Vascular Bleeding Research Articles

The Renal Vasculature: What the Radiologist Needs to Know.

The physiologic role of the kidneys is dependent on the normal structure and functioning of the renal vasculature. Knowledge and understanding of the embryologic basis of the renal vasculature are necessary for the radiologist. Common anatomic variants involving the renal artery (supernumerary arteries and prehilar branching) and renal vein (supernumerary veins, delayed venous confluence, retroaortic or circumaortic vein) may affect procedures like renal transplantation, percutaneous biopsy, and aortic aneurysm repair. Venous compression syndromes (anterior and posterior nutcracker syndrome) can be symptomatic and can be diagnosed with a combination of radiologic features. Renal artery stenosis is commonly atherosclerotic and is diagnosed with Doppler US, CT angiography, or MR angiography. Fibromuscular dysplasia, the second most common cause of renal artery narrowing, has a characteristic string-of-beads appearance resulting from multifocal stenoses and dilatations. Manifestations of renal vasculitis differ depending on whether the affected vessels are large, medium, or small. Renal vascular injury is graded according to the American Association for the Surgery of Trauma (AAST) renal injury scale, which defines vascular injury and active bleeding in renal injuries. Both renal arteries and veins are affected by primary neoplasms or secondarily by neoplasms from adjacent structures. Differentiation between bland thrombus and tumor thrombus and the extent of involvement dictate management in malignancies, especially renal cell carcinoma. Aneurysms, pseudoaneurysms, arteriovenous malformations, and arteriovenous fistulas can affect renal vessels and can be diagnosed with specific imaging features. The radiologist has a critical role in identification of specific imaging characteristics and establishing the diagnosis in the varied pathologic conditions affecting the renal vasculature, which is critical for directing management. Thus, the renal vasculature should be an integral part of radiologists' checklist. ©RSNA, 2021.

Comparison of a Single Versus Double Perclose Technique for Percutaneous Transfemoral Transcatheter Aortic Valve Replacement.

The optimal strategy for arterial closure in percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR) remains under debate. Single-center, prospective, observational study of consecutive patients undergoing TF-TAVR between March 2018 and December 2019 who underwent closure with an upfront single vs double Perclose device. Device success, access-site vascular, and bleeding complications were defined according to the Valvular Academic Research Consortium (VARC)-2 criteria. Inverse-probability of treatment weighting (IPTW) was used to balance baseline characteristics between groups. A total of 241 patients (mean age, 81.4 ± 8.5 years, 47% women) were included, of which 127 underwent an upfront single-Perclose (SP) strategy and 114 underwent an upfront double-Perclose (DP) strategy. Fifty-six percent of patients were treated with a CoreValve (Medtronic). The SP group was less likely to be on dialysis and on aspirin, but were more likely to receive a CoreValve, with larger valve sizes and larger delivery sheaths. Baseline characteristics were well balanced after IPTW adjustment. Device success rate was comparable between groups (96% in the SP group vs 93% in the DP group; P=.39). The SP technique was associated with fewer vascular complications (8.7% in the SP group vs 26.3% in the DP group; P<.01; IPTW relative risk [RR], 0.34; 95% confidence Interval [CI], 0.16-0.71) and bleeding complications (2.4% in the SP group vs 12.3% in the DP group; P<.01; IPTW RR, 0.21; 95% CI, 0.06-0.76) compared with the DP technique. There were no differences in 30-day mortality. An upfront SP technique is equally efficacious and not associated with increased vascular and bleeding complications compared with an upfront DP technique in patients undergoing percutaneous TF-TAVR.

Dry Field Closure of Large-Bore Access With Iliac Artery Angioplasty Through the Ipsilateral Sheath: The Single-Access Dry-Closure Technique.

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Meanwhile, the interventional community has gradually shifted from an open surgical to endovascular closure. However, vascular access complications and bleeding still remain a significant risk. Various techniques involving an additional access site have been described to allow for endovascular bailout of potential complications. However, these by themselves create an additional burden to procedural morbidity. Furthermore, the weight of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the "second arterial access" strategy. For that reason, we propose an alternative strategy, the "single-access dry-closure" technique, which provides vascular access control without the additional burden and risk of a second arterial access. This involves the use of low-pressure iliac artery occlusive angioplasty, delivered through the ipsilateral sheath during the endovascular closure. We hereby describe the steps, advantages and disadvantages of this novel technique. We also include the description of multiple technical variations depending on the use of one or two preclosed Proglide devices. This novel approach seems to be a safe, effective, simple, fast and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. It also lowers contrast volume and radiation exposure while improving the overall set-up and operator ergonomics.

