Comparative Effectiveness of Implantable Cardioverter Defibrillators for Primary Prevention in Women

Circulation: Heart Failure

Volumn 9, Issue 1, 2016, Pages

  Zeitler, Emily P ^a,b   Hellkamp, Anne S ^a   Schulte, Phillip J ^c   Fonarow, Gregg C ^d   Hernandez, Adrian F ^a,b   Peterson, Eric D ^a,b   Sanders, Gillian D ^a   Yancy, Clyde W ^e   Al Khatib, Sana M ^a,b  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c MAYO CLINIC   (United States)

^d Ronald Reagan University of California   (United States)

^e NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Comparative effectiveness research; heart failure; implantable cardioverter defibrillators; morbidity; mortality; women

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CREATININE; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; HEMOGLOBIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; SODIUM; UREA;

AGED; ANEMIA; ARTICLE; ASTHMA; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; CHRONIC KIDNEY FAILURE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL PRACTICE; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DEPRESSION; DIABETES MELLITUS; FEMALE; FOLLOW UP; HEART ATRIUM ARRHYTHMIA; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MEDICAID; MEDICARE; MORTALITY RATE; PRIMARY PREVENTION; PRIORITY JOURNAL; PROPENSITY SCORE; SURVIVAL RATE; SYSTOLIC BLOOD PRESSURE; TEACHING HOSPITAL; TRANSIENT ISCHEMIC ATTACK; UREA NITROGEN BLOOD LEVEL; ADVERSE EFFECTS; CARDIOVERSION; CHI SQUARE DISTRIBUTION; COMPARATIVE STUDY; DEVICES; GOVERNMENT; HEART LEFT VENTRICLE FUNCTION; HEART STROKE VOLUME; HOSPITALIZATION; KAPLAN MEIER METHOD; MALE; MARKOV CHAIN; MONTE CARLO METHOD; MORTALITY; PATHOPHYSIOLOGY; PROPORTIONAL HAZARDS MODEL; REGISTER; RISK ASSESSMENT; RISK FACTOR; SEX DIFFERENCE; STATISTICAL MODEL; TIME FACTOR; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY;

AGED; AGED, 80 AND OVER; CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); CHI-SQUARE DISTRIBUTION; COMPARATIVE EFFECTIVENESS RESEARCH; DEFIBRILLATORS, IMPLANTABLE; ELECTRIC COUNTERSHOCK; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; KAPLAN-MEIER ESTIMATE; LOGISTIC MODELS; MALE; MARKOV CHAINS; MONTE CARLO METHOD; PRIMARY PREVENTION; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODELS; REGISTRIES; RISK ASSESSMENT; RISK FACTORS; SEX FACTORS; STROKE VOLUME; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR FUNCTION, LEFT;

EID: 84955243430     PISSN: 19413289     EISSN: 19413297     Source Type: Journal    
DOI: 10.1161/CIRCHEARTFAILURE.115.002630     Document Type: Article

References (27)

1. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; 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;352:225-237. doi: 10.1056/NEJMoa043399.
2. Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151-2158. doi: 10.1056/NEJMoa033088.
3. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996;335:1933-1940. doi: 10.1056/NEJM199612263352601.
4. Redberg RF. Disparities in use of implantable cardioverter-defibrillators: moving beyond process measures to outcomes data. JAMA. 2007;298:1564-1566. doi: 10.1001/jama.298.13.1564.
5. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Tracy CM, Epstein AE, Darbar D, DiMarco JP, Dunbar SB, Estes NA III, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Heart Rhythm Society. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61:e6-75. doi: 10.1016/j. jacc.2012.11.007.
6. Al-Khatib SM, Hellkamp AS, Hernandez AF, Fonarow GC, Thomas KL, Al-Khalidi HR, Heidenreich PA, Hammill S, Yancy C, Peterson ED; Get With the Guidelines Steering Committee and Hospitals. Trends in use of implantable cardioverter-defibrillator therapy among patients hospitalized for heart failure: have the previously observed sex and racial disparities changed over time Circulation. 2012;125:1094-1101. doi: 10.1161/CIRCULATIONAHA.111.066605.
7. Santangeli P, Pelargonio G, Dello Russo A, Casella M, Bisceglia C, Bartoletti S, Santarelli P, Di Biase L, Natale A. Gender differences in clinical outcome and primary prevention defibrillator benefit in patients with severe left ventricular dysfunction: a systematic review and meta-analysis. Heart Rhythm. 2010;7:876-882. doi: 10.1016/j. hrthm.2010.03.042.
8. Ghanbari H, Dalloul G, Hasan R, Daccarett M, Saba S, David S, Machado C. 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;169:1500-1506. doi: 10.1001/archinternmed.2009.255.
9. Henyan NN, White CM, Gillespie EL, Smith K, Coleman CI, Kluger J. The impact of gender on survival amongst patients with implantable cardioverter defibrillators for primary prevention against sudden cardiac death. J Intern Med. 2006;260:467-473. doi: 10.1111/j.1365-2796.2006.01713.x.
10. Russo AM, Poole JE, Mark DB, Anderson J, Hellkamp AS, Lee KL, Johnson GW, Domanski M, Bardy GH. Primary prevention with defibrillator therapy in women: results from the Sudden Cardiac Death in Heart Failure Trial. J Cardiovasc Electrophysiol. 2008;19:720-724. doi: 10.1111/j.1540-8167.2008.01129.x.
11. Zeitler EP, Hellkamp AS, Fonarow GC, Hammill SC, Curtis LH, Hernandez AF, Al-Khalidi HR, Curtis JP, Heidenreich PA, Anstrom KJ, Peterson ED, Mark DB, Hammill BG, Sanders GD, Al-Khatib SM. Primary prevention implantable cardioverter-defibrillators and survival in older women. JACC Heart Fail. 2015;3:159-167. doi: 10.1016/j. jchf.2014.09.006.
12. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy C, Young JB; OPTIMIZE-HF Investigators and Hospitals. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA. 2007;297:61-70. doi: 10.1001/jama.297.1.61.
13. Fonarow GC, Abraham WT, Albert NM, Gattis WA, Gheorghiade M, Greenberg B, O'Connor CM, Yancy CW, Young J. Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF): rationale and design. Am Heart J. 2004;148:43-51. doi: 10.1016/j.ahj.2004.03.004.
14. 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;157:995-1000. doi: 10.1016/j.ahj.2009.04.002.
15. Rosenbaum PR, Rubin DB. Constructing a control group using multivariate matched sampling methods that incorporate the propensity score. Am Stat. 1985;39:33-38.
16. Chae SH, Koelling TM. Patient and physician determinants of implantable cardioverter defibrillator use in the heart failure population. Congest Heart Fail. 2010;16:141-146. doi: 10.1111/j.1751-7133.2009.00139.x.
17. Sherazi S, Zareba W, Daubert JP, McNitt S, Shah AH, Aktas MK, Block RC. Physicians' knowledge and attitudes regarding implantable cardioverter-defibrillators. Cardiol J. 2010;17:267-273.
18. Narayanan K, Reinier K, Uy-Evanado A, Teodorescu C, Chugh H, Marijon E, Gunson K, Jui J, Chugh SS. Frequency and determinants of implantable cardioverter defibrillator deployment among primary prevention candidates with subsequent sudden cardiac arrest in the community. Circulation. 2013;128:1733-1738. doi: 10.1161/CIRCULATIONAHA.113.002539.
19. Pokorney SD, Miller AL, Chen AY, Thomas L, Fonarow GC, de Lemos JA, Al-Khatib SM, Peterson ED, Wang TY. Implantable Cardioverter-Defibrillator Use Among Medicare Patients With Low Ejection Fraction After Acute Myocardial Infarction. JAMA. 2015;313:2433-2440. doi: 10.1001/jama.2015.6409.
20. Hess PL, Laird A, Edwards R, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Hall WJ, Steinman R, Dorian P, Hallstrom A, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Al-Khatib SM, Piccini JP, Inoue LY, Sanders GD. Survival benefit of primary prevention implantable cardioverter-defibrillator therapy after myocardial infarction: does time to implant matter A meta-analysis using patient-level data from 4 clinical trials. Heart Rhythm. 2013;10:828-835. doi: 10.1016/j. hrthm.2013.02.011.
21. Chen J, Normand SL, Wang Y, Krumholz HM. National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008. JAMA. 2011;306:1669-1678. doi: 10.1001/jama.2011.1474.
22. Dharmarajan K, Hsieh AF, Kulkarni VT, Lin Z, Ross JS, Horwitz LI, Kim N, Suter LG, Lin H, Normand SL, Krumholz HM. Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study. BMJ. 2015;350:h411.
23. Russo AM, Daugherty SL, Masoudi FA, Wang Y, Curtis J, Lampert R. Gender and outcomes after primary prevention implantable cardioverterdefibrillator implantation: Findings from the National Cardiovascular Data Registry (NCDR). Am Heart J. 2015;170:330-338. doi: 10.1016/j. ahj.2015.02.025.
24. Hess PL, Greiner MA, Al-Khatib SM, Masoudi FA, Varosy PD, Fogel RI, Curtis LH, Hernandez AF. Same-day discharge and risks of mortality and readmission after elective ICD placement for primary prevention. J Am Coll Cardiol. 2015;65:955-957. doi: 10.1016/j.jacc.2014.12.032.
25. Curtis LH, Greiner MA, Hammill BG, DiMartino LD, Shea AM, Hernandez AF, Fonarow GC. Representativeness of a national heart failure quality-of-care registry: comparison of OPTIMIZE-HF and non-OPTIMIZE-HF Medicare patients. Circ Cardiovasc Qual Outcomes. 2009;2:377-384. doi: 10.1161/CIRCOUTCOMES.108.822692.
26. Heidenreich PA, Fonarow GC. Are registry hospitals different A comparison of patients admitted to hospitals of a commercial heart failure registry with those from national and community cohorts. Am Heart J. 2006;152:935-939. doi: 10.1016/j.ahj.2006.06.037.
27. Heidenreich PA, Hernandez AF, Yancy CW, Liang L, Peterson ED, Fonarow GC. Get With The Guidelines program participation, process of care, and outcome for Medicare patients hospitalized with heart failure. Circ Cardiovasc Qual Outcomes. 2012;5:37-43. doi: 10.1161/CIRCOUTCOMES.110.959122.