Abstract
Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) is the first self-expandable transcatheter heart valve introduced to the market, characterized by supra-annular design to enhance valve function, after obtaining Conformité Européenne (CE) Mark in 2007. CoreValve has undergone design changes to improve function to reduce transcatheter aortic valve implantation (TAVI)-related complications such as vascular complications, paravalvular leak, and pacemaker implantation. CoreValve Evolut R, a smaller profile delivery system, provides an option for valve recapture and repositioning that can assist in the precise deployment of the valve. The most recent commercially available CoreValve Evolut PRO is equipped with an outer wrap designed to enhance the contact between the valve and the aortic annulus. Many studies have shown efficacy of these devices on various patients with different comorbidities and surgical risks including extreme, high, intermediate, or even low risk. Medtronic, Inc. devices are the most commonly used self-expandable transcatheter heart valves for patients who have severe aortic stenosis and undergo TAVI and have been implanted in more than 160,000 patients worldwide (until October 2017). Ongoing trials are expected to obtain TAVI indication for younger and lower surgical-risk patients, while there still remain issues to improve outcomes and long-term safety.
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Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, Investigators P. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP, Investigators S. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.
Husser O, Pellegrini C, Kessler T, Burgdorf C, Thaller H, Mayr NP, Ott I, Kasel AM, Schunkert H, Kastrati A, Hengstenberg C. Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: a single-center experience. JACC Cardiovasc Interv. 2015;8:1809–16.
Kalra SS, Firoozi S, Yeh J, Blackman DJ, Rashid S, Davies S, Moat N, Dalby M, Kabir T, Khogali SS, Anderson RA, Groves PH, Mylotte D, Hildick-Smith D, Rampat R, Kovac J, Gunarathne A, Laborde JC, Brecker SJ. Initial experience of a second-generation self-expanding transcatheter aortic valve: the UK & Ireland Evolut R Implanters’ registry. JACC Cardiovasc Interv. 2017;10:276–82.
Binder RK, Webb JG, Willson AB, Urena M, Hansson NC, Norgaard BL, Pibarot P, Barbanti M, Larose E, Freeman M, Dumont E, Thompson C, Wheeler M, Moss RR, Yang TH, Pasian S, Hague CJ, Nguyen G, Raju R, Toggweiler S, Min JK, Wood DA, Rodes-Cabau J, Leipsic J. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial. J Am Coll Cardiol. 2013;62:431–8.
Okuyama K, Jilaihawi H, Kashif M, Takahashi N, Chakravarty T, Pokhrel H, Patel J, Forrester JS, Nakamura M, Cheng W, Makkar RR. Transfemoral access assessment for transcatheter aortic valve replacement: evidence-based application of computed tomography over invasive angiography. Circ Cardiovasc Imaging. 2015;8:e001995.
Willson AB, Webb JG, Labounty TM, Achenbach S, Moss R, Wheeler M, Thompson C, Min JK, Gurvitch R, Norgaard BL, Hague CJ, Toggweiler S, Binder R, Freeman M, Poulter R, Poulsen S, Wood DA, Leipsic J. 3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J Am Coll Cardiol. 2012;59:1287–94.
Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011;78:432–43.
Detaint D, Lepage L, Himbert D, Brochet E, Messika-Zeitoun D, Iung B, Vahanian A. Determinants of significant paravalvular regurgitation after transcatheter aortic valve: implantation impact of device and annulus discongruence. JACC Cardiovasc Interv. 2009;2:821–7.
Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tolg R, Zachow D, Guerra E, Massberg S, Schafer U, El-Mawardy M, Richardt G, investigators C. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014;311:1503–14.
Khawaja MZ, Rajani R, Cook A, Khavandi A, Moynagh A, Chowdhary S, Spence MS, Brown S, Khan SQ, Walker N, Trivedi U, Hutchinson N, De Belder AJ, Moat N, Blackman DJ, Levy RD, Manoharan G, Roberts D, Khogali SS, Crean P, Brecker SJ, Baumbach A, Mullen M, Laborde JC, Hildick-Smith D. Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative). Circulation. 2011;123:951–60.
Debry N, Sudre A, Elquodeimat I, Delhaye C, Schurtz G, Bical A, Koussa M, Fattouch K, Modine T. Prognostic value of the ratio between prosthesis area and indexed annulus area measured by MultiSlice-CT for transcatheter aortic valve implantation procedures. J Geriatr Cardiol. 2016;13:483–8.
Dvir D, Webb JG, Piazza N, Blanke P, Barbanti M, Bleiziffer S, Wood DA, Mylotte D, Wilson AB, Tan J, Stub D, Tamburino C, Lange R, Leipsic J. Multicenter evaluation of transcatheter aortic valve replacement using either SAPIEN XT or CoreValve: degree of device oversizing by computed-tomography and clinical outcomes. Catheter Cardiovasc Interv. 2015;86:508–15.
