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.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
19 February 2021