Latest news with #leadlesspacemaker
Medscape
25-06-2025
- Health
- Medscape
NICE Backs Leadless Pacemakers for Some Heart Patients
The National Institute for Health and Care Excellence (NICE) has provisionally recommended leadless cardiac pacemaker implantation for patients with bradyarrhythmias who require single-chamber pacing. In draft guidance, NICE said there was insufficient evidence to support their use for dual-chamber pacing outside of research settings. Benefits Over Traditional Pacemakers The recommendation is based on an evidence review involving over one million patients across multiple studies. These included a randomised controlled trial, four systematic reviews with meta-analyses, five registry studies, four prospective studies, and two retrospective studies. Leadless pacemakers were found to be effective at detecting abnormal heart rhythms, restoring normal pacing, and improving quality of life. Unlike conventional transvenous pacemakers (TVPs), they do not require a chest incision, reducing the risk of infection and other complications, the regulator noted. 'The evidence demonstrates that leadless pacemakers can effectively regulate heart rhythm while reducing the risk of complications associated with traditional pacemakers, particularly infections and lead-related issues,' said Dr Anastasia Chalkidou, HealthTech programme director at NICE. How Leadless Pacemakers Work Bradyarrhythmias, which affect around 1 in 1000 people are typically treated with TVPs. These devices consist of a subcutaneous pacemaker box and leads that connect to the heart. For single-chamber leadless pacemakers, the proximal end is attached to a deflectable delivery catheter system. It is usually inserted percutaneously through the femoral or jugular vein using an introducer sheath. It is then moved into the right atrium, through the tricuspid valve, and into the right ventricle. Dual-chamber systems, which are still under evaluation, involve placing two devices — one in the right atrium and another in the right ventricle — during a single procedure. NICE highlighted that TVPs are known to carry risks, including lead failure and generator-related complications. Leadless pacemaker implantation may be preferable for patients with a history of device infection, endocarditis, immunosuppression, limited vascular access, or high infection risk. Call for Further Research While the draft guidance supports leadless pacemakers for single-chamber pacing, NICE said that more evidence is needed before endorsing their wider use. This includes research on patient selection — such as age, comorbidities, and the underlying cause of bradyarrhythmia — as well as data on implantation sites and clinical outcomes. Long-term durability of leadless devices also remains an area for investigation. 'The incidence of bradyarrhythmias increases with age, making this guidance particularly relevant to our ageing population,' said Professor Tom Clutton-Brock, chair of NICE's interventional procedures advisory committee. The draft guidance is open for public consultation until 23 July 2025. The advisory committee will meet again on 11 September 2025 to review feedback and finalise recommendations.
Free Malaysia Today
05-06-2025
- Business
- Free Malaysia Today
IJN successfully implants dual-chamber leadless pacemaker, a first in Southeast Asia
Senior consultant cardiologist Dr Azlan Hussin (left), IJN CEO Dr Ezani Taib (right) and chief clinical officer Dr Shaiful Azmi Yahya holding the dual-chamber leadless pacemaker device at the press conference today. (Bernama pic) PETALING JAYA : The National Heart Institute (IJN) today announced it has successfully implanted the world's first dual-chamber leadless pacemaker system, the Abbott AVEIR™ DR, on several of its patients. Senior consultant cardiologist and interventional electrophysiology & implantable devices clinical director Dr Azlan Hussin said it was also a historic achievement as IJN is the first hospital in Southeast Asia to carry out the procedure. At a press conference today, he said this major achievement reflects IJN's commitment to setting new standards in cardiac care. 'This groundbreaking dual-chamber leadless pacemaker will revolutionise care for our current patients and create a significant opportunity to expand the number of people we can serve, including children. 'By eliminating traditional wires (leads) and surgical pockets, this leadless system significantly reduces the risk of complications such as infections, lead dislodgement, or vessel occlusion,' Azlan said. He added that 18 patients have received the new device, with the first procedure carried out on May 27. According to Azlan, this milestone also builds on IJN's decade-long experience with leadless pacemaker technology, during which nearly 900 patients have undergone procedures involving wireless pacemakers. He said the long-term complication rate is typically 1-2%, comparable to and, in some cases, lower than that of conventional pacemakers. Azlan said the AVEIR™ DR system offers a range of potential benefits, including a shorter procedure time of about 20 minutes to one hour, depending on the patient's heart condition. 