One of the challenges that transcatheter aortic valve replacement (TAVR) continues to face is percutaneous access closure with percutaneous closure systems (PCS).
However, several systems have been developed, either by plug—such as the MANTA system—or by suture (SU)—such as the ProStar and ProGlide systems.
Both of these have been tested in different analyses, but to date they are similar and still continue to have certain difficulties.
Researchers conducted a meta-analysis of two randomized and eight observational studies including a total of 3113 patients. Of these, 1358 received the MANTA (43.6%) system, while 1755 received either the ProStar or ProGlide (56.4%) systems.
The primary endpoint (PEP) was major vascular complication according to VARC-2 criteria.
Mean patient age was 80 years old and most subjects were male. Self-expanding valves were used the most, and in most cases heparin was reverted.
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There were no differences in the PEP (3.1% vs. 3.3 %; odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52−1.53; p = 0.67).
The PCS failure rate was lower in the PL D group (6.2% vs. 8.9 %; OR: 0.60; 95% CI: 0.44−0.83; p = 0.002; I2 = 14%). However, in this group there was a greater trend towards unplanned vascular access intervention (8.2% vs. 5.9 %; OR: 1.35; 95% CI: 0.97−1.89; p = 0.07; I2 = 3%).
There were no differences in the rates for mortality, bleeding (major, minor or life-threatening), transfusion, bruising, pseudoaneurysm, lower limb ischemia, or arteriovenous fistulae.
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In randomized trials, the rates of bleeding, major bleeding, and minor vascular complications were lower in those who received a plug PCS vs. SU PCS.
Conclusion
In patients undergoing TAVR, closure using plug-based PCSs was associated with a similar safety profile than SU-based PCSs. However, subgroup analysis demonstrated that the plug-based PCSs were associated with a higher incidence of vascular and bleeding complications in randomized studies.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Reference: Ramy Sedhom MD, et al. Catheter Cardiovasc Interv. 2023;101:817–827.
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