Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation
Background and aimsRight phrenic nerve palsy is the most frequent complication of cryoballoon procedures. The SMARTFREEZE™ console (Boston Scientific, St. Paul, MN, USA) has integrated a new tool for diaphragm monitoring—the Diaphragm Movement Sensor; however, it has not been evaluated in clinical p...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-03-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2024.1361761/full |
| _version_ | 1797256479344951296 |
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| author | Elsa Schemoul Lilith Tovmassian Julien Mancini Julien Mancini Linda Koutbi Cédric Biermé Jean-Claude Deharo Jean-Claude Deharo Frédéric Franceschi Frédéric Franceschi Baptiste Maille Baptiste Maille |
| author_facet | Elsa Schemoul Lilith Tovmassian Julien Mancini Julien Mancini Linda Koutbi Cédric Biermé Jean-Claude Deharo Jean-Claude Deharo Frédéric Franceschi Frédéric Franceschi Baptiste Maille Baptiste Maille |
| author_sort | Elsa Schemoul |
| collection | DOAJ |
| description | Background and aimsRight phrenic nerve palsy is the most frequent complication of cryoballoon procedures. The SMARTFREEZE™ console (Boston Scientific, St. Paul, MN, USA) has integrated a new tool for diaphragm monitoring—the Diaphragm Movement Sensor; however, it has not been evaluated in clinical practice. We aimed to assess the diagnostic performance of the Diaphragm Movement Sensor based on compound motor action potential data recorded simultaneously.MethodsThirty consecutive patients (mean age 63.2 ± 10.2 years) were included. We simultaneously recorded the compound motor action potential and the Diaphragm Movement Sensor during cryoapplications in the right pulmonary veins. The right phrenic nerve was paced at 60 per minute, 12 V and 2.9 ms. Compound motor action potential monitoring with a 30% decrease cutoff for the diagnosis of phrenic nerve threatening was considered the gold standard. The Diaphragm Movement Sensor decrease threshold was also set at 30%.ResultsConsidering compound motor action potential monitoring, phrenic nerve threatening occurred 11 times (in seven patients) among 84 cryoapplications (13.1%) at the right pulmonary veins. The sensitivity and specificity of the Diaphragm Movement Sensor were, respectively, 33% (95% CI: 7%–70%) and 49% (95% CI: 38%–61%; P < 0.001). The predictive positive and negative values for the Diaphragm Movement Sensor were, respectively, 7% (95% CI: 2%–20%) and 86% (95% CI: 72%–95%). The Diaphragm Movement Sensor gave an erroneous diagnosis in 44/84 cryoapplications (52.4%).ConclusionsThe diagnostic performance of the Diaphragm Movement Sensor is low, and the relevance of its use in clinical practice may be debated. |
| first_indexed | 2024-04-24T22:22:24Z |
| format | Article |
| id | doaj.art-592aeb9658074e1b855acbd813878441 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-24T22:22:24Z |
| publishDate | 2024-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-592aeb9658074e1b855acbd8138784412024-03-20T05:13:29ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2024-03-011110.3389/fcvm.2024.13617611361761Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluationElsa Schemoul0Lilith Tovmassian1Julien Mancini2Julien Mancini3Linda Koutbi4Cédric Biermé5Jean-Claude Deharo6Jean-Claude Deharo7Frédéric Franceschi8Frédéric Franceschi9Baptiste Maille10Baptiste Maille11Department of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceBiostatistics Department, Aix-Marseille University, INSERM, IRD, ISSPAM, APHM, SESSTIM, Hôpital de la Timone, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceCenter for CardioVascular and Nutrition Research (C2VN), INSERM, INRA, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceCenter for CardioVascular and Nutrition Research (C2VN), INSERM, INRA, Marseille, FranceDepartment of Cardiology, CHU Timone, Aix-Marseille University, Marseille, FranceCenter for CardioVascular and Nutrition Research (C2VN), INSERM, INRA, Marseille, FranceBackground and aimsRight phrenic nerve palsy is the most frequent complication of cryoballoon procedures. The SMARTFREEZE™ console (Boston Scientific, St. Paul, MN, USA) has integrated a new tool for diaphragm monitoring—the Diaphragm Movement Sensor; however, it has not been evaluated in clinical practice. We aimed to assess the diagnostic performance of the Diaphragm Movement Sensor based on compound motor action potential data recorded simultaneously.MethodsThirty consecutive patients (mean age 63.2 ± 10.2 years) were included. We simultaneously recorded the compound motor action potential and the Diaphragm Movement Sensor during cryoapplications in the right pulmonary veins. The right phrenic nerve was paced at 60 per minute, 12 V and 2.9 ms. Compound motor action potential monitoring with a 30% decrease cutoff for the diagnosis of phrenic nerve threatening was considered the gold standard. The Diaphragm Movement Sensor decrease threshold was also set at 30%.ResultsConsidering compound motor action potential monitoring, phrenic nerve threatening occurred 11 times (in seven patients) among 84 cryoapplications (13.1%) at the right pulmonary veins. The sensitivity and specificity of the Diaphragm Movement Sensor were, respectively, 33% (95% CI: 7%–70%) and 49% (95% CI: 38%–61%; P < 0.001). The predictive positive and negative values for the Diaphragm Movement Sensor were, respectively, 7% (95% CI: 2%–20%) and 86% (95% CI: 72%–95%). The Diaphragm Movement Sensor gave an erroneous diagnosis in 44/84 cryoapplications (52.4%).ConclusionsThe diagnostic performance of the Diaphragm Movement Sensor is low, and the relevance of its use in clinical practice may be debated.https://www.frontiersin.org/articles/10.3389/fcvm.2024.1361761/fullatrial fbrillationcryoballoon ablationcomplicationphrenic nerve—injuriesCMAP |
| spellingShingle | Elsa Schemoul Lilith Tovmassian Julien Mancini Julien Mancini Linda Koutbi Cédric Biermé Jean-Claude Deharo Jean-Claude Deharo Frédéric Franceschi Frédéric Franceschi Baptiste Maille Baptiste Maille Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation Frontiers in Cardiovascular Medicine atrial fbrillation cryoballoon ablation complication phrenic nerve—injuries CMAP |
| title | Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation |
| title_full | Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation |
| title_fullStr | Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation |
| title_full_unstemmed | Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation |
| title_short | Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation |
| title_sort | diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures the first clinical evaluation |
| topic | atrial fbrillation cryoballoon ablation complication phrenic nerve—injuries CMAP |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2024.1361761/full |
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