Objective To compare the early outcomes of domestic third-generation magnetically levitated left ventricular assist device (LVAD) with or without concomitant mitral valvuloplasty (MVP). Methods The clinical data of 17 end-stage heart failure patients who underwent LVAD implantation combined with preoperative moderate to severe mitral regurgitation in Fuwai Central China Cardiovascular Hospital from May 2018 to March 2023 were retrospectively analyzed. The patients were divided into a LVAD group and a LVAD+MVP group based on whether MVP was performed simultaneously, and early outcomes were compared between the two groups. Results There were 4 patients in the LVAD group, all males, aged (43.5±5.9) years, and 13 patients in the LVAD+MVP group, including 10 males and 3 females, aged (46.8±16.7) years. All the patients were successful in concomitant MVP without mitral reguragitation occurrence. Compared with the LVAD group, the LVAD+MVP group had a lower pulmonary artery systolic pressure and pulmonary artery mean pressure 72 h after operation, but the difference was not statistically different (P>0.05). Pulmonary artery systolic pressure was significantly lower 1 week after operation, as well as pulmonary artery systolic blood pressure and pulmonary artery mean pressure at 1 month after operation (P<0.01). There was no statistically significant difference in blood loss, operation time, cardiopulmonary bypass time, aortic cross-clamping time, mechanical ventilation time, or ICU stay time between the two groups (P>0.05). The differences in 1-month postoperative mortality, acute kidney injury, reoperation, gastrointestinal bleeding, and thrombosis and other complications between the two groups were not statistically significant (P>0.05). Conclusion Concomitant MVP with implantation of domestic third-generation magnetically levitated LVAD is safe and feasible, and concomitant MVP may improve postoperative hemodynamics without significantly increasing perioperative mortality and complication rates.
Regurgitation is an abnormal condition happens when left ventricular assist devices (LVADs) operated at a low speed, which causes LVAD to fail to assist natural blood-pumping by heart and thus affects patients’ health. According to the degree of regurgitation, three LVAD’s regurgitation states were identified in this paper: no regurgitation, slight regurgitation and severe regurgitation. Regurgitation index (RI), which is presented based on the theory of dynamic closed cavity, is used to grade the regurgitation of LVAD. Numerical results showed that when patients are in exercising, resting and sleeping state, the critical speed between slight regurgitation and no regurgitation are 6 650 r/min, 7 000 r/min and 7 250 r/min, respectively, with corresponding RI of 0.401, 0.300 and 0.238, respectively. And the critical speed between slight regurgitation and severe regurgitation are 5 500 r/min, 6 000 r/min and 6 450 r/min, with corresponding RI of 0.488, 0.359 and 0.284 respectively. In addition, there is a negative relation correction between RI and rotational speed, so that grading the LVAD’s regurgitation can be achieved by determining the corresponding critical speed. Therefore, the detective parameter RI based on the signal of flow is proved to be able to grade LVAD’s regurgitation states effectively and contribute to the detection of LVAD’s regurgitation, which provides theoretical basis and technology support for developing a LVADs controlling system with high reliability.
Objective To investigate the feasibility of a long-term left ventricular assist device placed in the aortic valve annulus for terminal cardiopathy. Methods An implantable aortic valve pump （23ram outer diameter, weighing 31g） was developed. There were a central rotor and a stator in the device. The rotor was consisted of driven magnets and an impeller, the stator was consisted of a motor coil with an iron core and outflow guide vanes. The device was implanted identical to an aortic valve replacement, occupying no additional anatomic space. The blood was delivered directly from left ventricle to the aortic root by aortic valve pump like natural ventricle, neither connecting conduits nor ＂bypass＂ circuits were necessary, therefore physiologic disturbances of natural circulation was less. Results Aortic valve pump was designed to cycle between a peak flow and zero net flow to approximate systole and diastole. Bench testing indicated that a blood flow of 7L/min with 50 mmHg（1kPa = 7.5mmHg） pressure could be produced by aortic valve pump at 15 000r/min. A diastole aortic pressure of 80mmHg could be maintained by aortic valve pump at 0L/min and the same rotating speed. Conclusions This paper exhibits the possibility that an aortic valve pump with sufficient hemodynamic capacity could be made in 23mm outer diameter, 31g and it could be implantable. This achievement is a great progress to extend the applications of aortic valve pump in clinic and finally in replacing the natural donor heart for heart transplantation. Meanwhile, this is only a little step, because many important problems, such as blood compatibility and durability, require further investigation.
