1Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie Mainz, Deutschland; 2Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 3Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; 4Maastricht UMC+Heart+Vascular Center Department of Vascular Surgery Maastricht, Niederlande; 5Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie, Kardiologie III-Angiologie Mainz, Deutschland
Background
Endovascular interventions such as transcatheter aortic valve implantations (TAVI), circulatory support with extracorporeal membrane oxygenation(ECMO) as well as peripheral arterial disease intervention (PAD) are performed percutaneously via transfemoral access. Access site complications are an omnipresent concern, and predictive for interventional outcome by increasing 30-day mortality.
The prevalence of vascular complications (VC) has only slightly decreased over the last years. A lot of research has been performed, but consistent risk factors have not been identified. Earlier meta-analysis have shown that the use of ultrasound guided (USG) puncture reduces the risk for access site complications in several types of procedures. Advantages offered by USG puncture are most accurate guidance of puncture. USG closure can mitigate the risk of access vessel occlusion by deploying the entire device intravascularly, placing the closure device extravascularly, and preventing improper closure caused by anterior or posterior calcification, summarized by ensuring precise deployment at the intended location.
Objective
The aim of this study was to evaluate the effect of USG vs. CC (CC) after cardiovascular interventions with artery puncture, and the impact on the incidence of access complications.
Methods
A systematic literature search was performed using the Web of science, Cochrane Database and Medline database. Studies reporting and comparing the incidence of access site complications after USG arterial closure for transfemoral cardiac procedures were included. Meta-analyses were performed to analyze the effect of the chosen closure technique on access site complication, as reported in the studies.
Results
3 TAVI, 2 ECMO and 3 PAD studies were included. 5 studies evaluated a plug-based and 1 a suture-based closure device, of which 4 used Manta 2 ExoSeal, 1 AngioSeal and 1 ProGlide. All studies were retrospectively conducted and published between 2018 and 2023. The usage of the different closure devices in the particular interventions is summarized in table 1.
In ECMO patients, the incidence of access complications was 9.8%, in TAVI patients 7.1% and in PAD patients 3.3% after USG closure at the primary access site.
2162 patients were included in the USG closure group and 830 patients in the CC group.
We included 2162 USG closure and 830 CC patients in this meta-analysis. In the USG TAVI closure group, 868 patient received Manta closure and 63 ProGlide closure. The remaining 1131 patients received USG closure using an AngioSeal in a PAD procedure. In the CC group 58 ProGlide and 337 Manta closures, as well as 335 AngioSeal closures were included.
USG closure reduced access site complications (OR 0.44, 95% CI 0.30 –0.64, P <0.0001, Figure 1), major VC (OR 0.22, 95% CI 0.08 –0.57, P = 0.002, Figure 2) and bleeding complications (OR 0.38, 95% CI 0.15 –0.96, P = 0.04; Figure 3) significantly compared to CC. Minor VC were not significantly decreased using USG closure (OR 0.22, 95% CI 0.04–1.35, P = 0.1)
Conclusion
USG closure is an upcoming topic in vascular closure and is already used in various cardiovascular interventions. Compared to CC, USG closure reduced access site complications, major VC and bleeding complications in a pooled analysis of retrospective studies including large and small sheath size procedures. Further and especially prospective research is needed to validate the findings of this meta-analysis of retrospective data.