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1.
BMC Cardiovasc Disord ; 24(1): 342, 2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38970014

ABSTRACT

BACKGROUND: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications. CASE PRESENTATION: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography. CONCLUSION: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.


Subject(s)
Delayed Diagnosis , Femoral Artery , Hemorrhage , Punctures , Humans , Female , Aged , Femoral Artery/diagnostic imaging , Hemorrhage/etiology , Hemorrhage/therapy , Treatment Outcome , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Predictive Value of Tests , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Hemostatic Techniques/instrumentation , Hemostatic Techniques/adverse effects
2.
Br J Nurs ; 33(14): S25-S29, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39023019

ABSTRACT

BACKGROUND: The significance of vascular access devices for patients in the emergency department (ED) is undeniable. When it comes to evaluating the effectiveness of interventions, randomised controlled trials (RCTs) stand out as the most reliable sources of evidence compared with other study designs. AIM: To explore and synthesise the findings from RCTs related to vascular access devices in the ED setting. METHODS: A systematic search will be conducted in electronic medical databases including the Cochrane Central Register of Controlled Trials, Pubmed, CINAHL and Embase databases. All RCTs focusing on peripheral intravenous catheters, central venous catheters and intraosseous catheters, published in English and Chinese in peer-reviewed journals within the past decade, will be included. CONCLUSION: This scoping review will summarise the current state of evidence for vascular access devices in the ED setting. This will identify gaps in the literature and, in turn, assist clinicians and researchers in pinpointing areas for future exploration and provide a valuable guide for future research.


Subject(s)
Emergency Service, Hospital , Randomized Controlled Trials as Topic , Vascular Access Devices , Humans , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/methods , Review Literature as Topic
3.
Trials ; 25(1): 380, 2024 Jun 12.
Article in English | MEDLINE | ID: mdl-38867301

ABSTRACT

BACKGROUND: Maintaining venous access is of great clinical importance. Running a slow continuous infusion to keep the vein open (KVO) is often used in peripheral intravenous catheters (PIVCs). Previous studies have compared the effects of intermittent flushing and continuous infusion via peripherally inserted central catheters (PICCs). In this study, we applied KVO to central venous catheters (CVCs) and compared the occlusion rate of this technique with that of the intermittent flushing technique. METHOD: This is a randomized controlled trial of 14 hospitals in China. A total of 250 patients will be recruited in this study, and they will be randomized at a 1:1 ratio. After study inclusion, patients who will undergo CVC insertion will receive intermittent flushing with prefilled saline syringes (control group) or KVO infusion with elastic pumps (test group). All the catheters will be checked for patency by scoping Catheter Injection and Aspiration (CINAS) Classification on Days 3 and 7. The primary outcome is the rate of catheter occlusion in 7 days. Patients will be followed up until 9 days after CVC insertion, catheter occlusion, or catheter removal. The secondary outcomes are the rate of catheter occlusion in 3 days, nurse satisfaction, cost-effectiveness, adverse event rate, catheter-related bloodstream infection rate, catheter-related thrombosis rate, extravasation rate, phlebitis rate, and catheter migration. DISCUSSION: We expect that the trial will generate findings that can provide an evidence-based basis for the improvement and optimization of clinical catheter flushing techniques. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2200064007. Registered on 23 September 2022. https://www.chictr.org.cn/showproj.html?proj=177311 .


Subject(s)
Catheter Obstruction , Catheterization, Central Venous , Central Venous Catheters , Multicenter Studies as Topic , Humans , Central Venous Catheters/adverse effects , Catheterization, Central Venous/adverse effects , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/methods , Catheter Obstruction/etiology , China , Equivalence Trials as Topic , Middle Aged , Adult , Male , Treatment Outcome , Female , Time Factors , Randomized Controlled Trials as Topic , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/methods , Catheters, Indwelling/adverse effects , Infusions, Intravenous , Therapeutic Irrigation/adverse effects , Therapeutic Irrigation/methods , Therapeutic Irrigation/instrumentation , Aged
4.
Curr Opin Anaesthesiol ; 37(4): 400-405, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38841917

