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1.
J Vasc Surg ; 79(2): 420-435.e1, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37944771

ABSTRACT

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.


Subject(s)
Carotid Stenosis , Stroke , Humans , Carotid Stenosis/diagnosis , Carotid Stenosis/diagnostic imaging , Consensus , Delphi Technique , Stroke/diagnosis , Stroke/etiology , Constriction, Pathologic
2.
Ann Vasc Surg ; 99: 50-57, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37858666

ABSTRACT

BACKGROUND: Patients with no-option chronic limb-threatening ischemia (no-option CLTI) have limited therapeutic options. The PROMISE II study evaluated, transcatheter arterialization of deep veins (TADV) as a treatment option for no-option CLTI. In the current study patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia). METHODS: We used propensity matching to compare patients from the PROMISE II prospective study of the TADV intervention with simultaneously enrolled CLTI patients that were note candidates for PROMISE II but were enrolled in to CLariTI natural history registry. Untreated no-option CLTI (CLariTI) patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and P values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was amputation-free survival (AFS). RESULTS: Diabetes was present in over 75% of patients. All patients had tissue loss and 35-46% had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6 months, was 66.1% by Kaplan-Meier estimate for PROMISE II patients (n = 105) compared to 39.1% in the no-option cohort of CLariTI (n = 121) and 44.0% in the full cohort (no-option and patients not meeting entry criteria combine, n = 180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29% improved (P < 0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45% compared to the no-option control patients. CONCLUSIONS: Transcatheter arterialization of deep veins (TADV) resulted in improved 6 month AFS in no-option CLTI patients and appears to be a promising therapy in patients with no-option CLTI.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Chronic Limb-Threatening Ischemia , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Treatment Outcome , Prospective Studies , Standard of Care , Risk Factors , Ischemia/diagnostic imaging , Ischemia/surgery , Limb Salvage/methods , Chronic Disease , Retrospective Studies , Endovascular Procedures/adverse effects
3.
Diagnostics (Basel) ; 13(21)2023 Nov 01.
Article in English | MEDLINE | ID: mdl-37958259

ABSTRACT

Atherosclerosis, a chronic inflammatory disease affecting the large arteries, presents a global health risk. Accurate analysis of diagnostic images, like computed tomographic angiograms (CTAs), is essential for staging and monitoring the progression of atherosclerosis-related conditions, including peripheral arterial disease (PAD). However, manual analysis of CTA images is time-consuming and tedious. To address this limitation, we employed a deep learning model to segment the vascular system in CTA images of PAD patients undergoing femoral endarterectomy surgery and to measure vascular calcification from the left renal artery to the patella. Utilizing proprietary CTA images of 27 patients undergoing femoral endarterectomy surgery provided by Prisma Health Midlands, we developed a Deep Neural Network (DNN) model to first segment the arterial system, starting from the descending aorta to the patella, and second, to provide a metric of arterial calcification. Our designed DNN achieved 83.4% average Dice accuracy in segmenting arteries from aorta to patella, advancing the state-of-the-art by 0.8%. Furthermore, our work is the first to present a robust statistical analysis of automated calcification measurement in the lower extremities using deep learning, attaining a Mean Absolute Percentage Error (MAPE) of 9.5% and a correlation coefficient of 0.978 between automated and manual calcification scores. These findings underscore the potential of deep learning techniques as a rapid and accurate tool for medical professionals to assess calcification in the abdominal aorta and its branches above the patella.

4.
J Vasc Surg ; 78(3): 647, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37599031
6.
N Engl J Med ; 388(13): 1171-1180, 2023 Mar 30.
Article in English | MEDLINE | ID: mdl-36988592

ABSTRACT

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).


