Kenya Nasu1, Etsuo Tsuchikane, Satoru Sumitsuji. 1. The Department of Cardiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi Higashinari Osaka-City, Osaka, Japan. yuya0728@m3.kcn.ne.jp
Abstract
BACKGROUND: The Prostar XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation. OBJECTIVES: The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem. METHODS: This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing. RESULTS: Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar XL and conventional manual compression groups in the EDEN trial. CONCLUSION: We conclude that the Prostar XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures.
BACKGROUND: The Prostar XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation. OBJECTIVES: The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem. METHODS: This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing. RESULTS: Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar XL and conventional manual compression groups in the EDEN trial. CONCLUSION: We conclude that the Prostar XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures.
Authors: Benjamin J Sieniewicz; Timothy R Betts; Simon James; Andrew Turley; Christian Butter; Martin Seifert; Lucas V A Boersma; Sam Riahi; Petr Neuzil; Mauro Biffi; Igor Diemberger; Pasquale Vergara; Martin Arnold; David T Keane; Pascal Defaye; Jean-Claude Deharo; Anthony Chow; Richard Schilling; Jonathan Behar; Christopher A Rinaldi Journal: Heart Rhythm Date: 2020-03-09 Impact factor: 6.343
Authors: Christoph Thomas; Volker Steger; Stefan Heller; Martin Heuschmid; Dominik Ketelsen; Claus D Claussen; Klaus Brechtel Journal: Radiol Res Pract Date: 2013-01-14