RESUMEN
INTRODUCTION: V-Healthy (Center for Vascular Awareness Inc, Latham NY) is a grassroots vascular health education and awareness campaign that educates high school students about the importance of the vascular disease risks they face today and its impact decades later, and empowers health care professionals and schoolteachers to lead vascular health education in their communities. This study evaluates the impact of the V-Healthy initiative in empowering and educating adolescents about the implications of vascular disease risk factors and in creating a blueprint for a community outreach program that focuses on vascular health and disease education and awareness. METHODS: The V-Healthy program is an initiative that connects community vascular health care professionals and educators with high school students, for a day of vascular health education. The V-Healthy program curriculum is provided in two distinct stages. Stage I consists of didactic vascular health education and takes place in the classroom for the duration of one class period (40-50 minutes). The class period is divided into four sessions including a PowerPoint presentation to teach the impact of vascular disease risk factors (hypertension, diabetes, hyperlipidemia, smoking/vaping, and genetics) on the development of peripheral arterial disease, venous disease, aortic disease, and stroke, and three hands-on sessions that introduce students to vascular innovation and technology, vascular patients, and the diagnosis of a vascular disease risk factor such as hypertension. Stage I concludes with a student questionnaire aimed to gauge students' retention of the material and attitude toward the program. Stage II offers students (with parental consent) the opportunity to participate in the "Diagnosing Hypertension" study. Students were provided automated blood pressure monitors and taught to measure blood pressure in their parents daily for 1 week. Findings are recorded in designated blood pressure logs, which are then categorized using the 2018 American Heart Association blood pressure categorization system: normal (<120/<80), elevated (120-129/<80), stage I (130-139/80-89), or stage II (≥140/≥90). No identifiable student or guardian information is collected. RESULTS: Over 3 years, more than 12,000 students participated in the V-Healthy program and 5120 students completed student surveys, which indicated that 97% improved their understanding of vascular health, >93% could identify vascular disease risk factors, 84% wanted to educate their families, and 76% wanted more vascular health education. A total of 1064 students participated in the "Diagnosing Hypertension" study and diagnosed hypertension in 73% of their parents: 34% for stage I hypertension and 39% for stage II hypertension. Over a 3-year period of this study, the number of schools participating increased 20-fold (from 1 to 20), the number of volunteer vascular health professionals and schoolteachers increased 13-fold (from 16 to 210), and our ability to connect with and impact high school students grew 15-fold (from 800 to over 12,000). CONCLUSIONS: V-Healthy is the first program to connect over 12,000 students to vascular health professionals in their communities to empower them to diagnose and understand vascular disease risk factors and their implications on the development of vascular disease. Furthermore, the V-Healthy program has displayed substantial growth over a 3-year period in impacting high school students and vascular health care professionals, and has the potential to be used as a blueprint for community-based vascular health education and awareness initiatives.
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Educación en Salud , Hipertensión , Adolescente , Humanos , Estudiantes , Curriculum , Hipertensión/diagnóstico , Factores de RiesgoRESUMEN
In the present study, suspended sediment load (SSL), sediment yield and erosion rates in Pindari Glacier basin (PGB) and Kafni Glacier basin (KGB) have been estimated using daily discharge and suspended sediment concentration (SSC) data for three ablation seasons (2017-2019). For this, one meteorological observatory and two gauging sites have been established at Dwali (confluence point), and water samples have been collected twice in a day for high flow period (July to September) and daily for lean period (May, June and October). An area-velocity method and stage-discharge relationship has been established to convert water level into discharge (m3 s-1). For estimating SSC (mg/l), collected water samples have been filtered, dried, analysed and confirmed with an automatic suspended solid indicator. Further, SSL, sediment yield and erosion rates have been computed using SSC data. The results reveal that mean annual discharge in PGB (35.06 m3 s-1) has been found approximately 1.7 times higher than KGB (20.47 m3 s-1). The average SSC and SSL in PGB have been observed about 396.07 mg/l and 1928.34 tonnes, and in KGB, it is about 359.67 mg/l and 1040.26 tonnes, respectively. The SSC and SSL have followed the pattern of discharge. A significant correlation of SSC and SSL has been found with discharge in both the glacierized basins (p < 0.01). Interestingly, average annual sediment yield in PGB (3196.53 t/km2/yr) and KGB (3087.23 t/km2/yr) have been found almost identical. Likewise, the erosion rates in PGB and KGB have been witnessed about 1.18 and 1.14 mm/yr, respectively. Sediment yield and erosion rates in PGB and KGB have been found in correspondence with other basins of Central Himalaya. These findings will be beneficial for engineers and water resource managers in the management of water resources and hydropower projects in high-altitude areas and in the planning and designing of water structures (dams, reservoirs etc.) in downstream areas.
