The Role of Customizable Stent Grafts for Treating Complex Anatomies

Dharampal S Rawat, Senior Director – Cardiovascular, Terumo Aortic and Life Care Solutions in a recent interaction with India Pharma Outlook magazine shared his views on how advancements in endovascular grafts are addressing complex anatomical variations for high-risk patients, innovative solutions in cardiac surgery, such as the endovascular vessel harvester, are transforming bypass procedures and more.

Dharampal is an experienced Business leader with over 25 years of working in the medical device industry. He has a strong background in Sales & Marketing Management, P&L Business Planning, and Market Research. Dharampal has held senior roles across leading companies including Terumo India, Meril Life Sciences, Medtronic, and Abbott Vascular. He has been recognized for his achievements in business development and leadership.

Customizable stent grafts are tailored to match individual anatomies, especially in aortic conditions involving aneurysms and dissection. How are advancements in these grafts addressing complex anatomical variations for high-risk patients?

Customized stent grafts, are grafts made as per the anatomy of a specific patient. It is more like a prescribed graft and not a graft which is readily available on the shelf. There is a process to the whole exercise of delivering a customized graft. The steps begin from the doctor sending us the 3D CT images of the aorta of the patient. After, post-evaluation of the aorta, a certain design of the graft is finalized in consultation with the doctor, and the graft is made from end-to-end as a new product. Therefore, it is a dedicated graft for that particular patient, and it can only be used for him/her since it has been designed according to the anatomical challenges of that patient. Today, this is a technology which is evolving much faster globally as well, and Terumo Aortic is one of the leaders in custom grafts because we are committed to delivering the best solutions to meet the needs of all the patients who need aortic repair.

Today, these grafts are highly specialized and require a specific skill set for proper deployment. While not every doctor is trained in this technique, our organization goes beyond providing custom grafts for patients. We also offer comprehensive training and support to ensure the graft is deployed optimally, leading to the best possible outcomes for high-risk patients. These patients are high-risk and not suitable candidates for open surgery, which is usually the other option for treating the aortic disease. Hence, sometimes this is the only solution for the patient.

Innovative solutions in cardiac surgery, such as the endovascular vessel harvester, are transforming bypass procedures. How has this product improved patient outcomes and surgical efficiency in India?

One of Terumo Cardiovascular’s most innovative products is endovascular vessel harvester (EVH). In simple language, EVH is a device that supports surgeons in extracting veins for bypass surgery. Today, if a patient is undergoing bypass surgery, grafts are used to bypass the blood flow. A graft is nothing but a vein that is extracted surgically, either from the legs or from the radial arms of the patient. Surgically means the whole leg is almost cut open to extract the vein.

Now, this vein is used to bypass the arteries of the heart. However, there are two major challenges – firstly, it is a larger procedure and secondly, it impacts the patient's cosmetic looks after some time.

It is deployed through a comprehensive research and refinement process for consistent and successful saphenous vein and radial artery harvesting for coronary artery bypass grafting (CABG) procedures and peripheral artery bypass grafting.

This is where EVH comes into play. EVH helps in implementing a minor incision into the limb, through which the doctors can extract the vein effortlessly, without creating any trauma or cut on the patient's limbs. This is a crucial consideration, especially when young patients or female patients undergo bypass surgery. These patients will have to live with the long-term impact of a large scar on their legs or arms, which can be both physically and emotionally significant. However, with EVH, such visible scars can be completely avoided, offering a more cosmetically appealing and less traumatic option.

Thus, it is a procedure which helps you take out the best outcome with a minimum incision made to the patient. And this is helping doctors today in several ways. It not only helps doctors perform procedures with greater precision, leading to higher patient satisfaction, but it also significantly reduces the case turnaround time, making the process more efficient overall.

Terumo’s EVH is designed for safe, efficient and successful vessel harvesting. Therefore, the patient has to invest less time in the OR than the patient used to invest earlier. This is a technology which was introduced last year in India. It is gaining momentum and we are seeing numerous hospitals adopting the technology for their patients.

Endovascular grafts deployed through femoral artery represent minimally invasive alternative for treating aortic diseases. How do these devices compare to traditional surgical approaches in terms of recovery time and complication rates?

As we treat an increasing number of patients, we witness significant technological advancements compared to the era of open surgery, where patients were extensively incised, and grafts were manually stitched and operated on by cardiac surgeons. This approach was not only time-consuming and required a high level of skill, but it was also highly traumatic for the patients. The treatment for aneurysms and dissection is moving too quickly towards adopting a very high percentage of endovascular treatment.

This means through a percutaneous way of deploying the grafts in the disease segment of the aorta. These procedures are smaller and not time-consuming. They are much quicker and just through a small incision in the groin or in the femoral artery, the whole graft can be deployed at the disease portion, whether it is on the thoracic part or whether it is the abdominal part of the aorta. Now, this is a great leap of technology as here the patient is quickly discharged sometimes within 48 hours), whereas an open surgery patient may have to be admitted in the hospital for a week. Endovascular grafts represent a significant advancement in medical technology, allowing for quicker treatment of patients, with a learning curve that is gradually being overcome. As the Indian cardiovascular market continues to grow, the expertise of our doctors, particularly vascular surgeons performing procedures through the femoral approach, is advancing rapidly.

Access to cutting-edge cardiovascular solutions is vital for improving outcomes in resource-limited settings. What specific challenges have businesses encountered in expanding the reach of cardiovascular and Terumo Aortic portfolios, and how are businesses overcoming them?

In high-technology continuously evolving products, the primary challenge is the training and learning curve for operators. This is an issue that every company introducing advanced technology faces, due to the limited availability of training resources, learning opportunities, and hands-on experience. However, addressing this challenge is essential for the successful adoption of any technology.

Launched in 2018, the Terumo India Skill Lab (TISL) is a pioneering initiative that offers simulation-based learning. This approach ensures healthcare professionals are able continuously learn and upskill in a setting that suits their busy schedules. By combining live events, digital colloquium, patient resources and medical education, Terumo India is addressing the skills gap while improving healthcare delivery and patient outcomes across the country.

The other limiting factor includes the self-pay-dominated market of India. Lastly, since these technologies are high-end, it is expensive to build these technologies.