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<meta name="DC.Title" content="HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results" />
<meta name="DC.Identifier" content="10.3174/ajnr.A0936" />
<meta name="DC.Date" content="2008-02-01" />
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<meta name="DC.Description" content="BACKGROUND AND PURPOSE: Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS.

MATERIALS AND METHODS: Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis.

RESULTS: Four hundred ninety-nine patients were recruited. Coiling was successful in 98.6%. Mean aneurysm size was 6.5 mm (26% were ≥10 mm), 53% were recently ruptured aneurysms, and an assist device was used in 46%. Seventy procedural adverse events were reported in hydrogel coils and 86 in control arms. The 3-month mortality rate was 3.6% in hydrogel coils and 2.0% in control arms; the difference was not significant ( P = .6). There was a lower 2-month mortality rate in the HELPS subarachnoid hemorrhage cohort (4.1%) than would be anticipated from the International Subarachnoid Aneurysm Trial (7%). There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms. Ninety-six percent of patients discharged were World Federation of Neurosurgeons grade 0–2 at discharge. No difference was found between arms in the operator assessment of angiographic occlusions ( P = .3).

CONCLUSION: These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum." />
<meta name="DC.Contributor" content="P.M. White" />
<meta name="DC.Contributor" content="S.C. Lewis" />
<meta name="DC.Contributor" content="H. Nahser" />
<meta name="DC.Contributor" content="R.J. Sellar" />
<meta name="DC.Contributor" content="T. Goddard" />
<meta name="DC.Contributor" content="A. Gholkar" />
<meta name="DC.Contributor" content="on behalf of the HELPS Trial Collaboration" />
<meta name="article:published_time" content="2008-02-01" />
<meta name="article:section" content="EXPEDITED PUBLICATION" />
<meta name="citation_title" content="HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results" />
<meta name="citation_abstract" lang="en" content="&lt;p&gt;&lt;b&gt;BACKGROUND AND PURPOSE:&lt;/b&gt; Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS.&lt;/p&gt;&lt;p&gt;&lt;b&gt;MATERIALS AND METHODS:&lt;/b&gt; Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis.&lt;/p&gt;&lt;p&gt;&lt;b&gt;RESULTS:&lt;/b&gt; Four hundred ninety-nine patients were recruited. Coiling was successful in 98.6%. Mean aneurysm size was 6.5 mm (26% were ≥10 mm), 53% were recently ruptured aneurysms, and an assist device was used in 46%. Seventy procedural adverse events were reported in hydrogel coils and 86 in control arms. The 3-month mortality rate was 3.6% in hydrogel coils and 2.0% in control arms; the difference was not significant (&lt;i&gt;P&lt;/i&gt; = .6). There was a lower 2-month mortality rate in the HELPS subarachnoid hemorrhage cohort (4.1%) than would be anticipated from the International Subarachnoid Aneurysm Trial (7%). There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms. Ninety-six percent of patients discharged were World Federation of Neurosurgeons grade 0–2 at discharge. No difference was found between arms in the operator assessment of angiographic occlusions (&lt;i&gt;P&lt;/i&gt; = .3).&lt;/p&gt;&lt;p&gt;&lt;b&gt;CONCLUSION:&lt;/b&gt; These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum.&lt;/p&gt;" />
<meta name="citation_journal_title" content="American Journal of Neuroradiology" />
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<meta name="citation_firstpage" content="217" />
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<meta name="citation_author" content="P.M. White" />
<meta name="citation_author" content="S.C. Lewis" />
<meta name="citation_author" content="H. Nahser" />
<meta name="citation_author" content="R.J. Sellar" />
<meta name="citation_author" content="T. Goddard" />
<meta name="citation_author" content="A. Gholkar" />
<meta name="twitter:title" content="HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results" />
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<meta name="twitter:description" content="BACKGROUND AND PURPOSE: Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS.

MATERIALS AND METHODS: Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis.

