International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study.

BACKGROUND: Distal radial access (DRA) has been proposed to improve procedure ergonomics and favor radial artery patency. Although promising data, nothing is known on evolving hand function after DRA. OBJECTIVES: This study sought to comprehensively evaluate hand function in patients undergoing DRA. METHODS: Real-world patients undergoing DRA undertook a thorough multimodality assessment of hand function implementing multidomain questionnaires (Disabilities of the Arm, Shoulder and Hand and Levine-Katz), and motor (pinch grip test) and sensory (Semmes-Weinstein monofilaments test) examinations of both hands. All assessments were performed at preprocedural baseline and planned at 1-, 6-, and 12-month follow-up (FU). Adverse clinical and procedural events were documented too. RESULTS: Data of 313 patients (220 men, age 66 ± 10 years) from 9 international centers were analyzed. The Disabilities of the Arm, Shoulder and Hand and the Levine-Katz scores slightly improved from baseline to FU (P = 0.008 and P = 0.029, respectively). Pinch strength mildly improved from baseline to FU (P < 0.001 for both the left and right hands). Similarly, touch pressure threshold appeared to faintly improve in both the left and right hands (P < 0.012 for all the sites). For both motor and sensory function tests, comparable findings were found for the DRA hand and the contralateral one, with no significant differences between them. Repeated assessment of all tests over all FU time points similarly showed lack of worsening hand function. Access-related adverse events included 19 harmless bleedings and 3 forearm radial artery and 3 distal radial artery occlusions. None affected hand function at FU. CONCLUSIONS: In a systematic multidimensional assessment, DRA was not associated with hand function impairment. Moreover, DRA emerges as a safe alternative vascular access.

Distal arteriovenous fistula formation after percutaneous coronary intervention: An old complication of a new access site.

Dorsal or distal transradial artery access has recently gained popularity due to several perceived benefits that include favorable ergonomics, the potential for rapid hemostasis and lower rates of vascular complications. Still, no vascular access site is free of complications and reports of hematoma and pseudoaneurysm formation related to distal radial artery access have been reported in the literature. We present a case of a 71-year-old male who developed an arteriovenous fistula (AVF) involving the distal left radial artery following repeated access of the artery. This rare complication is likely avoidable with a comprehensive understanding of the surrounding anatomy and proper procedural technique, including the routine use of ultrasound for access.

Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide.

Conventional radial access has been shown to have many advantages over the transfemoral approach. The risk of potential radial artery occlusion and subsequent hand ischaemia can be reduced further by accessing the vessel distally at the anatomical snuffbox, allowing maintenance of antegrade flow to the hand by the superficial palmar arch branch. Additional potential advantages of distal radial access in comparison to the conventional radial approach at the wrist include fewer puncture-site complications and faster post-procedural haemostasis as the vessel is very superficial. Furthermore, it provides another safe, non-femoral option for vascular access. The use of ultrasound guidance enables the operator to identify important anatomical landmarks and avoid injuring adjacent structures. We provide a detailed step-by-step guide for performing distal radial access using sonographic and anatomical correlation, thereby facilitating safe access and optimising technical success.

Distal Versus Conventional Transradial Artery Access for Coronary Angiography and Intervention: A Meta-Analysis.

BACKGROUND: Distal transradial artery access (dTRA) through the anatomical snuffbox is a novel approach for performing coronary angiography and interventions. However, the safety and efficacy of dTRA as compared to conventional TRA (cTRA) remains unknown. We aim to evaluate the outcomes of dTRA versus cTRA for coronary angiography and intervention. METHODS: Electronic search of the National Library of Medicine PubMed and Cochrane Library databases was performed until April 2019 for studies comparing the clinical outcomes of dTRA approach versus conventional TRA (cTRA) approach in coronary angiography and interventions. Random-effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was failure of access site utilization. Other outcomes included access site hematoma, radial artery spasm, dissection, and occlusion. RESULTS: Five studies (4 observational and 1 randomized controlled) with a total of 6746 patients (dTRA n = 3209 and cTRA n = 3537) were available for analysis. The failure rate was similar in dTRA and cTRA groups (5.26% versus 3.75%; RR = 1.36; 95%CI 0.41-4.48; p = 0.62). Similarly, no difference was observed between dTRA and cTRA in regards to access site hematoma (1.20% versus 1.24%, RR = 1.01; 95%CI 0.49-2.07; p = 0.99), radial artery spasm (1.42 versus 3.84%, RR = 0.91; 95%CI 0.32-2.62; p = 0.86), or radial artery dissection (0.11 versus 0.20%, RR = 0.63; 95%CI 0.18-2.16; p = 0.46). The rate of radial artery occlusion was lower with dTRA (2.30 versus 4.86%, RR = 0.51; 95%CI 0.32-0.81; p = 0.004) as compared to cTRA. CONCLUSION: Distal TRA appears to be a safe and effective alternative to conventional TRA. The outcomes of this novel technique warrant further randomized studies.

