Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Science Advisory From the American Heart Association

Circulation

Volumn 133, Issue 17, 2016, Pages 1715-1727

  Piccini, Jonathan P ^a   Allen, Larry A ^a   Kudenchuk, Peter J ^a   Page, Richard L ^a   Patel, Manesh R ^a   Turakhia, Mintu P ^a  

^a NONE

Author keywords

AHA Scientific Statements; implantable cardioverter defibrillator; sudden cardiac death; ventricular fibrillation; ventricular tachycardia; wearable cardioverter defibrillator

Indexed keywords

ASSISTED CIRCULATION; CLINICAL EFFECTIVENESS; CONGESTIVE CARDIOMYOPATHY; CORONARY ARTERY BYPASS GRAFT; DEFIBRILLATION; DEFIBRILLATOR; DEVICE APPROVAL; DEVICE INFECTION; DEVICE REMOVAL; DEVICE SAFETY; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE REVASCULARIZATION; HEART TRANSPLANTATION; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HIGH RISK PATIENT; HUMAN; NONISCHEMIC CARDIOMYOPATHY; NONISCHEMIC DILATED CARDIOMYOPATHY; OUT OF HOSPITAL CARDIAC ARREST; PATIENT COMPLIANCE; PATIENT DECISION MAKING; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROGNOSIS; RESUSCITATION; REVIEW; SUDDEN CARDIAC DEATH; WEARABLE CARDIOVERTER DEFIBRILLATOR; CLINICAL TRIAL (TOPIC); DEATH, SUDDEN, CARDIAC; MEDICAL SOCIETY; PROCEDURES; UNITED STATES;

AMERICAN HEART ASSOCIATION; CLINICAL TRIALS AS TOPIC; DEATH, SUDDEN, CARDIAC; DEFIBRILLATORS; HUMANS; UNITED STATES;

EID: 84961878476     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIR.0000000000000394     Document Type: Review

References (80)

