{"title":"Long-term outcomes and the possibility of repeat puncture after suture-mediated closure device for femoral vein access.","authors":"Akio Chikata, Takeshi Kato, Kazuo Usuda, Shuhei Fujita, Michiro Maruyama, Kanichi Otowa, Takashi Kusayama, Kenshi Hayashi, Masayuki Takamura","doi":"10.1007/s10840-025-02003-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Long-term safety and reaccessibility following the use of suture-mediated vascular closure systems (SMC) for femoral vein access are not well documented. This study aimed to assess the long-term outcomes and feasibility of repeated femoral vein punctures after SMC.</p><p><strong>Methods: </strong>We analyzed 282 patients who underwent elective catheter ablation via femoral vein access using an 8-13 Fr sheath. Patients were randomized into the pre-close or post-close groups using the ProGlide/ProStyle single-suture technique (Abbott Vascular). Duplex ultrasound evaluations were performed on day 1, day 90, and at 1 year to evaluate vascular complications. The primary and secondary endpoints included major and minor complications within 1 year. Reaccessibility was assessed in patients who required repeated procedures.</p><p><strong>Results: </strong>Successful re-access was achieved in 21 patients (14.9%) in the pre-close group and 16 patients (11.3%) in the post-close group who underwent repeat procedures. Long-term safety was analyzed in 91 (64.5%) and 98 (69.5%) patients in the pre-close and post-close groups, respectively. The major complication rate was 2/189 (1.1%), and the minor complication rate was 28/189 (14.8%). No difference in complication rates was observed between the pre-close group (0/91, 0.0% major, 12/91, 13.2% minor) and post-close group (2/98, 2% major, 16/98, 16.3% minor), with P-values of 0.50 and 0.68, respectively. No new vascular stenosis occurred during the chronic phase in either group.</p><p><strong>Conclusion: </strong>In the long-term follow-up after femoral vein access using SMC, new-onset chronic stenosis was not observed, and reaccess was possible in repeat procedures.</p><p><strong>Clinical trial registration: </strong>UMIN000049174.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Interventional Cardiac Electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10840-025-02003-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Long-term safety and reaccessibility following the use of suture-mediated vascular closure systems (SMC) for femoral vein access are not well documented. This study aimed to assess the long-term outcomes and feasibility of repeated femoral vein punctures after SMC.
Methods: We analyzed 282 patients who underwent elective catheter ablation via femoral vein access using an 8-13 Fr sheath. Patients were randomized into the pre-close or post-close groups using the ProGlide/ProStyle single-suture technique (Abbott Vascular). Duplex ultrasound evaluations were performed on day 1, day 90, and at 1 year to evaluate vascular complications. The primary and secondary endpoints included major and minor complications within 1 year. Reaccessibility was assessed in patients who required repeated procedures.
Results: Successful re-access was achieved in 21 patients (14.9%) in the pre-close group and 16 patients (11.3%) in the post-close group who underwent repeat procedures. Long-term safety was analyzed in 91 (64.5%) and 98 (69.5%) patients in the pre-close and post-close groups, respectively. The major complication rate was 2/189 (1.1%), and the minor complication rate was 28/189 (14.8%). No difference in complication rates was observed between the pre-close group (0/91, 0.0% major, 12/91, 13.2% minor) and post-close group (2/98, 2% major, 16/98, 16.3% minor), with P-values of 0.50 and 0.68, respectively. No new vascular stenosis occurred during the chronic phase in either group.
Conclusion: In the long-term follow-up after femoral vein access using SMC, new-onset chronic stenosis was not observed, and reaccess was possible in repeat procedures.
期刊介绍:
The Journal of Interventional Cardiac Electrophysiology is an international publication devoted to fostering research in and development of interventional techniques and therapies for the management of cardiac arrhythmias. It is designed primarily to present original research studies and scholarly scientific reviews of basic and applied science and clinical research in this field. The Journal will adopt a multidisciplinary approach to link physical, experimental, and clinical sciences as applied to the development of and practice in interventional electrophysiology. The Journal will examine techniques ranging from molecular, chemical and pharmacologic therapies to device and ablation technology. Accordingly, original research in clinical, epidemiologic and basic science arenas will be considered for publication. Applied engineering or physical science studies pertaining to interventional electrophysiology will be encouraged. The Journal is committed to providing comprehensive and detailed treatment of major interventional therapies and innovative techniques in a structured and clinically relevant manner. It is directed at clinical practitioners and investigators in the rapidly growing field of interventional electrophysiology. The editorial staff and board reflect this bias and include noted international experts in this area with a wealth of expertise in basic and clinical investigation. Peer review of all submissions, conflict of interest guidelines and periodic editorial board review of all Journal policies have been established.