Short Term Quality of Life Following Transcatheter Aortic Valve Replacement

Background: Transcatheter aortic valve replacement (TAVR) is the recommended therapy for patients with severe calcific aortic stenosis (AS) who are not suitable candidates for surgery. The aim of this study is to evaluate the quality of life (QOL) for patients with severe AS with extreme and high surgical risk following TAVR with the Core Valve Medtronic prosthesis. Methods: An analysis of patients who underwent TAVR with the Medtronic selfexpanding Core Valve system (Medtronic, Inc.) at the University of Miami hospital was conducted between April 2011, and March 2014. Demographic and clinical data were obtained from inpatient and outpatient clinical records. QOL assessment was realized with the SF-12 Health-Survey. The questionnaire was administered at baseline, 6 months and 1 year after TAVR. Missing values were treated with median based imputation. Results: A total of 71 patients underwent TAVR therapy. Of these, 63 patients successfully completed or partially completed the SF12 questionnaire at 6 months follow up. Mean age was 85.0 ± 8.2 years and 65% were male. Eight patients (11.3%) died during follow up. After 6 months, a significant improvement in both scores (PCS 37.0; p < 0.001 and MCS 52.5 p < 0.001) was observed. Conclusions: The main finding of this study is that TAVR in patients with severe AS is followed by early improvements in quality of life. The results show a marked improvement in functional status and a significant improvement in quality of life in both physical and mental components. referred to the University of Miami Hospital for evaluation of TAVR. All patients eligible for the procedure had to be considered at high or extreme risk for SAVR if 2 cardiac surgeons and 1 interventional cardiologist at the clinical site estimated high (≥ 15% and ≤ 50%) or extreme (≥ 50%) risk for mortality or irreversible morbidity at 30 days with SAVR. Inclusion criteria were as follows: severe symptomatic aortic stenosis defined as an aortic valve area 0.8 cm2 or aortic valve index 0.5 cm2/m2 and either a mean aortic valve gradient > 40 mm Hg or a peak aortic valve velocity > 4.0 m/s at rest or with a dobutamine stress if the left ventricular ejection fraction was < 50%. Principal exclusion criteria were an active gastrointestinal hemorrhage within the prior 3 months, a major stroke within the prior 6 months, or a life expectancy < 1 year. All patients underwent TAVR via an iliofemoral, transaortic or subclavian approach, using the Medtronic selfexpanding Core Valve system (Medtronic, Inc.). All patients gave their informed written consent after receiving complete information about risk and benefits of the study and procedure. Quality of Life assessment QOL was prospectively assessed using the SF-12 Health-Survey at baseline, 6 months and 1 year follow-up [7,8]. The SF-12 questionnaire consists of 12 questions, which measure functioning in 8 multi-item domains of daily life, such as: physical functioning, role limitation to physical health problems, bodily pain, general health, vitality as a measure of energy and fatigue, social functioning, role limitations due to emotional problems, and mental health related to psychological distress and psychological well-being. The Mental Component Summary (MCS) and the Physical Component Summary (PCS) are the 2 meta-scores of the SF-12, which combines the 8 domains and represent overall physical and mental functioning [8]. Higher SF-12 scores indicate better QOL, positive changes in SF-12 scores indicate improvement in QOL, and a negative change indicates deterioration. The scoring system and the interpretation of results of SF-12 has been explained elsewhere [8]. The questionnaires were administered by dedicated research staff to the participating patients during their screening for the TAVR procedure at the outpatient clinic and at their scheduled 6-months and 1-year clinical visit. After explaining the method and the purpose, the patients were then asked to complete the questionnaire. Statistical Analysis Continuous variables were presented as mean + standard Introduction Transcatheter Aortic Valve Replacement (TAVR) has emerged as an alternative treatment modality for patients with severe aortic stenosis (AS) who are at high or extreme risk for surgical aortic valve replacement (SAVR) [1]. Previous studies have shown that TAVR results in substantial reductions in symptoms and mortality [2-5]. Despite these health benefits, the assessment of quality of life (QOL) remains critical in these patients who often express quality of life over quantity of life [6]. The aim of this study is to evaluate the changes in quality of life in elderly patients with severe AS who underwent TAVR. Methods and Patient selection From April 2011 until March 2014, 71 consecutive patients were