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Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P = 0.002, OR 15.29, 95% CI 2.76–85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95–57.80) were significantly higher in the group with puncture-site complications. Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment. [ABSTRACT FROM AUTHOR]

Positive susceptibility vessel sign (SVS) in patients with acute ischaemic stroke has been associated with friable red blood cell-rich clots and more effective recanalisation using stent retrievers versus contact aspiration. We compared the safety and efficacy of stent retrievers plus contact aspiration (combined technique) versus contact aspiration alone as the first-line thrombectomy technique in patients with acute ischaemic anterior circulation stroke and SVS-positive occlusions. Adaptive Endovascular Strategy to the Clot MRI in Large Intracranial Vessel Occlusion (VECTOR) was a prospective, randomised, open-label study with blinded evaluation. Patients with SVS-positive anterior circulation occlusions on pretreatment MRI and arterial puncture within 24 h of symptom onset were enrolled from 22 centres in France. A centralised web-based method was used by interventional neuroradiologists for dynamic randomisation by minimisation. Patients were randomly assigned 1:1 to the combined technique or contact aspiration alone. The primary outcome was expanded Thrombolysis in Cerebral Infarction (eTICI) grade 2c or 3 reperfusion after three or fewer passes on post-treatment angiogram, adjudicated by a blinded independent central imaging core laboratory. The intention-to-treat population was used to assess the primary and secondary outcomes. This trial is registered with ClinicalTrials.gov (NCT04139486) and is complete. Between Nov 26, 2019, and Feb 14, 2022, 526 patients were enrolled, of whom 521 constituted the intention-to-treat population (combined technique, n=263; contact aspiration alone, n=258). The median age of participants was 74·9 years (IQR 64·4–83·3); 284 (55%) were female and 237 (45%) male. The primary outcome did not differ significantly between groups (152 [58%] of 263 patients for the combined technique vs 135 [52%] of 258 for contact aspiration; odds ratio [OR] 1·27; 95% CI 0·88–1·83; p=0·19). Procedure-related adverse events occurred in 32 (12%) of 263 patients in the combined technique group and 27 (11%) of 257 in the contact aspiration group (OR 1·14; 0·65–2·00; p=0·65). The most common adverse event was intracerebral haemorrhage (146 [56%] of 259 patients for the combined technique vs 123 [49%] of 251 for contact aspiration; OR 1·32; 0·91–1·90; p=0·13). All-cause mortality at 3 months occurred in 57 (23%) of 251 patients in the combined technique group and 48 (19%) of 247 in the contact aspiration group (OR 1·19; 0·76–1·86; p=0·45), none of which was treatment-related. The results of the VECTOR trial do not show superiority of the combined stent retriever plus contact aspiration technique over contact aspiration alone in patients with SVS-positive occlusion with respect to achieving eTICI 2c–3 within three passes. These findings support the use of either the combined technique or contact aspiration alone as the initial thrombectomy strategy in patients with acute anterior circulation stroke with SVS on pretreatment MRI. Cerenovus. [ABSTRACT FROM AUTHOR]

Transradial access is an important tool for many neuroendovascular procedures. Occlusion of the radial or ulnar artery is not uncommon after transradial or transulnar access and can present a challenge for patients requiring repeat angiography. Between March 2022 and June 2023, patients undergoing transradial or transulnar angiography who were found to have a radial artery occlusion or ulnar artery occlusion were identified. Repeat catheterization of the occluded artery was attempted using a 21-gauge single wall puncture needle and a 0.021-inch wire to traverse the occlusion and insert a 23-cm sheath into the brachial artery. A total of 25 patients undergoing 26 angiograms during the study period were found to have a radial artery occlusion or ulnar artery occlusion. Successful repeat catheterization of the occluded artery was achieved in 21 of 26 cases (80.7%). Outer diameter sheath size ranged from 5 Fr (0.0655 inch) to 8 Fr (0.1048 inch). No access complications were encountered. Number of prior angiograms, time since prior angiogram, and prior angiogram procedure time were associated with lower likelihood of successful access. Transradial or transulnar neuroangiography through an occluded radial or ulnar artery is safe and feasible by traversing the occlusion into the brachial artery with a 23-cm sheath. Repeat catheterization is most successful in patients with an arterial occlusion <6 months old. This technique is important in patients who have limited options for arterial access, avoiding access site complications inherent in transfemoral access, and in patients who specifically require radial or ulnar artery access. [ABSTRACT FROM AUTHOR]

The anterior-posterior fluoroscopic guidance (the AP technique) is a standard method for common femoral artery (CFA) access, but the rate of CFA access with ultrasound vs. the AP technique was not significantly different. We have shown an oblique fluoroscopic guidance (the oblique technique) with a micropuncture needle (MPN) resulted in CFA access in 100 % of patients. The outcome of the oblique vs. AP technique is unknown. We compared the utilities of the oblique vs. AP technique for CFA access with a MPN in patients undergoing coronary procedures. A total of 200 patients were randomized to the oblique vs. AP technique. Using the oblique technique, a MPN was advanced to the mid pubis in the 20° ipsilateral right-or left anterior oblique view with fluoroscopic guidance and the CFA was punctured. In the AP technique, a MPN was advanced to the mid femoral head in the AP view with fluoroscopic guidance and the CFA was punctured. The primary endpoint was the rate of successful access to the CFA. The rates of first pass and CFA access were higher with the oblique vs. AP technique (82 % vs. 61 %, and 94 % vs. 81 %, respectively; P < 0.01). The number of needle punctures was lower with the oblique vs. AP technique (1.1 ± 0.39 vs. 1.4 ± 0.78, respectively; P < 0.01). In high CFA bifurcations, the rate of CFA access was higher with the oblique vs. AP technique (76 % vs. 52 %, respectively; P < 0.01). Vascular complications were lower with the oblique vs. AP technique (1 % vs. 7 %, respectively; P < 0.05). Our data suggest that the oblique technique, compared with the AP technique, significantly increased the rates of first pass and access to the CFA, and decreased the number of punctures and vascular complication. ClinicalTrials.gov Identifier: NCT 03955653. • The AP technique is a standard method for common femoral artery (CFA) access. • It has been reported the rate of CFA access with ultrasound guidance vs. the AP technique was not significantly different. • We investigated the utilities of a novel oblique vs. standard AP technique with micropuncture needle for CFA access. • We showed that the oblique vs. AP technique significantly increased the rate first pass and access and to the CFA. • We also showed that the oblique vs. AP technique decreased the number of punctures and vascular complications. [ABSTRACT FROM AUTHOR]

