Arterial Closure Devices Versus Manual Compression for Femoral Haemostasis in Interventional Radiological Procedures: A Systematic Review and Meta-Analysis

Purpose  

The use of arterial closure devices (ACDs) in interventional radiology (IR) procedures has not yet been validated by large-scale randomised controlled trials or meta-analysis. Improved haemostasis and early mobilisation are publicised advantages; however, anecdotal evidence of haemorrhagic and ischaemic complications with ACDs is also apparent. Meta-analysis from interventional cardiology cannot be directly extrapolated for IR patients.     

Image-Directed Fine-needle Aspiration Biopsy of the Thyroid with Safety-engineered Devices

Purpose  

The purpose of the present study was to integrate safety-engineered devices into outpatient fine-needle aspiration (FNA) biopsy of the thyroid in an interventional radiology practice.     

French Sizing of Medical Devices is not Fit for Purpose

Purpose

The purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.

Methods

The labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.

Results

A total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm. The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.

Conclusions

Our results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.     

Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients

PURPOSE

Exoseal is a vascular clo sure device consisting of a plug applier and a bio-absorbent polyglycolic acid plug available in sizes 5 F, 6 F, and 7 F. In this study, we aimed to evaluate the effectiveness and safety of the Exoseal vascular closure device (Cordis Corporation, Bridgewater, New Jersey, USA) for puncture site closure after antegrade endovascular procedures in peripheral arterial occlusive disease (PAOD) patients.

MATERIALS AND METHODS

In this retrospective study, a total of 168 consecutive patients who underwent an interventional procedure due to PAOD, were included. In each case, an antegrade peripheral endovascular procedure was performed via the common femoral artery using the Seldinger technique, and Exoseal 5 F, 6 F, or 7 F was used for access site closure. The primary endpoint was a technically successful application of Exoseal. All complications at the access site within 24 hours were registered as a secondary endpoint.

RESULTS

In a group of 168 patients (64.9% men, average age 71.9±11.9 years), the technical application of Exoseal was successful in 166 patients (98.8%). Within the first 24 hours after the procedure, 12 complications (7.2%) were recorded including, three pseudoaneurysms (1.8%) and nine hematomas (5.4%). None of the complications required surgical intervention.

CONCLUSION

Exoseal is a safe and effective device with high technical success and acceptable complication rates for access site closure after antegrade peripheral endovascular procedures.Femoral access sites are important sources of complications in endovascular procedures. In addition to conventional manual compression, arterial closure devices have been successfully used for the purpose of hemostasis at the femoral arterial access site in interventional radiology, cardiology, and angiology for several years. The effectiveness and safety of these devices have already been proven in numerous studies (1). Vascular closure devices were developed to address the increasing time constraints in everyday clinical routine, as well as to increase patient comfort after interventional procedures. Most of these devices have been evaluated for retrograde access.Exoseal (Cordis Corporation, Bridgewater, New Jersey, USA) is a vascular closure device consisting of a plug applier and a bio-absorbent polyglycolic acid plug available in sizes 5 F, 6 F, and 7 F. Exoseal is inserted into the branch canal directly outside the arterial vessel wall and underneath the fascia of the neurovascular bundle. The polyglycolic acid plug increases platelet aggregation, as well as promoting erythrocyte accumulation within the network of the plug. This results in closure of both vessel wall and branch canal. Exoseal gets hydrolyzed into carbon dioxide and water via the Kreb’s cycle and it is completely reabsorbed within 60–90 days (2).The available data studying the role of Exoseal in peripheral vascular interventions is limited, and to this date, there are only two studies published that address the use of this device in antegrade femoral access (3, 4).The aim of this study was to evaluate the effectiveness and safety of Exoseal use for access site closure following antegrade vascular procedures on peripheral arterial occlusive disease (PAOD) patients. According to our literature research, this is the largest patient cohort that has been investigated in that respect so far.     

Malpractice claims in interventional radiology: frequency, characteristics and protective measures

Purpose

The use of interventional radiology procedures has considerably increased in recent years, as has the number of related medicolegal litigations. This study aimed to highlight the problems underlying malpractice claims in interventional radiology and to assess the importance of the informed consent process.

Materials and methods

The authors examined all insurance claims relating to presumed errors in interventional radiology filed by radiologists over a period of 14 years after isolating them from the insurance database of all radiologists registered with the Italian Society of Medical Radiology (SIRM) between 1 January1993 and 31 December 2006.

Results

In the period considered, 98 malpractice claims were filed against radiologists who had performed interventional radiology procedures. In 21 cases (21.4%), the event had caused the patient’s death. In >80% of cases, the event occurred in a public facility. The risk of a malpractice claim for a radiologist practising interventional procedures is 47 per 1,000, which corresponds to one malpractice claim for each 231 years of activity.

