Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.

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Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry

Vascular ◽

10.1177/1708538120966126 ◽

2020 ◽

pp. 170853812096612 ◽

Cited By ~ 1

Author(s):

Nicola Troisi ◽

Giovanni De Blasis ◽

Mauro Salvini ◽

Stefano Michelagnoli ◽

Carlo Setacci ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Saphenous Vein ◽

Limb Ischemia ◽

Primary Patency ◽

Secondary Patency ◽

Bypass Patency ◽

The Mean

Objectives Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results Patients were predominantly male ( n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.

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Abstract 17943: Clinical Factors That Determine the Superiority of Femoropopliteal Stenting Compared With Balloon Angioplasty

Circulation ◽

10.1161/circ.132.suppl_3.17943 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Seiichi Hiramori ◽

Yoshimitsu Soga ◽

Yohei Kobayashi ◽

Yusuke Tomoi ◽

Shinichi Shirai ◽

...

Keyword(s):

Propensity Score ◽

Propensity Score Matching ◽

Balloon Angioplasty ◽

Type A ◽

Primary Patency ◽

Hazard Ratio ◽

Lesion Length ◽

Clinical Factors ◽

Stent Group ◽

Ambulatory Patients

Background: It has reported that femoropopliteal stenting is superior to balloon angioplasty. However, it remains unclear that what factors affect the superiority of stent compared with balloon angioplasty. Purpose: To investigate the efficacy of stent in femoropopliteal lesions and clinical factors that affect the superiority of femoropopliteal stenting compared with balloon angiography. Methods: We analyzed consecutive 1523 de novo femoropopliteal lesions performing endovascular therapy between January 2004 and December 2013 by means of propensity score matching. We assessed the efficacy of stent for femoropopliteal lesion on primary patency and assisted-primary patency, and clinical factors that determine the superiority of stent compared with balloon angioplasty. Results: 265 lesions in each group were selected by propensity score matching model for comparison. No difference was found in primary patency at 3 year between stent group and non-stent group (58.7% vs 49.3%, p=.06) and in assisted- primary patency at 3 year (63.8% vs 61.6%, p=.89). For the subgroup analysis, hazard ratio for primary patency in non-hemodialytic (hazard ratio [HR], 0.69; 95% confidential interval [CI], 0.50-0.96; p=.03) or ambulatory patients (HR, 0.69; 95% CI, 0.52-0.92; p=.01), or occlusive (HR, 0.58; 95% CI, 0.37-0.91; p=.02), non-calcified (HR, 0.63; 95% CI, 0.39-0.99; p=.04), TASCII non type A (HR, 0.65; 95% CI, 0.46-0.91; adjusted p=.01), or long (>100mm) (HR, 0.57; 95% CI, 0.32-0.98; p=.04) lesions showed the superiority of stent compared with balloon angioplasty. Conclusions: Our data suggests that femoropopliteal stenting is not necessarily recommended for all femoropopliteal lesions. However, it seems that femoropopliteal stenting is effective in non-hemodialytic or ambulatory patients, or lesions such as occlusive, non-calcified, TASC II non type A, or lesion length > 100mm compared with balloon angioplasty.

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Six-Month Angiographic and Clinical Outcomes of Therapeutic Ultrasound Pretreatment Associated With Plain Balloon Angioplasty for Below-the-Knee Lesions in Patients With Critical Limb Ischemia: A Prospective, Single-Center Pilot Study

Journal of Endovascular Therapy ◽

10.1177/1526602819829904 ◽

2019 ◽

Vol 26 (2) ◽

pp. 191-198

Author(s):

Costantino Del Giudice ◽

Roberto Gandini

Keyword(s):

Pilot Study ◽

Clinical Outcomes ◽

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

High Intensity ◽

Low Frequency ◽

Limb Ischemia ◽

Primary Patency ◽

Single Center ◽

Ultrasound Energy

Purpose: To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions. Materials and Methods: A prospective, nonrandomized, single-center pilot study enrolled 12 patients (mean age 72.2±5.3 years; 8 men) with critical limb ischemia (9 Rutherford category 5 and 3 category 6) between January and November 2017. Of the 19 target lesions, 11 had severe calcification. Patients were treated with the Kapani ultrasound system before conventional balloon dilation. Primary safety endpoints included 30-day death, major target limb amputation, and target vessel acute occlusion. The main efficacy outcome was primary patency at 6 months, defined as freedom from both clinically-driven target lesion revascularization (TLR) and angiographically-defined restenosis (>50% lumen reduction). Results: Technical success (<30% residual stenosis) was achieved in all lesions without complications or stent implantation. Ultrasound energy was delivered over a mean 185.2±67.3 seconds followed by low-pressure dilation (mean 6.1±1.9 atm). Angiography confirmed primary patency at 6 months in 18 (95%) of 19 lesions. No death, TLR, or amputation was reported in follow-up. Complete ulcer healing was observed in all 12 patients at 6 months. Conclusion: This pilot trial with a small number of patients suggests that low-frequency, high-intensity ultrasound energy delivery followed by plain balloon angioplasty is a safe approach to treat infrapopliteal atherosclerotic lesions. Angiographically-documented results at 6 months indicate a potential for this combined therapy in the treatment of CLI patients with calcified BTK lesions. Further studies on a larger randomized cohort are needed to confirm these positive clinical outcomes.