ABSTRACT

PURPOSE OF REVIEW: This review summarizes the latest findings and recommendations about the characteristics, indications and use of peripheral and central long-term venous access devices.The various complications inherent in these devices are becoming better known, and their contributing factors determined, which could make it possible to reduce their incidence. RECENT FINDINGS: Some measures are integrated into recommendations for good practice, such as appropriate selection of devices, the preferential use of the thinnest catheters, and cyanoacrylate glue and dressings impregnated with chlorhexidine. SUMMARY: Improving understanding of the phenomena leading to infectious and thrombotic complications, as well as better knowing the differences between intravenous devices and their respective indications, should lead to improvement of in-hospital and out-of-hospital care.


Subject(s)
Catheterization, Peripheral , Humans , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/methods , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/methods , Catheterization, Central Venous/adverse effects , Catheter-Related Infections/prevention & control , Catheter-Related Infections/etiology , Catheters, Indwelling/adverse effects , Central Venous Catheters/adverse effects
5.
Cochrane Database Syst Rev ; 6: CD013366, 2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38940297

ABSTRACT

BACKGROUND: Peripherally inserted central catheters (PICCs) facilitate diagnostic and therapeutic interventions in health care. PICCs can fail due to infective and non-infective complications, which PICC materials and design may contribute to, leading to negative sequelae for patients and healthcare systems. OBJECTIVES: To assess the effectiveness of PICC material and design in reducing catheter failure and complications. SEARCH METHODS: The University of Queensland and Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the WHO ICTRP and ClinicalTrials.gov trials registers to 16 May 2023. We aimed to identify other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials, as well as relevant systematic reviews, meta-analyses, and health technology assessment reports. We contacted experts in the field to ascertain additional relevant information. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating PICC design and materials. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were venous thromboembolism (VTE), PICC-associated bloodstream infection (BSI), occlusion, and all-cause mortality. Secondary outcomes were catheter failure, PICC-related BSI, catheter breakage, PICC dwell time, and safety endpoints. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 12 RCTs involving approximately 2913 participants (one multi-arm study). All studies except one had a high risk of bias in one or more risk of bias domain. Integrated valve technology compared to no valve technology for peripherally inserted central catheter design Integrated valve technology may make little or no difference to VTE risk when compared with PICCs with no valve (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.19 to 2.63; I² = 0%; 3 studies; 437 participants; low certainty evidence). We are uncertain whether integrated valve technology reduces PICC-associated BSI risk, as the certainty of the evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Integrated valve technology may make little or no difference to occlusion risk when compared with PICCs with no valve (RR 0.86, 95% CI 0.53 to 1.38; I² = 0%; 5 studies; 900 participants; low certainty evidence). We are uncertain whether use of integrated valve technology reduces all-cause mortality risk, as the certainty of evidence is very low (RR 0.85, 95% CI 0.44 to 1.64; I² = 0%; 2 studies; 473 participants). Integrated valve technology may make little or no difference to catheter failure risk when compared with PICCs with no valve (RR 0.80, 95% CI 0.62 to 1.03; I² = 0%; 4 studies; 720 participants; low certainty evidence). We are uncertain whether integrated-valve technology reduces PICC-related BSI risk (RR 0.51, 95% CI 0.19 to 1.32; I² = not applicable; 2 studies (no events in 1 study); 542 participants) or catheter breakage, as the certainty of evidence is very low (RR 1.05, 95% CI 0.22 to 5.06; I² = 20%; 4 studies; 799 participants). Anti-thrombogenic surface modification compared to no anti-thrombogenic surface modification for peripherally inserted central catheter design We are uncertain whether use of anti-thrombogenic surface modified catheters reduces risk of VTE (RR 0.67, 95% CI 0.13 to 3.54; I² = 15%; 2 studies; 257 participants) or PICC-associated BSI, as the certainty of evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces occlusion (RR 0.69, 95% CI 0.04 to 11.22; I² = 70%; 2 studies; 257 participants) or all-cause mortality risk, as the certainty of evidence is very low (RR 0.49, 95% CI 0.05 to 5.26; I² = not applicable; 1 study; 111 participants). Use of anti-thrombogenic surface modified catheters may make little or no difference to risk of catheter failure (RR 0.76, 95% CI 0.37 to 1.54; I² = 46%; 2 studies; 257 participants; low certainty evidence). No PICC-related BSIs were reported in one study (111 participants). As such, we are uncertain whether use of anti-thrombogenic surface modified catheters reduces PICC-related BSI risk (RR not estimable; I² = not applicable; very low certainty evidence). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces the risk of catheter breakage, as the certainty of evidence is very low (RR 0.15, 95% CI 0.01 to 2.79; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Antimicrobial impregnation compared to non-antimicrobial impregnation for peripherally inserted central catheter design We are uncertain whether use of antimicrobial-impregnated catheters reduces VTE risk (RR 0.54, 95% CI 0.05 to 5.88; I² = not applicable; 1 study; 167 participants) or PICC-associated BSI risk, as the certainty of evidence is very low (RR 2.17, 95% CI 0.20 to 23.53; I² = not applicable; 1 study; 167 participants). Antimicrobial-impregnated catheters probably make little or no difference to occlusion risk (RR 1.00, 95% CI 0.57 to 1.74; I² = 0%; 2 studies; 1025 participants; moderate certainty evidence) or all-cause mortality (RR 1.12, 95% CI 0.71 to 1.75; I² = 0%; 2 studies; 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter failure (RR 1.04, 95% CI 0.82 to 1.30; I² = not applicable; 1 study; 221 participants; low certainty evidence). Antimicrobial-impregnated catheters probably make little or no difference to PICC-related BSI risk (RR 1.05, 95% CI 0.71 to 1.55; I² = not applicable; 2 studies (no events in 1 study); 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter breakage (RR 0.86, 95% CI 0.19 to 3.83; I² = not applicable; 1 study; 804 participants; low certainty evidence). AUTHORS' CONCLUSIONS: There is limited high-quality RCT evidence available to inform clinician decision-making for PICC materials and design. Limitations of the current evidence include small sample sizes, infrequent events, and risk of bias. There may be little to no difference in the risk of VTE, PICC-associated BSI, occlusion, or mortality across PICC materials and designs. Further rigorous RCTs are needed to reduce uncertainty.