Discussion

Interventional radiology, a discipline with a biological risk profile similar to that of surgery, exposes practitioners to a high risk of medicolegal litigation both because of problems intrinsic to the techniques used and because of the need to operate on severely ill patients with compromised clinical status.

Conclusions

Litigation prevention largely depends on both reducing the rate of medical error and providing the patient with correct and coherent information. Adopting good radiological practices, scrupulous review of procedures and efficiency of the instruments used and audit of organisational and management processes are all factors that can help reduce the likelihood of error. Improving communication techniques while safeguarding the patient’s right to autonomy also implies adopting clear and rigorous processes for obtaining the patient’s informed consent to the medical procedure.     

A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures

Objective  

Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. New haemostatic dressings have been developed to control heavy bleeding. To evaluate the efficacy of a new kaolin-based haemostatic bandage for femoral artery closure after diagnostic or interventional procedures compared with manual compression.     

Endovaskuläre Interventionen beim Polytrauma

Clinical issue

In recent years interventional radiology has significantly changed the management of injured patients with multiple trauma. Currently nearly all vessels can be reached within a reasonably short time with the help of specially preshaped catheters and guide wires to achieve bleeding control of arterial und venous bleeding.

Standard treatment/treatment innovations

Whereas bleeding control formerly required extensive open surgery, current interventional methods allow temporary vessel occlusion (occlusion balloons), permanent embolization and stenting.

Diagnostic work-up

In injured patients with multiple trauma preinterventional procedural planning is performed with the help of multidetector computed tomography whenever possible.

Performance

Interventional radiology not only allows minimization of therapeutic trauma but also a considerably shorter treatment time.

Achievements

Interventional bleeding control has developed into a standard method in the management of vascular trauma of the chest and abdomen as well as in vascular injuries of the upper and lower extremities when open surgical access is associated with increased risk. Additionally, pelvic trauma, vascular trauma of the superior thoracic aperture and parenchymal arterial lacerations of organs that can be at least partially preserved are primarily managed by interventional methods.

Practical recommendations

In an interdisciplinary setting interventional radiology provides a safe and efficient means of rapid bleeding control in nearly all vascular territories in addition to open surgical access.     

Summary of the Italian inter-society recommendations for radiation protection optimization in interventional radiology

Objectives

A Working Group coordinated by the Italian National Institute of Health (Istituto Superiore di Sanità) and the National Workers Compensation Authority (Istituto Nazionale per l’Assicurazione contro gli Infortuni sul Lavoro, INAIL) and consisting of 11 Italian scientific/professional societies involved in the fluoroscopically guided interventional practices has been established to define recommendations for the optimization of patients and staff radiation protection in interventional radiology. A summary of these recommendations is here reported.

Materials and methods

A multidisciplinary approach was used to establish the Working Group by involving radiologists, interventional radiologists, neuroradiologists, interventional cardiologists, occupational health specialists, medical physicists, radiation protection experts, radiographers and nurses. The Group operated as a “Consensus Conference”. Three main topics have been addressed: patient radiation protection (summarized in ten “golden rules”); staff radiation protection (summarized in ten “golden rules”); and education/training of interventional radiology professionals.

Results

In the “golden rules”, practical and operational recommendations were provided to help the professionals in optimizing dose delivered to patients and reducing their own exposure. Operative indications dealt also with continuing education and training, and recommendations on professional accreditation and certification.

Conclusions

The “Consensus Conference” was the methodology adopted for the development of these recommendations. Involvement of all professionals is a winning approach to improve practical implementation of the recommendations, thus getting a real impact on the optimization of the interventional radiology practices.

     

Percutaneous management of postoperative bile leaks after upper gastrointestinal surgery

Purpose  

This study was designed to investigate the benefit of percutaneous interventional management of patients with postoperative bile leak on clinical outcome. Primary study endpoints were closure of the bile leak and duration of percutaneous transhepatic biliary drainage (PTBD) treatment. Secondary study endpoints were necessity of additional CT-guided drainage catheter placement, course of serum CRP level as parameter for inflammation, and patients’ survival.     

Arterielle Verschlusssysteme

Clinical/methodical issue

Access site complications after endovascular catheterization sometimes require open surgery and negatively impair safety, patient comfort and reimbursement. Increasing numbers of procedures and patients with multiple anticoagulants as well as cost pressure explain the demand for an immediate and stable access site closure.

Standard radiological methods

Manual compression followed by compression bandage and bed rest for 4–24 h is still the gold standard but is unable to prevent access site complications in all cases.

