{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T14:53:08Z","timestamp":1788447188711,"version":"build-2803163510"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,11,13]],"date-time":"2023-11-13T00:00:00Z","timestamp":1699833600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pacing Clinical Electrophis"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and aims<\/jats:title>\n                    <jats:p>The safety evaluation of TactiFlex, a novel contact\u2010force sensing catheter with a flexible 4\u2010mm tip irrigated through laser\u2010cut kerfs, has been ongoing. This study aimed to verify the safety of this type of catheter.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Study 1: Radiofrequency (RF) applications at a range of powers (30\u201350\u00a0W), contact forces (10\u201320\u00a0g), and durations (10\u201360 s) using perpendicular\/parallel catheter orientation with half\u2010normal (HNS) or normal saline irrigation were compared between TactiFlex (4\u2010mm tip) and TactiCath (3.5\u2010mm tip) with temperature\u2010controlled mode in excised porcine hearts. Study 2: The relation between RF applications using TactiFlex and the incidence of steam\u2010pops in the real clinical cases were examined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Study\u20101: 576 RF lesions were examined. TactiFlex demonstrated a significantly lower risk of steam\u2010pops (5[1.7%] vs. 59[20.5%],\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt; .0001). Compared to 3.5\u2010mm\u2010tip catheter (TactiCath), 4\u2010mm\u2010tip catheter (TactiFlex) produced smaller lesion volume at perpendicular (193[98\u2013554]mm\n                      <jats:sup>3<\/jats:sup>\n                      vs. 263[139\u2013436]mm\n                      <jats:sup>3<\/jats:sup>\n                      ,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt; .0001), but relatively similar lesion volume at parallel contact (243[105\u2013443]mm\n                      <jats:sup>3<\/jats:sup>\n                      vs. 278[180\u2013440]mm\n                      <jats:sup>3<\/jats:sup>\n                      ,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a0.06). HNS\u2010irrigation tended to increase the lesion volume in both catheters and to increase the incidence of steam\u2010pops with TactiCath, but not with TactiFlex. The cut\u2010off value of %impedance\u2010drop ( =\u00a0absolute impedance\u2010drop\/initial impedance) of 20% predicted steam\u2010pops with a sensitivity\u00a0=\u00a0100% and specificity\u00a0=\u00a089.6% in TactiFlex.\n                    <\/jats:p>\n                    <jats:p>Study\u20102: 5496 RF applications in 84 patients (51AFs\/8ATs\/3AVNRTs\/4AVRTs\/17PVCs\/4VTs) using TactiFlex were analyzed. Four steam\u2010pops (0.07%) in three patients with pericardial effusion were observed (%impedance\u2010drop\u00a0=\u00a024%\/26%\/29%\/35%, respectively). The cut\u2010off value of %impedance\u2010drop\u00a0=\u00a020%, derived from ex\u2010vivo study, showed sensitivity\u00a0=\u00a0100% and specificity\u00a0=\u00a090.1% in detecting steam\u2010pops.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>TactiFlex reduced the risk of steam\u2010pops than TactiCath. %impedance\u2010drop\u00a0\u2264\u00a020% may be reasonable for safely use with a sufficient safety margin. For 4\u2010mm\u2010tip catheter, parallel\u2010contact may be recommended for larger lesion creation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pace.14868","type":"journal-article","created":{"date-parts":[[2023,11,14]],"date-time":"2023-11-14T01:03:16Z","timestamp":1699923796000},"page":"1536-1545","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Safety verification of a novel irrigation catheter with flexible tip of laser\u2010cut kerfs and contact force sensor"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9324-9603","authenticated-orcid":false,"given":"Junji","family":"Yamaguchi","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"},{"name":"Department of Clinical and Diagnostic Laboratory Science Tokyo Medical and Dental University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8473-7514","authenticated-orcid":false,"given":"Masateru","family":"Takigawa","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7210-0671","authenticated-orcid":false,"given":"Masahiko","family":"Goya","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tasuku","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Ikenouchi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2441-3593","authenticated-orcid":false,"given":"Hidehiro","family":"Iwakawa","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Akita University Graduate School of Medicine  Akita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miho","family":"Negishi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kentaro","family":"Goto","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Tokyo Medical and Dental 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Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pace.14868","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,10]],"date-time":"2024-04-10T05:25:51Z","timestamp":1712726751000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pace.14868"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,13]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1111\/pace.14868"],"URL":"https:\/\/doi.org\/10.1111\/pace.14868","archive":["Portico"],"relation":{},"ISSN":["0147-8389","1540-8159"],"issn-type":[{"value":"0147-8389","type":"print"},{"value":"1540-8159","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,13]]},"assertion":[{"value":"2023-08-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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