• Multicenter analysis of endovascular procedures and implants from major trauma centers. • Most common procedures in thoracic aorta and axillosubclavian vessels. • Predominantly femoral access - broad range of stents/stent grafts and sizes used. • Reintervention rare and typically endovascular. Endovascular techniques are increasingly used to repair major traumatic vascular injuries, but most endovascular implants are not designed/approved for trauma-specific indications. No inventory guidelines exist for the devices used in these procedures. We aimed to describe the use and characteristics of endovascular implants used for repair of vascular injuries to allow for better inventory management. This CREDiT study is a six-year retrospective cohort analysis of endovascular procedures performed for repair of traumatic arterial injuries at five participating US trauma centers. For each treated vessel, procedural and device details were recorded and outcomes assessed with the aim of defining the range of implants and sizes used for these interventions. A total of 94 cases were identified; 58 (61%) were descending thoracic aorta, 14 (15%) axillosubclavian, 5 carotid, 4 abdominal aortic, 4 common iliac, 7 femoropopliteal, and 1 renal. Vascular surgeons performed 54% of cases, trauma surgeons 17%, IR/CT Surgery 29%. Systemic heparin was administered in 68% and procedures were performed a median of 9 h after arrival (IQR 3–24 h). Primary arterial access was femoral in 93% of cases, 49% were bilateral. Brachial/radial access was used primarily in 6 cases, and secondary to femoral in 9. The most common implant was self-expanding stent graft; 18% used >1 stent. Implants ranged in diameter and length based on vessel size. Five of 94 implants underwent reintervention (1 open surgery) at a median of 4d postop (range 2–60d). Two occlusions and 1 stenosis were present at follow-up at a median of 1 month (range 0–72 m). Endovascular reconstruction of injured arteries requires a broad range of implant types, diameters, and lengths which should be readily available in trauma centers. Stent occlusions/stenoses are rare and can typically be managed by endovascular means. [ABSTRACT FROM AUTHOR]

Large bore arterial hemostasis for emergent MCS initiation in cardiogenic shock and during failures of suture mediated vascular closure devices (VCD) necessitates dry/post-closure technique for successful closure. Use of the alternative MANTA fluoroscopic DOT technique, without depth finder, as post closure and as 'bail-out' in this high-risk patient population is described. All patients who underwent emergent percutaneous transfemoral MCS initiation, without use of upfront sutured-mediated pro-glide VCDs, and procedures where proglide-perclose technique (PPT) failed to achieve hemostasis were post-closed with the alternative MANTA fluoroscopic DOT technique (without depth finder) as primary method or as 'bail-out'. Patient related factors, cardiovascular co-morbidities, clinical indication, distribution of 14F versus 18F MANTA, and types of procedures obtained. Primary outcomes of access site related acute flow-limiting limb ischemia or bleeding requiring intervention analyzed. 27 patients met inclusion criteria; mean age 64 years, majority male 19 (70 %), more than half obese (56 %) with mean BMI 31.06 kg/m2. 22 (81 %) had emergent MCS initiation and 5 (19 %) PPT hemostasis failures. Types of percutaneous MCS support included; 11 (44 %) Impella CP, 2 (7 %) 15F arterial ECMO, 6 (22 %) 17F arterial ECMO, 4 (15 %) 19F ECMO. All achieved hemostasis utilizing alternative MANTA fluoroscopic DOT technique without vascular complications of bleeding or acute ischemic limb. The alternative MANTA fluoroscopic DOT technique (without depth finder) can be successfully applied as post-closure for emergent MCS support delayed hemostasis and as bail-out for per-close suture mediated VCD failures for large bore arterial hemostasis. [Display omitted] • Vascular complications are associated with high morbidity and mortality with pMCS and other large bore arterial procedures. • There is a lack of consistent, efficient and predictable method for post-closure in this patient population. • Post-closure with MANTA fluoroscopic DOT technique for delayed hemostasis and 'bail-out' for pro-glide failures described. [ABSTRACT FROM AUTHOR]

The number of endovascular procedures performed with arterial puncture has been increasing in recent years. Some patients have complications developing at the arterial puncture site. The aim of the study was to evaluate the effectiveness of ultrasound in the diagnosis of complications after arterial punctures. The study included 256 patients referred to the Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, with suspicion of complications after femoral (76 patients), brachial (44) and radial (136) artery punctures. All of the ultrasound examinations were performed with a LOGIQ 7 apparatus using a 6-12 MHz probe and a 3.5 MHz probe, in B-mode and Doppler options. 36 pseudoaneurysms, 15 fistulas and three cases of arterial dissection were found in the examined patients. In 5 cases, segmental radial artery coagulation was diagnosed. In 3 of these patients, a pseudoaneurysm and fistula coexisted. In 15 patients, who were diagnosed with pseudoaneurysms, a procedure of percutaneous injection of thrombin into their lumen and exclusion from circulation was performed. Conclusions: Ultrasound examination allows for explicit diagnosis of vascular complications after femoral and radial artery punctures and qualification for percutaneous treatment. [ABSTRACT FROM AUTHOR]

Intraoperative spinal angiography via the popliteal artery for patients in the prone position has been reported only twice in 4 patients. This study aimed to clarify the safety precautions to be taken with this technique in a larger patient cohort. Seven patients with spinal vascular disorders underwent intraoperative spinal angiography in the prone position via the popliteal artery. Ultrasound was used to evaluate the neurovascular anatomy in the popliteal fossa and guide the arterial puncture. Patient characteristics, features of angiography devices, puncture attempts, and angiography-related complications, such as hematoma formation and injury to the neurovascular bundle, were analyzed. The average number of arterial puncture attempts was 1.3 times (range: 1–2). Sheaths (4 and 4.5 Fr) with different ineffective lengths were used. In 1 case, a 4.5-Fr sheath was replaced with a 4-Fr sheath with a shorter noneffective length as the length of the catheter limited access to the target. Catheters with Type-JB2 tip shapes were used for craniocervical junction lesions, and those with Type-KAGAWA tip shapes were used for thoracic and lumbar spinal lesions. No puncture site complications were observed in any patient. Intraoperative spinal angiography via the popliteal artery was an effective tool in surgeries for spinal vascular diseases. The introduction of the ultrasound enabled atraumatic puncture of the popliteal artery. Spinal targets above T5 to T6 may be inaccessible from the popliteal fossa when using a 100-cm-long catheter. [ABSTRACT FROM AUTHOR]

Various vascular closure devices (VCDs) are commonly used for percutaneous transcatheter aortic valve replacement (TAVR). However, superiority and safety profile among them remain unclear. We compared periprocedural complications among various VCDs in patients undergoing TAVR. PubMed and EMBASE were searched through January 2022 to identify clinical studies comparing any 2 VCDs of Prostar, Proglide and MANTA in patients who underwent TAVR. Studies using surgical cut-down or alternative access other than transfemoral approach were excluded. We analyzed the odds ratios (ORs) of vascular complications (VC), bleeding, acute kidney injury and all-cause mortality using a network meta-analysis. All outcomes were defined by Valve Academic Research Consortium 2 criteria. Two randomized controlled trials and 15 observational studies were identified, yielding a total of 11,344 patients including Prostar (n = 4499), Proglide (n = 5705), or MANTA group (n = 1140). The rates of major VC and life-threatening and major bleeding were significantly lower in Proglide compared to Prostar (OR [95 % CI] = 0.54 [0.32–0.89], 0.68 [0.52–0.90], and 0.49 [0.26–0.95], respectively). There was no significant difference in major VC and bleeding between Proglide and MANTA groups. Proglide was associated with a lower rate of acute kidney injury (0.56 [0.34–0.92]) and red blood cell transfusion (0.39 [0.16–0.98]) compared to Prostar. There was no significant difference in additional interventions and 30-day overall mortality among three groups. In this network meta-analysis of VCD in patients undergoing TAVR, MANTA and Proglide had comparable outcomes while Proglide appears superior to Prostar in terms of major VC and bleeding. • We compared Prostar, Proglide and MANTA in patients who underwent TAVR. • Vascular and bleeding complication were lower in Proglide compared to Prostar. • There was no difference in vascular and bleeding outcomes between Proglide and MANTA. [ABSTRACT FROM AUTHOR]

