Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter
Background Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SM...
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| Published in | Journal of interventional cardiac electrophysiology Vol. 67; no. 6; pp. 1437 - 1443 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Springer US
01.09.2024
Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1572-8595 1383-875X 1572-8595 |
| DOI | 10.1007/s10840-024-01773-3 |
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| Abstract | Background
Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications.
Methods
Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications.
Results
Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site.
Conclusions
This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.
Graphical abstract |
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| AbstractList | BackgroundFollowing catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications.MethodsThirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications.ResultsMean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site.ConclusionsThis study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site. Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications. Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site. Background Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. Methods Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications. Results Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. Conclusions This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site. Graphical abstract Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications.BACKGROUNDFollowing catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications.Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications.METHODSThirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications.Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site.RESULTSMean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site.This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.CONCLUSIONSThis study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site. |
| Author | Kolluri, Raghu Steinhaus, Daniel Shah, Anand Kiani, Soroosh Simoes, Tiessa Gupta, Sanjaya Lloyd, Michael S. Westerman, Stacy B. Nie, Hong Kline, Jessica Pingle, Sandeep C. |
| Author_xml | – sequence: 1 givenname: Sanjaya orcidid: 0000-0002-1789-4712 surname: Gupta fullname: Gupta, Sanjaya email: sgupta@saint-lukes.org organization: Division of Cardiology, Saint Luke’s Mid-America Heart Institute, University of Missouri Kansas City School of Medicine – sequence: 2 givenname: Raghu surname: Kolluri fullname: Kolluri, Raghu organization: Syntropic Core Lab – sequence: 3 givenname: Tiessa surname: Simoes fullname: Simoes, Tiessa organization: Abbott Vascular – sequence: 4 givenname: Sandeep C. surname: Pingle fullname: Pingle, Sandeep C. organization: Abbott Vascular – sequence: 5 givenname: Hong surname: Nie fullname: Nie, Hong organization: Abbott Vascular – sequence: 6 givenname: Michael S. surname: Lloyd fullname: Lloyd, Michael S. organization: Division of Cardiology, Emory University – sequence: 7 givenname: Daniel surname: Steinhaus fullname: Steinhaus, Daniel organization: Division of Cardiology, Saint Luke’s Mid-America Heart Institute, University of Missouri Kansas City School of Medicine – sequence: 8 givenname: Stacy B. surname: Westerman fullname: Westerman, Stacy B. organization: Division of Cardiology, Emory University – sequence: 9 givenname: Anand surname: Shah fullname: Shah, Anand organization: Division of Cardiology, Emory University – sequence: 10 givenname: Jessica surname: Kline fullname: Kline, Jessica organization: Division of Cardiology, Saint Luke’s Mid-America Heart Institute, University of Missouri Kansas City School of Medicine – sequence: 11 givenname: Soroosh surname: Kiani fullname: Kiani, Soroosh organization: Division of Cardiology, Emory University, Division of Cardiovascular Medicine, UMass Chan Medical School |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38413483$$D View this record in MEDLINE/PubMed |
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| Keywords | Duplex ultrasound Closure device Catheter ablation Atrial fibrillation |
| Language | English |
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| PublicationTitle | Journal of interventional cardiac electrophysiology |
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Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure... Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC)... BackgroundFollowing catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure... |
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| SubjectTerms | Ablation Access control Aged Arteries Atrial Fibrillation - surgery Atrial Flutter - surgery Cardiac arrhythmia Cardiology Catheter Ablation - methods Catheters Female Femoral Vein - surgery Fibrillation Hemostasis Hemostatics Humans Male Medical instruments Medicine Medicine & Public Health Middle Aged Postoperative Complications - epidemiology Radiofrequency ablation Safety Safety management Sheaths Suture Techniques Treatment Outcome Ultrasonography, Doppler, Duplex Veins Venous access |
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| Title | Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter |
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