PMID- 37057326 OWN - NLM STAT- MEDLINE DCOM- 20230417 LR - 20230417 IS - 0253-3758 (Print) IS - 0253-3758 (Linking) VI - 51 IP - 4 DP - 2023 Apr 24 TI - [Long-term outcome of EVAHEART I implantable ventricular assist device for the treatment of end stage heart failure: clinical 3-year follow-up results of 15 cases]. PG - 393-399 LID - 10.3760/cma.j.cn112148-20220614-00472 [doi] AB - 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) mumol/L vs. (17.39+/-7.68) mumol/L; (95.82+/-34.88) mumol/L vs. (77.32+/-43.81) mumol/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. FAU - Chen, H B AU - Chen HB AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Wang, X Q AU - Wang XQ AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Du, J AU - Du J AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Shi, J AU - Shi J AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Ji, B Y AU - Ji BY AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Shi, L AU - Shi L AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Shi, Y S AU - Shi YS AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Zhou, X T AU - Zhou XT AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Yang, X H AU - Yang XH AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. FAU - Hu, S S AU - Hu SS AD - Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Beijing 100037, China. LA - chi GR - 2022-GSP-QZ-7/High-Level Hospital Clinical Research Projects/ GR - SZSM201911018/Program for Famous Hospitals, Specialities and Doctors in Shenzhen/ GR - SZXK080/Program for Shenzhen Key Medical Discipline Contruction/ PT - English Abstract PT - Journal Article PL - China TA - Zhonghua Xin Xue Guan Bing Za Zhi JT - Zhonghua xin xue guan bing za zhi JID - 7910682 SB - IM MH - Humans MH - Male MH - Adult MH - Middle Aged MH - Female MH - *Heart Failure/complications MH - Follow-Up Studies MH - Retrospective Studies MH - *Heart-Assist Devices MH - Quality of Life EDAT- 2023/04/15 06:00 MHDA- 2023/04/17 06:41 CRDT- 2023/04/14 02:46 PHST- 2023/04/17 06:41 [medline] PHST- 2023/04/14 02:46 [entrez] PHST- 2023/04/15 06:00 [pubmed] AID - 10.3760/cma.j.cn112148-20220614-00472 [doi] PST - ppublish SO - Zhonghua Xin Xue Guan Bing Za Zhi. 2023 Apr 24;51(4):393-399. doi: 10.3760/cma.j.cn112148-20220614-00472.