Puncture Site Hematoma Research Articles

The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial.

Introduction and AimRadial artery approach angiography is the current gold standard for coronary status diagnostics and eventual percutaneous revascularization (PCI). Currently, application of adequate, patent hemostasis based physical torniquets are used for puncture site control, to avoid bleeding, radial artery occlusion and damage (RAO and RAD). The Radial Artery Puncture Hemostasis Evaluation (RAPHE) is a prospective, randomized, multicenter clinical trial designed to investigate new, simplified techniques of radial artery hemostasis utilizing physical compression free methods.Methods and ResultsThe RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc. These devices will be investigated in a standalone configuration. Control group is a standard pneumatic airbladder-based compression device. A total of 600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups. Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, (pseudo)aneurism and/or fistula formation, measured post-procedure and at sixty days.ConclusionThe results from this trial will provide valuable information on new, simplified methods of radial artery hemostasis options and possibly simplify post-puncture management of patients.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT04857385].

Conduction system pacing with AV node ablation versus catheter ablation for treatment of persistent atrial fibrillation in patients with heart failure with reduced ejection fraction

Abstract Funding Acknowledgements Type of funding sources: None. Background In patients with persistent atrial fibrillation (PeAF) and heart failure with reduced ejection fraction (HFrEF) current guidelines recommend treatment of AF with catheter ablation (CA) (1). Recurrence of either AF or atrial flutter, often requiring additional procedures, are not uncommon, thus optimal long-term treatment of these patients is still unknown. Recently conduction system pacing (CSP), with more physiological ventricular activation, has made the ‘’pace and ablate’’ strategy an attractive alternative for the treatment of PeAF refractory to medical therapy (2). Purpose Long term data comparing CA with conduction system pacing and AV node ablation (CSP/AVNa) for treatment of patients with PeAF and HFrEF is lacking. Hence, we sought to compare clinical outcomes of both treatment modalities. Methods In a retrospective study consecutive patients under 75 years of age, with PeAF and left ventricular ejection fraction (LVEF) less than 50%, treated with CSP/AVNa from 2018 to 2021 in UMC Ljubljana were included. A control patient treated with CA for PeAF matched in age, sex and LVEF was assigned for each included CPS/AVNa patient. Both groups were compared for procedure-related characteristics, echocardiographic parameters, hospitalisations for heart failure and all-cause mortality. Results Among 771 patients referred for interventional treatment of AF, 23 patients treated with CSP/AVNa were included and compared with 23 CA matched controls. The general characteristics of both groups are summarised in Table 1. The mean follow-up was 20 ± 10 and 21 ± 8 months for CPS/AVNa and CA group, respectively (p=0.76). In CPS/AVNa group 83% received his bundle pacing and 17% left bundle branch area pacing. A selective CSP was achieved in 43% of CSP/AVNa patients. In addition to pulmonary vein isolation, additional ablation lines were performed in 35% of patients in the CA group. Significant improvement in LVEF was observed in both groups, 12% ± 11% (p<0.001) in CSP/AVNa and 21% ± 12% (p<0.001) in CA group. Hospitalisations for HF were rare during the follow-up, with 9% in CSP/AVNa and 4% in the CA ablation group (p=0.561). All-cause mortality was 9% in CSP/AVNa and 0% in CA group (p=0.153). However, major comorbidities were more common in the CSP/AVNa group than in the CA group, 3.4 ± 1.6 and 2.3 ± 1.5, respectively (p=0.017). Procedure-related characteristics are summarised in Table 1. In each group, 2 minor procedure-related adverse events were observed: 2 acute rises in pacing threshold post-AVNa in CSP/AVNa group and puncture site hematoma and transient pericardial effusion in CA group. Conclusion In patients with PeAF and HFrEF, CSP/AVNa treatment strategy seems to derive similar clinical outcomes compared to CA approach. Larger prospective randomised data are needed to further confirm these initial findings and determine optimal long-term treatment strategy for this group of patients.

Systematic review and meta-analysis: Efficacy and safety of balloon angioplasty in salvaging non-matured arteriovenous fistulas.

This study aimed to evaluate the clinical and technical success rates achieved after performing balloon-assisted maturation (BAM) for non-matured arteriovenous fistula (AVF). For this, a systematic review and meta-analysis were conducted by searching PubMed and Scopus databases. Studies regarding AVFs not suitable for use based on clinical examination or ultrasound criteria and BAM use for correcting the underlying stenotic lesion were eligible for inclusion in the meta-analysis. Accordingly, 13 studies with 1427 patients with non-matured AVF who underwent BAM were included. The pooled random effect for the clinical success rate was 90% (95% CI, 86%-93%), and that for the technical success rate was 97% (95% CI, 94%-99%). Complications after BAM were reported in 1.7%-41% of the patients. Complications included venous ruptures, wall hematomas, and puncture site hematomas. Early-BAM group had better clinical success rates. BAM is an effective intervention for salvaging non-matured AVF. The procedure is safe and feasible, and high clinical and technical success rates can be achieved. The complications were also manageable without serious sequelae.

