Is Biology Destiny or Can We Optimize Care for All Patients?
Authors: Pamela S. Douglas, Lesley H. Curtis
Journal: Annals of Internal Medicine (2012)

Editorials7 February 2012Is Biology Destiny or Can We Optimize Care for All Patients?Pamela S. Douglas, MD and Lesley H. Curtis, PhDPamela S. Douglas, MDFrom Duke University Medical Center, Durham, NC 27715, and Duke Clinical Research Institute, Durham, NC 27705.Search for more papers by this author and Lesley H. Curtis, PhDFrom Duke University Medical Center, Durham, NC 27715, and Duke Clinical Research Institute, Durham, NC 27705.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-156-3-201202070-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Women are often underrepresented in randomized, controlled trials, yet they make up a substantial proportion of patients seen in practice. A one-size-fits-all approach ignores the underlying biological differences between men and women and sometimes results in excess mortality for female patients (1). In such cases, the lack of generalizable data on treatment efficacy makes the practice of evidence-based medicine in individual patients more challenging. Against this background, the validity of applying a one-size-fits-all approach to the use of implantable cardioverter-defibrillators (ICDs) deserves careful evaluation.Ample evidence indicates sex-related differences in the epidemiology of sudden death and in the underlying biology ...References1. Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, et al; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005;294:3108-16. [PMID: 16380591] CrossrefMedlineGoogle Scholar2. Ghani A, Maas AH, Delnoy PP, Ramdat Misier AR, Ottervanger JP, Elvan A. Sex-based differences in cardiac arrhythmias, ICD utilisation and cardiac resynchronisation therapy. Neth Heart J. 2011;19:35-40. [PMID: 22020857] CrossrefMedlineGoogle Scholar3. Yarnoz MJ, Curtis AB. More reasons why men and women are not the same (gender differences in electrophysiology and arrhythmias). Am J Cardiol. 2008;101:1291-6. [PMID: 18435960] CrossrefMedlineGoogle Scholar4. Hsich EM, Piña IL. Heart failure in women: a need for prospective data. J Am Coll Cardiol. 2009;54:491-8. [PMID: 19643307] CrossrefMedlineGoogle Scholar5. Ghanbari H, Dalloul G, Hasan R, Daccarett M, Saba S, David S, et al. Effectiveness of implantable cardioverter-defibrillators for the primary prevention of sudden cardiac death in women with advanced heart failure: a meta-analysis of randomized controlled trials. Arch Intern Med. 2009;169:1500-6. [PMID: 19752408] CrossrefMedlineGoogle Scholar6. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-50. [PMID: 15152059] CrossrefMedlineGoogle Scholar7. Zareba W, Moss AJ, Jackson Hall W, Wilber DJ, Ruskin JN, McNitt S, et al; MADIT II Investigators. Clinical course and implantable cardioverter defibrillator therapy in postinfarction women with severe left ventricular dysfunction. J Cardiovasc Electrophysiol. 2005;16:1265-70. [PMID: 16403053] CrossrefMedlineGoogle Scholar8. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225-37. [PMID: 15659722] CrossrefMedlineGoogle Scholar9. Hernandez AF, Fonarow GC, Liang L, Al-Khatib SM, Curtis LH, LaBresh KA, et al. Sex and racial differences in the use of implantable cardioverter-defibrillators among patients hospitalized with heart failure. JAMA. 2007;298:1525-32. [PMID: 17911497] CrossrefMedlineGoogle Scholar10. Curtis LH, Al-Khatib SM, Shea AM, Hammill BG, Hernandez AF, Schulman KA. Sex differences in the use of implantable cardioverter-defibrillators for primary and secondary prevention of sudden cardiac death. JAMA. 2007;298:1517-24. [PMID: 17911496] CrossrefMedlineGoogle Scholar11. MacFadden DR, Crystal E, Krahn AD, Mangat I, Healey JS, Dorian P, et al. Sex differences in implantable cardioverter-defibrillator outcomes: findings from a prospective defibrillator database. Ann Intern Med. 2012;156:195-203. [PMID: 19221223] LinkGoogle Scholar12. Peterson PN, Daugherty SL, Wang Y, Vidaillet HJ, Heidenreich PA, Curtis JP, et al; National Cardiovascular Data Registry. Gender differences in procedure-related adverse events in patients receiving implantable cardioverter-defibrillator therapy. Circulation. 2009;119:1078-84. [PMID: 19221223] CrossrefMedlineGoogle Scholar13. Peterson ED, Lansky AJ, Kramer J, Anstrom K, Lanzilotta MJ; National Cardiovascular Network Clinical Investigators. Effect of gender on the outcomes of contemporary percutaneous coronary intervention. Am J Cardiol. 2001;88:359-64. [PMID: 11545754] CrossrefMedlineGoogle Scholar14. Wathen MS, DeGroot PJ, Sweeney MO, Stark AJ, Otterness MF, Adkisson WO, et al; PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. 2004;110:2591-6. [PMID: 15492306] MedlineGoogle Scholar15. U.S. Food and Drug Administration. Draft Guidance for Industry and Food and Drug Administration Staff: Evaluation of Sex Differences in Medical Device Clinical Studies. Silver Spring, MD: U.S. Food and Drug Administration; 2011. Accessed at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm on 21 December 2011. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Duke University Medical Center, Durham, NC 27715, and Duke Clinical Research Institute, Durham, NC 27705.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-3038.Corresponding Author: Pamela S. Douglas, MD, Duke University Medical Center, 7022 North Pavilion, Box 17969, Durham, NC 27715; e-mail, pamela.[email protected]edu.Current Author Addresses: Dr. Douglas: Duke University Medical Center, 7022 North Pavilion, Box 17969, Durham, NC 27715.Dr. Curtis: Duke University Medical Center, 6046 North Pavilion, Box 17969, Durham, NC 27715 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoSex Differences in Implantable Cardioverter-Defibrillator Outcomes: Findings From a Prospective Defibrillator Database Derek R. MacFadden , Eugene Crystal , Andrew D. Krahn , Iqwal Mangat , Jeffrey S. Healey , Paul Dorian , David Birnie , Christopher S. Simpson , Yaariv Khaykin , Arnold Pinter , Kumaraswamy Nanthakumar , Andrew J. Calzavara , Peter C. Austin , Jack V. Tu , and Douglas S. Lee Metrics 7 February 2012Volume 156, Issue 3Page: 241-242KeywordsArrhythmiaCardiomyopathiesDecision makingElectrophysiological techniquesHeart failurePatientsSafetySudden cardiac death ePublished: 7 February 2012 Issue Published: 7 February 2012 CopyrightCopyright © 2012 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...