The current state of left ventricular assist devices: challenges facing further development

References

• McMurray JJ, Adamopoulos S, Anker SD, et al. ESC guidelines for the diagnosis and treatment of acute and chronic HF 2012: the task force for the diagnosis and treatment of acute and chronic HF 2012 of the European Society of Cardiology. Developed in collaboration with the HF association (HFA) of the ESC. Eur Heart J. 2012;33(14):1787–1847.
   PubMed Web of Science ®Google Scholar
• Mozaffarian D, Benjamin EJ, Go AS, et al. Executive summary: heart disease and stroke statistics; 2015 update: a report from the American Heart Association. Circulation. 2015;131(4):434–441.
   Web of Science ®Google Scholar
• Roger VL, Weston SA, Redfield MM, et al. Trends in HF incidence and survival in a community-based population. JAMA. 2004;292(3):344–350.
   PubMed Web of Science ®Google Scholar
• Multiple Cause of Death 1999–2013 on CDC WONDER Online Database, released 2015 [Internet]. Data are from the Multiple Cause of Death Files, 1999–2013, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. 2015. [cited 2015 Jun 14]. Available from: http://wonder.cdc.gov/mcd-icd10.html
   Google Scholar
• Lund LH, Edwards LB, Kucheryavaya AY, et al. The registry of the international society for heart and lung transplantation: thirty-first official adult heart transplant report—2014; focus theme: retransplantation. J Heart Lung Transplant. 2014;33(10):996–1008.
   PubMed Web of Science ®Google Scholar
• Colvin-Adams M, Smith JM, Heubner BM, et al. OPTN/SRTR 2013 annual data report: heart. Am J Transplant. 2015;15(S2):1–28.
   PubMedGoogle Scholar
• Stewart GC, Givertz MM. Mechanical circulatory support for advanced HF: patients and technology in evolution. Circulation. 2012;125(10):1304–1315.
   PubMed Web of Science ®Google Scholar
• McMurray JJ, Adamopoulos S, Anker SD, et al. ESC guidelines for the diagnosis and treatment of acute and chronic HF 2012: the task force for the diagnosis and treatment of acute and Chronic HF 2012 of the European Society of Cardiology. Developed in collaboration with the HF Association (HFA) of the ESC. Eur J HF. 2012;14(8):803–869.
   Web of Science ®Google Scholar
• Long JW, Kfoury AG, Slaughter MS, et al. Long-Term destination therapy with the HeartMate XVE left ventricular assist device: improved outcomes since the REMATCH study. Congestive HF. 2005;11(3):133–138.
   PubMedGoogle Scholar
• Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage HF. N Engl J Med. 2001;345(20):1435–1443.
   PubMed Web of Science ®Google Scholar
• Giridharan GA, Lee TJ, Ising M, et al. Miniaturization of mechanical circulatory support systems. Artif Organs. 2012;36(8):731–739.
   PubMed Web of Science ®Google Scholar
• Martin J, Friesewinkel O, Benk C, et al. Improved durability of the HeartMate XVE left ventricular assist device provides safe mechanical support up to 1 year but is associated with high risk of device failure in the second year. J Heart Lung Transplant. 2006;25(4):384–390.
   PubMed Web of Science ®Google Scholar
• Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007;357(9):885–896.
   PubMed Web of Science ®Google Scholar
• Slaughter MS, Rogers JG, Milano CA, et al. Advanced HF treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361(23):2241–2251.
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Pagani FD, et al. Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Transplant. 2014;33(6):555–564.
   PubMed Web of Science ®Google Scholar
• Teuteberg JJ, Stewart GC, Jessup M, et al. Implant strategies change over time and impact outcomes: insights from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). JACC: HF. 2013;1(5):369–378.
   Google Scholar
• Boyle AJ, Ascheim DD, Russo MJ, et al. Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification. J Heart Lung Transplant. 2011;30(4):402–407.
   PubMed Web of Science ®Google Scholar
• Ammirati E, Oliva FG, Colombo T, et al. Mid-term survival after continuous-flow left ventricular assist device versus heart transplantation. Heart Vessels [Internet]. 2015. [cited 2015 Sep 17]. Available from: http://link.springer.com/article/10.1007%2Fs00380-015-0654-4#
   Google Scholar
• Williams ML, Trivedi JR, McCants KC, et al. Heart transplant vs left ventricular assist device in heart transplant-eligible patients. Ann Thorac Surg. 2011;91(5):1330–1333; discussion 1333-1334.
