RESUMEN
OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.
Asunto(s)
Estenosis Carotídea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/diagnóstico , Estenosis Carotídea/diagnóstico por imagen , Consenso , Técnica Delphi , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etiología , Constricción PatológicaRESUMEN
Background Fibromuscular dysplasia (FMD) is a nonatherosclerotic arterial disease that has a variable presentation including pulsatile tinnitus (PT). The frequency and characteristics of PT in FMD are not well understood. The objective of this study was to evaluate the frequency of PT in FMD and compare characteristics between patients with and without PT. Methods and Results Data were queried from the US Registry for FMD from 2009 to 2020. The primary outcomes were frequency of PT among the FMD population and prevalence of baseline characteristics, signs/symptoms, and vascular bed involvement in patients with and without PT. Of 2613 patients with FMD who were included in the analysis, 972 (37.2%) reported PT. Univariable analysis and multivariable logistic regression were performed to explore factors associated with PT. Compared with those without PT, patients with PT were more likely to have involvement of the extracranial carotid artery (90.0% versus 78.6%; odds ratio, 1.49; P=0.005) and to have higher prevalence of other neurovascular signs/symptoms including headache (82.5% versus 62.7%; odds ratio, 1.82; P<0.001), dizziness (44.9% versus 22.9%; odds ratio, 2.01; P<0.001), and cervical bruit (37.5% versus 15.8%; odds ratio, 2.73; P<0.001) compared with those without PT. Conclusions PT is common among patients with FMD. Patients with FMD who present with PT have higher rates of neurovascular signs/symptoms, cervical bruit, and involvement of the extracranial carotid arteries. The coexistence of the 2 conditions should be recognized, and providers who evaluate patients with PT should be aware of FMD as a potential cause.
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Displasia Fibromuscular , Acúfeno , Arterias Carótidas , Displasia Fibromuscular/diagnóstico por imagen , Displasia Fibromuscular/epidemiología , Humanos , Sistema de Registros , Acúfeno/diagnóstico , Acúfeno/epidemiología , Estados UnidosRESUMEN
We present the unusual case of a mycotic right common iliac artery pseudoaneurysm caused by the methicillin-susceptible Staphylococcus aureus (MSSA) of indeterminate etiology in a healthy 57-year-old man with no risk factors for infection, trauma, or malignancy. The patient initially presented with worsening subacute right lower quadrant pain and was found to have a pseudoaneurysm of the right common iliac artery. Given concern for rupture on a computed tomography angiogram (CTA), he underwent exclusion of the pseudoaneurysm with a covered stent. At the time of presentation, he had no signs or symptoms of infection. However, the patient developed fever, chills, and worsening right lower quadrant pain 13 days after the index operation and was found to have a leukocytosis, blood cultures positive for MSSA, and progressive soft-tissue changes involving the right common iliac artery on CTA consistent with infection. He was definitively treated with stent explantation, aggressive debridement and replacement with an in situ cryopreserved bypass, and short-term suppressive antibiotic therapy.
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Aneurisma Falso/microbiología , Aneurisma Infectado/cirugía , Aneurisma Ilíaco/microbiología , Infecciones Estafilocócicas/microbiología , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/cirugía , Aneurisma Infectado/diagnóstico por imagen , Aneurisma Infectado/microbiología , Antibacterianos/administración & dosificación , Implantación de Prótesis Vascular/instrumentación , Desbridamiento , Remoción de Dispositivos , Procedimientos Endovasculares/instrumentación , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Aneurisma Ilíaco/cirugía , Masculino , Persona de Mediana Edad , Infecciones Estafilocócicas/diagnóstico por imagen , Infecciones Estafilocócicas/cirugía , Stents , Resultado del TratamientoRESUMEN
Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.
Asunto(s)
Aorta Torácica/cirugía , Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular , Cateterismo Periférico , Procedimientos Endovasculares , Hemorragia/prevención & control , Hemostasis , Técnicas Hemostáticas/instrumentación , Dispositivos de Cierre Vascular , Anciano , Anciano de 80 o más Años , Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Cateterismo Periférico/efectos adversos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Hemorragia/sangre , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Masculino , América del Norte , Estudios Prospectivos , Punciones , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. BACKGROUND: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. METHODS: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. RESULTS: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. CONCLUSIONS: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).
Asunto(s)
Estenosis Carotídea/terapia , Endarterectomía Carotidea/efectos adversos , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Recurrencia , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults. METHODS: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention. RESULTS: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%. CONCLUSIONS: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success.
Asunto(s)
Angioplastia de Balón , Coartación Aórtica/terapia , Implantación de Prótesis Vascular , Adulto , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Coartación Aórtica/diagnóstico por imagen , Coartación Aórtica/mortalidad , Coartación Aórtica/fisiopatología , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Oclusión de Injerto Vascular/terapia , Humanos , Masculino , Persona de Mediana Edad , Supervivencia sin Progresión , Recurrencia , Retratamiento , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Factores de Tiempo , Grado de Desobstrucción Vascular , Adulto JovenRESUMEN
OBJECTIVES: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BACKGROUND: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. METHODS: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. RESULTS: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. CONCLUSIONS: Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients.
Asunto(s)
Estenosis Carotídea/terapia , Procedimientos Endovasculares/instrumentación , Stents Metálicos Autoexpandibles , Anciano , Anciano de 80 o más Años , Aleaciones , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Endarterectomía Carotidea/efectos adversos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Estudios Prospectivos , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Aortoiliac occlusive disease results in varying degrees of pelvic and lower extremity arterial insufficiency. Treatment approach has evolved, and endovascular therapies are being successfully reported for high-grade lesions. However, Trans Atlantic Inter-Society Consensus D often necessitates open revascularization. Disease limited to the infrarenal segment does not typically affect intestinal perfusion in the absence of visceral aortic or mesenteric vessel involvement. Chronic mesenteric ischemia most commonly occurs due to atherosclerotic disease of 2 or 3 of the mesenteric vessels. The marginal artery of Drummond is an important component of the collateral network that allows for continued intestinal perfusion. We report a case of short-segment subtotal infrarenal aortic occlusion, proximal to the inferior mesenteric artery (IMA) in the absence of significant mesenteric disease. The patient had resultant lifestyle limiting claudication and chronic mesenteric ischemia. Angiographic evaluation demonstrated "mesenteric steal" physiology with retrograde flow via the arc of Riolan and IMA to perfuse the aortoiliac circulation. Successful endovascular recanalization with a balloon-expandable covered stent was achieved, resolving the arterial insufficiency in both the mesenteric and lower extremity vascular beds. The patient denied any symptoms on postoperative day 1 and at 1-month follow-up.
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Enfermedades de la Aorta/complicaciones , Arteriopatías Oclusivas/complicaciones , Claudicación Intermitente/etiología , Arteria Mesentérica Inferior/fisiopatología , Isquemia Mesentérica/etiología , Circulación Esplácnica , Dolor Abdominal/etiología , Angioplastia de Balón/instrumentación , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/fisiopatología , Enfermedades de la Aorta/terapia , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Arteriopatías Oclusivas/terapia , Enfermedad Crónica , Circulación Colateral , Angiografía por Tomografía Computarizada , Humanos , Claudicación Intermitente/diagnóstico por imagen , Claudicación Intermitente/fisiopatología , Claudicación Intermitente/terapia , Masculino , Arteria Mesentérica Inferior/diagnóstico por imagen , Isquemia Mesentérica/diagnóstico por imagen , Isquemia Mesentérica/fisiopatología , Isquemia Mesentérica/terapia , Persona de Mediana Edad , Stents , Resultado del Tratamiento , Pérdida de PesoRESUMEN
OBJECTIVES: The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA). BACKGROUND: General considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GORE® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction. METHODS: Patients at high risk for CEA (N = 250) were treated with CAS using the GEF study device paired with an FDA-approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre-determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab. RESULTS: The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30-day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre-defined performance goal (P < 0.001). The 30-day rate for death and major stroke was 1.2% and for death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among non-octogenarians. CONCLUSION: In patients at high risk for CEA undergoing CAS, the GEF not only showed high rates of successful deployment but also met the primary endpoint of low death, stroke, and MI rates, thus demonstrating safety and effectiveness.
Asunto(s)
Estenosis Carotídea/terapia , Dispositivos de Protección Embólica , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Infarto del Miocardio/prevención & control , Estudios Prospectivos , Diseño de Prótesis , Factores Protectores , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/prevención & control , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Fibromuscular dysplasia (FMD) is a noninflammatory arterial disease that predominantly affects women. The arterial manifestations may include beading, stenosis, aneurysm, dissection, or tortuosity. OBJECTIVES: This study compared the frequency, location, and outcomes of FMD patients with aneurysm and/or dissection to those of patients without. METHODS: The U.S. Registry for FMD involves 12 clinical centers. This analysis included clinical history, diagnostic, and therapeutic procedure results for 921 FMD patients enrolled in the registry as of October 17, 2014. RESULTS: Aneurysm occurred in 200 patients (21.7%) and dissection in 237 patients (25.7%); in total, 384 patients (41.7%) had an aneurysm and/or a dissection by the time of FMD diagnosis. The extracranial carotid, renal, and intracranial arteries were the most common sites of aneurysm; dissection most often occurred in the extracranial carotid, vertebral, renal, and coronary arteries. FMD patients with dissection were younger at presentation (48.4 vs. 53.5 years of age, respectively; p < 0.0001) and experienced more neurological symptoms and other end-organ ischemic events than those without dissection. One-third of aneurysm patients (63 of 200) underwent therapeutic intervention for aneurysm repair. CONCLUSIONS: Patients with FMD have a high prevalence of aneurysm and/or dissection prior to or at the time of FMD diagnosis. Patients with dissection were more likely to experience ischemic events, and a significant number of patients with dissection or aneurysm underwent therapeutic procedures for these vascular events. Because of the high prevalence and associated morbidity in patients with FMD who have an aneurysm and/or dissection, it is recommended that every patient with FMD undergo one-time cross-sectional imaging from head to pelvis with computed tomographic angiography or magnetic resonance angiography.
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Aneurisma/etiología , Disección Aórtica/etiología , Displasia Fibromuscular/complicaciones , Sistema de Registros , Aneurisma/diagnóstico , Aneurisma/epidemiología , Disección Aórtica/diagnóstico , Disección Aórtica/epidemiología , Angiografía por Tomografía Computarizada , Femenino , Displasia Fibromuscular/diagnóstico , Humanos , Angiografía por Resonancia Magnética , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
Since its advent in 1991, endovascular aortic aneurysm repair (EVAR) has become a mainstay of treatment for abdominal aortic aneurysms (AAA). Studies such as the comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR 1) trial, have demonstrated the effectiveness of EVAR in reducing perioperative mortality. Technological improvements in graft design and delivery account for an increasing utilization of endovascular repair. Newer branch and fenestrated graft designs have allowed for treatment of patients with complex aortic anatomy that previously could not be treated with EVAR. Endovascular repair, while dominant, is unlikely to eliminate the need for open repair or to relegate open surgery for AAA to historical interest only. The unprecedented adoption of EVAR has led to complications and modes of failure that were not seen with open repair. The rate of failure is markedly increased when endografts are used outside of the instructions for use (IFU). The long-term durability of fenestrated and investigational branch devices remains to be established. The demand for an endovascular approach by patients and the willingness of physicians to place endografts outside the anatomic IFU criteria may have resulted in the pendulum swinging too far away from open surgical management. The consequence of reduced open aortic surgeries is a concern for both patient care as well as training for vascular surgery fellows. Vascular surgery training programs will require innovative changes in training to assure that vascular surgery trainees will have the requisite skill and experience required to competently perform open surgical repair on what will undoubtedly be some of the most complex aortic pathology.
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Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Quirúrgicos Vasculares/tendencias , Aneurisma de la Aorta Abdominal/economía , Implantación de Prótesis Vascular/métodos , Educación de Postgrado en Medicina/tendencias , Procedimientos Endovasculares/economía , Procedimientos Endovasculares/métodos , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Stents , Procedimientos Quirúrgicos Vasculares/educaciónRESUMEN
The American Board of Vascular Medicine (ABVM) was conceived through the Society for Vascular Medicine and this year will complete 10 years of certifying physicians who practice vascular medicine and endovascular medicine. The value of certification to our physicians, patients, and field cannot be understated. This paper reviews the highlights of the test development process, quality assurance measures, and management of these high stakes examinations.
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Cardiología/normas , Competencia Clínica/normas , Procedimientos Endovasculares/normas , Licencia Médica/normas , Consejos de Especialidades/normas , Procedimientos Quirúrgicos Vasculares/normas , Cardiología/historia , Evaluación Educacional , Procedimientos Endovasculares/historia , Historia del Siglo XXI , Humanos , Licencia Médica/historia , Garantía de la Calidad de Atención de Salud/normas , Indicadores de Calidad de la Atención de Salud/normas , Consejos de Especialidades/historia , Estados Unidos , Procedimientos Quirúrgicos Vasculares/historiaRESUMEN
OBJECTIVE: The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. METHODS: Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months. RESULTS: Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred. CONCLUSIONS: Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Arteria Femoral/cirugía , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Competencia Clínica , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Arteria Femoral/diagnóstico por imagen , Técnicas Hemostáticas/instrumentación , Humanos , Interpretación de Imagen Asistida por Computador , Imagenología Tridimensional , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Valor Predictivo de las Pruebas , Diseño de Prótesis , Stents , Técnicas de Sutura/instrumentación , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Estados UnidosAsunto(s)
Arteriopatías Oclusivas/cirugía , Estenosis Carotídea/cirugía , Stents , Arteria Vertebral/patología , Comités Consultivos , American Heart Association , Angiografía/métodos , Arteriopatías Oclusivas/diagnóstico por imagen , Estenosis Carotídea/diagnóstico por imagen , Endarterectomía Carotidea/normas , Femenino , Humanos , Masculino , Pronóstico , Sociedades Médicas , Resultado del Tratamiento , Ultrasonografía Doppler/métodos , Estados Unidos , Procedimientos Quirúrgicos Vasculares/normas , Arteria Vertebral/cirugíaRESUMEN
BACKGROUND: Fibromuscular dysplasia (FMD), a noninflammatory disease of medium-size arteries, may lead to stenosis, occlusion, dissection, and/or aneurysm. There has been little progress in understanding the epidemiology, pathogenesis, and outcomes since its first description in 1938. METHODS AND RESULTS: Clinical features, presenting symptoms, and vascular events are reviewed for the first 447 patients enrolled in a national FMD registry from 9 US sites. Vascular beds were imaged selectively based on clinical presentation and local practice. The majority of patients were female (91%) with a mean age at diagnosis of 51.9 (SD 13.4 years; range, 5-83 years). Hypertension, headache, and pulsatile tinnitus were the most common presenting symptoms of the disease. Self-reported family history of stroke (53.5%), aneurysm (23.5%), and sudden death (19.8%) were common, but FMD in first- or second-degree relatives was reported only in 7.3%. FMD was identified in the renal artery in 294 patients, extracranial carotid arteries in 251 patients, and vertebral arteries in 82 patients. A past or presenting history of vascular events were common: 19.2% of patients had a transient ischemic attack or stroke, 19.7% had experienced arterial dissection(s), and 17% of patients had an aneurysm(s). The most frequent indications for therapy were hypertension, aneurysm, and dissection. CONCLUSIONS: In this registry, FMD occurred primarily in middle-aged women, although it presents across the lifespan. Cerebrovascular FMD occurred as frequently as renal FMD. Although a significant proportion of FMD patients may present with a serious vascular event, many present with nonspecific symptoms and a subsequent delay in diagnosis.
Asunto(s)
Displasia Fibromuscular/diagnóstico , Displasia Fibromuscular/epidemiología , Sistema de Registros , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Displasia Fibromuscular/terapia , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Estados Unidos/epidemiología , Adulto JovenAsunto(s)
Enfermedades de las Arterias Carótidas/terapia , Arteria Carótida Externa , Enfermedades Vasculares/terapia , Arteria Vertebral , Aterosclerosis/diagnóstico , Aterosclerosis/terapia , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/terapia , Enfermedades de las Arterias Carótidas/complicaciones , Enfermedades de las Arterias Carótidas/diagnóstico , Enfermedades de las Arterias Carótidas/cirugía , Arteria Carótida Externa/anatomía & histología , Arteria Carótida Externa/cirugía , Estenosis Carotídea/diagnóstico , Estenosis Carotídea/terapia , Diabetes Mellitus/terapia , Endarterectomía Carotidea/normas , Fibrinolíticos/uso terapéutico , Humanos , Hiperlipidemias/complicaciones , Hiperlipidemias/tratamiento farmacológico , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Radiografía , Factores de Riesgo , Cese del Hábito de Fumar , Stents/normas , Enfermedades Vasculares/complicaciones , Enfermedades Vasculares/diagnóstico , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/cirugía , Arteria Vertebral/diagnóstico por imagen , Arteria Vertebral/cirugía , Disección de la Arteria Vertebral/diagnóstico , Disección de la Arteria Vertebral/terapiaRESUMEN
We describe a complex case of ascending aortic pseudoaneurysm after open repair of ascending aortic aneurysm and aortic valve replacement. Although treatment was complicated due to intra-operative graft migration, the patient was successfully treated with endovascular technique.