Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves

Ronald K Binder; Stefan Stortecky; Dik Heg; David Tueller; Raban Jeger; Stefan Toggweiler; Giovanni Pedrazzini; Franz W Amann; Enrico Ferrari; Stephane Noble; Fabian Nietlispach; Francesco Maisano; Lorenz Räber; Marco Roffi; Jürg Grünenfelder; Peter Jüni; Christoph Huber; Stephan Windecker; Peter Wenaweser

doi:10.1161/CIRCINTERVENTIONS.115.002653

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves

Circ Cardiovasc Interv. 2015 Oct;8(10):e002653. doi: 10.1161/CIRCINTERVENTIONS.115.002653.

Authors

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

Affiliations

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.

PMID: 26453687
DOI: 10.1161/CIRCINTERVENTIONS.115.002653

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.

Keywords: aortic valve stenosis; bleeding; transcatheter aortic valve replacement; transcatheter heart valve; transcutaneous aortic valve implantation; vascular complications.

Publication types

Clinical Trial
Multicenter Study
Observational Study

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / surgery*
Aortic Valve Stenosis / epidemiology
Aortic Valve Stenosis / surgery*
Cohort Studies
Female
Heart Valve Prosthesis / adverse effects
Heart Valve Prosthesis / statistics & numerical data*
Humans
Male
Postoperative Complications / epidemiology
Postoperative Complications / prevention & control*
Prospective Studies
Risk
Switzerland
Transcatheter Aortic Valve Replacement*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01368250