The ACCESS-TAVI trial revealed a significant reduction in both major and minor access site-related vascular complications with the combined suture and plug-based strategy compared to the suture-only strategy. The trial results were presented by Tobias A. Rheude, MD, of the German Heart Center, Technical University of Munich, Germany, in a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, DC, on Tuesday. With advancements in TAVI technology and procedural techniques, outcomes have progressively improved. However, vascular complications at access sites continue to present challenges. The ACCESS-TAVI study addresses this by investigating the efficacy of different vascular closure strategies in a randomized, controlled trial. The ACCESS-TAVI trial evaluated patients with severe aortic stenosis who were eligible for transfemoral access. Participants were randomly assigned to one of two groups: a combined suture/plug group using two ProGlidesTM/ProStylesTM (Abbot Cardiovascular) or a suture-only group using one ProGlideTM/ProStyleTM. The primary was composite of major or minor access site-related vascular complications according to VARC-3 criteria during index hospitalization. Secondary endpoints included time to hemostasis, and bleeding events. The study enrolled 454 patients, with 230 in the suture/plug group and 224 in the suture-only group. The mean age was 80 years, with a higher percentage of females in the suture/plug group (51.7%) compared to the suture-only group (42%). There were no significant differences between the two cohorts regarding hypertension, diabetes, coronary artery disease, peripheral artery disease, or baseline hemoglobin levels. Additionally, there was no difference in the tortuosity of the primary access site between the two groups. Results showed that the suture/plug group experienced significantly lower rates of access site-related complications compared to the suture-only group (26.5% vs. 54%, p<0.001). The time to hemostasis was significantly longer in the suture-only group (206±171 seconds vs. 108±208 seconds, p<0.001), leading to prolonged manual compression and extended procedure time. Additionally, the incidence of bleeding events classified as Type 2 or greater was significantly higher in the suture-only group (12.1% vs. 6.2%, p=0.032). One of the main limitations of this study, which should be considered when interpreting the results, is that ultrasound-guided puncture was only used in approximately 60% of cases. These findings emphasize the benefit of utilizing a combined suture and plug approach for vascular access closure in TAVI procedures. This technique not only reduces the risk of vascular complications but also decreases procedure times, promoting faster recovery and potentially improving patient outcomes. Dr. Rheude and his team highlight the significance of these results in refining TAVI procedures and enhancing patient safety. ACCESS-TAVI marks a pivotal step toward establishing evidence-based protocols in vascular closure strategies, ultimately contributing to better clinical practice and patient care standards in cardiology. Image Caption: Tobias A. Rheude, MD, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org