Transapical miniaturized ventricular assist device: design and initial testing.

Transapical miniaturized ventricular assist device: design and initial testing.
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经心尖微型心室辅助装置:设计和初始测试。

DOI:
10.1016/j.jtcvs.2011.01.011
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发表时间:
2011
期刊:
The Journal of thoracic and cardiovascular surgery
影响因子:
--
通讯作者:
Koenig,StevenC
Koenig,StevenC
中科院分区:
--
文献类型:
--
作者:
Slaughter,MarkS;Giridharan,GuruprasadA;Tamez,Dan;LaRose,Jeff;Sobieski,MikeA;Sherwood,Leslie;Koenig,StevenC

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左心室辅助装置越来越多地用于治疗晚期和其他难治性心力衰竭患者,作为移植或目的治疗的桥梁。我们评估了一种新的小型化左心室辅助装置,需要最小的手术植入,可能允许植入在早期阶段heartfailure.METHODSHEartWare(迈阿密湖泊,弗拉)开发的经心尖小型化心室辅助装置。急性(n = 4)、1周(n = 2)和30天(n = 4)牛模型实验评价了器械的血流动力学有效性和生物相容性,该器械通过左胸小切口植入,在左心室心尖处单次插入,无需体外循环。器械流出道插管穿过主动脉瓣。华法林组的国际标准化比值维持在2.0 - 2.5之间。对血流动力学、超声心动图、荧光镜检查、血液学和血液化学测量结果进行了评价。该装置在15,000 ± 1000 rpm下运行(功耗,3.5-6.0 W)。器械维持正常终末器官灌注,无明显溶血(0-30 mg/dL)。无泵故障或器械相关并发症。尸检时,在内膜、主动脉瓣叶或主动脉根部未观察到异常。有没有证据表明,血栓栓塞或异常的任何周边endorgans.CONCLUSIONSWe成功地证明了一种新的心室内辅助装置,可以完全植入通过左心室心尖部的可行性。这种经心尖手术入路无需胸骨切开术、器械囊袋、心肺转流术、心室取芯术和流出道移植物吻合术。
BACKGROUNDLeft ventricular assist devices are increasingly used to treat patients with advanced and otherwise refractory heart failure as bridge to transplant or destination therapy. We evaluated a new miniaturized left ventricular assist device that requires minimal surgery for implantation, potentially allowing implantation in earlier stage heart failure.METHODSHeartWare (Miami Lakes, Fla) developed transapical miniaturized ventricular assist device. Acute (n = 4), 1-week (n = 2), and 30-day (n = 4) bovine model experiments evaluated hemodynamic efficacy and biocompatibility of the device, which was implanted through small left thoracotomy with single insertion at apex of left ventricle without cardiopulmonary bypass. The device outflow cannula was positioned across the aortic valve. The international normalized ratio was maintained between 2.0 and 2.5 with warfarin. Hemodynamic, echocardiographic, fluoroscopic, hematologic, and blood chemistry measurements were evaluated.RESULTSThe device was successfully implanted through the left ventricular apex in all 10 animals. The device was operated at 15,000 ± 1000 rpm (power consumption, 3.5–6.0 W). The device maintained normal end-organ perfusion with no significant hemolysis (0–30 mg/dL). There were no pump failures or device-related complications. At autopsy, no abnormalities were seen in endocardium, aortic valve leaflets, or aortic root. There was no evidence of thromboembolism or abnormalities in any peripheral end organs.CONCLUSIONSWe successfully demonstrated feasibility of a novel intraventricular assist device that can be completely implanted through left ventricular apex. This transapical surgical approach eliminates needs for sternotomy, device pocket, cardiopulmonary bypass, ventricular coring, and construction of an outflow graft anastomosis.