RESUMEN
BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.
Asunto(s)
Arterias Carótidas/cirugía , Estenosis Carotídea/cirugía , Educación de Postgrado en Medicina/métodos , Endarterectomía Carotidea/educación , Procedimientos Endovasculares/educación , Sistema de Registros , Medición de Riesgo/métodos , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Salud Global , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Stents , Factores de TiempoRESUMEN
BACKGROUND: When introduced to a new procedure, physicians improve their performance and reduce their procedural adverse event rates rapidly during the initial cases and then improvement slows, signaling that proficiency has been achieved. Determining when they have acquired proficiency has important implications for procedural innovation, education, credentialing, and patient safety. We analyzed the worldwide experience with transcarotid artery revascularization (TCAR), a hybrid approach to carotid revascularization, to identify the (1) procedural performance measures associated with clinical and technical adverse events; (2) target levels of performance measures that minimize adverse event rates; and (3) number of TCAR cases needed to achieve the target levels for the performance measures. METHODS: The patient, lesion, and physician characteristics were collected for each TCAR procedure performed by each physician worldwide in an international quality assurance database. Four procedural performance measures were recorded for each procedure: flow-reversal time, fluoroscopy time, contrast volume, and total skin-to-skin time. Composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure), occurring within 24 hours were also recorded. Correlations between each performance measure and the clinical and technical adverse event rates were computed. The inflection points in the performance measures were identified at which no further improvements occurred in the adverse event rates. Finally, the minimum number of TCAR cases required to achieve the target performance measure levels was computed. RESULTS: A total of 18,240 procedures performed by 1273 physicians were analyzed. Of the 18,240 patients, 34.9% were women and 62.5% were asymptomatic. The flow-reversal time correlated with clinical adverse events adjusted for age, sex, and symptomatic status (R2 = 0.91; P < .0001) and adjusted technical adverse events (R2 = 0.86; P < .0001). The skin-to-skin time correlated with adjusted technical adverse events (R2 = 0.92; P < .0001). A reduction in flow-reversal times to <13.1 minutes and the skin-to-skin time to <81 minutes did not translate into further improvements in the adverse event rates. A minimum of 26 TCAR cases was required to achieve the target flow-reversal time, and a minimum of 15 cases was required to achieve the target skin-to-skin time. CONCLUSIONS: The flow-reversal time and skin-to-skin time are appropriate performance measures for establishing the level of expertise of physicians as they acquire skills to perform TCAR. A target time of ≤13.1 minutes for flow-reversal and 81 minutes for skin-to-skin time minimized the adverse event rates. Familiarity with the steps involved in performing TCAR was achieved after ≥15 cases, and minimizing clinical adverse events occurred after ≥26 cases.
Asunto(s)
Estenosis Carotídea , Procedimientos Endovasculares , Accidente Cerebrovascular , Benchmarking , Arterias Carótidas/cirugía , Estenosis Carotídea/cirugía , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Curva de Aprendizaje , Masculino , Estudios Retrospectivos , Factores de Riesgo , Stents , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Simulation continues to be an important adjunct to vascular surgery training, yet the optimal implementation of simulation to complement conventional surgical training continues to evolve. This study aims to find areas for improvement in current simulation-based training of open vascular skills by characterizing the experience of vascular trainees attending a national simulation-based course. METHOD: This was a survey study conducted at the simulation course of the Annual UCLA/SVS Symposium: A Comprehensive Review and Update of What's New in Vascular and Endovascular Surgery, a national vascular surgery meeting. The survey consisted of 17 questions and was administered on paper or electronically via the Audience Response System, before the start of the course. The survey assessed the participants' experience in formal training, simulation training, and comfort with open surgical procedures. RESULTS: Between 2013 and 2018, the survey was completed by 150 participants of which 65% were vascular fellows. Only 48% of the participants had formal training in suturing and surgical instruments. Most participants had formal training in basic vascular techniques and advanced vascular operations. In 71%, simulation was incorporated into basic technique training and 60% in open surgical training. Simulation training was most commonly utilized in learning anastomotic techniques and open abdominal aortic aneurysm repair. Simulation skills were deemed translatable to the operating room by 59% of participants. Most participants were comfortable performing open vascular procedures. However, 68% of participants were uncomfortable performing an abdominal aortic aneurysm repair. CONCLUSIONS: There continues to be a significant portion of trainees who do not undergo a simulation-based education. Current simulation training is being targeted to meet trainee needs in open vascular surgery, specifically open aneurysm repair. Nonetheless, trainees continue to have doubts regarding applicability of simulation-based skills to the operating theater. Further studies investigating access to simulation education as well as its translatability are needed.
