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Transmyocardial revascularization devices: technology update

Identifieur interne : 000425 ( Pmc/Curation ); précédent : 000424; suivant : 000426

Transmyocardial revascularization devices: technology update

Auteurs : Bogdan A. Kindzelski [États-Unis] ; Yifu Zhou [États-Unis] ; Keith A. Horvath [États-Unis]

Source :

RBID : PMC:4274152

Abstract

Transmyocardial laser revascularization (TMR) emerged as treatment modality for patients with diffuse coronary artery disease not amendable to percutaneous or surgical revascularization. The procedure entails the creation of laser channels within ischemic myocardium in an effort to better perfuse these areas. Currently, two laser devices are approved by the US Food and Drug Administration for TMR – holmium:yttrium–aluminum–garnet and CO2. The two devices differ in regard to energy outputs, wavelengths, ability to synchronize with the heart cycle, and laser–tissue interactions. These differences have led to studies showing different efficacies between the two laser devices. Over 50,000 procedures have been performed worldwide using TMR. Improvements in angina stages, quality of life, and perfusion of the myocardium have been demonstrated with TMR. Although several mechanisms for these improvements have been suggested, evidence points to new blood vessel formation, or angiogenesis, within the treated myocardium, as the major contributory factor. TMR has been used as sole therapy and in combination with coronary artery bypass grafting. Clinical studies have demonstrated that TMR is both safe and effective in angina relief long term. The objective of this review is to present the two approved laser devices and evidence for the safety and efficacy of TMR, along with future directions with this technology.


Url:
DOI: 10.2147/MDER.S51591
PubMed: 25565905
PubMed Central: 4274152

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PMC:4274152

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</TEI>
<pmc article-type="review-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Med Devices (Auckl)</journal-id>
<journal-id journal-id-type="iso-abbrev">Med Devices (Auckl)</journal-id>
<journal-id journal-id-type="publisher-id">Medical Devices: Evidence and Research</journal-id>
<journal-title-group>
<journal-title>Medical Devices (Auckland, N.Z.)</journal-title>
</journal-title-group>
<issn pub-type="epub">1179-1470</issn>
<publisher>
<publisher-name>Dove Medical Press</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">25565905</article-id>
<article-id pub-id-type="pmc">4274152</article-id>
<article-id pub-id-type="doi">10.2147/MDER.S51591</article-id>
<article-id pub-id-type="publisher-id">mder-8-011</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Review</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Transmyocardial revascularization devices: technology update</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Kindzelski</surname>
<given-names>Bogdan A</given-names>
</name>
<xref ref-type="aff" rid="af1-mder-8-011"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Zhou</surname>
<given-names>Yifu</given-names>
</name>
<xref ref-type="aff" rid="af1-mder-8-011"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Horvath</surname>
<given-names>Keith A</given-names>
</name>
<xref ref-type="aff" rid="af1-mder-8-011"></xref>
<xref ref-type="corresp" rid="c1-mder-8-011"></xref>
</contrib>
</contrib-group>
<aff id="af1-mder-8-011">Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA</aff>
<author-notes>
<corresp id="c1-mder-8-011">Correspondence: Keith A Horvath, Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Building 10 Room B1D47, 10 Center Drive, Bethesda, MD 20892, USA, Tel +1 301 451 7098, Fax +1 301 451 5459, Email
<email>horvathka@mail.nih.gov</email>
</corresp>
</author-notes>
<pub-date pub-type="collection">
<year>2015</year>
</pub-date>
<pub-date pub-type="epub">
<day>18</day>
<month>12</month>
<year>2014</year>
</pub-date>
<volume>8</volume>
<fpage>11</fpage>
<lpage>19</lpage>
<permissions>
<copyright-statement>© 2015 Kindzelski et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License</copyright-statement>
<copyright-year>2015</copyright-year>
<license>
<license-p>The full terms of the License are available at
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link>
. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.</license-p>
</license>
</permissions>
<abstract>
<p>Transmyocardial laser revascularization (TMR) emerged as treatment modality for patients with diffuse coronary artery disease not amendable to percutaneous or surgical revascularization. The procedure entails the creation of laser channels within ischemic myocardium in an effort to better perfuse these areas. Currently, two laser devices are approved by the US Food and Drug Administration for TMR – holmium:yttrium–aluminum–garnet and CO
<sub>2</sub>
. The two devices differ in regard to energy outputs, wavelengths, ability to synchronize with the heart cycle, and laser–tissue interactions. These differences have led to studies showing different efficacies between the two laser devices. Over 50,000 procedures have been performed worldwide using TMR. Improvements in angina stages, quality of life, and perfusion of the myocardium have been demonstrated with TMR. Although several mechanisms for these improvements have been suggested, evidence points to new blood vessel formation, or angiogenesis, within the treated myocardium, as the major contributory factor. TMR has been used as sole therapy and in combination with coronary artery bypass grafting. Clinical studies have demonstrated that TMR is both safe and effective in angina relief long term. The objective of this review is to present the two approved laser devices and evidence for the safety and efficacy of TMR, along with future directions with this technology.</p>
</abstract>
<kwd-group>
<title>Keywords</title>
<kwd>laser</kwd>
<kwd>revascularization</kwd>
<kwd>angiogenesis</kwd>
<kwd>coronary artery disease</kwd>
</kwd-group>
</article-meta>
</front>
<floats-group>
<fig id="f1-mder-8-011" position="float">
<label>Figure 1</label>
<caption>
<p>Illustration showing left thoracotomy and exposure of the heart for TMR.</p>
<p>
<bold>Notes:</bold>
The handpiece and 1 mm transmural channels in the myocardium are shown. The channels are created one per square centimeter, beginning inferiorly and moving superiorly to the anterior section of the heart. Total channel number depends on size and ischemic territory.</p>
<p>
<bold>Abbreviation:</bold>
TMR, transmyocardial revascularization.</p>
</caption>
<graphic xlink:href="mder-8-011Fig1"></graphic>
</fig>
<fig id="f2-mder-8-011" position="float">
<label>Figure 2</label>
<caption>
<p>Transmyocardial revascularization lasers.</p>
<p>
<bold>Notes:</bold>
(
<bold>A</bold>
) Heart Laser CO
<sub>2</sub>
Transmyocardial Revascularization System (Novadaq Technologies Inc., BC, Canada). (
<bold>B</bold>
) SolarGen TMR Ho:YAG Laser System (CardioGenesis Corporation, Foothill Ranch, CA, USA) with associated fiberoptic handpiece.</p>
<p>
<bold>Abbreviations:</bold>
Ho:YAG, holmium:yttrium–aluminum–garnet; TMR, transmyocardial revascularization.</p>
</caption>
<graphic xlink:href="mder-8-011Fig2"></graphic>
</fig>
<fig id="f3-mder-8-011" position="float">
<label>Figure 3</label>
<caption>
<p>Illustration of CO
<sub>2</sub>
laser.</p>
<p>
<bold>Notes:</bold>
Energy from the laser is delivered via hollow tubes and is reflected by mirrors to reach the epicardial surface of the heart. Transmural channels are created using a single 20 J pulse.</p>
</caption>
<graphic xlink:href="mder-8-011Fig3"></graphic>
</fig>
<fig id="f4-mder-8-011" position="float">
<label>Figure 4</label>
<caption>
<p>Stop-action photography of laser pulses.</p>
<p>
<bold>Notes:</bold>
(
<bold>A</bold>
) Stop-action photography of laser pulses created with the CO
<sub>2</sub>
laser. The CO
<sub>2</sub>
laser creates a clean and straight channel within the tissue. (
<bold>B</bold>
) Stop-action photography of laser pulses created with the Ho:YAG laser. The Ho:YAG laser creates wider explosive ablations within the tissue.</p>
<p>
<bold>Abbreviation:</bold>
Ho:YAG, holmium:yttrium–aluminum–garnet.</p>
</caption>
<graphic xlink:href="mder-8-011Fig4"></graphic>
</fig>
<fig id="f5-mder-8-011" position="float">
<label>Figure 5</label>
<caption>
<p>Angina relief at 12 months.</p>
<p>
<bold>Notes:</bold>
Summary of angina relief in five randomized controlled trials at 1-year follow-up as defined by a decrease of two or more angina classes. Column graph illustrates differences between medical management and transmyocardial revascularization plus medical management groups. Corresponding
<italic>P</italic>
-values are shown below the bars.</p>
<p>
<bold>Abbreviations:</bold>
MM, medical management; TMR, transmyocardial revascularization.</p>
</caption>
<graphic xlink:href="mder-8-011Fig5"></graphic>
</fig>
<fig id="f6-mder-8-011" position="float">
<label>Figure 6</label>
<caption>
<p>Procedural timeline for NIH Clinical Trial (NCT01557543) in patients undergoing TMR plus direct mesenchymal stem cell injections.</p>
<p>
<bold>Notes:</bold>
Preoperative MRI and echocardiography are done along with bone marrow harvest 3 weeks before TMR procedure. Mesenchymal stem cells are isolated from bone marrow and expanded ex vivo. Following laser channel creation during TMR, mesenchymal stem cells are injected into the ischemic myocardium. Follow-up MRI and echocardiography are done at 1 month, 3 months, 6 months, and 12 months and compared to baseline imaging.</p>
<p>
<bold>Abbreviations:</bold>
MRI, magnetic resonance imaging; NIH, National Institutes of Health; TMR, transmyocardial revascularization.</p>
</caption>
<graphic xlink:href="mder-8-011Fig6"></graphic>
</fig>
<table-wrap id="t1-mder-8-011" position="float">
<label>Table 1</label>
<caption>
<p>Canadian Cardiovascular Society Angina Classification System</p>
</caption>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th valign="top" align="left" rowspan="1" colspan="1">Class</th>
<th valign="top" align="left" rowspan="1" colspan="1">Description</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top" align="left" rowspan="1" colspan="1">I</td>
<td valign="top" align="left" rowspan="1" colspan="1">Ordinary physical activity, such as walking and climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation.</td>
</tr>
<tr>
<td valign="top" align="left" rowspan="1" colspan="1">II</td>
<td valign="top" align="left" rowspan="1" colspan="1">Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly; walking uphill; walking or stair climbing after meals, in cold, in wind, or under emotional stress; or only during the few hours after awakening. Angina occurs on walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions.</td>
</tr>
<tr>
<td valign="top" align="left" rowspan="1" colspan="1">III</td>
<td valign="top" align="left" rowspan="1" colspan="1">Marked limitations of ordinary physical activity. Angina occurs on walking one to two blocks on the level and climbing one flight of stairs in normal conditions and at a normal pace.</td>
</tr>
<tr>
<td valign="top" align="left" rowspan="1" colspan="1">IV</td>
<td valign="top" align="left" rowspan="1" colspan="1">Inability to carry on any physical activity without discomfort; anginal symptoms may be present at rest.</td>
</tr>
</tbody>
</table>
</table-wrap>
</floats-group>
</pmc>
</record>

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