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

Vascular ◽  
2020 ◽  
pp. 170853812096612 ◽  
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.

Results of isolated infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia in high-risk diabetic patients

Vascular ◽  
2016 ◽  
Vol 24 (5) ◽  
pp. 515-522 ◽  
Author(s):  
E Tartaglia ◽  
A Lejay ◽  
Y Georg ◽  
M Roussin ◽  
F Thaveau ◽  
...  
Keyword(s):  
High Risk ◽  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Diabetic Patients ◽  
Secondary Patency ◽  
Cerebrovascular Event ◽  
Arterial Lesions ◽  
Infrapopliteal Angioplasty

Aim Infrapopliteal occlusive arterial lesions mostly characterize diabetic patients arteriopathy. Diabetic patients are prone to multiple comorbidities that make them candidates for low-invasive therapeutic options. The aim of this study was to evaluate the safety of infrapopliteal angioplasty in high-risk diabetic patients. Methods We undertook a study (retrospective study of a prospectively collected database) of all infrapopliteal endovascular revascularizations performed for critical limb ischemia in high-risk (≥3 major comorbidities) diabetic patients in our institution between 2008 and 2010. Study end points were safety, technical success rate, healing rate, overall 1-year survival, primary patency, secondary patency and limb salvage rates. Results A total of 101 high-risk diabetic patients (160 arterial lesions: 94 stenosis and 66 occlusions) underwent infrapopliteal endovascular surgery. No major adverse cardiovascular or cerebrovascular event was recorded within 30 days. Two major adverse limb events (two thromboses requiring major amputation) and seven minor adverse events were recorded. Technical and healing rates were, respectively, 83% and 78%. The 1-year survival, primary patency, secondary patency and limb salvage rates were, respectively, 86%, 67%, 83% and 84%. Conclusion Infrapopliteal angioplasty can be considered as a safe and feasible option for high-risk diabetic patients with critical limb ischemia.

Long-Term Results of Distal Bypass for Intermittent Claudication

2020 ◽  
Vol 55 (1) ◽  
pp. 5-10
Author(s):  
Taira Kobayashi ◽  
Masaki Hamamoto ◽  
Takanobu Okazaki ◽  
Tomoaki Honma ◽  
Shinya Takahashi
Keyword(s):  
Intermittent Claudication ◽  
Saphenous Vein ◽  
Barthel Index ◽  
Daily Activity ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Long Term Results ◽  
Secondary Patency ◽  
The Mean

Background: Distal bypass (DB) is the optimal treatment for patients with critical limb ischemia (CLI). However, effectiveness of DB for patients with intermittent claudication (IC) remains uncertain. This study aimed to analyze long-term results of DB for IC patients (IC-DB) compared with those of DB for CLI patients (CLI-DB). Methods: Patients undergoing DB from January 2009 to July 2018 at a single institution were retrospectively reviewed. Operative details, primary and secondary patency, amputation free survival rate (AFS), and long-term exercise capacity using Barthel index were analyzed. Results: Out of 302 DB (245 patients), 49 IC-DB were performed in 43 patients: 38 males, mean age 70.3 ± 8.0 years, diabetes mellitus 51%, chronic renal failure with hemodialysis 7%. The Great saphenous vein was used in 47 limbs, the small saphenous vein in 1, and the arm vein in 1. These grafts were bypassed in a non-reversed fashion for 35 limbs, in an in-situ fashion in 9, and in a reversed fashion in 5. The mean operative time was 173 min. The mean follow-up was 25 ± 26 months. Primary and secondary patency of IC-DB was 79% and 94% at 1 year, 71% and 90% at 3 years, 65% and 90% at 5 years, which were significantly higher than those of CLI-DB (primary patency: P = .007, secondary patency: P = .025). AFS of IC-DB and CLI-DB was 100% and 77% at 1 year, 93% and 52% at 3 years, and 90% and 43% at 5 years (IC-DB vs. CLI-DB, p < .0001). Barthel index of IC-DB unchanged at discharge (median 100) and at the last visit (median 100), showing daily activity was maintained adequately. Conclusions: DB could offer a promising approach for patients with IC because of durable graft patency, acceptable AFS, and maintenance of daily activity.

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

Vascular ◽  
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.

Single Tertiary Care Center Outcomes After Lower Extremity Cadaveric Vein Bypass for Limb Salvage

2020 ◽  
Vol 54 (5) ◽  
pp. 430-435
Author(s):  
Kuldeep Singh ◽  
Amandeep Juneja ◽  
Tushar Bajaj ◽  
Christian Voto ◽  
Jonathan Schor ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Limb Salvage ◽  
Saphenous Vein ◽  
Tertiary Care ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Limb Amputation ◽  
Secondary Patency ◽  
Acute Limb Ischemia ◽  
Long Term Outcome

Objective: Cadaveric saphenous vein (CV) conduits are used in rare instances for limb salvage in patients without autogenous veins although long-term outcome data are scarce. This study was designed to evaluate the outcomes of CV bypass in patients with threatened limbs. Methods: We retrospectively reviewed the charts from 2010 to 2017 of 25 patients who underwent 30 CV allografts for critical limb ischemia and acute limb ischemia. Patient charts were reviewed for demographics, comorbidities, smoking status, indications for bypass, and outcomes. Primary outcomes included graft patency, major amputation rates, and mortality. Secondary outcomes measured included infection rates, 30-day major adverse cardiac events (MACE) and major adverse limb events (MALE). Statistical analysis was performed using time series and Kaplan-Meier survival curves. Results: A total of 30 limbs received CV lower extremity bypasses (20 males, 10 female), and the average age was 68 ± 4 years. Primary patency rates were 71%, 42%, and 28% at 3, 6, and 12 months, respectively. Assisted primary patency rates were 78%, 56%, and 37% at 3, 6, and 12 months, respectively. Secondary patency rates were 77%, 59%, and 28% at 3, 6, and 12 months, respectively. Minor amputations, defined as amputations below the transmetatarsal level occurred in 5 (20%) patients. Wound infection occurred in 8 (32%) patients which was managed with local wound care and no patients required an extraanatomic bypass for limb salvage. Thirty-day MALE occurred in 7 (23.3%) patients. We had no 30-day mortality or MACE. The average graft length was 64.2 ± 8 cm with an average graft diameter of 3.9 ± 2 mm. Amputation-free survival and overall survival at 12 months were 20 (68%) and 21 (84%), respectively. Conclusions: Cadaveric saphenous vein allograft may be used as a bypass conduit as a viable surgical option before limb amputation. Despite the poor patency rates, the limb salvage rates of cadaveric vein grafts demonstrate that this alternate conduit may be considered when no autogenous vein is available.

scholarly journals The role of directional atherectomy in critical-limb ischemia

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.

scholarly journals Results of in situ femoropopliteal (tibial) bypass in patients with extended lower limbs arterial bed lesion and critical ischemia

2015 ◽  
Vol 96 (6) ◽  
pp. 942-949 ◽  
Author(s):  
N V Krepkogorskiy ◽  
D G Bulatov
Keyword(s):  
Quality Control ◽  
Saphenous Vein ◽  
Lower Limb ◽  
Great Saphenous Vein ◽  
Limb Ischemia ◽  
Critical Ischemia ◽  
Shunt Thrombosis ◽  
Bypass Patency

Aim. To specify the indications for in situ femoropopliteal (tibial) bypass, to study complications rate immediately after, within 1 and 2 years of the surgery. Methods. The study group included 33 patients with symptoms of critical lower limb ischemia, who underwent femoral-popliteal or femoral-tibial bypass. 4 (12.1%) cases of type C and 29 (87.9%) cases of type D arterial bed lesions according to TASC II classification were revealed after investigation. Patients were followed up for 2 years period. Shunt thrombosis rate, condition of the trophic ulcers, chronic arterial ischemia stage before and after the surgery, mortality, lower limb amputation were measured outcomes. Results. Repeated reconstructions rate for primary shunt thrombosis immediately after surgery was 30.3±8.0%. Shunt thrombosis (secondary) occurred in only three (9.1±5.0%) patients. The main causes which led to the shunt thrombosis during or at the 1st day after the surgery, were absence of intraoperative valvulotomy quality control and presence of unligated great saphenous vein tributaries. Trophic defects healing was observed in 3 (30.0±14.5%) of 10 patients with ulcers immediately after surgery and in all cases (100.0%) by the end of 1 year follow-up. The total number of high-level amputations within 2 years was 25.8±7.9%, the overall mortality rate within 2 years was 6.1±4.2%. Femoral-popliteal or femoral-tibial bypass surgery allowed to preserve the limb in 74.2% of patients within 2 years of follow-up. Bypass patency was preserved in 41.7% of patients out of 24 in situ bypass surgeries for the follow-up time. In our opinion critical limb ischemia with significant and extended arterial bed lesions of D and C types (according to TASC II score) is one of the indications for in situ femoropopliteal (tibial) bypass as for the surgery of the first choice. Endovascular treatment is also impossible for this type of lesion, as alternative surgeries using reversed autovein and synthetic explant do not meet all the requirements for an extended bypass. Conclusion. The lack of adequate intraoperative valvulotomy quality control and presence of unligated great saphenous vein tributaries may be the causes of early postoperative shunt thrombosis; despite the low femoropopliteal (tibial) bypass patency rate in patients with critical ischemia, the surgery was recognized as efficient as it allowed to preserve the limbs in 74.2% of patients.

The Upper-Arm Basilic-Cephalic Loop: A Valueable Alternative for Below-Knee Arterial Reconstruction

2021 ◽  
pp. 153857442098061
Author(s):  
Florian K. Enzmann ◽  
Peter Metzger ◽  
Julio Ellacuriaga San Martin ◽  
Werner Dabernig ◽  
Fatema Akhavan ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Saphenous Vein ◽  
Bypass Graft ◽  
Primary Patency ◽  
Secondary Patency ◽  
Upper Arm ◽  
Autologous Vein ◽  
Tertiary Referral Center ◽  
Vein Grafts ◽  
First Choice

Introduction: Despite advances of endovascular interventions, bypass surgery remains the gold standard for treatment of long and complex arterial occlusions in the lower limb. Autologous vein is regarded superior to other options. As the graft of first choice, the great saphenous vein (GSV) is often not available due to previous bypass, stripping or poor quality. Other options like arm veins (AV) are important alternatives. As forearm portions of AVs are often unusable, a graft created from the upper arm basilic and cephalic veins provides a valuable alternative. Patients and Methods: We analyzed consecutive patients treated at an academic tertiary referral center between 01/1998 and 07/2018 using arm veins as the main peripheral bypass graft. Study endpoints were primary patency, secondary patency, limb salvage and survival. Results: In the observed time period 2702 bypass procedures were performed at our institution for below-knee arterial reconstructions. Vein grafts used included the ipsilateral GSV (iGSV; n = 1937/71.7%), contralateral GSV (cGSV; 192/7.1%), small saphenous vein (SSV; 133/4.9%), prosthetic conduits (61/2.3%) and different configurations of AV (379/14%). In the majority of patients receiving AV grafts a complete continuous cephalic or basilic vein (CAV) was used (n = 292/77%). If it was not possible to use major parts of these 2 veins, either spliced arm vein grafts (SAV) (42/11%) or an upper arm basilic-cephalic loop graft (45/12%) were used. Median follow-up was 27 (interquartile range: 8-50) months. After 3 years secondary patency (CAV: 85%; SAV: 62%; loop: 66%; p = 0.125) and limb salvage rates (CAV: 79%, SAV: 68%; loop: 79%; p = 0.346) were similar between the 3 bypass options. Conclusion: The encouraging results of alternative AV configurations highlight their value in case the basilic or cephalic veins are not useable in continuity. Especially for infragenual redo-bypass procedures, these techniques should be considered to offer patients durable revascularization options.

Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions

Vascular ◽  
2021 ◽  
pp. 170853812110298
Author(s):  
Görkem Yiğit
Keyword(s):  
Critical Limb Ischemia ◽  
Bypass Graft ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Rotational Atherectomy ◽  
Total Occlusion ◽  
The Mean ◽  
Knee Pathology ◽  
Drug Coated Balloon

Objectives In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) ( n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients ( p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients ( p < 0.001). Conclusions Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

Bifurcated bypass in severe chronic limb threatening ischaemia

Vascular ◽  
2021 ◽  
pp. 170853812199985
Author(s):  
Daniele Adami ◽  
Michele Marconi ◽  
Alberto Piaggesi ◽  
Davide M Mocellin ◽  
Raffaella N Berchiolli ◽  
...  
Keyword(s):  
Survival Rates ◽  
Primary Patency ◽  
Free Survival ◽  
Mortality And Morbidity ◽  
Bypass Patency ◽  
Stage 4 ◽  
Endovascular Approach ◽  
The Mean ◽  
Clinical Records

Objectives Revascularization according to the angiosome concept is of proven importance for limb salvage in chronic limb threatening ischaemia but it is not always practicable. Bifurcated bypasses could be considered as an option when an endovascular approach is not feasible or has already failed and a single bypass would not allow direct revascularization of the ischaemic area. Bifurcated bypasses are characterized by landing on two different arteries, the main artery (in direct continuity with the foot vessels) and the secondary one (perfusing the angiosome district). The aim of this study is to evaluate the safety and effectiveness of bifurcated bypass in chronic limb threatening ischaemia. Methods Thirty-five patients were consecutively treated with a bifurcated bypass for chronic limb threatening ischaemia from January 2014 to December 2019 in a single vascular surgery centre. Data from clinical records and operative registers were collected prospectively in an electronic database and retrospectively analysed. Primary and primary assisted bypass patency, amputation-free survival, morbidity and mortality rates at 12 and 24 months were analysed. Results Mean follow-up period was 25.1 months (range 2–72 months). Thirty-six bifurcated bypasses were performed on 35 patients (age 75.3 ± 7.2 years; 69.4% were male). According to Wound, Ischemia, foot Infection classification 22.2% belonged to stage 3 and 77.8% to stage 4 and the mean Rutherford’s class was 5.1 ± 0.7. Immediate technical success was 100%. Early mortality and morbidity rates were respectively 5.5%, and 33.3%; foot surgery was performed in 50% of cases with wound healing in all patients. Primary patency and primary assisted bypass patency were 96.7% and 100% at 6 months; 85.2% and 92% at 12 months, 59.9% and 73.4% at 24 months, respectively. Amputation-free survival at 12 and 24 months was, respectively, 95.6% and 78.8%. Overall survival rates at 12 and 24 months were respectively 94.4% and 91.6%. Conclusions Bifurcates bypass can provide good results in patients with chronic limb threatening ischaemia without endovascular option, especially in diabetic ones. Bifurcated bypass is a complex surgical solution, both to be planned and performed, and it is quite invasive for frail patients that should be accurately selected.

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