Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths.

Radial artery spasm may cause severe discomfort during radial artery sheath removal. A hydrophilic-coated sheath may reduce the force required to remove a radial sheath. This force may be quantified using an automatic pullback device (APD). The objective of this study was to assess if a hydrophilic coating reduces the required force and discomfort associated with removal of a radial sheath following transradial coronary intervention. Ninety patients undergoing percutaneous coronary intervention via the radial artery were randomly assigned to two groups receiving either coated or uncoated introducer sheaths. Radifocus Introducer II (Terumo) 25 cm, 6 Fr radial sheaths and sheaths that were identical apart from the presence of the coating were used in all patients. The APD was used for sheath removal at the end of the procedure. Three patients (7%) in the coated group experienced discomfort during automatic sheath removal, compared to 12 patients (27%) in the uncoated group (P = 0.02). The maximum pullback force (MPF) was significantly lower in the coated compared to the uncoated group (0.24 +/- 0.31 vs. 0.44 +/- 0.33 kg; P = 0.003). Similarly, the mean pullback force was significantly lower in the coated group (0.14 +/- 0.23 vs. 0.32 +/- 0.24 kg; P < 0.001). Only one patient (2%) in each group had an MPF greater than 1.0 kg together with clinical evidence of radial artery spasm. Removal of the coated Terumo Radifocus sheath requires less force than an identical uncoated sheath. The coated sheath was also associated with less discomfort for the patient.     

Evaluation of a spasmolytic cocktail to prevent radial artery spasm during coronary procedures.

Radial artery spasm is a frequent complication of the transradial approach for coronary angiography and angioplasty. Recently, we have been able to quantify spasm using the automatic pullback device. The objective of this study was to assess the efficacy of an intra-arterial vasodilating cocktail in reducing the incidence and severity of radial artery spasm. A hundred patients undergoing coronary procedures via the radial artery were divided into two groups of 50 each. Patients in group A received intra-arterial cocktail (5 mg of verapamil plus 200 micro g nitroglycerine in 10 ml of normal saline), while patients in group B did not receive any vasodilating drug. The pullback device was used for sheath removal at the end of the procedure. Seven (14%) patients in group A experienced pain (i.e., pain score of III-V) during automatic sheath removal, as compared to 17 (34%) in group B (P = 0.019). The mean pain score was significantly lower in group A than in group B (1.7 +/- 0.94 vs. 2.08 +/- 1.07; P = 0.03). The maximal pullback force (MPF) was also significantly lower for group A (0.53 +/- 0.52 kg; range, 0.10-3.03 kg) as compared to group B (0.76 +/- 0.45 kg; range, 0.24-1.99 kg; P = 0.013). Only 4 (8%) patients in group A had an MPF value greater than 1.0 kg, suggesting the presence of significant radial artery spasm, as opposed to 11 (22%) in group B (P = 0.029). Administration of an intra-arterial vasodilating cocktail prior to sheath insertion reduces the occurrence and severity of radial artery spasm.     

经桡动脉冠状动脉介入诊疗术后桡动脉损伤的影响因素分析

目的:探讨接受桡动脉冠状动脉介入诊疗患者术后,桡动脉损伤的情况及影响因素。方法:入选2008年5月至2009年10月,于安贞医院就诊拟行冠状动脉造影的患者966例,随机分为4F动脉鞘管组和6F动脉鞘管组。分析两组患者桡动脉并发症〔如桡动脉闭塞(RAO)、桡动脉痉挛(RAS)等〕的发生率,通过多因素Logistic回归分析RAO的危险因素。结果:4F鞘管组和6F鞘管组中,RAO(0.8%vs.2.9%,P=0.018),RAS(1.2%vs.3.5%,P=0.021),桡动脉内膜增厚率(1.0%vs.4.1%,P=0.002),前臂小血肿(0.6%vs.2.5%,P=0.020),患肢疼痛(1.2%vs.4.1%,P=0.006)等的发生率及压迫止血时间〔(4.62±0.98)vs.(6.36±0.93)h,P<0.001〕,4F组均低于6F组,差异有统计学意义。两组患者均未出现前臂大血肿、假性动脉瘤、动静脉瘘及骨筋膜室综合征。RAO经多因素回归分析显示,大尺径动脉鞘管、术后压迫止血时间过长是发生RAO的危险因素。结论:经桡动脉PCI中选择小直径动脉鞘管,避免术后长时间的压迫止血有利于降低RAO的发生率,同时减少桡动脉内膜损伤,提高患者舒适度。     

