Incidence and Predictors of Access Site Vascular Complications Following Ultrasound-Guided MANTA Closure Deployment

2021 ◽  
pp. 152660282110594
Author(s):  
Hirokazu Miyashita ◽  
Noriaki Moriyama ◽  
Mika Laine
Keyword(s):  
Academic Research ◽  
Vascular Complications ◽  
Common Femoral Artery ◽  
Anterior Wall ◽  
Vascular Complication ◽  
Bleeding Complications ◽  
Access Site ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
The Us

Purpose: There is no report on the reproducibility of the ultrasound-navigated MANTA deployment (US-MANTA) technique and little is known about predictors for US-MANTA-related vascular complication (VC). This study aimed to assess the incidence and predictors of access-site VC using the US-MANTA technique and report insights of MANTA-related VC from consecutive cases following large-bore arteriotomy. Materials and Methods: Consecutive patients who underwent transfemoral transcatheter aortic valve replacement with the US-MANTA technique from November 2018 to February 2020 were evaluated. MANTA-related VC was defined as access-site complications leading to major or minor VCs based on Valve Academic Research Consortium-2 criteria. Results: Among 378 patients, 23 cases (6.1%) of MANTA-related VC (major VC: n=7 [1.9%], minor VC: n=16 [4.2%]) were identified. No significant difference was observed in the incidence of MANTA-related VC over the observational period (first quartile: 5.3%, second: 5.4%, third: 7.4%, and fourth: 6.3%, p>.50). In 7 patients with MANTA-related major VC, 4 (57.1%) of complications resulted from incomplete apposition of the toggle due to anterior wall calcification of the common femoral artery (CFA). Anterior calcification of the CFA determined by computed tomography was identified as an independent predictor of MANTA-related VCs. Conclusions: The US-MANTA technique sustainably provides a low rate of access-site VCs following large-bore arteriotomy. Incomplete apposition of the toggle due to anterior calcification of the CFA may lead to ongoing vascular and bleeding complications.

scholarly journals Ultrasound- Versus Fluoroscopy-Guided Strategy for Transfemoral Transcatheter Aortic Valve Replacement Access: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Rafail A. Kotronias ◽  
Jonathan J.H. Bray ◽  
Skanda Rajasundaram ◽  
Flavien Vincent ◽  
Cedric Delhaye ◽  
...  
Keyword(s):  
Systematic Review ◽  
Transcatheter Aortic Valve Replacement ◽  
Ultrasound Guidance ◽  
Meta Analysis ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Ultrasound Guided ◽  
Access Site ◽  
Transcatheter Aortic Valve ◽  
Life Threatening

Background: Access site vascular and bleeding complications remain problematic for patients undergoing transcatheter aortic valve replacement (TAVR). Ultrasound-guided transfemoral access approach has been suggested as a technique to reduce access site complications, but there is wide variation in adoption in TAVR. We performed a systematic review and meta-analysis to compare access site vascular and bleeding complications according to the Valve Academic Research Consortium-2 classification following the use of either ultrasound- or conventional fluoroscopy-guided transfemoral TAVR access. Methods: Medline, Embase, Web of Science, and The Cochrane Library were searched to November 2020 for studies comparing ultrasound- and fluoroscopy-guided access for transfemoral TAVR. A priori defined primary outcomes were extracted: (1) major, (2) minor, and (3) major and minor (total) access site vascular complications and (4) life-threatening/major, (5) minor, and (6) life-threatening, major, and minor (total) access site bleeding complications. Results: Eight observational studies (n=3875) were included, with a mean participant age of 82.8 years, STS score 5.81, and peripheral vascular disease in 23.5%. An ultrasound-guided approach was significantly associated with a reduced risk of total (Mantel-Haenszel odds ratio [MH-OR], 0.50 [95% CI, 0.35–0.73]), major (MH-OR, 0.51 [95% CI, 0.35–0.74]), and minor (MH-OR, 0.59 [95% CI, 0.38–0.91]) access site vascular complications. Ultrasound guidance was also significantly associated with total access site bleeding complications (MH-OR, 0.59 [95% CI, 0.39–0.90]). The association remained significant in sensitivity analyses of maximally adjusted minor and total vascular access site complications (MH-OR, 0.51 [95% CI, 0.29–0.90]; MH-OR, 0.44 [95% CI, 0.20–0.99], respectively). Conclusions: In the absence of randomized studies, our data suggests a potential benefit for ultrasound guidance to obtain percutaneous femoral access in TAVR. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/ ; Unique identifier: CRD42020218259.

