Abstract
Background
Heart failure has the highest rates of adult hospitalisations, the highest mortality rates and significant costs associated with its care. The cost of heart failure is expected continue to grow on a global scale, with $108 billion spent on heart failure in 2012. Mortality rates are high, with incident cases of heart failure resulting in 30% 1-year mortality, and in hospital mortality of acute heart failure, 28%.
Methods and Results
This article reviews the devices currently in use for the treatment of heart failure, as well as those that are under investigation. A review of the mechanism of action of devices, the literature supporting their application as therapy, and the cost effectiveness associated with their use are discussed. Conventional techniques discussed herein include the guideline-supported therapies of mechanical circulatory support (MCS) and cardiac resynchronisation therapy (CRT). Novel devices that are discussed include invasive physiological monitoring, neuromodulation, percutaneous ventricular assist devices (VADs) and cardiac contractility modulation (CCM). There has been advancement in mechanical circulatory support devices for the treatment of both acute and chronic heart failure. In addition to MCS, only CRT has resulted in reduced mortality.
Conclusion
Due to the clinical and economic arguments, treatment of heart failure is said to be the biggest unmet need in cardiology today. The data reviewed herein support this statement.
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References
Mosterd A, Hoes AW (2007) Clinical epidemiology of heart failure. Heart 93:1137–1146
Yturralde RF, Gaasch WH (2005) Diagnostic criteria for diastolic heart failure. Prog Cardiovasc Dis 47:314–319
Reynolds HR, Hochman JS (2008) Cardiogenic shock: current concepts and improving outcomes. Circulation 117:686–697
Hunt SA, Abraham WT, Chin MH et al (2009) Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed. J Am Coll Cardiol 53:e1–e90
Dickstein K, Cohen-Solal A, Filippatos G et al (2008) ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart. Eur J Heart Fail 10:933–989
Yancy CW, Lopatin M, Stevenson LW et al (2006) Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: A Report From the Acute Decompensated Heart Failure National Registry (ADHERE) Database. J Am Coll Cardiol 47:76–84
Bhatia RS, Tu JV, Lee DS et al (2006) Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med 355:260–269
Bleumink GS, Knetsch AM, Sturkenboom MCJM et al (2004) Quantifying the heart failure epidemic: prevalence, incidence rate, lifetime risk and prognosis of heart failure The Rotterdam Study. Eur Heart J 25:1614–1619
MacIntyre K, Capewell S, Stewart S et al (2000) Evidence of improving prognosis in heart failure: trends in case fatality in 66,547 patients hospitalized between 1986 and 1995. Circulation 102:1126–1131
McMurray JJV, Adamopoulos S, Anker SD et al (2012) ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart. Eur Heart J 33:1787–1847
Cook C, Cole G, Asaria P et al (2014) The annual global economic burden of heart failure. Int J Cardiol 171:368–376
Lloyd-Jones D, Adams R, Carnethon M et al (2009) Heart disease and stroke statistics—2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 119:e21–e181
Slaughter MS, Pagani FD, McGee EC et al (2013) HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 32:675–683
World’s First Endovascular Neuromodulation Device Implanted in Man for the Treatment of Congestive Heart Failure|Journal of Invasive Cardiology. http://www.invasivecardiology.com/news/worlds-first-endovascular-neuromodulation-device-implanted-man-treatment-congestive-heart. Accessed 18 Feb 2016
Rose EA, Gelijns AC, Moskowitz AJ et al (2001) Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 345:1435–1443
Kirklin JK, Naftel DC, Pagani FD et al (2012) Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg 144:584–603
Slaughter MS, Rogers JG, Milano CA et al (2009) Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 361:2241–2251
Kirklin JK, Naftel DC, Kormos RL et al (2011) Third INTERMACS Annual Report: the evolution of destination therapy in the United States. J Heart Lung Transplant 30:115–123
Aaronson KD, Slaughter MS, Miller LW et al (2012) Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 125:3191–3200
Stretch R, Sauer CM, Yuh DD et al (2014) National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol 64:1407–1415
Kirklin JK, Naftel DC, Pagani FD et al (2014) Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Transplant 33:555–564
Rogers JG, Bostic RR, Tong KB et al (2012) Cost-effectiveness analysis of continuous-flow left ventricular assist devices as destination therapy. Circ Heart Fail 5:10–16
Birks EJ (2010) The comparative use of ventricular assist devices: differences between Europe and the United States. Tex Heart Inst J 37:565–567