Subject(s)
Catheter-Related Infections , Catheterization, Peripheral , Equipment Design , Equipment Failure , Randomized Controlled Trials as Topic , Venous Thromboembolism , Humans , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Catheter-Related Infections/prevention & control , Venous Thromboembolism/prevention & control , Venous Thromboembolism/etiology , Catheter Obstruction , Central Venous Catheters/adverse effects , Cause of Death , Bias , Catheterization, Central Venous/adverse effects , Catheterization, Central Venous/instrumentation , Bacteremia/prevention & control , Bacteremia/etiology
6.
Ann Vasc Surg ; 106: 205-212, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38823479

ABSTRACT

BACKGROUND: To examine the safety and efficacy of ZelanteDVT™ catheter rheolytic thrombectomy in the treatment of patients with iliac vein stent thrombosis. METHODS: A retrospective analysis method was conducted by means of collecting the data of 32 patients who had completed the treatment of iliac vein stent thrombosis with ZelanteDVT catheter rheolytic thrombectomy from March 2019 to March 2023. Data on clinical characteristics, technical success, clinical success, complications, and early follow-up were analyzed. RESULTS: The technical success rates were 100%, intraoperatively, in which 22 cases were improved to thrombus clearance Grade II (50-90%), 10 were Grade III (>90%). There were 21 cases treated with subsequent catheter-directed thrombolysis, and the average urokinase administration of (120.90 ± 29.63)∗10ˆ4 units. The clinical success rates were 100% and the swelling of the affected limbs were significantly improved, a significant difference in the pre/postoperative between-thigh circumference difference [(5.16 ± 1.08) vs. (1.75 ± 0.84), P < 0.000]. The pre/postoperative Venous Clinical Severity Score was [(12.94 ± 1.70) vs. (7.44 ± 1.31), P < 0.000]. No serious complications occurred during the perioperative period. The postoperative and 12-month stent patency rate was 100.00% (32/32) and 71.88% (23/32), respectively. CONCLUSIONS: The ZelanteDVT catheter rheolytic thrombectomy seems to have a promising application prospect for the treatment of patients with iliac vein stent thrombosis.


