Vascular closure devices in TAVI: MANTA versus ProGlide in a propensity-matched population

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Sa Mendes ◽  
A Oliveira ◽  
R Campante Teles ◽  
P Araujo Goncalves ◽  
J Brito ◽  
...  
Keyword(s):  
Propensity Score ◽  
Learning Curve ◽  
Primary Endpoint ◽  
Femoral Artery ◽  
Statistical Significance ◽  
Vascular Complications ◽  
Artery Stenosis ◽  
Closure Device ◽  
Efficacy And Safety ◽  
Life Threatening

Abstract Background Vascular complications increase morbidity and mortality in transcatheter aortic valve implantation (TAVI). A collagen plug-based closure device - MANTA® was recently introduced as an alternative to the suture-mediated ProGlide® vascular closure device (VCD). Data regarding the efficacy and safety comparing both VCD is scarce. The present study sought to compare the effectiveness of both devices. Methods Single center retrospective analysis on prospectively collected data of 300 consecutive patients who underwent TAVI using MANTA® or ProGlide® since 2018. A 1:1 propensity-score matched population derived by a multivariate logistic regression model based on age, sex, body mass index, pre-procedural haemoglobin, EuroSCORE II, main access calcification and the sheath-to-artery ratio. The primary endpoint was the composite of major or life-threatening bleeding (VARC-2 definition), femoral artery stenosis/dissection, pseudoaneurysm and need for endovascular/surgical bailout intervention. Results The propensity score matching resulted in 129 matched pairs. The median age was 84 years old [IQR 80–87], 42% males with a median EuroSCOREII of 4.29% [IQR 3.05–6.24]. There were no differences in the primary endpoint between MANTA ® and ProGlide® cohorts (3.9% vs 7.8%, p=0.287, respectively). The rates of the primary endpoint with the MANTA® device decreased with center experience, with relatively steep learning curve effect concerning device success. Major or life-threatening bleeding (3.1% vs 5.4%, p=0.540) and pseudoaneurysm (0.8% vs 2.3%, p=0.622) occurred less frequently in MANTA® cohort, but the differences did not reach statistical significance. Endovascular (stent or balloon) or surgical rescue intervention (9.3% vs 5.4%, p=0.341) and femoral artery stenosis/dissection (6.2% vs 3.1%, p=0.376), were also similar rates. In ProGlide® cohort, to achieve VCD success (without primary endpoint events), 15.5% needed more than 2 devices, significantly different from MANTA ® (p<0,001). Conclusions In patients undergoing transfemoral TAVI, the MANTA® VCD showed a similar efficacy and safety compared to the ProGlide® device and it reduced significantly the need of additional VCDs for completion of hemostasis. These results were obtained despite a clear learning curve associated with MANTA. Funding Acknowledgement Type of funding source: None

scholarly journals Stenosis Caused by Suture-Mediated Vascular Closure Device in an Angiographic Normal Common Femoral Artery: Its Mechanism and Management

2018 ◽  
Vol 53 (1) ◽  
pp. 58-61
Author(s):  
Young Jin Youn ◽  
Salman Khalid ◽  
Michael Azrin ◽  
Juyong Lee
Keyword(s):  
Femoral Artery ◽  
Vascular Complications ◽  
Bed Rest ◽  
Common Femoral Artery ◽  
Artery Stenosis ◽  
Closure Device ◽  
Standard Management ◽  
Percutaneous Coronary ◽  
Coronary Procedure ◽  
Femoral Puncture

Vascular closing devices (VCDs) are widely used to replace manual compression at the femoral puncture site and to reduce the discomfort of patients undergoing percutaneous coronary procedure by shortening bed rest. Among the vascular complications related to these devices, the femoral artery stenosis or occlusion is rarely reported, and its standard management is not well established. We report a case of symptomatic femoral artery stenosis caused by suture-mediated VCD and managed using rotational atherectomy device and balloon angioplasty. In addition, we propose the possible mechanisms for this complication.

Use of vascular closure devices for endovascular interventions requiring a direct puncture of PETE grafts

VASA ◽  
2018 ◽  
Vol 47 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Artur I. Milnerowicz ◽  
Aleksandra A. Milnerowicz ◽  
Marcin Protasiewicz ◽  
Wiktor Kuliczkowski
Keyword(s):  
Statistical Significance ◽  
Vascular Complications ◽  
Vascular Complication ◽  
Inguinal Region ◽  
Closure Device ◽  
Manual Compression ◽  
Direct Puncture ◽  
Endovascular Interventions ◽  
Vascular Closure Devices ◽  
Closure Group

