Abbreviations: DT, destination therapy; ePTFE, expanded polytetrafluoroethylene; LVAS, left ventricular assist system; TAH, total artificial heart... Lifetime Circulatory Support Must NotB
Trang 1Study 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 d d NA 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 [108] Pulsatile BTT d NA d d NA d d NA d d NA 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 d d NA 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 d d NA d d NA 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 d d NA 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 d d NA 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 d d NA 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.
Trang 2Lifetime Circulatory Support Must Not
Be Restricted to Transplant Centers
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 $60,000 per year [4]
The strategy of lifetime left ventricular assist device (LVAD) deployment is based on the success of mechanical bridge to transplantation
[5] First-generation LVADs were designed to re-place the failing left ventricle by providing stroke volume and pulsatile blood flow (Fig 1a, b)[6] Blood is actively withdrawn from the dilated chamber and pumped in a pulsatile manner to the ascending aorta at a rate of between 4 and
10 L/min In patients dying of cardiogenic shock these devices sustain life until a donor organ is available, provide symptomatic relief, reverse multiorgan dysfunction, and attenuate the cyto-kine and humeral responses to heart failure [7] Transplant outcomes are improved because termi-nally ill patients are in better condition to survive major surgery[8] In turn comes the observation that mechanical unloading of the failing heart and increased coronary blood flow have impor-tant beneficial effects on the diseased myocar-dium Reduced wall tension and stroke work result in decreased myocyte hypertrophy, apopto-sis, myocytolyapopto-sis, and fibrosis Myocyte genetic expression and metabolic processes revert toward normal[9] As a result LVADs can occasionally
be removed following functional improvement of the native heart (Fig 2)[10] Bridge to recovery occurs more often in inflammatory conditions, such as myocarditis, intoxication, or idiopathic dilated cardiomyopathy
With the exception of the United States, Germany, and France, bridge to transplantation
is an expensive and infrequent intervention In the study by Sharples and colleagues[11]evaluating the ventricular assist device program in the United
* Oxford Heart Centre, John Radcliffe Hospital,
Headley Way, Headington, Oxford OX3 9DU, United
Kingdom.
E-mail address: swestaby@AHF.org.uk
1551-7136/07/$ - see front matter Ó 2007 Elsevier Inc All rights reserved.
Heart Failure Clin 3 (2007) 369–375