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Further Observations Regarding Less Aggressive Management of the PDA Joe Kaempf, MD

Further Observations Regarding Less Aggressive Management of the PDA Joe Kaempf, MD Providence St. Vincent Medical Center Portland, OR 3.14.12. PSVMC PDA Study in VLBWs Indomethacin use decreased from 79% to 26% 28 day total fluids decreased from 140 ml/kg/d to 130 ml/kg/d

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Further Observations Regarding Less Aggressive Management of the PDA Joe Kaempf, MD

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  1. Further Observations Regarding Less Aggressive Management of the PDA Joe Kaempf, MD Providence St. Vincent Medical Center Portland, OR 3.14.12

  2. PSVMC PDA Study in VLBWs Indomethacin use decreased from 79% to 26% 28 day total fluids decreased from 140 ml/kg/d to 130 ml/kg/d Ligation rate decreased from 45% to 33% No significant change in mortality, any single morbidity, or morbidity count CLD + Death >7 days did increase from 40% to 54% More infants sent home with PDAs (6% to 19%) but most closed spontaneously and no increase in ligation/coiling. J Perinatology, in press

  3. Era 105-07Era 2 08-6.09 PSVMC 139 72 RCH 76 43 SAL 21 7 SCR 4 7 Total 240 129

  4. Era 1Era 2P Value PMA (wks) 27.4 +/- 2 27.3 +/- 2 0.54 BWT (g) 989 +/-229 951 +/-274 0.16 Fluids Day 1-28 142+/-11 132 +/-9 <.001 (ml/kg/d) Week 1 127 115 <.001 Week 2 144 134 <.001 Week 3 148 139 <.001 Week 4 151 141 <.001 Indomethacin 79% 26% <.001 Day 1st Dose 5/4 12/13 <.001 mean/median

  5. Era 1Era 2P Value Ligation 44% 38% .27 Day of Lig 15/11 24/21 <.001 mean/median NCPAP Days 22/22 27/26 .02 mean/median Ventilator Days 11/7 14/8 .29 mean/median

  6. Era 1Era 2P Value Grade 3-4 IVH 10% 8% .48 PVL 4% 2% .23 ROP Stage 1-2 31% 40% ROP Stage 3-4 10% 9% .26 NEC 8% 10% .48 SIP 4% 4% .95 Late Infxn 13% 15% .63

  7. Era 1Era 2P Value Hospital Days 68/68 73/73 .07 mean/median D/C >/=40 wks 18% 28% .09 Number of Major 0.8 0.9 Morbidities/pt Morbidities/Day .01 .01 .56 (LRT Poisson Count)

  8. Era 1Era 2P Value Mortality >Day7 9% 13% .23 CLD 34% 48% <.01 Mortality or CLD 42% 57% <.01

  9. “Stoicism is very close to one of the most subtle tenets of Oriental wisdom, and of Tibetan Buddhism in particular: contrary to the commonplace idea that one “cannot live without hope”, hope is the greatest of misfortunes. For it is by nature an absence, a lack, a source of tension in our lives. For we live in terms of plans, chasing after objectives located in a more or less distant future, and believing that our happiness depends upon their accomplishment.” Luc Ferry, A Brief History of Thought, 2010

  10. Red Era 1 Blue Era 2

  11. Red Era 1 Blue Era 2

  12. Logistic Regression Predictors for CLDOdds Ratio (95%CI)P Value PMA (by week) 0.81 (0.68, 0.97) .02 BWT (by 100 g) 0.76 (0.66, 0.87) <.001 Era 2 1.77 (1.07, 2.91) .03

  13. Poisson Regression Predictors NICU MorbiditiesRate Ratio (95% CI)P Value PMA (by week) 0.90 (0.82, 0.99) .03 BWT (by 100g) 0.86 (0.80, .93) <.001 Male 1.31 (1.04, 1.67) .02 Era 2 0.97 (.76, 1.24) .81

  14. CLD, SIVH, PVL, SROP, NEC, SIP, Any Late Infection Which, if any, are associated with the largest negative impact on long term health and neurologic function? Should we try to prevent one at the risk of increasing another?

  15. Era 1

  16. Era 2 What were the major practice changes Era 1 v. Era 2?

  17. Diagnosing and treating a PDA is an intricate clinical assessment, a complex and nuanced decision path based upon weaving the presence or absence of multiple variables – there is no EBM protocol as yet that we might be hoping for. Don’t create a problem where there is none. The decision to treat or not treat a PDA should be based upon a thorough clinical history, serial physical exams, respiratory support needs, cardiac exam, and echocardiography. Laboratory markers (e.g., BNP) do not yet have sufficient Sens/Spec/PPV/NPV. Prophylactic COX inhibitors should never be prescribed. Early use of COX inhibitors or ligation (~first 7-10 days of life) should generally be avoided unless a PDA is significant by echocardiogram, the exam is impressive, cardiorespiratory problems are obvious, and the infant is ~ELGAN.

  18. Echocardiographic Risks PDA diameter >/= 2-3 mm LA and LV chamber enlargement left-to-right shunt PDA/PA ratios? Physical Exam Risks cardiac murmur that is full, holosystolic, spills into diastole hyperdynamic precordium easily palpable, full-to-bounding pulses wide pulse pressure low diastolic pressure *decreased skin and mucous membrane perfusion* Respiratory Support Risks NCPAP (or HFNC >/= 3 l/min) and FiO2 >24% any mechanical ventilation not weaning pulmonary edema/vascular congestion on CXR Historical Risks ELGAN (<29 weeks GA), male, no-antenatal steroids, yes-antenatal indomethacin…..

  19. “Improve mankind? That is the last thing that I of all people will promise. Don’t expect new idols from me; let the old idols learn what it costs to have feet of clay. To overthrow idols – my word for ideals – that is my business. Reality has lost its value, its meaning, its veracity, and an ideal world has been fabricated to take its place. The lie of the ideal has hitherto been the curse on reality, through which mankind itself has become mendacious and false down to its deepest instincts.” Friedrich Nietzsche Ecce Homo, 1888

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