Abstract. Background: Effectiveness of vascular closure devices during endovascular procedures requiring a direct puncture of a vascular prosthesis placed in the inguinal region is unknown. Patients and methods: The retrospective analysis included 134 patients with a history of polyethylene terephthalate (PETE) graft implantation in the inguinal region. In 20 (15 %) patients, haemostasis was achieved with manual compression, in 21 (16 %) with the StarClose™, and in 93 (69 %) with the AngioSeal™ device. Results: The incidence of vascular complications in the manual compression group was higher (at a threshold of statistical significance) than in the device closure group (45.0 vs. 24.5 %, p = 0.059). The difference was considered statistically significant when manual compression was compared with the AngioSeal™ closure group (45.0 vs. 13.9 %, p < 0.01). The vascular complication rate in the StarClose™ group was significantly higher than in the AngioSeal™ group (71.4 vs. 13.9 %, p < 0.000001). While haematomas were the only vascular complications observed after application of AngioSeal™, both haematomas and pseudoaneurysms were found in the StarClose™ group. Conclusions: The AngioSeal™ vascular closure device provides better local haemostasis than the StarClose™ device or manual compression during endovascular interventions requiring a direct puncture of PETE grafts

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.

scholarly journals Successful Angioplasty of a Superficial Femoral Artery Stenosis Caused by a Suture-Mediated Closure Device

2003 ◽  
Vol 26 (4) ◽  
pp. 410-412 ◽  
Author(s):  
Joseph J. Gemmete ◽  
Narasimham Dasika ◽  
Andrew R. Forauer ◽  
Kyung Cho ◽  
David M. Williams
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Artery Stenosis ◽  
Closure Device

scholarly journals Intravascular Images of Common Femoral Artery Stenosis as a Complication of the Repeated Use of a Suture-mediated Closure Device

Angioscopy ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. 14-18
Author(s):  
Masato Matsushita ◽  
Masamichi Takano ◽  
Yasushi Miyauchi ◽  
Wataru Shimizu
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Artery Stenosis ◽  
Closure Device ◽  
Repeated Use

scholarly journals Efficacy and Safety of Different Doses of Bevacizumab Combined With Pemetrexed and Platinum in First-Line Treatment of Advanced NSCLC: A Retrospective-Real World Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Chun-Hua Zhou ◽  
Feng Yang ◽  
Wen-Juan Jiang ◽  
Yong-Chang Zhang ◽  
Hai-Yan Yang ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Statistical Significance ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
First Line ◽  
Free Survival ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
The Cost ◽  
Different Doses

Background: Bevacizumab was demonstrated to have efficacy in patients with NSCLC. However, application of different doses of bevacizumab in different clinical trials was overlooked. This study aims to investigate the effects and safety of different doses of bevacizumab in the treatment.Methods: From January 2016 to March 2020, 79 patients with NSCLC received first-line combination treatment with chemotherapy (pemetrexed + platinum) and bevacizumab for four cycles; patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab combined with pemetrexed, of which 57 patients received bevacizumab at a dose of 7.5 mg/kg and 22 patients at a dose of 15 mg/kg. The primary endpoint was progression-free survival, and secondary endpoints were overall response rate, disease control rate, and adverse events.Results: There was no significant difference between two groups in effectiveness; Median PFS in 7.5 mg/kg group and in 15 mg/kg group were 8.0 and 8.7 months, respectively (p = 0.663), reaching the primary endpoint. The ORR and DCR in the bevacizumab 7.5 and 15 mg/kg group were 45.46 and 86.0% vs. 50 and 90.9% showing no statistical significance (p = 0.804 and 0.717). Most of side effects were tolerable. The incidences of overall toxicities were higher in 15 mg/kg group (p = 0.001). No new safety signals were observed.Conclusion: We did not detect significant difference of efficacy and safety between 7.5 mg/kg group and 15 mg/kg group for bevacizumab administration, the cost-effectiveness of the 7.5 mg/kg group was significantly better than that of the 15 mg/kg group.

Development of a Chronic Canine Ovariohysterectomy Model to Evaluate Vaginal Cuff Healing Using Two Closure Systems

2021 ◽  
pp. 155335062110393
Author(s):  
David Wiseman ◽  
Josa A. Hanzlik ◽  
James A. Richardson ◽  
John M. Shelton ◽  
Bret M. Evers ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Statistical Significance ◽  
Test Group ◽  
Analysis Data ◽  
Closure Device ◽  
Vaginal Cuff ◽  
Suitable Animal Model ◽  
Secondary Endpoints ◽  
The Difference ◽  
Muscle Changes

Background and Purpose. This study established a suitable animal model of ovariohysterectomy; characterized the course and pattern of vaginal healing after ovariohysterectomy; and compared healing obtained after closure of the vaginal cuff with a novel cuff-closure device (Zip-stitch® clips) and VICRYL® sutures. Research Design and Study Sample. This prospective, randomized, controlled, blinded animal study was conducted in 27 mongrel hounds according to an IACUC-approved protocol. Each animal underwent ovariohysterectomy followed by vaginal cuff closure with Zip-stitch or VICRYL. At two or six weeks, animals were sacrificed for gross and histological analysis. Data Collection. The primary endpoint was the difference in the fraction of vaginal cuff healed six weeks after application of the closure device. Secondary endpoints included histopathologic cellular and tissue responses, including inflammation, necrosis, infection, and vascular and muscle changes. Results. In the test group, there were two distinct locations where fibrotic or granular tissue fusion between the anterior and posterior vaginal walls was observed: in tissue “captured” by a clip or in tissue around the clip. The fraction of the vaginal cuff healed was similar in animals treated with Zip-stitch clips and those treated with sutures at six weeks (68±10% vs 67±18%; P=.148, test for non-inferiority) after surgery. The test article performed similarly or better than the control article in terms of the intensity or extent of the secondary endpoints. Conclusions. Subject to further confirmation, this study supports Zip-stitch clips as a method to maintain immediate post-operative approximation of the vaginal cuff leading to healing but did not achieve statistical significance in its primary endpoint.

