TR Band Research Articles

Prevention of radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC). A randomized duplex ultrasound follow-up study

BackgroundThere might be a beneficial effect of transient ulnar artery compression in prevention of radial artery occlusion (RAO) after trans-radial catheterization. ObjectiveThe objective of this study was to assess, by Duplex ultrasound, the efficacy of simultaneous ulnar and radial artery compression (SURC), in prevention of RAO, compared to conventional and patent hemostasis techniques. Patients and methodsFour hundred and fifty consecutive patients undergoing elective trans-radial catheterization were enrolled. Patients were randomized in 1:1:1 fashion into 3 groups; conventional hemostasis (Group A, n = 150 patients), patent hemostasis (Group B, n = 150 patients), and SURC technique (Group C, n = 150 patients). RAO was assessed by duplex ultrasound at 1-h post TR band removal (primary endpoint), and at 1-month. ResultsThe primary endpoint, RAO 1-h post TR-band removal, was significantly lower among patients of group C as compared to those of group A and B (1.3%, 6.7%, and 7.3%, respectively –p = 0.03). This was still consistent at 1-month (0.7%, 8%, and 6%, respectively –p = 0.03). Multiple regression analyses revealed that lower radial artery diameter (RAD) after flow-mediated dilatation (FMD) independently predicted RAO at 1-h, while RAD at 1-h post-TR band removal was the only independent predictor of RAO at 1-month. Receiver operator characteristic (ROC) analysis showed that RAD at 1-h post-TR band removal at cut-off ≤1.75 mm could predict RAO at 1-month with high accuracy (AUC = 0.9, CI = 0.8–1.0, p < 0.001–86% sensitivity, and 95% specificity). ConclusionA technique of SURC is associated with less incidence of early and late RAO compared to conventional hemostasis techniques.

Frequency and Predictors of Radial Artery Occlusion in Patients Undergoing Percutaneous Coronary Intervention.

Background and objectiveTransradial access (TRA) has become the preferred route for percutaneous coronary interventions (PCI), and this site is often a chink in the armor for staged PCI. In this study, we aimed to evaluate the incidence and predictors of radial artery occlusion (RAO) after TRA.MethodsWe conducted a retrospective study involving 1,307 patients who underwent PCI at the Tabba Heart Institute (THI) in Karachi, Pakistan from August 2018 to June 2019. TR band was used for hemostasis after PCI.ResultsThe primary outcome of our study was RAO, which was observed in 11.3% of the study subjects. On multivariate analysis, female gender [odds ratio (OR): 1.79, 95% CI: 1.21-2.64], cardiovascular instability (OR: 2.5, 95% CI: 1.22-5.11), dyslipidemia (OR: 0.61, 95% CI: 0.4-0.92), and a higher number of diseased vessels were found to be predictors of RAO (p=0.004).ConclusionRAO is often an asymptomatic complication of TRA. To ensure radial artery patency, a carefully thought-out management plan and follow-up must be devised for high-risk patients.

Study on the Safety of the New Radial Artery Hemostasis Device.

Objective At present, the use of particular radial hemostatic devices after coronary angiography (CAG) or percutaneous coronary intervention (PCI) has become the primary method of hemostasis. Most control studies are based on the products already on the market, while only a few studies are on the new hemostatic devices. The aim of this study is to compare a new radial artery hemostasis device which is transformed based on the invention patent (Application number: CN201510275446) with TR Band (Terumo Medical) to evaluate its clinical effects. Methods In a prospective randomized clinical trial, 60 patients after CAG or PCI were randomly divided into two groups, patients in the trial group (CD group) using a new radial artery hemostasis device to stop bleeding and the control group (TR group) using the TR Band. The method is to collect relevant data of the two groups and compare the differences in hemostasis, local complications, and patient discomfort between the two groups. Results The hemostatic devices in both groups achieved adequate hemostasis, and there was no failure to stop bleeding. The new radial artery hemostasis device was better than the TR band in pain and swelling (P < 0.05). There were no significant differences in bleeding, hematoma, ecchymosis, skin damage, and local infection between the two groups (P > 0.05). Conclusions The sample of the new radial artery hemostasis device can stop bleeding effectively at the puncture site after CAG or PCI and is not inferior to the TR Band balloon hemostatic device in safety and is better in comfort.

Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial.

The aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol. Shorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access. A total of 443 patients were randomized to the TRB or PFHP+ TRB, with complete TRB deflation attempted 60minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation. Time to complete TRB deflation was 66 ± 14minutes with the PFHP vs 113 ± 56minutes for the TRB alone (P< 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P<0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P=0.20). RAO was rare (<1%), although 41% of patients received<5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15minutes vs 138 ± 62minutes; P< 0.001) and composite complications (10.0% vs 24.2%; P=0.04) were reduced with the PFHP. Compared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952).

Iatrogenic Arteriovenous Fistula After Distal Transradial Coronary Angiography.

A 61-year-old woman with a history of hypertension, glucose intolerance, hyperlipidemia, and Sjögren syndrome presented at our hospital with crescendo angina. An exercise stress test with myocardial perfusion imaging revealed a severe, medium-sized apical defect. We made several attempts under ultrasonographic guidance to enter the right distal radial artery at the anatomic snuffbox for diagnostic coronary angiography. Access was obtained on the third attempt. A subsequent coronary angiogram revealed high-grade stenosis of the proximal left anterior descending coronary artery and diagonal branch. The patient then underwent successful percutaneous coronary intervention (PCI) with use of a 6F extra backup 3.5 guide catheter. At her follow-up visit on postoperative day 3, the patient was asymptomatic and reported no chest pain. However, physical examination revealed a thrill over the anatomic snuffbox. A duplex ultrasonogram showed an arteriovenous fistula (AVF) at the access site (Fig. 1A), which we decided to treat with simple compression. First, we modified a radial compression device (TR Band; Terumo Interventional Systems) to fit over the anatomic snuffbox by removing the device's rounded plastic support plate. We then positioned the device over the AVF, inflated it with 16 mL of air, and kept it in place for 4 hours (Fig. 2). A repeat duplex ultrasonogram confirmed resolution of the AVF (Fig. 1B). One month later, a follow-up duplex ultrasonogram showed a patent distal radial artery and no AVF.Coronary angiography through the distal radial artery, a technique pioneered by Kiemeneij, is widely used.1 Advantages include improved patient comfort and shorter hemostasis times.2,3 However, we have found the learning curve to be steeper than for traditional transradial coronary angiography. Ultrasonographic guidance is very useful in the absence of a strong or palpable pulse, especially in smaller females. In rare cases, the distal radial artery approach can result in formation of an AVF at the access site because of the artery's proximity to venous structures and relatively small caliber. Detecting and treating such iatrogenic complications early is key. Simple manual compression should be considered first, although surgical correction may be necessary.4 In this case, we successfully treated an AVF in the anatomic snuffbox with use of a modified compression device.Section editor: Raymond F. Stainback, MD

Efficacy of the hemostatic device VasoSTAT and the study of hemostatic factor

Recently, trans-radial intervention has gained popularity as a common procedure to reduce hemorrhagic complications. However, the cuff-type hemostatic device (TR Band) previously used at our institution required 6 h to achieve hemostasis. Since July 2016, we have been using the VasoSTAT, a new hemostatic device that could achieve hemostasis in 4 h. In a verification study, we found that prolonged activated clotting time (ACT) was related to transient hemorrhage occurrence after the hemostatic procedure. Therefore, we designed a hemostatic protocol based on ACT and evaluated its efficacy. In this retrospective and observational study, 78 and 111 patients used the VasoSTAT and TR Band, respectively, from July 2015 to May 2017. In the VasoSTAT group, the ACTs were significantly lower in the hemostasis success (246 ± 46 s) than in the failure group patients (327 ± 59 s) (P < 0.01). Therefore, we applied the hemostatic protocol to 271 patients from May 2017 to March 2020. The hemostasis success rate was 96% in the post-protocol applied group patients, which was significantly higher than the 82% success rate in the pre-protocol applied group patients (P < 0.01). VasoSTAT resulted in adequate hemostasis in 4 h. Further, ACT was predictive of adequate hemostasis.

Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial).

Vascular access site complications following transradial coronary procedures are less common and severe compared to femoral approach. Radial artery occlusion is considered the main adverse effect. As radial access is gaining more acknowledgement, complication awareness, and understanding is important. The aim was to assess complication rates following transradial coronary procedures and to compare two radial compression devices in a non-inferiority randomized controlled trial. Four hundred and ninety-nine patients were randomized to radial compression with a new device (RY Stop, n = 248) or the reference device (TR Band, n = 251) following transradial coronary procedures. Radial artery occlusion persistent at 90 days was the primary endpoint. Discomfort and accounts of vascular complications at access site were secondary endpoints. Radial artery occlusion was observed in 5% (n = 26) for the entire cohort with no difference between groups (RY Stop 6% vs. TR Band 5%; P = 0.69). Patients overall reported low levels of discomfort and the median scores were similar in both groups; RY Stop: 7 vs. TR Band: 10 (P = 0.90). There were few incidents of bleeding (7%), however, they were significantly more frequent with the RY Stop (12%) than with the TR Band (3%; P = 0.001). Few patients (4%) developed access site haematomas, and the incidence was similar in the two groups (P = 0.98). We observed a radial artery occlusion rate of 5% at 90 days post-procedure. Access site discomfort and vascular complication rates were low. Overall, the RY Stop compression device was not inferior to the TR Band except occurrences of bleeding.

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.

Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a...

Transulnar Catheterization in Patients with Failed Ipsilateral Transradial Access: Novel TR Band Modification for Dual-Site Hemostasis

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

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route.

AimCoronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction.MethodsAll patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale.ResultsA total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 (n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 (n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 (p = 0.01).ConclusionA protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

Feasibility and safety of transradial access for pediatric neurointerventions

BackgroundDiagnostic cerebral angiograms are increasingly being performed by transradial access (TRA) in adults, following data from the coronary literature supporting fewer access-site complications. Despite this ongoing trend in neuroangiography, there...

TR BAND® “LIGHT” PROTOCOL WITH REDUCED COMPRESSION AND DURATION TO REDUCE RADIAL ARTERY OCCLUSION

Radial artery occlusion (RAO) rates of 7 - 8% occur early after transradial access (TRA) using standard compression protocols with a mechanical compression device, i.e. TR band® (Terumo, Japan). Factors associated with increased rates of RAO include longer compression times, higher compression

798 Case of a Percutaneous Balloon Aortic Valvuloplasty Via the Radial Approach

Symptomatic severe aortic stenosis (AS) is common in the elderly with a prevalence of 10% in the age group>than 80. Aortic valve replacement (AVR) is the recommended treatment for patients with symptomatic severe AS. In certain cases, bridging to AVR with a balloon aortic valvuloplasty (BAV) may be needed to stablise the patient. We present a trans-radial BAV case. A frail 76 year-old female with severe AS (mean gradient 70mmHg) admitted with congestive cardiac failure was being considered for trans-catheter aortic valve implantation (TAVI). Due to complex access, anatomical issues and frailty, she was planned for a BAV to assess her symptomatic improvement prior to undertaking an alternate access TAVI. A trans-femoral route was initially attempted. Under conscious sedation, a 5-French sheath was inserted into the right common femoral artery (left common femoral was occluded) under ultrasound guidance with the use of a micro-puncture needle. A slippery wire and a BMW wire were unsuccessful in crossing a severely stenosed external iliac artery. With repeated attempts a retrograde dissection resulted, and this strategy was abandoned. A 6-French radial sheath was inserted and upgraded to a 7-French. The aortic valve was crossed with an AL 0.75 and a straight wire. BAV was undertaken with a 16 mm TYSHAK II (7French compatible). Trans-aortic Peak to Peak gradient went from 80mmHg to 50mmHG. Haemostasis achieved with a TR Band and manual pressure. To our knowledge, this is the first case of a successful BAV via the radial approach.

