Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator

Circulation

Volumn 128, Issue 9, 2013, Pages 944-953

  Weiss, Raul ^a   Knight, Bradley P ^b   Gold, Michael R ^c   Leon, Angel R ^d   Herre, John M ^e   Hood, Margaret ^f   Rashtian, Mayer ^g   Kremers, Mark ^h   Crozier, Ian ⁱ   Lee, Kerry L ^j   Smith, Warren ^f   Burke, Martin C ^k  

^a OHIO STATE UNIVERSITY   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d EMORY UNIVERSITY   (United States)

^e Sentara Cardiology Specialists   (United States)

^f AUCKLAND CITY HOSPITAL   (New Zealand)

^g Foothill Cardiology   (United States)

^h Carolinas Heart and Vascular Institute   (United States)

ⁱ CHRISTCHURCH HOSPITAL   (New Zealand)

^j DUKE UNIVERSITY   (United States)

^k UNIVERSITY OF CHICAGO   (United States)

more..

Author keywords

Defibrillators; Heart arrest; Implantable; Tachycardia

Indexed keywords

CREATINE KINASE; CREATININE;

ADULT; AGED; ARTICLE; BODY MASS; COHORT ANALYSIS; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DEATH; DEVICE SAFETY; ELECTRODE; FEMALE; FLUOROSCOPY; FOLLOW UP; HEART ARREST; HEART ATRIUM FIBRILLATION; HEART EJECTION FRACTION; HEART INFARCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HEART RHYTHM; HEART VENTRICLE ARRHYTHMIA; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; HYPERTENSION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MAJOR CLINICAL STUDY; MALE; PRIMARY PREVENTION; PRIORITY JOURNAL; PULSE GENERATOR; QRS COMPLEX; RISK FACTOR; SENSITIVITY ANALYSIS; T WAVE; TREATMENT OUTCOME;

DEFIBRILLATORS, IMPLANTABLE; HEART ARREST; TACHYCARDIA;

ADULT; AGED; COHORT STUDIES; DEFIBRILLATORS, IMPLANTABLE; EQUIPMENT SAFETY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TACHYCARDIA, VENTRICULAR; TREATMENT OUTCOME;

EID: 84883221412     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.113.003042     Document Type: Article

References (33)

