Survival prognosis and clinical experience of HeartCon-type left ventricular assist device implantation for treating patients with end-stage heart failure: a single-center retrospective study from China

Introduction

With the aging of the population, the incidence of heart failure (HF) continues to rise worldwide. Since 2018, total hospitalization costs associated with HF have increased at an average annual rate of 16.14%. End-stage heart failure (ESHF) represents the terminal stage of HF. When standardized drug therapy becomes ineffective, patients experience significantly reduced activity tolerance and poor quality of life. They also often face increased financial burdens due to frequent hospitalizations and care requirements, along with an ever-present risk of death. Although allogeneic heart transplantation (HTx) remains the gold standard treatment for ESHF, its global clinical application is severely limited by the scarcity of heart donors. According to the China Heart Transplant Registry, only 5,331 HTx surgeries were performed in mainland China between 2015 and 2023, averaging approximately 592 cases annually. Over the past decade, left ventricular assist devices (LVADs), particularly third-generation continuous flow (CF) LVADs, have demonstrated significant survival benefits compared to optimal medical therapies and have emerged as an effective alternative for treating ESHF besides HTx (1). The one-year survival rate of LVAD recipients reached 83.0%, approaching that of HTx (2). The recent ELEVATE registry study reported a five-year overall survival rate of 63.3% among 463 HeartMate III patients, which is comparable to that of HTx (3). The 2023 Annual Report from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) highlighted that recipients of magnetically levitated LVADs (n=10,920) exhibited superior 1-year (86% vs. 79%) and 5-year (64% vs. 44%) survival rates compared to those with non-magnetically levitated devices (4). In addition, the indications for LVAD implantation and the type of device applied have changed over the past few years, with 81.1% of patients implanted with LVADs as destination therapy (DT), and the vast majority was third-generation CF LVADs implantation (2).

LVADs have been widely used for many years in Europe, the United States, and other developed countries with mature technologies, however, due to the high costs of equipment and surgeries, as well as the restrictions imposed by medical insurance, it still cannot be widely applied. In China, its clinical application is still in its infancy and has only gained attention in the past five years. A multi-center clinical trial involving 50 HeartCon-type LVAD implantations successfully completed a 90-day safety and efficacy evaluation using a prospective, single-group target-value method, marking the largest sample size for LVAD implantations in mainland China to date. On July 13, 2022, the HeartCon-type LVAD was approved for registration and marketing by the National Medical Products Administration (NMPA) of China. Since then, it has been used in over 200 ESHF patients. In our cardiac center, 36 cases of HeartCon-type LVAD implantation had been completed as of November 2023, and the longest implantation time has exceeded 4.2 years. It is expected to provide a stable, reliable and relatively inexpensive LVAD. In this study, we conducted a single-center analysis of patients who underwent HeartCon-type LVAD implantations, evaluating their safety, postoperative complications, and survival prognosis and shared some clinical experience. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-810/rc).

Methods

Study subjects

This single-center, retrospective, observational study included all patients who underwent HeartCon-type LVAD implantation from the start of our program in September 15, 2020 to November 30, 2023. Clinical data were collected after obtaining the approval of the Ethics Committee of TEDA International Cardiovascular Hospital (No. 2025-0327-1), and informed consent was obtained from each of the patients. Follow-up extended to November 30, 2023. The study conforms with the Declaration of Helsinki and its subsequent amendments, and the ISHLT Ethics statement.

Implanted device

The HeartCon-type implantable LVAD, manufactured by ROCOR Medical Technology Co., Ltd., Tianjin, China, weighs 180 g and features a magnetic-liquid suspension rotor with a flow rate ranging from 1 to 10 L/min (Figure 1).

Figure 1 Implanted components of HeartCon-type LVAD. (A) Vascular protection frame; (B) ventricular suture ring; (C) HeartCon blood pump. LVAD, left ventricular assist device.

Surgical methods, indications and contraindications

Patients without a history of median thoracotomy routinely underwent median thoracotomy under general anesthesia and cardiopulmonary bypass. The inflow cannula of the HeartCon-type LVAD was inserted into the apical portion of the left ventricle, while the outflow graft was anastomosed to the ascending aorta. For patients with a history of prior median thoracotomy, a left anterolateral thoracotomy was performed, and the outflow graft was anastomosed to the descending aorta (5).

Evaluation of postoperative adverse events

• Pump-related adverse events: (i) failures of sterile implanted components, including pump failure due to thrombosis, pump replacement, and percutaneous lead breakage; (ii) failures of non-sterile active components, such as controller startup errors, monitor malfunctions, and battery output failures.
• Postoperative complications: the statistical data and incidence calculation results of postoperative complications were analyzed using the INTERMACS engine (https://intermacs.kirso.net). The main complications included bleeding, infection, right HF and neurological complications.

