Neuro-AFib Study Launch Meeting
Feb. 18, 2020, 8 am - 4 pm - Hotel Indigo, Los Angeles, CA
On February 18th, 2020 over 70 vascular neurologists and a few cardiologists from across the U.S. and Canada participated in the Neuro-AFib Study Launch Meeting at the Hotel Indigo in Los Angeles. The exciting full-day meeting marked the start of the Neuro-AFib Study investigating atrial fibrillation (AF) management and stroke etiology and prevention in AF patients. The meeting featured 15 presentations divided over four sessions, each moderated by experts in their respective fields. Time was allotted at the end of each session for extensive group discussion.
The opening session of the day, moderated by Drs. Magdy Selim (Beth Israel) and Daniel Woo (University of Cincinnati) focused on cutting edge topics in AF workup and management. After a brief opening statement by the Neuro-AFib principal investigator Dr. Edip Gurol (MGH), Dr. Lee Schwamm (MGH) provided an excellent overview of cryptogenic stroke and AF monitoring. Following, Dr. Brad Worrall (University of Virginia) discussed the genetic and epigenetic underpinnings of the condition as well as new biomarkers of AF. Various ablation techniques for AF management were discussed by Dr. Doug Gibson (Scripps). Subsequently, Dr. Shadi Yaghi (NYU) discussed left atrial appendage morphology, arguing the importance of the left atrial appendage in embolism formation. Dr. Doug Gibson closed the session, discussing closure of the appendage as a stroke prevention treatment, highlighting the WATCHMAN device.
Session 2 focused on the Neuro-AFib Study in depth, featuring a presentation by Dr. Gurol discussing the study’s rationale, design, and aims, as well as prospects for future related research. Dr. Gurol stated that about 20% of all acute ischemic strokes in the U.S. are related to AF, and many of these strokes occur in patients on oral anticoagulation. There are also about 24,000 oral anticoagulated-related intracranial hemorrhages (ICHs) in U.S. AF patients annually. The Neuro-AFib Study will evaluate the mechanisms and outcomes of ischemic stroke and ICH in AF patients, focusing on management of AF and stroke risk, as well as long-term outcomes for these patients. To accomplish these aims, the study will collect data from stroke centers across the U.S. in a retrospective phase and prospective phase. For the retrospective phase, data will be collected from stroke patients with AF admitted to over 30 different stroke centers in 2018 and 2019, most of which were represented at the Launch Meeting. The prospective phase, to begin in early 2021, will enroll recently admitted stroke patients with AF from ten U.S. stroke centers and prospectively follow them through the study duration. The five year study plans to collect clinical, laboratory, and imaging data on about 12,000 patients over the two phases, making this the largest cohort study of AF stroke patients to date. This study is only the initial step, for Dr. Gurol and his collaborators, paving the way for future RCTs and the formation of a Neuro-Cardio Consortium.
Session 2 ended with a talk given by Dr. Joe Broderick (University of Cincinnati) on StrokeNET, the NIH led consortium designed to facilitate the execution of stroke clinical trials. Dr. Broderick gave a broad overview of ongoing trials and discussed the role of StrokeNET in shaping the future of clinical stroke research. During the question and comment period, meeting participants reiterated their enthusiasm for and interest in expanding stroke research in AF, concurring upon the timely need for this research.
After a brief intermission for lunch, presentations resumed with Session 3 focused on current trials on topics related to the Neuro-AFib Study. Many studies are underway comparing left atrial appendage closure to oral anticoagulants, including the most recently announced CHAMPION AF trial, comparing the efficacy of the WATCHMAN FLX left atrial appendage closure device to direct oral anticoagulants for reducing stroke risk in AF patients post ablation. NIH-funded studies such as SATURN, ASPIRE and Sleep SMART were also discussed. Different from these studies, the Neuro-AFib Study will collect a large amount of neuro-imaging data on AF patients, paving the way to expand the current scope of RCTs to better understand stroke risk and stroke etiology in a large variety of patients, including those at high ischemic and hemorrhagic stroke risk based on novel imaging markers.
The rest of Session 3 consisted of three presentations by neurologists at leading stroke centers that have developed successful collaborations with their cardiology colleagues at their local institutions. Neurologist Dr. Timothy Lukovits shared his experience working with cardiology at Dartmouth-Hitchcock Medical Center, highlighting their efforts creating patient-decision making resources for neuro-cardio patients. Dr. David Rose followed-up with a presentation discussing the University of South Florida’s establishment of a neuro-cardiology program, characterized by a “freeze and thaw clinic model” with reserved slots allowing patients to be seen by a stroke neurologist in the morning and then by a cardiologist on the same day in an afternoon clinic. Dr. Andrew Russman ended the session discussing the AF Stroke Prevention Center established at Cleveland Clinic that combines the expertise of electrophysiology, vascular medicine, gastroenterology, and neurovascular medicine to address, via a multidisciplinary team, stroke risk in AF patients with high bleeding risk. This session brought to the forefront the importance of expanding neuro-cardio collaborations for improved stroke prevention in AF patients and others with cardiac conditions, highlighting the need for better collaborations within institutions and joint neuro-cardio research studies. Meeting participants and leadership agreed with the need for the formation of a neuro-cardiology consortium.
The day ended with a session entitled “ongoing research and future directions,” and featured presentations on new research findings. Dr. Farhaan Vahidy (Houston Methodist Hospital) opened the session, presenting his research on trends in ischemic stroke using a large Medicare database. Dr. David Tirschwell (University of Washington) gave a talk on embolic stroke of unknown source (ESUS), discussing the diagnostic criteria and challenges associated with the current classification. He highlighted the NAVIGATE ESUS and RESPECT ESUS studies, two trials which failed to show a benefit of anticoagulation over aspirin monotherapy in ESUS patients. Additionally, he reviewed the increasing literature on substenotic atherosclerosis as well as PFO-related stroke, proposing the potential removal of these entities from definition of ESUS. The subsequent lecture was given by Dr. Alvin Das (MGH) who presented his research on underlying cerebral small vessel disease etiologies in oral anticoagulation related hemorrhages. He compared the hemorrhage locations and microbleed locations of NOAC-related hemorrhages with warfarin-related hemorrhages, finding there were more cerebellar hemorrhages in the warfarin group compared to the NOAC group, and more deep bleeds in the NOAC group. Within the NOAC-related hemorrhage group, small vessel disease markers indicating high hemorrhagic risk were found at a very high frequency. Dr. Robert Stanton (University of Cincinnati) ended the day discussing the risks and benefits of anticoagulation resumption after intracerebral hemorrhage using a Markov state transition model. His population-based retrospective study demonstrated that resuming anticoagulation results in a net loss of quality-adjusted life years.
Overall, the Neuro-AFib Study Launch meeting consisted of high-quality scientific talks related to the theme of stroke etiology and prevention in AF patients, and provided a forum for discussion of related topics. Dr. Gurol introduced the Neuro-AFib Study, set to investigate stroke etiology and prevention in AF patients. The study will shortly commence collecting data on AF stroke patients and continue collection over the next five years. Importantly, the meeting also heralded the need for the formation of a Neuro-Cardio Consortium, a platform dedicated to addressing stroke prevention in AF patients and those with other cardiac conditions that brings together the expertise of both neurologists and cardiologists for shared learning and research to improve the care of these complex patients. The unanimous decision was to form the Neuro-Cardio Consortium and plan its first large-scale meeting, potentially in the first half of 2021.
by Alvin Das & Alyssa Wohlfahrt