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Monitoreo del Ambiente , Sedimentos Geológicos , Sedimentos Geológicos/análisis , Monitoreo del Ambiente/métodos , Agua/análisis , Recursos Hídricos , IndiaRESUMEN
PURPOSE: We hypothesized that a pain management prescribing tool embedded in the electronic health record system of a multihospital health care system would decrease prescription opioids for postoperative pain by hand, orthopedic, plastic, and spine surgeons. METHODS: A prescribing tool for postoperative pain was designed for hand, orthopedic, plastic, and spine surgeons and implemented into electronic discharge order sets in a 10-hospital health care system. Stakeholders were educated on tool use in person and/or by email on 2 occasions. A dashboard was created to monitor opioid pill quantities and morphine milligram equivalents (MMEs) prescribed. Overall compliance with the suggested opioid amounts was assessed for 20 months after tool implementation. A subgroup of 6 hand surgeons, one of whom was instrumental in designing the tool, were evaluated for MMEs prescribed, opioid refills, patient emergency room visits, and patient readmissions within 30 days after discharge. Comparisons in this subgroup were made from 12 months before to 15 months after tool implementation. RESULTS: The mean system-wide compliance with the suggested opioid pill quantities and MMEs prescribed in all 4 specialties improved by less than 5%. In the subgroup of hand surgeons, 5 of whom championed tool use, prescribed MMEs decreased by 10% during each of the 4 quarters before launching the tool and contracted an additional 26% in the first quarter after tool implementation. Opioid refills held steady at 5%, and there were no emergency room visits or readmissions within 30 days after discharge in this patient subgroup. CONCLUSIONS: The prescribing tool had a negligible impact on system-wide compliance with suggested prescription opioid pill quantities and MMEs. In a small group of surgeons who championed the use of the tool, there was a significant and sustained decline in MMEs prescribed without adversely impacting patient refills, emergency room visits, or readmissions. CLINICAL RELEVANCE: An electronic prescribing tool to assist surgeons in lowering opioid prescription pill quantities and MMEs may have a negligible impact on prescribing behavior in a multihospital health care system.
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Analgésicos Opioides , Registros Electrónicos de Salud , Humanos , Analgésicos Opioides/uso terapéutico , Plásticos/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Prescripciones de Medicamentos , Atención a la Salud , Pautas de la Práctica en MedicinaRESUMEN
OBJECTIVE: The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. METHODS: In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. RESULTS: A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). CONCLUSIONS: The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Diseño de Prótesis , Reoperación , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: The objective of this study was to report the 5-year outcomes of the Food and Drug Administration investigational device exemption clinical trial of endovascular aneurysm repair (EVAR) with the Ovation stent graft (Endologix, Irvine, Calif) for elective treatment of abdominal aortic aneurysm (AAA). METHODS: The study comprised 161 patients who underwent EVAR as part of the prospective, international, multicenter pivotal Ovation stent graft trial. The main inclusion criteria were AAA diameter ≥5 cm, proximal neck length ≥7 mm, neck angulation ≤60 degrees, and bilateral iliac fixation length ≥10 mm. The primary end point was a composite outcome of primary clinical success at 5 years. Primary clinical success was defined in accordance with the Society for Vascular Surgery guidelines as successful aneurysm exclusion without aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion, aneurysm rupture, graft migration, or conversion to open repair. Secondary end points included freedom from reintervention, all-cause mortality, and aneurysm-related mortality. RESULTS: Patients were predominantly male (87.6%) and elderly with a mean age of 73 ± 7.7 years; 66 patients (41%) had challenging anatomy and would be considered outside the instructions for use with other stent grafts, 26 (16.2%) had a proximal neck length <10 mm, and 53 (33%) had a minimum access vessel diameter <6 mm. Technical success was 100%. Of 126 surviving patients, 84 (66.7%) completed 5-year follow-up. The 5-year primary clinical success rate was 78%, aneurysm-related mortality was 1% (one patient), and all-cause mortality was 25%. The AAA-related death resulted from AAA post-EVAR rupture at 49 months in a patient who refused treatment for a type IB endoleak. Freedom from type I or type III endoleak was 95.1%. Freedom from secondary interventions was 80.2%. Most of the reinterventions were performed for type II endoleak (24 [63.1%]) or for limb thrombosis or stenosis (7 [18.4%]). There was no graft migration. None of the patients required open conversion. CONCLUSIONS: Five-year results from the Ovation pivotal and continued access investigational device exemption trials demonstrate excellent long-term durability of this endograft despite that 41% of patients had anatomy unfit for other stent grafts. There were no migrations or conversions to open repair and 99% freedom from aneurysm-related mortality. These results suggest a less invasive on-label endovascular option for patients with challenging anatomy who may otherwise require hybrid or open repair.