Fibrin(ogen) as a Therapeutic Target: Opportunities and Challenges.

Fibrinogen is one of the key molecular players in haemostasis. Thrombin-mediated release of fibrinopeptides from fibrinogen converts this soluble protein into a network of fibrin fibres that form a building block for blood clots. Thrombin-activated factor XIII further crosslinks the fibrin fibres and incorporates antifibrinolytic proteins into the network, thus stabilising the clot. The conversion of fibrinogen to fibrin also exposes binding sites for fibrinolytic proteins to limit clot formation and avoid unwanted extension of the fibrin fibres. Altered clot structure and/or incorporation of antifibrinolytic proteins into fibrin networks disturbs the delicate equilibrium between clot formation and lysis, resulting in either unstable clots (predisposing to bleeding events) or persistent clots that are resistant to lysis (increasing risk of thrombosis). In this review, we discuss the factors responsible for alterations in fibrin(ogen) that can modulate clot stability, in turn predisposing to abnormal haemostasis. We also explore the mechanistic pathways that may allow the use of fibrinogen as a potential therapeutic target to treat vascular thrombosis or bleeding disorders. Better understanding of fibrinogen function will help to devise future effective and safe therapies to modulate thrombosis and bleeding risk, while maintaining the fine balance between clot formation and lysis.

Thromboses and Hemostasis Disorders Associated with COVID-19: The Possible Causal Role of Cross-Reactivity and Immunological Imprinting.

By examining the issue of the thromboses and hemostasis disorders associated with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) through the lens of cross-reactivity, it was found that 60 pentapeptides are shared by SARS-CoV-2 spike glycoprotein (gp) and human proteins that— when altered, mutated, deficient or, however, improperly functioning— cause vascular diseases, thromboembolic complications, venous thrombosis, thrombocytopenia, coagulopathies, and bleeding, inter alia. The peptide commonality has a relevant immunological potential as almost all of the shared sequences are present in experimentally validated SARS-CoV-2 spike gp-derived epitopes, thus supporting the possibility of cross-reactions between the viral gp and the thromboses-related human proteins. Moreover, many of the shared peptide sequences are also present in pathogens to which individuals have previously been exposed following natural infection or vaccinal routes, and of which the immune system has stored imprint. Such an immunological memory might rapidly trigger anamnestic secondary cross-reactive responses of extreme affinity and avidity, in this way explaining the thromboembolic adverse events that can associate with SARS-CoV-2 infection or active immunization.

Short term outcomes of Impella circulatory support for high-risk percutaneous coronary intervention a systematic review and meta-analysis.

Aim of this study is to evaluate short term safety and efficacy of Impella in high risk percutaneous coronary intervention (HR-PCI) population. While several studies demonstrated the clinical significance of Impella in HR-PCI, few data exist about its impact on short term outcome. All studies reporting short term outcomes of PCI with any Impella device were included. The primary endpoint was either in-hospital or 30-day mortality, while vascular complications, post-procedural stroke, post-procedural dialysis and bleeding complications were assessed as secondary outcomes. Nine studies with 7448 patients were included. Median age was 69.5 years old (67-73), with a mean ejection fraction of 29.7% (20%-39%) and a Syntax score of 30.2 (25. 5-33, interquartile [IQR]). Impella 2.5 was the most commonly used axial flow pump used to support these PCIs (88.7%). In-hospital death was observed in 5.09% of patients (95% confidence interval [CI] 3.69-6.49, I2 = 78%), while vascular complications in 2.53% of patients (1.07-4.00, I2 = 89%) and post-procedural stroke in 2.77% of patients (0.50-6.05, I2 = 98%). Major bleeding occurred in 5.98% of patients (3.66-8.31, I2 = 90%) and post-procedural dialysis in 4.44% of patients (1.50-7.37, I2 = 93% all CI 93%). Use of Impella in high risk PCI appears to have an acceptable rate of complication, especially regarding vascular complications and major bleedings.

