Corevalve system

Manufactured by Medtronic

Sourced in United States

The CoreValve system is a minimally invasive medical device used for the treatment of aortic valve stenosis. It is designed to replace a patient's diseased aortic valve without open-heart surgery. The CoreValve system is implanted through a small incision in the leg or chest, and is intended to provide a less invasive treatment option for patients who are at high or extreme risk for traditional surgical aortic valve replacement.

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Lab products found in correlation

Sapien system, by Edwards Lifesciences (2 mentions) Evolut r pro, by Medtronic (1 mentions) Lotus valve, by Boston Scientific (1 mentions) Prostar xl, by Abbott (1 mentions) Corevalve, by Medtronic (1 mentions) Edwards sapien xt valve, by Edwards Lifesciences (1 mentions)

Spelling variants of this product

CoreValve (109 citations) CoreValve Revalving System (7 citations) Medtronic CoreValve/Evolut R Revolving System (3 citations)

10 protocols using corevalve system

Transfemoral TAVR with Self-Expanding Devices

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From among 1767 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent transfemoral (TF) TAVR with newer-generation self-expanding devices from 2015 to April 2020 at the Heart Centre Düsseldorf, we included 473 patients with complete data in this retrospective analysis. Balloon-expandable valves, valve-in-valve procedures, pure aortic regurgitation, bicuspid valves, TAVR with other self-expanding devices at low count, and procedures without available MSCT data were excluded. Hence, only TF TAVR with the self-expanding CoreValve System (Medtronic Inc., Minneapolis, MN; Evolut R/Pro) was included. All procedures were performed according to current guideline recommendations and under local anesthesia. The initial study cohort was further separated into patients undergoing TAVR under FP (n = 284; 60.0%) or RP (n = 189; 40.0%). Due to the heterogeneity of the two populations, a propensity-score matching was employed to match RP and FP patients for risk (logistic EuroSCORE I), aortic valve area, aortic valve and left ventricular outflow calcification. One-to-one propensity-score-matching created 189 patients in the FP group and 189 patients in the RP group to a total of 378 patients of the final study cohort. A full overview of the study design and the most important read-outs are displayed in the Graphical abstract.

Veulemans V., Maier O., Piayda K., Berning K.L., Binnebößel S., Polzin A., Afzal S., Dannenberg L., Horn P., Jung C., Westenfeld R., Kelm M, & Zeus T. (2021). Factors associated with a high or low implantation of self-expanding devices in TAVR. Clinical Research in Cardiology, 110(12), 1930-1938.

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TAVI Procedural Guidelines and Antiplatelet Therapy

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All procedures were performed under general anaesthesia using the CoreValve™ System (Medtronic, MN, USA). Planning and execution of TAVI have been described previously [8] (link). After TAVI, antiplatelet therapy consisted of clopidogrel 75 mg for 3 months and aspirin 75 mg indefinitely. In patients receiving oral anticoagulation (OAC), OAC therapy was typically interrupted 3 days prior to TAVI and resumed shortly after the procedure in combination with clopidogrel 75 mg for the first three months.

De Backer O., Arnous S., Lønborg J., Brooks M., Biasco L., Jönsson A., Franzen O.W, & Søndergaard L. (2014). Recovery from Anemia in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation – Prevalence, Predictors and Clinical Outcome. PLoS ONE, 9(12), e114038.

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Severe Aortic Stenosis TAVR Outcomes

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This is a prospective cohort study conducted at ten centres in Europe. All patients with symptomatic severe AS undergoing TAVR with either a self-expanding CoreValve system (Medtronic, Minneapolis, MN) or a mechanically expanded Lotus valve (Boston Scientific, Natick, MA) were eligible. Exclusion criteria included: poor echocardiographic window (defined as two or more inadequately visualized myocardial segments [considering a 17-segment model]), the presence of atrial fibrillation (AF) at the initial evaluation, the existence of an unstable cardiac condition (such as an acute coronary syndrome or significant pericardial effusion) or refusal to provide written informed consent. The patients were evaluated at two points in time, prior to the procedure, generally between 24 and 48 h before the implant (visit 1 or V1), and on the planned discharge day (visit 2 or V2). The study was approved by our ethics committee and endorsed by the different committees at each participant center.

Lozano Granero V.C., Fernández Santos S., Fernández-Golfín C., Plaza Martín M., de la Hera Galarza J.M., Faletra F.F., Swaans M.J., López-Fernández T., Mesa D., La Canna G., Echeverría García T., Habib G., Martíne Monzonís A, & Zamorano Gómez J.L. (2018). Immediate improvement of left ventricular mechanics following transcatheter aortic valve replacement. Cardiology journal, 25(4).

