Study MCSD Infection Bleeding Neurological Dysfunction Outcomes Assist device References Type Indication N % Incid N % Incid N % Incid N % Incid BTT % Wean % Mort % Incid 1 year TxSv % AbioCor [61,62] Pulsatile DT 0 0 0 4 57.1 1.94 3 42.86 1.45 0 0 0.00 0 0 0 0 5 71.43 2.42 d NA d Arrow LionHeart [32] Pulsatile DT d NA ddNA d 57 247.8 2.61 d NA d ddddddd NA ddddddd Berlin Heart InCor [75] Flow BTT 0 0 0 4 26.7 0.64 4 26.67 0.64 3 20 0.48 5 33.33 1 6.667 6 40 0.967 d NA d HeartMate I [94] Pulsatile BTT 8 25 1.36 4 12.5 0.68 2 6.25 0.34 3 9.38 0.51 20 62.5 1 3.125 6 18.75 1.023 d NA d Heartmate I [95] Pulsatile BTT 57 58.8 3.06 20 20.6 1.08 2 2.062 0.11 12 12.4 0.65 74 76.29 2 2.062 24 24.74 1.29 69 93.2 HeartMate I [105] Pulsatile BTT 10 62.5 1.38 6 37.5 0.83 2 12.5 0.28 20 125 2.76 12 75 1 6.25 1 6.25 0.138 7 58.3 HeartMate I [106] Pulsatile BTT 41 36 3.11 28 24.6 2.12 16 14.04 1.21 4 3.51 0.30 57 50 3 2.632 34 29.82 2.576 d NA d HeartMate I [107] Pulsatile BTT 125 44.6 1.45 31 11.1 0.36 75 26.79 0.87 3 1.07 0.03 188 67.14 10 3.571 82 29.29 0.953 158 84 HeartMate I [9] Pulsatile DT 1.24 0.56 0.39 0.08 0 0 0 0 41 60.29 0.6 d NA d HeartMate I [108] Pulsatile BTT d NA ddNA ddNA ddNA d 88 73.95 0 0 20 16.81 0.864 78 88.6 HeartMate I [43] Pulsatile BTT 15 29.4 0.78 d NA d 1 1.961 0.05 5 9.8 0.26 36 70.59 0 0 15 29.41 0.778 31 86.1 HeartMate II [109] Flow BTT/DT d NA ddNA d 1 6.667 0.14 1 6.67 0.14 1 6.667 0 0 2 13.33 0.274 d NA d Jarvik FlowMaker [16] Flow DT 1 5.88 0.06 1 5.88 0.06 4 23.53 0.24 0 0 0.00 1 5.882 0 0 8 47.06 0.487 d NA d Jarvik FlowMaker [110] Flow BTT/DT d NA ddNA ddNA d 10 9.8 0.17 ddddddd NA ddddddd (CardioWest) [111] Pulsatile BTT 4 3.15 0.40 33 26 3.34 2 1.575 0.20 1 0.79 0.10 ddddddd NA ddddddd Micromed DeBakey [31] Flow BTT 5 3.33 0.16 48 32 1.58 16 10.67 0.53 4 2.67 0.13 62 41.33 1 0.667 68 45.33 2.237 d NA d Micromed DeBakey [15] Flow BTT 2 6.67 0.58 8 26.7 2.32 3 10 0.87 0 0 0.00 20 66.67 0 0 0 0 0 d NA d Micromed DeBakey [30] Flow BTT 0 0 0.00 4 23.5 0.97 2 11.76 0.49 0 0 0.00 14 82.35 0 0 2 11.76 0.486 d NA d Novacor LVAS [43] Pulsatile BTT 5 38.5 1.23 d NA d 3 23.08 0.74 0 0 0.00 9 69.23 0 0 2 15.38 0.493 7 77.8 Novacor LVAS [112] Pulsatile BTT d NA d 59 12.7 0.33 d NA d 0 0 0.00 155 33.41 21 4.526 147 31.68 0.821 d NA d (ePTFE) [65] Pulsatile NA d NA ddNA d 9 10.23 0.31 d NA d ddddddd NA ddddddd Novacor LVAS (Pol) [113] Pulsatile BTT 104 36.9 1.36 82 29.1 1.07 54 19.15 0.71 d NA ddNA d 82 29.08 1.071 d NA d (Vasc) [113] Pulsatile BTT 58 28.7 1.15 59 29.2 1.17 23 11.39 0.46 d NA ddNA d 65 32.18 1.291 d NA d CardioWest TAH [114] Pulsatile BTT 29 35.8 1.65 23 28.4 1.31 5 6.173 0.28 1 1.23 0.06 64 79.01 0 0 17 20.99 0.968 55 85.9 CardioWest TAH [115] Pulsatile BTT 5 11.9 0.51 8 19 0.81 4 9.524 0.40 2 4.76 0.20 11 26.19 0 0 24 57.14 2.425 d NA d Totals 25 26.1 23.7 1.03 24.8 24.9 1.18 13.7 24.98 0.61 3.6 10.9 0.29 45.39 51.09 2.22 1.639 32.3 27.97 57.9 82 Because of differences in adverse event reporting criteria, data might be incomplete or interpreted differently and not accurately comparable for the experiences with different assist devices. For an in-deep analysis, the authors suggest readers to refer to the original publication. Abbreviations: DT, destination therapy; ePTFE, expanded polytetrafluoroethylene; LVAS, left ventricular assist system; TAH, total artificial heart. 