1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2013 update: a report from the American Heart Association [published correction appears in Circulation. 2013;127:e841]. Circulation. 2013;127:e6-e245. doi: 10.1161/CIR.0b013e31828124ad.
2. Stecker EC, Vickers C, Waltz J, Socoteanu C, John BT, Mariani R, McAnulty JH, Gunson K, Jui J, Chugh SS. Population-based analysis of sudden cardiac death with and without left ventricular systolic dysfunction: two-year findings from the Oregon Sudden Unexpected Death Study. J Am Coll Cardiol. 2006;47:1161-1166. doi: 10.1016/j.jacc.2005.11.045.
3. 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.
4. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction [published correction appears in N Engl J Med. 2005;352:2146]. N Engl J Med. 2002;346:877-883. doi: 10.1056/NEJMoa013474.
5. Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease: Multicenter Unsustained Tachycardia Trial Investigators [published correction appears in N Engl J Med. 2000;342:1300]. N Engl J Med. 1999;341:1882-1890. doi: 10.1056/NEJM199912163412503.
6. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias: the Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators. N Engl J Med. 1997;337:1576-1583.
7. 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.
8. Adler A, Halkin A, Viskin S. Wearable cardioverter-defibrillators. Circulation. 2013;127:854-860. doi: 10.1161/CIRCULATIONAHA. 112.146530.
9. Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell I; Resuscitation Outcomes Consortium Investigators. Regional variation in out-of-hospital cardiac arrest incidence and outcome [published correction appears in JAMA. 2008;300:1763]. JAMA. 2008;300:1423-1431. doi: 10.1001/jama.300.12.1423.
10. Epstein AE, Di Marco JP, Ellenbogen KA, Estes NA 3rd, 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. 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. Circulation. 2013;127:e283-e352. doi: 10.1161/CIR.0b013e318276ce9b.
11. Ezekowitz JA, Armstrong PW, McAlister FA. Implantable cardioverter defibrillators in primary and secondary prevention: a systematic review of randomized, controlled trials. Ann Intern Med. 2003;138:445-452.
12. Nanthakumar K, Epstein AE, Kay GN, Plumb VJ, Lee DS. Prophylactic implantable cardioverter-defibrillator therapy in patients with left ventricular systolic dysfunction: a pooled analysis of 10 primary prevention trials. J Am Coll Cardiol. 2004;44:2166-2172. doi: 10.1016/j.jacc.2004.08.054.
13. Wilber DJ, Zareba W, Hall WJ, Brown MW, Lin AC, Andrews ML, Burke M, Moss AJ. Time dependence of mortality risk and defibrillator benefit after myocardial infarction. Circulation. 2004;109:1082-1084. doi: 10.1161/01.CIR.0000121328.12536.07.
14. 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.
15. Solomon SD, Glynn RJ, Greaves S, Ajani U, Rouleau JL, Menapace F, Arnold JM, Hennekens C, Pfeffer MA. Recovery of ventricular function after myocardial infarction in the reperfusion era: the healing and early afterload reducing therapy study. Ann Intern Med. 2001;134:451-458.
16. Elefteriades JA, Tolis G Jr, Levi E, Mills LK, Zaret BL. Coronary artery bypass grafting in severe left ventricular dysfunction: excellent survival with improved ejection fraction and functional state. J Am Coll Cardiol. 1993;22:1411-1417.
17. Bax JJ, Poldermans D, Elhendy A, Cornel JH, Boersma E, Rambaldi R, Roelandt JR, Fioretti PM. Improvement of left ventricular ejection fraction, heart failure symptoms and prognosis after revascularization in patients with chronic coronary artery disease and viable myocardium detected by dobutamine stress echocardiography. J Am Coll Cardiol. 1999;34:163-169.
18. Murphy NF, O'Loughlin C, Ledwidge M, McCaffrey D, McDonald K. Improvement but no cure of left ventricular systolic dysfunction in treated heart failure patients. Eur J Heart Fail. 2007;9:1196-1204. doi: 10.1016/j. ejheart.2007.10.001.
