National Heart Institute (IJN) introduces Evolut FX device to treat aortic stenosisJuly 23, 2024
The National Heart Institute or better known as Institut Jantung Negara (IJN) recently made history by being the first hospital in Malaysia to introduce the Evolut™ FX device, the latest innovation in treating aortic stenosis. The device promises to be especially useful for addressing the needs of patients with small aortic annulus, particularly in smaller-built Asian patients and in women.
Developed by global medical device company Medtronic, the Evolut™ FX is the latest device of its kind and specifically designed to be used for transcatheter aortic valve implantation (TAVI). TAVI is a relatively new and minimally invasive alternative to open-heart surgery for treating aortic stenosis, where the new valve is guided to the heart via a catheter. Designed with patient safety and efficacy in mind, a stand-out feature of the Evolut FX is its three radiopaque markers, which help doctors better ensure that the valve is properly implanted. A special showcase of the procedure was carried out on 22 July by the institute's Cardiology Department head and senior consultant cardiologist Datuk Dr Shaiful Azmi Yahaya at the center's newly upgraded hybrid operating theatre. Also in attendance was Health Minister Datuk Seri Dr Dzulkefly Ahmad. The device was first successfully implanted in two patients on May 7 by a team led by Dr Shaiful Azmi, alongside interventional cardiologist Yohei Ohno of Tokai University Hospital, Japan. Both patients are currently recovering well. Aortic stenosis occurs when the aortic valve narrows, disrupting blood flow from the heart to the rest of the body. Current research shows that the condition impacts women differently from men, with women being less likely to receive timely treatment. Additionally, data from surgical reports indicate that as many as 44% of patients have a small aortic annulus, the ring-shaped structure where the aortic valve meets the heart’s left ventricle. Recognizing this disparity, and the fact that women are often underrepresented in clinical trials, Medtronic funded a multicenter, randomized controlled trial to understand how valve design can help patients with small annuli. The study, called the SMART Trial, is the largest of its kind to primarily enroll women. The first-year results of the trials were published in the New England Journal of Medicine in April 2024, and showed that the Evolut FX device improved outcomes for patients with a small annulus. “IJN was the first in Asia to carry out TAVI in 2009, and we’re always eager to keep pushing the envelope of what’s possible,” said IJN chief executive officer Datuk Dr Aizai Azan Abdul Rahim. “We’re pleased to introduce this new device, as it enables us to better tailor treatment plans based on patients’ unique needs.” Additionally, IJN also unveiled its upgraded hybrid operating theatre, which combines the capabilities of a traditional operating room with advanced imaging technology for more precise visualization during complex procedures. This enables surgeons to a wide range of minimally invasive and open surgical procedures within a single, integrated environment. Meeting the standards of the most advanced facilities in Europe, the upgraded theatre is equipped with state-of-the-art imaging systems including a co-registration of its high-resolution 3D transoesophageal echo imaging and its real-time fluoroscopy. A key benefit of the new hybrid operating theatre is that it enables specialists of various disciplines to seamlessly work together and switch between surgical procedures all in one place. “In the past, patients with complex heart conditions may have to undergo multiple surgeries and repeated hospital visits. With advanced imaging systems and tools all in one place, this new theatre helps us be more surgically precise and opt for minimally invasive approaches where possible,” explained Dr Aizai Azan. He added that as patients do not need to be transported to different sites for different procedures, the risk of infection is also minimized. “Furthermore, this new hybrid facility allows us to free up more labs and operating theatres, so that we can handle an increased caseload. We hope to leverage this state-of-the-art facility to further expand our range of services,” he said. EXPLORE FURTHER |
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