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OBJECTIVE: Vascular surgeons are often called upon to provide emergent surgical assistance to other specialties for iatrogenic complications, both intraoperatively and in the inpatient setting. The management of iatrogenic vascular injury remains a critical role of the vascular surgeon, especially in the context of the increasing adoption of percutaneous procedures by other specialties. This study aims to characterize consultation timing, management, and outcomes for iatrogenic vascular injuries. METHODS: This study identified patients for whom vascular surgery was consulted for iatrogenic vascular complications from February 1, 2022, to May 12, 2023. Patient information, including demographic information, injury details, and details of any operative intervention, was retrospectively collected from February 1, 2022, to October 13, 2022, and prospectively collected for the remainder of the study period. Analyses were performed with R (version 2022.02.03). RESULTS: There were 87 patients with consultations related to iatrogenic vascular injury. Of these, 42 (46%) were female and the mean age was 59 years (±18 years). The most common consulting services were cardiology (32%), cardiothoracic surgery (26%), general surgery (8%), and neurointerventional radiology (10%). Reasons for consultation included hemorrhage (36%), limb ischemia (36%), and treatment of pseudoaneurysm (23%). A total of 24% of consults were intraoperative, 20% of consults related to extracorporeal membrane oxygenation cannulation, and 16% of consults related to ventricular assist devices including left ventricular assist device and intra-aortic balloon pump. The majority of these consult requests (60%) occurred during evening and night hours (5 PM to 7 AM). Emergent intervention was required in 62% of cases and consisted of primary open surgical repair of arterial injury (54%), endovascular intervention (21%), and open thromboembolectomy (15%). Overall, in-hospital mortality for the patient cohort was 20% and the reintervention rate was 23%, reflecting the underlying complexity of the illness and nature of the vascular injury in this patient group. CONCLUSIONS: Vascular surgeons play an essential role in managing emergent life-threatening hemorrhagic and ischemic iatrogenic vascular complications in the hospitalized setting. The complications require immediate bedside or intraoperative consult and often emergent open surgical or endovascular intervention. Furthermore, many of these require urgent management in the evening or overnight hours, and therefore the high frequency of these events represents a potential significant resource utilization and workforce issue to the vascular surgery workforce.
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Centros Médicos Académicos , Enfermedad Iatrogénica , Procedimientos Quirúrgicos Vasculares , Lesiones del Sistema Vascular , Humanos , Femenino , Masculino , Persona de Mediana Edad , Lesiones del Sistema Vascular/cirugía , Lesiones del Sistema Vascular/terapia , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/epidemiología , Estudios Retrospectivos , Procedimientos Quirúrgicos Vasculares/efectos adversos , Anciano , Adulto , Factores de Tiempo , Derivación y Consulta/estadística & datos numéricos , Cirujanos , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.
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Autorización Previa , Humanos , Estudios RetrospectivosRESUMEN
OBJECTIVE: Patients with peripheral artery disease (PAD) undergo lower extremity revascularization (LER) for symptomatic relief or limb salvage. Despite LER, patients remain at increased risk of platelet-mediated complications, such as major adverse cardiac and limb events (MACLE). Platelet activity is associated with cardiovascular events; yet little is known about the dynamic nature of platelet activity over time. We therefore investigated the change in platelet activity over time and its association with long-term cardiovascular risk. METHODS: Patients with PAD undergoing LER were enrolled into the multicenter, prospective Platelet Activity and Cardiovascular Events (PACE) study. Platelet aggregation was assessed by light transmission aggregometry (LTA) to submaximal epinephrine (0.4µ M) immediately prior to LER, and on post-operative day 1 or 2 (POD1) and 30 (POD30). A hyperreactive platelet phenotype was defined as >60% aggregation. Patients were followed longitudinally for MACLE, defined as the composite of death, myocardial infarction, stroke, major lower extremity amputation, or acute limb ischemia leading to reintervention. RESULTS: Among 287 patients undergoing LER, mean age was 70 ± 11 years, 33% were female, 61% were white, and 89% were on baseline antiplatelet therapy. Platelet aggregation to submaximal epinephrine induced a bimodal response; 15.5%, 16.8%, and 16.4% of patients demonstrated a hyperreactive platelet phenotype at baseline, POD1, and POD30, respectively. Platelet aggregation increased by 18.5% (P=0.001) from baseline to POD1, which subsequently returned to baseline at POD30. After a median follow-up of 19 months, MACLE occurred in 165 (57%) patients. After adjustment for demographics, clinical risk factors, procedure type, and antiplatelet therapy, platelet hyperreactivity at POD1 was associated with a significant hazard of long-term MACLE (aHR 4.61, 95% CI 2.08-10.20, P<0.001). CONCLUSION: Among patients with severe PAD, platelet activity increases following LER. Platelet hyperreactivity to submaximal epinephrine on POD1 is associated with long-term MACLE. Platelet activity following LER may represent a modifiable biomarker associated with excess cardiovascular risk.
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BACKGROUND: Duplex-derived velocity measurements are often used to determine the need for carotid revascularization. There is evidence that severe ipsilateral carotid stenosis can cause artificially elevated velocities in the contralateral carotid artery, which may decrease following ipsilateral revascularization. The objective of this study was to determine if contralateral carotid artery duplex velocities decrease following ipsilateral carotid endarterectomy or stenting procedures. METHODS: This is a single institutional retrospective study of prospectively collected data on all patients who underwent carotid revascularization from 2013 to 2021. Patients with immediate preoperative and first postoperative Duplex scan within 4 months of carotid revascularization at our vascular laboratory were included for analysis. Patients with contralateral occlusion were excluded. Duplex criteria used to define moderate (50-69%) and severe (>70%) stenosis were systolic velocity ≥125 cm/sec and ≥230 cm/sec, respectively. RESULTS: Between 2013 and 2021, 129 patients with bilateral carotid stenosis underwent either carotid endarterectomy (98) or a stenting procedure (31). The majority of patients (90%) underwent intervention for severe stenosis. Preoperatively, the contralateral artery was categorized as severe in 30.4% patients. After ipsilateral carotid revascularization, 86 patients (67.2%) saw a decrease in the contralateral artery peak systolic velocity (PSV), while the remaining remained stable or increased. Fifty-four patients had a change in designated stenosis severity in the contralateral artery. Between the carotid endarterectomy and stenting cohorts, there was no significant difference in the proportion of patients whose contralateral velocity decreased (69.4% vs. 61.3%, P = 0.402). Patients with coronary artery disease and diabetes were significantly less likely to experience a decrease in the contralateral artery PSV after ipsilateral intervention (P = 0.018 and P = 0.033). CONCLUSIONS: In patients with bilateral carotid disease, ipsilateral revascularization can change the contralateral artery velocity and perceived disease severity. Most patients were noted to have a decrease in the contralateral artery PSV, although almost one-third either stayed stable or increased. On multivariable analysis, patients with coronary artery disease and diabetes were less likely to see a decrease in the contralateral artery PSV after intervention. Patients who are at risk for artificial elevation of the contralateral artery may warrant a re-evaluation of the contralateral artery after ipsilateral intervention. These patients are potentially better assessed with axial imaging, although further research is needed.
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Estenosis Carotídea , Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Endarterectomía Carotidea , Humanos , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Constricción Patológica , Estudios Retrospectivos , Ultrasonografía Doppler Dúplex/métodos , Resultado del Tratamiento , Arterias Carótidas , Endarterectomía Carotidea/efectos adversos , Arteria Carótida Interna/diagnóstico por imagen , Velocidad del Flujo SanguíneoRESUMEN
OBJECTIVE: Management of acute limb ischemia (ALI) has seen greater utilization of catheter-based interventions over the last two decades. Data on their efficacy is largely based on comparisons of catheter-directed thrombolysis (CDT) and open thrombectomy. During this time, many adjuncts to CDT have emerged with different mechanisms of action, including pharmacomechanical thrombolysis (PMT) and aspiration mechanical thrombectomy (AMT). However, the safety and efficacy of newer adjuncts like AMT have not been well established. This study is a retrospective analysis of the contemporary management of ALI comparing patients treated with aspiration mechanical thrombectomy to patients treated with the more established CDT adjunct, pharmacomechanical thrombolysis. METHODS: Patients undergoing peripheral endovascular intervention for ALI using an adjunctive device were identified through query of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) module from 2014 to 2019. Patients with a nonviable extremity (Rutherford ALI Stage 3), prior history of ipsilateral major amputation, popliteal aneurysm, procedures that were deemed elective (>72 h from admission), procedures that did not utilize an endovascular adjunctive device, and patients without short-term follow-up were all excluded from analysis. The primary outcome was a composite outcome of freedom from major amputation and/or death in the perioperative time period. RESULTS: We identified 528 patients with Rutherford ALI Stage 1 or 2 who were treated with an endovascular adjunct. 433 patients did not undergo aspiration mechanical thrombectomy (no AMT group) and 95 patients did undergo aspiration mechanical thrombectomy (AMT group). The amputation-free survival across all patients was 93.4%. There were significant differences in demographic, comorbidity, and treatment variables between groups (e.g., gender, prior percutaneous coronary intervention (PCI), history of prior peripheral artery disease intervention, and history of prior infra-inguinal PVI), so a propensity score matched analysis was included to account for these group differences. In the propensity score matched analysis, there was no significant difference in major amputation (AMT 7.4% vs no AMT 3.2%, p = 0.13) or death (AMT 95.8% survival vs no AMT 98.4% survival, p = 0.23) with the use of aspiration mechanical thrombectomy. However, there was significantly worse amputation-free survival with the use of aspiration mechanical thrombectomy (AMT 88.4% vs no AMT 95.3%, p = 0.03). On multivariate analysis, prior supra-inguinal bypass (OR 4.85, 1.70-13.84, p = 0.003), Rutherford ALI Stage 2B (OR 3.13, 1.47-6.67, p = 0.003), and aspiration mechanical thrombectomy (OR 2.71, 1.03-7.17, p = 0.05) were associated with the composite outcome. CONCLUSIONS: Short-term amputation-free survival rates of endovascular management of acute limb ischemia are adequate across all modalities. However, aspiration mechanical thrombectomy was associated with significantly worse amputation-free survival compared to other endovascular adjuncts alone (i.e., pharmacomechanical thrombolysis). Severe limb ischemia (Rutherford ALI Stage 2B) and prior supra-inguinal bypass were associated with worse amputation-free survival regardless of the choice of endovascular intervention.
