Momodou L Jammeh, Julia Suggs, George L Adams, Ehrin J Armstrong, Jihad Mustapha, Mohamed A Zayed
{"title":"Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes.","authors":"Momodou L Jammeh, Julia Suggs, George L Adams, Ehrin J Armstrong, Jihad Mustapha, Mohamed A Zayed","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with diabetes and critical limb threatening ischemia (CLTI) are at significantly higher risk of limb loss and death. Here we evaluate the outcomes of orbital atherectomy (OA) for treatment of CLTI in patients with and without diabetes.</p><p><strong>Methods: </strong>Retrospective analysis of the LIBERTY 360 study was performed to evaluate baseline demographics, and peri-procedural outcomes between patients with CLTI, and with and without diabetes. Hazard ratios (HRs) were determined with Cox regression to examine the impact of OA in patients with diabetes and CLTI over a 3-year follow-up.</p><p><strong>Results: </strong>A total of 289 patients (201 with diabetes, 88 without diabetes) with Rutherford classification 4-6 were included. Patients with diabetes had higher proportion of renal disease (48.3% vs 28.4%, p=0.002), prior minor/major limb amputation (26% vs 8%, p<0.005), and presence of wounds (63.2% vs 48.9%, p=0.027). Operative times, radiation dosage, and contrast volume were similar between groups. The rate of distal embolization was higher in patients with diabetes (7.8% vs 1.9%, p=0.01; OR 4.33 [0.99, 18.88], p=0.05). However, at 3-years post-procedure, patients with diabetes had no differences in freedom from target vessel/lesion revascularization (HR 1.09, p=0.73), major adverse events (MAE; HR 1.25, p=0.36), major target limb amputation (HR 1.74, p=0.39), and death (HR 1.11, p=0.72).</p><p><strong>Conclusion: </strong>The LIBERTY 360 observed high limb preservation and low MAEs in patients with diabetes and CLTI. Higher distal embolization was observed with OA in patients with diabetes, but OR did not indicate a significant difference in risk between groups.</p>","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"2 2","pages":"E29-E37"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10103796/pdf/nihms-1888830.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9683545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Single-Center Experience With Optical Coherence Tomography-Guided Directional Atherectomy System for Below-the-Knee Critical Limb Ischemia","authors":"Sehrish Memon","doi":"10.25270/jcli/oem21-00002","DOIUrl":"https://doi.org/10.25270/jcli/oem21-00002","url":null,"abstract":"BACKGROUND. Below-the-knee (BTK) peripheral arterial disease (PAD) more often presents as critical limb ischemia. Endovascular revascularization strategies continue to evolve to achieve long-term limb-salvage outcomes. A single-center experience with optical coherence tomography (OCT)-guided atherectomy using Pantheris SV (Avinger) is reported. METHODS. All patients with PAD in femoropopliteal or infrapopliteal vessels (n = 27) who underwent plaque debulking by Pantheris SV were analyzed retrospectively. Baseline comorbidities, Rutherford classification, lesion length and characteristics, adjunctive treatment strategy, device-related failures/complications, and major adverse events were analyzed. Additionally, 6-month target-lesion revascularization (TLR) rate was available for 21 of 27 patients. RESULTS. Mean patient age was 70.5 years, 16 patients (59%) were women, and 19 patients (70%) had Rutherford class 5 to 6 symptoms. A total of 58 vessels were treated, including 32 iliofemoropopliteal and 26 infrapopliteal vessels. Chronic occlusions were present in 19% of iliofemoropopliteal lesions and 17.2% of infrapopliteal lesions. The most commonly treated BTK lesion (12 of 26) was the anterior tibial artery (ATA). Following atherectomy, 21 were treated with angioplasty, 4 with angioplasty followed by coronary drug-eluting stent (DES), and 1 with cutting balloon and laser atherectomy. Four failures/complications occurred; 3 of these were device related (failure to pass through lesion due to proximal ATA angulation, coronary DES dislodgment while treating BTK in-stent restenosis, and 1 requiring laser atherectomy for no-flow post atherectomy and angioplasty). At 6 months, 2 of 21 patients (9.5%) required revascularization interventions. CONCLUSION. Treatment of BTK-PAD with imaging guided Pantheris SV atherectomy device appears to be safe, with low rate of TLR at 6 months. Future multicenter randomized trials are needed to confirm these findings.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78761869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G. Latsios, A. Karanasos, A. Synetos, C. Tsioufis, K. Toutouzas
{"title":"Acute Occlusion of 14 Fr Femoral Access Site After Suture/Collagen Device Failure and Successful Transradial Recanalization","authors":"G. Latsios, A. Karanasos, A. Synetos, C. Tsioufis, K. Toutouzas","doi":"10.25270/jcli/clig21-00008","DOIUrl":"https://doi.org/10.25270/jcli/clig21-00008","url":null,"abstract":"This case demonstrates the need for caution when using a collagen-based closure device as bailout for failure of suture-based devices in large-diameter arterial access, as acute vessel closure is possible. Standard interventional cardiology techniques aided the rapid resolution of this complication, while radial artery as secondary access did not hamper our efforts.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89962444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"CLI is a Major Public Health Concern With Prognosis Worse Than Many Types of Cancer","authors":"J. Mustapha","doi":"10.25270/jcli/oem21-00001","DOIUrl":"https://doi.org/10.25270/jcli/oem21-00001","url":null,"abstract":"Despite advancing technologies available to treat CLI, we clearly have a long journey ahead of us on behalf of our patients. With the Journal of Critical Limb Ischemia, we are pleased to be able to provide a forum for original CLI work that will be reviewed by multidisciplinary, international CLI experts who understand the complex nature of CLI. The Editorial Board of Journal of Critical Limb Ischemia comprises physicians from across the globe who understand the difficulty and complexity of gathering CLI data. They are vascular surgeons, interventional cardiologists and radiologists, podiatrists, angiologists, and wound care experts. These experts are well aware of the reality of the advanced and complex nature of CLI disease with high 5-year mortality. Because of this, we believe that CLI trials should be modeled after diseases that have a high mortality rate over a short period of time. We must be able to capture the true nature of the disease and its impact on patients affected by it. If we continue to model CLI studies under the conventional nature of vascular disease in general we will never be able to achieve meaningful and convincing data to change the course of therapy. We desperately need new technologies to treat CLI to reduce the incidence of unnecessary amputations occurring in the United States and throughout the world. We clearly can, and must, do better. Our patients are demanding progress.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90811388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Optimizing Laser Atherectomy for Different Lesion Morphologies","authors":"George L. Adams, V. Subramanian","doi":"10.25270/jcli/clig21-00007","DOIUrl":"https://doi.org/10.25270/jcli/clig21-00007","url":null,"abstract":"Objective. To understand the impact of fluence and repetition rate on outcomes of superficial femoral artery (SFA) and popliteal artery laser atherectomy based on lesion type (calcific, homogenous, heterogeneous, and restenosis). Methods. Patients with de novo or restenotic (≥50%) SFA and popliteal artery atherosclerotic disease were enrolled. All lesions were sequentially treated with Turbo-Power laser atherectomy (Spectranetics) at 3 predetermined intensity settings: low (fluency, 40 mJ/mm2; repetition rate, 60 Hz); medium (fluency, 60 mJ/mm2; repetition rate, 40 Hz); and high (fluency, 60 mJ/mm2; repetition rate, 60 Hz). Angiography and intravascular ultrasound (IVUS) were performed to characterize plaque morphology and evaluate residual stenosis. Follow-up was 30 days and medical records were reviewed through 12 months for adverse events. Results. Forty-five patients with 57 lesions (12 homogenous, 15 heterogeneous, 15 calcific, and 15 restenotic) were enrolled. Rutherford classification ranged from 2-5, average lesion length was 98.2 ± 91.2 mm, and average diameter stenosis was 82.5 ± 17.9%. Compared with baseline, all lesion types had significant improvement in final postprocedure (atherectomy + any adjunctive therapies) diameter stenosis. Prior to adjunctive therapy, the heterogeneous and restenosis groups saw improvement in minimum lumen area following each stage of the laser treatment. However, the calcific and homogenous groups saw little change in minimum lumen area between the medium- and high-intensity laser treatments. Within 6 months, a total of 6 patients had target-lesion revascularizations. No major amputations or deaths occurred through follow-up. Conclusion. Laser intensity settings during atherectomy should be selected based on lesion morphology. IVUS was essential in defining plaque morphology.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"140 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86593413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mervin Lim, T. Chong, S. L. Chan, S. Yap, Ankur Patel, K. H. Tay, T. Tang
{"title":"Use of the Ranger Paclitaxel-Coated Balloon in Patients With Chronic Limb-Threatening Ischemia: Short-Term Safety and Efficacy Results From Singapore","authors":"Mervin Lim, T. Chong, S. L. Chan, S. Yap, Ankur Patel, K. H. Tay, T. Tang","doi":"10.25270/jcli/clig20-00002","DOIUrl":"https://doi.org/10.25270/jcli/clig20-00002","url":null,"abstract":"Chronic limb-threatening ischemia, also known as critical limb ischemia (CLI), is the most advanced stage of peripheral arterial disease (PAD), and patients have high risk of major lower-limb amputation and mortality. An endovascular-first approach has become the preferred revascularization strategy for these patients. The aim of the study was to evaluate the safety and short-term efficacy of the Ranger paclitaxel-coated balloon (PCB; Boston Scientific) in the setting of CLI. Methods. This was a single-center, single-arm, multi-investigator, prospective study of CLI patients who underwent endovascular revascularization using the Ranger PCB from July 2019 to November 2019 at Singapore General Hospital in Singapore. Data were retrieved from the Vascular Quality Initiative database recently set up at this institution. Primary lesion patency, amputation-free survival (AFS), freedom from target-lesion revascularization (TLR), and complete wound healing were the efficacy endpoints of interest at 6 months post intervention. Results. A total of 84 patients (87 limbs; 229 lesions) were enrolled. Fifty-one of the 84 patients (60.7%) were men. Baseline characteristics included diabetes mellitus in 76/84 patients (90.5%), chronic renal impairment in 25/84 patients (29.8%), and Rutherford category 6 foot wounds in 22/87 limbs (24.7%). TASC D lesions were present in 63/229 lesions (27.9%) and moderate/severe vessel wall calcification was present in 167/229 lesions (72.9%). Immediate technical success was achieved in 218/229 lesions (95.2%) with no device-related mortality at 30 days. Primary patency rates at 3 months and 6 months were 76/82 (92.7%) and 69/81 (85.2%), respectively. Six-month primary patency rates of below-the-knee (BTK) lesions treated with and without Ranger balloons were 89/94 (94.7%) and 34/41 (82.9%), respectively (P=.03). Six-month AFS occurred in 68/78 (87.2%) and freedom from TLR occurred in 73/81 (90.1%). Six-month complete wound healing rate was respectable, at 28/50 (56.0%). Conclusion. Use of the Ranger PCB showed favorable outcomes and short-term patency rates, especially in the BTK region, in what is an otherwise challenging patient cohort. Extended follow-up is awaited to evaluate the long-term safety and efficacy of the balloon.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"87 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88215314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
T. Clark, A. Vance, M. Mantell, S. Reddy, C. Shackles
{"title":"Antegrade and Retrograde Crossing of Chronic Total Occlusions Using the Outback Re-entry Device","authors":"T. Clark, A. Vance, M. Mantell, S. Reddy, C. Shackles","doi":"10.25270/jcli/clig21-00010","DOIUrl":"https://doi.org/10.25270/jcli/clig21-00010","url":null,"abstract":"Purpose. The Outback device (Cordis) enables true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs). This study compared outcomes of patients who underwent subintimal recanalization of lower-extremity arterial CTOs utilizing the Outback device via antegrade and retrograde approaches. Methods. A retrospective analysis identified 39 patients with Rutherford 3 (n = 13), 4 (n = 13), and 5 disease (n = 13) where the Outback device was utilized (19 antegrade crossing femoropopliteal CTOs, 20 retrograde [17/20 transpedal access crossing femoropopliteal/tibioperoneal CTOs, 3/20 femoral access crossing iliac CTOs]) after conventional techniques failed. Mean age was 70.5 years and 67% were men. Most patients had multifocal and/or long-segment occlusions, with 41% having combined above- and below-knee disease. Results. Overall technical success was 90% (95% antegrade and 85% retrograde cohort; P=.15). There were no major complications and 4 minor complications (prolonged bleeding, femoral pseudoaneurysm requiring thrombin injection, and 2 small access-site hematomas). Fifteen percent of the retrograde cohort subsequently underwent distal bypass, compared with 0% in the antegrade cohort (P=.23). A single amputation occurred, in the antegrade group. Twelve-month target-vessel unassisted primary patency was higher with antegrade use (76% in the antegrade group vs 48% in the retrograde group; P=.03), but 12-month assisted primary patency was similar (85% in the antegrade group vs 79% in the retrograde group; P=.85). Conclusion. The Outback can be used safely and effectively from both antegrade and retrograde approaches during recanalization of CTOs. Lower target-vessel unassisted primary patency using the retrograde transpedal approach indicates the need for closer surveillance to achieve high rates of limb salvage.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90830222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}