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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3876_Библиотеки_им_академика_М_И_Перельмана
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12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
12.3.2.6 Infrainguinal Bypass Following Failed
Endovascular Intervention
A systematic review and meta-analysis of all studies that compared primary infrainguinal bypass with bypass after failed endovascular intervention for PAD was performed by Hossain etal. [18] to determine whether bypass after failed endovascular
intervention leads to inferior outcomes. Fifteen studies involving 11,886 patients
met the inclusion criteria. No signicant differences were found in 30-day mortality
or 30-day amputation rates comparing primary bypass with bypass after failed
endovascular intervention. However, 1year amputation free survival was higher in
the patients who had primary bypass (OR 1.30; 95% CI 1.10-1.52) compared with
patients who had bypass after failed endovascular therapy. There was also worse
1year primary patency (OR 1.65; 95% CI 1.04-2.62) for patients with prior failed
endovascular intervention and there was a trend towards higher rates of early graft
occlusion. The existing literature is limited by observational study design, inconsistent patient selection, and signicant heterogeneity, yet suggests that bypass following failed endovascular intervention may result in suboptimal outcomes. Physicians
who care for patients with peripheral arterial disease should consider the effect of
endovascular treatment failure on future interventions.
12.3.2.7 Venous Arterialization forCLTI
In theory, venous arterialization allows reversal of blood ow through the capillaries, increases ow in existing collateral vessels, and stimulates angiogenesis. Yan
et al. [19] systematically reviewed original venous arterialization studies for
CLTI.Twelve studies included 442 patients that underwent treatment for 445 limbs
(374 patients and 377 limbs underwent venous arterialization while remainder
underwent traditional bypass and served as control subjects). Seven studies
described supercial vein arterialization, 2 studies described open deep vein arterialization (DVA), 2 studies described hybrid DVA, 6 studies described percutaneous
DVA, and 3 studies described a mix of venous arterialization techniques. The pooled
30-day mortality was 3.7%, 30-day morbidity was 15.5%, 30-day major adverse
cardiovascular event was 5.2% and 30-day major adverse limb event was 16.7%.
The pooled 1-year limb-salvage rate was 79.0% and 1-year survival rate was 85.7%.
Venous arterialization has an acceptable 1-year limb salvage rate, however, this is
based on low levels of evidence.
12.3.2.8 30-Day Readmission totheHospital after Revascularization
A systematic review and meta-analysis aimed to determine the incidence of and risk
factors for 30-day readmission after revascularization for PAD [20]. Fourteen publications reporting the outcomes of 526,008 patients were included. Reported

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readmission rates ranged from 10.9% to 30.0% with a mean of 16.4%. The following risk factors had a signicant association with readmission: female sex, black
race, dependent functional status, critical limb ischemia, emergency admission,
hypertension, heart failure, chronic pulmonary disease, diabetes, chronic kidney
disease, dialysis dependence, smoking, postoperative bleeding, and postoperative
sepsis. Approximately one in six patients undergoing revascularization for PAD are
readmitted within 30 days of their procedure. The ndings from this systematic
review demonstrate a need for strategies to better lter out patients at high risk for
readmission at the initial admission. An important limitation of the included studies
was they were all based on data from the US healthcare system. It is, therefore,
unclear as to how these results relate to patients in other settings.
