scholarly journals A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions

2019 ◽  
Vol 26 (5) ◽  
pp. 727-731 ◽  
Author(s):  
Max M. Meertens ◽  
Michiel W. de Haan ◽  
Geert W. H. Schurink ◽  
Barend M. E. Mees
Keyword(s):  
Pilot Study ◽  
Brachial Artery ◽  
Secondary Outcome ◽  
Control Group ◽  
Closure Device ◽  
Manual Compression ◽  
Access Site ◽  
Historical Cohort ◽  
Endovascular Interventions ◽  
High Incidence

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

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 Usefulness of a Nonsuture Closure Device in Patients Undergoing Diagnostic Coronary and Peripheral Angiography

2017 ◽  
Vol 26 (04) ◽  
pp. 228-233
Author(s):  
John Owens ◽  
Shaun Bhatty ◽  
Robert Donovan ◽  
Andrea Tordini ◽  
Peter Danyi ◽  
...  
Keyword(s):  
Closure Device ◽  
Complication Rates ◽  
Manual Compression ◽  
Access Site ◽  
Femoral Access ◽  
Peripheral Angiography ◽  
Major Complications ◽  
Increased Risk ◽  
Male Patients ◽  
To Receive

AbstractVascular access site complications can follow diagnostic coronary and peripheral angiography. We compared the complication rates of the Catalyst vascular closure device, with the complication rates after manual compression in patients undergoing diagnostic angiographic procedures via femoral access. We studied 1,470 predominantly male patients undergoing diagnostic coronary and peripheral angiography. Catalyst closure devices were used in 436 (29.7%) patients and manual compression was used in 1,034 (70.3%) patients. The former were allowed to ambulate after 2 hours, while the latter were allowed to ambulate after 6 hours. Major complications occurred in 4 (0.9%) patients who had a Catalyst device and in 14 (1.4%) patients who had manual compression (odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.22–2.1, p = 0.49). Any complications occurred in 51 (11.7%) patients who had a Catalyst closure device and in 64 (6.2%) patients who had manual compression (OR: 2, CI: 1.4–3, p < 0.01). After adjustment for other variables and for a propensity score reflecting the probability to receive the closure device, the association of major complications with the use of the closure device remained not significant (OR: 0.54, 95% CI: 0.17–1.7, p = 0.29), while the association of any complications with the use of the Catalyst device remained significant (OR: 1.9, 95% CI: 1.3–2.9, p < 0.01). The Catalyst device was not associated with an increased risk of major groin complications but was associated with an increased risk of any complications compared with manual compression. Patients receiving the closure device ambulated sooner.

scholarly journals Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease

2016 ◽  
Vol 64 (1) ◽  
pp. 104-108.e1 ◽  
Author(s):  
Talje M. Fokkema ◽  
Robert C. Minnee ◽  
Gert-Aldert H. Kock ◽  
Joost G.A.M. Blomjous ◽  
Anco C. Vahl ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Closure Device ◽  
Manual Compression ◽  
Peripheral Artery ◽  
Endovascular Interventions ◽  
Artery Disease ◽  
Arterial Closure Device

scholarly journals Effect of Umbilical Cord Milking on Severity of Hypoxic Ischemic Encephalopathy in Asphyxiated Neonates A Pilot study

2021 ◽  
Author(s):  
Roshith J Kumar ◽  
Manoj Varanattu
Keyword(s):  
Pilot Study ◽  
Umbilical Cord ◽  
Primary Outcome ◽  
Tertiary Care ◽  
Hypoxic Ischemic Encephalopathy ◽  
Secondary Outcome ◽  
Control Group ◽  
Case Group ◽  
Ischemic Encephalopathy ◽  
Umbilical Cord Milking

Background: The present study was aimed to evaluate the effect of umbilical cord milking technique on severity of Hypoxic Ischemic Encephalopathy (HIE) in asphyxiated neonates and assessed by Modified Sarnats staging as primary outcome, APGAR score at 5 minutes and Respiratory support requirement as secondary outcome. Methods: This was a randomized, controlled pilot study conducted in neonatology department at a tertiary care centre, Thrissur, Kerala. The neonates were divided into two groups non milking group, control (n=38) and umbilical cord milking, case [UCM] (n=32) and their outcomes were compared. In the intervention group, the cord was cut at 30 cm from umbilical stump within 30 seconds of birth and euthermia was maintained. The umbilical cord was raised and milked from the cut end towards the infant 3 times with speed at 10 cm/sec and then clamped 2 to 3 cm from the umbilical stump. In the control group, the umbilical cord was clamped without doing cord milking. Results: In this study moderate to severe HIE were less in case group 46.9 % than control group 55.1% and less neonates 44.7 % had Mild HIE in control group compared to case group 53.1% even though result was statistically not significant as primary outcome (p value not significant). Eight neonates (21.6%) in control group had Apgar at 5 min score 0 to 3, whereas only 4 (12.5%) neonates in cord milking group. Conclusions: The insufficient knowledge of placental transfusion limits and benefits leads to a wide variation in the management of cord clamping. It would be useful to standardise the UCM procedure in order to offer protocols applicable to clinical practice, and to spread knowledge among professionals through educational programs.

scholarly journals The Effect of Exercise During Pregnancy on Maternal and Offspring Vascular Outcomes: a Pilot Study

2020 ◽  
Author(s):  
Áine Brislane ◽  
Helen Jones ◽  
Sophie M. Holder ◽  
David A. Low ◽  
Nicola D. Hopkins
Keyword(s):  
Pilot Study ◽  
Carotid Artery ◽  
Sample Size ◽  
Cerebral Autoregulation ◽  
Vascular Function ◽  
Moderate Intensity ◽  
Randomised Control Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Maternal Exercise

AbstractThe aim of this pilot study is to obtain estimates for the change in maternal cerebrovascular (primary) and offspring vascular structure (secondary) during healthy pregnancy that includes structured exercise. Eighteen pregnant women self-assigned to a moderate-intensity aerobic exercise intervention or a control group. Maternal cerebral blood flow (CBF) at the middle cerebral artery, cerebro- and peripheral-vascular function was assessed at the end of each trimester. Offspring carotid artery intima-media thickness (IMT) was measured within 12 weeks of birth. For exploratory purposes, we performed statistical analysis to provide estimates of the change for primary and secondary outcome variables. Maternal CBF reduced (− 8 cm s−1 [− 14 to − 2]) with evidence of change to cerebral autoregulation (normalised gain: 0.12 %cm s−1% mmHg−1mmHg/% [− 0.18 to 0.40]) during pregnancy. Offspring carotid IMT was smaller in the exercise group (− 0.04 mm [− 0.12–0.03]) compared with controls. Based upon this data, a sample size of 33 and 57 in each group is required for low-frequency normalised gain and offspring IMT, respectively. This would provide 90% power to detect statistically significant (P < 0.05) between group differences in a randomised controlled trial. CBF is reduced in pregnancy, possibly due to reduced vascular resistance and altered maternal cerebral autoregulation. Maternal exercise had negligible effects on cerebrovascular adaptation to pregnancy, but we observed lower offspring carotid artery wall thickness following maternal exercise. Our directional findings and sample size estimations should be explored in a fully powered randomised control trial.Clinical trial registration: The trial was registered on March 14th at https://register.clinicaltrials.gov (NCT03079258). Participant enrolment began on 3rd April 2016.

Abstract 266: The Usefulness of a Collagen Plug Vascular Closure Device in Patients Undergoing Coronary and Peripheral Percutaneous Intervention

2013 ◽  
Vol 33 (suppl_1) ◽  
Author(s):  
John T Owens ◽  
Andrea Tordini ◽  
Shaun Bhatty ◽  
Peter Danyi ◽  
Kalpesh Patel ◽  
...  
Keyword(s):  
Medical Center ◽  
Veterans Administration ◽  
Closure Device ◽  
Minor Bleeding ◽  
Complication Rates ◽  
Manual Compression ◽  
Access Site ◽  
Percutaneous Coronary ◽  
Male Patients ◽  
The Mean

Background Vascular access site complications can follow coronary and peripheral angioplasty procedures and be associated with significant morbidity. We compared the complication rates of the Angioseal closure device with complication rates after manual compression in patients undergoing coronary and peripheral interventional procedures. Methods and Results We studied 553 predominantly male patients undergoing percutaneous coronary, peripheral interventions, FFR or IVUS at a Veterans Administration Medical Center. The mean age was 64.6 years. Angioseal closure devices were used in 388 (70%) patients and manual compression was used in 165 (30%) patients. Major groin complications such as arteriovenous fistula, pseudoaneurysm or hematoma greater than 5 cm occurred in 16 (4.16%) patients who had an Angioseal closure device and 11 (6.67%) patients in whom manual compression was used for hemostasis (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.29-1.40; P=0.26). Other complications such as minor bleeding requiring additional manual compression, bruising, pain and swelling occurred in 32 (8.42%) patients who had an Angioseal closure device and 21 (12.4%) patients who had manual compression (OR 0.65, 95% CI 0.36-1.17; P=0.15). After adjustment for other comorbid factors such as age, type of anticoagulant used, peripheral vascular disease and chronic kidney disease, the association of major complications with the use of the Angioseal closure device remained similar to manual compression (OR 0.75, 95% CI 0.28-1.91; P=0.49). However, there was a trend for fewer minor complications with the closure device (OR 0.57, 95% CI 0.26-1.08; P=0.08). Conclusion In this cohort of predominantly male patients undergoing percutaneous coronary and peripheral intervention, the use of the Angioseal closure device was not associated with a decreased risk of major groin complications, but was associated with a trend for a decreased risk of minor complications compared to manual compression.

scholarly journals Hemostasis After Brachial Artery Access With the MynxGrip Device: A Case Report

2018 ◽  
Vol 12 ◽  
pp. 117954681875929 ◽  
Author(s):  
Arturo Giordano ◽  
Stefano Messina ◽  
Gennaro Maresca ◽  
Giuseppe Biondi-Zoccai
Keyword(s):  
Case Report ◽  
Iliac Artery ◽  
Brachial Artery ◽  
Endovascular Procedures ◽  
Standard Of Care ◽  
Clinical Vignette ◽  
Closure Device ◽  
Manual Compression ◽  
Alternative Means ◽  
Limited Spectrum

Purpose: Brachial access is occasionally used for endovascular procedures when other more established or safer ones (eg, femoral or radial) are contraindicated. Although manual compression is the standard of care after brachial arteriotomy, suboptimal compression may lead to bleeding or thrombosis. Arteriotomy closure devices have thus been proposed as an alternative means to achieve hemostasis after brachial arteriotomy. Yet, there is a paucity of evidence and a limited spectrum of devices suitable for brachial arteriotomy closure. We present the use of the MynxGrip closure device after brachial arteriotomy. Case: A 70-year-old gentleman underwent brachial arteriotomy followed by iliac artery stenting with a 7F compatible device. Hemostasis was then achieved with the MynxGrip device, uneventfully. Conclusions: This clinical vignette highlights the feasibility and safety of brachial use of the MynxGrip device in experienced hands, suggesting that it can represent a useful adjunct to the armamentarium of the endovascular specialist.

Sign in / Sign up

Export Citation Format

Share Document