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OBJECTIVES: Generative artificial intelligence (AI) has emerged as a promising tool to engage with patients. The objective of this study was to assess the quality of AI responses to common patient questions regarding vascular surgery disease processes. METHODS: OpenAI's ChatGPT-3.5 and Google Bard were queried with 24 mock patient questions spanning seven vascular surgery disease domains. Six experienced vascular surgery faculty at a tertiary academic center independently graded AI responses on their accuracy (rated 1-4 from completely inaccurate to completely accurate), completeness (rated 1-4 from totally incomplete to totally complete), and appropriateness (binary). Responses were also evaluated with three readability scales. RESULTS: ChatGPT responses were rated, on average, more accurate than Bard responses (3.08 ± 0.33 vs 2.82 ± 0.40, p < .01). ChatGPT responses were scored, on average, more complete than Bard responses (2.98 ± 0.34 vs 2.62 ± 0.36, p < .01). Most ChatGPT responses (75.0%, n = 18) and almost half of Bard responses (45.8%, n = 11) were unanimously deemed appropriate. Almost one-third of Bard responses (29.2%, n = 7) were deemed inappropriate by at least two reviewers (29.2%), and two Bard responses (8.4%) were considered inappropriate by the majority. The mean Flesch Reading Ease, Flesch-Kincaid Grade Level, and Gunning Fog Index of ChatGPT responses were 29.4 ± 10.8, 14.5 ± 2.2, and 17.7 ± 3.1, respectively, indicating that responses were readable with a post-secondary education. Bard's mean readability scores were 58.9 ± 10.5, 8.2 ± 1.7, and 11.0 ± 2.0, respectively, indicating that responses were readable with a high-school education (p < .0001 for three metrics). ChatGPT's mean response length (332 ± 79 words) was higher than Bard's mean response length (183 ± 53 words, p < .001). There was no difference in the accuracy, completeness, readability, or response length of ChatGPT or Bard between disease domains (p > .05 for all analyses). CONCLUSIONS: AI offers a novel means of educating patients that avoids the inundation of information from "Dr Google" and the time barriers of physician-patient encounters. ChatGPT provides largely valid, though imperfect, responses to myriad patient questions at the expense of readability. While Bard responses are more readable and concise, their quality is poorer. Further research is warranted to better understand failure points for large language models in vascular surgery patient education.
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OBJECTIVES: Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes. METHODS: Three hundred subjects were enrolled in the Platelet Activity and Cardiovascular Events (PACE) study prior to lower extremity revascularization, of whom 104 were on clopidogrel. Light transmission platelet aggregation was measured in response to ADP 2 µm immediately prior to revascularization. Patients were followed longitudinally for a median follow-up of 18 months. The primary endpoint was major adverse limb events (MALE) defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to percent ADP-induced aggregation. Poor response to clopidogrel was defined by >50% aggregation. RESULTS: Overall, the median age was 70 (63, 76) and 35.6% were female. Twenty-nine (27.9%) patients experienced MALE during their follow-up. Median aggregation to ADP 2 µ m was 22.5% (Q1-Q3: 10%, 50%) and 27 subjects (26%) were clopidogrel poor responders. Baseline aggregation was higher in subjects who went on to develop a MALE than those without MALE (43% vs 20%, p = .017). Subjects with aggregation > median (22.5%) were more likely to experience MALE than aggregation < median (38.5% vs 17.3%, p = .029). After multivariable adjustment for age, sex, race/ethnicity, BMI, diabetes, coronary artery disease, and aspirin use, aggregation > median was associated with MALE (adjusted HR [aHR] 2.67, 95% CI 1.18-6.01, p = .018). When stratified by established cut-offs for responsiveness to clopidogrel (50% aggregation), poor responders were more likely to experience MALE than normal responders (44.4% vs 22.1%, aHR 2.18, 95% CI 1.00-4.78, p = .051). CONCLUSIONS: Among patients undergoing lower extremity revascularization on clopidogrel, higher baseline percent aggregation is associated with increased risk for major adverse limb events.
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Enfermedad de la Arteria Coronaria , Enfermedad Arterial Periférica , Humanos , Femenino , Anciano , Masculino , Clopidogrel/efectos adversos , Extremidad Inferior , Amputación Quirúrgica , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/tratamiento farmacológico , Enfermedad Arterial Periférica/cirugíaRESUMEN
BACKGROUND: Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. METHODS: The use of the 4F WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU postmarket clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± standard deviation days from the procedure in patients enrolled on dialysis. RESULTS: Procedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9% ± 4.5%, 80.7% ± 4.1%, and 87.8% ± 3.3%, respectively. Time to maturity averaged 41 ± 17 days. Time to successful cannulation averaged 68 ± 51 days. Device-related serious adverse events were reported in 3 of 120 patients (2.5%) and procedure-related serious adverse events occurred in 7 of 120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120 [10.8%]) and maintenance (11/120 [9.2%]). CONCLUSIONS: Percutaneous creation of native dialysis fistulae with the 4F WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Use of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4F device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger bore devices.
