Safety and Efficacy of Arterial Closure Devices Following Antegrade Femoral Access: A Case–Control Study

2020 ◽  
Vol 54 (7) ◽  
pp. 612-617
Author(s):  
Louis-Xavier Barrette ◽  
Ansar Z. Vance ◽  
Mark P. Mantell ◽  
Kathleen M. Kratz ◽  
Jonas W. Redmond ◽  
...  
Keyword(s):  
Control Group ◽  
Closure Device ◽  
Consecutive Series ◽  
Complication Rates ◽  
Success Rates ◽  
Femoral Access ◽  
Safety And Efficacy ◽  
Antegrade Approach ◽  
Device Deployment ◽  
Percutaneous Revascularization

Purpose: Vascular closure device (VCD) use following antegrade femoral access may present unique challenges relative to retrograde access. We retrospectively compared safety and efficacy of these devices between antegrade and retrograde patient cohorts undergoing percutaneous intervention. Materials and Methods: Over a 5-year period, a consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). Device deployment success rates, time to ambulation, and complication rates were compared to a contemporaneous control group of 401 limbs in 305 patients who underwent closure following retrograde access (VCD-R) during revascularization or embolization procedures. Results: Closure was attempted in VCD-A using 53 StarClose, 35 Perclose, and 19 Angio-Seal devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. Closure was attempted in VCD-R using 215 StarClose, 119 Perclose, and 67 Angio-Seal devices with hemostasis in 357/401 (89.0%) limbs. Device deployment failure occurred in 7/107 (6.5%) of VCD-A and 20/401 (5.0%) of VCD-R ( P = .52), independent of specific device type. Femoral pseudoaneurysm developed in 1/107 and 1/401 of VCD-A and VCD-R ( P = .31), and minor hematoma developed in 3/107 and 8/401 of the VCD-A and VCD-R ( P = .61). Mean time to ambulation was 204.1 minutes in VCD-A and 204.8 minutes in VCD-R ( P = .97). Conclusion: Antegrade femoral closure was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was the same in both groups despite higher heparin doses in the antegrade patients.

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.

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures

2020 ◽  
Vol 27 (3) ◽  
pp. 414-420 ◽  
Author(s):  
Zvonimir Krajcer ◽  
David A. Wood ◽  
Neil Strickman ◽  
Nelson Bernardo ◽  
Chris Metzger ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Major Complication ◽  
Multicenter Trial ◽  
Closure Device ◽  
Study Cohort ◽  
Complication Rates ◽  
Vascular Closure Device ◽  
Primary Analysis ◽  
Femoral Access ◽  
Endovascular Interventions

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

scholarly journals Safety and efficacy of a novel neurosurgical enhanced recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial

2019 ◽  
Vol 130 (5) ◽  
pp. 1680-1691 ◽  
Author(s):  
Yuan Wang ◽  
Bolin Liu ◽  
Tianzhi Zhao ◽  
Binfang Zhao ◽  
Daihua Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Perioperative Management ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Tertiary Care ◽  
Hospital Length Of Stay ◽  
Control Group ◽  
Complication Rates ◽  
Safety And Efficacy ◽  
Eras Protocol

OBJECTIVEAlthough enhanced recovery after surgery (ERAS) programs have gained acceptance in various surgical specialties, no established neurosurgical ERAS protocol for patients undergoing elective craniotomy has been reported in the literature. Here, the authors describe the design, implementation, safety, and efficacy of a novel neurosurgical ERAS protocol for elective craniotomy in a tertiary care medical center located in China.METHODSA multidisciplinary neurosurgical ERAS protocol for elective craniotomy was developed based on the best available evidence. A total of 140 patients undergoing elective craniotomy between October 2016 and May 2017 were enrolled in a randomized clinical trial comparing this novel protocol to conventional neurosurgical perioperative management. The primary endpoint of this study was the postoperative hospital length of stay (LOS). Postoperative morbidity, perioperative complications, postoperative pain scores, postoperative nausea and vomiting, duration of urinary catheterization, time to first solid meal, and patient satisfaction were secondary endpoints.RESULTSThe median postoperative hospital LOS (4 days) was significantly shorter with the incorporation of the ERAS protocol than that with conventional perioperative management (7 days, p < 0.0001). No 30-day readmission or reoperation occurred in either group. More patients in the ERAS group reported mild pain (visual analog scale score 1–3) on postoperative day 1 than those in the control group (79% vs. 33%, OR 7.49, 95% CI 3.51–15.99, p < 0.0001). Similarly, more patients in the ERAS group had a shortened duration of pain (1–2 days; 53% vs. 17%, OR 0.64, 95% CI 0.29–1.37, p = 0.0001). The urinary catheter was removed within 6 hours after surgery in 74% patients in the ERAS group (OR 400.1, 95% CI 23.56–6796, p < 0.0001). The time to first oral liquid intake was a median of 8 hours in the ERAS group compared to 11 hours in the control group (p < 0.0001), and solid food intake occurred at a median of 24 hours in the ERAS group compared to 72 hours in the control group (p < 0.0001).CONCLUSIONSThis multidisciplinary, evidence-based, neurosurgical ERAS protocol for elective craniotomy appears to have significant benefits over conventional perioperative management. Implementation of ERAS is associated with a significant reduction in the postoperative hospital stay and an acceleration in recovery, without increasing complication rates related to elective craniotomy. Further evaluation of this protocol in large multicenter studies is warranted.Clinical trial registration no.: ChiCTR-INR-16009662 (chictr.org.cn)

Success and Complication Rates with Prehospital Placement of an Esophageal-Tracheal Combitube as a Rescue Airway

2006 ◽  
Vol 21 (2) ◽  
pp. 97-100 ◽  
Author(s):  
Thomas R. Calkins ◽  
Ken Miller ◽  
Mark I. Langdorf
Keyword(s):  
Endotracheal Tube ◽  
A Priori ◽  
Dental Trauma ◽  
Spontaneous Circulation ◽  
Airway Device ◽  
Control Group ◽  
Complication Rates ◽  
Success Rates ◽  
Return Of Spontaneous Circulation ◽  
Fail Safe

AbstractIntroduction:Previous studies have proven the success of the EsophagealTracheal Combitube (ETC) as a primary airway, but not as a rescue airway.Objective:The object of this study was to observe success and complication rates of paramedic placement of an ETC as a rescue airway, and to compare success rates with endotracheal tube (ETT) intubation. The primary outcome indicator was placement with successful ventilation. Complication rates, esophageal placement, and return of spontaneous circulation (ROSC) were secondary measures.Methods:A retrospective review of the records of patients who had ETC attempts by Emergency Medical Services (EMS) was conducted for a period of three years. Complications were defined a priori. The ETC is used primarily as rescue airway for a failed attempt at an endotracheal tube (ETT) intubation. A control group for ETT placements was drawn from the EMS quality assurance (QA) database for the same period.Results:Esophageal-Tracheal Combitube insertion was attempted on 162 patients, of which, 113 (70%) were successful, 46 (28%) failed, and the outcome of three (2%) was not recorded. Inability to place the ETC occurred in 29 (18%) patients, and accounted for 48% (22/46) of failures. The use of the ETC caused dental trauma in one patient, and one placement of the ETC was related to the onset of subcutaneous emphysema. Blood in the ETC from active upper gatrointestinal bleeding occurred in nine patients (6%), and four tubes (3%) became dislodged en route to the hospital. The a priori complication rate was 44/162 (27%). Inability to determine placement of the ETC due to emesis from both ports occurred in 21 cases. Combining these problems with the a priori complications, the overall rate was 40% (65/162). EsophagealTracheal Combitube location was noted in a subset of 90 charts, of which, 76 (84%) were esophageal, and 14 (16%) were tracheal. Thirteen of 126 (10%) patients in cardiac arrest had return of spontaneous circulation (ROSC) in the field after placement of the ETC. An ETT was attempted in 128 control patients, of which, 107 (84%) were successful, 21 (16%) failed (odds ratio (OR) for ETT vs. ETC = 2.1; 95% CI = 1.12–3.86).Conclusion:Despite a low ROSC rate, the complication and success rates of ETC are acceptable for a rescue airway device. Tracheal placement of the Combitube is uncommon, but requires fail-safe discrimination. Similar to previous reports, the success ratio for ETT was greater than for the ETC.

scholarly journals 843 Annular Closure Device for Disc Herniation: Meta-Analysis of Clinical Outcome and Complications

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
C S Ong ◽  
W J Choy ◽  
K Phan ◽  
A Diwan ◽  
R Mobbs
Keyword(s):  
Disc Herniation ◽  
Weighted Mean Difference ◽  
Lumbar Disc ◽  
Meta Analysis ◽  
Control Group ◽  
Closure Device ◽  
Complication Rates ◽  
Early Results ◽  
Annular Closure Device

Abstract Aim To assist surgeons to determine a potential approach to reduce incidences of recurrent lumbar disc herniation and assess the current devices regarding their outcomes and complications. Method Four electronic full-text databases were systematically searched through September 2017. All results were pooled utilising meta-analysis with weighted mean difference and odds ratio as summary statistics. Results Four studies met inclusion criteria. Three studies reported the use of Barricaid (ACD) while one study reported the use of Anulex (AR). A total of 24 symptomatic reherniation were reported among 811 discectomies with ACD/AR as compared to 51 out of 645 in the control group (OR: 0.34; 95% CI: 0.20,0.56; I2 = 0%; P &lt; 0.0001). Durotomies were lower among the ACD/AR patients with only 3 reported cases compared to 7 in the control group (OR: 0.54; 95% CI: 0.13, 2.23; I2 = 11%; P = 0.39). Similar outcomes for post-operative Oswestry Disability Index and visual analogue scale were obtained when both groups were compared. Conclusions Early results showed the use of Barricaid and Anulex devices are beneficial for short term outcomes demonstrating a reduction in symptomatic disc reherniation with low post-operative complication rates. Long-term studies are required to further investigate the efficacy of such devices.

scholarly journals Safety and efficacy of arteriovenous fistula angioplasties performed by nephrologists: report from a Brazilian interventional nephrology center

2021 ◽  
Author(s):  
Ricardo P. Franco ◽  
Miguel C. Riella ◽  
Domingos C. Chula ◽  
Marcia T. de Alcântara ◽  
Marcelo M. do Nascimento
Keyword(s):  
Success Rate ◽  
Low Income ◽  
Complication Rates ◽  
Technical Failure ◽  
Success Rates ◽  
Technical Success ◽  
Safety And Efficacy ◽  
Technical Success Rate ◽  
Venous Stenosis ◽  
First Choice

ABSTRACT Introduction: Arteriovenous fistulas (AVF) are the first choice vascular access for hemodialysis. However, they present a high incidence of venous stenosis leading to thrombosis. Although training in interventional nephrology may improve accessibility for treatment of venous stenosis, there is limited data on the safety and efficacy of this approach performed by trained nephrologists in low-income and developing countries. Methods: This study presents the retrospective results of AVF angioplasties performed by trained nephrologists in a Brazilian outpatient interventional nephrology center. The primary outcome was technical success rate (completion of the procedure with angioplasty of all stenoses) and secondary outcomes were complication rates and overall AVF patency. Findings: Two hundred fifty-six angioplasties were performed in 160 AVF. The technical success rate was 88.77% and the main cause of technical failure was venous occlusion (10%). The incidence of complications was 13.67%, with only one patient needing hospitalization and four accesses lost due to the presence of hematomas and/or thrombosis. Grade 1 hematomas were the most frequent complication (8.2%). The overall patency found was 88.2 and 80.9% at 180 and 360 days after the procedure, respectively. Conclusion: Our findings suggest that AVF angioplasty performed by trained nephrologists has acceptable success rates and patency, with a low incidence of major complications as well as a low need for hospitalization.

scholarly journals Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

2013 ◽  
Vol 19 (3) ◽  
pp. 353-358 ◽  
Author(s):  
Ammar Taha ◽  
Ellen K Walsh ◽  
Kathryn A Wright ◽  
Iftikhar Ahmed ◽  
Nucharin Supakul ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Color Doppler ◽  
Color Doppler Ultrasound ◽  
Closure Device ◽  
Complication Rates ◽  
Femoral Access ◽  
Small Series ◽  
The Right ◽  
Neurointerventional Procedures

This retrospective study evaluated the safety and feasibility of a new arterial femoral access closure device in neurointerventional procedures. The study includes all consecutive adult patients who underwent femoral arteriotomy closure with the MynxGrip™ closure device after Neurointerventional procedures performed between June and December 2012. All patients had a follow-up color Doppler ultrasound (US) within 48 hours after the procedure, which was independently interpreted by two experienced radiologists to evaluate for access site complications. Device success/failure, sheath size, ambulation time, and periprocedural complications were recorded. Fifty-five closure devices were deployed in 53 patients. There were 23 (43%) males and 30 (57%) females; age ranged from 22 to 84 years (mean: 52.1 years). Thirty of the 55 procedures (55%) were therapeutic and 25 were diagnostic interventions (45%). Sheath sizes used were 5F in 35 procedures (64%) and 6F in 20 procedures (36%). The right femoral artery was accessed in 51 procedures (93%) and the left in four procedures (7%). There was only one (1.8%) minor periprocedural complication (small hematoma). Hemostasis was successful in 51 of the 55 procedures (93%) with subsequent early ambulation. No device-induced complications associated with serious clinical sequelae were reported. In our small series, the MynxGrip™ femoral access closure device provided a safe and feasible way of closing the femoral artery puncture site after neurointerventional procedures with low minor complication rates and no major complications. Further large prospective randomized trials are necessary to evaluate the efficacy of the device.

Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study

Vascular ◽  
2021 ◽  
pp. 170853812110627
Author(s):  
Athanasios Diamantopoulos ◽  
Romman Nourzaie ◽  
Doug Mulholland ◽  
Steven G Dolan ◽  
Irfan Ahmed ◽  
...  
Keyword(s):  
Prospective Study ◽  
Closure Device ◽  
Complication Rates ◽  
Technical Success ◽  
Vascular Closure Device ◽  
Safety And Efficacy ◽  
Post Procedure ◽  
Vascular Sheath ◽  
Peripheral Arterial ◽  
A Prospective Study

Objectives This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. Methods Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. Results A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. Conclusion The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

Pedagogical Explanation Methods of Teaching Matrix Programming Operations: Effects on Students’ Achievements in IPCs

2015 ◽  
Vol 1 (3) ◽  
pp. 69
Author(s):  
Arjan Skuka
Keyword(s):  
Programming Languages ◽  
Teaching And Learning ◽  
Computer Programming ◽  
General Level ◽  
Control Group ◽  
Group Model ◽  
Computer Engineering ◽  
Success Rates ◽  
Engineering Department ◽  
Students Success

Despite the fact that introductory programming courses (IPCs) are taught at universities for more than thirty years, students still find computer programming very difficult to learn. Programming pedagogy deals with the methods and principles of teaching and learning computer programming. The programming pedagogical approaches that have been proposed to increase the efficiency of teaching and learning computer programming mostly focus on the tools, paradigms, programming languages and environments used in IPCs. To increase significantly the students’ success rates in IPCs, these approaches should be complemented with pedagogical explanation (PE) methods. This research is focused on a PE method of teaching sequential search of a matrix row (SSMR). The research was designed as experimental study with pretest-posttest control group model, involving students of Computer Engineering department Izmir University. While the experimental group was subjected to a pedagogical explanation method, a traditional explanation method was applied in the control group. To collect the research data, an achievement pretest, posttest and a questionnaire were developed and applied. The research findings showed the effectiveness of teaching SSMR by using a PE method. This method positively influenced students’ level of topic comprehension, which consequently improved their achievements. In order for students to understand better the other matrix programming operations, similar PE methods should be developed and used in IPCs. On a more general level, the results of this research suggested that PE methods should be developed and used for other topics that students usually find difficult to understand in IPCs. Using these methods can be a very important factor in significantly increasing students’ success in IPCs.

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