Background: The distal radial approach (DRA) is a novel catheter cannulation technique to access the distal radial artery for coronary angiography (CAG). It is associated with less occurrence of puncture site occlusion than the conventional transradial approach. However, cannulation failure occasionally occurs due to difficulty in puncturing the smaller distal radial artery. Nitroglycerin is expected to improve the rate of successful DRA via its vasodilative and vasospasm-preventive effects.Methods: The DRA in CAG using transdermal NitroGlycerin patch (DRANG) study is a single-center, double-arm, parallel-assignment, double-blinded, randomized, controlled trial. Eligible patients with angina pectoris who are scheduled to receive CAG via DRA at the National Cerebral and Cardiovascular Center will be enrolled and allocated to the nitroglycerin group (n = 46) or the no-treatment group (n = 46). The nitroglycerin group will receive a transdermal nitroglycerin patch pre-integrated with a covering material that completely conceals the patch on their upper arm on the puncture side. The no-treatment group will receive only the covering material. Applications are performed 2-8 h before puncture while the patient wears an eye mask. Physicians who are blinded to the allocation and have similar experience with DRA puncture will perform DRA using the Seldinger technique with a 22-gauge needle. The primary outcome is the rate of successful palpation-guided distal radial artery cannulation with the first puncture. The secondary outcomes are the rate of successful distal radial artery cannulation, number of punctures, procedure time, use of ultrasound guidance, diameter of the distal radial artery and changes before and after patch application, and occurrence of arterial vasospasm, occlusion, or hypotension.Conclusions: This study will allow us to determine the impact of a transdermal nitroglycerin patch on the rate of successful DRA and validate its effectiveness as a DRA pretreatment.Trial Registration: jRCTs051210128. [ABSTRACT FROM AUTHOR]

Intraoperative angiography (IOA) has been shown to be a useful adjunct in surgical treatment of cerebral aneurysms. However, its use can be limited by hybrid operating room availability. On the other hand, the use of C-arm fluoroscopy can add challenges to IOA during navigation of the aortic arch and selection of the great vessels. We aimed to describe a simple method of IOA that can be applied during surgery of paraclinoid aneurysms and can be performed in a normal operating room without the need to navigate the aortic arch. In patients undergoing surgery for paraclinoid aneurysms with need for cervical carotid artery exposure, IOA was performed using a single plane C-arm fluoroscopy unit after direct puncture of the carotid artery. Five patients were included: 2 with subarachnoid hemorrhage, 2 with unruptured aneurysm and history of subarachnoid hemorrhage, and 1 with unruptured aneurysm. There were 2 internal carotid blister aneurysms, 2 ophthalmic artery aneurysms, and 1 superior hypophyseal artery aneurysm. IOA was performed using direct carotid puncture through the neck incision required for proximal control. In all cases, intraoperative images were of sufficient quality to determine the completeness of aneurysm occlusion as well as parent and branching vessel patency. There were no postoperative infarctions and no complications related to IOA. IOA using direct carotid puncture can be performed in a standard operating room with the use of a C-arm, eliminating the need to catheterize the great vessels of the aortic arch. [ABSTRACT FROM AUTHOR]

Anastomosis of the microvessels requires high-level skills and extensive basic training. This study was performed to introduce and evaluate an inexpensive laboratory device as a training aid. Micro-tubes of 0.8 mm inner diameter and 0.5/0.8 mm wall thickness mimicking human vein/artery were printed from a silicon-containing hydrogel using three-dimensional printing technology. The hydrogel components are optimized to render the printed tubes biomechanical features resembling the blood vessels of a living organism. These artificial vessels were connected to a pump for fluid flow, simulating the blood circulation. Forty medical interns were assigned to two equal groups. The 20 interns in group A practiced anastomosis using the training aid for a total of 10 hours over 5 days. The 20 interns in group B practiced anastomosis using the traditional gum pieces and silicone tubes. Then, all interns performed anastomosis on rat carotid arteries, and their performance was scored by a team of five experienced maxillofacial surgeons. The average success score and time required for anastomosis were compared between the two groups. The mean success score of group A was significantly higher than that of group B (0.83 ± 0.12 vs 0.64 ± 0.10, P < 0.001). The mean anastomosis time of group A was significantly shorter than that of group B (10.2 ± 1.1 vs 17.2 ± 1.4 minutes, P < 0.001). This training device for vessel microanastomosis is an inexpensive, practical, and effective tool for use in laboratories and also reduces the use of animals. [ABSTRACT FROM AUTHOR]

Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. From May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. This largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT04392492. • This is the largest ever real-world evaluation of the novel plug-based vascular closure device (VCD) MANTA. • A total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. • A larger sheath diameter to femoral artery diameter ratio was associated with an increase of vascular complications. • No significant differences in major complications were seen between individual interventionists irrespective of experience. • The MANTA VCD was effective and safe for arterial access-site management with low complication rates. [ABSTRACT FROM AUTHOR]

Objectives: Endovascular Aneurysm Repair is an established treatment for abdominal aortic aneurysm which requires arterial access via the groin. Most centres perform percutaneous ultrasound-guided access into the common femoral artery for delivery of the stent graft. The profile of endovascular devices necessitates large sheath sizes, therefore formal closure of the arterial puncture site is required. Various percutaneous devices are available, with data lacking on efficacy and mid-term safety profile. We present outcomes from a single centre with the Perclose ProGlide™ (Abbott Vascular Devices, CA, USA) suture-mediated system, using the well described "pre-close" technique.Materials& Methods: Data were collected from operative records and electronic medical records. Patients undergoing standard (EVAR) or complex (F/B-EVAR) aneurysm repair between March 2015 and September 2019 were included. Complications were recorded per-patient and per-groin procedure.Results: 266 patients were included; 182 (68.4%) standard infrarenal EVAR, 84 (31.6%) F/B-EVAR. There were a total of 484 groin procedures performed. Intraoperative Perclose ProGlide™ success was 98.1% (per patient) or 99.0% (per groin procedure). 30-day groin complication rate was 6.1% (per patient) or 3.1% (per groin procedure). There were no pre- or peri-operative factors which predicted the occurrence of groin complications. The rate of groin complications was not related to sheath size.Conclusions: Our data support the use of percutaneous access with a pre-close technique for a variety of endovascular aneurysm repair procedures with both large- and small-bore access. The Perclose ProGlide™ system provides excellent mid-term complication-free and reintervention-free outcomes for groin procedures. [ABSTRACT FROM AUTHOR]