Validation of the all-comers design: Results of the TARGET-AC substudy.

BACKGROUND: Results of clinical trials are often criticized by low inclusion rate and potential sampling bias in patient recruitment. The aim of this validation registry is to evaluate how far an all-comers design in the context of clinical research can ensure the representation of the true all-comers population. METHODS: This validation registry is a prospective international multicentre registry, conducted at 10 out of the total 21 centers, participating in TARGET-AC (registered under NCT02520180). During a predefined four-week period data were recorded prospectively on all PCIs performed in the participating centers, whether or not patients were enrolled in TARGET-AC. Data were collected on patient demographics, angiographic lesion- and procedural characteristics. For patients who were not enrolled in the study, operators were asked to declare the reason for not enrolling the patient, using a single-choice questionnaire. RESULTS: A total of 131 patients were enrolled in the TARGET-AC study during the investigated period (ER group), standing as 20% (range 4% and 54%) of all eligible cases per protocol. In the ER group more patients presented with stable angina (61% vs. 43%, respectively; P < .001). Whereas ST-elevation infarction was less common (5% vs. 26%, respectively; P < .001), there was no difference in non-ST elevation acute coronary syndrome (32% vs. 27%, respectively; P = .248). Risk factors and comorbidities did not show any difference between the ER and the non-enrolled (NER) groups, except for greater rate of significant valvular disease in the NER group (12% vs 19%, respectively; P = .037). The NER group presented more thrombotic stenoses than the ER group (20% vs 12%, respectively; P = .040). No difference was found in any other investigated angiographic parameters, like target vessels, bifurcation lesion, severe calcification or chronic total occlusions. Admission during regular working hours and availability of study nurse were associated with markedly higher recruitment rate. CONCLUSION: Results suggest that TARGET AC was outbalanced for stable patients over primary PCIs as compared to real world. However in terms of risk factors and comorbidities the trial managed to represent the collective of real world clinical practice. Fairly representative cases were included at an average inclusion-to-eligible rate of 20%.

Distal transradial access as default approach for coronary angiography and interventions.

BACKGROUND: Distal transradial access (dTRA) as a refinement of the conventional transradial access has advantages in terms of patient and operator comfort and risk of radial artery (RA) occlusion. RA preservation with this new technique could be a relevant issue in patients requiring its future use. In turn, one relevant drawback is the more challenging puncture of a smaller artery. In order to evaluate the real world feasibility and safety of both right (rdTRA) and left (ldTRA) distal transradial access as default access site for routine coronary angiography (CAG) and percutaneous coronary intervention (PCI), this prospective observational registry was conducted. METHODS: From February to July 2019, 435 consecutive patients underwent CAG and/or PCI (620 procedures at all, by two experienced transradial operators) through rdTRA or ldTRA. RESULTS: Mean patient age was 62.4 years old. Most were male (66.0%). The majority (49.4%) of patients had an acute coronary syndrome; overall, 15.2% with ST-elevation acute myocardial infarction (STEMI). Distal RA was successfully punctured in all patients, always without ultrasound guidance, with puncture and sheath insertion at until 2 attempts in the vast majority of patients. We had only 3.0% access site crossovers (successful arterial puncture but failed sheath insertion), mainly performed via the contralateral dTRA (53.8%). Successful dTRA sheath insertion was then achieved in 98.6% of all 435 patients. Redo ipsilateral dTRA was performed in 2.5% of patients. Distal and proximal RA pulses were palpable in all patients at hospital discharge. No major adverse cardiac and cerebrovascular events and no major complications were recorded. CONCLUSIONS: dTRA as default approach for routine CAG and/or PCI by experienced transradial operators appears to be safe and feasible. Further randomized and larger trials are still needed to assure the clinical benefits and the safety of this new technique.

