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1.
Article in English | MEDLINE | ID: mdl-38548696

ABSTRACT

INTRODUCTION: The optimal management of blunt thoracic aortic injury (BTAI) remains controversial, with experienced centers offering therapy ranging from medical management to TEVAR. We investigated the utility of a machine learning (ML) algorithm to develop a prognostic model of risk factors on mortality in patients with BTAI. METHODS: The Aortic Trauma Foundation registry was utilized to examine demographics, injury characteristics, management and outcomes of patients with BTAI. A STREAMLINE (A Simple, Transparent, End-To-End Automated Machine Learning Pipeline Facilitating Data Analysis and Algorithm Comparison) model as well as logistic regression (LR) analysis with imputation using chained equations was developed and compared. RESULTS: From a total of 1018 patients in the registry, 702 patients were included in the final analysis. Of the 258 (37%) patients who were medically managed, 44 (17%) died during admission, 14 (5.4%) of which were aortic related deaths. 444 (63%) patients underwent TEVAR and 343 of which underwent TEVAR within 24 hours of admission. Amongst TEVAR patients, 39 (8.8%) patients died and 7 (1.6%) had aortic related deaths. (Table 1) Comparison of the STREAMLINE and LR model showed no significant difference in ROC curves and high AUCs of 0.869 (95% CI, 0.813 - 0.925) and 0.840 (95% CI, 0.779 - 0.900) respectively in predicting in-hospital mortality. Unexpectedly, however, the variables prioritized in each model differed between models (Figure 1A-B). The top three variables identified from the LR model were similar to that from existing literature. The STREAMLINE model, however, prioritized location of the injury along the lesser curve, age and aortic injury grade (Figure 1A). CONCLUSIONS: Machine learning provides insight on prioritization of variables not typically identified in standard multivariable logistic regression. Further investigation and validation in other aortic injury cohorts are needed to delineate the utility of ML models. LEVEL OF EVIDENCE: Level IIIStudy TypeOriginal research (prognostic/epidemiological).

2.
J Vasc Surg ; 78(1): 142-149, 2023 07.
Article in English | MEDLINE | ID: mdl-36822257

ABSTRACT

OBJECTIVE: Dual antiplatelet therapy (DAPT) continues to be the preferred medication regimen after the placement of a carotid stent using the transcarotid revascularization (TCAR) technique despite a dearth of quality data. Therefore, this investigation was performed to define the risks associated with antiplatelet choice. METHODS: We queried all patients who underwent TCAR captured by the Vascular Quality Initiative from September 2016 to June 2022, to determine the association between antiplatelet choice and outcomes. Patients maintained on DAPT were compared with those receiving alternative regimens consisting of single antiplatelet, anticoagulation, or a combination of the two. A 1:1 propensity-score match was performed with respect to baseline comorbidities, functional status, anatomic/physiologic risk, medications, and intraoperative characteristics. In-hospital and 1-year outcomes were compared between the groups. RESULTS: During the study period, 29,802 procedures were included in our study population, with 24,651 (82.7%) receiving DAPT and 5151 (17.3%) receiving an alternative antiplatelet regimen. A propensity-score match with respect to 29 variables generated 4876 unique pairs. Compared with patients on DAPT, in-hospital ipsilateral stroke was significantly higher in patients receiving alternative antiplatelet regimens (1.7% vs 1.1%, odds ratio [95% confidence interval]: 1.54 [1.10-2.16], P = .01), whereas no statistically significant difference was noted with respect to mortality (0.6% vs 0.5%, 1.35 [0.72-2.54], P = .35). A composite of stroke/death was also more likely in patients receiving an alternative regimen (2.4% vs 1.7%, 1.47 [1.12-1.93], P = .01). Immediate stent thrombosis (2.75 [1.16-6.51]) and a nonsignificant trend toward increased return to the operating room were more common in the alternative patients. Conversely, the incidence of perioperative myocardial infarction was lower in the alternative regimen group (0.4% vs 0.7%, 0.53 [0.31-0.90], P = .02). At 1 year after the procedure, we observed an increased risk of mortality (hazard ratio [95% confidence interval]: 1.34 [1.11-1.63], P < .01) but not stroke (0.52 [0.27-0.99], P = .06) in patients treated with an alternative medication regimen. CONCLUSIONS: This propensity-score-matched analysis demonstrates an increased risk of in-hospital stroke and 1-year mortality after TCAR in patients treated with an alternative medication regimen instead of DAPT. Further studies are needed to elucidate the drivers of DAPT failure in patients undergoing TCAR to improve outcomes for carotid stenting patients.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Stroke , Humans , Platelet Aggregation Inhibitors/adverse effects , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/therapy , Carotid Stenosis/complications , Risk Factors , Treatment Outcome , Retrospective Studies , Stroke/etiology , Stroke/prevention & control , Stroke/epidemiology , Stents/adverse effects , Endovascular Procedures/adverse effects , Risk Assessment
3.
Vasc Endovascular Surg ; 57(4): 344-349, 2023 May.
Article in English | MEDLINE | ID: mdl-36533891