Uncontrolled bleeding from internal noncompressible wounds is a major cause of prehospital death in military personnel and civilian populations. An ideal hemostatic sealant for emergency care should quickly control blood loss and be removed without debridement for the follow-up treatment in the operating room, yet the lack of suitable materials to meet both requirements is the bottleneck. Herein, we suggest an injectable and dissolvable hydrogel sealant for hemorrhage management of noncompressible wounds. To this end, a 4-arm poly(ethylene glycol) (PEG) crosslinker modified with thioester linkages and terminated with aldehyde groups is designed and synthesized, and to modulate the gel properties and make it suitable as a hemostatic sealant, a mixed amino component composed of poly(ethylene imine) and adipic dihydrazide is employed to react with the PEG crosslinker to form the adhesive and elastic sealant for the first time. The aldehyde groups provide the adhesion to the tissues, and the amino component affords the procoagulant ability. More importantly, the thioester moieties allow the on-demand dissolution of sealant via a thiol-thioester exchange reaction upon exposure to an exogenous thiolate solution. In the rat femoral artery puncture and liver injury models, the administration of the hydrogel sealant dramatically reduces blood loss, and its subsequent removal does not induce rebleeding. Consequently, this hydrogel sealant with the unique feature of on-demand dissolution can not only efficiently control bleeding in emergent scenarios, but also allow non-traumatic re-exposure of wounds during subsequent surgical care. Sealants, adhesives or hemostatic dressings currently used in emergency situations not only require manual pressure to control bleeding, but also face removal by cutting and mechanical debridement to enable eventual surgical treatment. In this study, we design and develop an injectable and adhesive hydrogel sealant with good procoagulant capacity and on-demand dissolution feature. The application of the hydrogel sealant substantially reduces bleeding from internal noncompressible wounds without the need for direct pressure, and demonstrates for the first time that its controlled removal without debridement does not cause rebleeding. Considering that there are currently no commercial wound sealant systems with the feature of on-demand dissolution, the hydrogel sealant developed by us is expected to address an unmet clinical need. [Display omitted] [ABSTRACT FROM AUTHOR]

Bleeding causes ∼5.8 million deaths globally; half of the patients die if rapid hemostasis is not achieved. Here, we report a chitosan-casein (CC)-based nanofibrous polyelectrolyte complex (PEC) that could clot blood within 10 s in the rat femoral artery model in vivo. The nanofiber formation by self-assembly was also optimized for process parameters (concentration, mixing ratio, pH, and ultrasonication). Results showed that increasing the concentration of chitosan from 10 % to 90 % in the formulation increased the productivity (r = 0.99) of PECs but led to increased blood clotting time (r = 0.90) due to an increase in zeta potential (r = 0.98), fiber diameter (r = 0.93), and decreased surface porosity (r = −0.99), absorption capacity (r = −0.99). The pH also influenced the zeta potential of PEC, with an optimized pH of 8.0 ± 0.1 yielding clear nanofibers. Sonication improved the segregation of nanofibers by promoting water removal. The optimized PECs containing chitosan and casein in the ratio of 30:70 (CC30) at a pH of 8.0 and dehydration under sonication could clot the blood within 9 ± 2 s in vitro and 9 ± 2 s in rat femoral artery puncture model. The CC30 formulation did not cause any irritation or corrosion on rat skin. Histopathology and immunohistochemistry of various organs showed that CC30 was biocompatible and non-immunogenic under in vivo conditions. [Display omitted] • Nanofibrous chitosan and casein-based hemostatic agent of fiber diameter ∼25 nM can be obtained by self-assembly. • Self-assembly of chitosan and casein PEC into nanofibers depend on pH, concentration, and sonication. • Fiber diameter can be increased or decreased by changing the proportion of chitosan and casein. • The self-assembled nanofibrous PEC is highly potent for rapid hemostasis in both in vitro and in vivo conditions. [ABSTRACT FROM AUTHOR]

Background: Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites.Objective: We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD.Methods: From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition.Results: Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32-0.91, p = 0.022).Conclusions: The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study. [ABSTRACT FROM AUTHOR]

Introduction: Historically, coronary angiography and percutaneous coronary intervention involved accessing the femoral artery via palpation. However, recently there has been a trend towards using a transradial approach and ultrasound guidance for arterial access. Studies have shown that these techniques respectively improve major bleeding rates and access outcomes. There have been no studies conducted that assess the time it takes to train operators to attain proficiency. This sub-analysis of the Standard versus Ultrasound-guided Radial and Femoral access in coronary angiography and intervention (SURF) trial aims to assess the number of procedures required to attain proficiency in ultrasound-guided transradial and transfemoral access.Methods: The SURF trial randomised 1,388 patients undergoing coronary angiography and/or percutaneous coronary intervention into standard or ultrasound-guidance and radial or femoral access in a 2×2 factorial design. Operators who participated in this trial were required to have performed at least 50 standard and 10 ultrasound-guided punctures for each of transradial and transfemoral access. Cases were then chronologically ordered and stratified into groups of five, from which the primary endpoint measured was a progression in mean access time and first-pass success rates.Results: Across all operators, there was a reduction in mean access time between procedures one to five and six to 10 with ultrasound-guided femoral punctures (60.5 secs-51.5 secs, p=0.029) and between procedures 11 to 15 and 16 to 20 ultrasound-guided radial punctures (74s to 62.5 secs, p=0.082). This trend was more obvious in trainees, with significant reductions in mean access time between procedures one to five and six to 10 from 73.5 to 53.5 seconds (p<0.001) for ultrasound-guided femoral access and from 99.5 seconds to 60 seconds (p=0.024) for ultrasound-guided radial access. There were no trends with standard transradial access.Conclusion: The numbers required to attain competency in ultrasound-guided femoral and radial access are 15 and 25 punctures, respectively. Fifty (50) punctures appear adequate for proficiency in a standard transradial approach. These numbers are useful in incorporating into training program for advanced trainees and interventionalists. [ABSTRACT FROM AUTHOR]

Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy. The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke. At a median follow-up of 502 days (IQR 225–1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively. CSR implantation is safe and reduces angina in patients with refractory angina. • Procedural success achieved in 96.7% of the patients. • The overall rate of complications is 5.7%, never resulting in intra-/peri-procedural MI or deat. [ABSTRACT FROM AUTHOR]

At present, dynamic needle-tip positioning (DNTP) technology is applied in arteriovenous puncture, challenging the use of ultrasound technology alone and palpation. Our goals were to extract data from experimental DNTP, ultrasound and palpation studies, using Review Manager, Version 5.3, for data analysis, and to evaluate whether DNTP has certain advantages in puncture. PubMed, EMBASE, the Cochrane Library, CNKI and WanFang Data Knowledge Service Platform were searched for randomized and non-randomized studies that compared DNTP with conventional ultrasound-guided techniques, no DNTP or palpation. The risk ratio with 95% confidence interval was calculated using the model corresponding to the I² value. Studies were identified to compare clinical indexes. With respect to clinical indexes, DNTP is better in terms of first-attempt success, overall success and complications. However, in infants, first-attempt success, overall success and number of additional punctures did not indicate good efficacy for DNTP compared with palpation. Artery puncture was also not performed well under ultrasound. On the basis of the current evidence, the advantages of DNTP over palpation and ultrasound are reflected in the successful first attempt rate of all groups and in all subgroups except infants. Therefore, for emergencies in elderly patients, DNTP can be used as a general method. Given that some of the studies were of low quality, more trials of high quality should be conducted to further verify the findings. [ABSTRACT FROM AUTHOR]

