Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure

Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure Pedro Beraldo de Andrade, MD, Marden André Tebet, MD, Ederlon Ferreira Nogueira, MD, Vinícius Cardozo Esteves, MD, Mônica Vieira Athanazio de Andrade, RN, André Labrunie, MD, PhD, and Luiz Alberto Piva e Mattos, MD, PhD São Paulo, Brazil Background Unsuccessful radial artery puncture, inability to advance the guide catheter to the ascending aorta, and inadequate guide catheter support represent mechanisms of transradial approach failure. With the rationale of sharing the same efficacy and safety promoted by radial access, the transulnar approach represents an alternative access site for percutaneous coronary procedures. Methods Between May 2007 and May 2012, 11,059 coronary invasive procedures were performed in a single institution: 10,108 by transradial approach (91.4%), 541 by transfemoral approach (4.9%), and 410 by transulnar approach (3.7%). Patients who underwent coronary procedures through transulnar access were included in a prospective registry of effectiveness and safety. Results Diagnostic procedures accounted for 71.8% of cases, and the right ulnar access was the most common route (88.9%). Procedure success was high (98.5%), with a crossover rate of 1.5% (6 cases), of which 5 were achieved through the contralateral radial access and 1 through femoral approach. Complications related to access site were low (3.9%), consisting mostly of minor bleeding due to subcutaneous hematomas. There were no cases of major bleeding, nerve injury, pseudoaneurysm, arteriovenous fistula, or necessity of vascular surgical repair. Conclusions The transulnar approach represents an alternative to the transradial approach in selected cases when performed by radial-trained operators, sharing a high success rate and extremely low incidence of access-site complications. (Am Heart J 2012;164:462-7.) Beyond the proven benefits regarding patient comfort and reduced hospitalization time, the transradial approach has an established role as a bleeding-avoidance strategy among patients undergoing invasive coronary procedures. 1 Such benefits are more evident among radial-trained operators and in patients at high risk for bleeding, especially those with acute coronary syndrome. 2 However, unsuccessful radial artery puncture, inability to advance the guide catheter to the ascending aorta, and inadequate guide catheter support represent mechanisms of transradial approach failure. 3 Even among dedicated radialists, the crossover rate can reach more than 2%. 4 In addition, radial artery occlusion may occur in 5% of From the Santa Casa de Marília, Marília, São Paulo, Brazil. Submitted June 6, 2012; accepted August 3, 2012. Reprint requests: Pedro Beraldo de Andrade, MD, Invasive Cardiology, Santa Casa de Marília, Av. Vicente Ferreira, 828 Cascata, Marília, São Paulo, Brazil 17515 900. E-mail: pedroberaldo@gmail.com 0002-8703/$ - see front matter 2012, Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ahj.2012.08.001 patients at hospital discharge, preventing its reuse in future procedures. 5 In this context, the transulnar approach represents an alternative access site for percutaneous coronary procedures. With the rationale of sharing the same efficacy and safety promoted by radial access, it can be easily performed by operators familiar with the transradial approach. 6-8 The aim of this study was to demonstrate daily practice situations in which the transulnar approach proves a suitable option, reporting the success rate and possible complications related to its use. Methods Patients who underwent coronary procedures through transulnar access were included in a prospective registry of effectiveness and safety. The effectiveness of the technique was evaluated by procedure success rate, defined as completion of coronary angiography and left ventriculography with adequate coronary opacification, and percutaneous coronary intervention obtaining residual lesion less than 20%, with no need of crossover. The procedure and fluoroscopy times were obtained

