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https://doi.org/10.1177/1526602818763352
Journal of Endovascular Therapy
1 –9
© The Author(s) 2018
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DOI: 10.1177/1526602818763352
www.jevt.org
A SAGE Publication
Clinical Investigation
Introduction
Vascular calcification is a common finding in peripheral
artery disease (PAD) and may represent a significant chal-
lenge for endovascular therapy.1 The length of disease and
degree of calcification are thought to be major contributors
to technical failure rates, which may have an incidence as
high as 25% for chronic total occlusions (CTOs) of the fem-
oropopliteal segment.2,3 Moreover, severe calcification can
compromise the intraluminal passage of guidewires and
balloon catheters, forcing them into a subintimal plane that
may result in reentry failure. It may also act as a physical
impediment to stents and antirestenotic therapies such as
763352JETXXX10.1177/1526602818763352Journal of Endovascular TherapyDias-Neto et al
research-article2018
1Department of Angiology and Vascular Surgery, São João Hospital
Center, Porto, Portugal
2Cardiovascular Research Center, Faculty of Medicine, University of
Porto, Portugal
3Division of Interventional Angiology, University Hospital Leipzig, Germany
4Vascular Surgery, University Hospital Leipzig, Germany
5Faculty of Medicine, University of New South Wales, Sydney, New
South Wales, Australia
6Department of Surgery, Prince of Wales Hospital, Randwick, New
South Wales, Australia
Corresponding Author:
Marina Dias-Neto, Rua do Amial, n° 507 1° esquerdo, Porto, 4200-061,
Portugal.
Email: marina_f_neto@hotmail.com
Endovascular Treatment of Severely
Calcified Femoropopliteal Lesions Using
the “Pave-and-Crack” Technique: Technical
Description and 12-Month Results
Marina Dias-Neto, MD/MSc1,2 , Manuela Matschuck, MD3,
Yvonne Bausback, MD3, Ursula Banning-Eichenseher, PhD3,
Sabine Steiner, MD, MSc3, Daniela Branzan, MD4, Holger Staab, MD4,
Ramon L. Varcoe, MBBS, MS, FRACS, PhD5,6 , Dierk Scheinert, MD, PhD3,
and Andrej Schmidt, MD, PhD3
Abstract
Purpose: To report midterm results of the “pave-and-crack” technique to facilitate safe and effective scaffolding of heavily
calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. Methods: Data were collected
retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November
2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions
were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly
two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting,
the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then
implanted to “pave” the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque
was “cracked” before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were
estimated using the Kaplan-Meier method. Results: Procedural success was achieved in 100% and technical success (residual
stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera.
Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days,
and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI
patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%,
respectively; freedom from TLR was 85%. Conclusion: Despite severe lesion calcification, patients experienced high technical
success and a safe and durable therapy at midterm follow-up with the femoropopliteal “pave-and-crack” technique.
Keywords
angioplasty, calcification, endovascular treatment, femoropopliteal segment, interwoven stent, occlusion, peripheral artery
disease, popliteal artery, stenosis, stent, stent-graft, superficial femoral artery
2 Journal of Endovascular Therapy 00(0)
drug-coated balloons (DCBs), as evidenced by worse
patency outcomes in this group.1,4,5
The presence of vessel wall calcification is a predictor of
poor clinical outcome after revascularization. Although the
exact etiology is not certain, a heavy burden of calcified
plaque is known to result in increased rates of restenosis,
patency loss, and inferior rates of amputation-free sur-
vival.1,6 It is thought that this may relate to lumen compro-
mise and increased vessel recoil with standard angioplasty
and early-generation stents. The prognostic value of severe
calcification cannot be ignored and certainly underscores
the importance of strategies to overcome residual stenosis
and recoil using the latest in angioplasty and stenting
techniques.
The “pave-and-crack” technique was first described by
the Malmö group in iliac arteries to facilitate the safe intro-
duction of aortic stent-grafts through diseased access ves-
sels.7 It involves first lining those arteries with a covered
stent, followed by an aggressive balloon dilation to facili-
tate the introduction of the main aortic stent-graft. That
same concept has been used by our group to treat severely
calcified femoropopliteal occlusive disease as a strategy to
allow safe arterial wall dissection and/or perforation prior
to definitive endovascular treatment. The aggressive predi-
lation was followed by implantation of Supera stents
(Abbott Vascular, Santa Clara, CA, USA) to provide high
radial force to resist elastic recoil and extrinsic compression
from plaque. This report provides a detailed description of
the technique in the setting of femoropopliteal disease, doc-
uments its safety, and analyzes midterm outcomes.
Methods
Study Design and Patient Population
A retrospective study was conducted of 67 consecutive
PAD patients (mean age 71±8 years; 54 men) who under-
went the femoropopliteal pave-and-crack technique during
endovascular treatment at a single center between September
2011 and February 2017. All patients provided written
informed consent.
Cardiovascular risk factors were frequent in this cohort
and significant medical comorbidities were prevalent (Table
1). Most patients (52/65, 80%) presented with or had been
treated for symptomatic contralateral arterial disease and
had a high prevalence of past ipsilateral surgical and/or
endovascular target vessel procedures (45/67, 67%).
Furthermore, 15% (10/66) had a history of unsuccessful tar-
get limb revascularization attempts in other hospitals before
referral to our center.
Most patients had Rutherford category 3 ischemia
(40/64, 62%), and a third (22/64, 34%) had critical limb
ischemia. The superficial femoral artery (SFA) and the first
segment of the popliteal artery were the most frequently
affected regions. However, the second and the third seg-
ment of the popliteal artery were also diseased in 54% and
23% of patients, respectively. The femoropopliteal lesions
were predominately classified as TASC (TransAtlantic
Inter-Society Consensus) D (52/67, 78%; Table 2); CTOs
were common (61/66, 92%). The mean lesion length was
26.9±11.2 cm.
Calcification of target lesions was characterized using
two scoring systems based on biplanar fluoroscopy and
digital subtraction imaging. The Peripheral Artery Calcium
Scoring System (PACSS), described by Rocha-Singh et al,8
was used to quantify intimal and medial vessel wall calcifi-
cation. PACSS stratifies calcium degree in 5 grades: grade
0, no visible calcium at the target lesion site; grade 1, unilat-
eral calcification <5 cm long; grade 2, unilateral calcifica-
tion ≥5 cm; grade 3, bilateral wall calcification <5 cm; and
grade 4, bilateral calcification ≥5 cm. Two-thirds (40/64,
62%) of the target lesions exhibited PACSS grade 4.
An additional classification of “severe” calcification was
used to represent the same definition utilized commonly in
clinical trials as an exclusion criterion. This was defined as
Table 1. Demographics and Clinical Characteristics of the 67
Patients in the Study.a
Age, y 71.4±8.5
Men 54/67 (81)
Diabetes 32/67 (52)
Smoking (previous or current) 49/62 (79)
Dyslipidemia 60/67 (90)
Hypertension 65/67 (97)
Coronary artery disease 30/66 (46)
Chronic heart failure (NYHA II and III) 12/65 (10)
Cerebrovascular disease 16/66 (24)
Chronic renal insufficiency (grade 2–5) 24/46 (52)
Chronic pulmonary obstructive disease 12/62 (19)
Contralateral treated or symptomatic disease 52/65 (80)
Previous surgical or endovascular treatment
of target limb
45/67 (67)
Previous surgical treatment of target lesionb29/67 (43)
Previous endovascular treatment of target
lesion
18/67 (23)
Previous failed target lesion revascularization 10/66 (15)
Baseline Rutherford category
2 2/64 (3)
3 40/64 (62)
4 4/64 (6)
5 13/64 (20)
6 5/64 (8)
Ankle-brachial index 0.56±0.52
Abbreviations: NYHA, New York Heart Association classification for
heart failure.
aContinuous data are presented as the means ± standard deviation;
categorical data are given as the count/sample (percentage).
bFemoropopliteal or femoral–below-knee bypass or femoral
thromboendarterectomy.
Dias-Neto et al 3
dense circumferential calcification continuously extending
>5 cm prior to contrast injection. According to this defini-
tion, severe calcification was present in 61% (40/66).
Procedure Description
During the study period all lesions underwent attempted
revascularization regardless of the calcification grade. The
pave-and-crack technique was used for most severely calci-
fied lesion segments, and it was intended that a Supera stent
would be implanted in all cases to facilitate lumen gain. A
variety of techniques were used for the lesser calcified seg-
ments proximal and/or distal to the target segment (eg,
DCBs as standalone therapy or in combination with any bare
nitinol, Supera, or drug-eluting stent; Table 3). An example
of a typical case is provided in Figure 1.
