Distal Versus Conventional Radial Access for Coronary Angiography and Intervention The DISCO RADIAL Trial

BACKGROUND Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation

Incidence and clinical course of limb dysfunction post cardiac catheterization: a systematic review

BackgroundWe sought to systematically review the available literature on limb dysfunction after transradial or transfemoral cardiac catheterization.Methods & ResultsMEDLINE and EMBASE were searched for studies evaluating any transradial or transfemoral procedures and limb function outcomes. Data was extracted, results were narratively synthesized with similar treatment arms. 15 studies with 3616 participants were included in transradial access (TRA) group. 3 studies reported nerve damage with a combined incidence of 0.16%, 4 studies reported sensory loss, tingling and numbness with a pooled incidence of 1.61%. Pain after TRA was the most common form of limb dysfunction (7.77%) reported in 3 studies. The incidence of hand dysfunction defined as disability, grip strength change, power loss or neuropathy was low at 0.49%. Although RAO was not a primary end point for this review, it was observed in 3.57% of the participants in a total of 8 studies included.4 studies with 15,903,894 participants were included in the transfemoral access (TFA) group. Rate of peripheral neuropathy was observed at 0.004%, sensory neuropathy due to local groin injury and retroperitoneal haematomas was 0.04% and 0.17% respectively, whereas motor deficit due to femoral and obturator nerve damage was 0.13%.ConclusionsLimb dysfunction post cardiac catheterization is rare, patients may have nonspecific sensory and motor complaints that resolve over a period of time

SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals

Chronic radial artery occlusion does not cause exercise induced hand ischemia

Objectives: The aim of the study was to evaluate the occurrence of hand ischemia in patients with radial artery occlusion (RAO), using the contralateral hand as control. Background: Radial artery occlusion is a common complication (6%) after transradial access (TRA) but rarely leads to major ischemic events due to the collateral perfusion of the hand. However, it has been reported that RAO can become symptomatic, possibly as a consequence of hand ischemia. To evaluate the existence of exercise induced hand ischemia in patients with RAO, we initiated the present study. Methods: After a transradial coronary procedure, patients with suspicion of RAO were asked for study participation. After informed consent, radial ultrasound was performed. In patients with confirmed RAO, rest perfusion of the digits was analyzed by laser Doppler digital imaging. Occurrence of ischemia during exercise was assessed with transcutaneous oxygen pressure (TcPO2) and thumb capillary lactate. All analyses were performed in both the RAO side as well as the contralateral side as control. Results: RAO occlusion was confirmed in 18 patients. After 5 min of exercise there were no significant differences in TcPO2 (51.4 mmHg [±17.2] vs 43.9 mmHg [±15.5], P = 0.18) or lactate (2.0 mmol/L [±0.7] vs 2.1 mmol/L [±0.7], P = 0.80) between RAO side and control side. Differences in mean TcPO2 were found to be stable during exercise and not different from baseline differences. Conclusions: Chronic radial artery occlusion does not lead to exercise induced hand ischemia

Hand Sensibility after Transradial Arterial Access: An Observational Study in Patients with and without Radial Artery Occlusion

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Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access

Contains fulltext : 246507.pdf (Publisher’s version ) (Open Access

A randomised trial of sheathless versus conventional access for transradial interventions

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Inflammatory cell content of coronary thrombi is dependent on thrombus age in patients with ST-elevation myocardial infarction