19. van Campen LC, Visser FC, Visser CA. Ejection fraction improvement by beta-blocker treatment in patients with heart failure: an analysis of studies published in the literature. J Cardiovasc Pharmacol. 1998;32(suppl 1):S31-S35.
20. McNamara DM, Starling RC, Cooper LT, Boehmer JP, Mather PJ, Janosko KM, Gorcsan J 3rd, Kip KE, Dec GW; IMAC Investigators. Clinical and demographic predictors of outcomes in recent onset dilated cardiomyopathy: results of the IMAC (Intervention in Myocarditis and Acute Cardiomyopathy)-2 study [published correction appears in J Am Coll Cardiol. 2011;58:1832]. J Am Coll Cardiol. 2011;58:1112-1118. doi: 10.1016/j.jacc.2011.05.033.
21. Marchlinski FE, Jessup M. Timing the implantation of implantable cardioverter-defibrillators in patients with nonischemic cardiomyopathy. J Am Coll Cardiol. 2006;47:2483-2485. doi: 10.1016/j.jacc.2006.01.075.
22. Wong M, Staszewsky L, Latini R, Barlera S, Glazer R, Aknay N, Hester A, Anand I, Cohn JN. Severity of left ventricular remodeling defines outcomes and response to therapy in heart failure: Valsartan Heart Failure Trial (Val-HeFT) echocardiographic data. J Am Coll Cardiol. 2004;43:2022-2027. doi: 10.1016/j.jacc.2003.12.053.
23. Solomon SD, Zelenkofske S, McMurray JJ, Finn PV, Velazquez E, Ertl G, Harsanyi A, Rouleau JL, Maggioni A, Kober L, White H, Van de Werf F, Pieper K, Califf RM, Pfeffer MA; Valsartan in Acute Myocardial Infarction Trial (VALIANT) Investigators. Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both [published correction appears in N Engl J Med. 2005;353:744]. N Engl J Med. 2005;352:2581-2588. doi: 10.1056/NEJMoa043938.
24. Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Køber L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD; VALIANT Investigators. Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation. 2010;122:597-602. doi: 10.1161/CIRCULATIONAHA.110.940619.
25. 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.
26. Kadish A, Schaechter A, Subacius H, Thattassery E, Sanders W, Anderson KP, Dyer A, Goldberger J, Levine J. Patients with recently diagnosed nonischemic cardiomyopathy benefit from implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006;47:2477-2482. doi: 10.1016/j. jacc.2005.11.090.
27. Bänsch D, Antz M, Boczor S, Volkmer M, Tebbenjohanns J, Seidl K, Block M, Gietzen F, Berger J, Kuck KH. Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: the Cardiomyopathy Trial (CAT). Circulation. 2002;105:1453-1458.
28. Hohnloser SH, Kuck KH, Dorian P, Roberts RS, Hampton JR, Hatala R, Fain E, Gent M, Connolly SJ; DINAMIT Investigators. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004;351:2481-2488. doi: 10.1056/NEJMoa041489.
29. Steinbeck G, Andresen D, Seidl K, Brachmann J, Hoffmann E, Wojciechowski D, Kornacewicz-Jach Z, Sredniawa B, Lupkovics G, Hofgärtner F, Lubinski A, Rosenqvist M, Habets A, Wegscheider K, Senges J; IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009;361:1427-1436. doi: 10.1056/NEJMoa0901889.
30. Larsen MP, Eisenberg MS, Cummins RO, Hallstrom AP. Predicting survival from out-of-hospital cardiac arrest: a graphic model. Ann Emerg Med. 1993;22:1652-1658.
31. Link MS, Atkins DL, Passman RS, Halperin HR, Samson RA, White RD, Cudnik MT, Berg MD, Kudenchuk PJ, Kerber RE. Part 6: electrical therapies: automated external defibrillators, defibrillation, cardioversion, and pacing: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care [published correction appears in Circulation. 2011;123:e235]. Circulation. 2010;122(suppl 3):S706-S719. doi: 10.1161/CIRCULATIONAHA.110.970954.
32. Gundry JW, Comess KA, De Rook FA, Jorgenson D, Bardy GH. Comparison of naive sixth-grade children with trained professionals in the use of an automated external defibrillator. Circulation. 1999;100:1703-1707.
33. Nichol G, Stiell IG, Laupacis A, Pham B, De Maio VJ, Wells GA. A cumulative meta-analysis of the effectiveness of defibrillator-capable emergency medical services for victims of out-of-hospital cardiac arrest. Ann Emerg Med. 1999;34(pt 1):517-525.