As a global disease, heart failure affects at least 26 million people, and its prevalence is still rising. Besides, the mortality rate and readmission rate remain high. Advanced heart failure is the terminal stage of various heart diseases, and often requires some treatments other than drug intervention, such as heart transplantation which is the gold standard for treatment of heart failure. However, limited by the number of donors, the number of heart transplants in the world has reached a bottleneck. There is a huge gap between the number of patients who need heart transplants and patients who get hearts for survival successfully in reality. With the exploration and development of mechanical circulation support devices for more than half a century, they have become a wonderful treatment for patients with advanced heart failure. This article will introduce the latest progress of mechanical circulatory support devices at home and abroad from the aspects of temporary and long-term devices.
The implantation of left ventricular assist device (LVAD) has significantly improved the quality of life for patients with end-stage heart failure. However, it is associated with the risk of complications, with unplanned readmissions gaining increasing attention. This article reviews the influencing factors, prediction methods and models, and intervention measures for unplanned readmissions in LVAD patients, aiming to provide scientific guidance for clinical practice, assist healthcare professionals in accurately assessing patients' conditions, and develop rational care plans.
Objective To investigate the efficacy and safety of the Corheart 6 left ventricular assist system in patients with end-stage heart failure. Methods A retrospective study was conducted on patients with end-stage heart failure who were treated with Corheart 6 left ventricular assist system from March 2022 to June 2024 in 4 hospitals in Jiangsu Province. The efficacy of the device was evaluated by comparing changes in clinical indicators at preoperative, discharge, 3-month postoperative, and 6-month postoperative timepoints, including the New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), and left ventricular end-diastolic diameter (LVEDD). The safety of the device was assessed by analyzing the intraoperative position and orientation of the blood pump inlet cannula, as well as the incidence of adverse events. Results In this study, 39 patients were collected, including 34 males and 5 females with a mean age of (56.4±12.5) years, ranging from 20 to 75 years. There was no operative death. There was no death in postoperative 3 months with a survival rate of 100.0%. There were 3 deaths in 6 months postoperatively, with a survival rate of 92.3%. All patients had a preoperative NYHA cardiac function classification of class Ⅳ. The NYHA cardiac function class of the patients improved (P<0.05) at discharge, 3 and 6 months after surgery when compared to the preoperative period. LVEF was significantly higher at 3 months after surgery than that during the preoperative period (P<0.05). LVEDD was significantly smaller at discharge, 3 and 6 months after surgery than that during the preoperative period (P<0.05). The safety evaluation's findings demonstrated that all 39 patients' intraoperative blood pump inlet tubes were oriented correctly, the artificial blood vessel suture sites were appropriate, there were no instances of device malfunction or pump thrombosis, or instances of bleeding or hemolysis, and the rate of the remaining adverse events was low. Conclusion With a low rate of adverse events and an excellent safety profile, the Corheart 6 left ventricular assist system can efficiently enhance cardiac function in patients with end-stage heart failure. It also has considerable clinical uses.
