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Comparison of Rotational Atherectomy Versus Orbital

Atherectomy for the Treatment of Heavily Calcified


Coronary Plaques
Michael S. Lee, MDa,*, Kyung Woo Park, MD, PhDb, Evan Shlofmitz, DOc, and
Richard A. Shlofmitz, MDd

We evaluated the outcomes of patients with severe coronary artery calcification (CAC) who
underwent rotational atherectomy (RA) and orbital atherectomy (OA). Severe CAC
increases the complexity of percutaneous coronary intervention (PCI) because of the
difficulty in optimizing stent expansion, leading to worse clinical outcomes. Both devices are
effective treatment strategies for severe CAC. No comparisons have been performed to
evaluate the clinical outcomes after RA and OA. The outcomes of 67 patients with severe
CAC who underwent RA from July 2012 to June 2015 and 60 patients who underwent OA
from February 2014 to September 2016 were evaluated. The primary end point was the rate
of 30-day major adverse cardiac and cerebrovascular events, comprising cardiac death,
myocardial infarction, target vessel revascularization, and stroke. The primary end point
was similar in the RA and OA groups (6% vs 6%, p >0.9), as were the individual end points
of death (0% vs 2%, p [ 0.8), myocardial infarction (6% vs 4%, p [ 0.7), target vessel
revascularization (0% vs 0%, p >0.9), and stroke (0% vs 0%, p >9). Procedural success was
achieved in all patients. Angiographic complications were uncommon in both groups.
No patient had stent thrombosis. In conclusion, both RA and OA are safe and effective for
the treatment of severe CAC as they provided similar clinical outcomes at short-term
follow-up. Ó 2017 Elsevier Inc. All rights reserved. (Am J Cardiol 2017;119:1320e1323)

Coronary artery calcification (CAC) was observed in safety and efficacy of orbital atherectomy (OA) up to
38% of all lesions with angiography and 74% with intra- 3 years, including a low rate of target lesion
vascular ultrasound.1 The treatment of severe CAC is revascularization.6e8 We report the first evaluation of clin-
technically challenging because of the difficulty in ical outcomes comparing RA with OA for the treatment of
advancing balloons and stents and achieving optimal stent severe CAC.
expansion, which may increase the risk of stent thrombosis
and in-stent restenosis.2 Forceful advancement of a drug- Methods
eluting stent in a heavily calcified lesion may damage the
polymer coating. Percutaneous coronary intervention (PCI) This retrospective analysis included 67 consecutive
of severe CAC is associated with worse clinical patients who underwent RA from July 2012 to June 2015
outcomes.3,4 and 50 consecutive patients who underwent OA from
Coronary atherectomy devices modify the calcified January 2015 to September 2016 at the UCLA Medical
plaque to facilitate stent delivery and optimize stent Center, Los Angeles, California. All patients had severe
expansion. The guidelines for PCI provide a class IIa CAC, as defined by the presence of radio-opacities on
recommendation for the use of rotational atherectomy (RA) fluoroscopy of the vessel wall. Patients who presented with
for the treatment of fibrotic or heavily calcified plaques that ST-elevation myocardial infarction were excluded. The
cannot be crossed by a balloon catheter or adequately dilated institutional review board approved the review of the data.
before stent implantation (level of evidence C).5 The Eval- Rotational atherectomy (Boston Scientific, Maple Grove,
uate the Safety and Efficacy of OAS in Treating Severely Minnesota) contains a rotating olive-shaped burr coated with
Calcified Coronary Lesions (ORBIT II) trial reported the 2,000 to 3,000 microscopic diamond chips that modifies the
calcified plaque and changes vessel compliance. The other
components include the console, a nitrogen tank, and a tur-
bine that is activated by a foot pedal. The burr, which is
a
Division of Cardiology, UCLA Medical Center, Los Angeles, bonded to the drive shaft, advances over a 0.009-inch
California; bDepartment of Internal Medicine and Cardiovascular Center, RotaWire (Boston Scientific). A Rota-flush solution con-
Seoul National University Hospital, Seoul, Republic of Korea; cDepartment
taining 10,000 units of heparin in a 1-liter bag of normal
of Cardiology, Northwell Health, Manhasset, New York; and dCardiology
saline solution was infused through the drive shaft to mini-
Department, St. Francis Hospital-The Heart Center, Roslyn, New York.
Manuscript received November 26, 2016; revised manuscript received and
mize the heat and friction between the device and RotaWire.
accepted January 18, 2017. The coronary orbital atherectomy device (Cardiovascular
See page 1323 for disclosure information. Systems, Inc. [CSI], St Paul, Minnesota) requires the
*Corresponding author: Tel: 310-696-9523; fax: 310-825-9012. ViperSlide (CSI) lubricant that is continuously infused
E-mail address: mslee@mednet.ucla.edu (M.S. Lee). through the drive shaft to minimize heat generation and