ABSTRACT

OBJECTIVE: Carotid endarterectomy (CEA) performed several days after onset of symptoms has been shown to be optimal in preventing procedure-related stroke. Transcarotid artery revascularization (TCAR) is an alternative hybrid procedure to treat high-risk for CEA patients. In this investigation, our aim is to determine the effect of timing of TCAR in symptomatic patients. METHODS: Procedures were captured prospectively at 2 independent health systems from 2016-2022 within a carotid intervention database. A retrospective analysis of this database was performed to generate cohorts by time to revascularization from onset of symptoms, with the short-interval revascularization (SIR) group defined as having a time to revascularization between 2-5 days; and long-interval revascularization (LIR) group having a time to revascularization of 6-180 days. Univariate analysis was performed comparing the cohorts at an α of .05. RESULTS: During the study period, 875 TCARs were captured, including 321 procedures performed in symptomatic patients. Of these, 84 had revascularization performed within 6 days after onset of symptoms (SIR) while 237 additional cases were completed 6 or more days after onset of symptoms (LIR). Baseline comorbidities were grossly similar between cohorts. Intraoperatively, SIR patients were less likely to develop bradycardia (4.8% vs 22.2%, P = .01) and experienced a shorter operative time (58 minutes vs 65 minutes, P = .02). Estimated blood loss, flow reversal time, radiation exposure, fluoroscopic time and contrast volume were identical between the groups. Length of stay in SIR patients was longer (1, IQR [1-3] vs 1, IQR [1-2] days, P < .01). Additionally, SIR patients seemed to trend toward a higher rate of reinterventions (3.6% vs .4%, P = .06). The incidence of ipsilateral or contralateral stroke, cranial nerve palsy, myocardial infarction, hematoma, stent thrombosis and death were statistically identical between the 2 groups. CONCLUSION: Like the previous results established for CEA, symptomatic patients undergoing TCAR demonstrate similar outcomes if the procedure is performed 48 hours after the neurologic event.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Stroke , Humans , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Endovascular Procedures/adverse effects , Retrospective Studies , Risk Factors , Treatment Outcome , Time Factors , Stroke/etiology , Stents/adverse effects , Risk Assessment
4.
Vasc Endovascular Surg ; 57(3): 215-221, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36428225

ABSTRACT

INTRODUCTION: Carotid revascularization in patients with end-stage renal disease (ESRD) continues to be a controversial topic, as life expectancy is poor, thus, preventing the recouperation of cumulative stroke-risk reduction in the postoperative period. We performed this primarily descriptive analysis of the results of transcarotid revascularization (TCAR) in renal failure patients. METHODS: A retrospective review of two independent carotid revascularization databases maintained at two large health systems were performed to capture all consecutive TCAR procedures. Patients were classified as either (1) ESRD or (2) preserved renal function (PRF) and compared with standard univariate techniques, where appropriate. RESULTS: From December 2015 to April 2022, 851 consecutive TCARs were attempted at our participating facilities. Of these, 27 were performed in ESRD patients (all hemodialysis). These patients were younger and presented with a higher Charlson Comorbidity Index. The incidence of a high anatomic risk criterion as defined for the Centers for Medicare and Medicaid Services (CMS) were similar between groups, as was the incidence of a symptomatic carotid lesion. There were no differences between the groups in terms of intraoperative characteristics and the postoperative medication management were grossly similar by renal function. In the 30-day perioperative period, there were no stroke, death, or myocardial infarction in the 27 ESRD patients treated with TCAR. The mean duration of follow-up in the ESRD cohort was 15.0 months. During this time, there was no ipsilateral stroke events, one contralateral stroke, and one MI. All 27 carotid stents remained patent during this period. Six patients perished after TCAR at a mean interval of 12.2 months after TCAR. CONCLUSION: Survival is poor after carotid revascularization via the TCAR technique on intermediate follow-up. Careful patient selection is required to identify those who will survive to collect on the cumulative stroke-risk reduction afforded by carotid intervention.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Kidney Failure, Chronic , Stroke , Humans , Aged , United States , Carotid Stenosis/surgery , Endovascular Procedures/adverse effects , Risk Factors , Treatment Outcome , Medicare , Stroke/etiology , Renal Dialysis/adverse effects , Kidney Failure, Chronic/complications , Stents/adverse effects , Retrospective Studies , Risk Assessment
5.
Ann Surg ; 278(3): e620-e625, 2023 09 01.
Article in English | MEDLINE | ID: mdl-36325904

