Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Balloon-Expandable Transcatheter Heart Valve A Single-Center Experience

被引:45
作者
Husser, Oliver [1 ]
Pellegrini, Costanza [1 ]
Kessler, Thorsten [1 ]
Burgdorf, Christof [1 ]
Thaller, Hannah [1 ]
Mayr, N. Patrick [2 ]
Ott, Ilka [1 ]
Kasel, Albert M. [1 ]
Schunkert, Heribert [1 ,3 ]
Kastrati, Adnan [1 ,3 ]
Hengstenberg, Christian [1 ,3 ]
机构
[1] Tech Univ Munich, Deutsch Herzzentrum Munchen, Klin Herz & Kreislauferkrankungen, D-80636 Munich, Germany
[2] Tech Univ Munich, Deutsch Herzzentrum Munchen, Inst Anasthesiol, D-80636 Munich, Germany
[3] Deutsch Zentrum Herz & Kreislauf Forsch DZHK eV, German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany
关键词
aortic valve stenosis; outcome; SAPIEN; 3; transfemoral transcatheter aortic valve implantation; VARC-2; PERMANENT PACEMAKER IMPLANTATION; SAPIEN; 3; EDWARDS SAPIEN; VASCULAR COMPLICATIONS; RISK; STENOSIS; METAANALYSIS; DEFINITIONS; PREDICTORS; COREVALVE;
D O I
10.1016/j.jcin.2015.08.014
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVES Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria. BACKGROUND Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited. METHODS A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days. RESULTS The mean age was 81.0 +/- 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed. CONCLUSIONS We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor. (C) 2015 by the American College of Cardiology Foundation.
引用
收藏
页码:1809 / 1816
页数:8
相关论文
共 34 条
[1]   MULTICENTER, PROSPECTIVE, RANDOMIZED, SINGLE BLIND, CONSECUTIVE ENROLLMENT EVALUATION A NOVOLIMUS-ELUTING CORONARY STENT SYSTEM WITH BIOABSORBABLE POLYMER COMPARED TO A ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM: 6-MONTH ANGIOGRAPHIC AND IVUS RESULTS AND 24-MONTH CLINICAL: THE EXCELA BD STUDY [J].
Abizaid, Alexandre ;
Schofer, Joachim ;
Botelho, Roberto ;
Verheye, Stefan ;
Costa, Ricardo ;
Tanajura, Luiz Fernando ;
Morrison, Lynn ;
Toyloy, Sara ;
Fitzgerald, Peter .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 61 (10) :E1207-E1207
[2]   SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR) [J].
Achenbach, Stephan ;
Delgado, Victoria ;
Hausleiter, Joerg ;
Schoenhagen, Paul ;
Min, James K. ;
Leipsic, Jonathon A. .
JOURNAL OF CARDIOVASCULAR COMPUTED TOMOGRAPHY, 2012, 6 (06) :366-380
[3]   Comparison of Hemodynamic Performance of the Balloon-Expandable SAPIEN 3 Versus SAPIEN XT Transcatheter Valve [J].
Amat-Santos, Ignacio J. ;
Dahou, Abdellaziz ;
Webb, John ;
Dvir, Danny ;
Dumesnil, Jean G. ;
Allende, Ricardo ;
Ribeiro, Henrique B. ;
Urena, Marina ;
Paradis, Jean-Michel ;
DeLarochelliere, Robert ;
Dumont, Eric ;
Bergeron, Sebastien ;
Thompson, Christopher R. ;
Pasian, Sergio ;
Bilodeau, Sylvie ;
Leipsic, Jonathon ;
Larose, Eric ;
Pibarot, Philippe ;
Rodes-Cabau, Josep .
AMERICAN JOURNAL OF CARDIOLOGY, 2014, 114 (07) :1075-1082
[4]   Influence of Transcatheter Aortic Valve Replacement Strategy and Valve Design on Stroke After Transcatheter Aortic Valve Replacement [J].
