Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in TR severity assessment from baseline
Study Overview
Brief Summary
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation.
The goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.
Detailed Description
Participant recruitment: At University of Washington Medical Center, 30 to 40 patients with mild tricuspid valve regurgitation (TR) receive LVAD placement annually. A predicted 50 - 60% of these patients will agree to be enrolled in this study, for an estimation of 15 to 20 participants a year. With an enrollment period of 2 years, the study aims to enroll 30 to 40 participants
Study interventions and Specific Techniques: Prior to screening data collection and protocol defined procedures, the participant must sign the consent form. Within 30 days prior to randomization (as part of routine clinical care), a complete transthoracic echocardiogram will be performed, evaluated, and reported. Within 7 days prior to randomization (as part of routine clinical care): 1) a medical history and physical exam is performed; 2) New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) Classes are established and documented; 3) all current medications and therapies are recorded on study documents; 4) the participant will complete the Duke Activity Status Index for quality of care (QOL) assessment.
Randomization: Randomization procedure will be performed intra-operatively, following sternotomy and before cannulation of aorta. Randomization will follow a computer generated simple randomization process. Participants will be randomized with equal probability to receive LVAD implantation alone or LVAD implantation plus surgical repair of their tricuspid valve (TV). The nature of the treatments precludes masking of participants and their treating clinicians to treatment assignment.
Surgical technique: Participants randomly assigned to receive tricuspid valve repair (TVR) in addition to LVAD implantation will undergo repair with standard techniques. After bicaval cannulation and with the heart beating, a right atriotomy is created and the TV exposed. A patent foramen ovale (PFO), if present, is closed primarily. 2-0 braided sutures are placed radially through the tricuspid annulus from the lateral fibrous trigone counterclockwise to the medial fibrous trigone, thus avoiding the conduction system. An incomplete semi-rigid annuloplasty ring is then suspended after appropriate sizing. Any ventricular pacing leads are then mobilized from leaflet and subvalvular adhesions and placed in the commissure between the septal and posterior leaflets. The septal and posterior leaflets are then approximated from the junction of the rough and smooth zone back to the leads, bicuspidizing the valve, and trapping the ventricular leads away from the tricuspid valve orifice.
Tricuspid valve assessment: The 3 leaflets of the TV will be assessed with echocardiography. The midesophageal inflow-outflow view and the midesophageal modified bicaval TV view will be chosen for Doppler interrogation of transvalvular flow. 3D examinations will also be assessed. 3D Transesophageal echocardiography (TEE) permits the precise description of the elliptical shape of the TV annulus and its dimensions in a clinically feasible fashion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant or their legal representative has signed an informed consent
- •Over 18 years of age
- •Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD
Exclusion Criteria
- •Prior tricuspid valve repair
- •Any evidence of structural (chordal or leaflet) tricuspid valve disease
- •Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
- •Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
- •Body Mass Index (BMI) > 45
- •Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant
- •History of cardiac transplant or cardiomyoplasty
- •Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management
- •Presence of active, uncontrolled infection
- •Evidence of intrinsic hepatic disease as defined by liver enzyme values
- •History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis
- •Need for chronic renal replacement therapy (e.g. chronic dialysis)
- •Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- •Any condition, other than heart failure, that could limit survival to less than 1 year
- •Participant refuses to be enrolled in study
- •Institution inmates.
Arms & Interventions
LVAD+TVR
In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.
Intervention: Left ventricular assist device (LVAD) (Device)
LVAD+TVR
In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.
Intervention: Tricuspid Valve Repair (TVR) (Procedure)
LVAD only
LVAD placement will be performed without additional tricuspid valve repair (TVR). The inflow cannula will be sutured to the left ventricular apex followed by the outflow cannula placed in the ascending aorta. This will be performed under cardiopulmonary bypass. Echocardiographic parameters relevant to study will be collected throughout the procedure.
Intervention: Left ventricular assist device (LVAD) (Device)
Outcomes
Primary Outcomes
Change in TR severity assessment from baseline
Time Frame: 13 months
Tricuspid Regurgitation (TR) severity as measured by vena contracta width and area will be assessed using echocardiography within 7 days prior to implantation (baseline) up to 13 months postoperative. TR severity is assessed on a range of mild to severe.
Secondary Outcomes
- Change in quality of life (QOL) from baseline(13 months)
- Change in RV function from baseline(13 months)
Investigators
Kei Togashi
Assistant Professor, Division of Cardiothoracic Anesthesiology
University of Washington