Reduction of discomfort at sheath removal during transradial coronary procedures with the use of a hydrophilic-coated sheath.

Some patients experience discomfort at sheath removal during transradial procedures. We hypothesized that the use of a hydrophilic-coated sheath (HCS) would reduce the traction force needed at withdrawal and therefore the pain experienced by patients. Patients referred for coronary intervention were randomized to undergo transradial procedure with the use of HCS or with nonhydrophilic sheath (NHS). At removal of the sheath, peak traction force was recorded using an electronic traction gauge and patients were asked to quantify their pain. A total of 90 patients participated in the study. The mean +/- SD peak traction force at sheath removal was 265 +/- 167 g and 865 +/- 318 g in the HCS and NHS groups, respectively (69% reduction; P < 0.001). Mean maximal pain score was 0.6 +/- 1.2 and 4.8 +/- 2.9 in the HCS and NHS groups, respectively (88% reduction; P < 0.0001). Use of HCS for transradial procedures reduces considerably the traction force needed for sheath removal as well as pain experienced by patients when compared to NHS.     

Usefulness of hydrophilic coating on arterial sheath introducer in transradial coronary intervention.

Radial artery spasm is one of the major problems during transradial coronary intervention (TRI). The sheath introducer with hydrophilic coating may reduce the incidence of spasm and reduce the difficulty in removing it from the radial artery under the situation of spasm artery spasm. After we compared the friction resistance between the sheath introducer with hydrophilic coating and that without coating (nine samples each) in vitro, the sheath introducers with and without hydrophilic coating were randomly used in 37 and 36 patients, respectively, who underwent elective TRI with a 6 Fr introducer sheath. Hydrophilic coating of sheath introducer reduced friction resistance by 70% (P < 0.00001) in in vitro model and facilitated sheath removal after finishing TRI (P = 0.0003). Hydrophilic coating of sheath introducer is useful in TRI.     

Radial artery spasm during transradial coronary procedures

Although transradial access (TRA) for coronary procedures has many advantages over the transfemoral approach, it's still not the dominant route used in coronary interventions. Radial artery spasm (RAS) is an important limitation of TRA. We performed a search of published literature to estimate the prevalence and possible risk factors of RAS in patients undergoing transradial coronary procedure. Nineteen published papers including 7197 patients were identified as relevant; reported incidence of RAS was 14.7% altogether. It varies depending upon the criteria used, on applied premedications, and on sheath or catheter selection. Use of hydrophilic coated sheaths and catheters can reduce the incidence of RAS to 1%, while intra-arterial application of verapamil (1.25-5 mg) and nitroglycerin (100-200 μg) can reduce the incidence of RAS up to 3.8%. We concluded that RAS is still problematic in transradial access, and that besides hydrophilic materials, the use of intra-arterial vasodilators remains mandatory in RAS prevention. However, the optimal spasmolytic cocktail is yet to be confirmed by valid spasm criteria.     

