RESUMO
Objective: To evaluate the long-term efficacy and safety of the implantable ventricular assist system EVAHEART I in clinical use. Methods: Fifteen consecutive patients with end-stage heart failure who received left ventricular assist device therapy in Fuwai Hospital from January 2018 to December 2021 were enrolled in this study, their clinical data were retrospectively analyzed. Cardiac function, liver and kidney function, New York Heart Association (NYHA) classification, 6-minute walk distance and quality of life were evaluated before implantation and at 1, 6, 12, 24 and 36 months after device implantation. Drive cable infection, hemolysis, cerebrovascular events, mechanical failure, abnormally high-power consumption and abnormal pump flow were recorded during follow up. Results: All 15 patients were male, mean average age was (43.0±7.5) years, including 11 cases of dilated cardiomyopathy, 2 cases of ischemic cardiomyopathy, and 2 cases of valvular heart disease. All patients were hemodynamically stable on more than one intravenous vasoactive drugs, and 3 patients were supported by preoperative intra aortic balloon pump (IABP). Compared with before device implantation, left ventricular end-diastolic dimension (LVEDD) was significantly decreased ((80.93±6.69) mm vs. (63.73±6.31) mm, P<0.05), brain natriuretic peptide (BNP), total bilirubin and creatinine were also significantly decreased ((3 544.85±1 723.77) ng/L vs. (770.80±406.39) ng/L; (21.28±10.51) μmol/L vs. (17.39±7.68) μmol/L; (95.82±34.88) μmol/L vs. (77.32±43.81) μmol/L; P<0.05) at 1 week after device implantation. All patients in this group were in NYHA class Ⅳ before implantation, and 9 patients could recover to NYHA class Ⅲ, 3 to class Ⅱ, and 3 to class Ⅰ at 1 month after operation. All patients recovered to class Ⅰ-Ⅱ at 6 months after operation. The 6-minute walk distance, total quality of life and visual analogue scale were significantly increased and improved at 1 month after implantation compared with those before operation (P<0.05). All patients were implanted with EVAHEART I at speeds between 1 700-1 950 rpm, flow rates between 3.2-4.5 L/min, power consumption of 3-9 W. The 1-year, 2-year, and 3-year survival rates were 100%, 87%, and 80%, respectively. Three patients died of multiple organ failure at 412, 610, and 872 d after surgery, respectively. During long-term device carrying, 3 patients developed drive cable infection on 170, 220, and 475 d after surgery, respectively, and were cured by dressing change. One patient underwent heart transplantation at 155 d after surgery due to bacteremia. Three patients developed transient ischemic attack and 1 patient developed hemorrhagic stroke events, all cured without sequelae. Conclusion: EVAHEART I implantable left heart assist system can effectively treat critically ill patients with end-stage heart failure, can be carried for long-term life and significantly improve the survival rate, with clear clinical efficacy.
Assuntos
Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Feminino , Insuficiência Cardíaca/complicações , Seguimentos , Estudos Retrospectivos , Coração Auxiliar , Qualidade de VidaRESUMO
Objective: To observe the changes of parameters derived from transthoracic echocardiography (TTE) before and after left ventricular assist device (LVAD) implantation, and to evaluate the clinical value of TTE in the perioperative period of LVAD implantation. Methods: This is a retrospective study. The data of patients who underwent LVAD implantation in Fuwai Hospital from January 2018 to December 2020 were analyzed retrospectively. The TTE parameters, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and total bilirubin (TBil) before and 1 month after LVAD implantation were collected and analyzed. Results: A total of 12 male patients undergoing LVAD implantation were included in this study. The mean age was (43.3±8.6) years. The left atrial volume index ((41.4±12.8)ml/m2 vs. (74.9±30.7)ml/m2, P<0.001), left ventricular end-diastolic volume index ((152.1±35.3)ml/m2 vs. (205.5±35.7)ml/m2, P<0.001), left ventricular end-systolic volume index ((112.5±27.9)ml/m2 vs. (155.1±29.1)ml/m2, P<0.001), right atrial diameter index ((23.7±3.5)mm/m2 vs. (27.2±5.8)mm/m2, P=0.023), right ventricular internal diameter at end-diastole ((24.6±2.7)mm vs. (30.0±4.8)mm, P<0.001), tricuspid annular plane systolic excursion ((11.5±2.9)mm vs. (14.6±2.8)mm, P=0.007), systolic pulmonary arterial pressure ((29.2±4.8) mmHg vs. (55.1±19.3) mmHg, P<0.001, 1 mmHg=0.133 kPa) were significantly reduced at 1 month post LVAD implantation as compared to before LVAD implantation. The aortic sinus diameter ((33.8±4.7)mm vs. (31.6±5.1)mm, P=0.007), left ventricular ejection fraction ((26.3±3.0)% vs. (23.8±4.4)%, P=0.016), right ventricular fractional area change ((31.0±8.6)% vs. (23.8±5.5)%, P=0.004) at 1 month post LVAD implantation were significantly higher than before LVAD implantation. The degree of mitral and tricuspid regurgitation decreased, and the inspiratory collapse rate of inferior vena cava increased (all P<0.05). NT-proBNP ((1 418.4±812.6)ng/L vs. (5 097.5±3 940.4)ng/L, P=0.004) and TBil ((12.4±5.4)μmol/L vs. (27.5±14.0)μmol/L, P=0.001) decreased significantly at 1 month post LVAD implantation. Conclusions: TTE results show that LVAD could effectively relieve left ventricular load and improve right ventricular function. TTE can monitor the cardiac structural and functional changes during the perioperative period of LVAD implantation, and provide the imaging evidence for clinical evaluation of the therapeutic effect of LVAD.