'The system also provides real-time pacing analysis, enabling physicians to confirm accurate device placement during the procedure before the final implantation into the heart chamber,' he said. IJN CEO Dr Ezani Taib told reporters the new procedure comes with a slight increase in cost, but that it was normal with any new technology. 'As with any new technology, the initial cost is slightly higher. However, in general, IJN's charges are significantly lower than those at most private hospitals,' he said. When asked if other hospitals in the country could also perform the procedure, Ezani explained that IJN had both the right expertise and infrastructure to offer the service. 'People need to understand this is not just about business. It's about having the clinical expertise, advanced technology, and the right facilities. 'At IJN, innovation isn't just about introducing new technology, it's about creating real, meaningful impact. The AVEIR™ DR implantation marks a leap forward in cardiac care and reinforces our role as a regional leader,' he said. Ezani also emphasised the importance of awareness and early intervention in addressing cardiovascular disease, which remains a significant health challenge in Malaysia. The AVEIR™ DR system, designed for patients with slow or irregular heart rhythms, marks a major breakthrough in cardiac pacing. Unlike traditional pacemakers, the AVEIR™ DR system consists of two miniaturised devices, each one-tenth the size of conventional models, implanted directly into the heart's right atrium and ventricle. The AVEIR™ DR system consists of two miniaturised devices that are implanted directly into the heart's right atrium and ventricle. (Bernama pic) As the world's first dual-chamber leadless pacemaker, it provides synchronised, beat-to-beat pacing without the risks associated with leads. The system features a minimally invasive design, long-term retrievability, and future-ready adaptability. In 2018, IJN made history as the first hospital outside the US to implant the world's smallest pacemaker, the Micra AV.
Malay Mail
05-06-2025
- Business
- Malay Mail
IJN makes history as first in SE Asia to implant dual-chamber wireless pacemaker
KUALA LUMPUR, June 5 — The National Heart Institute (IJN) has made medical history by becoming the first centre in South-east Asia to successfully implant the world's first dual-chamber leadless pacemaker system, the Abbott AVEIR™ DR. Senior consultant cardiologist and Interventional Electrophysiology & Implantable Devices clinical director Datuk Dr Azlan Hussin said the achievement reflects IJN's commitment to setting new standards in cardiac care both in Malaysia and the region. 'This groundbreaking dual-chamber leadless pacemaker will revolutionise care for our current patients and create a significant opportunity to expand the number of people we can serve, including children. 'By eliminating traditional wires (leads) and surgical pockets, this leadless system significantly reduces the risk of complications such as infections, lead dislodgement, or vessel occlusion,' he said at a press conference at IJN today. He noted that the long-term complication rate is typically between one and two per cent, comparable to, and in some cases lower than, that of conventional pacemakers. To date, 18 patients have received the new device, with the first implantation conducted on May 27. This milestone builds on IJN's decade-long experience with leadless pacemaker technology, during which nearly 900 patients have undergone procedures involving wireless pacemakers. IJN chief clinical officer, Datuk Dr Shaiful Azmi Yahya (centre), presenting the first leadless dual-chamber pacemaker implant in Southeast Asia after a press conference at IJN today. — Bernama pic Dr Azlan said the AVEIR™ DR system offers a range of potential benefits, including a shorter procedure time typically between 20 minutes to one hour, depending on the patient's heart condition. 'The system also provides real-time pacing analysis, enabling physicians to confirm accurate device placement during the procedure before the final implantation into the heart chamber,' he said. IJN chief executive officer Prof Datuk Seri Dr Mohamed Ezani Md Taib said the initial cost of the procedure is slightly higher due to the new technology. 'As with any new technology, the initial cost is slightly higher. However, in general, IJN's charges are significantly lower than those at most private hospitals,' he said. On whether other hospitals in Malaysia could adopt the procedure, Dr Mohamed Ezani said it's not just about offering a service, it's about having the right expertise and infrastructure. 