Critical Limb Ischemia Non-Responders: Patients Who Do Not Respond to Revascularization, Factors That Identify Non-Response and Non-Responder Prevalence and Markets
There is a group of critical limb ischemia (CLI) patients who do not respond to endovascular and surgical revascularization despite a successful procedure. The lack of response is reflected in unhealed or delayed healing of ulcers and wounds, as well as major amputation.
This patient group is termed Non-Responders. Delayed ulcer healing, amputation and frequent repeat revascularizations associated with non-response adversely affects patient quality of life, as well as adds significantly to healthcare costs.
This report contains a comprehensive analysis of the potential risk factors associated with these difficult to treat patients. Seven risk factors are identified and analyzed with regard to ability to predict non-response and to calculate the number of U.S. CLI patients in the Non-Responder category.
Prevalence of CLI Non-Responders is calculated for each of the seven risk factors for 2015-2030. Non-Responder estimates are based on the prevalence of each risk factor in the CLI population. Percent prevalence data from peer-reviewed publications is applied to the number of CLTI cases calculated according to the Diabetes Method.
Prevalence represents the potential market assuming all CLI patients are diagnosed and treated. However, according to our research, only a fraction of patients are diagnosed and treated. For each risk factor, the current market is estimated for 2015-2030.
Since CLI is commonly bilateral, all Non-Responder estimates are made for limbs as well as for patients. The percentage afflicted with bilateral disease is based on data in the peer-reviewed literature.
Major topics include microvascular disease, foot artery disease, the impact of diabetes and chronic kidney disease on CLI, consequences of chronic ischemia and neuroischemic foot.
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