Evolut pro

Manufactured by Medtronic

Sourced in United States, Ireland

The Evolut PRO is a medical device developed by Medtronic for use in transcatheter aortic valve replacement (TAVR) procedures. It is designed to address aortic stenosis, a condition where the aortic valve narrows, restricting blood flow from the heart to the rest of the body. The Evolut PRO serves as a replacement valve that is delivered via a catheter-based procedure, without the need for open heart surgery.

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Lab products found in correlation

Evolut r, by Medtronic (26 mentions) Corevalve, by Medtronic (15 mentions) Sapien 3, by Edwards Lifesciences (9 mentions) Sapien xt, by Edwards Lifesciences (5 mentions) Sapien 3 ultra, by Edwards Lifesciences (3 mentions) Edwards sapien xt, by Edwards Lifesciences (3 mentions) Evolut pro plus, by Medtronic (2 mentions) Accurate neo, by Boston Scientific (2 mentions) Evolut series, by Medtronic (2 mentions) Mimics v18, by Materialise (1 mentions) Lotus valve, by Boston Scientific (1 mentions) Sapien 3, by Medtronic (1 mentions) Skyscan 1272, by Bruker (1 mentions) 64 row ct scanner, by GE Healthcare (1 mentions) Mimics medical 21, by Materialise (1 mentions) Acurate neo, by Boston Scientific (1 mentions) Edwards sapien xt or s3 prosthesis, by Edwards Lifesciences (1 mentions) Perclose proglide system, by Abbott (1 mentions) Enveo r inline sheath, by Medtronic (1 mentions)

Spelling variants of this product

Evolut R Pro (11 citations) CoreValve Evolut R/PRO (4 citations) Evolut Pro Plus (3 citations) CoreValve Evolut R/ Pro/Pro + (2 citations) Evolut R and Pro (2 citations) CoreValve™ Evolut™ Pro (2 citations)

30 protocols using evolut pro

Advances in Transcatheter Aortic Valve Implantation

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TAVI procedures included either a transfemoral or a transapical approach.
At the beginning of our program [11 (link)], the procedures were performed under general anesthesia and with femoral cut-down. Afterwards, we implemented an awake procedure and the fully percutaneous management of the femoral access, and this approach represents our daily practice nowadays (>95% of cases).
We used two platforms: the Edwards balloon expandable (Sapien 3^® and Sapien 3 Ultra (Edwards Life-Sciences Corp., Irvine, CA, USA)) and the Medtronic self-expandable (Evolut™ R, Evolut ™ Pro, Evolut™ Pro+ (Medtronic, Minneapolis, MN, USA)) prostheses. The prosthesis size was chosen according to the recommendation charts supplied by the companies, based on preoperative CT scan measurements.

Malvindi P.G., Bifulco O., Berretta P., Alfonsi J., Cefarelli M., Zingaro C., Capestro F., D’Alfonso A, & Di Eusanio M. (2023). Improved Early Outcomes in Women Undergoing Aortic Valve Interventions. Journal of Clinical Medicine, 12(17), 5749.

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TAVR Valve Implantation and ECG Assessment

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Standard 12-lead ECGs were collected at hospital admission and before discharge. Each 12-lead ECG was interpreted by a selected group of electrophysiologists working in our hospital. The predominant TAVR valve types implanted at our cardiac catheterization laboratory during the study period were from the Evolut series (Evolut-R, Evolut Pro and EvolutPro+, Medtronic, Dublin, Ireland) and Sapien 3 Ultra (Edwards Lifesciences, California). TAVR technique implantation, type, and valvular size, as vascular approach used, were done according to the last deployment techniques.

De Lucia R., Giannini C., Parollo M., Barletta V., Costa G., Giannotti Santoro M., Primerano C., Angelillis M., De Carlo M., Zucchelli G., Bongiorni M.G, & Petronio A.S. (2023). Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test. Europace, 25(3), 1116-1125.

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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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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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Transcatheter Bioprosthetic Valve Perforation and Laceration

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We tested radiofrequency-assisted transcatheter perforation and laceration of exterior-mounted bovine pericardial leaflets on a representative bioprosthetic heart valve (19mm Trifecta valve, Abbott St Jude Medical) submerged in a 0.9% saline bath with a remote dispersive electrode [Supplement Figure 1]. Two lacerations were attempted on the bioprosthetic heart valve. One leaflet was lacerated from base to tip and the second from mid-point to tip. A third scallop was left intact and served as a control.
Balloon expandable (20mm Sapien 3, Edwards Lifesciences) and self-expanding (23mm Evolut Pro, Medtronic) were deployed in the bioprosthetic valve to test splaying of split leaflet around the open cells of the transcatheter heart valve and propagation of the split in the leaflet. A second valve (25mm Mitroflow, Sorin Livanova) was cut with a scalpel and leaflet splaying was also tested with appropriately sized balloon expanding and self-expanding valves.

Khan J.M., Dvir D., Greenbaum A.B., Babaliaros V.C., Rogers T., Aldea G., Reisman M., Mackensen G.B., Eng M.H., Paone G., Wang D.D., Guyton R.A., Devireddy C.M., Schenke W.H, & Lederman R.J. (2018). Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human.”. JACC. Cardiovascular interventions, 11(7), 677-689.

