Table 3.
CLI amputation rates
| Publication | Country/region | Data source (years) | Population details | Methods | Amputation rate or incidence |
|---|---|---|---|---|---|
| Marstona (2006)74 | Chapel Hill, NC | University of North Carolina Wound Management Center (1999–2005) | CLI patients with unhealed ulcers not candidates for revascularization | Retrospective analysis of prospectively collected data | 1-Year 38% |
| Henry (2011)28 | United States | Nationwide Inpatient Sample (2003–2007) | Hospitalized CLI patients except those with EVT plus amputation | ICD-9 diagnosis and procedure codes used to identify cases and procedures; multivariate regression analyses | During Admission 24.2% Significant Odds Ratiosb Black: 2.15 Native American: 2.00 Low income: 1.12–1.34 Private insurance: 0.74 Medicaid: 1.26 |
| Peacock (2011)65 | Minnesota | State-based hospital claims database (2005–2008) | Patients with lower limb ischemic amputationc | ICD-9 diagnosis and procedure codes used to identify cases and procedures | Age-Adjusted Incidence All: 20.0/100,000 Rural: 21.4/100,000 Urban: 19.6/100,000 |
| O’Brien-Irr (2012)25 | New York State | SPARCS database (2001–2008) | CLI patients undergoing vascular intervention | ICD-9 diagnosis and procedure codes used to identify cases and procedures | During Admission Rutherford 4: 3.1% Rutherford 5: 26.7% Rutherford 6: 55.0% |
| Baser (2013)19 | United States | 100% Medicare inpatient/outpatient/denominator files (2007–2008) | US Medicare population | ICD-9 and CPT codes used to identify CLI cases | Annual Incidence Overall: 12.5% Asian: 3.6% Hispanic: 9.7% White: 11.7% Black: 20.5% DM-: 7.0% DM+: 19.4% |
| Abu Dabrh (2015)3 | Multi-national | Published literature (1986–2013)d | Natural history CLI patients not receiving revascularization | Meta-analysis of 8 RCTs and 5 case series | 1-Year Major amputation: 22% |
| Howard (2015)75 | United Kingdom (Oxfordshire) | Medical records (2002–2012) | CLI patients within the OXVASC study population (no age restriction) | Prospective, population-based study | 1-Year 6.6% 5-Year 43.4% |
| Reinecke (2015)26 | Germany | German health insurer data (2009–2011) | Hospitalized CLI patients | ICD-10 dx and German procedure (OPS) codes to identify cases and procedures | Index Hospitalization Rutherford 4: 1.6% Rutherford 5: 9.8% Rutherford 6: 42.0% 1-Year Rutherford 6: 59.6% 4-Year Rutherford 4: 12.1% Rutherford 5: 35.3% Rutherford 6: 67.3% |
| Agarwal (2016)22 | United States | Nationwide Inpatient Sample (2003–2011) | Hospitalized CLI patients | ICD-9 diagnosis and procedure codes used to identify cases and procedures | Annual Major Amputation 2003: 16.7% 2011: 10.8% |
| Luders (2016)24 | Germany | German health insurer data (2009–2012) | Hospitalized CLI patients (Rutherford 1–3 as reference group) | ICD-10 diagnosis and German procedure (OPS) codes to identify cases and procedures | Hazard Ratio vs Rutherford 1–3 (median follow-up =2.1 years) Rutherford 4: 3.0 Rutherford 5: 9.1 Rutherford 6: 28.3 |
| Spreen (2016)27 | The Netherlands | Pooled patient-level data from the PADI and JUVENTAS trials (2006-unknown) | CLI patients undergoing one of the PADI or JUVENTAS interventions | Analysis of pooled RCT data | Time: Major Amp. (DM-/DM+) 6 months: 11.4%/19.7% 1 year: 16.0%/23.8% 2 years: 17.8%/28.3% 3 years: 18.7%/29.2% 4 years: 20.4%/30.8% 5 years: 20.4%/34.1% |
| Baubeta Fridh (2017)76 | Sweden | Swedish National Quality Register for Vascular Surgery (Swedvasc) (2008–2013) | CLI patients who had a revascularization treatment | Observational cohort study | Time: Major Amputation 6 months: 12.0% 1 year: 14.8% 2 years: 17.2% 3 years: 18.6% |
| Klaphake (2017)31 | The Netherlands | Large teaching hospital (2006–2013) | CLI patients undergoing major amputation | Retrospective analysis of medical records | During Study Period Major Amputation: 26% |
| Martinez (2018)64 | United States | Nationwide Readmissions Database (2013–2014) | CLI patients undergoing revascularization procedures | ICD-9 diagnosis and procedure codes used to identify cases and procedures | During Index Admission Amputation: 5.4% |
| Masoomi (2018)73 | United States | Nationwide Readmissions Database (2013) | CLI patients with/without revascularization procedures | ICD-9 diagnosis and procedure codes used to identify cases and procedures | During Index Admission Major Amputation: 16.2% |
| Mustapha (2018)20 | United States | Medicare fee-for-service Parts A and B (2011–2015) | Adult US Medicare population | ICD-9 and CPT codes used to identify CLI cases | During Index Admission Major Amputation: 6% |
Notes: aAlthough the publication date criteria excluded studies prior to 2007, few papers document the natural history of CLI disease and, therefore, this paper was included within the review; bReference groups in the multivariate logistic regression: Race/ethnicity=white; median income quartiles=Q4 (highest income); payer=Medicare; cUnclear if entire population was CLI; dPublication dates listed; data used in the individual studies may be considerably older.
Abbreviations: Amp, amputation; CLI, critical limb ischemia; CPT, Current Procedural Terminology®; DM, diabetes mellitus; EVT, endovascular treatment; ICD-9/10, International Classification of Diseases 9th/10th Revision; JUVENTAS, Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-Arterial Supplementation; OPS, Operationen und Prozedurenschlüssel [German procedure classification]; OXVASC, Oxford Vascular Study; PADI, Percutaneous Transluminal Balloon Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia; RCT, randomized clinical trial; SPARCS, Statewide Planning and Research Cooperative System.