Aims: Out of hospital cardiac arrest (OHCA) is still a leading cause of mortality worldwide. In recent years, resuscitative endovascular balloon occlusion of the aorta (REBOA) has been progressively studied as an adjunct to standard advanced life support (ALS) in both traumatic and non-traumatic refractory OHCA. Since January 2019, the REBOA procedure has been applied to all the patients experiencing both traumatic and non-traumatic refractory OHCA (≥15 min of cardiopulmonary resuscitation) not eligible for ECPR for clinical or logistic reasons. We aimed at describing the feasibility and effects of REBOA performed both in the Emergency Department and in the pre-hospital environment served by the local HEMS for refractory OHCA.Methods: Twenty consecutive patients experiencing refractory OHCA and in whom REBOA was attempted in 2019 and 2020 were included in the study, Utstein data and REBOA specific variables were recorded.Results: Successful catheter placement was achieved in 18 out of 20 patients, 11 of these were non-traumatic OHCAs while 7 were traumatic OHCAs, the 2 failures were related to repeated arterial puncture failure. Median time between the EMS dispatch and REBOA catheter placing attempt was 46 min. An increase in etCO2 over 10 mmHg was observed after balloon inflation in 12 out of 18 patients (8/11 non-traumatic and 4/7 traumatic OHCAs), a sustained ROSC was observed in 5 patients (1 traumatic and 4 non-traumatic OHCA) that were subsequently admitted to the ICU. Four out of the 5 patients reached the criteria for brain death in the subsequent 24 h while one patient experienced another episode of refractory cardiac arrest in ICU and subsequently died.Conclusion: Our data confirm the feasibility of REBOA technique as an adjunct to ALS in both the ED and prehospital phase and most of the treated patients experienced a transient ROSC after balloon inflation while 5 out of 18 experienced a sustained ROSC. However, while in the trauma setting increasing evidence suggests an improved survival when REBOA is applied to refractory OHCA, in non-traumatic OHCA this has yet to be demonstrated and large studies are needed. [ABSTRACT FROM AUTHOR]

Background: Women undergoing percutaneous coronary intervention (PCI) are at higher risk for bleeding and vascular complications than men. Multiple approaches have been utilized to reduce bleeding in the modern era of PCI, including radial access, reduced GP IIb/IIIa inhibitor use, increased vascular closure device use, smaller sheath size and novel antithrombotic regimens. Nevertheless, few studies have assessed the impact of these techniques on the gap between men and women for such complications following PCI. We sought to quantify bleeding and vascular complications over time between men and women.Methods: We queried The Dartmouth Dynamic Registry for consecutive PCI's performed between January 2003 and June 2016. Demographic information, procedural characteristics, and in-hospital outcomes were collected and compared between men and women over the years.Results: We reviewed 15,284 PCI cases, of which 4384 (29%) were performed in women. Radial access increased from none in 2003 to nearly 40% in 2016. Use of GP IIb/IIIa and femoral access decreased substantially over the same time. Bleeding and vascular complication rates decreased significantly in women (13.2% to 3%; 6.5% to 0.8%, respectively) and men (3.5% to 0.7%, 3.4% to 0.7%, respectively). The overall bleeding and vascular complication rates decreased more for women than men, narrowing the gender gap.Conclusions: The incidence of bleeding and vascular complications fell between 2003 and 2016 in both men and women. Vascular complications have become less common over time, and based on our analysis, there was no longer any difference between the sexes for this outcome. Bleeding following PCI has decreased in both sexes over time; however, women continue to bleed more than men. [ABSTRACT FROM AUTHOR]

Background/purpose: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania).Methods/materials: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports.Results: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD. [ABSTRACT FROM AUTHOR]

The most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. Between March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. The mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). The single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach. • Currently the main access site is mostly closed with two ProGlide devices. • A single ProGlide technique was feasible without increased complications. • This technique was more cost effective than the double-ProGlide approach. [ABSTRACT FROM AUTHOR]

• Elevated venous lactate predicts adverse outcomes in normotensive pulmonary embolism. • Optimal prognostic performance was observed for venous lactate ≥3.3 mmol/l. • Adding venous lactate to the 2019 ESC algorithm may improve risk stratification. • The established threshold for arterial lactate has limited specificity in venous samples. Arterial lactate is an established risk marker in patients with pulmonary embolism (PE). However, its clinical applicability is limited by the need of an arterial puncture. In contrast, venous lactate can easily be measured from blood samples obtained via routine peripheral venepuncture. We investigated the prognostic value of venous lactate with regard to in-hospital adverse outcomes and mortality in 419 consecutive PE patients enrolled in a single-center registry between 09/2008 and 09/2017. An optimised venous lactate cut-off value of 3.3 mmol/l predicted both, in-hospital adverse outcome (OR 11.0 [95% CI 4.6–26.3]) and all-cause mortality (OR 3.8 [95%CI 1.3–11.3]). The established cut-off value for arterial lactate (2.0 mmol/l) and the upper limit of normal for venous lactate (2.3 mmol/l) had lower prognostic value for adverse outcomes (OR 3.6 [95% CI 1.5–8.7] and 5.7 [95% CI 2.4–13.6], respectively) and did not predict mortality. If added to the 2019 European Society of Cardiology (ESC) algorithm, venous lactate <2.3 mmol/l was associated with a high negative predictive value (0.99 [95% CI 0.97–1.00]) for adverse outcomes in intermediate-low-risk patients, whereas levels ≥3.3 mmol/l predicted adverse outcomes in the intermediate-high-risk group (OR 5.2 [95% CI 1.8–15.0]). Venous lactate above the upper limit of normal was associated with increased risk for adverse outcomes and an optimised cut-off value of 3.3 mmol/l predicted adverse outcome and mortality. Adding venous lactate to the 2019 ESC algorithm may improve risk stratification. Importantly, the established cut-off value for arterial lactate has limited specificity in venous samples and should not be used. [ABSTRACT FROM AUTHOR]

Vertebro-vertebral arteriovenous fistula (VVAVF) is a condition in which there is an arteriovenous shunt directly connecting the extracranial vertebral artery to the vertebral venous plexus. Many reports have described fistula occlusion or vertebral artery trapping as treatments for VVAVF. Here, we describe a case in which endovascular treatment for recurrent VVAVF using a transfemoral approach was unsuccessful; thus, the vertebral artery (VA) was directly punctured during open surgery and the treatment was successful. The patient was a 47-year-old female who had undergone endovascular treatment for VVAVF. The patient developed subarachnoid hemorrhage. Digital subtraction angiography revealed a left VVAVF. The left VA was trapped with coils at the C2 and C3 levels and an arteriovenous shunt formed from the VA between the 2-coil mass to the vertebral venous plexus. In addition, reflux was observed in the spinal vein. Endovascular treatment was attempted with a transfemoral approach, but we could not reach the shunt. Five days post-treatment, the patient had a second subarachnoid hemorrhage and surgery was performed to occlude the radiculomedullary vein; however, residual reflux went into the spinal vein from another spinal level. Later, the VA was directly punctured and treated with N-butyl cyanoacrylate, and the shunt disappeared. Direct puncture of the vertebral artery was useful in this case, where it was difficult to reach the lesion. Although direct VA puncture is associated with more complications than the transfemoral or transbrachial approach, it may be an option when other methods are difficult. [ABSTRACT FROM AUTHOR]

Vascular complications during transcatheter aortic valve implantation (TAVI) are relatively common, and some of them related to the transfemoral secondary access. The use of the transradial access (TRA) as an alternative vascular approach for transfemoral TAVI could reduce these complications, however, the treatment of potential vascular peripheral issues from this access has been scarcely described. The advance of a wire from the TRA to the primary transfemoral access at the beginning of the procedure could help the management of eventual vascular complications. A new TRA technique during transfemoral TAVI procedures is described, reporting the results in the first forty-two patients in one center. [ABSTRACT FROM AUTHOR]