34. Bardy GH, Lee KL, Mark DB, Poole JE, Toff WD, Tonkin AM, Smith W, Dorian P, Packer DL, White RD, Longstreth WT Jr, Anderson J, Johnson G, Bischoff E, Yallop JJ, McNulty S, Ray LD, Clapp-Channing NE, Rosenberg Y, Schron EB; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008;358:1793-1804. doi: 10.1056/NEJMoa0801651.
35. Brignole M. Are complications of implantable defibrillators under-estimated and benefits over-estimated? Europace. 2009;11:1129-1133. doi: 10.1093/europace/eup174.
36. Ezekowitz JA, Rowe BH, Dryden DM, Hooton N, Vandermeer B, Spooner C, McAlister FA. Systematic review: implantable cardioverter defibrillators for adults with left ventricular systolic dysfunction. Ann Intern Med. 2007;147:251-262.
37. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. 2007;115:2474-2480. doi: 10.1161/CIRCULATIONAHA.106.663807.
38. Borleffs CJ, van Erven L, van Bommel RJ, van der Velde ET, van der Wall EE, Bax JJ, Rosendaal FR, Schalij MJ. Risk of failure of transvenous implantable cardioverter-defibrillator leads. Circ Arrhythm Electrophysiol. 2009;2:411-416. doi: 10.1161/CIRCEP.108.834093.
39. Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363:36-44. doi: 10.1056/NEJMoa0909545.
40. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, Maass AH, de Groot JR, van Oostrom AJ, Theuns DA, Jordaens LJ, Wilde AA, Knops RE. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol. 2012;60:1933-1939. doi: 10.1016/j.jacc.2012.06.053.
41. Hauser RG. The subcutaneous implantable cardioverter-defibrillator: should patients want one? J Am Coll Cardiol. 2013;61:20-22. doi: 10.1016/j.jacc.2012.07.069.
42. Auricchio A, Klein H, Geller CJ, Reek S, Heilman MS, Szymkiewicz SJ. Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation. Am J Cardiol. 1998;81:1253-1256.
43. Klein HU, Meltendorf U, Reek S, Smid J, Kuss S, Cygankiewicz I, Jons C, Szymkiewicz S, Buhtz F, Wollbrueck A, Zareba W, Moss AJ. Bridging a temporary high risk of sudden arrhythmic death: experience with the wearable cardioverter defibrillator (WCD). Pacing Clin Electrophysiol. 2010;33:353-367. doi: 10.1111/j.1540-8159.2009.02590.x.
44. Dillon KA, Szymkiewicz SJ, Kaib TE. Evaluation of the effectiveness of a wearable cardioverter defibrillator detection algorithm. J Electrocardiol. 2010;43:63-67. doi: 10.1016/j.jelectrocard.2009.05.010.
45. Knops RE, Kooiman KM, Ten Sande JN, de Groot JR, Wilde AA. First experience with the wearable cardioverter defibrillator in the Netherlands. Neth Heart J. 2012;20:77-81. doi: 10.1007/s12471-011-0227-9.
46. Feldman AM, Klein H, Tchou P, Murali S, Hall WJ, Mancini D, Boehmer J, Harvey M, Heilman MS, Szymkiewicz SJ, Moss AJ; WEARIT Investigators and Coordinators; BIROAD Investigators and Coordinators. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD [published correction appears in Pacing Clin Electrophysiol. 2004;27:following Table of Contents]. Pacing Clin Electrophysiol. 2004;27:4-9.
47. Reek S, Geller JC, Meltendorf U, Wollbrueck A, Szymkiewicz SJ, Klein HU. Clinical efficacy of a wearable defibrillator in acutely terminating episodes of ventricular fibrillation using biphasic shocks. Pacing Clin Electrophysiol. 2003;26:2016-2022.
48. Chung MK, Szymkiewicz SJ, Shao M, Zishiri E, Niebauer MJ, Lindsay BD, Tchou PJ. Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival. J Am Coll Cardiol. 2010;56:194-203. doi: 10.1016/j.jacc.2010.04.016.
49. Collins KK, Silva JN, Rhee EK, Schaffer MS. Use of a wearable automated defibrillator in children compared to young adults. Pacing Clin Electrophysiol. 2010;33:1119-1124. doi: 10.1111/j.1540-8159. 2010.02819.x.
50. Everitt MD, Saarel EV. Use of the wearable external cardiac defibrillator in children. Pacing Clin Electrophysiol. 2010;33:742-746. doi: 10.1111/j.1540-8159.2010.02702.x.
