1.Porter, ME. What is value in health care? N Engl J Med. 2010;363:2477–2481.
2.Gelijns, AC, Killelea, B, Vitale, M, Mankad, V, Moskowitz, AJ. The dynamics of pediatric device innovation: Putting evidence in context. In: Safe medical devices for children. Washington, DC: Institute of Medicine, National Academy Press; 2006:302–326.
3.Gelijns, AC, Rosenberg, N. The dynamics of technological change in medicine. Health Aff (Millwood). 1994;13:28–46.
4.Drummond, M, Griffin, A, Tarricone, R. Economic evaluation for devices and drugs–same or different? Value Health. 2009;12:402–404.
5.Sorenson, C, Tarricone, R, Siebert, M, Drummond, M. Applying health economics for policy decision making: Do devices differ from drugs? Europace. 2011;13 (Suppl 2):ii54–ii58.
6.Taylor, RS, Iglesias, CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: Are they that different? Value Health. 2009;12:404–406.
8.Kirisits, A, Redekop, WK. The economic evaluation of medical devices: Challenges ahead. Appl Health Econ Health Policy. 2013;11:15–26.
11.Hulstaert, F, Neyt, M, Vinck, I, et al.Pre-market clinical evaluations of innovative high-risk medical devices in Europe. Int J Technol Assess Health Care. 2012;28:278–284.
12.Dhruva, SS, Bero, LA, Redberg, RF. The strength of study evidence examined by the FDA in pre-market approval of cardiovascular devices. JAMA. 2009;302:2679–2685.
13.Chen, CE, Dhruva, SS, Redberg, RF. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA. 2012;308:1740–1742.
14.Rose, EA, Gelijns, AC, Moskowitz, AJ, et al.Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001;345:1435–1443.
16.Parides, MK, Moskowitz, AJ, Ascheim, DD, Rose, EA, Gelijns, AC. Progress versus precision: Challenges in clinical trial design for left ventricular assist devices. Ann Thorac Surg. 2006;82:1140–1146.
18.Dowling, RD, Park, SJ, Pagani, FD, et al.HeartMate VE LVAS design enhancements and its impact on device reliability. Eur J Cardiothorac Surg. 2004;25:958–963.
19.Alli, OO, Booker, JD, Lennon, RJ, et al.Transcatheter aortic valve implantation. Assessing the learning curve. JACC Cardiovasc Interv. 2012;5:72–79.
20.Lange, R, Bleiziffer, S, Mazzitelli, D, et al.Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients. A glimpse into the future. J Am Coll Cardiol. 2012;59:280–287.
21.Pisano, GP, Bohmer, R, Edmondson, AC. Organizational differences in rates of learning: Evidence from the adoption of minimally invasive cardiac surgery. Manage Sci. 2001;47:752–768.
22.Holzhey, DM, Seeburger, J, Misfeld, M, Borger, MA, Mohr, FW. Learning minimally invasive mitral valve surgery: A cumulative sum sequential probability analysis of 3895 operations from a single high-volume center. Circulation. 2013;128:483–491.
23.Rosenberg, N.Inside the black box: Technology and economics. Cambridge: Cambridge University Press; 1983
24.Lietz, K, Long, JW, Kfoury, AG, et al.Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: Implications for patient selection. Circulation. 2007;116:497–505.
25.Cowger, J, Sundareswaran, K, Rogers, JG, et al.Predicting survival in patients receiving continuous flow left ventricular assist devices: The HeartMate II risk score. J Am Coll Cardiol. 2013;61:313–321.
26.Gregoric, I, Wadia, Y, Radovancevic, B, et al.HeartMate vented-electric left ventricular assist system: Technique for intrathoracic or intraperitoneal implantation via a left thoracotomy. J Heart Lung Transplant. 2004;23:759–762.
27.Pasque, MK, Hanselman, T, Shelton, K, Hedges, R, Keohe-Huck, B. Operative strategies to reduce complications in Novacor left ventricular assist device placement. J Card Surg. 2004;19:329–335.
28.Wagner, F, Buz, S, Neumeyer, HH, Hetzer, R, Hocher, B, Nitric oxide inhalation modulates endothelin-1 plasma concentration gradients following left ventricular assist device implantation. J Cardiovasc Pharmacol. 2004;44 (Suppl 1):S89–S91.
29.Holdy, K, Dembitsky, W, Eaton, LL, et al.Nutrition assessment and management of left ventricular assist device patients. J Heart Lung Transplant. 2005;24:1690–1696.
30.Dang, NC, Naka, Y. Perioperative pharmacotherapy in patients with left ventricular assist devices. Drugs Aging. 2004;21:993–1012.
31.Holman, WL, Rayburn, BK, McGiffin, DC, et al.Infection in ventricular assist devices: Prevention and treatment. Ann Thorac Surg. 2003;75(Suppl):S48–S57.
32.Zietkiewicz, M, Garlicki, M, Domagała, J, et al.Successful use of activated recombinant factor VII to control bleeding abnormalities in a patient with a left ventricular assist device. J Thorac Cardiovasc Surg. 2002;123:384–385.
33.Miller, LW, Nelson, KE, Bostic, RR, et al.Hospital costs for left ventricular assist devices for destination therapy lower costs for implantation in the post-REMATCH era. J Heart Lung Transplant. 2006;25:778–784.
34.Pagani, FD, Long, JW, Dembitsky, WP, Joyce, LD, Miller, LW. Improved mechanical reliability of the HeartMate XVE left ventricular assist system. Ann Thorac Surg. 2006;82:1413–1418.
35.Long, JW, Healy, AH, Rasmusson, BY, et al.Improving outcomes with long-term “destination” therapy using left ventricular assist devices. J Thorac Cardiovasc Surg. 2008;135:1353–1360.
36.Slaughter, MS, Sobieski, MA, Gallagher, C, Dia, M, Silver, MA. Low incidence of neurologic events during long-term support with the HeartMate XVE left ventricular assist device. Tex Heart Inst J. 2008;35:245–249.
37.Feldman, AM, de Lissovoy, G, Bristow, MR, et al.Cost effectiveness of cardiac resynchronization therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial. J Am Coll Cardiol. 2005;46:2311–2321.
38.Yao, G, Freemantle, N, Calvert, MJ, et al.The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator. Eur Heart J. 2007;28:42–51.
39.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;54:312–321.
40.Boyle, A, Teuteberg, J, Ascheim, DD, et al.Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification. J Heart Lung Transplant. 2011;30:402–407.
41.Kirklin, JK, Naftel, DC, Kormos, RL, et al.Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013;32:141–156.
42.Slaughter, MS, Rogers, JG, Milano, CA, et al.HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241–2251.
43.Park, SJ, Milano, CA, Tatooles, AJ, et al.Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5:241–248.
44.Ascheim, DD, Gelijns, AC, Rose, EA. Innovation with experience using implantable left ventricular assist devices. Circ Heart Fail. 2009;2:1–2.
45.Tunis, SR, Pearson, SD. Coverage options for promising technologies: Medicare's ‘coverage with evidence development’. Health Aff (Millwood). 2006;25:1218–1230.
46.Campbell, B. NICE medical technology guidance: Devices and diagnostics. Heart. 2011;97:1794–1795.
47.Campbell, B. The NICE Medical Technologies Advisory Committee and medical technologies guidance. Heart. 2011;97:674–675.