PMID- 21747054
OWN - NLM
STAT- MEDLINE
DCOM- 20110926
LR  - 20220318
IS  - 1524-4539 (Electronic)
IS  - 0009-7322 (Linking)
VI  - 124
IP  - 4
DP  - 2011 Jul 26
TI  - One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European 
      Outcome (SOURCE) registry: the European registry of transcatheter aortic valve 
      implantation using the Edwards SAPIEN valve.
PG  - 425-33
LID - 10.1161/CIRCULATIONAHA.110.001545 [doi]
AB  - BACKGROUND: Transcatheter aortic valve implantation was developed to provide a 
      therapeutic option for patients considered to be ineligible for, and to mitigate 
      mortality and morbidity associated with, high-risk surgical aortic valve 
      replacement. METHODS AND RESULTS: The Edwards SAPIEN Aortic Bioprosthesis 
      European Outcome (SOURCE) Registry was designed to assess initial post commercial 
      clinical transcatheter aortic valve implantation results of the Edwards SAPIEN 
      valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients 
      enrolled at 32 centers. One-year outcomes are presented. Patients with the 
      transapical approach (n=575) suffered more comorbidities than transfemoral 
      patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 
      25.8%; P=0.007). These groups are different; therefore, outcomes cannot be 
      directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% 
      for transapical and 81.1% for transfemoral patients, and 73.5% of surviving 
      patients were in New York Heart Association (NYHA) class I or II at 1 year. 
      Combined transapical and transfemoral causes of death were cardiac in 25.1%, 
      noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal 
      failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent 
      noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, 
      renal disease, liver disease, and smoking as variables with the highest hazard 
      ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and 
      hypertension were associated with lower mortality. CONCLUSION: The SOURCE 
      Registry is the largest consecutively enrolled registry for transcatheter aortic 
      valve implantation procedures. It demonstrates that with new transcatheter aortic 
      techniques excellent 1-year survival in high-risk and inoperable patients is 
      achievable and provides a benchmark against which future transcatheter aortic 
      valve implantation cohorts and devices can be measured.
FAU - Thomas, Martyn
AU  - Thomas M
AD  - Director of Cardiovascular Services, Cardiology Department, St. Thomas' Hospital, 
      Westminster Bridge Rd., London, UK. mttwins@aol.com
FAU - Schymik, Gerhard
AU  - Schymik G
FAU - Walther, Thomas
AU  - Walther T
FAU - Himbert, Dominique
AU  - Himbert D
FAU - Lefevre, Thierry
AU  - Lefevre T
FAU - Treede, Hendrik
AU  - Treede H
FAU - Eggebrecht, Holger
AU  - Eggebrecht H
FAU - Rubino, Paolo
AU  - Rubino P
FAU - Colombo, Antonio
AU  - Colombo A
FAU - Lange, Rudiger
AU  - Lange R
FAU - Schwarz, Rebecca R
AU  - Schwarz RR
FAU - Wendler, Olaf
AU  - Wendler O
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110711
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve Stenosis/*mortality/*surgery
MH  - Cardiac Catheterization
MH  - Carotid Stenosis/mortality
MH  - Cause of Death
MH  - *Cohort Studies
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/*methods/*mortality
MH  - Humans
MH  - Hyperlipidemias/mortality
MH  - Hypertension/mortality
MH  - Kidney Diseases/mortality
MH  - Liver Diseases/mortality
MH  - Male
MH  - Postoperative Complications/mortality
MH  - Registries
MH  - Smoking/mortality
MH  - Treatment Outcome
EDAT- 2011/07/13 06:00
MHDA- 2011/09/29 06:00
CRDT- 2011/07/13 06:00
PHST- 2011/07/13 06:00 [entrez]
PHST- 2011/07/13 06:00 [pubmed]
PHST- 2011/09/29 06:00 [medline]
AID - CIRCULATIONAHA.110.001545 [pii]
AID - 10.1161/CIRCULATIONAHA.110.001545 [doi]
PST - ppublish
SO  - Circulation. 2011 Jul 26;124(4):425-33. doi: 10.1161/CIRCULATIONAHA.110.001545. 
      Epub 2011 Jul 11.