., El Faquir N., Mortier P., de Jaegere P., De Backer O., Sondergaard L., Ruile P., Mylotte D., McConkey H., Rajani R., Laborde J.C, & Brecker S.J. (2019). Patient-Specific Computer Simulation of Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Morphology. Circulation. Cardiovascular imaging, 12(10).

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Evaluating Transcatheter Valve Leaflet Splay

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Self-expanding (29mm EvolutR, Medtronic) and balloon expandable (26mm Sapien3, Edwards) THVs were implanted in the jig to splay each lacerated leaflet. Twenty leaflet splays (BASILICA = 10, BA-BASILICA = 10) were analyzed. Splay angle was defined as the maximum angle created by lacerated/splayed leaflet edges. Leaflet tip splay was defined as the maximum distance between the two free edges of the leaflet tip. Splay area represented the total area of the resulting gap (Figure 1, Figure 2).

Perdoncin E., Bruce C.G., Babaliaros V.C., Yildirim D.K., Depta J.P., McCabe J.M., Gleason P.T., Xie J., Grubb K.J., Paone G., Kohli K., Kamioka N., Khan J.M., Rogers T., Lederman R.J, & Greenbaum A.B. (2021). Balloon-augmented Leaflet Modification with BASILICA and LAMPOON: Benchtop Validation and First In-Man Experience.. Circulation. Cardiovascular interventions, 14(11), e011028.

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Transcatheter Aortic Valve Implantation

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Patients underwent Medtronic CoreValve or Evolut R (Medtronic Inc., Minneapolis, Minnesota) or Boston Lotus (Boston Scientific Corporation, Natick, MA) valve implantation. Trans-femoral was the default approach with other techniques (subclavian and direct aortic) chosen in the case of unsuitable femoral access. All procedures were performed by 2 experienced operators. Left ventricular end diastolic pressure (LVEDP) was measured invasively at the beginning and end of the procedure.

Dobson L.E., Musa T.A., Uddin A., Fairbairn T.A., Swoboda P.P., Erhayiem B., Foley J., Garg P., Haaf P., Fent G.J., Malkin C.J., Blackman D.J., Plein S, & Greenwood J.P. (2016). Acute Reverse Remodelling After Transcatheter Aortic Valve Implantation: A Link Between Myocardial Fibrosis and Left Ventricular Mass Regression. The Canadian journal of cardiology, 32(12).

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Post-TAVI Aortic Stent Evaluation

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In accordance to the guidelines after thoracic aortic stent implantation a post-TAVI CTA was performed in all patients within our institution [8 (link)]. The purpose of this CTA was to identify possible complications, e.g. aortic injuries or thrombosis of the valves. Reasons for not performing a post-procedural CTA were described previously, e.g. renal insufficiency or frailty [9 (link)]. All patients with evaluable pre- and post-TAVI CTA and implanted newer generation SEV (Evolut R, Medtronic Inc., Minneapolis, USA) between January 2015 and June 2020 were candidates for study inclusion. Patients with valve-in-valve procedures were excluded. Experienced operators (each with an experience of at least 100 TAVI-procedures) implanted all THVs via a transfemoral access. The multidisciplinary, institutional heart team decided on TAVI eligibility, procedural feasibility as well as the preferred access route or prosthesis type and size [10 (link)]. All patients gave written informed consent for TAVI and the anonymized use of clinical, procedural, and follow-up data at the time of the intervention. The study was approved by the local institutional review board and complies with the Declaration of Helsinki.

Breitbart P., Minners J., Hein M., Schröfel H., Neumann F.J, & Ruile P. (2021). Implantation depth and its influence on complications after TAVI with self-expanding valves. The International Journal of Cardiovascular Imaging, 37(10), 3081-3092.

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TAVI Outcomes with Evolut Valves

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The study was based on data acquired from the TAVI Zabrze Registry – a database comprising patients with severe AS treated with TAVI. Its purpose is to assess and monitor the outcomes of the treatment applied.
The adopted time interval was between 10 August 2015 (the very first patient with an Evolut R/PRO valve implanted) and 31 December 2019. At that time, 282 patients with severe AS were treated in our centre, including 120 patients treated by our heart team. This analysis includes 87 who received self-expandable Medtronic Evolut R and Evolut PRO valves (sizes: 23, 26, 29 and 34; no patients needed the smallest 23 mm valve). This study excluded patients with a previously implanted aortic valve prosthesis (no valve-in-valve). Selection criteria for the adequate valve size were made using a multi-slice computed tomography (MSCT) scan. They were based on an annulus diameter calculated by the following formula: annulus perimeter/3.14 and according to the Medtronic recommendations. Patients with extra-large annuli (annulus > 30 mm, area > 683 mm² or perimeter > 94.2 mm – not recommended by Medtronic) were not analysed.
All patients were divided into two groups: Group I: 59 (67.81%) patients treated with Evolut 26 and 29 valves, and Group II: 28 (32.18%) patients treated with Evolut 34 valves.

Wilczek K., Chodór P., Harpula J., Hrapkowicz T., Włoch Ł., Chodór-Rozwadowska K., Honisz G., Gąsior M, & Kalarus Z. (2023). Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves. Postępy w Kardiologii Interwencyjnej = Advances in Interventional Cardiology, 19(4), 359-366.

