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Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.
Bertges, Daniel J; White, Roseann; Cheng, Yu-Ching; Sun, Tianyi; Ramkumar, Niveditta; Goodney, Philip P; Wilgus, Rebecca W; Lottes, Aaron E; Smale, Joshua A; Drozda, Joseph; Raska, Melanie; Heise, Ted; Jones, W Schuyler; Tcheng, James E; Eldrup-Jorgensen, Jens; Sedrakyan, Art; Malone, Misti L; Marinac-Dabic, Danica; Thatcher, Robert; Morales, Pablo; Krucoff, Mitchell W; Cronenwett, Jack L.
Afiliación
  • Bertges DJ; University of Vermont Medical Center, Division of Vascular Surgery, Burlington, VT. Electronic address: daniel.bertges@uvmhealth.org.
  • White R; Your Third Opinion, Chapel Hill, NC.
  • Cheng YC; US Food and Drug Administration, Silver Spring, Md.
  • Sun T; Departments of Cardiothoracic Surgery and Populations Health Sciences, Weill Cornell College of Medicine, New York, NY.
  • Ramkumar N; Section of Vascular Surgery and the Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
  • Goodney PP; Section of Vascular Surgery and the Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
  • Wilgus RW; Department of Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
  • Lottes AE; Purdue University, West Lafayette, Ind.
  • Smale JA; BD Peripheral Intervention, Tempe, Ariz.
  • Drozda J; Mercy Health, Chesterfield, Mo.
  • Raska M; Boston Scientific Corporation, Marlborough, Mass.
  • Heise T; MED Institute, West Lafayette, IN.
  • Jones WS; Department of Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
  • Tcheng JE; Department of Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
  • Eldrup-Jorgensen J; Division of Vascular Surgery, Maine Medical Center, Portland, Me.
  • Sedrakyan A; Departments of Cardiothoracic Surgery and Populations Health Sciences, Weill Cornell College of Medicine, New York, NY.
  • Malone ML; US Food and Drug Administration, Silver Spring, Md.
  • Marinac-Dabic D; US Food and Drug Administration, Silver Spring, Md.
  • Thatcher R; 4C Medical Technologies, Brooklyn Park, Minn.
  • Morales P; US Food and Drug Administration, Silver Spring, Md.
  • Krucoff MW; Department of Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
  • Cronenwett JL; Section of Vascular Surgery and the Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
J Vasc Surg ; 73(5): 1702-1714.e11, 2021 05.
Article en En | MEDLINE | ID: mdl-33080324
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Arteria Poplítea / Benchmarking / Indicadores de Calidad de la Atención de Salud / Arteria Femoral / Enfermedad Arterial Periférica / Procedimientos Endovasculares / Claudicación Intermitente / Isquemia Tipo de estudio: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged80 País/Región como asunto: America do norte Idioma: En Revista: J Vasc Surg Asunto de la revista: ANGIOLOGIA Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Arteria Poplítea / Benchmarking / Indicadores de Calidad de la Atención de Salud / Arteria Femoral / Enfermedad Arterial Periférica / Procedimientos Endovasculares / Claudicación Intermitente / Isquemia Tipo de estudio: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged80 País/Región como asunto: America do norte Idioma: En Revista: J Vasc Surg Asunto de la revista: ANGIOLOGIA Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos