PMID- 30590565
OWN - NLM
STAT- MEDLINE
DCOM- 20200903
LR  - 20200903
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 40
IP  - 5
DP  - 2019 Feb 1
TI  - Comparison of balloon-expandable vs. self-expandable valves in patients 
      undergoing transfemoral transcatheter aortic valve implantation: from the 
      CENTER-collaboration.
PG  - 456-465
LID - 10.1093/eurheartj/ehy805 [doi]
AB  - AIMS: The aim of this study was to compare clinical outcomes of patients 
      undergoing transfemoral transcatheter aortic valve implantation (TAVI) with 
      balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter 
      aortic valve implantation is a minimally invasive and lifesaving treatment in 
      patients with aortic valve stenosis. Even though BE-valves and SE-valves are both 
      commonly used on a large scale, adequately sized trials comparing clinical 
      outcomes in patients with severe aortic valve stenosis treated with BE-valves 
      compared with SE-valves are lacking. METHODS AND RESULTS: In this 
      CENTER-collaboration, data from 10 registries or clinical trials, selected 
      through a systematic search, were pooled and analysed. Propensity score 
      methodology was used to reduce treatment selection bias and potential 
      confounding. The primary endpoints were mortality and stroke at 30 days follow-up 
      in patients treated with BE-valves compared with SE-valves. Secondary endpoints 
      included clinical outcomes, e.g. bleeding during hospital admission. All outcomes 
      were split for early-generation BE-valves compared with early-generation 
      SE-valves and new-generation BE-valves with new-generation SE-valves. The overall 
      patient population (N = 12 381) included 6239 patients undergoing TAVI with 
      BE-valves and 6142 patients with SE-valves. The propensity matched population had 
      a mean age of 81 +/- 7 years and a median STS-PROM score or 6.5% [interquartile 
      range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not 
      statistically different in patients undergoing TAVI with BE-valves compared with 
      SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval 
      (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with 
      BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, 
      patients treated with BE-valves had a three-fold lower risk of requiring 
      pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, 
      P < 0.001). In contrast, patients treated with new-generation BE-valves more 
      frequently experienced major and life-threatening bleedings compared with 
      new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, 
      P < 0.001). CONCLUSION: In this study, which is the largest study to compare 
      valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker 
      implantation was lower in patients undergoing transfemoral TAVI with BE-valves 
      compared with SE-valves. In contrast, patients treated with new-generation 
      BE-valves more often suffered from major or life-threatening bleedings than 
      patients with new-generation SE-valves. Mortality at 30-days was not 
      statistically different in patients treated with BE-valves compared with 
      SE-valves. This study was a propensity-matched analysis generated from 
      observational data, accordingly current outcomes will have to be confirmed in a 
      large scale randomized controlled trial.
FAU - Vlastra, Wieneke
AU  - Vlastra W
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
FAU - Chandrasekhar, Jaya
AU  - Chandrasekhar J
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, USA.
FAU - Munoz-Garcia, Antonio J
AU  - Munoz-Garcia AJ
AD  - Department of Cardiology, Hospital Universitario Virgen de la Victoria, Campus de 
      Teatinos, S/N, Malaga, Spain.
FAU - Tchetche, Didier
AU  - Tchetche D
AD  - Clinique Pasteur, 45 Avenue de Lombez - BP 27617 - 31076 TOULOUSE, Toulouse, 
      France.
FAU - de Brito, Fabio S Jr
AU  - de Brito FS Jr
AD  - Heart Institute (InCor), University of Sao Paulo Medical School, Av. Dr. Eneas 
      Carvalho de Aguiar, 44 - Cerqueira Cesar, Sao Paulo - SP, Brazil.
FAU - Barbanti, Marco
AU  - Barbanti M
AD  - Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of 
      Catania, Via Salvatore Citelli, 6, Catania CT, Italy.
FAU - Kornowski, Ran
AU  - Kornowski R
AD  - Cardiology Department, Rabin Medical Center, Ze'ev Jabotinsky St 39, Petah Tikva, 
      Israel.
FAU - Latib, Azeem
AU  - Latib A
AD  - Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 
      Milano, 58, Milano MI, Italy.