Postoperative endpoint events and survival evaluation

The endpoints of this study included postoperative death, HTx, pump removal, pump replacement, and continuous survival with the pump. Survival rates were calculated at 90 days, 6 months, 1 year, and 2 years post-implantation. Survival was defined as patients who were successfully bridged to HTx, weaned from HeartCon due to myocardial recovery and continuously receiving HeartCon support.Survival with the pump at each time point was calculated by excluding those who transited to HTx and successfully weaned from support due to myocardial recovery.

Statistical analysis

Continuous data were expressed as mean ± standard deviation, while categorical data were presented as frequencies or percentages. Paired t-test was used for a within subject comparison of quantitative measurements. Survival data were analyzed by Kaplan-Meier analysis. Differences were considered to be statistically significant at P<0.05, and all statistical analyses were performed using IBM SPSS 24.0 software.

Results

Study cohort

A total of 36 patients were included in this study, comprising 21 males (21/36, 8.3%) aged 49.2±14.8 years, with a body mass index (BMI) of 23.2±4.2 kg/m². The predominant diagnosis was dilated cardiomyopathy (32/36, 88.9%). All patients were classified as New York Heart Association (NYHA) class IV before HeartCon implantations. According to the INTERMACS classification, there were 29 (29/36, 80.6%), 2 (2/36, 5.6%), and 5 (5/36, 13.9%) patients with INTERMACS profiles 2, 3, and 4, respectively. The preoperative data of the patients were shown in Table 1.

Surgery

All cases underwent successful surgery, with 35 patients receiving median thoracotomy and one patient undergoing left anterior external thoracotomy due to a prior history of median thoracotomy for coronary artery bypass grafting. There was 1 case (1/36, 2.8%) of right heart assist device implantation due to severe right HF in the perioperative period, 6 cases (6/36, 16.7%) of mitral valvuloplasty, 32 cases (32/36, 88.9%) of tricuspid valvuloplasty, and 3 cases (3/36, 8.3%) of aortic valve replacement. Left auricle closure was performed in 25 patients (25/36, 69.4%) and 2 patients received left ventricular cryoablation (2/36, 5.6%).

Outcomes

The 90 days, 6 months, 1 year, and 2 years survival rates were 94%, 94%, 91%, and 91%, respectively (Figure 2). At one month postoperatively, the median of left ventricular end-diastolic diameter significantly decreased from 73.3±9.6 mm preoperatively to 57.9±15.4 mm (t=6.267, P<0.01). Additionally, the median of left ventricular ejection fraction (LVEF) improved from 25.2%±6.8% to 34.6%±8.4% (t=−7.311, P<0.01). During the postoperative follow-up period, there were a total of five deaths (5/36, 13.9%), one cardiac transplantation (1/36, 2.8%), two pump removals (2/36, 5.6%) due to myocardial recovery and 28 survivals (28/36, 77.8%) living with the pump. The pump removal times were on the 403 days and the 719 days after the surgery. The time of death for the five patients was 23, 93, 159, 598 and 769 days after the surgery.

Figure 2 Kaplan-Meier survival analysis curve of the 36 patients after HeartCon-type LVAD implantations. CI, confidence interval; LVAD, left ventricular assist device.

Adverse events

Postoperative adverse events including pump-related events and postoperative complications, and the annual frequency of events were shown in Table 2. No failure occurred in the core component of the device. Table 3 showed the reasons for unplanned readmissions. Driveline infection and malignant arrhythmias were the most common causes of unplanned readmissions. Among the 36 HeartCon recipients, 12 cases (12/36, 33.3%) experienced at least one readmission, with two patients readmitted twice and two patients three times. Figure 3 presented the endpoint event follow-up curves.

Figure 3 Competing outcomes analysis.

Discussion

This single-center retrospective study evaluated the efficacy and safety of the HeartCon-type LVAD, an implantable hydrodynamic-magnetically levitated device developed in China, for the treatment of ESHF. HeartCon demonstrated satisfactory performance, with low incidences of pump-related adverse events (2.8%) and high post-implant survival rates of 94%, 94%, 91%, and 91% at 3 months, 6 months, 1 year, and 2 years, respectively, from a numerical perspective, its performance was not inferior to that of other devices (1). Additionally, the annual average frequency of adverse events and the cumulative 2-year mortality rate were low among HeartCon recipients. These findings suggest that HeartCon implantation represents a safe and effective treatment for ESHF patients.

Compared to earlier-generation devices, third-generation LVADs are smaller, easier to implant intrathoracically, and feature an inflow port directly inserted into the left ventricle. Therefore, LVAD implantation in the last decade has been largely dominated by the third-generation CF LVADs.