Subject(s)
Iliac Vein , Stents , Thrombectomy , Vascular Patency , Venous Thrombosis , Humans , Male , Female , Retrospective Studies , Middle Aged , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Iliac Vein/surgery , Treatment Outcome , Thrombectomy/adverse effects , Thrombectomy/instrumentation , Aged , Venous Thrombosis/therapy , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/physiopathology , Time Factors , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Adult , Vascular Access Devices , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Thrombolytic Therapy/adverse effects
7.
J Cardiovasc Electrophysiol ; 35(8): 1701-1705, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38845191

ABSTRACT

INTRODUCTION: Transvenous lead extractions (TLEs) for cardiac implantable electronic device complications often encounter difficulties with strong adhesions to the myocardium or vessels. In this report, we introduce a novel "Four-Stage Rocket" technique for effective TLE in cases where conventional methods fail. METHODS AND RESULTS: Two challenging cases where conventional TLE methods failed were treated using a combination of four devices: Needle's Eye Snare, Agilis NxT Steerable Introducer, GlideLight Laser sheath, and GORE® DrySeal Flex Introducer sheath, employed via the inferior vena cava. The "Four-Stage Rocket" technique successfully detached firmly adhered leads near the tricuspid valve annulus, where the traditional superior vena cava approach was inadequate. CONCLUSION: The "Four-Stage Rocket" technique offers a potential alternative in complex TLE cases, aligning the laser direction with the adhesion detachment and reducing the tissue damage risk.


Subject(s)
Defibrillators, Implantable , Device Removal , Femoral Vein , Lasers , Pacemaker, Artificial , Humans , Device Removal/instrumentation , Device Removal/methods , Male , Aged , Treatment Outcome , Female , Middle Aged , Catheterization, Peripheral/instrumentation
8.
Cochrane Database Syst Rev ; 5: CD013023, 2024 05 23.
Article in English | MEDLINE | ID: mdl-38780138

