Current use of transcatheter aortic valve replacement (TAVR) has increased in intermediate-risk patients and has even been used in low-risk patients. Vascular access-related complications and bleeding are still frequent after transfemoral TAVR, being associated with poor short- and long-term outcomes. Using percutaneous closure devices has allowed operators to close the access site without surgery. The ProGlide device has proven to be superior to the Prostar XL.
Combining suture-based closure devices with a collagen plug closure device has been reported to be safe and feasible as a rescue strategy to avoid complications. This approach could reduce obstruction and pressure on the common femoral artery. However, real-world results for this strategy are scarce.
The aim of this retrospective study was to compare the use of two ProGlide vs. one Proglide + 1 plug closure device in terms of vascular complications and bleeding in patients undergoing transfemoral TAVR.
The primary endpoint (PEP) was access-related major vascular complications and in-hospital bleeding. The secondary endpoint (SEP) included vascular complications, device failure, bleeding, and the need for surgery, endovascular treatment, and red blood cell transfusion.
A total of 989 patients were analyzed, and after using propensity score matching (PSM) to homogenize the groups, 874 patients were analyzed. Mean patient age was 80 years old, and 45% of subjects were female. The double ProGlide arm had a lower rate of patients on chronic dialysis, and tortuosity as assessed on AngioCT was also lower.
Read also: Non-Cardiac Surgery After TAVR Is Safe.
The right transfemoral access was the most frequent main access, with radial access being the most frequent secondary access in the double ProGlide arm. The most frequently used valve was SAPIEN 3, followed by ACURATE Neo, and EVOLUT R. In the double ProGlide arm, a higher amount of contrast was used.
The PEP was significantly higher in the double ProGlide group (11.4% vs. 3.0%; p < 0.001). This same group had a higher rate of device failure (2.7% vs. 0.9%; p = 0.044) and more frequently required unplanned surgery or endovascular treatment (3.9% vs. 0.9%; p = 0.004).
In a multivariate analysis, age and prior coronary artery disease were independently associated with a higher incidence of the PEP, whereas the use of ProGlide + a plug closure device was independently associated with lower incidence of the PEP.
Conclusion
Combining suture-based closure devices with associated plug devices could potentially reduce access- and bleeding-related major vascular complications, as well as the need for surgery and endovascular treatment after TAVR.
Dr. Andrés Rodríguez.
Member of the editorial board of SOLACI.org.
Original Title: Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation
Reference: Jonas M.D. Gmeiner et al EuroIntervention 2022;18.
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