Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications

Masiero, Giulia; D'Angelo, Livio; Fovino, Luca Nai; Fabris, Tommaso; Cardaioli, Francesco; Rodinò, Giulio; Benedetti, A.; Boiago, Mauro; Continisio, Saverio; Montonati, Carolina; Sciarretta, Tommaso; Zuccarelli, Vittorio; Scotti, Andrea; Lorenzoni, Giulia; Pavei, Andrea; Napodano, Massimo; Fraccaro, Chiara; Iliceto, Sabino; Marchese, Alfredo; Esposito, Giovanni

doi:10.3389/fcvm.2022.832242

Cited by 9 publications

(8 citation statements)

References 25 publications

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“…The MANTA VCD studies showed that the incidence of minor complications varied up to 14%, the incidence of major complications was up to 3%, and life-threatening complications was up to 4% according to the VARC-2 criteria for bleeding, which is comparable to our results ( 9 , 10 , 18 – 20 ). It is necessary to point out the study by Maisero et al ( 21 ), published in February 2022 as the only research in which the frequency of bleeding complications was classified according to the newest VARC-3 criteria, used in this study. The results showed that the frequencies of mild VARC 1 bleeding complications were higher (14% vs. 4%), while the results in other categories roughly correspond with our study (VARC 2: 1% vs. 2%; VARC 3–4: 2% vs. 5%).…”

Section: Discussionmentioning

confidence: 99%

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures

Košak¹,

Lulić

Jakljević

et al. 2023

Front. Cardiovasc. Med.

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BackgroundsThe vascular closure device (VCD) is a medical device used for achieving hemostasis of vascular access sites greater than 8 Fr. We compared complications after placement of Perclose ProGlide (Abbott Vascular, USA), a percutaneous suture-mediated closure system, with MANTA VCD (Teleflex Vascular, USA), a collagen-based closure device.MethodsThis retrospective cohort study analyzed procedures performed between 2016 and 2021. We compared the incidence of bleeding complications according to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium-3 (VARC-3) criteria. The comparison was made between two cohorts of patients: in the first, vascular access sites were closed with a double Perclose ProGlide system, and in the second with an 18 Fr MANTA VCD.ResultsA total of 189 patients were included in the study, out of which 63% were male and 37% were female, with a median age of 79 (72–83) years. All devices were used for femoral arterial access closure. A double Perclose ProGlide was used in 91 (48%) patients, while MANTA VCD was used in 98 patients (52%). The distribution of patients by VARC-3 and BARC bleeding criteria differs between groups (p = 0.017). A significantly higher incidence of VARC 1 (14% vs. 4%; p = 0.020) and BARC 1–2 (14% vs. 4%; p = 0.020) complications in the Perclose ProGlide cohort was observed. VARC 3 (1% vs. 5%; p = 0.213) and BARC 3b (1% vs. 5%; p = 0.213) complications showed higher, but statistically non-significant rates of major bleeding complications in the MANTA VCD cohort. The need for subsequent surgical revision did not show a significant difference between the cohorts (2% vs. 6%; p = 0.281).ConclusionThe Perclose ProGlide cohort was associated with a significantly higher rate of milder complications. MANTA VCD cohort had a higher rate of major bleeding complications, requiring more complex treatment with a potentially larger impact on quality of life.

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Section: Discussionmentioning

confidence: 99%

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures

Košak¹,

Lulić

Jakljević

et al. 2023

Front. Cardiovasc. Med.

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“…Nonetheless, recent evidence suggest that the reported low rates of vascular complications are often not observed in the early roll-in phase of the device in real-world scenarios. 37 Therefore, operator’s experience and centre volumes with individual VCDs should be factored in the decision-making process also for the MANTA device. Furthermore, the MANTA device is not available in many centres and that the overall experience of many skilled TAVR operators with this device is still quite limited.…”

Section: Discussionmentioning

confidence: 99%

Large-bore arterial access closure after transcatheter aortic valve replacement: a systematic review and network meta-analysis

Montalto

Munafò

Arzuffi

et al. 2022

European Heart Journal Open

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Background As the indications to transcatheter aortic valve replacement (TAVR) expand to patients at increasingly lower risk, procedure-related vascular and bleeding complications events must be minimized. We aimed to evaluate the impact of different large-bore arterial access closure devices on clinical outcomes after TAVR. Methods We searched for papers that reported outcomes according to the type of vascular closure device/technique used after TAVR and performed a Bayesian network meta-analysis (NMA). Results Fifteen studies involving 9,259 patients who underwent access site closure using PROSTAR™ XL percutaneous vascular surgical system (Abbott Vascular, Santa Clara, CA, USA), Perclose ProGlide™ suture-mediated closure system (Abbott) or MANTATM vascular closure device (Teleflex, Morrisville, NC, USA) were included. NMA showed MANTA to have the highest likelihood of reducing a primary composite endpoint of intra-hospital death, major vascular complications and major or life-threatening bleedings (Surface Under the Cumulative Ranking curve Analysis [SUCRA] 94.8%) but this was mitigated when only randomized clinical trials and propensity-matched cohorts were included (SUCRA 56.1%). The ProGlide showed the highest likelihood to reduce major or life-threatening bleedings, especially with increasing procedural complexity, and the MANTA device to reduce major and minor vascular complications. The ProStar XL device performed poorly in all explored endpoints. Conclusions Available evidence summarized through a NMA shows that ProGlide and MANTA devices appear to be both valid VCDs globally, and to be the best options to minimize vascular complications and reduce bleeding in patients undergoing TAVR, respectively.

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“…The striking similitude of predictors of vascular outcomes with use of either of these VCDs corroborate the theory of these factors. Variables such as age [ 34 , 35 ], female gender [ 36 ], severity of calcification or peripheral vascular disease [ 10 , 29 , 36 ], increased sheath size [ 10 ], higher sheath to femoral artery ratio [ 35 , 37 , 38 ], depth of arteriotomy site, and femoral artery size [ 10 , 29 ] play an important role in speculating vascular outcomes and have been shown as predicting variables for vascular outcomes with both VCDs. Calcification in the artery may lead to failure of VCD deployment despite having different mechanisms of failure with each device.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Suture-Based and Collagen-Based Vascular Closure Devices for Large Bore Arteriotomies—A Meta-Analysis of Bleeding and Vascular Outcomes

Sohal

Mathai

Nagraj

et al. 2022

JCDD

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Background: Large bore access procedures rely on vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) such as ProGlide and ProStar XL have been readily used, but recently, newer generation collagen-based vascular closure devices (C-VCD) such as MANTA have been introduced. Data on comparisons of these devices are limited. Methods: PubMed, Scopus and Cochrane were searched for articles on vascular closure devices using keywords, (“Vascular closure devices” OR “MANTA” OR “ProStar XL” OR “ProGlide”) AND (“outcomes”) that resulted in a total of 875 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 were compared between the two types of VCDs. The event level data were pooled across trials to calculate the Odds Ratio (OR) with 95% CI, and analysis was done with Review Manager 5.4 using random effects model. Results: Pooled analyses from these nine studies resulted in a total of 3410 patients, out of which 2855 were available for analysis. A total of 1229 received C-VCD and 1626 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were similar to patients who received S-VCD ((OR: 0.70 (0.35–1.39), p = 0.31, I2 = 55%), OR:0.92 (0.53–1.61), p = 0.77, I2 = 65%)). The vascular complications (major and minor) in patients who received C-VCD were also similar to patients who received S-VCD ((OR: 1.01 (0.48–2.12), p = 0.98, I2 = 52%), (OR:0.90 (0.62–1.30), p = 0.56, I2 = 35%)). Conclusions: Bleeding and vascular complications after large bore arteriotomy closure with collagen-based vascular closure devices are similar to suture-based vascular closure devices.

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Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications

Cited by 9 publications

References 25 publications

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures

Large-bore arterial access closure after transcatheter aortic valve replacement: a systematic review and network meta-analysis

Comparison of Suture-Based and Collagen-Based Vascular Closure Devices for Large Bore Arteriotomies—A Meta-Analysis of Bleeding and Vascular Outcomes

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