51. La Page MJ, Canter CE, Rhee EK. A fatal device-device interaction between a wearable automated defibrillator and a unipolar ventricular pacemaker. Pacing Clin Electrophysiol. 2008;31:912-915. doi: 10.1111/j.1540-8159.2008.01110.x.
52. Epstein AE, Abraham WT, Bianco NR, Kern KB, Mirro M, Rao SV, Rhee EK, Solomon SD, Szymkiewicz SJ. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013;62:2000-2007. doi: 10.1016/j.jacc.2013.05.086.
53. Mitrani RD, McArdle A, Slane M, Cogan J, Myerburg RJ. Wearable defibrillators in uninsured patients with newly diagnosed cardiomyopathy or recent revascularization in a community medical center. Am Heart J. 2013;165:386-392. doi: 10.1016/j.ahj.2012.12.014.
54. Zishiri ET, Williams S, Cronin EM, Blackstone EH, Ellis SG, Roselli EE, Smedira NG, Gillinov AM, Glad JA, Tchou PJ, Szymkiewicz SJ, Chung MK. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:117-128. doi: 10.1161/CIRCEP.112.973552.
55. Kao AC, Krause SW, Handa R, Karia D, Reyes G, Bianco NR, Szymkiewicz SJ; Wearable defibrillator use In heart Failure (WIF) Investigators. Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BMC Cardiovasc Disord. 2012;12:123. doi: 10.1186/1471-2261-12-123.
56. Saltzberg MT, Szymkiewicz S, Bianco NR. Characteristics and outcomes of peripartum versus nonperipartum cardiomyopathy in women using a wearable cardiac defibrillator. J Card Fail. 2012;18:21-27. doi: 10.1016/j. cardfail.2011.09.004.
57. Rao M, Goldenberg I, Moss AJ, Klein H, Huang DT, Bianco NR, Szymkiewicz SJ, Zareba W, Brenyo A, Buber J, Barsheshet A. Wearable defibrillator in congenital structural heart disease and inherited arrhythmias. Am J Cardiol. 2011;108:1632-1638. doi: 10.1016/j. amjcard.2011.07.021.
58. Bloch Thomsen PE, Jons C, Raatikainen MJ, Moerch Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Gang UJ, Hoest N, Boersma LV, Platou ES, Becker D, Messier MD, Huikuri HV; Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) Study Group. Long-term recording of cardiac arrhythmias with an implantable cardiac monitor in patients with reduced ejection fraction after acute myocardial infarction: the Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) study. Circulation. 2010;122:1258-1264. doi: 10.1161/CIRCULATIONAHA.109.902148.
59. van Rees JB, Borleffs CJ, de Bie MK, Stijnen T, van Erven L, Bax JJ, Schalij MJ. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011;57:556-562. doi: 10.1016/j.jacc.2010.06.059.
60. Clinical Trials. Gov. Vest Prevention of Early Sudden Death Trial and VEST Registry. http://clinicaltrials.gov/ct2/show/NCT01446965?term=v est+wearable&rank=1. Accessed November 14, 2014.
61. Gronda E, Bourge RC, Costanzo MR, Deng M, Mancini D, Martinelli L, Torre-Amione G, O'Hara ML, Chambers S. Heart rhythm considerations in heart transplant candidates and considerations for ventricular assist devices: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates-2006 [published correction appears in J Heart Lung Transplant. 2006;25:1276]. J Heart Lung Transplant. 2006;25:1043-1056. doi: 10.1016/j.healun.2006.06.005.
62. Nery PB, Fernandes R, Nair GM, Sumner GL, Ribas CS, Menon SM, Wang X, Krahn AD, Morillo CA, Connolly SJ, Healey JS. Device-related infection among patients with pacemakers and implantable defibrillators: incidence, risk factors, and consequences. J Cardiovasc Electrophysiol. 2010;21:786-790. doi: 10.1111/j.1540-8167.2009.01690.x.
63. Vaughan-Sarrazin MS, Hannan EL, Gormley CJ, Rosenthal GE. Mortality in Medicare beneficiaries following coronary artery bypass graft surgery in states with and without certificate of need regulation. JAMA. 2002;288:1859-1866.
64. Toda K, Mackenzie K, Mehra MR, Di Corte CJ, Davis JE, McFadden PM, Ochsner JL, White C, Van Meter CH Jr. Revascularization in severe ventricular dysfunction (15% < OR = LVEF < OR = 30%): a comparison of bypass grafting and percutaneous intervention. Ann Thorac Surg. 2002;74:2082-2087.