0002-9149/17/$ - see front matter Ó 2017 Elsevier Inc. All rights reserved. www.ajconline.org
http://dx.doi.org/10.1016/j.amjcard.2017.01.025
Coronary Artery Disease/RA Versus OA for Severely Calcified Coronary Lesions 1321

Table 1 Table 2
Baseline clinical characteristics Procedural characteristics
Variable RA OA p-value Variable RA OA p-value
(N¼67) (N¼50) (N¼67) (N¼50)

Age (years) 61  12 62  11 0.8 Anticoagulation


Men 46 (69%) 34 (68%) 0.9 Heparin 67 (100%) 50 (100%) >0.9
Diabetes mellitus 26 (39%) 18 (36%) 0.8 Patients pretreated with clopidogrel 65 (97%) 48 (96%) 0.9
Hypertension 44 (66%) 38 (76%) 0.4 Vascular access 0.7
Hypercholesterolemia 43 (64%) 36 (72%) 0.3 Transfemoral 66 (99%) 47 (94%)
Prior stroke 5 (7%) 3 (6%) 0.9 Transradial 1 (1%) 3 (6%)
Previous myocardial infarction 16 (24%) 11 (22%) 0.8 Maximum burr size (mm) 1.5  0.1 NA
Previous percutaneous coronary intervention 19 (28%) 15 (30%) 0.8 OA device speed (revolutions/min)
Previous coronary artery bypass grafting 88 (12%) 5 (10%) 0.8 Low only, 80,000 NA 14 (28%)
Left ventricular ejection fraction (%) 52  13 51  12 0.8 Low and high, 80,000 and 120,000 NA 36 (72%)
Elective percutaneous coronary intervention 45 (67%) 34 (68%) 0.9 Burr(s) per case 1.3  0.2 NA
Acute coronary syndrome 22 (33%) 16 (32%) 0.9 Passes per case 3.6  1.2 3.3  1.3 0.7
Unstable angina 15 (22%) 12 (24%) Type of stent 0.9
Non-ST-elevation myocardial infarction 7 (10%) 4 (8%) Drug-eluting 61 (91%) 46 (92%)
ST-elevation myocardial infarction 0 0 Bare metal 7 (9) 4 (8)
Stents per case 1.4  0.6 1.5  0.4 0.7
OA ¼ orbital atherectomy; RA ¼ rotational atherectomy. Vessels treated 1.3  0.2 1.3  0.3 0.9
Temporary pacemaker 5 (7%) 0 0.2
Intra-aortic balloon pump 6 (9%) 2 (4%) 0.3
friction. A 1.25-mm crown is coated with 30-mm diamonds Impella 2 (3%) 1 (2%) 0.9
and eccentrically mounted to expand laterally while rotating Extracorporeal membrane oxygenation 0 1 (2%) 0.9
as a result of centrifugal force and is advanced over the Bail-out use of GP IIb/IIIa inhibitors 0 0 >0.9
Final TIMI flow >0.9
0.01400 ViperWire (CSI). A 6F guiding catheter was used for
0-1 0 0
all cases. 2 0 0
Standard techniques for PCI were used. All patients were 3 67 (100%) 50 (100%)
pretreated with dual antiplatelet therapy before PCI. French size 0.6
Unfractionated heparin was administered to maintain the 6F 63 (94%) 50 (100%)
activated clotting time >250 seconds. It was the discretion of 8F 4 (6%) 0
the operator to insert a temporary pacing lead, use a hemo-
NA ¼ not applicable; OA ¼ orbital atherectomy; RA ¼ rotational
dynamic support device, and use intravascular ultrasound for
atherectomy.
the assessment of lesion morphology and stent expansion.
Drug-eluting stents were implanted unless there was a
contraindication to prolonged dual antiplatelet therapy. surgery, and/or PCI during the first 24 hours. Data on
The typical burr-to-artery ratio was 0.5. However, if the angiographic complications included perforation, dissection
lesion was severely stenotic and the reference vessel leading to less than thrombolysis in myocardial infarction
diameter was 3 mm, a 1.25-mm burr was initially used grade 3 flow, and no reflow. Baseline demographic and
followed by larger burrs. The RA burr was tested and procedural data and adverse clinical events were entered
primed before insertion into the guiding catheter at 150,000 into a dedicated PCI database.
to 170,000 rpm while being mounted on the RotaWire. After Continuous variables are presented as mean  SD and
all patients were treated with low-speed (80,000 rpm) compared using the Student t test. Categorical variables are
atherectomy, high-speed (120,000 rpm) atherectomy was presented as percentages and compared using the chi-square
performed if the reference vessel diameter was at least test. A p value <0.05 was considered statistically signifi-
3 mm. Each pass was limited to 20 seconds. cant. All data were processed with SPSS (version 20.0,
The duration of the dual antiplatelet therapy was at least SPSS-PC, Inc., Chicago, Illinois).
1 month for a bare metal stent and 1 year for a drug-eluting
stent.
Results
The primary end point was the rate of 30-day major
adverse cardiac and cerebrovascular events, defined as the Baseline demographic and procedural characteristics
composite of death, myocardial infarction (MI), target vessel were well matched in both groups (Tables 1 and 2).
revascularization (TVR), and stroke. MI was defined as Procedural success and angiographic complications were
recurrent symptoms with new ST-segment elevation or similarly low in both groups (Table 3).
re-elevation of cardiac markers to at least twice the upper The primary end point was similar in the RA and OA
limit of normal. TVR was defined as repeat revasculariza- groups (6% vs 6%, p >0.9), as were the individual end
tion of the target vessel. The Academic Research points of death (0% vs 2%, p ¼ 0.8), MI (6% vs 4%,
Consortium definition of stent thrombosis was used.9 p ¼ 0.7), TVR (0% vs 0%, p >0.9), and stroke (0% vs 0%,
Procedural success was defined as residual stenosis 30% p >9) (Table 4). The 1 patient who died was a 43-year-old
and thrombolysis in myocardial infarction grade 3 flow man who had cardiac arrest at home, had cardiopulmonary
without death, emergency coronary artery bypass graft resuscitation, was intubated, and had enhanced
1322 The American Journal of Cardiology (www.ajconline.org)

Table 3 Larger burrs (1.75 mm) require 7F guiding catheters,


Angiographic complications whereas OA can be performed with a 6F guiding catheter for
Variable RA OA p value all cases.
(N¼67) (N¼50) Because of the single axis of rotation, the burr is in
constant contact with the plaque, resulting in thermal injury
Procedural success 67 (100%) 50 (100%) >0.9
and platelet activation.10 The average particulate size with
Perforation 0 1 (2%) 0.9
Cardiac tamponade 0 1 (2%) 0.9
RA is 5 mm, and particles are released in boluses compared
Dissection leading to less than 0 0 >0.9 with the OA crown, which is in intermittent contact and
TIMI grade 3 flow continuously releases 2-mm particles, accounting for less
No reflow 5 (7%) 2 (4%) 0.4 distal embolization and the differences in the rates of slow/
Stent loss 0 0 >0.9 no-flow with RA (2% to20%) and OA (0.9%).6,11e14
A disadvantage of RA is that the RotaWire needs to be
OA ¼ orbital atherectomy; RA ¼ rotational atherectomy.
exchanged for a workhorse wire. This may be explained by
Table 4 the fact that it has a 0.009-inch-diameter shaft and is not
Clinical Events at 30 days supportive enough to advance balloons and stents. The
ViperWire, which has a 0.012-inch-diameter shaft, can
Variable RA OA p value
support the advancement of balloons and stents. It can be cut
(N¼67) (N¼50)
with a scissor to approximate the length of a 160-cm
Major adverse cardiac and cerebrovascular 4 (6%) 3 (6%) >0.9 guidewire to complete the PCI.
events Another potential advantage of OA may be in patients
Cardiac death 0 1 (2%) 0.8 with angulated and eccentric lesions. The guidewire may lie
Myocardial infarction 4 (6%) 2 (4%) 0.7 preferentially against the wall of the vessel as opposed to the
Target vessel revascularization 0 0 >0.9 center, so-called guidewire bias, as a result of the contour of
Stroke 0 0 >0.9
the vessel and the position of the guiding catheter. The burr
Stent thrombosis 0 0 >0.9
may ablate asymmetrically on the RotaWire, possibly
OA ¼ orbital atherectomy; RA ¼ rotational atherectomy. creating a “furrow” as opposed to debulking throughout the
entire vessel. The angle of the vessel correlated with the
pre-RA and post-RA luminal changes in the vertical axis but
extracorporeal membrane oxygenation initiated for cardio- not the horizontal axis, validating the guidewire bias effect.
genic shock despite being treated with 4 vasopressors. He Asymmetric CAC may further augment guidewire bias
underwent emergent orbital atherectomy of the left main and because the RotaWire may not guide the burr toward the
left anterior descending arteries because he was not a calcified lesion, leading to inadequate ablation during
candidate for surgical revascularization. No patients expe- advancement, increasing the risk of burr entrapment.
rienced stent thrombosis. In contrast, the orbital movement of the crown may over-
come these issues because it ablates throughout the entire
circumference of the vessel and is less influenced by the
Discussion
guidewire position or the eccentricity of the calcified plaque.
In the first analysis that compared clinical outcomes of Optical coherence tomography demonstrated that
OA with those of RA, the main finding of this study was that compared with RA, OA resulted in more modification of the
both devices were safe and effective for the treatment of plaque, including longer cuts and deeper dissections, which
severe CAC, with low rates of angiographic complications may explain the lower percentage of stent strut malap-
and adverse clinical outcomes. position and a trend toward improved stent expansion.15
OA is faster to set up and easier to use because it does not Rotational atherectomy may be preferred in treating
require a nitrogen tank or a foot pedal to activate the device. aorto-ostial disease because OA is associated with subopti-
The mechanism of action, centrifugal force, involves the mal anchoring and stabilization of the proximal portion of
crown spinning on the ViperWire and orbiting along the the device while inside the guiding catheter. One technique
periphery of the vessel to debulk the plaque even further to overcome this issue is to initially advance the crown
with each pass, whereas the RA burr has only 1 axis of distally followed by ablating the aorto-ostial lesion while
rotation on the RotaWire and ablates a fixed diameter. The pulling back the device proximally. Another technique is to
single axis of rotation also gives rise to the possibility of firmly engage the tip in the calcified aorto-ostial lesion
burr entrapment because it ablates only in the antegrade to constrain its orbit before activating the device. The
direction because of the lack of diamond coating on the ORBIT II trial excluded patients with vessels >4 mm.6 The
proximal portion of the burr. In contrast, the OA ablates 1.25-mm crown orbiting at high speed may not sufficiently
bidirectionally, lowering the risk of crown entrapment. The modify plaque in larger vessels. A 2-mm RA burr might be
operator has fingertip control to switch from low speed to preferred in these larger vessels. Patients with vessels
high speed to treat a larger vessel diameter because of <2.5 mm were also excluded because the 1.25-mm crown
ablation of a larger radius. With RA, an assistant is required may be too large and increase the risk of perforation. The tip
to adjust the speed on the console, and the burr requires of the OA device does not have an ablative surface and may
removal, exchange to a larger burr, and readvancement to not traverse subtotally occluded calcified lesions. The
progressively ablate more extensively for large vessels, ablative surface is at the tip of the burr and may be preferred
increasing the procedural time and complexity of the case. to cross subtotal occlusions.
Coronary Artery Disease/RA Versus OA for Severely Calcified Coronary Lesions 1323

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