Using the Casper Stent in Carotid Angioplasty: A Single Center Experience

Abstract Objectives To establish the success rate in endovascular internal carotid artery (ICA) stenosis recanalization using the double-layer stent Casper-RX (Microvention, Inc 35 Enterprise, Aliso Viejo, California, United States of America) and to identify the main comorbidities in individuals with ICA stenosis, morphological characteristics of the stenosis, diagnostic methods, intraoperative complications, as well as morbidity and mortality within 30 days of the surgical procedure. Materials and Methods Retrospective analysis of 116 patients undergoing ICA angioplasty with a degree of stenosis ≥ 70% using Casper-RX stenting who underwent this procedure from April 2015 to December 2019. Results Technical success was achieved in 99.1% of the patients. Three of them had postprocedural complications: one transient ischemic attack (TIA) and two puncture site hematomas. A cerebral protection filter was not used in only two procedures, as these consisted of dissection of the carotid. There was satisfactory recanalization and adequate accommodation of the stents in the previously stenosed arteries, with no restenosis in 99.4% of the cases. Conclusion The endovascular treatment of extracranial carotid stenoses using the Casper-RX stent showed good applicability and efficacy. Although only two cases of thromboembolic complications occurred during the procedure, further investigation and studies on the effectiveness of this new device are needed.

A nomogram for predicting the risk of femoral pseudoaneurysm after neurointerventional procedures.

BackgroundBecause femoral pseudoaneurysm (FPA) is a dangerous complication of interventional procedures with a risk of life-threatening bleeding, our aim was to develop a predictive nomogram for FPA after neurointervention, and to suggest the best method for early identification of FPA.MethodsWe searched the PubMed database for literature addressing FPA after interventional procedures to analyze the risk factors, and we also reviewed the clinical data of patients from the Department of Neurosurgery who underwent neurointerventional procedures. Selected parameters were analyzed by univariate and multivariate logistic regression analysis. A nomogram was constructed using the independent risk factors by a multivariate regression model, and was validated by bootstrap resampling method, as well as receiver operating characteristic (ROC) curve, decision curve analysis (DCA) and calibration curve. The influence on the detection rate of FPA with Doppler ultrasound was also analyzed with Fisher’s exact test.ResultsAccording to existing studies, female sex, diabetes and hypertension are major risk factors of FPA. Among 1,098 clinical patients, hypertension (P=0.044), higher body mass index (BMI) (P=0.020), larger sheath size (P=0.049), puncture site hematoma (P=0.011) and closure failure (P=0.003) were identified as independent risk factors. The nomogram including these factors showed robust discrimination [C-index, 0.916; 95% confidence interval (CI): 0.810–1.022] with an area under the curve of 0.916. DCA indicated clinical utility, and the calibration curves showed an acceptable consistency. A significant improvement in the detection rate occurred when Doppler ultrasound was utilized (P=0.031).ConclusionsThe presented nomogram showed favorable predictive accuracy for FPA after neurointervention. We recommend ultrasound examination for patients at high risk of FPA evaluated by the nomogram.

Efficacy and Safety Differences between Domestic Paclitaxel Drug-Coated Balloons and Metal Bare Stents in the Treatment of ASO of Femoral-Popliteal Arteries Type IIA-C.

The aim in this study was to investigate the efficacy and safety of domestic paclitaxel-coated balloon (DCB) and bare metal stent (BMS) in the treatment of Transatlantic Cooperative Organization Consensus II (ASC II) types A–C femoral-popliteal arteriosclerosis obliterans (ASO). A total of 103 patients with ASC II A–C femoropopliteal ASO, who received treatment in our hospital from March 2020 to March 2021, were retrospectively selected and divided into the DCB group (n = 56) and BMS group (n = 47), according to treatment methods. The general clinical data and surgical results were compared between the two groups. The patients were followed up, and the primary patency rate, restenosis rate, freedom from target lesion revascularization (f-TLR), and limb preservation rate were recorded. The liver and kidney functions before and after operation and the occurrence of major postoperative adverse events were recorded. The operation was successful in both groups. The minimum diameter of the DCB group was smaller than that of the BMS group after treatment (P < 0.05). At 6 and 12 months after operation, the Rutherford classification decreased and ABI index increased in both groups (P < 0.05), but there was no significant difference (P > 0.05). At 6 and 12 months after surgery, f-TLR was significantly higher in the DCB group than in the BMS group (P < 0.05); at 12 months after surgery, the restenosis rate was lower in the DCB group than in the BMS group (P < 0.05). There was no significant difference in the primary patency rate and limb preservation rate at 6 and 12 months after operation between the two groups (P > 0.05). Before and after operation, there was no significant difference in liver and kidney function between the two groups (P > 0.05). Within 12 months after surgery, 1 patient in the DCB group developed puncture site hematoma 3 days after surgery, and 1 patient in the BMS group developed acute thrombosis 1 day after surgery, and no intervention-related deaths occurred. Domestic paclitaxel DCB can achieve better f-TLR and lower restenosis rate than BMS in the treatment of type II A–C femoral-popliteal artery ASO. Short-term and medium-term efficacy and safety are comparable to BMS.

