Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry
Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized f...
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| Veröffentlicht in: | Circulation Journal 2019/11/25, Vol.83(12), pp.2443-2451 |
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| creator | Heeger, Christian-H. Phan, Huong-Lan Meyer-Saraei, Roza Fink, Thomas Sciacca, Vanessa Liosis, Spyridon Brüggemann, Ben Große, Niels Fahimi, Bezhad Sano, Makoto Kuck, Karl-Heinz Ouyang, Feifan Vogler, Julia Eitel, Charlotte Tilz, Roland Richard |
| description | Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.Conclusions:The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases. |
| doi_str_mv | 10.1253/circj.CJ-19-0766 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2313648996</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2313648996</sourcerecordid><originalsourceid>FETCH-LOGICAL-c623t-d3f1f31aa388d501032b060fa85c3cd56e7754dc56764fd583c16211cdba29b13</originalsourceid><addsrcrecordid>eNpFkcFu1DAURSNERUthzwp5yYIUO46dhF0bDcNUKaBO6dZy7OepR4lT7AQpu_kJVvwd_AiZZmg3tvXeuUeybhS9IfiMJIx-UNar7Vl5GZMixhnnz6ITQtMsTvMEP39487jIU3ocvQxhi3FSYFa8iI4pyXDOGDuJfq9BdU7HS3DgZW87h25tGGTTjGg5WA0aVTKARxfTqJu253UzY-sx9NAi03n0bWjazkk_oluwDq1CNzMfUQXSO-s2qBz8T3iP1tJAPyLpNFoYY5VU49_d7s_uF7q5A3S1uK5WX9A1bGzo_fgqOjKyCfD6cJ9G3z8tbsrPcfV1uSrPq1jxhPaxpoYYSqSkea4ZJpgmNebYyJwpqjTjkGUs1YrxjKdGs5wqwhNClK5lUtSEnkbvZu-9734MEHrR2qCgaaSDbggioYTyNC8KPqF4RpXvQvBgxL237fRzQbDYVyIeKhHlpSCF2FcyRd4e7EPdgn4M_O9gApYzsA293MAjIH1vVQMHY04n__58Uj8Rd9ILcPQfbMKk5w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2313648996</pqid></control><display><type>article</type><title>Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry</title><source>J-STAGE Free</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Heeger, Christian-H. ; Phan, Huong-Lan ; Meyer-Saraei, Roza ; Fink, Thomas ; Sciacca, Vanessa ; Liosis, Spyridon ; Brüggemann, Ben ; Große, Niels ; Fahimi, Bezhad ; Sano, Makoto ; Kuck, Karl-Heinz ; Ouyang, Feifan ; Vogler, Julia ; Eitel, Charlotte ; Tilz, Roland Richard</creator><creatorcontrib>Heeger, Christian-H. ; Phan, Huong-Lan ; Meyer-Saraei, Roza ; Fink, Thomas ; Sciacca, Vanessa ; Liosis, Spyridon ; Brüggemann, Ben ; Große, Niels ; Fahimi, Bezhad ; Sano, Makoto ; Kuck, Karl-Heinz ; Ouyang, Feifan ; Vogler, Julia ; Eitel, Charlotte ; Tilz, Roland Richard</creatorcontrib><description>Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.Conclusions:The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.</description><identifier>ISSN: 1346-9843</identifier><identifier>ISSN: 1347-4820</identifier><identifier>EISSN: 1347-4820</identifier><identifier>DOI: 10.1253/circj.CJ-19-0766</identifier><identifier>PMID: 31708555</identifier><language>eng</language><publisher>Japan: The Japanese Circulation Society</publisher><subject>Action Potentials ; Aged ; Atrial fibrillation ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - physiopathology ; Atrial Fibrillation - surgery ; Cardiac Catheters ; Catheter ablation ; Catheter Ablation - adverse effects ; Catheter Ablation - instrumentation ; Clinical Competence ; Equipment Design ; Female ; Heart Rate ; Humans ; Laser balloon ; Laser Therapy - adverse effects ; Laser Therapy - instrumentation ; Learning Curve ; Male ; Middle Aged ; Patient Safety ; Prospective Studies ; Pulmonary vein isolation ; Pulmonary Veins - physiopathology ; Pulmonary Veins - surgery ; Registries ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome</subject><ispartof>Circulation Journal, 2019/11/25, Vol.83(12), pp.2443-2451</ispartof><rights>2019 THE JAPANESE CIRCULATION SOCIETY</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c623t-d3f1f31aa388d501032b060fa85c3cd56e7754dc56764fd583c16211cdba29b13</citedby><cites>FETCH-LOGICAL-c623t-d3f1f31aa388d501032b060fa85c3cd56e7754dc56764fd583c16211cdba29b13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1877,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31708555$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Heeger, Christian-H.