Since November 2019, four types of third-generation LVAD products have been registered and marketed in mainland China. The HeartCon-type LVAD, a domestically produced device, has demonstrated safety and efficacy in a multi-center clinical trial involving the largest sample size to date. HeartCon-type LVAD adopts a hybrid suspension technique, i.e., passive permanent magnetic levitation and dynamic pressure liquid levitation. A centrifugal pump and a disc motor are integrated in one unit, the dual-redundant motors enable smooth start of the device from either side of the motor, which guarantees normal startup and operation. As a result, no restart failures have ever occurred. The HeartCon-type LVAD minimizes axial stiffness while ensuring radial stiffness, thus increasing the thickness of the dynamic pressure surface and reducing wall shear stress. The outer diameter of HeartCon impeller is 36 mm, larger than that of the HVAD (34 mm), leading to a 15% increase in the liquid float bearing area which consequently increases impeller efficiency and reduces wall shear stress. Furthermore, by using high-precision mechanical polishing technique, the surface smoothness of the impeller is greatly improved. All these help optimize the liquid float bearing surface, thus avoiding hemolysis and improving blood compatibility. The flow channel design avoids blood flow “static zone” and turbulence, which also significantly lowers the risk of blood clots forming. In fact, in vitro platelet activation test of HeartCon proved that platelets are not activated throughout the 6 h testing period.

The large-scale multicenter RCTs such as MOMENTUM 3 (with more than 1,000 patients and long-term follow-up) have demonstrated the outstanding safety and efficacy of HeartMate III in both bridge to transplantation (BTT) and DT indications. In 2017, it was approved for pre-transplantation auxiliary support treatment, and in 2018, it was approved for permanent replacement therapy. HeartMate 3 employs a completely contactless suspension technology. HeartCon utilizes blood or a very thin lubricating fluid layer to provide additional fluid dynamic pressure for stable support. Both perform exceptionally well in terms of blood cell damage, but the principles are slightly different. The size and weight of HeartCon-type LVAD have limited its application potential in patients with small body sizes (especially those with small thoracic cavities or children). In contrast, HeartMate 3 is applicable to a wider range of patients. Therefore, we are currently developing the second-generation small-sized HeartCon-type LVAD, and it is about to be applied in clinical practice.

When comparing the data of this study with other types of LAVD studies worldwide, some differences were found. Our patients were relatively younger, mainly due to the fact that HeartCon-type LVAD is one of the earliest devices on the Chinese market. We first needed to observe its feasibility and safety, so we selected young patients with severe heart diseases but relatively normal organ functions. Secondly, our cohort mainly consisted of patients who had undergone surgery and those awaiting transplantation. The proportion of non-ischemic causes was higher, including 88.9% of dilated cardiomyopathy and 8.3% of other types of heart diseases (such as hypertrophic non-obstructive cardiomyopathy and congenital myocardial hypoplasia, etc.). This is consistent with the higher prevalence of non-ischemic causes in transplant patients in China, as most ischemic cardiomyopathy patients still prefer coronary artery bypass grafting as the treatment of choice. Moreover, due to the fact that this new technology of LVAD is still in the early stage of application in China, most patients have a low acceptance of this new technology, resulting in difficulties in recruitment and a smaller number of included cases than other large international studies.

By the end of our submission, our team has performed or participated in a total of 203 HeartCon-type LVAD implantations in 16 centers in China, including our center, and the multi-center results of a larger sample are worthy of expectation and need to be summarized in the future. Here we also would like to share our initial clinical experience and reflections on some issues through the following aspects.

Among HeartCon recipients, when chest drainage decreased, heparin was used as a “bridge” to reduce activated partial thromboplastin time from 80 to 50–60 s, with the former serving as the conventional standard (6,7). Warfarin is used alongside heparin. As warfarin requires 3 days to reach steady-state plasma levels after oral administration, a loading dose was administered early, either on the day of surgery or the following day after chest drainage reduction, based on the patient’s warfarin metabolism genotype. No aspirin is used. A relatively lower international normalized ratio upper limit of 2.5 was applied to guide warfarin dosage adjustments (8,9). Reducing the intensity of heparin and warfarin anti-coagulation while eliminating aspirin use significantly decreased postoperative bleeding complications without increasing the risk of pump thrombosis. Use of artificial plasma is contraindicated during surgery and in postoperative period because it prolongs clotting time and even causes bleeding. Additionally, excessive intraoperative use of anticoagulants or plasma should be avoided, as it may lead to medical anti-thrombin deficiency and reduce the efficacy of postoperative bridging heparin (10). The advection circulation produced by CF-LVAD results in a “high-quality hypotension” state, a term we coined, which has not been previously reported. We postulate that the loss of blood flow pulsatility during CF-LVAD support compromises physiological regulatory signals that control precapillary resistance vessels and precapillary sphincters, ultimately leading to their dysfunction, allowing blood to flow unrestrictedly into the capillaries. The diameters and flow rates of capillaries increase compared to physiological conditions. Therefore, despite low blood pressure, the total blood volume per unit tissue increases, resulting in higher tissue perfusion quality than under physiological conditions. Based on this understanding, we reduced the maximum mean arterial pressure (MAP) control level in our patients from the generally accepted 80 to 75 mmHg (11,12). Practical experience has demonstrated that even in a 70-year-old HeartCon recipient, maintaining MAP at 70 mmHg does not result in ischemia in major organs such as the brain and kidneys.