Initial Clinical Experience of a Novel Device (the ÒFriend CatheterÓ) for Local Anesthetic Delivery Around Indwelling Arterial Sheaths

The removal of femoral arterial sheaths, particularly after they have been in place for some hours, is a source of pain for patients undergoing invasiveive cardiac procedures. Methods of reducing this pain include systemic sedatives, analgesics and local anesthetic. We tested a new disposable plastic device, called the òFriend,ó designed to reduce pain associated with sheath removal. The Friend wraps around a standard 8 Fr sheath allowing local anesthetic infiltration through side holes into local tissue. METHODS: Seventy-two patients undergoing interventional procedures were randomized to 3 groups for anesthetic administration just prior to sheath removal. Group 1 (control) received no local anesthetic. Group 2 (local) received 10 ml of lignocaine directly infiltrated with syringe and needle around the sheath. Group 3 (Friend) had the Friend inserted with the sheath and 10 ml of lignocaine was delivered via the device. Pain around the sheath was assessed prior to, during and just after, sheath removal using a 5 point verbal scale. RESULTS: Sixty-two patients completed the study. There were no serious complications related to the Friend device. The Friend group patients had significantly less pain associated with sheath removal than the control group. (Mean pain difference 1.28 vs. 0.34, p = 0.04). Pain scores in group 2 (local) did not differ significantly from the control group. The additional estimated cost involved in using the Friend was $16.93 per patient. CONCLUSIONS: The Friend device is a new, inexpensive and safe method of reducing pain associated with removal of arterial sheaths after cardiac interventional procedures.     

Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention

To test the feasibility of using guiding catheters equal to or greater than 7 Fr in transradial coronary intervention (TRI), we measured the inner diameter of the radial artery (RA) and its flow using two-dimensional ultrasound and Doppler examinations before and after TRI in 250 Japanese patients. The incidence of severe flow reduction of the RA after TRI was 6.8% on average (7.2%, 4.7%, and 8.3% in patients with 6, 7, and 8 Fr sheaths used, respectively), which increased from 4.0% to 13.0% (P = 0.0113) if the ratio of the RA inner diameter/sheath outer diameter was less than 1.0. The frequency of this ratio (≥ 1.0) for 7 and 8 Fr sheaths was 71.5% and 44.9% in male patients and 40.3 and 24.0% in female patients, respectively. We conclude that the use of guiding catheters equal to or greater than 7 Fr in the radial artery is feasible in selected patients. Cathet. Cardiovasc. Intervent. 46:173–178, 1999. © 1999 Wiley-Liss, Inc.     

Minimally invasive transradial intervention using sheathless standard guiding catheters

Objectives : We evaluated a sheathless transradial technique for interventions using standard five and six French nonhydrophilic guiding catheters. Background : Miniaturization of transradial interventions may serve to improve patient comfort and reduce the risk of access‐site complications. Guiding catheters carry an outer diameter approximately 2 Fr sizes smaller than their corresponding introducer sheaths. Methods : We identified consecutive patients who underwent transradial intervention between August 2010 and December 2010 using 5 or 6 Fr guides with a sheathless technique. Results : A total of 11 patients were identified (mean age 70.7 ± 10.9 years; 73% male). Single coronary intervention was performed in 10 patients and renal artery intervention in one. Right radial access and 6 Fr guide catheters were used in the majority (each 73%). Five techniques were used to create an inner dilator as the taper. Four of these inner tapers (standard diagnostic catheters, hydrophilic diagnostic catheters, long sheath dilators and guide extensions) enabled successful sheathless guide insertion in all 10 patients attempted. One technique (a partially inflated angioplasty balloon protruding from the guide) attempted in one patient was unsuccessful. All interventional procedures were successful, there were no radial artery access‐site complications and in no case was cross‐over to femoral artery access‐site required. Conclusion : Sheathless transradial intervention using standard 5 and 6 Fr guiding catheters is a safe and effective method for treatment of coronary and peripheral vascular lesions. © 2011 Wiley Periodicals, Inc.     

