Device Therapies: New Indications and Future Directions

Author(s): Prabhat Kumar, Jennifer D. Schwartz.

Journal Name: Current Cardiology Reviews

Volume 11 , Issue 1 , 2015

Become EABM
Become Reviewer

Graphical Abstract:


Abstract:

Implantable cardioverter-defibrillator (ICDs), cardiac resynchronization (CRT) and combination (CRT-D) therapy have become an integral part of the management of patients with heart failure with reduced ejection fraction (HFrEF). ICDs treat ventricular arrhythmia and CRTs improve left ventricular systolic function by resynchronizing ventricular contraction. Device therapies (ICD, CRT-D), have been shown to reduce all-cause mortality, including sudden cardiac death. Hospitalizations are reduced with CRT and CRT-D therapy. Major device related complications include device infection, inappropriate shocks, lead malfunction and complications related to extraction of devices. Improvements in device design and implantation have included progressive miniaturization and increasing battery life of the device, optimization of response to CRT, and minimizing inappropriate device therapy. Additionally, better definition of the population with the greatest benefit is an area of active research.

Keywords: Cardiac implantable electronic device, cardiac resynchronization therapy (CRT), heart failure (HF), implantable cardioverter-defibrillator (ICD), primary prevention, secondary prevention, sudden cardiac death (SCD).

