MANTA Vascular Closure Device Research Articles

The MANTA vascular closure device in transfemoral TAVI: a real-world cohort

The MANTA vascular closure device in transfemoral TAVI: a real-world cohort

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI.

Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment. We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI. Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention. Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint. Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.

MANTA vascular closure device bleeding and vascular complications in association with cardiovascular risk factors: a large single centre experience

Abstract Background Percutaneous cardiovascular interventions such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and mechanical circulatory support (MCS) involve large-bore arterial cannulation. Clinically significant bleeding and vascular complications are frequently encountered as a consequence of arterial cannulation. Collagen-based vascular closure devices (VCD) such as MANTA VCD are increasingly utilized to achieve arterial vascular access closure. This study aims to explore the association between cardiovascular risk factors and bleeding and vascular complications in procedures utilizing MANTA VCD. Methods A large single-centre retrospective study was performed of patients who underwent TAVR, BAV, and MCS in which arterial access closure was achieved with MANTA VCD. All cases from June 2019 to September 2020 were included. The primary efficacy outcome was defined as immediate haemostasis. The secondary safety outcome was defined as Valve Academic Research Consortium-3 (VARC-3) criteria bleeding and vascular complications. Baseline patient characteristics were obtained to evaluate the association between cardiovascular risk factors and outcomes. Results One hundred and seventy-four cases involved vascular access site closure using MANTA VCD. Immediate haemostasis of the access site was achieved in 92.5% of cases (n=161) whereas 7.5% of cases had failed immediate haemostasis (n=13). VARC-3 criteria bleeding and vascular complications occurred in 12.1% of cases (n=21). Cardiovascular risk factors including coronary artery disease and smoking history were associated with an increased risk for bleeding and vascular complications. Rate of bleeding and vascular complications among patients with coronary artery disease (CAD) (n=71) was 18.3% whereas the rate among patients without CAD (n=103) was 7.8%; this association was statistically significant with an odds ratio of 2.66 (95% CI 1.04 – 6.81, p &amp;lt; 0.05). Rate of bleeding and vascular complications among patients with a smoking history (n=67) was 19.4% whereas the rate among patients without a smoking history (n=107) was 7.5%; this association was statistically significant with an odds ratio of 2.98 (95% CI 1.16 – 7.63, p &amp;lt; 0.05). There was no statistically significant difference in the rate of bleeding and vascular complications for other cardiovascular risk factors such as, hypertension, peripheral vascular disease, atrial fibrillation, obesity, diabetes, chronic kidney disease, or chronic obstructive pulmonary disease. Conclusions MANTA VCD is a safe and effective tool for arterial access closure in procedures such as TAVR, BAV, and MCS. CAD and smoking are associated with a higher risk for VARC-3 criteria bleeding and vascular complications. Further multicentre studies are necessary to explore the association of cardiovascular risk factors with vascular access site closure complications and improve outcomes.

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair

ObjectiveThe MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). MethodsAll data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. ResultsIn total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. ConclusionsThis single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

Percutaneous decannulation of venoarterial extracorporeal membrane oxygenation using the Manta vascular closure device: A systematic review and meta-analysis.

To perform a systematic review and meta-analysis of the techniques and outcomes associated with percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA-ECMO) using the Manta vascular closure device. Peripheral VA-ECMO can be used to treat critically ill patients with conditions such as refractory cardiogenic shock. After percutaneous implantation of VA-ECMO, VA-ECMO can also be decannulated completely percutaneously by using a vascular closure device. The Manta vascular closure device is a dedicated device used in the closure of large-bore arteriotomies by sandwiching the arteriotomy with an intra-arterial toggle and an extraluminal collagen plug. We performed a thorough literature search using various electronic databases. We included studies that reported outcomes after peripheral femorofemoral VA-ECMO decannulation with the Manta vascular closure device. We performed a meta-analysis of proportions on outcome measures, including technical success, bleeding complications, vascular complications, wound complications, major amputation, and procedural-related deaths. We included seven studies with a total of 116 patients. The overall technical success of percutaneous decannulation of VA-ECMO with the Manta vascular closure device was 93.7%. The overall incidence of bleeding, vascular and wound complications was 1.7%, 13.8%, and 3.4%, respectively. No patient required lower limb amputation or died due to VA-ECMO decannulation. Percutaneous decannulation with the Manta vascular closure device is an effective and safe procedure that should be considered in suitable patients on VA-ECMO.

