Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR
Key result
Surgical cutdown and percutaneous access for TF-TAVR resulted in identical rates of major and minor vascular complications at 30 days (26.7% in each group).
Why the study?
Does percutaneous access with closure devices reduce vascular complications compared to surgical cutdown in patients undergoing transfemoral TAVR?
Population
30 consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR)
Comparison
Percutaneous access with closure devices vs Surgical cutdown access
Design
RCT, Randomized to either surgical cutdown or percutaneous access
Follow-up
30 days
Authors
Discussion
Loading...
Member takes
Implication
Should not change TF-TAVR access practices; pilot data leaves open need for larger trials.
Study Design
Type
RCT (n=30)
Randomization
randomized
Structured PICO
Does percutaneous access with closure devices reduce vascular complications compared to surgical cutdown in patients undergoing transfemoral TAVR?
P
Population
30 consecutive patients undergoing transfemoral transcatheter aortic valve replacement, followed for 30 days.
I
Intervention
Percutaneous access with closure devices
C
Comparator
Surgical cutdown access
O
Outcome
Composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2 (VARC-2)safety
Main Result
Absolute Event Rate: 26.7% vs 26.7%
In a small pilot RCT, percutaneous access for transfemoral TAVR demonstrated equivalent safety to surgical cutdown regarding 30-day vascular complications.
Limitations
- Small sample size (pilot study)
- small sample size
Cite This Study
Holper et al. (2013) conducted an RCT in transfemoral transcatheter aortic valve replacement (TF-TAVR) (n=30). Surgical cutdown vs. Percutaneous access was evaluated on Composite of major and minor vascular complications at 30 days. Surgical cutdown and percutaneous access for TF-TAVR resulted in identical rates of major and minor vascular complications at 30 days (26.7% in each group).