One-Year Outcomes of Two Different Paclitaxel-Eluting Stents (Zilver PTX and Eluvia) for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D Obstructive Femoropopliteal Lesions

Background: Endovascular therapy is one of the standard treatment options for patients with peripheral arterial disease. Paclitaxel-eluting stents (PES) have shown promising results in the treatment of obstructive femoropopliteal lesions. Two types of PES, namely, Zilver PTX (Cook Medical, USA) and Eluvia (Boston Scientific, USA), are available worldwide. However, no study has yet compared the outcomes of applying both PES types in the real world. Objectives: This study aimed to assess the one-year outcomes of two different types of PES for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Patients and Methods: This single-center, retrospective, observational study examined 37 limbs of 34 patients (30 males and four females) with the mean age of 71.9 ± 9.1 years (range, 53-90 years), who were included consecutively from February 2017 to May 2018. In all patients, either a Zilver PTX (Cook Medical) or an Eluvia (Boston Scientific) PES was used for TASC C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Moreover, the patients’ one-year primary patency rate, freedom from clinically driven target lesion revascularization (TLR), and event-free survival rates were determined. Results: The mean lesion length was measured to be 24.6 ± 6.6 cm (range, 9 - 46 cm). Based on the results, 78% of the lesions (29 limbs) showed occlusion, and 46% (17 limbs) showed more than moderate calcification. According to the TASC classification, type D lesions were detected in 25 (68%) limbs, while type C lesions were detected in 12 (32%) limbs. The mean number of stents used was 2.5 ± 0.7 per limb (range, 1 - 3) to cover a mean length of 24.3 ± 7.9 cm (range, 6-35 cm). Overall, 56 Zilver PTX stents for 23 limbs and 36 Eluvia stents for 14 limbs were used. The Kaplan-Meier estimates of one-year primary patency and freedom from TLR were 78% and 88%, respectively (Zilver PTX stent, 76.3% and 81.2%, respectively; Eluvia stent, 91.7% and 100%, respectively). Major adverse events were reported in two patients (2/37, 5.4%), including acute thrombotic occlusion of the treated lesions. Conclusion: Both types of PES showed promising one-year outcomes for TASC C/D lesions regarding safety and efficacy, without any significant differences; therefore, they can be considered as an alternative therapeutic approach for surgery.

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Bifurcated bypass in severe chronic limb threatening ischaemia

Vascular ◽

10.1177/1708538121999856 ◽

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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Application of Immediate Loaded Mini Dental Implants for Retaining Mandibular Overdenture Prosthesis in Edentulous Patients: A Systematic Review

Applied Sciences ◽

10.3390/app112210724 ◽

2021 ◽

Vol 11 (22) ◽

pp. 10724

Author(s):

Abdulaziz A. AlHelal

Keyword(s):

Dental Implants ◽

English Literature ◽

Treatment Options ◽

Survival Rates ◽

Tissue Response ◽

Marginal Bone Loss ◽

Probing Depth ◽

The Mean ◽

Edentulous Patients ◽

Mandibular Overdenture

The aim was to systematically review the efficacy of immediate loaded mini dental implants (MDIs) to retain mandibular overdentures in regards to survival rates of MDIs, peri-implant clinical and radiographic tissue response and associated factors. A literature search of English literature was performed using Google Scholar, Scopus, Web of Science, MEDLINE (OVID), EMBASE, and PubMed using predetermined inclusion criteria. Specific terms were utilized in searching from the inception of the respective databases up to April 2021. The focused question was: Do immediate loaded MDIs supporting mandibular overdentures present favorable treatment options for prosthetic rehabilitation? The 11 articles included in the present review examined 349 patients (198 males + 171 females [66.65 ± 6.28 years]) in which 1190 MDIs were placed to retain mandibular overdentures. The mean follow-up duration was 24.5 months. The cumulative survival rate of MDIs was 97.3%. The mean scores of plaque index, gingival index, probing depth, and bleeding on probing ranged between 0–3, 0–3, and 1.203–1.76 respectively, whereas the mean marginal bone loss values ranged from 0.42 ± 0.56 mm to 1.26 ± 0.64 mm. The results identified that the application of immediate loaded MDIs to retain mandibular overdentures are a potential treatment modality for edentulous patients.

