PMID- 30346515
OWN - NLM
STAT- MEDLINE
DCOM- 20200909
LR  - 20200909
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Linking)
VI  - 55
IP  - 4
DP  - 2019 Apr 1
TI  - Outcomes after transaortic transcatheter aortic valve implantation: long-term 
      findings from the European ROUTEdagger.
PG  - 737-743
LID - 10.1093/ejcts/ezy333 [doi]
AB  - OBJECTIVES: There is lack of data regarding the longer-term outcomes of patients 
      undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We 
      aimed to provide a contemporary snapshot of the types and frequencies of events 
      in the year following TAo-TAVI. METHODS: The Registry of the Utilization of the 
      TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, 
      European, prospective, observational registry of aortic stenosis patients 
      undergoing TAo-TAVI. Patients were grouped according to the composite end point 
      death, myocardial infarction, stroke/transient ischaemic attack, major vascular 
      complications, life-threatening bleeding, acute kidney injury (AKI) and/or 
      cardiovascular rehospitalization. RESULTS: Two hundred and fifty-three patients 
      with a mean age of 81.5 +/- 5.8 years were included, of whom 89 (35.2%) patients 
      met the composite end point (the event group) and 164 (64.8%) patients did not 
      (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 
      71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 
      11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal 
      insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 
      1 year, the most common event was death (19.1%), followed by AKI stage II or III 
      (14.7%). The baseline renal insufficiency was the strongest independent predictor 
      of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval 
      (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and 
      pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an 
      independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). 
      CONCLUSIONS: Long-term outcomes after TAo-TAVI appear to be similar to those for 
      TAVI via other non-transfemoral access routes. Awareness of characteristics 
      associated with poorer outcomes may aid patient selection and identification of 
      those requiring closer post-procedural monitoring. CLINICAL TRIAL REGISTRATION 
      NUMBER: ClinicalTrials.gov identifier: NCT01991431.
CI  - (c) The Author(s) 2018. Published by Oxford University Press on behalf of the 
      European Association for Cardio-Thoracic Surgery. All rights reserved.
FAU - Cocchieri, Riccardo
AU  - Cocchieri R
AD  - Department of Cardiothoracic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, 
      Netherlands.
FAU - Petzina, Rainer
AU  - Petzina R
AD  - Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, 
      Kiel, Germany.
FAU - Romano, Mauro
AU  - Romano M
AD  - Department of Thoracic and Cardiovascular Surgery, Institut Hospitalier Jacques 
      Cartier, Massy, France.
FAU - Jagielak, Dariusz
AU  - Jagielak D
AD  - Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, 
      Poland.
FAU - Bonaros, Nikolaos
AU  - Bonaros N
AD  - Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria.
FAU - Aiello, Marco
AU  - Aiello M
AD  - Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S. Matteo, 
      Pavia University School of Medicine, Pavia, Italy.
FAU - Lapeze, Joel
AU  - Lapeze J
AD  - Department of Cardiovascular Surgery, Hospital Louis Pradel, Lyon, France.
FAU - Laine, Mika
AU  - Laine M
AD  - Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland.
FAU - Chocron, Sidney
AU  - Chocron S
AD  - Department of Cardiac Surgery, Hospital Jean Minjoz, University Hospital of 
      Besancon, Besancon, France.
FAU - Muir, Douglas
AU  - Muir D
AD  - Department of Cardiothoracic Surgery, James Cook Hospital, Middlesbrough, UK.
FAU - Eichinger, Walter
AU  - Eichinger W
AD  - Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany.
FAU - Thielmann, Matthias
AU  - Thielmann M
AD  - Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, 
      University Hospital Essen, Essen, Germany.
FAU - Labrousse, Louis
AU  - Labrousse L
AD  - Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, Bordeaux, France.
FAU - Rein, Kjell Arne
AU  - Rein KA
AD  - Department of Cardiothoracic Surgery, Rikshospital Oslo, Oslo, Norway.
FAU - Verhoye, Jean-Philippe
AU  - Verhoye JP
AD  - Department of Cardiovascular Surgery, CHU Rennes, Rennes, France.
FAU - Gerosa, Gino
AU  - Gerosa G
AD  - Department of Cardiac Surgery, University of Padova, Padova, Italy.
FAU - Bapat, Vinayak
AU  - Bapat V
AD  - Department of Cardiac Surgery, St. Thomas'Hospital, London, UK.
FAU - Baumbach, Hardy
AU  - Baumbach H
AD  - Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, 
      Stuttgart, Germany.
FAU - Sims, Helen
AU  - Sims H
AD  - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
FAU - Deutsch, Cornelia
AU  - Deutsch C
AD  - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
FAU - Bramlage, Peter
AU  - Bramlage P
AD  - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
FAU - Kurucova, Jana
AU  - Kurucova J
AD  - Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland.
FAU - Thoenes, Martin
AU  - Thoenes M
AD  - Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland.
FAU - Frank, Derk
AU  - Frank D
AD  - Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, 
      Kiel, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01991431
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - Germany
TA  - Eur J Cardiothorac Surg
JT  - European journal of cardio-thoracic surgery : official journal of the European 
      Association for Cardio-thoracic Surgery
JID - 8804069
SB  - IM
MH  - Aged, 80 and over
MH  - Aortic Valve Stenosis/surgery
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Proportional Hazards Models
MH  - Prospective Studies
MH  - Registries/statistics & numerical data
MH  - Risk Factors
MH  - Transcatheter Aortic Valve Replacement/adverse 
      effects/methods/mortality/*statistics & numerical data
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Balloon-expandable
OT  - Follow-up
OT  - Mortality
OT  - Transaortic
OT  - Transcatheter aortic valve implantation
EDAT- 2018/10/23 06:00
MHDA- 2020/09/10 06:00
CRDT- 2018/10/23 06:00
PHST- 2018/05/17 00:00 [received]
PHST- 2018/08/30 00:00 [revised]
PHST- 2018/09/06 00:00 [accepted]
PHST- 2018/10/23 06:00 [pubmed]
PHST- 2020/09/10 06:00 [medline]
PHST- 2018/10/23 06:00 [entrez]
AID - 5135840 [pii]
AID - 10.1093/ejcts/ezy333 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.