65. Bigger JT Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. 1997;337:1569-1575. doi: 10.1056/NEJM199711273372201.
66. Centers for Medicaid & Medicare Services. National coverage determination for implantable automatic defibrillators (20.4). 2005. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1 10&ncdver=2&NCAId=148&NcaName=Computed+Tomographic+Angi ography&IsPopup=y&bc=AAAAAAAAAEAAAA%3d%3d. Accessed March 9, 2016.
67. Steinberg JS, Mittal S. The federal audit of implantable cardioverter-defibrillator implants: lessons learned. J Am Coll Cardiol. 2012;59:1270-1274. doi: 10.1016/j.jacc.2011.12.026.
68. Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR, Hohnloser SH, Indik J, Lee R, Mehra MR, Menon V, Page RL, Shen W-K, Slotwiner DJ, Stevenson LW, Varosy PD, Lisa Welikovitch. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. Circulation. 2014;130:94-125.
69. Epstein AE, Di Marco JP, Ellenbogen KA, Estes NA 3rd, 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. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) [published correction appears in Circulation. 2009;120:e34-e35]. Circulation. 2008;117:e350-e408. doi: 10.1161/CIRCUALTIONAHA.108.189742.
70. Pearson GD, Veille JC, Rahimtoola S, Hsia J, Oakley CM, Hosenpud JD, Ansari A, Baughman KL. Peripartum cardiomyopathy: National Heart, Lung, and Blood Institute and Office of Rare Diseases (National Institutes of Health) workshop recommendations and review. JAMA. 2000;283:1183-1188.
71. Amos AM, Jaber WA, Russell SD. Improved outcomes in peripartum cardiomyopathy with contemporary. Am Heart J. 2006;152:509-513. doi: 10.1016/j.ahj.2006.02.008.
72. Schoppet M, Maisch B. Alcohol and the heart. Herz. 2001;26:345-352.
73. Henderson R, Keiding N. Individual survival time prediction using statistical models. J Med Ethics. 2005;31:703-706. doi: 10.1136/jme.2005.012427.
74. Haga K, Murray S, Reid J, Ness A, O'Donnell M, Yellowlees D, Denvir MA. Identifying community based chronic heart failure patients in the last year of life: a comparison of the Gold Standards Framework Prognostic Indicator Guide and the Seattle Heart Failure Model. Heart. 2012;98:579-583. doi: 10.1136/heartjnl-2011-301021.
75. Allen LA, Gheorghiade M, Reid KJ, Dunlay SM, Chan PS, Hauptman PJ, Zannad F, Konstam MA, Spertus JA. Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life. Circ Cardiovasc Qual Outcomes. 2011;4:389-398. doi: 10.1161/CIRCOUTCOMES.110.958009.
76. Stehlik J, Edwards LB, Kucheryavaya AY, Benden C, Christie JD, Dipchand AI, Dobbels F, Kirk R, Rahmel AO, Hertz MI; International Society of Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transplantation: 29th official adult heart transplant report-2012. J Heart Lung Transplant. 2012;31:1052-1064. doi: 10.1016/j.healun.2012.08.002.
77. Uriel N, Jorde UP, Woo Pak S, Jiang J, Clerkin K, Takayama H, Naka Y, Schulze PC, Mancini DM. Impact of long term left ventricular assist device therapy on donor allocation in cardiac transplantation. J Heart Lung Transplant. 2013;32:188-195. doi: 10.1016/j.healun.2012.11.010.
78. Allen LA, Stevenson LW, Grady KL, Goldstein NE, Matlock DD, Arnold RM, Cook NR, Felker GM, Francis GS, Hauptman PJ, Havranek EP, Krumholz HM, Mancini D, Riegel B, Spertus JA; on behalf of American Heart Association; Council on Quality of Care and Outcomes Research; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia. Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation. 2012;125:1928-1952. doi: 10.1161/CIR.0b013e31824f2173.
79. Buxton AE, Lee KL, Hafley GE, Pires LA, Fisher JD, Gold MR, Josephson ME, Lehmann MH, Prystowsky EN; MUSTT Investigators. Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease: lessons from the MUSTT study. J Am Coll Cardiol. 2007;50:1150-1157. doi: 10.1016/j.jacc.2007.04.095.
80. Clinical Trials. Gov. Study of the Wearable Defibrillator in Heart-Failure Patients (SWIFT). http://clinicaltrials.gov/ct2/show/NCT01326624?term =swift+wearable&rank=1. Accessed November 14, 2014.