1091900

research-article2022
JETXXX10.1177/15266028221091900Journal of Endovascular TherapySanon et al

A SAGE Publication

Clinical Investigation

Journal of Endovascular Therapy

Incidence of Procedure-Related
1­–10
© The Author(s) 2022
Article reuse guidelines:
Complications in Patients Treated With sagepub.com/journals-permissions
DOI: 10.1177/15266028221091900
https://doi.org/10.1177/15266028221091900

Atherectomy in the Femoropopliteal www.jevt.org

and Tibial Vessels in the Vascular Quality

Initiative

Omar Sanon, MD1 , Matthew Carnevale, MD2, Jeffrey Indes, MD2, Qi Gao, PhD2,
Evan Lipsitz, MD, MBA1 , and Issam Koleilat, MD3

Abstract
Purpose: To compare procedural complications in patients undergoing atherectomy plus angioplasty (A+A) and plain
balloon angioplasty (POBA). Materials and Methods: Patients in the Vascular Quality Initiative (VQI) registry undergoing
first-time peripheral vascular intervention (PVI) were included. Those undergoing aortoiliac or pedal interventions,
primary stenting, or hybrid procedures were excluded. Patients were stratified by lesion location (femoropopliteal [FP]
or tibial [TIB]). The primary outcomes were target vessel dissection, distal embolization, and provisional stent placement.
Secondary outcomes included postoperative complications and the need for subsequent interventions. Results: 12 499
patients undergoing FP (49.6% A+A) and 6736 patients undergoing TIB (17.0% A+A) interventions were identified. In
the FP group, A+A was associated with greater intraoperative target vessel dissection (4.5% vs 2.6%, p<0.001), distal
embolization (1.5% vs 0.7%, p =0.001), and provisional stent placement (1.5% vs 0%, p<0.001); and greater postoperative
target vessel dissection (4.2% vs 2.0%, p<0.001) and distal embolization (0.9% vs 0.4%, p=0.034). In the TIB group, A+A
was associated with fewer intraoperative vessel dissection (0.8% vs 2.3%, p=0.011) but greater provisional stent placement
(0.3% vs 0%, p<0.001). TIB A+A was also associated with higher rates of technical success (97.6% vs 95.1%, p<0.001).
Conclusions: Atherectomy was associated with increased procedural-related complications in femoropopliteal, but not
in tibial vessels. Future studies addressing lesion morphology, device design, and technique may help define its role in
peripheral vascular interventions.

Keywords
peripheral vascular disease, atherectomy, balloon angioplasty, Vascular Quality Initiative

Introduction In one meta-analysis of femoropopliteal interventions,

Endovascular interventions have become first-line in the
management of peripheral vascular disease due to reduced
perioperative morbidity and mortality and shortened hospi-
tal stays compared with open bypass surgery.1–4 Atherectomy
has emerged as one of the various endovascular modalities
to treat peripheral vascular lesions, with several options
including rotational, excisional, and laser, to excise or deb-
ulk heavily calcified luminal atheroma.5–7 However, the use
of atherectomy has become a controversial topic in periph-
eral vascular interventions (PVI) as a majority of the evi-
dence has not found a benefit to atherectomy plus
angioplasty (A+A) over plain balloon angioplasty (POBA).
the risk of distal embolization and the need for
bailout stenting were no different in atherectomy versus no
1
Department of Vascular Surgery, Northwell Health, Lenox Hill Hospital,
New York, NY, USA
2
Division of Vascular and Endovascular Surgery, Albert Einstein College
of Medicine, Montefiore Medical Center, Bronx, NY, USA
3
Department of Surgery, Community Medical Center, RWJBarnabas
Health, Tom’s River, NJ, USA
Corresponding Author:
Issam Koleilat, Community Medical Center, RWJBarnabas Health, 67
Route 37 West, Riverwood 1, Suite 200B, Tom’s River, NJ 08755, USA.
Email: ikoleilat@gmail.com
2 Journal of Endovascular Therapy 00(0)
atherectomy groups.8 In another meta-analysis of tibial ves-
sels, A+A and POBA were associated with similar out-
comes of vessel dissection, residual stenosis, and long-term
mortality and amputation rates.9 Similarly, a Cochrane
review found no benefit of A+A over POBA.10 Although
this study did find that A+A did result in a lower rate of
bailout stenting, lower rates of dissection, and lower infla-
tion pressures, embolization rates were higher.
Unfortunately, conclusions regarding the effect of atherec-
tomy on vessel complications such as dissection are limited
given the few studies that reported on these outcomes. At
the least, there were no differences in amputation rates or
target vessel revascularization. The authors concluded that
current trials have been underpowered and of poor quality,
and larger studies are needed.
Still, the idea of debulking atherectomy in preparation of
the vessel for subsequent angioplasty persists in the litera-
ture and has seen increased use in the United States within
recent years.11–14 This may be an imported concept from the
coronary literature where atherectomy has become increas-
ingly popular15,16 As such, there remain gaps in the litera-
ture regarding the utility of A+A. It is for this reason we
sought to evaluate the periprocedural outcomes of patients
undergoing A+A in the Vascular Quality Initiative (VQI) to
determine if lower extremity vessel preparation with ather-
ectomy is associated with periprocedural outcomes.
Materials and Methods
Data Source
The VQI registry is a network of regional quality improve-
ment groups functioning as a Patient Safety Organization
(PSO) of the Society for Vascular Surgery (SVS).
Participating institutions include academic medical centers,
community hospitals, office-based labs, and private prac-
tices across the United States and Canada.17 The VQI col-
lects several patient- and disease-specific characteristics
and outcomes from qualified procedures up to 1 year post-
operatively and includes data from a variety of specialties.
Data are audited periodically using hospital billing claims
to ensure all eligible cases are entered accurately.18
Cohort Criteria
All patients undergoing first-time elective PVI procedures
in the superficial femoral, popliteal, or tibial arteries from
2004 to 2019 were included. Patients who underwent con-
comitant bypass surgery, aortoiliac, or pedal interventions,
primary stent placement, treatment for nonocclusive dis-
ease (eg, aneurysms or pseudoaneurysms), procedures
involving open exposures or endarterectomy, and interven-
tions involving more than 1 target vessel were excluded.
Patients presenting with acute limb ischemia or a history of
a prior ipsilateral above or below the knee amputation were
also excluded. The remaining cases were then stratified by
lesion location, either femoropopliteal (FP) or tibial (TIB)
vessels.
Outcomes
The primary outcome was a composite of intraoperative tar-
get vessel dissection, distal embolization, and provisional
stent placement. Secondary outcomes included periopera-
tive complications before discharge including cardiac com-
plications (myocardial infarction [MI], congestive heart
failure [CHF], dysrhythmia), renal complications (new
increase in creatinine of ≥ 0.5 mg/dL or new dialysis initia-
tion), pulmonary complications (pneumonia, need for ven-
tilator support, pulmonary embolism) access site
complications (hematoma, infection, pseudoaneurysm,
arteriovenous fistula), amputation during admission, treat-
ment diameter, treatment length, technical success, emboli-
zation, dissection, need for additional intervention, and
mortality.
Statistical Analysis
Categorical variables were analyzed using Fischer exact
test for nonparametric data or χ2 test for parametric data.
Continuous variables were analyzed using t test for para-
metric data or Wilcoxon rank sum test for nonparametric
data. A multivariable logistic regression model was used to
adjust for clinically relevant factors potentially associated
with the composite outcome for each of the FP and TIB
groups. All statistical analyses were performed using SAS
9.4 (SAS Institute, Inc., Cary, NC, USA). Alpha was set at
0.05. This was a retrospective study utilizing deidentified
patient data from the PVI module of the VQI and was thus
exempt from institutional review board approval or require-
ments of patient consent.
Results
Demographics and Preoperative Details
A total of 12 499 patients undergoing FP (49.6% atherec-
tomy) and 6736 patients undergoing TIB (17.0% atherec-
tomy) interventions were identified (Table 1). Patients in the
FP group undergoing A+A were more likely to be White
(80.2% vs 76.8%; p<0.001), male (59.2% vs 52.2%;
p<0.001), ambulatory (84.9% vs 77.1%; p<0.001), full
functional status (55.0% vs 48.5%; p<0.0001), and have a
history of CAD (33.2% vs 30.1%; p=0.002). However, they
were less likely to be dialysis-dependent (4.6% vs 7.3%;
p<0.001). Patients in both vessel groups had comparable
Medicare/Medicaid and private insurer rates. Additionally,
in both FP and TIB groups, patients undergoing A+A were
Sanon et al 3

