Latest news with #atrialFibrillation
Medscape
5 days ago
- Health
- Medscape
Evidence-Based Guidelines Issued for LAAO Devices
Created to address the 'uncertainty and practice variation' that surrounds transcatheter left atrial appendage occlusion (LAAO), the Society for Cardiovascular Angiography and Interventions and the Heart Rhythm Society have published jointly the first set of guidelines for the use of the procedure. 'There is tremendous diversity in left atrial appendage occlusion practice regarding appropriate patients, periprocedural imaging, adjunctive medical therapy, and management of device leak and device-related thrombus,' said Andrew M. Goldsweig, MD, MS, director of cardiovascular clinical research at the University of Massachusetts-Baystate, in Springfield, Massachusetts, who led the group that wrote the recommendations. Nonvalvular atrial fibrillation (AF) is a major risk factor for stroke, and it is a condition that affects at least 12 million individuals in the US, according to data cited in the new guidelines. Oral anticoagulation is a first-line strategy for reducing stroke risk in patients with the arrhythmia, but the benefit is potentially compromised in people at high risk for bleeding. More Than 100K Implants Per Year and Growing Clots associated with nonvalvular AF commonly form in the left atrial appendage. The FDA has approved two LAAO systems for the prevention of stroke: the Amplatzer Amulet (Abbott) and the Watchman (Boston Scientific). Earlier this month, the FDA announced that Boston Scientific is recalling Watchman systems that were performed without the use of positive pressure-controlled ventilation. The agency said at least 120 people have been seriously injured, and 17 have died, after undergoing the procedure. For both systems, the current indication remains limited to people with contraindications to oral anticoagulation; however, the consensus expressed in the new guidelines is that this restriction is 'outdated' in the wake of evidence that has become available since the publication of pivotal trials that preceded approval of both available devices. How often devices are being implanted outside current FDA labeling is unclear, but LAAO has become 'one of the most frequent procedures' in cardiology, with an estimated 100,000 performed in 2024, according to data cited by Goldsweig. Eight evidence-based recommendations, covering patient selection, how imaging should be employed to assess and follow patients, and whether adjunctive oral anticoagulation should be considered in those with peridevice leak or device-related thrombus, were outlined in the new guidelines, which were simultaneously published in the Journal of the Society for Cardiovascular Angiography & Interventions and Heart Rhythm . Two address patient selection. The first reiterates the current indication, which is that LAAO should be considered in patients with nonvalvular AF with a contraindication to oral anticoagulation. The second identifies LAAO and oral anticoagulation as treatment options for patients with nonvalvular AF who do not necessarily have a contraindication to oral anticoagulation. Specifically, the guideline includes LAAO as an option for those 'with strong preferences to avoid long-term oral anticoagulation.' Based on current evidence, 'the main point of this recommendation is that LAAO is every bit as good as OAC [oral anticoagulant] — maybe even better — in terms of preventing atrial fibrillation-associated stroke,' Goldsweig said. Superiority for LAAO cannot be claimed because the large, randomized trials conducted to date have all employed a noninferiority design, Goldsweig acknowledged. Although earlier noninferiority trials, such as PREVAIL, compared LAAO to warfarin, most of the patients in the comparator group in the latest of these trials received a non-vitamin K oral anticoagulant. This trial, called OPTION, published earlier this year, compared arms for noninferiority on the primary composite endpoint of death from any cause, stroke, or systemic embolism at 36 months. Over the study period, the endpoint was reached by 8.5% in the LAAO group and 18.5% in the anticoagulation group, which easily met statistical significance for noninferiority. Superiority ( P < .001) for LAAO was also shown, but this result was hypothesis-generating given that the trial was not designed to study superiority. Trials May Expand Indications for LAAO Trials comparing LAAO to anticoagulant therapy as a first-line stroke prevention strategy among those who are candidates for either are underway. The CHAMPION-AF trial with the Watchman device and the CATALYST trial with the Amplatzer Amulet device in patients are in progress. Results are expected in 2026. Three other sets of recommendations