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J Thorac Cardiovasc Surg 2008;135:347-354
© 2008 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery

Jane W. Newburger, MD, MPH^a,h,_*, Richard A. Jonas, MD^b,g,_*, Janet Soul, MD^c,j, Barry D. Kussman, MBBCh^d,i, David C. Bellinger, PhD, MSc^c,j, Peter C. Laussen, MD^a,i, Richard Robertson, MD^e,k, John E. Mayer, Jr, MD^b,g, Pedro J. del Nido, MD^b,g, Emile A. Bacha, MD^b,g, Joseph M. Forbess, MD^b,g,, Frank Pigula, MD^b, Stephen J. Roth, MD, MPH^a, Karen J. Visconti, PhD^b, Adre J. du Plessis, MBChB, MPH^c,j, David M. Farrell, MA, CCP^b, Ellen McGrath, RN^a, Leonard A. Rappaport, MD^f,h, David Wypij, PhD^a,h,l

^a Department of Cardiology, Children’s Hospital Boston, Boston, Mass
^b Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
^c Department of Neurology, Children’s Hospital Boston, Boston, Mass
^d Department of Anesthesiology, Children’s Hospital Boston, Boston, Mass
^e Department of Radiology, Children’s Hospital Boston, Boston, Mass
^f Department of Pediatrics, Children’s Hospital Boston, Boston, Mass
^g Department of Surgery, Harvard Medical School, Boston, Mass
^h Department of Pediatrics, Harvard Medical School, Boston, Mass
ⁱ Department of Anesthesia, Harvard Medical School, Boston, Mass
^j Department of Neurology, Harvard Medical School, Boston, Mass
^k Department of Radiology Harvard Medical School, Boston, Mass
^l Department of Biostatistics, Harvard School of Public Health, Boston, Mass.

Received for publication October 11, 2006; revisions received January 9, 2007; accepted for publication January 29, 2007.

^_* Address for reprints: Jane W. Newburger, MD, MPH, Department of Cardiology, Children’s Hospital Boston, 300 Longwood Ave, Boston, MA 02115. (Email: jane.newburger{at}cardio.chboston.org).

Objectives: We previously reported that postoperative hemodynamics and developmental outcomes were better among infants randomized to a higher hematocrit value during hypothermic cardiopulmonary bypass. However, worse outcomes were concentrated in patients with hematocrit values of 20% or below, and the benefits of hematocrit values higher than 25% were uncertain.

Methods: We compared perioperative hemodynamics and, at 1 year, developmental outcome and brain magnetic resonance imaging in a single-center, randomized trial of hemodilution to a hematocrit value of 25% versus 35% during hypothermic radiopulmonary bypass for reparative heart surgery in infants undergoing 2-ventricle repairs without aortic arch obstruction.

Results: Among 124 subjects, 56 were assigned to the lower-hematocrit strategy (24.8% ± 3.1%, mean ± SD) and 68 to the higher-hematocrit strategy (32.6% ± 3.5%). Infants randomized to the 25% strategy, compared with the 35% strategy, had a more positive intraoperative fluid balance (P = .007) and lower regional cerebral oxygen saturation at 10 minutes after cooling (P = .04) and onset of low flow (P = .03). Infants with dextro-transposition of the great arteries in the 25% group had significantly longer hospital stay. Other postoperative outcomes, blood product usage, and adverse events were similar in the treatment groups. At age 1 year (n = 106), the treatment groups had similar scores on the Psychomotor and Mental Development Indexes of the Bayley Scales; both groups scored significantly worse than population norms.

Conclusions: Hemodilution to hematocrit levels of 35% compared with those of 25% had no major benefits or risks overall among infants undergoing 2-ventricle repair. Developmental outcomes at age 1 year in both randomized groups were below those in the normative population.

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