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has significantly reduced stroke risk&#44; up to 40&#37; of patients with AF are untreated&#44; due to intolerance&#44; bleeding&#44; or other contraindications&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#44;5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Left atrial appendage occlusion &#40;LAAO&#41; aims to perform complete mechanical blockage of the LAA&#44; which is the anatomical origin of around 90&#37; of the thrombi that cause stroke&#46; The two main trials comparing LAAO with warfarin&#44; PROTECT AF and PREVAIL&#44; demonstrated that closure is non-inferior for the prevention of ischemic stroke and is superior for the prevention of cardiovascular and all-cause mortality&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;5&#44;6</span></a> However&#44; the randomized clinical trials were restricted to a single device and did not include patients who were intolerant to anticoagulation&#46; Percutaneous LAAO&#44; like AF ablation&#44; has not been properly assessed in randomized trials with the standard current comparator&#44; DOACs&#44; in terms of major cardiovascular events&#46; There have&#44; of course&#44; been large observational studies that suggest a reduction in stroke risk compared with risk estimates such as the CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc score&#46; These studies often included patients who were only prescribed antiplatelet agents or took no antiplatelet or anticoagulant agents at all following the implantation procedure&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> Furthermore&#44; there is no evidence that the presence of peri-device leak is associated with subsequent thromboembolic events&#44; although these studies had short follow-up periods and varying antithrombotic regimens &#40;antiplatelet&#44; anticoagulant or both&#41;&#46; In the largest randomized trial&#44; PROTECT AF &#40;455 participants&#41;&#44; and in 339 patients from the multicenter Amplatzer Cardiac Plug study&#44; the number of ischemic events was low &#40;16 and seven&#44; respectively&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The study by Paiva et al&#46; published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> is highly relevant to this question&#46; They set out to determine whether the risk-benefit ratio of LAAO for cerebrovascular prevention is superior to that of DOACs over a mean follow-up of 17 months&#46; This prospective observational study assessed 302 patients &#40;62 of whom were excluded&#41; with non-valvular AF at high risk for stroke admitted to a single reference center between 2015 and 2017&#46; The authors concluded that LAAO &#40;n&#8239;&#61;&#8239;91&#41; 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This naturally reflects the different profiles of these two patient groups but does not consistently favor the LAAO group&#46; Three devices used in real-world practice&#44; selected by individual operators&#44; are analyzed&#58; the AMPLATZER Cardiac Plug&#8482; or Amulet&#8482; &#40;St&#46; Jude Medical&#41; and the WATCHMAN&#8482; &#40;Boston Scientific&#41;&#46; The study portrays real-world contemporary anticoagulant and antiplatelet regimens following LAAO&#44; including the fact that a fifth of these patients stopped antiplatelet treatment six months after device implantation&#44; and observes that mortality in the DOACs group was initially higher&#44; while in the LAAO group it was distributed more evenly over the follow-up period&#46; Finally&#44; it reports a very real risk of fatal bleeding&#44; with two deaths due to severe bleeding&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The authors point out certain methodological limitations&#46; Besides the biases inherent to the study design&#44; its statistical power &#40;approximate and not always consensual&#41; was estimated at 51&#37;&#44; indicating a 49&#37; probability of not finding a statistically significant difference and a 5&#37; probability of finding a difference that does not exist &#40;type 1 error&#41;&#46; However&#44; this does not invalidate the conclusions&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">It is important to bear in mind that despite progress&#44; stroke prevention&#44; by LAAO and generally in the context of non-valvular AF&#44; still faces several challenges&#46; The CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc and HAS-BLED risk scores&#44; which are recommended in the guidelines&#44; are useful tools but have their limitations&#46; Even in the best circumstances&#44; they are not particularly robust for predicting individual stroke and bleeding risk&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Individuals who stand to derive greater benefit from LAAO &#8211; those who are intolerant of chronic anticoagulation &#8211; are excluded from studies of the procedure&#44; despite its growing use in these cases&#46; For example&#44; a recent meta-analysis of 12 observational studies &#40;seven retrospective and five prospective&#41; in patients with a history of intracranial bleeding concluded that LAAO can potentially be an effective and relatively safe treatment option after shared decision-making with individual patients&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The presence on screening exams of thrombi in the LAA that do not respond to anticoagulation is another exclusion criterion in the major studies&#44; due to concerns that they increase the risk of complications&#46; The impact of embolic protection devices in such cases is not known&#44; but there have been reports of successful implantation using appropriate techniques and selected devices&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The LAA&#8217;s considerable anatomical variability in shape&#44; volume&#44; length and width requires a variety of devices to be available&#46; In addition&#44; fibrosis of this structure may have prognostic impact&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Increasing access to three-dimensional ICE may help to widen the use of LAAO&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;11</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">In conclusion&#44; the study by Paiva et al&#46; is original and has the merit of describing the profile of a real-world population of Portuguese patients with non-valvular AF at high stroke risk&#46; It indicates that percutaneous LAAO is safe and effective compared to DOAC therapy in the medium term&#46; The use of LAAO is supported by the pressing need for therapeutic alternatives to chronic OAC&#44; but assessment of the prognostic value of the procedure requires further validation in randomized trials&#44; led by individual researchers or by medical societies&#46; That is our present challenge&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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My patient cannot or will not comply with oral anticoagulation. Do I cross my fingers or cross the septum?