involve periprocedural imaging, which is not being employed consistently across centers performing LAAO, according to Goldsweig. In one recommendation, pre-procedure transesophageal echocardiography or CT is identified as preferable to no such imaging. In the second and third, transesophageal echocardiography or CT are recommended, respectively, during and after the procedure. The remaining recommendations involve the use of oral anticoagulation following LAAO procedures with attention to peridevice leak and device-related thrombus, but data for these recommendations are generally limited, so they are accompanied by discussions of knowledge gaps. The authors of the guidelines caution that the relative role of oral anticoagulation and LAAO in nonvalvular AF is an evolving area. Many of the recommendations were labelled as 'conditional' based on evidence that generated 'low certainty.' Differences in relative acute and long-term costs, which were not addressed in the new guidelines, are another factor that might affect a stroke prevention strategy for individual patients. The Centers for Medicare and Medicaid Services announced a 27% reduction in the proposed 2026 Medicare fee schedule for the procedure. The American College of Cardiology, which attributed the proposed change to ' a proposed efficiency adjustment reduction,' is among several cardiology groups protesting the potential change. Some interventionalists have posted on social media that they can perform the procedure in under 10 minutes and about the safety of safe-day discharge of patients — practices that suggest clinicians are becoming more efficient with LAAO. But whether those statements influenced cardiometabolic syndrome is unclear. The expansion of LAAO past current indications is not uniformly embraced. John M. Mandrola, MD, a clinical electrophysiologist in Louisville, Kentucky, and host of the This Week in Cardiology podcast on has been a long-time critic of LAAO. The popularity of 'this well-compensated procedure has gotten ahead of the evidence,' he said. 'For evidence-minded physicians who are concerned about the rapid rise in LAAO procedures in patients without absolute contraindications to oral anticoagulants,' the conclusion that LAAO is as good as oral anticoagulation 'is very premature,' Mandrola said. Not least of his concerns, he noted that LAAO 'failed to show noninferiority to warfarin — a weaker comparator to the now commonly used direct-acting oral anticoagulants.' Mandrola said most patients now undergoing LAAO would not have been eligible for the pivotal Watchman vs warfarin trials. He has repeatedly called for a more conservative approach until proper trials provide evidence of equivalence. Mandrola said older patients with multiple competing causes of stroke — a common type of patient receiving LAAO — likely derive little to no net benefit from the focal strategy of appendage closure. The principal investigator of the recently published OPTION trial, Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic in Cleveland, emphasized the need to consider risks and benefits. 'I think it is reasonable to consider LAAO as an alternative to oral anticoagulation' on the basis of patient preference, he said, but only 'after a careful and thorough shared decision discussion with patients regarding the potential acute complications and the potential for leaks and device-related thrombus.' Goldsweig, Mandrola, and Wazni reported having no relevant financial conflicts of interest.
Medscape
07-08-2025
- Health
- Medscape
Does Obesity Raise AF Risk Directly or Via Comorbidities?
TOPLINE: Individuals with overweight or obesity have a higher risk for atrial fibrillation (AF) than those with normal weight. Nearly one fourth of the increased risk with obesity is mediated by comorbid conditions, whereas the remaining risk is directly mediated by obesity. METHODOLOGY: Obesity is associated with an increased risk for AF, yet it remains unclear whether this risk stems directly from excess adiposity or is mediated by comorbid conditions. Researchers conducted a retrospective cohort study of patients aged ≥ 40 years with a documented BMI across German general practices between 2005 and 2023. Participants were categorized as underweight (BMI < 18.5), normal weight (18.5-24.9), overweight (25.0-29.9), or obesity (≥ 30). The primary outcome was incident AF within 10 years of the index date. A causal mediation analysis estimated the proportion of AF risk mediated by comorbidities, including type 2 diabetes, hypertension, dyslipidemia, ischemic heart disease, and heart failure. TAKEAWAY: The study included 1 22,464 participants with normal weight (mean age, 58.9 years; 61.6% women), 150,783 with overweight (mean age, 60.7 years; 44.5% women), and 