ABSTRACT

BACKGROUND: Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail, requiring reinsertion. Dressings and securement devices maintain AC function and prevent complications such as infection. OBJECTIVES: To evaluate the effectiveness of peripheral AC dressing and securement devices to prevent failure and complications in hospitalised people. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus up to 16 May 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to 16 May 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different dressing and securement devices for the stabilisation of ACs in hospitalised people. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias using Cochrane's RoB 1 tool. We resolved disagreements by discussion, or by consulting a third review author when necessary. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included five RCTs with 1228 participants and 1228 ACs. All included studies had high risk of bias in one or more domains. We present the following four comparisons, with the remaining comparisons reported in the main review. Standard polyurethane (SPU) plus tissue adhesive (TA) compared with SPU: we are very uncertain whether use of SPU plus TA impacts rates of AC failure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.20 to 0.98; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Neither study (165 participants) reported catheter-related bloodstream infections (CRBSI), thus we are very uncertain whether SPU plus TA impacts on the incidence of CRBSI (very low-certainty evidence). It is very uncertain whether use of SPU plus TA impacts AC dislodgement risk (RR 0.54, 95% CI 0.03 to 9.62; I² = 44%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts AC occlusion rates (RR 1.20, 95% CI 0.37 to 3.91; I² = 3%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts rates of adverse events with few reported events across groups (RR 0.89, 95% CI 0.09 to 8.33; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Bordered polyurethane (BPU) compared to SPU: we are very uncertain whether use of BPU impacts rates of AC failure (RR 0.67, 95% CI 0.21 to 2.13; 1 study, 60 participants; very low-certainty evidence). BPU may make little or no difference to CRBSI compared to SPU (RR 3.05, 95% CI 0.12 to 74.45; I² = not applicable as 1 study (60 participants) reported 0 events; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to the risk of AC dislodgement compared with SPU (RR 0.75, 95% CI 0.17 to 3.22; I² = 0%; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to occlusion risk compared with SPU (RR 0.80, 95% CI 0.60 to 1.07; I² = 0%; 2 studies, 572 participants; low-certainty evidence). It is very uncertain whether BPU impacts on the risk of adverse events compared with SPU (RR 0.33, 95% CI 0.01 to 7.87; 1 study, 60 participants; very low-certainty evidence). SPU plus sutureless securement devices (SSD) compared to SPU: we are very uncertain whether SPU plus SSD impacts risk of AC failure compared with SPU (RR 0.78, 95% CI 0.40 to 1.52; I² = 0%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain if SPU plus SSD impacts CRBSI incidence rate with no events in both groups (2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of dislodgement (RR 0.14, 95% CI 0.01 to 2.57; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of AC occlusion (RR 1.94, 95% CI 0.50 to 7.48; I² = 38%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain whether SPU plus SSD impacts on the risk of adverse events (RR 1.94, 95% CI 0.19 to 20.24; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). Integrated securement dressings compared to SPU: integrated securement dressings may result in little or no difference in risk of AC failure compared with SPU (RR 1.96, 95% CI 0.80 to 4.84; 1 study, 105 participants; low-certainty evidence); may result in little or no difference in CRBSI incidence with no events reported (1 study, 105 participants; low-certainty evidence); may result in little or no difference in the risk of dislodgement (RR 0.33, 95% CI 0.04 to 3.04; 1 study, 105 participants; low-certainty evidence), may result in little or no difference in occlusion rates with no events reported (1 study, 105 participants; low-certainty evidence), and may result in little or no difference in the risk of adverse events (RR 0.35, 95% CI 0.01 to 8.45; 1 study, 105 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: There is currently limited rigorous RCT evidence available about the relative clinical effectiveness of AC dressing and securement products. Limitations of current evidence include small sample size, infrequent events, and heterogeneous outcome measurements. We found no clear difference in the incidence of AC failure, CRBSI, or adverse events across AC dressing or securement products including SPU, BPU, SSD, TA, and integrated securement products. The limitations of current evidence means further rigorous RCTs are needed to reduce uncertainty around the use of dressing and securement devices for ACs.


Subject(s)
Bandages , Catheter-Related Infections , Catheterization, Peripheral , Polyurethanes , Randomized Controlled Trials as Topic , Humans , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Catheter-Related Infections/prevention & control , Bias , Equipment Failure
9.
Circ Cardiovasc Interv ; 17(6): e013842, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38708595

ABSTRACT

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.


Subject(s)
Endovascular Procedures , Hemostatic Techniques , Suture Techniques , Vascular Closure Devices , Humans , Prospective Studies , Male , Female , Aged , Hemostatic Techniques/instrumentation , Hemostatic Techniques/adverse effects , Treatment Outcome , Time Factors , Suture Techniques/adverse effects , Suture Techniques/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Aged, 80 and over , Equipment Design , Punctures , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Hemorrhage/prevention & control , Hemorrhage/etiology , Middle Aged , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Risk Factors , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging
10.
J Vasc Interv Radiol ; 35(8): 1203-1208, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38704139

ABSTRACT

PURPOSE: To compare the outcomes of fluoroscopic versus portable placement of peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in pediatric patients. MATERIALS AND METHODS: This is a single-center, retrospective review of 346 upper-extremity PICC placements (286 fluoroscopic and 60 portable; mean age, 9.83 years [SD ± 5.58]; 49.1% female) and 138 tunneled femoral CVC placements (56 fluoroscopic and 82 portable; mean age, 0.23 years [SD ± 0.36]; 57.0% female). Portable placements used mobile plain-film radiography. All lines were placed by board-certified interventional radiologists. RESULTS: Fluoroscopic PICC placements had a lower procedure time (43.9 vs 57.9 minutes; P < .001), radiation dosage (342 vs 590 mGy·cm2; P < .001), incidence of technical failure (0% vs 3.3%; P = .029), and incidence of catheter malfunction (1.7% vs 12.1%; P < .001) compared with portable PICC placements. Fluoroscopic CVC placements had a lower procedure time (42.6 vs 54.8 minutes; P < .001) and radiation dosage (63.8 vs 405 mGy·cm2; P < .001) compared with portable CVC placements. No technical failures were found in either CVC groups and the difference was nonsignificant for catheter malfunction (0% vs 7.3%; P = .081). Fluoroscopic placements of PICCs and CVCs had a lower incidence rate of central line-associated bloodstream infection compared with portable placements (0.71 vs 2.22 cases per 1,000 line-days; P = .046). Overall, fluoroscopic placements of PICCs and CVCs had fewer adverse events compared with portable placements (3.2% vs 14.8%; P < .001). Portable procedure setting was the only significant factor associated with adverse events (odds ratio, 33.77; 95% CI, 4.56-757.01). CONCLUSIONS: Fluoroscopic placements of PICCs and CVCs are associated with lower procedure time, radiation dose, and risk of adverse events compared with portable placements in pediatric patients.