As balloon dilation of a severely calcified femoropopli-
teal segment may invoke significant pain, local tumescent
anesthesia was sometimes administered over the whole
length of the calcified segment. After anesthetizing the skin,
a 9-cm, 21-G needle (Cook Medical, Bloomington, IN,
USA) was directed to the calcified area using fluoroscopy.
Periadventitial needle tip position was confirmed by observ-
ing movement of the calcified blood vessel under the tip of
the needle while in close proximity and by changing the
C-arm position to observe the needle tip relative to the
artery in multiple projections. Injection of lidocaine 1% was
performed every 2 to 3 cm along the blood vessel, with the
intention that the fluid would spread circumferentially and
longitudinally in the periadventitial space. Complete anes-
thesia of the SFA from its origin to the adductor canal com-
monly required 2 to 3 skin penetrations; the first popliteal
segment could also be anesthetized with the needle placed
in a caudal direction.
Arterial access was obtained with 6- to 8-F sheaths via
an antegrade ipsilateral (Radiofocus Introducer; Terumo,
Tokyo, Japan) or retrograde contralateral crossover
approach (Balkin; Cook Medical). In cases of a stenotic tar-
get lesion, crossing was performed with a 0.018-inch guide-
wire [either a V-18 Control (Boston Scientific, Marlborough,
Table 2. Angiographic Characteristics.a
TASC II class
B 4/67 (6)
C 11/67 (16)
D 52/67 (78)
Lesion length, cm 26.9±11.2
Chronic total occlusion 61/66 (92)
Target lesion location
SFA 63/67 (94)
P1 47/65 (72)
P2 35/65 (54)
P3 15/64 (23)
Calcification (PACSS)
1 3/64 (5)
2 2/64 (3)
3 19/64 (30)
4 40/64 (62)
Severe calcificationb40/66 (61)
Runoff vessels
0 1/62 (2)
1 19/62 (31)
2 26/62 (42)
3 16/62 (26)
Abbreviations: P1-P3, segments of the popliteal artery; PACSS,
Peripheral Artery Calcium Scoring System; SFA, superficial femoral
artery; TASC, TransAtlantic Inter-Society Consensus.
aContinuous data are presented as the means ± standard deviation;
categorical data are given as the count/sample (percentage).
bDense circumferential calcification and calcification extending >5 cm in
length prior to contrast injection.
Table 3. Procedure Characteristics.a
Maximum balloon diameter, mm
5 3/59 (5)
6 28/59 (47)
7 21/59 (36)
8 5/59 (9)
9 2/59 (3)
Use of high pressure or cutting
balloon
23/65 (35)
Perforation 39/66 (59)
Viabahn cumulative length, cm 16.5±8.7 (n=51)
Viabahn maximum diameter, mm
5 2/67 (3)
6 34/67 (51)
7 28/67 (42)
8 3/67 (5)
SUPERA cumulative length, cm 22.9±12.0 (n=51)
SUPERA maximum diameter, mm
5 32/67 (48)
6 34/67 (51)
7 1/67 (2)
Additional procedures
Iliac 4/66 (6)
Femoropopliteal 42/66 (62)
DCB 24/64 (37)
Nitinol stent 18/64 (25)
DES 11/64 (17)
Other 5/64 (8)
BTK 13/67 (19)
Manual aspiration thrombectomy 1/67 (2)
Procedure duration, min 125±43 (n=67)
Radiation
Dose area product, Gy∙cm250.0±39.0 (n=51)
Fluoroscopy time, min 40±16 (n=52)
Abbreviations: BTK, below-the-knee; DCB, drug-coated balloon; DES,
drug-eluting stent.
aContinuous data are presented as the means ± standard deviation;
categorical data are given as the count/sample (percentage).