112,674 with obesity (mean age, 60.1 years; 53% women). Over 10 years, AF occurred in 7.2% of participants with normal weight, 10.1% with overweight, and 13.2% with obesity. Compared to those with normal weight, the risk for AF was 43% higher among individuals with obesity (P <.001) and 12% higher among those with overweight (P < .001), with greater risks in men. Mediation analysis revealed that 27% of obesity-related AF risk was mediated by comorbidities, whereas 79% was attributed to direct effects of obesity. IN PRACTICE: "Effective management of hypertension, diabetes and dyslipidaemia could help to achieve a meaningful reduction in the proportion of AF cases attributable to obesity. At the same time, the persistent direct effect of BMI on AF, despite adjustment for comorbidities, indicates that weight reduction must remain a central focus of preventive strategies," the authors wrote. SOURCE: This study was led by Jamschid Sedighi, MD, Justus-Liebig-University in Giessen, Germany. It was published online in Diabetes, Obesity and Metabolism. LIMITATIONS: BMI was measured only at baseline; thus, associations reflect initial BMI rather than changes over time. Confounding factors may have remained. Reliance on diagnostic codes may have underestimated the cases of paroxysmal or asymptomatic AF. DISCLOSURES: No specific study funding was reported. Two authors disclosed receiving speaker/consulting honoraria from AstraZeneca and Pfizer, and one also received honoraria from additional sources including Novartis, Berlin-Chemie, and Lilly. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
08-07-2025
- Health
- Medscape
AI-ECG Model Predicts Vascular Risk in Migraine Patients
MINNEAPOLIS — Artificial intelligence (AI) may help identify patients with migraine at an increased risk for atrial fibrillation (AF) and other vascular complications, new research showed. Results of a retrospective study that evaluated more than 29,000 patients who had migraine with and without aura showed the AI prediction model output identified patients at higher risk for paroxysmal AF as well as a composite outcome of vascular events that included acute myocardial infarction (MI), acute ischemic stroke (AIS), and venous thromboembolism using patients' ECG data. The study builds on previous research from the same group showing that migraine with aura is associated with an increased risk of developing stroke and adverse vascular events, study investigator Chia-Chun Chiang, MD, associate professor of neurology at the Mayo Clinic in Rochester, Minnesota, said in a presentation at the American Headache Society (AHS) Annual Meeting 2025, as reported to Medscape Medical News . 'Our studies showed that ECG, a widely available test, coupled with AI algorithms, has the potential to be used in clinical practice to screen and identify migraine patients at risk for adverse vascular events,' Chiang said. Vascular Event Prediction The researchers evaluated 29,928 patients with migraine who received one or more standard 12-lead ECGs between 2000 and 2020, which included 13,250 patients with aura and 16,678 without aura. Patients had a mean age of 44.3 years and a median follow-up of 54 months. Researchers input data from each patient's index ECG into an AI model to assess the risk of developing AF. They also calculated each patient's delta age — defined as the AI-predicted age based on ECG data minus the individual's actual chronological age. Higher delta age values have previously been associated with endothelial dysfunction and increased cardiovascular mortality, the researchers noted. The study's primary outcome was the incidence of acute MI, AIS, venous thromboembolism, or death as a composite outcome, with a separate outcome of new-onset AF. Overall, 4662 patients (15.6%) developed adverse events, and new-onset AF occurred in 1384 patients. Using a multivariate Cox regression model that adjusted for factors such as age, sex, aura, and vascular risk factors, researchers found every 10% increase in output of the AI model (hazard ratio [HR], 1.15; 95% CI, 1.12-1.18) and a 10-year increase in delta age (HR, 1.16; 95% CI, 1.12-1.21) was associated with a higher likelihood of developing adverse vascular events. There was also a higher likelihood of developing new-onset AF with a higher AI model output (HR, 1.31; 95% CI, 1.26-1.37), and among those with new-onset AF, there was a higher risk for adverse vascular events (HR, 2.43; 95% CI, 2.17-2.73). Other risk factors identified by the AI-ECG AF model output included coronary artery disease (HR, 2.02; 95% CI, 1.79-2.27; P < .001), congestive heart failure (HR, 1.89; 95% CI, 1.53-2.34; P < .001), diabetes mellitus (HR, 1.67; 95% CI, 1.50-1.86; P < .001), hypertension (HR, 1.42; 95% CI, 1.32-1.52; P < .001), tobacco use (HR, 1.38; 95% CI, 1.27-1.51; P < .001), male sex (HR, 1.19; 95% CI, 1.11-1.27; P < .001), and migraine with aura (HR, 1.12; 95% CI, 1.06-1.18; P < .001). The researchers used Contal and O'Quigley's method to determine the value at which patients would be categorized into groups at high and low risk for adverse vascular events. They found that an AI model output of 1% or more (HR, 1.45; 95% CI, 1.36-1.54) and a delta age of 1 year or more (HR, 1.09; 95% CI, 1.02-1.16) were the optimal cutoffs to categorize patients into high-risk and low-risk groups. Chiang noted her group is validating the study's results and also evaluating factors such as echocardiography results and migraine characteristics that could aid in risk stratification and prediction in patients with migraine. 'The AI models could potentially be used in clinical practice as a screening tool to identify patients at risk, helping clinicians with risk stratification, and facilitate early prevention of adverse vascular events,' Chiang said. Innovative Research The study's large sample size, validated outcomes, and risk adjustments lend credibility to its results, Adriana Rodriguez-Barrath, MD, a neuro-ophthalmologist with University of Iowa Health Care, Iowa City, Iowa, told Medscape Medical News . 'The study is a meaningful step forward in our understanding of migraine as a systemic, rather than solely neurologic, condition, particularly by highlighting its association with elevated risks of AF and stroke,' she explained. 'What sets this study apart is its innovative use of AI-ECG models to estimate two novel cardiovascular biomarkers.' The AI model estimating the probability of AF and delta age 'offers noninvasive, scalable, and inexpensive tools that go beyond traditional risk stratification methods,' she said. Migraine is not an isolated neurological condition, and research has previously shown migraine with and without aura has been linked to conditions such as AF and stroke, Rodriguez-Barrath noted. 'By applying AI-ECG to a migraine population, the study provides compelling evidence that subclinical cardiovascular risk may already be encoded in the ECG signals of patient with migraine, especially those with aura, even before overt cardiovascular disease develops,' she added. Also commenting on the research, Deborah Reed, MD, associate professor of neurology and director of the Headache Program at University Hospitals and Case Western Reserve University School of Medicine in Cleveland, said the result shows the model accurately predicts and identifies risk factors for adverse events in patients with migraine. 'The strength of this study is the large population that was studied and the development of these tools to predict [AF] and adverse vascular events. I am excited to see where this leads,' Reed told Medscape Medical News . However, many of the risk factors identified are already known to clinicians, she said. 'Although there was increased vascular risk in patients who were older, male, and had migraine with aura, these are all well-known risk factors for vascular events,' said Reed. Reed said she discusses vascular risk in patients who have migraine with aura as they develop other risk factors and in patients considering oral contraceptives. 'As we follow our patients over a lifetime, most physicians will discuss risk factors for vascular events, neurologists included,' she explained. 'When I discuss this with my patients, I add migraine with aura to the risk factors including family history, diabetes, lifestyle, cholesterol, and exercise.' AI in Clinical Practice? Reed suggested that confidently informing patients of their elevated risk for vascular outcomes could help motivate them to prioritize lifestyle changes, despite the challenges involved. 'I think it would be great if we could just get an [ECG] and have a computer tell us our individual risk of [AF] or other vascular events. At the end of the day, there are risk factors you can treat and there are those you cannot. Migraine with aura is quite preventable,' she added. AI tools have the potential to identify both high-risk groups earlier and offer personalized preventative strategies, Rodriguez-Barrath said, but should be seen as 'adjuncts, not replacements, for clinical judgment.' 'All algorithms are trained on population-level data and may miss the nuances of individual patient contexts, such as comorbidities, psychosocial factors, or atypical presentations,' she said. 'As clinicians, we bring human experience, ethical reasoning, and the ability to integrate complex clinical narratives, something no algorithm can replicate. Therefore, AI can enhance our decision-making, but it is our clinical acumen that ensures safe, patient-centered care,' she added.
