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Association between arteriotomy-depth/femoral-artery phenotype and the type of vascular injury. AFAP indicates arteriotomy-depth/femoral-artery phenotype.
Source publication
Background/purpose:
The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications.
Methods/m...
Contexts in source publication
Context 1
... depth was measured using the dedicated MANTA depth locator provided in the MANTA kit and featured the distance from skin entry to the arteriotomy, which was affected by the puncture angulation (in principle 45°; Online Fig. 1). A deep arteriotomy (i.e. covered by a long trajectory of subcutaneous tissues) and small femoral artery diameter were suspect for a higher risk for VCD failure and access complications. We looked at different phenotypes based on arteriotomy depth and femoral artery diameter (AFAP) as ...
Context 2
... association between AFAP and the type of vascular injury is presented in Fig. 1. From AFAP-1 to AFAP-2 and 3, there was a gradual increase in occurrence of any type of vascular injury except for injury caused by dissection, stenosis or occlusion which occurred significantly more often in patients with AFAP-3 as compared to patients with AFAP-1 or ...
Context 3
... which, during closure, may hinder to retract the VCD under the recommended 45° angle. This angle is important to achieve optimal intraluminal toggle position and avoid arterial injury such as dissection, stenosis or occlusion which were particularly prevalent in patients with an unfavorable arteriotomydept/femoral-diameter phenotype (AFAP-3, Fig. 1). On the other hand, it is likely that patients exhibiting such unfavorable vascular anatomy are at elevated risk for vascular injury with any type of closure ...
Citations
... 8 Although a recent meta-analysis identified some factors that were likely to lead to plug-based closure device failure, calcification specifically was not considered. 9 Furthermore, given the difference in mechanism between the plug-and suture-based closure strategies, it may be that one or the other strategy is more favorable for a given set of circumstances or a particular patient cohort. ...
Background
The location and severity of vascular calcification may influence closure device success in transfemoral transcatheter aortic valve implantation. The aim of this study was to analyze effects of vascular access-site calcification on vascular and bleeding outcomes post-transcatheter aortic valve implantation.
Methods
The Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE) trial assigned 516 patients to access site closure using a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The principal finding of the overall study was that access-site or access-related complications were more common after the plug-based strategy compared to percutaneous closure with a suture-based strategy. In this predefined subgroup analysis, the overall cohort was split into patients with and without anterior calcification at the access site and divided by degree of calcification severity using the classification system developed in the MANTA vs. suture-based vascular closure after transcatHeter aortic valve replacement (MASH) trial. Differences in bleeding and vascular complications were compared. The primary endpoint consisted of access-site- or access-related major and minor vascular complications.
Results
There were more access-site-related major and minor vascular complications for patients with anterior wall vascular calcification and MASH severe calcification. No significant interaction with choice of closure technique in terms of access-site-related major and minor vascular complications was observed (odds ratio 1.70, 95% CI 0.77-3.78, p = 0.19 for the primary endpoint in plug- vs. suture-based strategy in patients with anterior calcification, odds ratio 1.78, 95% CI 0.56-5.65, p = 0.33 for primary endpoint in plug- vs. suture-based strategy with MASH severe calcification, pint = 0.97 for anterior calcification, pint = 0.95 for MASH severe calcification).
Conclusions
The total number of vascular complications was found to be greater in the presence of anterior and MASH severe calcification. Overall, the presence of anterior or severe calcification does not significantly modify the efficacy of the suture-based strategy compared to the plug-based strategy.
... Multiple adult studies have demonstrated high technical success rate of the MANTA device from 96 to 100% [1,2,[4][5][6][7][8][9]. This confirms a short learning curve for learners, which is promising for adoption of this device for pediatric ECMO decannulation. ...
VA-ECMO can be lifesaving in cardiogenic shock in children. While surgical vascular repair is the current standard of care for decannulation, it comes with notable risks. We present a series of eight patients who underwent decannulation with a collagen plug-based vascular closure device (MANTA) for the common femoral artery. Seven of the patients were successfully decannulated without access site-related vascular complications. One required conversion to surgical cut-down with arterial repair due to device failure. This series demonstrates the successful use of the MANTA device in percutaneous VA-ECMO decannulation in the pediatric population, while highlighting potential technical challenges for success.
