Minimally Invasive Cardiac Valvular Surgery Clinical Trial
Official title:
Comparison of Outcomes for Minimally Invasive and Conventional Cardiac Valvular Surgery: A Prospective Cohort Study
The conventional approach to heart valve operations is through a sternotomy. This involves a vertical incision in the sternum (breastbone) to gain access to the heart and its related structures. Post-operative recovery after sternotomy can take anywhere from 6 weeks to 3 months due to the time required for the sternum to fully heal. Minimally invasive valve surgery is a less invasive alternative to conventional open-heart surgery. At the Foothills Medical Centre, surgeons perform minimally invasive valve surgery through a technique called right mini-thoracotomy. This involves a small incision on the right upper chest and leaves the sternum fully intact. It is unclear whether minimally invasive valve surgery provides better clinical outcomes and quality of life compared to conventional open heart surgery. The purpose of this research study is to compare the clinical outcomes of minimally invasive valve surgery via right mini-thoracotomy to conventional surgery via open-heart surgery. The results of this study will inform surgeons of the benefits and disadvantages of minimally invasive surgery compared to the current standards. This will help in developing better treatment strategies for patients requiring valve therapy.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | November 15, 2023 |
| Est. primary completion date | November 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Aged = 18 years of age - Undergoing non-emergent isolated aortic valve or mitral valve surgery - Full median sternotomy approach or minimally invasive approach via right anterior/anterolateral mini-thoracotomy - English speaking - Geographically accessible; able and willing to attend follow-up visits - Written informed consent Exclusion Criteria: - Recent CPR - Previous cardiac surgery - Emergency surgery (operative intervention within 24 hours of assessment) - Previous permanent pacemaker implantation - Poor respiratory function - two or more measurements of FVC, FEV1, or PEF <80% of predicted value based on age, gender, and height at baseline - History of a bleeding disorder - Excessively poor baseline health-related quality of life or physical functioning that would preclude a reasonable expected post-operative recovery to baseline - Active significant systemic infection, (e.g. endocarditis, sepsis) a history of recurrent systemic infections; or have taken an antibiotic within 2 weeks prior to surgery - Cognitive impairment (e.g., confusion, dementia, Alzheimer's disease, current substance abuse) that would preclude completion of survey questions or following instructions to complete pulmonary function testing - History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated, with no evidence of recurrence) - Recent history of significant drug or alcohol abuse - Participation in another study that would affect the ability to obtain adequate follow-up |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post-operative recovery of respiratory function (FVC) | Rate of post-operative recovery of respiratory function to baseline as measured by forced vital capacity (FVC) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer. | 12 months | |
| Primary | Post-operative recovery of respiratory function (FEV1) | Rate of post-operative recovery of respiratory function to baseline as measured by forced expiratory volume (FEV1) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer. | 12 months | |
| Primary | Post-operative recovery of respiratory function (PEF) | Rate of post-operative recovery of respiratory function to baseline as measured by peak expiratory flow (PEF) in litres/minute from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer. | 12 months | |
| Primary | Post-operative pain | Severity of post-operative pain from baseline to 12 months post-surgery. Pain will be measured using an 11-point numeric rating scale (0 to 10). The scales will be associated with descriptors 0=none, 10=worst. Patients will be assessed for pain at the surgical incision sites (ie. sternum/rib/groin), chest, breast, neck, back, arms, and legs - areas of the body which may be affected by sternotomy or minimally invasive surgery. As pain might also interfere with function and mobility, participants will be asked to what degree the pain associated with their surgical incisions interfere with their ability to breath, cough, walk, and sleep. | 12 months | |
| Primary | Post-operative analgesic use | Type (narcotics vs non-narcotics) and amount of analgesic use in milligrams will be collected from baseline to 12 months post-surgery as indicators of pain. | 12 months | |
| Primary | Post-operative recovery of health-related quality of life (EQ5D) | Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ5D questionnaire from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of two components: a self-reported measure of HRQL and a valuation of health states relative to full-health. The health status description component measures HRQL according to a five dimensional classification system. The dimensions are mobility, self-care, usual activities, pain and mood. There are five levels in each dimension resulting in 3125 theoretically possible health states which can be converted to a single index score. | 12 months | |
| Primary | Post-operative recovery of health-related quality of life (EQ VAS) | Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ VAS (visual analogue scale) from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of a component using a visual analogue scale to determine self-reported measures of HRQL. The self-reported measure involves rating one's own health on a scale of 0-100 using a visual analogue scale where 100 represents the best health one can imagine and 0 representing the worst health. | 12 months | |
| Primary | Post-operative recovery of health-related quality of life (KCCQ-12) | Rate of post-operative recovery of health-related quality of life (HRQL) as determined by KCCQ-12 from baseline to 12 months post-surgery. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a validated self-administered questionnaire that independently measures the patient's perception of their health status using 12 items. The KCCQ-12 quantifies 4 distinct domains: symptom frequency, physical function, social limitation, and quality of life, from which an overall summary score can be derived. Scores are generated from each domain and scaled from 0 to 100 - 0 denoting the worst and 100 the best possible status. | 12 months | |
| Primary | Post-operative recovery of health-related quality of life (HAQ) | Rate of post-operative recovery of health-related quality of life (HRQL) as determined by HAQ from baseline to 12 months post-surgery. The Health Assessment Questionnaire (HAQ) is a validated index used to identify difficulty in performing activities of daily living. Questions require that participants identify how much difficulty they have had managing a variety of activities of daily living such as: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and activities. This questionnaire focuses on both fine and gross motor skills which are greatly affected in heart surgery patients due to post-operative pain and discomfort. The highest score (indicating the greatest disability) within each of the eight dimensions is used to calculate the 'disability index'. | 12 months | |
| Primary | Post-operative complications | Post-operative complications including: early mortality, stroke, post-operative atrial fibrillation, permanent pacemaker implantation, paravalvular leak, pulmonary complication, wound infection, acute kidney injury, and reoperation from baseline to 12 months post-surgery. | 12 months | |
| Primary | Post-operative valve function | Post-operative valve function as determined by valve gradients and degree of leakage from baseline to 12 months post-surgery. | 12 months | |
| Primary | Perioperative outcomes | Perioperative outcomes including: postoperative ventilation time, cardiopulmonary bypass time, cross-clamp time, amount of blood transfusion, returns to operating room, and length of ICU and hospital stay from baseline to discharge from hospital. | Up to 12 months | |
| Primary | Health services resource usage | Health services resource usage using the items examined for the perioperative outcomes (ie. ventilation time, length of ICU and hospital stay, etc…) as well as any additional health care services after discharge ie. visits to health care provider, home care services, hospital admissions, and emergency visits from baseline to 12 months post-surgery. | 12 months |