P3736Predictors of access site complication in transfemoral transcatheter aortic valve implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Potratz ◽  
N Kramer ◽  
K Mohemed ◽  
S Scholtz ◽  
W Scholtz ◽  
...  
Keyword(s):  
Risk Factors ◽  
Regression Analysis ◽  
Aortic Valve ◽  
Vascular Complications ◽  
Calcium Score ◽  
Vascular Complication ◽  
Access Site ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) is an increasing common treatment option for patients (pts) with symptomatic severe aortic stenosis (AS). Despite its proven effectiveness and decreasing complication rate, vascular access site complications still occur in 5–7% of the cases and are associated with increased mortality and morbidity. Purpose The aim of this study was to analyze pts with vascular complications during TAVI procedure to better understand underlying mechanisms and aid future risk stratification. Methods From our ongoing single center TAVI registry encompassing over 1600 pts, we recruited 200 pts with vascular complications. By using propensity score 1:2 matching 400 controls without vascular complications were identified. Matching was done for peripheral vascular disease, age, gender, sheath size and BMI using the nearest neighbor algorithm. In the femoral artery, a localized, upward calcium scoring over 10 cm starting from the bifurcation was conducted in all pts using the 3mensio structural heart software ver. 8.0 (Pie Medical Imaging BV). Comparison between groups was done using the t-test. Multiple regression analysis was used to identify risk factors independently associated with vascular complication. Results Using VARC-2 definitions 22 (11%) pts classified as major and 178 (89%) as minor vascular complications. Patients with vascular complications had a significantly longer duration of hospitalization 17.1 days vs. 14.4 days (p=0.001), were more often on oral anticoagulation in 22.3% vs. 15.1%, (p=0.03) and had low preprocedural hemoglobin (11.8 vs. 12.1 (p=0.03). Vascular complications resulted in significantly higher 30 day mortality (7.4% vs. 3.2%, p=0.02). Detailed analysis of the femoro-iliacal vessels showed a higher percentage of kinking (50.5% vs. 33%, p = <0.001) in pts with vascular complications, however the calcium score was not significantly different (269.57 vs. 267.18, p=0.94). Of interest, pts with major vascular complications had a significantly higher calcium score as compared to controls (500.3 vs. 267.2, p=0.002). Major complications also translated in an even higher mortality after 30 days (18.2% vs. 3.2% (p = <0.001) and hospitalization time (days): 27.7 vs. 14.5 (p = <0.001) Multiple regression analysis identified vascular kinking (p = <0.001) and oral anticoagulation (p=0.04) at admission to be independent risk factors for vascular complication in the overall cohort whereas calcium score was only predictive for major vascular complications (p=0.04) Conclusion This study confirms that vascular complications during TAVI are associated with increased 30 day mortality and longer hospitalization. Patient dependent factors are the main predictors for vascular complications and should be considered thoroughly.

scholarly journals Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

2020 ◽  
Vol 28 (12) ◽  
pp. 639-644 ◽  
Author(s):  
J. Halim ◽  
L. Missault ◽  
M. Lycke ◽  
J. Van der Heyden
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Closure Device ◽  
Single Centre ◽  
Access Site ◽  
Transcatheter Aortic Valve

Abstract Objectives The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). Background To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. Methods In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. Results Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. Conclusions This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

scholarly journals Transcatheter aortic valve replacement using the iSleeve expandable sheath in small femoral arteries

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001703
Author(s):  
Natalie Glaser ◽  
Crochan J. O'Sullivan ◽  
Nawzad Saleh ◽  
Dinos Verouhis ◽  
Magnus Settergren ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Femoral Artery ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Femoral Arteries ◽  
Transcatheter Aortic Valve ◽  
Significant Difference

BackgroundSmall femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries.MethodsIn this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5–9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9–5.4).ResultsThere was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter.ConclusionTransfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.