Safety and Effectiveness of Coronary Angiography or Intervention through the Distal Radial Access: A Meta-Analysis.

Objectives Searching the literature for coronary angiography (CAG) or intervention through distal radial access (DRA) and performing a meta-analysis. Background Coronary angiography (CAG) or intervention through distal radial access (DRA) may have a similar success rate, low radial artery occlusion rate, low radial artery spasm rate, and low rate of puncture site hematoma for patients with coronary heart disease. Therefore, the randomized controlled trials (RCTs) were searched, and the data were pooled for meta-analysis to evaluate the effectiveness and safety of DRA. Methods RCTs comparing the CAG or intervention through DRA vs. transradial access (TRA) published between January 1, 2017, and May 4, 2021, were searched in the PubMed, Embase, and Cochrane databases. The endpoints included the rate of access success and the number of radial artery occlusions, radial artery spasms, and puncture site hematomas. The data were extracted, and a random-effects model was used for analysis. Results Among 204 studies, 6 RCTs (with 2825 participants) met the inclusion criteria. Compared to TRA, the access success rate in DRA (p=0.1) and the lower rate of puncture site hematoma were not significantly different (p=0.646), while the radial artery occlusion rate (p < 0.001) and radial artery spasm rate (p=0.029) were significantly lower. Conclusion In summary, DRA has a similar access success rate and incidence of hematoma at the puncture site, but a lower incidence of RAO and spasm compared to TRA. These findings demonstrated that DRA is a safe and effective access for CAG or intervention.

Transcatheter mitral valve repair (TMVR) using MitraClip in patients younger than 65 years: a multicenter analysis of 2-years outcomes

Abstract Background TMVR using MitraClip became a well-established interventional therapy for severe MR. However, TMVR has been almost only applied to old aged patients rejected from surgical therapy. Objective To present 2-years outcomes of 36 patients younger than 65 years with no surgical options treated by TMVR. Methods A retrospective clinical and TEE study was conducted to evaluate 36 patients younger than 65 years treated by TMVR in 3 heart centers. Results Mean age of the 36 study patients was 56.3±6.6 years, male gender was 72.2%. High operative risk was estimated by STS score (mean = 8.73±2.97) and EuroSCORE (mean = 24.71±12.79). All patients were refused for surgery by heart team decision, therefore admitted to TMVR. Baseline severity of MR was assessed by 3D-TEE based biplane vena contracta width (mean = 8.35±1.87 mm). Baseline transmitral mean pressure gradient was 1.81±0.78 mmHg. 21 patients showed mitral annular dilatation as the main cause of MR, 8 patients had leaflet prolapse, 4 patients exhibited papillary muscle displacement leading to leaflet tethering and 3 patients showed mitral leaflet thickening and/or retraction due to fibrosis. Procedural success was achieved in all patients with 1/2/3 clips implanted in 52.8%/44.4%/2.8% of cases with a mean of 1.5 clip per case. Two grades or more reduction in severity of MR (MR grade ≤ II/IV) was accomplished in 88.9% of patients. Mean postprocedural MPG was 3.78±1.96 mmHg. Average follow-up (FU) period was 25,8 months and the median was 20 months (25th–75th percentile: 12–36 months). During 2-years FU, statistically significant difference (p value &amp;lt;0.002) was detected for NT-proBNP levels compared to baseline (mean = 9870±10819, median = 7748, 25th–75th percentile: 2702–14237 pg/ml) and at follow up visits (mean = 7645±11292, median = 3263, 25th-75th percentile: 883–8078 pg/ml). Furthermore, persistent symptomatic improvement during FU, defined as NYHA functional class improvement by 2 or more Grades, was achieved in 69% of patient in parallel with efficient reduction of MR in 34 patients so that a second intervention by reclipping was required in 2 patients to correct recurrent significant MR. Only two patients experienced procedure-related complications by large puncture site hematoma. No procedure-related mortality during the first 30 days was detected. However, mortality was recorded in 2 patients during the first month and was attributed to severe advanced heart failure in one case and septicemia after exclusion of infective endocarditis in another case. Over 2 years FU, other 5 patients passed away, 3 cases owing to advanced heart failure, one case due to multi-organ failure and one because of tumor disease. Conclusion TMVR in patients younger than 65 years refused from surgical repair provides satisfactory clinical and echocardiography outcomes at 2 years. Future studies should evaluate the outcomes of MitraClip in this population in a larger cohort. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Hassan M.H. Mohammed received a scholarship grant from the Egyptian ministry of higher education and Minia University, Egypt.

