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1.
J Vasc Surg ; 78(5): 1313-1321, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37524153

RESUMEN

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

2.
Am Heart J ; 232: 71-83, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33157067

RESUMEN

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients.


Asunto(s)
Angioplastia , Stents Liberadores de Fármacos , Mortalidad , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/cirugía , Moduladores de Tubulina/administración & dosificación , Comités Consultivos , Angioplastia de Balón , Aterectomía , Elementos de Datos Comunes , Exactitud de los Datos , Recolección de Datos , Arteria Femoral/cirugía , Humanos , Metaanálisis como Asunto , Arteria Poplítea , Ensayos Clínicos Controlados Aleatorios como Asunto , Reproducibilidad de los Resultados , Medición de Riesgo , Stents
3.
J Vasc Surg ; 73(5): 1702-1714.e11, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33080324

RESUMEN

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. METHODS: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. CONCLUSIONS: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.


Asunto(s)
Benchmarking , Procedimientos Endovasculares/instrumentación , Arteria Femoral , Claudicación Intermitente/terapia , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Indicadores de Calidad de la Atención de Salud , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Benchmarking/normas , Enfermedad Crítica , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Procedimientos Endovasculares/normas , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Mortalidad Hospitalaria , Humanos , Claudicación Intermitente/diagnóstico por imagen , Claudicación Intermitente/mortalidad , Claudicación Intermitente/fisiopatología , Isquemia/diagnóstico por imagen , Isquemia/mortalidad , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Indicadores de Calidad de la Atención de Salud/normas , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
4.
J Vasc Surg ; 67(2): 637-644.e30, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29389426

RESUMEN

OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.


Asunto(s)
Prótesis Vascular , Aprobación de Recursos/normas , Procedimientos Endovasculares/instrumentación , Enfermedad Arterial Periférica/terapia , Sistema de Registros/normas , Stents , United States Food and Drug Administration/normas , Procedimientos Quirúrgicos Vasculares/instrumentación , Minería de Datos/normas , Registros Electrónicos de Salud/normas , Procedimientos Endovasculares/efectos adversos , Humanos , Cooperación Internacional , Informática Médica/normas , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Vigilancia de Productos Comercializados/normas , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología , Procedimientos Quirúrgicos Vasculares/efectos adversos , Flujo de Trabajo
5.
Circ J ; 82(2): 316-322, 2018 01 25.
Artículo en Inglés | MEDLINE | ID: mdl-29367497

RESUMEN

BACKGROUND: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.


Asunto(s)
Equipos y Suministros/normas , Enfermedad Arterial Periférica , Sistema de Registros/normas , Monitoreo Epidemiológico , Humanos , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/terapia , Estándares de Referencia
6.
AMIA Annu Symp Proc ; 2019: 864-873, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-32308883

RESUMEN

BACKGROUND: To assess the current state of clinical data interoperability, we evaluated the use of data standards across 38 large professional society registries. METHODS: The analysis included 4 primary components: 1) environmental scan, 2) abstraction and cross-tabulation of clinical concepts and corresponding data elements from registry case report forms, dictionaries, and / or data models, 3) cross-tabulation of same across national common data models, and 4) specifying data element metadata to achieve native data interoperability. RESULTS: The registry analysis identified approximately 50 core clinical concepts. None were captured using the same data representation across all registries, and there was little implementation of data standards. To improve technical implementation, we specified 13 key metadata for each concept to be used to achieve data consistency. CONCLUSION: The registry community has not benefitted from and does not contribute to interoperability efforts. A common, authoritative process to specify and implement common data elements is greatly needed.


Asunto(s)
Elementos de Datos Comunes , Interoperabilidad de la Información en Salud , Metadatos , Sistema de Registros/normas , Femenino , Humanos , Masculino , Sociedades , Estados Unidos
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