Dataset Information

MANTA Versus Suture-based Closure Devices Following Transcatheter Aortic Valve Replacement: An Updated Meta-analysis.

ABSTRACT:

Background

Vascular access closure is essential in large-bore arteriotomy procedures, such as transcatheter aortic valve replacement. Suture-based devices are frequently used for vascular access closure. MANTA (Teleflex) is a collagen plug-based device used to achieve hemostasis with evolving efficacy and safety data. This study aimed to evaluate plug-based versus suture-based closure devices following large-bore arteriotomy procedures.

Methods

We conducted a systematic review searching PubMed, Cochrane Library, and ClinicalTrials.gov (inception through November 2021) for studies evaluating plug-based versus suture-based closure devices following large-bore arteriotomy procedures. We performed a meta-analysis comparing the length of stay, device failure, mortality, bleeding, and vascular complications between these 2 types of devices.

Results

Eleven studies (2 randomized controlled trials and 9 observational studies) with a total of 3123 patients were included in this analysis. Compared with suture-based devices, plug-based devices were associated with a significant decrease in the length of stay (standardized mean difference: -0.14; 95% CI, -0.25 to -0.03) and vascular closure device failure (odds ratio, 0.63; 95% CI, 0.44-0.91) following the procedure. There were no significant differences in all-cause mortality, major or minor bleeding, and major or minor vascular complications between plug-based and suture-based closure devices.

Conclusions

Plug-based vascular closure devices were associated with a shorter length of stay and lower risk of device failure following large-bore arteriotomy procedures without differences in mortality, bleeding, or vascular complications than suture-based closure devices.

SUBMITTER: Al-Abdouh A

PROVIDER: S-EPMC11308113 | biostudies-literature | 2022 Sep-Oct

REPOSITORIES: biostudies-literature

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Publications

MANTA Versus Suture-based Closure Devices Following Transcatheter Aortic Valve Replacement: An Updated Meta-analysis.

Al-Abdouh Ahmad A Abusnina Waiel W Mhanna Mohammed M Barbarawi Mahmoud M Jabri Ahmad A Bizanti Anas A Abdel-Latif Ahmed A Goldsweig Andrew M AM Alkhouli Mohamad M Lichaa Hady H Kerrigan Jimmy J Paul Timir K TK

Journal of the Society for Cardiovascular Angiography & Interventions 20220630 5

<h4>Background</h4>Vascular access closure is essential in large-bore arteriotomy procedures, such as transcatheter aortic valve replacement. Suture-based devices are frequently used for vascular access closure. MANTA (Teleflex) is a collagen plug-based device used to achieve hemostasis with evolving efficacy and safety data. This study aimed to evaluate plug-based versus suture-based closure devices following large-bore arteriotomy procedures.<h4>Methods</h4>We conducted a systematic review se ...[more]

PMID: 39131480

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Project description:BackgroundTranscatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis in intermediate, high-risk, and inoperable patients. TAVR has multiple access routes, including transfemoral (TF), transapical (TA), direct aortic (DA), axillary, transcarotid, and transcaval. The most commonly applied algorithm is a TF-first approach, where only when patients are unsuitable for TF are alternatives such as TA considered. An infrequent - but dreaded - risk is left ventricular (LV) apical bleeding from tearing or rupture with the TA approach. With burgeoning transcatheter mitral technology that requires a TA approach, the study aim was to develop a mathematical model to determine suture forces for TA closure.MethodsPreoperative cine-cardiac magnetic resonance imaging (MRI) was used to acquire three-dimensional (3D) LV geometry at end-systole and end-diastole. Endocardial and epicardial boundaries were manually contoured using MeVisLab, a surface reconstruction software. 3D surfaces of endocardium and epicardium were reconstructed, and surfaces at end-systole were used to create a 3D LV finite element (FE) mesh. TA access was mimicked by developing a 10-mm defect within the LV FE model. The LV apex was closed using a virtual suture technique in FE analysis with the application of two virtual sutures. After virtual closure, a FE analysis was performed of LV model diastolic filling and systolic contraction.ResultsProof of concept was achieved to develop an LV transapical access site and perform FE analysis to achieve closure. The FE method of virtual suture technique successfully approximated the LV apical defect. The peak axial forces on virtual sutures at end-diastole and end-systole were 0.445N and 0.736N, respectively.ConclusionsA LV TA access model was mathematically developed that could be used to evaluate the suture tension of the TA closure process. Further development of this approach may be useful to risk-stratify patients in the future for LV apical tearing. Video 1: Cine cardiac magnetic resonance imaging of the left ventricle. Video 2: Slow motion animation of left ventricular baseline simulation. Video 3: Animation of the virtual suturing process.

Project description:AimsThere is evidence to suggest that the subtype of aortic stenosis (AS), the degree of myocardial fibrosis (MF), and level of aortic valve calcification (AVC) are associated with adverse cardiac outcome in AS. Because little is known about their respective contribution, we sought to investigate their relative importance and interplay as well as their association with adverse cardiac events following transcatheter aortic valve replacement (TAVR).Methods and resultsOne hundred consecutive patients with severe AS and indication for TAVR were prospectively enrolled between January 2017 and October 2018. Patients underwent transthoracic echocardiography, multidetector computed tomography, and left ventricular endomyocardial biopsies at the time of TAVR. The final study cohort consisted of 92 patients with a completed study protocol, 39 (42.4%) of whom showed a normal ejection fraction (EF) high-gradient (NEFHG) AS, 13 (14.1%) a low EF high-gradient (LEFHG) AS, 25 (27.2%) a low EF low-gradient (LEFLG) AS, and 15 (16.3%) a paradoxical low-flow, low-gradient (PLFLG) AS. The high-gradient phenotypes (NEFHG and LEFHG) showed the largest amount of AVC (807 ± 421 and 813 ± 281 mm3 , respectively) as compared with the low-gradient phenotypes (LEFLG and PLFLG; 503 ± 326 and 555 ± 594 mm3 , respectively, P < 0.05). Conversely, MF was most prevalent in low-output phenotypes (LEFLG > LEFHG > PLFLG > NEFHG, P < 0.05). This was paralleled by a greater cardiovascular (CV) mortality within 600 days after TAVR (LEFLG 28% > PLFLG 26.7% > LEFHG 15.4% > NEFHG 2.5%; P = 0.023). In patients with a high MF burden, a higher AVC was associated with a lower mortality following TAVR (P = 0.045, hazard ratio 0.261, 95% confidence interval 0.07-0.97).ConclusionsMF is associated with adverse CV outcome following TAVR, which is most prevalent in low EF situations. In the presence of large MF burden, patients with large AVC have better outcome following TAVR. Conversely, worse outcome in large MF and relatively little AVC may be explained by a relative prominence of an underlying cardiomyopathy. The better survival rates in large AVC patients following TAVR indicate TAVR induced relief of severe AS-associated pressure overload with subsequently improved outcome.

Project description:BackgroundThe past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions.MethodsCARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan-Meier curve was used to estimate the risk of adverse events during follow-up.ResultsThe mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7-8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%).ConclusionsTAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients.Trial registrationhttps://www.chictr.org.cn/ (No. ChiCTR2000038526).

Dataset Information

MANTA Versus Suture-based Closure Devices Following Transcatheter Aortic Valve Replacement: An Updated Meta-analysis.

Background

Methods

Results

Conclusions

Publications

MANTA Versus Suture-based Closure Devices Following Transcatheter Aortic Valve Replacement: An Updated Meta-analysis.

Similar Datasets

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