Background: The transbrachial approach (TBA) is an alternative method to the transfemoral approach (TFA). We herein aimed to evaluate the safety and efficacy of the TBA for endovascular thrombectomy (EVT) in patients with acute large vessel occlusion stroke.Methods: We reviewed the records of 297 patients who had undergone EVT from January 2015 to July 2019. Eighteen patients who had undergone 19 procedures were included. Indications for arterial access, devices, recanalization rates, complication rates, and clinical outcomes were evaluated.Results: There were 15 and 4 cases of anterior and posterior circulation stroke, respectively. The mean patient age was 80.1 years. Eight patients were male. The median National Institutes of Health Stroke Scale score was 18. The total procedure duration tended to be longer when the TBA was used after failure of the TFA (n = 6, 32%, median: 60.5 min) than when the TBA was used as the first treatment approach (n = 13, 68%, median: 22 min). Optimal recanalization (a modified Thrombolysis in Cerebral Infarction score of 2b or 3) was achieved for 15 procedures. Local complications were observed in two cases: one with brachial artery pseudoaneurysm and another with brachial artery occlusion. Three patients with anterior circulation stroke exhibited good clinical outcomes (modified Rankin score ≤ 2) at 90 days. Symptomatic intracranial hemorrhage occurred in one patient. Mortality was noted in four patients.Conclusion: The TBA for EVT is a suitable alternative when adoption of the TFA is difficult or impossible. [ABSTRACT FROM AUTHOR]

Objectives: This study investigated the feasibility and safety of transulnar access (TUA) and efficacy of novel TR band modification for dual site hemostasis in patients with failed ipsilateral transradial approach.Background: Failed transradial access requires cross over to alternative access site. There is paucity of data on feasibility and safety of ipsilateral TUA due to concern of potential risk of hand ischemia.Methods: We retrospectively reviewed ten patients who underwent coronary angiography and intervention via ulnar artery in the setting of failed ipsilateral transradial access. Patent hemostasis for both ulnar and radial arteries was achieved with novel modification of the TR band to compress both arteries at the same level of puncture sites.Results: TUA after failed ipsilateral transradial access was successful in all ten cases. All patients were followed within 7 days and there were no adverse complications such as ulnar artery occlusion, nerve injury, or hand ischemia.Conclusion: TUA maybe a safe and viable option when cross over is necessary from failed ipsilateral transradial access. Modification of the TR band for both radial and ulnar access site can achieve patent hemostasis effectively at the level of both puncture sites. [ABSTRACT FROM AUTHOR]

Background: Subclavian vein puncture is commonly used in the intensive care unit (ICU) but is associated with complications.Objective: Our aim was to compare the efficacy and safety of static ultrasound-guided subclavian vein puncture with traditional anatomical landmark-guided subclavian vein puncture in critically ill patients in the ICU.Methods: This pilot randomized controlled trial enrolled patients admitted to the ICU and requiring subclavian vein puncture between November 2017 and September 2018. The patients were randomized to ultrasound-guided puncture or anatomical landmark-guided puncture. The primary outcome measure was the puncture success rate. The secondary outcome measures included the number of punctures, rate of success at the first attempt, puncture time (i.e., procedure duration) and incidence of complications.Results: A total of 194 patients were included in the analyses. Compared with the anatomical landmarks group, the ultrasound group had a higher puncture success rate (91.7% vs. 77.6%; p = 0.007), lower rate of complications (7.3% vs. 20.4%; p = 0.008), and lower incidence of mispuncture of an artery (2.1% vs. 14.3%; p = 0.002). There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05).Conclusions: Static ultrasound-guided subclavian vein puncture is superior to the traditional landmark-guided approach for critically ill patients in the ICU. It is suggested that static ultrasound-guided puncture techniques should be considered for subclavian vein puncture in the ICU.Trial Registration: ChiCTR1900024051. [ABSTRACT FROM AUTHOR]

Background: Endovascular procedures nowadays are generally performed via the femoral and radial artery. Although not routinely used by many, there is still an essential role for vascular interventions via brachial access. The technological advancement of endovascular devices leads to a significant increase of the variety of percutaneously treatable vascular pathology. The brachial artery approach nowadays is becoming crucial for complex procedures either as single access or in the context of mandatory double vascular approach for many complex interventions.Objective: To evaluate the safety and efficacy of brachial artery access for diagnostic arteriography and endovascular interventions in different vascular territories in a single-center setting on the basis of a retrospective analysis of prospectively collected data in a large patient cohort.Methods: Between 01/2013 and 09/2016, 11,274 endovascular procedures were performed in our hospital, 847 (7.5%) of them via brachial access, presenting the database for this study. All demographic, clinical, and periprocedural data were obtained prospectively and included in the computerized hospital records, and on this basis, a retrospective analysis was performed.Results: While the radial access was the most used and constant for coronary and noncoronary interventions in our center (71%) in this period, the use of brachial access increased (from 4% to 12%) causing the femoral to decrease (from 27% to 16%). We used the brachial approach for diagnostic purposes in 162 patients (19%) and for head to toe endovascular interventions (including angioplasty, stenting, thrombolysis, or as adjunctive access) in 685 patients (81%). For 53 patients (6.2%), this was the only possible access for endovascular intervention. Overall access site-related complications occurred in 25 patients (2.9%), in 19 of them (2.2%) required surgical correction, for brachial artery thrombosis or pseudoaneurysm. The other six were managed conservatively. No permanent neurological deficits of the arm or severe bleeding were observed. Minor complications, mostly hematomas, occurred in 62 patients (7.3%), but they required no further treatment.Conclusion: Brachial artery access expands our capability to perform complex procedures by allowing us to reach arterial targets in all territories. Complications of brachial vascular access are gradually decreasing together with the decrease of the crossing profile of the devices used in practice. However, when they occur, they often require surgical treatment. The growing experience of the team not only while obtaining the access but also while achieving adequate hemostasis ("patent hemostasis") is of great importance for minimizing the complications. [ABSTRACT FROM AUTHOR]

Objectives: To determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR).Background: Limited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14-16 French (F) sheaths.Methods: We recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively.Results: The final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1-9.2) and presence of CAD (OR 8.2; 95% CI 1.8-37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84-14; p = 0.086). There were no independent predictors of PCDF.Conclusion: Contemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths. [ABSTRACT FROM AUTHOR]

Background: Real world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known.Methods: All consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention.Results: A total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed.Conclusion: In this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed. [ABSTRACT FROM AUTHOR]

