Journal of Vascular Surgery最新文献

{"title":"Inferring acute economic aspects of endovascular deep vein thrombosis management from a literature-based comparative cohort analysis","authors":"A.S. Misono, N.J. Mouawad, A.S. Niekamp, M.C. Bunte","doi":"10.1016/j.jvs.2024.10.008","DOIUrl":"10.1016/j.jvs.2024.10.008","url":null,"abstract":"","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":"80 6","pages":"Pages A13-A14"},"PeriodicalIF":3.9,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142699226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent advances in proteomic analysis to study carotid artery plaques","authors":"G. Cruz-González, J.F. Meschia, B.J. Madden, M. Prudencio, C.A. Polania-Sandoval, J. Hartwell, E. Oyefeso, R. Benchaaboune, T. Brigham, S.J.S. Sandhu, C. Charlesworth, G.P. Pujari, L. Petrucelli, A. Pandey, Y. Erben","doi":"10.1016/j.jvs.2024.10.007","DOIUrl":"10.1016/j.jvs.2024.10.007","url":null,"abstract":"","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":"80 6","pages":"Page A13"},"PeriodicalIF":3.9,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142699225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The anterior saphenous vein. Part 4. Clinical and technical considerations in treatment. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology","authors":"E.M. Boyle, R. Drgastin, N. Labropoulos, A. Caggiati, A. Gasparis, S. Doganci, M. Meissner","doi":"10.1016/j.jvs.2024.10.004","DOIUrl":"10.1016/j.jvs.2024.10.004","url":null,"abstract":"","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":"80 6","pages":"Page A13"},"PeriodicalIF":3.9,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142700126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuroophthalmic outcomes following carotid intervention for ocular symptoms.","authors":"Boshra Al Ibraheem, Tiziano Tallarita, Sasha A Mansukhani, Mokhshan Ramachandran, James Manz, Jenny Lau, Bayan Moustafa, Andrew D Calvin, Thomas Carmody, Indrani Sen","doi":"10.1016/j.jvs.2024.11.015","DOIUrl":"https://doi.org/10.1016/j.jvs.2024.11.015","url":null,"abstract":"<p><strong>Introduction: </strong>The long term neuroophthalmic outcomes following carotid intervention in patients presenting with pre-operative visual symptoms vary widely based on the underlying etiology of retinal ischemia and are not well understood.</p><p><strong>Methods: </strong>We performed a retrospective review of consecutive patients presenting with retinal ischemia who subsequently underwent carotid intervention from January 2018 to December 2022. Patients were classified into three groups [Group I: Amaurosis fugax (AF)/ vascular transient monocular vision loss (TMVL), Group II: Ocular Ischemic Syndrome (OIS) and Group III: Central/Branch Retinal Artery Occlusion (C/BRAO)]. Clinical details and the nature of visual symptoms were recorded. Outcomes analyzed were ipsilateral symptom recurrence, visual improvement, stroke rate and survival.</p><p><strong>Results: </strong>There were 90 patients included in this study (70 male, 75+ 9 years); 31 patients (34%) in Group I (AF), 7 patients (8%) in Group II(OIS), and 52 patients (58%) in Group III (C/BRAO). Atherosclerotic risk factors were similar across groups with similar preoperative antiplatelet and statin use. Interventions performed were carotid endarterectomy in 64 (71%), transfemoral carotid artery stenting in 21 (23%), transcarotid artery revascularization in 4 (4%) and carotid artery bypass in one patient (1%). Median follow-up was 38.5 months (range 0- 207 months). There was no recurrence of transient or permanent retinal ischemic events in any patient in the Group I. In Group II, 5 of 7 patients presenting with transient symptoms of OIS showed resolution of symptoms and ocular signs. Two patients presenting with permanent vision loss in Group II had no improvement but no worsening symptoms, and visual decline was reported in two patients in Group III. Ipsilateral stroke rate was 2% at 5 years for the entire group. Survival was 93% and 82% at 1 and 5 years, with no difference between groups (p<0.05) There was 1 post-operative death from ischemic stroke secondary to stent thrombosis within 30 days (Group III), with no long-term mortality from cerebrovascular disease in the rest of the cohort.