Subject(s)
Amputation, Surgical , Arteriovenous Shunt, Surgical , Chronic Limb-Threatening Ischemia , Endovascular Procedures , Aged , Female , Humans , Male , Bayes Theorem , Chronic Limb-Threatening Ischemia/mortality , Chronic Limb-Threatening Ischemia/surgery , Endovascular Procedures/methods , Endovascular Procedures/mortality , Ischemia/mortality , Ischemia/surgery , Limb Salvage/methods , Limb Salvage/mortality , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/surgery , Prospective Studies , Risk Factors , Treatment Outcome , Amputation, Surgical/methods , Amputation, Surgical/mortality , Leg Ulcer/physiopathology , Leg Ulcer/surgery , Leg Ulcer/therapy , Catheterization , Arteriovenous Shunt, Surgical/methods , Wound Healing , Adult , Middle Aged , Aged, 80 and over , Leg/blood supply , Leg/surgery , Arteries/surgery , Veins/surgery
7.
Vascular ; 30(4): 607-615, 2022 Aug.
Article in English | MEDLINE | ID: mdl-34165017

ABSTRACT

OBJECTIVE: To identify predictors of aortic aneurysm formation at or above an infrarenal abdominal aortic aneurysm repair. METHODS: A total of 881 infrarenal abdominal aortic aneurysm repairs were identified at a single institution from 2004 to 2008; 187 of the repairs were identified that had pre-operative and post-operative computed tomography imaging at least one year or greater to evaluate for aortic degeneration following repair. Aortic diameters at the celiac, superior mesenteric, and renal arteries were measured on all available computed tomographic scans. Aortic thrombus and calcification volumes in the visceral and infrarenal abdominal aortic segments were calculated. Multivariable modeling was used with log transformed variables to determine potential predictors of future aortic aneurysm development after infrarenal abdominal aortic aneurysm repair. RESULTS: Of the 187 patients in the cohort, 100 had an open abdominal aortic aneurysm repair while 87 were treated with endovascular repair. Proximal aortic aneurysms developed in 26% (n = 49) of the cohort during an average of 72 ± 34.2 months of follow-up. After multivariable modeling, visceral segment aortic thrombus on pre-operative computed tomography imaging increased the risk of aortic aneurysm development above the infrarenal abdominal aortic aneurysm repair within both the open abdominal aortic aneurysm (hazard ratio 2.04, p = 0.033) and endovascular repair (hazard ratio 3.31, p = 0.004) cohorts. Endovascular repair was independently associated with a higher risk of future aortic aneurysm development after infrarenal abdominal aortic aneurysm repair when compared to open abdominal aortic aneurysm (hazard ratio 2.19, p = 0.025). CONCLUSIONS: Visceral aortic thrombus present prior to abdominal aortic aneurysm repair and endovascular repair are both associated with an increased risk of future proximal aortic degeneration after infrarenal abdominal aortic aneurysm repair. These factors may predict patients at higher risk of developing proximal aortic aneurysms that may require complex aortic repairs.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Thrombosis , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/etiology , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Retrospective Studies , Risk Factors , Thrombosis/diagnostic imaging , Thrombosis/etiology , Thrombosis/surgery , Time Factors , Treatment Outcome
9.
J Vasc Surg ; 74(5): 1626-1635, 2021 11.
Article in English | MEDLINE | ID: mdl-34019990

ABSTRACT

OBJECTIVE: We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System. METHODS: Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention. CONCLUSIONS: The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.


Subject(s)
Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Ischemia/surgery , Lower Extremity/blood supply , Peripheral Arterial Disease/surgery , Stents , Vascular Access Devices , Aged , Aged, 80 and over , Amputation, Surgical , Blood Vessel Prosthesis Implantation/adverse effects , Chronic Disease , Endovascular Procedures/adverse effects , Feasibility Studies , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Prospective Studies , Regional Blood Flow , Retreatment , Time Factors , Treatment Outcome , United States , Vascular Patency
10.
12.
J Vasc Surg ; 71(6): 2038, 2020 06.
Article in English | MEDLINE | ID: mdl-32446512
13.
J Vasc Surg ; 72(5): 1753-1760, 2020 11.
Article in English | MEDLINE | ID: mdl-32247698

