Amputations and mortality in in-hospital treated patients with peripheral artery disease and diabetic foot syndrome

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Abstract

Aims

The prevalence of diabetes mellitus (DM) and its associated complications such as peripheral artery disease (PAD) and diabetic foot syndrome (DFS) are increasing worldwide. We aimed to determine the contemporary acute and long-term outcome of patients with PAD and DFS in Germany.

Methods

Nationwide, anonymized data of 40,335 patients hospitalized for PAD and/or DFS from the years 2009–2011 were analyzed and followed up until 2013. Patients were classified into 3 groups: DFS, PAD+DM and PAD without DM. In-hospital and long-term outcome (1156 days, 95% CI 1.151–1.161) regarding major and minor amputation and mortality was assessed. Cumulative amputation-free survival and overall survival rates were calculated using Kaplan–Meier analysis.

Results

The proportion of DFS, PAD+DM and PAD only was 17.3%, 21.5% and 61.2%, respectively. At index-hospitalization, DFS patients had the highest amputation (31.9% vs. 11.1% vs. 6.0%), yet the lowest revascularization rate (18.2% vs. 67.8% vs. 71.6%) compared to patients with PAD only and PAD+DM (P < 0.001). Cumulative 4-year survival (57.4%, 60.8% and 70.0%) and amputation-free-survival (45.4%, 74.4% and 86.5%) were lowest for DFS followed by PAD+DM and PAD only (P < 0.001).

Conclusions

Patients with diabetes, particularly those with DFS, have persistent high rates of limb amputation and of mortality in a real-world setting. Our data emphasize the need for further dedicated research to identify and target the underlying causes of the extraordinary poor outcome in this high risk population.

Introduction

The prevalence of diabetes mellitus (DM) is increasing worldwide (Murray et al., 2015, Zimmet et al., 2014) just as the diabetes-associated complications (Gregg, Li, Wang, et al., 2014) such as peripheral artery disease (PAD) and especially diabetic foot syndrome (DFS). Patients with DM have a lifetime probability of 15%–25% for developing foot ulcers (Abbott et al., 2002, Singh et al., 2005, Wild et al., 2004) which are a precursor of limb amputation, particularly in the presence of ischemia and infection. Concomitant PAD is present in approximately 50%–70% of diabetic foot ulcers and is a strong predictor of adverse outcome in ulcer healing, limb amputation, morbidity, and mortality (Prompers et al., 2007, Prompers, Schaper, et al., 2008). Moreover, both PAD and DM are associated with extensive resource utilization and costs (Prompers, Huijberts, Schaper, et al., 2008).

Measures such as campaigns to increase the awareness of DM-associated vascular complications (World Health Organization: Diabetes Care and Research in Europe: The St. Vincent Declaration. Geneva, World Health Org, 1989) alongside with the progress in medical and interventional treatment modalities during the last decades might be suggestive of an improved outcome of patients with DM and PAD. Indeed, a continuous advance in integrated management of DM has resulted in considerable decrease of DM-related complications during the last two to three decades (Gregg, Li, et al., 2014, Gregg, Zhuo, et al., 2014). Even in patients with DFS a dedicated multidisciplinary approach resulted in favorable short- and long-term outcome (Apelqvist et al., 2011, Apelqvist et al., 2008; Apelqvist and Larsson, 2000, Krishnan et al., 2008). However, those data were derived from single-centers with excellent expertise in diabetic foot care, hence not representative of the up-to-date real-world practice. Contemporary data confirming or reputing such assumptions in the real-world setting are lacking. Therefore, we conducted a thorough retrospective analysis in a large German nation-wide cohort to determine the frequency of DFS and of PAD with and without concomitant DM and the current practice of care regarding revascularization, and to assess the acute and long-term outcome in terms of limb amputation and mortality.

Section snippets

Subjects, materials and methods

The entities of the German diagnosis related groups (G-DRG) and of the patient allocation have previously been described in details (Reinecke, Unrath, Freisinger, et al., 2015).

Anonymized data of a large German health insurance (BARMER GEK, covering approximately eight million people, respective 10% of the entire German population) were analyzed. All patients hospitalized between 2009 and 2011 with a main diagnosis of PAD of the lower limb (GM-ICD-10 codes I70.20–I70.24) or with a main

Baseline characteristics and comorbidities

Among 40,335 analyzed patients, the distribution of DFS, PAD+DM, and of PAD alone was 17.3%, 21.5%, and 61.2%, respectively. Baseline characteristics of these three subgroups are presented in Table 1.

Compared to patients with PAD+DM and PAD, DFS patients were younger and had a higher proportion of male gender and of obesity, yet lower proportions of smoking and dyslipidemia (P < 0.001, Table 1). The frequencies of chronic kidney disease and chronic heart failure were highest among DFS, followed

Discussion

This contemporary, nation-wide study demonstrates the continuing poor prognosis of patients with DFS and documents the detrimental impact of diabetes on the short- and long-term outcome regarding limb amputation and mortality in patients with atherosclerotic vascular disease. To the best of our knowledge, this is the study with the largest cohort of DFS patients (n = 6996) and the first nation-wide, population-based study in patients with and without concomitant DM reporting detailed information

Acknowledgments

We thank Mrs. Susanne Schüler and Dr. Christiane Engelbertz, both Division of Vascular Medicine, Department of Cardiovascular Medicine, University Hospital Muenster, for their excellent assistance during manuscript preparation.

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    Funding: No sources of funding.

    Conflict of interest: H. Reinecke has received grants for participation in multicenter trials from Bard, Bayer, Biotronik, and Pluristem and consultant fees from BMS and Pluristem. N.M. Malyar has received travel support from Bard, Bayer, Cordis, Daiichi-Sankyo, and Medtronic and speaker honoraria from Medac and UCB Pharma. The other authors have nothing to declare.

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