[1]
The cardiac insufficiency bisoprolol study II (CIBIS-II): a randomised trial. Lancet 1999; 353: 9-13.
[2]
Garg R, Yusuf S. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Collaborative Group on ACE Inhibitor Trials. JAMA 1995; 273: 1450-6.
[3]
Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999; 341: 709-17.
[4]
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL randomised intervention trial in congestive heart failure (MERIT-HF). Lancet 1999; 353: 2001-7.
[5]
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: 1576-83.
[6]
Connolly SJ, Gent M, Roberts RS, et al. Canadian implantable defibrillator study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation 2000; 101: 1297-302.
[7]
Kuck KH, Cappato R, Siebels J, Ruppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH). Circulation 2000; 102: 748-54.
[8]
Connolly SJ, Hallstrom AP, Cappato R, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J 2000; 21: 2071-8.
[9]
Oseroff O, Retyk E, Bochoeyer A. Subanalyses of secondary prevention implantable cardioverter-defibrillator trials: antiarrhythmics versus implantable defibrillators (AVID), Canadian Implantable Defibrillator Study (CIDS), and Cardiac Arrest Study Hamburg (CASH). Curr Opin Cardiol 2004; 19: 26-30.
[10]
Domanski MJ, Sakseena S, Epstein AE, et al. Relative effectiveness of the implantable cardioverter-defibrillator and antiarrhythmic drugs in patients with varying degrees of left ventricular dysfunction who have survived malignant ventricular arrhythmias. AVID Investigators. Antiarrhythmics Versus Implantable Defibrillators. J Am Coll Cardiol 1999; 34: 1090-5.
[11]
Sheldon R, Connolly S, Krahn A, Roberts R, Gent M, Gardner M. Identification of patients most likely to benefit from implantable cardioverter-defibrillator therapy: the Canadian Implantable Defibrillator Study. Circulation 2000; 101: 1660-4.
[12]
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: 1569-75.
[13]
Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med 2004; 351: 2481-8.
[14]
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. N Engl J Med 1999; 341: 1882-90.
[15]
Moss AJ, Hall WJ, Cannom DS, et al. 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: 1933-40.
[16]
Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-83.
[17]
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-37.
[18]
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004; 350: 2151-8.
[19]
Theuns DA, Smith T, Hunink MG, Bardy GH, Jordaens L. Effectiveness of prophylactic implantation of cardioverter-defibrillators without cardiac resynchronization therapy in patients with ischaemic or non-ischaemic heart disease: a systematic review and meta-analysis. Europace 2010; 12: 1564-70.
[20]
Santangeli P, Pelargonio G, Dello Russo A, et al. 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: 876-82.
[21]
Kong MH, Al-Khatib SM, Sanders GD, Hasselblad V, Peterson ED. Use of implantable cardioverter-defibrillators for primary prevention in older patients: a systematic literature review and meta-analysis. Cardiol J 2011; 18: 503-14.
[22]
Santangeli P, Di Biase L, Dello Russo A, et al. Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillators. Ann Intern Med 2010; 153: 592-9.
[23]
Goldenberg I, Vyas AK, Hall WJ, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. J Am Coll Cardiol 2008; 51: 288-96.
[24]
Ghio S, Constantin C, Klersy C, et al. Interventricular and intraventricular dyssynchrony are common in heart failure patients, regardless of QRS duration. Eur Heart J 2004; 25: 571-8.
[25]
Cazeau S, Leclercq C, Lavergne T, et al. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med 2001; 344: 873-80.
[26]
Abraham WT, Fisher WG, Smith AL, et al. Multicenter InSync Randomized Clinical Evaluation: Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346: 1845-53.
[27]
Leclercq C, Walker S, Linde C, et al. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J 2002; 23: 1780-7.
[28]
Auricchio A, Stellbrink C, Sack S, et al. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol 2002; 39: 2026-33.
[29]
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA 2003; 289: 2685-94.
[30]
Auricchio A, Stellbrink C, Butter C, et al. Clinical efficacy of cardiac resynchronization therapy using left ventricular pacing in heart failure patients stratified by severity of ventricular conduction delay. J Am Coll Cardiol 2003; 42: 2109-16.
[31]
Higgins SL, Hummel JD, Niazi IK, et al. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol 2003; 42: 1454-9.
[32]
Abraham WT, Young JB, Leon AR, et al. Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure. Circulation 2004; 110: 2864-8.
[33]
Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004; 350: 2140-50.
[34]
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005; 352: 1539-49.
[35]
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure the cardiac resynchronization-heart failure (CARE-HF) trial extension phase. Eur Heart J 2006; 27: 1928-32.
[36]
Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med 2009; 361: 1329-38.
[37]
Linde C, Abraham WT, Gold MR, et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol 2008; 52: 1834-43.
[38]
Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med 2010; 363: 2385-95.
[39]
Curtis AB, Worley SJ, Adamson PB, et al. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med 2013; 368: 1585-93.
[40]
Woo GW, Petersen-Stejskal S, Johnson JW, Conti JB, Aranda JA Jr, Curtis AB. Ventricular reverse remodeling and 6-month outcomes in patients receiving cardiac resynchronization therapy: analysis of the MIRACLE study. J Interv Card Electrophysiol 2005; 12: 107-13.
[41]
Barsheshet A, Goldenberg I, Moss AJ, et al. Response to preventive cardiac resynchronization therapy in patients with ischaemic and nonischaemic cardiomyopathy in MADIT-CRT. Eur Heart J 2011; 32: 1622-30.
[42]
Sipahi I, Carrigan TP, Rowland DY, Stambler BS, Fang JC. Impact of QRS duration on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Arch Intern Med 2011; 171: 1454-62.