Subject(s)
Catheterization, Central Venous , Catheterization, Peripheral , Radiation Dosage , Radiography, Interventional , Humans , Female , Retrospective Studies , Male , Child , Fluoroscopy , Radiography, Interventional/adverse effects , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/adverse effects , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Adolescent , Child, Preschool , Infant , Time Factors , Risk Factors , Central Venous Catheters , Radiation Exposure/adverse effects , Equipment Failure , Age Factors , Catheters, Indwelling
14.
JAMA Pediatr ; 178(5): 437-445, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38558161

ABSTRACT

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.


Subject(s)
Catheterization, Peripheral , Equipment Failure , Humans , Female , Male , Catheterization, Peripheral/methods , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/economics , Child , Child, Preschool , Infant , Bandages/economics , Australia , Polyurethanes , Tissue Adhesives/administration & dosage
15.
Australas Emerg Care ; 27(3): 192-197, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38490874

ABSTRACT

BACKGROUND: Hospitals frequently introduce new medical devices. However, the process of clinicians adapting to these new vascular access devices has not been well explored. The study aims to explore clinicians' experience with the insertion of a new guidewire peripheral intravenous catheter (PIVC) introduced in the emergency department (ED) setting. METHODS: The study was conducted at two EDs in Queensland, Australia, utilising a qualitative explorative approach. Interviews were conducted with guidewire PIVC inserters, including ED doctors and nurses, and field notes were recorded by research nurses during insertions. Data analysis was performed using inductive content analysis, from which themes emerged. RESULTS: The study compiled interviews from 10 participants and field notes from 191 observation episodes. Five key themes emerged, including diverse experience, barriers related to the learning process, factors influencing insertion success, and recommendations to enhance clinicians' acceptance. These themes suggest that the key to successful adoption by clinicians lies in designing user-friendly devices that align with familiar insertion techniques, facilitating a smooth transfer of learning. CONCLUSION: Clinician adaptation to new devices is vital for optimal patient care. Emergency nurses and doctors prefer simplicity, safety, and familiarity when it comes to new devices. Providing comprehensive device training with diverse training resources, hands-on sessions, and continuous expert support, is likely to enhance clinician acceptance and the successful adoption of new devices in ED settings.


Subject(s)
Catheterization, Peripheral , Emergency Service, Hospital , Qualitative Research , Humans , Catheterization, Peripheral/methods , Catheterization, Peripheral/instrumentation , Queensland , Emergency Service, Hospital/organization & administration , Female , Male , Interviews as Topic/methods , Adult , Middle Aged
16.
Neurocrit Care ; 41(1): 202-207, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38379103