</p><p><strong>Conclusions: </strong>Neuro-ophthalmic outcomes following carotid intervention for visual symptoms is favorable with low symptomatic recurrence following both carotid endarterectomy and carotid artery stenting. Intervention for OIS when detected early (with transient symptoms) is associated with resolution of symptoms and prevention of permanent visual loss.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence and Predictors of Gastrointestinal Hemorrhage following Mesenteric Revascularization.","authors":"Armin Farazdaghi, Diego V S Rodrigues, Claire Cassianni, Jill J Colglazier, Gustavo S Oderich, Manju Kalra, Fahad Shuja, Melinda Schaller, Todd Rasmussen, Randall R DeMartino, Bernardo C Mendes","doi":"10.1016/j.jvs.2024.11.006","DOIUrl":"https://doi.org/10.1016/j.jvs.2024.11.006","url":null,"abstract":"<p><strong>Objectives: </strong>Post-operative gastrointestinal hemorrhage (GIH) following mesenteric revascularization when performed either open (OR) or endovascularly (ER) has been clinically observed but not reported. The aim of the study is to assess the incidence and predictors of GIH in patients undergoing mesenteric revascularization.</p><p><strong>Methods: </strong>Single-center retrospective review of consecutive patients treated with open or endovascular mesenteric revascularization from 2009-2019. Patients with non-occlusive mesenteric ischemia, intraoperative or perioperative death within 24 hours, or no post-operative follow-up were excluded. Primary endpoints were incidence and predictors of clinically significant GIH within 30- and 60 days postoperatively. Clinically significant GIH (CS-GIH) was defined if patients required RBC transfusion, hospital re-admission, escalation to intensive care, prolonged discontinuation of anticoagulation, or need for endoscopy/colonoscopy.</p><p><strong>Results: </strong>A total of 260 patients presented with mesenteric ischemia and underwent OR/ER. 205 patients met inclusion criteria (139 female [68%], mean age of 69.9 years [range 18-92 years]). Presentation was chronic mesenteric ischemia in 128 patients (62%), acute-on-chronic in 45 (22%) and acute in 32 (16%). 93 (45%) underwent OR, 93 (45%) ER, and 19 (9%) hybrid. 50 patients (24%) presented with GIH, 44 (21%) within 30 days of OR/ER, at a median time of 6.5 days postoperatively. CS-GIH occurred in 37 patients (18%), which led to death in two patients (1%), prolongation of ICU course or transfer to ICU in 28 patients (14%), RBC transfusion in 21 (10%), diagnostic/therapeutic endoscopy/colonoscopy in 18 (9%), and hospital readmission in 14 patients (7%). Endoscopy/Colonoscopy was diagnostic in 9 patients (ulcer in five patients, angioectasia in two, and anastomotic bleeding or colonic necrosis in one each), therapeutic in four, and identifying one patient with diffuse bleeding requiring operative intervention. Factors associated with increased risk of CS-GIH were bowel resection during index hospitalization (OR 11.29, p < 0.001), acute presentation (OR 5.42, p < 0.001), atrial fibrillation (OR 3.01, p = 0.004), first-time initiation of antiplatelet therapy (OR 2.61, p = 0.01), and treatment with stenting (2.31, p = 0.03 OR) (Table I).</p><p><strong>Conclusion: </strong>Patients undergoing mesenteric revascularization are at high risk for postoperative gastrointestinal hemorrhage, which increases morbidity and hospitalization resources in nearly 20% of patients. Specific patient groups are at high risk for CS-GI hemorrhage. Post-operative care pathways should consider these risk factors to reduce CS-GIH after mesenteric revascularization to improve outcomes.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A systematic review of therapies for aortobronchial fistulae.","authors":"Christiana Anastasiadou, George Trellopoulos, Stavroula Kastora, Ioannis Kakisis, Anastasios Papapetrou, George Galyfos, George Geroulakos, Angelos Megalopoulos","doi":"10.1016/j.jvs.2021.08.112","DOIUrl":"https://doi.org/10.1016/j.jvs.2021.08.112","url":null,"abstract":"<p><strong>Objective: </strong>The aim of the study was to summarize epidemiologic data about aortobronchial fistulas and compare outcomes (mortality, recurrence, re-operation) of open, staged, and endovascular repair of aortobronchial fistula.</p><p><strong>Methods: </strong>A systematic literature review was conducted to identify eligible studies published between January of 1999 and December of 2019. The Cochrane Library, PubMed and Scopus databases were used as search engines. Eligible studies included articles reporting postoperative outcomes (death/follow-up). Literature review revealed only case reports and small case series and thus, only descriptive data with data heterogeneity was available. The corresponding authors were contacted to provide additional information or outcome updates (recurrence/reoperation/death).</p><p><strong>Results: </strong>Overall, 214 patients (90 studies) underwent 271 procedures (including re-do procedures and staged procedures). Most of the patients were treated by endovascular means (72.42%). Open surgical repair was performed in 21.96% and staged procedures in 5.6%. Aortobronchial fistulae located most often in the descending thoracic aorta (Zone 3,4) (64,6%) and in Zone 2 (23,8%). Fourteen percent of aortobronchial fistulae developed after thoracic endovascular aneurysm repair. Recurrence or infection occurred in 20% (43 patients). Recurrences were at some extend associated with the presence of endoleak. Long-term antibiotic administration (>1 month) was instituted in 63 patients (29.4%), whilst 90 patients (42%) did not receive antibiotics beyond hospitalization. From the remaining 61, 3 received life-long antibiotics and for 58 patients data were not available. Considering outcomes, mean follow-up was 25.1 months (0-188 months) and not significantly different among treatments.</p><p><strong>Limitations: </strong>Literature review has revealed only case reports and small case series and thus, only descriptive data were available. Randomized controlled trials are not available due to the rarity of the disease which significantly decreases the power of the present study. Also, this study reflects significant data heterogeneity due to the nature of the analyzed manuscripts and would benefit from large patient cohort studies which till today have not been conducted.</p><p><strong>Conclusion: </strong>Aortobronchial fistula is a complex disease. Endoleaks may be involved in the development and in recurrence process and they should not be disregarded. Considering major outcomes (length of follow-up), the available treating strategies are equal and thus, surgeons should feel confident to apply the treatment of their choice, taking in mind their experience, patient's age, and clinical condition.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preoperative Radiological Features in Predicting Complications of Carotid Body Tumor Resection.","authors":"Tariq Alanezi, Faris Alomran, Samer Koussayer, Omer Abdulrahim, Mohammed Dahman, Eyas Alsuhaibani, Riyadh Alokaili, Mohammed Al-Omran","doi":"10.1016/j.jvs.2024.11.008","DOIUrl":"10.1016/j.jvs.2024.11.008","url":null,"abstract":"<p><strong>Background: </strong>Carotid body tumors (CBTs) are rare neoplasms that pose significant surgical challenges. This study aims to evaluate the predictive utility of preoperative radiological characteristics on postoperative complications in patients undergoing CBT resection at a tertiary care center.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 106 patients who underwent CBT resection between 2003 and 2023. Patient demographics, tumor characteristics, and operative details were collected. The primary outcomes were an estimated blood loss (EBL) >250 mL and cranial nerve (CN) injury. Logistic regression models were used to identify significant preoperative radiological predictors, including Shamblin grade, Peking Union Medical College Hospital (PUMCH) grade, tumor distance to the base of the skull (DTBOS), and tumor volume.</p><p><strong>Results: </strong>One hundred and six patients were included. Higher Shamblin and PUMCH grades were significantly associated with increased EBL and CN injury. Specifically, the Shamblin grade alone predicted an EBL >250 mL with a McFadden R² value of 0.14, which slightly decreased to 0.13 when DTBOS and tumor volume were added. For CN injury, the Shamblin grade alone had an R² of 0.16, which significantly improved to 0.27 with the addition of DTBOS and further to 0.29 with tumor volume. The PUMCH grade alone predicted an EBL >250 mL with an R² value of 0.08, which did not significantly change with the addition of DTBOS and tumor volume. For CN injury, the PUMCH grade alone had an R² of 0.14, improving to 0.21 with DTBOS and to 0.22 with tumor volume. Furthermore, a 1-cm decrease in DTBOS significantly increased the odds of requiring a blood transfusion (OR = 2.26, 95% CI: 1.28-4.01, p=0.0051) and the risk of CN injury (OR = 3.65, 95% CI: 1.98-6.73, p<0.0001).</p><p><strong>Conclusion: </strong>This study identified novel preoperative radiological predictors that enhance the predictive accuracy of standard classification systems, offering valuable insights for preoperative planning. While the Shamblin and PUMCH classifications are useful tools on their own, our findings demonstrate that incorporating additional radiological features, such as DTBOS and tumor volume, can substantially increase their predictive utility. Surgeons are encouraged to incorporate multiple preoperative radiological variables alongside traditional classification systems to better assess the risk of postoperative complications. Further research with larger, multi-institutional cohorts are necessary to validate these findings and refine predictive models.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiac Remodeling and Antihypertensive Medication Changes After Thoracic Endovascular Aortic Repair vs Open Surgical Repair.","authors":"Karen Yuan, Vamsi K Potluri, Akshita Gorantla, Nabeeha Khan, Irene Helenowski, Michael C Soult, Jeffrey Schwartz, Carlos F Bechara","doi":"10.1016/j.jvs.2024.11.007","DOIUrl":"10.1016/j.jvs.2024.11.007","url":null,"abstract":"<p><strong>Objective: </strong>Cardiovascular complications remain one of the major all-cause mortalities among patients who receive either thoracic endovascular aortic repair (TEVAR) or open surgical repair (OSR). Increased aortic stiffness after endograft deployment has been shown to induce left ventricular hypertrophy, diastolic dysfunction, and reduced coronary flow reserve. However, there is limited data on the hemodynamic effects after OR. The purpose of this study is to compare the cardiovascular and hemodynamic changes after TEVAR and OR.</p><p><strong>Methods: </strong>A retrospective analysis of 100 patients with thoracic aortic aneurysm or dissection who underwent open (n=50) or endovascular repair (n=50) was conducted. Information on demographics, medical and surgical history, and clinical outcomes were retrieved. Transthoracic echocardiographic (TTE) imaging results were collected to assess cardiac function. Changes to antihypertensive medication dosage and number were used as surrogate markers for hemodynamic changes and aortic stiffness.</p><p><strong>Results: </strong>No statistically significant differences were observed in antihypertensive medication number or dosage between the TEVAR and OSR group at 12 months, 24 months, and 36 months post-surgery. When adjusting for patient demographic factors of age, sex, and BSA in a multivariable generalized estimating equation model, patients who underwent TEVAR had a higher likelihood of receiving more antihypertensive medications (IRR = 1.131; P = .044). Patient characteristics such as BSA (IRR = 1.266; P = .001), HTN (IRR = 2.070; P ≤ .001), DM (IRR = 1.474; P ≤ .001), ESRD (IRR = 1.304; P = .011) were also associated with a higher number of antihypertensive medications. A significant increase in beta-blockers (P ≤ .001) and diuretics (P = .046) intake was observed post-TEVAR and post-OR. No significant differences in left ventricular ejection fraction and left ventricular hypertrophy were observed between the two groups.</p><p><strong>Conclusions: </strong>We observed a greater likelihood of antihypertensive medications escalation following TEVAR, suggesting an increase in aortic stiffness post-operatively. No significant differences in cardiac remodeling were observed between the two groups. Our findings emphasize the need for an improved post-operative cardiac surveillance program in patients undergoing both TEVAR and OSR. Furthermore, additional innovation is needed to create aortic grafts that are more compatible with the native aorta in order to reduce long-term cardiovascular complications.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anesthesia choice for frail patients undergoing endovascular repair of non-ruptured infrarenal abdominal aortic aneurysms.","authors":"Renxi Li, Anton Sidawy, Bao-Ngoc Nguyen","doi":"10.1016/j.jvs.2024.10.077","DOIUrl":"https://doi.org/10.1016/j.jvs.2024.10.077","url":null,"abstract":"<p><strong>Background: </strong>While general anesthesia is the predominant choice in endovascular aneurysm repair (EVAR), recent studies have suggested that locoregional anesthesia could be a viable alternative for suitable patients. Frailty has been identified as an independent predictor of elevated mortality and morbidity in EVAR. However, the choice of anesthesia in frail patients undergoing EVAR has not been explored.</p><p><strong>Methods: </strong>This study aimed to compare the 30-day outcomes of non-emergent intact infrarenal EVAR in frail patients receiving either locoregional or general anesthesia. Patients who underwent infrarenal EVAR were identified in ACS-NSQIP database from 2012-2022. Frail patients were selected by 5-item Modified Frailty Index (mFI-5)≥2. Exclusion criteria included age<18 years, ruptured abdominal aortic aneurysm (AAA), emergency, and acute intraoperative conversion to open. A 1:1 propensity-score matching was used to match demographics, baseline characteristics, aneurysm diameter, distal aneurysm extent, and concomitant procedures between patients under locoregional and general anesthesia. Thirty-day postoperative outcomes were evaluated.</p><p><strong>Results: </strong>Among 16,438 patients who underwent EVAR, 4812 (29.27%) were frail. Among the frail patients, 483 (10.04%) were under locoregional anesthesia while 4,329 (89.96%) were under general anesthesia. After propensity-score matching, patients under locoregional or general anesthesia had comparable 30-day mortality (2.07% vs 2.48%, p=0.83) or any complications.</p><p><strong>Conclusion: </strong>Locoregional and general anesthesia were found to have comparable postoperative outcomes in frail patients undergoing EVAR unruptured AAA, which did not align with the suggestion that locoregional anesthesia might be more advantageous in frail patients. While the patient's preferences should be considered, the choice of anesthesia should still be individualized to take into account the patient's age, comorbidities, AAA anatomy and the complexity of the case, as well as previous surgical and anesthesia experiences.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease.","authors":"Venita Chandra, Alexandra J Lansky, Sameh Sayfo, Nicolas W Shammas, Peter Soukas, James Park, Michael Siah, Anvar Babaev, Ryan Shields, Nick E J West, Ehrin Armstrong","doi":"10.1016/j.jvs.2024.11.003","DOIUrl":"https://doi.org/10.1016/j.jvs.2024.11.003","url":null,"abstract":"<p><strong>Background: </strong>Below the knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty (PTA) in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core-lab adjudicated, prospective, multi-center single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System.</p><p><strong>Methods: </strong>Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events (MALE) or post-operative death (POD) at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core lab-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through two years.</p><p><strong>Results: </strong>A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. Mean target lesion length was 76 ± 65mm, diameter stenosis was 78 ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core lab. After IVL, residual stenosis was reduced to 29%, and to 26% after optional post-dilatation and/or stent implantation. At 30 days, there were no deaths, MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4.0 ± 5.0 (P<0.0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days.</p><p><strong>Conclusions: </strong>The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient QoL and wound healing, with minimal adverse events at 30-day follow-up.</p>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}