American Heart Journal Volume 164, Number 4 de Andrade et al 463 starting from the arterial puncture until removal of the introducer. Safety was evaluated by the occurrence of inhospital vascular complications related to the puncture site. The registry was approved by our local ethics committee and a written informed consent was obtained from each patient. Definitions Major bleeding was defined as: type 3 [(3a) bleeding with hemoglobin decrease 3 and b5 g/dl, or red blood cell transfusion; (3b) bleeding with hemoglobin decrease 5 g/dl, or cardiac tamponade, or bleeding that requires surgical intervention, or bleeding requiring intravenous vasoactive drugs; (3c) intracranial hemorrhage, confirmed by autopsy or subcategory, image analysis, or lumbar puncture, or intraocular bleeding with impaired vision]; or type 5 [(5a) probable fatal bleeding, (5b) final fatal bleeding] in accordance with the definition of Bleeding Academic Research Consortium. 9 Local hematomas were graded using the EASY classification 10 : type I, 5 cm diameter; type II, 10 cm diameter; type III, N10 cm but not above the elbow; type IV, extending above the elbow; type V, anywhere with ischemic threat of the hand. Asymptomatic arterial occlusion was defined by blocking of ulnar blood flow with no signs of insufficient blood tissue perfusion. Patency of the ulnar artery was controlled before discharge by physical examination and plethysmography, consisting of checking the peripheral oxygen saturation curve of the fifth finger during compression of the radial artery. Doppler ultrasound was not routinely performed, only when a complication was suspected. Ulnar nerve injury was defined by the occurrence of sensitive or mechanical hand compromise after ulnar puncture with persistent signs or symptoms for a period of 24 hours, as a consequence of direct injury by accidental nerve puncture, excessive compression, or extrinsic compression by hematoma or pseudoaneurysm. Other access-site complications included arteriovenous fistula, pseudoaneurysm, complication requiring surgery, or local infection requiring antibiotics. Transulnar approach technique The arm was abducted to approximately 70. Through hyperextension of the wrist and infiltration of 1 to 2 ml of lidocaine 2%, the ulnar artery was punctured at 1 to 3 cm proximal to the pisiform bone, using a 20- to 22-gauge needlemounted intravenous catheter and the Seldinger technique. After the puncture, a 0.021 inch guide-wire was introduced, followed by a small cutaneous incision with a No.11 surgical blade and the insertion of a 5F or 6F short sheath (Radifocus II, Terumo, Japan). A solution containing 5000 IU unfractionated heparin and 10 mg isosorbide mononitrate was administered through the extension of the sheath. In patients undergoing percutaneous coronary intervention, weight-adjusted unfractionated heparin (100 IU/kg) bolus was administered through a venous line to achieve and maintain an activated clotting time between 250 and 350 seconds. Analgesia and sedation with synthetic opioids and benzodiazepines were used as needed. At the end of the procedure, the introducer was immediately removed and hemostasis was achieved with compressive dressing or with radial compression device (TR Band, Terumo, Japan) adapted to the transulnar technique. It consists in placing the TR Band upside down, allowing adequate alignment of the inflated balloon over the ulnar artery. TR Band was placed Table I. Baseline clinical demographic characteristics Variables N = 387 Women, n (%) 210 (54.3) Mean age, years 61.2 ± 11.4 Diabetes mellitus, n (%) 139 (35.9) Systemic arterial hypertension, n (%) 325 (84.0) Current smoker, n (%) 93 (24.0) Dyslipidemia, n (%) 225 (58.1) Previous myocardial infarction, n (%) 73 (18.9) Previous percutaneous coronary intervention, n (%) 75 (19.4) Previous coronary artery bypass grafting, n (%) 30 (7.8) routinely after percutaneous coronary intervention and after coronary angiography using diameter catheters larger than 5F. Clinical examination of the puncture site and evaluation of the ulnar pulse were performed at the time of hospital discharge, about 2 to 3 hours after completion of the diagnostic procedures and the morning following completion of therapeutic procedures. The Allen test was not routinely performed. Statistical analysis Categorical variables are expressed as frequency and percentage, compared with the chi-square test. Continuous variables are expressed as mean and standard deviation, compared with the Student t test or Fisher's exact test. P b.05 was considered statistically significant. Statistical analyses were carried out using SPSS Statistics software package for Windows, version 19.0 (SPSS Inc, Chicago, IL). No extramural funding was used to support this work. The authors are solely responsible for the design and conduct of this study, all study analyses and drafting and editing of the manuscript. Results Between May 2007 and May 2012, 11,059 coronary invasive procedures were performed in a single institution: 10,108 by transradial approach (91.4%), 541 by transfemoral approach (4.9%), and 410 by transulnar approach (3.7%), the last representing the analyzed sample. 387 patients were included, of whom 210 (54.3%) were women, the mean age was 61.2 ± 11.4 years, and 139 (35.9%) were diabetic. The baseline clinical characteristics of patients are shown in Table I. Stable angina or silent ischemia was the predominant indication (55.3%), followed by non ST-segment elevation acute myocardial infarction (39.3%), and ST-segment elevation acute myocardial infarction (5.4%). The procedure characteristics are expressed in Table II. Diagnostic procedures accounted for 71.8% of cases, and the right ulnar access was the most common route (88.9%). The indication for ulnar approach was: a wider and easily palpable pulse compared to the radial in 73.2% of the cases, thus aiming to avoid the occurrence of vasospasm, patient discomfort or procedure failure; occurrence of radial artery spasm in 10.8%; absence of radial pulse in 9.0%; severe tortuosity of the radial artery in 5.7%, where the progression of the guide-wire was not possible; and

464 de Andrade et al American Heart Journal October 2012 Table II. Procedure characteristics Variables N = 410 Indication of the procedure Stable angina/silent ischemia/valvulopathy, n (%) 227 (55.3) Non ST-segment elevation myocardial infarction, n (%) 161 (39.3) ST-segment elevation acute myocardial infarction, n (%) 22 (5.4) Type of procedure Coronary angiography, n (%) 287 (70) Right and left heart catheterization, n (%) 6 (1.5) Intravascular ultrasound, n (%) 1 (0.3) Elective percutaneous coronary intervention, n (%) 86 (20.9) Ad hoc percutaneous coronary intervention, n (%) 30 (7.3) Number of catheters used, MD±DP Coronary angiography 2.1 ± 0.7 Percutaneous coronary intervention 1.2 ± 0.4 Ad hoc percutaneous coronary intervention 2.6 ± 0.8 Catheter diameter size Coronary angiography 5F, % 94.2 6F, % 5.8 Percutaneous coronary intervention 6F, % 97.5 7F, % 2.5 Ad hoc percutaneous coronary intervention 5F, % 3.6 6F, % 96.4 Procedure duration, min Coronary angiography 19.6 ± 8.3 Percutaneous coronary intervention 40.3 ± 13.9 Ad hoc percutaneous coronary intervention 59.6 ± 29.1 Fluoroscopy time, min Coronary angiography 3.2 ± 2.0 Percutaneous coronary intervention 10.4 ± 5.9 Ad hoc percutaneous coronary intervention 17.8 ± 12.8 Figure Reasons for transulnar approach. hypoplasia of the radial artery in 1.3% of the cases (Figure). From our entire cohort of transulnar procedure patients, 211 (54.5%) had undergone a previous coronary invasive procedure, of whom 133 (63.0%) through the transradial approach and 39 (18.5%) through the transulnar approach. Of these, the totality had been submitted to transulnar percutaneous coronary intervention the following day after transulnar coronary angiography. Table III. Technical features related to access site failure Reasons for crossover N (%) Ulnar puncture failure 3 (50.0) Severe ulnar spasm 1 (16.6) Ulnar artery chronic occlusion 1 (16.6) Severe subclavian tortuosity 1 (16.6) Table IV. In-hospital access site complications Access site complications N = 410 Hematoma, n (%) 13 (3.2) Type I, n (%) 8 (61.5) Type II, n (%) 1 (7.7) Type III, n (%) 2 (15.4) Type IV, n (%) 2 (15.4) Type V, n (%) 0 Major bleeding, n (%) 0 Pseudoaneurysm, n (%) 0 Arteriovenous fistula, n (%) 0 Asymptomatic occlusion of the ulnar artery, n (%) 3 (0.7) Ulnar nerve lesion, n (%) 0 Good-quality coronary angiography images were obtained for all diagnostic procedures but one, owing to a severe spasm making it impossible to conclude the procedure. To perform coronary angiography, the use of 5F Judkins right and left catheters were predominant (94%), whereas in percutaneous coronary intervention, 6F catheters (Voda Left or Extra Back-up to left coronary artery and Judkins Right or Amplatz Left to right coronary artery) with an internal lumen of 0.070 in and stent implantation were used in 97% of the procedures. Procedure success was high (98.5%), with a crossover rate of 1.5% (6 cases), of which 5 were achieved through the contra lateral radial access and one through femoral approach. Success was not achieved in these cases due to failure in obtaining ulnar access (3); occurrence of severe ulnar spasm (1); previous ulnar artery occlusion, in spite of a prominent palpable distal pulse (1); and severe tortuosity of subclavian artery and ascending aorta making it unsuitable to obtain reasonable back-up for the performance of a percutaneous coronary intervention in a saphenous vein graft (1) (Table III). Complications related to access site were low, consisting mostly of minor bleeding due to subcutaneous hematomas (Table IV). There were no cases of major bleeding, nerve injury, pseudoaneurysm, arteriovenous fistula, or necessity of vascular surgical repair. Moderate to severe spasm was reported in 1.5% of procedures, vasovagal reaction in 0.5%, and asymptomatic occlusion of the ulnar artery at the time of hospital discharge in 0.7% of cases. Bailout ipsilateral transulnar approach after radial access failure, presented in 46 cases, exhibited similar patterns of complications when compared with de novo ulnar artery puncture. Efficacy and safety data

American Heart Journal Volume 164, Number 4 de Andrade et al 465 Table V. Efficacy and safety results of transulnar approach studies Author, Year Patients (n) Procedures (n) Size Success (%) Crossover (%) Complications (n) Terashima, 2001 6 9 9 (Cath) Dashkoff, 2002 7 5 5 Talwar, 2003 17 30 30 Limbruno, 2004 8 13 13 Lanspa, 2004 18 1 1 (Cath) Mangin, 2005 19 117 122 4F 77.8 22.2 3 local hematomas 5-6F 100 0 0 5-6F 96.6 3.4 0 6F 76.9 23.1 2 local hematomas 5F 100 0 0 4-7F 85.2 14.8 5 local hematomas 1 large hematoma 1 pseudoaneurysm Aptecar, 2005 13 172 173 4-6F 91 9 7 local hematomas 1 asymptomatic 1 pseudoaneurysm Gourassas, 2004 20 3 3 6F 100 0 0 (PCI) Lanspa, 2005 14 13 12 5-6F 92.3 7.7 0 (Cath) Rath, 2005 21 100 100 5-6F 95 5 1 local hematoma 1 artery perforation 1 transient paraesthesia Aptecar, 2006 11 216 319 4-5F 93.1 6.9 1 large hematoma 5 local hematomas 1 arteriovenous fistula 5 asymptomatic Knebel, 2008 22 28 26 Andrade, 2008 23 1 1 Vassilev, 2008 12 92 92 Li, 2010 24 120 120 5-6F 93 7 2 local hematomas 2 asymptomatic 6F 100 0 0 6F 74.8 25.2 5 local hematomas 2 large hematomas 5-7F 98.3 1.7 7 local hematomas 2 asymptomatic 6F 100 0 0 Agostoni, 2011 15 1 1 James, 2012 25 1 1 Sheathless 7F 100 0 0 Andrade, 2012 387 410 5-7F 98.5 1.5 11 local hematomas 2 large hematomas 3 asymptomatic Cath, Coronary angiography; PCI, percutaneous coronary intervention; TRA, transradial approach regarding transulnar approach in coronary invasive procedures, including the results of our new registry and totaling 1,309 patients are summarized in Table V. During the same time interval of five years 9,609 patients in our institution underwent 10,108 transradial coronary invasive procedures. The mean age was 61.4 ± 11.2 years, 40.1% were female, 78.6% had diagnoses of systemic hypertension, 28.9% of diabetes and 26.6% were current smokers. Compared to the transulnar group, the baseline demographic and procedure characteristics were well balanced, except for a high percentage of women and diabetic patients in the transulnar population. Efficacy and safety access site endpoints were comparable between the 2 strategies (Table VI). Discussion In the present registry, we report the results of 410 coronary procedures performed using the transulnar approach. During 5 years, 387 patients, representing approximately 4% of the cases, were selected for the transulnar approach, when the radial approach proved to

466 de Andrade et al American Heart Journal October 2012 Table VI. Access-site efficacy and safety comparison between transradial and transulnar approach Transradial (n = 10,108) Transulnar (n = 410) P Successful access site, n (%) 9,936 (98.3) 404 (98.5).86 Crossover rate, n (%) 171 (1.7) 6 (1.5).87 Procedure duration, minutes 21.0 ± 15.0 25.3 ± 15.5 b.0001 Fluoroscopic time, minutes 5.2 ± 17.5 5.4 ± 5.5.88 Number of catheters used, 2.0 ± 0.9 1.9 ± 0.6.02 MD±DP Local hematoma, n (%) 353 (3.5) 13 (3.2).83 Large hematoma, n (%) 70 (0.7) 2 (0.5).85 Asymptomatic artery occlusion, n (%) 91 (0.9) 3 (0.7).7 be unavailable or prone to technical failure, especially for a small caliber or weak pulse on physical examination, justifying the high percentage of women in our sample. We achieved a high success rate of the technique in our series, (N98%), with a low crossover rate (1.5%). Ulnar access represents our second choice in the case of inability to use the radial approach, but this decision is always based on the presence of an easily palpable and broad enough ulnar pulse. In the randomized PCVI-CUBA trial, consecutive unselected patients were randomized to ulnar or radial approach before palpation of the forearm pulses and Allen's test were done. Successful access was obtained in 93.1% of patients in the ulnar group and in 95.5% of patients in the radial group (P =.82). 11 However, we observe in the daily practice a more difficult perception of an ulnar artery feasible for percutaneous puncture when compared to radial. In a report of 131 consecutive unselected patients undergoing ulnar coronary procedures by operators experienced with the radial approach, the authors reported the absence of palpable or sufficiently broad ulnar pulse in 29.8% of cases, and failed attempts to obtain access in 25.2%, representing a success rate of only 45%. 12 The studies also differ in determining which is the largest branch of the brachial artery, with some analysis using Doppler ultrasound showing similar diameters between the radial and ulnar arteries. 11,13 The course of the radial artery is more superficial, making it more readily palpable and easily compressible, thus making it our preferable access route, currently representing more than 90% of procedures. In 46 procedures (11.2%), the transulnar access was used after a failed attempt to obtain the ipsilateral transradial access, mostly due to spasms. Although possible questions may arise concerning the safety of following the procedure through the transulnar approach after radial artery spasm, we did not find any cases of ischemia of the hand, or even pain during the procedure. Similar findings were reported in a study where 12 patients who underwent transulnar procedures after radial access failure had an angiogram of the hand at the end of the procedure. 14 Seven of the 12 cases showed a patent radial artery, indicating a transient spasm. One patient showed chronic occlusion of the radial artery, with collateral branches from both arteries supplying the palmar arch. Even the remaining four cases with possible acute occlusion exhibited flow to the palmar arch through collateral circulation without evidence of ischemia. Simultaneous presence of 2 sheaths in the ipsilateral radial and ulnar artery has also been described as feasible during the performance of primary percutaneous coronary intervention. 15 The rationale for the use of the transulnar approach in these circumstances would be to not waste time in preparing the other arm or leg, especially in emergency situations such as an acute myocardial infarction, the possibility of using the same introducer, guide, and needle initially employed, and preservation of a possible contralateral radial graft conduit in cases of coronary artery bypass grafting indication, beyond the recognized benefits in reducing vascular complications. Vascular complication rates in our series were low, restricted mainly to subcutaneous hematomas without clinical symptoms. Although there is a higher prevalence of diagnostic procedures, thus setting a lower risk population, the absence of episodes of major bleeding certifies the premise that the transulnar approach shares the same benefits offered by the transradial approach. Ulnar nerve injury, a potentially serious complication, was not observed in our registry, in accordance with similar publications. 16 Limitations of our study are its non-randomized nature, though the registries play an important role in reflecting the real-world clinical practice. In addition, patients were selected from those with an ulnar pulse feasible for percutaneous access. The results are restricted to the period of hospitalization, without routine Doppler ultrasound assessment, which could underestimate asymptomatic complications such as arterial occlusion, pseudoaneurysm, or arteriovenous fistula. However, there was no clinical evidence of hand ischemia. The total number of patients and procedures, although small, represents the largest series reported to date on the use of the transulnar approach for coronary invasive procedures. Conclusions Our registry adds data to the available evidence regarding the feasibility, efficacy, and safety of the transulnar approach for invasive coronary procedures. Since bleeding complications are associated with increased morbidity and mortality, the transulnar approach represents an elegant alternative to the transradial approach in selected cases when performed by radialtrained operators, sharing a high success rate and extremely low incidence of access site complications.

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