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Derivación Arteriovenosa Quirúrgica/instrumentación , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Diálisis Renal , Insuficiencia Renal Crónica/terapia , Extremidad Superior/irrigación sanguínea , Adulto , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Ensayos Clínicos como Asunto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Arteria Radial/cirugía , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Arteria Cubital/cirugía , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular , Adulto JovenRESUMEN
BACKGROUND: Potential complications of pelvic flow disruption during aortic aneurysm repair include buttock ischemia and mesenteric ischemia. Unilateral or bilateral hypogastric artery flow interruption, either from atherosclerosis or intentionally to facilitate aneurysm repair, is considered problematic in endovascular repair; however, it has not been well studied in open abdominal aortic aneurysm (AAA) repair (OAR). We sought to examine the effect of interruption of flow to one or both hypogastric arteries on outcomes after OAR. METHODS: The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing elective open AAA repair between 2003 and 2020. (redundant) Patients with appropriate data on their hypogastric arteries postoperatively were stratified into two groups-patent bilaterally (normal pelvic perfusion, NPP) and unilateral or bilateral occlusion or ligation (compromised pelvic perfusion, CPP). Primary endpoints were 30-day major morbidity (myocardial infarction, respiratory complications, renal injury, and lower extremity or intestinal ischemia) and mortality. RESULTS: During the study period, 9.492 patients underwent elective open AAA repair-860 (9.1%) with compromised pelvic perfusion and 8,632 (90.9%) with patent bilateral hypogastric arteries. The groups had similar cardiac risk factors, including a history of coronary artery disease, prior coronary intervention, and the use of P2Y12 inhibitors and statins. A majority of patients in the CPP cohort had concurrent iliac aneurysms (63.3% vs. 24.8%; P < 0.001). The perioperative mortality was significantly higher in patients with compromised pelvic perfusion (5.5% vs. 3.1%; P < 0.001). Bilateral flow interruption had a trend toward higher perioperative mortality compared to unilateral interruption (7.1% vs. 4.7%; P < 0.147). The CPP group also had increased rates of myocardial injury (6.7% vs. 4.7%; P = 0.012), renal complications (18.9% vs. 15.9%; P = 0.024), leg and bowel ischemia (3.5% vs. 2.1%; P = 0.008; and 5.7% vs. 3.4%; P < 0.001, respectively). On multivariable analysis, CPP was associated with increased perioperative mortality (OR 1.47, CI 1.14-1.88, P = 0.003). On Kaplan-Meier analysis, there was no difference in survival at 2 years postdischarge between the NPP and CPP cohorts (86.1% vs. 87.5%, log-rank P = 0.275). CONCLUSIONS: Compromised pelvic perfusion is associated with increased perioperative complications and higher mortality in patients undergoing OAR. The sequelae of losing pelvic perfusion, in addition to the presence of more complex atherosclerotic and aneurysmal disease resulting in more difficult dissection, likely contribute to these findings. Thus, patients considered for OAR who have occluded hypogastric arteries or aneurysmal involvement of the hypogastric artery preoperatively may be candidates for more conservative management beyond traditional size criteria.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia Mesentérica , Humanos , Cuidados Posteriores , Resultado del Tratamiento , Alta del Paciente , Arteria Ilíaca/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Aorta Abdominal/cirugía , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Isquemia/etiología , Isquemia Mesentérica/diagnóstico por imagen , Isquemia Mesentérica/cirugía , Isquemia Mesentérica/etiología , Factores de Riesgo , Estudios Retrospectivos , Complicaciones Posoperatorias/cirugíaRESUMEN
OBJECTIVE: Wound complications after major lower extremity amputations (LEAs) are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are few data on its use in major LEAs. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would decrease the risk of complications as compared with a standard dressing in patients with peripheral vascular disease undergoing major LEA. METHODS: Fifty-four consecutive patient limbs with a history of peripheral arterial disease underwent below-knee or above-knee amputations. This was a retrospective review of a prospectively maintained database from January 2018 to December 2019, and it included 23 amputations in the NPWT group and 31 amputations in the standard dressing group. NPWT using the PREVENA system was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a nonadherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value of less than .05 was considered statistically significant. RESULTS: For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared with the standard group (44% vs 13%; P = .011), as well as trends toward increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared with the standard group (52% vs 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared with the standard group (13% vs 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI, and one incision line necrosis. In the standard group, there were four wound dehiscences with deep SSI, three superficial SSIs, four incision line necroses, and one stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard groups (3% vs 4% and 4.3% vs 10%, respectively). CONCLUSIONS: Closed incision NPWT may decrease the incidence of wound complications in vascular patients undergoing major LEA. This held true even among a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.
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Amputación Quirúrgica , Extremidad Inferior/irrigación sanguínea , Terapia de Presión Negativa para Heridas , Enfermedad Arterial Periférica/cirugía , Cicatrización de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica/efectos adversos , Amputación Quirúrgica/mortalidad , Comorbilidad , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Terapia de Presión Negativa para Heridas/efectos adversos , Terapia de Presión Negativa para Heridas/mortalidad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Dehiscencia de la Herida Operatoria/etiología , Dehiscencia de la Herida Operatoria/mortalidad , Dehiscencia de la Herida Operatoria/prevención & control , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/mortalidad , Infección de la Herida Quirúrgica/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. METHODS: A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral, or deep femoral artery revascularization were excluded (n = 206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g., popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. RESULTS: We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4-French sheath, while a majority of retrograde CFA interventions utilized a 6-French sheath for access (87.7% vs 69.5%, P < 0.001). Significantly less fluoroscopy (9.5 vs 16.4 min, P < 0.001) and contrast (25.4 vs 38.5 mL, P < 0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA vs 94.8% retrograde CFA access (P = 0.42). The overall rate of complications was low for both cohorts (2.7% vs 3.7%, P = 0.78) and there were no statistical differences in access site complications (1.1% vs 1.5%, P = 0.94), hematoma (0.7% vs 1.1%, P = 0.84), and pseudoaneurysm (0.4% vs 0%, P = 0.98) between techniques. CONCLUSIONS: Percutaneous antegrade SFA access can be performed safely in the outpatient setting and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.