Table 1.  Demographics and Preoperative Characteristics.

Femoropopliteal (n=12,499) Tibial (n=6,736)

POBA POBA A+A

  (n=6,304) A+A (n=6,195) p-value (n=5,592) (n=1,144) p-value
Age (mean±SD) 69.4±11.5 68.5±11.0 <0.0001 70±12.1 70±12 0.2354
Race <0.0001 0.572
 White 4,841 (76.8%) 4968 (80.2%) 3859 (69.0%) 764 (66.8%)  
 Other 1,460 (23.2%) 1,224 (19.8%) 1,731 (31.0%) 379 (33.2%)  
Gender <0.0001 0.9848
 Male 3289 (52.2%) 3670 (59.2%) 3684 (65.9%) 754 (65.9%)  
 Female 3015 (47.8%) 2525 (40.8%) 1908 (34.1%) 390 (34.1%)  
Ethnicity 0.6333 0.7789
  Not Hispanic 5982 (95.2%) 5896 (95.4%) 5107 (91.7%) 1044 (91.4%)  
 Hispanic 299 (4.8%) 283 (4.6%) 464 (8.3%) 98 (8.6%)  
BMI (mean±SD) 28.2±6.4 28.5±6.1 0.0064 28.7±6.5 29.6±6.4 <0.0001
Preoperative ambulatory status <0.0001 <0.0001
 Ambulatory 4785 (77.1%) 5217 (84.9%) 3389 (61.3%) 773 (69.3%  
  Ambulatory with assistance 1,391 (22.4%) 920 (14.9%) 2,081 (37.7%) 338 (35.3%)  
  Not ambulatory 30 (0.5%) 10 (0.2%) 58 (1.0%) 5 (0.4%)  
Preoperative functional status <0.0001 0.0351
 Full 961 (48.5%) 1995 (55.0%) 1240 (41.3%) 279 (44.6%)  
  Light work 464 (23.4%) 874 (24.1%) 748 (24.9%) 128 (20.5%)  
  Self care 361 (18.2%) 603 (16.6%) 638 (21.3%) 146 (23.4%)  
  Assisted care 187 (9.4%) 148 (4.1%) 348 (11.6%) 71 (11.4%)  
  Bed bound 8 (0.4%) 7 (0.2%) 27 (0.9%) 1 (0.2%)  
Primary insurer <0.0001 0.0139
 Medicare 3190 (55.2%) 3225 (54.7%) 3118 (58.9%) 695 (63.2%)  
 Medicaid 357 (6.2%) 352 (6.0%) 320 (6.0%) 70 (6.4%)  
 Commercial 1990 (34.4%) 2161 (36.6%) 1673 (31.6%) 308 (28.0%)  
 Military/VA 39 (0.7%) 54 (0.9%) 49 (0.9%) 10 (0.9%)  
  Non-US insurance 104 (1.8%) 4 (0.1%) 43 (0.8%) 1 (0.1%)  
  Self pay 103 (1.8%) 101 (1.7%) 90 (1.7%) 15 (1.4%)  
History of cerebrovascular disease 316 (15.3%) 492 (13.4%) 0.0496 558 (18.3%) 105 (16.1%) 0.1979
History of CAD 1879 (30.1%) 2037 (33.2%) 0.0002 1734 (31.3%) 354 (31.2%) 0.9917
History of CHF 1176 (18.7%) 1007 (16.3%) 0.0004 1461 (26.1%) 294 (25.7%) 0.7617
History of cardiac dysrhythmias 404 (19.5%) 657 (17.9%) 0.1261 824 (27.0%) 192 (29.5%) 0.1814
History of COPD 1551 (24.6%) 1541 (24.9%) 0.721 1019 (18.2%) 196 (17.1%) 0.3797
History of diabetes 3327 (100%) 3117 (100%) N/A 3966 (100%) 824 (100%) N/A
Dialysis dependence 458 (7.3%) 287 (4.6%) <0.0001 865 (15.5%) 192 (16.8%) 0.5018
History of HTN 5605 (89.0%) 5485 (88.6%) 0.4784 5039 (90.1%) 1026 (89.7%) 0.6615
History of CABG 1162 (20.1%) 1268 (21.5%) 0.0562 1128 (21.3%) 242 (22.1%) 0.5601
History of PCI 1310 (22.7%) 1594 (27.0%) <0.0001 1135 (21.4%) 245 (22.3%) 0.5085
History of smoking <0.0001 0.0593
 Never 1445 (23.0%) 1136 (18.4%) 2456 (44.0%) 538 (47.2%)  
 Prior 2852 (45.3%) 2781 (45.0%) 2227 (39.9%) 443 (38.9%)  
 Current 1998 (31.7%) 2269 (36.7%) 903 (16.2%) 158 (13.9%)  
Preoperative creatinine level 1.1±0.6 mg/dL 1.1±0.5 mg/dl <0.0001 1.2±0.7 mg/dL 1.2±0.8 mg/dL 0.6214
(mean±SD)
Preoperative ACEI use 3081 (53.1%) 3298 (55.8%) 0.001 2539 (47.9%) 526 (47.8%) 0.3875
Preoperative aspirin use 4502 (71.4%) 4622 (74.6%) 0.0009 3748 (67.1%) 745 (65.2%) 0.5123
Preoperative anticoagulation use 867 (13.8%) 704 (11.4%) <0.0001 1231 (22.0%) 267 (23.4%) 0.7301
Preoperative cilostazol 140 (6.8%) 320 (8.7%) 0.0007 117 (3.8%) 27 (4.2%) 0.4388

