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13th Annual C. Walton Lillehei Memorial Lecture – Invisible problems in cardiovascular surgery: What we can learn from prospective observational studies?*

Published online by Cambridge University Press:  18 January 2013

James S. Tweddell*
Affiliation:
The Division of Cardiothoracic Surgery, Department of Surgery, Medical College of Wisconsin and the Herma Heart Center, Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States of America
*
Correspondence to: Dr J. S. Tweddell, MD, The Division of Cardiothoracic Surgery, Department of Surgery, Medical College of Wisconsin and the Herma Heart Center, Children's Hospital of Wisconsin, 900 W. Wisconsin Avenue, Milwaukee, Wisconsin 53226, United States of America; E-mail: [email protected]

Abstract

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Type
Original Article
Copyright
Copyright © Cambridge University Press 2012

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Footnotes

*

Presented at: The Children's Hospital of Philadelphia Cardiology 2012, 16th Annual Update on Pediatric and Congenital Cardiovascular Disease, Orlando, Florida, February 22–26, 2012.

References

1. Tweddell, JS, Hoffman, GM, Fedderly, RT, et al. Phenoxybenzamine improves systemic oxygen delivery after the Norwood procedure. Ann Thorac Surg 1999; 67: 161167; discussion 167–168.CrossRefGoogle ScholarPubMed
2. Tweddell, JS, Hoffman, GM, Mussatto, KA, et al. Improved survival of patients undergoing palliation of hypoplastic left heart syndrome: lessons learned from 115 consecutive patients. Circulation 2002; 106 (Suppl 1): I82I89.CrossRefGoogle ScholarPubMed
3. Hoffman, GM, Tweddell, JS, Ghanayem, NS, et al. Alteration of the critical arteriovenous oxygen saturation relationship by sustained afterload reduction after the Norwood procedure. J Thorac Cardiovasc Surg 2004; 127: 738745.CrossRefGoogle ScholarPubMed
4. Tweddell, JS, Ghanayem, NS, Mussatto, KA, et al. Mixed venous oxygen saturation monitoring after stage 1 palliation for hypoplastic left heart syndrome. Ann Thorac Surg 2007; 84: 13011310; discussion 1310–1301.CrossRefGoogle ScholarPubMed
5. Hoffman, GM, Mussatto, KA, Brosig, CL, et al. Systemic venous oxygen saturation after the Norwood procedure and childhood neurodevelopmental outcome. J Thorac Cardiovasc Surg 2005; 130: 10941100.CrossRefGoogle ScholarPubMed
6. Ghanayem, NS, Hoffman, GM, Mussatto, KA, et al. Perioperative monitoring in high-risk infants after stage 1 palliation of univentricular congenital heart disease. J Thorac Cardiovasc Surg 2010; 140: 857863.CrossRefGoogle ScholarPubMed
7. Hoffman, GM, Ghanayem, NS, Kampine, JM, et al. Venous saturation and the anaerobic threshold in neonates after the Norwood procedure for hypoplastic left heart syndrome. Ann Thorac Surg 2000; 70: 15151520; discussion 1521.CrossRefGoogle ScholarPubMed
8. Hoffman, GM, Ghanayem, NS, Mussatto, KA, Berens, RJ, Tweddell, JS. Postoperative two-site NIRs predicts complications and mortality after stage 1 palliation of HLHS. Anesthesiology 2007; 107: A234.Google Scholar
9. Hoffman, GM, Ghanayem, NS, Stuth, EA, Berens, RJ, Tweddell, JS. NIRS-derived somatic and cerebral saturation difference provides non-invasive real-time hemodynamic assessment of cardiogenic shock and risk of anaerobic metabolism. Anesthesiology 2004; 99: A-1514.Google Scholar
10. Hoffman, GM, Mussatto, KA, Brosig, CL, Tweddell, JS, Ghanayem, NS. Cerebral oxygenation and neurodevelopmental outcome in hypoplastic left heart syndrome. Anesthesiology 2008; 109: A7.Google Scholar
11. Hoffman, GM, Ghanayem, NS, Mussatto, KA, et al. Perioperative somatic near-infrared spectroscopy predicts postoperative renal function following neonatal cardiac surgery. Circulation 2005; 112 (Suppl 2): II-367.Google Scholar
12. Stampfer, MJ, Colditz, GA. Estrogen replacement therapy and coronary heart disease: a quantitative assessment of the epidemiologic evidence. Prev Med 1991; 20: 4763.CrossRefGoogle ScholarPubMed
13. Grady, D, Rubin, SM, Petitti, DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 1992; 117: 10161037.CrossRefGoogle ScholarPubMed
14. Psaty, BM, Heckbert, SR, Atkins, D, et al. The risk of myocardial infarction associated with the combined use of estrogens and progestins in postmenopausal women. Arch Intern Med 1994; 154: 13331339.CrossRefGoogle ScholarPubMed
15. Sidney, S, Petitti, DB, Quesenberry, CP Jr. Myocardial infarction and the use of estrogen and estrogen–progestogen in postmenopausal women. Ann Intern Med 1997; 127: 501508.CrossRefGoogle ScholarPubMed