Cut-down outperforms complete percutaneous transcatheter valve implantation

2018 ◽  
Vol 26 (2) ◽  
pp. 107-113 ◽  
Author(s):  
Markus Mach ◽  
Manuel Wilbring ◽  
Bernhard Winkler ◽  
Konstantin Alexiou ◽  
Utz Kappert ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Academic Research ◽  
Bleeding Complications ◽  
Primary Study ◽  
Access Site ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Access Complications ◽  
Valve Implantation

Background The ideal approach for transfemoral transcatheter aortic valve implantation is still widely debated. The objective of this study was to compare access and bleeding complications of complete percutaneous versus the surgical cut-down approach for transfemoral transcatheter aortic valve implantation. Methods The study included 667 consecutive patients from November 2008 to December 2016, 466 in the percutaneous group and 201 in the cut-down group. There were no significant differences in baseline characteristics between the 2 groups. Primary study endpoints were vascular access site and bleeding complications according to the Valve Academic Research Consortium II criteria. Results Mean procedure time was shorter in the cut-down group: 93.5 ± 22.0 (percutaneous) vs. 69 ± 19 min (cut-down), p < 0.001. The rate of access complications was higher in the percutaneous group: 20.4% (95/466) vs. 8.5% (17/201), p = 0.037; with predominantly minor complications in the percutaneous cohort: 14.4% (67/466) vs. 2.5% (5/201), p = 0.04. Bleeding complications were more frequent in the percutaneous group: 21.9% (102/466) vs. 4.5% (9/201), p = 0.01. Hospital mortality was 5.2% in the percutaneous group and 1.9% in the cut-down group ( p = 0.075). Conclusions Surgical cut-down provided controlled access and resulted in fewer access site and bleeding complications. Nonetheless, major access complications were not significantly different between the two cohorts. The two approaches must be seen as complementary techniques. A portfolio containing both techniques is the only way to provide a tailor-made and patient-orientated approach ensuring the safest access based on the individual vessel condition.

Abstract 016: Endovascular Management of Major Vascular Access Site Complications During Transcatheter Aortic Valve Implantation (TAVI).

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Muhammad U Majeed ◽  
Kelly D Green ◽  
Marat Fudim ◽  
Mark A Robbins ◽  
David X Zhao
Keyword(s):  
Vascular Access ◽  
Vascular Complications ◽  
Covered Stents ◽  
Endovascular Management ◽  
Access Site ◽  
Femoral Access ◽  
Access Site Complication ◽  
Small Series ◽  
Significant Difference ◽  
Endovascular Approach