Iatrogenic femoral pseudoaneurysm (false aneurysm) due to arterial access following cardiovascular procedures is becoming common because of the increase in number and complexity of the procedures. Recently, percutaneous thrombin injection is becoming a popular treatment of these false aneurysms. The aim of this study was to assess the efficacy and safety of femoral pseudoaneurysm closure using ultrasound-guided thrombin injection in comparison to ultrasound-guided compression. A retrospective analysis was undertaken of 65 patients who presented to our vascular department with iatrogenic femoral pseudoaneurysm between January 2015 and March 2019. Twenty-five patients underwent ultrasound-guided thrombin injection, and 40 were treated using ultrasound-guided compression therapy. The primary outcome measured was efficacy, while other outcomes examined were safety, procedure duration, and cost. A total of 65 patients (45 males, 20 female) were identified with a mean age of 62 years. Out of the 65, 40 patients (28 males, 12 female) underwent ultrasound-guided compression therapy (group A) with a mean aneurysm size of 2.9 cm, and 25 (17 male, 8 female) underwent ultrasound-guided thrombin injection (group B) with a mean pseudoaneurysm sac size of 3.7 cm. The success rate of thrombosis in group A was 70% and in group B was 92%. No significant complications were reported in both groups. Ultrasound-guided thrombin injection should be considered as the first line of treatment for uncomplicated femoral pseudoaneurysms because it has a higher thrombosis and lower recurrence rates, when compared with ultrasound-guided compression treatment. [ABSTRACT FROM AUTHOR]

Background: Taking a sample of arterial blood is widely reported as a cause of significant pain.Objectives: To compare three anesthetic methods with standard practice (no anesthesia) to establish which was the most effective in reducing pain caused by radial artery puncture in patients requiring an arterial blood gas test in the emergency department (ED).Methods: A randomized controlled trial was conducted to compare the effectiveness between anesthetic cream, cryoanalgesia, and subcutaneous mepivacaine in reducing pain caused by radial artery puncture in ED patients.Results: After comparing perceived pain during arterial puncture, the lowest median score was obtained in the mepivacaine group (1 interquartile range 0.6-1.3) and the highest median score in the control group (5 interquartile range 4.0-7.0). When comparing the control group with the three intervention groups, the Kruskal-Wallis test showed that mepivacaine (p = 0.023) and cryoanalgesia (p = 0.012) were associated with significantly lower pain scores. The anesthetic cream (p = 0.861) intervention group did not produce a statistically significant median difference compared with the control group.Conclusions: The results of this study encourage the use of anesthetic methods like cryoanalgesia or mepivacaine for their proven effectiveness in reducing or eliminating pain during arterial puncture. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of the study was to evaluate the efficacy and safety of the "percutaneous direct puncture of occluded superficial femoral artery (SFA)" technique for recanalization of SFA, after failure of antegrade recanalization in patients with limited access to retrograde popliteal and crural arteries.Material and Methods: Between April 2014 and November 2017, 10 patients with CLI (Critical limb ischemia) underwent endovascular recanalization with direct percutaneous puncture of occluded SFA after failed antegrade recanalization. All patients had a long segment (39,9 ± 2.8 cm) occluded SFA without stump causing failed antegrade recanalization with a cannulated guidewire in the SFA origin. After unsuccessful attempts with the antegrade approach, the retrograde direct puncture technique of the occluded SFA was performed and followed by antegrade recanalization. Patients were followed up clinically with Doppler ultrasonography and according to the Rutherford scale at 1, 3, 6 and 12 months after discharge.Results: Technical success was achieved in 8/10 patients (80%).The mean follow-up period was 25,1 ± 9,6 months. One patient underwent major amputation, resulting in 90% limb salvage rate at 12 and 24 months. Amputation-free survival estimated by Kaplan-Meier analysis was 60% at 12 and 24 months. Primary patency rates were 62.5% at 12 and 24 months and secondary patency rates were 87.5% at 12 and 24 months.Conclusion: Treatment of SFA occlusions without a stump in CLI patients via the percutaneous direct puncture of occluded SFA approach improved technical success and clinical recovery, especially in cases unsuitable for conventional antegrade and retrograde approaches. [ABSTRACT FROM AUTHOR]

Verification of complete occlusion or resection of neurovascular lesions is often performed using intraoperative angiography. Surgery for spinal vascular lesions such as arteriovenous malformations (AVMs) and arteriovenous fistulas (AVFs) is typically performed with the patient in the prone position, making intraoperative angiography difficult. No standardized protocol is available for intraoperative angiography during spinal surgery with the patient in the prone position. We have described our experience using radial artery access for intraoperative angiography in thoracic spinal neurovascular procedures performed with the patient in the prone position. We reviewed the data from all patients who had undergone surgical resection of spinal vascular lesions in the prone position with radial artery vascular access for intraoperative angiography. The patients were treated in a hybrid endovascular operating room. A total of 4 patients were treated in the prone position using transradial artery access intraoperative angiography for confirmation of complete resection of the vascular lesions. Of the 4 patients, 2 had undergone surgery for a dural AVF, 1 for a pial AVF, and 1 for an AVM of the filum terminale. None of the patients had experienced any procedural complications. Radial artery access for intraoperative angiography during spinal neurovascular procedures in which selective catheterization of a thoracic branch is necessary is feasible, safe, and practical. [ABSTRACT FROM AUTHOR]

Background: Transcatheter left atrial appendage occlusion (LAAO) has become a suitable alternative to anticoagulation in patients with atrial fibrillation (AF). However, volume-outcome relationships at the individual operator level have not been studied.Methods: Study population included 425 consecutive patients with AF undergoing LAAO from August 2015 to November 2018 by seven operators at BUMC-Phoenix. Operator volume was divided in tertiles by those with <40 cases/year (2 operators), 41-80 cases/year (3 operators) and >80 cases/year (2 operators). Patient data including comorbidities, labs, medications, procedural characteristics and outcomes were collected. The primary composite outcome was major adverse cardiac events (MACE) including mortality, stroke, bleeding and vascular complications.Results: Mean age was 75 ± 8 years and 251 (59%) were males. Mean CHA2DS2-VASc score was 4.5 ± 1.3 points and mean HASBLED score was 3.9 ± 1.0 points. MACE outcome was similar in the three operator groups in both unadjusted (p = 0.83) and adjusted (OR = 0.59: 95% Confidence Interval [CI]: 0.15-2.29, p = 0.45) analysis. The occurrence MACE was also similar between Interventional Cardiologist (IC) and Electrophysiologist (EP) operators in an unadjusted (p = 0.24) and adjusted (OR = 0.60: 95% CI: 0.21-1.68, p = 0.33) analysis. The secondary outcome of technical success did not differ among the three tertiles (p = 0.37) and among IC & EP operators respectively (p = 0.24) as well.Conclusion: Operator experience does not affect MACE and technical success even after adjusting for comorbidities. These results suggest a lower learning curve for LAAO with high technical success achievable even by low volume operators. [ABSTRACT FROM AUTHOR]