(continued)
4 Journal of Endovascular Therapy 00(0)

Table 1.  (continued)

Femoropopliteal (n=12,499) Tibial (n=6,736)

POBA POBA A+A

  (n=6,304) A+A (n=6,195) p-value (n=5,592) (n=1,144) p-value
Preoperative antiplatelet use 2414 (38.3%) 2715 (43.8%) <0.0001 1749 (31.3%) 395 (34.6%) 0.1246
Preoperative beta-blocker use 2328 (55.0%) 1387 (54.8%) 0.2516 1485 (58.6%) 264 (53.7%) 0.2049
Preoperative statin use 4351 (69.1%) 4515 (72.9%) <0.0001 3718 (66.5%) 754 (66.0%) 0.8092
Preoperative ipsilateral ABI (mean±SD) 0.7±1.1 0.7±0.4 0.0671 1.0±4.1 1.0±0.6 0.8872
ASA Classification <0.0001 0.7439
 1 70 (1.8%) 42 (1.8%) 29 (1.2%) 7 (1.5%)  
 2 934 (24.0%) 739 (31.2%) 443 (18.7%) 87 (18.6%)  
 3 2616 (67.2%) 1468 (61.9%) 1624 (68.6%) 313 (66.9%)  
 4 271 (7.0%) 120 (5.1%) 271 (11.4%) 61 (13.0%)  
 5 2 (0.1%) 1 (0.0%) 0 (0.0%) 0 (0.0%)  
Preoperative ipsilateral TBI (mean±SD) 0.4±0.4 0.4±0.4 0.2482 0.4±0.4 0.4±0.5 0.4561
Presenting leg symptoms <0.0001 0.0668
  Asymptomatic claudication 191 (3.0%) 117 (1.9%) 99 (1.8%) 20 (1.8%)  
  Mild claudication 83 (1.3%) 185 (3.0%) 37 (0.7%) 9 (0.8%)  
  Moderate claudication 280 (4.5%) 757 (12.3%) 108 (1.9%) 28 (2.5%)  
  Severe claudication 484 (7.7%) 1377 (22.3%) 217 (3.9%) 48 (4.2%)  
  Non-specified claudication 2347 (37.3%) 1682 (27.2%) 382 (6.9%) 90 (7.9%)  
  Ischemic rest pain 759 (12.1%) 672 (10.9%) 559 (10.0%) 103 (9.0%)  
  Tissue loss 1894 (30.1%) 1231 (20.0%) 3769 (67.6%) 779 (68.4)  
Tissue Loss Severity 0.6839 0.0089
 Shallow 477 (70.0%) 516 (68.5%) 1249 (60.8%) 294 (68.4%)  
 Deep 165 (24.2%) 197 (26.2%) 644 (31.3%) 104 (24.2%)  
 Extensive 39 (5.7%) 40 (5.3%)  
Infection 0.2176 0.0761
 None 448 (64.6%) 518 (69.3%) 1158 (56.4%) 272 (62.4%)  
 Mild 143 (20.6%) 140 (18.7%) 473 (23.0%) 92 (21.1%)  
 Moderate 80 (11.5%) 66 (8.8%) 335 (16.3%) 61 (14.0%)  
 Severe 22 (3.2%) 24 (3.2%) 88 (4.3%) 11 (2.5%)  
Procedural setting <0.0001 <0.0001
  Hospital outpatient 1329 (64.3%) 2488 (67.8%) 1595 (52.2%) 358 (55.0%)  
  Hospital inpatient 673 (32.6%) 561 (15.3%) 1395 (45.7%) 201 (30.9%)  
  Ambulatory center 48 (2.3%) 310 (8.5%) 42 (1.4%) 62 (9.5%)  
 Office 16 (0.8%) 308 (8.4%) 22 (0.7%) 30 (4.6%)  
TASC II grade <0.0001 0.0015
 A 2185 (41.9%) 1304 (26.4%) 849 (18.9%) 119 (14.3%)  
 B 1531 (29.4%) 1519 (30.7%) 718 (16.0%) 139 (16.6%)  
 C 818 (15.7%) 1131 (22.9%) 1034 (23.0%) 175 (21.0%)  
 D 260 (5.0%) 580 (11.7%) 1024 (22.8%) 231 (27.7%)  
Treatment length (mean±SD) 11.4±12.3 cm 15.1±12.8 cm <0.0001 12.9±16.5 cm 15.4±11.6 cm <0.0001
Occlusion length (mean±SD) 5.8±11.0 cm 8.6±11.6 cm <0.0001 6.3±14.5 cm 8.1±10.7 cm 0.0005
Vessel calcification <0.0001 <0.0001
 None 533 (28.6%) 698 (20.7%) 709 (25.7%) 137 (23.4%)  
  Focal calcification 131 (7.0%) 153 (4.5%) 126 (4.6%) 28 (4.8%)  
  Mild calcification 180 (9.7%) 270 (8.0%) 329 (11.9%) 30 (5.1%)  
  Moderate calcification 325 (17.5%) 562 (16.7%) 445 (16.1%) 98 (16.8%)  
  Severe calcification 366 (19.7%) 1166 (34.6%) 565 (20.5%) 206 (35.2%)  
Use of embolic protection device 91 (1.5%) 1892 (30.6%) <0.0001 18 (0.3%) 64 (5.6%) <0.0001
Use of CTO device 40 (1.9%) 167 (4.6%) <0.0001 60 (2.0%) 30 (4.6%) <0.0001

Abbreviations: ASA, American Society of Anesthesiology; ACEI, angiotensin-converting enzyme inhibitor; ABI, ankle-brachial index; A+A, atherectomy
and angioplasty; BMI, body mass index; CABD, coronary artery bypass graft; CAD, coronary artery disease; COPD, chronic obstructive pulmonary
disease; CTO, chronic total occlusion; CHF, congestive heart failure; HTN, hypertension; PCI, percutaneous coronary intervention; POBA, plain
balloon angioplasty; TBI, toe-brachial index; TASC, Trans-Atlantic Inter-Society Consensus.
Bold values indicate statistical significance.
Sanon et al 5
Table 2.  Primary Intraoperative Outcomes.
Femoropopliteal (n=12499)
  POBA (n=6304) A+A (n=6195)
Composite outcome 174 (2.8%) 366 (5.9%)
Target lesion dissection 53 (2.6%) 164 (4.5%)
Distal embolization 30 (0.7%) 39 (1.5%)
Provisional stent placement 0 (0.0%) 95 (1.5%)
Abbreviations: A+A, atherectomy and angioplasty; POBA, plain balloon angioplasty.
Bold values indicate statistical significance.
more likely to have a Trans-Atlantic Inter-Society Consensus
(TASC) D lesion (FP 11.7% vs 5.0%; p<0.001; TIB 27.7%
vs 22.8 %; p=0.002), more severe vessel calcification (FP
34.6% vs 19.7%; p<0.001; TIB 35.2% vs 20.5%; p<0.001),
longer lesions (FP 8.6 vs 5.8 cm; p<0.001; TIB 8.1 vs 6.3
cm; p=0.001), and more likely to be treated in an office set-
ting (FP 8.4% vs 0.8%; p<0.001; TIB 4.6% vs 0.7%;
p<0.001). In both vessel groups, A+A was more likely to
be associated with concomitant use of embolic protection
(FP 30.6% vs 1.5%; p<0.001; TIB 5.6% vs 0.3%; p<0.001)
and chronic total occlusion devices (FP 4.6% vs 1.9%;
p<0.001; TIB 4.6% vs 2.0%; p<0.001) during procedures.
Bivariable Unadjusted Analyses
In the FP group, A+A was associated with a higher rate of
the composite outcome (5.9% vs 2.8%; p<0.001).
Additionally, A+A at the FP level were associated with
higher rates of intraoperative target lesion dissection (4.5%
vs 2.6%; p<0.001), distal embolization (1.5% vs 0.7%;
p=0.001), and provisional stent placement (1.5% vs 0%;
p<0.001) (Table 2). In the FP group, patients undergoing
A+A had lower rates of death in the perioperative period
(0.1% vs 0.4%; p=0.004), higher rates of technical success
(97.6% vs 95.1%; p<0.001), higher rates of postoperative
distal embolization to either leg (0.9% vs 0.4%; p=0.034),
and higher rates of postoperative dissection (4.2% vs 2.0%;
p<0.001). A+A was also associated with smaller treatment
diameter (5.4 vs 5.0; p<0.0001) and shorter treatment
length (56.4 mm vs 84.0 mm; p<0.001) (Table 3).
For patients in the TIB group, A+A and POBA did not
exhibit a significant difference in the rate of the composite
outcome (3.2% vs 3.8%; p=0.363). However, there was a
higher rate of provisional stenting (0.3% vs 0.0%; p<0.001)
and a lower rate of lesion dissection (0.8% vs 2.3%;
p=0.011) with A+A for TIB (Table 2). In patients undergo-
ing PVI at the TIB level, A+A was associated with a shorter
mean device treatment length (43.3 vs 91.6 mm; p<0.001)
and fewer postoperative renal complications (0.3% vs
1.2%; p=0.045).
Tibial (n=6736)
p-value POBA (n=5592) A+A (n=1144) p-value
<0.0001 212 (3.8%) 37 (3.2%) 0.3625
0.0003 71 (2.3%) 5 (0.8%) 0.0111
0.001 36 (1.4%) 9 (1.8%) 0.5008
<0.0001 0 (0.0%) 3 (0.3%) 0.0001
Multivariate Logistic Regression Model
We created multivariate logistic regression models for both
FP and TIB groups controlling for preoperative statin use,
ASA class, smoking status, dialysis dependance, occlusion
length, treatment length, vessel calcification, and use of an
embolic protection device.
In the FP group, the composite outcome was positively
associated with current smokers vs never smokers (OR 1.5;
p=0.041), TASC II grade D vs grade A lesions (OR 2.3;
p<0.001), and concomitant use of an embolic protection
device (OR 1.6; p=0.002). Focal vessel calcification
appeared to be protective from the composite outcome (OR
0.3; p=0.004) (Table 4).
In the TIB group, the composite outcome was positively
associated with current smokers vs never smokers (OR 2.1;
p=0.002). Moderate vessel calcification appeared protective
from the composite outcome (OR 0.5; p=0.023) (Table 5).
Discussion
In this retrospective observational study, we demonstrated
that intraoperatively, A+A was associated with higher rates
of distal embolization, target vessel dissection, and provi-
sional stent placement in FP vessels when compared with
POBA. Additionally, patients undergoing A+A in FP ves-
sels were more likely to experience higher rates of postop-
erative distal embolization and higher rates of postoperative
dissection. Conversely, A+A was associated with higher
rates of technical success of the procedure and lower rates
of perioperative death following interventions in FP ves-
sels. In those undergoing interventions involving TIB ves-
sels, we observed higher rates of provisional stent
placement, but a lower rate of target lesion dissection.
These findings are largely consistent with previous studies
and reviews of A+A and POBA.8–10,14,19–21 In a similar retro-
spective study utilizing the VQI database, Bai et al demon-
strated A+A superior to POBA in terms of technical success
and 1 year primary patency in isolated FP interventions.
However, this study also showed that A+A did not confer
any benefit in the clinical outcomes of major amputation or
6 Journal of Endovascular Therapy 00(0)

