<div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="277130110" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{10}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">The risk of major bleeding (MB) after left atrial appendage occlusion (LAAO) is highest at 6-</span><span class="NormalTextRun SCXW58952419 BCX8">months</span><span> </span><span class="NormalTextRun SCXW58952419 BCX8">post-</span><span class="NormalTextRun SCXW58952419 BCX8">LAAO but significantly decrease</span><span class="NormalTextRun SCXW58952419 BCX8">s</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>after 6<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">months</span><span class="NormalTextRun SCXW58952419 BCX8">,<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">data from the Amulet IDE study show</span><span class="NormalTextRun SCXW58952419 BCX8">.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1731819833" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{12}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">These data were reported by Boris Schmidt, MD, of the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW58952419 BCX8">Cardioangiologisches</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>Centrum<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW58952419 BCX8">Bethanien</span><span class="NormalTextRun SCXW58952419 BCX8">, Frankfurt, Germany, and colleagues from the U.S., Denmark,<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">Spain</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and Belgium, in a manuscript published online Wednesday in<span> </span></span></span><span class="NormalTextRun SCXW58952419 BCX8">JAMA Cardiology</span><span class="NormalTextRun SCXW58952419 BCX8">.</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1635273132" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{14}"><span class="NormalTextRun SCXW58952419 BCX8">Investigators in the<span> </span></span><a class="Hyperlink SCXW58952419 BCX8" href="https://clinicaltrials.gov/study/NCT02879448?term=NCT02879448&rank=1" target="_blank" rel="noreferrer noopener"><span class="NormalTextRun SCXW58952419 BCX8" data-ccp-charstyle="Hyperlink">Amulet IDE trial</span></a><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>examined the incidence, predictors,<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">treatment</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and outcomes of MB post-LAAO. LAAO is often used to treat patients who are at higher risk of bleeding complications.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1399356206" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{16}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Patient data were collected between 2016 and 2019, and follow-up took place<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">through</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>5 years.<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">Dat</span><span class="NormalTextRun SCXW58952419 BCX8">a</span><span> </span><span class="NormalTextRun SCXW58952419 BCX8">were</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>analyzed between May 2025 and November 2025.<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">Patients were randomized<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">1:1<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">to receive the Amulet<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">(Abbott Cardiovascular)<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">or<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">WATCHMAN</span><span> </span><span class="NormalTextRun SCXW58952419 BCX8">(Boston Scientific)<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">device</span><span class="NormalTextRun SCXW58952419 BCX8">.</span><span class="NormalTextRun SCXW58952419 BCX8"> </span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="915810277" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{18}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">The primary endpoint of this study was a composite of stroke, systemic<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">embolism</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and cardiovascular death.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1802661911" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{20}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">A total of 1,833 patients were included in the study (mean age=75.8 years; 42.3% female). Over 5-year follo</span><span class="NormalTextRun SCXW58952419 BCX8">w-up, 18.1% of patients had MB.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="2015702124" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{22}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Patients who experienced MB were older compared with patients who had no MB (76.8 years vs 74.7 years)</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and more MB patients had diabetes (38.7% vs 34.1%),<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">prior</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>MB (45.3% vs 28.0%</span><span class="NormalTextRun SCXW58952419 BCX8">)</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and kidney disease (9.4%<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">vs 4.5%)</span><span class="NormalTextRun SCXW58952419 BCX8">. Patients with MB also had<span> </span></span></span><span class="NormalTextRun SCXW58952419 BCX8">higher CHA</span><span class="NormalTextRun Subscript SCXW58952419 BCX8" data-fontsize="12">2</span><span class="NormalTextRun SCXW58952419 BCX8">DS</span><span class="NormalTextRun Subscript SCXW58952419 BCX8" data-fontsize="12">2</span><span class="NormalTextRun SCXW58952419 BCX8">-VASc (4.8 vs 4.6) and HAS-BLED (3.4 vs 3.2) scores.</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="2067319118" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{24}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Patients were more likely to experience MB within the 6-month period post-LAAO,<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">roughly 20.5%</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>per year. After 6-</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">months</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>post-procedure, this percentage dropped to 3.9% each year<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">up to 5 years.