Objective: Several patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) have complex peripheral arterial disease (PAD) that increases risk of vascular complications and failure of vascular closure device (VCD). Endovascular bailout of failed VCD is performed through contralateral femoral access. Further due to multiple different anatomic reasons the contralateral femoral access and "up and over" approach is unavailable for endovascular bailout of the VCD failure. We evaluated a novel bailout technique of obtaining an additional access in ipsilateral common femoral artery (CFA) or superficial femoral artery (SFA) distal to the main CFA access used for TAVR device.Methods: We prospectively identified patients who were at high risk for VCD failure and had unavailable contralateral CFA approach from the pre-TAVR evaluation with multislice CT angiography. The data was collected prospectively for the TVT registry and retrospectively reviewed. All patients had an additional distal access obtained in the CFA or proximal SFA under direct fluoroscopy guidance after achieving main CFA access for TAVR. Using an inner 0.021″ micro-dilator from the 4-Fr micropuncture mini stick max access kit (AngioDynamics, Marlborough, MA) and a 200 cm long 0.018″ wire, the distal access was secured in place through the TAVR procedure. After completing the TAVR if the VCD gained successful hemostasis, the 0.021″ dilator was removed with manual pressure. If the VCD failed to achieve hemostasis, the distal access was upsized to a 7 Fr sheath for carrying out endovascular repair of the TAVR access. If the distal access was upsized to 7 Fr, that access was treated with VCD. The patients were monitored for acute in-hospital complication and followed for 6 months.Results: During 2017 & 2018, 97.4% of 186 TAVRs were performed via femoral approach at our center. Six patients met the criteria for high-risk access and non-availability of the contralateral "up and over" approach. Of the 6 patients enrolled in this prospective study, 3 required endovascular management of TAVR access because of failed VCDs and were treated with covered stents using the distal ipsilateral access. The remaining 3 patients had successful use of VCDs for the TAVR access and the prophylactic access with 0.021″ dilator was managed with manual pressure. None of the six patients suffered any further vascular complication or bleeding. At the 6-month follow up no vascular complications or clinically driven events were identified from the TAVR access or additional distal ipsilateral access.Conclusion: This novel technique of prophylactic ipsilateral distal femoral access can provide an alternative bailout strategy for patients at high risk of closure device failure and unavailable contralateral femoral approach during transfemoral TAVR. [ABSTRACT FROM AUTHOR]

Transcatheter electrosurgery refers to a family of procedures using radiofrequency energy to vaporize and traverse or lacerate tissue despite flowing blood. The authors review theory, simulations, and benchtop demonstrations of how guidewires, insulation, adjunctive catheters, and dielectric medium interact. For tissue traversal, all but the tip of traversing guidewires is insulated to concentrate current. For leaflet laceration, the "Flying V" configuration concentrates current at the inner lacerating surface of a kinked guidewire. Flooding the field with non-ionic dextrose eliminates alternative current paths. Clinical applications include traversing occlusions (pulmonary atresia, arterial and venous occlusion, and iatrogenic graft occlusion), traversing tissue planes (atrial and ventricular septal puncture, radiofrequency valve repair, transcaval access, Potts and Glenn shunts), and leaflet laceration (BASILICA, LAMPOON, ELASTA-Clip, and others). Tips are provided for optimizing these techniques. Transcatheter electrosurgery already enables a range of novel therapeutic procedures for structural heart disease, and represents a promising advance toward transcatheter surgery. [ABSTRACT FROM AUTHOR]

Background: There are few studies on the use of a mechanical chest compression (meCC) device during transport in patients with out-of-hospital cardiac arrest (OHCA).Objective: The aim of our study was to compare the performance of an meCC device with that of manual chest compression during transport after OHCA.Methods: This study used data from the national cardiac arrest registry of patients with OHCA of presumed cardiac etiology. The primary exposure was the use of an meCC device by an Emergency Medical Services provider while transporting a patient to the emergency department. The primary endpoint was good cerebral performance category at discharge. We compared survival and neurologic outcomes between an meCC device group and a manual chest compression group. We also performed an interaction analysis to assess changes in study outcomes of meCC device use by the initial electrocardiogram (ECG) and transport time interval (TTI).Results: Among 30,021 adult patients after OHCA with presumed cardiac etiology, an meCC device was used in 2357 (7.6%). After adjustment for possible confounders, there were no significant differences with respect to good neurologic recovery in the outcomes of patients who were treated with an meCC device and those who received manual chest compression (adjusted odds ratio [AOR] 0.66; 95% confidence interval [CI] 0.43-1.02) and survival to discharge (AOR 0.83; 95% CI 0.64-1.06). In the interaction model, the AOR of the meCC device study outcome did not interact with the initial ECG and TTI.Conclusions: The meCC device did not show better study outcomes than manual compression. [ABSTRACT FROM AUTHOR]

Objectives: This study investigated the feasibility, safety, and the acute outcome of primary retrograde tibio pedal approach (TPA) in the treatment of peripheral arterial disease (PAD) with femoropopliteal (FP) chronic total occlusion (CTO).Background: With maturing in endovascular technology and further development in new devices, endovascular therapy has become a comparable and preferred treatment for patients with PAD. The retrograde TPA has not been studied to treat FP CTO extensively.Methods: We performed a retrospective analysis of 98 consecutive patients who underwent peripheral angiogram and intervention of 123 FP CTO lesions from June 1st, 2016 to June 30th, 2018 in a single center. Peripheral angiography and percutaneous balloon angioplasty was done primarily via retrograde TPA. Demographic data, procedural success rate, peri-procedural major adverse complications, and 30-day outcomes were recorded.Results: Out of 123 procedures, the dorsalis pedis artery/distal anterior tibial artery was the most common TPA site (59%) followed by the posterior tibial artery in 27% patients and peroneal artery in 14% patients. In 40 (33%) FP CTO lesions, additional transradial accesses were needed for controlled antegrade and retrograde tracking (CART) technique. Overall procedural success was achieved in 122 FP CTO (99%) lesions. No patients had significant access site bleeding, hematoma, worsening kidney dysfunction or acute limb ischemia within 30-day following this procedure.Conclusions: The primary retrograde TPA for FP CTO lesions is safe and feasible. With a combination of tibio pedal and transradial approach, our procedural success rate is very high for FP CTO intervention. [ABSTRACT FROM AUTHOR]

Hemostasis valves are commonly used in neurointerventions. We propose a novel concept for fixing hemostasis valves to the operating table during procedures. Moreover, we report our preliminary in vitro experience using these new devices created using a 3-dimensional printer. The hemostasis valve holder (HVH) comprises 2 components: an inner fixer and an outer socket. It was designed to be suitable for use with all rotational hemostasis valves commercially available. HVH contains magnets at the bottom that facilitate its attachment to a thin steel board beneath a sterilized drape on the working table. We evaluated the HVH's efficacy via in vitro experiments involving stent placement by a single operator. HVH allowed easy attachment to and detachment from the rotational hemostasis valve. Moreover, the use of multiple HVHs facilitated operators to concentrate on the procedure because they continuously prevented the unexpected movement of devices at several points. Use of HVHs enables stent placement to be performed even by a single operator. We observed that forming a loop of the stent delivery catheter between 2 HVHs enhanced the device control. HVHs should be more useful than conventional methods, particularly in cases requiring fine complementary control of both a microcatheter and microguidewire. [ABSTRACT FROM AUTHOR]

A 15-month-old child with repaired dextro-transposition of the great arteries with ventricular septal defect presented with bradycardia and active coronavirus disease 2019. She was found to have second-degree atrioventricular block, which progressed to complete heart block. Management included investigation for multisystemic inflammatory syndrome in children associated with coronavirus disease 2019, viral myocarditis, and postoperative late atrioventricular block after arterial switch operation with ventricular septal defect closure. The patient required pacemaker implantation for persistent complete heart block. This is the first case of complete heart block in a congenital heart patient with coronavirus disease 2019. • A child with repaired D-TGA and VSD presented with active COVID-19 infection and developed complete heart block. • This case reviews the differential diagnosis of heart block in a child with repaired congenital heart defect and COVID-19. • This is the first case of a child with congenital heart disease presenting with COVID-19 and arrhythmia requiring a pacemaker [ABSTRACT FROM AUTHOR]