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Background: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. Methods: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. Results: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). Conclusions: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Safe and rapid radial hemostasis achieved using a novel topical hemostatic patch: Results of a first‐in‐human pilot study using hydrophobically modified polysaccharide‐chitosan

The transradial approach (TRA) for catheter interventions decreases vascular complications and bleeding versus transfemoral approach. Reducing time to hemostasis and preventing radial artery occlusion (RAO) following TRA are important and incompletely realized aspirations. This first-in-human study sought to evaluate the efficacy of a novel, topically applied compound (hydrophobically modified polysaccharide-chitosan, hm-P) plus minimal required pneumatic compression, to achieve rapid radial arterial hemostasis in post-TRA procedures compared with de facto standards. About 50 adult patients undergoing 6 French diagnostic TRA procedures were prospectively enrolled. At procedure completion, a topical hm-P impregnated patch was placed over the dermotomy and TR Band (TRB) compression was applied to the access site. This patch was used as part of a novel rapid deflation protocol with a primary outcome of time to hemostasis. Photographic and vascular ultrasound evaluation of the radial artery was performed to evaluate the procedural site. Time to hemostasis was 40.5 min (IQR: 38-50 min) with the majority of patients (n = 39, 78%) not requiring reinflation. Patients with bleeding requiring TRB reinflation were more likely to have low body weight and liver dysfunction, with absence of hypertension and LV dysfunction. The rate of RAO was 0% with predischarge radial artery patency documented in all patients using vascular ultrasound. One superficial hematoma was noted. No late bleeding events or cutaneous reactions were reported in the study follow-up. Topical application of hm-P in conjunction with pneumatic compression was safe and resulted in rapid and predictable hemostasis at the arterial puncture site.

Impella versus extracorporal life support in cardiogenic shock: a propensity score adjusted analysis.

AimsThe mortality in cardiogenic shock (CS) is high. The role of specific mechanical circulatory support (MCS) systems is unclear. We aimed to compare patients receiving Impella versus ECLS (extracorporal life support) with regard to baseline characteristics, feasibility, and outcomes in CS.Methods and resultsThis is a retrospective cohort study including CS patients over 18 years with a complete follow‐up of the primary endpoint and available baseline lactate level, receiving haemodynamic support either by Impella 2.5 or ECLS from two European registries. The decision for device implementation was made at the discretion of the treating physician. The primary endpoint of this study was all‐cause mortality at 30 days. A propensity score for the use of Impella was calculated, and multivariable logistic regression was used to obtain adjusted odds ratios (aOR).In total, 149 patients were included, receiving either Impella (n = 73) or ECLS (n = 76) for CS. The feasibility of device implantation was high (87%) and similar (aOR: 3.14; 95% CI: 0.18–56.50; P = 0.41) with both systems. The rates of vascular injuries (aOR: 0.95; 95% CI: 0.10–3.50; P = 0.56) and bleedings requiring transfusions (aOR: 0.44; 95% CI: 0.09–2.10; P = 0.29) were similar in ECLS patients and Impella patients. The use of Impella or ECLS was not associated with increased odds of mortality (aOR: 4.19; 95% CI: 0.53–33.25; P = 0.17), after correction for propensity score and baseline lactate level. Baseline lactate level was independently associated with increased odds of 30 day mortality (per mmol/L increase; OR: 1.29; 95% CI: 1.14–1.45; P < 0.001).ConclusionsIn CS patients, the adjusted mortality rates of both ECLS and Impella were high and similar. The baseline lactate level was a potent predictor of mortality and could play a role in patient selection for therapy in future studies. In patients with profound CS, the type of device is likely to be less important compared with other parameters including non‐cardiac and neurological factors.

Non-operative management of blunt splenic trauma: The role of splenic artery embolization depending on the severity of parenchymal injury

PurposeTo address the disagreement about the need for splenic artery embolization (SAE) in medium grade blunt splenic trauma this retrospective study evaluates the clinical outcome of non-operative management (NOM) and the possible impact of a more liberal indication for primary SAE. MethodFrom 01/2010 to 12/2019 186 patients presented with splenic injury on computed tomography (CT) after blunt abdominal trauma. The extent of splenic injuries according to Marmery, vascular pathologies, active bleeding as well as clinical and laboratory parameters were recorded and analyzed with regard to the success rates of NOM and SAE. Procedural complications and clinical outcome were noted. The number needed to treat (NNT) was determined for a possible extension of the indication for SAE to grade 3 injuries. ResultsOf 186 patients 126 were managed non-operatively, 47 underwent primary SAE and twelve splenectomy. NOM was successful in 119/126 (94 %) patients. Conversion rate was significantly higher in patients with active bleeding or vascular pathology. Patients with failed NOM had a significantly greater decrease in haemoglobin and haematocrit levels. Primary SAE was successful in 45/47 (96 %) cases. Major complications occurred in four cases (9%), all managed without sequela. The NNT in grade 3 splenic injuries equals 13. ConclusionsNOM of low to medium-grade blunt splenic trauma has a low failure rate. Presence of active haemorrhage is the most important predictor for failure of NOM. SAE should be reserved for high-grade injuries and visible vascular pathology or active bleeding to avoid a disproportionate increase in the NNT.

