University of Fukui

APHRS: New data confirm robust long-term durability and highly efficient procedure performed without fluoroscopy Successful launch in Japan follows recent reimbursement approval Approvals across APAC including China and Australia broaden reach for patients GALWAY, Ireland and SYDNEY, Sept. 27, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the presentation of clinical study results demonstrating a high rate of durable lesion formation for the PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). Invasive remapping conducted approximately two months post-ablation with the PulseSelect PFA System demonstrated durable isolation in 98% of pulmonary veins (PV) and 96% of patients had all veins isolated. Results were presented as a late breaking clinical trial at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia. "Real-world evidence on chronic lesion formation and durability is critical as use of PFA for the treatment of Afib rapidly increases, making these results impactful and timely for the electrophysiology community," said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard's Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas. "Our research shows that treatment with PulseSelect results in durable lesion formation, which is the cornerstone of successful pulmonary vein isolation and an important addition to previous evidence establishing the safety and effectiveness of this technology." About the Study A total of 25 AFib patients with persistent or paroxysmal AFib (56% paroxysmal, 52% male, 69±9 years) undergoing pulmonary vein isolation (PVI) with the PulseSelect PFA System were evaluated. Invasive remapping conducted in all patients (57±9 days post-ablation) demonstrated durable isolation in 98% of PVs (102/104), and 96% of patients (24/25) had all veins isolated. All index ablation procedures were conducted using intracardiac echocardiography and electroanatomical mapping (EAM) without fluoroscopy. General anesthesia was used in 24 of 25 patients, and all patients were discharged on the same day. Average skin-to-skin procedure time was 36 minutes. Acute PV isolation was achieved in 100% of patients. There were no complications during an average follow-up of 74 days. PulseSelect Global Expansion Broad adoption of PulseSelect continues globally, with more than 10,000 cases performed worldwide. In the Asia Pacific (APAC) region, milestones include regulatory approvals in China and Australia and launch in Japan following reimbursement approval. Prof. Hiroshi Tada, Professor of the Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan, and President of the Japanese Heart Rhythm Society, said "PulseSelect is the first PFA catheter to receive reimbursement approval in Japan based on clinical trial results that include Japanese patients. We believe that the future widespread availability of this breakthrough technology under insurance coverage will be of great significance in the history of arrhythmia treatment in Japan." "These important results clearly address the durability question and add to the real-world evidence for PulseSelect," said Rebecca Seidel, president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "With expansion in new markets across the Asia Pacific region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with AFib." AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases.2-5 For more information on PulseSelect, visit Medtronic.com. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. References Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126. 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Scientists have investigated lamprey embryos using cutting-edge microscopic techniques to reveal interesting insights about vertebrate head evolution, clarifying an unresolved mystery in basic science. Since the 18th century, several theories regarding the origin of the vertebrate head have been proposed. However, owing to the lack of molecular and morphological studies, the question of whether the vertebrate head evolved as a modified embryonic segment or originated as an independent unsegmented head remains unanswered. Now, scientists from Japan have investigated lamprey embryos using cutting-edge microscopic techniques to reveal interesting insights about vertebrate head evolution, clarifying an unresolved mystery in basic science. The origin of the vertebrate skull is a topic of much debate among evolutionary biologists. Some believe that the vertebrate head has developed as a result of modification of the segmental elements of the trunk, such as the vertebrae and somites. On the other hand, others believe that the vertebrate head has evolved as a new, unsegment body part, unrelated to other widely observed embryonic segments somites. Interestingly, previous studies on embryos have revealed the presence of some vestiges of somites in the head mesoderm (e.g., head cavities and somitomeres). However, homology between trunk somites and such head segments has been controversial. The failure to understand the evolutionary origins of the vertebrate head is also attributable to the lack of studies on extant species such as lampreys, which are known to share several traits with fossil jawless vertebrates and retain primitive traits related to the head mesoderm. While some studies have focused on the embryonic morphology of lampreys, they have often fallen short because of challenges like tissue destruction and acidic fixation during examination, making it difficult to observe the formation of head mesoderm and trunk somites. Now, however, a research team led by Assistant Professor Takayuki Onai from the University of Fukui, Japan, has utilized advanced techniques like transmission electron microscopy and serial block-face scanning electron microscopy (SBF-SEM) to understand the development of the head mesoderm and somites in lamprey embryos. The researchers also analyzed the morphology and gene expression patterns of cephalochordate and hemichordate (both being invertebrates) to understand the origins of somites and head mesoderm from an evolutionary perspective. This paper was made available online in iScience on November 13, 2023, and is co-authored by Dr. Noritaka Adachi from Aix-Marseille Université, Dr. Hidetoshi Urakubo from the National Institute for Physiological Sciences (NIPS), Dr. Fumiaki Sugahara from Hyogo Medical University, Dr. Toshihiro Aramaki from Osaka University, Dr. Mami Matsumoto from NIPS and Nagoya City University, and Dr. Nobuhiko Ohno from NIPS and Jichi Medical University. To clarify the presence or absence of somites in the head mesoderm during early stages of diversification, the researchers focused on rosettes, which are major somite patterns and are important for the subsequent development of vertebrae. Their initial observations of lamprey embryos showed that the tissue closely related to the formation of facial muscles and other elements of the skull, known as the head mesoderm, did have cell clusters with features similar to somite rosettes. To clarify if these cell clusters were indeed rosettes, they conducted ultrastructural experiments, including the SBF-SEM and gene expression analysis. This examination of the cellular morphology and gene expression revealed that the cell clusters were clearly distinct from rosettes. "The cell clusters we observed are likely lamprey-specific features, as they are not recognizable in the head mesoderm of both hagfish and shark embryos," explains Dr. Onai. Furthermore, gene expression analysis also revealed the absence of segmental expression of somitogenesis-related genes, indicating their distinctiveness from somites. These findings indicate that the rosette pattern typically seen in somites is not necessarily the essential or most basic feature that defines the process of bodily segmentation. Moreover, the experiments provide evidence that the vertebrate head mesoderm diverged during the early phases of vertebrate evolution. Furthermore, comparison of embryos of hemichordates (a basal deuterostome), amphioxus (a basal chordate), and vertebrates revealed that the somites likely arose from the "endomesoderm" tissue of an ancient deuterostome ancestor. The evolutionary origin of somites has been the central question in zoology for more than 150 years, and in this study, Onai et al., revealed the enigma. Regarding the evolutionary mechanism for the emergence of head mesoderm, they found that the head mesoderm emerged upon the segregation of mesodermal genes between the front and back parts (rostro-caudal axis) of organisms. "Taken together, our findings revealed a different evolutionary origin for the vertebrate head mesoderm, suggesting that it evolved from the repatterning of an ancient mesoderm and diversified even before the emergence of jawed vertebrates," concludes Dr. Onai. In summary, the finding that the cell clusters present in the head mesoderm are distinct morphologically and molecularly from somites, favors a new model where the vertebrate head mesoderm diverged during early evolution. This sheds more light on the age-old debate on the evolution of the vertebrate head and can help us advance the understanding of our own origins.