Ronald K Binder1, Stefan Stortecky1, Dik Heg1, David Tueller1, Raban Jeger1, Stefan Toggweiler1, Giovanni Pedrazzini1, Franz W Amann1, Enrico Ferrari1, Stephane Noble1, Fabian Nietlispach1, Francesco Maisano1, Lorenz Räber1, Marco Roffi1, Jürg Grünenfelder1, Peter Jüni1, Christoph Huber1, Stephan Windecker1, Peter Wenaweser2. 1. From the Department of Cardiology and Department of Cardiovascular Surgery, University Heart Centre Zurich, University Hospital Zurich, Zurich, Switzerland (R.K.B., F.N., F.M.); Department of Cardiology and Department of Cardiovascular Surgery, Swiss Cardiovascular Centre, Bern University Hospital, Bern, Switzerland (S.S., L.R., C.H., S.W., P.W.); Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Triemli Hospital Zurich, Zurich, Switzerland (D.T.); Department of Cardiology and Department of Cardiovascular Surgery, Basel University Hospital, University of Basel, Basel, Switzerland (R.J.); Cantonal Hospital Lucerne, Lucerne, Switzerland (S.T.); Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland (G.P.); Department of Cardiology, Klinik im Park, Hirslanden Clinic Zurich, Zurich, Switzerland (F.W.A.); Department of Cardiothoracic Surgery, Lausanne University Hospital, Lausanne, Switzerland (E.F.); Department of Cardiology, Geneva University Hospital, Geneva, Switzerland (S.N., M.R.); and Heart Clinic Hirslanden, Hirslanden Clinic Zurich, Zurich, Switzerland (J.G.). 2. From the Department of Cardiology and Department of Cardiovascular Surgery, University Heart Centre Zurich, University Hospital Zurich, Zurich, Switzerland (R.K.B., F.N., F.M.); Department of Cardiology and Department of Cardiovascular Surgery, Swiss Cardiovascular Centre, Bern University Hospital, Bern, Switzerland (S.S., L.R., C.H., S.W., P.W.); Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Triemli Hospital Zurich, Zurich, Switzerland (D.T.); Department of Cardiology and Department of Cardiovascular Surgery, Basel University Hospital, University of Basel, Basel, Switzerland (R.J.); Cantonal Hospital Lucerne, Lucerne, Switzerland (S.T.); Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland (G.P.); Department of Cardiology, Klinik im Park, Hirslanden Clinic Zurich, Zurich, Switzerland (F.W.A.); Department of Cardiothoracic Surgery, Lausanne University Hospital, Lausanne, Switzerland (E.F.); Department of Cardiology, Geneva University Hospital, Geneva, Switzerland (S.N., M.R.); and Heart Clinic Hirslanden, Hirslanden Clinic Zurich, Zurich, Switzerland (J.G.). peter.wenaweser@insel.ch.
Abstract
BACKGROUND: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27). CONCLUSIONS: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.
BACKGROUND: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XTpatients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XTpatients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27). CONCLUSIONS: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.
Authors: Masahiko Asami; Thomas Pilgrim; Stefan Stortecky; Dik Heg; Eva Roost; Stephan Windecker; Lukas Hunziker Journal: Clin Res Cardiol Date: 2019-03-30 Impact factor: 5.460
Authors: Thomas Pilgrim; Stefan Stortecky; Fabian Nietlispach; Dik Heg; David Tueller; Stefan Toggweiler; Enrico Ferrari; Stéphane Noble; Francesco Maisano; Raban Jeger; Marco Roffi; Jürg Grünenfelder; Christoph Huber; Peter Wenaweser; Stephan Windecker Journal: J Am Heart Assoc Date: 2016-11-17 Impact factor: 5.501
Authors: Thomas Pilgrim; Joe K T Lee; Crochan J O'Sullivan; Stefan Stortecky; Sara Ariotti; Anna Franzone; Jonas Lanz; Dik Heg; Masahiko Asami; Fabien Praz; George C M Siontis; René Vollenbroich; Lorenz Räber; Marco Valgimigli; Eva Roost; Stephan Windecker Journal: Open Heart Date: 2018-01-20