The high prevalence of malignant arrhythmias following LVAD implantation is a major cause of rehospitalization within the first two years post-implantation. Ventricular tachycardia (VT) or ventricular fibrillation (VF) occurs in 20–50% of patients with LVAD, significantly increasing the risk of mortality (13,14). VT/VF represents an electrophysiological manifestation of intrinsic myocardial lesions, which may persist in patients surviving with LVAD support. Under continuous circulatory support, VT generally causes only mild increases in venous and right atrial pressures without posing a life-threatening risk. Urgent reversal or ablation is necessary if VT/VF leads to severe hemodynamic instability. Electroversion does not compromise the LVAD device. The AHA recently reported short-term success rates of 77% to 86% for radiofrequency ablation of ventricular arrhythmia (VA), with recurrence rates ranging from 15% to 85% depending on the strategies and approaches used (15). Pump thrombosis may occur following catheter radiofrequency ablation, with higher incidence rates observed when the ablation site is near the apical area around the blood pump inflow tube. For patients with frequent pre-procedural malignant arrhythmias, epicardial or endocardial direct-view cryoablation, or a combination of radiofrequency and cryoablation, may be performed alongside LVAD implantation to prevent post-procedural arrhythmia exacerbation or severe LVAD “wall-sucking” events. According to Topkara et al. from Columbia University Medical Center, fewer than 5% of post-LVAD cardiac recoveries achieve complete bridge-to-recovery (BTR) outcomes (16,17). Although INTERMACS identifies clinical indications for reverse remodeling favorable to BTR—such as younger age, shorter HF duration, and non-ischemic HF—the majority of medical institutions focus solely on using LVADs as BTT or DT, often neglecting the importance of rational medication use, LVAD speed adjustments, and cardiac monitoring to optimize BTR outcomes. It has been proven that cardiac function improves significantly in the early stages of mechanical support, and the rate of successful weaning from the support is as high as 47.5% (19/40) after implementing the above strategies, on the basis of correct indication evaluation. The survival rate following pump removal is 90% at 1 year, 77% at 3 years, 67% at 5 years, and 45% at ten years (18,19). Serial echocardiograms conducted 2–4 weeks postoperatively help identify candidates suitable for BTR (20,21). Maximal cardiac recovery typically occurs 30 days to 6 months post-LVAD implantation (22,23). However, prolonged over-mechanical support could result in myocardial atrophy and calcium cycling abnormalities, leading to irreversible impairment. This view seems to be justified by the principle of “use it or lose it”.

Currently, no literature provides a direct comparison of BTR, BTT, and DT to guide patient stratification and decision-making. In the author’s opinion, BTR is appropriate for ESHF patients with relatively mild myocardial impairment; DT is better suited for those with moderate impairment who can achieve stable circulation under the condition of long-term coexistence of “two hearts”; and BTT is most suitable for patients with severe myocardial impairment whose cardiac function cannot be restored through prolonged LVAD use alone. BTT is also applicable for patients awaiting HTx who require short-term mechanical circulatory support. Given the global shortage of organ donors, particularly in China—where psychological and economic pressures make patients reluctant to undergo reoperation for HTx—it may be appropriate to select patients with INTERMACS class 3–5 for LVAD implantation (24). There are some limitations in this study: first, the sample size of this study is relatively small, which needs to be further expanded; secondly, the observation time is not long enough, and the long-term prognosis of postoperative patient needs to be further observed.

Conclusions

In conclusion, this study demonstrates that HeartCon-type LVAD, a domestically produced implantable LVAD in China, has proven safety and efficacy in treating ESHF. It offers patients a new option for improving quality of life, successfully bridging to HTx, and achieving potential long-term survival. We also hope that our summarized clinical experience and reflections can serve as a valuable reference for international peers.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-810/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-810/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-810/prf

Funding: This study was supported by the Tianjin Key Medical Discipline Construction Project (grant No. TJYXZDXK-3-036C).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-810/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of TEDA International Cardiovascular Hospital (No. 2025-0327-1), and informed consent was taken from all the patients.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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