O meu doente não pode, não quer ou não cumpre a anti-coagulação oral. Cruzo os dedos ou cruzo o septo?
Rui Campante Telesa,b
a Hospital de Santa Cruz, Unidade de Intervenção Cardiovascular, Carnaxide, Portugal
b Nvna Medical School, Centro de Estudos de Doenças Crónicas, Lisboa, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Atrial fibrillation &#40;AF&#41; is a prevalent disease that affects up to 3&#37; of the population and accounts for 1&#8211;3&#37; of health care costs due to stroke&#44; sudden death&#44; heart failure&#44; unplanned hospitalizations and other complications&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Once non-valvular AF is diagnosed&#44; a multidisciplinary and multifaceted approach is required&#44; including acute management&#44; treatment of underlying and concomitant conditions&#44; rate and rhythm control&#44; and prevention of the most feared complication&#44; stroke&#46; The tendency for blood pooling in the left atrium and left atrial appendage &#40;LAA&#41; due to AF was first reported in 1996&#44; and although oral anticoagulation with vitamin K antagonists and direct oral anticoagulants &#40;DOACs&#41; has significantly reduced stroke risk&#44; up to 40&#37; of patients with AF are untreated&#44; due to intolerance&#44; bleeding&#44; or other contraindications&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#44;5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Left atrial appendage occlusion &#40;LAAO&#41; aims to perform complete mechanical blockage of the LAA&#44; which is the anatomical origin of around 90&#37; of the thrombi that cause stroke&#46; The two main trials comparing LAAO with warfarin&#44; PROTECT AF and PREVAIL&#44; demonstrated that closure is non-inferior for the prevention of ischemic stroke and is superior for the prevention of cardiovascular and all-cause mortality&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;5&#44;6</span></a> However&#44; the randomized clinical trials were restricted to a single device and did not include patients who were intolerant to anticoagulation&#46; Percutaneous LAAO&#44; like AF ablation&#44; has not been properly assessed in randomized trials with the standard current comparator&#44; DOACs&#44; in terms of major cardiovascular events&#46; There have&#44; of course&#44; been large observational studies that suggest a reduction in stroke risk compared with risk estimates such as the CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc score&#46; These studies often included patients who were only prescribed antiplatelet agents or took no antiplatelet or anticoagulant agents at all following the implantation procedure&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> Furthermore&#44; there is no evidence that the presence of peri-device leak is associated with subsequent thromboembolic events&#44; although these studies had short follow-up periods and varying antithrombotic regimens &#40;antiplatelet&#44; anticoagulant or both&#41;&#46; In the largest randomized trial&#44; PROTECT AF &#40;455 participants&#41;&#44; and in 339 patients from the multicenter Amplatzer Cardiac Plug study&#44; the number of ischemic events was low &#40;16 and seven&#44; respectively&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The study by Paiva et al&#46; published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> is highly relevant to this question&#46; They set out to determine whether the risk-benefit ratio of LAAO for cerebrovascular prevention is superior to that of DOACs over a mean follow-up of 17 months&#46; This prospective observational study assessed 302 patients &#40;62 of whom were excluded&#41; with non-valvular AF at high risk for stroke admitted to a single reference center between 2015 and 2017&#46; The authors concluded that LAAO &#40;n&#8239;&#61;&#8239;91&#41; was not inferior to long-term treatment with NOAC &#40;n&#8239;&#61;&#8239;149&#41; for preventing the composite endpoint of death&#44; stroke and major bleeding&#46; This result differs from those of previous large observational studies&#44; in which the reduction in stroke risk was similar in patients who received only antiplatelets&#44; or neither antiplatelets nor anticoagulants&#44; after the procedure&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The study has several merits&#46; It provides a clear picture of the skill and expertise of a highly-regarded Portuguese group with extensive experience in this procedure&#44; whose success rate is 96&#46;3&#37;&#44; and who make use of guidance by intracardiac echocardiography &#40;ICE&#41; and