Validação de protocolo para obtenção de hemostasia com dispositivo de compressão radial TR BandTM após intervenção coronária percutânea

Cathet Cardio Intervent

Mattos

Rinaldi

et al. 2016

Self Cite

Section: Methodsmentioning

confidence: 99%

Comparison of a vascular closure device versus the radial approach to reduce access site complications in non‐ST‐segment elevation acute coronary syndrome patients: The angio‐seal versus the radial approach in acute coronary syndrome trial

Cathet Cardio Intervent

Mattos

Rinaldi

et al. 2016

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“…The TR Band device (Terumo Medical Corporation, Tokyo, JP) will be applied to obtain homeostasis according to a previously validated protocol [ 31 , 32 ]. Immediately after procedure completion, the sheath is initially pulled by approximately 2 cm.…”

Section: Methodsmentioning

confidence: 99%

Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients

Mattos

Tebet

et al. 2013

Trials

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BackgroundArterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy.MethodsARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair.ResultsEnrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014.ConclusionsThe ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.Trial registrationClinicalTrials.gov identifier: NCT01653587

“…8 Immediately after the procedure, the sheath was withdrawn by approximately 2 cm. The device was applied to the patient with a green marker (located in the center of the largest balloon) positioned exactly at the puncture orifice, facilitating the localization, visualization, and control of possible bleeding.…”

Section: Hemostasis Technique While Maintaining Antegrade Flowmentioning

confidence: 99%

Use of a Selective Radial Compression Device to Prevent Radial Artery Occlusion After Coronary Invasive Procedure

Barbosa

Revista Brasileira de Cardiologia Invasiva (English Version)

et al. 2014

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Background: In addition to providing greater comfort and convenience for the patient, the radial approach is associated to lower rates of vascular complications and major bleeding, with potential impact on morbidity and mortality. Thus, the adoption of strategies that reduce the risk of arterial occlusion after invasive procedures, enabling it to be reused, is desirable. Methods: Controlled prospective registry evaluating the impact of routine adoption of a selective radial compression device in patients with acute coronary syndrome without ST-segment elevation undergoing early invasive stratification through the radial access. Arterial patency was assessed by the Barbeau test at hospital discharge and at the 30-day follow-up. Results: Fifty-nine patients were evaluated, of which 83% underwent ad hoc percutaneous coronary intervention. Mean age was 64 ± 12.2, 66.1% were male and 28.8% had diabetes mellitus. The right radial access was used in 98.3% of cases, the number of catheters was 2.4 ± 0.6, with a diameter of 6 F in all cases, and the duration of the procedure was 32.4 ± 12.7 minutes. Spasm was reported in 10.2% of cases, hematoma > 5 cm in 3.4% and occlusion of the radial artery after the procedure and at 30 days in 6.8% and 3.4% of the cases, respectively. Conclusions: The TR Band ® radial compression device is safe and effective in obtaining reduced rates of radial artery occlusion after invasive coronary procedures.