Thirty-day readmission rates are used as a performance metric by the Centers for
Medicare & Medicaid Services to judge the quality of hospital care and to penalize
hospitals with higher-than-expected readmission rates for certain target conditions
such as AMI, heart failure, and pneumonia. Kolte etal. [21] identied in the 2013 to
2014 Nationwide Readmissions Databases (USA) 60,998 index CLI hospitalizations (24.6% for rest pain, 37.2% for ulcer, and 38.2% for gangrene). The 30-day
readmission rates for hospitalizations for rest pain, ulcer, and gangrene were 14.8%,
19.5%, and 25.0%, respectively (Table 12.3). Infections (23.5%), persistent or
recurrent manifestations of peripheral artery disease (22.2%), cardiac conditions
Table 12.3 In-hospital outcomes of 60,998 patients with CLTI undergoing endovascular or
surgical therapy and discharged alive after index hospitalization. Nationwide Readmissions
Databases of the USA (according to [21])
Rest pain
Parameter
Age (years) 67.2±11.3 70.3±12.0 68.7±12.1
Women, n (%) 6565 (43.7) 9402 (41.4) 8921 (38.3)
Charlson comorbidity index 2.3±1.2 2.9±1.3 3.1±1.3
Revascularization
–Endovascular only, n (%) 4829 (32.2) 13,018 (57.3) 13,838 (59.4)
–Surgery only, n (%) 7950 (53.0) 7831 (34.5) 7391 (31.7)
–Hybrid, n (%) 2228 (14.8) 1857 (8.2) 2056 (8.8)
Amputation, n (%) 205 (1.4) 2041 (9.0) 10,626 (45.6)
Major bleeding, n (%) 2513 (16.7) 4081 (18.0) 5850 (25.1)
Acute kidney injury, n (%) 922 (6.1) 2911 (12.8) 4114 (17.7)
Acute myocardial infarction, n
(%)
Any complication, n (%) 6143 (40.9) 9608 (42.3) 12,105 (52.0)
Length of stay, days, n 5.4±5.5 8.5±8.8 13.6±13.3
Discharge home (self-care), n (%) 9743 (64.9) 8987 (39.6) 6297 (27.1)
Discharge skilled nursing facility,
n (%)
(n=15,007)
267 (1.8) 510 (2.2) 627 (2.7)
2075 (13.8) 6907 (30.4) 9694 (41.7)
Ulcer
(n=22,706)
Gangrene
(n=23,285)

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12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
(11.4%), procedural complications (11.0%), and endocrine issues (5.7%) were the
most common reasons for readmission. Thirty-day readmissions for CLI contributed to more than $624 million in healthcare costs in 2013 to 2014. Adoption of
30-day readmission rate for CLI as a performance metric may provide hospitals an
incentive to improve systems of care and to develop and implement strategies to
lower CLI readmissions. Multidisciplinary CLI teams and wound teams may represent one such strategy.
12.3.2.9 Atherectomy forPeripheral Arterial Disease
A Cochrane Review evaluated the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments [22]. Seven studies, with a
total of 527 participants and 581 treated lesions were included. Six studies compared atherectomy versus balloon angioplasty (BA). No studies compared atherectomy with bypass surgery. The review showed that the evidence is very uncertain
about the effect of atherectomy on patency, mortality and cardiovascular event rates
compared to plain balloon angioplasty, with or without stenting. There were no
clear differences in initial technical failure rates or target vessel revascularization
rates, but there may be reduced dissection and bailout stenting after atherectomy
although this is uncertain. The ndings of this review agree with current widespread
practice and established guidelines for balloon angioplasty in the routine treatment
of people with peripheral arterial disease who are amenable to standard angioplasty.
12.3.2.10 Drug-Coated Balloon Angioplasty fortheTreatment ofCLTI
Safety and efcacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with CLTI were investigated in a metaanalysis (26 studies, 12 retrospective, 14 prospective; 2108 patients) by Giannopoulos
etal. [23]. The overall 12-month all-cause mortality and major amputation rates
were 9% and 5%, respectively. A sensitivity analysis of the infrapopliteal lesions
demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, target lesion revascularization (TLR), major amputation, or mortality
over 12 months. However, patients with infrapopliteal lesions undergoing DCB
angioplasty did have a signicantly lower risk for reocclusion (10% vs 25%,
p=0.002).
The risk of all-cause mortality after treatment with paclitaxel-coated devices vs
uncoated controls in patients with chronic limb-threatening ischemia (CLTI) were
identied in a second meta-analysis (11 randomised trials, 2213 patients, mean
follow-up 25.6months) by Dinh etal. [24]. There were 161 (18.6%) deaths among
866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). This
meta-analysis demonstrated that there is no increased risk of all-cause mortality in
a predominately CLTI patient population treated with paclitaxel-coated vs uncoated

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devices. With clear benet and no suggestion of a link between the use of paclitaxelcoated devices and mortality, the authors recommended their continued use in this
high-risk patient population.
12.3.3 Registries
12.3.3.1 Endovascular Vs. Open Revascularization
Using the NSQIP database, Mehaffey et al. [25] found a total of 13,294 lower
extremity bypasses (LEBs) and infrainguinal endovascular interventions (IEI), with
8066 cases performed for CLI.Propensity matching identied 3848 cases (1924 per
group). At 30days, rates of MALEs were signicantly lower in the LEB group
(9.2% LEB vs IEI 12.2%; P=.003). Furthermore, there was no difference in 30-day
MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supported the effectiveness and primacy of LEB for
revascularization in CLI (Table12.4).
In the Nationwide Readmissions Database, a total of 66,277 patients were identied between 2016 and 2018 who underwent endovascular revascularization (ER)
Table 12.4 Lower extremity bypass (LEB) for critical limb ischemia vs infrainguinal endovascular
intervention (IEI). National Surgical Quality Improvement Program (NSQIP) database. Propensitymatched cohorts (according to [25])
Parameter IEI LEB P value
Patients, n 1924 1924
Age (years) 69±12 69±12 .42
Sex, male (%) 57.2 58.4 .47
ASA (%)
–Class 2 10.6 2.2 .09
–Class 3 57.1 66.6 .22
–Class 4 23.0 30.9 .34
Functional status, independent (%) 83.6 84.6 .63
Wound clean (%) 96.1 92.7 .08
Revascularization suprageniculate (%) 70.3 71.9
Revascularisation infrageniculate (%) 29.7 28.1
MALE (%) 12.2 9.2 .003
–Untreated loss of patency (%) 1.7 2.7 .03
–Reintervention (%) 5.5 4.8 .38
–Amputation (%) 6.8 4.2 .0003
MACE, % 3.7 4.9 .07
–CVA or MI (%) 2.1 2.8 .14
–Mortality (%) 2.1 2.9 .15
MALE major adverse limb event, MACE major adverse cardiovascular event, CVA cerebrovascular
accident, MI myocardial infarction

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12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
and surgical revascularization (SR) for CLI [26]. A total of 54,546 patients (82.3%)
underwent ER and 11,731 (17.7%) underwent SR.After propensity score matching,
11,106 matched pairs were found. Endovascular revascularization was associated
with an 18% higher risk of major amputation compared with SR (9.9% vs 8.4%;
P=.001). Endovascular revascularization and SR had similar mortality rates (4.7%
vs 4.4%; P=.39). However, the ER group had a 17% lower risk of in-hospital safety
outcomes compared with the SR group (23.3% vs 26.8%; odds ratio, 0.83; P<.001).
The results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared
with SR.However, the risk of major amputation was similar when both procedures
were performed at high-volume centers.
Mathlouthi etal. [27] identied all patients who had undergone limb revascularization from January 2010 to December 2016 in the Vascular Quality Initiative
Medicare-linked database. The aim of the study was to compare the midterm outcomes of the endovascular-rst (EVF) and bypass-rst (BF) strategies in patients
with CLTI.The EVF approach was applied to 12,062 patients (70%) and the BF
approach to 5166 patients (30%). At 2years, the BF group had achieved greater
rates of limb salvage (86.4% vs. 82.1%; P< 0.001), freedom from reintervention
(72% vs. 68%; P<0.001), AFS (66.9% vs. 56.3%; P<0.001), and freedom from
all-cause mortality (75.7% vs. 66.1%; P<0.001). After adjusting for potential confounders, an effect of the treatment strategy on limb salvage, reintervention, AFS
and all-cause mortality was not observed. The present study was the largest realword analysis showing the noninferiority of the EVF approach in patients with CLTI.
Patients who underwent intervention for CLTI from 2015-2018 were identied
by Latz et al. [28] using the American College of Surgeons National Quality
Improvement Program (NSQIP) Vascular Surgery module. A total of 10,783 patients
underwent an infrainguinal intervention for CLTI from 2015-2018. Of these, 6003
(55.7%) underwent LEB and 4780(44.3%) underwent infrainguinal endovascular
intervention (IEI). Forty percent of the cohort was considered “high anatomic risk”
by Objective Performance Goals (OPG) standards, and 13.6% were considered
“high clinical risk.” The IEI cohort vs. the LEB cohort experienced a myocardial
infarction (MI)/Stroke rate of 1.8% vs. 3.6% (p<.001) and had a mortality rate of
2.0% vs. 1.7% (p = .22), which yielded a composite MACE of 3.4% vs. 4.8%
(p=.001). The rate of reintervention for IEI vs LEB was 4.4% vs. 5.3% (p=.04),
the loss of patency (without re-intervention) rate was 1.8% vs. 1.8% (p=1.0), and
the major amputation rate was 4.1% vs. 3.5% (p=0.15), which resulted in a MALE
rate of 9.1% vs. 8.8% (p=0.50). Endovascular outcomes continue to demonstrate
inferiority in major amputation and overall MALE.However, endovascular intervention has a signicantly reduced incidence of MACE.

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12.3.3.2 Revascularization withPaclitaxel-Coated Devices inPatients
withCLTI
Smith etal. [29] retrospectively studied patients who underwent femoropopliteal
artery (FPA) intervention for an indication of CLTI in the Vascular Quality Initiative
peripheral vascular intervention database from 2016 to 2020. Data regarding the
safety and efcacy of paclitaxel (PTX)-coated peripheral arterial devices were analyzed in propensity score matched patients. Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX
propensity-matched patients. Peripheral vascular intervention using a paclitaxelcoated device was associated with improved limb salvage, primary patency, and
freedom from major adverse limb events at the 18-month follow-up compared with
uncoated devices. This benet was not associated with an increase in all-cause mortality out to 4.5 years. Peripheral vascular intervention using a paclitaxel-coated
device in patients with chronic limb-threatening ischemia is associated with
improved limb salvage and freedom from major adverse limb events.
12.3.3.3 Endovascular Revascularization in Patients with Impaired
Ambulatory Capacity
The Global Vascular Guidelines recommend offering primary amputation to CLTI
patients who have pre-existing dysfunctional or unsalvageable limb, a poor functional status (e.g., bedridden), or a short life expectancy after shared decisionmaking with the patient and health care team. Naazie etal. [30] evaluated the impact
of impaired ambulatory capacity on the outcomes of peripheral vascular interventions (PVI) among patients with CLTI using the Vascular Quality Initiative database. Of the 49,807 patients studied, 28,469 (57.2%) were ambulatory, 15,148
(31.0%) were ambulatory with assistance, 5395 (10.8%) were wheelchair bound,
and 525 (1.1%) were bedridden. After PVI, there was a two-fold increase in the
odds of 30-day death in patients who were ambulatory with assistance (odds ratio
[OR], 2.03; P<.001) and wheelchair-bound patients (OR, 2.09; P<.001), and a
more than six-fold increase in bedridden patients (OR, 6.28; P<.001) compared
with ambulatory patients. Among ambulatory patients, the risks of major amputation and death within 1year were only 10% and 12%, respectively, whereas that of
bedridden patients were as high as 30% and 38%, respectively. A stepwise decrease
in amputation-free survival from 81% with full ambulatory capacity to less than
50% (47.7%) in bedridden patients was observed. These risks should be considered
during shared decision-making regarding management options for non-ambulatory
patients with CLTI.

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12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
12.3.3.4 Failed Femoropopliteal Covered Vs. Bare Metal Stents
DeCarlo etal. [31] sought to determine if patients with failed SFA covered stent
(CS) were more likely to present with more severe ischemic symptoms than patients
with failed SFA bare metal stent (BMS) in a retrospective review of data from the
Vascular Quality Initiative. There were 3721 patients: 3338 with index BMS, 383
with index CS.At reintervention, acute limb ischemia (ALI) was the presenting
symptom for 12.0% of the CS cohort vs 6.3% of the BMS cohort (P<.001). More
patients with an index CS underwent major amputation at the time of reintervention
(2.6% vs 1.0%; P=.006). This study demonstrates that patients with a failed SFA
CS are almost twice as likely to present with ALI as patients with a failed SFA
BMS.Patients with failed SFA CS are also more likely to present with more severe
ischemia, more likely to require an urgent or emergent reintervention, and more
likely to undergo an open bypass at the time of representation for failure. Concerns
about CS and their use in femoropopliteal occlusive disease have been raised. First,
the placement of a CS in the femoropopliteal segment could result in the coverage
of important collaterals. Second, the mechanism of failure with these grafts is
referred to as edge stenosis. The edge of the stiff CS causes intimal hyperplasia,
leading to compromised inow or outow and subsequent stent thrombosis, resulting in a new, long-segment occlusion. The risks of CS placement should be considered in operative planning and preoperative discussion for SFA stenting.
12.3.3.5 Lower Extremity Bypass inPatients onHemodialysis
Hemodialysis patients who underwent infrainguinal open operation using autogenous versus prosthetic conduits in the United States Renal Data System between
January 2007 and December 2011 were studied by Arhuidese etal. [32]. There were
9739 (autogenous: 59%, prosthetic: 49%) infrainguinal open bypass operations performed in this cohort. Of these, 4717 (48%) were femoral-popliteal, 3321 (34%)
were femoral-tibial, and 1701 (18%) were popliteal-tibial bypasses. Bypass operations were performed most commonly for critical limb ischemia (72%). Primary
patency was 18% for both types of conduits at 5years (P=.16). Comparing autogenous versus prosthetic conduits, primary-assisted patency was 23% vs 20% at
5years (P=.98), while secondary patency was 30% for both conduits at 5years
(P=.05). Absolute all-cause mortality during the study period was 58% for patients
who received autogenous bypasses versus 63% for patients who received prosthetic
bypasses. Multivariable analyses demonstrated greater patency (adjusted hazard
ratio [aHR]: 1.16; P=.003) and limb salvage (aHR: 1.12; P=.03) for autogenous
compared to prosthetic bypasses. The data conrm the long-term benets of autogenous conduits compared with prosthetic conduits in this high-risk population of
patients, especially for the treatment of distal lesions.

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12.3.3.6 High-Intensity Statin Therapy among Patients Undergoing
Lower Extremity Bypass
He etal. [33] performed a retrospective cohort study using the IBM MarketScan
database (2008 to 2017) to identify all insured adult patients with CLTI that underwent a LEB procedure, including those performed to above-knee and below-knee
targets. A total of 25,907 patients who underwent LEB for CLTI were identied, of
which 6696 (26%) were maintained on high-dose statins, 9297 (36%) were on lowdose statins, and 9914 (38%) had inconsistent pharmacy claims for statin therapy
after surgery. Patients maintained on high intensity statins after LEB had a signicantly lower risk-adjusted likelihood of requiring a reintervention or amputation as
compared with patients on low-intensity and/or limited (ie, inconsistent) statin therapy. These ndings were independent of the indication for revascularization, extent
of LEB, or whether an autologous vein graft was used. The results of this study
suggest that patients undergoing lower extremity bypass procedures for CLTI should
be up-titrated and/or maintained on high-intensity statin therapy to achieve the best
long-term outcomes.
12.3.3.7 Revascularization inActive Smokers
Active smokers undergoing lower extremity endovascular (LEE) revascularization
or open lower extremity bypass (LEB) were identied in the NSQIP data set [34].
From 2011 to 2014, 4706 lower extremity revascularizations were performed in
active smokers (37% of all revascularizations). In this group, 1497 were LEE revascularizations (55.6% for CLI, 13.4% for below-knee pathology) and 3209 were
LEB (68.9% CLI, 34.7% below-knee). Analysis of 30-day outcome revealed that in
active smokers, LEB for IC and CLI requires fewer reinterventions but is associated
with a higher rate of postoperative wound complications compared with LEE revascularization. However, the risk for limb amputation is higher in actively smoking
patients when treated by LEE revascularization compared with LEB for
CLI.Importantly, cardiovascular complications are signicantly higher in actively
smoking patients with IC undergoing LEB compared with LEE.This additional
cardiovascular risk should be carefully weighed when proposing LEB for actively
smoking patients with non-limb-threatening IC. The authors suggested smoking
cessation and avoiding open surgical bypass in claudicant patients who smoke.
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12.3.4 Clinical Trials withSpecic Questions
12.3.4.1 Drug-Coated Devices
IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with below the knee CLI.Subjects
were randomized 2:1 to DCB angioplasty or PTA.Freedom from clinically driven

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12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank
p = 0.406), and the incidence of the safety composite endpoint was 59.8% and
57.5% (log-rank p=0.309) in the DCB angioplasty and PTA groups, respectively
[35]. The rate of major amputation was 15.4% for DCB angioplasty compared with
10.6% for PTA (log-rank p=0.108). Additional analyses from this study showed no
increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA
(44.9%) (log-rank p=0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. No difference in clinical performance was found in patients with CLI treated with the
IN.PACT Amphirion DCB or PTA, including major amputation and mortality.
In the PADI trial, adults with CLI (Rutherford category ≥4) and infrapopliteal
lesions were randomized to receive DES with paclitaxel or PTA ± BMS ([36].
Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients)
with PTA±BMS.The 5-year major amputation rate was lower in the DES group
(19.3% vs 34.0% for PTA±BMS; p=0.091). In addition, the 5-year amputationfree survival and event-free survival were signicantly higher in the DES group
(31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After
1year, the cost difference per patient between DES and PTA±BMS is €1.679in
favor of DES and €2.694 after 3years. In this analysis, DES were cost-effective due
to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS
group. For the PADI trial, the 10-year results were published [37]. Ten years after
the rst inclusion, 109/137 (79.6%) patients had died. There was no signicant difference between mortality in the DES group compared with the PTA±BMS group
(Log-rank p value=0.12). No specic dose-related mortality (HR 1.00, 95% CI
0.99-1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93-1.18,
p=0.46) relationships were identied. In conclusion, the 10-year survival of CLI
patients treated below the knee (BTK) is poor. There were no signicant differences
between 10-year mortality in patients with CLI treated BTK with either paclitaxelcoated DES or PTA±BMS.
The Zilver PTX RCT [38] was a prospective, multinational, randomized study
comparing the safety and effectiveness of the polymer-free, paclitaxel-coated Zilver
PTX DES to PTA and provisional BMS placement in patients with femoropopliteal
PAD.There were 336 patients treated with the DES and 143 patients treated with
percutaneous transluminal angioplasty (PTA) or BMS.There was no difference in
all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES
versus 17.1% PTA/BMS through 5years, p=0.60).
12.3.4.2 Tack Endovascular System forPost-Angioplasty Dissections
The Tack Endovascular System (4F; Intact Vascular) is specically designed for
post-PTA dissection repair. A prospective, single-arm, multicenter study evaluated
the Tack Endovascular System for treating post-PTA dissections in the mid/distal
popliteal, tibial, and peroneal arteries [39]. Of the 233 patients enrolled, 117 (50.2%)
had Rutherford class 5 and 78 (33.5%) had Rutherford class 4. A total of 341

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post- PTA dissections were treated. Each patient received at least one Tack implant,
and 100% of the dissections resolved according to the angiographic core laboratory
ndings. The 6-month Tacked segment patency was 82.1% (247 of 301) and target
limb salvage was 98.5% (202 of 205). The Kaplan-Meier freedom from clinically
driven target lesion revascularization and amputation-free survival at 6months was
92.0% and 95.7%, respectively. Using Tack implants to repair below-the-knee dissections is safe and effective, with high rates of patency, limb salvage, and freedom
from major adverse limb events.
12.3.4.3 LimFlow System forPercutaneous Deep Vein Arterialization
The LimFlow System consists of arterial and venous catheters that allow ultrasonographic determination of crossover direction and location; an antegrade, over-thewire valvulotome; and selfexpanding stent grafts specically designed to divert
blood ow from the tibial (donor) artery into the tibial and pedal (recipient) venous
system. PROMISE I is a prospective, multicenter, single-arm, early feasibility study
of the LimFlow percutaneous deep vein arterialization (pDVA) approach to treating
no-option CLTI [40]. Of 32 enrolled patients, 31 (97%) were successfully treated
with the LimFlow System at the time of the procedure, and two (6.3%) were lost to
follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70%
respectively. The wound healing status of fully healed or healing was 67% at
6 months, and 75% at 12 months. Reintervention was performed in 16 patients
(52%) with 14 (88%) of the maintenance reinterventions occurring within the rst
3months. These results suggest early safety and provide an initial assessment of the
efcacy of the LimFlow pDVA System.
The PROMISE I study established the feasibility of transcatheter arterialization
of the deep veins for the treatment of no-option CLTI.The PROMISE II study was
performed to expand on this work to evaluate the effect of the procedure on
amputation- free survival and limb salvage as compared with an objective performance goal [41]. 105 patients who had CLTI were enrolled. Of the patients enrolled,
33 (31.4%) were women. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6months, 66.1% of the patients had
amputation-free survival. Limb salvage (avoidance of above-ankle amputation) was
attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely
healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63
patients (51%). No unanticipated device-related adverse events were reported.
Transcatheter arterialization of the deep veins was safe and could be performed successfully in patients CLTI and no conventional surgical or endovascular revascularization treatment options. The PROMISE II study was commented by McGinigle
etal. [42]. These authors considered the trial design as inadequate for an unproven
therapy. The presented 6-month outcomes (25% healing and 24% major amputation) reect the natural history of disease; similar outcomes may be achieved with
palliative wound care (absent the 37% reintervention rate). It is unclear which
patients might benet because data regarding the staging of wounds, ischemia, and
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