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Atención Ambulatoria , Cateterismo Periférico , Procedimientos Endovasculares , Arteria Femoral , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Cateterismo Periférico/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Punciones , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Upper extremity deep venous thrombosis (UEDVT) and its associated complications are increasing in incidence, but management strategies are largely derived from experience treating lower extremity deep venous thrombosis (LEDVT). The purpose of this study is to examine our single institution's experience with in-hospital venous thromboembolism (VTE), specifically the characteristics and outcomes of the UEDVT population as it compares to LEDVT. METHODS: This is a single tertiary care center retrospective cohort study of all consecutive inpatients diagnosed with acute VTE from June 2015 to December 2015. During this period, 4,495 patients underwent venous duplex examination (622 UE and 3,873 LE), identifying 83 inpatient DVTs. Chronic DVT and those diagnosed in the outpatient population were excluded. DVTs were classified as either provoked or unprovoked. Provoked DVT were defined as the presence of any of the following factors within 30 days prior to diagnosis: major surgery, immobilization (greater than 3 days of bedrest), trauma, infection requiring antibiotics, central venous access, pregnancy, and/or hormonal medication use. Inpatient pulmonary embolisms (PE) detected on chest computed tomography (CT) were also evaluated during this time frame. Patient data were collected, including age, gender, race, lifestyle factors, comorbidities, VTE risk factors, symptomatology at presentation, management including anticoagulation choice and filter placement if applicable, as well as discharge disposition. Statistical analysis was performed using GraphPad Prism 8.0 (GraphPad Software, San Diego, California), and a threshold P-value of <0.05 set for significance. RESULTS: During the study period, 83 DVTs (48 LEDVT, 35 UEDVT) and 24 PE were identified in 96 inpatients. Of these DVTs, 77.1% of these were defined as provoked. Eleven patients had simultaneous DVT and PE, and thirteen patients had PE with presumed occult pelvic or LEDVT. UEDVT patients had a higher proportion of comorbidities than LEDVT patients: coronary artery disease (25.7% vs. 13.1%, P = 0.16), congestive heart failure (20% vs. 6.6%, P = 0.09), as well as a trend toward higher incidence of malignancy (60% vs. 42.6%, P = 0.13). Of provoked VTE, UEDVT correlated more significantly with central venous catheters (88.4% vs. 12.5%, P=<0.0001), but was less commonly associated with prolonged bed rest (19.2% vs. 39.5%, P = 0.11). PE was diagnosed in 24/96 (25%) of the study population. Patients with LEDVT were found to have a significantly higher incidence of PE compared to those with UEDVT (34.4% vs. 8.6%, P = 0.006). Same-admission mortality for patients with VTE was 13/96 (13.5%). Of these, patients with UEDVT had significantly higher all-cause mortality than patients with LEDVT (28.5% vs. 4.9%, P = 0.004). When catheter-related UEDVT was excluded, there remained a significant difference in mortality between non-catheter-related UEDVT and LEDVT (33.3% vs. 4.9% P = 0.0119). CONCLUSIONS: This study demonstrates a high prevalence of UEDVT in hospitalized patients who experience VTE. Despite a lower incidence of synchronous PE, patients with UEDVT had a higher prevalence of significant medical comorbidities and higher all-cause mortality on the index hospital admission.
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Extremidad Inferior/irrigación sanguínea , Admisión del Paciente , Centros de Atención Terciaria , Trombosis Venosa Profunda de la Extremidad Superior/mortalidad , Extremidad Superior/irrigación sanguínea , Tromboembolia Venosa/mortalidad , Trombosis de la Vena/mortalidad , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Ciudad de Nueva York/epidemiología , Prevalencia , Pronóstico , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Ultrasonografía Doppler Dúplex , Trombosis Venosa Profunda de la Extremidad Superior/diagnóstico por imagen , Trombosis Venosa Profunda de la Extremidad Superior/terapia , Tromboembolia Venosa/diagnóstico por imagen , Tromboembolia Venosa/terapia , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapiaRESUMEN
BACKGROUND: The use of arteriovenous fistula (AVF) is hampered by long surgical wait times, slow maturation, and upwards of 60% that do not mature. We describe our clinical experience in using a system with a 4F catheter profile for endovascular AVF creation in patients on hemodialysis. METHODS: This was a multioperator, single-center, single-arm, prospective study intended to evaluate safety and efficacy of a 4 Fr endovascular AVF (endoAVF) system for the creation of vascular access in hemodialysis patients. The study was performed after institutional review board approval at Italian Hospital (Asuncion, Paraguay). Patients were followed up at regular intervals through 6 months to determine procedural, maturation, and cannulation success as well as intervention rate and patency. RESULTS: From May to November 2016, 32 patients underwent the endoAVF procedure with no device-related adverse events. An endoAVF was successfully created in the proximal forearm for all 32 patients (20 between the radial artery and radial vein; 12 between the ulnar artery and ulnar vein). Wrist access was used for 72% (23/32) of the procedures for the arterial catheter and 59% (19/32) of the procedures for the venous catheter. The device successfully created an endoAVF in every patient for a technical success rate of 100% (32/32). The device- or procedure-related serious adverse event rate was 3% (1/32); one patient experienced a venous guidewire perforation successfully managed with a stent graft. Primary and cumulative patency rates through 6 months were 83% and 87%, respectively, with an intervention rate of 0.21 per patient-year. Physiological suitability, as defined by target flow rates ≥500 ml/min and cannulation vessel diameters ≥4 mm, was achieved in 91% (29/32) of patients by 90 days. Successful 2-needle cannulation was achieved in 78% (21/27) by 90 days, with mean time to cannulation of 43 ± 14 days. Functional cannulation, as defined by successful 2-needle cannulation for two-thirds of the dialysis sessions within 1 month, was achieved in 95% (20/21) of the patients who were successfully cannulated for an overall rate of 74% (20/27). All patients who achieved functional cannulation had their central venous catheters (CVCs) removed before the 90-day follow-up for a CVC removal rate of 74% (20/27). CONCLUSIONS: The 4 Fr endoAVF system allowed for multiple access and fistula creation site options to tailor the procedure to individual patient anatomy. Furthermore, the outcomes are comparable to previous generation endoAVF technology, with a potentially improved safety profile because of the use of arteries at the wrist for access.