'Post-Close' Femoral Arterial Haemostasis at Endovascular Aneurysm Repair using a Dedicated Large-Bore Vascular Closure Device: A Prospective Real-World Audit.

Percutaneous access for endovascular aneurysm repair (EVAR) is commonplace, with its attendant benefits. The combination of continued reduction in device profile and evolution of vascular closure device (VCD) design drives successful and safe percutaneous EVAR. A new such VCD is the MANTA Large-Bore Closure Device designed in two iterations for closure of arterial defects from 10 to 25F. We present a prospective audit of 131 large-bore femoral closures using an 'all-comers' approach to device selection. One hundred and thirty-one large-bore femoral arterial defects were analysed. Both 14F and 18F MANTA VCDs were deployed in this series as per instructions for use. Primary objectives were technical success, particularly successful deployment, and haemostasis achieved. Failures were denoted as failure to deploy; failure to achieve haemostasis was denoted as active bleeding, haematoma, or pseudoaneurysm formation requiring intervention. Later complications assessed were vessel occlusion/thrombosis or stenosis. Seventy-six patients (65 males and 11 females, age 75.2 ± 8.7years) underwent a range of procedures including EVAR (n = 66), TEVAR (n = 2), and reinterventions (n = 8) requiring large-bore percutaneous femoral arterial access in 131 groins. Of these, the 14F MANTA VCD was used in 61 closures (defects ranging from 12 to 18F) and the 18F in 70 closures (defects ranging from 16 to 24F). Deployments achieved successful haemostasis in 120 (91.6%), and failures occurred in 11(8.4%) groins. This study indicates that a post-close approach using the novel MANTA Large-Bore Closure Device can be undertaken successfully to close a range of large-bore femoral arterial defects at EVAR/TEVAR with an acceptable rate ofcomplications.

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

The 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. This 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. A 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). The 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.

Decannulation of Percutaneous Femoro-femoral VA-ECMO Using the Manta Vascular Closure Device

Percutaneous cannulation improved femoro-femoral veno-arterial Extracorporeal Membrane Oxygenation (VA-ECMO) results, reducing infectious complications, but remains limited by vascular complications related to the arterial decannulation. Several techniques were described to perform a percutaneous decannulation but were limited by poor results or lacking reproducibility and fit to the VA-ECMO in cardiogenic shock. We report herein a novel simplified technic for femoro-femoral VA-ECMO decannulation: the combined use of Manta® and FemoSeal® for percutaneous VA-ECMO decannulation is an easy to learn, reproducible and effective technique, and appears to improve the outcomes of VA-ECMO.