ABSTRACT

OBJECTIVE: To define the risks associated with the replacement of dual antiplatelets for alternate medication regimens. BACKGROUND: Patients undergoing transcarotid artery revascularization (TCAR) for atherosclerotic disease in the Vascular Quality Initiative database from September 2016 to June 2022 were included. In all, 29,802 TCAR procedures were captured between 2016 and 2022, consisting of 24,651 (82.7%) maintained on dual antiplatelet therapy (DAPT) and 5151 (17.3%) on alternative regimens. METHODS: Patients maintained on DAPT were compared with those on alternative regimens consisting of any combination of single antiplatelet monotherapy and/or anticoagulation. RESULTS: On univariable analysis, patients on alternative medications were more likely to experience in-hospital death, ipsilateral stroke, any stroke, and transient ischemic attacks compared with patients in the DAPT group. The mortality rate was higher at 1 year in the alternative cohort (4.7% vs 7.0%, P <0.01). The use of alternate medication regimens was associated with increased odds of stroke and the composite outcome of in-hospital stroke/death compared with DAPT. There was also a significant association between alternative medication use and increased odds of in-hospital transient ischemic attack, immediate stent occlusion, and return to the operating room. At 1 year, there was no significant difference in the incidence of stroke between the 2 groups. However, the use of alternate regimens was associated with higher 1-year of mortality after multivariable adjustment. CONCLUSIONS: Patients not maintained on DAPT after TCAR experienced an increased risk of stroke and death in the perioperative and follow-up periods. Increased surgeon vigilance is required to ensure compliance with dual antiplatelets as recommended.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Stroke , Humans , Platelet Aggregation Inhibitors/therapeutic use , Carotid Stenosis/surgery , Hospital Mortality , Stroke/epidemiology , Stroke/etiology , Vascular Surgical Procedures/adverse effects , Treatment Outcome , Risk Factors , Stents/adverse effects , Endovascular Procedures/adverse effects , Retrospective Studies , Risk Assessment
6.
Vascular ; : 17085381221140158, 2022 Nov 15.
Article in English | MEDLINE | ID: mdl-36377465

ABSTRACT

OBJECTIVE: To determine whether a vascular surgery trainee's participation in transcarotid revascularization (TCAR), a new technology, affects patient safety and outcomes. DESIGN: Retrospective, institutional review of our carotid database was performed. Patients who underwent TCAR were stratified based on whether a vascular trainee was present during the procedure. Relevant demographics, comorbidities, anatomical indication, perioperative courses, and adverse events in the postoperative period were captured for statistical analysis. SETTING: Data were obtained from affiliated Memorial Hermann Hospitals in Houston, Texas. PARTICIPANTS: All patients who underwent TCAR from September 2017 to January 2022 were included. RESULTS: Of 486 patients who underwent TCAR, 173 (35.6%) were performed in the presence of a trainee, and 313 (64.4%) were performed without a trainee. Subjects in the trainee cohort had more challenging anatomy, defined as a higher rate of carotid bifurcation above C2, restenotic disease, previous ipsilateral neck dissection, and neck radiation. The trainee cohort had higher rates of estimated blood loss (61.1 ± 66 vs. 35.5 ± 39 mL, p < 0.01), longer operative time (64.8 ± 30.3 vs. 57.9 ± 20.4 min, p < .01), longer cerebral blood flow reversal time (8.9 ± 6.1 vs. 7.9 ± 6.6 min, p = .01), and higher contrast administration (25.7 ± 12.0 vs. 21.1 ± 9.4 mL, p < .01). The ability to achieve technical success was similar between the two cohorts. There was no difference in the rates of cranial nerve palsy, ipsilateral stroke, hematoma, and stent thrombosis. Hospital length of stay, death (0% vs. 1.6%, p = .10), and stroke (1.1% vs. 2.8%, p = .22) were also similar between the two cohorts. CONCLUSION: Vascular surgery trainee's involvement during TCAR did not increase adverse outcomes, such as stroke and death, in the perioperative period. The results presented herein should encourage other teaching institutions to provide surgical trainees with supervised, hands-on experience during TCAR.

7.
Ann Vasc Surg ; 86: 43-49, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35803460

ABSTRACT

BACKGROUND: Transcarotid revascularization (TCAR) is a carotid stenting technique in which an external shunt between the common carotid artery and femoral vein is created to induce cerebral flow reversal as protection against procedure-related plaque embolism. We completed this analysis to determine if prolonged cerebral flow reversal was associated with adverse perioperative outcomes. METHODS: A retrospective review of a combined carotid revascularization database separately maintained at 2 high-volume TCAR health systems was completed. Procedures with captured intraoperative reverse flow duration was included, stratified into two cohorts at a cut-off of 8 mi, and examined with univariate analysis. RESULTS: Within the predesignated study period, 800 patients received a carotid stent via the TCAR technique at Indiana University Health (n = 350) and Memorial Hermann Health Systems (n = 450). In 132 of these procedures, the duration of reverse flow time was not captured and, therefore, excluded from further analysis. Using our prespecified cutoff for extended reverse flow duration (ERFD), we generated 256 cases, leaving an additional 412 procedures completed with a short reverse flow duration. Baseline comorbidities were comparable with respect to individual diagnoses but the overall disease burden in ERFD patients was slightly higher by Charlson Comorbidity Index (5.3 ± 0.1 vs. 5.7 ± 0.1, P = 0.02). With respect to indications and high anatomic risk criteria, both groups were similar, with exception of the presence of a surgically inaccessible carotid bifurcation, which was more frequent in the ERFD procedures (5.3% vs. 10.2%, P = 0.02). Intraoperatively, more blood loss (40.9 ± 2.2 vs. 48.9 ± 2.9 mLs, P = 0.03), operative time (55.2 ± 0.8 vs. 76.3 ± 1.6 min, P < 0.01), radiation (126.3 ± 17.5 vs. 281.9 ± 28.5 mGys, P < 0.01), contrast volume (19.9 ± 0.4 vs. 26.9 ± 0.9 mLs, P < 0.01), and fluoroscopy time (3.3 ± 0.8 vs. 6.3 ± 0.3 min, P < 0.01) were noted in the patients with extended flow reversal. However, this did not increase the risk of stroke (2.7% vs. 2.0%, P = 0.61), myocardial infarction (0.5% vs. 0%, P = 0.53), or death (1.2% vs. 0.4%, P = 0.41) in the 30-day perioperative period. CONCLUSIONS: Extended cerebral flow reversal, defined here as greater than 8 min, was not associated with increased risk of stroke, myocardial infarction, or death in this institutionally derived series.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Myocardial Infarction , Stroke , Humans , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Treatment Outcome , Risk Factors , Stents/adverse effects , Stroke/etiology , Myocardial Infarction/etiology , Retrospective Studies , Endovascular Procedures/adverse effects
8.
J Vasc Surg ; 76(4): 967-972, 2022 10.
Article in English | MEDLINE | ID: mdl-35640860

