Safety and Efficacy of a Novel Sealant‐Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial.
Background: While manual compression (MC) remains the standard of care to achieve hemostasis, a novel vascular closure device (VCD) was designed to achieve faster hemostasis without compromising safety. The objective of the ReliaSeal trial was to evaluate the safety and effectiveness of the Mynx Con...
| Publicado en: | Journal of Cardiovascular Electrophysiology Vol. 36; no. 5; pp. 1022 - 1032 |
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| Autores principales: | , , , , , , , , , , , , , , |
| Formato: | diagnostic images research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
May2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=185153657&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 185153657 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10453873 GSB jtl: Journal of Cardiovascular Electrophysiology issn: 10453873 maglogo: Y pubinfo: dt: May2025 vid: 36 iid: 5 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 185153657 183747648 185153657 185153657 10.1111/jce.16623 185153657 ppf: 1022 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Safety and Efficacy of a Novel Sealant‐Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial. aug: au: Summers, John Swarup, Vijay Parker, Ian Bumgarner, Joseph Brenyo, Andrew Saleh, Layth Sadanandan, Saihari Sanchez, Javier Beasley, Robert Gupta, Sanjaya Akram Khan, Muhammad Pascual, Mario Ramirez, Norman Sultana, Nusrath Adams, George affil: South Oklahoma Heart Research Center, Oklahoma City Oklahoma,, USA sug: subj: Patient Safety Evaluation Treatment Outcomes Evaluation Vascular Closure Devices Catheterization Surgical Site Lower Extremity Surgery Human Prospective Studies Randomized Controlled Trials Middle Age Aged Time Factors Walking Hemostasis Patient Discharge Descriptive Statistics Compression Therapy Adverse Effects Funding Source Middle Aged: 45-64 years Aged: 65+ years ab: Background: While manual compression (MC) remains the standard of care to achieve hemostasis, a novel vascular closure device (VCD) was designed to achieve faster hemostasis without compromising safety. The objective of the ReliaSeal trial was to evaluate the safety and effectiveness of the Mynx Control Venous VCD to close a single or multiple femoral venous access sites in one or both limbs in patients undergoing catheter‐based procedures. Methods: The ReliaSeal trial was a prospective, randomized controlled trial comparing VCD to MC in patients undergoing catheter‐based procedures requiring single or multiple access sites utilizing up to 12F sheaths. Endpoints included time to ambulation (TTA), time to hemostasis (TTH), time to discharge eligibility (TTDE), procedural/device success, and 30‐day major and minor access site complications. Results: Two hundred and seventy subjects were randomized to the VCD or MC arm (n = 177 vs. n = 93) with a mean age of 66.7 ± 11.27 years. TTA, TTH, and TTDE were significantly reduced in VCD subjects compared to MC (TTA: 2.6 ± 1.03 vs. 5.1 ± 4.35 h, p < 0.001; TTH: 2.1 ± 1.79 vs. 11.4 ± 7.19 min, p < 0.001; TTDE: 3.1 ± 1.24 vs. 5.5 ± 4.58 h, p < 0.001, respectively). Procedural and device success was achieved in 100% of VCD subjects, compared to 98.9% of the MC group. No major or minor complications occurred in the VCD group; with a 5% minor complication rate in the MC group. Conclusion: The use of VCD resulted in significant reductions in TTA, TTH, and TTDE, with no major or minor complications and a high success rate. Summary: What is known:Manual compression (MC) remains the standard of care to achieve hemostasis following catheter ablation for atrial fibrillation at many hospitals.There is a growing need to achieve efficient, safe, and effective post‐procedure venous hemostasis in order to improve the post‐procedure recovery process to reduce vascular access complications, reduce patient discomfort, and shorten the recovery period to facilitate same‐day discharge.What the study adds:The ReliaSeal trial was a prospective, randomized controlled trial comparing vascular closure devices (VCD) to manual compression (MC) in patients undergoing catheter‐based procedures requiring single or multiple access sites utilizing up to 12F sheaths.Compared to subjects receiving MC, there was a shorter time to ambulation (TTA), time to hemostasis (TTH), and time to discharge eligibility (TTDE) in subjects receiving VCD.VCD use was associated with a high success rate with no major or minor complications. pubtype: Academic Journal doctype: diagnostic images research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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