How to limit radial artery spasm during percutaneous coronary interventions: The spasmolytic agents to avoid spasm during transradial percutaneous coronary interventions (SPASM3) study

Aims : To compare the efficacy of three vasodilators in preventing radial artery spasm (RAS) in patients undergoing transradial percutaneous coronary interventions (PCI). Methods and Results : 731 patients were randomized to receive diltiazem 5 mg, verapamil 2.5 mg, or isosorbide dinitrate (ISDN) 1 mg before coronary intervention. RAS occurred in 20.1% in the whole population and was significantly reduced by verapamil and ISDN compared to diltiazem (16.2, 17.2, and 26.6%, respectively; P < 0.006). There was also a trend towards less severe pain (more than 8 on a numerical scale from 0 [no pain] to 10 [maximal pain]), and less severe RAS (complete catheter blockage or severe pain), among patients treated by verapamil compared to ISDN and diltiazem (1.3% vs. 2.8% vs. 2.9%, P = 0.43 and 5.1% vs. 6.2% vs. 9.5%, respectively, P = 0.13). No difference was found between the three vasodilators in terms of crossover or safety events. Female gender, failure at first attempt to access the radial artery, emergency procedures, and the use of diltiazem were independent predictors of RAS. Conclusion : Verapamil and ISDN considerably reduce the incidence of RAS compared to diltiazem during transradial PCI. © 2013 Wiley Periodicals, Inc.     

Atraumatic complex transradial intervention using large bore sheathless guide catheter

The Asahi sheathless guide catheter system is a hydrophilic catheter with a central dilator that does not require an introducer sheath during transradial percutaneous coronary intervention. Conventional sheath introducers are often 1‐ to 2F larger than the catheter itself; therefore, this system enables the use of a larger French catheter during procedures than would otherwise be possible using conventional techniques. We describe the use of a 7.5F sheathless guide catheter system with a smaller outer diameter than a conventional 6F introducer sheath in 16 cases performed transradially involving rotablation, crush stent bifurcation lesions, 7F proximal protection, and thrombectomy devices. Such cases would otherwise not always be possible if performed using conventional transradial techniques in patients with smaller radial artery sizes. © 2008 Wiley‐Liss, Inc.     

Entrapment of a folded-over introducer sheath in the iliofemoral artery: an unusual complication of PTCA guiding catheter exchange

An arterial introducer sheath became folded over in the iliac artery during PTCA. This probably resulted from withdrawal of a doubled over Judkins left coronary guiding catheter through the introducer sheath. Nonsurgical, atraumatic removal was accomplished after the acute bend of the introducer sheath had been withdrawn to the site of arterial entrance.     

Entrapment of a folded-over introducer sheath in the lliofemoral artery: An unusual complication of PTCA guiding catheter exchange

An arterial introducer sheath became folded over in the iliac artery during PTCA. This probably resulted from withdrawal of a doubled over Judkins left coronary guiding catheter through the introducer sheath. Nonsurgical, atraumatic removal was accomplished after the acute bend of the introducer sheath had been withdrawn to the site of arterial entrance.     

桡动脉痉挛分析及药物干预试验

目的通过桡动脉造影法观察桡动脉痉挛(RAS)的相关因素,比较不同配方血管解痉剂对于RAS的效果。方法接受经桡动脉途径介入治疗(TRI)的患者180例,其中男性97例,女性83例。随机分入硝酸甘油组(硝酸甘油200μg),尼卡地平组(尼卡地平200μg),鸡尾酒组(硝酸甘油100μg+尼卡地平100μg),每组60例。在常规桡动脉造影后分别经鞘给予协定药物。给药后1、2 min分别行桡动脉造影。以方差分析法比较3组患者给药前、给药后1、2 min RAS发生率的变化。桡动脉痉挛程度通过计算机定量分析法(QCA)测得,桡动脉狭窄>70%定义为桡动脉痉挛,出现导管因痉挛发生推送、旋转困难以及拔管时阻力大、疼痛等临床表现定义为临床桡动脉痉挛。用Logistic回归分析桡动脉痉挛相关因素。结果 180例患者桡动脉正常参考段内径在基线水平为1.08～3.76 mm,平均为(2.24±0.52)mm。用药前RAS总发生率为10.6%,临床RAS发生率为6.2%。桡动脉直径、桡动脉鞘直径及既往TRI术≥2次是RAS的独立相关因素。硝酸甘油组、尼卡地平组和鸡尾酒组在桡动脉穿刺后RAS的发生率分别为15.0%、8.3%和8.3%,给药后1 min分别降至3.3%、5.0%和1.7%,给药后2 min分别降至1.7%、3.3%和0%。硝甘-尼卡组、尼卡-鸡尾酒组RAS发生率差异有统计学意义,但硝甘-鸡尾酒组桡动脉RAS发生率差异无统计学意义。结论 RAS总发生率为10.6%,其独立相关因素包括桡动脉直径、桡动脉鞘外径及既往TRI术≥2次。硝酸甘油及尼卡地平均具有明显扩张桡动脉的作用,但硝酸甘油及两者联合应用比单用尼卡地平有更大优势。     