Genereux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, Davidson CJ, Eisenhauer AC, Makkar RR, Bergman GW, Babaliaros V, Bavaria JE, Velazquez OC, Williams MR, Hueter I, Xu K, Leon MB, Investigators PT. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012;60:1043–52.
Ducrocq G, Francis F, Serfaty JM, Himbert D, Maury JM, Pasi N, Marouene S, Provenchere S, Iung B, Castier Y, Leseche G, Vahanian A. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. EuroIntervention. 2010;5:666–72.
Toggweiler S, Gurvitch R, Leipsic J, Wood DA, Willson AB, Binder RK, Cheung A, Ye J, Webb JG. Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol. 2012;59:113–8.
Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchetche D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S, Investigators FS. Clinical outcomes with a repositionable self-expanding transcatheter aortic valve prosthesis: the International FORWARD Study. J Am Coll Cardiol. 2017;70:845–53.
Lenders GD, Collas V, Hernandez JM, Legrand V, Danenberg HD, den Heijer P, Rodrigus IE, Paelinck BP, Vrints CJ, Bosmans JM. Depth of valve implantation, conduction disturbances and pacemaker implantation with CoreValve and CoreValve Accutrak system for transcatheter aortic valve implantation, a multi-center study. Int J Cardiol. 2014;176:771–5.
Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: the CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015;8:837–46.
Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010;56:1623–9.
Guetta V, Goldenberg G, Segev A, Dvir D, Kornowski R, Finckelstein A, Hay I, Goldenberg I, Glikson M. Predictors and course of high-degree atrioventricular block after transcatheter aortic valve implantation using the CoreValve Revalving System. Am J Cardiol. 2011;108:1600–5.
Ferreira ND, Caeiro D, Adao L, Oliveira M, Goncalves H, Ribeiro J, Teixeira M, Albuquerque A, Primo J, Braga P, Simoes L, Ribeiro VG. Incidence and predictors of permanent pacemaker requirement after transcatheter aortic valve implantation with a self-expanding bioprosthesis. Pacing Clin Electrophysiol. 2010;33:1364–72.
Schulz E, Jabs A, Gori T, von Bardeleben S, Hink U, Kasper-Konig W, Vahl CF, Munzel T. Transcatheter aortic valve implantation with the new-generation Evolut R: comparison with CoreValve(R) in a single center cohort. Int J Cardiol Heart Vasc. 2016;12:52–6.
Alli OO, Booker JD, Lennon RJ, Greason KL, Rihal CS, Holmes DR Jr. Transcatheter aortic valve implantation: assessing the learning curve. JACC Cardiovasc Interv. 2012;5:72–9.
Ben-Dor I, Pichard AD, Satler LF, Goldstein SA, Syed AI, Gaglia MA Jr, Weissman G, Maluenda G, Gonzalez MA, Wakabayashi K, Collins SD, Torguson R, Okubagzi P, Xue Z, Kent KM, Lindsay J, Waksman R. Complications and outcome of balloon aortic valvuloplasty in high-risk or inoperable patients. JACC Cardiovasc Interv. 2010;3:1150–6.
Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI balloon valvuloplasty registry. Circulation. 1991;84:2383–97.
Liao YB, Meng Y, Zhao ZG, Zuo ZL, Li YJ, Xiong TY, Cao JY, Xu YN, Feng Y, Chen M. Meta-analysis of the effectiveness and safety of transcatheter aortic valve implantation without balloon predilation. Am J Cardiol. 2016;117:1629–35.
Auffret V, Regueiro A, Campelo-Parada F, Del Trigo M, Chiche O, Chamandi C, Puri R, Rodes-Cabau J. Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: a systematic review and meta-analysis. Catheter Cardiovasc Interv. 2017;90:839–50.
Ciuca C, Tarantini G, Latib A, Gasparetto V, Savini C, Di Eusanio M, Napodano M, Maisano F, Gerosa G, Sticchi A, Marzocchi A, Alfieri O, Colombo A, Saia F. Trans-subclavian versus transapical access for transcatheter aortic valve implantation: a multicenter study. Catheter Cardiovasc Interv. 2016;87:332–8.
Petronio AS, De Carlo M, Bedogni F, Maisano F, Ettori F, Klugmann S, Poli A, Marzocchi A, Santoro G, Napodano M, Ussia GP, Giannini C, Brambilla N, Colombo A. 2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access. J Am Coll Cardiol. 2012;60:502–7.
Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R, Valve-in-Valve International Data Registry I. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014;312:162–70.