Yahoo
08-07-2025
- Business
- Yahoo
Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)xii. It enables safe and efficienti,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurexiii,xiv,xv and is compatible with deep and/or conscious sedation.2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: In inspIRE, 80% of patients achieved freedom from recurrence with zero primary adverse In admIRE, results showed a 75% overall primary effectiveness success rate3, a 2.9% primary adverse event rate4,xix, 100% of patients achieved acute procedural success5, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy6. In the ongoing VARIPURE registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasmsxx. "The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care," stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. "The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes." Atrial Fibrillation affects over 16 million people in Asia-Pacificxxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizzinessxxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortalityxxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. "PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients" said Dr. Yasuo Okumura7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. "PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients." About the VARIPULSE™ PlatformThe VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. Cautions Concerning Forward-Looking Statements: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012 ________________________________________ 1 When compared to procedures that did not use navigation systems. 2 Based on a subset of 29 deep sedation patients from the inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency. 3 Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I/III AADs at greater doses during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF/AT/AFL recurrences. The protocol defined performance goal is 50%. 4 Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%. 5 Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255). 6 Visualization performed with ICE and the CARTO™ 3 System. 7 Dr. Okumura serves as a consultant for Johnson & Johnson but was not compensated for this announcement ________________________________________ i Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161/CIRCEP.122.011780 pg 4 ii Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8 iii Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303–2310 (2024). pg 2 iv Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/ PMID: 37323994; PMCID: PMC10264259. Pg 6 v VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3 vi Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093/europace/euaf012. Pg 4 results section vii Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1 viii Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197 ix Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111/pace.15177. Epub ahead of print. PMID: 40153431. x Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland xi Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517 xii Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211. xiii Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783 xiv Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8. xv Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8. xvi Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093/europace/euad222. PMID: 37470452; PMCID: PMC10434733. xvii De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Pürerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320. xviii Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. xix Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333. xx Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA. xxi Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from xxii American Heart Association . (2024, August 12). What are the symptoms of atrial fibrillation?. xxiii Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161/CIR.0000000000001193 Media contacts:Carlos Taveras Ctaveras@ FarleyEfarley1@ View original content: SOURCE Johnson & Johnson MedTech Sign in to access your portfolio
Yahoo
08-07-2025
- Business
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Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)xii. It enables safe and efficienti,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurexiii,xiv,xv and is compatible with deep and/or conscious sedation.2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: In inspIRE, 80% of patients achieved freedom from recurrence with zero primary adverse In admIRE, results showed a 75% overall primary effectiveness success rate3, a 2.9% primary adverse event rate4,xix, 100% of patients achieved acute procedural success5, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy6. In the ongoing VARIPURE registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasmsxx. "The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care," stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. "The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes." Atrial Fibrillation affects over 16 million people in Asia-Pacificxxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizzinessxxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortalityxxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. "PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients" said Dr. Yasuo Okumura7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. "PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients." About the VARIPULSE™ PlatformThe VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. Cautions Concerning Forward-Looking Statements: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012 ________________________________________ 1 When compared to procedures that did not use navigation systems. 2 Based on a subset of 29 deep sedation patients from the inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency. 3 Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I/III AADs at greater doses during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF/AT/AFL recurrences. The protocol defined performance goal is 50%. 4 Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%. 5 Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255). 6 Visualization performed with ICE and the CARTO™ 3 System. 7 Dr. Okumura serves as a consultant for Johnson & Johnson but was not compensated for this announcement ________________________________________ i Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161/CIRCEP.122.011780 pg 4 ii Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8 iii Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303–2310 (2024). pg 2 iv Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/ PMID: 37323994; PMCID: PMC10264259. Pg 6 v VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3 vi Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093/europace/euaf012. Pg 4 results section vii Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1 viii Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197 ix Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111/pace.15177. Epub ahead of print. PMID: 40153431. x Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland xi Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517 xii Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211. xiii Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783 xiv Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8. xv Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8. xvi Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093/europace/euad222. PMID: 37470452; PMCID: PMC10434733. xvii De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Pürerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320. xviii Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. xix Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333. xx Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA. xxi Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from xxii American Heart Association . (2024, August 12). What are the symptoms of atrial fibrillation?. xxiii Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161/CIR.0000000000001193 Media contacts:Carlos Taveras Ctaveras@ FarleyEfarley1@ View original content: SOURCE Johnson & Johnson MedTech Sign in to access your portfolio
