Keywords
peripheral artery disease - atherectomy - arteries - angiography
Introduction
Peripheral arterial disease (PAD) is a widespread condition characterized by atherosclerotic
narrowing or occlusion of peripheral arteries. It affects millions of patients worldwide,
resulting in significant limitations in quality of life and a high disease burden.
In 2015, an estimated 237 million individuals were affected, representing a 22% increase
compared to 202 million in 2010. In Germany, the prevalence of PAD ranges from 3–10%
in the general population and increases to as much as 20% among individuals over the
age of 70 [1].
Projections suggest that the number of PAD patients will continue to rise due to demographic
changes and the growing prevalence of risk factors such as diabetes mellitus. Statistical
models predict a further increase in PAD prevalence through at least 2030 [2].
Advances in endovascular therapies have introduced various treatment modalities, including
balloon angioplasty, stenting, and vessel preparation, e.g. plaque modification and/or
debulking. The benefit and superiority of drug-coated balloons (DCB) over conventional
percutaneous transluminal angioplasty (PTA) in symptomatic femoropopliteal PAD, with
a favorable safety profile, have been well established for a long time [3]. Atherectomy has emerged as a complementary technique designed to debulk atherosclerotic
plaque and optimize vessel preparation before adjunctive therapies such as balloon
angioplasty, with or without DCB. The role of atherectomy remains a topic of debate,
with ongoing evaluations regarding its impact on long-term patency rates, restenosis
reduction, and clinical outcomes. While some studies suggest that atherectomy may
enhance luminal gain and vessel compliance, others for example highlight the increased
risks of distal embolization and vessel trauma, necessitating careful patient selection
and procedural optimization [4]
[5].
This narrative review explores the role of atherectomy in the treatment of PAD. Guidelines,
current studies, and systematic reviews are considered to evaluate the effectiveness,
safety, and significance of this procedure in comparison to other treatment methods.
Therapeutic Recommendations in the S3-AWMF Guideline for Peripheral Arterial Disease
(PAD)
Therapeutic Recommendations in the S3-AWMF Guideline for Peripheral Arterial Disease
(PAD)
The current guidelines on PAD from the German Society for Angiology emphasize structured
exercise therapy (SET) and best medical therapy (BMT) as first-line treatment, particularly
in Stage II PAD (Claudication), where at least 3–6 months of SET and BMT should precede
any invasive intervention. Revascularization is reserved for patients with persistent
symptoms or critical limb-threatening ischemia (CLTI, Stage III–IV), where urgent
intervention is necessary to prevent limb loss. Both open surgical and endovascular
revascularization options are seen as viable approaches, each with their own advantages
and limitations. While recent data (e.g. BASIL-2 trial [6]) indicate a possible benefit in amputation-free survival following endovascular
treatment, this comes at the cost of a higher rate of reinterventions.
Overall, due to conflicting trial results, treatment selection should be individualized,
based on comorbidities, vascular anatomy, and multidisciplinary consultation.
Supervised exercise therapy should continue after revascularization to enhance functional
outcomes.
Overview of Atherectomy Systems
Overview of Atherectomy Systems
An atherectomy is an endovascular procedure designed to remove atherosclerotic plaque
from arterial walls, improving blood flow and alleviating symptoms associated with
PAD. Various atherectomy systems are available, each with unique mechanisms and applications
tailored to different lesion types and anatomical considerations.
The primary categories of atherectomy systems include rotational, directional rotational,
orbital rotational, and laser atherectomy, as well as systems designed for mechanical
thrombectomy and atherectomy. The choice for a specific atherectomy system depends
on several factors, including the lesion’s composition, location, and severity. [Table 1] summarizes the most common atherectomy systems, their mechanisms, and their clinical
applications. This review does not examine laser atherectomy in detail due to its
currently very limited use in Germany.