Shuhaiber JH, Jenkins D, Berman M et al (2008) The Papworth experience with the Levitronix CentriMag ventricular assist device. J Heart Lung Transplant 27:158–164
Gilotra NA, Stevens GR (2014) Temporary mechanical circulatory support: a review of the options, indications, and outcomes. Clin Med Insights Cardiol 8:75–85
John R, Long JW, Massey HT et al (2011) Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support. J Thorac Cardiovasc Surg 141:932–939
Cheng JM, Den Uil CA, Hoeks SE et al (2009) Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. Eur Heart J 30:2102–2108
Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC) AF, Steg PG, James SK et al (2012) ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 33: 2569–2619
Kirkpatrick JN, Wieselthaler G, Strueber M et al (2015) Ventricular assist devices for treatment of acute heart failure and chronic heart failure. Heart 101:1091–1096
Burkhoff D, Cohen H, Brunckhorst C et al (2006) A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. Am Heart J 152:469(e1–e8)
Thiele H, Lauer B, Hambrecht R et al (2001) Reversal of cardiogenic shock by percutaneous left atrial-to-femoral arterial bypass assistance. Circulation 104:2917–2922
Kapur NK, Paruchuri V, Jagannathan A, et al. 307 Mechanical circulatory support for right ventricular failure: The TandemHeart in RIght VEntricular Support (THRIVE) Registry. J Hear Lung Transplant 31. doi:10.1016/j.healun.2012.01.315. (Epub ahead of print 2012)
O’Neill WW, Kleiman NS, Moses J et al (2012) A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation 126:1717–1727
Thiele H, Zeymer U, Neumann F-J et al (2013) Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet (London, England) 382:1638–1645
Smith EJ, Reitan O, Keeble T et al (2009) A first-in-man study of the reitan catheter pump for circulatory support in patients undergoing high-risk percutaneous coronary intervention. Catheter Cardiovasc Interv 73:859–865
McAlister FA, Ezekowitz J, Hooton N et al (2007) Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA 297:2502–2514
Brignole M, Auricchio A, Baron-Esquivias G et al (2013) 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association. Eur Heart J 34:2281–2329
Tracy CM, Epstein AE, Darbar D et al (2012) 2012 ACCF/AHA/HRS focused update of the 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 S. Circulation 126:1784–1800
Brignole M, Auricchio A, Baron-Esquivias G et al (2013) 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association. Europace 15:1070–1118
Bax JJ, Abraham T, Barold SS et al (2005) Cardiac resynchronization therapy: part 2—issues during and after device implantation and unresolved questions. J Am Coll Cardiol 46:2168–2182
Kashani A, Barold SS (2005) Significance of QRS complex duration in patients with heart failure. J Am Coll Cardiol 46:2183–2192
Adabag S, Roukoz H, Anand IS et al (2011) Cardiac resynchronization therapy in patients with minimal heart failure: a systematic review and meta-analysis. J Am Coll Cardiol 58:935–941
Feldman AM, de Lissovoy G, Bristow MR et al (2005) Cost effectiveness of cardiac resynchronization therapy in the comparison of medical therapy, pacing, and defibrillation in heart failure (COMPANION) trial. J Am Coll Cardiol 46:2311–2321
Fox M, Mealing S, Anderson R et al (2007) The clinical effectiveness and cost-effectiveness of cardiac resynchronisation (biventricular pacing) for heart failure: systematic review and economic model. Health Technol Assess 11: iii–iv, ix-248
Yao G, Freemantle N, Calvert MJ et al (2007) The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator. Eur Heart J 28:42–51
Daubert J-C, Saxon L, Adamson PB et al (2012) 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management. Europace 14:1236–1286
Costanzo MR, Guglin ME, Saltzberg MT et al (2007) Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol 49:675–683
Kwong JSW, Yu C-M (2014) Ultrafiltration for acute decompensated heart failure: a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol 172:395–402
Del Trigo M, Bergeron S, Bernier M et al (2016) Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. Lancet 387:1290–1297
Hasenfuß G, Hayward C, Burkhoff D et al (2016) A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet 387:1298–1304
Bourge RC, Abraham WT, Adamson PB et al (2008) Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. J Am Coll Cardiol 51:1073–1079
Kuck K-H, Bordachar P, Borggrefe M et al (2014) New devices in heart failure: an European Heart Rhythm Association report: developed by the European Heart Rhythm Association; endorsed by the Heart Failure Association. Europace 16:109–128
Magalski A, Adamson P, Gadler F et al (2002) Continuous ambulatory right heart pressure measurements with an implantable hemodynamic monitor: a multicenter, 12-month follow-up study of patients with chronic heart failure. J Card Fail 8:63–70
