Treatment of calcified coronary artery lesions.

Expert Review of Cardiovascular Therapy

ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20

Treatment of calcified coronary artery lesions Mohamed Farag MSc, Charis Costopoulos MD, Diana A Gorog MD PhD, Abhiram Prasad MD & Manivannan Srinivasan MD To cite this article: Mohamed Farag MSc, Charis Costopoulos MD, Diana A Gorog MD PhD, Abhiram Prasad MD & Manivannan Srinivasan MD (2016): Treatment of calcified coronary artery lesions, Expert Review of Cardiovascular Therapy, DOI: 10.1586/14779072.2016.1159513 To link to this article: http://dx.doi.org/10.1586/14779072.2016.1159513

Accepted author version posted online: 29 Feb 2016.

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Date: 11 March 2016, At: 03:13

Publisher: Taylor & Francis Journal: Expert Review of Cardiovascular Therapy DOI: 10.1586/14779072.2016.1159513

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Treatment of calcified coronary artery lesions Mohamed Farag MSc1*, Charis Costopoulos MD1, 2*, Diana A Gorog MD PhD3, Abhiram 1East

Prasad MD4, Manivannan Srinivasan MD1

and North Hertfordshire NHS Trust, Hertfordshire, UK 2University

4St

3Imperial

of Cambridge, UK

College, London, UK

George's University Hospitals NHS Trust, UK

* These authors contributed equally to this work. Corresponding Author: Manivannan Srinivasan Lister Hospital

East and North Hertfordshire NHS Trust Stevenage SG1 4AB

Tel: +44 (0) 1438 781550 Fax: +44 (0) 1438 781794 E-mail: [email protected]

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ABSTRACT Heavily calcified coronary plaques represent a complex lesion subset and a challenge to the interventional cardiologist, as they are often resistant to simple plaque modification with


conventional balloon angioplasty. Inadequate plaque modification can lead to stent

underdeployment, which itself predisposes to in-stent restenosis and stent thrombosis.

Over the years, a number of mechanical devices ranging from modified angioplasty balloons to atherectomy devices have become available in order to tackle such lesions. Here we review these devices concentrating on the evidence behind their use.

Key words: percutaneous coronary intervention, angioplasty, calcified lesions, rotablation, atherectomy devices

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ABBREVIATIONS BMS = bare metal stent

DES = drug-eluting stent


MI = myocardial infarction OA = orbital atherectomy

OCT = optical coherence tomography RA = rotational atherectomy

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INTRODUCTION Since its introduction in 1979, percutaneous coronary intervention (PCI) has been shown to be a safe and effective procedure for the treatment of most coronary lesion subsets (1).


Improvements in operator experience in conjunction with advances in device technology and adjunctive pharmacotherapy have allowed over recent years the percutaneous

treatment of increasingly complex lesions. However, certain lesion subsets still pose a

challenge to the interventional cardiologist. One such lesion subset is fibrocalcific

atheromatous plaques, which account for the lesion type in 17-35% of patients undergoing PCI (2, 3). In the presence of a heavily calcified lesion, poor lesion preparation often leads to stent underexpansion and malapposition, and thereby increasing the risk of stent

thrombosis and in-stent restenosis (ISR) (4, 5). Stent underexpansion due to the surrounding calcium can also be very challenging for interventionalists (6). This is

particularly relevant in the drug eluting stent (DES) era, where adequate stent expansion is

essential for optimal clinical outcomes (7). Indeed, stent underexpansion and residual reference segment stenosis are related to stent thrombosis after DES implantation (8). A

number of devices, ranging from specialized balloons to the more complex atherectomy

devices have therefore been designed to tackle such lesions prior to stent implantation. Here we review these devices and discuss the evidence regarding their use.

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TREATMENT OF FIBROCALCIFIC LESIONS Double-wire Technique The double-wire technique (buddy-wire) is a widely used technique to advance balloons


and stents inside a calcified or tortuous/angulated coronary artery during PCI. The technique involves advancing a second 0.014 inch coronary guide wire alongside the one being used. It improves the balloon or stent support and also provides guiding catheter

stability (9). It is considered a low cost, quick and easily available method for complex lesions during PCI.

Specialized Balloons Mechanisms of conventional balloon angioplasty include compression, disruption and

dissection of the underlying plaque as well as longitudinal extension of the coronary artery.

Although plain ordinary balloon angioplasty (POBA) may be effective, it can also lead to

major dissection or even coronary rupture when used in calcified plaques due to eccentric balloon dilatation. This is especially the case with the more trackable semi-compliant

balloons commonly used as predilatation tools. Although a non-compliant balloon can be

used for lesion preparation, as balloon expansion is more uniform at higher pressures; this may not only be more difficult to deliver, but also may result in inadequate lesion preparation. Specialized balloons currently available address some of these issues.

The AngioSculpt (AngioScore Inc., Fremont, CA, USA) [Figure 1] is a semi-compliant balloon

surrounded by a spiral nitinol element that works in combination with the balloon in order to ‘score’ (cut into) the target lesion upon balloon inflation (5, 10). Available balloon

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diameters range from 2.0 to 3.5mm, in 0.5mm increments with three balloon lengths from

10 to 20mm in 5mm increments. As the balloon inflates, the spire wires slide and rotate over the balloon with the radial forces of the balloon concentrated along the surfaces of the nitinol frame. This results in more controlled balloon expansion, reducing barotrauma and


the risk of critical coronary dissection and perforation. In addition, it helps to prevent

balloon slippage and allows higher inflation pressures. These features are particularly important in calcified lesions, as they tend to have an abrupt edge where balloon overdilatation is more likely to occur and adjacent lipid-laden areas of disease are more prone to perforation. Furthermore, as the properties of this device help to prevent plaque

crush, AngioSculpt use for these lesions may also reduce distal embolization. In the nonrandomized, observational study by de Ribamar Costa et al., use of the AngioSculpt was

associated with an increased DES expansion and a reduction in the mismatch between achieved and predicted stent dimensions in patients who had de novo lesions in native

coronary arteries (11). Optical coherence tomography (OCT) reports from patients treated with AngioSculpt have demonstrated satisfactory dilatation of the calcified portion of the lesion with safe dissections in the non-calcified segments (12, 13).

The Flextome Cutting Balloon (Boston Scientific, Natick, MA, USA), which incorporates

three or four radially directed microsurgical blades on the surface of the balloon, is another device that can be used for the modification of calcified lesions [Figure 2]. It is available in 2.0-4.0mm in diameter, with 0.25mm increments and in three lengths (6, 10 and 15mm). It creates endovascular incisions that are propagated with balloon inflation and like the

AngioSculpt balloon; it achieves better lumen expansion at lower pressures. The intravascular ultrasound study by Okura et al. suggested that lesion modification with a 7

cutting balloon is associated with greater plaque burden reduction as well as acute lumen gain in calcified lesions compared to POBA (14).

The Scoreflex balloon (OrbusNeich, Hong Kong, China) is a relatively novel semi-compliant


balloon with a dual wire system and is another device designed for use in focused force angioplasty. Available balloon diameters range from 2.0 to 4.0mm, in 0.5mm increments

with three balloon lengths from 10 to 20mm in 5mm increments. The concept of the

AngioSculpt and Scoreflex balloon catheters is similar; however, the number of scoring

elements is lower in the Scoreflex, with three in the AngioSculpt and two in the Scoreflex. Therefore, the Scoreflex balloon may have the potential advantage of easier delivery through severely stenotic lesions. A study in vitro by Kawase et al. suggested that the Scoreflex balloon can expand a calcified lesion with lower pressure than that of a conventional balloon (15).

The Lacrosse NSE (Goodman Co. Ltd., New Zealand) is another relatively novel balloon with

3 triangular nylon elements (width 0.014 inch and height 0.015 inch) that are free floating

on the outside of the balloon surface and attached proximal and distal to a 13 mm balloon,

providing an efficacious scoring effect on the calcified lesion. Available balloon diameters range from 2.0 to 4.0mm, in 0.25mm increments. Delivery of Lacrosse NSE to the lesion location in a clinical setting is more difficult than a conventional balloon (16). The unique

balloon design has made it well suited for the "leopard-crawl" technique. This technique

uses a low inflation pressure to create a wedge into the calcification and then subsequently advances the catheter during balloon deflation to facilitate balloon delivery through the stenosis. Repeating this process facilitates balloon delivery across the target lesion (16).

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Atherectomy Devices Atherectomy has taken several different forms including directional atherectomy or plaque

excision (SilverHawk, ev3, Inc., Plymouth, Minnesota), laser atherectomy, rotational


atherectomy (RA), and more recently orbital atherectomy (OA). Directional atherectomy is approved for use in the peripheral vasculature and not in coronary vasculature. Laser Atherectomy

Excimer laser coronary atherectomy (ELCA) makes use of high-power ultraviolet pulses (wavelength 308 nm) generated through a fiberoptic catheter to vaporize thin sections of

tissue without causing significant damage to surrounding tissue. The Spectranetics CVX300 (Spectranetics, Colorado Springs, CO, USA) ELCA system is composed of the excimer

laser generator (CVX 300) and the pulsed xenon-chloride catheters available in 0.9, 1.4, 1.7 and 2mm diameter. The laser catheter is advanced through a coronary guide catheter

seated at the origin of the coronary artery. Laser output from the generator is activated with a foot pedal as the catheter is advanced very slowly through the stenosis as to not

exceed the rate of tissue ablation. Manual flush saline infusion before and during ablation is

required for safety reasons. Activation of 10 seconds is followed by a mandatory rest of 5 seconds, which is continued until either the catheter has traversed the lesion, or sufficient

lesion modification has occurred to permit balloon crossing or expansion. ELCA has been demonstrated to facilitate angioplasty in balloon-resistant coronary lesions and in lesions refractory to high pressure balloon inflations (17, 18). Fernadez et al., in a study of 58 cases

of balloon failure treated with ELCA ± RA, reported 91% success rate, with only one case of ELCA failure where RA succeeded (19). In that study, there were four procedure-related 9

complications, two of which were coronary perforations. One was directly attributable to

ELCA and led to subsequent mortality. In a small study by Nishino et al., the use of OCT

immediately after ELCA for in-stent restenosis lesions revealed larger lumen area

compared with Flextome Cutting Balloon, which may support favourable effects of ELCA for


in-stent restenosis (20). The ELLEMENT study suggested the feasibility of ELCA to improve stent underexpansion in unexpanded stented lesions (21). The use of ELCA has also been

shown to be both safe and effective in other PCI lesion subsets including saphenous vein grafts (22) and chronic total occlusions (23). Rotational Atherectomy

Rotational atherectomy (RA), introduced in 1990, is shown to be safe and effective in the

treatment of calcific coronary lesion subsets (24-26). Its main mechanism of action entails high-speed rotational plaque ablation (140,000-160,000 revolutions per minute, rpm) and

pulverization by the abrasive diamond coated burr (25) [Figure 3]. The burrs come in 8

sizes ranging from 1.25 to 2.5 mm. The guiding catheter is selected based on the required burr size; 8F guide is used for burr sizes ranging from 1.25 to 2.0 mm, 9F guide for burr

sizes ranging from 2.15 to 2.38 mm, and 10F guide for the 2.5 mm burr. In the

contemporary era, the main objective of its usage is to both modify the plaque and debulk the lesion prior to implantation of a coronary stent [Figure 4]. Utilizing the principle of differential cutting, the “rotabaltor” (Boston Scientific, Natick, MA, USA) ablates the

inelastic tissue such as fibrocalcific atheroma selectively. However, its usage has been varied and in fact declining as many operators and institutions are reluctant to use this

technology. A recent study from the National Heart, Lung and Blood institute dynamic 10

registry regarding PCI of moderate to severe calcified coronary lesions, reported that only

14.9% of cases had RA prior to deployment of a coronary stent (27). The reasons for

underutilization of RA may be multi-factorial, such as lack of adequate exposure and training and fear of misconceptions that it is associated with a very high rate of serious


complications. The role of RA has evolved over the last decade from a device to remove

large quantities of calcific plaque to merely modifying these plaques to permit adequate balloon and stent expansion. Currently, evidence from randomized trials and clinical

experience suggests that applying a burr to artery ratio of 0.6-0.7 (1.5-1.75mm burr size) is

usually effective in achieving adequate lesion preparation prior to stenting (28-30). Other important procedural considerations, which have evolved over time include slow burr

advancement, the use of a to- and fro- pecking motion, shorter burr run times (15-20 sec) and avoidance of a sudden drop in rpm (19, 30). These, along with advances in adjunctive

pharmacotherapy have led to significant reduction in complications such as coronary

artery spasm, vessel perforation, slow or no reflow and periprocedural myocardial infarction (MI). Traditionally, RA is performed using the femoral approach. This along with

the need for larger sheath sizes used for the ablative device, longer procedure time and frequent use of glycoprotein IIb/IIIa inhibitors may lead to an increase in major access site

bleeding complications. The use of radial access has been shown to reduce the incidence of

major access site bleeding complication by almost 60% (31, 32). Recently, radial access has been increasingly used for most lesion subsets including calcific coronary lesions. The

safety and efficacy of radial access in patients undergoing RA has been increasingly reported including the use of larger size sheaths and sheathless guides (33-36).

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Despite its availability for over 2 decades, there is paucity of data regarding the

effectiveness of RA followed by stenting in routine clinical practice. Most of the evidence is derived from retrospective single centre observational studies (Table 1). In the bare-metal stent (BMS) era, there have been only two randomized trials with conflicting results. In the


EDRES (Effects of Debulking on Restenosis) trial, involving 150 patients, RA followed by

stenting had no effect on final stent diameter compared to stenting alone (37). However, the stenting strategy involving RA was shown to reduce binary angiographic stenosis at 6-

month follow up (27% vs. 34%; p=0.05). In the SPORT (Stenting Post Atherectomy) trial, 750 patients were randomized to either balloon dilatation or RA prior to stent deployment.

Procedural success was higher in RA group (93.6% vs. 88%; p=0.01). However, this failed to translate into better clinical outcomes (38). In the recently published ROTAXUS (Rotational Atherectomy Prior to Taxus Stent) trial, 240 patients with calcified lesions were randomized to RA followed by stenting and to stenting without RA groups. Procedural

success was shown to be higher in the RA group (92.5% vs. 83.3%, p=0.03) although at 9month angiographic follow-up in-stent late lumen loss was higher in the RA group

(0.44±0.58mm vs. 0.31±0.52mm, p=0.04), despite an initially higher acute lumen gain (1.56±0.43mm vs. 1.44±0.49mm, p=0.01). Target-lesion revascularization, major adverse cardiac events and stent thrombosis did not differ between the two groups (39). Although

the ROTAXUS trial suggests that RA may not improve clinical outcomes, the fact that it was

associated with a higher procedural success suggests that it still has an important role in

lesions where plaque modification with balloon predilatation is ineffective. Furthermore, in the same trial, adjunctive pharmacotherapy during RA was not routinely used and this may

have played a role in shaping final results. Similar conclusions were drawn by the recent 12

retrospective study by Cockburn et al. where 2152 patients treated with RA were propensity-matched to a population treated with conventional predilation tools. Although

patients treated with RA demonstrated worse clinical outcomes at a mean follow-up of 2.4

years in the subgroup with left main stem disease or peripheral vascular disease, RA was


associated with improved survival emphasizing the role this has in highly-calcified lesions

(40). It is important to note that the risk of some the complications seen in the aforementioned studies can be reduced with appropriate pharmacotherapy, as this can minimize the impact of certain physiological responses evoked by RA.

During the process of RA, micro-particles (5-10 µm in diameter) are generated from pulverized plaques (29). These particles may cause platelet activation in the distal circulation, thereby impairing coronary microcirculation. glycoprotein IIb/IIIa receptor inhibitors have been shown to be effective in the prevention of this complication during RA.

In a randomized trial, Kini et al. reported that upfront use of abciximab was associated with

a 50% reduction in periprocedural MI and procedural morbidity (41). Another unique

complication during RA is the occurrence of slow reflow/ no reflow phenomenon, which is reported in up to 2.6% of cases (42, 43). This is due to a combination of distal embolization

and coronary vasospasm. Usually this is treated with a cocktail of adenosine and vasodilators such as nitroglycerin and calcium antagonists, although there are no

randomized trials assessing the effectiveness of different cocktails. Thus, the choice of such

cocktails rests with local preference and experience. Slow flow may also be attributed to coronary vasospasm created by heat, generated by friction between the drive coil and the

guide wire. The use of Rotaglide lubricant may help prevent and reduce the severity of spasm (30). Finally, the choice of anticoagulants may reduce the access site bleeding risk 13

associated with RA, as this often requires femoral access and larger size introducer sheaths, both of which increase the risk of such complications. One such anticoagulant is bivalirudin, a direct thrombin inhibitor. Compared to heparin with concomitant use of glycoprotein

IIb/IIIa inhibitors, bivalirudin has been shown to be effective in reducing major adverse


cardiac events in patients undergoing PCI, driven mainly by reduction in major bleeding (44-46). A subanalysis of the ROTAXUS trial showed that bivalirudin was associated with less periprocedural MI (15.7% vs. 38.7%, p=0.01) with a trend towards fewer access site bleeds (2.9% vs. 10.2%, p=0.09) compared with heparin in patients undergoing RA (47).

Although the continued development of RA technology and use of adjunctive medications

have reduced the presence of procedural complications, patients undergoing RA are still more likely to develop vascular spasm, perforation, or transient vessel occlusions (48). Moreover, RA frequently produces transient bradyarrhythmias, which may necessitate

temporary pacemaker placement or vasopressor support. Aetiologies of these arrhythmias

include vagal responses or localized adenosine release (49). RA is intended for use in patients with single or multiple native atherosclerotic lesions with a stenosis that is ideally

less than 25 mm in length, can be passed with a guidewire, and does not pose undue risk to the patient. It should not be used in saphenous vein grafts, last remaining conduit with

compromised left ventricular function, or where there is angiographic evidence of fresh thrombus or significant dissection at the treatment site. Orbital Atherectomy

Orbital atherectomy (OA) (Diamondback 360° Orbital Atherectomy System, Cardiovascular Systems, Inc., St. Paul, Minnesota), was introduced in 2007 nearly three decades after RA 14

(50). This device provides an additional safe and effective tool for the treatment of patients

with severely calcified coronary lesions (51). It works by utilizing an orbiting eccentric diamond-coated crown on the end of a drive shaft powered by a pneumatic drive console and rotates at speeds varying from 60,000 to 200,000 rpm in a similar fashion to RA


[Figure 5]. In contrast to the RA, the OA crown is eccentric in shape and therefore, orbits on

the wire rather than spinning concentrically on the wire. This unique characteristic provides several potential advantages over RA. The crown is only in contact with one part of the vessel wall at any given moment, such that it does not obstruct blood flow through a stenosed vessel. In OA, unlike RA, the microscopic particulate matter that results from the

sanding action on the plaque is continuously washed away in the blood stream rather than building up into a large bolus, which is subsequently released downstream in the case of

RA when the catheter is disengaged from the plaque resulting in distal embolization. Also, in OA, the lack of continuous contact with the vessel wall minimizes heat generation, a

potential cause of restenosis. In the pilot ORBIT I trial, the safety and feasibility of OA for the treatment of de novo calcified lesions was evaluated with promising results for up to 5 years post-stent deployment (52-54). The sequel trial, ORBIT II, showed the consistent

benefit of OA yet in a larger subset of patients with de novo calcified lesions and stents

were successfully delivered in almost all of the lesions (98.2%) with good angiographic final results (55, 56). Complications such as periprocedural MI occurred at lower rates compared with other reports utilizing RA in calcific lesions (57, 58). Increasing use of OCT provides real-time imaging during atherectomy and will help operators to direct the plaque

excision. A small study by Kini et al. showed that OA resulted in deeper tissue modifications as shown by OCT imaging (59). This finding might provide an explanation for a better stent 15

apposition after OA as compared to RA. However, despite the observed benefit of OA over RA, there is still no randomised trial directly comparing head-to-head OA to RA. Such a comparison is essential to ascertain the incremental benefits of OA over RA.


Expert commentary With an increasingly aging population and a higher prevalence of diabetes mellitus and

kidney disease, interventional cardiologists are more likely to encounter complex calcified coronary artery lesions in everyday clinical practice. Such lesions are often particularly

challenging to treat percutaneously, with risks of failure of balloon expansion, stent

malapposition and underexpansion, with short and long term consequences. Specialized balloons and atherectomy devices can help tackle such resistant calcified lesions, refractory to simple balloon predilatation, and allow adequate lesion preparation to achieve optimal stenting outcomes. Adequate plaque modification is likely to be especially important as we

enter an era of bioresorbable vascular scaffold use, where good lesion preparation is paramount.

Five-year view In patients undergoing PCI of calcified coronary artery lesions, optimized methods of lesion

preparation are needed. Further advances are required, especially in the early management of such lesions, which should include aggressive risk factor and lifestyle modification.

Current data from previous studies are limited by small sample size. Properly designed randomized trials are needed, with the implementation of angiographic follow-up and the

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use of intravascular imaging, to determine the optimal and effective management strategies in this complex and growing patient population.


Key issues • • •

• • • •

• • •

Percutaneous coronary intervention has been shown to be a safe and effective treatment of most coronary artery lesion subsets. With an increasingly aging population and a higher prevalence of diabetes mellitus and kidney disease, calcified coronary arteries are here to stay. In the presence of a heavily calcified lesion, poor lesion preparation often leads to stent underexpansion and malapposition, and thereby increasing the risk of stent thrombosis and in-stent restenosis. The double-wire technique is a simple, quick and easily available method for complex lesions during PCI. Reports from patients treated with AngioSculpt specialized balloon have demonstrated satisfactory angiographic results. Compared to plain ordinary balloon angioplasty, Flextome specialized balloon was associated with better angiographic results. Excimer laser coronary atherectomy has been demonstrated to facilitate angioplasty in balloon-resistant coronary artery lesions and in lesions refractory to high pressure balloon inflations. Rotational atherectomy has been shown to be safe and effective in the treatment of most calcified coronary artery lesion subsets. Orbital atherectomy provides an additional safe and effective tool for the treatment of patients with severely calcified coronary artery lesions. Properly designed randomized trials are needed to determine the optimal and effective management strategies for calcified coronary artery lesions.

Financial and competing interests disclosure

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The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

REFERENCES Reference annotations * Of interest

** Of considerable interest

1. Baber U, Kini AS, Sharma SK. Stenting of complex lesions: an overview. Nat Rev Cardiol. 2010;7(9):485-496. 2. Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, et al. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005;96(9):1242-1247. 3. Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in realworld patients. Cardiovasc Revasc Med. 2008;9(1):2-8. 4. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64-70. 5. Moses JW, Carlier S, Moussa I. Lesion preparation prior to stenting. Rev Cardiovasc Med. 2004;5 Suppl 2:S16-S21. 6. Ashikaga T, Yoshikawa S, Isobe M. The effectiveness of excimer laser coronary atherectomy with contrast medium for underexpanded stent: The findings of optical frequency domain imaging. Catheter Cardiovasc Interv. 2015;86(5):946-949. 7. Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010;56(23):1897-1907. 8. Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2005;45(7):995-998. 9. Burzotta F, Trani C, Mazzari MA, Mongiardo R, Rebuzzi AG, Buffon A, et al. Use of a second buddy wire during percutaneous coronary interventions: a simple solution for some challenging situations. J Invasive Cardiol. 2005;17(3):171-174.

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10. Finet G, Weissman NJ, Mintz GS, Satler LF, Kent KM, Laird JR, et al. Mechanism of lumen enlargement with direct stenting versus predilatation stenting: influence of remodelling and plaque characteristics assessed by volumetric intracoronary ultrasound. Heart. 2003;89(1):84-90. 11. de Ribamar Costa J, Mintz GS, Carlier SG, Mehran R, Teirstein P, Sano K, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100(5):812-817. 12. Takano M, Yamamoto M, Murakami D, Takano H, Asai K, Yasutake M, et al. Optical coherence tomography after new scoring balloon angioplasty for in-stent restenosis and de novo coronary lesions. Int J Cardiol. 2010;141(3):e51-e53. 13. Kanai T, Hiro T, Takayama T, Fukamachi D, Watanabe Y, Ichikawa M, et al. Three-dimensional visualization of scoring mechanism of ‘AngioSculpt’ balloon for calcified coronary lesions using optical coherence tomography. Journal of Cardiology Cases. 2012;5:e16-e19. 14. Okura H, Hayase M, Shimodozono S, Kobayashi T, Sano K, Matsushita T, et al. Mechanisms of acute lumen gain following cutting balloon angioplasty in calcified and noncalcified lesions: an intravascular ultrasound study. Catheter Cardiovasc Interv. 2002;57(4):429-436. 15. Kawase Y, Saito N, Watanabe S, Bao B, Yamamoto E, Watanabe H, et al. Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis. Cardiovasc Interv Ther. 2014;29(2):134-139. 16. Ashida K, Hayase T, Shinmura T. Efficacy of lacrosse NSE using the "leopard-crawl" technique on severely calcified lesions. J Invasive Cardiol. 2013;25(10):555-564. 17. Fernandez JP, Hobson AR, McKenzie DB, Talwar S, O'Kane PD. How should I treat severe calcific coronary artery disease? EuroIntervention. 2011;7(3):400-407. 18. Badr S, Ben-Dor I, Dvir D, Barbash IM, Kitabata H, Minha S, et al. The state of the excimer laser for coronary intervention in the drug-eluting stent era. Cardiovasc Revasc Med. 2013;14(2):93-98. 19. Fernandez JP, Hobson AR, McKenzie D, Shah N, Sinha MK, Wells TA, et al. Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions. EuroIntervention. 2013;9(2):243-250. **A study to determine the outcomes of ELCA ± RA. 20. Nishino M, Lee Y, Nakamura D, Yoshimura T, Taniike M, Makino N, et al. Differences in optical coherence tomographic findings and clinical outcomes between excimer laser and cutting balloon angioplasty for focal in-stent restenosis lesions. J Invasive Cardiol. 2012;24(10):478-483. 21. Latib A, Takagi K, Chizzola G, Tobis J, Ambrosini V, Niccoli G, et al. Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry. Cardiovasc Revasc Med. 2014;15(1):8-12. 22. Ebersole D, Dahm JB, Das T, Madyoon H, Vora K, Baker J, et al. Excimer laser revascularization of saphenous vein grafts in acute myocardial infarction. J Invasive Cardiol. 2004;16(4):177-80. 23. Azzalini L, Ly HQ. Laser atherectomy for balloon failure in chronic total occlusion. When the going gets tough. Int Heart J. 2014;55(6):546-549. 24. Kovach JA, Mintz GS, Pichard AD, Kent KM, Popma JJ, Satler LF, et al. Sequential intravascular ultrasound characterization of the mechanisms of rotational atherectomy and adjunct balloon angioplasty. J Am Coll Cardiol. 1993;22(4):1024-1032. 25. Bersin RM, Simonton CA. Rotational and directional coronary atherectomy. Catheter Cardiovasc Interv. 2003;58(4):485-499. 26. Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interv. 2014;7(4):345-353. * An article appraising the use of RA. 19


27. Bangalore S, Vlachos HA, Selzer F, Wilensky RL, Kip KE, Williams DO, et al. Percutaneous coronary intervention of moderate to severe calcified coronary lesions: insights from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv. 2011;77(1):22-28. ** An important registry study of PCI of calcified lesions 28. Safian RD, Feldman T, Muller DW, Mason D, Schreiber T, Haik B, et al. Coronary angioplasty and Rotablator atherectomy trial (CARAT): immediate and late results of a prospective multicenter randomized trial. Catheter Cardiovasc Interv. 2001;53(2):213-220. 29. Whitlow P, Bass T, Kipperman R, Sharaf B, Ho K, Cutlip D, et al. Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS). American Journal of Cardiology. 2001;87(6):699-705. * A randomised trial appraising the use of RA burrs. 30. Cavusoglu E, Kini AS, Marmur JD, Sharma SK. Current status of rotational atherectomy. Catheter Cardiovasc Interv. 2004;62(4):485-498. 31. Agostoni P, Biondi-Zoccai GG, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44(2):349-356. 32. Rao SV, Ou FS, Wang TY, Roe MT, Brindis R, Rumsfeld JS, et al. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008;1(4):379-386. 33. Watt J, Oldroyd KG. Radial versus femoral approach for high-speed rotational atherectomy. Catheter Cardiovasc Interv. 2009;74(4):550-554. 34. From AM, Gulati R, Prasad A, Rihal CS. Sheathless transradial intervention using standard guide catheters. Catheter Cardiovasc Interv. 2010;76(7):911-916. 35. Mamas M, D'Souza S, Hendry C, Ali R, Iles-Smith H, Palmer K, et al. Use of the sheathless guide catheter during routine transradial percutaneous coronary intervention: a feasibility study. Catheter Cardiovasc Interv. 2010;75(4):596-602. 36. Kassimis G, Patel N, Kharbanda RK, Channon KM, Banning AP. High-speed rotational atherectomy using the radial artery approach and a sheathless guide: a single-centre comparison with the "conventional" femoral approach. EuroIntervention. 2014;10(6):694-699. 37. Dunn B. The effects of debulking on restenosis (EDRES). J Saudi Heart Assoc. 1998;10:55. 38. Buchbinder M, Fortuna R, Sharma S, Bass T, Kipperman R, Greenberg J, et al. Debulking prior to stenting improves acute outcomes: Early results from the SPORT trial. Journal of the American College of Cardiology. 2000;35(2):8A. 39. Abdel-Wahab M, Richardt G, Joachim Büttner H, Toelg R, Geist V, Meinertz T, et al. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013;6(1):10-19. ** An important randomised trial on the use of RA for PCI. 40. Cockburn J, Hildick-Smith D, Cotton J, Doshi S, Hanratty C, Ludman P, et al. Contemporary clinical outcomes of patients treated with or without rotational coronary atherectomy--an analysis of the UK central cardiac audit database. Int J Cardiol. 2014;170(3):381-387. 41. Kini A, Reich D, Marmur JD, Mitre CA, Sharma SK. Reduction in periprocedural enzyme elevation by abciximab after rotational atherectomy of type B2 lesions: Results of the Rota ReoPro randomized trial. Am Heart J. 2001;142(6):965-969. 42. Sharma SK, Dangas G, Mehran R, Duvvuri S, Kini A, Cocke TP, et al. Risk factors for the development of slow flow during rotational coronary atherectomy. Am J Cardiol. 1997;80(2):219-222.

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43. Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, et al. Rotational atherectomy for fibro-calcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interv. 2010;75(6):919-927. 44. Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289(7):853-863. 45. Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007;369(9565):907-919. 46. Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, et al. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013;369(23):2207-2217. 47. Akin I, Khattab AA, Büttner HJ, Toelg R, Geist V, Neumann FJ, et al. Comparison of bivalirudin and heparin in patients undergoing rotational atherectomy: a subanalysis of the randomised ROTAXUS trial. EuroIntervention. 2014;10(4):458-465. 48. Wasiak J, Law J, Watson P, Spinks A. Percutaneous transluminal rotational atherectomy for coronary artery disease. Cochrane Database Syst Rev. 2012;12:CD003334. * An important review on the use of RA for PCI. 49. Braden G, Bailey R, Fitzgerald D, Young T, Utley L, Applegate R. Mechanisms of bradyarrhythmias associated with rotational atherectomy. J Am Coll Cardiol.1996;27(2s1):168. 50. Colombo A, Panoulas VF. After 3 decades, at long last, a new device to deal with calcific lesions. JACC Cardiovasc Interv. 2014;7(5):519-520. 51. Chambers JW, Diage T. Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treating de novo, severely calcified lesions. Expert Rev Med Devices. 2014;11(5):457-466. 52. Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013;81(7):1134-1139. ** An important study on the use of OA for PCI. 53. Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, et al. Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial). Cardiovasc Revasc Med. 2014;15(4):204-208. 54. Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, et al. Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial. Cardiovasc Revasc Med. 2015. 55. Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518. 56. Généreux P, Lee AC, Kim CY, Lee M, Shlofmitz R, Moses JW, et al. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015. 57. Warth DC, Leon MB, O'Neill W, Zacca N, Polissar NL, Buchbinder M. Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients. J Am Coll Cardiol. 1994;24(3):641-648. * An important registry study on the use of RA for PCI. 58. MacIsaac AI, Bass TA, Buchbinder M, Cowley MJ, Leon MB, Warth DC, et al. High speed rotational atherectomy: outcome in calcified and noncalcified coronary artery lesions. J Am Coll Cardiol. 1995;26(3):731-736. 21


59. Kini AS, Vengrenyuk Y, Pena J, Motoyama S, Feig JE, Meelu OA, et al. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interv. 2015;86(6):1024-1032. 60. Cortese B, Aranzulla TC, Godino C, Chizzola G, Zavalloni D, Tavasci E, et al. Drug-eluting stent use after coronary atherectomy: results from a multicentre experience - The ROTALINK I study. J Cardiovasc Med (Hagerstown). 2015. 61. Yabushita H, Takagi K, Tahara S, Fujino Y, Warisawa T, Kawamoto H, et al. Impact of rotational atherectomy on heavily calcified, unprotected left main disease. Circ J. 2014;78(8):1867-1872. 62. Schwartz BG, Mayeda GS, Economides C, Kloner RA, Shavelle DM, Burstein S. Rotational atherectomy in the drug-eluting stent era: a single-center experience. J Invasive Cardiol. 2011;23(4):133139. 63. Benezet J, Díaz de la Llera LS, Cubero JM, Villa M, Fernández-Quero M, Sánchez-González A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011;23(1):28-32. 64. Kubota T, Ishikawa T, Nakano Y, Endoh A, Suzuki T, Sakamoto H, et al. Retrospective comparison of clinical and angiographic outcomes after sirolimus-eluting and bare-metal stent implantation in 312 consecutive, nonrandomized severely calcified lesions using a rotablator. Int Heart J. 2011;52(2):65-71. 65. Mezilis N, Dardas P, Ninios V, Tsikaderis D. Rotablation in the drug eluting era: immediate and long-term results from a single center experience. J Interv Cardiol. 2010;23(3):249-253. 66. Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, et al. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010;23(3):240-248. 67. Furuichi S, Sangiorgi GM, Godino C, Airoldi F, Montorfano M, Chieffo A, et al. Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions. EuroIntervention. 2009;5(3):370-374.

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Figure Legends


Figure 1: The AngioSculpt (AngioScore Inc., Fremont, CA, USA)

23


Figure 2: The Flextome Cutting Balloon (Boston Scientific, Natick, MA, USA)

24

Figure 3: High-speed rotational atherectomy


Optimal technique includes use of a single burr with burr-to-artery ratio of 0.5 to 0.6rotational speed of 140,000 to 150,000 rpm, gradual burr advancement using a pecking motion, short ablation runs of 15 to 20 s, and avoidance of decelerations >5,000 rpm.

25

Figure 4: Rotational atherectomy angiographic sequence


The arrows indicate the location of the underexpanded ring in each image. A: right coronary artery prior to the interventional procedure, B: unsuccessful preimplantation dilatation using a non-compliant balloon (2.0 x 18-mm Trek), C: rotablation with a 2.0-mm olive-shaped burr, D: repeated preimplantation dilatation followed by drug-eluting stent placement (3.5 x 20-mm Xience-Pro), E: final satisfactory angiographic result.

26

Figure 5: Orbital atherectomy


Optimal technique includes use of an eccentrically mounted “crown” that is diamond coated and rotates at speeds varying from 60,000 to 200,000 rpm in a similar fashion to rotational atherectomy.

27

Table 1: Selected studies showing RA followed by implantation of either BMS or DES

Study

Year Patients


name

ROTALINK I (60)

(n)

2015

1397

Study

Procedure

Procedural

Study

design

Type

success

endpoints

Retrospective

RA+POBA vs.

NA

Death, MI, TLR

RA+DES

et al.

64

Retrospective

RA+DES

despite an unexpected

increase in periprocedural 95.3%

(61)

AbdelWahab et

240

Randomized

al. (39) Schwartz et al. (62)

Angiographic And clinical outcomes

2013

2011

158

Retrospective

RA+DES

92.5%

Angiographic

DES

83.3%

outcomes

vs.

RA+DES/BMS

preferable strategy after lower long-term MACE,

RA+BMS

2014

DES implantation is a

RA, as it is associated with

vs.

Yabushita

Results/Conclusions

vs.

96.4%

And clinical Procedural success

MI

RA associated with high

procedural success and low complication rate for

calcified unprotected left main lesions

RA did not significantly

improve angiographic or clinical outcomes

Procedural success high with RA

28

Benezet et al.

2011

102

Retrospective

RA+DES

97.1%

Death, MI, TLR

Safe and effective

2011

312

Retrospective

RA+DES

98%

Death and non-

RA+DES significantly

(63) Kubota et al.


(64)

Rathore et al.

RA+BMS 2010

516

Retrospective

(43) Mezilis et al.

vs.

2010

150

Retrospective

RA+DES vs.

RA+BES

RA+DES

95%

95.8%

(65)

Vaquerizo et al.

2010

145

Retrospective

al.

RA+DES vs.

100%

CB+DES 2009

95

Retrospective

RA+DES

98%

(67)

reduced the primary end point

Procedural and

RA+DES significantly

outcomes

and TLR

angiographic

Angiographic and clinical outcomes

(66)

Furuichi et

fatal MI

reduces binary restenosis RA+DES has a favorable effect on clinical and

angiographic outcomes

Angiographic

Both strategies associated

outcomes

outcomes

and clinical

with has excellent midterm

Angiographic

RA+DES associated with

outcomes

rates and low TLR

and clinical

high procedural success

BMS = bare-metal stent, CB = cutting balloon, DES = drug-eluting stent, MI = myocardial infarction, POBA = plain old balloon angioplasty, RA = rotational atherectomy, TLR = target lesion revascularization

29

Rotablation in the treatment of high-risk patients with heavily calcified left-main coronary lesions.

Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions.

Cost-effectiveness of orbital atherectomy compared to rotational atherectomy in treating patients with severely calcified coronary artery lesions in Japan.

Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treating de novo, severely calcified lesions.

Transradial versus transfemoral rotablation for heavily calcified coronary lesions in contemporary drug-eluting stent era.

Lumen and calcium characteristics within calcified coronary lesions. Comparison of computed tomography coronary angiography versus intravascular ultrasound.

Prognostic significance of calcified plaque among symptomatic patients with nonobstructive coronary artery disease.

Should calcified neurocysticercosis lesions be surgically removed?

GuideLiner-Facilitated Rotational Atherectomy in Calcified Right Coronary Artery: The "Child" Makes the Difference.

Lymphocyte ratio is associated with non-calcified plaque burden in patients with coronary artery disease.

Newly developed lesions in right coronary artery during PCI.

Coronary artery lesions in Takayasu arteritis: pathological considerations.

Subclavian artery angioplasty for treatment of coronary artery steal syndrome.

Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial.

Comparison of serial quantitative evaluation of calcified coronary artery plaque by ultrafast computed tomography in persons with and without obstructive coronary artery disease.

Evolving treatment options in coronary artery disease.

Epicardial adipose tissue is associated with extensive coronary artery lesions in patients undergoing coronary artery bypass grafting: an observational study.

Percutaneous coronary intervention strategies and prognosis for graft lesions following coronary artery bypass grafting.

Resolute zotarolimus eluting stent for treatment of long coronary lesions.

Presence and extent of coronary calcified plaque evaluated by coronary computed tomographic angiography are independent predictors of ischemic stroke in patients with suspected coronary artery disease.

Usefulness of rotational atherectomy with optical frequency domain imaging guidance for severe calcified coronary lesions after Kawasaki disease.

Biodegradable polymer Biolimus-eluting stent (Nobori®) for the treatment of coronary artery lesions: review of concept and clinical results.

Endovascular treatment of lesions in the below-knee popliteal artery.

Association of Toll-like receptor 2-positive monocytes with coronary artery lesions and treatment nonresponse in Kawasaki disease.