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Clinical expert consensus document on rotational atherectomy from the Japanese association of cardiovascular intervention and therapeutics: update 2023

Clinical expert consensus document on rotational atherectomy from the Japanese association of... The Task Force on Rotational Atherectomy of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) proposed the expert consensus document to summarize the techniques and evidences regarding rotational atherec‑ tomy (RA) in 2020. Because the revascularization strategy to severely calcified lesions is the hottest topic in contemporary percutaneous coronary intervention (PCI), many evidences related to RA have been published since 2020. Latest advance‑ ments have been incorporated in this updated expert consensus document. Keywords Rotational atherectomy · Calcification · Percutaneous coronary intervention · Intravascular ultrasound · Opticalcoherence tomography Introduction compared to North America and European countries, RA in Japan has uniquely developed with the aid of greater usage Severe calcification in atherosclerotic plaques has been the of intravascular imaging devices [6, 7]. Since the cost of most common cause of poor clinical outcomes since the intravascular ultrasound (IVUS) or optical coherence tomog‑ beginning of percutaneous coronary intervention (PCI) raphy (OCT) during percutaneous coronary intervention [1–3]. Rotational atherectomy (RA) has been widely used (PCI) has been covered by the government insurance system for severely calcified coronary lesions for more than 20 years in Japan, RA operators could easily access to IVUS or OCT. to improve clinical outcomes in patients with severely calci‑ IVUS has been used to understand the guidewire bias and to fied lesions. Recently, North American expert review as well decide appropriate burr sizes during RA [8], whereas OCT as European expert consensus on RA have been published can be used to measure the thickness of calcification during to provide a clinical standard for RA operators [4, 5]. As RA [9], which could result in appropriate burr size up [10]. * Kenichi Sakakura Cardiovascular Center, Kyoto Katsura Hospital, Kyoto, Japan ksakakura@jichi.ac.jp Division of Cardiology, Ootakanomori Hospital, Kashiwa, Japan Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1‑847 Amanuma, Omiya, Department of Cardiovascular Medicine, Kitasato University Saitama 330‑8503, Japan School of Medicine, Sagamihara, Japan 2 9 Department of Cardiology, Saiseikai Yokohama City Eastern Department of Cardiology, Fukuoka Sanno Hospital, Hospital, Yokohama, Japan Fukuoka, Japan 3 10 Department of Cardiology, Miyazaki Medical Association Department of Cardiovascular Medicine, Chiba University Hospital, Miyazaki, Japan Graduate School of Medicine, Chiba, Japan 4 11 Division of Cardiology, Sakurabashi Watanabe Hospital, Department of Cardiology, Tokai University School Osaka, Japan of Medicine, Isehara, Japan Division of Interventional Cardiology, Sapporo Cardio Vascular Clinic, Sapporo Heart Center, Sapporo, Japan Vol.:(0123456789) 1 3 K. Sakakura et al. Furthermore, the prevalence of PCI with RA has been higher long calcified lesions. The lesion modification, which in Japan than in other countries. In fact, the prevalence of facilitate the delivery and expansion of DES, would be the PCI with RA was approximately 3.3% in Japan [11], which most frequent purpose in the contemporary RA, and the was similar to those in United Kingdom (3.1%) or France long‑term outcomes of DES following RA was acceptable (2.9%) and was higher than those in Italy (1.3%) or Germany [16–22], except specific lesions such as calcified nodule (0.8%) [5]. [23, 24]. The mid‑term or long‑term clinical outcomes On the other hand, RA had not been allowed to any opera‑ following RA might not be satisfactory in specific char ‑ tors without on‑site surgical back ‑up in Japan until April acteristics such as hemodialysis or malnutrition [25–27], 2020. However, the government and the Japanese Associa‑ partly because the natural prognosis of patients with such tion of Cardiovascular Intervention and Therapeutics (CVIT) characteristics would be worse than without such charac‑ worked together, and released the new facility criteria for teristics. Incomplete stent apposition (ISA) is frequently RA in April 2020, which allowed operators to perform RA observed in severely calcified lesions or calcified nodules without on‑site surgical back ‑up. The new facility criteria even after the lesion modification by RA [28 , 29], while has rapidly increased the number of RA operators in Japan. the clinical significance of ISA in severely calcified lesions In fact, more than 300 facilities have completed the RA remains undetermined. training program that was organized by CVIT and manu‑ Moreover, RA might prevent the polymer damage, when facturer (Boston Scientific Japan). Early experience from a DES was delivered to the calcified lesions [30]. Although new comer facility was reported [12], suggesting the safety the initial results of debulking using RA was not satisfac‑ and feasibility of RA in new comer facilities. The Task Force tory, the debulking might have developed with the aid of on Rotational Atherectomy of CVIT proposed the expert imaging devices and drug‑coated balloon in Japan [31– 35]. consensus document on RA to summarize the techniques Furthermore, the long‑term outcomes following RA with and evidences regarding RA in 2020 [13]. Because the plain old balloon angiography was acceptable when the tar‑ revascularization strategy to severely calcified lesions is the get lesions were limited to large coronary arteries (diam‑ hottest topic in contemporary PCI, many evidences related eter ≥ 3 mm) [36]. Intravascular lithotripsy (IVL) is a novel to RA have been published since 2020. Latest advancements technique to treat severely calcified lesions. Although the have been incorporated in this updated expert consensus combination of RA and IVL has not been systematically document. examined, RA may facilitate the IVL catheter to reach the severely calcified lesions [37, 38]. The contemporary indi‑ cations for RA is summarized in Table 1. In IVUS, calcifi‑ Aim of RA cations are typically described as high echoic signals with an acoustic shadow behind the signal [39]. Reverberations Before the stent era, the main purpose of RA was to debulk that are concentric and arctic lines at equal intervals would atherosclerotic plaques including calcification in coro‑ be observed within the acoustic shadow [39, 40]. Because nary arteries [14]. However, the incidence of restenosis reverberations are closely associated with smooth surface of was considerable following debulking using RA [15]. the calcified lesions [41], reverberations may be observed in Emergence of drug‑eluting stent (DES) has dramatically the calcified lesions after RA as well as the unmodified cal‑ changed the indications of PCI, which included diffuse cified lesions with smooth surface. Recently, Jinnouchi, et al. Table 1 Contemporary Definite indications Severely calcified lesions (typically 360 degree calcification) indications for rotational Napkin ring calcification atherectomy Calcification showing reverberation in IVUS Device uncrossable lesions IVUS/OCT could not cross (relatively common) Microcatheter could not cross (relatively rare) Possible indications Moderately calcified lesions (> 180 degree calcification) High risk lesions Lesions with thrombus Lesions with extensive dissection Lesions with an angle Bypass graft lesions Contraindication Last remaining vessel with compromised left ventricular function IVUS intravascular ultrasound, OCT optical coherent tomography 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… reported the association between slow flow following RA aorta. Although the Impella (Abiomed, Danvers, MA, USA) and reverberations [42]. However, the clinical significance is not allowed to use as a support device for patients who of the natural reverberations has not sufficiently investigated. undergo elective high‑risk PCI in Japan, the Impella is con‑ A systematic review and metaanal ‑ ysis compared the clinical sidered to be an option as a support device for elective PCI outcomes between planned RA and bailout RA, and reported with RA in USA [49]. If patients with cardiogenic shock that planned RA resulted in significantly shorter procedural already received the Impella or V‑ A ECMO supports, RA times, less contrast use, lesser dissection rates and fewer to the severely calcified lesions can be a bailout option from stents used as compared to bailout RA [43]. cardiogenic shock. Furthermore, although the beta‑blockers are cornerstone for optimal medical therapy, some operators hesitate to use beta‑ blockers, because of the possible risk of Junior RA operator slow flow [50]. Of course, bradycardia (heart rate < 60 bpm) could be a problem during RA, beta‑blockers can be contin‑ In this document, we defined junior RA operator as RA ued, because the risk of slow flow was comparable between operator with less than 50 RA experiences. Because the with and without beta‑blockers [51]. number of RA cases per operator as well as the number Arrhythmia such as bradycardia or atrioventricular block of RA cases per year in the facility was inversely associ‑ sometimes happens in RA, especially during the treatment ated with adverse events [11, 44, 45], the number of RA of RCA. Temporary pacing is a reliable option to continue cases per operator would be important to prevent severe procedures during arrhythmia. However, senior RA opera‑ complications. Moreover, the good indication for RA is not tors may not use temporary pacing by several reasons: (1) necessarily low‑risk. For example, the ostial right coronary short ablation time may not induce sustained arrhythmia, artery (RCA) lesions have been recognized a good indica‑ (2) cough resuscitation may be effective for arrhythmia dur ‑ tion for RA [46], whereas RA to the ostial RCA is known to ing RA [52], (3) there is a risk of ventricular perforation be technically difficult [47]. Therefore, the recommendation induced by temporary pacing catheter [53, 54]. Nevertheless, for junior RA operators may be different from that for senior it would be a safe approach for junior RA operators to insert operators in some sections. temporary pacing for specific lesions. Brady ar ‑ rhythmia can occur during RA to RCA, dominant left circumflex (LCX), left main trunk, and rarely left anterior descending artery Patient’s general conditions, mechanical (LAD) lesions. In this document, we recommend junior support, temporary pacing RA operators to consider temporary pacing for RA to RCA, dominant LCX, and left main trunk lesions. When we plan to perform RA, we should evaluate patient’s Kusumoto et al. reported a unique case of trans‑coronary general conditions such as vital signs and cardiac functions. pacing via RotaWire [55]. In this case report, the cathode of Although there was no evidence regarding blood pressure an external pacemaker was attached to the distal external end during RA, it would be important to keep systolic blood of the guide wire using a crocodile clip, whereas the anode pressure (SBP) ≥ 120  mmHg (at least ≥ 100  mmHg) for was attached to the needle which is inserted under the skin the prevention of complications such as slow flow. If slow of the anaesthetized groin [55]. The possibility of temporary flow occurred in patients with left ventricular dysfunction, guidewire pacing can be discussed as potential substitutes there would be a greater risk of hemodynamic collapse. If a for temporary pacing catheters. However, since there are patient with left ventricular dysfunction shows low SBP, we several limitations such as coronary spasm or twitching dia‑ may consider to use mechanical supports such as intraaor ‑ tic phragm in temporary guidewire pacing, we do not recom‑ balloon pumping (IABP) before RA. Chen et al. reported mend temporary guidewire pacing in this document yet. that the major adverse cardiac event rate was higher in RA with bailout IABP than in RA with primary IABP [48], implying that the use of IABP should be implemented at Guide catheter for RA the beginning of RA if a complex procedure is anticipated. Although it is very rare to insert veno‑arterial extracorpor ‑ Although RA is possible either trans‑radial, trans‑femoral, eal membrane oxygenation (V‑ A ECMO) for elective PCI or trans‑ brachial [56–58], RA operators should recognize with RA, it is an option for very high‑risk PCI with RA the maximum burr size for each guide catheter size. A 6‑Fr to take additional arterial and venous sheathes just in case guide catheter can accommodate ≤ 1.75 mm burr, where as a of emergent V‑ A ECMO. Moreover, if such patient would 7 Fr guide catheter can accommodate ≤ 2.0 mm burr. When undergo elective RA, it is better to evaluate the abdominal RA operators consider ≥ 2.15mm bur ‑ r, a 8 Fr guide catheter and thoracic aorta by computed tomography (CT) to check is necessary. However, if there is a severe tortuosity in a the contraindications for IABP such as aneurysm or shaggy guide catheter, operators may feel a strong resistance during 1 3 K. Sakakura et al. advancing the burr in the guide catheter, which results in the Therefore, the use of microcatheter is recommended to burr‑size down. Moreover, if operators make side‑holes in bring RotaWires to the target. RA operators should use the a guide catheter by themselves, such handmade side‑holes conventional 0.014‑inch guidewire to cross the lesion, and may prevent the burr from advancing in the guide catheter. then exchange the conventional guidewire to the RotaWire For junior RA operators, it is important to check coronary using microcatheter. Recently, the manufacturer (Boston flow more frequently than senior RA operators to notice the scientific, Marlborough, MA, USA) refined both RotaWire occurrence of slow flow or perforation immediately, which floppy and RotaWire Extra‑support, and introduced both would be easier in ≥ 7 Fr guide than in 6 Fr guide because of RotaWire drive floppy and RotaWire drive extra‑support the large dimeter of the drive shaft sheath (4.3 Fr). [61]. The torque response has considerably improved in The choice of guide catheter curves varies even among both RotaWire drive floppy and extra‑support. However, senior RA operators. Although the appropriate back‑up sup‑ we still recommend to use the conventional 0.014‑inch port is important for stable procedures, the strongest backup ‑ guidewire to cross the lesion, and then exchange the con‑ support, which is sometimes required for PCI to chronic total ventional guidewire to the RotaWire drive using micro‑ occlusion, would not be necessary for RA. The coaxial posi‑ catheter not to make a bend in RotaWires. The guidance tioning of the guide catheter would be of utmost importance for selection of RotaWires is shown in Table 2. for successful RA. However, the strong back‑up support can be a key to success in limited cases [59]. Appropriate burr size Guidewire for RA In early experiences with RA, big burrs were used to Two types of guidewire for RA have been commercially debulk the calcified plaques. However, a randomized trial available: RotaWire floppy (Boston scientific, Marlbor ‑ comparing small burrs (burr/artery ratio of ≤ 0.7) with ough, MA, USA) and RotaWire Extra‑support (Boston large burrs (burr/artery ratio of > 0.7) revealed that small scientific, Marlborough, MA, USA). Both RotaWires burrs achieved similar immediate lumen enlargement and have 0.014‑inch/0.36 mm spring tip and 0.009 inch/0.23‑ late target vessel revascularization compared with large mm guidewire shaft. However, the length of the tapered burrs, but showed fewer complications [62]. Further‑ segment is considerably different between RotaWire more, a recent retrospective study reported that bur/artery floppy and RotaWire Extra‑support. RotaWire floppy ratio > 0.61 was associated with worse clinical outcomes has long tapered shaft (13 cm of < 0.0077‑inch/0.20 mm [63]. European expert consensus document recommend shaft) and short spring tip (22 mm), whereas RotaWire burr/artery ratio of 0.6 [5], and North America expert con‑ Extra‑ support has short tapered shaft (5 cm of < 0.009‑ sensus document recommend burr/artery ratio of 0.4–0.6 inch/0.23 mm shaft) and long spring tip (28 mm) [60]. [4]. In this document, we recommend burr/artery ratio of For successful RA, it is important not to make a bend 0.4–0.6 without intravascular imaging devices, and recom‑ in RotaWires, because a bend in RotaWires substantially mend to use intravascular imaging if RA operators aim to increase the friction force between burr and RotaWire. achieve burr/artery ratio of ≥ 0.6. Table 2 Guidance for selection of RotaWires Characteristics or specific situations RotaWire floppy or extra‑support Ability to ablate the severely calcified plaques (ablation efficiency) Extra‑support > floppy Ability to straighten the tortuous coronary artery Extra‑support > floppy Ability to strengthen the back‑up force in the system Extra‑support > floppy When pre‑intravascular imaging devices cross the lesion and provide Select either Extra‑support or floppy according to the information from sufficient information regarding the guidewire bias imaging devices and angiography When operators cannot judge the guidewire bias from angiography Floppy first and/or intravascular imaging When junior RA operators cannot understand which RotaWires are Floppy first more suitable to the lesion When the burr cannot cross the lesion, the exchange from floppy to May work well, because of the change of the contact point. However, extra‑support the strong guidewire bias may cause deep ablation When the burr cannot cross the lesion, the exchange from extra‑sup‑ May work well, because of the change of the contact point port to floppy 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 3 Guidance for use of the second burr Size down or size up Situations Comments Size down When the first burr cannot cross the lesion, operators This size down is important to prevent severe complications. It is should size down with the second burr better for junior RA operators to consider size down, when the burr could not cross the lesion after 4–6 RA sessions. If there are signs of slow flow such as chest pain or ECG changes, immediate size down should be considered Size up When operators aim to use the big burr Generally, the range of size up would be 0.25–0.75 mm. Junior RA (≥ 1.75 mm), start with the small burr (≤ 1.5 mm) operators should select the 0.25‑mm or 0.50 mm size up for safety, and then size up to the big burr Size up Operators started with the first burr, and checked The thickness of calcification derived from OCT may be helpful to intravascular imaging after the pass of the first decide the necessity of size up. Before size up, operators should burr. Intravascular imaging revealed the insuffi‑ check signs of slow flow such as chest pain or ECG changes cient ablation, which recommended the size up Size up Operators finished RA with the first burr, and then Careful manipulation of RotaWire is necessary, because there balloon (non‑compliant balloon, scoring balloon, would be some dissections after balloon dilatation or cutting balloon) dilatation was tried. However, the lesion was not dilated sufficiently (typically dog‑bone phenomenon), and then size up to the big burr Size up During RA, no additional speed down was observed No additional speed down in spite of forceful manipulation of the in spite of the forceful manipulation of the burr. burr is the high‑risk situation for burr entrapment or perforation Operators judged that the burr did not contact to the calcification adequately, and then sized‑up to increase the contact area For lesion modification, single burr may be sufficient facilities in Japan. In brief, the ROTAPRO™ system is to facilitate stent delivery and stent expansion. However, composed of a digital console and an advancer including second burr is sometimes necessary even for lesion modi‑ buttons to activate devices [61]. The ROTAPRO™ system fication. The guidance for second burr is summarized in eliminated the foot pedal. Table 3. Duration of individual runs is also important to prevent complications. Manufacturer recommend the duration of individual runs less than 30 s. In general, longer duration Burr manipulation and rotation speed would be associated with greater amount of debris. For junior RA operators, short duration (e.g. ≤ l5–20 s) for a A pecking motion (quick push‑forward/pull‑back move‑ single session would be recommended. Furthermore, it is ment of the burr) has been a standard burr manipulation important to check the situations such as ECG and vital in RA [5]. Although several burr manipulations have been signs between the sessions. conducted by RA experts, the common part of burr manip‑ Regarding the rotational speed, since manufacturer ulation is to push‑forward from the platform and pull‑back set the minimum speed as 140,000 rotations per min‑ the burr to the platform. The speed of manipulation varies ute (rpm), and the maximum speed as 190,000  rpm widely among experts. Some experts prefer very quick, [ 64], this consensus document also recommends whereas other experts prefer very slow. Either speed is to use 140,000–190,000  rpm, and may consider to acceptable as long as the following points are considered: use > 190,000 rpm when operators feel difficulty to cross (1) Operators should control the burr’s motion. If operators the lesion. There was a debate whether low rotational feel difficult to control the burr’s motion, the speed may be speed can reduce the risk of slow flow. Platelet aggre‑ too quick, (2) operators should avoid excessive rotational gation was greater in high‑speed (180,000 rpm) than in speed down, and (3) operators should not deactivate the low‑speed (140,000 rpm) in an early experiment in vitro system when the burr is in the middle of stenosis, which [65], which has not been proved in vivo. Recently, a rand‑ may result in the entrapment of the burr. Operators should omized control study comparing low‑speed (140,000 rpm) deactivate the system when the burr was pulled‑ back to with high‑speed (190,000 rpm) revealed that the incidence the platform. Furthermore, the ROTAPRO™ system (Bos‑ of slow flow was similar between low ‑speed and high‑ ton scientific, Marlborough, MA, USA) has been gradu‑ speed [66]. Therefore, it is not reasonable to use low‑speed ally introduced to new comer facilities as well as existing for the prevention of slow flow. On the other hand, there 1 3 K. Sakakura et al. were several interesting findings from Japan regarding use the dynaglide mode only when operators remove the the additional lumen gain in low‑speed RA. Mizutani, burr, not a few RA operators use the dynaglide mode when et al. reported that the greater debulking area following operators bring the burr to the platform. In this document, low‑speed (< 150,000 rpm) was confirmed by OCT [67]. we would like to show the risk and benefit of both ways Yamamoto, et al. also reported that the greater debulking (using dynaglide or not) in Table 4. Because both ways have area following very low speed (110,000 rpm) was con‑ some disadvantage, operators need to understand both ways firmed by OCT [68]. However, Kobayashi, et al. reported to avoid possible complications. that there were no additional lumen gain following low speed (120,000  rpm) [69]. Considering the above evi‑ dences, low speed (140,000 rpm) within the instructions Rota cocktail for use could be an option to acquire additional lumen gain, but very low speed (< 140,000 rpm) should not be RA advancer has a saline infusion port. Although the instruc‑ used, especially for junior RA operators. tions for use does not recommend to use any drugs into the The very‑high speed (> 190,000 rpm) is sometimes used saline bag, various drugs have been used to prevent slow in Japan [9, 70]. A bench test showed that the RotaWire flow. A representative combination of drugs was verapamil may be spinning under the maximum rotational speed [71], 10 mg (5 mg), nitroglycerin 5 mg (2.5 mg), heparin 10,000 while the RotaWire theoretically would not spin during high‑ unit (5000 unit), and saline 1000  ml (500  ml). Another speed mode because of the internal brake and WireClip. The representative combination of drugs was nicorandil 24 mg spinning of RotaWire may be associated with the guidewire (12 mg), nitroglycerin 5 mg (2.5 mg), heparin 10,000 unit failure [72, 73], which have not been proved in the large (5000 unit), and saline 1000 ml (500 ml). Two randomized registry data. studies compared nicorandil based cocktail with verapamil based cocktail, and showed that the incidence of slow flow was significantly lower in the nicorandil based cocktail than in the verapamil based cocktail [75, 76]. Preferred cocktail How to bring the burr to the platform varied widely among RA experts, partly because intra‑cor ‑ onary injection of vasodilators such as nicorandil or nitro‑ Before activating the burr, it is a key to success to bring prusside was easily performed in the contemporary catheter the burr into the platform with keeping the RotaWire stable laboratories. Either combinations of drugs are acceptable, position. However, several troubles were frequently observed as long as intra‑coronary injection of vasodilators are avail‑ in the above process. The RotaWire could advance too deep able in a catheter laboratory. If only saline is used for RA, or be pulled‑back. The RotaWire may make a loop at the the activated coagulation time should be checked before RA outside of the guide catheter, which can result in severe com‑ to prevent possible thrombus formation. plications [74]. Although the manufacturer recommends to Table 4 Advantages and disadvantages of using dyna glide mode when operators bring the burr to the platform Using dynaglide mode No dynaglide mode Extent of resistance, when operators advance Less Greater the burr RotaWire tends to advance more distally, when No Yes operators advance the burr RotaWire tends to be pulled back, when opera‑ Usually no, but possibly yes when the Usually no, but possibly yes when assistant tors advance the burr coaxiality of guide catheter was not pulled the wire too much maintained Possibility of making a loop at the outside of Very rare Yes (very dangerous if operators could not notice the guide catheter it) Combination between an operator and an Not important Important (an assistant have to control the assistant RotaWire during advancing the burr) Jumping phenomenon, when operators activate Rare Yes, therefore it is important to fix a nob at the burr at the platform 1–2 cm apart from the end in advancer Damage to the inner lumen of the guide catheter Possible No 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 5 Comparison of intravascular imaging in RA between IVUS and OCT IVUS OCT Strong points Since IVUS dos not need to eliminate red blood cells, OCT can provide the more detailed information regard‑ operators can use IVUS safely when dissection or ing calcification such as thickness of calcification hematoma occurred following RA Weak points IVUS cannot prove the thickness of calcification Difficult to use for ostial RCA or ostial LMT lesions Since OCT need to eliminate red blood cells, it is dif‑ ficult to use OCT safely when dissection or hematoma occurred following RA Need to be careful for volume overload following multiple observations, especially for patients with low cardiac function May miss calcification when soft tissue buried the calcification Judgement of guidewire bias Accurate, but IVUS probe tends to separate from the Accurate guidewire when operators push an IVUS catheter. Before checking the guidewire bias, operators should pull the IVUS catheter a bit to correct the separation between the guidewire and IVUS probe Efficacy versus safety IVUS would increase the safety in RA. IVUS can be OCT would increase the efficacy such as aggressive used in severe complications following RA, and the ablation in RA role of IVUS would be critical in some situations lesions, and showed the incidence of complications was Imaging devices in RA comparable [87]. Moreover, the risk of complications was greater in imaging device uncrossable lesions than in imag‑ Imaging devices such as IVUS or OCT is useful in RA ing device crossable lesions [88]. Junior RA operators [77–84]. In this document, we recommend to use IVUS should be careful about those imaging device uncrossable or OCT before, during, and after RA. Since both IVUS lesions. Small balloon dilatation before RA can be an option and OCT have advantages and disadvantages, each device for junior RA operators to prevent the severe complications. should be selected according to the purpose of RA in each Recently, Maehara and colleagues developed the IVUS case. The advantages and disadvantages of IVUS and calcium score as well as the OCT calcium score [89, 90]. OCT are summarized in Table  5. Recently, Kawaguchi, The OCT calcium score was composed of maximum cal‑ et al. reported the impact of the degree of guidewire bias cium angle (> 180º = 2 points), maximum calcium thick‑ in the vessel’s healthy portion on coronary perivascular ness (> 0.5 mm = 1 point), and calcium length (> 5 mm = 1 trauma in RA [85], which suggests the greater risk of ves‑ point) [89]. The OCT calcium score was closely associated sel perforation when the intravascular imaging catheter is with stent underexpansion [89], which suggests that the pushing the normal vessel to distort the vessel structure lesions with high OCT calcium score would require RA to (tenting phenomenon). Moreover, Hashimoto, et al. also achieve optimal stent expansion. The IVUS calcium score reported that there is a higher risk of medial injury due to was composed of length of superficial calcification > 270º the RA procedure, especially near the bifurcation of the (≥ 5 mm = 1 point), presence of 360º superficial calcifica‑ left anterior descending artery and diagonal branch when tion (yes = 1 point), presence of calcified nodule (yes = 1 the guidewire and IVUS catheter are close to the healthy point), and vessel diameter (< 3.5 mm = 1 point) [90]. They side of the vessel wall [86]. advocated that operators should consider the use of atherec‑ Although intravascular imaging before RA can pro‑ tomy devices to avoid stent underexpansion when the target vide useful information regarding appropriate burr size or lesion’s IVUS calcium score was ≥ 2 points [90]. Although RotaWire, intravascular imaging catheter may not cross the both IVUS and OCT calcium scores have a potential impact severely calcified lesions. If pre‑RA imaging is critical for on the indication for RA, intravascular imaging catheters safe RA (e.g., ostium of left circumflex lesions), the use may not cross the severely calcified lesions before RA. of guide‑extension catheters may be considered to cross These calcium scores may be more applicable to decide the the lesion. For imaging device uncrossable lesions, small indication for the burr size up or other aggressive lesion burrs (1.25  mm or 1.5  mm burrs) would be the choice. modifications after the small burr cross the lesion rather than Either 1.25 mm or 1.5 mm burrs is to be decided at opera‑ to decide the indication for RA. tor’s discretion. Sakakura, et al. compared the complications between 1.25 mm and 1.5 mm burrs for IVUS‑uncrossable 1 3 K. Sakakura et al. flow to TIMI‑2 flow, then TIMI‑2 flow to TIMI‑1 flow, Endpoint of RA etc.) as long as operators do not ablate lipid‑rich plaques. Therefore, it is important to watch ST‑ elevations in ECG, Operators should set an appropriate endpoint of RA for each which usually antecedent slow flow. If the TIMI2 slo ‑ w flow case. In general, when a burr crosses a lesion without any occurs, RA should be stopped temporarily until the TIMI‑3 resistance and no additional speed down is observed, opera‑ flow was restored. Most transient TIMI‑2 slow flow would tors can finish RA unless operators consider burr size‑up not result in periprocedural myocardial infarction if treated (conventional/classical endpoint of RA). In the contempo‑ immediately [94]. If blood pressure fall following slow flow, rary PCI, the endpoint of RA may become more complex, noradrenaline diluted in saline is injected to restore blood owing to the development of IVUS/OCT. If operators use pressure. If noradrenaline did not work, the prompt insertion IVUS before RA, the crack in the napkin‑ring calcification of IABP would be a next option. Intra‑coronary vasodila ‑ can be an endpoint of RA [8]. If operators use OCT before tors such as nitroprusside, nicorandil, and nitroglycerine are RA, the residual thickness of calcification or dissection can used to treat slow flow. Although there were no literatures be an endpoint of RA [9, 91]. However, operators, especially comparing the efficacy among such vasodilators, nitroprus‑ junior RA operators, should not stick to the conventional/ side may be the most potent vasodilator for slow flow [95]. classical endpoint of RA, if there are signs of slow flow or Although nicorandil may be more ee ff ctive than nitroglycer ‑ other complications. ine [96], the rapid injection of nicorandil may provoke fatal arrhythmia or even cardiac arrest [97]. The use of microcath‑ eters or double lumen catheters would be considered to mini‑ Complications: slow flow mize the risk of vasodilatorinduced h ‑ ypotension. Appropri‑ ate timing of intracor ‑ onary vasodilators would be important Slow flow is the most frequently observed complication fol‑ to treat slow flow. Operators should check ECG or vital signs lowing RA. The incidence of slow flow was approximately between sessions, and check the flow when the change of 5–20% [66, 76, 92], and varied widely among literatures, ECG was observed. In case of severe slow flow (TIMI‑0), partly because the timing of judgement (just after RA or the use of thrombectomy catheter can be considered before final shot) and the definition of slow flow were different the injection of intra‑coronary vasodilators. The prevention among literatures. Lesion length and burr‑to‑artery ratio and bailout for slow flow are summarized in Table  6. were reported as the determinants of slow flow [66, 93]. Furthermore, IVUS findings such as longer lesion length, the maximum number of reverberations, and the greater arc Complications: perforation/rupture of calcification at MLA may predict slow flow after RA [42]. For the prevention of slow flow, appropriate burr size, short Coronary perforation due to the burr is the most serious ablation time, and gentle manipulation avoiding excessive complication in RA, and the incidence of perforation in speed down would be important to minimize the amount of RA is approximately 1–2% [98–101]. If coronary perfora‑ debris caused by RA. A retrospective study revealed that tion occurs during RA, there would be a considerable risk short single session (≤ 15 s) was inversely associated with of in‑hospital death, especially the lesions involving left slow flow after RA [93], which suggests that short single main coronary artery [102]. The risk of perforation highly session can reduce the incidence of slow flow after RA. A depends on the lesion characteristics such as vessel tortuos‑ randomized control study to compare the incidence of slow ity or eccentricity of calcification. Since the shape of each flow following RA between the short single session strategy burr is ellipsoid [103], the RA burr cannot follow the sharply and the long single session strategy is currently ongoing angulated vessel, which results in the greater risk of perfo‑ [UMIN000047231]. Although there were no literatures, ration. The risk of perforation is generally considered to be some experts prefer to flash saline for the prevention of slow greater in an eccentric calcification such as calcified nod‑ flow during RA. Moreover, it is important to keep sufficient ules than in a concentric calcification such as napkin‑ring systolic blood pressure ≥ 120 mmHg (at least 100 mmHg). calcification. Thus, operators need to be careful for RA to If patient’s cardiac function is normal, suc ffi ient hydration is an eccentric calcification. The selection of appropriate burr also important. If a patient shows low blood pressure under size and RotaWire should be important to prevent perfora‑ poor cardiac function, IABP may be considered. Noradrena‑ tion, and the use of intravascular imaging devices would line diluted in saline is frequently used to keep blood pres‑ help operators to select appropriate burr size and RotaWire. sure. If operators took a venous sheath from femoral vein as If intravascular imaging shows the finding that the guide a rescue sheath, such sheath would be helpful to inject the wire is pushing the normal vessel to distort the vessel struc‑ drug immediately. Unlike slow flow during primary PCI, ture, the risk of vessel perforation/injury would be greater slow flow during RA is gradually developed (i.e. TIMI‑3 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 6 Prevention and bailout for slow flow Prevention or bailout Concept Specific methods Prevention Do not make a large amount of debris in a session Appropriate burr size Short ablation time Avoid excessive speed down Prevention Maintain sufficient blood pressure Keep SBP ≥ 120 mmHg (at least 100 mmHg) Use of diluted noradrenaline Consider IABP when low SBP is derived from low cardiac function Bailout Immediate treatment is most important Check the change of ST‑segment, vital signs, and symptom (chest pain) between sessions Use of diluted noradrenaline if SBP fall Use of intra‑coronary vasodilators such as nitroprusside SBP systolic blood pressure, IABP intra‑aortic balloon pumping following RA [85]. If intravascular imaging devices could catheter or a perfusion balloon catheter should be promptly not cross the lesion, small burrs (1.25 mm or 1.5 mm) should delivered to the lesion to seal the blood flow toward peri‑ be the choice, especially for junior RA operators. In general, cardial space. Since the pericardiocentesis is probably a RotaWire floppy would follow the vessel without distorting necessary in perforation following RA, the preparation the vessel configuration, whereas a RotaWire Extra ‑ support for pericardiocentesis is important in catheter laborato‑ would follow the vessel with distorting the vessel configura‑ ries using RA. Multiple covered stents may be necessary tion. Therefore, the route of the burr would be considerably to seal the blood flow [105, 106]. The use of guide exten‑ different between RotaWire floppy and RotaWire Extra‑ sion catheter or the use of double guide catheters may support, which suggests the importance of the choice of be considered to facilitate the delivery of covered stents RotaWires for the prevention of perforation. If the guidewire [107, 108], because there would be a risk of dislodgement bias was difficult to anticipate by intravascular imaging or of covered stents in severely calcified lesions. In the use angiography, a RotaWire floppy would be the choice. of double guide catheters, a balloon via the first guide The bailout of perforation caused by RA is basically catheter can be used to seal bleeding during the prepara‑ similar to that caused by PCI without RA except the fact tion of covered stent via the second guide catheter, and the that operators have to remove the RA system with keep‑ same balloon can be used as the distal anchor balloon to ing the RotaWire. If operators lost the RotaWire follow‑ facilitate the covered stent delivery. Moreover, operators ing massive perforation, there would be no guarantee should contact to cardiovascular surgeons immediately just of recrossing the guidewire. A Kusabi trapping balloon in case of unsuccessful percutaneous bailout. The preven‑ (Kaneka, Osaka, Japan) can be used for the retrieval tion and bailout for coronary perforation are summarized of ≤ 1.5  mm bur rs in ≥ 7  Fr systems [104]. A balloon in Table 7. Table 7 Prevention and bailout for coronary perforation/rupture Prevention or bailout Concept Specific methods/comments Prevention Risk assessment is of utmost importance for prevention of Greater risk in lesions with an angulation perforation following RA Risk of perforation is greater in eccentric calcification than in concentric calcification Prevention Use appropriate burr size, and select appropriate Do not push the burr too much, just deliver the bur to the RotaWires lesion Small burrs (≤ 1.5 mm) would be the choice for the high risk lesions Interpretation of guidewire bias derived from intravas‑ cular imaging would be important to select appropriate RotaWires Bailout Keep the RotaWire within the lesion, when perforation Do not be panic. Remove the Rota system with keeping the occur RotaWire within the lesion Covered stents and pericardiocentesis would be necessary in most cases Contact cardiovascular surgeons immediately in case of unsuccessful percutaneous bailout 1 3 K. Sakakura et al. catheter (double guide catheters) or not (single guide cath‑ Complications: burr entrapment eter). If operators selected the double guide systems, opera‑ tors would insert the conventional guidewire from the sec‑ Burr entrapment is a unique complication in RA, and the ond guide catheter, and then would try to dilate the proximal incidence of burr entrapment is not derived from multicenter part of the entrapped burr using a balloon [112]. If operators registries, but is available from single center studies rang‑ selected the single guide system, the next step would depend ing 0.4–0.8% [109, 110]. Burr entrapment can occur from on the guide catheter size (≥ 8 Fr or ≤ 7 Fr). If operators used several mechanisms. One is called as “Kokesi phenomenon” a ≥ 8 Fr guide system, operators would insert the conven‑ that the burr was trapped in the distal portion of the proximal tional guidewire, and then would try to dilate the proximal narrowing [110]. The mechanism of Kokesi phenomenon part using a balloon. However, if operators used a ≤ 7 Fr is considered to be that a friction heat enlarges the orifice guide system, operators need to cut and pull the drive shaft and the coefficiency of friction in motion is smaller than sheath (Fig. 1) [111], because a ≤ 7 Fr guide catheter cannot that of friction at rest [110]. This type of burr entrapment accommodate the drive shaft sheath, guidewire, and balloon may occur following forceful manipulation with small burrs. catheter together. After pulled out the drive shaft sheath, Another mechanism is the burr entrapment related to the operators can try to dilate the proximal part using a balloon. vessel angulation. Since the shape of the burr is ellipsoid Once operators pulled out the drive shaft sheath, operators and the diamond coating is not available at the tail of the can use inner catheters such as guide extension catheters burr, the burr can be trapped by non‑massive calcification at [113, 116, 117]. Of course, operators should recognize the the site of angulation. To prevent burr entrapment, operators possibility of unsuccessful percutaneous bailout, and need need to be careful about rotational speed reduction, sound to prepare the massive perforation or severe dissection fol‑ of ablation, and resistance during the burr manipulation. If lowing the burr retrieval [119]. The prevention and bailout operators encounter the burr entrapment, it is important to for burr entrapment are summarized in Table 8. assess the situation calmly. The presence of antegrade flow, ST‑segment elevations in ECG, and patient’s chest pain should be evaluated. If there is no antegrade flow beyond Complications: transection of the RotaWire the entrapped burr, the percutaneous bailout would be very difficult, and be limited to experienced senior RA operators. The transection of the RotaWire is a rare complication In the meantime, operators should contact cardiovascular in RA, and the incidence of transection of the RotaWire surgeons to discuss the surgical bailout. If the antegrade flow is not derived from multicenter registries, but may be is present without ST‑ segment elevations, operators would approximately 0.4–1% [120, 121]. There are two types of have a time to consider the percutaneous bailout techniques. the transection of the RotaWire: One is the transection Although there have been several percutaneous bailout tech‑ at the radiopaque part of the RotaWire, and the other is niques in literatures [111–118], the main difference among the transection at the radiolucent part of the RotaWire. various techniques was whether to use additional guide The transection of the radiopaque part is easy to notice. Fig. 1 How to cut and pull the drive shaft sheath. A A RA burr drive shaft remained in the same position. G, H A guide wire (0.014 (1.25  mm) was inserted into a 6  Fr guide catheter via a Y connec‑ inch) passed through the guide catheter via an inserter and Y‑connec‑ tor. B, C The drive shaft, drive shaft sheath, and RA wire were cut tor. I A 2.5 × 15  mm conventional balloon easily passed through the together near the advancer. D, E The drive shaft sheath was pulled guide catheter. This figure was reproduced with the permission from back and removed. F After the drive shaft sheath was removed, the Sakakura et al. [111] 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 8 Prevention and bailout for burr entrapment Prevention or bailout Concept Specific methods/comments Prevention Risk assessment is of utmost importance for prevention of Do not push the burr too much, just deliver the burr to the perforation following RA lesion Greater risk in lesions with an angulation Be careful about rotational speed deceleration, sound of ablation, and resistance during the burr manipulation Prevention Do not inactivate the burr in the middle of the calcified There is no diamond coating at the tail of the burr stenosis Moderate stenosis at the proximal of the target can be a cause of burr entrapment Bailout It is important to assess the situation such as the presence of Do not activate the burr after burr entrapment antegrade flow, calmly Bailout techniques are divided to single guide bailout or double guide bailout Contact cardiovascular surgeons immediately in case of unsuccessful percutaneous bailout If there were the transection of the radiopaque part of the Complications: disconnection of the burr RotaWire, operators should exchange the broken RotaWire to the new one. Since the retrieval of a transected fragment Disconnection of the burr is very rare complications, and of the RotaWire would be similar to that of the conven‑ there have been no literatures mentioning the incidence of tional guidewire, operators might try retrieval procedures disconnection of the burr. The exact reasons or mechanisms such as twin guidewire method [120]. If the transected of disconnection of the burr has not been specified. Even fragment of the RotaWire located at the far distal seg‑ senior RA operators with abundant experiences may not or ment of the treated vessel, operators might leave it at the may have a few cases with this complication. Theoretically, distal segment rather than retrieval. On the other hand, the disconnection of the burr could happen when opera‑ the transection of the radiolucent part of the RotaWire tors activate the burr after the burr was entrapped, or when is very difficult to notice. If operators could not notice operators advanced the burr in spite of strong resistance the transection of the radiolucent part of the RotaWire, within the stented segment or angulated segment. Opera‑ operators would have a vessel perforation [121–123]. In tors may notice the disconnection of the burr by the loss of fact, Wang et al. reported that the Rotawire damage with coordination between the burr motion and the nob motion. subsequent transection was the cause in 18.2% of cases The percutaneous bailout may be possible if the RotaWire with coronary perforations [101]. Moreover, there would is not transected, because the 0.014‑inch spring tip of the be a greater risk in retrieval of a transected fragment of RotaWire may work as the anchor. Imamura S, et al. reported the RotaWire, if the transection occurred at the radiolucent a case of the disconnection of the burr, which was success‑ part. Because the proximal part of the transected fragment fully treated percutaneously [124]. In their case report, since of the RotaWire would be sharp, the invisible sharp frag‑ the simple pullbac ‑ k using a guide extension catheter did not ment of the RotaWire may damage to the proximal vessel work, they sandwiched the disconnected burr between the wall, even to the aortic wall during the retrieval. IVUS inflated balloon and the guide extension catheter, and then may be helpful to identify the invisible fragment. pulled back together [124]. However, surgical bailout should Since the incidence of transection of the RotaWire is low, be considered to this rare complication [125]. the causes of transection have not fully understood. Because the metallic fatigue would be the possible cause of transec‑ tion, it may be important to avoid the continuous contact Specific lesions: RCA ostial lesions between the burr and the specific part of the RotaWire. If the RotaWire kinked at the outside of the guide catheter, Since clinical outcomes of RCA ostial lesions have been the transection of RotaWire would happen when the burr unsatisfactory for decades [126], RA has been considered advanced over the kinked RotaWire [74]. Furthermore, the to be a good indication for RCA ostial lesions with severe WireClip Torquer (Boston Scientific, Marlborough, MA, calcification [46]. However, a good indication does not nec‑ USA) should be equipped with the RotaWire during the essarily mean an appropriate lesion for junior RA operators. dyna‑glide mode as well as the high‑speed mode to avoid Sakakura, et al. reported that the excessive speed reduction the spinning of the RotaWire, which could be a cause of during RA was significantly associated with RCA ostial transection of the RotaWire. lesions [47], which suggests the difficulty of RA for RCA 1 3 K. Sakakura et al. ostial lesions. There are several reasons why RA for RCA big burrs for RCA ostial lesions. Furthermore, there may be ostial lesions are difficult. First, it is impossible to insert the an additional risk of cerebral infarction following RA for guide catheter to RCA coaxially. Operators would try to keep RCA ostial lesions. It may be important for the prevention guide catheter coaxial to RCA in aorta. Second, coaxial‑ of cerebral infarction to use small burrs for an initial attempt ity cannot be confirmed by LAO view, which is a standard to minimize the size of debris. Figure 2 summarized the why view in RA for RCA ostial lesions. Coaxiality is usually RA to ostial RCA is difficult. RA for RCA ostial lesions is confirmed by RAO view in conventional PCI. If the guide not recommended for junior RA operators without senior catheter can engage to the RCA, coaxiality would be kept RA operator’s back‑up. once operator check in the RAO view. However, if the guide catheter cannot engage to the RCA, coaxiality would not be kept during procedures. Because it is difficult to check the Specific lesions: LCX ostial lesions burr motion in RAO view due to the angiographical short‑ with substantial bending ening of the RCA ostial lesion, the frequent switch between RAO view and LAO view may be necessary to keep coaxi‑ Severely calcified left circumflex (LCX) ostial lesions ality during RA. Another option is to use straight cranial with substantial bending may be the highest risk lesion view, which allows operators to check coaxiality without in RA. The key to success would be the interpretation angiographical shortening of the RCA ostial lesion. of pre‑procedural intravascular imaging. If the pre‑pro‑ The selection of the RotaWire for RCA ostial lesions is cedural imaging device could cross the lesion and pro‑ also important. The RotaWire Extra‑Support may be pref‑ vide sufficient information including the guidewire bias, erable when operators intentionally remove the guide cath‑ operators could select appropriate RotaWires and burrs. eter from the RCA ostium, whereas the RotaWire Extra‑ However, if the pre‑procedural imaging device could not Support may be dangerous when operators cannot take a cross, operators need to select RotaWires and burrs from coaxial position. IVUS may help to estimate the risk of RA, the only angiographical information. In general, athero‑ especially when operators could not take a coaxial position. sclerotic plaques are observed in the lateral wall, whereas Although an IVUS catheter may not cross the lesion before atherosclerotic plaques are spared in the flow divider RA, an IVUS catheter would cross the lesion after the cross‑ regions (carina) [127]. If severe eccentric calcification ing of small burrs. IVUS should be tried before using the was observed in the lateral wall of the LCX ostium, there Fig. 2 Why RA to ostial RCA is difficult? 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… would be a risk of perforation in the carina side of the Specific lesions: unprotected left main LCX ostium due to the jumping of the burr. Operators lesions would try to ablate the lateral wall of the LCX ostium to avoid perforation in the carina side. However, if operators RA to the unprotected left main lesions requires special ablated the lateral wall too much, there would another attention, because slow flow may cause hemodynamic col‑ risk of perforation in the lateral wall side due to the deep lapse. However, Fuku et al. compared clinical outcomes of cut. Two types of perforation in LCX ostial lesions with left main PCI between with RA (n = 108) and without RA substantial bending are illustrated in Fig.  3. Operators (n = 1091), and showed the similar rate of complications need to select appropriate burr size, RotaWires, and burr in left main PCI between with RA and without RA [128], motion to prevent the above two types of perforation. In suggesting the acceptable safety in PCI to left main lesions angiography, it would be important to evaluate the actual using RA. In clinical practice, it would be important to contact point between the calcification and the RotaWire start with small burrs (≤ 1.5 mm burr) to prevent fatal slow using multiple projections. Although low‑dose radiation flow. However, the ≤ 1.5 mm burr may be too small as the angiography is important for patient’s safety, excessive final burr size considering the vessel diameter of left main low‑dose radiation angiography may sacrifice the visibil‑ lesions. It would be important to use IVUS/OCT to select ity of RotaWires or calcification. Since the visibility of an initial burr size and final burr size. If the severe calci‑ RotaWires or calcification is the cornerstone for high‑risk fied plaques exist at the ostium of left main, the procedure RA, operators should set the radiation dose not to pre‑ would be more complex as compared to calcified plaques at vent the visibility of RotaWires or calcification. Moreo‑ the middle of left main. In that situation, the stabilization ver, if there would be a perforation in the LCX ostium, of guide catheter at co‑axial position within aorta would be the percutaneous bailout would be difficult, because the the key to success like the ostium of RCA lesions. Further‑ implantation of covered stents may occlude the left ante‑ more, the use of IABP and/or temporary pacing should be rior descending artery (LAD). Therefore, the indication considered. RA for left main lesions is not recommended for as well as the strategy of RA to the LCX ostium should junior RA operators without senior RA operator’s back‑up. be carefully discussed. RA for LCX ostial lesions with If we do not limit the topic to the left main lesions, the substantial bending is not recommended for junior RA subgroup analysis of the PREPARE‑CALC study revealed operators without senior RA operator’s back‑up. that the incidence of side branch compromise was less Fig. 3 Schema of two types of perforation in LCX ostial lesions with substantial bending 1 3 K. Sakakura et al. frequently observed in lesions treated with RA than in performed an experimental study and found that the size of lesions treated without RA in bifurcation lesions [129]. the metallic particles generated during RA of stent struts Mizuno, et al. also reported that the incidence of side branch was 5.6 ± 3.6 μm, which suggested the safe size in a human compromise was less frequently observed in calcified bifur ‑ body [132]. Tips of stent ablation are (1) to select the appro‑ cation lesions with RA than in those without RA, even if RA priate burr size, (2) to ablate only stent struts first, (3) and was performed to the main vessel only [130]. On the other then ablate the calcification behind stent struts using the hand, Chen, et al. reported the higher risk of side branch second burr (size up). Since the risk of burr entrapment perforation, when RA was performed to both main vessel is greater during stent ablation, gentle manipulation with and side branch as compared to RA to the main vessel only gradual sizeup w ‑ ould be important. Although stent ablation [131]. Therefore, RA to both main vessel and side branch might be a single solution for the restenostic lesions caused should be reserved for senior RA operators. by under‑expanded stents, the long‑term outcomes was not satisfactory [133–136]. Coronary lithoplasty may be another option for stent underexpansion due to severe calcification Specific lesions: stent ablation [137], while sufficient follow ‑up data is not available yet. Stent ablation is not recommended for junior RA operators. Stent ablation is applied to the restenotic lesions caused by Furthermore, on‑site surgical back ‑up may be need because under‑expanded stents. Okamura, et al. described a case of greater risk of burr entrapment, when operators perform of stent ablation to treat restenosis lesions due to crush‑ stent ablation using big burrs. ing of a sirolimus‑eluting stent [132]. In their report, they Fig. 4 Schema of conven‑ tional and halfway rotational atherectomy. A–C illustrate the conventional rotational atherec‑ tomy, whereas D–F illustrate the halfway rotational atherec‑ tomy. A The burr positioned just before the calcified lesion. B The burr ablated the proximal segment of the calcified lesion. C The burr ablated the full seg‑ ment of the calcified lesion. D The burr positioned just before the calcified lesion. E The burr ablated the proximal segment of the calcified lesion. F Balloon dilatation was performed for the rest of the calcified lesion. This figure was reproduced with the permission from Sakakura, et al. [141] 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… lesion. Thus, the actual working range of the burr is approxi‑ Specific lesions: diffuse long lesions mately 30–50 mm. If the length of the target lesion was beyond 30–50 mm, operators need to move the platform RA was frequently performed for diffuse long lesions, and during the procedure. Although there were few literatures the long‑term outcomes of long lesions treated by RA were regarding how to move the platform during the procedure, comparable to those of short lesions treated by RA [138]. there were several ways among RA experts. The most impor‑ However, RA for diffuse long lesions may be difficult for tant point is to ablate the proximal part of the diffuse long junior RA operators, especially when there is an angle lesion sufficiently before moving the platform. Only 1 pass in the middle of diffuse long lesions. The presence of an would not be enough. Several passes would be necessary acute angulation on the lesion is reported to be associ‑ until no additional speed down was observed. Some experts ated with procedural failure of RA [139]. Sakakura, et al. prefer to size up the burr and ablate the proximal part of the reported the utility of halfway RA especially for lesions diffuse long lesion using big burrs to make a stable platform. with an angle [140, 141]. In brief, the operator does not After operators ablated the proximal part of the diffuse long advance the burr beyond the angle within the lesion to lesion sufficiently, operators could move the platform more avoid burr entrapment or vessel perforation, and balloon distally. Some experts prefer to use dynaglide mode to move dilatation is performed beyond the angle after RA (Fig. 4). the platform. Sliding sheath technique, in which operators Halfway RA may be useful especially for junior RA opera‑ park the burr to the distal end and then bring the advancer tors. If halfway RA did not work (e.g., balloon could not to follow the burr, may be used by some experts. Since the dilate the distal calcified lesion), switch from halfway RA outer diameter of the drive shaft sheath is 4.3 Fr (1.43 mm), to conventional RA should be considered. Although the the ablation by the burr1.25  ‑ mm may not be enough to move other option could be to use the guide extension catheter, the platform. RA beyond the guide extension catheter is not straight‑ forward. Another important aspect in RA for diffuse long lesions is to check the speed down of rotational speed. Although the excessive speed down during RA should be Specific lesions: ablation to an entrapped avoided, absence of reasonable speed down may mean that guidewire the burr does not contact to calcification adequately. If an operator pushes the burr too much in the absence of speed An entrapment of coronary guidewires is sometimes down, there would be substantial risk of burr entrapment observed in complex PCI. Forced pullbac ‑ k of the entrapped or vessel perforation. Therefore, an operator may change guidewire may damage coronary artery wall or provoke the RotaWires to facilitate the contact between the burr the fracture of guidewire. RA can be an option to cut the and the calcified plaques, switch to balloon dilatation entrapped guidewires [143–145]. In the comparison of (resultantly halfway RA), or rarely burr size‑ up to increase forced pull‑back by snare, the coronary artery is not sub‑ the contact area in the absence of reasonable speed down jected to excessive force if the contact point between the [103, 142]. burr and the fractured guidewire is controlled under IVUS Operators should also take care of ischemia during RA guidance [144]. However, since there is a potential risk that to the diffuse long lesions, because the risk of slow flow the RA burr may be entrapped in the spring wire, ablation is greater in the diffuse long lesions than the short lesions to an entrapped guidewire is not recommended for junior [66]. If operators noticed the signs of ischemia in the middle RA operators. of diffuse long lesions, size down of the burr would be the reasonable choice. Another option would be to take a short break with removing the burr from the coronary artery to Conclusions stabilize coronary flow and vital signs. If coronary flow is restored and vital signs are stabilized, operators can safely In this document, we provided the Japanese style RA, resume procedures. This document suggests an algorithm which uses intravascular imaging devices to achieve the for disuse long lesions, especially for junior RA operators maximum efficacy without sacrificing the safety. Our rec‑ (Fig. 5). ommendation focused on mainly junior RA operators, but The maximum working range of the burr is approximately would be helpful for senior RA operators for their more 70 mm. Operators usually set the nob at 1–2 cm apart from advanced procedures. the end, and set the platform at 1–2 cm proximal from the 1 3 K. Sakakura et al. Fig. 5 Algorithm: When opera‑ tors felt difficulty in RA for diffuse long calcified lesions Funding None. outcomes according to drug‑eluting stent generation. JACC Car ‑ diovasc Interv. 2020;13(12):1417–28. Data availability This consensus documet does not include original 2. Copeland‑Halperin RS, Baber U, Aquino M, Rajamanickam A, data. Roy S, Hasan C, Barman N, Kovacic JC, Moreno P, Krishnan P, Sweeny JM, Mehran R, Dangas G, Kini AS, Sharma SK. Prevalence, correlates, and impact of coronary calcification on Declarations adverse events following PCI with newer‑generation DES: Find‑ ings from a large multiethnic registry. Catheter Cardiovasc Interv. Conflict of interest Drs. Sakakura, Ito, Shibata, Okamura, Nakamura, 2018;91(5):859–66. Hamazaki, Ako, Yokoi, Kobayashi, and Ikari received speaking hono‑ 3. Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, raria from Boston Scientific. Drs. Sakakura, Shibata, Okamura, Na‑ Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice kamura, and Hamazaki served as a proctor for Rotablator for Boston MC, Kappetein AP, Thuijs D, Milojevic M, Noack T, Mohr FW, Scientific. Dr. Ikari received research grant from Boston Scientific. 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Publisher's Note Springer Nature remains neutral with regard to Wire cutting method using rotational atherectomy for stretched jurisdictional claims in published maps and institutional affiliations. spring wire during coronary intervention. JACC Case reports. 2021;3(17):1842–8. 1 3 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Cardiovascular Intervention and Therapeutics Springer Journals

Clinical expert consensus document on rotational atherectomy from the Japanese association of cardiovascular intervention and therapeutics: update 2023

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Abstract

The Task Force on Rotational Atherectomy of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) proposed the expert consensus document to summarize the techniques and evidences regarding rotational atherec‑ tomy (RA) in 2020. Because the revascularization strategy to severely calcified lesions is the hottest topic in contemporary percutaneous coronary intervention (PCI), many evidences related to RA have been published since 2020. Latest advance‑ ments have been incorporated in this updated expert consensus document. Keywords Rotational atherectomy · Calcification · Percutaneous coronary intervention · Intravascular ultrasound · Opticalcoherence tomography Introduction compared to North America and European countries, RA in Japan has uniquely developed with the aid of greater usage Severe calcification in atherosclerotic plaques has been the of intravascular imaging devices [6, 7]. Since the cost of most common cause of poor clinical outcomes since the intravascular ultrasound (IVUS) or optical coherence tomog‑ beginning of percutaneous coronary intervention (PCI) raphy (OCT) during percutaneous coronary intervention [1–3]. Rotational atherectomy (RA) has been widely used (PCI) has been covered by the government insurance system for severely calcified coronary lesions for more than 20 years in Japan, RA operators could easily access to IVUS or OCT. to improve clinical outcomes in patients with severely calci‑ IVUS has been used to understand the guidewire bias and to fied lesions. Recently, North American expert review as well decide appropriate burr sizes during RA [8], whereas OCT as European expert consensus on RA have been published can be used to measure the thickness of calcification during to provide a clinical standard for RA operators [4, 5]. As RA [9], which could result in appropriate burr size up [10]. * Kenichi Sakakura Cardiovascular Center, Kyoto Katsura Hospital, Kyoto, Japan ksakakura@jichi.ac.jp Division of Cardiology, Ootakanomori Hospital, Kashiwa, Japan Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1‑847 Amanuma, Omiya, Department of Cardiovascular Medicine, Kitasato University Saitama 330‑8503, Japan School of Medicine, Sagamihara, Japan 2 9 Department of Cardiology, Saiseikai Yokohama City Eastern Department of Cardiology, Fukuoka Sanno Hospital, Hospital, Yokohama, Japan Fukuoka, Japan 3 10 Department of Cardiology, Miyazaki Medical Association Department of Cardiovascular Medicine, Chiba University Hospital, Miyazaki, Japan Graduate School of Medicine, Chiba, Japan 4 11 Division of Cardiology, Sakurabashi Watanabe Hospital, Department of Cardiology, Tokai University School Osaka, Japan of Medicine, Isehara, Japan Division of Interventional Cardiology, Sapporo Cardio Vascular Clinic, Sapporo Heart Center, Sapporo, Japan Vol.:(0123456789) 1 3 K. Sakakura et al. Furthermore, the prevalence of PCI with RA has been higher long calcified lesions. The lesion modification, which in Japan than in other countries. In fact, the prevalence of facilitate the delivery and expansion of DES, would be the PCI with RA was approximately 3.3% in Japan [11], which most frequent purpose in the contemporary RA, and the was similar to those in United Kingdom (3.1%) or France long‑term outcomes of DES following RA was acceptable (2.9%) and was higher than those in Italy (1.3%) or Germany [16–22], except specific lesions such as calcified nodule (0.8%) [5]. [23, 24]. The mid‑term or long‑term clinical outcomes On the other hand, RA had not been allowed to any opera‑ following RA might not be satisfactory in specific char ‑ tors without on‑site surgical back ‑up in Japan until April acteristics such as hemodialysis or malnutrition [25–27], 2020. However, the government and the Japanese Associa‑ partly because the natural prognosis of patients with such tion of Cardiovascular Intervention and Therapeutics (CVIT) characteristics would be worse than without such charac‑ worked together, and released the new facility criteria for teristics. Incomplete stent apposition (ISA) is frequently RA in April 2020, which allowed operators to perform RA observed in severely calcified lesions or calcified nodules without on‑site surgical back ‑up. The new facility criteria even after the lesion modification by RA [28 , 29], while has rapidly increased the number of RA operators in Japan. the clinical significance of ISA in severely calcified lesions In fact, more than 300 facilities have completed the RA remains undetermined. training program that was organized by CVIT and manu‑ Moreover, RA might prevent the polymer damage, when facturer (Boston Scientific Japan). Early experience from a DES was delivered to the calcified lesions [30]. Although new comer facility was reported [12], suggesting the safety the initial results of debulking using RA was not satisfac‑ and feasibility of RA in new comer facilities. The Task Force tory, the debulking might have developed with the aid of on Rotational Atherectomy of CVIT proposed the expert imaging devices and drug‑coated balloon in Japan [31– 35]. consensus document on RA to summarize the techniques Furthermore, the long‑term outcomes following RA with and evidences regarding RA in 2020 [13]. Because the plain old balloon angiography was acceptable when the tar‑ revascularization strategy to severely calcified lesions is the get lesions were limited to large coronary arteries (diam‑ hottest topic in contemporary PCI, many evidences related eter ≥ 3 mm) [36]. Intravascular lithotripsy (IVL) is a novel to RA have been published since 2020. Latest advancements technique to treat severely calcified lesions. Although the have been incorporated in this updated expert consensus combination of RA and IVL has not been systematically document. examined, RA may facilitate the IVL catheter to reach the severely calcified lesions [37, 38]. The contemporary indi‑ cations for RA is summarized in Table 1. In IVUS, calcifi‑ Aim of RA cations are typically described as high echoic signals with an acoustic shadow behind the signal [39]. Reverberations Before the stent era, the main purpose of RA was to debulk that are concentric and arctic lines at equal intervals would atherosclerotic plaques including calcification in coro‑ be observed within the acoustic shadow [39, 40]. Because nary arteries [14]. However, the incidence of restenosis reverberations are closely associated with smooth surface of was considerable following debulking using RA [15]. the calcified lesions [41], reverberations may be observed in Emergence of drug‑eluting stent (DES) has dramatically the calcified lesions after RA as well as the unmodified cal‑ changed the indications of PCI, which included diffuse cified lesions with smooth surface. Recently, Jinnouchi, et al. Table 1 Contemporary Definite indications Severely calcified lesions (typically 360 degree calcification) indications for rotational Napkin ring calcification atherectomy Calcification showing reverberation in IVUS Device uncrossable lesions IVUS/OCT could not cross (relatively common) Microcatheter could not cross (relatively rare) Possible indications Moderately calcified lesions (> 180 degree calcification) High risk lesions Lesions with thrombus Lesions with extensive dissection Lesions with an angle Bypass graft lesions Contraindication Last remaining vessel with compromised left ventricular function IVUS intravascular ultrasound, OCT optical coherent tomography 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… reported the association between slow flow following RA aorta. Although the Impella (Abiomed, Danvers, MA, USA) and reverberations [42]. However, the clinical significance is not allowed to use as a support device for patients who of the natural reverberations has not sufficiently investigated. undergo elective high‑risk PCI in Japan, the Impella is con‑ A systematic review and metaanal ‑ ysis compared the clinical sidered to be an option as a support device for elective PCI outcomes between planned RA and bailout RA, and reported with RA in USA [49]. If patients with cardiogenic shock that planned RA resulted in significantly shorter procedural already received the Impella or V‑ A ECMO supports, RA times, less contrast use, lesser dissection rates and fewer to the severely calcified lesions can be a bailout option from stents used as compared to bailout RA [43]. cardiogenic shock. Furthermore, although the beta‑blockers are cornerstone for optimal medical therapy, some operators hesitate to use beta‑ blockers, because of the possible risk of Junior RA operator slow flow [50]. Of course, bradycardia (heart rate < 60 bpm) could be a problem during RA, beta‑blockers can be contin‑ In this document, we defined junior RA operator as RA ued, because the risk of slow flow was comparable between operator with less than 50 RA experiences. Because the with and without beta‑blockers [51]. number of RA cases per operator as well as the number Arrhythmia such as bradycardia or atrioventricular block of RA cases per year in the facility was inversely associ‑ sometimes happens in RA, especially during the treatment ated with adverse events [11, 44, 45], the number of RA of RCA. Temporary pacing is a reliable option to continue cases per operator would be important to prevent severe procedures during arrhythmia. However, senior RA opera‑ complications. Moreover, the good indication for RA is not tors may not use temporary pacing by several reasons: (1) necessarily low‑risk. For example, the ostial right coronary short ablation time may not induce sustained arrhythmia, artery (RCA) lesions have been recognized a good indica‑ (2) cough resuscitation may be effective for arrhythmia dur ‑ tion for RA [46], whereas RA to the ostial RCA is known to ing RA [52], (3) there is a risk of ventricular perforation be technically difficult [47]. Therefore, the recommendation induced by temporary pacing catheter [53, 54]. Nevertheless, for junior RA operators may be different from that for senior it would be a safe approach for junior RA operators to insert operators in some sections. temporary pacing for specific lesions. Brady ar ‑ rhythmia can occur during RA to RCA, dominant left circumflex (LCX), left main trunk, and rarely left anterior descending artery Patient’s general conditions, mechanical (LAD) lesions. In this document, we recommend junior support, temporary pacing RA operators to consider temporary pacing for RA to RCA, dominant LCX, and left main trunk lesions. When we plan to perform RA, we should evaluate patient’s Kusumoto et al. reported a unique case of trans‑coronary general conditions such as vital signs and cardiac functions. pacing via RotaWire [55]. In this case report, the cathode of Although there was no evidence regarding blood pressure an external pacemaker was attached to the distal external end during RA, it would be important to keep systolic blood of the guide wire using a crocodile clip, whereas the anode pressure (SBP) ≥ 120  mmHg (at least ≥ 100  mmHg) for was attached to the needle which is inserted under the skin the prevention of complications such as slow flow. If slow of the anaesthetized groin [55]. The possibility of temporary flow occurred in patients with left ventricular dysfunction, guidewire pacing can be discussed as potential substitutes there would be a greater risk of hemodynamic collapse. If a for temporary pacing catheters. However, since there are patient with left ventricular dysfunction shows low SBP, we several limitations such as coronary spasm or twitching dia‑ may consider to use mechanical supports such as intraaor ‑ tic phragm in temporary guidewire pacing, we do not recom‑ balloon pumping (IABP) before RA. Chen et al. reported mend temporary guidewire pacing in this document yet. that the major adverse cardiac event rate was higher in RA with bailout IABP than in RA with primary IABP [48], implying that the use of IABP should be implemented at Guide catheter for RA the beginning of RA if a complex procedure is anticipated. Although it is very rare to insert veno‑arterial extracorpor ‑ Although RA is possible either trans‑radial, trans‑femoral, eal membrane oxygenation (V‑ A ECMO) for elective PCI or trans‑ brachial [56–58], RA operators should recognize with RA, it is an option for very high‑risk PCI with RA the maximum burr size for each guide catheter size. A 6‑Fr to take additional arterial and venous sheathes just in case guide catheter can accommodate ≤ 1.75 mm burr, where as a of emergent V‑ A ECMO. Moreover, if such patient would 7 Fr guide catheter can accommodate ≤ 2.0 mm burr. When undergo elective RA, it is better to evaluate the abdominal RA operators consider ≥ 2.15mm bur ‑ r, a 8 Fr guide catheter and thoracic aorta by computed tomography (CT) to check is necessary. However, if there is a severe tortuosity in a the contraindications for IABP such as aneurysm or shaggy guide catheter, operators may feel a strong resistance during 1 3 K. Sakakura et al. advancing the burr in the guide catheter, which results in the Therefore, the use of microcatheter is recommended to burr‑size down. Moreover, if operators make side‑holes in bring RotaWires to the target. RA operators should use the a guide catheter by themselves, such handmade side‑holes conventional 0.014‑inch guidewire to cross the lesion, and may prevent the burr from advancing in the guide catheter. then exchange the conventional guidewire to the RotaWire For junior RA operators, it is important to check coronary using microcatheter. Recently, the manufacturer (Boston flow more frequently than senior RA operators to notice the scientific, Marlborough, MA, USA) refined both RotaWire occurrence of slow flow or perforation immediately, which floppy and RotaWire Extra‑support, and introduced both would be easier in ≥ 7 Fr guide than in 6 Fr guide because of RotaWire drive floppy and RotaWire drive extra‑support the large dimeter of the drive shaft sheath (4.3 Fr). [61]. The torque response has considerably improved in The choice of guide catheter curves varies even among both RotaWire drive floppy and extra‑support. However, senior RA operators. Although the appropriate back‑up sup‑ we still recommend to use the conventional 0.014‑inch port is important for stable procedures, the strongest backup ‑ guidewire to cross the lesion, and then exchange the con‑ support, which is sometimes required for PCI to chronic total ventional guidewire to the RotaWire drive using micro‑ occlusion, would not be necessary for RA. The coaxial posi‑ catheter not to make a bend in RotaWires. The guidance tioning of the guide catheter would be of utmost importance for selection of RotaWires is shown in Table 2. for successful RA. However, the strong back‑up support can be a key to success in limited cases [59]. Appropriate burr size Guidewire for RA In early experiences with RA, big burrs were used to Two types of guidewire for RA have been commercially debulk the calcified plaques. However, a randomized trial available: RotaWire floppy (Boston scientific, Marlbor ‑ comparing small burrs (burr/artery ratio of ≤ 0.7) with ough, MA, USA) and RotaWire Extra‑support (Boston large burrs (burr/artery ratio of > 0.7) revealed that small scientific, Marlborough, MA, USA). Both RotaWires burrs achieved similar immediate lumen enlargement and have 0.014‑inch/0.36 mm spring tip and 0.009 inch/0.23‑ late target vessel revascularization compared with large mm guidewire shaft. However, the length of the tapered burrs, but showed fewer complications [62]. Further‑ segment is considerably different between RotaWire more, a recent retrospective study reported that bur/artery floppy and RotaWire Extra‑support. RotaWire floppy ratio > 0.61 was associated with worse clinical outcomes has long tapered shaft (13 cm of < 0.0077‑inch/0.20 mm [63]. European expert consensus document recommend shaft) and short spring tip (22 mm), whereas RotaWire burr/artery ratio of 0.6 [5], and North America expert con‑ Extra‑ support has short tapered shaft (5 cm of < 0.009‑ sensus document recommend burr/artery ratio of 0.4–0.6 inch/0.23 mm shaft) and long spring tip (28 mm) [60]. [4]. In this document, we recommend burr/artery ratio of For successful RA, it is important not to make a bend 0.4–0.6 without intravascular imaging devices, and recom‑ in RotaWires, because a bend in RotaWires substantially mend to use intravascular imaging if RA operators aim to increase the friction force between burr and RotaWire. achieve burr/artery ratio of ≥ 0.6. Table 2 Guidance for selection of RotaWires Characteristics or specific situations RotaWire floppy or extra‑support Ability to ablate the severely calcified plaques (ablation efficiency) Extra‑support > floppy Ability to straighten the tortuous coronary artery Extra‑support > floppy Ability to strengthen the back‑up force in the system Extra‑support > floppy When pre‑intravascular imaging devices cross the lesion and provide Select either Extra‑support or floppy according to the information from sufficient information regarding the guidewire bias imaging devices and angiography When operators cannot judge the guidewire bias from angiography Floppy first and/or intravascular imaging When junior RA operators cannot understand which RotaWires are Floppy first more suitable to the lesion When the burr cannot cross the lesion, the exchange from floppy to May work well, because of the change of the contact point. However, extra‑support the strong guidewire bias may cause deep ablation When the burr cannot cross the lesion, the exchange from extra‑sup‑ May work well, because of the change of the contact point port to floppy 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 3 Guidance for use of the second burr Size down or size up Situations Comments Size down When the first burr cannot cross the lesion, operators This size down is important to prevent severe complications. It is should size down with the second burr better for junior RA operators to consider size down, when the burr could not cross the lesion after 4–6 RA sessions. If there are signs of slow flow such as chest pain or ECG changes, immediate size down should be considered Size up When operators aim to use the big burr Generally, the range of size up would be 0.25–0.75 mm. Junior RA (≥ 1.75 mm), start with the small burr (≤ 1.5 mm) operators should select the 0.25‑mm or 0.50 mm size up for safety, and then size up to the big burr Size up Operators started with the first burr, and checked The thickness of calcification derived from OCT may be helpful to intravascular imaging after the pass of the first decide the necessity of size up. Before size up, operators should burr. Intravascular imaging revealed the insuffi‑ check signs of slow flow such as chest pain or ECG changes cient ablation, which recommended the size up Size up Operators finished RA with the first burr, and then Careful manipulation of RotaWire is necessary, because there balloon (non‑compliant balloon, scoring balloon, would be some dissections after balloon dilatation or cutting balloon) dilatation was tried. However, the lesion was not dilated sufficiently (typically dog‑bone phenomenon), and then size up to the big burr Size up During RA, no additional speed down was observed No additional speed down in spite of forceful manipulation of the in spite of the forceful manipulation of the burr. burr is the high‑risk situation for burr entrapment or perforation Operators judged that the burr did not contact to the calcification adequately, and then sized‑up to increase the contact area For lesion modification, single burr may be sufficient facilities in Japan. In brief, the ROTAPRO™ system is to facilitate stent delivery and stent expansion. However, composed of a digital console and an advancer including second burr is sometimes necessary even for lesion modi‑ buttons to activate devices [61]. The ROTAPRO™ system fication. The guidance for second burr is summarized in eliminated the foot pedal. Table 3. Duration of individual runs is also important to prevent complications. Manufacturer recommend the duration of individual runs less than 30 s. In general, longer duration Burr manipulation and rotation speed would be associated with greater amount of debris. For junior RA operators, short duration (e.g. ≤ l5–20 s) for a A pecking motion (quick push‑forward/pull‑back move‑ single session would be recommended. Furthermore, it is ment of the burr) has been a standard burr manipulation important to check the situations such as ECG and vital in RA [5]. Although several burr manipulations have been signs between the sessions. conducted by RA experts, the common part of burr manip‑ Regarding the rotational speed, since manufacturer ulation is to push‑forward from the platform and pull‑back set the minimum speed as 140,000 rotations per min‑ the burr to the platform. The speed of manipulation varies ute (rpm), and the maximum speed as 190,000  rpm widely among experts. Some experts prefer very quick, [ 64], this consensus document also recommends whereas other experts prefer very slow. Either speed is to use 140,000–190,000  rpm, and may consider to acceptable as long as the following points are considered: use > 190,000 rpm when operators feel difficulty to cross (1) Operators should control the burr’s motion. If operators the lesion. There was a debate whether low rotational feel difficult to control the burr’s motion, the speed may be speed can reduce the risk of slow flow. Platelet aggre‑ too quick, (2) operators should avoid excessive rotational gation was greater in high‑speed (180,000 rpm) than in speed down, and (3) operators should not deactivate the low‑speed (140,000 rpm) in an early experiment in vitro system when the burr is in the middle of stenosis, which [65], which has not been proved in vivo. Recently, a rand‑ may result in the entrapment of the burr. Operators should omized control study comparing low‑speed (140,000 rpm) deactivate the system when the burr was pulled‑ back to with high‑speed (190,000 rpm) revealed that the incidence the platform. Furthermore, the ROTAPRO™ system (Bos‑ of slow flow was similar between low ‑speed and high‑ ton scientific, Marlborough, MA, USA) has been gradu‑ speed [66]. Therefore, it is not reasonable to use low‑speed ally introduced to new comer facilities as well as existing for the prevention of slow flow. On the other hand, there 1 3 K. Sakakura et al. were several interesting findings from Japan regarding use the dynaglide mode only when operators remove the the additional lumen gain in low‑speed RA. Mizutani, burr, not a few RA operators use the dynaglide mode when et al. reported that the greater debulking area following operators bring the burr to the platform. In this document, low‑speed (< 150,000 rpm) was confirmed by OCT [67]. we would like to show the risk and benefit of both ways Yamamoto, et al. also reported that the greater debulking (using dynaglide or not) in Table 4. Because both ways have area following very low speed (110,000 rpm) was con‑ some disadvantage, operators need to understand both ways firmed by OCT [68]. However, Kobayashi, et al. reported to avoid possible complications. that there were no additional lumen gain following low speed (120,000  rpm) [69]. Considering the above evi‑ dences, low speed (140,000 rpm) within the instructions Rota cocktail for use could be an option to acquire additional lumen gain, but very low speed (< 140,000 rpm) should not be RA advancer has a saline infusion port. Although the instruc‑ used, especially for junior RA operators. tions for use does not recommend to use any drugs into the The very‑high speed (> 190,000 rpm) is sometimes used saline bag, various drugs have been used to prevent slow in Japan [9, 70]. A bench test showed that the RotaWire flow. A representative combination of drugs was verapamil may be spinning under the maximum rotational speed [71], 10 mg (5 mg), nitroglycerin 5 mg (2.5 mg), heparin 10,000 while the RotaWire theoretically would not spin during high‑ unit (5000 unit), and saline 1000  ml (500  ml). Another speed mode because of the internal brake and WireClip. The representative combination of drugs was nicorandil 24 mg spinning of RotaWire may be associated with the guidewire (12 mg), nitroglycerin 5 mg (2.5 mg), heparin 10,000 unit failure [72, 73], which have not been proved in the large (5000 unit), and saline 1000 ml (500 ml). Two randomized registry data. studies compared nicorandil based cocktail with verapamil based cocktail, and showed that the incidence of slow flow was significantly lower in the nicorandil based cocktail than in the verapamil based cocktail [75, 76]. Preferred cocktail How to bring the burr to the platform varied widely among RA experts, partly because intra‑cor ‑ onary injection of vasodilators such as nicorandil or nitro‑ Before activating the burr, it is a key to success to bring prusside was easily performed in the contemporary catheter the burr into the platform with keeping the RotaWire stable laboratories. Either combinations of drugs are acceptable, position. However, several troubles were frequently observed as long as intra‑coronary injection of vasodilators are avail‑ in the above process. The RotaWire could advance too deep able in a catheter laboratory. If only saline is used for RA, or be pulled‑back. The RotaWire may make a loop at the the activated coagulation time should be checked before RA outside of the guide catheter, which can result in severe com‑ to prevent possible thrombus formation. plications [74]. Although the manufacturer recommends to Table 4 Advantages and disadvantages of using dyna glide mode when operators bring the burr to the platform Using dynaglide mode No dynaglide mode Extent of resistance, when operators advance Less Greater the burr RotaWire tends to advance more distally, when No Yes operators advance the burr RotaWire tends to be pulled back, when opera‑ Usually no, but possibly yes when the Usually no, but possibly yes when assistant tors advance the burr coaxiality of guide catheter was not pulled the wire too much maintained Possibility of making a loop at the outside of Very rare Yes (very dangerous if operators could not notice the guide catheter it) Combination between an operator and an Not important Important (an assistant have to control the assistant RotaWire during advancing the burr) Jumping phenomenon, when operators activate Rare Yes, therefore it is important to fix a nob at the burr at the platform 1–2 cm apart from the end in advancer Damage to the inner lumen of the guide catheter Possible No 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 5 Comparison of intravascular imaging in RA between IVUS and OCT IVUS OCT Strong points Since IVUS dos not need to eliminate red blood cells, OCT can provide the more detailed information regard‑ operators can use IVUS safely when dissection or ing calcification such as thickness of calcification hematoma occurred following RA Weak points IVUS cannot prove the thickness of calcification Difficult to use for ostial RCA or ostial LMT lesions Since OCT need to eliminate red blood cells, it is dif‑ ficult to use OCT safely when dissection or hematoma occurred following RA Need to be careful for volume overload following multiple observations, especially for patients with low cardiac function May miss calcification when soft tissue buried the calcification Judgement of guidewire bias Accurate, but IVUS probe tends to separate from the Accurate guidewire when operators push an IVUS catheter. Before checking the guidewire bias, operators should pull the IVUS catheter a bit to correct the separation between the guidewire and IVUS probe Efficacy versus safety IVUS would increase the safety in RA. IVUS can be OCT would increase the efficacy such as aggressive used in severe complications following RA, and the ablation in RA role of IVUS would be critical in some situations lesions, and showed the incidence of complications was Imaging devices in RA comparable [87]. Moreover, the risk of complications was greater in imaging device uncrossable lesions than in imag‑ Imaging devices such as IVUS or OCT is useful in RA ing device crossable lesions [88]. Junior RA operators [77–84]. In this document, we recommend to use IVUS should be careful about those imaging device uncrossable or OCT before, during, and after RA. Since both IVUS lesions. Small balloon dilatation before RA can be an option and OCT have advantages and disadvantages, each device for junior RA operators to prevent the severe complications. should be selected according to the purpose of RA in each Recently, Maehara and colleagues developed the IVUS case. The advantages and disadvantages of IVUS and calcium score as well as the OCT calcium score [89, 90]. OCT are summarized in Table  5. Recently, Kawaguchi, The OCT calcium score was composed of maximum cal‑ et al. reported the impact of the degree of guidewire bias cium angle (> 180º = 2 points), maximum calcium thick‑ in the vessel’s healthy portion on coronary perivascular ness (> 0.5 mm = 1 point), and calcium length (> 5 mm = 1 trauma in RA [85], which suggests the greater risk of ves‑ point) [89]. The OCT calcium score was closely associated sel perforation when the intravascular imaging catheter is with stent underexpansion [89], which suggests that the pushing the normal vessel to distort the vessel structure lesions with high OCT calcium score would require RA to (tenting phenomenon). Moreover, Hashimoto, et al. also achieve optimal stent expansion. The IVUS calcium score reported that there is a higher risk of medial injury due to was composed of length of superficial calcification > 270º the RA procedure, especially near the bifurcation of the (≥ 5 mm = 1 point), presence of 360º superficial calcifica‑ left anterior descending artery and diagonal branch when tion (yes = 1 point), presence of calcified nodule (yes = 1 the guidewire and IVUS catheter are close to the healthy point), and vessel diameter (< 3.5 mm = 1 point) [90]. They side of the vessel wall [86]. advocated that operators should consider the use of atherec‑ Although intravascular imaging before RA can pro‑ tomy devices to avoid stent underexpansion when the target vide useful information regarding appropriate burr size or lesion’s IVUS calcium score was ≥ 2 points [90]. Although RotaWire, intravascular imaging catheter may not cross the both IVUS and OCT calcium scores have a potential impact severely calcified lesions. If pre‑RA imaging is critical for on the indication for RA, intravascular imaging catheters safe RA (e.g., ostium of left circumflex lesions), the use may not cross the severely calcified lesions before RA. of guide‑extension catheters may be considered to cross These calcium scores may be more applicable to decide the the lesion. For imaging device uncrossable lesions, small indication for the burr size up or other aggressive lesion burrs (1.25  mm or 1.5  mm burrs) would be the choice. modifications after the small burr cross the lesion rather than Either 1.25 mm or 1.5 mm burrs is to be decided at opera‑ to decide the indication for RA. tor’s discretion. Sakakura, et al. compared the complications between 1.25 mm and 1.5 mm burrs for IVUS‑uncrossable 1 3 K. Sakakura et al. flow to TIMI‑2 flow, then TIMI‑2 flow to TIMI‑1 flow, Endpoint of RA etc.) as long as operators do not ablate lipid‑rich plaques. Therefore, it is important to watch ST‑ elevations in ECG, Operators should set an appropriate endpoint of RA for each which usually antecedent slow flow. If the TIMI2 slo ‑ w flow case. In general, when a burr crosses a lesion without any occurs, RA should be stopped temporarily until the TIMI‑3 resistance and no additional speed down is observed, opera‑ flow was restored. Most transient TIMI‑2 slow flow would tors can finish RA unless operators consider burr size‑up not result in periprocedural myocardial infarction if treated (conventional/classical endpoint of RA). In the contempo‑ immediately [94]. If blood pressure fall following slow flow, rary PCI, the endpoint of RA may become more complex, noradrenaline diluted in saline is injected to restore blood owing to the development of IVUS/OCT. If operators use pressure. If noradrenaline did not work, the prompt insertion IVUS before RA, the crack in the napkin‑ring calcification of IABP would be a next option. Intra‑coronary vasodila ‑ can be an endpoint of RA [8]. If operators use OCT before tors such as nitroprusside, nicorandil, and nitroglycerine are RA, the residual thickness of calcification or dissection can used to treat slow flow. Although there were no literatures be an endpoint of RA [9, 91]. However, operators, especially comparing the efficacy among such vasodilators, nitroprus‑ junior RA operators, should not stick to the conventional/ side may be the most potent vasodilator for slow flow [95]. classical endpoint of RA, if there are signs of slow flow or Although nicorandil may be more ee ff ctive than nitroglycer ‑ other complications. ine [96], the rapid injection of nicorandil may provoke fatal arrhythmia or even cardiac arrest [97]. The use of microcath‑ eters or double lumen catheters would be considered to mini‑ Complications: slow flow mize the risk of vasodilatorinduced h ‑ ypotension. Appropri‑ ate timing of intracor ‑ onary vasodilators would be important Slow flow is the most frequently observed complication fol‑ to treat slow flow. Operators should check ECG or vital signs lowing RA. The incidence of slow flow was approximately between sessions, and check the flow when the change of 5–20% [66, 76, 92], and varied widely among literatures, ECG was observed. In case of severe slow flow (TIMI‑0), partly because the timing of judgement (just after RA or the use of thrombectomy catheter can be considered before final shot) and the definition of slow flow were different the injection of intra‑coronary vasodilators. The prevention among literatures. Lesion length and burr‑to‑artery ratio and bailout for slow flow are summarized in Table  6. were reported as the determinants of slow flow [66, 93]. Furthermore, IVUS findings such as longer lesion length, the maximum number of reverberations, and the greater arc Complications: perforation/rupture of calcification at MLA may predict slow flow after RA [42]. For the prevention of slow flow, appropriate burr size, short Coronary perforation due to the burr is the most serious ablation time, and gentle manipulation avoiding excessive complication in RA, and the incidence of perforation in speed down would be important to minimize the amount of RA is approximately 1–2% [98–101]. If coronary perfora‑ debris caused by RA. A retrospective study revealed that tion occurs during RA, there would be a considerable risk short single session (≤ 15 s) was inversely associated with of in‑hospital death, especially the lesions involving left slow flow after RA [93], which suggests that short single main coronary artery [102]. The risk of perforation highly session can reduce the incidence of slow flow after RA. A depends on the lesion characteristics such as vessel tortuos‑ randomized control study to compare the incidence of slow ity or eccentricity of calcification. Since the shape of each flow following RA between the short single session strategy burr is ellipsoid [103], the RA burr cannot follow the sharply and the long single session strategy is currently ongoing angulated vessel, which results in the greater risk of perfo‑ [UMIN000047231]. Although there were no literatures, ration. The risk of perforation is generally considered to be some experts prefer to flash saline for the prevention of slow greater in an eccentric calcification such as calcified nod‑ flow during RA. Moreover, it is important to keep sufficient ules than in a concentric calcification such as napkin‑ring systolic blood pressure ≥ 120 mmHg (at least 100 mmHg). calcification. Thus, operators need to be careful for RA to If patient’s cardiac function is normal, suc ffi ient hydration is an eccentric calcification. The selection of appropriate burr also important. If a patient shows low blood pressure under size and RotaWire should be important to prevent perfora‑ poor cardiac function, IABP may be considered. Noradrena‑ tion, and the use of intravascular imaging devices would line diluted in saline is frequently used to keep blood pres‑ help operators to select appropriate burr size and RotaWire. sure. If operators took a venous sheath from femoral vein as If intravascular imaging shows the finding that the guide a rescue sheath, such sheath would be helpful to inject the wire is pushing the normal vessel to distort the vessel struc‑ drug immediately. Unlike slow flow during primary PCI, ture, the risk of vessel perforation/injury would be greater slow flow during RA is gradually developed (i.e. TIMI‑3 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 6 Prevention and bailout for slow flow Prevention or bailout Concept Specific methods Prevention Do not make a large amount of debris in a session Appropriate burr size Short ablation time Avoid excessive speed down Prevention Maintain sufficient blood pressure Keep SBP ≥ 120 mmHg (at least 100 mmHg) Use of diluted noradrenaline Consider IABP when low SBP is derived from low cardiac function Bailout Immediate treatment is most important Check the change of ST‑segment, vital signs, and symptom (chest pain) between sessions Use of diluted noradrenaline if SBP fall Use of intra‑coronary vasodilators such as nitroprusside SBP systolic blood pressure, IABP intra‑aortic balloon pumping following RA [85]. If intravascular imaging devices could catheter or a perfusion balloon catheter should be promptly not cross the lesion, small burrs (1.25 mm or 1.5 mm) should delivered to the lesion to seal the blood flow toward peri‑ be the choice, especially for junior RA operators. In general, cardial space. Since the pericardiocentesis is probably a RotaWire floppy would follow the vessel without distorting necessary in perforation following RA, the preparation the vessel configuration, whereas a RotaWire Extra ‑ support for pericardiocentesis is important in catheter laborato‑ would follow the vessel with distorting the vessel configura‑ ries using RA. Multiple covered stents may be necessary tion. Therefore, the route of the burr would be considerably to seal the blood flow [105, 106]. The use of guide exten‑ different between RotaWire floppy and RotaWire Extra‑ sion catheter or the use of double guide catheters may support, which suggests the importance of the choice of be considered to facilitate the delivery of covered stents RotaWires for the prevention of perforation. If the guidewire [107, 108], because there would be a risk of dislodgement bias was difficult to anticipate by intravascular imaging or of covered stents in severely calcified lesions. In the use angiography, a RotaWire floppy would be the choice. of double guide catheters, a balloon via the first guide The bailout of perforation caused by RA is basically catheter can be used to seal bleeding during the prepara‑ similar to that caused by PCI without RA except the fact tion of covered stent via the second guide catheter, and the that operators have to remove the RA system with keep‑ same balloon can be used as the distal anchor balloon to ing the RotaWire. If operators lost the RotaWire follow‑ facilitate the covered stent delivery. Moreover, operators ing massive perforation, there would be no guarantee should contact to cardiovascular surgeons immediately just of recrossing the guidewire. A Kusabi trapping balloon in case of unsuccessful percutaneous bailout. The preven‑ (Kaneka, Osaka, Japan) can be used for the retrieval tion and bailout for coronary perforation are summarized of ≤ 1.5  mm bur rs in ≥ 7  Fr systems [104]. A balloon in Table 7. Table 7 Prevention and bailout for coronary perforation/rupture Prevention or bailout Concept Specific methods/comments Prevention Risk assessment is of utmost importance for prevention of Greater risk in lesions with an angulation perforation following RA Risk of perforation is greater in eccentric calcification than in concentric calcification Prevention Use appropriate burr size, and select appropriate Do not push the burr too much, just deliver the bur to the RotaWires lesion Small burrs (≤ 1.5 mm) would be the choice for the high risk lesions Interpretation of guidewire bias derived from intravas‑ cular imaging would be important to select appropriate RotaWires Bailout Keep the RotaWire within the lesion, when perforation Do not be panic. Remove the Rota system with keeping the occur RotaWire within the lesion Covered stents and pericardiocentesis would be necessary in most cases Contact cardiovascular surgeons immediately in case of unsuccessful percutaneous bailout 1 3 K. Sakakura et al. catheter (double guide catheters) or not (single guide cath‑ Complications: burr entrapment eter). If operators selected the double guide systems, opera‑ tors would insert the conventional guidewire from the sec‑ Burr entrapment is a unique complication in RA, and the ond guide catheter, and then would try to dilate the proximal incidence of burr entrapment is not derived from multicenter part of the entrapped burr using a balloon [112]. If operators registries, but is available from single center studies rang‑ selected the single guide system, the next step would depend ing 0.4–0.8% [109, 110]. Burr entrapment can occur from on the guide catheter size (≥ 8 Fr or ≤ 7 Fr). If operators used several mechanisms. One is called as “Kokesi phenomenon” a ≥ 8 Fr guide system, operators would insert the conven‑ that the burr was trapped in the distal portion of the proximal tional guidewire, and then would try to dilate the proximal narrowing [110]. The mechanism of Kokesi phenomenon part using a balloon. However, if operators used a ≤ 7 Fr is considered to be that a friction heat enlarges the orifice guide system, operators need to cut and pull the drive shaft and the coefficiency of friction in motion is smaller than sheath (Fig. 1) [111], because a ≤ 7 Fr guide catheter cannot that of friction at rest [110]. This type of burr entrapment accommodate the drive shaft sheath, guidewire, and balloon may occur following forceful manipulation with small burrs. catheter together. After pulled out the drive shaft sheath, Another mechanism is the burr entrapment related to the operators can try to dilate the proximal part using a balloon. vessel angulation. Since the shape of the burr is ellipsoid Once operators pulled out the drive shaft sheath, operators and the diamond coating is not available at the tail of the can use inner catheters such as guide extension catheters burr, the burr can be trapped by non‑massive calcification at [113, 116, 117]. Of course, operators should recognize the the site of angulation. To prevent burr entrapment, operators possibility of unsuccessful percutaneous bailout, and need need to be careful about rotational speed reduction, sound to prepare the massive perforation or severe dissection fol‑ of ablation, and resistance during the burr manipulation. If lowing the burr retrieval [119]. The prevention and bailout operators encounter the burr entrapment, it is important to for burr entrapment are summarized in Table 8. assess the situation calmly. The presence of antegrade flow, ST‑segment elevations in ECG, and patient’s chest pain should be evaluated. If there is no antegrade flow beyond Complications: transection of the RotaWire the entrapped burr, the percutaneous bailout would be very difficult, and be limited to experienced senior RA operators. The transection of the RotaWire is a rare complication In the meantime, operators should contact cardiovascular in RA, and the incidence of transection of the RotaWire surgeons to discuss the surgical bailout. If the antegrade flow is not derived from multicenter registries, but may be is present without ST‑ segment elevations, operators would approximately 0.4–1% [120, 121]. There are two types of have a time to consider the percutaneous bailout techniques. the transection of the RotaWire: One is the transection Although there have been several percutaneous bailout tech‑ at the radiopaque part of the RotaWire, and the other is niques in literatures [111–118], the main difference among the transection at the radiolucent part of the RotaWire. various techniques was whether to use additional guide The transection of the radiopaque part is easy to notice. Fig. 1 How to cut and pull the drive shaft sheath. A A RA burr drive shaft remained in the same position. G, H A guide wire (0.014 (1.25  mm) was inserted into a 6  Fr guide catheter via a Y connec‑ inch) passed through the guide catheter via an inserter and Y‑connec‑ tor. B, C The drive shaft, drive shaft sheath, and RA wire were cut tor. I A 2.5 × 15  mm conventional balloon easily passed through the together near the advancer. D, E The drive shaft sheath was pulled guide catheter. This figure was reproduced with the permission from back and removed. F After the drive shaft sheath was removed, the Sakakura et al. [111] 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… Table 8 Prevention and bailout for burr entrapment Prevention or bailout Concept Specific methods/comments Prevention Risk assessment is of utmost importance for prevention of Do not push the burr too much, just deliver the burr to the perforation following RA lesion Greater risk in lesions with an angulation Be careful about rotational speed deceleration, sound of ablation, and resistance during the burr manipulation Prevention Do not inactivate the burr in the middle of the calcified There is no diamond coating at the tail of the burr stenosis Moderate stenosis at the proximal of the target can be a cause of burr entrapment Bailout It is important to assess the situation such as the presence of Do not activate the burr after burr entrapment antegrade flow, calmly Bailout techniques are divided to single guide bailout or double guide bailout Contact cardiovascular surgeons immediately in case of unsuccessful percutaneous bailout If there were the transection of the radiopaque part of the Complications: disconnection of the burr RotaWire, operators should exchange the broken RotaWire to the new one. Since the retrieval of a transected fragment Disconnection of the burr is very rare complications, and of the RotaWire would be similar to that of the conven‑ there have been no literatures mentioning the incidence of tional guidewire, operators might try retrieval procedures disconnection of the burr. The exact reasons or mechanisms such as twin guidewire method [120]. If the transected of disconnection of the burr has not been specified. Even fragment of the RotaWire located at the far distal seg‑ senior RA operators with abundant experiences may not or ment of the treated vessel, operators might leave it at the may have a few cases with this complication. Theoretically, distal segment rather than retrieval. On the other hand, the disconnection of the burr could happen when opera‑ the transection of the radiolucent part of the RotaWire tors activate the burr after the burr was entrapped, or when is very difficult to notice. If operators could not notice operators advanced the burr in spite of strong resistance the transection of the radiolucent part of the RotaWire, within the stented segment or angulated segment. Opera‑ operators would have a vessel perforation [121–123]. In tors may notice the disconnection of the burr by the loss of fact, Wang et al. reported that the Rotawire damage with coordination between the burr motion and the nob motion. subsequent transection was the cause in 18.2% of cases The percutaneous bailout may be possible if the RotaWire with coronary perforations [101]. Moreover, there would is not transected, because the 0.014‑inch spring tip of the be a greater risk in retrieval of a transected fragment of RotaWire may work as the anchor. Imamura S, et al. reported the RotaWire, if the transection occurred at the radiolucent a case of the disconnection of the burr, which was success‑ part. Because the proximal part of the transected fragment fully treated percutaneously [124]. In their case report, since of the RotaWire would be sharp, the invisible sharp frag‑ the simple pullbac ‑ k using a guide extension catheter did not ment of the RotaWire may damage to the proximal vessel work, they sandwiched the disconnected burr between the wall, even to the aortic wall during the retrieval. IVUS inflated balloon and the guide extension catheter, and then may be helpful to identify the invisible fragment. pulled back together [124]. However, surgical bailout should Since the incidence of transection of the RotaWire is low, be considered to this rare complication [125]. the causes of transection have not fully understood. Because the metallic fatigue would be the possible cause of transec‑ tion, it may be important to avoid the continuous contact Specific lesions: RCA ostial lesions between the burr and the specific part of the RotaWire. If the RotaWire kinked at the outside of the guide catheter, Since clinical outcomes of RCA ostial lesions have been the transection of RotaWire would happen when the burr unsatisfactory for decades [126], RA has been considered advanced over the kinked RotaWire [74]. Furthermore, the to be a good indication for RCA ostial lesions with severe WireClip Torquer (Boston Scientific, Marlborough, MA, calcification [46]. However, a good indication does not nec‑ USA) should be equipped with the RotaWire during the essarily mean an appropriate lesion for junior RA operators. dyna‑glide mode as well as the high‑speed mode to avoid Sakakura, et al. reported that the excessive speed reduction the spinning of the RotaWire, which could be a cause of during RA was significantly associated with RCA ostial transection of the RotaWire. lesions [47], which suggests the difficulty of RA for RCA 1 3 K. Sakakura et al. ostial lesions. There are several reasons why RA for RCA big burrs for RCA ostial lesions. Furthermore, there may be ostial lesions are difficult. First, it is impossible to insert the an additional risk of cerebral infarction following RA for guide catheter to RCA coaxially. Operators would try to keep RCA ostial lesions. It may be important for the prevention guide catheter coaxial to RCA in aorta. Second, coaxial‑ of cerebral infarction to use small burrs for an initial attempt ity cannot be confirmed by LAO view, which is a standard to minimize the size of debris. Figure 2 summarized the why view in RA for RCA ostial lesions. Coaxiality is usually RA to ostial RCA is difficult. RA for RCA ostial lesions is confirmed by RAO view in conventional PCI. If the guide not recommended for junior RA operators without senior catheter can engage to the RCA, coaxiality would be kept RA operator’s back‑up. once operator check in the RAO view. However, if the guide catheter cannot engage to the RCA, coaxiality would not be kept during procedures. Because it is difficult to check the Specific lesions: LCX ostial lesions burr motion in RAO view due to the angiographical short‑ with substantial bending ening of the RCA ostial lesion, the frequent switch between RAO view and LAO view may be necessary to keep coaxi‑ Severely calcified left circumflex (LCX) ostial lesions ality during RA. Another option is to use straight cranial with substantial bending may be the highest risk lesion view, which allows operators to check coaxiality without in RA. The key to success would be the interpretation angiographical shortening of the RCA ostial lesion. of pre‑procedural intravascular imaging. If the pre‑pro‑ The selection of the RotaWire for RCA ostial lesions is cedural imaging device could cross the lesion and pro‑ also important. The RotaWire Extra‑Support may be pref‑ vide sufficient information including the guidewire bias, erable when operators intentionally remove the guide cath‑ operators could select appropriate RotaWires and burrs. eter from the RCA ostium, whereas the RotaWire Extra‑ However, if the pre‑procedural imaging device could not Support may be dangerous when operators cannot take a cross, operators need to select RotaWires and burrs from coaxial position. IVUS may help to estimate the risk of RA, the only angiographical information. In general, athero‑ especially when operators could not take a coaxial position. sclerotic plaques are observed in the lateral wall, whereas Although an IVUS catheter may not cross the lesion before atherosclerotic plaques are spared in the flow divider RA, an IVUS catheter would cross the lesion after the cross‑ regions (carina) [127]. If severe eccentric calcification ing of small burrs. IVUS should be tried before using the was observed in the lateral wall of the LCX ostium, there Fig. 2 Why RA to ostial RCA is difficult? 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… would be a risk of perforation in the carina side of the Specific lesions: unprotected left main LCX ostium due to the jumping of the burr. Operators lesions would try to ablate the lateral wall of the LCX ostium to avoid perforation in the carina side. However, if operators RA to the unprotected left main lesions requires special ablated the lateral wall too much, there would another attention, because slow flow may cause hemodynamic col‑ risk of perforation in the lateral wall side due to the deep lapse. However, Fuku et al. compared clinical outcomes of cut. Two types of perforation in LCX ostial lesions with left main PCI between with RA (n = 108) and without RA substantial bending are illustrated in Fig.  3. Operators (n = 1091), and showed the similar rate of complications need to select appropriate burr size, RotaWires, and burr in left main PCI between with RA and without RA [128], motion to prevent the above two types of perforation. In suggesting the acceptable safety in PCI to left main lesions angiography, it would be important to evaluate the actual using RA. In clinical practice, it would be important to contact point between the calcification and the RotaWire start with small burrs (≤ 1.5 mm burr) to prevent fatal slow using multiple projections. Although low‑dose radiation flow. However, the ≤ 1.5 mm burr may be too small as the angiography is important for patient’s safety, excessive final burr size considering the vessel diameter of left main low‑dose radiation angiography may sacrifice the visibil‑ lesions. It would be important to use IVUS/OCT to select ity of RotaWires or calcification. Since the visibility of an initial burr size and final burr size. If the severe calci‑ RotaWires or calcification is the cornerstone for high‑risk fied plaques exist at the ostium of left main, the procedure RA, operators should set the radiation dose not to pre‑ would be more complex as compared to calcified plaques at vent the visibility of RotaWires or calcification. Moreo‑ the middle of left main. In that situation, the stabilization ver, if there would be a perforation in the LCX ostium, of guide catheter at co‑axial position within aorta would be the percutaneous bailout would be difficult, because the the key to success like the ostium of RCA lesions. Further‑ implantation of covered stents may occlude the left ante‑ more, the use of IABP and/or temporary pacing should be rior descending artery (LAD). Therefore, the indication considered. RA for left main lesions is not recommended for as well as the strategy of RA to the LCX ostium should junior RA operators without senior RA operator’s back‑up. be carefully discussed. RA for LCX ostial lesions with If we do not limit the topic to the left main lesions, the substantial bending is not recommended for junior RA subgroup analysis of the PREPARE‑CALC study revealed operators without senior RA operator’s back‑up. that the incidence of side branch compromise was less Fig. 3 Schema of two types of perforation in LCX ostial lesions with substantial bending 1 3 K. Sakakura et al. frequently observed in lesions treated with RA than in performed an experimental study and found that the size of lesions treated without RA in bifurcation lesions [129]. the metallic particles generated during RA of stent struts Mizuno, et al. also reported that the incidence of side branch was 5.6 ± 3.6 μm, which suggested the safe size in a human compromise was less frequently observed in calcified bifur ‑ body [132]. Tips of stent ablation are (1) to select the appro‑ cation lesions with RA than in those without RA, even if RA priate burr size, (2) to ablate only stent struts first, (3) and was performed to the main vessel only [130]. On the other then ablate the calcification behind stent struts using the hand, Chen, et al. reported the higher risk of side branch second burr (size up). Since the risk of burr entrapment perforation, when RA was performed to both main vessel is greater during stent ablation, gentle manipulation with and side branch as compared to RA to the main vessel only gradual sizeup w ‑ ould be important. Although stent ablation [131]. Therefore, RA to both main vessel and side branch might be a single solution for the restenostic lesions caused should be reserved for senior RA operators. by under‑expanded stents, the long‑term outcomes was not satisfactory [133–136]. Coronary lithoplasty may be another option for stent underexpansion due to severe calcification Specific lesions: stent ablation [137], while sufficient follow ‑up data is not available yet. Stent ablation is not recommended for junior RA operators. Stent ablation is applied to the restenotic lesions caused by Furthermore, on‑site surgical back ‑up may be need because under‑expanded stents. Okamura, et al. described a case of greater risk of burr entrapment, when operators perform of stent ablation to treat restenosis lesions due to crush‑ stent ablation using big burrs. ing of a sirolimus‑eluting stent [132]. In their report, they Fig. 4 Schema of conven‑ tional and halfway rotational atherectomy. A–C illustrate the conventional rotational atherec‑ tomy, whereas D–F illustrate the halfway rotational atherec‑ tomy. A The burr positioned just before the calcified lesion. B The burr ablated the proximal segment of the calcified lesion. C The burr ablated the full seg‑ ment of the calcified lesion. D The burr positioned just before the calcified lesion. E The burr ablated the proximal segment of the calcified lesion. F Balloon dilatation was performed for the rest of the calcified lesion. This figure was reproduced with the permission from Sakakura, et al. [141] 1 3 Clinical expert consensus document on rotational atherectomy from the Japanese association… lesion. Thus, the actual working range of the burr is approxi‑ Specific lesions: diffuse long lesions mately 30–50 mm. If the length of the target lesion was beyond 30–50 mm, operators need to move the platform RA was frequently performed for diffuse long lesions, and during the procedure. Although there were few literatures the long‑term outcomes of long lesions treated by RA were regarding how to move the platform during the procedure, comparable to those of short lesions treated by RA [138]. there were several ways among RA experts. The most impor‑ However, RA for diffuse long lesions may be difficult for tant point is to ablate the proximal part of the diffuse long junior RA operators, especially when there is an angle lesion sufficiently before moving the platform. Only 1 pass in the middle of diffuse long lesions. The presence of an would not be enough. Several passes would be necessary acute angulation on the lesion is reported to be associ‑ until no additional speed down was observed. Some experts ated with procedural failure of RA [139]. Sakakura, et al. prefer to size up the burr and ablate the proximal part of the reported the utility of halfway RA especially for lesions diffuse long lesion using big burrs to make a stable platform. with an angle [140, 141]. In brief, the operator does not After operators ablated the proximal part of the diffuse long advance the burr beyond the angle within the lesion to lesion sufficiently, operators could move the platform more avoid burr entrapment or vessel perforation, and balloon distally. Some experts prefer to use dynaglide mode to move dilatation is performed beyond the angle after RA (Fig. 4). the platform. Sliding sheath technique, in which operators Halfway RA may be useful especially for junior RA opera‑ park the burr to the distal end and then bring the advancer tors. If halfway RA did not work (e.g., balloon could not to follow the burr, may be used by some experts. Since the dilate the distal calcified lesion), switch from halfway RA outer diameter of the drive shaft sheath is 4.3 Fr (1.43 mm), to conventional RA should be considered. Although the the ablation by the burr1.25  ‑ mm may not be enough to move other option could be to use the guide extension catheter, the platform. RA beyond the guide extension catheter is not straight‑ forward. Another important aspect in RA for diffuse long lesions is to check the speed down of rotational speed. Although the excessive speed down during RA should be Specific lesions: ablation to an entrapped avoided, absence of reasonable speed down may mean that guidewire the burr does not contact to calcification adequately. If an operator pushes the burr too much in the absence of speed An entrapment of coronary guidewires is sometimes down, there would be substantial risk of burr entrapment observed in complex PCI. Forced pullbac ‑ k of the entrapped or vessel perforation. Therefore, an operator may change guidewire may damage coronary artery wall or provoke the RotaWires to facilitate the contact between the burr the fracture of guidewire. RA can be an option to cut the and the calcified plaques, switch to balloon dilatation entrapped guidewires [143–145]. In the comparison of (resultantly halfway RA), or rarely burr size‑ up to increase forced pull‑back by snare, the coronary artery is not sub‑ the contact area in the absence of reasonable speed down jected to excessive force if the contact point between the [103, 142]. burr and the fractured guidewire is controlled under IVUS Operators should also take care of ischemia during RA guidance [144]. However, since there is a potential risk that to the diffuse long lesions, because the risk of slow flow the RA burr may be entrapped in the spring wire, ablation is greater in the diffuse long lesions than the short lesions to an entrapped guidewire is not recommended for junior [66]. If operators noticed the signs of ischemia in the middle RA operators. of diffuse long lesions, size down of the burr would be the reasonable choice. Another option would be to take a short break with removing the burr from the coronary artery to Conclusions stabilize coronary flow and vital signs. If coronary flow is restored and vital signs are stabilized, operators can safely In this document, we provided the Japanese style RA, resume procedures. This document suggests an algorithm which uses intravascular imaging devices to achieve the for disuse long lesions, especially for junior RA operators maximum efficacy without sacrificing the safety. Our rec‑ (Fig. 5). ommendation focused on mainly junior RA operators, but The maximum working range of the burr is approximately would be helpful for senior RA operators for their more 70 mm. Operators usually set the nob at 1–2 cm apart from advanced procedures. the end, and set the platform at 1–2 cm proximal from the 1 3 K. Sakakura et al. Fig. 5 Algorithm: When opera‑ tors felt difficulty in RA for diffuse long calcified lesions Funding None. outcomes according to drug‑eluting stent generation. JACC Car ‑ diovasc Interv. 2020;13(12):1417–28. Data availability This consensus documet does not include original 2. Copeland‑Halperin RS, Baber U, Aquino M, Rajamanickam A, data. Roy S, Hasan C, Barman N, Kovacic JC, Moreno P, Krishnan P, Sweeny JM, Mehran R, Dangas G, Kini AS, Sharma SK. Prevalence, correlates, and impact of coronary calcification on Declarations adverse events following PCI with newer‑generation DES: Find‑ ings from a large multiethnic registry. Catheter Cardiovasc Interv. Conflict of interest Drs. Sakakura, Ito, Shibata, Okamura, Nakamura, 2018;91(5):859–66. Hamazaki, Ako, Yokoi, Kobayashi, and Ikari received speaking hono‑ 3. Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, raria from Boston Scientific. Drs. Sakakura, Shibata, Okamura, Na‑ Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice kamura, and Hamazaki served as a proctor for Rotablator for Boston MC, Kappetein AP, Thuijs D, Milojevic M, Noack T, Mohr FW, Scientific. Dr. Ikari received research grant from Boston Scientific. Davierwala PM, Onuma Y. 10‑ Year all‑ cause mortality following percutaneous or surgical revascularization in patients with heavy Open Access This article is licensed under a Creative Commons Attri‑ calcification. JACC Cardiovasc Interv. 2022;15(2):193–204. bution 4.0 International License, which permits use, sharing, adapta‑ 4. Sharma SK, Tomey MI, Teirstein PS, Kini AS, Reitman AB, Lee tion, distribution and reproduction in any medium or format, as long AC, Généreux P, Chambers JW, Grines CL, Himmelstein SI, as you give appropriate credit to the original author(s) and the source, Thompson CA, Meredith IT, Bhave A, Moses JW. North Amer‑ provide a link to the Creative Commons licence, and indicate if changes ican expert review of rotational atherectomy. Circ Cardiovasc were made. The images or other third party material in this article are Interv. 2019;12(5): e007448. included in the article's Creative Commons licence, unless indicated 5. 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Journal

Cardiovascular Intervention and TherapeuticsSpringer Journals

Published: Apr 1, 2023

Keywords: Rotational atherectomy; Calcification; Percutaneous coronary intervention; Intravascular ultrasound; Optical coherence tomography

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