Advertisement
Canadian Journal of Cardiology

Latest-Generation Transcatheter Aortic Valve Replacement Devices and Procedures

Published:March 24, 2017DOI:https://doi.org/10.1016/j.cjca.2017.03.012

      Abstract

      Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe symptomatic aortic stenosis who are at high or prohibitive surgical risk. More recently, TAVR has emerged as a valid alternative to surgical aortic valve replacement for treating intermediate-risk patients, and several studies are currently evaluating the role of TAVR in low-risk patients. Transcatheter heart valve (THV) technologies have evolved considerably over time, and important iterations have been implemented in many of the latest-generation devices to (1) reduce the size and improve delivery system properties; (2) improve valve deployment, repositioning, and retrievability; and (3) reduce paravalvular leaks. This article reviews the main characteristics of, and clinical results associated with, the newer-generation THVs while providing an overview of novel TAVR indications.

      Résumé

      Le remplacement valvulaire aortique par cathéter (RVAC) est un traitement qui a fait ses preuves chez les patients atteints de sténose aortique symptomatique grave qui présentent un risque chirurgical élevé ou prohibitif. Depuis peu, le RVAC constitue une solution de rechange valable à l’implantation valvulaire aortique chirurgicale chez les patients présentant un risque intermédiaire, et plusieurs études visant à évaluer le rôle du RVAC chez les patients présentant un faible risque sont en cours. Les technologies valvulaires percutanées (TVP) ont considérablement évolué au fil du temps, et des variantes importantes ont été mises en œuvre dans bon nombre de dispositifs de dernière génération afin de 1) réduire leur taille et améliorer les propriétés des systèmes d’implantation; 2) améliorer le déploiement, le repositionnement et la possibilité de retrait des valves; et 3) limiter les fuites paravalvulaires. Cet article passe en revue les principales caractéristiques des TVP de nouvelle génération et les résultats cliniques qui leur sont associés, tout en offrant un aperçu des nouvelles indications du RVAC.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Canadian Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Stewart B.F.
        • Siscovick D.
        • Lind B.K.
        • et al.
        Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study.
        J Am Coll Cardiol. 1997; 29: 630-634
        • Bonhoeffer P.
        • Boudjemline Y.
        • Saliba Z.
        • et al.
        Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction.
        Lancet. 2000; 356: 1403-1405
        • Cribier A.
        • Eltchaninoff H.
        • Bash A.
        • et al.
        Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis.
        Circulation. 2002; 106: 3006-3008
        • Ribeiro H.B.
        • Urena M.
        • Allende R.
        • Amat-Santos I.J.
        • Rodes-Cabau J.
        Balloon-expandable prostheses for transcatheter aortic valve replacement.
        Progress Ccardiovas Dis. 2014; 56: 583-595
        • Manoharan G.
        • Walton A.S.
        • Brecker S.J.
        • et al.
        Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system.
        JACC Cardiovasc Interv. 2015; 8: 1359-1367
        • Meredith I.T.
        • Hood K.L.
        • Haratani N.
        • Allocco D.J.
        • Dawkins K.D.
        Boston Scientific Lotus valve.
        EuroIntervention. 2012; 8: Q70-Q74
        • Willson A.B.
        • Rodes-Cabau J.
        • Wood D.A.
        • et al.
        Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.
        J Am Coll Cardiol. 2012; 60: 581-586
        • Kempfert J.
        • Mollmann H.
        • Walther T.
        Symetis ACURATE TA valve.
        EuroIntervention. 2012; : Q102-Q109
        • Treede H.
        • Mohr F.W.
        • Baldus S.
        • et al.
        Transapical transcatheter aortic valve implantation using the JenaValve system: acute and 30-day results of the multicentre CE-mark study.
        Eur J Cardiothorac Surg. 2012; 41: e131-e138
        • Binder R.K.
        • Rodes-Cabau J.
        • Wood D.A.
        • et al.
        Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.
        JACC Cardiovasc Interv. 2013; 6: 293-300
        • Webb J.
        • Gerosa G.
        • Lefevre T.
        • et al.
        Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.
        J Am Coll Cardiol. 2014; 64: 2235-2243
        • Husser O.
        • Pellegrini C.
        • Kessler T.
        • et al.
        Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: a single-center experience.
        JACC Cardiovasc Interv. 2015; 8: 1809-1816
        • Mauri V.
        • Reimann A.
        • Stern D.
        • et al.
        Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3.
        JACC Cardiovasc Interv. 2016; 9: 2200-2209
        • Vahanian A.
        • Urena M.
        • Walther T.
        • et al.
        Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.
        EuroIntervention. 2016; 12: e235-e243
        • Kodali S.
        • Thourani V.H.
        • White J.
        • et al.
        Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.
        Eur Heart J. 2016; 37: 2252-2262
        • Tarantini G.
        • Mojoli M.
        • Purita P.
        • et al.
        Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.
        EuroIntervention. 2015; 11: 343-350
        • De Torres-Alba F.
        • Kaleschke G.
        • Diller G.P.
        • et al.
        Changes in the pacemaker rate after transition from Edwards SAPIEN XT to SAPIEN 3 transcatheter aortic valve implantation: the critical role of valve implantation height.
        JACC Cardiovasc Interv. 2016; 9: 805-813
        • Ando T.
        • Briasoulis A.
        • Holmes A.A.
        • et al.
        Sapien 3 versus Sapien XT prosthetic valves in transcatheter aortic valve implantation: a meta-analysis.
        Int J Cardiol. 2016; 220: 472-478
        • Leon M.B.
        • Smith C.R.
        • Mack M.
        • et al.
        Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
        N Engl J Med. 2010; 363: 1597-1607
        • Smith C.R.
        • Leon M.B.
        • Mack M.J.
        • et al.
        Transcatheter versus surgical aortic-valve replacement in high-risk patients.
        N Engl J Med. 2011; 364: 2187-2198
        • Herrmann H.C.
        • Thourani V.H.
        • Kodali S.K.
        • et al.
        One-Year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis.
        Circulation. 2016; 134: 130-140
        • Vavuranakis M.
        • Kalogeras K.
        • Tousoulis D.
        Successful transcatheter aortic valve implantation of a low-profile last-generation aortic bioprosthesis in a patient with coarctation of the aorta.
        Can J Cardiol. 2016; 32: 1575.e5-1575.e7
      1. Windecker S. 30-Day outcomes following implantation of a repositionable self-expanding aortic bioprosthesis: first report from the FORWARD study. Paper presented at: Transcatheter Cardiovascular Therapeutics (TCT) meeting. October 29-November 2, 2016; Washington, DC.