Asunto(s)
Educación de Postgrado en Medicina , Entrenamiento Simulado , Cirujanos/educación , Procedimientos Quirúrgicos Vasculares/economía , Competencia Clínica , Congresos como Asunto , Curriculum , Humanos , Aprendizaje , Encuestas y CuestionariosRESUMEN
BACKGROUND AND PURPOSE: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. METHODS: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. RESULTS: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. CONCLUSIONS: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02536378.
Asunto(s)
Arterias Carótidas/cirugía , Enfermedades de las Arterias Carótidas/cirugía , Revascularización Cerebral/métodos , Dispositivos de Protección Embólica , Procedimientos Neuroquirúrgicos/métodos , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/cirugía , Endarterectomía Carotidea , Determinación de Punto Final , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Infarto del Miocardio/cirugía , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Prospectivos , Sistema de Registros , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/cirugía , Resultado del TratamientoRESUMEN
As the practice of medicine grows in complexity, the process of defining the expertise required for the competent execution of specific procedures has also become complex. The Society for Vascular Surgery therefore constituted a task force to provide informed recommendations on the knowledge, technical skills, resources, and infrastructure required to obtain and to maintain privileges for the safe and effective performance of transcarotid artery revascularization (TCAR). The TCAR procedure is being adopted rapidly, and it is therefore important that informed guidance be available expeditiously. Formal training in the pathophysiology and diagnosis of carotid occlusive disease and all management options is essential. Appropriate diagnostic, imaging, endovascular, surgical, and monitoring infrastructure is required, as are resources to maintain quality control. Credentialing and privileging require a combination of both open surgical and endovascular skills. As such, physicians must have hospital privileges to perform carotid endarterectomy. They should attend an appropriate program for education and simulated training in TCAR. In addition, physicians must have performed ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms plus ≥5 TCAR procedures as the primary operator (pathway 1); or they may have acquired ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms and a supplement of 5 TCAR procedures under proctored guidance if they have not performed sufficient TCAR procedures (pathway 2); or a team of two physicians can collaborate, combining the endovascular and surgical requirements plus at least 5 TCAR procedures under proctored guidance (pathway 3).
Asunto(s)
Competencia Clínica/normas , Habilitación Profesional/normas , Educación de Postgrado en Medicina/normas , Endarterectomía Carotidea/educación , Procedimientos Endovasculares/educación , Cirujanos/educación , Consenso , Endarterectomía Carotidea/normas , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/normas , Humanos , StentsRESUMEN
OBJECTIVE: Endovascular treatment has largely replaced open reconstruction of proximal brachiocephalic and left common carotid ostial arterial stenoses. The objective of this study was to report the technical feasibility and safety of a flow-based embolic protection system in stenting of single and tandem stenotic lesions of supra-aortic arch vessels. METHODS: All cases used flow-based neuroprotection by the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif). Case specifics, such as the stents used, the details of flow-based neuroprotection, the order in which lesions were treated, and the case-specific exceptions, are detailed in the body of the publication. The primary end point of this study was the occurrence of stroke or transient ischemic attack. RESULTS: Sixteen patients (12 women) with an average age of 68 years (range, 54-83 years) underwent endovascular stenting to treat single (11 patients) or tandem (5 patients) stenotic lesions of supra-aortic arch vessels. A total of 21 lesions were treated: 7 in the innominate artery, 1 in the right common carotid artery, 8 in the left common carotid artery, and 5 in the internal carotid artery (tandem cases). Eleven patients (69%) were symptomatic, and the stenoses of the five asymptomatic patients were identified during routine workup for comorbidities. Technical success was obtained in all cases. There were no strokes or transient ischemic attacks during the 30 days after the procedure. Minor complications included a minor wound dehiscence that healed secondarily without sequelae and a hematoma at the neck incision that resolved spontaneously without further intervention. CONCLUSIONS: The use of a transcarotid retrograde approach with flow-based neuroprotection is technically feasible for the endovascular stenting of single and tandem stenotic lesions of the supra-aortic arch vessels. These data further support the advantages of a transcarotid approach and flow-based neuroprotection to minimize the risk of intraoperative complications and embolic events during and after the procedure.