Radial artery occlusion: Preventing Insult to Injury

• Intra‐arterial nitroglycerin prior to transradial sheath removal may reduce the incidence of radial artery occlusion (RAO).
• Operators must observe careful attention to all aspects of transradial catheterization, particularly patent hemostasis; as well as independently monitor the institutional incidence of RAO to prompt improvements in practice.
• Future studies on the impact of pre‐puncture ultrasound, novel sheaths, hemostatic devices, and potent oral and intravenous antithrombotic therapy on 30‐day RAO diagnosed by ultrasound may allow further reduction of RAO in a real‐world practice.

     

Transradial coronary intervention using a novel 5‐Fr sheathless guiding catheter

We have recently developed a 5‐Fr sheathless guiding catheter system (Virtual 3‐Fr, Medikit, Japan), composed of a hydrophilic catheter and a central dilator. This combination of catheter and dilator enables us to introduce the catheter into the artery without the need of an introducer sheath. Because the outer diameter of this 5‐Fr sheathless guiding catheter system is approximately 2‐Fr sizes smaller than a conventional guiding catheter system, this system provides us with less invasive angioplasty and a puncture site injury equivalent to a conventional 3‐Fr introducer sheath. To demonstrate the potential of this 5‐Fr sheathless guiding system, we report two cases of chronic total occlusion successfully treated by the transradial approach. This novel 5‐Fr sheathless system may become a viable alternative to conventional guiding catheters, and provide a favorable impact upon vascular access complications and patient morbidity. © 2009 Wiley‐Liss, Inc.     

应用利多卡因外擦导管减少桡动脉痉挛的临床观察

目的:桡动脉痉挛是经桡动脉路径冠状动脉造影(CAG)和(或)介入治疗(PCI)的常见并发症之一。本研究旨在观察应用利多卡因外擦动脉鞘和造影导管,减少桡动脉痉挛的临床疗效。方法:将连续237例接受经桡动脉路径CAG/PCI的患者随机分为两组,分别于动脉鞘和造影/导引导管插入前应用2%利多卡因溶液(118例,利多卡因组)或0.9%氯化钠溶液(119例,对照组)外擦其表面。主要观察终点:严重桡动脉痉挛(导管推进或操作困难并伴前臂疼痛、桡动脉造影示管腔内径狭窄>70%)发生率。次要终点:前臂出血或血肿、患者不适程度以及操作成功率。结果:利多卡因组5例(4.2%)和对照组16例(13.4%)发生严重桡动脉痉挛(P=0.013);利多卡因组中无一例发生前臂出血或血肿,但对照组中3例前臂轻度出血(表现为造影剂外渗)和1例局部血肿形成,均经局部加压包扎后好转;利多卡因组因疼痛引起的重度不适减少;两组CAG/PCI均成功。结论:CAG/PCI时,应用2%利多卡因溶液外擦动脉鞘和造影/导引导管可能是一种减少严重桡动脉痉挛及其相关并发症的简易方法。     