4 Journal of Endovascular Therapy 00(0)
MA, USA) or Connect (Abbott Vascular)]. For CTOs, a
0.035-inch stiff angled Glidewire (Terumo) was chosen. If
it was not possible to reenter the distal reconstituted seg-
ment of the artery, either a reentry system was used or a
retrograde approach was performed in conjunction with the
reversed combined antegrade retrograde tracking (CART)
or double-balloon technique.9–11
As previously described,12 thorough predilation of the
lesion is crucial to avoid elongation of the Supera stent dur-
ing deployment. Balloon diameter must be at least equal to
the reference vessel diameter (RVD) and outer diameter
(OD) of the Supera stent. Semicompliant balloons (Pacific
or Admiral; Medtronic, Minneapolis, MN, USA) were used
for the principle dilation. A strategy of oversizing the bal-
loons by at least 0.5 mm was adopted (eg, a 6-mm balloon
was used to implant a 5-mm OD Supera stent) to account
for recoil in these recalcitrant lesions. Care was taken to
observe full expansion of the balloon in every case. If this
was not achieved, a short balloon of the same diameter was
chosen to apply focal pressure at the site of residual steno-
sis. If this second balloon was unsuccessful, a scoring bal-
loon (VascuTrak; Bard Peripheral Vascular, Tempe, AZ,
USA) or high-pressure, noncompliant balloon (Conquest;
Bard Peripheral Vascular) was used. Finally, if that strategy
was unsuccessful, a larger-diameter (1- or 2-mm) high-
pressure balloon was used.
In the initial experience with this technique, if a perfora-
tion occurred too severe to control with balloon tamponade,
a Viabahn stent-graft (W.L. Gore & Associates, Flagstaff,
AZ, USA) was implanted. Later, the technique was modi-
fied to implant a Viabahn when a perforation was antici-
pated. Criteria for a pending rupture were (1) incomplete
opening at 24 atmospheres of a balloon sized at least 1 mm
larger than the RVD or (2) complete plaque recoil that
required a high-pressure balloon and/or upsizing to 2 mm
over the RVD. After Viabahn implantation, care was taken
to confirm “cracking” of the plaque so that significant recoil
would be diminished.
A final maneuver was to reline the Viabahn with Supera
stents appropriately sized with an OD matching the Viabahn
(eg, 6.5-mm OD Supera into a 7-mm Viabahn). This was
thought necessary because it was either observed or esti-
mated that the Viabahn would be too pliant to resist the
remaining recoil forces even after cracking the plaque.
Follow-up Protocol
All patients received an early duplex ultrasound examina-
tion of the access sites and target lesion to rule out access
complications and confirm patency of the target vessel on
the first postprocedure day. Dual antiplatelet therapy was
utilized for a minimum of 6 months following Viabahn
implantation, followed by lifelong monotherapy with either
aspirin (100 mg/d) or clopidogrel (75 mg/d).
Outcome Measures and Definitions
Procedural success referred to the ability to implant the
stents as intended, while technical success was successful
revascularization with <30% residual stenosis and no com-
plications, such as embolization, access site pseudoaneu-
rysm, or hemorrhage. Dissection and perforation of the
target lesions were not considered complications as they
commonly occurred during optimized vessel preparation
with predetermined use of a covered stent.
Midterm outcomes were assessed by analyzing primary
and secondary patency, freedom from target lesion revascu-
larization (TLR), freedom from amputation, patient sur-
vival, and changes in Rutherford category and ankle-brachial
index (ABI) at 6 and 12 months. Major adverse cardiac
events (MACE), which included myocardial infarction,
stroke, or death, were evaluated at 30 days and 6 and 12
Figure 1. (A) Mid to distal, heavily calcified superficial femoral artery (SFA) occlusion. (B) Local anesthesia of the SFA occlusion using
a 9-cm, 21-G needle. (C) Incomplete expansion of a 6×40-mm balloon due to severe calcification. (D) Result after predilation showing
significant residual stenosis. (E) After deployment of a 7×150-mm Viabahn, aggressive and safe dilation using a 7×20-mm high pressure
balloon to achieve optimal vessel preparation. (F) Despite “cracking” the plaque, there is residual stenosis (black arrows) due to
recoil. (G) Result and outflow after relining with Supera stents.
Dias-Neto et al 5
months, as were major adverse limb events (MALE),
defined as amputation above the ankle or any reintervention
(endovascular or open) due to target lesion occlusion.