Athappan, Ganesh ;
Gajulapalli, R. Dilip ;
Sengodan, Prasanna ;
Bhardwaj, Anju ;
Ellis, Stephen G. ;
Svensson, Lars ;
Tuzcu, Emin Murat ;
Kapadia, Samir R. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2014, 63 (20) :2101-2110
[5]   Transcatheter Aortic Valve Replacement With the SAPIEN 3 A New Balloon-Expandable Transcatheter Heart Valve [J].
Binder, Ronald K. ;
Rodes-Cabau, Josep ;
Wood, David A. ;
Mok, Michael ;
Leipsic, Jonathon ;
De Larochelliere, Robert ;
Toggweiler, Stefan ;
Dumont, Eric ;
Freeman, Melanie ;
Willson, Alexander B. ;
Webb, John G. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2013, 6 (03) :293-300
[6]   Impact of Permanent Pacemaker Implantation on Clinical Outcome Among Patients Undergoing Transcatheter Aortic Valve Implantation [J].
Buellesfeld, Lutz ;
Stortecky, Stefan ;
Heg, Dik ;
Hausen, Sven ;
Mueller, Ralf ;
Wenaweser, Peter ;
Pilgrim, Thomas ;
Gloekler, Steffen ;
Khattab, Ahmed A. ;
Huber, Christoph ;
Carrel, Thierry ;
Eberle, Balthasar ;
Meier, Bernhard ;
Boekstegers, Peter ;
Jueni, Peter ;
Gerckens, Ulrich ;
Grube, Eberhard ;
Windecker, Stephan .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2012, 60 (06) :493-501
[7]   Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (FRench Aortic National Core Valve and Edwards) registry [J].
Chevreul, Karine ;
Brunn, Matthias ;
Cadier, Benjamin ;
Haour, Georges ;
Eltchaninoff, Helene ;
Prat, Alain ;
Leguerrier, Alain ;
Blanchard, Didier ;
Fournial, Gerard ;
Lung, Bernard ;
Donzeau-Gouge, Patrick ;
Tribouilloy, Christophe ;
Debrux, Jean-Louis ;
Pavie, Alain ;
Gilard, Martine ;
Gueret, Pascal .
ARCHIVES OF CARDIOVASCULAR DISEASES, 2013, 106 (04) :209-219
[8]   Transcatheter Aortic Valve Implantation With the Edwards SAPIEN Versus the Medtronic CoreValve Revalving System Devices A Multicenter Collaborative Study: The PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration) [J].
Chieffo, Alaide ;
Buchanan, Gill Louise ;
Van Mieghem, Nicolas M. ;
Tchetche, Didier ;
Dumonteil, Nicolas ;
Latib, Azeem ;
van der Boon, Robert M. A. ;
Vahdat, Olivier ;
Marcheix, Bertrand ;
Farah, Bruno ;
Serruys, Patrick W. ;
Fajadet, Jean ;
Carrie, Didier ;
de Jaegere, Peter P. T. ;
Colombo, Antonio .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 61 (08) :830-836
[9]   Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients [J].
Eggebrecht, Holger ;
Schmermund, Axel ;
Voigtlaender, Thomas ;
Kahlert, Philipp ;
Erbel, Raimund ;
Mehta, Rajendra H. .
EUROINTERVENTION, 2012, 8 (01) :129-138
[10]   Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry [J].
Eltchaninoff, Helene ;
Prat, Alain ;
Gilard, Martine ;
Leguerrier, Alain ;
Blanchard, Didier ;
Fournial, Gerard ;
Iung, Bernard ;
Donzeau-Gouge, Patrick ;
Tribouilloy, Christophe ;
Debrux, Jean-Louis ;
Pavie, Alain ;
Gueret, Pascal .
EUROPEAN HEART JOURNAL, 2011, 32 (02) :191-197