Retrieval of a detached transseptal sheath tip from a right pulmonary artery branch following catheter ablation

Transseptal introducer sheaths are being used with increasing frequency for left‐sided arrhythmia ablations and structural heart disease interventions. Sheath tip detachment and embolization is an uncommon but known complication, and several sheaths have been recalled due to such complications. We report a unique case of a fractured transseptal sheath tip that embolized to a branch of the right pulmonary artery in a patient who had undergone ablation of a left‐sided atypical atrial flutter. During final removal of one of the two long 8.5‐French SL1 transseptal sheaths used routinely as part of the ablation, the radiopaque tip of the sheath fractured and first embolized to the right atrium and subsequently to a secondary right pulmonary artery branch. Using techniques derived from percutaneous interventional approaches, including a multipurpose catheter, coronary guidewire, and monorail angioplasty balloon, the sheath tip was successfully wired through its inner lumen, trapped from the inside with the balloon, and removed from the body via a large femoral vein sheath, without complications. The approach detailed in this case may guide future cases and circumvent urgent surgical intervention. © 2015 Wiley Periodicals, Inc.     

法舒地尔在经桡动脉冠状动脉介入治疗中预防桡动脉痉挛疗效分析

目的观察法舒地尔在经桡动脉冠状动脉介入中预防桡动脉痉挛（RAS）的疗效。方法入选300例行经桡动脉冠状动脉介入治疗的冠心病患者,随机分为法舒地尔组（n=102）、硝酸甘油＋维拉帕米组（n=88）、对照组（n=110）。法舒地尔组术前半小时静滴法舒地尔30mg;硝酸甘油＋维拉帕米组在置入动脉鞘管后经鞘管注入硝酸甘油200μg＋维拉帕米5mg;对照组无特殊处理。结果法舒地尔组、硝酸甘油＋维拉帕米组与对照组RAS发生率分别为5.88%、5.68%、15.45%;前两组无统计学差异（P〉0.05）但均低于对照组,且差异有统计学意义（P〈0.05）。法舒地尔组局部症状和全身症状发生率均低于硝酸甘油＋维拉帕米组及对照组,差异均有统计学意义（P〈0.05）。结论法舒地尔能减少经皮冠状动脉介入治疗中RAS的发生率,且较少发生局部及全身症状。     

Randomized, controlled study of long-acting local anesthetic (levobupivacaine) in femoral artery sheath management during and after percutaneous coronary intervention

OBJECTIVE: To assess the effect of long-acting local anesthetic (levobupivacaine) in addition to lidocaine for the management of femoral artery sheaths during and after percutaneous coronary intervention (PCI). BACKGROUND: Femoral artery sheaths are commonly used during PCI. Sheath removal is often delayed after the procedure by which time short-acting local anesthetic agents may no longer be effective. METHODS: Sixty patients were randomized to either usual care or the administration of local levobupivacaine after PCI. Patients were asked to report their pain experienced on a visual analogue score. RESULTS: Thirty patients received additional levobupivacaine (0.5%) and 30 received standard care. There were no procedural differences between the groups, except that more patients in the control group received intravenous (IV) morphine at the time of sheath removal. There was no difference between the control group and levobupivacaine group in pain scores at the time of sheath insertion. (2.0 +/- 0.4 versus 1.8 +/- 0.3; p = 0.80). Both groups recorded low pain scores while waiting for sheath removal, and the score was slightly (but not significantly) lower in the levobupivacaine group (1.3 +/- 0.2 versus 0.8 +/- 0.2; p = 0.09). Pain scores were lower in the levobupivacaine group during sheath removal 2.2 +/- 0.4 versus 1.1 +/- 0.2; p = 0.02). There were no differences in terms of blood pressure between the groups at any time point. CONCLUSIONS: Levobupivacaine reduced the need for IV opiate and provided better analgesia than lidocaine alone in patients undergoing PCI.