ObjectiveTo compare the perioperative renal function changes in patients undergoing heart transplantation (HT) and left ventricular assist device (LVAD) implantation. MethodsPatients with end-stage heart failure who underwent surgical treatment at Beijing Anzhen Hospital, Capital Medical University from January 2019 to April 2024 were included. According to the surgical method, patients were divided into a HT group and a LVAD group, and the estimated glomerular filtration rate (eGFR) of patients before surgery and postoperative 1, 7, 30, 60 days was compared between the two groups. The patients with preoperative renal dysfunction were subdivided into subgroups for comparison of eGFR changes before surgery and 30 days after surgery between the two groups. ResultsA total of 112 patients were enrolled. There were 78 patients in the HT group, including 61 males and 17 females, aged (44.42±18.51) years. There were 34 patients in the LVAD group, including 30 males and 4 females, aged (54.94±11.37) years. Compared with the HT group, the average age of patients in the LVAD group was greater (P<0.001), body mass index was higher (P=0.008), preoperative eGFR was lower (P=0.009), and the proportions of smokers (P=0.017), alcohol drinkers (P=0.041), and diabetes mellitus (P=0.028) patients were higher. Among patients with preoperative renal dysfunction [eGFR<90 mL/(min·1.73 m2)], compared with the HT group, the postoperative eGFR of the LVAD group was significantly higher than that of the HT group, and it was significantly increased compared with that before surgery; the postoperative eGFR of the HT group was comparable to that before surgery, and more than half of the patients had a lower eGFR than before surgery. Among patients with preoperative renal dysfunction, 11 patients in the HT group received continuous renal replacement therapy, and 8 died early; 2 patients in the LVAD group received continuous renal replacement therapy, and 1 died early. ConclusionFor end-stage heart failure patients with combined renal dysfunction, compared with HT, LVAD implantation enables patients to obtain better renal function benefits.
Although heart transplantation remains to be the optimal treatment for advanced heart failure, its use has been largely limited due to shortage of available donor organs. Over the past two decades, left ventricular assist device (LVAD) has been significantly modified in size, durability and hemocompatibility. In addition to the bridge to transplantation, LVAD has become an attractive alternative to heart transplantation for end-stage heart failure as destination therapy for unsuitable candidates. Although the performance of LVAD has been improving greatly in recent years, there are still great challenges in the management of device complications and low quality of life after implantation. This review will summarize the types of LVAD, indications for implantation, postoperative management and adverse events.
Heart failure is one kind of cardiovascular disease with high risk and high incidence. As an effective treatment of heart failure, artificial heart is gradually used in clinical treatment. Blood compatibility is an important parameter or index of artificial heart, and how to evaluate it through hemodynamic design and in vitro hemolysis test is a research hotspot in the industry. This paper first reviews the research progress in hemodynamic optimization and in vitro hemolysis evaluation of artificial heart, and then introduces the research achievements and progress of the team in related fields. The hemodynamic performance of the blood pump optimized in this paper can meet the needs of use. The normalized index of hemolysis obtained by in standard vitro hemolysis test is less than 0.1 g/100 L, which has good hemolysis performance in vitro. The optimization method described in this paper is suitable for most of the development of blood pump and can provide reference for related research work.
The rotary left ventricular assist device (LVAD) has been an effective option for end-stage heart failure. However, while clinically using the LVAD, patients are often at significant risk for ventricular collapse, called suction, mainly due to higher LVAD speeds required for adequate cardiac output. Some proposed suction detection algorithms required the external implantation of sensors, which were not reliable in long-term use due to baseline drift and short lifespan. Therefore, this study presents a new suction detection system only using the LVAD intrinsic blood pump parameter (pump speed) without using any external sensor. Three feature indices are derived from the pump speed and considered as the inputs to four different classifiers to classify the pumping states as no suction or suction. The in-silico results using a combined human circulatory system and LVAD model show that the proposed method can detect ventricular suction effectively, demonstrating that it has high classification accuracy, stability, and robustness. The proposed suction detection system could be an important part in the LVAD for detecting and avoiding suction, while at the same time making the LVAD meet the cardiac output demand for the patients. It could also provide theoretical basis and technology support for designing and optimizing the control system of the LVAD.