Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Reparación del aneurisma aórtico abdominal percutáneo: Estado actual e implicancias futuras / Endovascular repair of abdominal aortic aneurysms: Current status and future directions

La reparación del aneurisma aórtico abdominal endovascular (EVAR) se encuentra ampliamente aceptada, siendo una alternativa no sólo efectiva sino también segura a la cirugía a cielo abierto, en aquellos pacientes que cuentan con anatomía apropiada. Como se han producido avances tecnológicosen lo que respecta a la reducción del perfil del dispositivo endovascular y a la complejidad del implante, los métodos percutáneos bilaterales de acceso de ambas arterias femorales han surgido como un esfuerzo para reducir no sólo las complicaciones de las heridas quirúrgicas, sino también el disconfort del paciente por la misma cirugía.Posteriormente, la introducción de la anestesia local con el enfoque percutáneo ha reducido lascomplicaciones que comúnmente se asocian con el uso de la anestesia general durante el EVAR. Previamente, la reparación del aneurisma aórtico abdominal percutáneo se ha descrito como la utilización de la técnica “preclose”. La meta de este trabajo es revisar la literatura y discutir sobre las implicancias futuras del acceso arterial femoral percutáneo con anestesia local para la reparacióndel aneurisma aórtico abdominal endovascular (PEVAR).

A cirurgia de reparação de aneurisma aórtico abdominal endovascular (EVAR) encontra-se vastamente aceita, sendo uma alternativa não só efetiva como também segura para a cirurgia a céu aberto, em pacientes que possuem anatomia apropriada. Devido aos progressos tecnológicos relativosà redução do perfil do dispositivo endovascular e à complexidade do implante, os métodos percutâneos bilaterais, de acesso a ambas as artérias femorais surgiram como um esforço para reduzir não apenas as complicações das feridas cirúrgicas, como também o desconforto do pacientepela própria cirurgia. Posteriormente, a introdução da anestesia local com o enfoque percutâneo reduziu as complicações que comumente são associadas ao uso da anestesia geral durante o EVAR. Previamente, acirurgia de reparação do aneurisma aórtico abdominal percutâneo foi descrita como a utilização da técnica “preclose”. A meta deste trabalho é rever a literatura e discutir as implicâncias futuras do acesso arterial femoral percutâneo com anestesia local para a cirurgia de reparação do aneurisma aórtico abdominal endovascular (PEVAR).

Endovascular repair of abdominal aortic aneurysms (EVAR) is currently widely accepted as an alternative which is not only effective but safe compared to open surgery in patients with the appropriateanatomy. As important technological progress has been achieved with regards to the reduction of the endograft profile and the complexity of the stent, bilateral percutaneous methodsthrough both femoral arteries have been developed in an effort to reduce not only the complications related to the surgical wound but also the discomfort of the patient related to surgery itself.Later, the introduction of local anesthesia with the percutaneous approach reduced the complicationswhich were commonly associated to the use of general anesthesia during EVAR. Previously, the percutaneous abdominal aortic aneurysm repair had been described as the utilization of the“preclose” technique. The purpose of this paper is to review the literature and discuss the future implications ofpercutaneous arterial femoral access with local anesthesia in percutaneous endovascular abdominal aortic aneurysm repair (PEVAR).