574 DOUBLE VASCULAR COMPLICATION IN THE SITE OF PUNCTURE AFTER TAVI: A CASE REPORT

Abstract Hemorrhages represent one of the most frequent complications during TAVI. Their rapid recognition and a prompt treatment are necessary to avoid hemorrhagic shock, which can lead the patient to death in a short time. We report the case of a 79-year-old woman affected by severe and symptomatic aortic stenosis, who underwent TAVI in our Cath-lab. Through a right femoral echo-guided arterial access, implantation of a 26 mm self-expandable aortic bio-prosthesis and hemostasis in the site of puncture with 18F Manta vascular closure device were performed. At the end of the procedure, through radial artery, a femoral angiography was performed, showing an important leak of contrast medium upper the site of puncture, without any change in arterial pressure or heart rate. After echo-guided cannulation of left femoral artery with 8F sheath, implantation of endoprosthesis in the site of hemorrhage and hemostasis of left femoral artery with 8F AngioSeal VIP vascular closure device were performed. In cardiac intensive care unit (CICU) low dosage of vasoactive agents and blood were administered, guaranteeing a good arterial pressure. Computed tomography (CT) was performed after two days and confirmed the presence of a retroperitoneal hematoma, without active bleeding. After six days, the patient left CICU and was admitted to the cardiological ward, starting a gradual mobilization. However, after 48 hours she reported abdominal pain and became rapidly hypotensive, tachycardic and asthenic, requiring readmission in CICU. Serum exams showed low hemoglobin concentration, an abdominal CT was perfomed, showing an active bleeding from left femoral artery and a homolateral retroperitoneal hematoma. The patient was rapidly lead in the cath lab. Angiography confirmed the hemorrage and an endoprosthesis was successfully implanted in the left femoral artery. Blood and vasoactive agents were administered with a progressive improvement in hemodynamic and clinical conditions of the patients. Post-operative course was complicated by fever and empiric antiobiotic therapy was administered until blood culture revealed no bacterial growth. A third CT showed the stability of the hematomas and the absence of active bleeding, allowing hospital discharge of the patient. Vascular complications are frequent and sneaky during TAVI procedures. A prompt treatment is of paramount importance to prevent hemorrhagic shock. TAVI operators should have experience in the field of peripheral intervention for the management of vascular complications.

Comparison of MANTA vs ProGlide Vascular Closure Device and 30-Day Outcomes in Transfemoral Transcatheter Aortic Valve Implantation.

Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have an increased mortality risk, and vascular closure device (VCD) use is mandatory. The percutaneous MANTA VCD (Teleflex) is a novel collagen-based technology for closure of large-bore arteriotomies. We compared the MANTA VCD with the suture-based ProGlide VCD (Abbott Vascular). A retrospective review was performed on all consecutive patients who underwent transfemoral TAVI in our center from January 1, 2015, to February 28, 2021, and 30-day outcomes were recorded. Major adverse cardiovascular events (MACE) were cardiac death, disabling stroke, and/or major VCs. Access site-related VCs were VCs related to the access site vessel from which the transcatheter valve was introduced and advanced. The MANTA VCD was used in 99 patients and the ProGlide in 224. There was 4.0% MACE in the MANTA group and 4.9% in the ProGlide group (P = .999). Overall VCs were 10.1% vs 7.6%, major VCs were 3.0% vs 2.2%, and minor VCs 7.1% vs 5.4%(P = .753). Access site-related VCs were 5.1% vs 5.8% in the (P = .999), and periprocedural vascular surgical intervention was needed in 6.1% of the MANTA group vs 2.2% of the ProGlide group (P = .099). There was no significant difference in MACE, mortality, cardiovascular mortality, VCs, access site-related VCs, periprocedural vascular surgical interventions, bleeding, or transfusion rate between the 2 groups. The MANTA VCD group had more periprocedural vascular surgical interventions which did not reach statistical significance.

Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation

Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p=0.001). VCD failure rate were 7.5% and 3.9%, respectively (p=0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p=0.023; minor: 8.1% vs 4.4%, p=0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p=0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (P_interaction=0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA.

Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique

Background: Vascular complications are a cause of increased morbidity and mortality when performing percutaneous procedures requiring large-bore arterial access. MANTA vascular closure device (VCD) is currently the only large-bore VCD using an intraluminal foot plate and an extraluminal collagen plug. The traditional depth locator approach might be compromised in; emergent cases without the required measurements, cases of hematoma formation, or other patient, procedure, or operator-specific variables. Furthermore, this technique can be used for postclosure in cases without the required measurement of depth. We describe vascular outcomes using fluoroscopy (fluoroscopic DOT technique) rather than traditional depth locator approach for vascular closure with the MANTA VCD. Methods: Fifty patients who underwent transcatheter aortic valve implantation (TAVI) were retrospectively analyzed using fluoroscopic DOT technique with 18F MANTA VCD between May and August 2021. All patients >18 years of age who qualified for transfemoral TAVI were included. Access was obtained with ultrasound guidance with vessel diameter of at least > 6 mm and free from anterior vessel wall calcification. Patient related factors and primary outcomes of access site bleeding and acute flow-limited limb ischemia requiring intervention were prospectively analyzed. Furthermore, 1 patient who failed hemostasis with suture-mediated VCD had successful hemostasis with fluoroscopic DOT technique as dry postclosure after balloon aortic valvuloplasty. Results: In total, 50 patients were analyzed with a mean age of 81 years and majority were male (56%). Majority had comorbidities of hypertension (88%) and hyperlipidemia (94%), 24% had peripheral arterial disease, 38% coronary artery disease, and 58% were former smokers. Importantly, 40% were obese with an average body mass index (BMI) of 29 kg/m2. There were no bleeding or ischemic limb complications post MANTA VCD deployment using the fluoroscopic DOT technique. Furthermore, none of the patients required peripheral intervention from index procedure to 1 month post verified during their 1-month post TAVR follow-up. Conclusion: Fluoroscopic DOT technique using the MANTA VCD is highly reproducible and allows hemostasis in a predictable manner for procedures requiring large-bore arterial access in the absence of MANTA depth measurement.

The MANTA Vascular Closure Device: Requiring Attention From Beginning to End, Reply

The MANTA Vascular Closure Device: Requiring Attention From Beginning to End, Reply

Percutaneous versus surgical femoral access in minimally invasive cardiac operations.

Both surgical and percutaneous femoral accesses for the establishment of extracorporeal circulation are used in minimally invasive cardiac surgeries. The goal of this study was to compare the outcomes with the MANTA vascular closure device after percutaneous arterial decannulation via the surgical approach. Between November 2018 and January 2021, a total of 490 consecutive patients underwent minimally invasive cardiac operations at our institution. Cannulation and decannulation of femoral vessels were under direct vision surgically or percutaneously. The MANTA system was used to close the femoral artery in all patients with percutaneous cannulation. Demographic, clinical and procedural data were collected retrospectively. Surgical cut-down and suture closure of the femoral artery was performed in 222 patients (45.3%); percutaneous access and closure with the MANTA system was used in 268 patients (54.7%). The surgical group presented a significantly higher incidence of any access site complication compared to the percutaneous group [18 patients (8.1%) vs 6 patients (2.2%); P = 0.003]. Lymph fistula and wound healing disorders occurred more frequently in the surgical group (3.2% vs 0% [P = 0.004] and 3.6% vs 0% [P = 0.002], respectively). Median procedural duration and stays in the intensive care unit were significantly lower in the percutaneous group {127 [interquartile range (IQR) 97-158] min vs 150 (IQR 117-185) min (P < 0.001) and 1 (IQR 1-2) day vs 2 (IQR 1-3) days (P = 0.008), respectively}. Percutaneous access and closure with the MANTA system are feasible, safe and associated with lower incidences of all-cause access site complications and shorter stays in the intensive care unit compared to surgical access and closure in minimally invasive cardiac surgeries.

Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations

BackgroundArterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. AimsTo evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). MethodsA single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. ResultsFrom May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. ConclusionThis largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve.Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT04392492.

Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center

BackgroundVascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. ObjectiveWe aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. MethodsFrom February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. ResultsOverall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022). ConclusionsThe M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.

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. 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. 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. 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.

Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms. The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD). We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100). The initial cohort (n=100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n=100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p=.03, as well as a reduction in MANTA-related bleeding complications to 5% p=.01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far. Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.

Dedicated Plug-Based Closure for Large Bore Access—The MARVEL Prospective Registry

A prospective, observational, multicenter review of 10 hospitals in Canada, Denmark, Netherlands, Finland, and Switzerland using the MANTA vascular closure device (Teleflex, Wayne, Pa) from February 2018 to July 2019.

Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis

Background/purposeThe 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/materialsThis patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. ResultsEight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17–76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46–4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17–4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26–4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. ConclusionsLarge-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.