Closure systems for TAVR procedures vary by complications, time to hemostasis
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In a trial of vascular closure systems in patients who had transcatheter aortic valve replacement, a plug-based system was associated with more vascular complications but shorter time to hemostasis compared with a suture-based system.
The CHOICE-CLOSURE trial was presented by Mohamed Abdel-Wahab, MD, consultant cardiologist and head of the department of structural heart disease at Heart Center Leipzig, Germany, at TCT 2021 and simultaneously published in Circulation.
For the investigator-initiated, multicenter study, 516 patients who underwent TAVR (mean age, 81 years; 56% men) were randomly assigned to vascular access-site large-bore closure with a pure plug-based system (Manta, Teleflex) or a primary suture-based system (ProGlide, Abbott Vascular).
“The most commonly used of these devices or strategies are either based on the so-called ProGlide technique, usually requiring two devices to close the arteriotomy side, and the more recently introduced Manta technique, which is a collagen-based device used to close the arterial access site,” Abdel-Wahab said during a press conference.
The primary endpoint, access-site or access-related major and minor vascular complications as defined by Valve Academic Research Consortium-2 criteria during index hospitalization, occurred in 19.4% of the plug-based group and 12% of the suture-based group (RR = 1.61; 95% CI, 1.07-2.44; P = .029), Abdel-Wahab said during the press conference.
Access-site or access-related bleeding was numerically higher in the plug-based group (11.6% vs. 7.4%; RR = 1.58; 95% CI, 0.91-2.73; P = .133), and there was no difference between the groups in device failure (plug, 4.7%; suture, 5.4%; RR = 0.86; 95% CI, 0.4-1.82; P = .841), he said.
Time to hemostasis was shorter in the plug-based group than in the suture-based group (80 seconds vs. 240 seconds; P < .001), according to the researchers.
There were no differences between the groups in death, MI or stroke.
“Severe complications up to 30 days were infrequent, with low and comparable mortality and life-threatening bleeding rates,” Abdel-Wahab said during the press conference. “A pure plug-based technique with the Manta device is associated with a shorter time to hemostasis but a higher rate of access-site or access-related vascular complications compared to a primary suture-based technique using the ProGlide device.”
Reference:
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Anthony A. Bavry, MD, MPH
It was important to conduct this trial. TAVR requires large-bore arterial access and optimal management of the access site to prevent bleeding complications is needed.
The plug-based vascular closure device (Manta) was not superior to the standard suture-based technique (Perclose). The Manta device was associated with a higher frequency of access-site bleeding or complications compared with the Perclose device.
Operator experience and institutional practice needs to be considered when deciding on vascular closure for TAVR. For most programs, the suture-based technique remains the preferred method of achieving vascular hemostasis.
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Abdel-Wahab M, et al. Late-Breaking Clinical Trials Session II, in Collaboration with JAMA. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando (hybrid meeting).
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