Complications related to vascular closure devices (VCDs) remain relatively common after transcatheter aortic valve implantation (TAVI), while the optimal suture-based strategy remains a subject of debate. This systematic review and meta-analysis aim to evaluate the efficacy and safety of single versus double Perclose VCD in patients undergoing transfemoral TAVI. A literature search was conducted across PubMed, Scopus, and Cochrane databases to identify appropriate studies. The primary outcome was technical success; secondary outcomes included vascular and bleeding complications, bailout interventions, and all-cause mortality. Seven studies (3940 patients) fulfilled the inclusion criteria. Technical success was comparable between the two strategies (relative risk [RR]: .89; 95% confidence interval [CI]: .64-1.22), while the single Perclose strategy was associated with a lower risk of major vascular complications (RR: .61; 95% CI: .40-.92), major bleeding (RR: .28; 95% CI: .11-.73) and bailout surgical interventions (RR: .45; 95% CI: .24-.84). There were no differences in minor vascular complications and all-cause mortality. Stepwise closure with the upfront single Perclose strategy demonstrated comparable technical success and a more favorable safety profile regarding major vascular complications and bleeding compared with the double Perclose strategy. Additional randomized controlled trials are essential to validate these findings.
LeeGChikweJMilojevicM, et al. ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis. Eur Heart J. 2023;44:796-812.
2.
LeonMBSmithCRMackMJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609-1620.
3.
MackMJLeonMBThouraniVH, et al. Transcatheter aortic-valve replacement in low-risk patients at five years. N Engl J Med. 2023;389:1949-1960.
4.
RankaSLahanSChhatriwallaAK, et al. Network meta-analysis comparing the short- and long-term outcomes of alternative access for transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2022;40:1-10.
5.
Abdel-WahabMHartungPDumpiesO, et al. Comparison of a pure plug-based versus a primary suture-based vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the CHOICE-CLOSURE randomized clinical trial. Circulation. 2022;145:170-183.
6.
Van WiechenMPTchétchéDOomsJF, et al. Suture- or plug-based large-bore arteriotomy closure. JACC Cardiovasc Interv. 2021;14:149-157.
7.
OttIShivarajuASchäfferN, et al. Parallel suture technique with ProGlide: a novel method for management of vascular access during transcatheter aortic valve implantation (TAVI). EuroIntervention. 2017;13:928-934.
8.
LiRWangLLiuQ, et al. Comparative study of single- versus double-ProGlide device strategy for access site closure of transfemoral transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2025;106(3):1639-1649.
9.
HollowedJAkhondiARabbaniA, et al. Single versus double Perclose techniques for vascular closure during transfemoral transcatheter aortic valve replacement. Catheter Catheter Cardiovasc Interv. 2022;99:2125-2130.
10.
ReifartJLiebetrauCWeferlingM, et al. Single versus double use of a suture-based closure device for transfemoral aortic valve implantation. Int J Cardiol. 2021;331:183-188.
11.
NaeemFTabassumSBurhanMQamarUAlraiesMCAbramovD.Dual ProGlide versus ProGlide and angio-seal for femoral access hemostasias in transcatheter aortic valve replacement: a meta-analysis of up-to-date evidence. Catheter Cardiovasc Interv. 2025;106:621-624.
12.
UpadhayaSUpretiAGuptaK, et al. Vascular closure devices for large bore femoral access after transfemoral transcatheter aortic valve replacement: a network meta-analysis. Catheter Cardiovasc Interv. 2025;106:423-432.
13.
BrookeBSSchwartzTAPawlikTM.MOOSE Reporting Guidelines for meta-analyses of observational studies. JAMA Surg. 2021;156:787.
14.
PageMJMcKenzieJEBossuytPM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
15.
WohlinCKalinowskiMRomero FelizardoKMendesE.Successful combination of database search and snowballing for identification of primary studies in systematic literature studies. Inf Softw Technol. 2022;147:106908.
16.
HosseiniMSJahanshahlouFAkbarzadehMAZareiMVaez-GharamalekiY.Formulating research questions for evidence-based studies. J Med Surg Public Health. 2024;2:100046.
17.
GénéreuxPPiazzaNAluMC, et al. Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77:2717-2146.
18.
KappeteinAPHeadSJGénéreuxP, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;60:1438-1454.