BACKGROUND: ST-elevation myocardial infarction (STEMI) is typically caused by an occlusive coronary thrombus. The process of intracoronary thrombus formation is poorly understood. It is known that inflammatory cells play a role in the formation and resolution of venous thrombi, however their role in coronary thrombosis is not clear. We therefore analyzed inflammatory cells in thrombi derived from patients with STEMI in relation to histologically classified thrombus age. METHODS: Thrombus aspirates of 113 patients treated with primary percutaneous coronary intervention were prospectively collected and classified (fresh, lytic, or organized) based on hematoxylin and eosin staining. The density of inflammatory cells neutrophils (MPO), monocytes/macrophages (CD68), lymphocytes (CD45), and the platelet area (CD31), were visualized using immunohistochemistry. Patients' history, medication, and laboratory data were registered. RESULTS: Fresh thrombi (76.1%) were the most abundant as compared to lytic (16.8%) and organized (7.1%) thrombi. Neutrophils were significantly less present in organized (169cells/mm(2)) compared to fresh (327 cells/mm(2)) and lytic thrombi (311 cells/mm(2)). Monocytes/macrophages were significantly more present in lytic (471 cells/mm(2)) than in fresh (312 cells/mm(2)) thrombi. We additionally found that thrombi from patients aged 50 years old contained significantly more neutrophils and monocytes/macrophages irrespective of thrombus age. Furthermore platelet area was smaller in patients on aspirin again irrespective of thrombus age. No gender differences were found. CONCLUSIONS: The composition of inflammatory cells differs with thrombus age in thrombosuction material of STEMI patients that in part depends on patient age and medication

The long-term effect of transradial coronary catheterisation on upper limb function

Item does not contain fulltextAIMS: Anatomic and physiologic changes that are induced by radial access may lead to a decrease of upper limb function at long-term follow-up; however, this has never been studied. We aimed to study the long-term effect of transradial catheterisation on upper limb function. METHODS AND RESULTS: Between January 2013 and April 2014, upper limb function was assessed in a total of 348 patients with complete one-year follow-up after coronary catheterisation. Upper limb function was assessed with the self-reported shortened version of the DASH questionnaire. The presence and severity of upper extremity cold intolerance was assessed with the self-reported CISS questionnaire. Both questionnaires were completed before the catheterisation and at one-year follow-up. Higher scores represent worse upper limb functionality or symptoms. The non-parametric Wilcoxon signed-rank test was used to assess the change of upper limb function and symptoms over time. Extremity complaints were reported at one-month and one-year follow-up. At one-year follow-up, upper limb function did not change over time when catheterisation was performed through the radial artery (p-value 0.20). Upper extremity was also not affected by cold intolerance at one-year follow-up (p-value 0.09). Extremity complaints were reported equally in both access groups and diminished significantly over time (p-value <0.001). CONCLUSIONS: Upper limb function was not affected at long-term follow-up after transradial procedures

Non-invasive assessment of the collateral circulation in the hand: validation of the Nexfin system and relation to clinical outcome after transradial catheterisation

AIMS: This study aims primarily to assess the extent of the collateral circulation of the hand in a combined population of healthy individuals and patients who underwent transradial catheterisation, using both the Nexfin system and laser Doppler perfusion imaging. METHODS AND RESULTS: In total, 85 adults were included in the study (18 healthy volunteers; 67 patients who underwent transradial catheterisation). The perfusion of the thumb was assessed prior to and during complete radial artery compression using laser Doppler perfusion imaging (LDPI) and the Nexfin system. The palmar collateral flow index (PCFI) was compared between both devices and PCFINEXFIN was related to hand angiography and the upper limb function, using the QuickDASH questionnaire. Mean PCFILDPI was 0.77+/-0.15 and mean PCFINEXFIN was 0.88+/-0.08. Both were significantly related (Pearson correlation=0.49, 95% CI: 0.31-0.64, p<0.001, agreement -0.11+/-0.13). PCFINEXFIN correlated with the maximal diameter of the superficial palmar arch (R=0.49, p=0.04) and total minimal arch diameter (R=0.51, p<0.02). High PCFINEXFIN, measured at baseline, was correlated with a lower QuickDASH score for pain, activity and total at one month post transradial catheterisation (p=0.02, p<0.01, p<0.01), but not with discomfort or disability. CONCLUSIONS: The Nexfin monitoring system is comparable with laser Doppler perfusion imaging in the quantification of the collateral perfusion in the hand. In patients, the Nexfin-derived collateral flow index measured at baseline is associated with clinical outcome at 30 days post transradial catheterisation