<div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="52723868" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{12}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Small mitral valve orifice area should not automatically rule out mitral valve transcatheter edge-to-edge repair (M-TEER) with the PASCAL system, new<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">findings</span><span> </span><span class="NormalTextRun SCXW225938741 BCX0">from the REPAIR study<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">suggest. </span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1689843873" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{14}"><span class="NormalTextRun SCXW225938741 BCX0">The REPAIR study, published in<span> </span></span><em><span class="NormalTextRun SCXW225938741 BCX0">JACC: Advances</span></em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">, found no statistically significant differences in mitral regurgitation reduction, symptom<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW225938741 BCX0">improvement</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>or<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">1</span><span class="NormalTextRun SCXW225938741 BCX0">-year outcomes between carefully selected patients with smaller and larger baseline valve areas.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1788586986" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{16}"><strong><span class="NormalTextRun SCXW225938741 BCX0">3D-MVOA measurements</span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="759615930" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{18}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Led by Philipp von Stein, MD, of the Department of Cardiology, Heart Center, Faculty of Medicine, University of Cologne, Germany</span><span class="NormalTextRun SCXW225938741 BCX0">,</span><span> </span><span class="NormalTextRun SCXW225938741 BCX0">the study<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">analyzed</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>1,189 patients with available<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">three-dimensional mitral valve orifice area (3D-MVOA) measurements</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>from the investigator-initiated REPAIR registry. </span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1080132068" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{20}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">In total, 338 patients,<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">representing</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>28% of the cohort, had a baseline 3D-MVOA below<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">4 cm</span><span class="NormalTextRun SCXW225938741 BCX0">²</span><span> </span><span class="NormalTextRun SCXW225938741 BCX0">—</span><span> </span><span class="NormalTextRun SCXW225938741 BCX0">an anatomical threshold<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">frequently</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>used to exclude patients from pivotal M-TEER trials due to concerns over iatrogenic mitral stenosis.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1335314628" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{22}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">“Almost one-third of patients with available measurements had baseline 3D-MVOA <</span><span class="NormalTextRun SCXW225938741 BCX0">4 cm</span><span class="NormalTextRun SCXW225938741 BCX0">²</span><span class="NormalTextRun SCXW225938741 BCX0">,” wrote the researchers.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1177244672" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{24}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">“</span><span class="NormalTextRun SCXW225938741 BCX0">Technical success was modestly lower, while MR reduction and 1-year clinical outcomes did not differ significantly. These data are consistent with the feasibility of PASCAL M-TEER in carefully selected patients with small 3D-MVOA at experienced centers.”</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="936516294" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{26}"><strong><span class="NormalTextRun SCXW225938741 BCX0">Procedural outcomes</span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="91794485" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{28}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Patients with smaller mitral valve areas had a modestly lower rate of technical<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">success but</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>achieved similar reductions in mitral regurgitation. </span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1031167062" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{30}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Technical success occurred in 95.9% of patients with 3D-MVOA below 4 cm², compared with 98.2% of those with 3D-MVOA of at least<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">4 cm</span><span class="NormalTextRun SCXW225938741 BCX0">², while MR reduction to 1+ or lower at discharge was<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">nearly identical</span><span class="NormalTextRun SCXW225938741 BCX0">, at 71.7% versus 71.8%.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1444059035" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{32}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">This pattern extended to clinical follow-up</span><span class="NormalTextRun SCXW225938741 BCX0">. NYHA class improved by at least one class at<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">30 days</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>in 61% of these patients, compared with 64% of those with larger valve areas, while one-year all-cause mortality was 13.0% versus 13.6%, respectively, with no significant adjusted difference.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="621469105" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{34}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun MacChromeBold SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">N</span><span class="NormalTextRun SCXW225938741 BCX0">o significant differences</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1616953058" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{36}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">“Regarding symptomatic improvement and clinical outcomes, no statistically significant differences were observed in NYHA class improvement, one-year all-cause mortality, or the composite of one-year all-cause mortality or hospitalization for HF</span><span class="NormalTextRun SCXW225938741 BCX0">,” wrote the researchers.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1155137824" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{38}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">“</span><span class="NormalTextRun SCXW225938741 BCX0">These findings should not be interpreted as evidence of equivalence, but they are reassuring in the context of the limited applicability of other treatments, including TMVR, in this anatomical subset.”</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1265589560" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{40}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">However, the authors urged caution in interpreting the results, noting that the study was based on registry data without independent core laboratory review and may not apply to less experienced<span> </span></span><span class="NormalTextRun SCXW225938741 BCX0">centers</span><span class="NormalTextRun SCXW225938741 BCX0">. </span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="695105765" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{42}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Nevertheless, they said small 3D-MVOA should not, by itself, prevent selected patients from being considered for PASCAL (Edwards Lifesciences) M-TEER</span><span class="NormalTextRun SCXW225938741 BCX0">.</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="1597356532" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{44}"><strong><span class="NormalTextRun SCXW225938741 BCX0">Source:</span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" paraid="716391590" paraeid="{da14130a-d520-4ee6-ab90-b52c6c0d3b57}{47}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Von Stein P, von Stein J,<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW225938741 BCX0">Schindhelm</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>F, et al. Small Mitral Valve Orifice Area in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study.<span> </span></span></span><em><span class="NormalTextRun SCXW225938741 BCX0">JACC: Advances</span></em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">. 2026</span><span class="NormalTextRun SCXW225938741 BCX0"><span> </span>July (Article in Press)</span><span class="NormalTextRun SCXW225938741 BCX0">.<span> </span></span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> </div> <div class="OutlineElement Ltr SCXW225938741 BCX0"> <p class="Paragraph SCXW225938741 BCX0" lang="EN-US" paraid="324870675" paraeid="{c071c70b-e225-4881-9e99-e5ba58b4df82}{129}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun MacChromeBold SCXW225938741 BCX0"><span class="NormalTextRun SCXW225938741 BCX0">Image Credit: </span><span class="NormalTextRun SpellingErrorV2Themed SCXW225938741 BCX0">mictoon</span><span class="NormalTextRun SCXW225938741 BCX0"> – stock.adobe.com</span></span><span class="EOP Selected SCXW225938741 BCX0" data-ccp-props="{"335551550":6,"335551620":6}"> </span></strong></p> </div>