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_3609_Библиотеки_им_академика_М_И_Перельмана
.pdf
19 Atherectomy andCalcium-Modifying Devices
https://t.me/medicina_free
191
20. Wissgott C, Kamusella P, Andresen R.Treatment of femoropopliteal stenoses and occlusions with mechanical rotational catheters:
comparison of results with the Rotarex and pathway devices. J
Cardiovasc Surg. 2012;53(2):177–86.
21. Tarricone A, Ali Z, Rajamanickam A, Gujja K, Kapur V,
Purushothaman KR, etal. Histopathological evidence of adventitial
or medial injury is a strong predictor of restenosis during directional atherectomy for peripheral artery disease. J Endovasc Ther.
2015;22(5):712–5.
22. Krishnan P, Tarricone A, Gee A, Farhan S, Kamran H, Kini A, etal.
Comparison and analysis between the NAV6 embolic protection lter and SpiderFX EPD lter in supercial femoral artery lesions. J
Interv Cardiol. 2021;2021:9047596.
23. Whitlow PL, Bass TA, Kipperman RM, Sharaf BL, Ho KK,
Cutlip DE, etal. Results of the study to determine rotablator and
transluminal angioplasty strategy (STRATAS). Am J Cardiol.
2001;87(6):699–705.
24. Saan RD, Feldman T, Muller DW, Mason D, Schreiber T, Haik
B, et al. Coronary angioplasty and Rotablator atherectomy trial
(CARAT): immediate and late results of a prospective multicenter
randomized trial. Catheter Cardiovasc Interv. 2001;53(2):213–20.
25. Tepe G, Brodmann M, Bachinsky W, Holden A, Zeller T,
Mangalmurti S, etal. Intravascular lithotripsy for peripheral artery
calcication: mid-term outcomes from the randomized disrupt PAD
III trial. J Soc Cardiovasc Angiogr Intervent. 2022;1(1):100341.
26. Wong CP, Chan LP, Au DM, Chan HWC, Chan YC.Efcacy and
safety of intravascular lithotripsy in lower extremity peripheral
artery disease: a systematic review and meta-analysis. Eur J Vasc
Endovasc Surg. 2022;63(3):446–56.
27. Holden A, Hill A, Walker A, Buckley B, Merrilees S, Nowakowski
P, etal. PRELUDE prospective study of the Serranator device in the
treatment of atherosclerotic lesions in the supercial femoral and
popliteal arteries. J Endovasc Ther. 2019;26(1):18–25.
28. Holden A, Lichtenberg M, Nowakowski P, Wissgott C, Hertting
K, Brodmann M.Prospective study of serration angioplasty in the
infrapopliteal arteries using the Serranator device: PRELUDE BTK
study. J Endovasc Ther. 2022;29(4):586–93.
29. Zeller T, Lopez L, Pigott JP.Acute outcomes with a novel plaque
modication system in real-world femoropopliteal lesions. J
Endovasc Ther. 2019;26(3):333–41.
Novel Endovascular Technologies
https://t.me/medicina_free
inFemoropopliteal Disease
AhmedAl-Nowfal andIrfanAhmed
20
Case Study
A 38-year-old male with renal transplant secondary to poorly
controlled diabetes myelitis, presented with gangrenous
right second and third toes.
CT angiogram demonstrates signicant 60% CFA stenosis.
Profunda is widely patent. The SFA proximally contains a signicant stenosis of around 80% and near-occlusive stenosis at
the adductor canal. No signicant popliteal or crura disease.
Patient was discussed in the regional vascular MDT. A hybrid
procedure was favoured with CFA endarterectomy and endovascular treatment of the supercial femoral and popliteal arteries.
Continued from page 207
Background
The supercial femoral and popliteal arteries (SFPA) are the
most common site of disease in patients with peripheral arterial disease (PAD) and present some of the greatest challenges for endovascular treatment.
According to the American College of Cardiology (ACC)
and American Heart Association (AHA) guidelines, endovascular treatment of supercial femoral and popliteal artery
disease is indicated for individuals with signicant disability
due to intermittent claudication or critical limb ischemia
when clinical features suggest:
• Patients with critical limb ischaemia who are at increased
risk of amputation and major cardiovascular ischemic events.
• Claudicants who after being treated with guideline- directed
management and therapy (including structured exercise
therapy) present with persistent lifestyle-limiting claudica-
tion when there is a favourable risk-benet ratio [1].
Since the 1980s there has been a remarkable advancement
in the endovascular treatment of lower-limb peripheral artery
A. Al-Nowfal (*) · I. Ahmed
London, UK
e-mail: ahmed.al-nowfal@nhs.net; irfan.ahmed@gstt.nhs.uk
disease, with the introduction of new interventional techniques
and devices. Techniques such as percutaneous transluminal
angioplasty with balloon dilation, stents, atherectomy, cutting
balloons, drug-coated balloon angioplasty and percutaneous
thrombectomy have become established in providing treatment with new techniques always on the rise.