ABSTRACT

OBJECTIVE: The Vascular Surgery Board of the American Board of Surgery (VSB-ABS) Qualifying and Certifying examinations are meant to assess qualifications to independently practice vascular surgery, but it is unclear whether examination performance correlates with clinical outcomes. We assessed this relationship using clinical outcomes data for VSB-ABS diplomates from the Society for Vascular Surgery Vascular Quality Initiative (SVS-VQI). METHODS: VSB-ABS examination performance for vascular surgeons participating in the SVS-VQI registry was characterized according to pass/fail status. Surgical experience was measured by number of years since completion of training. Examination performance and experience were compared with a composite clinical outcome (in-patient major adverse cardiac events or postoperative death [MACE+POD]) after arterial reconstructions (carotid stenting or endarterectomy, aortic aneurysm repair, open peripheral surgical bypasses) registered in the SVS-VQI. Multivariate mixed effects regression was performed adjusting for sex and surgery type, as well as clustering by surgeon and by hospital. RESULTS: From 2003 to 2017, complete data were available for 776 vascular surgeons who performed 124,171 arterial reconstructions (carotid n = 56,650; aortic n = 34,764; peripheral n = 32,757) registered in the SVS-VQI. Patient characteristics associated with higher odds of MACE+POD were female sex (odds ratio [OR] 1.07; 95% confidence interval [CI], 1.03-1.12; P = .006) and advancing age (OR, 1.04; 95% CI, 1.03-1.04; P < .001). Of the 776 surgeons, 149 (17%) had failed at least one VSB-ABS examination (group F). The unadjusted primary composite outcome of MACE+POD was marginally higher after operations performed by surgeons who never failed an examination (group P; 7% vs 6%; P = .03). This difference seems to be driven by higher rates of postoperative congestive heart failure in the aortic and lower extremity bypass cohorts as well as more postoperative myocardial infarctions after lower extremity bypass by group P surgeons. Following multivariable analyses, examination pass status was not associated with MACE+POD (OR, 0.98; 95% CI, 0.89-1.50; P = .517). However, increasing surgical experience correlated with significantly lower odds of MACE+POD (2% lower odds/year of experience since training [OR, 0.98; 95% CI, 0.98-0.99; P < .001]). CONCLUSIONS: VSB-ABS examination performance by SVS-VQI surgeons does not correlate with registry-reported mortality or cardiovascular complications. Increasing surgical experience is strongly associated with lower odds of cardiovascular morbidity and death.


Subject(s)
Cardiovascular Diseases/epidemiology , Certification , Clinical Competence , Postoperative Complications/epidemiology , Quality Indicators, Health Care , Vascular Surgical Procedures/adverse effects , Adult , Aged , Female , Humans , Male , Middle Aged , United States , Vascular Surgical Procedures/education
14.
J Vasc Surg ; 72(1): 204-208.e1, 2020 07.
Article in English | MEDLINE | ID: mdl-32061481