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="2094116386" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{26}"><span class="NormalTextRun SCXW58952419 BCX8">Nonprocedural MB accounted for most occurrences (88.8%). Gastrointestinal bleeding was the most common (252 of the 438 events).</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="495734634" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{28}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Conditions that increased the likelihood of MB included older age (</span><span class="NormalTextRun SCXW58952419 BCX8">p<0.001</span><span class="NormalTextRun SCXW58952419 BCX8">)</span><span class="NormalTextRun SCXW58952419 BCX8">, female sex</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>(</span><span class="NormalTextRun SCXW58952419 BCX8">p=0.04</span><span class="NormalTextRun SCXW58952419 BCX8">)</span><span class="NormalTextRun SCXW58952419 BCX8">, diabetes</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>(</span><span class="NormalTextRun SCXW58952419 BCX8">p=0.04</span><span class="NormalTextRun SCXW58952419 BCX8">)</span><span class="NormalTextRun SCXW58952419 BCX8">, prior</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>MB<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">(</span><span class="NormalTextRun SCXW58952419 BCX8">p<0.001</span><span class="NormalTextRun SCXW58952419 BCX8">)</span><span> </span><span class="NormalTextRun SCXW58952419 BCX8">and kidney disease</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>(</span><span class="NormalTextRun SCXW58952419 BCX8">p<0.001</span><span class="NormalTextRun SCXW58952419 BCX8">).</span><span> </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">Type</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>of device, antithrombotic medications, device<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">leak</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and device-related thrombus did not influence MB outcomes.</span></span><span class="EOP SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="949037226" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{30}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Patients with MB had higher rates of the composite primary endpoint (32.5% vs 18.0%, p<0.001).<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">Patients with MB also had significantly higher rates of two</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>individual</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>primary endpoint components: stroke (14.7% vs 6.6%) and cardiovascular death (24.4% vs 12.9%).</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="487000375" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{32}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Of the patients who had their first MB event, 47.1% of them were not in<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW58952419 BCX8">antithrombotics</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and 92 of these patients had recurrent events.<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">Patients who had MB had higher all-cause mortality rates compared with those who did not have MB (49.2% vs 25.4%, p<0.001), and 25 patients who had MB died overall.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="789893883" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{34}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Limitations of this study included the use of the<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">WATCHMAN</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>2.5 device and newer-generation devices may deliver different results, antithrombotic therapy after hospital discharge was not randomized, bleeding event details pre-LAAO were not<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW58952419 BCX8">listed</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>and incomplete follow-up data</span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>may make these findings less generalizable.</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="156944974" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{36}"><span class="NormalTextRun SCXW58952419 BCX8">Several underlying patient factors contribute to the increased risk of MB in patients undergoing LAAO, with this risk peaking at 6-months post-procedure.</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="488261581" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{38}"><strong><span class="NormalTextRun SCXW58952419 BCX8">Source:</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1325966714" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{40}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Schmidt B, Windecker S, Thaler D, et al. Incidence, predictors, management, and clinical impacts of major bleeding following left atrial appendage<span> </span></span><span class="NormalTextRun SCXW58952419 BCX8">occlusion</span><span class="NormalTextRun SCXW58952419 BCX8">: The Amulet IDE randomized clinical trial.<span> </span></span></span><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">JAMA<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW58952419 BCX8">Cardiol</span><span class="NormalTextRun SCXW58952419 BCX8">.</span></span><span class="NormalTextRun SCXW58952419 BCX8"><span> </span>2026 March 25 (Article in Press).</span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW58952419 BCX8"> <p class="Paragraph SCXW58952419 BCX8" paraid="1194501140" paraeid="{3a0e8a95-504e-4541-98ed-090132396138}{42}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW58952419 BCX8"><span class="NormalTextRun SCXW58952419 BCX8">Image Credit: </span><span class="NormalTextRun SpellingErrorV2Themed SCXW58952419 BCX8">ustas</span><span class="NormalTextRun SCXW58952419 BCX8"> – stock.adobe.com</span></span><span class="EOP Selected SCXW58952419 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></strong></p> </div>