title: Beyond the short-term: clinical outcome and valve performance 2 years after transcatheter aortic valve implantation in 227 patients.
abstract: OBJECTIVE
  Although the procedural feasibility of transcatheter aortic valve implantation has been shown by multiple groups, longer-term data are rare. We report on 2-year follow-up clinical and echocardiographic results after transcatheter aortic valve implantation in 227 patients.
  
  
  METHODS
  Patients' mean age was 81 ± 7 years, 59% were female, mean European System for Cardiac Operative Risk Evaluation was 21% ± 14%, mean Society of Thoracic Surgeons score was 7% ± 5%, and access routes were transfemoral (n = 164), transapical (n = 54), axillary (n = 5), or transaortic (n = 4). A CoreValve (Medtronic Inc, Minneapolis, Minn) prosthesis was implanted in 174 patients, and a SAPIEN prosthesis (Edwards Lifesciences, Irvine, Calif) was implanted in 53 patients. Clinical and echocardiographic investigations were performed at 6 months, 1 year, and 2 years.
  
  
  RESULTS
  Survival was 88.5% at 30 days, 75.9% at 6 months, 74.5% at 1 year, and 64.4% at 2 years. Patients improved significantly in New York Heart Association class after 6 months (from 3.2 ± 0.5 to 1.7 ± 0.7, P < .001) and up to 2 years (1.9 ± 0.7). Cumulative incidences of myocardial infarction, stroke, and life-threatening or major bleeding were 2.7%, 6.2%, and 16.2% at 2 years, respectively. The postprocedural mean transprosthetic gradient was 12 ± 4 mm Hg for all valves and did not change up to 2 years, and the effective orifice area was 1.5 ± 0.4 cm² with no change over 2 years of follow-up. Moderate or severe prosthetic regurgitation was present in 8% of patients at 2 years. In 6% of patients, the paravalvular or valvular regurgitation grade increased significantly over time.
  
  
  CONCLUSIONS
  With excellent functional recovery of the patients, good systolic valve function, and overall low morbidity at 2 years, transcatheter aortic valve implantation may be considered the treatment of choice for aortic valve stenosis in elderly patients with an increased risk for surgery with a heart-lung machine.
authors.affiliation: Clinic for Cardiovascular Surgery, German Heart Center Munich, Germany. bleiziffer@dhm.mhn.de
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.forename: Domenico
authors.initials: D
authors.lastname: Mazzitelli
authors.forename: Anke
authors.initials: A
authors.lastname: Opitz
authors.forename: Ina
authors.initials: I
authors.lastname: Hettich
authors.forename: Hendrik
authors.initials: H
authors.lastname: Ruge
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D018579:Patient Selection; D011474:Prosthesis Design; D020127:Recovery of Function; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography