The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization

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

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Femoral Angiogram Prior to Arteriotomy Closure Device Does Not Reduce Vascular Complications in Patients Undergoing Cardiac Catheterization

Journal of Interventional Cardiology ◽

10.1111/j.1540-8183.2007.00342.x ◽

2008 ◽

Vol 21 (2) ◽

pp. 204-208 ◽

Cited By ~ 4

Author(s):

RAVI K. RAMANA ◽

AMANDEEP SINGH ◽

ROBERT S. DIETER ◽

JOHN F. MORAN ◽

LOWELL STEEN ◽

...

Keyword(s):

Cardiac Catheterization ◽

Vascular Complications ◽

Closure Device

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Factors affecting vascular access complications in children undergoing congenital cardiac catheterization

Cardiology in the Young ◽

10.1017/s1047951111000989 ◽

2011 ◽

Vol 22 (2) ◽

pp. 136-144 ◽

Cited By ~ 10

Author(s):

Alaa M. Roushdy ◽

Noha Abdelmonem ◽

Azza A. El Fiky

Keyword(s):

Body Weight ◽

Adverse Events ◽

Cardiac Catheterization ◽

Vascular Access ◽

Vascular Complications ◽

P Value ◽

Factors Affecting ◽

Vein Thrombosis ◽

Access Complications ◽

A Prospective Study

AbstractBackgroundComplications at the vascular access sites are among the most common adverse events in congenital cardiac catheterization. The use of small-gauge catheters may reduce these events; however, other factors can contribute to the development of vascular complications.ObjectivesTo determine factors associated with the development of vascular access complications in children undergoing congenital cardiac catheterization.MethodsWe performed a prospective study of 403 patients who underwent diagnostic (62.5%) or interventional (37.5%) cardiac catheterization over a period of 6 months, and analysed the vascular complications during and immediately after the procedure.ResultsThe most common access-related adverse event was transient loss of pulsation (17.6%). Other less common access-related adverse events included subcutaneous haematoma (2%), bleeding (3%), vessel tear (0.2%), and vein thrombosis (0.2%). Patients who had no access-related adverse events had significantly higher age and body weight compared with those who had one or more access problems. Among 81 patients who had vascular access established in unplanned access sites, 30 patients (37%) had lost pulsations. Among the 322 patients who had vascular access established in planned access sites, however, only 41 patients had lost pulsation (13%). In addition, patients who had lost pulsations had significantly longer puncture time compared to those who had normal pulsations (p value 0.01).ConclusionFactors other than sheath size can contribute to access-related adverse events in children undergoing cardiac catheterization. Obtaining vascular access in unplanned access sites and longer puncture times increases the incidence of lost pulsations after catheterization. Younger age and smaller body weight are also associated with significant increase in access-related adverse events.

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Complications

Cardiac Catheterization and Coronary Intervention ◽

10.1093/med/9780198705642.003.0010 ◽

2020 ◽

pp. 277-314

Author(s):

Andrew Mitchell ◽

Giovanni Luigi De Maria ◽

Adrian Banning

Keyword(s):

Cardiac Catheterization ◽

Vascular Complications ◽

Air Embolism ◽

Limb Ischaemia ◽

Contrast Nephropathy ◽

Diagnostic Cardiac Catheterization ◽

Vasovagal Reactions ◽

Co Morbidity ◽

Coronary Perforation ◽

Haematoma Formation

Cardiac catheterization is an invasive study that involves real risks to the patient. The risks increase with patient age and co-morbidity. Though vascular complications (particularly haematoma formation) and vasovagal reactions are more common, the risk of serious complications from diagnostic cardiac catheterization and coronary angiography remains low. This chapter covers complications that may arise, including death, myocardial infarction, pulmonary oedema, stroke, hypotension, cardiac tamponade, contrast reactions, vasovagal reactions, arrhythmias, vascular complications, limb ischaemia, coronary dissection (including left main stem dissection and iatrogenic type A aortic dissection), air embolism, coronary perforation, renal failure, contrast nephropathy, and cholesterol embolization.

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Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization

American Journal of Critical Care ◽

10.4037/ajcc1998.7.4.308 ◽

1998 ◽

Vol 7 (4) ◽

pp. 308-313 ◽

Cited By ~ 16

Author(s):

A Simon ◽

B Bumgarner ◽

K Clark ◽

S Israel

Keyword(s):

Cardiac Catheterization ◽

Femoral Artery ◽

Vascular Complications ◽

Control Group ◽

Mechanical Compression ◽

Success Rates ◽

Manual Compression ◽

Diagnostic Cardiac Catheterization ◽

Compression Time ◽

Catheterization Procedure

BACKGROUND: Most cardiac catheterizations are performed via femoral artery access. Reported rates of both peripheral vascular complications and success rates for the use of manual and mechanical compression techniques to achieve femoral artery hemostasis after cardiac catheterization vary. OBJECTIVE: To determine is use of a mechanical clamp is as effective as standard manual pressure for femoral artery hemostasis after cardiac catheterization. METHODS: Subjects consisted of 720 patients from 2 community hospitals who had elective diagnostic cardiac catheterization via the femoral artery. The control group (n=343) received manual compression for hemostasis; the study group (n=377) received mechanical compression. Standard protocols were used for the 2 compression techniques. Pressure was applied for a minimum of 10 minutes for 5F and 6F sheaths and catheters and for a minimum of 15 minutes for 7F and 8F sheaths and catheters. Prospective data were collected and analyzed for each patients, including sheath or catheter size, blood pressure, height, weight, age, time from administration of local anesthetic to successful cannulation of the femoral artery, anticoagulation status, total compression time, physician performing the catheterization procedure, nurse or technician who obtained hemostasis, and complications. In follow-up, patients were asked site-specific and functional status questions 1 to 2 days after the catheterization procedure and again 3 days after the catheterization procedure. RESULTS: Data were analyzed by using frequency distributions, measures of central tendency, and measures of variability. Only 1 difference between the 2 groups was significant: manual compression time was 14.93 +/- minutes, whereas mechanical compression time was 17.13 +/- minutes. CONCLUSION: Mechanical compression is as effective as manual compression for femoral artery hemostasis after cardiac catheterization.

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

Journal of the American Heart Association ◽

10.1161/jaha.120.018042 ◽

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: clinicaltrials.gov ; Unique identifier: NCT02713932.

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