ABSTRACT

BACKGROUND: Elevated intracranial pressure (ICP) is a neurological emergency in patients with acute brain injuries. Such a state requires immediate and effective interventions to prevent potential neurological deterioration. Current clinical guidelines recommend hypertonic saline (HTS) and mannitol as first-line therapeutic agents. Notably, HTS is conventionally administered through central venous catheters (CVCs), which may introduce delays in treatment due to the complexities associated with CVC placement. These delays can critically affect patient outcomes, necessitating the exploration of more rapid therapeutic avenues. This study aimed to investigate the safety and effect on ICP of administering rapid boluses of 3% HTS via peripheral intravenous (PIV) catheters. METHODS: A retrospective cohort study was performed on patients admitted to Sisters of Saint Mary Health Saint Louis University Hospital from March 2019 to September 2022 who received at least one 3% HTS bolus via PIV at a rate of 999 mL/hour for neurological emergencies. Outcomes assessed included complications related to 3% HTS bolus and its effect on ICP. RESULTS: Of 216 3% HTS boluses administered in 124 patients, complications occurred in 8 administrations (3.7%). Pain at the injection site (4 administrations; 1.9%) and thrombophlebitis (3 administrations; 1.4%) were most common. The median ICP reduced by 6 mm Hg after 3% HTS bolus administration (p < 0.001). CONCLUSIONS: Rapid bolus administration of 3% HTS via PIV catheters presents itself as a relatively safe approach to treat neurological emergencies. Its implementation could provide an invaluable alternative to the traditional CVC-based administration, potentially minimizing CVC-associated complications and expediting life-saving interventions for patients with neurological emergencies, especially in the field and emergency department settings.


Subject(s)
Catheterization, Peripheral , Intracranial Hypertension , Humans , Saline Solution, Hypertonic/administration & dosage , Female , Retrospective Studies , Middle Aged , Male , Intracranial Hypertension/drug therapy , Intracranial Hypertension/etiology , Intracranial Hypertension/therapy , Adult , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/methods , Aged , Intracranial Pressure/drug effects , Emergencies , Brain Injuries/therapy
17.
Value Health Reg Issues ; 41: 123-130, 2024 May.
Article in English | MEDLINE | ID: mdl-38401289

ABSTRACT

OBJECTIVES: To evaluate the comparative effectiveness and cost-effectiveness of peripherally inserted central catheters (PICCs) compared with centrally inserted central catheters (CICCs). METHODS: Prospective cohort study was followed by an economic analysis over a 30-day time horizon. Propensity score matching was used to select hospitalized adults with similar indications for PICC or CICC. The composite outcome was device removal or replacement because of complications before the end of treatment. The economic evaluation was based on a decision tree model for cost-effectiveness analysis, with calculation of the incremental cost-effectiveness ratio (ICER) per catheter removal avoided. All costs are presented in Brazilian reais (BRL) (1 BRL = 0.1870 US dollar). RESULTS: A total of 217 patients were followed in each group; 172 (79.3%) of those receiving a PICC and 135 (62.2%) of those receiving a CICC had no device-related complication, respectively. When comparing the events leading to device removal, the risk of composite endpoint was significantly higher in the CICC group (hazard ratio 0.20; 95% CI 0.11-0.35). The cost of PICC placement was BRL 1290.98 versus BRL 467.16 for a CICC. In the base case, the ICER for placing a PICC instead of a CICC was BRL 3349.91 per removal or replacement avoided. On univariate sensitivity analyses, the model proved to be robust within an ICER range of 2500.00 to 4800.00 BRL. CONCLUSIONS: PICC placement was associated with a lower risk of complications than CICC placement. Although the cost of a PICC is higher, its use avoided complications and need for catheter replacement before the end of treatment.


Subject(s)
Catheterization, Central Venous , Catheterization, Peripheral , Adult , Aged , Female , Humans , Male , Middle Aged , Brazil , Catheterization, Central Venous/economics , Catheterization, Central Venous/instrumentation , Catheterization, Peripheral/economics , Catheterization, Peripheral/instrumentation , Cost-Effectiveness Analysis , Propensity Score , Prospective Studies
18.
Metas enferm ; 27(1): 82-90, Febr. 2024. tab
Article in Spanish | IBECS | ID: ibc-230213