Methodical innovations

Arterial vascular closure devices allow immediate and stable closure of the puncture channel either by suture or by implantation of occluding foreign bodies or gluing fluids.

Performance

The safety has been proven in several clinical trials. The main advantage lies in closing large lumen access sites without surgery and in patients treated with multiple anticoagulants as well as in outpatient procedures.

Achievements

They have become a valuable supplement to the interventional arsenal.

Practical recommendations

The physician, however, has to decide between different systems and mechanisms with respect to patient constitution, selected access vessel and level of calcification and diameter. Furthermore, all systems require a defined training prior the first use.     

Interventional Radiology-Operated Endoscopy as an Adjunct to Image-Guided Interventions

Purpose

Interventional radiology-operated endoscopy is an underused technique, which may have a significant impact on the ability to treat patients with a variety of conditions. The purpose of this article is to discuss the setup, equipment, and potential clinical uses of interventional radiology-operated endoscopy.

An Evaluation of Trends in Patient and Public Awareness of IR

Purpose

To evaluate patient and public awareness of interventional radiology (IR).

Diagnostic reference levels and complexity indices in interventional radiology: a national programme

Objectives

To propose national diagnostic reference levels (DRLs) for interventional radiology and to evaluate the impact of the procedural complexity on patient doses.

Methods

Eight interventional radiology units from Spanish hospitals were involved in this project. The participants agreed to undergo common quality control procedures for X-ray systems. Kerma area product (KAP) was collected from a sample of 1,649 procedures. A consensus document established the criteria to evaluate the complexity of seven types of procedures. DRLs were set as the 3rd quartile of KAP values.

Results

The KAP (3rd quartile) in Gy cm² for the procedures included in the survey were: lower extremity arteriography (n?=?784) 78; renal arteriography (n?=?37) 107; transjugular hepatic biopsies (THB) (n?=?30) 45; biliary drainage (BD) (n?=?314) 30; uterine fibroid embolization (UFE) (n?=?56) 214; colon endoprostheses (CE) (n?=?31) 169; hepatic chemoembolization (HC) (n?=?269) 303; femoropopliteal revascularization (FR) (n?=?62) 119; and iliac stent (n?=?66) 170. The complexity involved the increases in the following KAP factors from simple to complex procedures: THB x4; BD x13; UFE x3; CE x3; HC x5; FR x5 and IS x4.

Conclusions

The evaluation of the procedure complexity in patient doses will allow the proper use of DRLs for the optimization of interventional radiology.

Key Points

? National DRLs for interventional procedures have been proposed given level of complexity ? For clinical audits, the level of complexity should be taken into account. ? An evaluation of the complexity levels of the procedure should be made.

     

Clinical IR in Canada: The Evolution of a Revolution

Purpose

To investigate the current status and evolution of both the interventional radiologist’s role as a clinician and the practice of interventional radiology (IR) over the past decade in Canada.

National Survey to Identify Subspecialties at Risk for Physician Shortages in Canadian Academic Radiology Departments

Purpose

To identify subspecialty fields in Canadian academic radiology departments that are at risk for future manpower shortages. To determine reasons for the potential shortages and suggest potential solutions.

Methods

An anonymous online survey was sent by e-mail to radiology residents and academic radiology department heads in Canada. The survey was open from April 1 to August 1, 2006. Statistical analysis by using the SAS Frequency Procedure was performed on the results.

Results

Interventional radiology, neuroradiology, mammography, cardiac imaging, and pediatric radiology were identified as areas in which there will be increasing workforce demands. Mammography, pediatric radiology, and cardiac imaging were identified as areas in which there will be a potential decrease in supply. Of the residents, 65.83% intended on pursuing subspecialty training. Priorities were interesting work, job availability, and work schedule. Nuclear medicine, mammography, pediatric radiology, and interventional radiology were identified as the top 4 areas in which residents specifically did not want to pursue further subspecialty training. Only 15% of resident respondents received career counseling during residency, and only 50% of those residents thought it was adequate.

Conclusions

Our survey results indicate that mammography, cardiac imaging, and pediatric radiology are at risk for manpower shortages, and interventional radiology may be at risk. Increased efforts to recruit trainees may be necessary to ensure that these subspecialties maintain their presence in the future. Only 15% of the surveyed residents received career counseling during residency. This is a relatively untapped forum that academic staff could use to help recruit new trainees into these underserved subspecialties.     

PET/CT-guided Interventions: Personnel Radiation Dose

Purpose

To quantify radiation exposure to the primary operator and staff during PET/CT-guided interventional procedures.