'People need to understand that this is not just about business. It's about having the clinical expertise, advanced technology, and the right facilities, something IJN is proud to offer.' 'At IJN, innovation isn't just about introducing new technology, it's about creating real, meaningful impact. The AVEIR™ DR implantation marks a leap forward in cardiac care and reinforces our role as a regional leader,' he said. He also emphasised the importance of awareness and early intervention in addressing cardiovascular disease, which remains a significant health challenge in Malaysia. The AVEIR™ DR system, designed for patients with slow or irregular heart rhythms, marks a major breakthrough in cardiac pacing. Unlike traditional pacemakers, it consists of two miniaturised devices, each one-tenth the size of conventional models, implanted directly into the heart's right atrium and ventricle. As the world's first dual-chamber leadless pacemaker, it provides synchronised, beat-to-beat pacing without the risks associated with leads. The system features a minimally invasive design, long-term retrievability, and future-ready adaptability. In 2018, IJN made history as the first hospital outside the United States to implant the world's smallest pacemaker, the Micra AV. — Bernama KUALA LUMPUR, June 5 — The National Heart Institute (IJN) has made medical history by becoming the first centre in South-east Asia to successfully implant the world's first dual-chamber leadless pacemaker system, the Abbott AVEIR™ DR. Senior consultant cardiologist and Interventional Electrophysiology & Implantable Devices clinical director Datuk Dr Azlan Hussin said the achievement reflects IJN's commitment to setting new standards in cardiac care both in Malaysia and the region. 'This groundbreaking dual-chamber leadless pacemaker will revolutionise care for our current patients and create a significant opportunity to expand the number of people we can serve, including children. 'By eliminating traditional wires (leads) and surgical pockets, this leadless system significantly reduces the risk of complications such as infections, lead dislodgement, or vessel occlusion,' he said at a press conference at IJN today. He noted that the long-term complication rate is typically between one and two per cent, comparable to, and in some cases lower than, that of conventional pacemakers. To date, 18 patients have received the new device, with the first implantation conducted on May 27. This milestone builds on IJN's decade-long experience with leadless pacemaker technology, during which nearly 900 patients have undergone procedures involving wireless pacemakers. Dr Azlan said the AVEIR™ DR system offers a range of potential benefits, including a shorter procedure time typically between 20 minutes to one hour, depending on the patient's heart condition. 'The system also provides real-time pacing analysis, enabling physicians to confirm accurate device placement during the procedure before the final implantation into the heart chamber,' he said. IJN chief executive officer Prof Datuk Seri Dr Mohamed Ezani Md Taib said the initial cost of the procedure is slightly higher due to the new technology. 'As with any new technology, the initial cost is slightly higher. However, in general, IJN's charges are significantly lower than those at most private hospitals,' he said. On whether other hospitals in Malaysia could adopt the procedure, Dr Mohamed Ezani said it's not just about offering a service, it's about having the right expertise and infrastructure. 'People need to understand that this is not just about business. It's about having the clinical expertise, advanced technology, and the right facilities, something IJN is proud to offer.' 'At IJN, innovation isn't just about introducing new technology, it's about creating real, meaningful impact. The AVEIR™ DR implantation marks a leap forward in cardiac care and reinforces our role as a regional leader,' he said. He also emphasised the importance of awareness and early intervention in addressing cardiovascular disease, which remains a significant health challenge in Malaysia. The AVEIR™ DR system, designed for patients with slow or irregular heart rhythms, marks a major breakthrough in cardiac pacing. Unlike traditional pacemakers, it consists of two miniaturised devices, each one-tenth the size of conventional models, implanted directly into the heart's right atrium and ventricle. As the world's first dual-chamber leadless pacemaker, it provides synchronised, beat-to-beat pacing without the risks associated with leads. The system features a minimally invasive design, long-term retrievability, and future-ready adaptability. In 2018, IJN made history as the first hospital outside the United States to implant the world's smallest pacemaker, the Micra AV. — Bernama