Table 1 Overview of the most common atherectomy systems, their mechanisms, and their clinical
applications.
|
Atherectomy System
|
Examples (Manufacturer)
|
Mechanism
|
Applications
|
|
Rotational, front-cutting Atherectomy and Thrombectomy
|
JetStream (Boston Scientific), Phoenix (Philips)
|
Rotating cutting heads or blades remove plaques; includes aspiration of removed debris.
|
For soft, calcified and fibrotic plaques; suitable for various vessel sizes and lesion
types; suitable for in-stent restenosis.
|
|
Directional, rotational Atherectomy
|
HawkOne System (Medtronic)
|
Directional blade allows precise plaque removal by targeting specific areas, integrated
system captures debris.
|
For eccentric or localized plaques in peripheral arteries; suitable for in-stent restenosis.
|
|
Orbital Rotational Atherectomy
|
Diamondback 360 (CSI-Cardiovascular Systems)
|
Orbiting diamond-coated crown sands calcified plaques into micro-particles, no need
of capturing debris.
|
For calcified lesions in small or tortuous vessels; gradual plaque modification.
|
|
Rotational Thrombectomy and Atherectomy
|
Rotarex (BD), ByCross (Taryag Medical)
|
Rotating spiral creates suction via the Venturi effect (Rotarex), Rotating shaft with
expandible cutting wing (ByCross) remove thrombotic and atheromatous material; integrated
aspiration system captures debris.
|
For thrombotic and restenotic plaques; suitable for in-stent restenosis with thrombus.
|
|
Laser Atherectomy
|
Various laser systems (e.g., Spectranetics by Philips)
|
Uses UV laser energy to vaporize plaque and thrombus
|
For thrombotic and restenotic plaques.
|
In essence, atherectomy systems mainly remove atherosclerotic plaque from within the
arterial wall, typically in cases of chronic PAD. Thrombectomy systems are designed
to extract intravascular thrombi, most commonly in the setting of acute or subacute
occlusions. In clinical practice, most atherectomy systems offer a combination of
plaque removal and thrombus management. In systems such as Jetstream, Phoenix, HawkOne,
and Diamondback, the primary mechanism of action is atherectomy. In contrast, the
Rotarex system is a dedicated thrombectomy device.
The Diamondback system is the most extensively studied atherectomy device, largely
due to its widespread adoption in North America. However, when evaluating its relevance
to PAD, it is important to recognize that much of the available data relates to coronary
applications. A notable example is the multi-center, prospective ORBIT II trial, which
focused on the treatment of coronary plaque [7]
[8].
Atherectomy in the Femoropopliteal Region
Atherectomy in the Femoropopliteal Region
Atherectomy is mostly used in femoropopliteal PAD, particularly for lesions with moderate
to severe calcification, where conventional balloon angioplasty alone may be insufficient
due to risks of arterial recoil and dissection. As shown in [Table 1], several atherectomy devices are available. These devices aim to optimize vessel
compliance and enhance luminal gain [9]
[10]
[11]. Randomized trials and real-world registries have provided contrasting perspectives
on the benefits of atherectomy in femoropopliteal lesions, with data suggesting a
reduced need for bailout stenting and others indicating no significant long-term benefit
over angioplasty alone [12].
A recent prospective, single center observational study from 2024 (n=162) evaluated
the safety and effectiveness of the Jetstream Atherectomy System combined with a DCB
angioplasty for treating complex and calcified TASC C/D femoropopliteal lesions. On
average, the lesion length was 24.2±4.8 cm and >50% showed significant, heavy calcification.
The procedural success rate was 99% with low bailout stenting (7.4%) and led to significant
clinical improvements at 12 months, including a reduction in Rutherford classification
(3.7±0.6 to 1.0±0.9, p<0.05) and a notable increase in ABI (0.4±0.1 to 0.8±0.2, p<0.05).
Most patients remained free from target lesion revascularization (TLR) (92.6%) and
target vessel revascularization (TVR) (95.1%), though severe arterial calcification
was linked to inferior outcomes and higher adverse limb event rates. Importantly,
the lesion characteristics in this cohort, i.e. long-segment disease and heavy calcification,
closely reflect the profile of patients routinely encountered in daily clinical practice,
further underscoring the study’s practical relevance [13].
In contrast, the multi-center JET-RANGER randomized trial (n=43) comparing Jetstream
atherectomy combined with DCB versus DCB alone found no significant differences in
freedom from TLR at two years, although atherectomy reduced the need for bailout stenting
(0% in Jetstream + DCB vs. 50% in DCB group, p<0.0001) [5].