Methods

In this prospective study, 12 patients underwent PET/CT-guided interventions over a 6 month period. Radiation exposure was measured for the primary operator, the radiology technologist, and the nurse anesthetist by means of optically stimulated luminescence dosimeters. Radiation exposure was correlated with the procedure time and the use of in-room image guidance (CT fluoroscopy or ultrasound).

Results

The median effective dose was 0.02 (range 0–0.13) mSv for the primary operator, 0.01 (range 0–0.05) mSv for the nurse anesthetist, and 0.02 (range 0–0.05) mSv for the radiology technologist. The median extremity dose equivalent for the operator was 0.05 (range 0–0.62) mSv. Radiation exposure correlated with procedure duration and with the use of in-room image guidance. The median operator effective dose for the procedure was 0.015 mSv when conventional biopsy mode CT was used, compared to 0.06 mSv for in-room image guidance, although this did not achieve statistical significance as a result of the small sample size (p = 0.06).

Conclusion

The operator dose from PET/CT-guided procedures is not significantly different than typical doses from fluoroscopically guided procedures. The major determinant of radiation exposure to the operator from PET/CT-guided interventional procedures is time spent in close proximity to the patient.     

Suitability of Exoseal Vascular Closure Device for Antegrade Femoral Artery Puncture Site Closure

Purpose

To assess the efficacy and safety of the Exoseal vascular closure device for antegrade puncture of the femoral artery.

Methods

In a prospective study from February 2011 to January 2012, a total of 93 consecutive patients received a total of 100 interventional procedures via an antegrade puncture of the femoral artery. An Exoseal vascular closure device (6F) was used for closure in all cases. Puncture technique, duration of manual compression, and use of compression bandages were documented. All patients were monitored by vascular ultrasound and color-coded duplex sonography of their respective femoral artery puncture site within 12 to 36 h after angiography to check for vascular complications.

Results

In 100 antegrade interventional procedures, the Exoseal vascular closure device was applied successfully for closure of the femoral artery puncture site in 96 cases (96 of 100, 96.0 %). The vascular closure device could not be deployed in one case as a result of kinking of the vascular sheath introducer and in three cases because the bioabsorbable plug was not properly delivered to the extravascular space adjacent to the arterial puncture site, but instead fully removed with the delivery system (4.0 %). Twelve to 36 h after the procedure, vascular ultrasound revealed no complications at the femoral artery puncture site in 93 cases (93.0 %). Minor vascular complications were found in seven cases (7.0 %), with four cases (4.0 %) of pseudoaneurysm and three cases (3.0 %) of significant late bleeding, none of which required surgery.

Conclusion

The Exoseal vascular closure device was safely used for antegrade puncture of the femoral artery, with a high rate of procedural success (96.0 %), a low rate of minor vascular complications (7.0 %), and no major adverse events.     

Diagnostic reference levels in pediatric radiology in Austria

Background  

Because of the higher sensitivity to radiation in children, optimization plays an essential role in pediatric radiology. Diagnostic reference levels are a helpful tool to optimize patient dose for standard radiographic procedures.     

Bone Marrow Nails Created by Percutaneous Osteoplasty for Long Bone Fracture: Comparisons Among Acrylic Cement Alone,Acrylic-Cement–Filled Bare Metallic Stent,and Acrylic-Cement–Filled Covered Metallic Stent

Purpose  

This study was designed to compare the strength among bone marrow nails created to treat long bone fractures using interventional procedures.     

A national patient dose survey and setting of reference levels for interventional radiology in Bulgaria

Objectives

A national study on patient dose values in interventional radiology and cardiology was performed in order to assess current practice in Bulgaria, to estimate the typical patient doses and to propose reference levels for the most common procedures.

Methods

Fifteen units and more than 1,000 cases were included. Average values of the measured parameters for three procedures—coronary angiography (CA), combined procedure (CA?+?PCI) and lower limb arteriography (LLA)—were compared with data published in the literature.

Results

Substantial variations were observed in equipment and procedure protocols used. This resulted in variations in patient dose: air-kerma area product ranges were 4–339, 6–1,003 and 0.2–288 Gy cm² for CA, CA?+?PCI and LLA respectively. Reference levels for air kerma-area product were proposed: 40 Gy cm² for CA, 140 Gy cm² for CA?+?PCI and 45 Gy cm² for LLA. Auxiliary reference intervals were proposed for other dose-related parameters: fluoroscopy time, number of images and entrance surface air kerma rate in fluoroscopy and cine mode.

Conclusions

There is an apparent necessity for improvement in the classification of peripheral procedures and for standardisation of the protocols applied. It is important that patient doses are routinely recorded and compared with reference levels.

Key Points

? Patient doses in interventional radiology are high and vary greatly ? Better standardisation of procedures and techniques is needed to improve practice ? Dose reference levels for most common procedures are proposed