Complication rates of percutaneous brachial artery puncture: effect of live ultrasound guidance

PurposeThe current literature on the use of brachial artery access is controversial. Some studies found increased puncture site complications. Others found no higher complication rates than in patients with femoral or radial access. The purpose of this study was to determine the impact of ultrasound (US)-guidance on access site complications.Materials and methodsThis is a single-center retrospective study of all consecutive patients with brachial arterial access for interventional procedures. Complications were classified into minor complications (conservative treatment only) and major complications (requiring surgical intervention). The brachial artery was cannulated in the antecubital fossa under US-guidance. After the intervention, manual compression or closure devices, both followed by a compression bandage for 3 h, either achieved hemostasis.ResultsSeventy-five procedures in seventy-one patients were performed in the study period using brachial access. Access was successful in all cases (100%). Procedures in different vascular territories were performed: neurovascular (10/13.5%), upper extremity (32/43.2%), visceral (20/27.0%), and lower extremity (12/16.3%). Sheath size ranged from 3.2F to 8F (mean: 5F). Closure devices were used in 17 cases (22.7%). In total, six complications were observed (8.0%), four minor complications (5.3%, mostly puncture site hematomas), and two major complications, that needed surgical treatment (2.7%). No brachial artery thrombosis or upper extremity ischemia occurred.ConclusionExclusive use of US-guidance resulted in a low risk of brachial artery access site complications in our study compared to the literature. US-guidance has been proven to reduce the risk of access site complications in several studies in femoral access. In addition, brachial artery access yields a high technical success rate and requires no additional injection of spasmolytic medication. Sheath size was the single significant predictor for complications.

Accuracy and Feasibility of Ultrasound-Guided Intra-articular Injection of the Rat Hip Joint

Intra-articular injection is frequently used as an effective diagnostic and treatment tool for hip joint diseases. However, the underlying treatment mechanism remains unclear because of a lack of experimental animal models. A challenge facing researchers is how to accurately and consistently perform injections involving animal hip joints. The purpose of this study, then, was to establish an ultrasound (US)-guided intra-articular (IA) injection technique using rat hip joints and to evaluate its accuracy and feasibility versus a fluoroscopy (FL)-guided technique. For this study, 20 US-guided and 20 FL-guided IA injections were administered to separate groups of Sprague-Dawley rats. For each procedure, 50 μL of iohexol was injected into the hip joint using a 25G needle. The US-guided injections were performed using a linear probe, and the FL-guided IA injections were performed using C-arm X-ray fluoroscopy. All injections were verified by computed tomography imaging. The number of successful injections and needle repositions per injection, as well as operating times, were recorded, and the rats were observed for complications for 10 d after the injections. Statistical analysis was used to compare US-guided and FL-guided techniques with significance set at p < 0.05. The success rate was markedly higher for the US-guided interventions (90%) than for the FL-guided interventions (75%) (p<0.05). The intervention time was shorter in the US-guided group (95.95 ± 8.376 s) than in the FL-guided group (110.70 ± 20.236 s) (p < 0.05), and the median number of needles repositioned per injection in the US-guided group (1.20 ± 0.41) was notably less than that in the FL-guided group (1.60 ± 0.68) (p < 0.05). A puncture site hematoma was noted in two rat hips (10%) the day after injection in the FL-guided group. Overall, the study indicated that ultrasound-guided intra-articular injection of the hip is a feasible, accurate and safe method for use in rats. This makes it a promising tool for diagnosing coxofemoral pain, producing hip osteoarthritis animal models and administering intra-articular medication.

Distal Transradial Artery Access for Neuroangiography and Neurointerventions : Pitfalls and Exploring the Boundaries.