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Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Vascular ◽

10.1177/1708538120970817 ◽

2020 ◽

pp. 170853812097081

Author(s):

Aysen Y Engin ◽

Onur Saydam

Keyword(s):

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Primary Patency ◽

Rotational Atherectomy ◽

Secondary Patency ◽

Technical Success ◽

Technical Success Rate ◽

The Mean ◽

Drug Coated Balloon

Objectives The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. Methods Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. Results Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. Conclusions Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

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The role of directional atherectomy in critical-limb ischemia

Therapeutic Advances in Cardiovascular Disease ◽

10.1177/17539447211046953 ◽

2021 ◽

Vol 135 ◽

pp. 175394472110469

Author(s):

Prakash Krishnan ◽

Arthur Tarricone ◽

Simon Chen ◽

Samin Sharma

Keyword(s):

Lower Extremity ◽

Limb Salvage ◽

Critical Limb Ischemia ◽

Relevant Literature ◽

Limb Ischemia ◽

Primary Patency ◽

Lesion Length ◽

Secondary Patency ◽

Directional Atherectomy ◽

Procedural Success

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.

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Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arteries in critical limb ischemia

VASA ◽

10.1024/0301-1526/a000152 ◽

2011 ◽

Vol 40 (6) ◽

pp. 482-490 ◽

Cited By ~ 30

Author(s):

Brodmann ◽

Froehlich ◽

Dorr ◽

Gary ◽

Portugaller ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Patency Rate ◽

Limb Ischemia ◽

Primary Patency ◽

Stent Group ◽

Randomized Controlled ◽

Primary Stenting ◽

Infrapopliteal Arteries ◽

Percutaneous Transluminal

Background: In endovascular recanalisation of infrapopliteal arteries, studies have already pointed out the value of balloon angioplasty, but for stent implantation very few randomized controlled data exist so far. Patients and methods: We conducted a randomized controlled prospective trial in patients with critical limb ischemia (CLI) comparing the effect of percutaneous transluminal ballon angioplasty (PTA) versus primary stenting in infrapopliteal arteries, concerning 1-year clinical benefit and reobstruction rate. Results: 54 patients were either randomized for primary stenting (balloon expandable stent) or PTA alone, 33 patients were assigned to the PTA group, 21 patients to the stent group. The whole follow up period of 12 months was completed by 46 patients. Improvement by at least one Rutherford classification was reached by a total of 33 (75.0 %) of patients at month 12, 22 (81.5 %) in the PTA group and 11 (64.7 %) in the stent group. A complete ulcer healing at month 12 showed 21 (63.6 %) of all patients, with a higher percentage in patients treated with PTA alone 16 (80.0 %) vs 5 (38.5 %). 50.0 % of all patients showed re-obstruction over the follow-up period, 39.4 % of the PTA and 66.7 % of the stent group. At month 3 primary patency rate was nearly equal in both groups (76.7 % PTA vs 75.0 % stent), but drifted apart with the duration of the follow-up period, with a primary patency at month 12 in the PTA group of 48,1 % vs 35,3 % in the stent group. As for secondary patency at month 12 the PTA group showed a patency rate of 70.4 %, vs 52.9 % in the stent group. Conclusions: Primary stenting with balloon expandable stents in the infrapopliteal arteries does not outway the benefit of PTA alone with the application of modern hydrophilic balloon catheters in patients with CLI.

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Abstract 14816: Twelve-month Outcomes of Stenting versus Standard Balloon Angioplasty for the Below-the-Knee Arterial Disease Patients Underwent Percutaneous Transluminal Angioplasty

Circulation ◽

10.1161/circ.132.suppl_3.14816 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Seung Woon Rha ◽

Byoung Geol Choi ◽

Se Yeon Choi ◽

Jae Kyeong Byun ◽

Jin Oh Na ◽

...

Keyword(s):

Clinical Outcomes ◽

Limb Salvage ◽

Balloon Angioplasty ◽

Percutaneous Transluminal Angioplasty ◽

Arterial Disease ◽

Transluminal Angioplasty ◽

Below The Knee ◽

Procedural Success ◽

Percutaneous Transluminal ◽

Similar Incidence

Background: Although percutaneous transluminal angioplasty (PTA) is considered as an effective treatment strategy in patients (pts) with critical limb ischemia (CLI), below-the-knee (BTK) lesions with CLI is particularly challenging. This study sought to compare the 12-month outcomes following stenting versus standard plain old balloon angioplasty (POBA) alone in BTK lesions. Method: This study consisted of 339 consecutive lower extremity arterial disease pts (394 limbs, 1026 lesions included 716 BTK lesions) with BTK lesions from Sep 2004 to Dec 2013. All the enrolled pts were treated by stenting (bare metal stents, primary or provisional, 78 limbs in 73 pts) or POBA (316 limbs in 266 pts) with PTA. Procedural success, complications and clinical outcomes were compared between the two groups up to 12 months. To adjust potential confounders, a propensity score matched (PSM) analysis was performed using the logistic regression model. Results: After PSM analysis, 2 propensity-matched groups (56 pairs in pts, n= 112; 61 pairs in limbs, n=122, C-statistic=0.808) were generated, and the baseline & angiographic characteristics of the two groups were balanced. Procedural success, complication incidences were similar between the two groups. Six to 9-month CT or angiographic follow-up, there were similar incidence of binary restenosis, primary, and secondary patency. At 12 months, there were similar incidence of individual hard endpoints including mortality, myocardial infarction, limb salvage, and any extremity amputations except the target lesion and extremity revascularization. Repeat PTA incidence was higher in the stenting group than POBA group (table). Conclusion: Although the repeat PTA risk was increased with BTK stenting, other major individual clinical outcomes and limb salvage rates were similar between the POBA and stenting for the BTK lesions.

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Upper thigh loop prosthetic arterio-venous grafts (AVG) for dialysis access: An Indian perspective

The Journal of Vascular Access ◽

10.1177/11297298211055632 ◽

2021 ◽

pp. 112972982110556

Author(s):

Sekar Natarajan ◽

Jithin Jagan Sebastian

Keyword(s):

Upper Limb ◽

Limb Ischemia ◽

Primary Patency ◽

Central Vein ◽

Secondary Patency ◽

Dialysis Access ◽

Venous Grafts ◽

Vein Stenosis ◽

Central Vein Stenosis

Introduction: Hemodialysis forms the most common replacement therapy for majority of Indians suffering from chronic kidney disease (CKD). Multiple access failure and central vein stenosis has become commonplace in Indian dialysis access patients and there is a burgeoning need for more advanced hemodialysis (HD) access options. Upper thigh arterio-venous grafts (AVG) are seldom inserted due to fear of infection and limb ischemia. Materials and methods: This is a single institutional, retrospective, descriptive case study of consecutive patients who underwent upper thigh prosthetic AVG over a period of 7 years. All these patients had exhausted options of upper limb access and or had central vein stenosis. AVG from the proximal superficial femoral artery (SFA) to the proximal great saphenous vein (GSV) in a loop configuration using polytetrafluoroethylene (PTFE) was carried out in the upper thigh. Results: A total of 24 patients had undergone upper thigh loop AVG. Their age varied from 24 to 77 years. The median follow-up period was 3 years. Five of these grafts developed infection (21%) which led to primary failure. A primary patency of 71% (17/24 patients) was achieved at 1 year. Thrombosis developed at a mean of 16.7 months after the primary procedure. Adjunctive procedures such as thrombectomy, segmental replacement of graft, patch angioplasty, balloon angioplasty, and stenting were required in 75% of patients to achieve a secondary patency of 86% at 1 year. Three grafts were explanted without limb loss. Conclusion: Upper thigh loop AVG forms a reliable alternate dialysis access option for patients with failed upper limb access sites or central vein occlusion. Adjunctive procedures are key to maintaining patency in these grafts. Good secondary patency is achievable, and the infection rates are similar to arm AVG. Close follow-up and timely intervention are key to long term dialysis through these grafts.

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Evaluation of Clinical Outcomes After Revascularization in Patients With Chronic Limb-Threatening Ischemia: Results From a Prospective National Cohort Study (RIVALUTANDO)

Angiology ◽

10.1177/0003319720980619 ◽

2021 ◽

pp. 000331972098061

Author(s):

Gianmarco de Donato ◽

Filippo Benedetto ◽

Francesco Stilo ◽

Roberto Chiesa ◽

Domenico Palombo ◽

...

Keyword(s):

Cohort Study ◽

Clinical Outcomes ◽

Protective Factor ◽

Primary Patency ◽

Multicenter Cohort Study ◽

Below The Knee ◽

National Cohort ◽

Iloprost Infusion ◽

Lower Extremity Revascularization

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.

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Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

Journal of International Medical Research ◽

10.1177/03000605211006546 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052110065

Author(s):

Hao Ren ◽

Jie Liu ◽

Jiwei Zhang ◽

Baixi Zhuang ◽

Weiguo Fu ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Outcome Data ◽

Primary Patency ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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