Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3803_Библиотеки_им_академика_М_И_Перельмана
.pdf
Chapter 10
https://t.me/medicina_free
Preserving Vessel Integrity andReducing
Vascular Recoil withFocal Force Balloons
EfeK.Lambrinos, EdwardD.Tubberville, VinayakSubramanian,
andGeorgeL.Adams
Introduction
Percutaneous angioplasty (PTA) has been the trailblazer in the management of vascular disease for many years. More innovative tools have been created to treat various types of arterial lesions as the understanding of peripheral arterial disease has
advanced. Scoring balloons and focal force balloon technologies have become an
essential part of the interventionalist’s equipment. The “leave nothing behind” strategy has gained traction over the years due to the prevalence of in-stent restenosis
and vessel recoil following peripheral vascular interventions (PVI). This method
intends to diminish the development of permanent vascular prosthesis, which can
likely allow for future restenosis [1, 2]. Furthermore, recent developments in drug
technology have allowed for even more strides in the individualization of patient
care. In the following chapter, we will review the techniques utilizing focal force
and scoring balloons for vessel preparation and further evaluate the literature for the
use of such devices.
E. K. Lambrinos · E. D. Tubberville
Campbell University School of Osteopathic Medicine, Raleigh, NC, USA
e-mail: e_lambrinos1012@email.campbell.edu; edtubbervill0919@email.campbell.edu
V. Subramanian
Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA
e-mail: Vinayak.subramanian@utsouthwestern.edu
G. L. Adams (*)
UNC -Medical Center, Chapel Hill, NC, USA
e-mail: george.adams@unchealth.unc.edu
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2022
N. W. Shammas (ed.), Peripheral Arterial Interventions, Contemporary
Cardiology, https://doi.org/10.1007/978-3-031-09741-6_10
195
196
https://t.me/medicina_free
The idea of vessel preparation has become mainstreamed among endovascular
specialists specically aiming to treat patients with infrainguinal arterial disease [3,
4]. Focal force balloons are used mainly for two vessel preparatory purposes, the
rst one being to decrease vessel elastic recoil [5] and the second, to reduce the risk
of perforation and/or dissection [6].
The acknowledgement of the role of plaque characteristics can aid in differentiating between which device is most appropriate for preparing the vessel. Plaque
characteristics span a vast range of features, from including calcic, heterogenous,
and homogenous plaque [7]. Homogenous plaque is linked with thrombus development, typically seen in chronic total occlusions (CTO) and acute occlusions, and
also contains brocalcic or broelastic matter which is often seen in lesions of
chronic stenosis [8, 9]. In contrast, heterogenous plaque is associated with an
increased amount of calcication and cerebrovascular symptoms along with a predominance in carotid artery stenosis when compared to homogenous plaque [10,
11]. Calcied plaque is made of predominantly calcic deposits with a large variety
in presentation and is typically observed as deposits within intimal and medial layer
of the vessel [12]; they are mostly found in diabetic patients or those with chronic
renal insufciency and are commonly found in the blood vessels inferior to the
knee. The evaluation of the various plaque characteristics can be performed by considering the patient risk factors, the angiographic pattern, and the intraprocedural
intravascular ultrasound (IVUS) which allows the angiologist to personalize care
improving outcomes and reducing complications.
E. K. Lambrinos et al.
Functionalities ofBalloon Angioplasty andFocal
Force Balloons
The functionalities of balloon angioplasty are intricate and can be found in other
literature. In summary, a radial circumferential force is administered on the walls of
the individual vessel following the distention of the balloon, thereby causing the
size of the lumen to increase.
The greatest force from the balloon is focused primarily on the disease-free portions of the artery. A large force is also focused on the area between the disease-free
portions and the plaque causing the stenosis [13], followed by an elastic recoil that
presents whenever these over-expanded portions are returned to their normal size. A
potential poor outcome involves an arterial wall dissection that may occur when the
stress produced by the PTA is distributed through a fragile portion of either the
plaque or the vessel itself and is spread down the vessel. In the worst-case scenario,
this stress can produce an arterial perforation.
The purpose of the scoring balloons and focal force is to allow for a progressive
expansion of the vessel by focusing the pressure strictly on the plaque as opposed to
the vessel. A number of different designs have been manufactured to utilize this
strategy (Table10.1).