IntroductionThe distal transradial approach (dTRA) is progressively gaining more clinical use in the fields of cardiology and other vascular interventions, as it offers a number of advantages compared to conventional radial approach (TRA). These include lower rates of vascular occlusion which permits preservation of the proximal radial artery for future procedures in the event of a distal occlusion.AimTo share the experience in the use of dTRA for neurointerventions, showing its advantages, pitfalls as well as sharing our optimized puncture and hemostatic ultrarapid compression protocols to improve the use of this vascular access.MethodsA retrospective analysis of our experience of diagnostic and interventional procedures performed via dTRA using an optimized protocol for puncture and postpuncture compression of the dTRA was performed.The rate of complications (hematoma and arterial dissection at puncture site) femoral crossover, and assessment of postprocedural stenosis/occlusion with the ultrarapid compression protocol were also assessed.ResultsFrom March 2019 to July 2020 a total of 100 distal radial procedures were carried out and 53 diagnostic angiograms (53%) and 47 interventional procedures (47%) were included in the analysis. We achieved a 96% technical success, with a femoral crossover requirement in 3 cases (3%), and one conventional TRA crossover due to puncture failure.Of the patients 3 presented puncture site hematomas (3%) with no intervention required, 61 patients (61%) underwent the ultrarapid hemostasis protocol in association with a hemostatic pad. Ultrasound follow-up was performed in 20 patients (20%) at 1–2 months with 1 case of occlusion (5%) and 2 of radial stenosis (10%). In all 3 cases proximal radial artery remained patent.ConclusionThe dTRA is a safe and feasible access route for angiography and neurointerventions. Using vasodilators prepuncture, we attained a variable increase in the vascular diameter facilitating puncture and reducing the risk of occlusion and vascular spasm.A rapid deflation protocol for postpuncture hemostasis does not significantly increase the hematoma rate.

Access Site Complications of Peripheral Endovascular Procedures: A Large, Prospective Registry on Predictors and Consequences

Purpose The purpose of this study was to investigate predictors and consequences of acute vascular access site complications (ASCs) related to peripheral endovascular diagnostic or interventional procedures. Despite improvement of puncture techniques, access site–related morbidity and mortality is still considerable. Materials and Methods A total of 5263 participants who underwent 5385 endovascular procedures at a single center were consecutively included in this prospective, observational study. Primary outcomes were ASCs defined as composite of puncture site hematoma, pseudoaneurysm, arteriovenous fistula, and overt puncture site bleeding on the first day after procedure. Results ASCs occurred in 16.6% of peripheral endovascular procedures (78.6% hematomas, 18.9% pseudoaneurysms, 1.4% arteriovenous fistulas, 1.1% overt bleedings). Independent predictors were advanced age [odds ratio (OR) per 10 years: 1.12, p=0.004], female sex (OR men, 0.77; p=0.001), lysis (OR 3.56; p<0.001), periprocedural heparin (OR 5000 IU, 1.96; p=0.001; OR >5000 IU, 3.56; p=0.02), time to access (OR per 10 seconds, 1.01; p<0.001), sheath size (OR per French, 1.59; p<0.001), brachial artery access (OR vs retrograde transfemoral, 4.58; p<0.001), and compression only (OR Angio-Seal, 0.57, p=0.02; ProGlide, 0.36, p<0.001; FemoSeal, 0.57, p<0.001). Treatment was required in 20.2% and prolonged hospitalization in 17.7% of ASC. Three participants died from access site–related bleeding. Conclusion ASCs after peripheral endovascular procedures are associated with advanced age, female sex, periprocedural antithrombotic medication, brachial artery access, postinterventional bleeding, and nonuse of vascular closure devices.

RAVS Study: A Single Center Experience with Turbo hawk Directional Atherectomy Device to analyze it as an Emerging Modality for Treatment of Long Segment Femoro-Popliteal Occlusive Disease

Background: Despite advances to prevent and better manage patients with established Peripheral Arterial Disease (PAD), the incidence of PAD continues to increase and morbidity remains high, especially as the population ages. For physicians treating PAD cases, an understanding of the various treatment options, along with their benefits and limitations is crucial. Endovascular treatment with Turbo hawk atherectomy device has promising technical and clinical success rates. Objective: To consider Turbo hawk directional atherectomy as an important and safer endovascular modality for treatment of long segment Femoro-popliteal occlusive disease. Methods: This is a retrospective study which included 40 patients diagnosed with PAD (long segment occlusion of Femoro-popliteal arteries), who came to Ramaiah medical college hospital, Bangalore from June 2014 to June 2018 and fit into specified inclusion criteria with mean age of the patients being 61.5 years. All these patients underwent endovascular therapy with turbo hawk atherectomy device and post intervention was followed for a period of one year. Results: Primary technical success rate was 97%. Pre-operatively mean ABI was 0.27 and post–operative mean ABI was 0.64. An average length of corrected lesion was 10.5cms. Post-operatively one patient had an episode of distal embolization, two patients had dissection and three had puncture site hematomas, all of which were managed conservatively. No vessel perforation was observed in our study. Patients were followed up at 1 month, 6 months and 12 months postoperatively. Primary vessel patency rates at 6 and 12 -months were 96% and 85%. Conclusion: Directional atherectomy using turbo hawk device is safe, effective at 12 months for medium and long segment femoro-popliteal lesions in claudicants as well as in patients with critical limb threatening ischemia and has a primary patency rates of 85 % over 1-year period. Further, complication rates that warrants a treatment is also very low with Turbo hawk as seen with our study.

