Bich Lien Nguyen , Alessandro Persi , Eli S. Gang , Fabrizio Fattorini , Alessandra Oliva , Antonio Vitarelli , Nicola Alessandri , Robert J. Siegel , Antonio Ciccaglioni , Carlo Gaudio
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We aimed to assess binding sites between permanent cardiac pacing leads and cardiovascular structures using CartoSound™ three-dimensional (3D) imaging technology (Biosense Webster Inc., Diamond Bar, CA) during transvenous lead extraction, and compared outcomes to standard approach.</p></div><div><h3>Methods</h3><p>We recruited 291 patients undergoing percutaneous lead extraction, and 3D CartoSound anatomical mapping of the superior vena cava, right atrium (RA), coronary sinus, right ventricle (RV), pacing leads, and binding sites before, during, and after lead removal was randomly performed in 46 of them (38 men; mean age 73.7<!--> <!-->±<!--> <!-->10.5<!--> <!-->years; 1.96 leads/patient; mean time-from-implant of 62.7<!--> <!-->±<!--> <!-->51.8<!--> <!-->months) using a 10-Fr 3D SoundStar™ catheter and integrated into the Carto® mapping system.</p></div><div><h3>Results</h3><p>CartoSound was able to detect more intracardiac binding sites compared to fluoroscopy (RA 17.4% vs. 4.3%, p<!--> <!-->=<!--> <!-->0.04; RV 43.5% vs. 21.7%, p<!--> <!-->=<!--> <!-->0.04), but was unable to assess the subclavian/innominate veins. Binding sites volume correlated positively with time-from-implant (r<!--> <!-->=<!--> <!-->0.38, p<!--> <!--><<!--> <!-->0.05), and powered-sheath use (r<!--> <!-->=<!--> <!-->0.39, p<!--> <!--><<!--> <!-->0.05), and negatively with procedural success (r<!--> <!-->=<!--> <!-->−<!--> <!-->0.37, p<!--> <!--><<!--> <!-->0.05). When compared to standard approach, CartoSound use was characterized by a significantly lower mean procedure time (p<!--> <!-->=<!--> <!-->0.0001), major complications (p<!--> <!-->=<!--> <!-->0.03), and greater procedure success rates (p<!--> <!-->=<!--> <!-->0.03).</p></div><div><h3>Conclusions</h3><p>Real-time 3D binding sites assessment is feasible and improves transvenous lead extraction outcomes. Its role as a complementary information requires extensive validation, and might be beneficial for a tailored strategy.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"7 ","pages":"Pages 1-6"},"PeriodicalIF":0.0000,"publicationDate":"2015-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.006","citationCount":"2","resultStr":"{\"title\":\"Three-dimensional binding sites volume assessment during cardiac pacing lead extraction\",\"authors\":\"Bich Lien Nguyen , Alessandro Persi , Eli S. Gang , Fabrizio Fattorini , Alessandra Oliva , Antonio Vitarelli , Nicola Alessandri , Robert J. Siegel , Antonio Ciccaglioni , Carlo Gaudio\",\"doi\":\"10.1016/j.ctrsc.2015.08.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background/objectives</h3><p>Binding sites are the principal cause of failed lead removal and complications, and are not directly visualized by fluoroscopy. We aimed to assess binding sites between permanent cardiac pacing leads and cardiovascular structures using CartoSound™ three-dimensional (3D) imaging technology (Biosense Webster Inc., Diamond Bar, CA) during transvenous lead extraction, and compared outcomes to standard approach.</p></div><div><h3>Methods</h3><p>We recruited 291 patients undergoing percutaneous lead extraction, and 3D CartoSound anatomical mapping of the superior vena cava, right atrium (RA), coronary sinus, right ventricle (RV), pacing leads, and binding sites before, during, and after lead removal was randomly performed in 46 of them (38 men; mean age 73.7<!--> <!-->±<!--> <!-->10.5<!--> <!-->years; 1.96 leads/patient; mean time-from-implant of 62.7<!--> <!-->±<!--> <!-->51.8<!--> <!-->months) using a 10-Fr 3D SoundStar™ catheter and integrated into the Carto® mapping system.</p></div><div><h3>Results</h3><p>CartoSound was able to detect more intracardiac binding sites compared to fluoroscopy (RA 17.4% vs. 4.3%, p<!--> <!-->=<!--> <!-->0.04; RV 43.5% vs. 21.7%, p<!--> <!-->=<!--> <!