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Pagani FD, et al. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg. 2012;144(3):584–603.
   PubMed Web of Science ®Google Scholar
• Stahovich M, Fox S, Hallinan W, et al. REduce driveline trauma through stabilization and exit site management: results of the RESIST Study. J Heart Lung Transplant. 2014;33(4):S207–S208.
   Web of Science ®Google Scholar
• Karimi A, Beaver TM, Hess PJ, et al. Close antiplatelet therapy monitoring and adjustment based upon thrombelastography may reduce late-onset bleeding in HeartMate II recipients. Interact Cardiovasc Thorac Surg. 2014;18(4):457–465.
   PubMed Web of Science ®Google Scholar
• Stulak JM, Maltais S, Cowger J, et al. Prevention of percutaneous driveline infection after left ventricular assist device implantation: prophylactic antibiotics are not necessary. ASAIO J. 2013;59(6):570–574.
   PubMed Web of Science ®Google Scholar
• Starling RC, Moazami N, Silvestry SC, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370(1):33–40.
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Kormos RL, et al. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010;29(1):1–10.
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Kormos RL, et al. The fourth INTERMACS annual report: 4,000 implants and counting. J Heart Lung Transplant. 2012;31(2):117–126.
   PubMed Web of Science ®Google Scholar
• Jacques LB, Jensen TS, Jyme H, et al. Decision Memo for Ventricular Assist Devices as Destination Therapy (CAG-00119R2). Baltimore, MD: Center for Medicare & Medicaid Services; 2010.
   Google Scholar
• Thoratec Quarterly Earnings Reports [press release]. Pleasanton, CA: Thoratec Corp.; 2010–2015.
   Google Scholar
• HeartWare Quarterly Earnings Reports [press release]. Framingham, MA: Heartware Inc.; 2010–2015.
   Google Scholar
• Kirklin JK, Naftel DC, Pagani FD, et al. Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Transplant. 2014;33(6):555–564.
   PubMed Web of Science ®Google Scholar
• Rogers JG, Tatooles AJ, Park SJ, et al. Outcomes of mechanical circulatory support for destination therapy in NYHA class IIIB patients. Circulation. 2010;122 (21 Suppl):A13124.
   Google Scholar
• Eckman P, Rosenbaum A, Vongooru H, et al. Survival of INTERMACS Profile 4-6 patients after left ventricular assist device implant is improved compared to Seattle heart failure model estimated survival. J Card Fail. 2011;17(8):S38–S39.
   Web of Science ®Google Scholar
• Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63(17):1751–1757.
   PubMed Web of Science ®Google Scholar
• Estep JD, Starling RC, Horstmanshof DA, et al Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients (ROADMAP). J Heart Lung Transplant. 2015;34(4):S80.
   Web of Science ®Google Scholar
• Stewart GC, Kittleson MM, Cowger JA, et al. Who wants a left ventricular assist device for ambulatory heart failure? Early insights from the MEDAMACS screening pilot. J Heart Lung Transplant [Internet]. 2015. [cited 2015 Sep 17]. Available from: http://www.jhltonline.org/article/S1053-2498(15)01375-3/abstract
   Google Scholar
• Modica M, Ferratini M, Torri A, et al. Quality of life and emotional distress early after left ventricular assist device implant: a mixed-method study. Artif Organs. 2015;39(3):220–227.
   PubMed Web of Science ®Google Scholar
• Jakovljevic DG, McDiarmid A, Hallsworth K, et al. Effect of left ventricular assist device implantation and heart transplantation on habitual physical activity and quality of life. Am J Cardiol. 2014;114(1):88–93.
   PubMed Web of Science ®Google Scholar
• Thoratec Corporation’s (THOR) CEO Keith Grossman on Q4 2014 Results – Earnings Call Transcript. Pleasanton, CA: Thoratec Corp.; 2015 Feb 10.
