title: A systematic review on the safety of second-generation transcatheter aortic valves.
abstract: OBJECTIVE
  To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV).
  
  
  RESULTS
  All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves.
  
  
  CONCLUSIONS
  Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.
authors.affiliation: Department of Cardiovascular Medicine, Mount Sinai Hospital, New York, NY, USA.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Athappan
authors.forename: Rama D
authors.initials: RD
authors.lastname: Gajulapalli
authors.forename: Murat E
authors.initials: ME
authors.lastname: Tuzcu
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: Samir R
authors.initials: SR
authors.lastname: Kapadia
mesh_terms: D001021:Aortic Valve / Q000503:physiopathology*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D016017:Odds Ratio; D061214:Patient Safety; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome