Slender PCI: Extremely Minimally Invasive Percutaneous Coronary Intervention [1st ed.] 9789811537769, 9789811537776

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Slender PCI Extremely Minimally Invasive Percutaneous Coronary Intervention Fuminobu Yoshimachi Editor

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Slender PCI

Fuminobu Yoshimachi Editor

Slender PCI Extremely Minimally Invasive Percutaneous Coronary Intervention

Editor Fuminobu Yoshimachi Department of Cardiology Tokai University Hachioji Hospital Hachioji Tokyo Japan

ISBN 978-981-15-3776-9    ISBN 978-981-15-3777-6 (eBook) https://doi.org/10.1007/978-981-15-3777-6 © Springer Nature Singapore Pte Ltd. 2020 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore

Preface

Percutaneous coronary intervention (PCI) is less invasive than the bypass surgery. Minimally invasive treatment is one of the essences of PCI. It is reasonable to select PCI as a less invasive treatment, considering the similar outcomes obtained for revascularization. However, in recent years, numerous physicians are satisfied with the current situation. They are not trying to further reduce the invasiveness of PCI. They may be merely following the current procedure and recommendations in guidelines and they misunderstand the minimally invasive strategy of this approach. Guidelines are based on the evidence from previous studies; thus, they are useful in standardizing the procedure. However, guidelines do not provide new ideas or tips and tricks for the management of individual patients. We wish to offer more comfortable circumstances and less invasive treatment for our patients beyond the recommendations of guidelines. In other words, we have to practice beyond guidelines. Moreover, large academic conferences or excellent medical publications provide major directions towards the treatment of a disease, but do not effectively disseminate sufficient information for the management of individual patients. We the physicians should not neglect the need to improve our skills. Each interventional cardiologist has numerous tips for the management of patients, which should be shared with the relevant community worldwide. Such sharing of information may improve the procedure of PCI in the future. We have formed an organization called “Slender Club Japan.” The term “Slender” was selected based on the use of a small-diameter catheter for a less invasive PCI strategy. Currently, we study all minimally invasive treatments for revascularization rather than limiting our investigation to merely slender catheters. The aim is to reduce exposure, usage of contrast agent, pain or discomfort to patients, procedure time, bleeding complications, and other invasiveness to patients. Moreover, the working conditions and costs of doctors and healthcare staff also pose a burden to the society; thus, improvements in these areas are crucial. Although it is difficult to address all the topics related to less invasive PCI, this book contains numerous important pieces of information. After reading this book you will notice that the daily practice of PCI is not a simple routine work. It is

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important to make an effort to shift toward a slightly less invasive direction every day. In time, your treatment will be very different from your previous practice. Performing minimally invasive treatment is not linked to a higher salary or awards/recognition from society. The satisfaction of patients and colleagues is one of the rewards for interventional cardiologists practicing minimally invasive PCI. Even if no one is aware of our efforts for minimally invasive treatment, the smile of patients and their families indicates the great success of our strategy. Naturally, circumstances differ between hospitals or countries, and you may not be able to exactly replicate the methods described in this book. The true minimally invasive treatment is in you. It is a kind feeling for the patient. This book is the key to accessing this approach. Please enjoy reading this book. It will be your first step toward minimally invasive treatment.

Tokyo, Japan

Fuminobu Yoshimachi

Acknowledgments

Colleagues from Japan and around the world have contributed to this book entitled Slender PCI to freely spread information regarding minimally invasive percutaneous coronary intervention (PCI). This publication targets established international interventionalists as well as local Japanese physicians in any region of Japan. In addition, we believe that Slender PCI is an appropriate source of information for patients worldwide. I wish to thank all colleagues who participated in the production of this book and also for their hard work. Although many of our friends were not directly involved in writing this book, they contributed substantially through collaboration and discussion regarding minimally invasive intervention. The content of this book is an accumulation of tips and tricks that are not presented in large academic meetings or published in leading journal articles. Thank you all once again! We hope this book can be a guide for young physicians who are interested in minimally invasive intervention and the well-being of their patients. Such young and ambitious physicians possessing new ideas will lead the future developments in angioplasty. A little effort and ingenuity are required for Slender PCI, but those are not difficult. We can see the patient’s smile at the price of our effort. Also, it is not necessary for the patient and his family to know this good conduct. When treatment is over, at the meeting room drinking coffee with other physicians and members of the paramedical team, you can say “We performed extremely less invasive PCI for the patient today!” It is wonderful! We recommend consulting Slender PCI for the happiness of our patients, patients’ families, and all of us. We hope this field will develop further, and we do our best toward this goal. Finally, we have the web site of Slender Club Japan (https://slenderclubjapan.com), which is a study group for minimally invasive strategy. We hold an

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annual meeting in Japan. If you wish to know more, please join us. You may discover an unbelievable field and obtain information for your angioplasty room and strategy. Tokyo, Japan