While the previous studies addressed femoropopliteal disease, another recently published
ISO-POP trial specifically examined isolated lesions of the popliteal artery, an anatomically
mobile segment particularly prone to stent-related complications. The two-center trial
(n=62) assessed rotational atherectomy with assisted balloon angioplasty for isolated
popliteal artery lesions, directly comparing the Jetstream and Phoenix atherectomy
systems. The study demonstrated a high procedural success rate (98.4%) and low bailout
stenting (4.8%). Peripheral embolization occurred in 3.7% (subgroup A: rotational
atherectomy with Phoenix) and 5.7% (subgroup B: rotational atherectomy with Jetstream)
but was successfully managed. Median ABI significantly improved in both subgroups
(p<0.001). Based on the very promising study results, the authors advocate for a more
liberal application of atherectomy, particularly in anatomically challenging vascular
segments that are prone to stent fractures and occlusions [14].
Following the previously presented studies on rotational atherectomy, the next series
of investigations focus on directional atherectomy systems.
The first of these studies also targets isolated lesions of the popliteal artery:
a single-center study (n=72) compared DCB angioplasty and directional atherectomy
with antirestenotic therapy (DAART) for isolated popliteal artery lesions. Technical
success was 84% for DCB vs. 93% for DAART (p=0.24). At 12 months, primary patency
was significantly higher in the DAART group (82% vs. 65%, p=0.021), while freedom
from TLR was similar (82% vs. 94%, p=0.072). Secondary patency was identical for both
groups. Bailout stenting was more common after DCB (16% vs. 5%), while DAART had a
higher rate of aneurysmal degeneration (7% vs. 0%). The study suggests DAART may improve
patency, but both methods showed good long-term outcomes, with potential trade-offs
in complications [15].
The prospective, multi-center, randomized DEFINITIVE AR pilot study (n=121) on directional
atherectomy in CLTI investigated whether vessel preparation with directional atherectomy
(DA) before DCB angioplasty improves outcomes in femoropopliteal lesions. While DA+DCB
showed higher technical success (89,6% vs. 64,2%, p=0.004) and fewer flow-limiting
dissections (2% vs. 19%, p=0.01), key 12-month outcomes, such as restenosis, reintervention,
and patency, were comparable between the groups. Interestingly, a post hoc analysis
of the DEFINITIVE AR trial suggested that more effective debulking with ≤30% residual
stenosis after DA was associated with improved 12-month patency rates (88.2% angiographic,
84.2% duplex) compared to lesions with >30% residual stenosis (68.8% and 77.8% respectively),
highlighting a potential long-term benefit of thorough vessel preparation [16].
Building upon these findings, the VIVA REALITY study, as another prospective, multi-center
study (n=102), evaluated the use of DA for vessel preparation prior to DCB angioplasty
in patients with symptomatic, severely calcified femoropopliteal PAD. Among the treated
subjects, the mean lesion length was 17.9±8.1 cm, with nearly 40% being chronic total
occlusions. Provisional stenting was required in only 8.8% of cases. At 12 months,
primary patency was 76.7% and freedom from clinically driven TLR reached 92.6%. No
device- or procedure-related deaths occurred. These results support DA as a safe and
effective strategy in complex, calcified lesions [10].
While endovascular treatment of the common femoral artery (CFA) is typically reserved
for highly selected patients, Stavroulakis et al. retrospectively compared directional
atherectomy with antirestenotic therapy (DAART) to DCB angioplasty alone for treating
CFA atherosclerotic disease (n=47). Technical success rates were similar between the
two groups and while primary patency rates at 12 months did not significantly differ
(68% for DCB vs. 88% for DAART), the secondary patency rate was significantly higher
in the DAART group (100% vs. 81%, p=0.03). DAART was associated with a trend toward
improved vessel patency, though statistical significance was not reached. DCB angioplasty
resulted in more dissections, but they were not flow-limiting and bailout stenting
rates were comparable [17].