ABSTRACT

OBJECTIVE: Whereas bleeding complications requiring a return to the operating room (OR) after carotid endarterectomy (CEA) are infrequent (1%), they are associated with an increased 30-day combined postoperative stroke or death rate. Drain placement after CEA varies among vascular surgeons, and there are limited data to support the practice. The goal of this study was to evaluate factors leading to drain placement and the effect of drains on postoperative outcomes including return to OR for bleeding, stroke, and death. METHODS: There were 47,752 patients identified undergoing CEA using the Vascular Quality Initiative registry from 2011 to 2015. Demographic, preoperative, and intraoperative factors between patients who underwent CEA with (n = 19,425) and without (n = 28,327) drain placement were compared. End points included return to the OR for bleeding, stroke, death, postoperative wound infection, and hospital length of stay. We then compared postoperative outcomes between groups using mixed effect logistic regression models to control for correlation within center. Similar methods were used to show relationship between return to OR for bleeding and other variables. Subgroup analysis of patients with drain placement was compared among centers with high (>66.7% of cases), medium (33.3%-66.7%), and low (<33.3%) use. RESULTS: Patients with drain placement were more likely to be taking a preoperative P2Y12 antagonist (P < .001), to have prior CEA or carotid artery stenting (P < .001), to use dextran (P < .001), and to have a concomitant procedure or coronary artery bypass graft (P < .001) and less likely to use protamine (P < .001) compared with those without drain placement. Drain placement did not prevent return to the OR for bleeding (P < .22). Re-exploration of the carotid artery after closure in the OR (P < .001), preoperative P2Y12 antagonist use (P < .001), and no protamine use (P < .001) were predictors for return to the OR for bleeding among those with drain placement. Of patients requiring return to the OR for bleeding, drain placement did not influence 30-day stroke (P = .82), 30-day mortality (P = .43), or 30-day combined stroke/mortality (P = .42) compared with those without drain placement. Drain placement did not influence postoperative wound infection (P < .3). Hospital length of stay was increased in patients with drain placement (P < .001). Return to the OR for bleeding (P = .24), wound infection (P = .16), and length of stay (P = .94) did not differ between the groups of high, medium, and low drain use. CONCLUSIONS: Drain placement after CEA does not reduce return to the OR for bleeding, nor does it reduce perioperative stroke or death. Drain placement is associated with increased length of stay.


Subject(s)
Carotid Artery Diseases/surgery , Drainage , Endarterectomy, Carotid , Aged , Carotid Artery Diseases/mortality , Drainage/adverse effects , Drainage/mortality , Endarterectomy, Carotid/adverse effects , Endarterectomy, Carotid/mortality , Female , Humans , Length of Stay , Male , Middle Aged , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/surgery , Registries , Reoperation , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome
15.
J Vasc Surg ; 71(5): 1579-1586, 2020 05.
Article in English | MEDLINE | ID: mdl-31519511

ABSTRACT

OBJECTIVE: Data regarding the treatment of tandem carotid artery lesions at the bifurcation and ipsilateral, proximal common carotid artery (CCA) are limited. It has been suggested that concomitant treatment with carotid endarterectomy (CEA) and proximal ipsilateral carotid artery stenting confers a high risk of stroke and death. The objective of this study was to evaluate the technique and outcomes of this hybrid procedure at a single institution. METHODS: A retrospective chart review was performed including patients who underwent CEA + ipsilateral carotid artery stenting for treatment of atherosclerotic carotid artery disease between December 2007 and April 2017. Primary endpoints were postoperative myocardial infarction, neurologic event, and perioperative mortality. RESULTS: Twenty-two patients (15 male [68%]) underwent CEA + ipsilateral carotid artery stenting with a mean follow-up of 67 ± 77 months. The mean age was 70.0 ± 6.1 years old, all with a prior smoking history (eight current smokers [64%]). Twelve patients (55%) were treated for symptomatic disease and three had a prior ipsilateral CEA (one also with CAS). Computed tomographic angiography imaging was performed preoperatively in 21 patients (95%). CEA was performed first in 18 patients (82%) followed by ipsilateral carotid artery stenting. CEA was performed with a patch in 20 and eversion endarterectomy in two patients. Ipsilateral CCA was stented in 21 patients (96%) and one innominate was stented in a patient with a right CEA. Additional endovascular interventions were performed in three patients: 1 innominate stent, 1 distal ipsilateral internal carotid artery stent, and 1 right subclavian artery stent. All proximal stents were placed with sheath access through the endarterectomy patch in 12 (55%), CCA in 7 (32%), and through the arteriotomy before patching in 3 (14%). Distal internal carotid artery clamping was performed in 18 (90%, available 20) of patients before ipsilateral carotid artery stenting. All proximal lesions were successfully treated endovascularly with no open conversion. One dissection was created and treated effectively with stenting. One perioperative stroke (4.5%) occurred in a patient treated for symptomatic disease, 1 postoperative myocardial infarction (4.5%), and 2 patients (9.1%) with cranial nerve injuries. There was one patient who expired within 30 days, shortly after discharge for unknown reasons. The mean length of stay was 2.6 ± 2.0 days. CONCLUSIONS: In appropriately selected patients, concomitant CEA and ipsilateral carotid artery stenting can be safely performed in high-risk patients with a low risk of myocardial infarction, neurologic events, and perioperative mortality when careful surgical technique is used, using direct carotid access, and distal carotid clamping for cerebral protection before stenting.


Subject(s)
Carotid Stenosis/therapy , Endarterectomy, Carotid , Endovascular Procedures/instrumentation , Stents , Aged , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Endarterectomy, Carotid/adverse effects , Endarterectomy, Carotid/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome
16.
JACC Cardiovasc Interv ; 12(24): 2515-2524, 2019 12 23.
Article in English | MEDLINE | ID: mdl-31575518

ABSTRACT

OBJECTIVES: The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program. BACKGROUND: A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents. METHODS: We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling. RESULTS: There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality. CONCLUSIONS: Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412).


Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Femoral Artery , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Popliteal Artery , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/mortality , Cardiovascular Agents/adverse effects , Cause of Death , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Male , Middle Aged , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
17.
J Vasc Surg ; 70(3): 921-926, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31147113

ABSTRACT

OBJECTIVE: The objective of this study was to review our institute's open aortic surgery volume experience and its impact on Accreditation Council for Graduate Medical Education trainees. METHODS: A review was conducted of the vascular surgery department's operative database for all cases that underwent aortic aneurysm repair, whether open aortic repair (OAR), endovascular aneurysm repair (EVAR), or fenestrated EVAR (FEVAR). We also reviewed our graduating trainees' case logs. In the setting of our regionalized referral center, all patients who underwent open or endovascular aortic intervention between 2010 and 2014 at our main campus were included. The total number of aortic procedures performed by our graduation trainees was determined. All aortic aneurysm interventions, both open and endovascular (both EVAR and FEVAR), were included. The main outcome measures were the total number of aortic interventions, any change in trends of intervention, and the total number of open aortic cases that our graduation trainees had. RESULTS: During the 5-year period analyzed, a total of 1389 abdominal aortic aneurysm repair procedures were performed by OAR, EVAR, and FEVAR. Of those, 462 were OARs, representing 33.2% of the total; 440 were EVARs, representing 31.6%; and 487 were FEVARs, representing 35.2%. For all OAR procedures, there was a significant increase in the proportion of these cases over time (P = .014). The total number of EVAR and FEVAR cases performed annually during this time did not change, whereas the number of OAR cases has increased. Of the OARs, 59.3% were performed for juxtarenal aneurysms, whereas 22.9% involved type IV thoracoabdominal aortic aneurysms. On average, graduating vascular surgery trainees performed 23.1 OARs before graduation (range, 19-26). CONCLUSIONS: In contrast to the documented national trend of decreased OAR, our institute continues to see increased OAR relative to EVAR and FEVAR. Moreover, we theorized that the preservation of OAR volume in our program and other similar institutions might offer a practical solution to the challenge of addressing vascular surgery training in aortic surgery by OAR, EVAR, and FEVAR. Inclusive discussions at the national and international levels are needed to reach consensus regarding the future of vascular surgery training and key issues, such as additional, mandatory, subspecialized training in OAR and FEVAR for both residents and fellows who wish to receive certification in OAR; creation of centers of excellence for open aortic surgery that would centralize OAR and direct trainees to those centers for their needed training; and possibly development of new training strategies whereby single cases can be shared among trainees with alternating roles as exposure and closure vs repair.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Centralized Hospital Services , Education, Medical, Graduate , Endovascular Procedures/education , Hospitals, High-Volume , Regional Health Planning , Surgeons/education , Vascular Surgical Procedures/education , Workload , Centralized Hospital Services/trends , Clinical Competence , Curriculum , Databases, Factual , Education, Medical, Graduate/trends , Endovascular Procedures/trends , Hospitals, High-Volume/trends , Humans , Ohio , Referral and Consultation/trends , Regional Health Planning/trends , Surgeons/trends , Time Factors , Vascular Surgical Procedures/trends
18.
J Vasc Surg ; 68(3): 699-700, 2018 09.
Article in English | MEDLINE | ID: mdl-30144903
19.
Ann Vasc Surg ; 46: 322-330, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28807744

ABSTRACT

BACKGROUND: The aim of this study is to evaluate central venous stenosis (CVS) etiologies and presentation within a vascular surgery practice. We evaluated endovascular treatment modalities and the patency rates of our interventions. METHODS: Five-year retrospective review of endovascular intervention for CVS. Patient demographics, medical comorbidities, and variables were collected including etiology, indwelling device, previous upper extremity (UE) deep venous thrombosis, long-term UE indwelling device (defined as >30 days), malignancy status, hypercoagulable disorders, history of radiation or mediastinal fibrosis or masses, and anticoagulation and/or antiplatelet therapy. Follow-up variables included symptoms, imaging, and anticoagulation and/or antiplatelet utilization. Living patients without recent follow-up were contacted with a telephone survey regarding current symptoms. Patency was evaluated by imaging or clinically by recurrence of signs or symptoms through January 2016. RESULTS: A total of 61 patients underwent attempted endovascular CVS interventions from January 2007 to 2013. Forty-seven (83%) patients had successful interventions. There were 22 (36%) end-stage renal disease (ESRD) patients. The primary etiology in 79% of patients was benign CVS secondary to an indwelling device. Eighty-nine percent of the interventions were primary angioplasty (PTA). The overall primary patency rates at 6, 12, and 24 months were 49%, 34%, and 24%, respectively. Secondary patency rates at 6, 12, and 24 months were 97%, 93%, and 88%, respectively. There were no statistical differences in demographics or outcomes in patients treated successfully with PTA or those requiring stenting. There was no statistical difference in the patency rates between ESRD and non-ESRD patients. Previous interventions were not a predictor of loss of patency. CONCLUSIONS: Our study supported the rising trend of benign CVS predominantly secondary to indwelling devices. We demonstrated acceptable secondary patency with PTA alone. This study adds further support for a primary angioplasty strategy in treating benign CVS. The optimal endovascular treatment for benign CVS is still undefined.


Subject(s)
Endovascular Procedures/instrumentation , Stents , Unnecessary Procedures , Vascular Diseases/therapy , Veins/physiopathology , Adolescent , Adult , Aged , Aged, 80 and over , Anticoagulants/therapeutic use , Constriction, Pathologic , Databases, Factual , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Diseases/diagnostic imaging , Vascular Diseases/etiology , Vascular Diseases/physiopathology , Vascular Patency , Veins/diagnostic imaging , Young Adult
20.
J Vasc Surg ; 65(1): 271-275, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27876518

ABSTRACT

Carotid artery stenting performed with distal embolic protection devices continues to show elevated rates of periprocedural stroke, in particular with high-risk groups. This article discusses the factors associated with protection devices that may contribute to this complication, performs a literature review to assess outcomes of carotid stenting with proximal occlusion devices, and assesses the role of proximal occlusion devices in the management of patients with carotid artery stenosis.


Subject(s)
Angioplasty/instrumentation , Carotid Stenosis/therapy , Embolic Protection Devices , Intracranial Embolism/prevention & control , Stents , Stroke/prevention & control , Angioplasty/adverse effects , Carotid Stenosis/complications , Carotid Stenosis/diagnosis , Evidence-Based Medicine , Humans , Intracranial Embolism/etiology , Prosthesis Design , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome
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