   Google Scholar
• Foxen JL, Wagner J, Gatzke J, et al. Abstract 355: are left ventricular assist devices (LVAD) underutilized in HF? A pilot survey of provider assessment of LVAD candidacy and referral. Circ Cardiovasc Qual Outcomes. 2014;7(Suppl 1):A355.
   Google Scholar
• Galvao M, Saeed O, Immekus J, et al. An international survey to assess referral thresholds for destination therapy in non-inotrope-dependent patients: results of the CONSENSUS-DT study. J Card Fail. 2014;20(7):492–497.
   PubMed Web of Science ®Google Scholar
• National Coverage Determination (NCD) for Ventricular Assist Devices (20.9.1). 2014.
   Google Scholar
• Arnett DK. Public comments for ventricular assist devices for bridge-to-transplant and destination therapy (CAG-00432R). CMS.gov. Baltimore, MD: Center for Medicare & Medicaid Services; March 6, 2013, 2013.
   Google Scholar
• Frazier OH, Rose EA, McCarthy P, et al. Improved mortality and rehabilitation of transplant candidates treated with a long-term implantable left ventricular assist system. Ann Surg. 1995;222(3):327.
   PubMed Web of Science ®Google Scholar
• Frazier OH, Rose EA, Oz MC, et al. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg. 2001;122(6):1186–1195.
   PubMed Web of Science ®Google Scholar
• Pagani FD, Miller LW, Russell SD, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54(4):312–321.
   PubMed Web of Science ®Google Scholar
• Colvin‐Adams M, Smithy JM, Heubner BM, et al. OPTN/SRTR 2012 annual data report: heart. Am J Transplant. 2014;14(S1):113–138.
   PubMed Web of Science ®Google Scholar
• Birks EJ. A changing trend toward destination therapy: are we treating the same patients differently? Tex Heart Inst J Title. 2011;38(5):552.
   PubMed Web of Science ®Google Scholar
• Zoghbi W. Public comments for ventricular assist devices for bridge-to-transplant and destination therapy (CAG-00432R). Baltimore, MD: Center for Medicare & Medicaid Services; 2013.
   Google Scholar
• Wever-Pinzon O, Drakos SG, Kfoury AG, et al. Morbidity and mortality in heart transplant candidates supported with mechanical circulatory support. Is reappraisal of the current UNOS thoracic organ allocation policy justified? Circulation. 2012. DOI:10.1161/CIRCULATIONAHA.112.100123.
   PubMed Web of Science ®Google Scholar
• Fang JC, Stehlik J. Moving beyond “Bridges”*. JACC: HF. 2013;1(5):379–381.
   Google Scholar
• DeVore AD, Milano CA, Rogers JG. VAD therapy 20/20: moving beyond the myopic view of a nascent therapy. Ann Thorac Surg. 2014;3(6):603.
   Google Scholar
• Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013;32(7):675–683.
   PubMed Web of Science ®Google Scholar
• Slaughter MS, Rogers JG, Milano CA, et al. Advanced HF treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361(23):2241–2251.
   PubMed Web of Science ®Google Scholar
• Goldstein DJ, Naftel D, Holman W, et al. Continuous-flow devices and percutaneous site infections: clinical outcomes. J Heart Lung Transplant. 2012;31(11):1151–1157.
   PubMed Web of Science ®Google Scholar
• Wang JX, Smith JR, Bonde P. Energy transmission and power sources for mechanical circulatory support devices to achieve total implantability. Ann Thorac Surg. 2014;97(4):1467–1474.
   PubMed Web of Science ®Google Scholar
• Slaughter MS, Myers TJ. Transcutaneous energy transmission for mechanical circulatory support systems: history, current status, and future prospects. J Cardiac Surg. 2010;25(4):484–489.
   PubMed Web of Science ®Google Scholar
• Fu Y, Hu L, Ruan X, et al. A transcutaneous energy transmission system for artificial heart adapting to changing impedance. Artif Organs. 2015;39(4):378–387.
   PubMed Web of Science ®Google Scholar
• Sharma V, Deo SV, Stulak JM, et al. Driveline infections in left ventricular assist devices: implications for destination therapy. Ann Thorac Surg. 2012;94(5):1381–1386.
   PubMed Web of Science ®Google Scholar
• Forest SJ, Bello R, Friedmann P, et al. Readmissions after ventricular assist device: etiologies, patterns, and days out of hospital. Ann Thorac Surg. 2013;95(4):1276–1281.