19.
OuzzaniMHammadyHFedorowiczZElmagarmidA.Rayyan—a web and mobile app for systematic reviews. Syst Rev. 2016;5:210.
20.
StangA.Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol. 2010;25:603-605.
21.
LuoDWanXLiuJTongT.Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018;27:1785-1805.
22.
Tanriver-AyderEFaesCVan De CasteeleTMcCannSKMacleodMR.Comparison of commonly used methods in random effects meta-analysis: application to preclinical data in drug discovery research. BMJ Open Sci. 2021;5:e100074.
23.
FidlerVNagelkerkeN.The Mantel-Haenszel procedure revisited: models and generalizations. PLoS One. 2013;8:e58327.
24.
BeggCBMazumdarM.Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994;50:1088-1101.
25.
EggerMDavey SmithGSchneiderMMinderC.Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629-634.
26.
KodamaAYamamotoMShimuraT, 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(3):E55-E62.
27.
BazarbashiNAhujaKGadMM, 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.
28.
PhanDQattanMLeeMS, et al. Comparison of a single versus double perclose technique for percutaneous transfemoral transcatheter aortic valve replacement. J Invasive Cardiol. 2021;33(7):E540-E548.
29.
RoulotKKiblerMTrimailleA, et al. Femoral closure with single ProGlide® in transcatheter aortic valve implantation: a registry-based study. J Clin Med. 2025;14:7113.
30.
RoquesF.The logistic EuroSCORE. Eur Heart J. 2003;24:882.
31.
O’BrienSMFengLHeX, et al. The society of thoracic surgeons 2018 adult cardiac surgery risk models: part 2—statistical methods and results. Ann Thorac Surg. 2018;105:1419-1428.
32.
CheemaTVeneroCChampaneriaS, et al. Systematic review and meta-analysis comparing Manta device and perclose device for closure of large bore arterial access. J Vasc Access. 2025;26:15-21.
33.
IacovelliFBurattiniOSturdàF, et al. Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: a single-center real-world experience. Catheter Cardiovasc Interv. 2024;103:1125-1137.
34.
KahlertPAl-RashidFPlichtB, et al. Suture-mediated arterial access site closure after transfemoral aortic valve implantation. Catheter Cardiovasc Interv. 2013;81(2):E139- E150. doi:10.1002/ccd.24326
35.
VasileiosCIliasKGeorgeF, et al. Vascular complications in TAVI procedures: assessment, management, and outcomes-a retrospective study. Hellenic J Cardiol. Epub ahead of print 6 November 2024. DOI: 10.1016/j.hjc.2024.10.006.
36.
WinterMPBartkoPHoferF, et al. Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Sci Rep. 2020;10(1):15568.
37.
BarbashIMBarbantiMWebbJ, et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J. 2015;36:3370-3379.
38.
MehilliJJochheimDAbdel-WahabM, et al. One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. EuroIntervention. 2016;12:1298-1304.
39.
BarbantiMCapranzanoPOhnoY, et al. Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation. EuroIntervention. 2015;11:690-697.
40.
HondaYArakiMYamawakiM, et al. The novel echo-guided ProGlide technique during percutaneous transfemoral transcatheter aortic valve implantation. J Intervent Cardiol. 2018;31:216-222.
41.
SorropagoGSinghGSorropagoA, et al. A new percutaneous technique for effective vascular access site closure in patients undergoing transfemoral aortic valve implantation and thoraco-abdominal aortic aneurysm rEpair: the PASTE study. EuroIntervention. 2018;14:e1278-e1285.
42.
KotroniasRABrayJJHRajasundaramS, et al. Ultrasound- versus fluoroscopy-guided strategy for transfemoral transcatheter aortic valve replacement access: a systematic review and meta-analysis. Circ Cardiovasc Interv. 2021;14(10):e010742. doi:10.1161/CIRCINTERVENTIONS.121.010742
43.
FitzgeraldSDumpiesOShibataM, et al. Femoral arterial calcification and plug- vs. suture-based closure device strategies post-transcatheter aortic valve implantation: insights from CHOICE-CLOSURE. Struct Heart. 2024;8:100236.
44.
BarbantiMBinderRKFreemanM, et al. Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement. EuroIntervention. 2013;9:929-935.
