Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery

The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial

Edward Litton, Frances Bass, Cheryl Dickson, Graham Hillis, Deborah Inskip, Theresa Jacques, David McGiffin, Shay McGuiness, Jennene Miller, Rachael Parke, Hugh Playford, Chris Reid, Julian Smith, Noah Solman, Lavinia Tran, Elizabeth Yarad, Anthony Delaney, on behalf of the ANZICS Clinical Trials Group

Research output: Contribution to journalArticleResearchpeer-review

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.

Original languageEnglish
Number of pages9
JournalHeart Lung and Circulation
DOIs
Publication statusAccepted/In press - Apr 2019

Keywords

  • Intra-aortic balloon counterpulsation
  • Low cardiac output syndrome

Cite this

Litton, Edward ; Bass, Frances ; Dickson, Cheryl ; Hillis, Graham ; Inskip, Deborah ; Jacques, Theresa ; McGiffin, David ; McGuiness, Shay ; Miller, Jennene ; Parke, Rachael ; Playford, Hugh ; Reid, Chris ; Smith, Julian ; Solman, Noah ; Tran, Lavinia ; Yarad, Elizabeth ; Delaney, Anthony ; on behalf of the ANZICS Clinical Trials Group. / Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery : The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial. In: Heart Lung and Circulation. 2019.
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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.",
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Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery : The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial. / Litton, Edward; Bass, Frances; Dickson, Cheryl; Hillis, Graham; Inskip, Deborah; Jacques, Theresa; McGiffin, David; McGuiness, Shay; Miller, Jennene; Parke, Rachael; Playford, Hugh; Reid, Chris; Smith, Julian; Solman, Noah; Tran, Lavinia; Yarad, Elizabeth; Delaney, Anthony; on behalf of the ANZICS Clinical Trials Group.

In: Heart Lung and Circulation, 04.2019.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery

T2 - The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial

AU - Litton, Edward

AU - Bass, Frances

AU - Dickson, Cheryl

AU - Hillis, Graham

AU - Inskip, Deborah

AU - Jacques, Theresa

AU - McGiffin, David

AU - McGuiness, Shay

AU - Miller, Jennene

AU - Parke, Rachael

AU - Playford, Hugh

AU - Reid, Chris

AU - Smith, Julian

AU - Solman, Noah

AU - Tran, Lavinia

AU - Yarad, Elizabeth

AU - Delaney, Anthony

AU - on behalf of the ANZICS Clinical Trials Group

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N2 - 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.

AB - 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.

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