Yu C-M, Wang L, Chau E et al (2005) Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation 112:841–848
Ritzema J, Melton IC, Richards AM et al (2007) Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation 116:2952–2959
Troughton RW, Ritzema J, Eigler NL et al (2011) Direct left atrial pressure monitoring in severe heart failure: long-term sensor performance. J Cardiovasc Transl Res 4:3–13
Ritzema J, Troughton R, Melton I et al (2010) Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation 121:1086–1095
Maurer MS, Adamson PB, Costanzo MR et al (2015) Rationale and design of the left atrial pressure monitoring to optimize heart failure therapy study (LAPTOP-HF). J Card Fail 21:479–488
Abraham WT, Adamson PB, Bourge RC et al (2011) Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 377:658–666
Olshansky B, Sabbah HN, Hauptman PJ et al (2008) Parasympathetic nervous system and heart failure: pathophysiology and potential implications for therapy. Circulation 118:863–871
Domanski M (2003) A comparative analysis of the results from 4 trials of β-blocker therapy for heart failure: BEST, CIBIS-II, MERIT-HF, and COPERNICUS. J Card Fail 9:354–363
Kuck K-H, Cappato R, Siebels J et al (2000) Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH). Circulation 102:748–754
De Ferrari GM, Crijns HJGM, Borggrefe M et al (2011) Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J 32:847–855
Schwartz PJ, De Ferrari GM, Sanzo A et al (2008) Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail 10:884–891
Gold MR, Van Veldhuisen DJ, Hauptman PJ et al (2016) Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial. J Am Coll Cardiol. doi:10.1016/j.jacc.2016.03.525 (Epub ahead of print 29 March 2016)
Zipes DP, Neuzil P, Theres H et al (2016) Determining the feasibility of spinal cord neuromodulation for the treatment of chronic systolic heart failure: the DEFEAT-HF Study. JACC Heart Fail 4:129–136
Tse H-F, Turner S, Sanders P et al (2015) Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience. Heart Rhythm 12:588–595
Lovett EG, Schafer J, Kaufman CL (2009) Chronic baroreflex activation by the Rheos system: an overview of results from European and North American feasibility studies. In: Conf Proceedings Annu Int Conf IEEE Eng Med Biol Soc IEEE Eng Med Biol Soc Annu Conf 2009, pp 4626–4630
Georgakopoulos D, Little WC, Abraham WT et al (2011) Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail 17:167–178
Brandt MC, Madershahian N, Velden R et al (2011) Baroreflex activation as a novel therapeutic strategy for diastolic heart failure. Clin Res Cardiol 100:249–251
Abraham WT, Lindenfeld J, Reddy VY et al (2015) A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS Duration: study rationale and design. J Card Fail 21:16–23
Giallauria F, Vigorito C, Piepoli MF et al (2014) Effects of cardiac contractility modulation by non-excitatory electrical stimulation on exercise capacity and quality of life: an individual patient’s data meta-analysis of randomized controlled trials. Int J Cardiol 175:352–357
Radlberger P, Adlbrecht C, Mittermayr T (2011) Cardiac contractility modulation in patients with heart failure refractory to drug treatment. Exp Clin Cardiol 16:43–46
Chamogeorgakis T, Rafael A, Shafii AE et al (2013) Which is better. ASAIO J 59:607–611
Tsao N-W, Shih C-M, Yeh J-S et al (2012) 2012 Extracorporeal membrane oxygenation–assisted primary percutaneous coronary intervention may improve survival of patients with acute myocardial infarction complicated by profound cardiogenic shock. J Crit Care 27:530(e1–e11)
Sheu J-J, Tsai T-H, Lee F-Y et al (2010) Early extracorporeal membrane oxygenator-assisted primary percutaneous coronary intervention improved 30-day clinical outcomes in patients with ST-segment elevation myocardial infarction complicated with profound cardiogenic shock. Crit Care Med 38:1810–1817
Amat-Santos IJ, Bergeron S, Bernier M et al (2015) Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. Eurointervention 10:1127–1131
Anker SD, Coats AJS, Cristian G et al (2015) A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial). Eur Heart J 36:2297–2309
Sutton MG, Sharpe N (2000) Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation 101:2981–2988
Cilingiroglu M, Rollefson WA, Mego D (2013) Percutaneous implantation of a parachute device for treatment of ischemic heart failure. Cardiovasc Revasc Med 14:236–240
Costa MA, Pencina M, Nikolic S et al (2013) The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J 165:531–536
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Murphy, C., Zafar, H. & Sharif, F. An updated review of cardiac devices in heart failure. Ir J Med Sci 186, 909–919 (2017). https://doi.org/10.1007/s11845-017-1597-9
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DOI: https://doi.org/10.1007/s11845-017-1597-9