</creatorcontrib><creatorcontrib>Phan, Huong-Lan</creatorcontrib><creatorcontrib>Meyer-Saraei, Roza</creatorcontrib><creatorcontrib>Fink, Thomas</creatorcontrib><creatorcontrib>Sciacca, Vanessa</creatorcontrib><creatorcontrib>Liosis, Spyridon</creatorcontrib><creatorcontrib>Brüggemann, Ben</creatorcontrib><creatorcontrib>Große, Niels</creatorcontrib><creatorcontrib>Fahimi, Bezhad</creatorcontrib><creatorcontrib>Sano, Makoto</creatorcontrib><creatorcontrib>Kuck, Karl-Heinz</creatorcontrib><creatorcontrib>Ouyang, Feifan</creatorcontrib><creatorcontrib>Vogler, Julia</creatorcontrib><creatorcontrib>Eitel, Charlotte</creatorcontrib><creatorcontrib>Tilz, Roland Richard</creatorcontrib><title>Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry</title><title>Circulation Journal</title><addtitle>Circ J</addtitle><description>Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.Conclusions:The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.</description><subject>Action Potentials</subject><subject>Aged</subject><subject>Atrial fibrillation</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Atrial Fibrillation - surgery</subject><subject>Cardiac Catheters</subject><subject>Catheter ablation</subject><subject>Catheter Ablation - adverse effects</subject><subject>Catheter Ablation - instrumentation</subject><subject>Clinical Competence</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Heart Rate</subject><subject>Humans</subject><subject>Laser balloon</subject><subject>Laser Therapy - adverse effects</subject><subject>Laser Therapy - instrumentation</subject><subject>Learning Curve</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patient Safety</subject><subject>Prospective Studies</subject><subject>Pulmonary vein isolation</subject><subject>Pulmonary Veins - physiopathology</subject><subject>Pulmonary Veins - surgery</subject><subject>Registries</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1346-9843</issn><issn>1347-4820</issn><issn>1347-4820</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkcFu1DAURSNERUthzwp5yYIUO46dhF0bDcNUKaBO6dZy7OepR4lT7AQpu_kJVvwd_AiZZmg3tvXeuUeybhS9IfiMJIx-UNar7Vl5GZMixhnnz6ITQtMsTvMEP39487jIU3ocvQxhi3FSYFa8iI4pyXDOGDuJfq9BdU7HS3DgZW87h25tGGTTjGg5WA0aVTKARxfTqJu253UzY-sx9NAi03n0bWjazkk_oluwDq1CNzMfUQXSO-s2qBz8T3iP1tJAPyLpNFoYY5VU49_d7s_uF7q5A3S1uK5WX9A1bGzo_fgqOjKyCfD6cJ9G3z8tbsrPcfV1uSrPq1jxhPaxpoYYSqSkea4ZJpgmNebYyJwpqjTjkGUs1YrxjKdGs5wqwhNClK5lUtSEnkbvZu-9734MEHrR2qCgaaSDbggioYTyNC8KPqF4RpXvQvBgxL237fRzQbDYVyIeKhHlpSCF2FcyRd4e7EPdgn4M_O9gApYzsA293MAjIH1vVQMHY04n__58Uj8Rd9ILcPQfbMKk5w</recordid><startdate>20191125</startdate><enddate>20191125</enddate><creator>Heeger, Christian-H.</creator><creator>Phan, Huong-Lan</creator><creator>Meyer-Saraei, Roza</creator><creator>Fink, Thomas</creator><creator>Sciacca, Vanessa</creator><creator>Liosis, Spyridon</creator><creator>Brüggemann, Ben</creator><creator>Große, Niels</creator><creator>Fahimi, Bezhad</creator><creator>Sano, Makoto</creator><creator>Kuck, Karl-Heinz</creator><creator>Ouyang, Feifan</creator><creator>Vogler, Julia</creator><creator>Eitel, Charlotte</creator><creator>Tilz, Roland Richard</creator><general>The Japanese Circulation Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20191125</creationdate><title>Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry</title><author>Heeger, Christian-H. ; Phan, Huong-Lan ; Meyer-Saraei, Roza ; Fink, Thomas ; Sciacca, Vanessa ; Liosis, Spyridon ; Brüggemann, Ben ; Große, Niels ; Fahimi, Bezhad ; Sano, Makoto ; Kuck, Karl-Heinz ; Ouyang, Feifan ; Vogler, Julia ; Eitel, Charlotte ; Tilz, Roland Richard</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c623t-d3f1f31aa388d501032b060fa85c3cd56e7754dc56764fd583c16211cdba29b13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Action Potentials</topic><topic>Aged</topic><topic>Atrial fibrillation</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - physiopathology</topic><topic>Atrial Fibrillation - surgery</topic><topic>Cardiac Catheters</topic><topic>Catheter ablation</topic><topic>Catheter Ablation - adverse effects</topic><topic>Catheter Ablation - instrumentation</topic><topic>Clinical Competence</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Heart Rate</topic><topic>Humans</topic><topic>Laser balloon</topic><topic>Laser Therapy - adverse effects</topic><topic>Laser Therapy - instrumentation</topic><topic>Learning Curve</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patient Safety</topic><topic>Prospective Studies</topic><topic>Pulmonary vein isolation</topic><topic>Pulmonary Veins - physiopathology</topic><topic>Pulmonary Veins - surgery</topic><topic>Registries</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Heeger, Christian-H.</creatorcontrib><creatorcontrib>Phan, Huong-Lan</creatorcontrib><creatorcontrib>Meyer-Saraei, Roza</creatorcontrib><creatorcontrib>Fink, Thomas</creatorcontrib><creatorcontrib>Sciacca, Vanessa</creatorcontrib><creatorcontrib>Liosis, Spyridon</creatorcontrib><creatorcontrib>Brüggemann, Ben</creatorcontrib><creatorcontrib>Große, Niels</creatorcontrib><creatorcontrib>Fahimi, Bezhad</creatorcontrib><creatorcontrib>Sano, Makoto</creatorcontrib><creatorcontrib>Kuck, Karl-Heinz</creatorcontrib><creatorcontrib>Ouyang, Feifan</creatorcontrib><creatorcontrib>Vogler, Julia</creatorcontrib><creatorcontrib>Eitel, Charlotte</creatorcontrib><creatorcontrib>Tilz, Roland Richard</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Circulation Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heeger, Christian-H.</au><au>Phan, Huong-Lan</au><au>Meyer-Saraei, Roza</au><au>Fink, Thomas</au><au>Sciacca, Vanessa</au><au>Liosis, Spyridon</au><au>Brüggemann, Ben</au><au>Große, Niels</au><au>Fahimi, Bezhad</au><au>Sano, Makoto</au><au>Kuck, Karl-Heinz</au><au>Ouyang, Feifan</au><au>Vogler, Julia</au><au>Eitel, Charlotte</au><au>Tilz, Roland Richard</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry</atitle><jtitle>Circulation Journal</jtitle><addtitle>Circ J</addtitle><date>2019-11-25</date><risdate>2019</risdate><volume>83</volume><issue>12</issue><spage>2443</spage><epage>2451</epage><pages>2443-2451</pages><issn>1346-9843</issn><issn>1347-4820</issn><eissn>1347-4820</eissn><abstract>Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.Conclusions:The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.</abstract><cop>Japan</cop><pub>The Japanese Circulation Society</pub><pmid>31708555</pmid><doi>10.1253/circj.CJ-19-0766</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | J-STAGE Free; MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Action Potentials Aged Atrial fibrillation Atrial Fibrillation - diagnosis Atrial Fibrillation - physiopathology Atrial Fibrillation - surgery Cardiac Catheters Catheter ablation Catheter Ablation - adverse effects Catheter Ablation - instrumentation Clinical Competence Equipment Design Female Heart Rate Humans Laser balloon Laser Therapy - adverse effects Laser Therapy - instrumentation Learning Curve Male Middle Aged Patient Safety Prospective Studies Pulmonary vein isolation Pulmonary Veins - physiopathology Pulmonary Veins - surgery Registries Risk Assessment Risk Factors Time Factors Treatment Outcome |
| title | Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry |
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