Benefits of pressure-controlled hemostasis for transradial vascular access: a randomized controlled trial.

Transradial vascular access is widely used due to advantages such as facile hemostasis and reduced bed rest time. Accordingly, several hemostatic devices have been introduced for transradial vascular access. However, the pain caused by hemostatic compression has not yet been resolved. The objective of this study was to determine the optimal compression pressure to minimize pain at the hemostasis site without increasing complications after transradial catheterization. A total of 86 patients who underwent transradial catheterization from November 2014 to March 2015 were prospectively enrolled in this study. In group I (N.=42), the radial arteries were compressed by adjusting the air volume to reach systolic blood pressure plus 20 mmHg. For group II (N.=44), "conventional hemostasis" was performed by injecting a fixed volume (15 mL) of air into the air bag of the TR band. Complications, including pain, rebleeding, hematoma, and radial artery occlusion, were compared between the two groups. In addition, the pain level at the hemostasis site was assessed using a visual analog scale. The visual analog scale of group I was significantly lower than that of group II (1.548±1.549 vs. 2.466±1.682, P=0.01 at application; 1.202±1.700 vs. 2.818±2.060, P<0.001 at removal). The other complications were not significantly different between the two groups. Compared to conventional hemostasis, pressure-controlled hemostasis with systolic blood pressure plus 20 mmHg significantly reduced pain at the hemostasis site after transradial vascular access without increasing the incidence of other complications.

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route

AimCoronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction. MethodsAll patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale. ResultsA total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 (n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 (n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 (p = 0.01). ConclusionA protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio–guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio–guided complete revascularization versus infarct-related artery–only revascularization.

TCT-780 Randomized Comparison of Hemostasis Times Following Transradial Access With a Kaolin-Based Hemostatic Pad (QuikClot® Radial®) vs. Mechanical Compression (TR Band®)

Hemostasis after transradial access is usually achieved with a mechanical compression device. This study investigated the efficacy of the QuikClot Radial pad (QCRP) on hemostasis times compared with mechanical compression with a TR Band. Patients undergoing cardiac procedures using the radial

Incidence and predictors of radial artery occlusion after transradial coronary catheterization

BackgroundRadial artery occlusion (RAO) is considered the most common and devastating complication of transradial approach (TRA). It has been described as the “Achilles’ heel” of the transradial technique. Our aim was to assess the incidence and predictors of radial artery occlusion after transradial coronary catheterization.ResultsThis was a prospective study enrolling 164 patients undergoing percutaneous coronary interventions (PCI) via the transradial approach (TRA) using 6-F catheters. Doppler ultrasonography assessment of the radial artery (RA) was conducted on day 1 and 6 months following the procedure. The studied group included 104 male (63.4%) and 60 female (36.6%) patients with a mean age of 57.7 ± 8.8 years and a mean RA diameter of 2.8 ± 0.5 mm. On day 1, Doppler examination revealed RAO in 54 patients (32.9%). After 6 months, RAO was detected in 49 patients (29.9%). Interestingly, only 1 new case (0.9%) of RAO was noted, and 6 patients (11.1%) had regained their RA patency. On multivariate analysis, female gender, age, manual compression, and RA diameter emerged as independent predictors of RAO. Using TR band for hemostasis for only 2 h was recognized as a potent independent predictor of RA patency on day 1 and 6 months after the procedure (n = 2, 3.7% in the RAO group, vs. n = 23, 20.9% in the non-RAO group, p = 0.004).ConclusionRAO, although clinically a silent issue, has been the main complication following TRA. In patients with high predictors of RAO, careful management and close follow-up are required to ensure radial artery long-term patency.

Comparing TR Band to Statseal in Conjunction With TR Band II

Comparing TR Band to Statseal in Conjunction With TR Band II