1. Mirowski M, Reid PR, Mower MM, Watkins L, Gott VL, Schauble JF, Langer A, Heilman MS, Kolenik SA, Fischell RE, Weisfeldt ML. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med. 1980;303: 322-324.
2. The Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337: 1576-1584.
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; Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996;335: 1933-1940.
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. N Engl J Med. 2002;346: 877-883.
5. 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.
6. Reynolds MR, Cohen DJ, Kugelmass AD, Brown PP, Becker ER, Culler SD, Simon AW. The frequency and incremental cost of major complications among Medicare beneficiaries receiving implantable cardioverterdefibrillators. J Am Coll Cardiol. 2006;47: 2493-2497.
7. Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol. 2005;28: 926-932.
8. 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.
9. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Sagau W, Weisse U, Seidl K. Annual rate of transvenous lead defects in implantable cardioverter-defibrilators over a period of >10 years. Circulation. 2007;115: 2474-2480.
10. Bardy GH, Lee K, Mark D, Poole J, Fishbein D, Boineau R, Hellkamp A, Davidson-Ray L, Anstrom K, Johnson G, Anderson J, Reinhall P. Long term follow-up in the Sudden Cardiac Death Heart Failure Trial (SCDHeFT) [abstract]. Heart Rhythm. 2012;9: 1579.
11. Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, Karim SS, Bashir J, Greenspon AJ, DiMarco JP, Cooper JM, Onufer JR, Ellenbogen KA, Kutalek SP, Dentry-Mabry S, Ervin CM, Wilkoff BL. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. 2010;55: 579-586.
12. Bardy GH, Cappato R, Hood M, Rissmann RJ, Gropper CM, Ostroff AH. The totally subcutaneous ICD system (the S-ICD) [abstract]. Pacing Clin Electrophysiol. 2002;25(suppl II): 578.
13. 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.
14. 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, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL,Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP,Page RL, Riegel B, Tarkington LG, Yancy CW; 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); American Association for ThoracicSurgery; Society of Thoracic Surgeons. 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. Circulation.2008;117;e350-e408.
15. Bellardine Black CL, Stromberg K, van Balen GP, Ghanem RN, Breedveld RW, Tieleman RG. Is surface ECG a useful surrogate for subcutaneous ECG? Pacing Clin Electrophysiol. 2010;33: 135-145.
16. Burke MC, Song Z, Jenkins J, Alberts M, Del Priore J, Arzbaecher R. Analysis of electrocardiograms for subcutaneous monitors. J Electrocardiol. 2003;36(suppl): 227-232.
17. Burke MC, Toff WD, Ludmer PL, Barr CS, Beshai JF, O'Neill PG, Lee MA, Skehan JD, Kim SS, Cho S, Kang S, Lin AC, Knight BP. Comparisons during Multiple Postures of Resting ECG's (COMPARE) Study [abstract]. Heart Rhythm. 2009;6(suppl):S126.
18. Israel CW, Barold SS. Electrical storm in patients with an implanted defibrillator: a matter of definition. Ann Noninvasive Electrocardiol. 2007;12: 375-382.
19. Aydin A, Hartel F, Schluter M, Butter C, Kobe J, Seifert M, Gosau N, Hoffmann B, Hoffmann M, Vettorazzi E, Wilke I, Wegscheider K, Reichenspurner H, Echardt L, Steven D, Willems S. Shock efficacy of the the subcutaneous ICD for prevention of sudden cardiac death: initial multicenter experience. Circ Arrhythmia Electrophysiol. 2012; 5: 913-919.
20. ACC's NCDR ICD Registry. https://www.ncdr.com/WebNCDR/ICD. Accessed June 15, 2012.
21. Epstein AE, Kay GN, Plumb VJ, McElderry HT, Doppalapudi H, Yamada T, Shafiroff J, Syed ZA, Shkurovich S; ACT Investigators. Implantable cardioverter-defibrillator prescription in the elderly. Heart Rhythm. 2009;6: 1136-1143.
22. Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007;4: 1467-1470.
23. LE KY, Sohail MR, Friedman PA, Uslan DZ, Cha SS, Hayes DL, Wilson WR, Steckelberg JM, Baddour LM; Mayo Cardiovascular Infections Study Group. Clinical predictors of cardiovascular implantable electronic device-related infective endocarditis. Pacing Clin Electrophysiol. 2011; 34: 450-459.
24. Athan E, Chu VH, Tattevin P, Selton-Suty C, Jones P, Naber C, Miró JM, Ninot S, Fernández-Hidalgo N, Durante-Mangoni E, Spelman D, Hoen B, Lejko-Zupanc T, Cecchi E, Thuny F, Hannan MM, Pappas P, Henry M, Fowler VG Jr, Crowley AL, Wang A; ICE-PCS Investigators. Clinical characteristics and outcome of infective endocarditis involving implantable cardiac devices. JAMA. 2012;307: 1727-1735.
25. Wilkoff BL, Hess M, Young J, Abraham WT. Differences in tachyarrhythmia detection and implantable cardioverter defibrillator therapy by primary or secondary prevention indication in cardiac resynchronization therapy patients. J Cardiovasc Electrophysiol. 2004;15: 1002-1009.
26. Saba S, Ravipati LP, Voigt A. Recent trends in utilization of implantable cardioverter-defibrillators in survivors of cardiac arrest in the United States. Pacing Clin Electrophysiol. 2009;32: 1444-1449.
27. Rosenqvist M, Beyer T, Block M, den Dulk K, Minten J, Lindemans F; European 7219 Jewel ICD Investigators. Adverse events with transvenous implantable cardioverter-defibrillators: a prospective multicenter study. Circulation. 1998;98: 663-670.
28. Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008;359: 1009-1017.
29. Gold MR, Theuns DA, Knight BP, Sturdivant JL, Sanghera R, Ellenbogen KA, Wood MA, Burke MC. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012;23: 359-366.
30. Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M, Meyer TE, Jones PW, Boehmer JP. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010;122: 2359-2367.
31. Wilkoff BL, Williamson BD, Stern RS, Moore SL, Lu F, Lee SW, Birgersdotter-Green UM, Wathen MS, Van Gelder IC, Heubner BM, Brown ML, Holloman KK; PREPARE Study Investigators. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol. 2008;52: 541-550.
32. Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA III, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012;367: 2275-2283.
33. Gasparini M, Menozzi C, Proclemer A, Landolina M, Iacopino S, Carboni A, Lombardo E, Regoli F, Biffi M, Burrone V, Denaro A, Boriani G. A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study. Eur Heart J. 2009;30: 2758-2767.