Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.
Perclose ProGlide
percutaneous closure device failure
self‐expanding
transcatheter aortic valve implantation
transfemoral
vascular complications
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
19 Apr 2024
19 Apr 2024
Historique:
revised:
27
03
2024
received:
05
01
2024
accepted:
09
04
2024
medline:
19
4
2024
pubmed:
19
4
2024
entrez:
19
4
2024
Statut:
aheadofprint
Résumé
Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.
Sections du résumé
BACKGROUND
BACKGROUND
Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated.
AIMS
OBJECTIVE
The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems.
METHODS
METHODS
This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee.
RESULTS
RESULTS
A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified.
CONCLUSION
CONCLUSIONS
This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
Kolte D, Vlahakes GJ, Palacios IF, et al. Transcatheter versus surgical aortic valve replacement in low‐risk patients. J Am Coll Cardiol. 2019;74:1532‐1540. doi:10.1016/j.jacc.2019.06.076
Rosseel L, Montarello NJ, Nuyens P, et al. A systematic algorithm for large‐bore arterial access closure after TAVI: the TAVI‐MultiCLOSE study. EuroIntervention. 2024;20:e354‐e362. doi:10.4244/EIJ-D-23-00725
Kahlert P, Al‐Rashid F, Plicht B, et al. Suture‐mediated arterial access site closure after transfemoral aortic valve implantation. Catheter Cardiovasc Interv. 2013;81:E139‐E150. doi:10.1002/ccd.24326
Kodama A, Yamamoto M, Shimura T, et al. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN‐TAVI) Japanese multicenter registry. Catheter Cardiovasc Interv. 2017;90:E55‐E62. doi:10.1002/ccd.26686
Bazarbashi N, Ahuja K, Gad MM, et al. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020;96:442‐447. doi:10.1002/ccd.28585
Stabile E, Esposito G. A single stich is maybe enough. Catheter Cardiovasc Interv. 2020;96:448‐449. doi:10.1002/ccd.29155
Phan DQ, Qattan M, Lee MS, et al. Comparison of a single versus double perclose technique for percutaneous transfemoral transcatheter aortic valve replacement. J Invasive Cardiol. 2021;33:540.
Perrin N, Bonnet G, Leroux L, Ibrahim R, Modine T, Ben Ali W. Transcatheter aortic valve implantation: all transfemoral? Update on peripheral vascular access and closure. Front Cardiovasc Med. 2021;8:747583. doi:10.3389/fcvm.2021.747583
https://www.euroscore.org/
https://acsdriskcalc.research.sts.org/
Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation. JACC Cardiovasc Interv. 2011;4:851‐858. doi:10.1016/j.jcin.2011.03.019
Eghbalzadeh K, Kuhn EW, Sabashnikov A, et al. Vascular outlining”: augmented imaging for transfemoral access—a preclinical investigation. Thorac Cardiovasc Surg. 2020;68:158‐161. doi:10.1055/s-0038-1629922
Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42:1825‐1857. doi:10.1093/eurheartj/ehaa799
Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‐2 consensus document. Eur Heart J. 2012;33:2403‐2418. doi:10.1093/eurheartj/ehs255
Blanc B, Finch CA, Hallberg L, et al. Nutritional anemias: report of a WHO scientific group. World Health Organ Tech Rep Ser. 1968;405:5‐37.
Tomii D, Okuno T, Heg D, et al. Validation of the VARC‐3 technical success definition in patients undergoing TAVR. JACC Cardiovasc Interv. 2022;15:353‐364. doi:10.1016/j.jcin.2021.11.013
Griese DP, Reents W, Diegeler A, Kerber S, Babin‐Ebell J. Simple, effective and safe vascular access site closure with the double‐ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2013;82:E734‐E741. doi:10.1002/ccd.25053
Barbier CE, Lundin E, Melki V, James S, Nyman R. Percutaneous closure in transfemoral aortic valve implantation: A single‐centre experience. Cardiovasc Intervent Radiol. 2015;38:1438‐1443. doi:10.1007/s00270-015-1117-0
Borz B, Durand E, Tron C, et al. Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications. Catheter Cardiovasc Interv. 2014;83:E227‐E232. doi:10.1002/ccd.25390
Koehler T, Buege M, Schleiting H, Seyfarth M, Tiroch K, Vorpahl M. Changes of the eSheath outer dimensions used for transfemoral transcatheter aortic valve replacement. BioMed Res Int. 2015;2015:1‐6. doi:10.1155/2015/572681