In summary, current evidence on atherectomy in femoropopliteal PAD highlights its
potential to improve procedural success, reduce bailout stenting, and optimize vessel
preparation, particularly in long, calcified, and anatomically challenging lesions.
While some prospective and randomized trials suggest advantages in patency or technical
outcomes, others demonstrate no clear long-term superiority over angioplasty alone.
Directional and rotational atherectomy systems both show safety and feasibility, with
emerging data indicating that thorough debulking may translate into improved patency.
Overall, atherectomy appears most relevant in complex, heavily calcified disease and
segments at risk for stent-related complications, though its definitive long-term
benefit remains to be proven.
Atherectomy in the Crural Region
Atherectomy in the Crural Region
The role of atherectomy in below-the-knee (BTK) PAD is less established due to anatomical
challenges, including smaller vessel diameters and high rates of chronic total occlusions.
The study by Konijn et al. demonstrated distinct calcification patterns in arteries
above- and below-the-knee in patients with CLI. In the femoropopliteal arteries, CLI
patients predominantly showed severe, thick, irregular, or patchy calcifications,
which are consistent with intimal atherosclerotic disease. In contrast, in the crural
arteries, calcifications were more frequently annular, thin, and continuous, suggestive
of medial artery calcification (MAC). These findings indicate not only a difference
in distribution and morphology, but likely also reflect distinct underlying pathophysiological
mechanisms: atherosclerosis-driven intimal calcification in proximal segments versus
metabolically driven medial calcification distally. These anatomical and etiological
distinctions likely have prognostic and therapeutic implications, particularly in
tailoring treatment strategies for CLI patients [18]. These morphological differences are particularly relevant when considering endovascular
treatment approaches in BTK territory, where the predominance of MAC may limit the
mechanical effectiveness of plaque-modifying techniques such as atherectomy.
Limited evidence supports its superiority over today’s standard strategy with PTA
or DCB. A retrospective analysis suggests that while atherectomy with the Phoenix
atherectomy device may achieve high procedural success rates in BTK interventions,
it is associated with higher risks of distal embolization and perforation [11].
Another retrospective analysis of data from the multi-center Excellence in Peripheral
Artery Disease (XLPAD) registry analyzed 518 BTK endovascular interventions, with
43% using atherectomy. The specific atherectomy devices used in the data analyzed
were not differentiated in the analysis. Atherectomy use was less common in chronic
total occlusions (48% vs 58%, p=0.02). No significant associations were found with
baseline comorbidities, CLI, ankle-brachial index, vessel run-off or lesion location.
However, atherectomy was linked to a lower 1-year repeat target limb revascularization
rate (HR 0.41, p<0.01). Overall this analysis suggests that atherectomy improves BTK
intervention outcomes [19].
The prospective, multi-center, randomized OPTIMIZE BTK pilot trial (n=66) evaluated
orbital atherectomy (OA) + DCB angioplasty versus DCB alone for treating calcified
infrapopliteal/crural lesions. The technical success rates were 81.8% for OA + DCB
and 89.2% for DCB, with minor complications in both groups. Target lesion primary
patency was numerically higher in the OA + DCB group at 6 (88.2% vs 50.0%) and 12
months (88.2% vs 54.5%), though not statistically significant. No differences were
observed in MAE, TLR, amputation, or mortality at 12 months. The study concluded that
OA + DCB is safe [20].
In summary, infrapopliteal atherectomy faces unique challenges due to small vessel
size and the predominance of medial artery calcification, which may limit the mechanical
efficacy of plaque-modifying techniques. While retrospective data suggest possible
reductions in reintervention rates, safety concerns such as distal embolization and
perforation remain.
Early prospective trials indicate that atherectomy combined with DCB angioplasty is
safe and may improve patency, but without clear clinical superiority over standard
angioplasty. Accordingly, current evidence and guidelines support its use only in
selected cases with severe calcification [4].
The following case from our daily clinical routine illustrates the previously mentioned
applications of an atherectomy system in the femoropopliteal and crural region.
