Tee Labs Incubatee: HeartHill Successfully Completes China’s Longest pVAD Animal Study

In mid-June 2022, China successfully conducted a long-term animal study of a percutaneous ventricular assist device (pVAD). The animal study, which involved the pVAD running continuously for 10 days (with a designed duration of 5 days), has now been successfully completed. This achievement validates the long-term operational safety, reliability, and effectiveness of this pVAD product within the body. Furthermore, all experimental results from this animal study met and even exceeded the expected targets.

这是国内首例公开报道的经导管心室辅助装置（pVAD）的长期动物试验，且本次用于动物试验的pVAD产品由国产创新企业心岭迈德自主研发。

This marks the first publicly reported long-term animal study of a percutaneous ventricular assist device (pVAD) in China, and the pVAD product used in this study was independently developed by the innovative domestic company,HeartHill .

According to available information, a pVAD is a small blood pump that can be inserted into a ventricle via a minimally invasive interventional approach. It can partially or fully replace the heart’s pumping function, thereby maintaining blood circulation in the human body. pVAD products can be used for indications such as cardiogenic shock, high-risk PCI (percutaneous coronary intervention) protection, and heart failure, helping to increase the survival rate of relevant patients.

The success of this animal study not only signifies that China’s domestically developed, original pVAD is one step closer to clinical application but also represents another leap forward for China’s medical device industry in the innovation of high-end medical devices.

Long-Term Safe Operation, pVAD’s Reliability and Effectiveness Validated

According to reports, the indication for this animal study of pVAD product from HeartHill was cardiogenic shock. The study was designed for a duration of 5 days with the aim of verifying the long-term operational safety, reliability, and effectiveness of the product within a living body.

HeartHill stated: “In the animal study, a trained animal surgeon completed the correct placement of the pVAD from the vascular access point, across the aortic valve, and into the left ventricle in just 5 minutes. Post-operatively, the animal recovered well, with stable vital signs and normal indicators. Subsequently, the pVAD product operated within the test animal for double the designed duration (i.e., 10 days). This provided support for observing various data indicators of the pVAD in vivo and also afforded the pVAD with a sufficient design margin.”

The trial results showed: First, the pVAD product began working immediately after being placed in the target position within the animal’s body, providing 4-5 liters of blood flow per minute and effectively reducing cardiac preload. Second, the pVAD product operated safely and effectively within the animal for 10 days, with excellent results from hemolysis testing. Third, the pVAD has a short learning curve; it can be operated smoothly after simple training, greatly reducing the surgical time.

Reportedly, pVAD products mainly follow two technical routes: one with an internal motor and one with an external motor. The pVAD product used in this animal study employs the internal motor technical route.

From a principle standpoint, pVAD products with an internal motor have a shorter transmission distance and less vibration. This results in less damage to the myocardium and heart valves, more stable fluid dynamics, less turbulence, and a lower risk of damage to blood cells, hemolysis, and tissue injury. This makes it more suitable for stable long-term operation within the body.

In fact, the domestic market already has surgical heart pumps for diseases like heart failure. However, these products are designed for surgery, requiring open-chest placement, which is highly invasive and demands significant surgical experience and advanced medical facilities. Currently, only top-tier tertiary hospitals in first-tier cities perform surgical heart pump implantations.

Compared to surgical heart pumps, pVAD products are placed via percutaneous puncture or vascular incision, resulting in less trauma, faster patient recovery, and a shorter learning curve for the operator. For example, the animal surgeon who performed this experimental surgery was able to conduct the procedure independently after receiving training in January 2022. The placement of the pVAD in this surgery took only about 5 minutes, with simple and quick operation.

It should be noted that the aforementioned advantages of the pVAD product are due to its smaller size. To provide 4-5 liters of blood flow per minute with a smaller size, the pVAD product’s rotational speed must be extremely high, reaching tens of thousands of revolutions per minute. Furthermore, to operate continuously for 10 days inside an animal, the pVAD product must maintain stable rotation for hundreds of millions of cycles.