Comparison of analgesic efficacy between rectus sheath blockade, intrathecal morphine with bupivacaine, and intravenous patient-controlled analgesia in patients undergoing robot-assisted laparoscopic prostatectomy: a prospective, observational clinical study

BackgroundWe explored the analgesic outcomes on postoperative day (POD) 1 in patients undergoing robot-assisted laparoscopic prostatectomy (RALP) who received intravenous patient-controlled analgesia (IV-PCA), rectus sheath bupivacaine block (RSB), or intrathecal morphine with bupivacaine block (ITMB).MethodsThis was a prospective, observational clinical trial. Patients were divided into three groups: IV-PCA (n = 30), RSB (n = 30), and ITMB (n = 30). Peak pain scores at rest and with coughing, cumulative IV-PCA drug consumption, the need for IV rescue opioids, and Quality of Recovery-15 (QoR-15) questionnaire scores collected on POD 1 were compared among the groups.ResultsThe preoperative and intraoperative findings were comparable among the groups; the ITMB group required the least remifentanil of all groups. During POD 1, the ITMB group reported lower levels of pain at rest and with coughing, compared with the other two groups. During POD 1, incidences of severe pain at rest (10.0% vs. 23.3% vs. 40.0%) and with coughing (16.7% vs. 36.7% vs. 66.7%) were the lowest in the ITMB group compared with the RSB and IV-PCA groups, respectively. After adjustment for age, body mass index, diabetes mellitus, hypertension, and intraoperative remifentanil infusion, severe pain at rest was 0.167-fold less common in the ITMB group than in the IV-PCA group, while pain with coughing was 0.1-fold lower in the ITMB group and 0.306-fold lower in the RSB group, compared with the IV-PCA group. The ITMB group required lower cumulative IV-PCA drug infusions and less IV rescue opioids, while exhibiting a better QoR-15 global score, compared with the other two groups. Complications (nausea and pruritus) were significantly more common in the ITMB group than in the other two groups; however, we noted no ITMB- or RSB-related anesthetic complications (respiratory depression, post-dural headache, nerve injury, or puncture site hematoma or infection), and all patients were assessed as Clavien-Dindo grade I or II during the hospital stay.ConclusionAlthough ITMB induced complications of nausea and pruritus, this analgesic technique provided appropriate pain relief that enhanced patient perception related to early postoperative recovery.Trial registrationClinical Research Information Service, Republic of Korea, (approval number: KCT0005040) on May 20, 2020

Abstract 17312: Incidence of Periprocedural Complications in Patients With Percutaneous Coronary Intervention of Chronic Total Occlusions and Impact of Mortality

Background: Percutaneous recanalization of coronary chronic total occlusions (CTO) remains one of the biggest challenges in interventional cardiology and is known to be associated with higher complication rate compared to regular coronary angioplasty. The aim of the current study is to explore the frequency and clinical outcomes of patients with procedural complications. Methods: All patients with CTOs were included in prospective registry. CTO was defined as a total obstruction of a coronary artery with thrombolysis in myocardial infarction (TIMI) grade flow of 0 and duration of more than three months. Frequency of periprocedural complications were analyzed and all patients were followed-up for vital status. Results: For the purpose of current analysis we included 595 patients (66±10 years, 78% males) who underwent a total of 661 PCIs of chronic total occlusions. 623 procedures (94.3%) were successful with TIMI 3 final flow. In 10.9% (n=72) of the procedures there was a periprocedural complication defined as: coronary perforation (type I-III) 3.02% (n=20), puncture site haematoma 1.7%(n=11), coronary intramural haematoma 1.5%(n=10), coronary dissection n=5(0.8%). In 4 people (0.6%) there was perforation with formation of haemopericardium (type IV coronary perforation). On logistic regression analysis factors found to be significantly predictive for occurrence of complication were carotid artery disease (OR=4.794, CI: 1.718-13.374, p = 0.038) and renal failure (OR=1.774, CI: 1.060-2.967, p=0.016). At a median follow-up of 31 months (IQR 13-49) the overall death rate was 20.7% (n=123) and was significantly lower in noncomplicated vs complicated group (104/525, 19.8% vs 19/69, 27.5%, log-rank p=0.042). On Cox-regression analysis procedural complication was independent predictor of death (OR= 1.650, CI 1.011- 2.692, p= 0.042). Conclusion: In patients undergoing PCI for CTO the presence of periprocedural complication was independent predictors of mortality and these subjects had higher mortality rate at a median follow-up of 31 months.