RESULTS: Four hundred ninety-nine patients were recruited. Coiling was successful in 98.6%. Mean aneurysm size was 6.5 mm (26% were ≥10 mm), 53% were recently ruptured aneurysms, and an assist device was used in 46%. Seventy procedural adverse events were reported in hydrogel coils and 86 in control arms. The 3-month mortality rate was 3.6% in hydrogel coils and 2.0% in control arms; the difference was not significant ( P = .6). There was a lower 2-month mortality rate in the HELPS subarachnoid hemorrhage cohort (4.1%) than would be anticipated from the International Subarachnoid Aneurysm Trial (7%). There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms. Ninety-six percent of patients discharged were World Federation of Neurosurgeons grade 0–2 at discharge. No difference was found between arms in the operator assessment of angiographic occlusions ( P = .3).

CONCLUSION: These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum." />
<meta name="og-title" property="og:title" content="HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results" />
<meta name="og-url" property="og:url" content="http://ajnr-stage2.stage.highwire.org/content/29/2/217" />
<meta name="og-site-name" property="og:site_name" content="American Journal of Neuroradiology" />
<meta name="og-description" property="og:description" content="BACKGROUND AND PURPOSE: Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS.

MATERIALS AND METHODS: Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis.

RESULTS: Four hundred ninety-nine patients were recruited. Coiling was successful in 98.6%. Mean aneurysm size was 6.5 mm (26% were ≥10 mm), 53% were recently ruptured aneurysms, and an assist device was used in 46%. Seventy procedural adverse events were reported in hydrogel coils and 86 in control arms. The 3-month mortality rate was 3.6% in hydrogel coils and 2.0% in control arms; the difference was not significant ( P = .6). There was a lower 2-month mortality rate in the HELPS subarachnoid hemorrhage cohort (4.1%) than would be anticipated from the International Subarachnoid Aneurysm Trial (7%). There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms. Ninety-six percent of patients discharged were World Federation of Neurosurgeons grade 0–2 at discharge. No difference was found between arms in the operator assessment of angiographic occlusions ( P = .3).

CONCLUSION: These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum." />
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<div id="hw-article-author-popups-top-node-7867--61578503649" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">P.M. White </div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=P.M.%2BWhite%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=White%20P&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AP.M.%2BWhite%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-1"><div class="author-tooltip-name">S.C. 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        	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-volume highwire-cite-metadata">Vol. 29</span>, <span  class="highwire-cite-metadata-issue highwire-cite-metadata">Issue 2 </span><div  class="highwire-cite-metadata-pubdate highwire-cite-metadata">February 2008 </div></div>
      
      
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      <div class="highwire-cite-title">HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">P.M.</span> <span class="nlm-surname">White</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">S.C.</span> <span class="nlm-surname">Lewis</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">H.</span> <span class="nlm-surname">Nahser</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">R.J.</span> <span class="nlm-surname">Sellar</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">T.</span> <span class="nlm-surname">Goddard</span></span>, <span class="highwire-citation-author" data-delta="5"><span class="nlm-given-names">A.</span> <span class="nlm-surname">Gholkar</span></span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Feb 2008, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">29 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(2) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">217-223; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">DOI:</span> 10.3174/ajnr.A0936 </span></div>
  
  
  
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      <div class="highwire-cite-title">HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">P.M.</span> <span class="nlm-surname">White</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">S.C.</span> <span class="nlm-surname">Lewis</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">H.</span> <span class="nlm-surname">Nahser</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">R.J.</span> <span class="nlm-surname">Sellar</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">T.</span> <span class="nlm-surname">Goddard</span></span>, <span class="highwire-citation-author" data-delta="5"><span class="nlm-given-names">A.</span> <span class="nlm-surname">Gholkar</span></span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Feb 2008, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">29 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(2) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">217-223; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">DOI:</span> 10.3174/ajnr.A0936 </span></div>
  
  
  
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