Heart failure and valvular heart diseases, such as aortic stenosis, mitral regurgitation, tricuspid regurgitation, and pulmonary diseases, are leading causes of heart-related illnesses and death. Despite the availability and effectiveness of treatments, many patients, particularly elderly patients, with valvular heart disease (VHD) are left undiagnosed and/or untreated. In a UK cohort study, 12% of participants 75 years or older had previously undetected VHD, and the rate of undiagnosed was higher in areas with more socioeconomic deprivation. Since VHD is often undiagnosed and a frequent cause of heart failure, we will measure the frequency of VHD symptoms in a cohort of patients with heart failure. For one type of VHD, severe symptomatic aortic stenosis (ssAS), approximately 75% of ssAS patients 80 years or older in the United States do not receive treatment via aortic valve replacement. We seek to estimate the treatment rate for ssAS and other valvular heart disease conditions in the United Kingdom. Estimating the number of people with VHD, the number treated, and their associated health outcomes provides valuable information regarding the unmet treatment need and opportunities for improved outcomes among patients with valvular heart disease in the UK.
The aim of our study is to estimate the number of people with rheumatic or non-rheumatic VHD (e.g., stenosis or regurgitation of the aortic, mitral, tricuspid, or pulmonic valves), estimate the number treated, estimate the number of heart failure patients with VHD symptoms, study the patient pathway, and evaluate outcomes, accounting for patient demographics. Our study population is patients with valvular heart disease (VHD) or a heart failure (HF) hospitalization. VHD is defined either as a diagnosis of VHD in an inpatient or outpatient setting or receipt of a procedure for the treatment of VHD in an inpatient setting. Heart failure hospitalization is defined as a diagnosis of HF in an inpatient setting. Clinical Practice Research Datalink (CPRD) outpatient data and Hospital Episode Statistics (HES) data will be used to select the cohort and measures of interest. We will use descriptive statistics to describe patient and care characteristics for VHD and HF patients. Given the underdiagnosis of VHD, descriptive statistics of HF patients will inform the prevalence of VHD symptoms in this sample. In addition, this study aims to assess clinical and economic outcomes of VHD patients during the pre-, peri-, and post-treatment periods. We will run multivariate regressions to assess if treatment rates vary significantly by age group for each type of valvular heart disease, controlling for patient and practice characteristics. Additional models will be used to assess changes in other clinical and economic outcomes of interest, such as healthcare resource utilization, mortality, and procedure waiting time. Estimates will provide insight into the number of patients with valvular heart disease and treatment rates by subgroups. Understanding treatment rates and variation is a critical step to addressing the undertreatment of valvular heart disease and improving health outcomes, including survival.
Primary: Number of people with valvular heart disease (e.g., stenosis or regurgitation of the aortic, mitral, tricuspid, or pulmonic valves); Prevalence of surgical and transcatheter repair and replacement for the four heart valves (e.g., surgical aortic valve replacement, transcatheter aortic valve replacement, surgical mitral valve replacement, transcatheter edge to edge repair); Mortality (e.g., in-hospital, all-cause mortality, cardiovascular); Healthcare resource utilization (e.g., hospitalizations, outpatient visits, hospital readmissions, reintervention); Number of people with heart failure hospitalizations; Number of HF patients with valvular heart disease symptoms
Secondary: Time from diagnosis to treatment; Procedure characteristics (e.g., admission methods, transcatheter or surgical, waiting times); Length of stay during procedure hospitalization; Admission to the intensive care unit; Prevalence of concomitant procedures (e.g., coronary bypass graft); Risk of percutaneous coronary intervention; Conversion to surgery in case of a transcatheter intervention; Destination at discharge; Prevalence of complications following procedure (e.g., acute kidney infection, atrial fibrillation, disabling stroke, bleeding); Time to hospital readmission and reason for hospital readmission (i.e., diagnosis codes, reoperation)
Marcella Kelley - Chief Investigator - Edwards Lifesciences Corp. ( USA )
Marcella Kelley - Corresponding Applicant - Edwards Lifesciences Corp. ( USA )
Alissa Dratch - Collaborator - Edwards Lifesciences Corp. ( USA )
Anant Shanbhag - Collaborator - Edwards Lifesciences Corp. ( USA )
Christin Thompson - Collaborator - Edwards Lifesciences Corp. ( USA )
Godfred Marfo - Collaborator - Edwards Lifesciences Corp. ( USA )
Jose Benuzillo - Collaborator - Edwards Lifesciences Corp. ( USA )
Lisa Kemp - Collaborator - Edwards Lifesciences Corp. ( USA )
Michael Ryan - Collaborator - Edwards Lifesciences Corp. ( USA )
Rachele Busca - Collaborator - Edwards Lifesciences SA ( Switzerland )
Shannon Murphy - Collaborator - Edwards Lifesciences Corp. ( USA )
Soumya Chikermane - Collaborator - Edwards Lifesciences Corp. ( USA )
Stephanie Toney - Collaborator - Edwards Lifesciences Corp. ( USA )
Xiayu Jiao - Collaborator - Edwards Lifesciences Corp. ( USA )
Rachele Busca - Collaborator - Edwards Lifesciences SA ( Switzerland )
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data