Table 3.  Secondary Outcomes.

Femoropopliteal (n=12499) Tibial (n=6736)

  POBA (n=6304) A+A (n=6195) p-value POBA (n=6304) A+A (n=6195) p-value
Perioperative death 25 (0.4%) 8 (0.1%) 0.0036 31 (0.6%) 5 (0.4%) 0.6197
Treatment diameter 5.0±1.2 mm 5.4±2.9 mm <0.0001 2.8±1.3 mm 2.9±1.1 mm 0.1014
(average of 3 devices)
(mean±SD)
Treatment length 84.0±57.5 mm 56.5±35.9 mm <0.0001 91.6±66.6 mm 43.3±39.1 mm <0.0001
(average of 3 devices)
(mean±SD)
Technical result/success 5961 (95.1%) 6009 (97.6%) <0.0001 5253 (94.6%) 1068 (95.8%) 0.1127
Need for additional 75 (40.5%) 35 (37.6%) 0.6401 55 (31.8%) 15 (44.1%) 0.1649
treatment due to
technical result
Postoperative cardiac 21 (1.0%) 11 (0.3%) 0.0005 53 (1.7%) 7 (1.1%) 0.2279
complication
Postoperative myocardial 7 (0.3%) 1 (0.0%) 0.0024 13 (0.4%) 2 (0.3%) 0.6675
infarction
Postoperative pulmonary 15 (0.7%) 6 (0.2%) 0.0007 20 (0.7%) 4 (0.6%) 0.9097
complication
Postoperative renal 8 (0.4%) 9 (0.2%) 0.3434 36 (1.2%) 2 (0.3%) 0.0455
complication
Postoperative access site 56 (2.7%) 76 (2.1%) 0.1223 62 (2.0%) 9 (1.4%) 0.2766
complication
Postoperative contrast- 3 (0.1%) 1 (0.0%) 0.1045 0 (0.0%) 0 (0.0%) N/A
related complication
Other postoperative 21 (1.0%) 42 (1.1%) 0.6525 49 (1.6%) 7 (1.1%) 0.3173
complication
Postoperative thrombosis 0 (0.0%) 0 (0.0%) N/A 0 (0.0%) 0 (0.0%) N/A
of the access site
Postoperative 8 (0.4%) 32 (0.9%) 0.034 17 (0.6%) 2 (0.3%) 0.4203
embolization to either
leg
Postoperative dissection 7 (0.3%) 12 (0.3%) 0.9424 7 (0.2%) 0 (0.0%) 0.222
remote from target
lesion
Postoperative perforation 12 (0.6%) 16 (0.4%) 0.4515 12 (0.4%) 4 (0.6%) 0.4316
Amputation during 96 (14.0%) 74 (12.8%) 0.5442 378 (27.0%) 52 (25.7%) 0.6977
admission
Postoperative target 8 (0.4%) 14 (0.4%) 0.9662 8 (0.3%) 2 (0.3%) 0.8419
lesion thrombosis
Postoperative dissection 40 (2.0%) 154 (4.2%) <0.0001 17 (0.6%) 4 (0.6%) 0.8684

Abbreviations: A+A, atherectomy and angioplasty; POBA, plain balloon angioplasty.