Genicular Artery Embolization for Osteoarthritis Related Knee Pain: A Systematic Review and Qualitative Analysis of Clinical Outcomes.

Objective To systematically review the published literature on genicular artery embolization (GAE) for osteoarthritis (OA) related knee pain. Materials and Methods Using three databases, a systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Outcome measures included the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results Three single-arm studies were included from an initial search yielding 305 results. One hundred and eighty-sixknees in 133 patients with either mild-to-moderate (174/186, 94%) or severe (12/186, 6%) OA underwent embolization with either imipenem/cilastatin sodium (159/186, 85%) or embozene (27/186, 15%). Technical success was 100%. Average VAS improved from baseline at 1 day, 1 week, 1 month, 3 months, 4 months, 6 months, 1 year and 2 years (66.5 at baseline vs 33.5, 32.7, 33.8, 28.9, 29.0, 22.3, 14.8 and 14.0, respectively). Average WOMAC scores improved from baseline at 1, 3, 4, 6, 12 and 24 months (45.7 at baseline vs 24.0, 31.0, 14.8, 14.6, 8.2 and 6.2). Severe OA in 12 cases showed initially improved VAS, but was not sustained. Minor adverse events such as erythema in the region of embolization (21/186, 11%), puncture-site hematoma (18/186, 10%), paresthesia (2/186, 1%) and fever (1/186, 0.5%) were reported. Conclusion Limited single-arm studies report GAE is promising for treating OA-related pain. Most treatments performed for mild-to-moderate OA demonstrated durable clinical responses from 6months to 4years. Limited data for severe OA suggest a non-durable response. Future studies should be standardized to facilitate comparison and control for placebo effect.

Mid Term Results, Complications and Their Treatment After Cyanoacrylate Embolisation of Saphenous Veins

Background. The results of cyanoacrylate embolisation (CAE) of the great (GSV) and small (SSV) saphenous trunks in patients with varicose veins (VVs) of the lower limbs were evaluated. Methods. This is an ongoing prospective observational study that started in 2017 at the Hospital Neftyanik, including patients with VVs who underwent CAE of the GSV and/or SSV by VenaSeal technology. Patients are followed with clinical and ultrasound evaluation at one week, three, six, and 12 months after surgery, and then every year. Efficiency criteria are the technical success of the vein occlusion; absence of recanalisation; GSV stump length; vein involution; absence of truncal reflux; absence of reflux at the junction; no need to remove tributaries; no need for re-intervention on the trunk; clinical class by CEAP; and disease severity by VCSS. Safety criteria are the absence of adverse effects (AEs). Results. Between 2017–2019 CAE was performed on 122 limbs of 92 patients: 46 women and 46 men aged from 28 to 69 years (mean age, 45.3 ± 10.3 years) with the CEAP clinical of C2 (47.6%), C3 (35.2%), C4 (16.4%), and C5 (0.8%). The GSV trunk (diameter 4.5–18.0 mm; mean 9.0 ± 2.5) was treated in 82% and the SSV (3.7–13.0 mm; mean, 7.0 ± 2.3) in 18%. Technical success was achieved in all cases. The lengths of the GSV stump varied from 0 to 48 mm (mean, 19.0 ± 9.7). Sclerotherapy for varicose tributaries during the first three months was performed in 55 legs (45.1%). Patients were followed for three months (range one week–18 months). Additional sclerotherapy for varicose tributaries was required for 35 limbs (28.7%). Truncal recanalisation > 5 cm was found in eight limbs (6.6%) 3–12 months after intervention and required second CAE (n = 1), laser ablation (n = 1) or sclerotherapy (n = 4). Other AEs that did not require re-intervention were GSV trunk phlebitis (n = 8; 6.6%) or tributaries (n = 5; 4.1%), allergic reaction (n = 4; 3.3%), cord sensation (n = 5; 4.1%), glue propagation to the junction (n = 2; 1.6%), glue propagation out of the junction (n = 2; 1.6%), altered sensation (n = 4; 3.3%), and puncture site haematoma (n = 1; 0.8%). Conclusion. CAE is an effective method for saphenous vein ablation that is associated with an acceptable incidence of non-severe AEs with a low rate of re-interventions.

A comparison of the clinical effects and safety between the distal radial artery and the classic radial artery approaches in percutaneous coronary intervention.

