Abstract
Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients (n = 50) who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion) and continued (freedom from groin surgery in further course) technical success and major (deviations from expected outcome requiring surgery) and minor (other deviations from expected outcome) complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests) and operator experience (paired samples t-test). Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based) and 90.0%, 84.0%, 16.0%, and 16.0% (patient based), respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.
Highlights
Within the recent decade, the demand for transcatheter interventions has been increasing in both low-pro le and high-pro le systems (10–25 F)
Purpose. e purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective
With ongoing technical development, improved exibility, and lower pro les, the interest in percutaneously implantable devices has been increased in particular in elder patients with limited cardiovascular function and other comorbidities and high perioperative mortality. is is especially true for infrarenal and thoracic endovascular aneurysm repair (EVAR and TEVAR) as well as for transcatheter aortic valve implantation (TAVI). e number of these patients can be expected to grow in the near future due to the lower perioperative mortality of percutaneous procedures [2]
Summary
The demand for transcatheter interventions has been increasing in both low-pro le (up to 10 F) and high-pro le systems (10–25 F). While a large number of vascular closing products, such as collagen plugs, clips, and sealing agents, exist for the closure of smaller vessel access sites of up to 8 F, these devices are not sufficient for large artery access [1]. As necessary for EVAR, TEVAR, and TAVI, these devices have to be used off-label in terms of a so-called “preclosing” procedure [7, 8]. E aim of this study was to retrospectively evaluate the efficacy and safety of percutaneous vascular access site closure using the Prostar XL device in an unselected patient and operator collective at a single academic institution without excluding cases due to limited operator experience. Major Deviations requiring surgery (periinterventional bleeding requiring surgical conversion and larger pseudoaneurysms requiring invasive therapy). F 1: Overview over outcome measures (technical success and complications)
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