The Outback® Elite re-entry device (Cordis) was used after initial wire escalation attempts failed to re-enter into the true lumen of the stenotic lesion. For each procedure, radial access was obtained using a 4-Fr sheath, which was eventually upsized to a 6-Fr Slender Glidesheath (Terumo) to allow use of the Outback re-entry device. Final treatment of the CTO with angioplasty and/or stenting was performed at the discretion of the operator. Procedural success was defined as successful re-entry into the true vessel lumen with < 20% residual stenosis at the target lesion by the end of the procedure. Based on our prior success and low complication rates using the TR band (Terumo) and VasoStat (Forge Medical, Inc.) devices to achieve hemostasis at different transpedal puncture sites, we implemented the same previously described technique in all the cases (Patel et al. 2016 (link)). Each patient was discharged home 2 h post-procedure on atorvastatin 80 mg daily and dual antiplatelet therapy with daily aspirin 81 mg and clopidogrel 75 mg for at least 1 month. All patients had clinical follow-up at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment at the 1 month follow-up. Below are 3 selected cases to illustrate how the Outback® Elite re-entry device was utilized in each endovascular intervention.
Tr band
Manufactured by Terumo
Sourced in Japan
The TR band is a hemostasis compression device designed to facilitate safe and effective arterial access site management following percutaneous catheterization procedures. It applies controlled compression to the puncture site, promoting hemostasis without restricting blood flow.
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Lab products found in correlation
Renegade hi flo microcatheter, by Boston Scientific (1 mentions)
Radiofocus, by Terumo (1 mentions)
Radifocus introducer 2, by Terumo (1 mentions)
Launcher, by Medtronic (1 mentions)
Angio seal, by Terumo (1 mentions)
Radifocus introducer 2 transradial kit, by Terumo (1 mentions)
Angioseal, by Abbott (1 mentions)
17 protocols using tr band
1
Outback® Elite Device for CTO Recanalization
2
Periprocedural Morphine Use in Primary PCI
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Application of intravenous morphine in the periprocedural period (i.e., from onset of the symptoms to two hours following the PCI) was left to the physician’s discretion and was independent of the present analysis. During the study, morphine hydrochloride (molecular weight: 321.8 g/mol) was used exclusively, morphine sulfate (molecular weight: 668.8 g/mol) was not applied. Primary PCI was performed using standard techniques. The arterial sheath was removed immediately after the procedure. Bleeding from the radial artery was stopped using the TR Band (Terumo Europe, Leuven, Belgium), while the femoral artery was closed by the FemoSeal device (St. Jude Medical, St. Paul, MN). In cases of persistent femoral artery bleeding, manual compression was applied. All patients were treated with acetylsalicylic acid and a loading dose of 600 mg clopidogrel and discharged on dual antiplatelet therapy for at least 12 months. Successful PCI was defined as <50% diameter stenosis with a final TIMI flow grade≥2. Interventional cardiologists were high-volume operators (i.e., >200 PCIs/year) skilled in both transfemoral and transradial techniques. Left ventricular ejection fraction was assessed by echocardiography within 48 hours after the index procedure.
3
Radial Artery Angiography Procedure
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Angiography was performed via the right radial artery in all cases. Briefly, following local anesthesia with 1% lidocaine, the radial artery was punctured using the Seldinger technique. An intravenous bolus of heparin (5000 U) was given, with additional heparin administered at the operator's discretion if follow‐on coronary intervention was undertaken. Arterial sheaths were removed at the end of the procedure with hemostasis achieved by a compressive wrist band (TR band; Terumo).
4
Radial Artery Embolization Protocol
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Typical TRA UAE was performed after Barbeau’s eva-luation of the radial artery [17 (link)]. Patients with a type D response were excluded from the study. For every patient, an ultrasound image documented the radial artery to be 2 mm in size. Prior to the procedure, the skin overlying the left radial artery was anaesthetized with lidocaine and nitroglycerin paste. Under ultrasound guidance, the radial artery was accessed with a 21-gauge needle. After placement of a 5F vascular access sheath, a 5F angled tip hydrophilic Glidecath (Terumo, Tokyo, Japan) was advanced to the internal iliac artery. Through this, a Renegade Hi-Flo microcatheter was advanced (Boston Scientific, Natick, MA) and used to select the uterine artery (Figure 1 ). For each patient, a radial artery “cocktail” was utilized post-procedure which included 200 ug nitroglycerin, 2.5 mg verapamil, and 3000 units of heparin.
