Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period

Angiology ◽  
2021 ◽  
pp. 000331972110434
Author(s):  
Prakash Krishnan ◽  
Arthur Tarricone ◽  
Allen Gee ◽  
Serdar Farhan ◽  
Haroon Kamran ◽  
...  
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Complete Healing ◽  
Target Lesion Revascularization ◽  
Free Survival ◽  
Nitinol Stent ◽  
Effective Treatment Modality

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

2017 ◽  
Vol 51 (2) ◽  
pp. 60-66 ◽  
Author(s):  
Alessia Giaquinta ◽  
Ardita Vincenzo ◽  
Ester De Marco ◽  
Massimiliano Veroux ◽  
Pierfrancesco Veroux
Keyword(s):  
Wound Healing ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Free Survival ◽  
Tibial Arteries

Background: Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions. Objectives: This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm. Methods: All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates. Results: Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing. Conclusions: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

Event free survival in adults with relapsed ALL who underwent front-line therapy with CALGB 10403.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19005-e19005
Author(s):  
Suravi Raychaudhuri ◽  
Ilana Yurkiewicz ◽  
Gabriel N. Mannis ◽  
Bruno C. Medeiros ◽  
Steve E. Coutre ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cohort Study ◽  
Survival Time ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Event Free Survival ◽  
Front Line ◽  
Free Survival ◽  
First Relapse

e19005 Background: CALGB 10403 is a pediatric-inspired ALL regimen that has recently been shown to have improved survival rates in adolescents and young adults with ALL when compared to historical outcomes with traditional adult ALL regimens (Stock et. al, 2019). Methods: This is a retrospective cohort study of ALL patients who received induction CALGB 10403 at Stanford University (both on and off trial), achieved CR1, and subsequently relapsed. Primary outcome of interest was event free survival from time of diagnosis. Events were defined as relapse or death. Secondary outcomes were overall survival and event free survival from first relapse. Patients were censored at time of last clinical follow up. Results: 25 patients met inclusion criteria and received front-line CALGB 10403 from April 2010 to September 2018. At the time of initial diagnosis median age was 30 years (range 18 – 39 years). 68% of patients were male. 48% of patients were overweight and 40% were obese. 76% of patients had precursor B cell ALL while 24% had T cell ALL. 12% had CNS disease at diagnosis. 36% of patients had WBC greater than 30k. 12% of patients had CRLF2 rearrangement. 12% of patients were MRD positive after first induction. 20% of patients received rituximab. Median event free survival time from diagnosis was 20 months (range 3 – 79 months) and median overall survival time was 53 months. Blinatumomab was the most common salvage therapy after 1st relapse, followed by inotuzumab. 15 patients (60%) achieved CR2, of which 4 (27%) were MRD positive after 2nd induction. 15 patients (60%) went to HSCT. Of the patients who achieved CR2, 8 relapsed for a second time. Median event free survival time after first relapse was 23 months. Survival 1 year after relapse was 60%. 11 of the 25 patients were alive at last follow up. Median follow up time of survivors was 6 years. Conclusions: This is a descriptive retrospective cohort study of adult patients in a real world setting who received CALGB 10403 induction and subsequently relapsed. Compared to other studies of relapsed ALL patients who were induced with traditional chemotherapy (Fielding et. al, 2007), survival 1 year after relapse was much higher (60% vs. 22%). As CALGB 10403 becomes an increasingly common induction regimen for AYA and adults with ALL, further outcomes study is required.[Table: see text]

scholarly journals Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions

2014 ◽  
Vol 8s2 ◽  
pp. CMC.S15224
Author(s):  
Michael Lichtenberg ◽  
Birgit Hailer ◽  
Matthias Kaeunicke ◽  
Wilhelm-Friedrich Stahlhoff ◽  
Dirk Boese ◽  
...  
Keyword(s):  
Renal Insufficiency ◽  
Patency Rate ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Walking Distance ◽  
Lesion Length ◽  
Nitinol Stent

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

Status and Determinants of Treatment Outcomes Among New Tuberculosis Patients in South Korea: A Retrospective Cohort Study

2021 ◽  
pp. 101053952110005
Author(s):  
Hyunjin Son ◽  
Jeongha Mok ◽  
Miyoung Lee ◽  
Wonseo Park ◽  
Seungjin Kim ◽  
...  
Keyword(s):  
Cohort Study ◽  
South Korea ◽  
Success Rate ◽  
Treatment Outcomes ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Health Care Facilities ◽  
Tuberculosis Patients ◽  
Lost To Follow Up

This is a retrospective cohort study using notification data in South Korea. We evaluated the nationwide status, regional differences, and the determinants of treatment outcomes among tuberculosis patients. Treatment success rate improved from 77.0% in 2012 to 86.0% in 2015. The lost to follow-up rate was higher among older people, males, and foreign nationals. Health care facilities designated for the Public-Private Mix (PPM) project showed higher success rate and lower rate of lost to follow-up. Moreover, municipalities with low regional deprivation index had higher PPM project coverage. Since there is a large regional difference in the coverage of the PPM project, an additional community-based support program should be implemented, especially for tuberculosis patients residing in region with low PPM project coverage.

scholarly journals Treatment of de novo coronary artery lesions with paclitaxel drug coated balloons (DCB) in diabetic and non-diabetic patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
De Novo ◽  
Target Lesion ◽  
Diabetic Group ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Coronary Artery Lesions ◽  
Artery Disease

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None

scholarly journals Relationship between heavy metal exposure and type 2 diabetes: a large-scale retrospective cohort study using occupational health examinations

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e039541
Author(s):  
Jun Ho Ji ◽  
Mi Hyeon Jin ◽  
Jung-Hun Kang ◽  
Soon Il Lee ◽  
Suee Lee ◽  
...  
Keyword(s):  
Heavy Metals ◽  
Type 2 Diabetes ◽  
Heavy Metal ◽  
Cohort Study ◽  
Retrospective Cohort ◽  
Metal Exposure ◽  
Heavy Metal Exposure ◽  
Lead And Cadmium

ObjectivesTo investigate the associations between heavy metal exposure and serum ferritin levels, physical measurements and type 2 diabetes mellitus (DM).DesignA retrospective cohort study.SettingChangwon, the location of this study, is a Korean representative industrial city. Data were obtained from medical check-ups between 2002 and 2018.ParticipantsA total of 34 814 male subjects were included. Of them, 1035 subjects with lead exposure, 200 subjects with cadmium exposure and the 33 579 remaining were assigned to cohort A, cohort B and the control cohort, respectively. Data including personal history of alcohol and smoking, age, height, weight, the follow-up duration, haemoglobin A1c (HbA1c), fasting blood sugar (FBS), ferritin levels, and lead and cadmium levels within 1 year after exposure were collected.Primary outcome measureIn subjects without diabetes, changes in FBS and HbA1c were analysed through repeated tests at intervals of 1 year or longer after the occupational exposure to heavy metals.ResultsIn Cohort A, DM was diagnosed in 33 subjects. There was a significant difference in lead concentrations between the subjects diagnosed with DM and those without DM during the follow-up period (3.94±2.92 mg/dL vs 2.81±2.03 mg/dL, p=0.002). Simple exposure to heavy metals (lead and cadmium) was not associated with DM in Cox regression models (lead exposure (HR) 1.01, 95% CI: 0.58 to 1.77, p 0.971; cadmium exposure HR 1.48, 95% CI: 0.61 to 3.55, p=0.385). Annual changes in FBS according to lead concentration at the beginning of exposure showed a positive correlation (r=0.072, p=0.032).ConclusionOur findings demonstrated that simple occupational exposure to heavy metals lead and cadmium was not associated with the incidence of DM. However, lead concentrations at the beginning of the exposure might be an indicator of DM and glucose elevations.

scholarly journals Pioglitazone use and Parkinson’s disease: a retrospective cohort study in Taiwan

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e023302 ◽  
Author(s):  
Hsiu-Feng Wu ◽  
Li-Ting Kao ◽  
Jui-Hu Shih ◽  
Hui-Han Kao ◽  
Yu-Ching Chou ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Asian Population ◽  
Secondary Outcome ◽  
Study Cohort ◽  
Patients With Diabetes

ObjectivesMany researchers have expected pioglitazone to serve as an effective neuroprotective agent against Parkinson’s disease (PD). Therefore, we conducted this cohort study to investigate the association between pioglitazone use and PD by using a large Asian population-based dataset in Taiwan.DesignRetrospective cohort study.SettingTaiwan.Participants7906 patients with diabetes who had received pioglitazone were defined as the study cohort, and 7906 matched patients with diabetes who had not received pioglitazone were defined as the comparison cohort.Primary and secondary outcome measuresWe tracked each patient individually over a 5-year follow-up period to identify those diagnosed as having PD during this period. We performed Cox proportional hazard regression analyses to evaluate the HRs for PD between the study and comparison cohorts.ResultsThe findings indicated that among the sampled patients, PD occurred in 257 (1.63%): 119 (1.51%) pioglitazone users and 138 (1.75%) non-users. The adjusted HR for PD within the follow-up period was 0.90 (95% CI: 0.68 to 1.18) in the patients who had received pioglitazone compared with the matched patients who had not received pioglitazone. Moreover, this study revealed that pioglitazone use was not associated with PD incidence in men (HR: 1.06, 95% CI: 0.71 to 1.59) or women (HR: 0.84, 95% CI: 0.61 to 1.15).ConclusionsThis study did not find the relationship between pioglitazone use and PD incidence, regardless of sex, among an Asian population of patients with diabetes.

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