Suture-Based Percutaneous Closure vs. Plug for Large Arteriotomies

This research was designed to test the superiority of plug-based vs. suture-based vascular closure devices in large arteriotomies, such as transcatheter aortic valve replacement (TAVR).

Cierre con sutura o plug

Vascular complications from TAVR are relevant and, in many cases, derive from problems with the closure device.

The MASH (MANTA vs. Suture-based vascular closure after transcatheter aortic valve replacement) study was conducted in two centers, where patients undergoing TAVR were randomized to the MANTA device vs. 2 ProGlides.

The primary endpoint was a composite of major and minor access-related complications. The secondary endpoint included clinically relevant access-site bleeding, time to hemostasis, and device failure (not achieving hemostasis within 5 minutes or requiring an additional maneuver, such as stenting, surgery, or another device).

Between 2018 and 2020, 210 patients were enrolled (mean age: 81; mean STS: 2.7%).


Read also: Should We Discontinue Anticoagulation Before TAVR?


There were no differences in vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Furthermore, clinically relevant bleeding rates were similar (9% vs. 6%, respectively, p = 0.57).

Device failure was less frequent with the MANTA device (20% vs. 40%, p < 0.001). To fix that issue, MANTA usually required surgery or a covered stent, while ProGlide could frequently solve the vascular complication with an additional closure device.

Conclusion

The plug-based vascular percutaneous closure device was similar in terms of vascular complications and bleeding compared with a suture-based device.

Device failure was lower with MANTA, but rescue maneuvers when needed were different that those required by the ProGlide.

Original title: Suture- or Plug-Based Large-Bore Arteriotomy Closure. A Pilot Randomized Controlled Trial.

Reference: Maarten P. van Wiechen et al. J Am Coll Cardiol Intv 2021, article in press.https://doi.org/10.1016/j.jcin.2020.09.052.


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