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DOI: 10.1055/s-0041-1725824
A Prospective Randomized Comparison of Manta and Proglide in Terms of Vascular Complications in TAVI
Objectives: Vascular and bleeding complications following transcatheter aortic valve implantation (TAVI) are known to increase morbidity and mortality. We aimed to compare the rate of vascular and bleeding complications between a novel plug-based vascular closure device (PB-VCD) and a wide available suture-based vascular closure device (SB-VCD) in patients undergoing TAVI in a prospective randomized study.
Methods: From September 2019 to April 2020, a total of 145 patients with severe aortic stenosis scheduled for isolated transfemoral TAVI were prospectively included. Block-randomization using varying block sizes was performed to randomize patients either to PB-VCD (n = 73, 50.3%) or to SB-VCD (n = 72, 49.7%) in a 1:1 ratio. The primary endpoint of the study was any vascular complication (major and minor combined) defined in accordance to the Valve Academic Research Consortium – II (VARC-II) criteria. Secondary endpoints were rates of VARC-II bleeding complications.
Result: The rate of any vascular complication according to VARC-II occurred in 21.9% (n = 16) and 26.4% (n = 19) of patients treated with PB-VCD and SB-VCD respectively (p = 0.664). Details regarding individual vascular and bleeding VARC-II endpoints are listed in the attached table.
Complication definition, n (%) |
SB-VCD (n = 72) |
PB-VCD (n = 73) |
p-Value |
Primary endpoint |
|||
Any vascular complication |
19 (26.4) |
16 (21.9) |
0.664 |
Individual vascular complications according to VARC-II |
|||
Major vascular complications |
6 (8.3) |
8 (11.0) |
0.799 |
Minor vascular complications |
13 (18.1) |
8 (11.0) |
0.328 |
Individual bleeding complications according to VARC-II |
|||
Life-threatening bleed |
6 (8.3) |
6 (8.2) |
1.000 |
Major bleeding |
5 (7.0) |
8 (11.0) |
0.597 |
Minor bleeding |
9 (12.5) |
6 (8.2) |
0.566 |
Conclusion: PB-VCD and SB-VCD show comparable results in all assessed rates of vascular and bleeding complications defined in accordance to VARC-II criteria. Presented results should be interpreted under the light of the relatively low sample size of the study.
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No conflict of interest has been declared by the author(s).
Publication History
Article published online:
19 February 2021
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