Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation
Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation
Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and
 leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first
 catheter-based transfemoral aortic valve replacement at the University of Rouon. This
 historical step initiated a dramatic shift in the treatment of AS with more than 50% of
 patients being treated interventionally instead of the surgical approach, today.

 Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic
 valve stenosis but little is known about psychiatric comorbidities or frailty in these
 patients. Data from our group suggest an inflammatory trigger for depression and potentially
 other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are
 associated with considerable changes in the inflammatory state of the patients. However, no
 study has prospectively examined the interaction of these inflammatory markers and mood
 disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically,
 however, scientifically there is only emerging data with half of all PubMed-indexed
 publications being less than 18 months old and clinical use of various scores still under
 discussion.

 The " Effect of interventional aortic valve replacement on emotional status, quality of life,
 frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a
 prospective epidemiological cohort study to recruit 102 patients with symptomatic severe
 aortic valve stenosis within 18 months. All of these patients will undergo standardized
 cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory
 analysis focussing on the inflammatory state. The study aims to integrate these
 interdisciplinary findings to optimize patient treatment.
Aortic valve stenosis (AS) shows a high prevalence in Western civilizations with an
 increasing incidence and is associated with high morbidity and mortality. AS is a
 degenerative disease and therefore the main reason for the increasing prevalence is the
 higher proportion of elderly patients in western societies. Untreated symptomatic AS is
 characterized by severe morbidity with mainly dyspnea, orthopnea and reduced exercise
 capacity. In addition, AS has a very high mortality (50-90% in 2 years), most often due to
 lung edema as a result of increased afterload of the left ventricle. So far, there is no
 medical treatment available improving mortality in these patients. For decades, the only
 known therapy has been surgical aortic valve replacement (SAVR), having shown a dramatic
 reduction in mortality. However, many of the patients suffering from AS are octogenarians or
 even older and also suffer from multiple comorbidities. Thus, many of these patients are
 considered inoperable using a surgical approach. Exactly 15 years ago Alain Cribier performed
 the first catheter-based transfemoral aortic valve replacement at the University of Rouon.
 This historical step initiated a dramatic shift in the treatment of AS with more than 50% of
 patients being treated interventionally instead of the surgical approach, today.

 Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic
 valve stenosis but little is known about psychiatric comorbidities or frailty in these
 patients. Data from our group suggest an inflammatory trigger for depression and potentially
 other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are
 associated with considerable changes in the inflammatory state of the patients. However, no
 study has prospectively examined the interaction of these inflammatory markers and mood
 disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically,
 however, scientifically there is only emerging data with half of all PubMed-indexed
 publications being less than 12 months old and clinical use of various scores still under
 discussion.

 The " Effect of interventional aortic valve replacement on emotional status, quality of life,
 frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a
 prospective epidemiological cohort study to recruit 102 patients with symptomatic severe
 aortic valve stenosis within 18 months. All of these patients will undergo standardized
 cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory
 analysis focussing on the inflammatory state. The study aims to integrate these
 interdisciplinary findings to optimize patient treatment.
Inclusion Criteria:

 -  Symptomatic aortic valve stenosis

 -  Planned elective transcatheter aortic valve replacement

 -  Willingness and ability to provide signed informed consent (IC) form prior to
 participation in any study-related procedures

 Exclusion Criteria:

 -  Disease reducing life expectancy to < 1 year

 -  Severe immune-system modulating or -affecting disease