16. Cauley, JA, Cummings, SR, Black, DM, Mascioli, SR, Seeley, DG. Prevalence and determinants of estrogen replacement therapy in elderly women. Am J Obstet Gynecol 1990; 163 (Pt 1): 14381444.CrossRefGoogle ScholarPubMed
17. Barrett-Connor, E. Postmenopausal estrogen and prevention bias. Ann Intern Med 1991; 115: 455456.CrossRefGoogle ScholarPubMed
18. Petitti, DB. Coronary heart disease and estrogen replacement therapy. Can compliance bias explain the results of observational studies? Ann Epidemiol 1994; 4: 115118.CrossRefGoogle ScholarPubMed
19. Beral, V, Banks, E, Reeves, G. Evidence from randomised trials on the long-term effects of hormone replacement therapy. Lancet 2002; 360: 942944.CrossRefGoogle ScholarPubMed
20. Rossouw, JE, Anderson, GL, Prentice, RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial. JAMA 2002; 288: 321333.Google ScholarPubMed
21. Ohye, RG, Sleeper, LA, Mahony, L, et al. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med 2010; 362: 19801992.CrossRefGoogle ScholarPubMed
22. Addonizio, LJ. Pediatric ventricular assist devices – first steps for babies. N Engl J Med 2012; 367: 567568.CrossRefGoogle ScholarPubMed
23. Almond, CS, Buchholz, H, Massicotte, P, et al. Berlin heart EXCOR pediatric ventricular assist device investigational device exemption study: study design and rationale. Am Heart J 2011; 162: 425435; e426.CrossRefGoogle ScholarPubMed
24. Foreman, C. H100004, HUD Number: 2000-0064, Berlin Heart EXCOR Pediatric Assist Device (VAD), 2011. http://www.accessdata.fda.gov/cdrh_docs/pdf10/h100004a.pdf Google Scholar
25. Fraser, CD, Jaquiss, RDB, Rosenthal, DN, et al. Prospective trial of a pediatric ventricular assist device. N Engl J Med 2012; 367: 532541.CrossRefGoogle ScholarPubMed
26. Royston, D, Bidstrup, BP, Taylor, KM, Sapsford, RN. Effect of aprotinin on need for blood transfusion after repeat open-heart surgery. Lancet 1987; 2: 12891291.CrossRefGoogle ScholarPubMed
27. Henry, DA, Moxey, AJ, Carless, PA, et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2001; 1: CD001886.Google Scholar
28. Sedrakyan, A, Treasure, T, Elefteriades, JA. Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: a systematic review and meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg 2004; 128: 442448.CrossRefGoogle ScholarPubMed
29. Mangano, DT, Tudor, IC, Dietzel, C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006; 354: 353365.CrossRefGoogle ScholarPubMed
30. Mangano, DT, Miao, Y, Vuylsteke, A, et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA 2007; 297: 471479.CrossRefGoogle ScholarPubMed
31. Bekelman, JE, Li, Y, Gross, CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289: 454465.CrossRefGoogle ScholarPubMed
32. Fergusson, DA, Hebert, PC, Mazer, CD, et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008; 358: 23192331.CrossRefGoogle ScholarPubMed
33. Benson, K, Hartz, AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000; 342: 18781886.CrossRefGoogle ScholarPubMed
34. Concato, J, Shah, N, Horwitz, RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000; 342: 18871892.CrossRefGoogle ScholarPubMed
35. Ioannidis, JP, Haidich, AB, Pappa, M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001; 286: 821830.CrossRefGoogle ScholarPubMed
36. Tricoci, P, Allen, JM, Kramer, JM, Califf, RM, Smith, SC Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 2009; 301: 831841.CrossRefGoogle ScholarPubMed
37. Hammill, BG, Hernandez, AF, Peterson, ED, Fonarow, GC, Schulman, KA, Curtis, LH. Linking inpatient clinical registry data to Medicare claims data using indirect identifiers. Am Heart J 2009; 157: 9951000.CrossRefGoogle ScholarPubMed
38. Dokholyan, RS, Muhlbaier, LH, Falletta, JM, et al. Regulatory and ethical considerations for linking clinical and administrative databases. Am Heart J 2009; 157: 971982.CrossRefGoogle ScholarPubMed
39. Hernandez, AF, Hammill, BG, Peterson, ED, et al. Relationships between emerging measures of heart failure processes of care and clinical outcomes. Am Heart J 2010; 159: 406413.CrossRefGoogle ScholarPubMed
40. Pasquali, SK, Jacobs, JP, Shook, GJ, et al. Linking clinical registry data with administrative data using indirect identifiers: implementation and validation in the congenital heart surgery population. Am Heart J 2010; 160: 10991104.CrossRefGoogle ScholarPubMed
41. Pasquali, SK, Li, JS, He, X, et al. Comparative analysis of antifibrinolytic medications in pediatric heart surgery. J Thorac Cardiovasc Surg 2012; 143: 550557.CrossRefGoogle ScholarPubMed
42. Kaltman, JR, Andropoulos, DB, Checchia, PA, et al. Report of the Pediatric Heart Network and National Heart, Lung, and Blood Institute Working Group on the perioperative management of congenital heart disease. Circulation 2010; 121: 27662772.CrossRefGoogle Scholar