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Endofuga/epidemiología , Procedimientos Endovasculares/instrumentación , Anciano , Anciano de 80 o más Años , Aorta Abdominal/anatomía & histología , Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aortografía , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Quirúrgicos Electivos/efectos adversos , Procedimientos Quirúrgicos Electivos/instrumentación , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Prospectivos , Diseño de Prótesis , Stents/efectos adversos , Terapias en Investigación/efectos adversos , Terapias en Investigación/instrumentaciónRESUMEN
OBJECTIVE: We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes. METHODS: This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial. RESULTS: Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymptomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin. CONCLUSIONS: TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach's circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA.
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Enfermedades de las Arterias Carótidas/terapia , Dispositivos de Protección Embólica , Procedimientos Endovasculares/instrumentación , Embolia Intracraneal/prevención & control , Stents , Accidente Cerebrovascular/prevención & control , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades de las Arterias Carótidas/epidemiología , Enfermedades de las Arterias Carótidas/fisiopatología , Circulación Cerebrovascular , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Incidencia , Embolia Intracraneal/epidemiología , Embolia Intracraneal/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Recurrencia , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. METHODS: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. RESULTS: In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. CONCLUSIONS: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.
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Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Técnicas de Sutura/instrumentación , Suturas , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Técnicas de Sutura/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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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
PURPOSE: To investigate the current readability of online information pertaining to hip arthroscopy. METHODS: The terms "hip arthroscopy" and "hip scope" were entered into the advanced search functions of Google, Yahoo!, and Bing on March 25, 2017, and results from the first 3 pages were analyzed. Results were required to be unique, accessible websites with information about hip arthroscopy conveyed primarily via analyzable text. Two reviewers applied inclusion criteria to the initial 97 results, discussing to reach consensus in cases of disagreement. Overall, 60 unique results were reviewed with 48 meeting inclusion criteria. Websites were categorized as physician-sponsored, academic, commercial, governmental and nonprofit organization (NPO), or unspecified. Readability was measured via 6 different indices: the Flesch-Kincaid grade level (FKGL), Flesch Reading Ease (FRE), Gunning Fog Score, SMOG Index, Coleman-Liau Index (CLI), and Automated Readability Index (ARI) along with an average grade level and readability classification score. RESULTS: Forty-eight unique websites were assessed for readability, with physician-sponsored webpages composing the majority (47.92%) followed by academic sources (35.42%). The webpages' average grade level, incorporating information from all 6 metrics, was 12.79 ± 1.98. CONCLUSIONS: The current readability of online information pertaining to hip arthroscopy is at an inappropriately high reading level compared with the sixth-grade level recommended by the American Medical Association and National Institutes of Health, thus introducing significant barriers to understanding for many patients. Online materials should be edited to reduce word and sentence length and complexity, use simpler terms, and minimize use of passive voice to facilitate patient knowledge acquisition and understanding of online information about hip arthroscopy. CLINICAL RELEVANCE: This study shows that the current readability of online information on hip arthroscopy exceeds the suggested sixth-grade reading level. It also emphasizes the need for simplifying written materials and offers specific suggestions on doing so to increase accessibility of information for patients.