ACRA Perfusion Study.

BACKGROUND: Transradial intervention (TRI) may impair digital perfusion with hand dysfunction as a result. However, the effect of TRI on digital perfusion has never been investigated, including the influence of variations of the collateral arterial network and the effect on hand dysfunction. METHODS AND RESULTS: We investigated the effect of TRI on digital perfusion by laser Doppler perfusion imaging. Laser Doppler perfusion imaging was performed at baseline, during radial access, TR band application, and at discharge. We compared tissue perfusion of the homolateral thumb (access site) with the contralateral thumb (comparator) during radial access as primary outcome. The hand circulation was assessed with angiography. Upper extremity function was evaluated with the validated QuickDASH questionnaire at baseline and follow-up. A significant reduction of tissue perfusion was observed during radial access and TR band application in the homolateral thumb (-32%, -32%, respectively) and contralateral thumb (-34%, -21%, respectively). We detected no perfusion difference between the homolateral and contralateral thumb during radial access (217; interquartile range, 112-364 versus 209; interquartile range, 99-369 arbitrary flux units; P=0.59). Reduced perfusion of the thumb during radial access was not associated with incompleteness of the superficial palmar arch ( P=0.13). Digital perfusion improved at discharge, though it remained below baseline levels (homolateral -11% and contralateral -14%). Hand dysfunction at 18 months was not associated with TRI-induced perfusion reduction ( P=0.54). CONCLUSIONS: TRI is safe. Digital perfusion is reduced in both hands during radial access and TR band application but is not associated with future loss of hand function and variations of the arterial hand supply.

Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers.

AIMS: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk®) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population. METHODS AND RESULTS: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 µm vs. XIENCE V 82.3 µm) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9±0.3% vs. 100±0.1%, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. CONCLUSIONS: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

The Radial Artery for Percutaneous Coronary Procedures or Surgery?

This article summarizes the current research on the benefits of using the transradial approach for percutaneous procedures and the radial artery as a conduit for coronary artery bypass surgery. Based on the available evidence, the authors provide recommendations for the use of the radial artery in patients undergoing percutaneous or surgical coronary procedures.

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial.

BACKGROUND: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

The ACRA Anatomy Study (Assessment of Disability After Coronary Procedures Using Radial Access): A Comprehensive Anatomic and Functional Assessment of the Vasculature of the Hand and Relation to Outcome After Transradial Catheterization.

BACKGROUND: The palmar arches serve as the most important conduits for digital blood supply, and incompleteness may lead to digital ischemia when the radial artery becomes obstructed after cardiac catheterization. The rate of palmar arch incompleteness and the clinical consequences after transradial access are currently unknown. METHODS AND RESULTS: The vascular anatomy of the hand was documented by angiography in 234 patients undergoing transradial cardiac catheterization. In all patients, a preprocedural modified Allen test and Barbeau test were performed. Upper-extremity function was assessed at baseline and 2-year follow-up by the QuickDASH. Incompleteness of the superficial palmar arch (SPA) was present in 46%, the deep palmar arch was complete in all patients. Modified Allen test and Barbeau test results were associated with incompleteness of the SPA (P=0.001 and P=0.001). The modified Allen test had a 33% sensitivity and 86% specificity for SPA incompleteness with a cutoff value of >10 seconds and a 59% sensitivity and 60% specificity with a cutoff value of >5 seconds. The Barbeau test had a 7% sensitivity and 98% specificity for type D and a 21% sensitivity and 93% specificity for types C and D combined. Upper-extremity dysfunction was not associated with SPA incompleteness (P=0.77). CONCLUSIONS: Although incompleteness of the SPA is common, digital blood supply is always preserved by a complete deep palmar arch. Preprocedural patency tests have thus no added benefit to prevent ischemic complications of the hand. Finally, incompleteness of the SPA is not associated with a loss of upper-extremity function after transradial catheterization.

Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI).

AIMS: The aim of this technical report is to demonstrate the feasibility of the left distal transradial approach for patients in whom left radial access is preferred over right radial access for coronary angiography and interventions. This procedure is more convenient for the operator. For the right-handed patient, the left radial access is more convenient because of the free use of the right hand after the procedure. In addition, this technique reduces the chance of radial artery occlusion at the site of the distal forearm. METHODS AND RESULTS: Coronary access via the left distal radial artery at the anatomical snuffbox allows comfortable positioning of the dorsal side of the patient's left hand near the right groin. The operator can puncture the artery and perform the coronary cannulation at a safe distance from the radiation source and without the need to bend over the patient. This technique will be described in detail. Procedural and clinical results in the first 70 patients are described. Out of 118 consecutive patients assigned to the author's operation programme, 70 patients were considered suitable for left distal radial access. There were eight procedural failures, requiring crossover to traditional right radial or left radial approach. All other procedures were successful, without major discomfort for the patient and operator. No radial artery occlusions at the site of the forearm were encountered. CONCLUSIONS: Left distal transradial coronary access via the anatomical snuffbox, as default technique for patients who need or prefer left radial access over right radial access, deserves further exploration.

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

AIMS: 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.

Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial.

AIMS: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS: In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.

Endothelial dysfunction and the occurrence of radial artery spasm during transradial coronary procedures: the ACRA-Spasm study.

AIMS: The aim of this study was to analyse the relation between endothelial dysfunction (ED) and the occurrence of radial artery spasm (RAS) during transradial coronary procedures. METHODS AND RESULTS: From May 2014 to June 2015, endothelial function was assessed by EndoPAT and FMD before the procedure in 165 patients referred for coronary angiography or intervention. The primary endpoint was RAS, defined by patient's symptoms and procedural characteristics. The mean age of the study population was 63 years and 71% were male. In total 16% of the patients experienced RAS. The incidence of RAS did not differ between patients with and without ED (13.8% vs. 20.2%, OR 0.63, 95% CI: 0.25-1.58, p=0.32). The strongest predictors of RAS were a ratio of radial artery inner diameter and sheath outer diameter smaller than 1 (OR 4.7, 95% CI: 1.35-16.5, p=0.009) and a combination of clinical characteristics presented as an RAS risk score of at least 4 (p=0.007, OR 3.7, 95% CI: 1.37-9.89). CONCLUSIONS: Endothelial dysfunction was not found to be a predictor of the occurrence of radial artery spasm in a cohort of patients undergoing elective heart catheterisation. Radial artery-sheath mismatch is the strongest pre-procedural predictor of RAS.

Safety and feasibility of the new 5 Fr Glidesheath Slender.

The aim of this study was to evaluate the safety and feasibility of the new 5 Fr Glidesheath Slender (GSS). The transradial (TR) approach has become popular because of several advantages, such as a reduced rate of vascular access site complications. However, because the radial artery is narrow, a limitation of TR access is the potential for artery spasm or occlusion. Studies of radial artery size demonstrate that 5 Fr sheaths are too wide for more than 10 % of patients. The GSS (Terumo, Tokyo, Japan) is a new radial sheath with a thinner wall and a hydrophilic coating. It has an inner diameter that is compatible with a 5 Fr guiding catheter, while the outer diameter is similar to that of a 4 Fr sheath. A total of 21 consecutive patients undergoing transradial angiography and/or transradial percutaneous coronary intervention with the 5 Fr GSS were included, and safety and feasibility of the device were assessed. Transradial angiography was performed in 10 patients, and transradial intervention in 11 patients. All procedures were successful, without the need for conversion to the transfemoral approach. The radial artery occlusion rate was 0 %, including a patient who had experienced six previous radial artery punctures. There were no cases of artery spasm, hematoma, major bleeding or functional disorders. One coronary artery perforation caused by a guidewire was reported, but it was unrelated to the sheath introducer. The new 5 Fr GSS was safe and feasible for transradial angiography and transradial intervention.