Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

Overview

About this study

This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Candidate for a Left Ventricular Assist Device (LVAD)
  • Advanced Heart Failure as determined by New York Heart Association classification III or IV

Exclusion Criteria:

  • Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
  • Physical activity is contraindicated

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sudhir Kushwaha, M.D.

Closed for enrollment

More information

Publications

  • Surgical risk models estimate operative outcomes while controlling for heterogeneity in 'case mix' within and between institutions. In cardiac surgery, risk models are used for patient counselling, surgical decision-making, clinical research, quality assurance and improvement, and financial reimbursement. Importantly, risk models are only as good as the databases from which they are derived; physicians and investigators should, therefore, be aware of shortcomings of clinical and administrative databases used for modelling risk estimates. The most frequently modelled outcome in cardiac surgery is 30-day mortality. However, results of randomized trials to compare conventional surgery versus transcatheter aortic valve implantation (TAVI) indicate attrition of surgical patients at 2-4 months postoperatively, suggesting that 3-month survival or mortality might be an appropriate procedural end point worth modelling. Risk models are increasingly used to identify patients who might be better-suited for TAVI. However, the appropriateness of available statistical models in this application is controversial, particularly given the tendency of risk models to misestimate operative mortality in high-risk patient subsets. Incorporation of new risk factors (such as previous mediastinal radiation, liver failure, and frailty) in future surgical or interventional risk-prediction tools might enhance model performance, and thereby optimize patient selection for TAVI. Read More on PubMed
  • Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality. With the ageing population, the prognostic determinants among others include frailty, health status, disability, and cognition. These constructs are seldom measured and factored into clinical decision-making or evaluation of the prognosis of these at-risk older adults, especially as it relates to high-risk interventions. Addressing this need effectively requires increased awareness and their recognition by the treating cardiologists, their incorporation into risk prediction models when treating an elderly patient with underlying complex CVD, and timely referral for comprehensive geriatric management. Simple measures such as gait speed, the Fried score, or the Rockwood Clinical Frailty Scale can be used to assess frailty as part of routine care of elderly patients with CVD. This review examines the prevalence and outcomes associated with frailty with special emphasis in patients with CVD. Read More on PubMed
  • Heart failure (HF) is associated with the derangement of muscle structure and metabolism, contributing to exercise intolerance, frailty, and mortality. Reduced handgrip strength is associated with increased patient frailty and higher morbidity and mortality. We evaluated handgrip strength as a marker of muscle function and frailty for prediction of clinical outcomes after ventricular assist device (VAD) implantation in patients with advanced HF. Read More on PubMed
  • Frailty is recognized as a major prognostic indicator in heart failure. There has been interest in understanding whether pre-operative frailty is associated with worse outcomes after implantation of a left ventricular assist device (LVAD) as destination therapy. Read More on PubMed
  • The objective of this prospective randomized controlled study was to compare the long-term effects of a structured physical activity intervention with those of aerobic exercises alone, in a cohort of elderly patients who had undergone elective cardiac surgery, and who were classified as frail at the end of rehabilitation based on their Short Physical Performance Battery (SPPB) score. At the end of rehabilitation, 140 frail elderly patients were randomly allocated either to the intervention group (IG) or to the control group (CG). CG participants received the usual aerobic exercise prescription, while IG participants were also taught additional exercises for strength, flexibility, balance and coordination. The improvement in SPPB score after 1 year was the outcome of the study. IG showed a significant improvement in SPPB score (9.0 ± 1.1 vs. 7.7 ± 1.4, p < 0.001), while no significant change was found in CG (7.7 ± 1.6 vs. 7.6 ± 1.5, p = 0.252). IG also showed a significantly higher proportion of participants who improved their SPPB score of at least 1 point (70 vs. 37%, p < 0.001). In conclusions, our structured physical activity intervention significantly improves the SPPB score in frail elderly patients who have undergone elective cardiac surgery. An intervention that improves the SPPB score might delay the occurrence of mobility disability. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312414

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