... The VCDs have played a significant role in reducing risk of vascular complications but failure of their deployment remains a genuine concern. In a patient level metaanalysis of 891 patients, 3.1% of the complications occurred due to incomplete arteriotomy closure, which constituted about 34% of the total vascular complications [29]. Meighem et al., in their study of 986 patients, reported closure device failure as a cause of 64% of the major vascular complications and 29% of life threatening/disabling bleeding [6]. ...
... 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. ...
... 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. ...
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.
... The MANTA VCD (Teleflex Inc., Pennsylvania, USA) is the first commercially available collagen-based technology dedicated for large bore arteriotomy closure approved by the United States Food and Drug Administration (FDA) (6,7). A reliable safety and efficacy have been well established in selected TAVR populations, but comparative studies with conventional suture-based devices have provided heterogenous results (8)(9)(10)(11)(12). Therefore, we sought to evaluate MANTA VCD performance for large bore arteriotomy closure in an unselected singlecenter TF-TAVR population, with a focus on access-site vascular complications rates and predictors. ...
... *Started before target procedure. rate of MANTA-access vascular events (up to 19%) in the early randomized studies (8)(9)(10)(11)(12). In our analysis focused on intermediate/low risk TAVRtreated patients, we confirmed a high arteriotomy closure success rate (98%) by the use of MANTA device, extending these results to patients also excluded in early studies as those with obesity, excessive calcifications, and/or tortuosity of the ileo-femoral artery (6)(7)(8)(9)(10). ...
... rate of MANTA-access vascular events (up to 19%) in the early randomized studies (8)(9)(10)(11)(12). In our analysis focused on intermediate/low risk TAVRtreated patients, we confirmed a high arteriotomy closure success rate (98%) by the use of MANTA device, extending these results to patients also excluded in early studies as those with obesity, excessive calcifications, and/or tortuosity of the ileo-femoral artery (6)(7)(8)(9)(10). The rate of overall MANTA-access vascular complications (11%) was in line with previous observational registries and early trials and is definitely lower than in the largest randomized available experience mainly driven by a reduction of major events (8)(9)(10)(11)(12)25). ...
Backgrounds
Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.
Methods
Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.
Results
Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age ( p = 0.04), minimum common femoral artery diameter (CFA) ( p < 0.01), sheath-to-femoral-artery ratio (SFAR) ( p < 0.01), and a lower puncture height ( p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.
Conclusions
In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.
... 8 The current literature on this topic is mostly limited to relatively small case series with varying results, whereas a complex analysis of potential anatomic predictors has rarely been performed. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] The aim of this study was to evaluate the efficacy and safety of the novel plug-based MANTA-VCD in a large patient cohort as current data was mainly acquired in a relatively small series. ...
... Indeed, logistic regression revealed that the chance of suffering a major complication is 3.6-fold higher among women than among men. This finding is consistent with previous studies, 4,10,12,26,27 and might be based on gender-specific differences in anatomy. Our analysis shows that female patients have a significantly shorter CFA, a smaller vessel angulation at the puncture site, a shorter minimal luminal diameter, and smaller vessel perimeter and area. ...
... The major vascular adverse event rate attributed to the use of the MANTA VCD presented in the previous studies is very heterogenous, and ranges from none up to 9.3%. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] In our opinion, this variety cannot be clearly explained, and it is only in some extent related to the different study design or methods when analyzing the above-mentioned reports. For example, De Palma et al report a major complication rate of only 1.1%, but evaluated arterial patency post vascular closure only clinically, and angiography was not obtained systematically. ...
Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series.
Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself.
Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications.
Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.
... This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure -A patient level meta-analysis [1] . The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. ...
... All events were adjudicated by independent clinical event committees. A detailed description of the study population, MANTA device, the percutaneous procedures, ileofemoral data and clinical outcome assessment is presented in the main article [1] . Continuous variables were compared using the Student t-test or Mann Whitney U test when appropriate. ...
