Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis

Sakata, Tomoki; Kuno, Toshiki; Fujisaki, Tomohiro; Yokoyama, Yujiro; Misumida, Naoki; Sugiura, T.; Latib, Azeem

doi:10.1016/j.carrev.2022.08.011

Cited by 4 publications

(6 citation statements)

References 37 publications

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“…In contrast to our analysis, none of the previously published meta-analyses could find a difference between the two VCDs in terms of vascular complications [16][17][18]. Most likely, this is due to mixing of RCTs and OS in previous meta-analyses, possibly leading to a high risk of bias and heterogeneity of results.…”

Section: Discussioncontrasting

confidence: 99%

“…Furthermore, all previous metaanalyses did not differentiate between access-site related vascular complications and overall vascular complications (including non-access-site related ones). Furthermore, two of the previous meta-analyses included the ProStar device in the cohort of suture based VCD [16,18], and previous studies have already demonstrated that the ProStar device is inferior to ProGlide [1].…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, meta-analyses comparing both VCDs have been recently performed [16][17][18], but none of them found a difference in terms of vascular complications or bleeding events between both techniques. However, these meta-analyses have important methodological limitations, particularly by mixing OS and randomized controlled trials (RCTs).…”

Section: Introductionmentioning

confidence: 99%

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Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

et al. 2023

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Background Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. Aims We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). Methods We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. Results Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43–0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16–2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32–1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82–2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07–11.33], p = 0.04, I2 = 0%). Conclusions While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique. Graphical abstract

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

et al. 2023

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“…47 Evidence supporting the effectiveness of currently available VCDs for large-bore sheath procedures, such as TAVR and pLVAD placement, is less robust, with heterogenous outcomes. [48][49][50][51][52] Some operators recommend large-bore sheath removal in the catheterization laboratory using a dry closure technique, in which a balloon is inflated proximal to the access site, at which point the sheath is removed and a Perclose ProGlide system deployed. 53 Careful observation for bleeding post-sheath removal is important, as the balloon tamponade can be reinstituted while repairing the closure site.…”

Section: Vascular Closure Techniques and Devicesmentioning

confidence: 99%

Strategies for Reducing Vascular and Bleeding Risk for Percutaneous Left Ventricular Assist Device-supported High-risk Percutaneous Coronary Intervention

Vetrovec¹,

Kaki²,

Wollmuth³

et al. 2022

Heart International

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In patients at high risk for haemodynamic instability during percutaneous coronary intervention (PCI), practitioners are increasingly opting for prophylactic mechanical circulatory support, such as the Impella® heart pump (Abiomed, Danvers, MA, USA). Though Impellasupported high-risk PCI (HRPCI) ensures haemodynamic stability during the PCI procedure, access-related complication rates have varied significantly in published studies. Reported variability in complication rates relates to many factors, including anticoagulation practices, access and closure strategy, post-procedure care and variations in event definitions. This article aims to outline optimal strategies to minimize vascular and bleeding complications during Impella-supported HRPCI based on previously identified clinical, procedural and postprocedural risk factors. Practices to reduce complications include femoral skills training, standardized protocols to optimize access, closure, anticoagulation management and post-procedural care, as well as the application of techniques and technological advances. Protocols integrating these strategies to mitigate access-related bleeding and vascular complications for Impella-supported procedures can markedly limit vascular access risk as a barrier to appropriate large-bore mechanical circulatory support use in HRPCI.

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“…Since this first-in-man case, TAVR was considered to be an alternative treatment option for patients with severe aortic stenosis at high surgical risk, as surgical aortic valve replacement (SAVR) was considered to have an unacceptably elevated risk of complications or death 2–5. Continuous advances in TAVR technology have created different types of access, such as classical transfemoral, transcaval, trans‐subclavian, transaxillary, transcarotid, transaortic and transapical 6–8. In addition, ongoing improvements in devices and techniques also decreased the composite adverse events and mortality 9…”

Section: Introductionmentioning

confidence: 99%

Remote ischaemic preconditioning for transcatheter aortic valve replacement: a protocol for a systematic review with meta-analysis and trial sequential analysis

Zhang,

Du,

Chen

et al. 2024

BMJ Open

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IntroductionTranscatheter aortic valve replacement (TAVR) has become an important treatment in patients with aortic valve disease with the continuous advancement of technology and the improvement of outcomes. However, TAVR-related complications still increase patient morbidity and mortality. Remote ischaemic preconditioning (RIPC) is a simple procedure that provides perioperative protection for many vital organs. However, the efficiency of RIPC on TAVR remains unclear based on inconsistent conclusions from different clinical studies. Therefore, we will perform a protocol for a systematic review and meta-analysis to identify the efficiency of RIPC on TAVR.Methods and analysisEnglish databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang Database, VIP Database and China National Knowledge Infrastructure) and trial registry databases will be searched from inception to December 2023 to identify randomised controlled trials of RIPC on TAVR. We will calculate mean differences or standardised mean differences with 95% CIs for continuous data, and the risk ratio (RR) with 95% CIs for dichotomous data by Review Manager version 5.4. Fixed-effects model or random-effects model will be used according to the degree of statistical heterogeneity assessed by the I-square test. We will evaluate the risk of bias using the Cochrane risk-of-bias tool 2 and assess the evidence quality of each outcome by the Grading of Recommendations Assessment, Development and Evaluation. The robustness of outcomes will be evaluated by trial sequential analysis. In addition, we will evaluate the publication bias of outcomes by Funnel plots and Egger’s regression test.Ethics and disseminationEthical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.PROSPERO registration numberCRD42023462926

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Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis

Cited by 4 publications

References 37 publications

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

Strategies for Reducing Vascular and Bleeding Risk for Percutaneous Left Ventricular Assist Device-supported High-risk Percutaneous Coronary Intervention

Remote ischaemic preconditioning for transcatheter aortic valve replacement: a protocol for a systematic review with meta-analysis and trial sequential analysis

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