Bold values indicate statistical significance.

reintervention after 1 year.19 Another VQI study showed
higher rates of 5 year amputation and major adverse limb
events in A+A compared with other endovascular interven-
tions.22 A review by Katsanos et al found higher technical
success of A+A in FP and infrapopliteal vessels, at the cost
of increased risk of periprocedural distal embolization. This
increased risk of distal embolization has been well docu-
mented in other studies10,23 and the use of an embolic protec-
tion device has been recommended with atherectomy in
certain patient populations.24 The clinical relevance of distal
embolization can be disputed, as one study showed that it
does not affect patency or limb salvage rates.25 Nonetheless,
our study echoes this established increased risk of distal
embolization and introduces target vessel dissection and the
need for provisional stenting as another potential risk in the
use of atherectomy in FP vessels.
The aforementioned studies have largely focused on PVI
in FP vessels, and the evidence regarding the utility of A+A
Sanon et al 7

Table 4.  Multivariate Model for Composite Outcome in Femoropopliteal Vessel Group.

Variable Level OR 95% CI p-value

Preoperative statin use Yes 0.91 0.674 1.229 0.5397
No, for medical reason 1.605 0.843 3.054 0.1495
Noncompliant 1.02 0.1 10.425 0.9864
vs No  
Dialysis dependance Functioning transplant 1.055 0.242 4.606 0.9433
On dialysis 0.622 0.323 1.198 0.1557
vs No  
History of smoking Prior 1.044 0.733 1.488 0.81
Current 1.45 1.015 2.073 0.0412
vs Never  
Preoperative aspirin use Yes 0.939 0.697 1.266 0.6804
No, for medical reason 1.421 0.646 3.126 0.3822
Noncompliant 0.895 0.085 9.377 0.9261
vs No  
TASC II grade B 1.17 0.801 1.71 0.4162
C 1.459 0.987 2.155 0.0581
D 2.296 1.558 3.382 <.0001
Protect adjacent artery 6.947 3.128 15.429 <.0001
vs A  
Treatment length 1.006 0.996 1.016 0.2507
Occlusion length 1.006 0.996 1.016 0.2463
Vessel calcification Focal 0.283 0.12 0.667 0.0039
Mild claudication 0.715 0.449 1.139 0.1578
Moderate 0.689 0.464 1.022 0.0641
Severe claudication 0.903 0.643 1.269 0.5569
Not evaluated 0.799 0.511 1.248 0.3235
vs None  
Use of embolic Yes vs No 1.611 1.188 2.183 0.0021
protection device
Treatment type A+A vs POBA 0.936 0.693 1.266 0.669

Abbreviations: A+A, atherectomy and angioplasty; CI, confidence interval; OR, odds ratio; POBA, plain balloon angioplasty; SE, standard error; TASC,
Trans-Atlantic Inter-Society Consensus.
Bold values indicate statistical significance.

in TIB is scarce. One retrospective study found similar 6
month outcomes between A+A and POBA in TIB interven-
tions, but was limited by a small sample size.26 A single-cen-
ter review of 418 interventions in TIB vessels demonstrated
no significant advantage of A+A over POBA regarding
patency, limb salvage rate, and survival in 3 years.20 An
industry-sponsored single-arm study specifically of direc-
tional atherectomy by McKinsey et al27 and subsequent sub-
analysis28 did identify 189 infrapopliteal vessels treated with
atherectomy. Unfortunately, procedural success was only
achieved in 84% of patients despite a low provisional stent
rate (1.6%). Overall, our study appears to represent the larg-
est sample size to date comparing A+A to POBA in TIB ves-
sels. However, our results only include intraoperative and
perioperative outcomes. Additional studies focusing long-
term outcomes of A+A in TIB vessels are needed.
Interestingly, we did find that patients undergoing A+A
had larger treatment device diameters on average in the
femoropopliteal segment, but not in the tibial segment as
compared with those receiving POBA. Although it may not
be possible to know the exact effects atherectomy had on
individual vessel preparation from this data set, A+A may
allow for a larger treatment diameter in the femoropopliteal
vessels. Further study specifically evaluating the technique
and impact of vessel preparation may be warranted. Still,
there did not seem to be any associated difference in the
tibial vessels.
While seemingly counterintuitive, we found that in the
TIB vessels, A+A resulted in higher observed rates of pro-
visional stent placement but a lower rate of target lesion
dissection. It is conceivable that a provisional stent may
have resolved any dissection noted. As such, no further dis-
section would have been seen during completion angiogra-
phy and therefore no dissection was coded in the VQI data
set. It is for this reason that we elected to evaluate both vari-
ables of dissection and provisional stenting.
8 Journal of Endovascular Therapy 00(0)

Table 5.  Multivariate Model for Composite Outcome in Tibial Vessel Group.

Variable Level OR 95% CI p-value

Preoperative statin Yes 1.031 0.674 1.579 0.8874
use No, for medical reason 0.697 0.159 3.054 0.6318
Noncompliant <0.001 <0.001 >999.999 0.9898
vs No  
Dialysis dependance Functioning transplant 1.113 0.338 3.663 0.8605
On dialysis 0.651 0.352 1.205 0.1721
vs No  
History of smoking Prior 0.865 0.563 1.33 0.5087
Current 2.111 1.328 3.356 0.0016
vs Never  
Preoperative aspirin Yes 0.866 0.571 1.314 0.4996
use No, for medical reason 0.316 0.042 2.381 0.2636
Noncompliant <0.001 <0.001 >999.999 0.9921
vs No  
TASC II grade B 1.229 0.642 2.35 0.534
C 0.931 0.491 1.765 0.8269
D 1.178 0.664 2.091 0.5749
Protect adjacent artery 4.928 1.572 15.456 0.0062
vs A  
Treatment length 0.995 0.975 1.016 0.6597
Occlusion length 1.006 0.985 1.027 0.5877
Vessel calcification Focal 0.329 0.099 1.1 0.0711
Mild claudication 0.735 0.398 1.357 0.3254
Moderate 0.487 0.262 0.904 0.0226
Severe claudication 0.924 0.567 1.507 0.7509
Not evaluated 0.63 0.343 1.156 0.136
vs None  
Use of embolic Yes vs No 2.29 0.498 10.524 0.2869
protection device
Treatment type A+A vs POBA 0.385 0.198 0.749 0.0049