Background: Major vascular access site complications remain a challenge in the field of TAVI and are associated with higher 30 day mortality. However, outcomes following endovascular management with covered stents for such complications are not well established. Methods: We reviewed the one year data of patients who underwent TAVI at our institution with a Sapien valve by percutaneous femoral approach. Identified were patients who suffered major vascular complications according to the definitions set forth by the Valve Academic Research Consortium. We then compared the outcome of patients managed by an endovascular approach with a population whose femoral access site complications were managed surgically/endovascularly (85.7% surgically), as reported from the Partner trial. Results: A total of 16 patients experienced Major Vascular complications. TAVI was aborted on 2 patients due to access site complication. Excluded were 3 patients who had benign small ascending aortic dissections after successful valve deployment and 3 patients who were managed surgically. Ten remaining patients were managed by a pure endovascular approach with covered stents. Four of these patients suffered ilio-femoral dissection, 4 had perforation and 2 had both perforation and dissection. No significant difference was observed in pre and post procedure creatinine (1.01 vs 1.14, p=0.16) and none required dialysis within 30 days, as compared with 8.1% in Partner trial. We observed no statistically significant difference between the Partner trial cohort and our patients in 30 day all cause mortality (14.1% vs 10%, p=1), stroke rate (4.8% vs 0%, p=1), access site hematoma (22.9% vs 0%, p=0.1), retroperitoneal bleed (9.5% vs 0%, p=0.6), pseudoaneurysm (3.4% vs 0%, p=1), and gastrointestinal ischemia (1.6% vs 0%). No access site infection, stent thrombosis, or stenosis leading to limb ischemia were noted clinically at 30 day follow-up. Conclusion: Many patients with major vascular complications during TAVI can be treated with a pure endovascular approach. In our small series we observed no difference in concurrent complications when an endovascular repair can be rapidly initiated as compared to a primary surgical approach.

scholarly journals Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal

2020 ◽  
Vol 2020 ◽  
pp. 1-4
Author(s):  
Rajiv Tayal ◽  
Michael DiVita ◽  
Christoph W. Sossou ◽  
Alexis K. Okoh ◽  
Kelly Stelling ◽  
...  
Keyword(s):  
Axillary Artery ◽  
Academic Research ◽  
Bleeding Complications ◽  
Manual Compression ◽  
Access Site ◽  
Suitable Alternative ◽  
Compression Time ◽  
Intravenous Heparin ◽  
Randomized Control ◽  
Research Consortium

Background. The prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. Methods. Data were collected from a prospective internal registry of patients who had a Maquet® (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. They were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50–80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Results. 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. The median duration of IABP implantation was 12 days (range 1–54 days). Median compression time was 20 minutes (range 5–60 minutes). There were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. Conclusion. Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings.

scholarly journals Impact of Mean Platelet Volume on Combined Safety Endpoint and Vascular and Bleeding Complications following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Caroline J. Magri ◽  
Alaide Chieffo ◽  
Alessandro Durante ◽  
Azeem Latib ◽  
Matteo Montorfano ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Mean Platelet Volume ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Platelet Volume ◽  
Transcatheter Aortic Valve ◽  
Safety Endpoint ◽  
Life Threatening ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Background. Vascular and bleeding complications remain important complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). Platelets play an important role in bleeding events. Mean platelet volume (MPV) is an indicator of platelet activation. The objective of this study was to assess whether low MPV is an indicator of major vascular and bleeding complications following TF-TAVI.Methods. A retrospective cohort study of 330 subjects undergoing TF-TAVI implantation was performed. The primary study endpoint was the occurrence of combined safety endpoint (CSEP); secondary endpoints included major vascular complications and life-threatening bleeding. Endpoints were defined according to Valve Academic Research Consortium 2.Results. The CSEP at 30 days was reached in 30.9%; major vascular complications were observed in 14.9% while life-threatening bleeding occurred in 20.6%. Logistic Euroscore and MPV were independent predictors of CSEP. Predictors of vascular complications were female sex, previous myocardial infarction, red blood cell distribution width (RDW), and MPV while predictors of life-threatening bleeding were peripheral arterial disease, RDW, and MPV.Conclusion. A low baseline MPV was shown for the first time to be a significant predictor of CSEP, major vascular complications, and life-threatening bleeding following TF-TAVI.

scholarly journals Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry

2020 ◽  
Vol 9 (21) ◽  
Author(s):  
Sergio Berti ◽  
Francesco Bedogni ◽  
Arturo Giordano ◽  
Anna S. Petronio ◽  
Alessandro Iadanza ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Analysis ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
End Point ◽  
Transcatheter Aortic Valve ◽  
Vascular Closure Devices ◽  
Score Analysis

Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clini​caltr​ials.gov ; Unique identifier: NCT02713932.

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