Добавил:
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_3876_Библиотеки_им_академика_М_И_Перельмана

.pdf
Скачиваний:
0
Добавлен:
15.09.2026
Размер:
10 Мб
Скачать
☆
280
https://t.me/medicina_free
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 etal. [18] to determine whether bypass after failed endovascular intervention leads to inferior outcomes. Fifteen studies involving 11,886 patients met the inclusion criteria. No signicant differences were found in 30-day mortality or 30-day amputation rates comparing primary bypass with bypass after failed endovascular intervention. However, 1year 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 1year 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 signicant 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 forCLTI
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 supercial 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 totheHospital 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
12.3 Results
https://t.me/medicina_free
281
readmission rates ranged from 10.9% to 30.0% with a mean of 16.4%. The follow­ing risk factors had a signicant 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 etal. [21] identied 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)
282
https://t.me/medicina_free
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 forPeripheral 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 fortheTreatment ofCLTI
Safety and efcacy 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 etal. [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 signicantly 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 identied in a second meta-analysis (11 randomised trials, 2213 patients, mean follow-up 25.6months) by Dinh etal. [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
12.3 Results
https://t.me/medicina_free
283
devices. With clear benet 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 identied 3848 cases (1924 per group). At 30days, rates of MALEs were signicantly 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 (Table12.4).
In the Nationwide Readmissions Database, a total of 66,277 patients were identi­ed 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
284
https://t.me/medicina_free
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 etal. [27] identied 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 2years, 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 identied 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 signicantly reduced incidence of MACE.
12.3 Results
https://t.me/medicina_free
285
12.3.3.2 Revascularization withPaclitaxel-Coated Devices inPatients
withCLTI
Smith etal. [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 efcacy 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 benet 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 etal. [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 1year 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.
286
https://t.me/medicina_free
12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)
12.3.3.4 Failed Femoropopliteal Covered Vs. Bare Metal Stents
DeCarlo etal. [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 inow or outow 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 inPatients onHemodialysis
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 etal. [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 5years (P=.16). Comparing autog­enous versus prosthetic conduits, primary-assisted patency was 23% vs 20% at 5years (P=.98), while secondary patency was 30% for both conduits at 5years (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 conrm the long-term benets of autog­enous conduits compared with prosthetic conduits in this high-risk population of patients, especially for the treatment of distal lesions.
12.3 Results
https://t.me/medicina_free
12.3.3.6 High-Intensity Statin Therapy among Patients Undergoing
Lower Extremity Bypass
He etal. [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 identied, 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 signi­cantly 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 inActive Smokers
Active smokers undergoing lower extremity endovascular (LEE) revascularization or open lower extremity bypass (LEB) were identied 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 signicantly 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.
287
12.3.4 Clinical Trials withSpecic 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
288
https://t.me/medicina_free
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 signicantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1year, the cost difference per patient between DES and PTA±BMS is €1.679in favor of DES and €2.694 after 3years. 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 signicant dif­ference between mortality in the DES group compared with the PTA±BMS group (Log-rank p value=0.12). No specic 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 identied. In conclusion, the 10-year survival of CLI patients treated below the knee (BTK) is poor. There were no signicant 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 5years, p=0.60).
12.3.4.2 Tack Endovascular System forPost-Angioplasty Dissections
The Tack Endovascular System (4F; Intact Vascular) is specically 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
12.3 Results
https://t.me/medicina_free
289
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 6months 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 forPercutaneous 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 specically 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 3months. These results suggest early safety and provide an initial assessment of the efcacy 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 6months, 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 etal. [42]. These authors considered the trial design as inadequate for an unproven therapy. The presented 6-month outcomes (25% healing and 24% major amputa­tion) reect 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 benet because data regarding the staging of wounds, ischemia, and