To replace or not to replace: A systematic approach to respond to device advisories

Journal of Cardiovascular Electrophysiology

Volumn 20, Issue 2, 2009, Pages 164-170

  Priori, Silvia G ^a,b   Auricchio, Angelo ^c   Nisam, Seah ^d   Yong, Patrick ^e  

^a IRCCS   (Italy)

^b UNIVERSITY OF PAVIA   (Italy)

^c DIVISION OF CARDIOLOGY   (Switzerland)

^d Boston Scientific ^*  (Belgium)

^e Clinical Affairs   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ARTIFICIAL HEART PACEMAKER; CARDIOVASCULAR RISK; DEFIBRILLATOR; DEVICE; HEART ARRHYTHMIA; HUMAN; IMPLANT; LONGEVITY; METHODOLOGY; MORBIDITY; MORTALITY; PRIORITY JOURNAL; PROBABILITY; PROSTHESIS FAILURE; RISK BENEFIT ANALYSIS; SUDDEN DEATH;

ALGORITHMS; ARRHYTHMIAS, CARDIAC; DEATH, SUDDEN, CARDIAC; DECISION MAKING; DEFIBRILLATORS, IMPLANTABLE; DEVICE REMOVAL; EQUIPMENT FAILURE; HUMANS; MODELS, STATISTICAL; REOPERATION; RISK ASSESSMENT; TACHYCARDIA, VENTRICULAR; VENTRICULAR FIBRILLATION;

EID: 61349144388     PISSN: 10453873     EISSN: 15408167     Source Type: Journal    
DOI: 10.1111/j.1540-8167.2008.01291.x     Document Type: Article

References (26)

1. Zipes DP, Camm AJ, Borggrefe M, Buxton A, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss A, Myerburg R, Priori S, Quinones M, Roden D, Silka M, Tracy C : American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association and the Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death - executive summary: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Eur Heart J 2006 27 : 2099 2140.
2. Wilkoff B : ICDs: Dealing with less than perfect. J Cardiovasc Electrophysiol 2005 16 : 796 797.
3. Higgins S : The dark side of the new era. PACE 2006 29 : 459 460.
4. Carlson M, Wilkoff B, Maisel W, Ellenbogen K, Saxon L, Prystowsky E, Alpert J, Cain M, Ching E, Curtis A, Davies W, Hammill S, Hauser R, Lampert R, Zipes D : Recommendations from the Heart Rhythm Society task force on device performance policies and guidelines. Hearth Rhythm 2006 3 : 1250 1273.
5. Auricchio A, Gropp M, Ludgate S, Vardas P, Brugada J, Priori S : European Heart Rhythm Association guidance document on cardiac rhythm management product performance. Europace 2006 8 : 313 322.
6. Santini M, Brachmann J, Cappato R, Davies W, Farre J, Levy S, Quesada A, Ricci R, Rowland E, Sulke N : Policy statement. Recommendations of the European Cardiac Arrhythmia Society Committee on device failures and complications. PACE 2006 29 : 653 669.
7. Amin M, Marchar D, Wood M, Ellenbogen K : Management of recalled pacemakers and implantable cardioverter-defibrillators: A decision analysis model. JAMA 2006 296 : 412 420.
8. Santucci P : Implantable cardioverter-defibrillator failures and recalls: Where do we go from here? Heart Rhythm 2006 3 : 645 646.
9. Laupacis A, Sackett D, Roberts R : An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988 318 : 1728 1733.
10. Salukhe T, Dimopoulos K, Sutton R, Coats A, Piepoli M, Francis D : Life-years gained from defibrillator implantation; markedly nonlinear increase during 3 years of follow-up and its implications. Circulation 2004 109 : 1848 1853.
11. Barratt A, Wyer PC, Hatala R, McGinn T, Dans AL, Keitz S, Moyer V, For GG : Tips for learners of evidence-based medicine: 1. Relative risk reduction, absolute risk reduction and number needed to treat. CMAJ 2004 171 : 353 358.
12. Bender R : Calculating confidence intervals for the number needed to treat. Control Clin Trials 2001 22 : 102 110.
13. Gould P, Krahn A (for the Canadian Heart Rhythm Society Working Group on Device Advisories) : Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006 295 : 1907 1911.
14. Zareba W, Moss A, Daubert J, Hall J, Robinson J, Andrews M : Implantable cardioverter defibrillator in high-risk long QT syndrome patients. J Cardiovasc Electrophysiol 2003 14 : 337 341.
15. Brugada J, Brugada R, Antzelevitch C, Towbin J, Nademanee K, Brugada P : Long-term follow-up of individuals with the electrocardiographic pattern of right bundle-branch block and ST-segment elevation in leads V1 to V3. Circulation 2002 105 : 73 78.
16. Moss A, Hall J, Cannom D, Daubert J, Higgins S, Klein H, Levine J, Saksena S, Waldo A, Wilber D, Brown M, Heo M : Improved survival with an implanted defibrillator in patients with coronary artery disease at high risk of ventricular arrhythnmia. N Engl J Med 1996 335 : 1933 1940.
17. Guidant Product Performance Report, Feb 24, 2006 http://www.guidant.com/ ppr/ppr-archives/2006/q3-ppr.pdf.
18. Medtronic Cardiac Rhythm Management Product Performance Report 2006, First Edition, Jan 2006 http://www.p.medtronic.com/newsroom/content/ 1141235932436.pdf.
19. St. Jude Medical Cardiac Rhythm Management Product Performance Report 2006, April 2006. http://www.sjm.com/documents/ppr.pdf.
20. Moss A, Greenberg H, Case R, Zareba W, Hall J, Brown M, Daubert J, McNitt S, Andrews M, Elkin A : Long-term clinical course of patients after termination of ventricular tacharrhythmia by an implanted defibrillator. Circulation 2004 11 : 3760-3765.
21. Gula L, Massel D, Krahn A, Skanes A, Yee R, Klein G : Survival rates as a guide to implanted cardioverter-defibrillator replacement strategies for device recalls - adding statistical insight to clinical intuition. Am Heart J 2007 153 : 253 259.
22. Hammill S, Stevenson LW, Kadish A, Kremers M, Heidenreich P, Lindsay B, Mirro M, Radford M, Wang Y, Lang C, Harder J, Brindis R : Review of the Registry's first year, data collected, and future plans. Heart Rhythm 2007 4 : 1260 1263.
23. Wilkoff B : Lead failures: Dealing with even less perfect. Heart Rhythm 2007 4 : 897 899.
24. Bracke FA, Meijer A, van Gelder LM : Lead extraction for device related infections: A single-centre experience. Europace 2004 6 : 243 247.
25. http://www.medtronic.com/fidelis/physician-letter.html. Oct 15, 2007.
26. Vlay SC : Concerns about the Riata® ST (St. Jude Medical) ICD Lead. Pacing Clin Electrophysiol 2008 31 : 1 2.