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Artroscopía , Alfabetización en Salud , Articulación de la Cadera , Evaluación de Resultado en la Atención de Salud , Humanos , Internet , Estados UnidosRESUMEN
BACKGROUND: Glenoid component loosening after total shoulder arthroplasty (TSA) may occur if retroversion is not corrected to <10°. However, accurately measuring postoperative glenoid component version has been difficult without postoperative computed tomography (CT), adding cost and radiation exposure outside of the standard radiographic follow-up. We present a new method to assess glenoid component version after TSA using only routine preoperative CT and postoperative radiographs (x-rays). METHODS: Preoperative glenoid version was measured using established methods with an axillary x-ray, 2-dimensional CT, and Glenosys software (Imascap, Plouzané, France). Postoperative glenoid component version and inclination were measured for 61 TSA patients using Mimics software (Materialise, Leuven, Belgium) with preoperative CT and postoperative x-rays. Four patients also had postoperative CTs. Glenoid implantation and imaging were performed on 14 cadavers, allowing validation of results against the gold standard postoperative CT glenoid retroversion measurement. RESULTS: Compared with the gold standard, retroversion and inclination measurement error was 2° ± 1° and 2° ± 1°, respectively. Average postoperative version correction was 6° ± 7°, with 35 of 61 patients (57%) corrected to <10° of retroversion. Correlation between preoperative version measurement methods was good to very good, except on the axillary x-ray. Patients not corrected to <10° of retroversion had significantly higher preoperative retroversion (14° ± 6°) than those corrected to <10° (6° ± 7°; P < .00001). CONCLUSIONS: Glenoid component retroversion after TSA can be accurately measured with a method using only routine preoperative CT and postoperative x-rays, validated to within 1.9° of the gold standard postoperative CT measurement. Future studies using this method may correlate glenoid retroversion correction with glenoid component longevity to help optimize shoulder arthroplasty outcomes.
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Artroplastía de Reemplazo de Hombro/efectos adversos , Inestabilidad de la Articulación/etiología , Complicaciones Posoperatorias/etiología , Falla de Prótesis , Escápula/diagnóstico por imagen , Prótesis de Hombro , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Imagenología Tridimensional , Inestabilidad de la Articulación/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico por imagen , Estudios Retrospectivos , Programas Informáticos , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
BACKGROUND: The number of ruptured abdominal aortic aneurysm (r-AAA) patients who are treated by endovascular means is increasing as ruptured endovascular aneurysm repair (r-EVAR) enters the mainstream. However, even today, data on the incidence and behavior of endoleaks after r-EVAR are scarce. This study analyzed whether endoleaks behave differently after EVAR for rupture vs elective AAA repair. METHODS: From 2002 to 2013, there were 2052 patients who underwent EVAR for treatment of rupture (n = 166 [8.1%]) and elective repair (n = 1886 [91.9%]) of infrarenal AAA. Follow-up included computed tomography angiography at 1 month, at 6 months, and yearly thereafter. All type I and type III endoleaks were treated at the time of or shortly after the diagnosis. Persistent type II endoleaks at >6 months after EVAR without a decrease in AAA sac underwent translumbar or transfemoral embolization procedures. Data were prospectively collected in a vascular database. RESULTS: During a mean follow-up of 30 months, patients had a significantly lower incidence of type II endoleaks after r-EVAR compared with elective endovascular aneurysm repair (e-EVAR; n = 15 [9.0%] vs n = 380 [20.2%]; P < .01). Although the incidence of type I endoleaks is similar after r-EVAR (n = 9 [5.4%] and e-EVAR (n = 83 [4.4%]; P = .68), the r-EVAR patients required stent graft explantation more frequently (n = 9 [5.4%] vs n = 20 [1.1%]; P < .01). Whereas the need for secondary intervention was comparable in both r-EVAR (n = 33 [19.9%]) and e-EVAR (n = 439 [23.3%]; P = .37) groups, patients undergoing percutaneous embolization procedures trended toward significance between the two groups (n = 11 [6.6%] vs n = 216 [11.5%]; P = .06) with endoleaks. CONCLUSIONS: Compared with e-EVAR, patients who undergo r-EVAR experience a similar incidence of type I endoleaks and a significantly lower incidence of type II endoleaks. The endoleaks in both e-EVAR and r-EVAR patients can frequently be managed by endovascular means. However, r-EVAR patients with type I and type II endoleaks are at a significantly higher risk for stent graft explantation.
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Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/cirugía , Implantación de Prótesis Vascular/efectos adversos , Endofuga/epidemiología , Procedimientos Endovasculares/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/mortalidad , Aortografía/métodos , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Comorbilidad , Angiografía por Tomografía Computarizada , Bases de Datos Factuales , Remoción de Dispositivos , Procedimientos Quirúrgicos Electivos , Embolización Terapéutica , Urgencias Médicas , Endofuga/diagnóstico por imagen , Endofuga/mortalidad , Endofuga/terapia , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , New York/epidemiología , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
CONDENSED ABSTRACT: The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed. SUBJECT CODE: Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined. METHODS: Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates. RESULTS: About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates ranged from 9.2% to 19.7%. Multivariable analysis demonstrated that baseline ABI and baseline target lesion length predicted both primary patency and TLR. Further, these two variables interacted significantly to better predict TLR outcomes when used in combination. CONCLUSION: The 12-month clinical effectiveness of bare nitinol stents to treat patients with symptomatic femoropopliteal PAD is acceptable and is impacted by clinical and lesion-specific characteristics. These data provide an important and useful benchmark to compare the clinical benefit of emerging endovascular PAD therapies. © 2017 Wiley Periodicals, Inc.
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Aleaciones , Procedimientos Endovasculares/instrumentación , Arteria Femoral , Claudicación Intermitente/terapia , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Stents , Anciano , Índice Tobillo Braquial , Ensayos Clínicos como Asunto , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Claudicación Intermitente/diagnóstico por imagen , Claudicación Intermitente/fisiopatología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. METHODS: Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis. RESULTS: During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424). CONCLUSIONS: Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has significantly better primary patency than CFA atherectomy and PTA combined. CFA atherectomy + PTA has significantly better primary patency than CFA PTA-only at midterm, especially in patients with claudication. Future randomized controlled trials are warranted.
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Angioplastia de Balón/instrumentación , Aterectomía , Arteria Femoral , Enfermedad Arterial Periférica/terapia , Stents , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Aterectomía/efectos adversos , Aterectomía/mortalidad , Bases de Datos Factuales , Estudios de Factibilidad , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Selección de Paciente , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVES: EndoAnchors have been used to address proximal aortic neck complications including type Ia endoleaks and endograft migration after endovascular aortic aneurysm repair (EVAR). METHODS: The study population included 100 patients with one-year follow-up in the ANCHOR study. A primary cohort (N = 73) comprised patients who underwent EndoAnchor implantation at the time of an initial EVAR and a Revision cohort (N = 27) included patients treated remote from EVAR. A hostile neck was defined for neck length <10 mm, neck diameter >28 mm, angulation >60°, conical configuration or significant mural thrombus or calcium. RESULTS: Baseline anatomy included neck length of 17 ± 14 mm, diameter of 27 ± 5 mm, and angulation of 35 ± 18°; 83% of patients had hostile necks. Over 18 ± 4 months of clinical follow-up, six patients (6%) underwent aneurysm-related reinterventions. There were no aneurysm ruptures. Over 13 ± 2 months of imaging follow-up, freedom from type Ia endoleak was 95% in the Primary Arm and 77% in the Revision Arm (P = .006). Aneurysm sacs regressed > 5 mm within one year in 45% of the Primary cases and in 25% of the Revisions. Aneurysm expansion > 5 mm occurred in one revision patient. CONCLUSION: Despite a high frequency of hostile neck anatomy, proximal neck complications were relatively infrequent after EndoAnchor use.
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Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/prevención & control , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/prevención & control , Stents , Técnicas de Sutura/instrumentación , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Europa (Continente) , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Anclas para Sutura , Técnicas de Sutura/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: There is abundant evidence linking hostile proximal aortic neck anatomy to poor outcome after endovascular aortic aneurysm repair (EVAR), yet the definition of hostile anatomy varies from study to study. This current analysis was undertaken to identify anatomic criteria that are most predictive of success or failure at the aortic neck after EVAR. METHODS: The study group comprised 221 patients in the Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) clinical trial, a population enriched with patients with challenging aortic neck anatomy and failure of sealing. Imaging protocols were not protocol specified but were performed according to the institution's standard of care. Core laboratory analysis assessed the three-dimensional centerline-reformatted computed tomography scans. Failure at the aortic neck was defined by type Ia endoleak occurring at the time of the initial endograft implantation or during follow-up. Receiver operating characteristic curve analysis was used to assess the value of each anatomic measure in the classification of aortic neck success and failure and to identify optimal thresholds of discrimination. Binary logistic regression was performed after excluding highly intercorrelated variables, creating a final model with significant predictors of outcome after EVAR. RESULTS: Among the 221 patients, 121 (54.8%) remained free of type Ia endoleak and 100 (45.2%) did not. Type Ia endoleaks presented immediately after endograft deployment in 58 (58.0%) or during follow-up in 42 (42.0%). Receiver operating characteristic curve analysis identified 12 variables where the classification of patients with type Ia endoleak was significantly more accurate than chance alone. Increased aortic neck diameter at the lowest renal artery (P = .013) and at 5 mm (P = .008), 10 mm (P = .008), and 15 mm (P = .010) distally; aneurysm sac diameter (P = .001), common iliac artery diameters (right, P = .012; left, P = .032), and a conical (P = .049) neck configuration were predictive of endoleak. By contrast, increased aortic neck length (P = .050), a funnel-shaped aortic neck (P = .036), and neck mural thrombus content, as measured by average thickness (P = .044) or degrees of circumferential coverage (P = .029), were protective against endoleak. Binary logistic regression identified three variables independently predictive of type Ia endoleak. Neck diameter at the lowest renal artery (P = .002, cutpoint 26 mm) and neck length (P = .017, cutpoint 17 mm) were associated with endoleak, whereas some mural neck thrombus content was protective (P = .001, cutpoint 11° of circumferential coverage). CONCLUSIONS: A limited number of independent anatomic variables are predictive of type Ia endoleak after EVAR, including aortic neck diameter and aortic neck length, whereas mural thrombus in the neck is protective. This study suggests that anatomic measures with identifiable threshold cutpoints should be considered when defining the hostile aortic neck and assessing the risk of complications after EVAR.
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Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Técnicas de Apoyo para la Decisión , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Área Bajo la Curva , Endofuga/diagnóstico por imagen , Femenino , Humanos , Arteria Ilíaca/diagnóstico por imagen , Arteria Ilíaca/cirugía , Imagenología Tridimensional , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Valor Predictivo de las Pruebas , Estudios Prospectivos , Factores Protectores , Curva ROC , Interpretación de Imagen Radiográfica Asistida por Computador , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
OBJECTIVES: To evaluate longer-term safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral (SFA) and proximal popliteal arteries. BACKGROUND: Angioplasty and stenting are options for revascularization of symptomatic peripheral artery disease. While angioplasty alone is effective in short lesions, outcomes in longer lesions (i.e., mean 8.7 cm) show suboptimal patency rates of 33% at one year. METHODS: Two hundred eighty-seven patients (mean age 68 years, 66% male) were treated with the EverFlex™ Self-Expanding Peripheral Stent System. Patients were followed through 3 years with yearly core lab adjudicated duplex ultrasonography for patency, radiographic assessment of stent fractures, and resting ankle brachial indices. RESULTS: Overall freedom from loss of primary patency at 3 years was 60.0%. Patency was significantly higher for lesions ≤8 cm compared with lesions >8 cm (71.0 vs. 50.5%, P < 0.0001). There was no significant difference in patency between single-stent and multistent recipients (60.4 vs. 52.4%, P = 0.343). The three-year freedom from clinically driven target lesion revascularization was 70.0%. At 3 years, the overall stent fracture rate was 0.9%. CONCLUSIONS: DURABILITY II is the first investigational device exemption trial to report 3-year duplex Doppler defined stent patency and CD-TLR outcomes in long SFA and proximal popliteal lesions and demonstrated acceptable stent patency and freedom from CD-TLR with a low fracture rate. These data suggest that use of a single long stent provides reasonable long-term outcomes when intervention is required for symptomatic SFA and proximal popliteal arterial disease.
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Implantación de Prótesis Vascular/métodos , Claudicación Intermitente/cirugía , Arteria Poplítea/cirugía , Stents , Grado de Desobstrucción Vascular , Anciano , Femenino , Estudios de Seguimiento , Humanos , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/fisiopatología , Masculino , Diseño de Prótesis , Resultado del Tratamiento , Ultrasonografía Doppler DúplexRESUMEN
PURPOSE: To explore the use of EndoAnchors as an adjunct to endovascular abdominal aortic aneurysm repair for prevention of proximal neck complications in patients with challenging neck anatomy. METHODS: Over a 28-month period, 208 patients (159 men; mean age 72±8 years) were enrolled in the ANCHOR prospective, multicenter registry (ClinicalTrials.gov; identifier NCT01534819) for prophylaxis against proximal neck complications. Patients were eligible when, in the opinion of the investigators, they were at increased risk for type Ia endoleak or migration owing to a hostile neck (length <10 mm, diameter >28 mm, angulation >60°, mural thrombus or calcium >2 mm in thickness or >180° in circumference, or conical shape). Overall, 123/157 (78.3%) patients met the criteria for a hostile neck according to core laboratory assessment of 157 adequate preoperative computed tomographic (CT) images. RESULTS: Implantation of EndoAnchors was technically successful in 204/208 (98.1%) patients. The frequency of fracture was 0.3% (3/1118); there were no clinical sequelae associated with the fractures. Over the mean 14-month follow-up, 95.2% of patients were alive, and no deaths were attributable to EndoAnchors. There were no ruptures, migrations, or open surgical conversions. Aneurysm-related reinterventions were performed in 8 (3.8%) patients. Among 130 patients with postprocedure contrast CT studies, core laboratory analysis identified 2 (1.5%) patients with type Ia endoleaks. Aneurysm sac diameter decreased >5 mm in 42.9% of patients with CT scans at or beyond 1 year; 1.6% of patients developed sac enlargement >5 mm. CONCLUSION: Prophylactic EndoAnchor use for challenging aortic neck anatomy was associated with satisfactory midterm results.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/prevención & control , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/prevención & control , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Femenino , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del TratamientoAsunto(s)
Procedimientos Endovasculares , Especialización , Cirujanos , Enfermedades Vasculares/terapia , Procedimientos Quirúrgicos Vasculares , Actitud del Personal de Salud , Conducta Competitiva , Difusión de Innovaciones , Procedimientos Endovasculares/tendencias , Humanos , Relaciones Interpersonales , Liderazgo , Especialización/tendencias , Cirujanos/psicología , Cirujanos/tendencias , Enfermedades Vasculares/diagnóstico , Enfermedades Vasculares/fisiopatología , Procedimientos Quirúrgicos Vasculares/tendenciasRESUMEN
OBJECTIVE: The proximal aortic neck remains one of the challenges of endovascular aneurysm repair (EVAR), and the risk of type Ia endoleak and endograft migration is increased in patients with short, large-diameter, or highly angulated necks. EndoAnchors have been used as an adjunct to EVAR in such patients, and the aim of this study was to assess their benefit analyzed by indication for use. METHODS: During a 2-year period, 319 patients were enrolled at 43 sites in the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients, those undergoing first-time EVAR (primary arm, 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, 77). The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), with a type Ia endoleak evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (four). The revision arm was subdivided into patients presenting with a type Ia endoleak alone (45), endograft migration alone (11), and migration with endoleak (21). Technical success was site reported as satisfactory deployment of the desired number of EndoAnchors without fracture or loss of integrity. Procedural success was defined as technical success without type Ia endoleak at completion arteriography. Core laboratory analysis was performed on 249 baseline and 192 follow-up computed tomographic studies, 66 of which were available within the 1-year window. RESULTS: Technical and procedural success rates were highest in the prophylactically treated subset (172 of 178; 96.6%). Whereas the technical success of EndoAnchor deployment was also high in the other subsets, residual type Ia endoleaks were more frequent at completion angiography when the indication for EndoAnchor use was type Ia endoleak, both in the primary arm (17 of 60; 28%) and in the revision arm (9 of 45; 20%). During a median imaging follow-up of 7 months, 183 of 202 patients (90.1%) remained free of type Ia endoleaks. Primary prophylactic patients were free from type Ia endoleak in 110 of 114 cases (96.5%). The most challenging subset was revision patients treated for type Ia endoleak; type Ia endoleaks were evident during follow-up in 10 of 29 of the cases (34%). Sac regression >5 mm in patients with 1-year imaging was observed in 26 of 66 patients (39%) and was highest in the primary prophylaxis subset (20 of 43; 47%). CONCLUSIONS: EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.