357DESTINATION THERAPY Lifetime Circulatory Support Must Not Be Restricted to Transplant Centers Stephen Westaby, MS, PhD, FRCS * Oxford Heart Centre, John Radcliffe Hospital, Oxford, UK The problem Chronic heart failure affects around 5 million North Americans and 7 million Europeans each year, accounting for 2% of the total health care budget in Western countries [1] . The major com- ponent of health care costs is repeated hospital ad- missions to palliate intolerable symptoms and escalate medical treatment. It is estimated that be- tween 250,000 and 500,000 patients in the United States and approximately 2.2 million worldwide are in the terminal phase of heart failure (Stage D, New York Heart Association [NYHA] IV) and refractory to maximum medical therapy [2]. With around 10% of the population older than 65 years of age suffering systolic left ven- tricular dysfunction, the number of patients who have heart failure will double within the next 25 years. In this global context cardiac transplantation is irrelevant. Essentially re- stricted to patients younger than 65 years of age who do not have significant comorbidity, fewer than 2,200 donor hearts per year are made available in the United States and around 150 in the United Kingdom [3]. In a population constantly bombarded with media coverage of medical advances, there will be escalating de- mand for relief from severely symptomatic Stage D disease. Provided with an effective treatment, most civilized health care systems are prepared to intervene irrespective of cost. The treatment of advanced renal disease sets the precedent. Hemodialysis, which provides an overall 60% 2-year survival in the United States, is offered irrespective of age or transplant eligibility at a cost of around $60,000 per year [4]. The strategy of lifetime left ventricular assist device (LVAD) deployment is based on the success of mechanical bridge to transplantation [5]. First-generation LVADs were designed to re- place the failing left ventricle by providing stroke volume and pulsatile blood flow (Fig. 1a, b) [6]. Blood is actively withdrawn from the dilated chamber and pumped in a pulsatile manner to the ascending aorta at a rate of between 4 and 10 L/min. In patients dying of cardiogenic shock these devices sustain life until a donor organ is available, provide symptomatic relief, reverse multiorgan dysfunction, and attenuate the cyto- kine and humeral responses to heart failure [7]. Transplant outcomes are improved because termi- nally ill patients are in better condition to survive major surgery [8]. In turn comes the observation that mechanical unloading of the failing heart and increased coronary blood flow have impor- tant beneficial effects on the diseased myocar- dium. Reduced wall tension and stroke work result in decreased myocyte hypertrophy, apopto- sis, myocytolysis, and fibrosis. Myocyte genetic expression and metabolic processes revert toward normal [9]. As a result LVADs can occasionally be removed following functional improvement of the native heart (Fig. 2) [10]. Bridge to recovery occurs more often in inflammatory conditions, such as myocarditis, intoxication, or idiopathic dilated cardiomyopathy. With the exception of the United States, Germany, and France, bridge to transplantation is an expensive and infrequent intervention. In the study by Sharples and colleagues [11] evaluating the ventricular assist device program in the United * Oxford Heart Centre, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, United Kingdom. E-mail address: swestaby@AHF.org.uk 1551-7136/07/$ - see front matter Ó 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.hfc.2007.05.008 heartfailure.theclinics.com Heart Failure Clin 3 (2007) 369–375 . 1.03 24.8 24 .9 1.18 13.7 24 .98 0.61 3.6 10 .9 0. 29 45. 39 51. 09 2.22 1.6 39 32.3 27 .97 57 .9 82 Because of differences in adverse event reporting criteria, data might be incomplete or interpreted differently. around 10% of the population older than 65 years of age suffering systolic left ven- tricular dysfunction, the number of patients who have heart failure will double within the next 25 years. In this. Pulsatile BTT 29 35.8 1.65 23 28.4 1.31 5 6.173 0.28 1 1.23 0.06 64 79. 01 0 0 17 20 .99 0 .96 8 55 85 .9 CardioWest TAH [115] Pulsatile BTT 5 11 .9 0.51 8 19 0.81 4 9. 524 0.40 2 4.76 0.20 11 26. 19 0 0 24