ABSTRACT

Para gestionar el capital venoso del paciente con seguridad y responsabilidad es necesario aumentar la calidad de los cuidados proporcionados, unificando y estandarizando los criterios de actuación, basándose siempre en la mejor evidencia científica. Las enfermeras de los Servicios de Urgencias deben aplicar la evidencia en el manejo del catéter venoso central de inserción periférica (PICC), conocer el protocolo aprobado por la Dirección Asistencial de su hospital y, sobre todo, evitar la variabilidad en la actuación, que podría aumentar los riesgos relacionados con la atención sanitaria, así como la desconfianza del paciente. Mantener actualizados los conocimientos y promover la adquisición de habilidades en la práctica clínica es de suma importancia para garantizar cuidados de calidad en el manejo de este tipo de catéteres, debiéndose comprobar periódicamente el grado de cumplimiento de la evidencia recogida en los protocolos existentes en el hospital. Las enfermeras tienen el reto de estar al día en el manejo de los accesos vasculares, y deben responder con seriedad y evidencia a los cuidados que necesitan los pacientes a los que se atienden. En este manuscrito se objetiva la necesidad de formar y capacitar de forma continua a los profesionales para el manejo adecuado del PICC. (AU)


In order to manage the venous resource of the patient safely and with responsibility, it is necessary to increase the quality of care provided, unifying and standardizing performance criteria, always based on the best scientific evidence. Emergency Unit nurses must apply evidence in their use of the peripherally inserted central venous catheter (PICC), they must know the protocol approved by the Patient Care Management in their hospital and, most of all, must avoid variability of action, which could increase the risks associated with healthcare as well as mistrust by patients. It is extremely important to keep an updated knowledge and to promote the acquisition of clinical practice skills, in order to guarantee quality care in the use of this type of catheters; the level of compliance of the evidence collected in the hospital protocols must be confirmed periodically. Nurses face the challenge of being updated in the management of vascular accesses, and must give response with seriousness and evidence to the care needed by their patients. This manuscript sets out objectively the need for continuous training and qualification for professionals regarding the adequate use of PICC. (AU)


Subject(s)
Humans , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/methods , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/methods , Emergency Service, Hospital , Nursing Care/methods , Evidence-Based Practice , Evidence-Based Nursing , Patient Care
20.
Cardiovasc Revasc Med ; 62: 60-65, 2024 May.
Article in English | MEDLINE | ID: mdl-38184452

ABSTRACT

PURPOSE: Mechanical circulatory support (MCS) using a venoarterial extracorporeal membrane oxygenation (VA-ECMO) device or a catheter-type heart pump (Impella) is critical for the rescue of patients with severe cardiogenic shock. However, these MCS devices require large-bore cannula access (14-Fr and larger) at the femoral artery or vein, which often requires surgical decannulation. METHODS: In this retrospective study, we evaluated post-closure method using a percutaneous suture-mediated vascular closure system, Perclose ProGlide/ProStyle (Abbott Vascular, Lake Bluff, IL, Perclose), as an alternative procedure for MCS decannulation. Closure of 83 Impella access sites and 68 VA-ECMO access sites performed using Perclose or surgical method between January 2018 and March 2023 were evaluated. RESULTS: MCS decannulation using Perclose was successfully completed in all access sites without surgical hemostasis. The procedure time of ProGlide was shorter than surgical decannulation for both Impella and VA-ECMO (13 min vs. 50 min; p < 0.001, 21 min vs. 65 min; p < 0.001, respectively). There were no significant differences in the 30-day survival rate and major adverse events by decannulation including arterial dissection requiring endovascular treatment, hemorrhage requiring a large amount of red blood cell transfusion, and access site infection. CONCLUSION: Our results suggest that the post-closure technique using the percutaneous suture-mediated closure system appears to be a safe and effective method for large-bore MCS decannulation.


Subject(s)
Catheterization, Peripheral , Extracorporeal Membrane Oxygenation , Heart-Assist Devices , Hemostatic Techniques , Punctures , Vascular Closure Devices , Humans , Retrospective Studies , Male , Female , Treatment Outcome , Middle Aged , Aged , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/instrumentation , Time Factors , Hemostatic Techniques/instrumentation , Hemostatic Techniques/adverse effects , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Device Removal/adverse effects , Suture Techniques/instrumentation , Suture Techniques/adverse effects , Femoral Artery , Shock, Cardiogenic/therapy , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Shock, Cardiogenic/diagnosis , Risk Factors , Hemorrhage/etiology , Hemorrhage/prevention & control
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