Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery: The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial - 08/05/20
, Frances Bass, BN c, Cheryl Dickson, RN d, Graham Hillis, MBChB, PhD b, e, Deborah Inskip, RN f, Theresa Jacques, MBBS, FCICM f, David McGiffin, MBBS, FRACS g, Shay McGuiness, FANZCA, FCICM g, Jennene Miller, RN f, Rachael Parke, RN, PhD h, Hugh Playford, FANZCA, FCICM i, Chris Reid, PhD j, Julian Smith, MS, FRACS k, Noah Solman, BBiomed j, Lavinia Tran, PhD j, Elizabeth Yarad, MN c, Anthony Delaney, MBBS, PhD con behalf of the ANZICS Clinical Trials Group
Abstract |
Background |
Prophylactic intra-aortic balloon counterpulsation (IABC) is commonly used in selected patients undergoing coronary artery bypass graft (CABG) surgery, but definitive evidence is lacking. The aim of the multicentre PINBALL Pilot randomised controlled trial (RCT) was to assess the feasibility of performing a definitive trial to address this question.
Methods |
Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome were eligible for inclusion if the treating surgical team was uncertain as to the benefit of prophylactic IABC. The primary outcome of feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up.
Results |
The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants. For 20/24 (83%) participants, preoperative IABC use occurred according to study assignment. Six (6)-month follow-up was available for all enrolled participants, [IABC 1 death (8%) vs. control 1 death (9%), p = 0.95].
Conclusion |
The PINBALL Pilot recruitment rate was insufficient to demonstrate feasibility of a multicentre RCT of prophylactic IABC in high risk patients undergoing CABG surgery.
Le texte complet de cet article est disponible en PDF.Keywords : Intra-aortic balloon counterpulsation, Low cardiac output syndrome
Plan
Vol 29 - N° 5
P. 710-718 - mai 2020 Retour au numéro
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