INTRODUCTION:Minimized perfusion circuits (MPCs), although aiming at minimizing the adverse effects of cardiopulmonary bypass, have not yet gained popularity. This can be attributed to concerns regarding their safety, as well as lack of sufficient evidence of their benefit. METHODS: Described is a randomized, multicentre study comparing the MPC - ROCsafeRX to standard cardiopulmonary bypass in patients undergoing elective coronary artery bypass grafting and/ or aortic valve replacement. RESULTS:Five hundred patients were included in the study (252 randomized to the ROCsafeRX group and 248 to standard cardiopulmonary bypass). Both groups were well matched for demographic characteristics and type of surgery. No operative mortality and no device-related complications were encountered. Transfusion requirement (333 ± 603 vs. 587 ± 1010 ml; p=0.001), incidence of atrial fibrillation (16.3% vs. 24.2%; p=0.03) and the incidence of major adverse events (9.1% vs. 16.5%; p=0.02) were all in favour of the MPC group. CONCLUSION: These results confirm both the safety and efficacy of the ROCsafeRX MPC for a large variety of cardiac patients. Minimized perfusion circuits should, therefore, play a greater role in daily practice so that as many patients as possible can benefit from their advantages.
RCT Entities:
INTRODUCTION: Minimized perfusion circuits (MPCs), although aiming at minimizing the adverse effects of cardiopulmonary bypass, have not yet gained popularity. This can be attributed to concerns regarding their safety, as well as lack of sufficient evidence of their benefit. METHODS: Described is a randomized, multicentre study comparing the MPC - ROCsafeRX to standard cardiopulmonary bypass in patients undergoing elective coronary artery bypass grafting and/ or aortic valve replacement. RESULTS: Five hundred patients were included in the study (252 randomized to the ROCsafeRX group and 248 to standard cardiopulmonary bypass). Both groups were well matched for demographic characteristics and type of surgery. No operative mortality and no device-related complications were encountered. Transfusion requirement (333 ± 603 vs. 587 ± 1010 ml; p=0.001), incidence of atrial fibrillation (16.3% vs. 24.2%; p=0.03) and the incidence of major adverse events (9.1% vs. 16.5%; p=0.02) were all in favour of the MPC group. CONCLUSION: These results confirm both the safety and efficacy of the ROCsafeRX MPC for a large variety of cardiac patients. Minimized perfusion circuits should, therefore, play a greater role in daily practice so that as many patients as possible can benefit from their advantages.
Authors: Kyriakos Anastasiadis; John Murkin; Polychronis Antonitsis; Adrian Bauer; Marco Ranucci; Erich Gygax; Jan Schaarschmidt; Yves Fromes; Alois Philipp; Balthasar Eberle; Prakash Punjabi; Helena Argiriadou; Alexander Kadner; Hansjoerg Jenni; Guenter Albrecht; Wim van Boven; Andreas Liebold; Fillip de Somer; Harald Hausmann; Apostolos Deliopoulos; Aschraf El-Essawi; Valerio Mazzei; Fausto Biancari; Adam Fernandez; Patrick Weerwind; Thomas Puehler; Cyril Serrick; Frans Waanders; Serdar Gunaydin; Sunil Ohri; Jan Gummert; Gianni Angelini; Volkmar Falk; Thierry Carrel Journal: Interact Cardiovasc Thorac Surg Date: 2016-01-26
Authors: Pierre Tibi; R Scott McClure; Jiapeng Huang; Robert A Baker; David Fitzgerald; C David Mazer; Marc Stone; Danny Chu; Alfred H Stammers; Tim Dickinson; Linda Shore-Lesserson; Victor Ferraris; Scott Firestone; Kalie Kissoon; Susan Moffatt-Bruce Journal: J Extra Corpor Technol Date: 2021-06
Authors: Timothy Cheng; Rajas Barve; Yeu Wah Michael Cheng; Andrew Ravendren; Amna Ahmed; Steven Toh; Christopher J Goulden; Amer Harky Journal: JTCVS Open Date: 2021-10-01