Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
University of Washington
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.
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 cli…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant or their legal representative has signed an informed consent 2. Over 18 years of age 3. Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD Exclusion Criteria: 1. Prior tricuspid valve repair 2. Any evidence of structural (chordal or leaflet) tricuspid valve disease 3. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator 4. Existence of any ongoing mechanical circulatory support other than intra-aortic ba…
Interventions
- DeviceLeft ventricular assist device (LVAD)
Left ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.
- ProcedureTricuspid Valve Repair (TVR)
Participants will be randomly assigned to receive a tricuspid valve repair (TVR) to repair their tricuspid valve regurgitation in addition to an LVAD placement. Only half of enrolled participants will receive this procedure.
Location
- University of Washington Medical CenterSeattle, Washington