title: Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice.
  
  
  METHODS
  From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed.
  
  
  RESULTS
  Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort.
  
  
  CONCLUSIONS
  Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.
authors.affiliation: Herzzentrum Bonn, Medizinische Klinik Und Poliklinik II, Universitätsklinikum Bonn, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Sedaghat
authors.affiliation: Westdeutsches Herzzentrum Essen, Klinik Für Kardiologie, Universitätsklinikum Essen, Germany.
authors.forename: Fadi
authors.initials: F
authors.lastname: Al-Rashid
authors.affiliation: Herzzentrum Bonn, Medizinische Klinik Und Poliklinik II, Universitätsklinikum Bonn, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.affiliation: Westdeutsches Herzzentrum Essen, Klinik Für Thorax-Und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wendt
authors.affiliation: Westdeutsches Herzzentrum Essen, Klinik Für Thorax-Und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.affiliation: Herzzentrum Bonn, Medizinische Klinik Und Poliklinik II, Universitätsklinikum Bonn, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: Herzzentrum Bonn, Medizinische Klinik Und Poliklinik II, Universitätsklinikum Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Westdeutsches Herzzentrum Essen, Klinik Für Kardiologie, Universitätsklinikum Essen, Germany.
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
authors.affiliation: Herzzentrum Bonn, Medizinische Klinik Und Poliklinik II, Universitätsklinikum Bonn, Germany.
authors.forename: Nikos
authors.initials: N
authors.lastname: Werner
authors.affiliation: Westdeutsches Herzzentrum Essen, Klinik Für Kardiologie, Universitätsklinikum Essen, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Kahlert
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000628:therapy*; D002423:Cause of Death; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D018579:Patient Selection; D016016:Proportional Hazards Models; D011859:Radiography; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality*; D016896:Treatment Outcome
keywords: TAVI; TAVR; partner trial; risk prediction