FAU - D'Onofrio, Augusto
AU  - D'Onofrio A
AD  - Department of Cardiac, Thoracic and Vascular Sciences, Interventional Cardiology 
      Unit, University of Padova, Via Nicolo Giustiniani, 2, Padova PD, Italy.
FAU - Ribichini, Flavio
AU  - Ribichini F
AD  - Division of Cardiology, Department of Medicine, University of Verona, Policlinico 
      GB Rossi, Piazzale L.A. Scuro 10, Verona, Italy.
FAU - Baan, Jan
AU  - Baan J
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
FAU - Tijssen, Jan G P
AU  - Tijssen JGP
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
FAU - Trillo-Nouche, Ramiro
AU  - Trillo-Nouche R
AD  - Servicio de Cardiologia, Complejo Hospitalario Universitario de Santiago de 
      Compostela, Santiago de Compostela, Rua da Choupana, s/n, 15706 Santiago de 
      Compostela, A Coruna, Spain.
FAU - Dumonteil, Nicolas
AU  - Dumonteil N
AD  - Clinique Pasteur, 45 Avenue de Lombez - BP 27617 - 31076 TOULOUSE, Toulouse, 
      France.
FAU - Abizaid, Alexandre
AU  - Abizaid A
AD  - Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese, 500 - Vila 
      Mariana, Sao Paulo - SP, Brazil.
FAU - Sartori, Samantha
AU  - Sartori S
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, USA.
FAU - D'Errigo, Paola
AU  - D'Errigo P
AD  - National Centre for Global Helath-Istituto Superiore di Sanita, Viale Regina 
      Elena, 299, Roma RM, Italy.
FAU - Tarantini, Giuseppe
AU  - Tarantini G
AD  - Department of Cardiac, Thoracic and Vascular Sciences, Interventional Cardiology 
      Unit, University of Padova, Via Nicolo Giustiniani, 2, Padova PD, Italy.
FAU - Lunardi, Mattia
AU  - Lunardi M
AD  - Division of Cardiology, Department of Medicine, University of Verona, Policlinico 
      GB Rossi, Piazzale L.A. Scuro 10, Verona, Italy.
FAU - Orvin, Katia
AU  - Orvin K
AD  - Cardiology Department, Rabin Medical Center, Ze'ev Jabotinsky St 39, Petah Tikva, 
      Israel.
FAU - Pagnesi, Matteo
AU  - Pagnesi M
AD  - Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 
      Milano, 58, Milano MI, Italy.
FAU - Del Valle, Raquel
AU  - Del Valle R
AD  - Hospital Universitario Central de Asturias, Julian Claveria. S/N, 33011 Oviedo, 
      Asturias, Spain.
FAU - Modine, Thomas
AU  - Modine T
AD  - Centre Hospitalier Universitaire, 2, avenue Oscar Lambret - 59037 Lille, France.
FAU - Dangas, George
AU  - Dangas G
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, USA.
FAU - Mehran, Roxana
AU  - Mehran R
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, USA.
FAU - Piek, Jan J
AU  - Piek JJ
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
FAU - Delewi, Ronak
AU  - Delewi R
AD  - Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, 
      University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/surgery
MH  - Aortic Valve Stenosis/*surgery
MH  - Conversion to Open Surgery/statistics & numerical data
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/adverse effects
MH  - Humans
MH  - Male
MH  - Observational Studies as Topic
MH  - Pacemaker, Artificial/*statistics & numerical data
MH  - Postoperative Complications/epidemiology/mortality
MH  - Propensity Score
MH  - *Prosthesis Design
MH  - Registries
MH  - Stroke/*epidemiology/etiology
MH  - *Transcatheter Aortic Valve Replacement/methods/mortality
EDAT- 2018/12/28 06:00
MHDA- 2020/09/04 06:00
CRDT- 2018/12/28 06:00
PHST- 2018/09/10 00:00 [received]
PHST- 2018/11/13 00:00 [accepted]
PHST- 2018/12/28 06:00 [pubmed]
PHST- 2020/09/04 06:00 [medline]
PHST- 2018/12/28 06:00 [entrez]
AID - 5259360 [pii]
AID - 10.1093/eurheartj/ehy805 [doi]
PST - ppublish
SO  - Eur Heart J. 2019 Feb 1;40(5):456-465. doi: 10.1093/eurheartj/ehy805.