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Investigating whether bacteria or other organisms are present in the bloodstream at the time of transcatheter aortic valve implantation (TAVI)

Incidence of periprocedural bacteraemia associated with transcatheter aortic valve implantation (TAVI)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000709549
Enrollment
75
Registered
2024-06-06
Start date
2022-10-24
Completion date
2024-05-20
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aortic stenosis is a common valvular abnormality in adults. Its incidence increases with age. The only effective treatment options for severe aortic stenosis are surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). TAVI represents a less invasive alternative to SAVR. In patients with high surgical risk TAVI has been associated with increased 1-year survival compared with SAVR, along with reduced risk of death and hospitalisation compared with conservative management. More recently, TAVI has also been shown to result in significantly lower rates of death, stroke or rehospitalisation compared with SAVR in patients with low surgical risk. As such, we can expect an increase in the number of TAVI procedures in future. Infective endocarditis is a potential complication following TAVI insertion. The rate of infective endocarditis following TAVI has been variably reported between 1 and 3%, which is similar to the rate of prosthetic valve endocarditis (PVE) following SAVR. However, the microbiology of post-TAVI endocarditis is notably different from PVE or native valve infective endocarditis, with a predominance of Enterococci. The reasons for this difference have not been elucidated but may relate to the transfemoral approach utilised for the majority of TAVIs. This raises the possibility of periprocedural bacteraemia and subsequent seeding of the newly placed valve prosthesis. To date there have been no studies investigating the rate of periprocedural bacteraemia in patients undergoing TAVI. There is a paucity of literature surrounding antibiotic prophylaxis for TAVI procedures. The European Society of Cardiology guidelines advise that antibiotic prophylaxis should be considered in patients undergoing TAVI but give no recommendation as to the agent or duration. Cefazolin is frequently used as prophylaxis for cardiothoracic surgery and a number of institutions have extrapolated this to TAVI prophylaxis. However, little is known about the pharmacokinetics (PK) and pharmacodynamics (PD) of antibiotics including cefazolin in the TAVI population, in whom there are presumably dramatic changes in haemodynamics and organ perfusion periprocedurally. Furthermore, the predominance of Enterococci in post-TAVI endocarditis would suggest that cephalosporins are a suboptimal prophylactic antibiotic. In this study, we aim to explore the incidence of periprocedural bacteraemia in patients undergoing TAVI as a possible explanation for the unique microbiological profile of infective endocarditis in this group. Additionally, we will examine demographic and procedural data for associations with any observed bacteraemia. Given the unique haemodynamic changes observed during TAVI procedures we will also examine the PK profile of prophylactic antibiotics and correlate this with any observed bacteraemia.

Interventions

Participants undergoing inpatient transcatheter aortic valve implantation (TAVI) will be sequentially enrolled into the trial. Informed consent will be gained by a study investigator or their delegate. Participants will have blood cultures collected by the procedural cardiologist or nursing staff at three time points periprocedurally to investigate for bacteraemia. These time points are: 1) at the time of femoral puncture for the TAVI procedure 2) at the time of valve deployment during the TAV

Participants undergoing inpatient transcatheter aortic valve implantation (TAVI) will be sequentially enrolled into the trial. Informed consent will be gained by a study investigator or their delegate. Participants will have blood cultures collected by the procedural cardiologist or nursing staff at three time points periprocedurally to investigate for bacteraemia. These time points are: 1) at the time of femoral puncture for the TAVI procedure 2) at the time of valve deployment during the TAVI procedure (45-90min post time point 1) 3) the day following the TAVI procedure with routine pathology collection. Blood specimens will be collected through the femoral procedure sheath or arterial line at time points 1 and 2. Time point 3 specimens will be collected via peripheral venipuncture. Participants will be followed up, via review of their electronic medical record, at 12 months post-TAVI to assess for any episodes of infective endocarditis during the study period. Participants receiving cefazolin as antimicrobial prophylaxis for their procedure will be enrolled in a sub-study investigating periprocedural cefazolin pharmacokinetics and pharmacodynamics. A serum specimen will be collected at the same time points as the above blood culture collections. An additional serum specimen will be collected 4-8 hours post TAVI procedure.

Sponsors

Dr Christopher Robson
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

undergoing a clinically indicated TAVI procedure via a transfemoral approach able to provide informed consent

Exclusion criteria

known bacteraemia within 30 days prior to TAVI procedure receipt of systemic antibiotic therapy within 5 days prior to TAVI procedure (other than procedural prophylaxis)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026