A 79-year-old male patient presented via the emergency department with PAD at Fontaine
stage IIb-III on the left side with a re-occlusion of the popliteal artery following
prior recanalization with DCB angioplasty of the popliteal and anterior tibial artery
several months earlier. Current imaging revealed an occlusion starting at the mid
P2 segment of the popliteal artery, extending through the entire P3 segment, the tibiofibular
trunk, and into the proximal anterior tibial artery ([Fig. 1]). In cases where occlusion of the popliteal artery extends into the crural region,
it is often beneficial to selectively probe the crural vessels. Therefore, subsequent
access, such as to the tibiofibular trunk, is often no longer feasible following prior
isolated recanalization of the anterior tibial artery, even without stent-implantation.
Fig. 1 Occlusion starting at the mid P2 segment of the popliteal artery, extending through
the entire P3 segment, the tibiofibular trunk, and into the proximal anterior tibial
artery.
In this case, an intraluminal recanalization of the occlusion was performed using
two 0.014” guidewires, which were advanced into the anterior tibial artery and the
tibiofibular trunk ([Fig. 2]). Following successful guidewire passage, a rotational atherectomy was performed
using a 2.4/3.4 mm Jetstream system extending into the proximal below-the-knee vessels
via both guidewires. The final angiographic control after atherectomy and subsequent
DCB angioplasty (not shown) of the popliteal artery, tibiofibular trunk and proximal
anterior tibial artery demonstrated restored vessel patency without relevant residual
stenosis and no need of stent-implantation ([Fig. 3]).
Fig. 2 Atherectomy was performed using a 2.4/3.4 mm Jetstream system extending into the proximal
below-the-knee vessels.
Fig. 3 Final angiographic control after atherectomy and subsequent DCB angioplasty (not shown)
of the popliteal artery, tibiofibular trunk, and proximal anterior tibial artery.
Restored vessel patency without relevant residual stenosis and no need of stent-implantation.
Comparison with Other Endovascular Strategies
Comparison with Other Endovascular Strategies
While atherectomy has been the focus in the preceding sections, alternative endovascular
strategies also play a critical role in managing PAD. Conventional approaches such
as plain old balloon angioplasty (POBA) and DCB have long been established as standard
therapies.
As early as 2008, Tepe et al. demonstrated the benefit of DCB over POBA [21]. More recently, novel vessel preparation techniques, including intravascular lithotripsy
(IVL), as well as cutting and scoring balloons, have expanded the therapeutic toolbox,
particularly for heavily calcified lesions.
A meta-analysis of nine studies (699 patients; 4 randomized, 5 observational) compared
atherectomy plus balloon angioplasty (ABA) to balloon angioplasty (BA) alone in femoropopliteal
disease. In observational studies, ABA significantly reduced target lesion revascularization
(RR = 0.59; 95% CI, 0.40–0.85; p=0.005) and bailout stenting (RR = 0.32; 95% CI, 0.21–0.48;
p< 0.0001). However, randomized trials showed no significant difference in TLR or
primary patency (RR = 1.04; 95% CI, 0.95–1.14; p=0.37) favoring a balloon angioplasty
first strategy [22]. Following these findings, attention also has to be turned to the role of primary
stenting as an alternative to balloon-based strategies.
Over ten years ago, the RESILIENT trial showed that primary nitinol stenting significantly
improved 12-month patency (81.3% vs. 36.7%, p<0.0001) and reduced reintervention rates
compared to BA, despite high bailout stenting in the angioplasty group [23]. Also many years ago, the Zilver PTX trial demonstrated superior 5-year outcome
for patency and freedom from reintervention for the paclitaxel-coated drug-eluting
Zilver PTX stent (DES) versus standard angioplasty [24]
[25].
Since then, potential benefits of drug-eluting stents have been explored in several
additional studies. Among these, the work published by Stavroulakis et al. in 2021
[26], as well as the IMPERIAL trial as an direct comparison between the Zilver PTX DES
and Eluvia DES [27], are particularly noteworthy.