Assessing bleeding risk in 18 children with Osteogenesis imperfecta

Assessing bleeding risk in 18 children with <i>Osteogenesis imperfecta</i>

Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial

In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

Prostaglandin E1 Is an Efficient Molecular Tool for Forest Leech Blood Sucking.

From a survival perspective, it is hypothesized that leech saliva exhibits certain physiological effects to ensure fast blood-feeding, including analgesia, anesthesia, and anti-inflammation to stay undetected by the host and vasodilatation and anti-hemostasis to ensure a steady, rapid, and sustained blood flow to the feeding site. Many anti-hemostatic compounds have been identified in leech saliva, such as hirudin, calin, and bdellin A. However, no specific substance with direct vasodilatory and anti-inflammatory function has been reported from forest leech saliva. Herein, using activity-guided analysis, prostaglandin E1 (PGE1) was identified for the first time as an efficient molecular tool for forest leech blood sucking. The structure of PGE1 was analyzed by nuclear magnetic resonance spectroscopy and high-resolution electrospray ionization mass spectroscopy. PGE1 was found to be primarily distributed in the leech salivary gland (1228.36 ng/g body weight). We also analyzed how forest leech PGE1 affects platelet aggregation, skin vascular permeability, bleeding time, and pain. Results indicated that PGE1 efficiently inhibited platelet aggregation induced by adenosine diphosphate (ADP) (5 μM) with an IC50 of 21.81 ± 2.24 nM. At doses of 10, 100 nM, and 1 μM, PGE1 increased vascular permeability by 1.18, 5.8, and 9.2 times. It also prolonged bleeding time in a concentration-independent manner. In the formalin-induced mouse paw pain model, PGE1 suppressed acute pain. To the best of our knowledge, this is the first report on PGE1 in invertebrates. The functions of PGE1, such as vasodilation, platelet aggregation inhibition, anti-inflammation, and pain alleviation, may facilitate the ingestion of host blood by leeches.

In-Hospital and Mid-Term Outcomes of ECMO Support During Coronary, Structural, or Combined Percutaneous Cardiac Intervention in High-Risk Patients – A Single-Center Experience

IntroductionEvidence regarding the impact of prophylactic implantation of Extracorporeal Membrane Oxygenation (ECMO) during coronary or structural procedures is limited. The purpose of this paper is to evaluate the in-hospital and medium term outcomes of ECMO support in complex percutaneous coronary or structural intervention. MethodsThe present is an observational prospective study including consecutive patients who underwent to prophylactic ECMO implantation for percutaneous coronary intervention (PCI), structural or combined interventions between July 2018 and July 2020 in Maria Pia Hospital GVM Care & Research, Turin, Italy. Primary endpoints were in-hospital and medium term all-cause death. Secondary endpoints were vascular complication, bleeding and procedural success. Results27 patients were included with a mean age of 80 ± 6 years, 10 (37%) being diabetics and 19 (70%) with severe left ventricle dysfunction. Mean Logistic Euroscore was 28.7 ± 18.7. Seven patients (26%) underwent complex coronary revascularization, 7 (26%) combined PCI + TAVI, 5 (19%) combined PCI + Mitraclip, 5 (19%) TAVI alone and finally 3 (11%) combined TAVI + Mitraclip. The procedural success was 96%, with only one in-hospital death due to major vascular complication at the ECMO vascular access. At a mean follow-up of 11 ± 6.8 months 4 deaths were recorded (3 from not cardiovascular causes). ConclusionsProphylactic use of ECMO may be beneficial for high risk patients undergoing complex combined coronary/structural percutaneous interventions with good in-hospital and mid-term outcomes in term of safety and procedural success.

Clival fractures in children: a challenge in the trauma room setting!

