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.

Publication History

Article published online:
19 February 2021