Abbreviations: A+A, atherectomy and angioplasty; CI, confidence interval; OR, odds ratio; POBA, plain balloon angioplasty; SE, standard error; TASC,
Trans-Atlantic Inter-Society Consensus.
Bold values indicate statistical significance.

Despite growing evidence showing minimal-to-no ben-
efit of A+A over POBA and other endovascular interven-
tions, several reviews and clinical trials maintain its
utility.27,29–31 A recent retrospective study examining out-
comes of orbital atherectomy in data from the LIBERTY
360 trial found low rates of amputation in patients with
chronic limb-threatening ischemia and intermittent claudi-
cation after 3 years.32 In the midst of this conflicting evi-
dence, it is important to consider the increased health care
costs associated with atherectomy use in PVI.33 This is due
to not only the cost of the atherectomy device itself but also
concomitant use of embolic protection devices and high
reintervention rates.34
Indeed, current practice patterns showing increased
usage of atherectomy in PVI is concerning given the lack of
well-defined indications for its use.13 Several studies have
shown a shift in A+A being performed more often in
ambulatory surgery centers or office-based laboratories. It
is thought that this trend may be influenced by the generous
reimbursement rates of the procedure in these settings.11,12,35
One recent study found that 90% of the total Medicare pay-
ments to physicians during first-time FP procedures are
attributed to atherectomy, despite only accounting for about
half of the cases.36 While a discussion on reimbursement
and policy is beyond the scope of this study, we similarly
did find increased use of atherectomy in the office and
ambulatory as compared with hospital settings despite simi-
lar rates of primary insurers. This highlights the importance
of the need for greater regulatory guidance and cost-con-
tainment with regards to this technology.
There are several limitations to our study. Similar to
other studies utilizing the VQI database, the retrospective
nature of this study may be subject to selection bias and
confounding from other variables.13,19 Given the
Sanon et al 9
self-reported nature of database, many of the variables had
missing data. We were not able to delineate differences in
outcomes for different types of atherectomy devices (orbital,
directional, laser, etc) and compare A+A with primary
stenting. Additionally, we were unable to compare POBA
with newer drug-eluting balloon and stent technologies that
have shown promising results in other recent studies.14 Our
cohort was limited to interventions in single vessel groups
and thus our results cannot be extended to those undergoing
interventions in multiple vessels or multiple levels with
varying levels of disease severity.
Conclusion
Atherectomy was associated with increased intraoperative
complications in femoropopliteal but not in tibial vessels
when compared with plain balloon angioplasty. Future studies
addressing lesion morphology, device design, and technique
may help define its role in peripheral vascular interventions.
Authors’ Note
Abstract presented at the American College of Surgeons Clinical
Congress 2020 (10/2020).
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest
with respect to the research, authorship, and/or publication of this
article: IK has stock in Doximity and consults for Empire BCBS,
e-Health Connect and Medline. The remaining authors have no
competing interests otherwise.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iDs
Omar Sanon https://orcid.org/0000-0002-4074-9919
Evan Lipsitz https://orcid.org/0000-0002-6159-7459
Issam Koleilat https://orcid.org/0000-0001-8103-009X
References
1. Goodney PP, Beck AW, Nagle J, et al. National trends in
lower extremity bypass surgery, endovascular interventions,
and major amputations. J Vasc Surg. 2009;50(1):54–60.
2. Katsanos K, Tepe G, Tsetis D, et al. Standards of practice for
superficial femoral and popliteal artery angioplasty and stent-
ing. Cardiovasc Intervent Radiol. 2014;37(3):592–603.
3. Thomas MP, Jung Park Y, Grey S, et al. Temporal trends in periph-
eral arterial interventions: observations from the blue cross blue
shield of Michigan cardiovascular consortium (BMC2 PVI).
Catheter Cardiovasc Interv. 2017;89(4):728–734.
4. Pastromas G, Katsanos K, Krokidis M, et al. Emerging stent
and balloon technologies in the femoropopliteal arteries.
Scientificworldjournal. 2014;2014:695402–695406.
5. Mittleider D, Russell E. Peripheral atherectomy: appli-
cations and techniques. Tech Vasc Interv Radiol.
2016;19(2):123–135.
6. Franzone A, Ferrone M, Carotenuto G, et al. The role of ather-
ectomy in the treatment of lower extremity peripheral artery
disease. BMC Surg. 2012;12(suppl. 1):S13.
7. Mahmud E, Cavendish JJ, Salami A. Current treat-
ment of peripheral arterial disease. J Am Coll Cardiol.
2007;50(6):473–490.
8. Diamantopoulos A, Katsanos K. Atherectomy of the femo-
ropopliteal artery: a systematic review and meta-analysis of
randomized controlled trials. J Cardiovasc Surg (Torino).
2014;55(5):655–665.