   PubMed Web of Science ®Google Scholar
• Dowling RD, Gray LA Jr., Etoch SW, et al. The AbioCor implantable replacement heart. Ann Thorac Surg. 2003;75 (6 Suppl):S93–99.
   PubMed Web of Science ®Google Scholar
• Mehta SM, Pae WE Jr., Rosenberg G, et al. The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support. Ann Thorac Surg. 2001;71 (3 Suppl): S156–161; discussion S183-154.
   PubMed Web of Science ®Google Scholar
• Dowling RD, Gray LA Jr., Etoch SW, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. 2004;127(1):131–141.
   PubMed Web of Science ®Google Scholar
• Rintoul TC, Dolgin A. Thoratec transcutaneous energy transformer system: a review and update. ASAIO Journal. 2004;50(4):397–400.
   PubMed Web of Science ®Google Scholar
• Aquilina O. A brief history of cardiac pacing. Images Paediatr Cardiol. 2006;8(2):17–81.
   PubMedGoogle Scholar
• Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage HF. N Engl J Med. 2001;345(20):1435–1443.
   PubMed Web of Science ®Google Scholar
• Aggarwal A, Raghuvir R, Eryazici P, et al. The development of aortic insufficiency in continuous-flow left ventricular assist device-supported patients. Ann Thorac Surg. 2013;95(2):493–498.
   PubMed Web of Science ®Google Scholar
• Hiraoka A, Cohen JE, Shudo Y, et al. Evaluation of late aortic insufficiency with continuous flow left ventricular assist devicedagger. Eur J Cardiothorac Surg. 2015;48:400–406.
   PubMed Web of Science ®Google Scholar
• Wong K, Samaroo G, Ling I, et al. Intraventricular flow patterns and stasis in the LVAD-assisted heart. J Biomech. 2014;47(6):1485–1494.
   PubMed Web of Science ®Google Scholar
• Soucy KG, Giridharan GA, Choi Y, et al. Rotary pump speed modulation for generating pulsatile flow and phasic left ventricular volume unloading in a bovine model of chronic ischemic HF. J Heart Lung Transplant. 2014;34(1):122–131.
   PubMed Web of Science ®Google Scholar
• Soucy KG, Koenig SC, Giridharan GA, et al. Rotary pumps and diminished pulsatility: do we need a pulse? ASAIO Journal. 2013;59(4):355–366.
   PubMed Web of Science ®Google Scholar
• Smedira NG, Hoercher KJ, Lima B, et al. Unplanned hospital readmissions after HeartMate II implantation: frequency, risk factors, and impact on resource use and survival. JACC: HF. 2013;1(1):31–39.
   Google Scholar
• Lopilato AC, Doligalski CT, Caldeira C. Incidence and risk factor analysis for gastrointestinal bleeding and pump thrombosis in left ventricular assist device recipients. Artif Organs [Internet]. 2015. [cited 2015 Sep 17]. Available from: http://onlinelibrary.wiley.com/doi/10.1111/aor.12471/abstract
   Google Scholar
• Bhimaraj A, Uribe C, Suarez EE. Physiological impact of continuous flow on end-organ function: clinical implications in the current era of left ventricular assist devices. Methodist Debakey Cardiovasc J. 2015;11(1):12–17.
   PubMedGoogle Scholar
• Harvey L, Holley CT, John R. Gastrointestinal bleed after left ventricular assist device implantation: incidence, management, and prevention. Ann Thorac Surg. 2014;3(5):475–479.
   Google Scholar
• Meyer AL, Malehsa D, Budde U, et al. Acquired von Willebrand syndrome in patients with a centrifugal or axial continuous flow left ventricular assist device. JACC: HF. 2014;2(2):141–145.
   Google Scholar
• Suarez J, Patel CB, Felker GM, et al. Mechanisms of bleeding and approach to patients with axial-flow left ventricular assist devices. Circulation: HF. 2011;4(6):779–784.
   PubMed Web of Science ®Google Scholar
• Demirozu ZT, Radovancevic R, Hochman LF, et al. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2011;30(8):849–853.
