Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study

Abstract

ObjectivesTranscatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population.DesignWe undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT).ParticipantsWe screened patients undergoing TAVI at a single institution between June 2016 and February 2017.InterventionsParticipants were randomised post-TAVI to standard of care (control group) or standard of care plus exercise-based CR (intervention group).OutcomesWe assessed recruitment and attrition rates, uptake of CR, and explored changes in 6-min walk test, Nottingham Activities of Daily Living, Fried and Edmonton Frailty scores and Hospital Anxiety and Depression Score, from baseline (30 days post TAVI) to 3 and 6 months post randomisation. We also undertook a parallel study to assess the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the post-TAVI population.ResultsOf 82 patients screened, 52 met the inclusion criteria and 27 were recruited (3 patients/month). In the intervention group, 10/13 (77%) completed the prescribed course of 6 sessions of CR (mean number of sessions attended 7.5, SD 4.25) over 6 weeks. At 6 months, all participants were retained for follow-up. There was apparent improvement in outcome scores at 3 and 6 months in control and CR groups. There were no recorded adverse events associated with the intervention of CR. The KCCQ was well accepted in 38 post-TAVI patients: mean summary score 72.6 (SD 22.6).ConclusionsWe have demonstrated the feasibility of recruiting post-TAVI patients into a randomised trial of CR. We will use the findings of this pilot trial to design a fully powered multicentre RCT to inform the provision of CR and support guideline development to optimise health-related quality of life outcomes in this vulnerable population. Retrospectively registered 3rd October 2016 clinicaltrials.gov NCT02921880.Trial registrationClinicaltrials.Gov identifier NCT02921880Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0363-8) contains supplementary material, which is available to authorized users.

Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as Rescue or Bridge Therapy

“…The role of cardiac rehabilitation in patients undergoing BAV remains unknown in contrast to the TAVI population [34][35][36]. Physical exercise conditioning may be, however, limited in these patients due to the profile of comorbidities, frailty and poorer LV function compared to TAVI patients.…”

Are the group-based interventions improving the functional exercise capacity and quality of life of frail subjects with chronic heart failure?

“…Some authors show that frailty can be diagnosed in subjects who do not demonstrate any chronic illness, whereas others argue that chronic illnesses and frailty share many characteristics, the most commonly being HF 32 . To our knowledge in previous studies and systematic reviews the relationship between the effectiveness of various CR interventions and reducing frailty were investigated [33][34][35][36] . Although the duration of the applied rehabilitation interventions were short ranging from three to six weeks, consequently the improvements were less impressive.…”

Prevention and Reversal of Frailty in Heart Failure ― A Systematic Review ―

“…Seven studies evaluated CR programs in chronic heart disease, including patients with HF (Table 3): [21][22][23][24][25][26][27][28] Studies were excluded if they were not in English, were systematic reviews or if they did not include an intervention.…”