The recently published, prospective, multi-center, randomized BEST-SFA trial (n=120)
compared a stent-avoiding (SA) strategy using DCBs with a stent-preferred (SP) strategy
using the Eluvia DES for complex femoropopliteal lesions. At 12 months, primary patency
rates were similar (78.2% SA vs. 78.6% SP, p=1.0), and freedom from major adverse
events was also comparable (93.1% SA vs. 94.9% SP, p=0.717). Both strategies, emphasizing
lesion preparation (both scoring and cutting balloons were used, along with several
atherectomy systems, e.g. Jetstream, HawkOne, Diamondback) before drug-eluting device
use, demonstrated promising safety and efficacy [28].
In summary primary stenting of femoropopliteal lesions, particularly with DES, has
shown good outcomes in terms of freedom from restenosis and need for revascularization,
making it a compelling alternative to atherectomy in many cases [29].
Other methods of plaque modification include intravascular lithotripsy (IVL), which
alters the mechanical properties of calcified plaque through acoustic pressure waves.
IVL does not remove plaque but rather facilitates vessel compliance by fracturing
calcium in situ. In the Disrupt PAD III multi-center, randomized trial (n=306), IVL
was compared with standard PTA for vessel preparation in patients with moderately
to severely calcified femoropopliteal lesions prior to drug-coated balloon angioplasty.
IVL demonstrated superior procedural success (65.8% vs. 50.4%; p=0.01), lower rates
of flow-limiting dissections and provisional stenting and more frequent achievement
of ≤30% residual stenosis was documented. At one year, primary patency was significantly
higher in the IVL group (80.5% vs. 68.0%; p=0.017) and remained superior at two years
(70.3% vs. 51.3%; p=0.003). Rates of TLR and restenosis were similar between groups.
These findings support IVL as a safe and effective vessel preparation strategy in
calcified femoropopliteal disease, offering durable results with reduced need for
stenting [30]
[31].
As a less invasive alternative that avoids extensive plaque modification, scoring
balloon angioplasty represents another interesting vessel preparation technique. Although
published data on scoring balloon angioplasty in PAD patients are limited, a retrospective
single-center study with a relatively large cohort (n=425) evaluated the safety and
effectiveness of scoring balloon angioplasty using the AngioSculpt balloon in patients
with moderately to severely calcified femoropopliteal lesions. At 24-month follow-up,
there were no significant differences in freedom from TLR (82.3% vs. 78.1%; p>0.05),
survival, amputation rates, or stent-implantation rates between groups [32].
In addition to endovascular techniques, surgical revascularization remains an important
treatment option in patients with CLI, particularly in anatomically suitable cases.
This is reflected in key comparative trials such as BASIL and BEST-CLI, which have
directly evaluated primary endovascular versus open surgical strategies. BASIL-1 (n=452)
found no significant difference in outcomes between surgery and angioplasty, while
BASIL-2 (n=345) showed better amputation-free survival and lower mortality with an
endovascular-first approach in infra-popliteal PAD [6]
[33]. The BEST-CLI trial (n=1830) showed that surgery was superior when a good vein was
available (cohort 1), but both approaches had similar outcomes when alternative bypass
materials were needed (cohort 2) [34].
These study results of bypass surgery must also be taken into account.
In summary, several alternative strategies, in addition to atherectomy, play a central
role in PAD management. Balloon-based approaches, drug-eluting stents and novel vessel
preparation techniques such as IVL or scoring balloons have shown favorable outcomes,
particularly in calcified femoropopliteal disease. Large, randomized trials demonstrate
durable patency and reduced bailout stenting with drug-eluting stents and IVL, while
surgical bypass continues to be an important option in CLI patients with suitable
anatomy. These findings highlight the importance of tailoring revascularization strategies
to lesion characteristics and patient profiles.
Complications and Limitations
Complications and Limitations
Following the discussion of endovascular and surgical treatment strategies, it is
essential to address the potential complications associated with these interventions,
particularly in the context of atherectomy. Distal embolization is among the most
common, particularly in cases of severe or nodular calcification, where fragmented
debris may migrate into the distal vasculature. Vessel perforation is another concern,
especially in elongated or tortuous arteries, where device manipulation can compromise
the vessel wall. Additional risks include dissections pseudoaneurysm formation and
vessel spasm, all of which may impact procedural success and long-term outcomes.