        • Popma J.J.
        • Reardon M.J.
        • Khabbaz K.
        • et al.
        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 U.S. Study.
        JACC Cardiovasc Interv. 2017; 10: 268-275
      2. Sorajja P, Kodali S, Reardon M, et al. Outcomes in the commercial use of self-expanding prostheses in transcatheter aortic valve replacement: a comparison of the Medtronic CoreValve and Evolut R platforms in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry™. Paper presented at: Transcatheter Cardiovascular Therapeutics (TCT) meeting. October 29-November 2, 2016; Washington, DC.

        • Meredith Am I.T.
        • Walters D.L.
        • Dumonteil N.
        • et al.
        Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.
        J Am Coll Cardiol. 2014; 64: 1339-1348
        • Pilgrim T.
        • Stortecky S.
        • Nietlispach F.
        • et al.
        Repositionable versus balloon-expandable devices for transcatheter aortic valve implantation in patients with aortic stenosis.
        J Am Heart Assoc. 2016; 5: 11
        • Wohrle J.
        • Gonska B.
        • Rodewald C.
        • et al.
        Transfemoral aortic valve implantation with the repositionable LOTUS valve for treatment of patients with symptomatic severe aortic stenosis: results from a single-centre experience.
        EuroIntervention. 2016; 12: 760-767
        • De Backer O.
        • Gotberg M.
        • Ihlberg L.
        • et al.
        Efficacy and safety of the LOTUS Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: results from the Nordic LOTUS-TAVR registry.
        Int J Cardiol. 2016; 219: 92-97
        • Rampat R.
        • Khawaja M.Z.
        • Byrne J.
        • et al.
        Transcatheter aortic valve replacement using the repositionable LOTUS valve: United Kingdom experience.
        JACC Cardiovasc Interv. 2016; 9: 367-372
        • Manoharan G.
        • Linke A.
        • Moellmann H.
        • et al.
        Multicentre clinical study evaluating a novel resheathable annular functioning self-expanding transcatheter aortic valve system: safety and performance results at 30 days with the Portico system.
        EuroIntervention. 2016; 12: 768-774
      3. Søndergaard L. International long-term follow-up study of patients implanted with a PORTICOTM valve. First report: 30 days outcomes of the Portico I study. Presented at: EuroPCR. May 17-20, 2016; Paris, France.

