Table 4.
Long-term CLI mortality rates
| Publication | Country/region | Data source (years) | Population details | Methods | Long-term mortality |
|---|---|---|---|---|---|
| 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 | 1-Year After CLI dx: 30.3% After CLI dx + amp: 40.4% |
| Soga (2014)77 | Japan | Prospective, multicenter (n=17) database (2004–2011) | CLI patients undergoing endovascular treatment | Retrospective analysis of medical records | 2-Year 41% |
| Abu Dabrh (2015)3 | Multi-national | Published literature (1986–2013)a | Natural history CLI patients not receiving revascularization | Meta-analysis of 8 RCTs and 5 case series | 1-Year 18%-22%b |
| Howard (2015)75 | United Kingdom (Oxfordshire) | Medical records(2002–2012) | CLI patients within the OXVASC study population (no age restriction) | Prospective, population-based study | 30-Day 7.4% 5-Year 29.2% |
| Reinecke (2015)26 | Germany | German health insurer data (2009–2011) | Hospitalized CLI patients | ICD-10 diagnosis and German procedure (OPS) codes to identify cases and procedures | 1-Year Rutherford 6: 34.2% 4-Year Rutherford 4: 37.7% Rutherford 5: 52.2% Rutherford 6: 63.5% |
| 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: 2.01 Rutherford 5: 2.46 Rutherford 6: 3.59 |
| 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 Point: Mort. (DM-/DM+) 6 months: 8.0%/12.8% 1 year: 17.9%/19.2% 2 years: 25.6%/32.0% 3 years: 31.3%/38.1% 4 years: 36.1%/43.0% 5 years: 48.0%/55.7% |
| 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 Point: Mortality 6 months: 13.5% 1 year: 20.5% 2 years: 31.7% 3 years: 41.4% |
| Freisinger (2017)32 | Germany | German health insurer data (2009–2011) | Hospitalized CLI patients with tissue loss | ICD-10 diagnosis and German procedure (OPS) codes to identify cases and procedures | 4-Year (Rutherford 5) Without diabetes: 50% With diabetes: 50% 4-Year (Rutherford 6) Without diabetes: 63% With diabetes: 60% |
| Melillo (2016)78 | Italy | University hospital (Years not stated; 5–15 year follow-up) | CLI patients consecutively admitted to medical or surgical wards | Retrospective case-control study | Time Point: Mortality 1 year: 15% 2 years: 24% 5 years: 43% |
| van Haelst (2018)79 | The Netherlands | Hospital Discharge Register; Population Register; Cause of Death Register (1998–2010) | CLI patients not admitted in prior 3 years | ICD-9 and ICD-10 codes used to identify CLI cases | Time Point: Mort. (Male/Female) 1 yr (1998–2004): 25.9%/27.3% 1 yr (2005–2010): 24.5%/23.9% 5 yrs (1998–2004): 59.5%/60.3% 5 yrs (2005–2010): 57.9%/57.1% |
| 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 | 1-Year Rest pain: 16.2% Ulcer: 23.9% Gangrene: 33.2% 4-Year Rest pain: 40.1% Ulcer: 55.0% Gangrene: 68.5% |
Notes: aPublication dates listed; data used in the individual studies may be considerably older; bWith (22%) and without (18%) one study with substantially longer follow-up; 1-year mortality based on the median follow-up of the included studies being 1 year.
Abbreviations: Amp, amputation; CLI, critical limb ischemia; CPT, Current Procedural Terminology®; DM, diabetes mellitus; 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; yr(S), year(S).