After embolization, all wires and catheters were removed. Before removal of the sheath, a TR Band (Terumo, Somerset, NJ) was placed on the left wrist over the arteriotomy site and inflated to obtain haemostasis. The haemostasis was subsequently maintained for 60 minutes. Arterial haemostasis was reconfirmed as the cuff was incrementally deflated. Upon cuff removal by nursing staff in the recovery unit, the patient was observed for an additional 30 minutes prior to discharge.
After embolization, all wires and catheters were removed. Before removal of the sheath, a TR Band (Terumo, Somerset, NJ) was placed on the left wrist over the arteriotomy site and inflated to obtain haemostasis. The haemostasis was subsequently maintained for 60 minutes. Arterial haemostasis was reconfirmed as the cuff was incrementally deflated. Upon cuff removal by nursing staff in the recovery unit, the patient was observed for an additional 30 minutes prior to discharge.
5
Transradial Approach for Prostatic Artery Embolization
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Local anesthesia (2% lidocaine) was delivered to the subcutaneous tissues around the left radial artery. This artery was then accessed with a microintroducer kit (Galt) equipped with a 21-G needle under ultrasonography guidance. A 7-cm, 5-French vascular sheath (Radiofocus, Terumo) was placed over the 0.025-inch guidewire. An antispasmatic cocktail (2 mg verapamil, 0.2 mg nitroglycerin, and 2000 IU heparin) was diluted to 20 mL and slowly reinjected [4 (link)]. An additional cocktail was injected every 1 hour through the sheath. Using standard angiography devices including a 125-cm, 5-Fr diagnostic catheter (Davis; Jungsung Medical) and a 180-cm, 0.035-inch guidewire (Radiofocus; Terumo), both internal iliac arteries (IIAs) were accessed under fluoroscopic and 3D real-time navigation guidance. The 3D-guiding system provided a real-time overlay of the 3D roadmap, which could save fluoroscopic time and contrast medium (Fig. 3A ). The prostatic arteries were catheterized using a 150-cm microcatheter (1.7–1.9 Fr; Progreat Lambda, Terumo; Carnelian, Tokai Medical; and Pursue, Merit) and a 165-cm, 0.016-inch guidewire (Meister; Asahi Intecc). Hemostasis was achieved using a compression device (TR band; Terumo). Any conversion from TRA to TFA owing to catheterization difficulty or catheter length was recorded.
6
Radial Artery Compression Protocol
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Arterial sheaths were removed immediately after the procedure, then radial compression with a pneumatic device (TR Band of Terumo. Europe, Leuven, Belgium) was placed tightly around the wrist; the band was inflated with 15-18 mL of air to obtain homeostasis. The pneumatic device was kept in place for 2-3 h with repeated 2 mL air withdrawal to reduce inflation pressure. Finally, the tight dressing was applied at puncture site after device removal.
7
Radial Artery Access Technique for Coronary Angiography
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The access site was anaesthetized with lidocaine and then right radial arterial access was taken using a 6F radial sheath (Radifocus introducer II, Terumo, Japan). To reduce vasospasm and forearm discomfort, pre prepared mixture containing Nitroglycerine 100 μg, Diltiazem 5 mg and Lidocaine 21.3 mg was administered through the radial sheath. Unfractionated heparin was administered in all patients in doses of 100 units/kg.
Coronary angiograms were performed with 5 French (5F) diagnostic catheters (Optitorque, Terumo, Japan) followed by angioplasty using 6F standard coronary guiding catheters (Launcher, Medtronic Inc., Minneapolis, USA). Immediately after the procedure, the radial artery sheath was removed and haemaostasis was achieved by the application of haemaostasis device (TR band, Terumo, Japan) using patent haemaostasis technique.17 Procedural details like catheter exchanges, angiographic severity of coronary artery disease, number of vessels stented, total number of stents used in each patient, procedure time and radiation dose were noted for each patient.
Coronary angiograms were performed with 5 French (5F) diagnostic catheters (Optitorque, Terumo, Japan) followed by angioplasty using 6F standard coronary guiding catheters (Launcher, Medtronic Inc., Minneapolis, USA). Immediately after the procedure, the radial artery sheath was removed and haemaostasis was achieved by the application of haemaostasis device (TR band, Terumo, Japan) using patent haemaostasis technique.17 Procedural details like catheter exchanges, angiographic severity of coronary artery disease, number of vessels stented, total number of stents used in each patient, procedure time and radiation dose were noted for each patient.
8
Transradial Procedures and Digital Perfusion
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• With sequential laser Doppler perfusion imaging, we show that digital tissue perfusion is not reduced by radial access and TR band application as compared to the reference hand. • Digital tissue perfusion during transradial procedures is not associated with anatomic variants of the arterial supply or future loss of hand function, which confirms the safety of transradial procedures in every patient.
sheath (Terumo). A standard cocktail of 0.2 mg nitroglycerin and 5 mg verapamil was applied. A bolus of 5000 IU of unfractionated heparin was given for coronary angiography and adapted to the patient's body weight in case of percutaneous coronary intervention. The side of radial access was left to the discretion of the operator; however, the right radial artery is the access site of preference in our institution. A TR band (Terumo) was applied per manufacturer's instructions when the introducer sheath was removed.
sheath (Terumo). A standard cocktail of 0.2 mg nitroglycerin and 5 mg verapamil was applied. A bolus of 5000 IU of unfractionated heparin was given for coronary angiography and adapted to the patient's body weight in case of percutaneous coronary intervention. The side of radial access was left to the discretion of the operator; however, the right radial artery is the access site of preference in our institution. A TR band (Terumo) was applied per manufacturer's instructions when the introducer sheath was removed.
9
Detailed Angiography Procedure Protocols
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Details of angiography procedures, such as access site, size of the inserted sheath, amount of intraoperative administration of anticoagulant, and utilization of closure device for the access site, varied depending on the procedures and departments. For CAG and most conventional PCIs, right radial access was the first choice. Other access sites, including the left radial, brachial, and femoral arteries, were chosen in cases that required vascular access for haemodialysis in the right upper limb, occlusion of the right radial artery, and insertion of a large sheath. For procedures other than CAG and PCI, femoral access was the first choice; very rarely, popliteal access was chosen for endovascular treatment of PAD. In cases with radial access, after the procedure was completed, a compression band (TR BAND®; Terumo Corporation, Tokyo, Japan) was placed over the access site and left in place for 6 hours. In cases with femoral access, AngioSeal (Terumo) was occasionally employed at the discretion of the surgeon. Patients generally received intraoperative heparin administration, consisting of 2000 units for CAG and cerebral artery angiography and 5000 units for PCI, PAD, and cerebral aneurysm embolization.
10
Transradial Coronary Angiography and PCI Protocol
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The skin was infiltrated using 1% procaine hydrochloride (Teva). After insertion of the introducer with hydrophilic coating (Radifocus Introducer II Transradial Kit; needle 20 gauge, sheath 4 to 7 French, 10 cm; Terumo Europe), heparin sodium (70 IU/kg bolus for diagnostics and percutaneous coronary intervention [PCI] with planned use of a glycoprotein IIb/IIIa receptor inhibitor or 100 IU/kg bolus for elective PCI; Merckle), and the study medication (5 mg verapamil hydrochloride; Sanofi‐Aventis Chinoin, or 10 mL 0.9% w/v sodium chloride; Teva) were given intra‐arterially. Transradial coronary angiography and PCI were then performed according to the study protocol using standard techniques. The arterial sheath was removed immediately after the procedure and bleeding was stopped using a compression device (TR Band; Terumo Europe) for 6 to 8 hours.
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