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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\u003EEmerging technologies that address concerns that are not resolved by medication are discussed in this article, including partial circulatory support for medically refractory heart failure patients as well as a low-viscosity polymer that can be used to treat damaged tissue after acute myocardial infarction.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EEmerging technologies that address concerns that are not resolved by medication were the subject of discussion at a special late-breaking clinical trial session. Two notable presentations at that session included partial circulatory support for medically refractory heart failure patients and a low-viscosity polymer that can be used to treat damaged tissue after acute myocardial infarction (AMI).\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPartial Circulatory Support Improves Heart Function in Medically Refractory Heart Failure Patients\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003ETraditional ventricular assist devices (VADs) provide full support, taking over the work of the heart\u0027s main pumping chamber in end-stage heart failure patients who are in or near cardiogenic shock. Their use is restricted, however, because they require major surgery. Daniel Burkhoff, MD, PhD, Columbia University, New York, NY, presented results from the first-in-man study of the Synergy\u003Csup\u003E\u00ae\u003C\/sup\u003E Pocket Micro-pump (CircuLite, Saddlebrook, NJ), a small (the size of a AA battery, weight \u223c25 grams) device that can be implanted (off pump) with a mini-thoracotomy. The pump is positioned subcutaneously in a right subclavian pacemaker-like pocket. The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery. The Synergy micro-pump pumps 2.5\u20133.0 L\/min.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe primary objective of the study was to determine if partial support would be adequate to provide long-term benefits in New York Heart Association (NYHA) Class IIIb and early Class IV patients. Study endpoints included: pump performance, hemodynamic benefits, end organ function, exercise tolerance, and safety.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe study population comprised 16 subjects (13 men, 3 women; mean age 52 years) with NYHA Class IIIb (11 subjects) or early Class IV (5 subjects) heart failure despite optimal medical therapy, who were eligible for heart transplant and had a life expectancy \u22656 months without full VAD support. The average duration of support was 90 days (range 6 to 213 days).\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThirteen of the 16 patients were alive at 3 months. Results for 9 patients who were followed for a mean of 10 weeks showed significant increases in mean arterial pressure, cardiac index, and systolic and diastolic pulmonary arterial pressure (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Significant (p=0.003) reductions were also seen in capillary wedge pressure (29 \u00b1 5 vs 17 \u00b1 5). Adverse events (AEs) included 10 incidents of secondary thrombus in 9 patients. All occurred in patients who were using a first-generation pump, which has now been modified and tested in 11 patients for as long as 6 months without any incidence of thrombus. Other AEs included pump pocket hematoma (3 incidents), surgical bleeding, hemolysis, and sepsis (2 incidents each).\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\/9\/2\/21\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Long-term Hemodynamic Effects at 10\u0026#xB1;6 weeks (n=9).\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-69144017\u0022 data-figure-caption=\u0022Long-term Hemodynamic Effects at 10\u0026#xB1;6 weeks (n=9).\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\/9\/2\/21\/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\/9\/2\/21\/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\/9\/2\/21\/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\/11509\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003ELong-term Hemodynamic Effects at 10\u00b16 weeks (n=9).\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EDr. Burkhoff concluded that the Synergy Micro-Pump has the potential to expand the use of mechanical circulatory support to a large population of patients with severe medically refractory CHF who currently are not sick enough to justify the risks that are associated with implantation of a full-support LVAD.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EBL-1040 Myocardial Implant for the Treatment of Acute Myocardial Infarction\u003C\/h2\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EAlthough percutaneous coronary interventions (PCIs) and stents have done much to improve outcomes after AMI, treatment of the damaged tissue during the healing process has been lacking. Jonathan Leor, MD, Neufeld Cardiac Research Institute, Sheba Medical Center, Tel-Hashomer, Israel, presented the results of a pilot study that sought to determine the safety and efficacy of BL-1040 (BioLineRX, Jerusalem, Israel), a partially crosslinked alginate-based liquid polymer, in preventing deterioration of the damaged myocardium. BL-1040 is injected via a catheter in the infarct-related artery following PCI. It penetrates through the damaged capillaries into the damaged heart tissue, where it settles and turns into a gel that acts like a 3-dimensional scaffold and prevents thinning of the left ventricular wall. After about 6 weeks, BL-1040 is reabsorbed and excreted through the kidney.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003ETo be eligible for the study, subjects were required to be aged between 18 and 75 years, have experienced a first AMI (with 4 of 16 akinetic segments) with successful revascularization with PCI within 7 days, and have 1 or more of the following: left ventricular ejection fraction (LVEF) \u0026gt;20% and \u0026lt;45%; peak creatine kinase \u0026gt;2000 IU; and infarct size \u0026gt;25%, as measured by MRI. The primary study outcomes included adverse events (ie, MI, ventricular arrhythmias, cardiovascular hospitalization, symptomatic heart failure, renal failure, stroke, and death). Secondary outcome measures were: change from baseline in LV dimensions, regional (infarct-related) dimensions, global wall motion score, and LVEF. Follow-up visits occurred at 30, 60, 90, and 180 days post-procedure. Of the 10 subjects who have been treated to date, 4 have completed the 6-month follow-up period and 1 patient has completed the 3-month follow-up visit. Five patients have been recruited since January 2009.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EAt 90 days, LVEF increased to 49% (vs 47% at baseline). Diastolic volume decreased from 132 ml to 122 ml, and LV diastolic volume decreased from 67 ml to 62 ml. Pro-brain natriuretic peptide (BNP) levels went from 830 pg\/ml to 480 pg\/ml. No adverse events have been reported. The investigators have concluded that the use of BL-1010 is feasible and safe. Based on these early results, the ISMB unanimously approved opening enrollment to the remaining 25 patients. The study is expected to be completed in the third quarter of 2009.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2009 MD Conference Express\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\/9\/2\/21.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?nzmknd\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?nzmknd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}