Raimundo Vicente-Miralles, Nuria Rivas-Gándara, Pablo Jordán Marchite, Raquel Adeliño, María Ángeles Carmona, Mónica Díaz Barranco, Alicia Ascensión Ibañez Criado, Juan Miguel Ruiz Nodar, María Ajo Ferrer, Amaya García-Fernández, Vicente Bertomeu-Gonzalez, Juan Gabriel Martínez Martínez
{"title":"一种使用永久性起搏器发生器和主动固定导联的临时心脏刺激新装置：TEMPACE多中心前瞻性研究。","authors":"Raimundo Vicente-Miralles, Nuria Rivas-Gándara, Pablo Jordán Marchite, Raquel Adeliño, María Ángeles Carmona, Mónica Díaz Barranco, Alicia Ascensión Ibañez Criado, Juan Miguel Ruiz Nodar, María Ajo Ferrer, Amaya García-Fernández, Vicente Bertomeu-Gonzalez, Juan Gabriel Martínez Martínez","doi":"10.1093/ehjacc/zuaf111","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>To determine the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing (TCP) with active-fixation leads (TCPAFL).</p><p><strong>Methods: </strong>This was a multicenter, prospective, descriptive clinical investigation involving a medical device (ClinicalTrials.gov Identifier: NCT05351658). Between January 2023 and December 2024, all consecutive patients who underwent implantation of a temporary active-fixation pacemaker were included. The devices were secured using the KronoSafe® adapter throughout the period of use. Complications during TCPAFL were recorded, and R-wave sensing, lead impedance, and pacing threshold were determined every 48 hours.</p><p><strong>Results: </strong>Thirty patients (10 with atrioventricular block, 9 TAVI, 5 alcohol septal ablations, 2 slow atrial fibrillations, 2 bradycardia-tachycardia syndrome, and 2 pacemaker infections) who required TCP were included. Two centers participated in the study. The mean duration of TCP was 7.8 days (maximum 22 days), with 79.2% of the time spent in the cardiology ward. One complication (3%) was recorded, due to accidental traction of the system associated with an episode of agitation.</p><p><strong>Conclusions: </strong>TCPAFL using the KronoSafe® adapter is safe and effective, and its use can be extended outside the Intensive Care Unit.</p>","PeriodicalId":11861,"journal":{"name":"European Heart Journal: Acute Cardiovascular Care","volume":" ","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Novel Device for Temporary Cardiac Stimulation Using Permanent Pacemaker Generators and Active-Fixation Leads: The TEMPACE Multi-Center Prospective Study.\",\"authors\":\"Raimundo Vicente-Miralles, Nuria Rivas-Gándara, Pablo Jordán Marchite, Raquel Adeliño, María Ángeles Carmona, Mónica Díaz Barranco, Alicia Ascensión Ibañez Criado, Juan Miguel Ruiz Nodar, María Ajo Ferrer, Amaya García-Fernández, Vicente Bertomeu-Gonzalez, Juan Gabriel Martínez Martínez\",\"doi\":\"10.1093/ehjacc/zuaf111\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>To determine the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing (TCP) with active-fixation leads (TCPAFL).</p><p><strong>Methods: </strong>This was a multicenter, prospective, descriptive clinical investigation involving a medical device (ClinicalTrials.gov Identifier: NCT05351658). Between January 2023 and December 2024, all consecutive patients who underwent implantation of a temporary active-fixation pacemaker were included. The devices were secured using the KronoSafe® adapter throughout the period of use. Complications during TCPAFL were recorded, and R-wave sensing, lead impedance, and pacing threshold were determined every 48 hours.</p><p><strong>Results: </strong>Thirty patients (10 with atrioventricular block, 9 TAVI, 5 alcohol septal ablations, 2 slow atrial fibrillations, 2 bradycardia-tachycardia syndrome, and 2 pacemaker infections) who required TCP were included. Two centers participated in the study. The mean duration of TCP was 7.8 days (maximum 22 days), with 79.2% of the time spent in the cardiology ward. One complication (3%) was recorded, due to accidental traction of the system associated with an episode of agitation.</p><p><strong>Conclusions: </strong>TCPAFL using the KronoSafe® adapter is safe and effective, and its use can be extended outside the Intensive Care Unit.</p>\",\"PeriodicalId\":11861,\"journal\":{\"name\":\"European Heart Journal: Acute Cardiovascular Care\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-08-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Heart Journal: Acute Cardiovascular Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ehjacc/zuaf111\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Heart Journal: Acute Cardiovascular Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ehjacc/zuaf111","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
A Novel Device for Temporary Cardiac Stimulation Using Permanent Pacemaker Generators and Active-Fixation Leads: The TEMPACE Multi-Center Prospective Study.
Aims: To determine the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing (TCP) with active-fixation leads (TCPAFL).
Methods: This was a multicenter, prospective, descriptive clinical investigation involving a medical device (ClinicalTrials.gov Identifier: NCT05351658). Between January 2023 and December 2024, all consecutive patients who underwent implantation of a temporary active-fixation pacemaker were included. The devices were secured using the KronoSafe® adapter throughout the period of use. Complications during TCPAFL were recorded, and R-wave sensing, lead impedance, and pacing threshold were determined every 48 hours.
Results: Thirty patients (10 with atrioventricular block, 9 TAVI, 5 alcohol septal ablations, 2 slow atrial fibrillations, 2 bradycardia-tachycardia syndrome, and 2 pacemaker infections) who required TCP were included. Two centers participated in the study. The mean duration of TCP was 7.8 days (maximum 22 days), with 79.2% of the time spent in the cardiology ward. One complication (3%) was recorded, due to accidental traction of the system associated with an episode of agitation.
Conclusions: TCPAFL using the KronoSafe® adapter is safe and effective, and its use can be extended outside the Intensive Care Unit.
期刊介绍：
The European Heart Journal - Acute Cardiovascular Care (EHJ-ACVC) offers a unique integrative approach by combining the expertise of the different sub specialties of cardiology, emergency and intensive care medicine in the management of patients with acute cardiovascular syndromes.
Reading through the journal, cardiologists and all other healthcare professionals can access continuous updates that may help them to improve the quality of care and the outcome for patients with acute cardiovascular diseases.
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