10 Preserving Vessel Integrity andReducing Vascular Recoil withFocal Force Balloons
https://t.me/medicina_free
Table 10.1 Summary of focal force balloon types and sizes
Focal force balloons
Device name Size range
Peripheral cutting balloon 5–8mm diameter, 15–20mm lengths
Chocolate balloon 2.5–6mm diameter, 40–120mm lengths
Angiosculpt 2–8mm diameter, 10–40mm lengths
VascuTrack 2.0–7.0mm diameter, 20–300mm lengths
FLEX scoring catheter Variable diameter, 40–120cm working length
Fig. 10.1 Peripheral
Cutting Balloon device by
Boston Scientic
Peripheral Cutting Balloon (Boston Scientic) (Fig.10.1)
197
Device Mechanism
The peripheral cutting balloons are standard balloons that include four blades of
microsurgical precision found along the balloon surface, whose function is to make
distinct longitudinal cuts within the plaque. Initially, ination of the balloon occurs
to a pressure of 2atm to set the blades into position, which are then followed by an
ination to nominal pressures of 6atm once in contact with the plaque in order to
cut into the plaque.
Specications
There are two accessible forms of the peripheral cutting balloon: a monorail rapid
exchange (RX) catheter system and an over the wire (OTW). The two balloon
lengths that are currently marketed are 15 and 20mm, with available balloon diameters that span from 5.0 to 8.0mm. Catheter lengths range from 50 to 137cm (OTW)
and 142cm (RX).
198
https://t.me/medicina_free
E. K. Lambrinos et al.
Evidence andUse
Current evidence pertaining to the complexity of cutting balloons (CB) is limited.
RESCUT, the largest randomized controlled trial, analyzed the use of cutting balloons in the coronary arteries for in-stent restenosis [14]. The conclusion of this
study stated that the occurrence of in-stent restenosis did not decrease with the use
of cutting balloon angioplasty. However, it did in fact decrease the quantity of balloons that were required for each intervention and pointed toward a decrease in a
need for the use of stenting. Within the femoropopliteal arteries, studies have indicated safety in the treatment of these lesions. The use of cutting balloons in contrast
to plain old balloon angioplasty (POBA) in small (dened as <5cm) focal femoropopliteal lesions was analyzed in a randomized controlled trial [15, 16]. The study
concluded that POBA was superior to cutting balloon angioplasty and that cutting
balloon angioplasty, at 6months, has greater rates of restenosis. Furthermore, PTA
use was weighed against CB-PTA use in a prospective study involving 83 patients
with femoropopliteal lesions of short calcied occlusive nature (<3cm). This study
concluded that elastic recoil, arterial perforations, and dissections requiring stenting
were not experienced by lesions treated with CB-PTA, along with rates of both primary and secondary patency improving with the use of cutting balloon angioplasty [17].
There is inadequate proof that supports the use of CB as the rst-line treatment
of femoropopliteal lesions. An appreciation of plaque characteristics can allow for
better understanding of the use of this device. Additionally, the CB may be used for
hemodialysis stula site lesions, but further analysis shows that the CB has primarily been used and studied only within the treatment of in-stent stenosis and femoropopliteal stenosis, although the use of these balloons to treat these issues may be
considered an off-label use for this equipment. Care should be taken when stationing this balloon during the treatment of in-stent restenosis due to the possibility of
fracturing the stent from the microsurgical blades.
Chocolate PTA Balloon (Medtronic) (Fig.10.2)
Device Mechanism
The Chocolate PTA balloon incorporates a semi-compliant balloon surrounded by a
cage made of nitinol. Enlargement of the balloon allows for the balloon to expand
through the open spaces of the cage. At the locations where the balloon does not
expand, on the frame of the cage, it creates a network that places increased forces
on the plaque which gives rise to limited breaks within the plaque. The capacity to
focus the force from the balloon onto a smaller location allows for angioplasty to be
performed under lower pressures with lower rates of ow-limiting dissection.
10 Preserving Vessel Integrity andReducing Vascular Recoil withFocal Force Balloons
https://t.me/medicina_free
Fig. 10.2 CHOCOLATE
PTA device by Medtronic
Device Specications
199
The Chocolate balloon can be currently found in diameters of 2.5–6.0mm and with
balloon lengths of 40–120mm and a working length of 120–150cm. Compatibility
with a 0.014″ and 0.018″ guidewire is possible with its over-the-wire design.
Another version, with paclitaxel coating, is available and being assessed for effectiveness and safety in the USA.
Evidence andUse
The majority of evidence for the use of the Chocolate balloon can be found in the
Chocolate BAR registry, a prospective multicenter study used to examine the
Chocolate balloon when treating patients with peripheral artery disease [18]. The
study consisted of 262 patients totaling 290 femoropopliteal lesions with most of
the patients having moderate to severe peripheral artery disease (PAD, including
Rutherford 3–6). The average length of each lesion among those evaluated in the
study was 83.5mm, and 63.5% had calcic disease. In 85.1% of the cases, success
in the procedure was attained, with the dissection rate at 22.6%. Additionally, no
ow-limiting dissections were noted. Only 1.6% of cases necessitated bail-out
stenting. A drug-coated adaptation of the Chocolate balloon is being assessed for
effectiveness and safety.
200
https://t.me/medicina_free
The FDA has indicated that the Chocolate balloon may be used for the treatment
of peripheral vasculature lesions, including those of the iliac and infrainguinal arteries. The balloon is specically appropriate for heterogenous calcic plaque and
lesions of in-stent restenosis. Furthermore, the device is appropriate for lesions that
are located near bifurcations due to the plaque not typically shifting when the
inated balloon is in contact, in contrast to when used in conventional angioplasty.
E. K. Lambrinos et al.
AngioSculpt Balloon (Philips) (Fig.10.3)
Device Mechanism
The device includes two helical nitinol struts (scoring elements) that surround a
semi-compliant balloon. Upon ination of the balloon, the helical struts pierce the
plaque on direct contact and limit the balloon force onto these struts. This method
allows for angioplasty to occur at lower pressures of ination and overall decreases
the risks involved with dissections of uncontrolled nature. Originally, the device
was created to treat coronary lesions but has more recently been utilized for the
treatment of patients with peripheral arterial disease.
Device Specications
The AngioSculpt balloon can be currently found in diameters of 2.0–8.0mm and
with balloon lengths of 10–40 mm, with a working length of 90–155 cm.
Compatibility is with a 0.014 and 0.018 guidewire along with 5–6F sheaths.
Evidence andUse
A multicenter prospective study researched the technique of the AngioSculpt balloon for the treatment of infrapopliteal disease. The study included 42 patients (with
a total of 56 lesions). Most patients had a severe case of PAD, with Rutherford class
≥4 (90.5%). A total of 73% of lesions that were treated had moderate to severe
Fig. 10.3 Agniosculpt
PTA device by Phillips
10 Preserving Vessel Integrity andReducing Vascular Recoil withFocal Force Balloons
https://t.me/medicina_free
calcic disease with an average lesion length of 33.9±42.2mm. Procedural success
was achieved in 98.2% of all cases. Dissections that occurred following the angioplasty were present in 10.7% of lesions [19]. Another prospective study evaluated
31 patients (with a total of 36 lesions) with severe infrapopliteal disease to gauge the
effectiveness and safety of the device, with its successful use in all cases. A rate of
35.5% was evaluated for the stenting rate performed after device use due to a dissection of sub-optimal therapy. The survival rate after 1month without complications was 96.8%, and the primary patency after 1year was 61% [20].
The AngioSculpt may be used for lesion dilation in peripheral vasculature—
more specically the femoropopliteal, iliac, and infrapopliteal arteries.
201
VascuTrak (Bard) (Fig.10.4)
Device Mechanism
The device includes two wires attached to a semi-compliant balloon. After the balloon expands, the stress from the balloon is transferred through the wires to produce
contained breaks within the plaque. This equipment has not been studied systematically but is similar in action to other focal force balloons.
Specications
The VascuTrak can be found with diameter of 2–7mm and with balloon lengths of
20–300mm. The working length ranges from 80 to 140cm and is compatible with
a guidewire of 0.014 and 0.018.
Fig. 10.4 VascuTrack
Device by BARD
202
https://t.me/medicina_free
E. K. Lambrinos et al.
Evidence andUse
There is little evidence assessing the use of the VascuTrak balloon. Indications for
use of the VascuTrak include treatment of peripheral vessel lesions. The device may
also be used to treat brocalcic disease. The device’s simplistic design allows for
a vast selection of balloon lengths and sizes. Traditionally, a second wire was used
alongside an inated balloon to attain the same result in most coronary
interventions.
Shockwave Intravascular Lithotripsy (IVL) (Shockwave)
(Fig.10.5)
Device Mechanism
Shockwave intravascular lithotripsy (IVL) comprises of a traditional angioplasty
balloon mounted with ultrasound emitters capable of emitting pulsatile ultrasound
waves which mechanically modify the hard, typically calcic, plaque in the lesion
without damaging the elastic components of the healthy artery. The balloon is rst
inserted into the occluded artery and inated to a pressure of 4atm, and 30 shockwave impulses followed by 60 more are delivered after dilation to nominal pressure
has been achieved. The impulses function to break the calcied lesions into small
particles while preserving vessel integrity.
Specications
The Shockwave IVL device is available in two congurations: the Shockwave M5
used for treating peripheral arteries above the knee and the Shockwave S4 used to
target arteries below the knee (BTK). The M5 series ranges from 3.5 to 7.0mm in
Fig. 10.5 Shockwave
intravascular lithotripsy by
Shockwave Medical
10 Preserving Vessel Integrity andReducing Vascular Recoil withFocal Force Balloons
https://t.me/medicina_free
diameter, has a length of 60mm and a working length of 110cm, and can deliver up to
300 pulses maximally. The S4 series ranges from 2.5 to 4.0mm in diameter, is 40mm
in length, has a 135cm working length, and can deliver up to 160 maximum impulses.
203
Evidence andUse
Research on the use of Shockwave IVL has shown its effectiveness in treating
lesioned vessels resulting in better outcomes compared to traditional PTA. In a
study conducted by Marianne etal., 35 individuals presented with femoropopliteal
lesions that were on average 76.3% stenotic with an average lesion length of
61.5mm [21]. These lesions were heavily calcied in 64.1% of the patients with an
average calcied lesion length of 80.3mm. The study concluded with all patients
having procedural success with an average residual stenosis of 23.4% and a 2.9mm
acute gain. There were no implanted stents or vascular complications during the
procedure. The patients also showed 100% vessel patency as dened as <50% restenosis and 100% freedom from target lesion revascularization (TLR) at a 30-day
follow-up and 82.1% patency and 100% freedom from TLR at a 6-month follow-up.
Further studies demonstrated the increased efcacy of intravascular lithotripsy
(IVL) compared to traditional PTA [22, 23]. The largest randomized clinical trial of
IVL vs. PTA demonstrated that IVL was superior in most aspects. IVL demonstrated higher procedural success by 15.5%, higher lesions with residual stenosis
<30% by 14.5%, fewer ow-limiting dissections by 5.4%, fewer post-dilatations by
14.8%, and fewer stent placements by 13.7%. The main shortcoming of IVL was
that it was on par with PTA in TLR and major adverse events, although minimal in
both techniques.
Although IVL has had more extensive research in above-the-knee vessels, further evidence is still being collected for use in BTK treatment. Currently, there is 1
available study, conducted on a cohort of 20 patients with 100% calcication in
BTK vessels that resulted in 100% success in residual stenosis being <50% at
30days [24]. Overall, IVL is useful in a multitude of scenarios including where
stenting is contraindicated and in high-risk locations such as bifurcating lesions.
FLEX Scoring Catheter (VentureMed) (Fig.10.6)
Device Mechanism
The FLEX scoring catheter functions by preparing the lesion for balloon angioplasty by way of three microblades attached to three exible struts located along the
end of the catheter. FLEX focuses on improving vessel compliance, leading to lower
balloon pressures, leading to less vessel trauma. The catheter is mounted on a
204
https://t.me/medicina_free
Fig. 10.6 Flex Scoring Catheter by Venturemed
guidewire, and the section with three microblades is directed to the distal end of the
lesion. The operator can then engage the scoring elements of the catheter and pull
retrograde across the lesions within vessel. The unique aspect of the FLEX catheter
is that it will maintain 1atm of pressure on the blades as the operator pulls the catheter retrograde through the vessel. This dynamic scoring technology allows for precise parallel cuts along the treated vessel segment. Once proximal to the lesion, the
catheter blades can be disengaged, sent distal to the lesion, and rotated 30° or 90°,
and the process repeated for maximal plaque modication.
E. K. Lambrinos et al.
Specications
The FLEX catheter comes in one design. It is 6F compatible and can be used with
both 0.014″ and 0.018″ guidewire platforms and has working lengths of 40
or 120cm.
Evidence andUse
Studies using the FLEX scoring catheter have produced evidence supporting the
use in vessel preparation prior to angioplasty. In particular, the International
Symposium on Endovascular Therapy in 2018 referenced compiled data from multiple hospitals and operators on the FLEX catheter prior to angioplasty [25]. From
the symposium, the study titled “Early Clinical Results Using the FLEX Scoring
Catheter in 100 Femoropopliteal Chronic Total Occlusions” showed that of 100
Соседние файлы в папке Библиотека им академика М.И. Перельмана