transesophageal echocardiography&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> It is unusual in bringing together two different high stroke risk case mixes&#58; primary and secondary prevention by LAAO and secondary prevention with DOACs in the Neurology AF registry&#46; This naturally reflects the different profiles of these two patient groups but does not consistently favor the LAAO group&#46; Three devices used in real-world practice&#44; selected by individual operators&#44; are analyzed&#58; the AMPLATZER Cardiac Plug&#8482; or Amulet&#8482; &#40;St&#46; Jude Medical&#41; and the WATCHMAN&#8482; &#40;Boston Scientific&#41;&#46; The study portrays real-world contemporary anticoagulant and antiplatelet regimens following LAAO&#44; including the fact that a fifth of these patients stopped antiplatelet treatment six months after device implantation&#44; and observes that mortality in the DOACs group was initially higher&#44; while in the LAAO group it was distributed more evenly over the follow-up period&#46; Finally&#44; it reports a very real risk of fatal bleeding&#44; with two deaths due to severe bleeding&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The authors point out certain methodological limitations&#46; Besides the biases inherent to the study design&#44; its statistical power &#40;approximate and not always consensual&#41; was estimated at 51&#37;&#44; indicating a 49&#37; probability of not finding a statistically significant difference and a 5&#37; probability of finding a difference that does not exist &#40;type 1 error&#41;&#46; However&#44; this does not invalidate the conclusions&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">It is important to bear in mind that despite progress&#44; stroke prevention&#44; by LAAO and generally in the context of non-valvular AF&#44; still faces several challenges&#46; The CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc and HAS-BLED risk scores&#44; which are recommended in the guidelines&#44; are useful tools but have their limitations&#46; Even in the best circumstances&#44; they are not particularly robust for predicting individual stroke and bleeding risk&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Individuals who stand to derive greater benefit from LAAO &#8211; those who are intolerant of chronic anticoagulation &#8211; are excluded from studies of the procedure&#44; despite its growing use in these cases&#46; For example&#44; a recent meta-analysis of 12 observational studies &#40;seven retrospective and five prospective&#41; in patients with a history of intracranial bleeding concluded that LAAO can potentially be an effective and relatively safe treatment option after shared decision-making with individual patients&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The presence on screening exams of thrombi in the LAA that do not respond to anticoagulation is another exclusion criterion in the major studies&#44; due to concerns that they increase the risk of complications&#46; The impact of embolic protection devices in such cases is not known&#44; but there have been reports of successful implantation using appropriate techniques and selected devices&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The LAA&#8217;s considerable anatomical variability in shape&#44; volume&#44; length and width requires a variety of devices to be available&#46; In addition&#44; fibrosis of this structure may have prognostic impact&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Increasing access to three-dimensional ICE may help to widen the use of LAAO&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;11</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">In conclusion&#44; the study by Paiva et al&#46; is original and has the merit of describing the profile of a real-world population of Portuguese patients with non-valvular AF at high stroke risk&#46; It indicates that percutaneous LAAO is safe and effective compared to DOAC therapy in the medium term&#46; The use of LAAO is supported by the pressing need for therapeutic alternatives to chronic OAC&#44; but assessment of the prognostic value of the procedure requires further validation in randomized trials&#44; led by individual researchers or by medical societies&#46; That is our present challenge&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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ISSN: 21742049
Original language: English
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Revista Portuguesa de Cardiologia (English edition)
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