-->0.04), but was unable to assess the subclavian/innominate veins. Binding sites volume correlated positively with time-from-implant (r<!--> <!-->=<!--> <!-->0.38, p<!--> <!--><<!--> <!-->0.05), and powered-sheath use (r<!--> <!-->=<!--> <!-->0.39, p<!--> <!--><<!--> <!-->0.05), and negatively with procedural success (r<!--> <!-->=<!--> <!-->−<!--> <!-->0.37, p<!--> <!--><<!--> <!-->0.05). When compared to standard approach, CartoSound use was characterized by a significantly lower mean procedure time (p<!--> <!-->=<!--> <!-->0.0001), major complications (p<!--> <!-->=<!--> <!-->0.03), and greater procedure success rates (p<!--> <!-->=<!--> <!-->0.03).</p></div><div><h3>Conclusions</h3><p>Real-time 3D binding sites assessment is feasible and improves transvenous lead extraction outcomes. Its role as a complementary information requires extensive validation, and might be beneficial for a tailored strategy.</p></div>\",\"PeriodicalId\":91232,\"journal\":{\"name\":\"Clinical trials and regulatory science in cardiology\",\"volume\":\"7 \",\"pages\":\"Pages 1-6\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2015-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.006\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical trials and regulatory science in cardiology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2405587515300068\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical trials and regulatory science in cardiology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405587515300068","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 2
摘要
背景/目的结合位点是铅去除失败和并发症的主要原因,并且不能通过透视直接观察到。我们的目的是使用CartoSound™三维(3D)成像技术(Biosense Webster Inc., Diamond Bar, CA)在经静脉导联提取过程中评估永久性心脏起搏导联与心血管结构之间的结合位点,并将结果与标准方法进行比较。方法我们招募了291例经皮取铅术患者,随机选取其中46例(男性38例;平均年龄73.7±10.5岁;1.96领导/病人;使用10-Fr 3D SoundStar™导管并集成到Carto®测绘系统,平均植入时间为62.7±51.8个月。结果scartosound能检测到更多的心内结合位点(RA 17.4% vs. 4.3%, p = 0.04;RV 43.5% vs. 21.7%, p = 0.04),但无法评估锁骨下静脉/无名静脉。结合位点体积与植入时间呈正相关(r = 0.38, p <0.05),动力护套使用(r = 0.39, p <0.05),与手术成功率呈负相关(r = - 0.37, p <0.05)。与标准方法相比,使用CartoSound的特点是平均手术时间显著缩短(p = 0.0001),主要并发症(p = 0.03),手术成功率更高(p = 0.03)。结论实时三维结合位点评估是可行的,可提高经静脉铅拔出效果。它作为补充信息的作用需要广泛的验证,并且可能对量身定制的策略有益。
Three-dimensional binding sites volume assessment during cardiac pacing lead extraction
Background/objectives
Binding sites are the principal cause of failed lead removal and complications, and are not directly visualized by fluoroscopy. We aimed to assess binding sites between permanent cardiac pacing leads and cardiovascular structures using CartoSound™ three-dimensional (3D) imaging technology (Biosense Webster Inc., Diamond Bar, CA) during transvenous lead extraction, and compared outcomes to standard approach.
Methods
We recruited 291 patients undergoing percutaneous lead extraction, and 3D CartoSound anatomical mapping of the superior vena cava, right atrium (RA), coronary sinus, right ventricle (RV), pacing leads, and binding sites before, during, and after lead removal was randomly performed in 46 of them (38 men; mean age 73.7 ± 10.5 years; 1.96 leads/patient; mean time-from-implant of 62.7 ± 51.8 months) using a 10-Fr 3D SoundStar™ catheter and integrated into the Carto® mapping system.
Results
CartoSound was able to detect more intracardiac binding sites compared to fluoroscopy (RA 17.4% vs. 4.3%, p = 0.04; RV 43.5% vs. 21.7%, p = 0.04), but was unable to assess the subclavian/innominate veins. Binding sites volume correlated positively with time-from-implant (r = 0.38, p < 0.05), and powered-sheath use (r = 0.39, p < 0.05), and negatively with procedural success (r = − 0.37, p < 0.05). When compared to standard approach, CartoSound use was characterized by a significantly lower mean procedure time (p = 0.0001), major complications (p = 0.03), and greater procedure success rates (p = 0.03).
Conclusions
Real-time 3D binding sites assessment is feasible and improves transvenous lead extraction outcomes. Its role as a complementary information requires extensive validation, and might be beneficial for a tailored strategy.