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Extreme-Risk TAVR with CoreValve System

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The design and results of the CoreValve U.S. Extreme Risk Pivotal Trial have been reported previously (5 (link)). Briefly, the trial enrolled patients with severe aortic stenosis and New York Heart Association class II, III or IV heart failure symptoms. Patients were classified as extreme risk if the 30-day risk of mortality or irreversible morbidity was estimated to be ≥50% by 2 cardiac surgeons and 1 interventional cardiologist (5 (link)). In the screening process, each patient was reviewed in detail by a national screening committee that included at least 2 cardiac surgeons and 1 interventional cardiologist, each of whom had to agree that the patient met eligibility, risk, and imaging criteria for the trial. After confirmation by the trial oversight committee, patients underwent TAVR via an iliofemoral approach, using the Medtronic self-expanding CoreValve system (Medtronic, Inc., Minneapolis, MN). The study was approved by the institutional review board at each site, and all patients provided written informed consent prior to participation.

Osnabrugge R.L., Arnold S.V., Reynolds M.R., Magnuson E.A., Wang K., Gaudiani V.A., Stoler R.C., Burdon T.A., Kleiman N., Reardon M.J., Adams D.H., Popma J.J, & Cohen D.J. (2015). Health Status after Transcatheter Aortic Valve Replacement in Patients at Extreme Surgical Risk: Results from the CoreValve U.S. Trial. JACC. Cardiovascular interventions, 8(2), 315-323.

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Transcatheter Aortic Valve Implantation

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TAVI was performed using either a first-generation CoreValve system (Medtronic, Minneapolis, Minnesota, USA) or the Lotus aortic valve system (Boston Scientific Corporation, Natick, Massachusetts, USA) employing standard techniques as previously described for both vendors.18 19 (link) Multidetector CT was employed to assist annular sizing and assess aortic calcification prior to TAVI. Percutaneous femoral artery access was the default approach. Balloon valvuloplasty, rapid ventricular pacing and postdilatation (in the case of CoreValve) were employed at the discretion of the operator. All patients received weight-adjusted unfractionated heparin to maintain an activated clotting time >200 s and were treated with dual antiplatelet therapy (aspirin 75 mg and clopidogrel 75 mg) for a minimum of 3 months. None of the TAVI cases involved the use of a cerebral protection device.

Musa T.A., Uddin A., Loveday C., Dobson L.E., Igra M., Richards F., Swoboda P.P., Singh A., Garg P., Foley J.R., Fent G.J., Goddard A.J., Malkin C., Plein S., Blackman D.J., McCann G.P, & Greenwood J.P. (2019). Silent cerebral infarction and cognitive function following TAVI: an observational two-centre UK comparison of the first-generation CoreValve and second-generation Lotus valve. BMJ Open, 9(1), e022329.

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Retrospective Analysis of TAVR Outcomes

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From May 2011 to August 2019, a total of 2015 patients underwent TAVR with transfemoral (n = 1694, 84.1%) or transapical access (n = 321, 15.9%) and self-expandable (n = 1399, 69.4%) or balloon-expandable prosthesis (n = 616, 30.6%) at our institution. In this single-center, retrospective analysis, only patients with pre-procedural contrast-enhanced CT assessment and entirely calculated CHA₂DS₂-VASC and HAS-BLED scores, as well as logistic EuroSCORE I, EuroSCORE II, and STS-PROM scores, were enrolled. TAVR was performed according to current guidelines between 2011 and 2019, under local anesthesia for TF access and general anesthesia for TA access. TF TAVR was performed with different generations of either the self-expandable CoreValve System (Medtronic Inc., Minneapolis, MN, USA) or the balloon-expandable SAPIEN System (Edwards Lifesciences, Irvine, CA, USA); TA TAVR was only performed with the balloon-expandable SAPIEN System.

Maier O., Bosbach G., Piayda K., Afzal S., Polzin A., Westenfeld R., Jung C., Kelm M., Zeus T, & Veulemans V. (2022). Cerebrovascular Events after Transcatheter Aortic Valve Replacement: The Difficulty in Predicting the Unpredictable. Journal of Clinical Medicine, 11(13), 3902.

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Transcatheter Aortic Valve Implantation

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The study included 164 consecutive patients with severe aortic stenosis that underwent TAVI with a Medtronic CoreValve system© from June 2006 to November 2012, with available pre-operative Agatston score and pre-discharge transthoracic echocardiography. The details of the TAVI implantation procedure are described in full detail elsewhere [13 (link)–15 (link)]. The first five patients underwent TAVI with the second-generation Medtronic CoreValve delivery system, which is implanted using a 21Fr catheter inserted into the common femoral (n = 4) or the subclavian (n = 1) artery using surgical exposure without the use of an arterial sheath. All other patients underwent TAVI with the third-generation delivery system, using an 18Fr arterial sheath inserted into the femoral artery using an echocardiographic-guided Seldinger technique and closure with a 10Fr Prostar7 (Prostar XL, Abbott Vascular, IL); except for four who underwent the subclavian approach. All patients underwent general anesthesia, and valve implantation was done using cine and fluoroscopic guidance. The institutional review board approved the study.