Basic Endovascular Toolkit
When facing the challenge of treating a SFPA lesion it is
preferable to approach the treatment from an antegrade
approach. This will allow more talkability and pushability of
the wires, catheters and devices. However, in patients with a
large abdominal apron or hostile ipsilateral groin, a contralateral up-and-over approach can be utilised.
A list of suggested material is summarized in Table20.1.
Table 20.1 Suggested endovascular toolkit for the crossing of SFPA
stenosis or occlusions
Manufacturer Size/length
Wires
Any standard-access wire
Glidewire Floppy Terumo
Glidewire Stiff Terumo
Crossing wire Any 0.14 and 0.18
Sheaths
Any standard-access sheath Any 4–7 Fr/11cm
Balkin Sheath Cook Medical 5.5–8 Fr/40cm
Catheters
4 Fr support catheter (BERN
2, Vert)
Crossing catheter (quick
cross, navicross, CXI)
Balloons
0.35″ or 0.18 balloons
These are only a few suggested options based on the author’s experience and can cover the vast majority of cases
Radifocus
Radifocus
Any
Any
Any 4–8mm
0.035″
0.035″
0.035″
0.035″/4
Fr/65–90cm
0.018″–0.035″/65–
150cm
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
G. Geroulakos et al. (eds.), Mastering Endovascular Techniques, https://doi.org/10.1007/978-3-031-42735-0_20
193
194
https://t.me/medicina_free
A. Al-Nowfal and I. Ahmed
Novel Techniques in Percutaneous
Transluminal Angioplasty
Percutaneous transluminal angioplasty (PTA) is unchanged;
it remains the preferred recommended initial endovascular
treatment for SFPA disease, and it has a reported primary
success rate for up to 80% in 1year [2]. For many users the
use of adjunctive techniques is largely as a salvage therapy
for a suboptimal or failed result from balloon dilation.
There has been little development of standard PTA balloons on the markets. New devices such as The Medtronic
Chocolate™* PTA balloon, which is a nitinol-caged balloon
aimed to minimise ow-limiting dissections and reduce
recoil by creating segmented grooves along the entire lesion,
and the Medtronic Chameleon™ PTA balloon catheter,
which aims to be a combination of a high-pressure balloon
catheter and a diagnostic catheter, have failed to have a great
impact on the market.
Stents
Endovascular stenting in SFPA prevents the problems of
early elastic recoil, ow-limiting dissection and resistant stenosis after PTA and can thus be used for treatment of long
and calcied lesions. However, the biomechanics of SFPA
provides a unique challenge. It is subject to twisting,
stretching, external compression, torsion and exion. This
can lead to stent fractures and restenosis.
Selection of the primary endovascular treatment for
patients with SFPA disease with either PTA or a variety of
stents as the initial approach has been assessed in multiple
randomized trials, producing conicting results [3], with
current rans-Atlantic Inter-Society Consensus Document
(TASC II) recommending balloon angioplasty as the initial
preferred option for endovascular treatment SFPA lesions
and for stent placement only after a suboptimal or failed
result from PTA [4].
Stent designs have changed over the years, with interwoven nitinol stents such as the Abbot Supera™ Peripheral
Stent and the Veryan BioMimics 3D Vascular Stent having
become the mainstay stents used within the SFPA segment.
Their selected patented construction demostrate improvement in radial strength, the ability to recover from being
crushed and reduced foreshortening. This has led to better
anatomical and clinical outcomes than PTA alone or older
stainless-steel stents, with trials such as the RESILIENT trial
stating that at 12months, freedom from target lesion revascularisation was 87.3% for the stent group compared with
45.1% for the angioplasty alone group [5, 6].
20 Novel Endovascular Technologies inFemoropopliteal Disease
https://t.me/medicina_free
195
Example of Stent Use
A 74-year-old female with a diabetic foot ulcer.
Angiogram demonstrates mid supercial femoral artery
stenotic disease (SFA) stenosis, distal SFA occlusion,
some hibernating lumen in P1 popliteal artery and
severe stenosis in p popliteal artery (Image 1). Mid SFA
to P2 treated with 7 mm PTA and 6 mm DCB then
stented with a 6.5mm Supera (Image 2). Post-treatment
angiogram demonstrates a now widely patent SFA
(Image 3).
196
https://t.me/medicina_free
A. Al-Nowfal and I. Ahmed
Drug-Eluting Stents andBalloons
The administration of drugs using drug-coated balloons
(DCB) during angioplasty for SFPD can successfully deliver
effective local tissue concentrations of anti-proliferative
drugs to the lesions in the artery. This offers the potential for
sustained anti-restenotic efcacy.
Randomised trials have shown superiority of paclitaxel
DCBs (Boston Ranger DCB and Boston Eluvia drug-coated
stent) over just plain-balloon angioplasty for treatment of
PAD, and DCB is now considered the standard of care [7–15].
In March 2019 the FDA wrote to all health care professionals,
warning them that the treatment of peripheral arterial disease
with paclitaxel-coated balloons and paclitaxel eluting stents
was potentially associated with increased mortality.
Katsanos et al.’s meta-analysis of randomised trials
revealed a 68% relative risk increase in all-cause death with
paclitaxel-containing balloons and stents, beginning at 2
years. This increased to 93% at 5 years [16]. This called into
question the safety of paclitaxel-based drug-coated devices.
Alternative drugs for DCBs are therefore have been considered with Sirolimus has been the go-to alternative. Compared
to Paclitaxel, sirolimus is cytostatic in its mode of action with
a high margin of safety. It has a high transfer rate to the vessel
wall and has been shown to effectively inhibit neointimal
hyperplasia in the porcine coronary model [17]. In the coronary artery interventions, preliminary clinical studies using
Sirolimus DCBs Quantitative coronary angiography revealed
no differences in 6-month patency, with clinical events up to
12months also did not differ between the groups [18].
However, they are yet to demonstrate success in the treatment peripheral lower limb angioplasty. The main difculty
with Sirolimus compared with paclitaxel has remained the
difculty in transfer: because of their relative lack of lipophilicity compared with paclitaxel, limus drugs are notoriously difcult to coat onto the balloon in such a way that
they are retained until ination at the site of action, and then
slowly released in a sustained manner [19]. With historical
trails such the SIROCCO II study, a randomized trial of
sirolimus- coated nitinol stents compared to bare metal nitinol stents for SFPA disease, have also demonstrated no signicant difference in patency rates, but this was because the
restenosis rate in the bare stent group was unexpectedly low.
At 24months of follow-up, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare metal stent
group [20].
Currently, Medalliance, SELUTION DCB are hopeful to
have developed the technology to successfully transfer the
drug to the affected periphery artery lesion [21]. Further trials in the eld are ongoing with large, randomized trials such
as Success PT and FUTURE-SFA are in the recruitment
phase using a sirolimus-coated balloon versus standard balloon in the treatment of symptomatic SFPA disease.
20 Novel Endovascular Technologies inFemoropopliteal Disease
https://t.me/medicina_free
197
Example of Drug-Eluting Stent and Balloons
An 83-year-old male with a right-leg critical limb ischaemia with new ulcers in the dorsum of the foot.
Angiogram demonstrates widespread SFA (Image 1).
Treated with 6mm Boston Ranger DCB (Image 2) and
resistant stenosis treated with a 7 mm Boston Eluvia
drug-coated stent (Image 3). Post-treatment angiogram
demonstrates a now widely patent SFA (Image 4).
198
https://t.me/medicina_free
Atherectomy
Directional atherectomy was developed with the idea to
increase procedural luminal gain while avoiding barotraumas and vessel recoil. They are aimed to create concentric
lumens, optimising balloon-to-wall apposition for DCB or
other adjunctive therapies.
Initial results using the Simpson AtheroCath (Guidant,
Temecula, CA) were negative, stating that in lesions with
greater length than 2cm, the atherectomy results are signicantly worse than plain angioplasty [22]. However, in the
recent years there has been a new interest in debulking
devices with the development of new atherectomy systems,
such as the Boston Jetstream™ rotational atherectomy sys-
A. Al-Nowfal and I. Ahmed
tem or the Philips Phoenix atherectomy system. They are
both engineered to treat a wide range of lesion characteristics such as: long, diffuse disease and chronic total occlusions (CTO) with mixed morphologies like calcium, plaque
and thrombus. Recent studies such as the JET Registry
observed the treatment effects of the Boston Jetstream™
Atherectomy System in peripheral arterial disease of the
common femoral, supercial femoral or popliteal arteries
demonstrate 77.2% patency, with 81.7% freedom from target
lesion revascularisation within 12months, with only 1.4%
distal embolisation and 2.3% major adverse event [23]. The
EASE study data also conrms Phoenix’s ability to effectively treat a broad range of tissue types, from soft plaque to
calcied arteries, for peripheral arterial lesions with similar
high success rates [24].
20 Novel Endovascular Technologies inFemoropopliteal Disease
https://t.me/medicina_free
199
Example of Atherectomy
A 76-year-old male with right diabetic foot disease.
Osteomyelitis of the right forth toe and metatarsal rem-
nant. Angiogram demonstrates patent proximal
SFA. Complete occlusion of the distal SFA (Adductor
canal) with a patent popliteal artery (Image 1). After
luminal crossing of the lesion, covering lter inserted
(Image 2). Treated with 24 mm Phoenix atherectomy
through occluded segment. Post atherectomy treated with
a 5mm PTA and DCB.Post-treatment angiogram demonstrates a now widely patent SFA with no ow- limiting
dissections (Image 3).
200
https://t.me/medicina_free
A. Al-Nowfal and I. Ahmed
Intravascular Lithotripsy
Intravascular lithotripsy (IVL) is a novel approach for calcied plaque modication in in coronary and peripheral vessels. Diabetes mellitus or chronic kidney disease patients are
amongst those who suffer the greatest prevalent intravascular
calcication in PAD [25]. Aside from the known increased
cardiovascular mortality and morbidity risk [26], calcication also interfere with the delivery of endovascular therapies
in which it is responsible for suboptimal outcomes. These
include poor vessel expansion using standard PTA balloons,
with increased risk of restenosis, dissection, perforation and
distal embolisation [27].
Shockwave medical Intravascular lithotripsy uses multiple emitters mounted in a traditional angioplasty balloon
catheter that provide pulsatile sonic pressure energy to
disrupt supercial and deep calcium without affecting
local soft tissues or liberating emboli, thereby serving as
Example of Intravascular Lithotripsy
A 56-year-old man with non-healing fourth and fth toe
ulcers. Tight calcied distal supercial femoral artery dis-
ease (SFA) (Image 1). Treated with 7 mm Shockwave
a novel vessel preparation strategy to improve luminal
compliance and facilitate denitive endovascular treatment [27].
A systematic review and meta-analysis looking at outcomes post IVL performed for PAD showed 75.5% of the
lesions were reported to have severe calcication.
Comparison between pre-IVL and post-IVL diameter stenosis demonstrated a diameter stenosis reduction of 59.3%.
Vascular complications were rare, with ow-limiting dissection occurring in only 1.25% of cases [28].
The recently published PAD III trial states that primary
patency at 1year was signicantly greater in the IVL arm
80.5% vs. non-IVL 68.0%. The requirement for provisional
stenting was signicantly lower in the IVL group 4.6% vs.
non-IVL 18.3%. At 2years, primary patency remained signicantly greater in the IVL group 70.3% vs. non-IVL
51.3%, conrming IVL with a combination of DCB aids in
the leave-nothing-behind approach [29].
IVL and 6mm × 100mm Selution DCB (Image 2). Posttreatment angiogram demonstrates a now widely patent
SFA (Image 3).
20 Novel Endovascular Technologies inFemoropopliteal Disease
https://t.me/medicina_free
201
Re-entry Devices
Sub-intimal angioplasty technique was described by Bolia
et al. (1990), allowing endovascular treatment of chronic
total occlusions of the peripheral arteries [30]. The long
patency of a subintimal tract was poor. The technique also
increased the risk for propagation of the subintimal dissection into normal arteries beyond the occlusion damaging distal run off. However, improved wires and catheter, as well as
the development of high-quality nitinol stents to address the
acute technical and angiographic failure (such as ow limiting dissection) of subintimal angioplasty of chronic total
occlusions, the use of subintimal angioplasty increased. As
the technique became more accepted, it was becoming clear
the inability to get the wire and catheter to re-enter the true
lumen beyond the occlusion was the primary reason for technical failure affecting 10–15% of attempted cases [31–33].
Various methods were then developed to aid in re-entry
using standard wires, catheters, and balloons, with distal
pedal access becoming a favoured approach. The develop-
ment of re-entry device, however, allowed a safe method to
enter the true lumen, limiting the dissection of the vessel distal to the occlusion, and preserving critical collaterals and
distal run-off vessels.
There are many re-entry devices on the market with the
Cordis Outback® LTD® re-entry catheter having the largest
share. It is a 5 Fr, multipurpose-type angled guide catheter
with an integral nitinol hypotube ending in a curved needle
tip intended to be advanced from the end of the catheter to
penetrate from the dissection plane to the true lumen. A
0.014-inch guidewire could then be advanced through the
hypotube into the true lumen. Technical success rates with
the Outback in the SFPA was 64.5% with failure secondary
to inability to re-enter the true lumen, difculty tracking the
device over a wire, acute angle of aortic bifurcation in up and
over access difculty in tracking over the wire in calcied
occlusions, and difculty in penetrating calcied plaque at
the re-entry site [34]. Other devices such as the Philips
Pioneer Plus Catheter PPlus and Upstream peripheral Go
back catheter offer alternatives in the market.
Соседние файлы в папке Библиотека им академика М.И. Перельмана