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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EA patent foramen ovale (PFO) is common in the general population and has been associated with cryptogenic stroke, stroke following orthopedic or neurosurgery, migraines with aura, and sleep apnea, as well as other less common conditions (ie, orthodexia, decompression illness, and altitude sickness). This article examines studies on PFO closures, complications with these devices, and left atrial appendage procedures.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology genomics\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EA patent foramen ovale (PFO) is common in the general population and has been associated with cryptogenic stroke, stroke following orthopedic or neurosurgery, migraines with aura, and sleep apnea, as well as other less common conditions (ie, orthodexia, decompression illness, and altitude sickness). Jonathan M. Tobis, MD, David Geffen School of Medicine, UCLA, Los Angeles, California, USA, discussed some of the studies that have examined PFO closure in these patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EIt remains controversial whether PFO closure has benefit over medical management of the prevention of recurrent stroke. The Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care trial [RESPECT; Carroll JD et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013] compared the Amplatzer PFO closure device (St. Jude\u0027s Medical) with medical management with antiplatelet or warfarin therapy in patients with a PFO and prior cryptogenic stroke. Although the primary intention-to-treat (ITT) analysis showed no significant additional benefit associated with PFO closure (HR, 0.49; 95% CI, 0.22 to 1.11; log-rank p = .08), closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analyses. The overall frequency of serious adverse events did not differ significantly between the two groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Stroke (PC) trial also compared the Amplatzer device with medical therapy alone. Over 4 years, closure of a patent foramen ovale for secondary stroke prevention did not result in a significant reduction in the risk of recurrent embolic events or death compared with medical therapy [Meier B et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013].\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EWhen these two studies were combined in a meta-analysis, the difference in favor of the device was significant (p = .02), even in the ITT analysis [Tobis J. \u003Cem\u003EClev Clin J Med\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EPFO is also present in \u223c50% of individuals with migraine and aura and 50% of individuals with cryptogenic stroke also have migraines [Tobis JM, Azarbal B. \u003Cem\u003ETex Heart Inst J\u003C\/em\u003E 2005]. Data suggest that people who have migraines with or without aura are at a higher risk of ischemic stroke than is the general population (2.3 and 1.8 times greater risk, respectively [Etminan T et al. \u003Cem\u003EBMJ\u003C\/em\u003E 2005], and almost all are due to the presence of a PFO [Wilmshurt P et al. \u003Cem\u003EAm J Cardiol\u003C\/em\u003E 2006]. The Premium Migraine Trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00355056\u0026amp;atom=%2Fspmdc%2F14%2F13%2F29.atom\u0022\u003ENCT00355056\u003C\/a\u003E] is currently evaluating the impact of PFO closure on the incidence of disabling migraine headaches (ie, 6 to 14 days per month). Results are expected during 2014. Studies have also shown a higher frequency of PFO in patients with obstructive sleep apnea [Beelke M et al. \u003Cem\u003ESleep Med\u003C\/em\u003E 2003], but randomized trials are needed to assess whether closure is beneficial in these patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EDr. Tobis recommends that the cardiologist and neurologist cooperate in the management of patients with PFO and stroke or migraines and that the cardiologist should assume management responsibility for patients with PFO and other conditions, except those with sleep apnea, who should be managed by a sleep specialist.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EIn the United States, transcatheter atrial septal defect (ASD) closure in the adult patient is performed using either the Amplatzer Atrial Septal Occluder (ASO) or GORE Helex Septal Occluder HSO). Damien Kenny, MB, MD, Rush University Medical Center, Chicago, Illinois, USA, noted that, while both devices are safe and effective, there is an inconsistency of reporting the frequency of erosions and other complications with these devices, and he cautioned the audience to take note of a basis for any calculation of event rates (actual implant versus sales).\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EIn both the ASO and HSO US pivotal trials, the overall rate of complications was lower with a percutaneous device as compared with surgical ASD closure; however, this did not reach statistical significance in the Helex trial [Jones TK et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2007; Du ZD et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2002]. The most common device-related event in both studies was device embolization (0.2% with the ASO; 1.7% with the HSO).\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAt follow-up, the three most important complications reported are arrhythmia, embolization, and erosion for the ASO and periprocedural pericardial effusions, vessel damage, and thrombus formation for the HSO. Fracture is not an issue with the ASO; however, fracture rates as high as 6.4% have been reported for the HSO [Fagan T et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2009]. A recent meta-analysis of 28,142 patients (203 studies; 11 different devices) reported periprocedural rates of arrhythmia and heart block with ASD device closure of just under 2.5% and 0.4%, respectively [Abaci A et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2013]. Rates of thrombosis with both devices are low [Krumsdorf U et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2004]. A recent efficacy and long-term (5 years) safety study comparing transcatheter versus surgical closure of ASD reported that transcatheter ASD closure was associated with a higher long-term re-intervention rate (7.9% vs 0.3% at 5 years, p = .0038), with a mortality rate similar to surgery (5.3% vs 6.3% at 5 years, p = 1.00; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigures 1\u003C\/a\u003E and \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003E2\u003C\/a\u003E) [Kotowycz MA et al. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2013].\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Reintervention After ASD Closure Kaplan-Meier Estimates for Time to First Reintervention During the First 5 years of Follow-up\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1789933531\u0022 data-figure-caption=\u0022Reintervention After ASD Closure Kaplan-Meier Estimates for Time to First Reintervention During the First 5 years of Follow-up\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16417\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EReintervention After ASD Closure Kaplan-Meier Estimates for Time to First Reintervention During the First 5 years of Follow-up\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EASD=atrial septal defect.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced from Kotwycz MA et al. Long-Term Outcomes After Surgical Versus Transcatheter Closure of Atrial Septal Defects in Adults. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2013;6(5):497\u2013503. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Long-Term Mortality After ASD Closure Kaplan-Meier Estimates for Mortality During the First 5 Years of Follow-up\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1789933531\u0022 data-figure-caption=\u0022Long-Term Mortality After ASD Closure Kaplan-Meier Estimates for Mortality During the First 5 Years of Follow-up\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/29\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16418\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003ELong-Term Mortality After ASD Closure Kaplan-Meier Estimates for Mortality During the First 5 Years of Follow-up\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EASD=atrial septal defect.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced from Kotwycz MA et al. Long-Term Outcomes After Surgical Versus Transcatheter Closure of Atrial Septal Defects in Adults. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2013;6(5):497\u2013503. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EDevice erosion is an ongoing concern. One study with 28 patients noted higher rates of erosion in patients with deficient aortic rims and with the use of oversized devices [Amin Z et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2004]. Dr. Kenny noted a high proportion of women (3:1) in this study and suggested that not only were the devices potentially oversized but also that the 26-, 18-, and 34-mm devices appeared overly represented. Of possible concern with these particular devices (as well as the 11-mm device) is the rigidity of the wire mesh.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EDr. Kenny recommends the use of CT if there is a clinical suspicion of \u201csubacute\u201d erosion, more attention to patient sex and device size, and a greater appreciation for how all these parts fit together.\u003C\/p\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EHeart Teams have been used with good success for transcatheter aortic and mitral valve replacement procedures. Mark Reisman, MD, University of Washington, Seattle, Washington, USA, discussed the skills needed for performing left atrial appendage (LAA) closure with the Watchman device.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003ELAA closure using the Watchman device requires both technical skills and a thorough understanding of the LA anatomy. The fragile structures involved in the procedure, variability in the size and shape of the LAA, the location of the pulmonary veins (PV) in relation to the LAA, and the need to be careful of the pericardium are important aspects when accessing the LA via the transseptal approach. Meticulous attention to sheath management, the evolving role of atrial fibrillation ablation techniques, and the correct us of oral anticoagulants are also part of the needed skill set for performing this procedure.\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EPotential members of an LAA team include an imaging specialist comfortable with interventions, a partnership\/collaboration with a structural heart program (interventional cardiologist [IC] and electrophysiologist [EP]), as well as someone familiar with PV ablation and bailout therapies. Patients should undergo heart contrast computed tomography to determine suitable LAA position, orientation, size, and number of lobes.\u003C\/p\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EA multiphase training program has been created to ensure comprehensive device and procedure training for surgeons. It includes transseptal puncture experience, catheter manipulation in the LA, device delivery and deployment experience, transesophageal echocardiogram and intracardiac echo imaging skills, understanding of anticoagulation, and cardiac intervention complication management skills, including pericardial effusions. During training, practice dynamics are explored, involving an interventional\/heart team approach and collaborative EP and IC procedure involvement, assessment for willingness to engage in Therapy Awareness initiatives, ability to draw referrals from regional physicians, and practice dynamics that allow for a cadence of cases to build procedural confidence.\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003ELAA closure using the Watchman device requires a hospital infrastructure that supports Watchman procedures, including highly experienced interventional cardiologists, a multispecialty implanting team, and a dedicated echocardiologist.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/13\/29.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzoz81\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzoz81\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}