Di Martino L.F., Vletter W.B., Ren B., Schultz C., Van Mieghem N.M., Soliman O.I., Di Biase M., de Jaegere P.P, & Geleijnse M.L. (2015). Prediction of paravalvular leakage after transcatheter aortic valve implantation. The International Journal of Cardiovascular Imaging, 31(7), 1461-1468.

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Cardiac Imaging in TAVR Patients

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From 2010 to 2014, 90 consecutive patients with severe aortic stenosis undergoing TAVR either by the CoreValve system (Medtronic, Minneapolis, Minnesota) or the Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, California) were screened and 19 patients were excluded due to presence of atrial fibrillation or contraindications for CMR (all due to device therapy). In the remaining 71 patients (age 81 ± 6 years) TTE and CMR were performed after TAVR (Fig. 1). This study was approved by the Ethics committee of the Faculty of medicine, University RWTH Aachen. All research was performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all participants or their legal guardians (NCT 01966146).Figure 1

Patient selection chart.

Schröder J., Almalla M., Saad M., Mezger M., Keszei A., Frick M., Lotfi S., Hoffmann R., Becker M, & Altiok E. (2020). Distinct pressure half-time values by transthoracic echocardiography for grading of paravalvular regurgitation after transcatheter aortic valve replacement. Scientific Reports, 10, 2549.

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CoreValve U.S. Extreme Risk Trial

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The design and results of the CoreValve U.S. Extreme Risk Trial have been reported previously ^{1 (link)}. Briefly, the CoreValve U.S. Extreme Risk Trial was a single arm study that enrolled patients with severe symptomatic aortic stenosis, who were classified as being at extreme risk (i.e., 30 day mortality/morbidity was estimated at ≥ 50%) for traditional surgical AVR by two cardiac surgeons and one interventional cardiologist. After confirmation by the trial oversight committee, patients underwent TAVR using the self-expanding CoreValve system (Medtronic Inc., Minneapolis, MN) via either iliofemoral (IF) access or non-iliofemoral (non-IF) access by either a transaortic or subclavian approach. The study was approved by the institutional review board at each site, and all patients provided written informed consent prior to participation. Only patients who received a transcatheter valve were included in this analysis.

Baron S.J., Arnold S.V., Reynolds M.R., Wang K., Deeb M., Reardon M.J., Hermiller J., Yakubov S.J., Adams D.H., Popma J.J, & Cohen D.J. (2017). Durability of Quality of Life Benefits of Transcatheter Aortic Valve Replacement: Long-Term Results from the CoreValve US Extreme Risk Trial. American heart journal, 194, 39-48.

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TAVR Outcomes: Risk Scores and Procedural Trends

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From 2009 to 2019, out of 1329 patients with either TF (n = 980, 73.7%) or TA (n = 349, 26.3%) TAVR, CHA₂DS₂-VASC and HAS-BLED scores were calculated as well as the logistic EuroSCORE I and STS-PROM scores. The combined CHADS-BLED score was calculated by adding the values of the single CHA₂DS₂-VASC and HAS-BLED scores. All procedures were performed according to the current guidelines between 2009 and 2019, respectively, and under local anesthesia for TF access and general anesthesia for TA access. TF TAVR was performed with different generations of either the self-expandable CoreValve System (Medtronic Inc., Minneapolis, MN) or the balloon-expandable SAPIEN System (Edwards Lifesciences, Irvine, CA). TA TAVR was predominantly performed by using the SAPIEN System (Edwards Lifesciences, Irvine, CA) or in very few cases the Engager System (Medtronic Inc., Minneapolis, MN).
All patients provided written informed consent for TAVR and the use of clinical, procedural, and follow-up data for research. The study procedures were in accordance with the Declaration of Helsinki. The Institutional Ethics Committee of the Heinrich-Heine University approved the study protocol (4080). The study is registered at clinical trials (NCT01805739).

Veulemans V., Maier O., Bosbach G., Hellhammer K., Afzal S., Piayda K., Polzin A., Jung C., Westenfeld R., Mehdiani A., Lichtenberg A., Kelm M, & Zeus T. (2020). Impact of Combined “CHADS-BLED” Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement. Journal of Interventional Cardiology, 2020, 9414397.

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