Compared with a classic wrist puncture for radial artery catheterization, a distal radial artery puncture has the advantage of reducing the incidence of radial artery occlusion in anatomic and physiological procedures. This study aimed to explore the difference in clinical effects between the distal radial artery and classic radial artery approaches in percutaneous coronary intervention. A total of 620 patients who underwent coronary angiography and/or percutaneous coronary intervention in our hospital from December 2017 to December 2018 were enrolled in this study. These patients were divided into two groups based on the puncture site: a distal radial artery group and a classic radial artery group. There were 312 patients in the radial artery group and 308 patients in the classic radial artery group. The puncture time, puncture success rate, surgery time, implanted stents, puncture site hemorrhage, hematoma, aneurysm, and iliac artery occlusion rate were observed. There was no significant difference in puncture time, puncture success rate, surgery time, implanted stent, puncture site hemorrhage, hematoma and aneurysm (P>0.05), while the radial artery occlusion rate was lower in the distal radial artery group, and the difference was statistically significant (P<0.05). The results of this study showed that the distal radial artery approach had a lower rate of brachial artery occlusion, indicating that it could be used as an alternative to the classic radial artery approach.

Association of upper extremity and neck access with stroke in endovascular aortic repair

ObjectiveUpper extremity and neck access is commonly used for complex endovascular aortic repairs. We sought to compare perioperative stroke and other complications of (1) arm/neck (AN) and femoral or iliac access versus femoral/iliac (FI) access alone, (2) right- versus left-sided AN, and (3) specific arm versus neck access sites. MethodsPatients entered in the thoracic endovascular aortic repair/complex endovascular aortic repair registry in the Vascular Quality Initiative from 2009 to 2018 were analyzed. Patients with a missing access variable and aortic arch proximal landing zone were excluded. The primary outcome was perioperative in-hospital stroke. Secondary outcomes were other postoperative complications and 1-year survival. Kaplan-Meier curves and log-rank test were used for survival analysis. ResultsOf 11,621 patients with 11,774 recorded operations, 6691 operations in 6602 patients met criteria for analysis (1418 AN, 5273 FI). AN patients had a higher rate of smoking history (83.6% vs 76.1%; P < .0001), and prior stroke (12.6% vs 10.1%; P = .01). Operative time (280 ± 124 minutes vs 157 ± 102 minutes; P < .0001), contrast load (141 ± 82 mL vs 103 ± 67 mL; P < .0001), and estimated blood loss (300 mL vs 100 mL; P < .0001) were larger in the AN group, indicative of greater complexity cases. Overall, AN had a higher rate of stroke (3.1% vs 1.8%; P = .003) compared with FI and on multivariable analysis AN access was found to be an independent risk factor for stroke (odds ratio, 1.97; P = .0003). There was no difference in stroke when comparing right- and left-sided AN access (2.8% vs 3.2%; P = .71). Stroke rates were similar between arm, axillary, and multiple access sites, but were significantly higher in patients with carotid access (2.6% vs 3.5% vs 13% vs 3.7%; P = .04). AN also had higher rates of puncture site hematoma, access site occlusion, arm ischemia, and in-hospital mortality (7.1% vs 4.2%; P < .0001). At 1 year, AN had a lower survival rate (85.1% vs 88.1%; P = .03). ConclusionsUpper extremity and neck access for complex aortic repairs has a higher risk of stroke compared with femoral and iliac access alone. Right-sided access does not have a higher stroke rate than left-sided access. Carotid access has a higher stroke rate than axillary, arm, and multiple arm/neck access sites.

Safety and efficacy of the SeparGate™ balloon-guiding catheter in neurointerventional surgery: Study protocol of a prospective multicenter single-arm clinical trial

BackgroundThe balloon-guiding catheter (BGC) reportedly reduces the number of retrievals and occurrence of distal emboli, achieving superior revascularization results and improved clinical outcomes in acute stroke. This study will aim to examine the efficacy and safety of the new SeparGate™ BGC. DesignThis prospective multicenter single-arm clinical trial will aim to include 128 patients who fulfill its inclusion and exclusion criteria. All patients will receive endovascular interventional therapy with BGC assistance. The primary endpoint will be the immediate surgical success rate, while the secondary endpoint will be product performance. The safety evaluation will include serious adverse events such as puncture site hematoma and bleeding, cerebral vasospasm, vessel dissection, vessel perforation, air embolism, thrombus (acute or subacute), vessel occlusion, distal embolization, infection, adverse reaction to antiplatelet and anticoagulant drugs, intracranial hemorrhage, stroke, death, and device defect. DiscussionThe prospective multicenter trial will provide safety and efficacy information for the SeparGate™ BGC. Its findings will provide a clinical reference for endovascular adjuvant therapy of cerebrovascular disease. Trial registrationChiCTR1800014459.