Introduction
Abdominal and thoracic aortic aneurysms are a major cause of death in older adults. Most deaths post aneurysm repair result from cardiovascular events; consequently, patients benefit from statins and other medications to improve survival1. Some deaths may be preventable with cardiac rehabilitation, a multidisciplinary approach to cardiovascular recovery2. Cardiac rehabilitation is typically delivered over 8–12 weeks, combining supervised exercise, dietary and lifestyle modifications, smoking cessation, and optimization of medical therapy for cardiovascular risk factors3. Cardiac rehabilitation has been shown to be a cost-effective intervention in the management of coronary heart disease4, peripheral arterial disease5, and heart failure6. However, the feasibility and acceptability of cardiac rehabilitation in people who have undergone aneurysm repair remains unknown, as this cohort is likely older and more co-morbid than patients in whom cardiac rehabilitation has been shown to be of benefit. The primary aim of this study was to evaluate whether cardiac rehabilitation is both feasible and acceptable to patients following aortic aneurysm repair.
Methods
This 1:1, non-blinded feasibility randomized trial compared cardiac rehabilitation to standard care after elective repair of either abdominal or thoracic aortic aneurysms at two UK vascular centres. Patients <50 years, diagnosed with connective tissue disorders, or deemed too unfit for cardiac rehabilitation were excluded at screening. The cardiac rehabilitation group followed an 8-week structured programme focusing on medical risk reduction, supervised exercise, and lifestyle modification. Co-primary outcomes were enrolment (target: 60%) and cardiac rehabilitation compliance (target: 70%). Secondary outcomes included mortality, major adverse cardiovascular events (MACE), cardiovascular biomarkers, echocardiography, lifestyle, and quality of life metrics. This trial was supported by a British Heart Foundation Grant (PG/13/98/30490) and was registered with the ISRCTN: 65746249.
Results
From September 2014 to September 2015, 159 patients were screened, 97 were eligible, and 68 (70%) were randomized (standard care 34, cardiac rehabilitation (CR) 34). CR adherence was 62% (n = 21), with 13 withdrawals, primarily due to travel and personal commitments (69%). Seventeen (81%) of the 21 remaining patients in the CR group attended all eight CR sessions (Fig. 1). The groups were comparable in terms of age, sex, BMI, smoking status, ASA grade, and cardiovascular co-morbidities. The majority of patients had diagnoses of hypertension (n = 47, 69%) and hypercholesterolaemia (n = 50, 74%). The majority were taking an antiplatelet (n = 67, 99%) and a statin (n = 63, 93%). There were no deaths within the 32-week study period in either group. At 9.1 years (i.q.r. 8.9–9.3 years) median follow-up from randomization, the overall survival was 66% (n = 31), and comparable between groups (median 9.0 versus 8.8 years, P = 0.68). There were no differences in MACE, all adverse events, biochemical, urinary, and echocardiographic parameters. At 36 weeks, CR participants maintained higher physical activity levels compared to the standard care group (40 min versus 30 min, P = 0.042). (See Figures and Tables.)
Fig. 1.
CONSORT diagram for pilot randomized controlled trial of cardiac rehabilitation vs. standard care after aortic aneurysm repair
Discussion and conclusion
In this feasibility RCT we have shown that it is possible to recruit patients after abdominal and thoracic aortic aneurysm repair to a trial offering a structured cardiac rehabilitation programme, with 70% of approached patients enrolling in the study, and reaching randomization. Moreover, 81% of patients who began cardiac rehabilitation completed all of the planned sessions. Logistical issues pertaining to travel were cited as the biggest barrier to participation in a cardiac rehabilitation programme. It thus may be possible to achieve higher levels of recruitment if wider adoption of the standardized cardiac rehabilitation programmes occurred within regional centres, decentralizing these services from tertiary services only. Another solution to overcome the travel barrier is to adopt virtual or technology-assisted approaches to cardiac rehabilitation. These have been shown to also improve exercise capacity and be a potential alternative to centre-based CR.
A large explanatory RCT is required to determine if the benefits shown within the cardiac rehabilitation literature translate to those patients who have undergone repair of either aortic or thoracic aneurysms. Conducting such a trial has been shown to be feasible, with additional considerations on how to best deliver cardiac rehabilitation to maximize adherence.
Supplementary Material
Acknowledgements
We would like to thank Paul Seed, Ray Kausik, Michael Ussher, Jan D. Poloniecki, Rajan Sharma, Robert J. Hinchliffe, Matthew M. Thompson and Alan Karthikesalingam for assistance with obtaining the grant funding and protocol design.
Contributor Information
Michal Kawka, School of Health & Medical Sciences, City St George’s University of London, London, UK; St George’s Vascular Institute, St George’s Hospital, London, UK.
Sandeep S Bahia, Department of Vascular Surgery, East Kent Hospitals University NHS Foundation Trust, Kent, UK.
Matthew J Bown, Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
Iain Roy, School of Health & Medical Sciences, City St George’s University of London, London, UK; St George’s Vascular Institute, St George’s Hospital, London, UK.
Ian Loftus, St George’s Vascular Institute, St George’s Hospital, London, UK.
Peter Holt, School of Health & Medical Sciences, City St George’s University of London, London, UK; St George’s Vascular Institute, St George’s Hospital, London, UK.
James Budge, School of Health & Medical Sciences, City St George’s University of London, London, UK; St George’s Vascular Institute, St George’s Hospital, London, UK.
Funding
This trial was supported by a the British Heart Foundation (PG/13/98/30490).
Author contributions
Michal Kawka (Data curation, Formal analysis, Visualization, Writing—original draft, Writing—review & editing), Sandeep S. Bahia (Conceptualization, Investigation, Methodology, Writing—original draft, Writing—review & editing), Matthew J. Bown (Data curation, Investigation, Writing—original draft, Writing—review & editing), Iain Roy (Formal analysis, Supervision, Writing—original draft, Writing—review & editing), Ian Loftus (Methodology, Supervision, Writing—original draft, Writing—review & editing), Peter Holt (Conceptualization, Funding acquisition, Methodology, Writing—original draft, Writing—review & editing), and James Budge (Data curation, Formal analysis, Supervision, Writing—original draft, Writing—review & editing)
Disclosure
The authors declare no conflicts of interest
Supplementary material
Supplementary material is available at BJS online.
Data availability
Grouped (>10 patients) anonymized data used in the trial are available on request from the corresponding author.
Previous communications
Presented at British Society of Endovascular Therapy (BSET) 2016 Meeting.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Grouped (>10 patients) anonymized data used in the trial are available on request from the corresponding author.