The plug-based Manta (Teleflex) device was associated with significantly more vascular complications than the suture-based ProGlide (Abbott Vascular) device following transfemoral transcatheter aortic valve replacement (TAVR) in the CHOICE-CLOSURE trial.
The primary endpoint of access-site or access-related major and minor vascular complications during the index hospitalization occurred in 19.4% of patients closed with the Manta device and 12.0% closed primarily with the suture-based ProGlide device (relative risk, 1.61, 95% CI, 1.07 – 2.44; P = .029).
“In the subgroup analysis, we didn’t see an interaction that could help us to define a subgroup that could benefit from Manta,” observed lead investigator Mohamed Abdel-Wahab, MD, PhD, Heart Center Leipzig, University of Leipzig, Germany.
The team is taking a deeper dive, however, into factors that may have influenced the findings, such as puncture technique, the exact point of vessel puncture, the amount and location of calcification in the access vessels, and patient size.
“The other observation we have — and I think this is interesting and we are looking at it in more depth as well — was the use of the plug-based Manta technique as a bailout strategy because this was necessary in a small subgroup of patients in the ProGlide arm and it was actually successful in the majority, thereby avoiding complex endovascular interventions,” he said.
The results were presented during a late-breaking clinical trial session at the hybrid Transcatheter Cardiovascular Therapeutics (TCT) 2021, and published simultaneously in Circulation.
Abdel-Wahab noted that for almost a decade, suture-based devices were the only option for large-bore arteriotomy closure, but that several plug-based devices have been recently introduced, including the patch-based PerQseal (VivaSure Medical), membrane-based InClosure (InSeal Medical), and collagen-based Manta, which was approved in 2019 in the United States.
In the single-arm pivotal US SAFE MANTA trial, the time to hemostasis with Manta was just 24 seconds, and the vascular complication rate was low, at 4.2% among 263 patients undergoing various percutaneous procedures. In the more recent MASH trial, however, Manta failed to achieve superiority over ProGlide but had similar rates of vascular access-site-related complications (10% vs 4%; P = .16).
CHOICE-CLOSURE was performed at three German centers where operators were familiar with both large-bore devices and evenly randomized 516 patients to the 14 French Manta or the ProGlide device. Vascular access was obtained using digital subtraction angiography and road mapping in 72.8% of patients and ultrasound-guided puncture in 18.2%.
Two-thirds of patients had New York Heart Association class 3 or 4 heart failure, 44.6% were female, and the mean age was 80.5 years. The mean sheath size was 15.1 Fr in both groups.
To achieve complete hemostasis, use of an additional smaller device was allowed in patients receiving ProGlide after manual compression of at least 3 minutes. In all, 151 patients (58.5%) in the ProGlide group required an additional vascular closure device.
Rates of vascular closure device failure were similar in the Manta and ProGlide groups (4.7% vs 5.4%; P = .84).
Main access-site-related vascular complications were major in 3.9% of patients treated with Manta and 1.9% of patients treated with ProGlide (P = .29) and were minor in 15.5% and 10.5%, respectively (P = .11).
The time to hemostasis was shorter with the Manta, at 80 seconds, compared with 240 seconds with ProGlide (P < .001). Vascular closure device failure occurred in 4.7% and 5.4% of patients, respectively (P = .84).
At 30 days, the rate of access-site or access-related vascular complications, access-site or access-related bleeding, and/or vascular closure device failure was 19.8% for the plug-based group and 12.8% for the suture-based group (P = .043).
Mortality at 30 days was low and comparable in the Manta and ProGlide group (7 vs 5 deaths; P = .77), Abdel-Wahab said.
During a discussion of the results, Julinda Mehilli, MD, University Hospital Munich, Germany, said the data provide reassurance for using the ProGlide in her practice rather than plug-based devices, which are more time-consuming and difficult to place.
Suture-based devices also give operators the flexibility to add additional devices, if needed to achieve closure, “which is very practical for us,” she said. “But on the other side, it is important to know where we can use this [Manta] device.”
Fellow discussant Sammy Elmariah, MD, Massachusetts General Hospital, Boston, observed that “the practice within this trial clearly is very different than what, at least, I’ve experienced in the US, where ultrasound-based guidance for large bore-access is used almost universally.”
Ultrasound would likely give greater insight into the vessel anatomy, plaque, and calcification, he said. “Whether that will disproportionately impact complication rates with either of the procedures, I think is something that, unfortunately, we do not know.”
“Having said that, I’m also somewhat discouraged, I must say, that more than a decade into the TAVR experience we’re still seeing vascular complication rates that are in excess of 12% in both arms,” Elmariah said. “These are certainly clinically important events and there’s certainly a lot of data demonstrating the consequences of bleeding complications. So we desperately need to do better, regardless of which device we’re using.”
The study was funded by Helios Kliniken GmbH. Abdel-Wahab reports consulting fees/honoraria from Boston Scientific and Medtronic.
Circulaton. Published online November 5, 2021. Abstract
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