Simonato M, Webb J, Kornowski R, Vahanian A, Frerker C, Nissen H, Bleiziffer S, Duncan A, Rodes-Cabau J, Attizzani GF, Horlick E, Latib A, Bekeredjian R, Barbanti M, Lefevre T, Cerillo A, Hernandez JM, Bruschi G, Spargias K, Iadanza A, Brecker S, Palma JH, Finkelstein A, Abdel-Wahab M, Lemos P, Petronio AS, Champagnac D, Sinning JM, Salizzoni S, Napodano M, Fiorina C, Marzocchi A, Leon M, Dvir D. Transcatheter replacement of failed bioprosthetic valves: large multicenter assessment of the effect of implantation depth on hemodynamics after aortic valve-in-valve. Circ Cardiovasc Interv. 2016;9:e003651.
Midha PA, Raghav V, Condado JF, Okafor IU, Lerakis S, Thourani VH, Babaliaros V, Yoganathan AP. Valve type, size, and deployment location affect hemodynamics in an in vitro valve-in-valve model. JACC Cardiovasc Interv. 2016;9:1618–28.
Diemert P, Seiffert M, Frerker C, Thielsen T, Kreidel F, Bader R, Schirmer J, Conradi L, Koschyk D, Schnabel R, Reichenspurner H, Blankenberg S, Kuck KH, Treede H, Schaefer U. Valve-in-valve implantation of a novel and small self-expandable transcatheter heart valve in degenerated small surgical bioprostheses: the Hamburg experience. Catheter Cardiovasc Interv. 2014;84:486–93.
Bapat V, Adams B, Attia R, Noorani A, Thomas M. Neo-annulus: a reference plane in a surgical heart valve to facilitate a valve-in-valve procedure. Catheter Cardiovasc Interv. 2015;85:685–91.
Popma JJ, Reardon MJ, Khabbaz K, Harrison JK, Hughes GC, Kodali S, George I, Deeb GM, Chetcuti S, Kipperman R, Brown J, Qiao H, Slater J, Williams MR. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: results of the Evolut R US study. JACC Cardiovasc Interv. 2017;10:268–75.
Toggweiler S, Stortecky S, Holy E, Zuk K, Cuculi F, Nietlispach F, Sabti Z, Suciu R, Maier W, Jamshidi P, Maisano F, Windecker S, Kobza R, Wenaweser P, Luscher TF, Binder RK. The electrocardiogram after transcatheter aortic valve replacement determines the risk for post-procedural high-degree AV block and the need for telemetry monitoring. JACC Cardiovasc Interv. 2016;9:1269–76.
Chorianopoulos E, Krumsdorf U, Pleger ST, Katus HA, Bekeredjian R. Incidence of late occurring bradyarrhythmias after TAVI with the self-expanding CoreValve((R)) aortic bioprosthesis. Clin Res Cardiol. 2012;101:349–55.
Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–54.
Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK, CoreValve United States Clinical I. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63:1972–81.
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK, Investigators USCC. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.
Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015;65:2184–94.
Gomes B, Geis NA, Chorianopoulos E, Meder B, Leuschner F, Katus HA, Bekeredjian R. Improvements of procedural results with a new-generation self-expanding transfemoral aortic valve prosthesis in comparison to the old-generation device. J Interv Cardiol. 2017;30:72–8.
Giannini C, De Carlo M, Tamburino C, Ettori F, Latib AM, Bedogni F, Bruschi G, Presbitero P, Poli A, Fabbiocchi F, Violini R, Trani C, Giudice P, Barbanti M, Adamo M, Colombo P, Benincasa S, Agnifili M, Petronio AS. Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: a case-matched comparison. Int J Cardiol. 2017;243:126–31.
Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. JACC Cardiovasc Interv. 2018;11:160–8.
Acknowledgments
Armando Vergara-Martel: The Valve and Structural Heart Disease Intervention Center, Division of Cardiovascular Medicine, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center.
COI Disclosure
Dr. Patel reports honoraria and personal fees from Abbott Vascular, Boston Scientific, and Medtronic. Dr. Kalra reports personal fees from Medtronic and Philips. Dr. Attizzani is a consultant and proctor for Edwards Lifesciences and Medtronic; consultant for Abbott Vascular. The remaining authors report no conflicts of interest.
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Ichibori, Y., Patel, S.M., Kalra, A., Attizzani, G.F. (2019). Medtronic Program for Transcatheter Aortic Valve Implantation. In: Giordano, A., Biondi-Zoccai, G., Frati, G. (eds) Transcatheter Aortic Valve Implantation. Springer, Cham. https://doi.org/10.1007/978-3-030-05912-5_24
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