Statistical Analysis
Patient characteristics at baseline were summarized using
counts and percentages for nominal data and mean ± stan-
dard deviation for continuous data. The Wilcoxon sign-rank
test or paired sample t test were used for comparison of
paired ordinal or continuous variables, respectively. Kaplan-
Meier curves were used to estimate midterm outcomes. The
threshold of statistical significance was p<0.05. Statistical
analyses were performed using SPSS software (version 24;
IBM Corporation, Armonk, NY, USA).
Results
Local anesthesia was the norm; general anesthesia was per-
formed in only 2 cases during the early phase of our experi-
ence. Periadventitial local anesthesia was used in 24 (36%)
procedures to improve patient tolerance to the aggressive dila-
tion. Retrograde access was performed in 47 (70%) patients [7
SFAs, 19 crural arteries, and 6 dual distal punctures (most
often distal SFA and a crural artery); 5 cases had an unidenti-
fied retrograde puncture site]. Reentry systems were used in 12
(18%) cases, more commonly in the early phase of our experi-
ence and from an antegrade direction to facilitate reentry into a
balloon introduced from a retrograde direction. In only 2 cases
was a reentry system used without a bidirectional approach.
High pressure or cutting balloons were used (23/65,
35%) to facilitate successful dilation; more than half the
procedures were associated with perforation (39/66, 59%).
Forty-two procedures included additional femoropopliteal
interventions; the use of DCB was the most frequent com-
plementary treatment. Mean duration of all interventions
was 125±43 minutes with a fluoroscopy time of 40±16 min-
utes. The mean cumulative stent lengths were 16±9 cm for
the Viabahn and 23±12 cm for the Supera.
Early Outcomes
Procedural success was achieved in 100% and technical
success in 98% (66/67). A single patient demonstrated
residual stenosis >30% due to elastic recoil. Only 2 compli-
cations occurred: an intraprocedural distal embolization,
which was successfully treated with aspiration thrombec-
tomy and thrombolysis, and a pseudoaneurysm at the con-
tralateral femoral access site, which was successfully
resolved with manual compression. Two CLI patients died
within 30 days (3% MACE), and 3 patients (all claudicants)
underwent a TLR (4% MALE). There was a statistically
significant improvement in ABI (pre 0.56±0.52 vs post
0.96±0.19, p<0.001) after the procedure (Figure 2A).
Midterm Outcomes
Mean follow-up was 19±18 months, during which 19 (28%)
patients were lost to follow-up. Forty-eight patients had the
first follow-up at a mean 13 months after the intervention,
and 25 had a second follow-up at a mean 21 months. ABI
(Figure 2A) and Rutherford category (Figure 2B) at the 2
follow-up periods (Figure 2) were improved compared to
baseline.
Figure 2. (A) Box plot of the ankle-brachial index before (pre) and after (post) intervention and at the first (FU1) and second (FU2)
follow-up visits. Boxes are the 25th and 75th percentiles, the line is the mean, the whiskers are the minimum and maximum, and the
circles are outliers. (B) Bar graph of the Rutherford category changes from baseline to the first (FU1) and second (FU2) follow-up
visits.
6 Journal of Endovascular Therapy 00(0)
Primary and secondary patency estimates according to
the Kaplan-Meier analysis were 79% and 91%, respec-
tively, at 12 months (Figure 3A). In patients treated for
restenosis vs de novo disease, 12-month primary patency
estimates were 74% vs 95%, respectively, and secondary
patency 86% vs 100% (p>0.05).
Freedom from TLR was 85% (Figure 3B) at 12
months. All 7 cases requiring reintervention had occlu-
sion of the target lesion site. Freedom from major ampu-
tation for the 22 CLI patients was 100% and 90% at 6 and
12 months, respectively. One CLI patient (Rutherford
category 5) underwent the only major amputation at 8
months.
Two CLI patients died during follow-up (in the 6- and
12-month intervals). Patient survival was 93% and 90% at 6
and 12 months. For the entire series, MALE occurred in 9%
at 6 months and 12% at 12 months; in the subgroups, the
MALE estimates were 12% at 6 months and 14% at 12
months for claudicants and 4% at 6 months and 9% at 12
months for CLI patients.
Discussion
The pave-and-crack technique was created for use in
endovascular aneurysm repair procedures to facilitate the
introduction of stent-grafts through tight and calcified
iliac arteries. To our knowledge, no one has described this
technique in the femoropopliteal segment. In our experi-
ence, the strategy of accepting or intentionally inducing a
perforation enabled treatment of highly complex lesions,
very often with the highest levels of calcification, achiev-
ing excellent technical success with very few complica-
tions and good outcomes in short-term follow-up.
Severe calcification is recognized as a factor that
increases the technical difficulty and reduces the durability
of endovascular therapy in the femoropopliteal region.5 For
this reason, the TASC II consensus article assigns occlusive
lesions within severely calcified blood vessels to the more
complex categories.13 Furthermore, certain treatment
options may be inherently limited by calcification. A pro-
spective registry of femoropopliteal lesions treated with
DCBs showed that patency was inferior for the treatment of
calcified lesions compared to those less severely affected.4
While some believe that atherectomy devices are useful in
debulking the calcified lesion, alone or in combination with
DCBs,14–16 atherectomy may be cumbersome and in our
opinion less effective in the treatment of extremely calcified
lesions. Illustrating this point, a recent study evaluating
moderate to severely calcified femoropopliteal lesions dem-
onstrated that they were left with a core laboratory–adjudi-
cated 33% residual diameter stenosis after treatment with
directional atherectomy.14
Figure 3. Kaplan-Meier estimates of (A) primary and secondary patency and (B) freedom from target lesion revascularization (TLR).
Dias-Neto et al 7
There are also limitations with the current generation of
nitinol stents used in heavily calcified arteries. In a registry
evaluating patients treated for calcified femoropopliteal
occlusions using a reentry system followed by implantation
of laser-cut nitinol stents, there was a high proportion of
residual stenosis (≥30%) seen in 43% of cases.1 Those
patients with residual stenosis in turn had inferior 12-month
patency compared to patients successfully treated.1
The interwoven Supera nitinol stent has significantly
higher radial resistive force and crush resistance than laser-
cut stents, which may be ideal qualities for calcified
lesions.17–19 However, the design of the Supera stent requires
sufficient space in the lumen to facilitate complete stent
expansion and avoid elongation, a factor known to reduce
patency.19 Aggressive predilation and balloon oversizing
may be necessary to create that space; however, such
aggression in calcified arteries brings with it a significant
risk of perforation. In a small series that examined 34
patients (55% with severe calcification) treated with the
Supera stent, 5 (15%) patients developed a pseudoaneu-
rysm after vessel preparation.20 In our series, the rate of per-
foration was even higher (at least 59%), possibly due to the
even greater proportion of severely calcified lesions. These
studies demonstrate that aggressive dilation in advanced-
stage disease can lead to complications if not anticipated
and sealed during the intervention itself.
At the beginning of this experience, the Viabahn stent-
graft was used following a perforation that could not be
sealed by prolonged balloon dilation. However, our expe-
rience has led us to conclude that preplanned Viabahn
implantation is a more practicable compared with selec-
tive use and a safer method to prevent significant extrava-
sation. It also has the additional benefit of protecting the
subsequent balloons from rupture due to the sharp shards
of calcified plaque.
Our method of using Supera stents after implantation of
a Viabahn stent-graft is somewhat unconventional and has
been applied to take full advantage of the individual prop-
erties of each device. While the stent-graft provides a
mechanical barrier to facilitate exaggerated balloon dila-
tion, the Supera is used to overcome what is typically con-
siderable elastic recoil. The crush resistance of Viabahn is
usually insufficient to maintain a stenosis-free channel in
such blood vessels. By selectively using the two devices
Viabahn implantation could be reserved for the most calci-
fied segments of the lesion. The Supera stent would be
placed within it and usually extend proximally and distally
into segments where preparation of the artery was not so
problematic. Whether it could be sufficient to place a
Viabahn and break the plaque recoil forces by aggressive
dilation without relining with a Supera stent would be
another technique that needs to be investigated. Obviously,
this strategy would be less costly. However, since the tech-
nique described was reserved for extreme calcification,
which is seen infrequently (67 cases in a 5-year period),
costs were considered to be less important.
Our technique of fluoroscopically guided local anes-
thesia application to the periadventitial space around cal-
cified plaque warrants additional discussion. Aggressive
balloon dilation can be very painful, so much so that some
of our first cases were conducted under general anesthesia.
Later we found the tumescent application of 1% lidocaine
highly effective at preventing pain and avoiding more
intrusive anesthetic. Even long lesions of the femoropop-
liteal segment can be reached with a 9-cm-long, 21-G
needle with very few transitions through the skin by
directing the needle in the cranial or caudal direction. To
the best of our knowledge, this useful technique has not
been previously described.
In our series, 79% 12-month primary patency was
achieved for these complex femoropopliteal lesions,
which is in line with the 72% to 75% rates reported by
studies using Viabahn alone in long lesions.21–24 Studies
that have evaluated the use of the Supera stent in less com-
plex lesions demonstrated 1-year primary patency rates
between 79% and 94%.12,18–20,25 While the results from
those 2 strategies and our combined method appear simi-
lar, it is worth considering that our outcomes were achieved
in a group of patients with considerably longer lesions
(mean length 27 cm), a high rate of previous open or endo-
vascular limb treatment, and especially a high percentage
of severe calcification according to the PACSS, which
would have seen 61% of our cohort excluded from most
other endovascular device trials.
There is a suggestion in the literature that both the diam-
eter and oversizing of the Viabahn stent-grafts may have an
influence on long-term outcome. In a large series of 315
patients treated with covered stents for SFA disease, Kruse
et al22 found that the diameter of the Viabahn was a factor in
predicting better patency, with 7-mm stent-grafts superior at
5-year follow-up compared with smaller diameters. Another
study reported that greater oversizing detrimentally affects
the outcome of covered stents and may lead to inferior
results.26 Our pave-and-crack technique provides the oppor-
tunity to implant larger-diameter stent-grafts due to the
aggressive predilation of the artery. In 46% of our cases it
was possible to implant 7- or 8-mm-diameter Viabahns,
whereas in the Kruse series22 only 14% received ≥7-mm-
diameter stent-grafts. Aggressive postdilation and “crack-
ing” of the calcification with balloons as large as the
Viabahn itself also generates an opportunity to reduce over-
sizing by creating additional space. These factors each have
the potential to improve long-term outcomes.
The final advantage of this technique may be its potential
to reduce peripheral embolization. Patients with TASC D
lesions are at the highest risk of embolization after angio-
plasty, stenting, or atherectomy.14,27,28 Combining heavily
diseased and calcified arteries with the mandatory predilation
8 Journal of Endovascular Therapy 00(0)
required for the Supera stent brings with it a theoretically
increased risk of embolization, and the preimplantation of a
Viabahn stent-graft has the potential to mitigate that risk.
Limitations
This study was limited by the typical weaknesses inherent to
its retrospective nature; it was prone to selection bias, and the
cases selected were heterogeneous. There was also no core
laboratory–adjudicated analysis of the angiographic features
and degree of calcification of the target lesions. The method of
calcification scoring used has its own limitations and does not
fully describe the difficulty in passing a lesion or effectively
dilating the balloon during endovascular treatment. Due to the
tertiary referral nature of the center, loss to follow-up was sig-
nificant. This may affect the reliability of the reported longev-
ity of the procedure, but it does not diminish the value of the
technique itself. Patency is probably rather influenced by long
lesion length, and severe calcification does not play a domi-
nant role since no residual stenosis is left behind.
Conclusion
This study presents a novel endovascular strategy to deal
with severely calcified femoropopliteal lesions. Patients
from this series had extremely long, complex, and especially
calcified lesions, more so than those seen in comparable
endovascular studies. Despite that, there was excellent tech-
nical success, safety, and durable results to 12 months, which
supports the conclusion that the technique has promise and
warrants further application and study.
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: Dierk Scheinert is a consultant for Abbott, Biotronik, Boston
Scientific, Cook Medical, Cordis, C.R. Bard, Hemoteq, and
Medtronic and former stockholder in IDEV Technologies. Andrej
Schmidt is a consultant for Abbott, C.R. Bard, Boston Scientific,
Cook, Cordis, Intact Vascular, Medtronic, and Upstream Peripheral
and former stockholder in IDEV Technologies. Ramon Varcoe is a
consultant for Abbott, Boston Scientific, and Medtronic.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iDs
Marina Dias-Neto https://orcid.org/0000-0002-7934-2016
Ramon L. Varcoe https://orcid.org/0000-0001-5611-6991
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