Asunto(s)
Arteriopatías Oclusivas/terapia , Tronco Braquiocefálico , Estenosis Carotídea/terapia , Circulación Cerebrovascular , Dispositivos de Protección Embólica , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Arteriopatías Oclusivas/complicaciones , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Tronco Braquiocefálico/diagnóstico por imagen , Tronco Braquiocefálico/fisiopatología , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/fisiopatología , Procedimientos Endovasculares/efectos adversos , Estudios de Factibilidad , Femenino , Humanos , Ataque Isquémico Transitorio/etiología , Ataque Isquémico Transitorio/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. METHODS: Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. RESULTS: Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately. CONCLUSIONS: Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.).
Asunto(s)
Estenosis Carotídea/terapia , Endarterectomía Carotidea , Infarto del Miocardio/epidemiología , Stents , Accidente Cerebrovascular/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia , Estenosis Carotídea/mortalidad , Estenosis Carotídea/cirugía , Femenino , Estudios de Seguimiento , Humanos , Esperanza de Vida , Masculino , Persona de Mediana Edad , Riesgo , Accidente Cerebrovascular/prevención & controlRESUMEN
BACKGROUND: Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were always asymptomatic (AA). METHODS: We compared the periprocedural and 4-year risks of PS vs AA patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty. Proportional hazards models adjusting for age, sex, and treatment were used to assess the risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death at 4 years (any S+D within the periprocedural period and ipsilateral stroke out to 4 years) and the primary end point at 4 years (any stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4 years). Analysis was performed pooling the CEA-treated and CAS-treated patients, and separately for each treatment. RESULTS: Of 1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77 (7%) were PS. There was no difference in risk when comparing the AA and PS cohorts in the pooled CAS+CEA population for periprocedural S+D (2.0% vs 1.3%), S+D at 4 years (3.6% vs 3.2%), or the primary end point (5.2% vs 5.8%). There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately. CONCLUSIONS: In CREST, only a small minority of asymptomatic patients had previous ipsilateral symptoms. The outcomes of periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4 years, and the primary end point did not differ for AA patients compared with PS patients.
Asunto(s)
Estenosis Carotídea/terapia , Endarterectomía Carotidea , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Enfermedades Asintomáticas , Estenosis Carotídea/complicaciones , Estenosis Carotídea/mortalidad , Estenosis Carotídea/cirugía , Endarterectomía Carotidea/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate any intraoperative electroencephalographic (EEG) changes accompanying reversed flow with the ENROUTE Transcarotid Neuroprotection System during transcarotid artery revascularization (TCAR). METHODS: A post hoc analysis was performed of the first 81 consecutive lead-in patients (mean age 72.8±8 years; 61 men) enrolled in the ROADSTER 1 trial at 5 participating institutions. All patients had high-grade carotid artery stenosis [53 (59.3%) left sided; 12 (14.8%) contralateral occlusions] and high-risk criteria for carotid endarterectomy. A third had symptoms of either stroke (13, 16.0%) or transient ischemic attack (14, 17.3%). This subset of early patients underwent EEG monitoring to detect any cerebral changes during reversed flow as an added safety measure mandated by the ROADSTER 1 trial protocol. RESULTS: Mean flow reversal time was 12.9±8.2 minutes. The goal mean arterial pressure during reversed flow was 100 mm Hg, but 7 (8.6%) patients suffered hypotension. One (1.2%) patient had slight EEG changes secondary to blood pressure fluctuation; these resolved with blood pressure elevation. No other EEG changes were noted. One (1.2%) patient had a postoperative stroke and another (1.2%) had postoperative myocardial infarction (MI), leading to 2.5% 30-day stroke/death/MI rate. CONCLUSION: Temporary reversal of blood flow during TCAR is a safe maneuver and does not cause cerebral ischemia in the vast majority of patients, including those with contralateral carotid occlusion. Carotid stenting performed with reversed blood flow mitigates cerebral embolization and periprocedural stroke without concern for brain ischemia.
Asunto(s)
Ondas Encefálicas , Encéfalo/fisiopatología , Estenosis Carotídea/cirugía , Circulación Cerebrovascular , Dispositivos de Protección Embólica , Procedimientos Endovasculares/instrumentación , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/complicaciones , Estenosis Carotídea/fisiopatología , Ensayos Clínicos como Asunto , Electroencefalografía , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Monitorización Neurofisiológica Intraoperatoria/métodos , Ataque Isquémico Transitorio/etiología , Ataque Isquémico Transitorio/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated a higher periprocedural stroke and death (S+D) rate among patients randomized to carotid artery stenting (CAS) than to carotid endarterectomy (CEA). Herein, we seek factors that affect the CAS-CEA treatment differences and potentially to identify a subgroup of patients for whom CAS and CEA have equivalent periprocedural S+D risk. METHODS: Patient and arterial characteristics were assessed as effect modifiers of the CAS-CEA treatment difference in 2502 patients by the addition of factor-by-treatment interaction terms to a logistic regression model. RESULTS: Lesion length and lesions that were contiguous or were sequential and noncontiguous extending remote from the bulb were identified as influencing the CAS-to-CEA S+D treatment difference. For those with longer lesion length (≥12.85 mm), the risk of CAS was higher than that of CEA (odds ratio [OR], 3.42; 95% confidence interval [CI], 1.19-9.78). Among patients with sequential or remote lesions extending beyond the bulb, the risk for S+D was higher for CAS relative to CEA (OR, 9.01; 95% CI, 1.20-67.8). For the 37% of patients with lesions that were both short and contiguous, the odds of S+D in those treated with CAS was nonsignificantly 28% lower than for CEA (OR, 0.72; 95% CI, 0.21-2.46). CONCLUSIONS: The higher S+D risk for those treated with CAS appears to be largely isolated to those with longer lesion length and/or those with sequential and remote lesions. In the absence of those lesion characteristics, CAS appears to be as safe as CEA with regard to periprocedural risk of S+D.
Asunto(s)
Angioplastia/efectos adversos , Angioplastia/instrumentación , Arterias Carótidas/diagnóstico por imagen , Arterias Carótidas/cirugía , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Endarterectomía Carotidea/efectos adversos , Stents , Accidente Cerebrovascular/etiología , Anciano , Angioplastia/mortalidad , Estenosis Carotídea/mortalidad , Estenosis Carotídea/cirugía , Endarterectomía Carotidea/mortalidad , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Selección de Paciente , Valor Predictivo de las Pruebas , Radiografía , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Carotid stent and/or angioplasty (CAS) via the transfemoral route with distal protection carries twice the risk of stroke and/or death when compared with carotid endarterectomy (CEA) in multiple randomized trials. Potential causes for this include disadvantaged aortic arch anatomy and the need to traverse the lesion to place a distal protection device. This report describes the technique and our experience with direct CAS using flow reversal for embolic protection. METHODS: University of California at Los Angeles (UCLA) division of Vascular and Endovascular surgery was a participant in the multi-institutional Roadster Trial of high-risk patients. We are reporting on our experience with 8 patients who met high-risk criteria. Using a small supraclavicular cutdown, the Michi sheath from Silk Road Medical was inserted into the common carotid artery. This provides a working channel for internal CAS as well as a side port to reverse and divert blood flow to the femoral vein, for embolic protection. All patients qualified as medically high risk because of a combination of factors including advanced age, smoking history, hypertension, diabetes, coronary artery disease, or hostile neck anatomy. RESULTS: All 8 patients had 3 or more risk factors including age >75 years (6 of 8), smoking (6 of 8), hypertension (7 of 8), overt coronary artery disease (4 of 8), diabetes (2 of 8), and chronic obstructive pulmonary disease (1 of 8). All stenoses were in the 80-99% category, and all were asymptomatic. All patients tolerated temporary clamping with flow reversal with no electroencephalogram changes. There were no deaths, strokes, transient ischemic attacks, or myocardial infarctions. All patients were discharged on the first postoperative day. Follow-up ranged from 7 to 21 months. One patient developed in-stent restenosis (asymptomatic). CONCLUSIONS: Direct CAS with flow reversal appears to be a safe, less invasive alternative to CEA.
Asunto(s)
Angioplastia de Balón/instrumentación , Estenosis Carotídea/terapia , Dispositivos de Protección Embólica , Embolia Intracraneal/prevención & control , Stents , Dispositivos de Acceso Vascular , Anciano , Angioplastia de Balón/efectos adversos , Enfermedades Asintomáticas , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/fisiopatología , Circulación Cerebrovascular , Diseño de Equipo , Femenino , Humanos , Embolia Intracraneal/etiología , Embolia Intracraneal/fisiopatología , Los Angeles , Masculino , Flujo Sanguíneo Regional , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
The presence of a nonrecurrent laryngeal nerve (NRLN) during carotid endarterectomy (CEA) may significantly limit the exposure of the surgical field during this operation. Although its reported incidence is rare, NRLN typically overlies the carotid bifurcation and failure to recognize this anatomic variation increases the risk of NRLN injury. A retrospective chart review of all patients who underwent CEA for hemodynamically significant extracranial carotid stenosis between January 2005 and December 2014 was performed. All patients with NRLN encountered intraoperatively were identified. Clinical outcomes, surgical techniques, and complications were reviewed and reported. Four left-sided NRLN were identified and 4 were right sided. No cranial nerve deficits or injuries occurred after CEA in patients where NRLN was encountered. Two distinct surgical techniques were used to manage patients with NRLN and they are discussed in detail.
Asunto(s)
Arteria Carótida Común/cirugía , Estenosis Carotídea/cirugía , Disección , Endarterectomía Carotidea/métodos , Nervios Laríngeos/cirugía , Anciano , Arteria Carótida Común/diagnóstico por imagen , Arteria Carótida Común/fisiopatología , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/fisiopatología , Endarterectomía Carotidea/efectos adversos , Hemodinámica , Humanos , Nervios Laríngeos/anomalías , Masculino , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Nervio Vago/cirugíaRESUMEN
BACKGROUND AND PURPOSE: The purpose is to determine whether patching during carotid endarterectomy (CEA) affects the perioperative and long-term risks of restenosis, stroke, death, and myocardial infarction as compared with primary closure. METHODS: We identified all patients who were randomized and underwent CEA in Carotid Revascularization Endarterectomy versus Stenting Trial. CEA patients who received a patch were compared with patients who underwent CEA with primary closure without a patch. We compared periprocedural and 4-year event rates, 2-year restenosis rates, and rates of reoperation between the 2 groups. We further analyzed results by surgeon specialty. RESULTS: There were 1151 patients who underwent CEA (753 [65%] with patch and 329 [29%] with primary closure). We excluded 44 patients who underwent eversion CEA and 25 patients missing CEA data (5%). Patch use differed by surgeon specialty: 89% of vascular surgeons, 6% of neurosurgeons, and 76% of thoracic surgeons patched. Comparing patients who received a patch versus those who did not, there was a significant reduction in the 2-year risk of restenosis, and this persisted after adjustment by surgeon specialty (hazard ratio, 0.35; 95% confidence interval, 0.16-0.74; P=0.006). There were no significant differences in the rates of periprocedural stroke and death (hazard ratio, 1.58; 95% confidence interval, 0.33-7.58; P=0.57), in immediate reoperation (hazard ratio, 0.6; 95% confidence interval, 0.16-2.27; P=0.45), or in the 4-year risk of ipsilateral stroke (hazard ratio, 1.23; 95% confidence interval, 0.42-3.63; P=0.71). CONCLUSIONS: Patch closure in CEA is associated with reduction in restenosis although it is not associated with improved clinical outcomes. Thus, more widespread use of patching should be considered to improve long-term durability. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
Asunto(s)
Arterias Carótidas/patología , Endarterectomía Carotidea/métodos , Enfermedades de las Válvulas Cardíacas/cirugía , Anciano , Arterias Carótidas/cirugía , Estenosis Carotídea/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/prevención & control , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Riesgo , Stents , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates. METHODS: Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed. RESULTS: For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3. CONCLUSIONS: The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
Asunto(s)
Estenosis Carotídea/diagnóstico , Estenosis Carotídea/cirugía , Revascularización Cerebral/tendencias , Endarterectomía Carotidea/tendencias , Atención Perioperativa/tendencias , Stents/tendencias , Anciano , Anciano de 80 o más Años , Revascularización Cerebral/métodos , Endarterectomía Carotidea/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Perioperativa/métodos , Factores de Tiempo , Resultado del TratamientoAsunto(s)
Estenosis Carotídea , Disfunción Cognitiva , Accidentes por Caídas , Anciano , Algoritmos , Encéfalo , HumanosRESUMEN
The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of stroke among individuals who have not previously experienced a stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches to atherosclerotic disease of the cervicocephalic circulation, and antithrombotic treatments for preventing thrombotic and thromboembolic stroke. Further recommendations are provided for genetic and pharmacogenetic testing and for the prevention of stroke in a variety of other specific circumstances, including sickle cell disease and patent foramen ovale.
Asunto(s)
Prevención Primaria/métodos , Accidente Cerebrovascular/prevención & control , American Heart Association , Medicina Basada en la Evidencia , Humanos , Factores de Riesgo , Estados UnidosRESUMEN
OBJECTIVE: Patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) had duplex ultrasound (DU) scans prior to treatment and during follow-up to document the severity of carotid disease and the anatomic outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). An ultrasound core laboratory (UCL) reviewed DU data from the clinical sites. This analysis was done to determine the agreement between site-reported and UCL-verified DU velocity measurements. METHODS: Clinical site DU worksheets, B-mode images, and Doppler velocity waveforms for the treated carotid arteries were reviewed at the UCL. The highest internal carotid artery peak systolic velocity (PSV) and associated Doppler angle were verified. If the angle was misaligned by >3 degrees, it was remeasured at the UCL and the PSV was recalculated. Agreement for PSV was defined as site-reported PSV within ± 5% of UCL-verified PSV. Transcription errors were corrected by the UCL but were not considered as disagreements. Follow-up analysis was limited to patients who received the assigned treatment. RESULTS: The UCL reviewed 1702 prior-to-treatment and 1743 12-month follow-up DU scans (873 CEA, 870 CAS) from 111 clinical sites. Site-reported and UCL-verified PSV agreed in 1124 (66%) of the prior-to-treatment scans and 1200 (69%) of the follow-up scans. In those cases with a disagreement, Doppler angle accounted for disagreement in 339 (59%) of the prior-to-treatment scans and 277 (51%) of the follow-up scans. Based on a threshold PSV for ≥ 70% stenosis of ≥ 230 cm/s on the prior-to-treatment scans and ≥ 300 cm/s on the follow-up scans, UCL review resulted in reclassification of stenosis severity in 75 (4.4%) of the prior-to-treatment scans and 13 (0.75%) of the follow-up scans. There is evidence that the proportion of reclassification at follow-up was greater for CAS (10 scans; 1.2%) than for CEA (three scans; 0.34%) (P = .057). CONCLUSIONS: There was a high rate of agreement between site-reported and UCL-verified DU results in CREST, and UCL review was associated with a low rate of stenosis reclassification. However, angle alignment errors were quite common and prompted recalculation of velocity in 20% of prior-to-treatment scans and 18% of follow-up scans. The use of a UCL provides a uniform process for DU interpretation and can identify sources of error and suggest technical improvements for future studies.
Asunto(s)
Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Endarterectomía Carotidea , Procedimientos Endovasculares/instrumentación , Stents , Ultrasonografía Doppler Dúplex , Anciano , Velocidad del Flujo Sanguíneo , Estenosis Carotídea/fisiopatología , Distribución de Chi-Cuadrado , Endarterectomía Carotidea/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Ensayos de Aptitud de Laboratorios , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Estudios Prospectivos , Recurrencia , Flujo Sanguíneo Regional , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke. METHODS: We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. RESULTS: For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85). CONCLUSIONS: Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)