Leukodepletion for patients undergoing heart valve surgery

Spencer, Sally; Tang, Augustine; Khoshbin, Espeed

doi:10.1002/14651858.cd009507.pub2

Cited by 7 publications

(9 citation statements)

References 78 publications

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“…Participants, surgeons and research nurses were all blinded to the treatment allocation, only the perfusionist was aware of the lter used [28][29] .…”

Section: Patients On Renal Replacement Therapymentioning

confidence: 99%

“…Cochrane systematic review by the authors, failed to identify good quality trials in support of using leukodepletion in cardiac surgery in order to inform recommendations for a change in practice for its routine use [18] . Therefore this randomized trial was intended as a feasibility experiment to estimate key clinical, sub clinical and statistical parameters needed to design a larger more de nitive trial in this subject.…”

Section: Randomizedmentioning

confidence: 99%

“…It has been previously hypothesized that the inherent nephrotoxic effect of CPB may be signi cantly reduced by incorporating a leukodepletion lter into the circuit (LG-6 LeukoGuard® Leukocyte Reduction-Pall Corporation) to physically remove activated leukocytes [14− 17] . However the effectiveness of leukodepletion in reducing CPB-associated renal impairment has not been fully evaluated [18] .…”

Section: Introductionmentioning

confidence: 99%

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Is There A Renoprotective Value to Leukodepletion During Heart Valve Surgery? A Randomized Controlled Trial (ROLO)

Khoshbin

SPENCER²,

SOLOMON

et al. 2020

Preprint

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Background: Acute Kidney Injury (AKI) adversely affects outcomes after cardiac surgery. A major mediator of AKI is the activation of leukocytes through exposure to the cardiopulmonary bypass circuit. We evaluate the use of leukodepletion filters throughout bypass to protect against post-operative AKI by removing activated leukocytes during cardiac surgery. Methods: This is a single-centre, double-blind, randomized controlled trial comparing the use of leukodepletion versus a standard arterial filter throughout bypass. Elective adult patients undergoing heart valve surgery with or without concomitant procedures were investigated. The primary clinical outcome measured was the development of AKI according to the KDIGO criteria. Secondary measures included biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires. Results: The ROLO trial randomized 64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated). The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21%, 95% CI -2% to 44%). This clinical finding was supported by biomarker levels especially by a tendency toward glomerular insult at 48 hours, demonstrated by a raised serum Cystatin C (mean difference 0.11, 95% CI 0.00 to 0.23, p=0.068) in the leukodepleted group. There was however no clear association between the incidence or severity of AKI and length of hospital stay. On average, health related quality of life returned to pre-operative levels in both groups within 3 months of surgery. Conclusions: Leukocyte depletion during cardiopulmonary bypass does not significantly reduce the incidence of AKI after valvular heart surgery. Other methods to ameliorate renal dysfunction after cardiac surgery need to be investigated.Trial registration: The trial was registered by the International Standard Randomized Controlled Trial Number Registry ISRCTN42121335. Registered on the 18 February 2014. The trial was run by the Bristol Clinical Trials and Evaluation Unit. This trial was financially supported by the National Institute of Health Research (Research for Patient Benefit), award ID: PB-PG-0711-25090.

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“…Participants, surgeons and research nurses were all blinded to the treatment allocation, only the perfusionist was aware of the lter used [28][29] .…”

Section: Patients On Renal Replacement Therapymentioning

confidence: 99%

Section: Randomizedmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Is There A Renoprotective Value to Leukodepletion During Heart Valve Surgery? A Randomized Controlled Trial (ROLO)

Khoshbin

SPENCER²,

SOLOMON

et al. 2020

Preprint

Self Cite

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show abstract

“…It has been previously hypothesized that the inherent nephrotoxic effect of CPB may be significantly reduced by incorporating a leukodepletion filter into the circuit (LG-6 LeukoGuard® Leukocyte Reduction-Pall Corporation) to physically remove activated leukocytes [14][15][16][17]. However the effectiveness of leukodepletion in reducing CPB-associated renal impairment has not been fully evaluated [18].…”

Section: Introductionmentioning

confidence: 99%

Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO)

Khoshbin

Spencer

Solomon

et al. 2021

J Cardiothorac Surg

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Background Acute Kidney Injury (AKI) adversely affects outcomes after cardiac surgery. A major mediator of AKI is the activation of leukocytes through exposure to the cardiopulmonary bypass circuit. We evaluate the use of leukodepletion filters throughout bypass to protect against post-operative AKI by removing activated leukocytes during cardiac surgery. Methods This is a single-centre, double-blind, randomized controlled trial comparing the use of leukodepletion versus a standard arterial filter throughout bypass. Elective adult patients undergoing heart valve surgery with or without concomitant procedures were investigated. The primary clinical outcome measured was the development of AKI according to the KDIGO criteria. Secondary measures included biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires. Results The ROLO trial randomized 64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated). The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI − 2 to 44%). This clinical finding was supported by biomarker levels especially by a tendency toward glomerular insult at 48 h, demonstrated by a raised serum Cystatin C (mean difference 0.11, 95% CI 0.00 to 0.23, p = 0.068) in the leukodepleted group. There was however no clear association between the incidence or severity of AKI and length of hospital stay. On average, health related quality of life returned to pre-operative levels in both groups within 3 months of surgery. Conclusions Leukocyte depletion during cardiopulmonary bypass does not significantly reduce the incidence of AKI after valvular heart surgery. Other methods to ameliorate renal dysfunction after cardiac surgery need to be investigated. Trial registration The trial was registered by the International Standard Randomized Controlled Trial Number Registry ISRCTN42121335. Registered on the 18 February 2014. The trial was run by the Bristol Clinical Trials and Evaluation Unit. This trial was financially supported by the National Institute of Health Research (Research for Patient Benefit), award ID: PB-PG-0711-25,090.

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“…4 The rates of adverse transfusion reaction and of severe adverse donor reactions in the United States during the last 15 years have remained steady, at 0.24% and 0.13%, respectively. Febrile nonhemolytic reactions occurred at a rate of 1 reaction per 957 units of any blood component transfused.…”

mentioning

confidence: 99%

Bloody white cells—no problem: Let's solve hemorrhage out of the operating room

Body

2015

The Journal of Thoracic and Cardiovascular Surgery

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Leukodepletion for patients undergoing heart valve surgery

Cited by 7 publications

References 78 publications

Is There A Renoprotective Value to Leukodepletion During Heart Valve Surgery? A Randomized Controlled Trial (ROLO)

Is There A Renoprotective Value to Leukodepletion During Heart Valve Surgery? A Randomized Controlled Trial (ROLO)

Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO)

Bloody white cells—no problem: Let's solve hemorrhage out of the operating room

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