Fuminobu Yoshimachi

Contents

1 Introduction����������������������������������������������������������������������������������������������    1 Fuminobu Yoshimachi 2 What Is Slender PCI?������������������������������������������������������������������������������    3 Motomaru Masutani 3 Evidence for Slender Percutaneous Coronary Intervention����������������    7 Takashi Matsukage 4 Less Invasive Intervention: From a Forearm Radial to Distal Radial Approach ����������������������������������������������������������������������   15 Shigeru Saito 5 Distal Transradial Access for Arterial Angiography and Interventions: An Overview of Knowledge������������������������������������   23 Ferdinand Kiemeneij 6 Ultimate Less Radial Artery Occlusion Hemostasis Method on Slender PCI ����������������������������������������������������������������������������������������   39 Ivo Bernat 7 Distal Radial Approach for ST Elevation Myocardial Infarction������������������������������������������������������������������������������   47 Akihiko Takahashi 8 Backup Support of Slender Percutaneous Coronary Intervention Guiding Catheter ��������������������������������������������������������������   57 Fuminobu Yoshimachi 9 Radial Artery Puncture and Hemostasis ����������������������������������������������   69 Sandeep Nathan and Rajeev Anchan 10 Usefulness of Low-Concentration Contrast Medium in Coronary Angiography ����������������������������������������������������������������������   89 Takashi Harada ix

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11 Minimum Contrast PCI��������������������������������������������������������������������������  105 Naoki Masuda 12 Usefulness of Fractional Flow Reserve Measurement with the Four FRench Diagnostic Catheter (FFRFFR)������������������������  113 Masanori Kanehachi and Katsuhiko Masamura 13 4 Fr. Guiding Catheter����������������������������������������������������������������������������  127 Takashi Matsukage 14 3 Fr Diagnostic Catheter ������������������������������������������������������������������������  133 Yoshiaki Katahira 15 Sheathless Slender in the United Kingdom ������������������������������������������  145 Mamas A. Mamas, Ahmad Shoaib, and Karim Ratib 16 Slender Sheathless in Japan��������������������������������������������������������������������  153 Yoshitoki Takagawa 17 Slender PCI for Bifurcation Lesions������������������������������������������������������  167 Kaoru Sakurai 18 Use of Slender PCI in Undilatable Calcified Coronary Lesions����������  179 Akihiko Takahashi 19 Slender PCI for Chronic Total Occlusion: Microchannel Tracking Technique��������������������������������������������������������������������������������������������������  187 Motomaru Masutani 20 Histological Insight into the Pathology of Coronary Chronic Total Occlusion and Intervention ��������������������������������������������������������������������  193 Masataka Nakano 21 Slender CTO: 1P1G and Chameleon Technique����������������������������������  197 Ryuichi Kato and Ryo Oyama 22 CTO: Retrograde Approach ������������������������������������������������������������������  209 Fuminobu Yoshimachi

Chapter 1

Introduction Fuminobu Yoshimachi

The development of minimally invasive procedures for revascularization is an important theme in the field of interventional cardiology. In the balloon angioplasty era and in the bare-metal stent era, the success rate and outcome of percutaneous coronary angioplasty (PCI) were not satisfactory. The development of drug-eluting stents (DES) and other devices has improved and stabilized the outcome of PCI. However, complications continue to occur at a certain rate. Even in the absence of complications, numerous problems (i.e., pain/discomfort in patients, the heavy workload of healthcare professionals, and the financial burden associated with this intervention) continue to affect its success. To address these problems, the approach site for PCI was switched from the femoral artery to the radial artery/distal radial artery. Moreover, the design of catheters has also evolved from large diameters to more slender structures. In addition, it is established that minimally invasive treatment cannot be achieved merely through the use of a slender catheter. To overcome this limitation, it is also important to understand the systemic and psychological condition of the patients, examine the ventricular and renal functions, and minimize exposure and usage of contrast media. The cooperation of a multidisciplinary team (termed “co-medical staff” in Japanese), involving a nurse, an X-ray technician, and a clinical engineer, is essential for this activity. Fortunately, Japanese co-medical staff has been involved in this activity since the early days of PCI. Cooperation between interventional cardiologists and co-medical staff for the treatment of patients is characteristic of this activity. Previously, the only information we could obtain was provided by renowned individuals in large academic meetings. Of course, most of them are scientists rather than clinical physicians. It cannot be denied that the bulk of information was intended for scientists instead of patients. Unfortunately, one of the serious F. Yoshimachi (*) Department of Cardiology, Tokai University Hachioji Hospital, Hachioji, Tokyo, Japan e-mail: [email protected] © Springer Nature Singapore Pte Ltd. 2020 F. Yoshimachi (ed.), Slender PCI, https://doi.org/10.1007/978-981-15-3777-6_1

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problems of scientific society is commercialism. A portion of the provided information does not appear to be focused on patients. In recent years, exchange of information using the Internet has become popular, facilitating direct communication between local physicians and co-medical staff. Hence, it is currently possible to accumulate information that cannot be understood by inflexible authorities, and provide improved services to patients. The Slender Club Japan (SCJ)—a study group for less invasive catheter therapeutics—was established in 2007, aiming to improve this activity. The group usually convenes online, thus not limiting the participation of members according to their location. Apart from the annual academic meetings and live demonstrations, numerous workshops have been held in various local healthcare institutions in Japan to enhance the exchange of information between members of the SCJ. The content of these sessions is typically related to minimally invasive treatment. Moreover, several overseas physicians have participated in meetings of the SCJ. In recent years, numerous meetings regarding minimally invasive intervention have taken placed worldwide (e.g., Slender Club Europe and Slender Club Singapore). Interestingly, discussions taking into account local circumstances are flourishing in those meetings. There are unique tips & tricks for minimally invasive treatment, including the use of slender catheters. An enhanced understanding of the minimally invasive procedures by physicians and co-medical staff could result in safer, more effective, and comfortable treatment for patients. Therefore, it is essential to share the currently available knowledge more widely. Despite the effort of the members of the SCJ to improve the treatment of patients, the number of physicians who focus on minimally invasive treatment remains small. Nevertheless, we are aware that many physicians are interested in less invasive PCI. For that purpose, we decided to produce a publication for colleagues who cannot attend the SCJ meetings, those who hesitate to access our website and contact us, and future fellows. We condense the current knowledge regarding Slender PCI into this book, including basic ideas, evidence, special techniques, new topics, remarkable and creative findings, etc. Specialists and pioneers of minimally invasive treatment from around the world shared their knowledge and experience in this book. Through this book, we aim to introduce physicians and patients to the field of extremely less invasive intervention.

Chapter 2

What Is Slender PCI? Motomaru Masutani

Currently, the most widely used sizes of guiding catheters for the treatment of common cases are 6 or 7 French (Fr). The use of 8 Fr guiding catheters is reserved for the management of complex cases, such as those with bifurcation, calcification, chronic total occlusion (CTO) lesions, etc. However, percutaneous coronary intervention (PCI) requires the oral administration of antiplatelet agents. In addition, puncture-site complications (e.g., hemorrhage and hematoma) occur more frequently with the femoral approach versus the trans-radial approach. In the trans-radial approach, the use of a 6 Fr guiding catheter is associated with a higher incidence of bleeding events versus that reported with a 5 Fr guiding catheter [1]. Currently, almost all guidelines for PCI recommend the use of the trans-radial approach [2]. Moreover, although the trans-radial approach causes fewer puncture-site complications versus the transfemoral approach, 6 Fr or larger guiding catheters may cause radial arterial occlusion [3, 4]. The 5 Fr guiding catheters are compatible with most PCI devices (excluding the atherectomy device) and all imaging devices. Studies showed that the success rates of PCI with 5 Fr or 6 Fr guiding catheters were not different. In addition, the ratio of radial artery occlusion after PCI was reduced in the 5 Fr group [5]. Our group reported that the 5 Fr guiding catheter, 0.010-inch guidewire, and balloon systems were very useful and safe for the treatment of complex lesions and CTO [6–8]. Slender PCI is a less invasive procedure, through the distal radial or radial approach, and using a 5 Fr guiding catheter for patients with complex lesions. Furthermore, slender PCI does not only refer to the size of the device. The members of our Slender Club Japan always consider the needs of the patients and hospital staff. PCI is a less invasive therapy than bypass surgery. Nevertheless, PCI has some limitations, such as the use of contrast medium and exposure of patients to radiation. In patients with chronic kidney disease, use of a very low dose of contrast M. Masutani (*) Hakuhoukai Central Hospital, Amagasaki, Hyogo, Japan e-mail: [email protected] © Springer Nature Singapore Pte Ltd. 2020 F. Yoshimachi (ed.), Slender PCI, https://doi.org/10.1007/978-981-15-3777-6_2

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Fig. 2.1  Check of the proximal and distal reference sites

medium will prevent contrast medium-induced nephropathy. The limited dose of contrast medium is applied as much as possible in PCI. An intra-vascular ultrasound device is used to check the length of the target lesion, vascular size, and type of lesion, and determine the position of the stent using an imaging device (Fig. 2.1). Presentation of a case series. Ten patients with chronic kidney disease underwent PCI between June 2017 and January 2019. The mean volume of contrast medium was 11 mL (range: 0–30 mL). The level of serum creatinine was 1.53 mg/dL and 1.49 mg/dL prior to and after PCI, respectively. The level of epidermal growth factor receptor was 34–35  mL/min/1.732. There was no contrast medium-induced nephropathy in these patients, and all PCI procedures were successful. Slender PCI requires slender spirits. Slender spirits are for the patients and medical staff.

References 1. Agostoni P, et al. Radial versus femoral approach for percutaneous coronary diagnostic and intervention procedures systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44:349–56. 2. Neumann FJ, et  al. 2018 ESC/EACTS guidelines on myocardial revasculation. Eur Heart J. 2019;40:87–165. 3. Saito S, Miyake S, Hosokawa G, et al. Transradial coronary intervention in Japanese patients. Cather Cardiovasc Interv. 1999;46:37–41. 4. Saito S, Ikei H, Hosokawa G, et al. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Cather Cardiovasc Interv. 1999;46:173–8.

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5. Dahm JB, Vogelgesang D, Hummel A, et al. A randomized trial of 5 vs. 6 French transradial percutaneous coronary interventions. Cather Cardiovasc Interv. 2002;57:172–6. 6. Matsukage T, et al. A new 0.010-inch guidewire and compatible balloon catheter system: the IKATEN registry. Catheter Cardiovasc Interv. 2009;73:605–10. 7. Yoshimachi F, Masutani M, Matsukage T, et al. Kissing balloon technique within a 5 Fr guiding catheter using 0.010 inch guidewires and 0.010 inch guidewire-compatible balloons. J Invasive Cardiol. 2007;19:519–24. 8. Matsukage T, et al. A prospective multicenter registry of 0.010-inch guidewire and compatible system for chronic total occlusion: the OIKACHU registry. Catheter Cardiovasc Interv. 2010;75:1006–12.

Chapter 3

Evidence for Slender Percutaneous Coronary Intervention Takashi Matsukage

3.1  Introduction In 1989, Campeau successfully performed coronary angiography using a radial artery [1]. In 1992, Kiemeneij performed a transradial intervention (TRI) on the left anterior descending artery [2]. At the time, transfemoral interventions (TFI) were usual. However, TRI allowed patients to walk after the procedure without having to have a long rest period. In addition, other benefits including a reduction hospital stay and the workload of staff were evaluated and adopted in the clinical field. Today, 25 years after the invention of TRI, accumulated evidence has confirmed the benefits of this method, and many different types of devices for TRI have been invented. This Chapter outlines the evolution of slender percutaneous coronary intervention (PCI), the evidence for its effectiveness to date, as well as the future of TRI.

3.2  Issues for TRI in the Early Years In 1992, when the first TRI procedure was performed, balloon and stent devices were not as sophisticated as they are todays. Most of those devices were made of inflexible material compared to current devices. Most importantly, radial arteries are significantly narrower than femoral arteries, and therefore a catheter size of more than 6 Fr. was difficult to insert. This fact limited the use of such devices through a catheter. According to Japanese hospital data, patients for whom a 6 Fr. guiding catheter could be inserted into a radial artery was limited into 80% of the

T. Matsukage (*) Saitama Medical University/Saitama Medical Center, Saitama, Japan e-mail: [email protected] © Springer Nature Singapore Pte Ltd. 2020 F. Yoshimachi (ed.), Slender PCI, https://doi.org/10.1007/978-981-15-3777-6_3

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male population and 70% of the female population [3]. Cases requiring a greater than 7 Fr. guiding catheter were limited to those patients with a wider radial artery diameter. Also, a 6 Fr. guiding catheter in 1992 had a narrow lumen (0.061 inch), which was fully occupied by a balloon and guidewire; thus, a stent was not able to be inserted with this system, which required the re-insertion of a stent mounted on the balloon. In addition, the use of a narrower catheter faced a limitation in backup options. Since it was originally designed for the femoral artery, the 6 Fr. guiding catheter was not strong enough to support its approach, from a radial angle, into a coronary artery and this resulted in unstableness caused by detachment from the sidewall of the upper aorta. Therefore, TRI was not well supported plus the difficulties in the use of other devices was reported simultaneously. Based on these observations, it was concluded that TRI was not favored in the case of complex lesions, which requires strong backup as well as a procedure that, requires many other devices. In contrast, the benefits of TRI were recognized and in highly demand in the clinical field. We thus propose that the improvement and a reduction in the diameter of TRI devices has highlighted its benefits.

3.3  Large Inner Lumen 6 Fr. Guiding Catheter As mentioned above, the inner diameter of the 6 Fr. guiding catheter is 0.061 in. However, in 1996, Cordis (Miami, FL, USA) invented a catheter with an inner diameter of 0.064 inch and in 1998, Medtronic (Santa Rosa, CA, USA) invented a 6 Fr. guiding catheter with an inner diameter of 0.070  inch. Around this time, devices for TRI improved while other devices, such as balloons and stents, were modified to be narrower for a TRI procedure. Currently, Terumo (Tokyo, Japan) has a guiding catheter with a diameter of 0.071 inch. Nipro (Osaka, Japan) has a 6 Fr. guiding catheter with a 0.073 inch inner diameter. Such devices allow the insertion of two stents simultaneously.

3.4  M  iniaturization of the Outer Diameter of the Guiding Catheter Along with an improvement in quality and a reduction in the diameter of devices, guiding catheters have also shown a reduction in their diameter. In 1999, Medtronic invented a 5 Fr. guiding catheter and a Japanese company was actively involved in its improvement. Terumo invented a guiding catheter with a 0.059 inch inner diameter and Nipro invented a guiding catheter with a 0.061 inch inner diameter. These had the same diameter as the inner diameter of a 6 Fr. guiding catheter in the early days, with enough diameter for a regular balloon and stent.

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3.5  Slender Sheath Development At the insertion of the catheter, it is common to use a sheath with a valve to prevent the back flow of blood; it also allows the easier insertion of the catheter. However, as mentioned above, the radial artery is narrow, and for some groups of patients, especially older women, inserting a 6 Fr. sheath is difficult. Use of a 5 Fr. sheath increases its versatility, and can be used in 95% of patients, both men and women; it also expands the compatibility of a TRI.  However, the backup for this narrow diameter of catheter is not widely available; therefore, some devices are limited to PCI. However, TRI is not an option for a lesion that requires treatment with a large size Rotablator. In 2014, a sheath with the same inner diameter of 6 Fr. and with an outer diameter of conventional 5 Fr. sheath, called the GlideSheath Slender (GSS: Terumo Co., Tokyo, Japan), was invented [4]. The 6 Fr. GSS has the same luminal diameter in the sheath portion as the products of various companies, while the outer diameter has been decreased to 2.45 mm, which is approximately 0.3 mm smaller than the mean outer diameter of 2.74 mm for existing sheaths. This sheath makes invasive of conventional 5 Fr. sheath but allows the use of a 6 Fr. guiding catheter. In 2015, to expand its compatibility, the GSS had a 4 Fr. outer diameter with a 5 Fr. inner diameter; In addition a GSS with a conventional 6 Fr. sheath, outer diameter and a 7 Fr. inner diameter became available. Depending on the situation, a TRI is able to perform 1 Fr. less invasive than a conventional sheath [5, 6]. The invention of the GSS made it possible for treatments with a 7 Fr. guiding catheter.

3.6  Slender Techniques To improve the backup force for a catheter, a technique called a 5 in 6 mother/child catheter technique, which inserts a 5 Fr. guiding catheter inside a 6 Fr. guiding catheter to reinforce backup, was invented [7]. Thus, this allows a balloon and stent to reach a lesion, something a guiding catheter cannot reach. The versatility of the TRI has been expanded in this way. Currently, a child catheter, called a rapid exchange-type, enable the smooth insertion of the catheter. This is effective not only for stenting but also to treat thrombosis and percutaneous removal [8, 9]. In addition, the flexibility of its thinness allows the alteration of the shape of the catheter, meaning it can be inserted deep into the coronary artery. This technique can also reinforce its backup force [10]. A tortuous brachial artery is difficult for catheter insertions because of its hard friction. However, using a slender catheter reduces this friction, leading to a smooth procedure [11]. In addition, it is less invasive to insert the 5 Fr. guiding catheter directly into a radial artery without using a sheath [12]. According to a report, a new technique based on this method of putting a balloon at the tip of the catheter, called a balloon-assisted-tracking technique (BAT), can proceed without any complications at the puncture site of the coronary artery [13].

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3.7  Evidence of TRI TRI and its data relating to its use in various procedures has been slowly adopted in the clinical field. Meta-analysis demonstrated that TRI can especially reduce its hemorrhagic complications when compared to TFI [14]. In addition, particularly in the case of acute myocardial infarction, it not only reduces hemorrhagic complications but also reduces all major adverse cardiac events (MACE) [15]. Such reports triggered a large-scale randomized study on TRI and TFI led by multiple medical institutions with 7021 participants [16]. Significant differences in MACE were not found; however, TRI had a significantly lower hemorrhagic complication rate. Also, in a randomized study of 1001 patients with only ST elevation acute myocardial infarction, TRI had a significantly lower complication rate for both MACE and hemorrhagic complications [17].

3.8  Evidence of Small-Sized Guiding Catheter Depending on the diameter of a patient’s radial artery, it is common to use narrower guiding catheters in TRI. Of a total of 103,070 patients with continuous PCI, patients were grouped according to the guiding catheter size used: 64,335 patients had a 6 Fr. 32,676 patients had a 7 Fr. and 6059 patients had an 8 Fr. sized guiding catheter. The 8 Fr. and 7 Fr. groups showed significantly higher rates of hemorrhage, contrast agent-led nephropathy, and a reduction of more than 3 g/dL of hemoglobin, as well as MACE. Regardless of the mortality rate of such complications, the 6 Fr. group recorded the lowest mortality rate of all groups and the 8 Fr. group recorded the highest mortality rate [18]. In addition, in a comparison between a 6 Fr. and a narrower 5 Fr. guiding catheter, both had the same success rate in procedures; however, TRI using a 5 Fr. guiding catheter had a significantly lower score for occlusion of the radial artery than TRI with a 6 Fr. guiding catheter [19]. As well as being more comfortable, a 5 Fr. guiding catheter has a significantly higher comfortable level of patients than 6 Fr. in slender PCI cases [20].

3.9  Bleeding Complications Preceding paragraphs have explained how TRI can significantly lower hemorrhagic complications after a procedure. Why draw attention to this? It is because hemorrhagic complications can alter patient mortality rates. In PCI, in cases with and without hemorrhagic complications mortality rates are: 5.1% and 0.2%, respectively, 30 days after a procedure; 6.7% and 1.0% 6 months after a procedure and 8.7% and 1.9% a year after a procedure [21]. Also, a meta-­ analysis of research related to PCI with hemorrhagic complications showed that

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such complications, which required a blood transfusion, are a predictor for an increase in patient mortality rates [22]. Thus, reducing hemorrhage can reduce patient mortality rates. From such results and evidence from TRI, as explained in previous paragraphs, the guidelines of the European Society of Cardiology in 2018 classified PCI and coronary angiography with radial access as a class I-A recommendation [23].

3.10  Future Perspectives for Slender PCI As has been mentioned above, TRI is a well-established procedure; however, further improvements of devices are expected, such as further reducing the diameters of catheter and sheaths. Slender PCI may further reduce hemorrhagic complications. A recent report describes how a new stent crimped to a single guide wired balloon with an outer diameter of 0.030 inch and using a 4 Fr. coronary angiography catheter has been used to successfully treat patients [24, 25]. Also, distal transradial access from the anatomical snuff-box for TRI has drawn increased attention. This is a new approach from a further point (snuff-box) that, may reduce radial artery occlusion [26]. Another asset of TRI from the anatomical snuff-box is that it does not require patients to bend their arm for an optimized angle during the procedure; thus patients are able to be treated while in a natural posture. With the above in mind, slender PCI has the potential to increase its versatility as it further evolves.

References 1. Campeau L.  Percutaneous radial artery approach for coronary angiography. Catheter Cardiovasc Diagn. 1989;16(1):3–7. 2. Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Catheter Cardiovasc Diagn. 1993;30(2):173–8. 3. Saito S, Ikei H, Hosokawa G, Tanaka S.  Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999;46(2):173–8. 4. Aminian A, Dolatabadi D, Lefebvre P, Zimmerman R, Brunner P, Michalakis G, Lalmand J.  Initial experience with the Glidesheath slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up. Catheter Cardiovasc Interv. 2014;84(3):436–42. 5. Chugh Y, Chugh S, Matsukage T, Chugh SK. Safety and feasibility of 5 French Glidesheath Slender for complex transradial interventions in small diameter radial arteries. Indian Heart J. 2017;69(3):405–6. 6. Aminian A, Iglesias JF, Van Mieghem C, Zuffi A, Ferrara A, Manih R, Dolatabadi D, Lalmand J, Saito S. First prospective multicenter experience with the 7 French Glidesheath slender for complex transradial coronary interventions. Catheter Cardiovasc Interv. 2017;89(6):1014–20.

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7. Takahashi S, Saito S, Tanaka S, Miyashita Y, Shiono T, Arai F, Domae H, Satake S. Itoh T new method to increase a backup support of a 6 French guiding coronary catheter. Catheter Cardiovasc Interv. 2004;63(4):452–6. 8. Stys AT, Stys TP, Rajpurohit N, Khan MA.  A novel application of GuideLiner catheter for thrombectomy in acute myocardial infarction: a case series. J Invasive Cardiol. 2013;25(11):620–4. 9. Cunnington M, Egred M. GuideLiner, a child-in-a-mother catheter for successful retrieval of an entrapped rotablator burr. Catheter Cardiovasc Interv. 2012;79(2):271–3. 10. Kiemeneij F, Yoshimachi F, Matsukage T, Amoroso G, Fraser D, Claessen BE, Saito S. Focus on maximal miniaturization of transradial coronary access materials and techniques by the Slender Club Japan and Europe: an overview and classification. EuroIntervention. 2015;10(10):1178–86. 11. Matsukage T, Masuda N, Ikari Y. Successful transradial intervention by switching from 6Fr to 5Fr guiding catheter. J Invasive Cardiol. 2011;23:E153–5. 12. Matsukage T, Yoshimachi F, Masutani M, Saito S, Nakazawa G, Masuda N, Ogata N, Morino Y, Ikari Y. Virtual 3 Fr PCI system for complex percutaneous coronary intervention. EuroIntervention. 2009;5(4):515–7. 13. Mamas MA, George S, Ratib K, Kwok CS, Elkhazin A, Sandhu K, Stubbs J, Luxford P, Nolan J. 5-Fr sheathless transradial cardiac catheterization using conventional catheters and balloon assisted tracking; a new approach to downsizing. Cardiovasc Revasc Med. 2017;18(1):28–32. 14. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009;157(1):132–40. 15. Vorobcsuk A, Kónyi A, Aradi D, Horváth IG, Ungi I, Louvard Y, Komócsi A. Transradial versus transfemoral percutaneous coronary intervention in acute myocardial infarction systematic overview and meta-analysis. Am Heart J. 2009;158(5):814–21. 16. Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR, RIVAL Trial Group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomized, parallel group, multicentre trial. Lancet. 2011;377:1409–20. 17. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012;60:2481–9. 18. Grossman PM, Gurm HS, McNamara R, Lalonde T, Changezi H, Share D, Smith DE, Chetcuti SJ, Moscucci M, Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Percutaneous coronary intervention complications and guide catheter size: bigger is not better. JACC Cardiovasc Interv. 2009;2(7):636–44. 19. Dahm JB, Vogelgesang D, Hummel A, Staudt A, Völzke H, Felix SB. A randomized trial of 5 vs. 6 French transradial percutaneous coronary interventions. Catheter Cardiovasc Interv. 2002;57(2):172–6. 20. Gwon HC, Doh JH, Choi JH, Lee SH, Hong KP, Park JE, Seo JD. A 5Fr catheter approach reduces patient discomfort during transradial coronary intervention compared with a 6Fr approach: a prospective randomized study. J Interv Cardiol. 2006;19(2):141–7. 21. Feit F, Voeltz MD, Attubato MJ, Lincoff AM, Chew DP, Bittl JA, Topol EJ, Manoukian SV. Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 trial. Am J Cardiol. 2007;100(9):1364–9. 22. Doyle BJ, Rihal CS, Gastineau DA, Holmes DR Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol. 2009;53(22):2019–27.

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23. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO, ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87–165. 24. Sarno G, Okamura T, Gomez-Lara J, Garg S, Girasis C, Kopia G, Pomeranz M, Easterbrook W, van Geuns RJ, van der Giessen W, Serruys PW. The coronary stent-on-A-wire (SOAW). EuroIntervention. 2010;6(3):413–7. 25. Meier B, Binder RK, Vogel R.  Coronary stenting through 4 French diagnostic catheter. Catheter Cardiovasc Interv. 2012;79(1):122–4. 26. Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017;13(7):851–7.

Chapter 4

Less Invasive Intervention: From a Forearm Radial to Distal Radial Approach Shigeru Saito

4.1  Introduction Transradial catheterization was first introduced by Campeau [1] in coronary angiography. In 1992, Kiemeneij applied this approach to percutaneous coronary intervention (PCI) in order to reduce bleeding complications during Palmaz–Schatz coronary stent implantation under potent anticoagulation therapy with warfarin and heparin [2]. Since the introduction of transradial coronary intervention (TRI), enthusiasm for this technique among interventional cardiologists has gradually increased due to the lower incidence of associated arterial puncture site complications and increased patient comfort after PCI compared to a transfemoral approach.

4.1.1  S  ignificance of Radial Artery Occlusion after Radial Access Radial artery occlusion (RAO) after TRI is a unique complication that occurs after conventional or forearm radial access. Although several predisposing factors for increased RAO have been proposed, Saito clearly demonstrated that RAO was closely linked with the ratio between the inner diameter of the radial artery and the outer diameter of the sheath introducer [3]. RAO was observed to occur significantly more frequently if this ratio was less than 1.1 (13.0% vs. 4.0%; p = 0.011) (Fig. 4.1). In the Japanese patient population, 20% of females and 10% of males had a radial artery inner diameter less than a 6 Fr sheath outer diameter. RAO is anticipated to occur in 13% of this cohort (Fig. 4.2). In fact, a German registry reported the incidence of RAO reached 13.7% and 30.5% after 5- and 6 Fr sheath insertions, respectively, S. Saito (*) Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan e-mail: [email protected]; [email protected] © Springer Nature Singapore Pte Ltd. 2020 F. Yoshimachi (ed.), Slender PCI, https://doi.org/10.1007/978-981-15-3777-6_4

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S. Saito Sensitivity (-) Specificity (-)

Sensitivity AND Specificity

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The Ratio of RA Inner Diameter VS Sheath Outer Diameter

Fig. 4.1  Sensitivity and specificity of RAO according to the Ratio of radial artery inner diameter vs. sheath outer diameter. Modified from reference article [3]. RAO, radial artery occlusion

Cummulative Frequency of Radial Artery Inner Diameter

%Cummulative Frequency

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80 Female 60

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1.2 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 Radial Artery Diameter (mm)

Fig. 4.2  Cumulative frequency of radial artery inner diameter. Modified from reference article [3]

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17

among 455 patients [4]. RAP (Radial Artery Patency) and Bleeding, Efficacy, Adverse evenT and (BEAT) randomized clinical trials were conducted to examine RAO in 1836 patients after a 5- or 6 Fr sheath insertion [5]. The world’s largest international prospective randomized trial for RAO, which was conducted in Japan, Europe and the United States, showed the incidence to be 2.57%. Predictors included spasms of the radial artery, younger age, any access site complications including bleeding, not having aspirin, and a lower body weight. It was interesting that Japanese patients had a higher incidence of RAO than non-Japanese (3.6% vs. 1.2%; p = 0.002) [6]. Although RAO is not listed in major adverse cardiac events, preventing it is preferable. After RAO occurs, candidates for alternative access sites are limited for the next catheterization session; hand ischemia may also be induced on rare occasions. A patent radial artery is especially important in patients who have or may have a (future) hemodialysis shunt in their forearms. A radial approach is generally used for such patients for this reason. However, even if the distal radial artery becomes occluded after a procedure, forearm radial artery (FRA) patency may be preserved. This is the most important aspect of using a distal radial artery (DRA) approach.

4.1.2  History of Distal Radial Access Distal radial artery cannulation was first performed in 2011 by Russian doctors in order to recanalize the occluded radial artery within 6 h after transradial catheterization [7]. This is the first report of DRA cannulation. A DRA approach was further developed and applied in an endovascular intervention by Kaledin et al. [8], who classified the radial artery into three parts. According to their online report, 5983 patients underwent radial artery catheterization from 2013 and 2016. The forearm radial artery (FRA), the radial artery within the anatomical snuffbox (RAAS) and the radial artery at the dorsum of the hands (RADH) were used in 3099 (51.8%), 2775 (46.4%) and 109 (1.8%) of patients, respectively. Average arterial diameters of each puncture site measured by ultrasound were 2.7, 2.5 and 2.4  mm for FRA, RAAS and RADH, respectively (the distribution in size was not disclosed). Following their innovative work, Kiemeneij systematically introduced a distal radial approach for coronary intervention in 2017 [9]. In his article, he noted the possible advantages of DRA included (1) increased comfort for both patients and operators, (2) less chance of arterial occlusion at the puncture site, and (3) short hemostasis time, among other advantages.

4.1.3  DRA Puncture Technique At the beginning phase of our doing DRA, we have been using ultrasound guidance. However, after accumulating substantial experience, we have stopped using ultrasound guidance, simply because visualization of the puncture needle is often difficult, and because our puncture technique without ultrasound has been improving.

18 Fig. 4.3  Anatomy of distal radial artery

S. Saito Radial Artery at the Dorsum of Hands

Radial Artery within the Anatomical Snuffbox

Patients are laid down on the table with their arms parallel to their body. A 20G needle with a sheath (Venous cannula; Terumo or Medikit, both in Tokyo, Japan) is used for an arterial puncture. The DRA can be fixed by gentle pressure using the operator’s index and middle fingers. Local anesthesia at the puncture site is induced by 0.5 mL of lidocaine. The needle is inserted slowly, aiming at the pulsation with a narrow angle between it and the skin. Penetrating the periosteum with the needle should be avoided, otherwise patients will feel a severe pain. If the artery is successfully found, blood will rush back into the needle. A 0.025 inch hydrophilic J wire is advanced through the needle. If no resistance is felt at the tip of the wire, it should be slowly advanced into the artery. A slow clockwise and counter-clockwise gentle rotation is usually sustained while advancing the J wire. This wire manipulation can avoid the wire tip migrating or being trapped in a small side branch (Fig. 4.3). There are various hemostasis devices for DRA being developed by several companies (Medikit, Terumo or Merit Medical [South Jordan, UT, USA]). These incorporate a small transparent balloon into a magic-band fixable plastic band, which is inflated by air and controlled pressure applied. Our protocol for hemostasis is simple: (1) apply the device to the patient’s hand, (2) inflate the incorporated balloon with 10 mL of air, (3) remove the sheath introducer, (4) deflate the balloon gradually while watching for back bleeding, (5) add 1 or 2 mL of air into the balloon, (6) keep the balloon inflated for 3–4 h, (7) deflate the balloon completely, and (8) if rebleeding occurs, inflate the balloon again.

4.1.4  Our Experience of DRA Access Stimulated by the pioneering work outlined above, we have been using DRA in Kamakura, Japan since August 2017. Between August 2017 and 2018, DRA access was attempted in 1639 patients. Of our initial experiences, DRA puncture

4  Less Invasive Intervention: From a Forearm Radial to Distal Radial Approach

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70 60 50 40 30 20 10 0

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Fig. 4.4  Distribution of inner diameters of DRA and FRA. DRA Distal radial artery, FRA Forearm radial artery Table 4.1  Univariate Analyses for RAO after DRA Access Number of patients Sheath outer diameter (mm) Use of ≥6 Fr GSSa Procedure time (minutes) Any antiplatelet therapy DAPT Anticoagulation therapy Triple therapy Moderate/severe pain

DRA-RAO (−) 1201 2.19 ± 0.17 312 (24.9%) 29.3 ± 20.9 811 (64.6%) 490 (39.0%) 91 (7.3%) 21 (1.7%) 91 (7.3%)

DRA-RAO (+) 170 2.15 ± 0.12 12 (10.3%) 29.9 ± 17.8 56 (48.3%) 33 (28.4%) 6 (5.2%) 1 (0.9%) 17 (14.7%)

p 0.001