        • Del Trigo M.
        • Dahou A.
        • Webb J.G.
        • et al.
        Self-expanding Portico valve versus balloon-expandable SAPIEN XT valve in patients with small aortic annuli: comparison of hemodynamic performance.
        Rev Esp Cardiol (Engl Ed). 2016; 69: 501-508
        • Manoharan G.
        • Spence M.S.
        • Rodes-Cabau J.
        • Webb J.G.
        St Jude Medical Portico valve.
        EuroIntervention. 2012; : Q97-Q101
        • Makkar R.R.
        • Fontana G.
        • Jilaihawi H.
        • et al.
        Possible subclinical leaflet thrombosis in bioprosthetic aortic valves.
        N Engl J Med. 2015; 373: 2015-2024
        • Kempfert J.
        • Treede H.
        • Rastan A.J.
        • et al.
        Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA): 6-month outcomes.
        Eur J Cardiothorac Surg. 2013; 43 (discussion 57): 52-56
        • Kempfert J.
        • Holzhey D.
        • Hofmann S.
        • et al.
        First registry results from the newly approved ACURATE TA TAVI system†.
        Eur J Cardiothorac Surg. 2015; 48: 137-141
      4. Möllmann H. Symetis SAVI TF Registry. Presented at: EuroPCR. May 17-20, 2016; Paris, France.

        • Schaefer A.
        • Treede H.
        • Schoen G.
        • et al.
        Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves.
        Eur J Cardiothorac Surg. 2016; 50: 368-373
        • Silaschi M.
        • Treede H.
        • Rastan A.J.
        • et al.
        The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.
        Eur J Cardiothorac Surg. 2016; 50: 874-881
        • Seiffert M.
        • Conradi L.
        • Kloth B.
        • et al.
        Single-centre experience with next-generation devices for transapical aortic valve implantation.
        Eur J Cardiothorac Surg. 2015; 47: 39-45
        • Rudolph T.K.
        • Baldus S.
        JenaValve—transfemoral technology.
        EuroIntervention. 2013; : S101-S102
        • Leon M.B.
        • Smith C.R.
        • Mack M.J.
        • et al.
        Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.
        N Engl J Med. 2016; 374: 1609-1620
        • Thourani V.H.
        • Kodali S.
        • Makkar R.R.
        • et al.
        Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.
        Lancet. 2016; 387: 2218-2225
        • Phan K.
        • Wong S.
        • Phan S.
        • et al.
        Transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve stenosis—systematic review and meta-analysis.
        Heart Lung Circ. 2015; 24: 649-659
        • Mylotte D.
        • Lefevre T.
        • Sondergaard L.
        • et al.
        Transcatheter aortic valve replacement in bicuspid aortic valve disease.
        J Am Coll Cardiol. 2014; 64: 2330-2339
        • Yoon S.H.
        • Lefevre T.
        • Ahn J.M.
        • et al.
        Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.
        J Am Coll Cardiol. 2016; 68: 1195-1205
        • Jilaihawi H.
        • Chen M.
        • Webb J.
        • et al.
        A bicuspid aortic valve imaging classification for the TAVR era.
        JACC Cardiovasc Imaging. 2016; 9: 1145-1158
        • Chan V.
        • Malas T.
        • Lapierre H.
        • et al.
        Reoperation of left heart valve bioprostheses according to age at implantation.
        Circulation. 2011; 124: S75-S80
        • Dvir D.
        • Webb J.G.
        • Bleiziffer S.
        • et al.
        Transcatheter aortic valve implantation in failed bioprosthetic surgical valves.
        JAMA. 2014; 312: 162-170
        • Paradis J.M.
        • Del Trigo M.
        • Puri R.
        • Rodes-Cabau J.
        Transcatheter valve-in-valve and valve-in-ring for treating aortic and mitral surgical prosthetic dysfunction.
        J Am Coll Cardiol. 2015; 66: 2019-2037
        • Roy D.A.
        • Schaefer U.
        • Guetta V.
        • et al.
        Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation.
        J Am Coll Cardiol. 2013; 61: 1577-1584
        • Urena M.
        • Himbert D.
        • Ohlmann P.
        • et al.
        Transcatheter aortic valve replacement to treat pure aortic regurgitation on noncalcified native valves.
        J Am Coll Cardiol. 2016; 68: 1705-1706
        • Seiffert M.
        • Bader R.
        • Kappert U.
        • et al.
        Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.
        JACC Cardiovasc Interv. 2014; 7: 1168-1174
        • Dobson L.E.
        • Musa T.A.
        • Uddin A.
        • et al.
        Acute reverse remodelling after transcatheter aortic valve implantation: a link between myocardial fibrosis and left ventricular mass regression.
        Can J Cardiol. 2016; 32: 1411-1418