This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American device approval study (the Conformite Européene [CE] mark study and the investigational device exemption SAFE-MANTA study [2, 3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management.
Background:
Large bore arterial hemostasis for emergent MCS initiation in cardiogenic shock and during failures of suture mediated vascular closure devices (VCD) necessitates dry/post-closure technique for successful closure. Use of the alternative MANTA fluoroscopic DOT technique, without depth finder, as post closure and as 'bail-out' in this high-risk patient population is described.
Methods:
All patients who underwent emergent percutaneous transfemoral MCS initiation, without use of upfront sutured-mediated pro-glide VCDs, and procedures where proglide-perclose technique (PPT) failed to achieve hemostasis were post-closed with the alternative MANTA fluoroscopic DOT technique (without depth finder) as primary method or as 'bail-out'. Patient related factors, cardiovascular co-morbidities, clinical indication, distribution of 14F versus 18F MANTA, and types of procedures obtained. Primary outcomes of access site related acute flow-limiting limb ischemia or bleeding requiring intervention analyzed.
Results:
27 patients met inclusion criteria; mean age 64 years, majority male 19 (70 %), more than half obese (56 %) with mean BMI 31.06 kg/m2. 22 (81 %) had emergent MCS initiation and 5 (19 %) PPT hemostasis failures. Types of percutaneous MCS support included; 11 (44 %) Impella CP, 2 (7 %) 15F arterial ECMO, 6 (22 %) 17F arterial ECMO, 4 (15 %) 19F ECMO. All achieved hemostasis utilizing alternative MANTA fluoroscopic DOT technique without vascular complications of bleeding or acute ischemic limb.
Conclusion:
The alternative MANTA fluoroscopic DOT technique (without depth finder) can be successfully applied as post-closure for emergent MCS support delayed hemostasis and as bail-out for per-close suture mediated VCD failures for large bore arterial hemostasis.
To minimize complications during transcatheter aortic valve replacement ( TAVR ), extensive pre‐procedural planning is necessary to determine the most appropriate vascular access and closure approach. Transfemoral ( TF ) access remains the default route for procedures requiring large‐bore access, including TAVR; however, some patients remain ineligible to undergo TF due to unsuitable anatomy due to extensive peripheral artery disease and ultimately require alternative routes. Moreover, large‐bore vascular interventions have created challenges in closure management; fortunately, arteriotomy closure devices ( ACD s) have proven superior to manual compression. This chapter will review the most common vascular accesses used for TAVR and the available ACDs.
Background
The sex differences in utilization, safety outcomes, and healthcare resource utilization of patients with PE undergoing percutaneous pulmonary artery thrombectomy are not well characterized.
Research Question
What are the sex differences in outcomes for patients diagnosed with pulmonary embolism (PE) undergoing percutaneous pulmonary artery thrombectomy?
Study Design and Methods
This retrospective cross-sectional study used national inpatient claims data to identify patients in the U.S. with a discharge diagnosis of PE who underwent percutaneous thrombectomy between January 2016 and December 2018. We evaluated the demographics, comorbidities, safety outcomes (in-hospital mortality) and healthcare resource utilization (discharge to home, length of stay, and hospital charges) of PE patients undergoing percutaneous thrombectomy.
Results
Among 1,128,904 patients with a diagnosis of PE between 2016 and 2018, 5,160 (0.5%) patients underwent percutaneous pulmonary artery thrombectomy. When compared to males, females had higher procedural bleeding (16.9 vs. 11.2%; P < 0.05), required more blood transfusions (11.9% vs. 5.7%; p < 0.05), and had more vascular complications (5.0% vs. 1.5%; P < 0.05). Females had higher in-hospital mortality (16.9% vs 9.3%; adjusted OR: 1.9; 95% CI 1.2 to 3.0; P = 0.003) when compared to males. Although length of stay and hospital charges were similar to males, females were less likely to be discharged home after surviving hospitalization (47.9% vs. 60.3%; adjusted OR= 0.7; 95% CI: 0.50 to 0.99; P = 0.04).
Interpretation
In this large nationwide cohort, females with PE who underwent percutaneous thrombectomy had higher morbidity and in-hospital mortality compared to males.