scholarly journals Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

2015 ◽  
Vol 21 (3) ◽  
pp. 401-406 ◽  
Author(s):  
Ramesh Grandhi ◽  
Xiaoran Zhang ◽  
David Panczykowski ◽  
Phillip Choi ◽  
Christopher T Hunnicutt ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Vascular Complications ◽  
Arterial Puncture ◽  
Closure Device ◽  
Arterial Access ◽  
Vascular Closure Devices ◽  
Study Population ◽  
Clinically Significant ◽  
Angiographic Findings

Background and purpose Femoral artery injuries are known complications of percutaneous vascular closure devices (VCDs). We studied the incidence of delayed femoral artery angiographic irregularities after neurointerventional procedures in which the EXOSEAL extravascular closure device was used for femoral arterial puncture closure. Methods Adult patients who underwent femoral arterial puncture closures with an EXOSEAL VCD and had a follow-up femoral artery angiogram from June 2012 through August 2013 were reviewed. A blinded radiologist compared pre-deployment and follow-up femoral arteriograms for the presence of femoral artery stenosis, dissection, pseudoaneurysm, or development of an arteriovenous fistula. Hospital records were reviewed for major or minor complications of the groin site or femoral artery. Results The EXOSEAL VCD achieved hemostasis, without evidence of a groin hematoma or requiring subsequent prolonged manual compression, in 400 of 441 closures following transfemoral arterial access, representing a device success rate of 90.7%. A total of 98 patients underwent 102 repeat angiograms following closure with the EXOSEAL VCD. The average time to the repeat angiogram was 73.5 days (range 0–488, median 28). Follow-up femoral arteriography demonstrated an irregularity in seven cases, all of which were vessel stenoses of <50%. There were no dissections, pseudoaneurysms, infections, or ischemic events in the study population. Conclusions Angiographic irregularities were seen in 6.86% of cases after closure with the EXOSEAL VCD. There were no clinically significant vascular complications. Thus, femoral artery closure with EXOSEAL carries a low risk of clinically significant delayed angiographic findings.

Femoral Artery Stenosis Following Percutaneous Closure Using a Starclose Closure Device

2008 ◽  
Vol 31 (4) ◽  
pp. 814-816 ◽  
Author(s):  
Clare Louise Bent ◽  
Constantinos Kyriakides ◽  
Matthew Matson
Keyword(s):  
Femoral Artery ◽  
Percutaneous Closure ◽  
Artery Stenosis ◽  
Closure Device

Lokale Gefäßkomplikationen nach Einsatz des hämostatischen Verschlussystems Angio-SealTM

VASA ◽  
2002 ◽  
Vol 31 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Kirchhof ◽  
Schickel ◽  
Schmidt-Lucke ◽  
Schmidt-Lucke
Keyword(s):  
Vascular Surgery ◽  
Cardiac Catheterization ◽  
Femoral Artery ◽  
Diagnostic Delay ◽  
Vascular Complications ◽  
Duplex Sonography ◽  
Closure Device ◽  
Device Application ◽  
Femoral Arteries ◽  
The Common

Background: As an alternative to manual pressure techniques new systems for achieving arterial hemostasis after cardiac catheterization were developed. Here we report about the diagnosis and therapy of femoral artery complications after use of the closure device Angio-SealTM, consisting of an intraarterial anchor and extravascular collagen plug. Patients and methods: Angio-SealTM was deployed in 350 patients undergoing cardiac catheterization. Vascular investigations after device application consisted of ankle/brachial-pressure-index measurement, duplex sonography, and angiography. Results: Vascular complications occurred in 10 of 350 patients. In two patients complete occlusions of the superficial femoral artery required immediate vascular surgery. Stenoses of the superficial (five patients) and the common (three patients) femoral arteries were diagnosed in 8 cases. Of these 10 patients eight were obese, in 2 cases there was a further catheterization with Angio-SealTM device application via the same femoral approach. Until now six patients underwent successful surgery: in 4 cases the whole Angio-SealTMdevice was located intraarterially, there was 1 case of intima-dissection, and 1 case remained unclear due to a diagnostic delay of 7 months. In three patients with stenoses of the common femoral arteries without hemodynamic relevance no therapy was required. Conclusions: Occlusions or stenoses of femoral arteries after use of Angio-SealTM can be diagnosed easily by duplex sonography. All hemodynamic relevant complications (n = 7 of 350 [2%]) concerned a puncture of superficial femoral arteries. In these patients vascular surgery seems to be an adequate therapy.

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