9. Abdullah O, Omran J, Enezate T, et al. Percutaneous angio-
plasty versus atherectomy for treatment of symptomatic
infra-popliteal arterial disease. Cardiovasc Revasc Med.
2018;19(4):423–428.
10. Wardle BG, Ambler GK, Radwan RW, et al. Atherectomy
for peripheral arterial disease. Cochrane Database Syst Rev.
2020(9):CD006680.
11. Mukherjee D, Hashemi H, Contos B. The disproportion-
ate growth of office-based atherectomy. J Vasc Surg.
2017;65(2):495–500.
12. Jones WS, Mi X, Qualls LG, et al. Trends in settings for
peripheral vascular intervention and the effect of changes
in the outpatient prospective payment system. J Am Coll
Cardiol. 2015;65(9):920–927.
13. Mohan S, Flahive JM, Arous EJ, et al. Peripheral atherec-
tomy practice patterns in the United States from the Vascular
Quality Initiative. J Vasc Surg. 2018;68(6):1806–1816.
14. Katsanos K, Spiliopoulos S, Reppas L, et al. Debulking ather-
ectomy in the peripheral arteries: is there a role and what
is the evidence. Cardiovasc Intervent Radiol. 2017;40(7):
964–977.
15. Chambers JW, Behrens AN, Martinsen BJ. Atherectomy
devices for the treatment of calcified coronary lesions. Interv
Cardiol Clin. 2016;5(2):143–151.
16. Beohar N, Kaltenbach LA, Wojdyla D, et al. Trends in usage
and clinical outcomes of coronary atherectomy: a report from
the national cardiovascular data registry CathPCI registry.
Circ Cardiovasc Interv. 2020;13(2):e008239.
17. Cronenwett JL, Kraiss LW, Cambria RP. The society for
vascular surgery vascular quality initiative. J Vasc Surg.
2012;55(5):1529–1537.
18. Bensley RP, Beck AW. Using the vascular quality initiative
to improve quality of care and patient outcomes for vascular
surgery patients. Semin Vasc Surg. 2015;28(2):97–102.
19. Bai H, Fereydooni A, Zhuo H, et al. Comparison of
atherectomy to balloon angioplasty and stenting for iso-
lated femoropopliteal revascularization. Ann Vasc Surg.
2020;69:261–273.
20. Todd KE Jr, Ahanchi SS, Maurer CA, et al. Atherectomy
offers no benefits over balloon angioplasty in tibial inter-
ventions for critical limb ischemia. J Vasc Surg. 2013;58(4):
941–948.
21. Zia S, Juneja A, Shams S, et al. Contemporary outcomes of
infrapopliteal atherectomy with angioplasty versus balloon
angioplasty alone for critical limb ischemia. J Vasc Surg.
2020;71(6):2056–2064.
10 Journal of Endovascular Therapy 00(0)
22. Ramkumar N, Martinez-Camblor P, Columbo JA, et al.
29. Laird JR, Zeller T, Gray BH, et al. Limb salvage following
Adverse events after atherectomy: analyzing long-term out-
comes of endovascular lower extremity revascularization
techniques. J Am Heart Assoc. 2019;8(12):e012081.
23. Shrikhande GV, Khan SZ, Hussain HG, et al. Lesion types
and device characteristics that predict distal embolization dur-
ing percutaneous lower extremity interventions. J Vasc Surg.
2011;53(2):347–352.
24. Krishnan P, Tarricone A, Purushothaman KR, et al. An
algorithm for the use of embolic protection during atherec-
tomy for femoral popliteal lesions. JACC Cardiovasc Interv.
2017;10(4):403–410.
25. Ochoa Chaar CI, Shebl F, Sumpio B, et al. Distal emboliza-
tion during lower extremity endovascular interventions. J
Vasc Surg. 2017;66(1):143–150.
26. Tan TW, Semaan E, Nasr W, et al. Endovascular revascular-
ization of symptomatic infrapopliteal arteriosclerotic occlu-
sive disease: comparison of atherectomy and angioplasty. Int
J Angiol. 2011;20(1):19–24.
27. McKinsey JF, Zeller T, Rocha-Singh KJ, et al. Lower extrem-
ity revascularization using directional atherectomy. JACC
Cardiovasc Interv. 2014;7(8):923–933.
28. Rastan A, McKinsey JF, Garcia LA, et al. One-year out-
comes following directional atherectomy of infrapopliteal
artery lesions: subgroup results of the prospective, multi-
center DEFINITIVE LE trial. J Endovasc Ther. 2015;22(6):
839–846.
laser-assisted angioplasty for critical limb ischemia: results
of the LACI multicenter trial. J Endovasc Ther. 2006;13(1):
1–11.
30. Panaich SS, Arora S, Patel N, et al. In-hospital outcomes of
atherectomy during endovascular lower extremity revascular-
ization. Am J Cardiol. 2016;117(4):676–684.
31. Shammas NW, Lam R, Mustapha J, et al. Comparison of
orbital atherectomy plus balloon angioplasty vs J Endovasc
Ther. 2012;19(4):480–488.
32. Giannopoulos S, Secemsky EA, Mustapha JA, et al. Three-
year outcomes of orbital atherectomy for the endovascular
treatment of infrainguinal claudication or chronic limb-threat-
ening ischemia. J Endovasc Ther. 2020;27(5):714–725.
33. O’Brien-Irr MS, Harris LM, Dosluoglu HH, et al. Lower
extremity endovascular interventions: can we improve cost-
efficiency?. J Vasc Surg. 2008;47(5):982–987; discussion
987.
34. Mukherjee D, Contos B, Emery E, et al. High reintervention
and amputation rates after outpatient atherectomy for claudi-
cation. Vasc Endovascular Surg. 2018;52(6):427–433.
35. Smith ME, Sutzko DC, Beck AW, et al. Provider trends in
atherectomy volume between office-based laboratories and
traditional facilities. Ann Vasc Surg. 2019;58:83–90.
36. Hicks CW, Holscher CM, Wang P, et al. Use of atherec-
tomy during index peripheral vascular interventions. JACC
Cardiovasc Interv. 2021;14(6):678–688.