Stable operation for hundreds of millions, billions, and even hundreds of billions of cycles places higher demands on the technology related to pVAD component wear and electrode sealing. This is also one of the major challenges in the R&D of percutaneous ventricular assist devices.

However, as of now, HeartHill has successfully completed the independent R&D of the core components of its pVAD product and has achieved good results in this animal study. In this experiment, the HeartHill team and the animal study center have accumulated valuable experience in post-operative care. In the next steps, HeartHill will continue to challenge the safe and stable operation of its pVAD product in vivo for 15, 20, and 30 days.

Unmet Clinical Needs, Patients in Urgent Need of pVAD

The percutaneous ventricular assist device, pVAD, targets diseases with extremely high mortality rates for which there is currently a lack of effective clinical solutions. Besides cardiogenic shock, the indications for HeartHill’s pVAD also include high-risk PCI and heart failure. Currently, HeartHill’s pVAD products for high-risk PCI, cardiogenic shock, and heart failure have all entered the type-testing phase and are expected to begin First-in-Man (FIM) studies soon.

Currently, the annual volume of PCI procedures in China exceeds 1.2 million, of which approximately 30% are high-risk PCI, meaning at least 380,000 high-risk PCI patients each year. In a broader sense, high-risk PCI patients should be considered based on the complexity of their lesions, hemodynamic and anatomical features, and other comorbid underlying diseases. This should also include patients who cannot tolerate surgery, those who have had a post-CABG (Coronary Artery Bypass Grafting) procedure, or those who refuse surgery.

For high-risk PCI patients, revascularization can significantly improve their quality of life and reduce the risk of cardiovascular events. The use of appropriate mechanical circulatory support devices is recommended by guidelines and expert consensus. pVAD products can increase the patient’s aortic pressure, enhance coronary perfusion, reduce myocardial oxygen consumption, lessen the left ventricular burden, and improve left ventricular function, ultimately ensuring the safety of the PCI procedure.

As another indication for pVAD, cardiogenic shock is a clinical syndrome caused by heart pump failure, leading to insufficient cardiac output and tissue hypoperfusion, which in turn causes further systemic circulatory impairment. It has an extremely high mortality rate. Currently, there are over 300,000 cardiogenic shock patients in China.

In the past, treatment options for cardiogenic shock included drug therapy, mechanical ventilation, IABP (Intra-Aortic Balloon Pump), and VA-ECMO (Veno-Arterial Extracorporeal Membrane Oxygenation). However, drug therapy and mechanical ventilation are not curative methods. IABP provides limited coronary blood flow and has recently been downgraded to a Class III recommendation by the European Society of Cardiology (ESC). ECMO is complex to use, has high surgical risks, and is only used as a cardiac pump support device in a few hospitals in China.

Today, pVAD, as a minimally invasive interventional product that is less traumatic and clinically effective, is recommended by consensus and guidelines from several countries and regions. For example, the “2018 Chinese Expert Consensus on the Diagnosis and Treatment of Cardiogenic Shock” states that for hemodynamically unstable cardiogenic shock patients, rapid insertion of a mechanical assist device should be considered, and hospitals with the necessary resources may consider inserting a percutaneous left ventricular assist device.

Furthermore, pVAD is also aimed at heart failure, a disease known as the final battlefield in the cardiovascular field. The latest “Report on Cardiovascular Health and Diseases in China 2021” shows that the current number of cardiovascular disease patients in China is 330 million, among whom 8.9 million are heart failure patients.

Currently, the common treatment for heart failure patients is surgical intervention, but it is high-risk, highly invasive, and has high medical costs. pVAD products, on the other hand, are safe and easy to operate, less likely to cause thrombosis or bleeding, and are poised to become a new weapon in the treatment of heart failure, extending the lives of these patients.

In summary, high-risk PCI, cardiogenic shock, and heart failure are all diseases that are currently not well-managed clinically or present numerous pain points in clinical practice. The emergence of pVAD will provide a new option for these patients, potentially becoming a new source of hope. The success of this animal study brings these patients one step closer to that hope.