Clinical impact of paravalvular leaks on biomarkers and survival after transcatheter aortic valve implantation

Catheter Cardiovasc Interv. 2015 Feb 15;85(3):502-14. doi: 10.1002/ccd.25295. Epub 2013 Dec 31.

Abstract

Background: There is accumulating evidence that up to 20% of the implanted devices after TAVI are associated with a significant degree of paravalvular leaks, which appear to be associated with a negative clinical outcome.

Methods: A total of 355 patients with severe aortic valvular stenosis (AVS) were treated by TAVI (Corevalve n = 222, Edwards Sapien n = 133). Survival, NT-proBNP and the grade of PVL were quantified up to 12 months after implantation.

Results: Technical success rate was 97.8%. Thirty-day mortality was 9.6%. Post-procedural transvalvular aortic regurgitation was seen only in a minority of cases (5%), whereas PVL were frequently observed (grade: <1+ in 58.2%, ≥1-<2 in 33.9%, and ≥2 in 7.9%). There was a clear relation-ship between PVL and adverse outcome (P < 0.001). After a transient increase, NT-proBNP showed a significant decline. Interestingly, a PVL ≥2+ was associated with a much higher rise in NT-proBNP compared to the other groups (P < 0.01), and a post-procedural increase in NT-proBNP by more than 1640 ng L(-1) within 5 days was associated with a significant increase in rate of death (P < 0.01).

Conclusions: TAVI is an efficient treatment option for high-risk patients with severe AVS. The incidence of PVL is an inacceptable clinical problem. Serial measurement of NT-proBNP can be used for risk-stratification in patients with a significant PVL. In general, PVL graded ≥2+ is associated with a dramatically increased 6-month mortality. Therefore, any action to reduce paraprosthetical regurgitation is highly recommended.

Keywords: aortic valvular stenosis; paravalvular leak; transcatheter aortic valve implantation.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / blood
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / etiology*
  • Aortic Valve Insufficiency / mortality
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Biomarkers / blood
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / mortality
  • Female
  • Germany
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood*
  • Peptide Fragments / blood*
  • Predictive Value of Tests
  • Proportional Hazards Models
  • Prosthesis Failure*
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Substances

  • Biomarkers
  • Peptide Fragments
  • pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain