Cardiovascular Revascularization Medicine 26 (2021) 34–38

Contents lists available at ScienceDirect

Cardiovascular Revascularization Medicine

Orbital Atherectomy for Treatment of Severely Calcified Coronary Artery

Bifurcation Lesions: A Multicenter Analysis
Robert Sturm a,⁎, Ehrin J. Armstrong a, Benjamin Benhuri b, Naotaka Okamoto b, Yuliya Vengrenyuk b,
Evan Shlofmitz c, George E. Revtyak d, Brad J. Martinsen e, Zsuzsanna Igyarto e, Javier A. Valle a,
Stephen W. Waldo a, Baran Aksut f, Sean Bell f, Ryan Gardner g, Michael Lee h, Ramzan Zakir g, Adhir Shroff i,
Creighton Don f, Richard Shlofmitz j, Jeffrey W. Chambers k, Annapoorna Kini b, Samin Sharma b
a
Denver VA Medical Center, University of Colorado, Denver, CO, United States of America
b
Mount Sinai Cardiovascular Center, Icahn School of Medicine, New York, NY, United States of America
c
MedStar Washington Hospital Center, Washington, DC, United States of America
d
Indiana University, Indianapolis, IN, United States of America
e
Cardiovascular Systems, Inc., St. Paul, MN, United States of America
f
University of Washington, Seattle, WA, United States of America
g
Heart and Vascular Institute of Central Jersey, New Brunswick, NJ, United States of America
h
UCLA Medical Center, Los Angeles, CA, United States of America
i
University of Illinois Chicago, Chicago, IL, United States of America
j
St. Francis Hospital – The Heart Center, Roslyn, NY, United States of America
k
Metropolitan Heart & Vascular Institute, Minneapolis, MN, United States of America

a r t i c l e i n f o a b s t r a c t

Article history: Objective: This study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely
Received 20 September 2020 calcified coronary artery bifurcation lesions.
Accepted 29 October 2020 Background: Percutaneous coronary intervention (PCI) of severely calcified coronary artery lesions is associated
with lower procedural success and higher rates of target lesion failure compared to non-calcified lesions. OA is an
Keywords: effective treatment for calcified coronary artery lesions prior to stent implantation. However, there is little data
Orbital atherectomy
regarding the safety and efficacy of OA in patients with coronary artery bifurcation lesions.
Coronary calcification
Bifurcation lesions
Methods: Data were obtained from analysis of patients with severe coronary artery calcification who underwent
OA and coronary stent implantation at ten high-volume institutions. Data were pooled and analyzed to assess
peri-procedural outcomes and 30-day major adverse cardiac events (MACE).
Results: A total of 1156 patients were treated with OA and PCI. 363 lesions were at a coronary artery bifurcation.
There were no statistically significant differences in baseline characteristics between the bifurcation and non-
bifurcation groups. In the bifurcation group, treatment involved the left anterior descending artery and its
branches more frequently and right coronary artery less frequently. After propensity score matching, the 30-
day freedom from MACE was not statistically significant between the two groups.
Conclusion: In this multicenter cohort analysis, patients with severely calcified coronary bifurcation lesions had
low rates of MACE and target vessel revascularization at 30 days at rates comparable to non-bifurcation lesions.
This analysis demonstrates that OA is safe and effective for complex coronary lesions at both bifurcation and non-
bifurcation locations.
© 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction

Coronary artery calcification is increasingly prevalent during PCI and

Abbreviations: PCI, percutaneous coronary intervention; OA, orbital atherectomy; VA,
US Department of Veteran's Affairs; MACE, major adverse cardiac events; MI, myocardial
infarction; TVR, target vessel revascularization; LAD, left anterior descending artery;
RCA, right coronary artery; CABG, coronary artery bypass graft; DES, drug eluting stent.
⁎ Corresponding author at: 12631 E 17th Avenue, Aurora, CO 80045, United States of
America.
E-mail address: Robert.sturm@ucdenver.edu (R. Sturm).
is associated with higher rates of peri-procedural and long-term adverse
outcomes [1–5]. The use of coronary atherectomy devices can improve
procedural success and may reduce treatment time for these challeng-
ing lesions [6]. However, prior randomized controlled trials have failed
to show improved outcomes for atherectomy devices [7]. Recent obser-
vational studies have also demonstrated improved stent delivery and

https://doi.org/10.1016/j.carrev.2020.10.023
1553-8389/© 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
 R. Sturm et al. / Cardiovascular Revascularization Medicine 26 (2021) 34–38
favorable 30-day and long-term outcomes with orbital atherectomy
(OA) [8–10].
The safety of coronary OA has been supported in prior trials, includ-
ing the ORBIT II study that led to FDA approval. Additional analyses of
subgroups excluded from these studies have also been undertaken.
Lee et al. demonstrated safety and efficacy of OA in unprotected left
main disease as well as severely calcified small coronary artery vessels
[11,12]. Recently, Chambers et al. demonstrated a low risk of major ad-
verse cardiovascular events with the use of OA in bifurcation lesions in a
single-center study of 177 patients, of which 72 patients had bifurcation
lesions [13]. In this large multicenter analysis, we present data for peri-
procedural and 30-day major adverse cardiac events (MACE) for the use
of OA in the treatment of severely calcified coronary artery bifurcation
lesions.
2. Methods
This retrospective multicenter analysis included 1156 consecutive
patients with severe coronary artery calcification treated with OA at
ten high-volume institutions. No exclusion criteria were applied. The
use of standard PCI techniques, including OA followed by balloon dila-
tion, drug-eluting stent (DES) implantation, and post-dilation of all
stents with high-pressure non-compliant balloons was applied to all pa-
tients. The operator at time of intervention determined the severity of
calcification and decided on utilization of the OA device. All patients
underwent coronary OA at low speed (80,000 RPM) with additional
passes on high speed (120,000 RPM) left to the discretion of the opera-
tor for any reference vessel diameter greater than 3.0 mm by visual
estimate.
All angiograms were interpreted at the time of procedure by a phy-
sician with experience in coronary angiography. Severe calcification
was defined as the presence of radiopacities independent of cardiac mo-
tion and contrast injection or by the presence of 270 degrees or greater
of coronary artery calcium as determined by intravascular imaging. A bi-
furcation lesion was defined as any lesion extending past a side branch
of ≥2.0 mm [14].
Follow-up patient data were gathered from physician appointments
and documentation, including review of any outside hospital records
from admissions that were cardiac in nature. The primary endpoints
were freedom from 30-day and 1-year major adverse cardiac events
(MACE) defined as death, myocardial infarction (MI), or target vessel
revascularization (TVR).
The study was approved by each center's institutional review board.
2.1. Statistical analysis
XLSTAT (Version 2019.3.2; XLSTAT-LifeScience Data Analysis and
Statistical Solution. Addinsoft, New York, USA) software was used for
data collection and statistical analysis. Values presented are n (%) or
mean ± standard deviation. Missing data were imputed via the Replace
by the mode method for qualitative variables and the NIPALS method
for quantitative variables. Propensity score matched (PSM) analysis
was also utilized to optimize the balance of baseline demographics
and lesion characteristics. First, a logistic regression model was per-
formed using bifurcation subjects as a case and those without bifurca-
tions as a control. An a priori list of variables that were thought to be
related to the outcome, regardless of whether they were related to the
bifurcation status and/or treatment, was included in the PSM model.
Variables included in the PSM model were the following: age (years),
race/ethnicity, gender, number of vessels treated, pre-procedure diam-
eter stenosis (%); and history or diagnosis of smoking, diabetes, hyper-
tension (HTN), hyperlipidemia (HLD), chronic kidney disease (CKD),
dialysis, congestive heart failure (CHF), coronary artery bypass graft
(CABG), percutaneous coronary intervention (PCI), and myocardial in-
farction (MI). All subjects were matched using a one-to-one scheme
with the nearest number matching (1:1) method without replacement,
35
as well as an optimal algorithm of Mahalanobis distance with a toler-
ance of 0.001, caliper of 0.10*Sigma, and a confidence interval of 95%.
Assessment of the balance of the resulting PSM model was completed
by calculating the standardized differences (difference in means or
proportions divided by standard error) of baseline covariates. No/
Small/Moderate/Large/Very-Large imbalance of baseline variable
were defined as absolute standardized difference values of <0.20/
0.20–0.49/0.50–0.79/>0.80/>1.00, respectively (based on Cohen's
Effect Size Index of Standardized differences). In addition, given
that bifurcation subjects and non-bifurcation subjects with the
same propensity score will have similar distributions of observed
baseline covariates, a side-by-side box plot method was utilized to
compare the distribution of the logit propensity scores of all of the
observed subjects to the matched observed subjects to further cor-
roborate balance in the model. The c-statistic (received operator
characteristic area under the curve) and cost scores of the PSM
model were also evaluated. P-values for qualitative variables are
from the Chi-square test or the Fisher's exact test (if theoretical fre-
quencies were < 5). P-values for quantitative variables are from the
Mann-Whitney U test. The threshold of statistical significance was
p < 0.05.
3. Results
Among ten high-volume centers, a total of 1156 patients underwent
intervention with OA. Of those, 363 patients had a bifurcation lesion
where OA was used in at least one branch artery. Among patients
treated for bifurcation lesions, the majority were of Caucasian descent
(75.2%), and had a history of hypertension (89.3%), hyperlipidemia
(86.5%), diabetes mellitus (43.5%), and prior or current tobacco use
(32.8%). Similar rates of co-morbidities were observed in the group
treated with OA at non-bifurcation lesions (Table 1).
Most commonly, bifurcation lesions involved the left anterior de-
scending (LAD) artery and diagonal branches (46.6%). Over a third of
the time multiple bifurcation lesions were treated with OA (31.1%).
There was a significant difference in rate of interventions in the right
coronary artery (RCA) and left main coronary artery (LM) between
the non-bifurcation and bifurcation cohorts [(23.8% and 4.7%,
p < 0.0001; 1.4% and 3.9%, p = 0.007; respectively), Table 2].
There was no statistically significant difference in time of proce-
dure between OA non-bifurcation and bifurcation procedures
(83.7 min and 90.7 min, respectively). However, cases involving bi-
furcation lesions required significantly more fluoroscopy time
(24.2 min vs 26.3 min, p < 0.0001), more contrast (182.2 mL vs
197.3 mL, p < 0.0001) and had a slightly higher but clinically nonsig-
nificant degree of residual stenosis [(3% vs 6%, p < 0.0001), Table 3].
There were no differences in coronary dissections, perforations, and
distal embolization events in the unadjusted cohorts of non-
bifurcation compared to bifurcation [(13 vs 7, p = 0.726), (2 vs1,
p = 0.942), (1 vs 0, p = 0.498), Table 3].
Unadjusted thirty-day freedom from MACE was 11.3% in the bifurca-
tion group and 4.7% in the non-bifurcation group (p < 0.0001). Myocar-
dial infarctions (MI) occurred in 9.6% of patients in the bifurcation group
and 3.4% of patients in non-bifurcation group (p < 0.0001). The rates of
death and target vessel revascularization (TVR) were not statistically
different between the two groups (Table 4).
Propensity score matching (PSM) was performed to adjust for
baseline differences in the bifurcation vs. non-bifurcation groups.
The PSM model resulted in a c-statistic of 0.727 and a cost score of
2.52, as well as improved standardized differences after matching,
indicating an optimal and balanced PSM model. Similarly, there
was no statistical difference between baseline characteristics and co-
morbidities of patients who underwent OA of bifurcation or non-
bifurcation lesions (Table 1). While the treatment of RCA lesions
remained higher in the non-bifurcation group, propensity matching
resulted in a statistically significant difference in LAD interventions
36 R. Sturm et al. / Cardiovascular Revascularization Medicine 26 (2021) 34–38

Table 1
Baseline characteristics.

All subjects Propensity score-matched subjects

OA OA P-value Standardized OA OA P-value Standardized

non-bifurcation bifurcation difference non-bifurcation bifurcation difference
(N = 793) (N = 363) (N = 308) (N = 308)

Age (years) 70.9 ± 9.9 70.7 ± 10.5 0.856 0.020 70.1 ± 10.1 71.0 ± 10.4 0.216 0.088
Male gender 584 (73.6) 274 (75.5) 0.507 0.001 231 (75.0) 226 (73.4) 0.645 0.000
Ethnicity 0.167 0.081 0.921 0.008
Asian 44 (5.5) 28 (7.7) 0.157 0.008 27 (8.8) 23 (7.5) 0.555 0.004
Black/AA 64 (8.1) 32 (8.8) 0.670 0.008 25 (8.1) 24 (7.8) 0.882 0.001
Caucasian 613 (77.3) 273 (75.2) 0.435 0.001 229 (74.4) 238 (77.3) 0.397 0.000
Hispanic or 40 (5.0) 24 (6.6) 0.279 0.001 22 (7.1) 18 (5.8) 0.513 0.006
Latino
Native American 3 (0.4) 0 (0.0) 0.556 ∞ 0 (0.0) 0 (0.0) – –
Other 29 (3.7) 6 (1.7) 0.065 0.081 5 (1.6) 5 (1.6) 1.000 0.000
CKD 179 (22.6) 100 (27.5) 0.067 0.003 79 (25.6) 76 (24.7) 0.781 0.000
Dialysis 49 (6.2) 25 (6.9) 0.648 0.011 25 (8.1) 21 (6.8) 0.540 0.005
Diabetes 394 (49.7) 158 (43.5) 0.052 0.002 140 (45.5) 140 (45.5) 1.000 0.000
Heart failure 144 (18.2) 72 (19.8) 0.497 0.004 65 (21.1) 60 (19.5) 0.616 0.001
Hyperlipidemia 663 (83.6) 314 (86.5) 0.207 0.001 268 (87.0) 262 (85.1) 0.485 0.000
Hypertension 702 (88.5) 324 (89.3) 0.715 0.001 273 (88.6) 272 (88.3) 0.900 0.000
Prior MI 176 (22.2) 99 (27.3) 0.060 0.003 89 (28.9) 79 (25.6) 0.366 0.001
Prior PCI 331 (41.7) 155 (42.7) 0.759 0.002 138 (44.8) 136 (44.2) 0.871 0.000
Prior CABG 140 (17.7) 56 (15.4) 0.349 0.006 55 (17.9) 46 (14.9) 0.327 0.002
Smoker 251 (31.7) 119 (32.8) 0.702 0.003 109 (35.4) 103 (33.4) 0.611 0.000

Values are n (%) or mean ± standard deviation.

AA = African American; CABG = Coronary Artery Bypass Graft; CKD = Chronic Kidney Disease (Creatinine≥1.5 mg/dL); MI = Myocardial Infarction; OA = Orbital Atherectomy; PCI =
Percutaneous Coronary Intervention; ∞ = infinity; − = na.

(51% in bifurcation group compared to 40.3% in non-bifurcation
group, Table 2). As shown in Table 3, there were similarly low rates
of dissection, perforation, and embolization between cohorts. Fi-
nally, there was also no statistical difference between 30-day MACE
events between bifurcation and non-bifurcation groups after pro-
pensity score matching (Table 4).
4. Discussion
This multicenter analysis of 1156 patients who underwent OA prior
to PCI at ten high-volume centers demonstrates that OA is safe and effi-
cacious in preparation of severely calcified lesions prior to PCI. This
study includes a larger and more complex patient population than
ORBIT II with similar freedom from 30-day MACE [8]. While many of
the patients had typical comorbidities including hypertension, hyperlip-
idemia, and diabetes there was also a subset of patients with more
complex medical morbidities including heart failure, end stage renal
disease, prior PCI, and prior coronary artery bypass grafting.
Compared to the ORBIT II data, we observed similar rates of MACE in
the bifurcation cohort and improved rates of MACE in the non-
bifurcation cohort (10.4% vs 4.7% vs 11.3%) [8]. These data are also sim-
ilar to that observed for the use of OA in the treatment of left main dis-
ease [11]. We have previously published data on “real-world” lesions
from a cohort of patients treated at a single-center which also found
similar rates of MACE [13]. Lee et al. also previously described low
rates of adverse events and successful lesion preparation with OA in a
similar “real-world” cohort at three different high volume centers [8].
These outcomes suggest an overall safety and efficacy profile for OA in
several different lesion sub-types.
In a single-center analysis of OA for bifurcation lesions, Chambers et al.
observed lower rates of MACE compared to our observations, possibly at-
tributed to the much larger sample size represented with our data [13]. In

Table 2
Vessel and lesion characteristics.

All subjects Propensity score-matched subjects

OA OA P-value Standardized OA OA P-value Standardized

non-bifurcation bifurcation difference non-bifurcation bifurcation difference
(N = 793) (N = 363) (N = 308) (N = 308)

Pre-procedure diameter stenosis (%) 78.5 ± 12.5 71.4 ± 17.6 <0.0001 0.497 73.0 ± 14.8 73.8 ± 15.8 0.228 0.052
Pre-procedure target lesion length 36.5 ± 20.9 36.3 ± 22.9 0.419 0.009 37.5 ± 22.7 35.3 ± 22.3 0.183 0.098
(mm)
Target vessel < 0.0001 0.230 < 0.0001 0.317
LAD 397 (50.1) 169 (46.6) 0.268 0.002 124 (40.3) 157 (51.0) 0.008 0.001
LCX 94 (11.9) 35 (9.6) 0.268 0.010 34 (11.0) 31 (10.1) 0.694 0.002
LMCA 11 (1.4) 14 (3.9) 0.007 0.012 4 (1.3) 13 (4.2) 0.027 0.115
RCA 189 (23.8) 17 (4.7) <0.0001 0.031 69 (22.4) 17 (5.5) <0.0001 0.025
RI 5 (0.6) 3 (0.8) 0.709 0.101 1 (0.3) 3 (1.0) 0.316 ∞
Other 18 (2.3) 12 (3.3) 0.304 0.017 8 (2.6) 12 (3.9) 0.363 0.026
Multiple 79 (10.0) 113 (31.1) <0.0001 0.002 68 (22.1) 75 (24.4) 0.504 0.001
Target vessel number 1.1 ± 0.3 1.3 ± 0.5 <0.0001 0.534 1.2 ± 0.5 1.3 ± 0.4 0.538 0.221

Values are n (%) or mean ± standard deviation.

CABG = Coronary Artery Bypass Graft; LAD = Left Anterior Descending; LCX = Left Circumflex; LMCA = Left Main Coronary Artery; MI = Myocardial Infarction; OA = Orbital Atherec-
tomy; PCI = Percutaneous Coronary Intervention; RCA = Right Coronary Artery; RI = Ramus Intermedius; ∞ = infinity; − = na.
 R. Sturm et al. / Cardiovascular Revascularization Medicine 26 (2021) 34–38 37

Table 3
Procedural outcomes.

All subjects Propensity score-matched subjects

OA non-bifurcation OA bifurcation P-value OA non-bifurcation OA bifurcation P-value

(N = 793) (N = 363) (N = 308) (N = 308)

Total procedure time (minutes) 87.3 ± 50.3 90.7 ± 45.5 0.094 88.5 ± 50.2 90.6 ± 47.4 0.448
Total fluoroscopy time (minutes) 24.2 ± 16.8 26.3 ± 12.0 <0.0001 25.1 ± 13.3 25.4 ± 11.7 0.259
Total volume of contrast used (ml) 182.2 ± 91.6 197.3 ± 81.5 <0.0001 176.1 ± 90.1 199.5 ± 82.7 <0.0001
Final procedure stenosis (%) 2.8 ± 6.3 6.0 ± 6.3 <0.0001 4.1 ± 5.9 5.9 ± 6.3 0.001
Dissectiona 13 (1.6) 7 (1.9) 0.726 6 (1.9) 5 (1.6) 0.761
Dissection < 0.0001 0.039
Yes 13 (1.6) 7 (1.9) 6 (1.9) 5 (1.6)
No 412 (52.0) 120 (33.1) 135 (43.8) 105 (34.1)
Unknown 368 (46.4) 236 (65.0) 167 (54.2) 198 (64.3)
Perforationa 2 (0.3) 1 (0.3) 0.942 1 (0.3) 1 (0.3) 1.000
Perforation < 0.0001 0.020
Yes 2 (0.3) 1 (0.3) 1 (0.3) 1 (0.3)
No 423 (53.3) 126 (34.7) 140 (45.5) 109 (35.4)
Unknown 368 (46.4) 236 (65.0) 167 (54.2) 198 (64.3)
Embolizationa 1 (0.1) 0 (0.0) 0.498 0 (0.0) 0 (0.0) NA
Embolization 0.546 0.928
Yes 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
No 197 (24.8) 99 (27.3) 84 (27.3) 85 (27.6)
Unknown 595 (75.0) 264 (72.7) 224 (72.7) 223 (72.4)

Values are n (%) or mean ± standard deviation.

NA = not applicable.
OA = Orbital Atherectomy.
a
Missing data imputation method (Replace by the mode) used.

Table 4
30-Day outcomes.

All subjects Propensity score-matched subjects

OA non-bifurcation (N = 793) OA bifurcation (N = 363) P-value OA non-bifurcation (N = 308) OA bifurcation (N = 308) P-value

30-Day MACE 37 (4.7) 41 (11.3) <0.0001 19 (6.2) 31 (10.1) 0.077

Death 12 (1.5) 6 (1.7) 0.859 5 (1.6) 5 (1.6) 1.000
MI 27 (3.4) 35 (9.6) <0.0001 15 (4.9) 26 (8.4) 0.075
TVR 3 (0.4) 0 0.241 0 0 –

Values are n (%).

MACE = Major Adverse Cardiac Events; MI = Myocardial Infarction; TVR = Target Vessel Revascularization; OA = Orbital Atherectomy; − = NA.

both the single center study by Chambers et al. and this study, data are not
available for the rate of side branch occlusion due to the lack of an angio-
graphic core laboratory. Barman et al. previously published a small study
of 30 patients undergoing OA and observed a 40% rate of side branch oc-
clusion [15]. This unknown variable could confound our data and be an at-
tributable cause for the increased observed rates of myocardial infarction.
However, other adverse events for which data was available were low
and similar to prior published findings [8].
There are several limitations to this study. First, the majority of pa-
tients were Caucasian males, which limits generalizability of these data.
Second, access to patient follow-up data varies by availability. Third,
there is no control group of bifurcation lesions to compare orbital atherec-
tomy against. Additionally, adverse events were reported by individual
investigators and were not available for adjudication by a blinded com-
mittee. Selection bias is possible given the use of OA was based on opera-
tor preference. Lastly, as mentioned previously, the unknown rate of side
branch occlusion could be an attributable cause to adverse outcomes.
5. Conclusions
This study demonstrates that the use of OA in the preparation of se-
verely calcified coronary artery lesions is safe and efficacious in the
treatment of bifurcation lesions.
Declaration of competing interest
Dr. Armstrong is a consultant to Abbott Vascular, Boston Scientific,
Cardiovascular Systems, Inc. (CSI), Gore, Janssen, Medtronic, Philips,
and PQ Bypass. Dr. Revtyak is a consultant to Cardiovascular Systems.
Dr. Chambers is a consultant to CSI and works on clinical events com-
mittees for Boston Scientific. Dr. Shroff is a consultant to Cordis, Cardio-
vascular Systems, Inc. (CSI), Terumo, and Medtronic. Dr. E. Shlofmitz is a
consultant to Abbott Vascular and Opsens Medical. Dr. Waldo receives
research support to the Denver Research Institute from Abiomed, Car-
diovascular Systems Incorporated, Janssen Pharmaceuticals and Merck
Pharmaceuticals. Dr. Igyarto and Dr. Martinsen are employed by and
own stock in CSI. Dr. Sharma is a speaker for Abbott Vascular, Boston Sci-
entific, and Cardiovascular Systems. All other authors have no relation-
ships to disclose.
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