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Derivación Arteriovenosa Quirúrgica/instrumentación , Procedimientos Endovasculares/instrumentación , Diálisis Renal , Extremidad Superior/irrigación sanguínea , Dispositivos de Acceso Vascular , Adulto , Anciano , Derivación Arteriovenosa Quirúrgica/efectos adversos , Procedimientos Endovasculares/efectos adversos , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paraguay , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Reversal of flow in the vertebral artery (RFVA) is an uncommon finding on cerebrovascular duplex ultrasound examination. The clinical significance of RFVA and the natural history of patients presenting with it are poorly understood. Our objective was to better characterize the symptoms and outcomes of patients presenting with RFVA. METHODS: A retrospective review was performed of all cerebrovascular duplex ultrasound studies performed at our institution between January 2010 and January 2016 (N = 2927 patients). Individuals with RFVA in one or both vertebral arteries were included in the analysis. RESULTS: Seventy-four patients (74/2927 patients [2.5%]) with RFVA were identified. Half of the patients were male. Mean age at the time of the first ultrasound study demonstrating RFVA was 71 years (range, 27-92 years); 78% of patients had hypertension, 28% were diabetic, and 66% were current or former smokers. Indications for the ultrasound examination were as follows: 44% screening/asymptomatic, 7% anterior circulation symptoms, 20% posterior circulation symptoms, 28% follow-up studies after cerebrovascular intervention, and 5% upper extremity symptoms. At the time of the initial ultrasound examination, 21 patients (28%) had evidence of a prior carotid intervention (carotid endarterectomy or carotid stenting), 21 patients had evidence of moderate (50%-79%) carotid artery stenosis (CAS) in at least one carotid artery, and 12 patients (16%) had evidence of severe (>80%) CAS. Of the 15 patients presenting with posterior circulation symptoms, 11 (73%) had evidence of concomitant CAS. In contrast, 22 of the 59 patients (37%) without posterior circulation symptoms had duplex ultrasound findings of CAS (P = .01). The mean duration of follow-up was 28 ± 22 months. Follow-up data were available for 63 patients (85%), including the 15 patients who presented with posterior circulation symptoms. Of these 15 patients, 5 underwent subclavian artery revascularization, including balloon angioplasty and stenting in 4 patients and open/hybrid revascularization in 1 patient. Five individuals were awaiting intervention. Three patients underwent carotid endarterectomy for CAS, with resultant improvement in posterior circulation symptoms. Finally, one patient was deemed too high risk for intervention, and one patient was found to have an alternative cause for symptoms. The remaining 59 patients continued to be asymptomatic during follow-up. One patient progressed to vertebral artery occlusion, and six patients had progression of CAS. CONCLUSIONS: Symptomatic RFVA responds well to intervention, including subclavian artery stenting and carotid intervention in patients with CAS. The majority of patients with this finding are asymptomatic at the time of presentation. Although progression of vertebral artery disease is rare, these patients may benefit from monitoring for progression of CAS with surveillance ultrasound.
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Circulación Cerebrovascular , Trastornos Cerebrovasculares/diagnóstico por imagen , Ultrasonografía Doppler Dúplex , Ultrasonografía Doppler Transcraneal , Arteria Vertebral/diagnóstico por imagen , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades de las Arterias Carótidas/diagnóstico por imagen , Enfermedades de las Arterias Carótidas/etiología , Enfermedades de las Arterias Carótidas/fisiopatología , Enfermedades de las Arterias Carótidas/terapia , Trastornos Cerebrovasculares/etiología , Trastornos Cerebrovasculares/fisiopatología , Trastornos Cerebrovasculares/terapia , Endarterectomía Carotidea , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Flujo Sanguíneo Regional , Estudios Retrospectivos , Factores de Riesgo , Stents , Síndrome del Robo de la Subclavia/diagnóstico , Síndrome del Robo de la Subclavia/etiología , Síndrome del Robo de la Subclavia/fisiopatología , Síndrome del Robo de la Subclavia/terapia , Arteria Vertebral/fisiopatologíaRESUMEN
BACKGROUND: The goal of this study is to determine if compression therapy after endovenous ablation (EVA) of the great saphenous vein (GSV) improves efficacy and patient-reported outcomes of pain, ecchymosis, and quality of life. METHODS: This is a prospective randomized controlled trial from 2009 to 2013 comparing the use of thigh-high 30-40 mm Hg compression therapy for 7 days versus no compression therapy following EVA of the GSV. Severity of venous disease was measured by clinical severity, etiology, anatomy, pathophysiology scale and the Venous Clinical Severity Score (VCSS). Quality of life assessments were carried out with a Chronic Venous Insufficiency Questionnaire (CIVIQ-2) at days 1, 7, 14, 30, and 90, and the Visual Analog Pain Scale daily for the first week. Bruising score was assessed at 1 week post procedure. Postablation venous duplex was also performed. RESULTS: Seventy patients and 85 limbs with EVA were randomized. EVA modalities included radiofrequency ablation (91%) and laser ablation (9%). Clinical severity, etiology, anatomy, pathophysiology class and VCSS scores were equivalent between the 2 groups. There was no significant difference in patient-reported outcomes of postprocedural pain scores at day 1 (mean 3.0 vs. 3.12, P = 0.948) and day 7 (mean 2.11 vs. 2.81, P = 0.147), CIVIQ-2 scores at 1 week (mean 36.9 vs. 35.1, P = 0.594) and 90 days (mean 29.1 vs. 22.5, P = 0.367), and bruising score (mean 1.2 vs. 1.4, P = 0.561) in the compression versus no compression groups, respectively. Additionally, there was a 100% rate of GSV closure in both groups and no endothermal heat-induced thrombosis as assessed by postablation duplex. CONCLUSIONS: Compression therapy does not significantly affect both patient-reported and clinical outcomes after GSV ablation in patients with nonulcerated venous insufficiency. It may be an unnecessary adjunct following GSV ablation.
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Vendajes de Compresión , Terapia por Láser , Vena Safena/cirugía , Insuficiencia Venosa/cirugía , Equimosis/etiología , Femenino , Humanos , Terapia por Láser/efectos adversos , Masculino , Persona de Mediana Edad , Ciudad de Nueva York , Dimensión del Dolor , Dolor Postoperatorio/etiología , Presión , Estudios Prospectivos , Calidad de Vida , Vena Safena/diagnóstico por imagen , Vena Safena/fisiopatología , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/fisiopatologíaRESUMEN
BACKGROUND: Nutcracker syndrome, or mesoaortic compression of the left renal vein (LRV), with associated symptoms related to venous hypertension in the left kidney, is a rare entity that may result in severe symptoms requiring operative intervention. We report on 3 patients who presented with nutcracker syndrome, including one patient with a circumaortic LRV resulting in posterior nutcracker syndrome, who underwent successful endovascular treatment with renal vein stenting. A review of existing literature on endovascular management of nutcracker syndrome follows. METHODS: Three women (age range 28-43 years) presented with symptoms and imaging studies consistent with nutcracker syndrome. Symptoms included pelvic and flank pain in all 3 patients, and episodes of hematuria in 2 patients. Imaging studies demonstrated compression of the LRV between the superior mesenteric artery and aorta in 2 of the patients. The third patient was noted to have a circumaortic LRV. RESULTS: All 3 patients underwent venography and LRV stenting. Stents included a 12 × 40 mm self-expanding nitinol stent, 14 × 60 mm WALLSTENT, and 16 × 40 mm WALLSTENT. All patients were placed on clopidogrel postoperatively. The duration of follow-up ranged from 6 to 27 months. At follow-up, all 3 patients reported significant symptomatic improvement, and duplex ultrasonography demonstrated stent patency in all. CONCLUSIONS: Nutcracker syndrome is a rare condition that can be successfully treated with renal vein stenting via an endovascular approach. Results are encouraging at follow-up periods beyond 2 years.
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Procedimientos Endovasculares , Síndrome de Cascanueces Renal/terapia , Venas Renales , Adulto , Aleaciones , Clopidogrel , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Angiografía por Resonancia Magnética , Flebografía , Inhibidores de Agregación Plaquetaria/uso terapéutico , Diseño de Prótesis , Circulación Renal , Síndrome de Cascanueces Renal/diagnóstico por imagen , Síndrome de Cascanueces Renal/fisiopatología , Venas Renales/diagnóstico por imagen , Venas Renales/fisiopatología , Stents , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Lymphedema is an incurable and disfiguring disease secondary to excessive fluid and protein in the interstitium as a result of lymphatic obstruction. Pneumatic compression (PC) offers a novel modality for treatment of lymphatic obstruction through targeting lymphatic beds and mimicking a functional drainage system. The objective of this study is to demonstrate improved quality of life in patients with lower-extremity lymphedema. METHODS: Consecutive patients presenting to a single institution for treatment of lymphedema were all treated with PC for at least 3 months. All patients underwent a pre- and post-PC assessment of episodes of cellulitis, number of ulcers, and venous insufficiency. Post-PC symptom questionnaires were administered. Symptom improvement was the primary outcome for analysis. RESULTS: A total of 100 patients met inclusion criteria. At presentation, 70% were female with a mean age of 57.5 years. Secondary lymphedema was present in 78%. Mean length of PC use was 12.7 months with a mean of 5.3 treatments per week. Ankle and calf limb girth decreased after PC use, (28.3 vs. 27.5 cm, P = 0.01) and (44.7 vs. 43.8 cm, P = 0.018), respectively. The number of episodes of cellulitis and ulcers pre- and post-PC decreased from mean of 0.26-0.05 episodes (P = 0.002) and 0.12-0.02 ulcers (P = 0.007), respectively. Fourteen percent had concomitant superficial venous insufficiency, all of whom underwent venous ablation. Overall 100% of patients reported symptomatic improvement post-PC with 54% greatly improved. 90% would recommend the treatment to others. CONCLUSIONS: PC improves symptom relief and reduces episodes of cellulitis and ulceration in lower-extremity lymphedema. It is well tolerated by patients and should be recommended as an adjunct to standard lymphedema therapy. Screening for venous insufficiency is recommended.
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Aparatos de Compresión Neumática Intermitente , Linfedema/psicología , Linfedema/terapia , Calidad de Vida , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Incidencia , Extremidad Inferior , Linfedema/complicaciones , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Insuficiencia Venosa/epidemiologíaRESUMEN
We report the case of a 78-year-old man with coronary artery disease, chronic obstructive pulmonary disease, and chronic renal insufficiency with an enlarging 6.7-cm infrarenal abdominal aortic aneurysm. He also had a 4-cm right common iliac artery aneurysm, and right external iliac artery occlusion. The patient had a history of an axillobifemoral bypass graft placed 10 years prior for aortoiliac occlusive disease. We describe the use of an infrarenal aorto-uni-iliac graft and subsequent intentional graft occlusion as an endovascular solution to treat aneurysmal disease in this sick patient. He remains asymptomatic after surgery, with demonstrated occlusion of his aneurysms.
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Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Stents , Procedimientos Quirúrgicos Vasculares/métodos , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Estudios de Seguimiento , Humanos , Masculino , Diseño de Prótesis , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: A 61-year-old man with a previous endovascular repair and stage 5 chronic kidney disease presented with a symptomatic 4.5-cm left internal iliac artery aneurysm. The decision was made to proceed with endovascular repair. METHODS: The preoperative magnetic resonance angiography (MRA) scan was linked to on-table rotational imaging using the Artis zeego Fusion program (Siemens AG, Forchheim, Germany). Using the fused image as a road map, we undertook coil embolization of the left internal iliac artery, and a tapered stent graft was extended from the previous graft into the external iliac artery. RESULTS: Completion angiography revealed exclusion of the aneurysm sac. Three milliliters of contrast were used throughout the procedure. A follow-up magnetic resonance angiography scan at 1 month and duplex ultrasonography at 1 year revealed continued exclusion of the aneurysm sac. The patient's renal function remained unchanged. CONCLUSIONS: This case shows that in a patient with severe chronic kidney disease, fusion of preoperative imaging with intraoperative rotational imaging is feasible and can limit significantly the amount of contrast used during a complex endovascular procedure.
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Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco/diagnóstico , Aneurisma Ilíaco/cirugía , Interpretación de Imagen Asistida por Computador , Angiografía por Resonancia Magnética , Insuficiencia Renal Crónica/complicaciones , Programas Informáticos , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Medios de Contraste/efectos adversos , Embolización Terapéutica , Procedimientos Endovasculares/instrumentación , Gadolinio/efectos adversos , Compuestos Heterocíclicos/efectos adversos , Humanos , Aneurisma Ilíaco/complicaciones , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/efectos adversos , Valor Predictivo de las Pruebas , Cuidados Preoperatorios , Diseño de Prótesis , Insuficiencia Renal Crónica/diagnóstico , Stents , Resultado del Tratamiento , Ultrasonografía Doppler DúplexRESUMEN
OBJECTIVE: Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting. However, adherence to self-care has been poor, and APCDs require patients to remain immobile during treatment. We evaluated the safety and efficacy of a novel nonpneumatic compression device (NPCD) for treating lower extremity lymphedema vs an APCD. METHODS: A randomized, crossover head-to-head study was performed at nine sites in 2023. Patients were randomized to either the NPCD or a commercially available APCD. Patients used the randomly assigned initial device for 90 days with a 4-week washout period before a comparable 90-day use of the second device. RESULTS: A total of 71 patients (108 affected limbs) with lower extremity lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean decrease in limb edema volume (a mean limb volume decrease of 369.9 ± 68.19 mL [P < .05] vs 83.1 ± 67.99 mL [P < .05]). Significant improvement in Quality of Life was achieved for NPCD and but not for APCD treatment (score improvement of 1.01 ± 0.23 [P < .05] for NPCD vs 0.17 ± 0.18 [P > .05] for APCD). Patients reported greater adherence (81% vs 56%; P < .001) and satisfaction with the NPCD (78% vs 22%) compared with APCD. No device-related adverse events were reported. CONCLUSIONS: The novel NPCD is an effective treatment for decreasing limb volume in patients with lower extremity lymphedema. The NPCD was more effective than an APCD and resulted in superior limb volume decrease, greater improved quality of life, adherence, mobility, and patient satisfaction.