麻豆传媒

A head-to-head comparison of vascular closure devices defied expectations in the CHOICE-CLOSURE trial.

For large-bore arterial access site closure after transfemoral transcatheter aortic valve replacement (TAVR), use of the Manta plug-based vascular closure device resulted in significantly more access-site or access-related vascular complications (per VARC-2 definition) when compared with the doubling technique with the older, suture-based ProGlide (19.4% vs 12.0%, RR 1.61, 95% CI 1.07-2.44).

Manta's weakness appeared to be an excess in access site pseudoaneurysms and hematomas in particular, reported Mohamed Abdel-Wahab, MD, of Heart Center Leipzig-University of Leipzig, Germany, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held in Orlando and broadcast online. The results of the 516-person trial was simultaneously published in .

Abdel-Wahab said that his group had hypothesized the opposite, that Manta would be associated with a lower vascular complication rate.

This device delivers a collagen-based plug, precluding the use of an additional closure device, and had been associated with very short times to hemostasis, as well as high rates of device success in initial studies, even if it did flop later in the .

"Given the fact that Manta is a quite large closure device, it might imply an early effect of complete hemostasis while allowing micro-bleeding around the puncture site that is initially inapparent, both clinically and angiographically," the researchers suggested. "Technical and procedural measures to improve outcomes with the plug-based MANTA strategy need to be developed and specific indications need to be studied."

It remains to be seen which patients are a good fit for which device, Abdel-Wahab noted.

With vascular plugs such as Manta and the smaller Angio-Seal, patients run the risk of acute femoral occlusion that can lead to limb ischemia. A stent graft may be needed in these patients.

"A stent across the common femoral artery is a poor choice ... That can be a long-term devastating complication," cautioned TCT press conference panelist Keith Allen, MD, of Mid America Heart and Lung Surgeons in Kansas City, Missouri.

Nevertheless, "the MANTA device appears to be a possible bail-out strategy for device failure of the suture-based approach, since it offers a different and commonly effective vascular closure approach, though this needs to be assessed in a larger series of patients with suture-based device failure," Abdel-Wahab and colleagues wrote.

FDA approved the Manta in 2019. The ProGlide is a second-generation iteration of the decades-old Prostar and has been .

In CHOICE-CLOSURE, Manta and double ProGlide groups experienced similarly low rates of severe complications such as mortality and life-threatening bleeding.

was conducted at three sites in Germany in 2020-2021. Included were 516 TAVR recipients who were randomized to Manta pure plug-based vascular closure (the 18-French version only) or ProGlide primary suture-based vascular closure.

Among the patients, mean age was just over 80 in both Manta and ProGlide groups, and about 45% of participants were women. The average STS risk score was 4.0. Iliofemoral arteries were of similar size between study arms.

Reflecting real-world practice, double ProGlide recipients were allowed to get a small closure device (e.g., the Angio-Seal) after manual compression of at least 3 minutes to achieve complete hemostasis. This was not considered a device failure in the trial.

Abdel-Wahab reported that additional vascular closure devices were required for none in the Manta group and 58.5% of the double ProGlide arm (P<0.001).

All participating operators were said to be experienced with using both devices. However, operators may have had more cumulative experience with the older suture-based technique, Abdel-Wahab acknowledged during the TCT press conference.

He cautioned that the trial's results do not apply to the smaller 14-French Manta device or in cases where only a single ProGlide device is used for vascular closure.

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