A clival fracture is a rare but life-threatening traumatic brain injury in the adult and pediatric populations. To date, there are very few conclusive recommendations in the literature concerning the diagnosis and treatment of pediatric clival fractures. In 2014 and 2015, two pediatric patients with severe blunt head trauma and clival fractures were evaluated and treated at a level I trauma center. Both cases are documented and supplemented by an extensive review of the literature focusing on the diagnostic workup, classification, and clinical course of clival fractures in children. The clinical course of two children (8 and 9 years old) with clival fractures in concert with other intra- and extracranial injuries was analyzed. A total of 17 papers encompassing 37 patients (age range, 1-18 years) were included for a systematic review. The literature review revealed a mortality rate of 23% in pediatric patients with a clival fracture. Over 50% of the patients presented with cranial nerve damage, and two-thirds suffered from intracranial vascular damage or intracerebral bleeding. Clival fractures are a very rare but severe consequence of blunt head trauma in the pediatric population and may be challenging to diagnose, especially in cases with an unfused sphenooccipital synchondrosis. Vascular damage following clival fractures appears to be as common in pediatric patients as in adults. Therefore, contrast-enhanced CT of the cervical spine and head and/or magnetic resonance angiography is strongly recommended to rule out vascular injury of the extra- and intracranial brain-supplying vessels within the trauma room setting.

Abstract 16527: Peri-Procedural and 45-Day Outcomes in the Roll-In Cohort of the Amplatzer Amulet Ide Trial of Left Atrial Appendage Occlusion

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.

Abstract 14648: Gender Differences in Procedural Complications Associated With Atrial Fibrillation Catheter Ablation: A Systematic Review and Meta-analysis of 244,353 Patients

Introduction: Women undergoing atrial fibrillation catheter ablation (AFCA) have higher rates of vascular complications and major bleeding. However, studies have been underpowered to detect differences in rare complications such as stroke/transient ischemic attack (TIA) and procedural mortality. Methods: We performed a systematic review of databases (PubMed, World of Science, Embase) to identify studies published since 2010 reporting AFCA complications by gender. Six complications of interest were: 1) vascular/groin complications; 2) pericardial effusion/tamponade; 3) stroke/TIA; 4) permanent phrenic nerve injury; 5) major bleeding &amp; 6) procedural mortality. For meta-analysis, random effects models were used when heterogeneity between studies was ≥ 50% (vascular complications, major bleeding) and fixed effects models for other endpoints. Results: Of 5716 citations, 19 studies met inclusion criteria, comprising 244,353 patients undergoing AFCA, of whom 33% were women. Women were older (65.3 ± 11.2 vs. 60.4 ± 13.2 years), more likely hypertensive (60.6 vs. 55.5%) and diabetic (18.3 vs. 16.5%) and had higher CHA 2 DS 2 -VASc scores (3.0 ± 1.8 vs. 1.4 ± 1.4) (p&lt;0.0001 for all comparisons). The rates of all 6 complications were significantly higher in women (Table). However, despite statistically significant differences, the overall incidences of major complications were very low in both genders: stroke/TIA (women 0.51 vs. men 0.39%) and procedural mortality (women 0.25 vs. men 0.18%). Conclusion: Women experience significantly higher rates of AFCA complications. However, the incidence of major procedural complications is very low in both genders. The higher rate of complications in women may be partially attributable to older age and a higher prevalence of comorbidities at the time of ablation. More detailed studies are needed to better define the mechanisms of increased risk in women and to identify strategies for closing the gender gap.

The predictive value of CHA2DS2-VASc score on adverse in-hospital outcomes among patients with the acute coronary syndrome and atrial fibrillation who undergo PCI

Abstract Background Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and having concomitant atrial fibrillation (AF) have a greater risk of adverse short- and long-term outcomes and death compared with patients in the same setting but without AF. On the other hand, the predictive value of CHA2DS2-VASc score in terms of in-hospital mortality and periprocedural adverse events following PCI among patients with ACS and AF is unknown. Purpose We retrospectively analyzed data of patients with the main admission diagnosis of ACS that underwent PCI and had AF during the 2004–2014 period from the large nationwide US National Inpatient Sample (NIS) database. Methods A CHA2DS2-VASc score was calculated for each patient and incorporated into a multivariable-adjusted logistic regression to determine its independent impact on in-hospital outcomes consisting of death, acute kidney injury (AKI), bleeding, vascular injury, and stroke/transient ischemic attack (TIA). Results A total of 283,890 patients with AF who underwent PCI following ACS were included in the analysis. The average reported prevalence of the AF in the whole cohort was 10.0% with a significant trend (p&amp;lt;0.001) of increase during the observed 10-year period. The average age of the cohort was 72.1±11 years, 63.4% were male while the median CHA2DS2-VASc score was 3 (IQR 2–4). Crude rates of adverse in-hospital outcomes were significantly higher among patient groups with higher CHA2DS2-VASc score (Table 1). Following adjustment for baseline covariates, incremental increase in CHA2DS2-VASc score was independently associated with an increased odds of in-hospital death (OR 1.20, CI 95% 1.18–1.22), periprocedural vascular injury (OR 1.18, 95% CI 1.17–1.20), bleeding (OR 1.17, 95% CI 1.16–1.18), stroke/TIA (OR 1.17, 95% CI 1.15–1.19), and AKI (OR 1.05, 95% CI 1.04–1.06) (Figure 1). Conclusions The CHA2DS2-VASc score provides important prognostic information in ACS patients with AF undergoing PCI and is independently associated with in-hospital death and periprocedural adverse events. Therefore, CHA2DS2-VASc score could be used as a practical and inexpensive tool for risk stratification in this population. Figure 1 Funding Acknowledgement Type of funding source: None