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Outcomes of laparoscopic subtotal gastrectomy for gastric adenocarcinoma in Nghe An Friendship General Hospital

Vietnam Journal of Endolaparoscopic Surgery ◽

10.51199/vjsel.2019.3.7 ◽

2019 ◽

Vol 9 (3) ◽

Author(s):

Văn Chiến Đinh ◽

Keyword(s):

Lymph Nodes ◽

General Hospital ◽

Gastric Adenocarcinoma ◽

Survival Rates ◽

Subtotal Gastrectomy ◽

Female Ratio ◽

The Mean ◽

Laparoscopic Subtotal Gastrectomy ◽

One Year ◽

Lymph Nodes Dissection

Tóm tắt Đặt vấn đề: Đánh giá tính an toàn và hiệu quả của phẫu thuật nội soi cắt đoạn dạ dày nạo vét hạch trong điều trị ung thư biểu mô dạ dày. Phương pháp nghiên cứu: Nghiên cứu hồi cứu mô tả, tất cả người bệnh ung thư biểu mô dạ dày được phẫu thuật nội soi cắt đoạn dạ dày từ 2012 đến 2019. Kết quả: 278 người bệnh ung thư dạ dày được phẫu thuật nội soi cắt đoạn dạ dày, tuổi trung bình 60,2 (33 -78), tỷ lệ nam/nữ 3,3. Ung thư ở giai đoạn IA, IB, IIA, IIB, IIIA và IIIB lần lượt là 2,2%, 9,7%, 22,3%, 30,9%, 27,3% và 7,5%. Số hạch vét được trung bình 12,2 hạch, số hạch di căn trung bình 3,1 hạch. Tỷ lệ tai biến, biến chứng chung là 2,5%. Không có tử vong trong và sau mổ. Thời gian mổ trung bình là 185 phút, nằm viện sau mổ 8,1 ngày. Thời gian sống sau mổ 1 năm, 2 năm, 3 năm và 5 năm là 95,7%, 80,2%, 71,1% và 53,4%. Kết luận: Phẫu thuật nội soi cắt đoạn dạ dày nạo vét hạch là khả thi, an toàn và hiệu quả trong điều trị ung thư biểu mô dạ dày, thời gian hồi phục và nằm viện ngắn. Abstract Introduction: To assess the initial outcomes including the effectiveness, safety of laparoscopic subtotal gastrectomy with lymph nodes dissection for gastric adenocarcinoma. Material and Methods: Prospective study conducted from 2012 to 2019 in Nghe An Friendship General Hospital. All the patients underwent the laparoscopic subtotal gastrectomy with lymph nodes dissection for gastric adenocarcinoma enrolled. Results: 278 patients underwent laparoscopic subtotal gastrectomy with lymph nodes dissection, mean age was 60.2 (33 - 78). Male and female ratio was 3.3. Stages of the tumor were 2.2% IA, 9.7% IB, 22.3% IIA, 30.9% IIB, 27.3% IIIA and 7.5% IIIB. The mean of lymph nodes removed were 12.2 and mean lymph nodes metastasis were 3.1. The overall complication and incident rates were 2.5%. No per-operative and post-operative mortality was observed. The mean operative time was 185 min. The mean postoperative length stays were 8.1 days. Overall survival rates for one year, two years, three year and five years were 95.7%, 80.2%, 71,1% and 53.4% respectively. Conclusion: Laparoscopic subtotal gastrectomy with lymph node resection for gastric adenocarcinoma is safe and effective, shorten recovery time and hospitalization. Keyword: Laparoscopic subtotal gastrectomy.

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Ablation Outcomes for Atypical Atrial Flutter versus Recurrent Atrial Fibrillation Following Index Pulmonary Vein Isolation

10.22541/au.160866772.28141895/v1 ◽

2020 ◽

Author(s):

Tauseef Akhtar ◽

Usama Daimee ◽

Bhradeev Sivasambu ◽

Thomas Boyle ◽

Armin Arbab-Zadeh ◽

...

Keyword(s):

Atrial Fibrillation ◽

Atrial Flutter ◽

Survival Rates ◽

Free Survival ◽

Af Ablation ◽

Recurrent Atrial Fibrillation ◽

Background Data ◽

Ablation Success ◽

The Mean ◽

One Year

Background: Data related to electrophysiologic characteristics of atypical atrial flutter (AFL) following atrial fibrillation (AF) ablation and its prognostic value on repeat ablation success are limited. Methods: We studied consecutive patients undergoing a repeat LA ablation for either recurrent AF or atypical AFL, following 3 months after index AF ablation, between January 2012 and July 2019. The demographics, procedural data, complications, and 1-year arrhythmia-free survival rates were recorded for each subject after the first repeat ablation. Results: Of the total 336 included patients, 102 underwent a repeat ablation for atypical AFL and 234 for recurrent AF. The mean age was 63.7  10.7 years, and 72.6 % of patients were male. The atypical AFL cohort had significantly higher LA diameters (4.6 vs. 4.4 cm, p=0.04) and LA volume indices (LAVi; 85.1 vs. 75.4 ml/m2, p=0.03) compared to AF patients at repeat ablation. Atypical AFLs were roof-dependent in 35.6% and peri-mitral in 23.8% of cases. Major complications at repeat ablation occurred in 0.9 % of the total cohort. Arrhythmia-free survival at one year was significantly higher in the recurrent atypical AFL than the recurrent AF cohort (75.5 vs. 65.0 %, p=0.04). Conclusion: In our series, roof-dependent flutter is the most common form of atypical atrial flutter post AF ablation. Patients developing atypical AFL after index AF ablation have greater LA dimensions than patients with recurrent AF. The success rate of first repeat ablation is significantly higher among patients with recurrent atypical AFL compared to recurrent AF after index AF ablation.

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Thyroid cancer in Iceland 1955-1984

Acta Endocrinologica ◽

10.1530/acta.0.1180566 ◽

1988 ◽

Vol 118 (4) ◽

pp. 566-572 ◽

Cited By ~ 38

Author(s):

J. Hrafnkelsson ◽

J. G. Jonasson ◽

G. Sigurdsson ◽

H. Sigvaldason ◽

H. Tulinius

Keyword(s):

Thyroid Cancer ◽

Survival Rates ◽

Multiple Covariates ◽

Pathological Evaluation ◽

Cox's Regression ◽

Mean Size ◽

The Mean ◽

One Year ◽

Papillary Type ◽

Prognostic Power

Abstract. A retrospective study was carried out on the incidence of thyroid cancer in Iceland from 1955 to 1984. During this 30-year period 406 cases of thyroid cancer were registered. The incidence of 9.5 for females and 3.4 for males per 100 000 per year is at least twice as high as in the other Nordic countries and among the highest incidence figures reported anywhere. A considerable increase in the reported incidence of thyroid cancer was noted around 1965. The mean size of the cancer nodules at diagnosis decreased at the same time and survival rates of patients improved. The incidence decreased again during the last 5 years of the study period. Mortality rates remained similar during this 30-year period. The survival rate corrected for intercurrent death was similar for both papillary and follicular carcinomas. All patients with anaplastic carcinomas died within one year of diagnosis. Cox's regression analysis with multiple covariates revealed that age at diagnosis, anaplastic and medullary history type as compared with papillary type, pathological evaluation of tumour extent, and calendar period of diagnosis had significant prognostic power. Sex and follicular vs papillary histology type were not significant prognostic factors.

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Vessel Calcification as a Risk Factor for In-Stent Restenosis in Complex Femoropopliteal Lesions After Zilver PTX Paclitaxel-Coated Stent Placement

Journal of Endovascular Therapy ◽

10.1177/1526602819860124 ◽

2019 ◽

Vol 26 (5) ◽

pp. 613-620 ◽

Cited By ~ 6

Author(s):

Shigeo Ichihashi ◽

Tsuyoshi Shibata ◽

Naoki Fujimura ◽

Satoru Nagatomi ◽

Hiroshi Yamamoto ◽

...

Keyword(s):

Multivariate Analysis ◽

Risk Factor ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Stent Restenosis ◽

Wall Calcification ◽

Peripheral Arterial ◽

Zilver Ptx ◽

In Stent Restenosis

Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2–40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0–2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.

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Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience

Journal of Endovascular Therapy ◽

10.1177/15266028211049339 ◽

2021 ◽

pp. 152660282110493

Author(s):

Ali F. AbuRahma ◽

Matthew Beasley ◽

Zachary T. AbuRahma ◽

Meghan Davis ◽

Elliot Adams ◽

...

Keyword(s):

Clinical Outcome ◽

Limb Salvage ◽

Primary Patency ◽

Limb Amputation ◽

Morbidity Rate ◽

Lesion Length ◽

Single Center ◽

Total Occlusion ◽

Zilver Ptx ◽

Male Rate

Background: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. Patient Populations/Methods: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. Results: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A–C lesions. Mean follow-up was 18.4 months (1–76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A–C vs 59% and 59% for D lesions, p=0.001). Conclusion: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A–C lesions but inferior/unsatisfactory for TASC D lesions.

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Abstract 13533: 1-Year Results of Paclitaxel-Coating Nitinol Stent Placement for Chronic Total Occlusion in the Femoropopliteal Artey

Circulation ◽

10.1161/circ.130.suppl_2.13533 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Naotaka Murata ◽

Yoshimitu Soga ◽

Yusuke Tomoi ◽

Seiichi Hiramori ◽

Yohei Kobayashi ◽

...

Keyword(s):

Chronic Total Occlusion ◽

Ankle Brachial Index ◽

Primary Patency ◽

Lesion Length ◽

Total Occlusion ◽

Femoropopliteal Artery ◽

Nitinol Stent ◽

Kaplan Meier ◽

Zilver Ptx

Introduction: The mid-term outcomes of paclitaxel-coating nitinol stent (Zilver PTx) placement for chronic total occlusion (CTO) in the femoropopliteal artery have not been assessed. Hypothesis: Zilver PTx placement for CTO in the femoropopliteal artey is reliable. Methods: All patients enrolled in this prospective, single center study underwent Zilver PTx placement for de novo or restenotic CTO and non-CTO in the superficial femoral and/or popliteal artery. Baseline and follow-up Rutherford classification and Ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 3, 6, 12 months. Results: There were 61 of CTO and 58 of non-CTO treated. Mean age was 74 ± 8 years and male was 82 % in overall. Patients characteristics and degree of lesion calcification was not different significantly between two groups. CTO group had a longer mean lesion length than non-CTO group (209 mm ± 93 mm vs 131 mm ± 87 mm, P < .0001). Procedural success in both treatments was over 98 %. The operative complications were 3 cases in CTO group and 2 cases in non-CTO group. The primary patency of CTO group was significantly lower than non-CTO group in Kaplan-Meier estimate curves at 12 months (75 % vs 82 %, Log-rank P < 0.05). There were no significant differences in event-free survival or freedom from target lesion revascularization in Kaplan-Meier estimate curves at 12 months (68 % vs 70 %; Log-rank P = 0.82, 63 % vs 65 %; Log-rank P = 0.47, respectively). Both groups experienced a significant improvement in Rutherford classification and ABI after treatment, and these improvements were sustained to 12-months follow-up. Based on multivariate analysis, CTO was the negative predictor for primary patency at 12 months (HR 2.37, 95 % CI 1.02 to 5.9, adjusted P < 0.05). Conclusions: CTO influences negatively the primary patency of Zilver PTx placed in the femoropopliteal artery. However, Improvement of Rutherford classification and ABI at 12-months after CTO- intervention is sustained.

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Les particularités du rétinoblastome au Niger

European Scientific Journal ESJ ◽

10.19044/esj.2016.v12n3p84 ◽

2016 ◽

Vol 12 (3) ◽

pp. 84

Author(s):

Abba Kaka.H.Y ◽

Sylla F ◽

Ali M.H ◽

Amza A

Keyword(s):

Survival Rate ◽

Treatment Options ◽

Late Presentation ◽

Tumor Treatment ◽

Traditional Treatment ◽

History Of ◽

The Mean ◽

One Year ◽

The Right ◽

A Prospective Study

Aims: To describe the clinical peculiarities of retinoblastoma and to outline the difficulties in their management in our context. Patients and Methods: We carried out a prospective study in all the cases of retinoblastoma from January 2014 to July 2015 in Niamey National Hospital. We studied: age, sex, first sign, age at first symptoms, time taken to seek medical help, anterior treatment , consanguinity, laterality, stage of tumor, extension of tumor, treatment done, survival rate. Results: The study was about 57 kids, among which 38 boys and 19 girls giving a sex ratio of 2.The mean age at diagnosis was 32 months with extremes of 7 months and 6 years. The range 2 to 3 years were most affected with 35 cases (61, 4%). Leucocorie was the onset symptom in 50 cases (87, 7%), strabismus in 7 cases (12, 3%). Traditional treatment was seen in 45 patients (79%). Consanguinity was found in 45 cases (79%), no family history of tumor was found in this study. In 38 cases (66, 66%) diagnosis was after one year of onset, the left eye was affected in 22 patients (38, 59%), the right eye in 21 patients (36, 84%) and it was bilateral in 14 cases (24, 56%). All our patients were at stage V of Reese classification, the tumor was extra-ocular in 54 patients (94, 6%) and intra-ocular in 5, 4% of cases. Enucleation was performed in 46 cases (80, 70%) and 56 patients (94, 73%) underwent chemotherapy cure. The survival rate after 18 months was of 15, 78%. Conclusion: Late presentation, diagnosis at an advance stage, and limited treatment options are the main factors responsible for the low rate of survival in this study.

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Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system – 12-month results from the LOCOMOTIVE EXTENDED study

VASA ◽

10.1024/0301-1526/a000927 ◽

2020 ◽

pp. 1-8

Author(s):

Klaus Amendt ◽

Thomas Zeller ◽

Robert Proczka ◽

Ulrich Beschorner ◽

Nicola Troisi ◽

...

Keyword(s):

Delivery System ◽

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Target Lesion Revascularisation ◽

Extended Study ◽

Femoropopliteal Artery ◽

The Mean ◽

Drug Coated Balloon

Summary: Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

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