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Retrospective Study of TAVI Outcomes

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We retrospectively reviewed consecutive patients who underwent TAVI between January 1, 2016 and July 31, 2019 at St. Marianna University Hospital. TAVI was performed using balloon-expandable (Sapien XT and Sapien 3; Edwards Lifesciences, Irvine, CA, USA) and self-expandable devices (CoreValve, Evolut R, Evolut Pro, and Evolut Pro Plus; Medtronic, Minneapolis, MN, USA). The decision for TAVI was comprehensively made based on the patient’s activities of daily living, age, and the Society of Thoracic Surgeons (STS) score, and the procedural strategies, including valve type selection, were decided by a multidisciplinary heart team including cardiothoracic surgeons, anesthesiologists, interventional cardiologists, and echocardiography cardiologists. Patients who underwent emergency or urgent TAVI were excluded from the study because a poorer prognosis is expected for these patients and baseline echocardiographic data were insufficient.⁵ The study was approved by the appropriate institutional review board and conducted in accordance with the Declaration of Helsinki. Informed consent was acquired in the form of opt-out on the website.

Kobayashi Y., Izumo M., Okuyama K., Uenomachi N., Shoji T., Kai T., Okuno T., Sato Y., Kuwata S., Koga M., Ishibashi Y., Tanabe Y., Miyairi T, & Akashi Y.J. (2023). Feasibility of Transcatheter Aortic Valve Implantation in Patients With Very Severe Aortic Stenosis. Circulation Reports, 5(9), 358-364.

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Comparative Study of TAVI Techniques

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This study was designed as an allocated, prospective, single centre study. After exclusion criteria were applied, a total number of 139 consecutive patients who underwent TAVI with a self-expandable Evolut-R (Medtronic, Minneapolis, Minnesota, USA) valve at a single centre between February 2019 and June 2022 were included in the study. First 70 patients were enrolled to the routine pre-dilation (pre-BAV) group and the last 69 patients were included to direct-TAVI group without pre-dilation. The randomisation chart of the patients can be seen in Fig. 1.
Our study complies with the Declaration of Helsinki. All patients gave written informed consent and local ethics committee approved the study protocol (date: 02/27/2019, no: SBUSEAH-KAEK 2019/2/4). Clinical data, patient characteristics, laboratory data, echocardiography data, procedural variables, and details of the length of hospital stay were collected from hospital medical records.

Arslan U., Erdoğan G., Yenerçağ M., Aksan G., Uçar M., Görgün S., Akpinar Ç.K., Öztürk O., Yontar O.C, & Karagöz A. (2023). Direct transcatheter aortic valve implantation (TAVI) decreases silent cerebral infarction when compared to routine balloon valvuloplasty. The international journal of cardiovascular imaging, 39(10).

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Transcatheter Aortic Valve Replacement Outcomes

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During the study period, 4 types of THV, including SAPIEN XT, SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA), CoreValve, and Evolut R (Medtronic, Minneapolis, MN, USA), were approved and used in Japan; SAPIEN XT was approved for clinical use in August 2013. The SAPIEN XT 20-mm valve started to be used in May 2015. SAPIEN 3 was approved for only the transfemoral approach in May after the TAVR procedure (n=3,159), as shown in Figure 1.
A total of 5,870 patients were available for this study, with a median (IQR) age of 85 (81-88) years; 31.6% were male.

Meguro K., Kumamaru H., Kohsaka S., Hashimoto T., Kakizaki R., Kitamura T., Shimizu H, & Ako J. (2021). Transcatheter Aortic Valve Replacement in Patients With a Small Annulus　- From the Japanese Nationwide Registry (J-TVT). Circulation journal : official journal of the Japanese Circulation Society, 85(7).

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Transcatheter Aortic Valve Replacement

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The indication for and approach of TAVR were determined by the heart team, which consisted of cardiologists, cardiovascular surgeons, and anesthesiologists.² (link)
All patients received balloon-expandable valves (Sapien XT or Sapien 3; Edwards Lifesciences, Irvine, CA, USA) or self-expandable valves (Corevalve or Evolut R; Medtronic, Minneapolis, MN, USA) via a transfemoral or transapical approach under general anesthesia.

Imamura T., Narang N., Sobajima M., Tanaka S., Ushijima R., Fukuda N., Ueno H, & Kinugawa K. (2021). Inadequate Cardiac Unloading Following Transcatheter Aortic Valve Replacement. Circulation Reports, 3(10), 615-619.

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Transcatheter Aortic Valve Replacement Outcomes

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TAVR-related data such as procedural time, type of vascular access, type of valve, valve-in-valve implantation, pre- and post-TAVR dilatation, and the use of rapid pacing were recorded.
Successful TAVR were defined according to the presence of all the following criteria: absence of procedural mortality; correct positioning of a single prosthetic heart valve into the proper anatomical location; intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s) [19 (link)].
For the purpose of this analysis, we included the following SEV: CoreValve (Medtronic, Minneapolis, Minnesota), Evolut R (Medtronic, Minneapolis, Minnesota), Evolut PRO (Medtronic, Minneapolis, Minnesota), Symetis ACURATE neo (Symetis/Boston, Ecublens, Switzerland) and NVT ALLEGRA (New Valve Technology [NVT], Hechingen, Germany). SAPIEN XT (Edwards Lifesciences, Irvine, California), SAPIEN 3 (Edwards Lifesciences, Irvine, California), and SAPIEN 3 ULTRA (Edwards Lifesciences, Irvine, California) were considered BEV.

De Marzo V., Crimi G., Vercellino M., Benenati S., Pescetelli F., Della Bona R., Sarocchi M., Canepa M., Balbi M, & Porto I. (2021). Impact of bioprosthetic valve type on peri-procedural myocardial injury and mortality after transcatheter aortic valve replacement. Heart and Vessels, 36(11), 1746-1755.

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