   PubMed Web of Science ®Google Scholar
• Mondal NK, Sorensen EN, Feller ED, et al. Systemic inflammatory response syndrome after contentious-flow left ventricular assist device implantation and change in platelet mitochondrial membrane potential. J Card Fail. 2015;21:564–571.
   PubMed Web of Science ®Google Scholar
• Baghai M, Heilmann C, Nakamura L, et al. Platelet dysfunction and acquired von Willebrand syndrome in patients with left ventricular assist devices dagger. Eur J Cardiothorac Surg. 2014;62:421–427.
   Google Scholar
• Hasin T, Matsuzawa Y, Guddeti RR, et al. Attenuation in peripheral endothelial function after continuous flow left ventricular assist device therapy is associated with cardiovascular adverse events. Circ J. 2015;79(4):770–777.
   PubMed Web of Science ®Google Scholar
• Dassanayaka S, Slaughter MS, Bartoli CR. Mechanistic pathway(s) of acquired von Willebrand syndrome with a continuous-flow ventricular assist device: in vitro findings. ASAIO J. 2013;59(2):123–129.
   PubMed Web of Science ®Google Scholar
• Starling RC, Moazami N, Silvestry SC, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370(1):33–40.
   PubMed Web of Science ®Google Scholar
• Najjar SS, Slaughter MS, Pagani FD, et al. An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2014;33(1):23–34.
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Kormos RL, et al. Interagency registry for mechanically assisted circulatory support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2014;33(1):12–22.
   PubMed Web of Science ®Google Scholar
• Argiriou M, Kolokotron SM, Sakellaridis T, et al. Right HF post left ventricular assist device implantation. J Thorac Dis. 2014;6 Suppl 1:S52–59.
   PubMed Web of Science ®Google Scholar
• Takeda K, Takayama H, Colombo PC, et al. Late right HF during support with continuous-flow left ventricular assist devices adversely affects post-transplant outcome. J Heart Lung Transplant. 2015;34(5):667–674.
   PubMed Web of Science ®Google Scholar
• Letsou GV, Pate TD, Gohean JR, et al. Improved left ventricular unloading and circulatory support with synchronized pulsatile left ventricular assistance compared with continuous-flow left ventricular assistance in an acute porcine left ventricular failure model. J Thorac Cardiovasc Surg. 2010;140(5):1181–1188.
   PubMed Web of Science ®Google Scholar
• Kato TS, Chokshi A, Singh P, et al. Effects of continuous-flow versus pulsatile-flow left ventricular assist devices on myocardial unloading and remodeling. Circulation: HF. 2011;4(5):546–553.
   PubMed Web of Science ®Google Scholar
• Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol. 2013;2661(12):1209–1221.
   PubMed Web of Science ®Google Scholar
• Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics–2015 update: a report from the American Heart Association. Circulation. 2015;131(4): e29–322.
   PubMed Web of Science ®Google Scholar
• Baldwin JT, Mann DL. NHLBI’s program for VAD therapy for moderately advanced HF: the REVIVE-IT pilot trial. J Card Fail. 2010;16(11):855–858.
   PubMed Web of Science ®Google Scholar
• Roadmap study demonstrating benefits of HeartMate II left ventricular assist device presented at international society for heart and lung transplantation [press release]. Nice (France): International Society of Heart and Lung Transplantation; April 17, 2015.
   Google Scholar
• McIlvennan CK, Magid KH, Ambardekar AV, et al. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circulation: HF. 2014;7(6):1003–1013.
   PubMed Web of Science ®Google Scholar
• Schumer EM, Ising MS, Trivedi JR, et al. Early outcomes with marginal donor hearts compared with left ventricular assist device support in patients with advanced heart failure. Ann Thorac Surg. 2015;100:522–527.
   PubMed Web of Science ®Google Scholar
• Donneyong M, Cheng A, Trivedi JR, et al. The association of pretransplant HeartMate II left ventricular assist device placement and heart transplantation mortality. ASAIO J. 2014;60:294–299.
   PubMed Web of Science ®Google Scholar
• Trivedi JR, Cheng A, Singh R, et al. Survival on the heart transplant waiting list: impact of continuous flow left ventricular assist device as bridge to transplant. Ann Thorac Surg. 2014;98(3):830–834.
   PubMed Web of Science ®Google Scholar