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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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TAVI Outcomes: Pacemaker Implantation

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The retrospective index cohort consisted of 189 patients who had undergone TAVI in nine European centres. Patients with abnormal ECG [left/right bundle branch block (L/RBBB)] and/or permanent pacemaker before TAVI (n = 38) were excluded. Therefore, the final study cohort included 151 patients who were treated with the self-expanding CoreValve, Evolut R, and Evolut PRO valves (n = 107, Medtronic, MN, USA), or the mechanically expanding Lotus valve (n = 44, Boston Scientific, MA, USA). All patients were discussed in the multidisciplinary heart team. Valve type selection was based upon discretion of the operator/institution, whereas valve sizing was based upon multi-slice computed tomography (MSCT) derived baseline aortic root anatomy using the manufacturing sizing matrix, as described before.¹² (link) The primary and dependent outcome of interest was the occurrence of a new L/RBBB and/or PPI before discharge. All patients provided written informed consent for TAVI and the use of anonymous clinical, procedural, and follow-up data for research. The study was executed according to the Declaration of Helsinki, was approved by the ethics committees of all participating centres and did not fall under the scope of the Medical Research Involving Human Subjects Act.

Galli V., Loncaric F., Rocatello G., Astudillo P., Sanchis L., Regueiro A., De Backer O., Swaans M., Bosmans J., Ribeiro J.M., Lamata P., Sitges M., de Jaegere P, & Mortier P. (2021). Towards patient-specific prediction of conduction abnormalities induced by transcatheter aortic valve implantation: a combined mechanistic modelling and machine learning approach. European Heart Journal. Digital Health, 2(4), 606-615.

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Prospective TAVI Cohort Study

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We conducted a prospective single-center cohort study. Consecutive patients with severe symptomatic aortic stenosis undergoing workup for TAVI with either balloon-expandable (Edwards SAPIEN 3) or self-expandable (Medtronic Evolut R or Evolut Pro) valves between November 2016 and December 2020 were eligible for inclusion at Hôpital Sacré Coeur de Montréal, an intermediate-volume TAVI center in Montreal, Quebec. Excluded patients had either not undergone all imaging modalities or images were not interpretable (i.e., artefacts, no valve section). Patients with a prior bioprosthetic aortic valve were also excluded. The study was approved by the ethics committee and consent was obtained for all participants.

Massie C., Parent M., Berthelot-Richer M., Kouz R., Palisaitis D., Le V, & Poulin F. (2023). Automated and semi-automated 3D echocardiographic software for aortic annulus sizing in transcatheter aortic valve implantation helps bridge the gap between expert and novice operators. The International Journal of Cardiovascular Imaging, 39(9), 1707-1717.

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Percutaneous Cardiac Interventions and TAVI

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The CAs/PCIs were performed by either a standard femoral or radial percutaneous approach.
TAVI procedures were all performed electively by either percutaneous transfemoral access or by surgical transapical access. The Edwards SAPIEN‐XT, S3, or ULTRA (Edwards Lifesciences, Irvine, CA); the Medtronic CoreValve, Evolut‐R, or Evolut‐Pro (Medtronic, Inc., Minneapolis, MN); or the Accurate Neo (Boston Scientific, Marlborough, MA) were used, according to the patient’s anatomical characteristics as assessed by ECG‐gated computed tomography.
When patients undergoing TAVI had CA performed during the same procedure, the reported contrast volumes included the total administered amount.

Venturi G., Pighi M., Pesarini G., Ferrero V., Lunardi M., Castaldi G., Setti M., Benini A., Scarsini R, & Ribichini F.L. (2020). Contrast‐Induced Acute Kidney Injury in Patients Undergoing TAVI Compared With Coronary Interventions. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 9(16), e017194.

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Geometric Modeling of Transcatheter Aortic Valve

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The geometric model of the latest versions of the FDA approved devices, Medtronic Evolut R and Evolut PRO with stent size of 29 mm, were utilized [29 (link)]. Both models have identical geometries for the stent, bioprosthetic leaflets and inner cuff, while the Evolut PRO, the newer device, also includes an outer cuff, as can be seen in Fig. 2 (models 2a and 2b). The stent was generated in Matlab based on Bézier curves and resulted in a structured hexahedral mesh (≈70k elements with average dimensions of 0.06mm × 0.13mm × 0.32mm), with rectangular cross section dimensions of 0.4 mm × 0.2 mm for the struts. The stent was modeled with NiTi alloy material properties, by implementing a built-in Abaqus VUMAT, assuming purely superelastic behavior. The parameters that were used in the subroutine to represent the NiTi alloy behavior were based on the study by Auricchio et al. [38 (link), 39 (link)], and presented in Table 2. The leaflets and the cuff were meshed with shell (≈22k) and membrane (≈40k) elements, respectively, and assumed to have linear elastic material properties and thickness of 0.1 mm. The leaflets were modeled as bio-prosthesis porcine leaflets, with density of 1,120 kg/m³, Young’s modulus of 7.5 MPa and Poisson’s ratio of 0.45 [40 (link), 41 (link)]. The cuff was modeled with density of 1,280 kg/m³, Young’s modulus of 500 MPa and Poisson’s ratio of 0.3 [42 (link)].

Lavon K., Marom G., Bianchi M., Halevi R., Hamdan A., Morany A., Raanani E., Bluestein D, & Haj-Ali R. (2019). Biomechanical Modeling of Transcatheter Aortic Valve Replacement in a Stenotic Bicuspid Aortic Valve: Deployments and Paravalvular Leakage. Medical & biological engineering & computing, 57(10), 2129-2143.

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