Early and midterm outcomes after transaxillar versus transfemoral TAVI. data from the spanish TAVI registry

Abstract Transaxillary access (TAx) has emerged as a less invasive alternative access when transfemoral access (TF) is not possible in patients undergoing TAVI. The primary endpoint of this study was to compare total in-hospital and 30-day mortality of patients included in the Spanish TAVI registry that were treated by TAx versus TF access. Methods All patients included in the Spanish TAVI registry who were treated by TAx or TF access were analyzed. In-hospital and 30-days outcomes were assessed using the Valve Academic Research Consortium definitions. An analyses by propensity score matching and multilevel logistic regression was performed for comparing both groups. Results A total of 6603 patients were included, of whom 191 (2.9%) were treated by TAx and 6412 were treated with TF access. After the adjustment, the device success was similar between both groups (94%, TAx vs 95%, TF p=0.95) as well as the rate of vascular complications (11.9% Tax vs 11.9 TF; p=0.78), bleeding (7.7% TAx vs. 7.9% TF; p=0.62) and stroke (4.2% TAx vs. 2.0 TF; p=0.09). However, in-hospital and 30-day mortality was significantly higher in TAx access group versus TF 2.19 (1.13–4.26): p=0.02 and 2.11 (1.08–4, 13); P=0.02, respectively. Similarly, the rate of acute myocardial infarction 5.05 (1.94–13.1); p=0.001, renal complications 2.07 (1.19–3.60; p =) 0.01 and pacemaker implantation 1.56 (1.01–2.40); p=0.04 was higher in the TAx group versus TF. Conclusions Transaxillary access compared to transfemoral access is associated with an increase in total in-hospital and 30-day mortality, as a result TAx access should be considered only in those cases in which TF is not possible Funding Acknowledgement Type of funding source: None

Effectiveness and safety of high dose clopidogrel plus aspirin in ischemic stroke patients with the single CYP2C19 loss-of-function allele: a randomized trial

BackgroundDual antiplatelet aggregation therapy leads to better outcomes in patients with carotid artery stenosis, intracranial artery stenosis, minor strokes, or transient ischaemic attacks. However, carriers of the CYP2C19 loss-of-function allele may not experience the desired effects. We attempted to increase the clopidogrel dose to determine whether it would improve the outcomes of stroke patients who carry a single loss-of-function allele.MethodsWe recruited 131 patients with minor ischaemic stroke, within less than 7 days of stroke onset and a CYP2C19 loss-of-function allele, who had moderate-to-severe cerebral artery stenosis. Patients were divided into the high dose group (clopidogrel 150 mg per day + aspirin 100 mg per day over 21 days.) and a normal dose group (clopidogrel 75 mg per day + aspirin 100 mg per day over 21 days). The reported outcomes included any vascular or major bleeding events as the primary and safety endpoints, respectively.ResultsOne and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively. However, no significant difference was found between the two groups when adjusted for history of diabetes (hazard ratio, 5482; 95% confidence interval, 0.660 to 45.543; P = 0.115). No major bleeding events occurred.ConclusionsIn patients with ischaemic stroke who had a single CYP2C19 loss-of-function allele and moderate to severe cerebral stenosis, fewer vascular events occurred within 3 months with high dose of clopidogrel and aspirin than with normal dose of clopidogrel and aspirin. However, the difference between the two groups was not significant.Trial registrationClinical study of clopidogrel in the treatment of patients with symptomatic moderate to severe cerebral artery stenosis with intermediate metabolites of CYP2C19, URL: http://www.chictr.org.cn/. Unique identifier: ChiCTR1800017411, 07/28/2018;