ABSTRACT

BACKGROUND: In the present report, we have detailed the results derived from the adoption of transcarotid artery revascularization (TCAR) at a large health system based in the United States. METHODS: A retrospective review was performed of a prospectively maintained database capturing all carotid stents deployed using the ENROUTE neuroprotection device (Silk Road Medical, Sunnyvale, CA) and cerebral flow reversal. The demographics, intraoperative findings, and postoperative results were tabulated and reported. RESULTS: From September 2017 to December 2021, 429 TCAR procedures were attempted within the Memorial Hermann Health System. Preoperatively, all the patients were either asymptomatic with >70% stenosis (66.9%) or symptomatic with >50% stenosis (33.1%). The degree of stenosis was determined using computed tomography angiography and/or duplex ultrasound. We achieved a technical success rate of 99.1%, with the failures attributed to an inability to cross the lesion, an inability to track the stent, visualization of a flow-limiting dissection, and stent maldeployment for one patient each. During the 30-day perioperative period, nine strokes (2.3%) had occurred, three of which had occurred after discharge from the index operation and before the end of the 30-day period. No patient had experienced myocardial infarction. Five patients had died in the perioperative period. Three of the deaths were related to stroke, and two were attributed to cardiopulmonary events secondary to aspiration and likely pulmonary embolus. The mean follow-up after TCAR was 14.5 ± 12.0 months. During the follow-up period, two patients had required reintervention for in-stent stenosis. Ipsilateral to the implanted carotid stent, the overall (including perioperative) stroke incidence was 2.5%. Contralateral to the stent, the stroke incidence was 0.8%. The myocardial infarction rate was 0.8% during follow-up. Mortality in our study population was 5.1% during the follow-up period. CONCLUSIONS: After adoption of TCAR across the Memorial Hermann Health System, we found this procedure to be safe and efficacious with minimal perioperative risks comparable to the historically reported results associated with alternative carotid interventions.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Myocardial Infarction , Stroke , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Constriction, Pathologic/complications , Humans , Myocardial Infarction/etiology , Retrospective Studies , Risk Factors , Silk , Stents/adverse effects , Stroke/epidemiology , Treatment Outcome , United States
9.
J Cardiovasc Surg (Torino) ; 63(2): 222-228, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34825796

ABSTRACT

BACKGROUND: Submassive and massive pulmonary embolism is associated with a high risk of complications. We aimed to evaluate our initial experience with a mechanical thrombectomy device in the management of these patients. METHODS: A single-center, retrospective study was performed in patients with acute submassive and massive pulmonary embolism treated with the FlowTriever device (Inari Medical, Irvine, CA, USA) between June 2019 and November 2020. Clinical and technical parameters were analyzed during the hospitalization and at 30- and 180-days after the procedure. RESULTS: Fourteen patients were evaluated with a median (IQR) age of 60 (50-69) years and 64% were male. All had right heart strain as the main indication for thrombectomy. The procedure duration and fluoroscopic time was 52 (37-89) and 13 (9-24) minutes, respectively. There was 100% technical success, and the pulmonary arterial pressure went from 60 (48-65) mmHg to 40 (34-47) mmHg. Thrombolysis was used in two patients and nine patients required intensive care. 100% experienced improvement in symptoms at the time of discharge. There were no device-related complications, major bleeding events, myocardial infarctions, or deaths. Preprocedural hemoglobin was 13 (12-15) g/dL, and predischarge was 12 (10-13) g/dL. Overall postprocedural length of stay was three (2-6) days. All the patients were discharged with oral anticoagulation. There were no device-related complications or recurrence of embolism at 30 and 180 days. CONCLUSIONS: The mechanical thrombectomy device for submassive and massive pulmonary embolism is promising and appears a safe and effective procedure with 100% technical success, no complications, short intensive care requirement/stay, and good early clinical outcomes.


Subject(s)
Pulmonary Embolism , Acute Disease , Aged , Female , Humans , Male , Middle Aged , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/therapy , Retrospective Studies , Thrombectomy/adverse effects , Thrombolytic Therapy/methods , Treatment Outcome
10.
J Vasc Surg ; 74(4): 1135-1142.e1, 2021 10.
Article in English | MEDLINE | ID: mdl-33864828

ABSTRACT

OBJECTIVE: In the present study, we defined the outcomes and effects of pregnancy in a cohort of women of childbearing age with acute aortic dissection (AAD). METHODS: We reviewed our database of AAD to identify all eligible female patients. Women aged <45 years were included. Data on pregnancy timing with respect to the occurrence of dissection, the demographic data, dissection extent, dissection treatment, dissection-related outcomes, overall maternal and fetal mortality, and genetic testing results were analyzed. RESULTS: A total of 62 women aged <45 years had presented to us with AAD from 1999 to 2017. Of the 62 women, 37 (60%) had had a history of pregnancy at AAD. Of these 37 patients, 10 (27%) had had a peripartum aortic dissection, defined as dissection during pregnancy or within 12 months postpartum. Of the 10 AADs, 5 were type A and 5 were type B. Three patients had presented with AAD during pregnancy (one in the second and two in the third trimester). Five patients (50%) had developed AAD in the immediate postpartum period (within 3 months) and two (20%) in the late postpartum period. For the immediate postpartum AADs (<3 months), four of the five patients delivered via cesarean section. Of these 10 peripartum AADs, 3 (30%) had occurred in patients with known Marfan syndrome. In-hospital mortality for those with peripartum AAD was 10% (1 of 10). Fetal mortality was 20% (2 of 10). CONCLUSIONS: The frequency of aortic dissection in women of childbearing age at our institution was low. However, pregnancy might increase the risk of those young women genetically predisposed to dissection events. From these data, this risk appears to be greatest in the immediate postpartum period, even for those who undergo cesarean section. Close clinical and radiographic surveillance is required for all women with suspected aortopathy, especially in the third trimester and early postpartum period.


Subject(s)
Aortic Aneurysm/epidemiology , Aortic Dissection/epidemiology , Hospitalization , Maternal Age , Pregnancy Complications, Cardiovascular/epidemiology , Reproductive Health , Adult , Aortic Dissection/diagnostic imaging , Aortic Dissection/mortality , Aortic Dissection/therapy , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/mortality , Aortic Aneurysm/therapy , Databases, Factual , Female , Hospital Mortality , Humans , Maternal Mortality , Middle Aged , Pregnancy , Pregnancy Complications, Cardiovascular/diagnostic imaging , Pregnancy Complications, Cardiovascular/mortality , Pregnancy Complications, Cardiovascular/therapy , Prognosis , Retrospective Studies , Risk Assessment , Risk Factors , Texas/epidemiology , Time Factors
11.
Ann Vasc Surg ; 70: 565.e1-565.e5, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32768534

ABSTRACT

Carotid patch infection is a rare complication but one often associated with severe morbidity, including hemorrhage, stroke, cranial nerve injury, and mortality. We present a case of a gram-negative bacterial infection of a bovine pericardial carotid patch. Treatment ultimately required patch explantation and reconstruction with a femoral arterial interposition graft.


Subject(s)
Angioplasty/adverse effects , Bioprosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Carotid Stenosis/surgery , Device Removal , Femoral Artery/surgery , Pericardium/transplantation , Prosthesis-Related Infections/drug therapy , Saphenous Vein/transplantation , Aged , Angioplasty/instrumentation , Blood Vessel Prosthesis Implantation/instrumentation , Carotid Stenosis/diagnostic imaging , Femoral Artery/diagnostic imaging , Humans , Male , Prosthesis-Related Infections/diagnostic imaging , Prosthesis-Related Infections/microbiology , Treatment Outcome
12.
Surgery ; 168(6): 1066-1074, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32859392

ABSTRACT

BACKGROUND: Heparin-bonded polytetrafluoroethylene grafts were marketed to improve hemodialysis access outcomes but are twice the cost of standard polytetrafluoroethylene. We launched a randomized trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for hemodialysis access to compare patency. Since the trial began, additional studies were published with heterogeneous findings. We performed an interim analysis by Bayesian methods using prior probability from meta-analysis of existing literature. METHODS: NCT01601873 is a randomized, blinded trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for dialysis access at 5 sites. Planned sample size was 200 with 1-year primary patency as the primary endpoint. At interim analysis (50% of sample size at 1 year), we also performed a meta-analysis for 1-year primary patency with a random effects model to compute summary rate ratio and standard-error estimates. Meta-analysis estimates formed a prior probability for a Bayesian Cox regression model, and trial data were reanalyzed to develop posterior probability of heparin-bonded polytetrafluoroethylene effectiveness at our hypothesized effect size. Futility analysis was conducted using posterior probability estimates. RESULTS: One hundred and five patients were enrolled at the time of interim analysis. One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884). Summary rate ratio from the meta-analysis (1,209 patients) was 0.87 favoring heparin-bonded polytetrafluoroethylene (P = .33). Posterior hazard ratio from Cox regression was 0.90 (credible interval 0.70-1.13) favoring heparin-bonded polytetrafluoroethylene, which was not significant. Bayesian posterior probability of the a priori hypothesized 20% better patency with heparin-bonded polytetrafluoroethylene was 24%. Sample size to detect superiority with the small observed effect size would require about 3,800 subjects. CONCLUSION: Current evidence does not demonstrate sufficiently large benefit of heparin-bonded polytetrafluoroethylene over standard polytetrafluoroethylene for dialysis access to justify higher cost. Given similar 1-year patency rates, a conclusive finding of superiority was judged to be infeasible, and the trial was stopped for futility.


Subject(s)
Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Graft Occlusion, Vascular/prevention & control , Kidney Failure, Chronic/therapy , Renal Dialysis/instrumentation , Aged , Anticoagulants/pharmacology , Bayes Theorem , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/statistics & numerical data , Female , Follow-Up Studies , Graft Occlusion, Vascular/etiology , Graft Survival , Heparin/pharmacology , Humans , Male , Medical Futility , Middle Aged , Polytetrafluoroethylene , Prosthesis Design , Reoperation/statistics & numerical data , Treatment Outcome , Vascular Patency/drug effects
13.
J Vasc Surg ; 72(4): 1421-1426, 2020 10.
Article in English | MEDLINE | ID: mdl-32115317

ABSTRACT

BACKGROUND: Thoracic outlet syndrome (TOS) results from compression of the neurovascular structures in the thoracic outlet. Decompression provides relief of TOS symptoms. However, little is known about long-term function and quality of life (QoL) from a patient's perspective. The purpose of this study was to evaluate surgical and QoL outcomes after surgical decompression of the thoracic outlet using a paraclavicular approach. METHODS: A prospectively maintained database was used to conduct a retrospective review of patients who underwent thoracic outlet decompression between August 2004 and August 2018. We excluded patients without complete follow-up data. Functional outcomes were assessed by the Derkash classification (poor, fair, good, excellent) using contingency table methods, and QoL was assessed by the 12-Item Short Form Health Survey (SF-12) using general linear models. SF-12 was scored by published criteria, and scale-specific and aggregate mental and physical health-related QoL scores were computed. Aggregate QoL scores range from 0 (terrible) to 100 (perfect). Secondary outcomes included mortality, complications, and duration of hospital stay. RESULTS: We performed 105 operations for TOS, and 100 patients with complete follow-up data were included in the study. Five patients were lost to follow-up. Median age was 35 (interquartile range, 24-47) years, and 58 (58%) were female. The median duration of hospital stay was 4 (interquartile range, 3-5.5) days. Of these patients, 46 had venous etiology, 8 arterial, 42 neurogenic, and 4 mixed vascular and neurogenic. Good or excellent Derkash results were reported in 77 (77%) patients, 46 of 54 (85%) of those with vascular TOS vs 31 of 46 (67%) of those with neurogenic etiology (P < .036). SF-12 score was obtained in 93 of 100 (93%) with a median duration from surgery of 6.1 (3.3-9.3) years. Patients with neurogenic TOS (NTOS) reported significantly lower aggregate mental health QoL than patients with vascular-only TOS (57 vs 59; P < .016). This effect persisted across the entire duration of follow-up and was unaffected by time from surgery (regression P for time = .509). In contrast, aggregate physical function QoL was unaffected by neurogenic etiology (P = .303), and all patients improved linearly with time (0.5 scale unit/y; P < .009). Three patients with incomplete relief of symptoms after paraclavicular decompression for NTOS underwent pectoralis minor decompression. There were no deaths or injuries to the long thoracic nerve. Complications included pleural effusion or hemothorax requiring evacuation (n = 6), neurapraxia (n = 6), and lymph leak (n = 2) treated with tube thoracostomy. CONCLUSIONS: NTOS is associated with significantly worse functional outcome assessed by the Derkash classification. NTOS also demonstrated worse composite mental health QoL, which did not improve over time. In contrast, composite physical health QoL improved linearly with time from surgery regardless of etiology of TOS.


Subject(s)
Decompression, Surgical/methods , Mental Health/statistics & numerical data , Postoperative Complications/epidemiology , Quality of Life , Thoracic Outlet Syndrome/surgery , Adult , Decompression, Surgical/adverse effects , Female , Follow-Up Studies , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Postoperative Complications/etiology , Prospective Studies , Retrospective Studies , Surveys and Questionnaires/statistics & numerical data , Thoracic Outlet Syndrome/etiology , Thoracic Outlet Syndrome/mortality , Thoracic Outlet Syndrome/psychology , Time Factors , Treatment Outcome , Young Adult
14.
J Vasc Surg Cases Innov Tech ; 6(1): 67-70, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32072092

ABSTRACT

Hemosuccus pancreaticus is a rare form of upper gastrointestinal bleeding that accounts for roughly 1 in 1500 cases. It is characterized by hemorrhage from the ampulla of Vater secondary to rupture of a peripancreatic pseudoaneurysm or visceral artery pseudoaneurysm. Among the visceral artery pseudoaneurysms, gastroduodenal artery pseudoaneurysms are among the rarest. In this case report, we describe a successful coil embolization of a large ruptured gastroduodenal pseudoaneurysm in a patient with massive gastrointestinal bleeding.

15.
Ann Thorac Surg ; 109(3): e187-e189, 2020 03.
Article in English | MEDLINE | ID: mdl-31454526

ABSTRACT

Since its approval by the United States Food and Drug Administration in 2011, transcatheter aortic valve replacement has revolutionized the treatment of aortic valvular disease with a rapid increase in use. Potentially fatal aortic complications are rare, occurring in 0.2% to 1.1% of cases-all reported in the early perioperative period. We present a case of a late ascending aortic pseudoaneurysm with rupture secondary to erosion by an embolized transcatheter aortic valve occurring 6 years after implantation. The patient was successfully treated with a commercially available, off-the-shelf aortic endograft.


Subject(s)
Aneurysm, False/etiology , Aneurysm, False/surgery , Aorta/surgery , Aortic Aneurysm/etiology , Aortic Aneurysm/surgery , Aortic Rupture/etiology , Aortic Rupture/surgery , Aortic Valve , Embolism/complications , Endovascular Procedures , Heart Valve Diseases/complications , Postoperative Complications/etiology , Postoperative Complications/surgery , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Female , Humans
16.
J Vasc Surg Cases Innov Tech ; 5(4): 540-543, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31867469

ABSTRACT

Thoracic endovascular aortic repair is the standard treatment for blunt traumatic aortic injuries (BTAI). Approximately 40% of patients with BTAI require left subclavian artery (LSA) coverage for adequate proximal seal. Intentional LSA coverage is not benign; it is associated with complications including stroke, spinal cord ischemia, vertebrobasilar, and left arm ischemia. To avoid these devastating complications, LSA revascularization is recommended before elective zone II thoracic endovascular aortic repair, but is often omitted during emergent cases. We report two cases of aortic zone II traumatic grade III BTAI (aortic pseudoaneurysm) that we successfully treated with the GORE prior to TAG thoracic branch endoprosthesis.

17.
J Vasc Surg Cases Innov Tech ; 5(3): 201-204, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31289763

ABSTRACT

Complications associated with central venous catheterization include deep venous thrombosis and atrial thrombi, among others. Large thrombi, including intracardiac thrombi, have classically been managed medically or with open surgery. However, recent reports detail the utility of the AngioVac system (AngioDynamics, Latham, NY), a vacuum-assisted suction thrombectomy system using a venous-venous extracorporeal circuit. Here, we present the case of a critically ill woman with large right atrial thrombus, patent foramen ovale, and recent embolic stroke who underwent successful vacuum-assisted suction thrombectomy with use of the Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Mass) for stroke prevention.

18.
Eur J Vasc Endovasc Surg ; 57(5): 650-657, 2019 05.
Article in English | MEDLINE | ID: mdl-30910498

ABSTRACT

OBJECTIVES: The effect of superficial femoral artery (SFA) occlusion on long-term patency of aortofemoral bypasses (AFBs) for aortoiliac occlusive disease (AIOD) was examined. METHODS: The AIOD database was reviewed to identify risk factors for AFB failure. The status of the SFA at AFB procedure was categorised as patent; diseased treated (DT), if the SFA occlusion was intervened on concomitant to AFB; or diseased untreated (DU), if the SFA was occluded but not revascularised. Censoring hierarchies for primary patency and patent graft survival time were constructed. Data were analysed by contingency table, Kaplan-Meier, and Cox regression analysis. RESULTS: Between 2004 and 2015, 122 AFB (9 unifemoral, 113 bifemoral) for AIOD were performed. Seventy-five (61%) were female and the mean age was 60 ± 10 years. At the time of AFB, 50 (41%) had occluded SFAs (DT/DU). Of these, 15 had concomitant SFA revascularisation (i.e., DT) at the time of AFB. Patients with occluded SFAs had greater history of prior aortoiliac/infrainguinal procedures (aortoiliac 54% vs. 22%, infrainguinal 58% vs. 25%, both p < 0.001), Trans-Atlantic Inter-Society Consensus II classification of femoropopliteal type D lesions (78 vs. 10%, p < 0.001), Rutherford 4-6 categories (80% vs. 57%, p = 0.011), and longer hospital stay (median 11 vs. 7 days, p < 0.004). SFA status did not affect 30 day mortality (overall 9%); however, sub-analysis showed DT had significantly higher mortality than DU (p < 0.03). Over a median follow up of 7.7 (IQR 4.3-11.4) years, primary patency at one and five years was 98.3% and 91.2% in patients with patent SFAs, 87.9% and 82.7% in DU, and 72.7% and 43.6% in DT (p < 0.001), respectively. On multivariable analysis, low baseline glomerular filtration rate (HR 1.01, p = 0.022), DT (HR 3.7, p = 0.020), Rutherford 4-6 (HR 9.1, p = 0.048), and occluded SFA (HR 3.9, p = 0.009) adversely affected primary patency of AFBs. Long-term mortality was not different between the SFA status groups (p = 0.279). CONCLUSION: Baseline SFA occlusion predicted a fourfold increased hazard of primary AFB failure. Concomitant SFA revascularisation did not improve AFB durability and was associated with increased in hospital mortality.


Subject(s)
Aorta, Abdominal/surgery , Arterial Occlusive Diseases/surgery , Femoral Artery/surgery , Graft Occlusion, Vascular/etiology , Iliac Artery/surgery , Vascular Grafting , Vascular Patency , Aged , Female , Follow-Up Studies , Glomerular Filtration Rate , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications , Reoperation , Retrospective Studies , Risk Factors , Thrombosis/etiology , Vascular Grafting/adverse effects
19.
Ann Thorac Surg ; 106(5): 1333-1339, 2018 11.
Article in English | MEDLINE | ID: mdl-29944880

ABSTRACT

BACKGROUND: Sarcopenia may be an indicator of frailty. We used the total psoas area index (TPAI) to identify sarcopenia and evaluated the effect of preoperative TPAI on outcomes after descending thoracic aortic aneurysm (DTAA) repair. METHODS: Patients with DTAA between 2007 and 2015 who were undergoing thoracic endovascular aortic repair (TEVAR) and open surgical repair (OSR) with available preoperative imaging were analyzed. Sarcopenia was defined as TPAI <6.5cm2/m2. An adverse event was defined as the composite endpoint of three or more multisystem complications, discharge to other than home, or death within 30 days. RESULTS: A total of 282 of 386 DTAA repairs had imaging available for TPAI measurements; 71 of 282 (25%) patients underwent TEVAR, and 211 of 282 (75%) underwent OSR. Preoperative sarcopenia was similar in the two groups (OSR, 57% vs TEVAR, 48%, p = 0.188). Risk factors for sarcopenia were age >70 years, female sex, and large body surface area, whereas heritable thoracic aortic disease was a protective factor. OSR-treated patients with sarcopenia were older compared with patients without sarcopenia (p < 0.001), whereas TEVAR-treated patients had a similar age category distribution (p = 0.187). Patients with sarcopenia had significantly increased adverse events compared with patients who did not have sarcopenia in both groups (sarcopenia-TEVAR, 41% vs nonsarcopenia-TEVAR, 16%, p = 0.020; sarcopenia-OSR, 49% vs nonsarcopenia-OSR, 32%, p = 0.012). Determinants of long-term mortality were increasing age (parameter estimate [PE], 0.06, p < 0.001), TPAI as a decreasing linear function (PE, 0.36, p = 0.003), OSR (PE, 2.92, p = 0.003), and interaction between OSR and TPAI (PE, -0.34, p = 0.010). The interaction term showed that OSR increases long-term mortality risk in more sarcopenic patients. CONCLUSIONS: Preoperative sarcopenia significantly correlated with postoperative adverse events and long-term mortality after DTAA repair. If anatomically feasible, TEVAR should be considered in sarcopenic patients.


Subject(s)
Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/mortality , Cause of Death , Endovascular Procedures/methods , Sarcopenia/mortality , Aged , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnostic imaging , Blood Vessel Prosthesis Implantation/methods , Databases, Factual , Endovascular Procedures/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Multivariate Analysis , Preoperative Care/methods , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Sarcopenia/diagnosis , Survival Rate , Thoracotomy/methods , Thoracotomy/mortality , Treatment Outcome
20.
J Vasc Surg ; 67(2): 389-398, 2018 02.
Article in English | MEDLINE | ID: mdl-28947225

ABSTRACT

OBJECTIVE: The natural history and parameters for successful nonoperative management of blunt traumatic aortic injuries (BTAIs) involving the descending aorta are poorly understood. We examined our experience with nonoperative BTAI treatment (anti-impulse, blood pressure) and evaluated for determinants of successful outcomes. METHODS: We performed a review of our institutional prospective trauma registry database for all BTAI patients from 1999 to 2015. Computed tomography angiography was used to classify aortic injuries on the basis of severity: grade I, intimal tear; grade II, intramural hematoma; grade III, aortic pseudoaneurysm; and grade IV, free rupture. Grade IV injuries were excluded from nonoperative management. Baseline characteristics, clinical outcomes, and follow-up lesion resolution were compared within the medically managed cohort and between surgical and nonoperative groups using univariate and multivariable analysis. RESULTS: Among 338 BTAI patients admitted between 1999 and 2015, 67 BTAI patients were managed nonoperatively; 26 (54%) had grade I BTAI, 22 (46%) had grade II, and 2 (4%) had grade III. Both grade III injuries required a late thoracic endovascular aortic repair after initial medical management and were excluded from analysis. In all, 48 were managed with initial medical therapy, and the remaining 19 died on admission or before definitive treatment. Among the 48 medically managed, the median age was 34 years, and 14 (29%) were female. Six of the 48 (12%) were transferred from other facilities. There was no significant difference in baseline characteristics or early outcomes between BTAI grades. Median injury resolution time was 39 days for grade I and 62 days for grade II (P = .03). Compared with a surgical cohort, BTAI grade and Abbreviated Injury Scale score for the chest were the only significant determinants of propensity to operate. CONCLUSIONS: Based on these limited data, it appears that patients with minimal aortic injuries (grades I and II) may be managed medically, with the majority resolving within 8 weeks. Minimal aortic injury is associated with low mortality and excellent intermediate-term outcomes. Further prospective studies are required to validate these findings.


Subject(s)
Aneurysm, False/therapy , Aorta, Thoracic/injuries , Aortic Aneurysm, Thoracic/therapy , Aortic Dissection/therapy , Aortic Rupture/therapy , Vascular System Injuries/therapy , Wounds, Nonpenetrating/therapy , Adolescent , Adult , Aortic Dissection/diagnostic imaging , Aortic Dissection/mortality , Aneurysm, False/diagnostic imaging , Aneurysm, False/mortality , Aorta, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Aortic Rupture/diagnostic imaging , Aortic Rupture/mortality , Aortography/methods , Clinical Decision-Making , Computed Tomography Angiography , Female , Hospital Mortality , Humans , Injury Severity Score , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Propensity Score , Proportional Hazards Models , Registries , Retrospective Studies , Risk Factors , Texas , Time Factors , Treatment Outcome , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/mortality , Wounds, Nonpenetrating/diagnostic imaging , Wounds, Nonpenetrating/mortality , Young Adult
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