[43]
Sipahi I, Chou JC, Hyden M, Rowland DY, Simon DI, Fang JC. Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Am Heart J 2012; 163: 260.
[44]
Rossillo A, Verma A, Saad EB, et al. Impact of coronary sinus lead position on biventricular pacing: mortality and echocardiographic evaluation during long-term follow-up. J Cardiovasc Electrophysiol 2004; 15: 1120-5.
[45]
Thebault C, Donal E, Meunier C, et al. Sites of left and right ventricular lead implantation and response to cardiac resynchronization therapy observations from the REVERSE trial. Eur Heart J 2012; 33: 2662-71.
[46]
Wilton SB, Shibata MA, Sondergaard R, Cowan K, Semeniuk L, Exner DV. Relationship between left ventricular lead position using a simple radiographic classification scheme and long-term outcome with resynchronization therapy. J Interv Card Electrophysiol 2008; 23: 219-27.
[47]
Singh JP, Klein HU, Huang DT, et al. Left ventricular lead position and clinical outcome in the multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT) trial. Circulation 2011; 123: 1159-66.
[48]
Merchant FM, Heist EK, McCarty D, et al. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm 2010; 7: 639-44.
[49]
Foley PW, Chalil S, Ratib K, et al. Fluoroscopic left ventricular lead position and the long-term clinical outcome of cardiac resynchronization therapy. Pacing Clin Electrophysiol 2011; 34: 785-97.
[50]
Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging 2012; 13: 991-1000.
[51]
Fung JW, Lam YY, Zhang Q, et al. Effect of left ventricular lead concordance to the delayed contraction segment on echocardiographic and clinical outcomes after cardiac resynchronization therapy. J Cardiovasc Electrophysiol 2009; 20: 530-5.
[52]
Singh JP, Fan D, Heist EK, et al. Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy. Heart Rhythm 2006; 3: 1285-92.
[53]
Gold MR, Birgersdotter-Green U, Singh JP, et al. The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy. Eur Heart J 2011; 32: 2516-24.
[54]
Wilton SB, Leung AA, Ghali WA, Faris P, Exner DV. Outcomes of cardiac resynchronization therapy in patients with versus those without atrial fibrillation: a systematic review and meta-analysis. Heart Rhythm 2011; 8: 1088-94.
[55]
Beshai JF, Grimm RA, Nagueh SF, et al. Cardiac-resynchronization therapy in heart failure with narrow QRS complexes. N Engl J Med 2007; 357: 2461-71.
[56]
Thibault B, Harel F, Ducharme A, et al. Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial. Circulation 2013; 127: 873-81.
[57]
Ellenbogen KA, Gold MR, Meyer TE, et al. Primary results from the SmartDelay determined AV optimization: a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) trial: a randomized trial comparing empirical, echocardiography-guided, and algorithmic atrioventricular delay programming in cardiac resynchronization therapy. Circulation 2010; 122: 2660-8.
[58]
Abraham WT, Leon AR, St John Sutton MG, et al. Randomized controlled trial comparing simultaneous versus optimized sequential interventricular stimulation during cardiac resynchronization therapy. Am Heart J 2012; 164: 735-41.
[59]
Delnoy PP, Ritter P, Naegele H, et al. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study. Europace 2013; 15(8): 1174-81.
[60]
Boriani G, Muller CP, Seidl KH, et al. Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The resynchronization for the hemodynamic treatment for heart failure management II implantable cardioverter defibrillator (RHYTHM II ICD) study. Am Heart J 2006; 151: 1050-8.
[61]
Rao RK, Kumar UN, Schafer J, Viloria E, De Lurgio D, Foster E. Reduced ventricular volumes and improved systolic function with cardiac resynchronization therapy: a randomized trial comparing simultaneous biventricular pacing, sequential biventricular pacing, and left ventricular pacing. Circulation 2007; 115: 2136-44.
[62]
Epstein AE, DiMarco JP, Ellenbogen KA, et al. 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-e75.
[63]
Daubert JC, Saxon L, Adamson PB, et al. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management. Europace 2012; 14: 1236-86.
[64]
Stevenson WG, Hernandez AF, Carson PE, et al. Indications for cardiac resynchronization therapy: 2011 update from the Heart Failure Society of America Guideline Committee. J Card Fail 2012; 18: 94-106.
[65]
Forleo GB, Mantica M, Di Biase L, et al. Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: early results of a prospective multicenter study. Heart Rhythm 2012; 9: 1822-8.
[66]
Sperzel J, Danschel W, Gutleben KJ, et al. First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead. Europace 2012; 14: 365-72.
[67]
Thibault B, Dubuc M, Khairy P, et al. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace 2013; 15(7): 984-91.
[68]
Leclercq C, Gadler F, Kranig W, et al. A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure. J Am Coll Cardiol 2008; 51: 1455-62.
[69]
Padeletti L, Pieragnoli P, Ricciardi G, et al. Acute hemodynamic effect of left ventricular endocardial pacing in cardiac resynchronization therapy: assessment by pressure-volume loops. Circ Arrhythm Electrophysiol 2012; 5: 460-7.
[70]
Scott PA, Yue AM, Watts E, Zeb M, Roberts PR, Morgan JM. Transseptal left ventricular endocardial pacing reduces dispersion of ventricular repolarization. Pacing Clin Electrophysiol 2011; 34: 1258-66.
[71]
Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 2010; 363: 36-44.
[72]
Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol 2012; 60: 1933-9.
[73]
Wathen MS, DeGroot PJ, Sweeney MO, et al. 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.
[74]
Wathen MS, Sweeney MO, DeGroot PJ, et al. Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease. Circulation 2001; 104: 796-801.
[75]
Wilkoff BL, Williamson BD, Stern RS, et al. 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: 541-50.


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 11
ISSUE: 1
Year: 2015
Page: [33 - 41]
Pages: 9
DOI: 10.2174/1573403X1101141106121553

Article Metrics

PDF: 54
HTML: 2
EPUB: 1
PRC: 1