A retrospective analysis of large-scale data (n=16.838) from a US- and Canada-wide
registry for vascular procedures, published in 2019 found that atherectomy was associated
with higher rates of amputation and major adverse limb events (MALEs) compared to
stenting and PTA, with a 5-year MALE rate of 38% for atherectomy versus 33% for PTA
and 32% for stenting. In the analyzed data, no distinction was made between the different
atherectomy systems. Multivariable Cox regression showed a 10% to 14% increased risk
of adverse outcomes after atherectomy compared to PTA, which was statistically significant
only for MALEs (HR: 1.14; 95% CI, 1.06–1.30). Nearly 1 in 3 patients undergoing atherectomy
experienced a MALE within five years. Mentioned risks included embolization rates
ranging from 4% to 21%, necessitating the use of embolic protection devices in high-risk
cases [35].
Another retrospective analysis of adverse event reports from the FDA’s MAUDE database
(n=500) provided insights into real-world complications associated with the Jetstream
Atherectomy System for the treatment of PAD. The most frequently reported patient-related
events were embolism (4.4%), dissection (3.4%), and vessel perforation (2.4%). Device
malfunctions included guidewire entrapment (27%), loss of blade rotation (23%), and
aspiration failure (20%) [36]. These device malfunctions, which are likewise encountered in daily routine, underscore
the importance of proper device handling and technique to mitigate avoidable complications.
Regarding embolic protection devices (EPDs), several studies demonstrate a clear benefit
compared to atherectomy without a filter system. Banerjee et al. showed that the use
of the Nav-6 filter during Jetstream atherectomy in complex infrainguinal PAI was
associated with numerically lower rates of distal embolization (1.8% vs. 8%; p<0.10)
without increasing rates of death or amputation. The filter was more frequently used
in longer lesions (146 ± 106 mm vs. 91 ± 72 mm; p<0.01), more severe stenoses (95%
vs. 87%; p<0.04) and chronic total occlusions (33% vs. 8.3%; p<0.01) [37]. A comparison and analysis between the Nav-6 EPD and the Spider FX EPD exhibited
similar effectiveness in preventing major adverse events (MAEs) in patients with symptomatic
PAD, with no significant differences in individual types of MAEs or total number of
MAEs between the two groups [38]. In another two-center study, a high rate of peripheral embolization (21%) was observed
without the use of distal embolic protection [39].
However, a retrospective study from Fereydooni et al. analyzed the impact of EPDs
during atherectomy for peripheral vascular interventions using data from 21,500 procedures.
Despite an increase in EPD use from 8.8% to 22.7% (p<0.003) over time (2010–2018),
propensity-matched analysis (1,007 patients per group) found no significant difference
in short-term outcomes (distal embolization, technical success or 30-day mortality)
or 1-year outcomes (primary patency, amputation rates, reintervention or mortality).
These findings suggest that EPDs add cost and fluoroscopy time without improving clinical
outcomes [40].
Vessel perforation is another significant complication, particularly in severely calcified
and curved or elongated lesions, with rates ranging from 2% to 7% in several studies
[41]. Other reported complications include slow-flow phenomena, abrupt vessel closure
and in rare cases, acute limb ischemia due to large plaque embolization [5]. Therefore, thrombus aspiration techniques should be readily available during the
procedure.
Cost-effectiveness remains a debated issue, as atherectomy is significantly more cost-intensive
than PTA or DCB alone [42]. Some cost-analysis models suggest that routine atherectomy may not be justified
unless used in highly selective patient populations, such as those with heavy calcification,
in-stent restenosis, or if a mobile segment is affected [43].
Finally, operator experience and institutional expertise play crucial roles in procedural
success. Additionally, the lack of standardization in patient selection, procedural
technique, and adjunctive therapies further complicates the assessment of atherectomy’s
overall benefit.
Future Perspectives and Clinical Recommendations
Future Perspectives and Clinical Recommendations
Future research should focus on large-scale randomized controlled trials (RCTs) comparing
atherectomy plus DCB versus DCB alone or atherectomy plus DCB versus stent-preferred
strategy in both femoropopliteal and BTK disease. Accordingly, there is also a need
for studies investigating the long-term clinical impact of atherectomy [44]. Standardized patient selection criteria and procedural guidelines must be established
to optimize treatment outcomes and improve reproducibility across different healthcare
centers.
In the future, the use of intravascular ultrasound (IVUS) should be adopted more widely
in PAD treatment to accurately assess vessel size, plaque burden, and to optimize
the atherectomy itself. For example, IVUS was already used as early as 2015 in the
Jetstream Calcium Study to assess lumen gain following atherectomy [45]. In another retrospective analysis of 43 patients undergoing peripheral endovascular
interventions, vessel diameters assessed by digital subtraction angiography were compared
to those measured using IVUS. Angiographic estimations, performed independently and
blinded to IVUS data, consistently underestimated vessel size, particularly in female
patients. IVUS provided more accurate and detailed measurements of the arterial lumen,
highlighting its potential value in guiding treatment decisions [46].
The now-discontinued Pantheris atherectomy system by Avinger, Inc. combined directional
atherectomy with optical coherence tomography guidance (OCT). OCT-guided atherectomy
has proven to be a safe and effective approach for treating femoropopliteal disease.
The enhanced precision offered by optical coherence tomography allows for more thorough
plaque removal while minimizing damage to the vessel wall [47]. A combination of atherectomy and IVUS within a single device would therefore also
be an interesting approach.
Accordingly, it is important for the future to develop and evaluate new atherectomy
systems, in order to achieve more effective and safer vessel preparation and ultimately
improve outcomes for PAD patients. A retrospective, nonrandomized study evaluated
the novel ByCross atherectomy system in 39 patients with 41 complex femorodistal arterial
lesions, achieving acute procedural success in 95.1% of cases, including 26.8% without
wire guidance. At six months, the mean stenosis was reduced from 96.4% to 21.7%, with
a low MAE rate and no device-related complications at 30 days, despite no use of embolic
protection. These results suggest that the ByCross system is safe and effective for
crossing and treating complex lower-extremity arterial occlusions, with high success
rates and sustained patency. Long-term data have not yet been published [48].
Overall, we see the diverse possibilities of atherectomy as a significant expansion
of endovascular treatment options.
In our clinical experience with more than 2,000 atherectomy procedures in recent years,
such as in long-segment femoropopliteal occlusions, vessel preparation using atherectomy
is safe and beneficial with a low rate of stent-implantation.
Achieving good results requires careful intraluminal crossing of the lesion. If necessary,
additional retrograde crural access can facilitate intraluminal probing of a femoropopliteal
lesion in most cases [49]
[50].
[Table 2] summarizes subjective, experience-based indications, based on our daily clinical
practice, for specific atherectomy devices according to lesion morphology.
Table 2 Subjective, experience-based indications for specific atherectomy devices according
to lesion morphology. Grading of recommendation: – : not recommended; x: conditionally
recommended; xx: recommended; xxx: highly recommended.
|
Device
|
Jetstream
|
Phoenix
|
HawkOne
|
Diamond-back
|
Turbo-Elite
|
Rotarex
|
|
Type
|
Rotational
|
Rotational
|
Directional
|
Orbital
|
Laser
|
Rotational
|
|
Eccentric lesion
|
x
|
–
|
xxx
|
x
|
x
|
–
|
|
Soft/fibrotic plaque
|
xx
|
x
|
xx
|
–
|
x
|
x
|
|
Thrombotic lesion
|
xx
|
x
|
x
|
–
|
xx
|
xxx
|
|
Calcified lesion
|
xxx
|
x
|
x
|
xx
|
–
|
–
|
|
Chronic total occlusion
|
xxx
|
x
|
x
|
–
|
x
|
x
|
|
In-stent restenosis
|
xx
|
x
|
xxx
|
–
|
x
|
–
|
|
In-stent restenosis with thrombus
|
xxx
|
xx
|
xx
|
–
|
xx
|
xxx
|
Conclusion
Atherectomy remains a promising technique in the context of modern PAD treatments.
While it provides plaque debulking/modification and vessel preparation advantages,
its long-term patency benefits need to be investigated further.
Patient selection, lesion characteristics, and device-specific factors should guide
its use to ensure optimal outcomes in PAD revascularization.
