Tricuspid Valve Repair + LVAD for Heart Failure

Overseen by Kei Togashi, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Disqualifiers: Pregnancy, Stroke, Infection, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether fixing a leaky heart valve during the implantation of a heart pump can help patients who have mild to moderate valve issues. The goal is to see if this combined approach improves heart function and reduces complications after surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tricuspid Valve Repair + LVAD for Heart Failure?

Research shows that using a left ventricular assist device (LVAD) like HeartMate II or HeartMate 3 can significantly improve survival in patients with severe heart failure. Additionally, combining LVAD with tricuspid valve repair has been successfully used in some cases, although it may increase the risk of temporary right heart support. ^{1 2 3 4 5}

Is the combination of Tricuspid Valve Repair and LVAD generally safe for humans?

Research shows that the HeartMate II and HeartMate 3 LVADs have been used safely in patients with advanced heart failure, with studies focusing on outcomes like stroke and mortality. The HeartMate 3, in particular, has been evaluated for safety and effectiveness, and the combination with tricuspid valve procedures has been assessed for safety in patients with these devices. ^{6 7 8 9 10}

How is the treatment of tricuspid valve repair with LVAD unique for heart failure?

This treatment is unique because it combines tricuspid valve repair with the implantation of a left ventricular assist device (LVAD), which helps the heart pump blood. This approach addresses both the mechanical support of the heart and the repair of valve issues, which may improve outcomes for patients with heart failure. ^{3 7 11 12 13}

Research Team

Kei Togashi, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 18 with advanced heart failure symptoms who are scheduled for an LVAD implant and have mild tricuspid regurgitation. It's not for pregnant individuals, those with psychiatric or severe cognitive issues, uncontrolled infections, other life-limiting conditions, high surgical risk as judged by the investigator, participation in confounding studies, inmates, liver disease patients, recent stroke victims or significant cerebral vascular disease sufferers.

Inclusion Criteria

I have severe heart failure and am getting an LVAD implant.

Participant or their legal representative has signed an informed consent

I am over 18 years old.

Exclusion Criteria

Pregnancy

I have not had a stroke or significant blockage in my brain's blood vessels in the last 3 months.

You are currently using any mechanical heart support other than an intra-aortic balloon pump.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-randomization

Participants undergo medical history, physical exam, and echocardiogram prior to randomization

4 weeks

1 visit (in-person)

Treatment

Participants receive LVAD implantation with or without tricuspid valve repair

10 days

Inpatient stay

Follow-up

Participants are monitored for changes in RV function, TR severity, and quality of life

13 months

Regular follow-up visits

Treatment Details

Interventions

• Left ventricular assist device (LVAD) (Device)
• Tricuspid Valve Repair (TVR) (Procedure)

Trial Overview The study examines if surgically fixing the tricuspid valve at the same time as implanting a left ventricular assist device (LVAD) can improve health outcomes. Researchers will monitor how well the repaired valve works post-surgery and look at patient recovery times and quality of life.

Participant Groups

Group I: LVAD+TVR Experimental Treatment 2 Interventions

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.

Group II: LVAD only Active Control 1 Intervention

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.

Left ventricular assist device (LVAD) is already approved in Canada, Japan for the following indications:

Approved in Canada as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

Approved in Japan as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Society of Cardiovascular Anesthesiologists

Collaborator

Trials

3

Recruited

5,600+

Findings from Research

The study presents the largest single-center experience of exchanging a HeartMate II (HMII) LVAD for a HeartWare (HVAD) device, involving 11 male patients with a mean age of 55 years, demonstrating that this exchange can be performed safely with manageable postoperative complications.

Despite one early postoperative death due to sepsis, the overall outcomes were acceptable, with no patients requiring further device exchanges or heart transplants during the follow-up period, which averaged over 1555 days for the remaining patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device exchange from Heartmate II to HeartWare HVAD. Beaupre, RA., Alnajar, A., Sugiura, T., et al.[2020]

In a study comparing the HeartWare HVAD and HeartMate3 devices, mid-term survival rates were similar for both devices, with 2-year survival at 61% for HVAD and 68% for HeartMate3, indicating comparable efficacy in supporting patients with severe heart failure.

However, patients using the HeartWare HVAD experienced a significantly higher risk of complications, including device malfunction, neurological dysfunction, and intracranial bleeding, suggesting that while survival rates are similar, the safety profile of HVAD may be concerning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis. Potapov, EV., Nersesian, G., Lewin, D., et al.[2021]

In a study of 526 patients who received left ventricular assist devices, 21% underwent concomitant tricuspid valve repair, which was associated with a higher incidence of early right heart failure requiring temporary right ventricular assist devices (18% vs. 11%).

Despite the increased risk of early right heart failure, the study found no significant differences in long-term outcomes such as rehospitalizations or mortality between patients who had tricuspid repair and those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant tricuspid valve repair in left ventricular assist device implantation may increase the risk for temporary right ventricular support but does not impact overall outcomes. Mihalj, M., Jezovnik, MK., Benk, J., et al.[2023]

The HeartMate 3 is currently the only commercially available durable left ventricular assist device for patients with end-stage heart failure, highlighting its importance in treatment options.

Patients needing a pump exchange from the HeartWare HVAD must transition to the HeartMate 3, indicating its central role in ongoing heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HeartWare to HeartMate 3 left ventricular assist device exchange via a left lateral thoracotomy. Nersesian, G., Montagner, M., Lanmueller, P., et al.[2022]

From 2017 to 2019, in-hospital mortality rates for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD) decreased significantly, showing a trend of -1.8% per year, indicating improved survival outcomes.

Despite the decrease in mortality, the rates of in-hospital strokes (both ischemic and hemorrhagic) did not show significant changes, suggesting that while LVADs improve survival, they are still associated with a higher risk of stroke (almost double the odds compared to those without LVAD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-hospital stroke and mortality trends after left ventricular assist device implantation in the United States from 2017 to 2019. Lopez, J., Mark, J., Wahood, W., et al.[2023]

In a study of 83 patients with advanced heart failure, those who underwent a concomitant tricuspid valve procedure during HeartMate II implantation experienced a significant reduction in tricuspid regurgitation by 50.2% after one month, compared to a worsening of 18.6% in those who did not have the procedure.

The tricuspid valve procedure also led to improvements in right ventricular remodeling, as indicated by a significant reduction in right ventricular end-diastolic area, while overall survival rates were similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices. Maltais, S., Topilsky, Y., Tchantchaleishvili, V., et al.[2022]

A retrospective analysis of 200 patients (100 with HeartWare HVAD and 100 with HeartMate 3) showed that while early survival rates at one year were similar for both devices (62.2% for HW and 66.7% for HM3), the complication profiles differed significantly.

Patients with the HeartWare HVAD experienced a higher incidence of cerebral bleeding and hemocompatibility-related adverse events compared to those with the HeartMate 3, indicating that while both devices are effective, the HeartMate 3 may have a safer profile regarding certain complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre. Mueller, M., Hoermandinger, C., Richter, G., et al.[2021]

The HeartMate II (HM II) LVAD has been successfully implanted in 571 patients across Europe, showing a 69% overall survival rate to transplantation, recovery, or ongoing support, with a mean support duration of 236 days.

While the HM II LVAD is effective for long-term support in advanced heart failure, there are notable adverse events, including high rates of bleeding (42-59%) and infections, indicating a need for improved management of these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European results with a continuous-flow ventricular assist device for advanced heart-failure patients. Lahpor, J., Khaghani, A., Hetzer, R., et al.[2019]

In a study of 27 patients receiving the HeartMate 3 (HM3) left ventricular assist device, the 1-year survival rate was 85.2%, with no cases of pump thrombosis or strokes reported, indicating a strong safety profile.

The main complication observed was LVAD-related infection in 22.2% of patients, but overall, the HM3 demonstrated excellent midterm outcomes with no technical complications or need for pump exchanges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. Hanke, JS., Dogan, G., Zoch, A., et al.[2019]

In a study of 352 adult patients undergoing LVAD implantation, 24% had concomitant cardiac procedures, primarily tricuspid valve annuloplasty, which was associated with higher in-hospital mortality (22% vs. 14%) compared to those without additional surgeries.

Despite the increased perioperative risks, one-year survival rates were similar between patients who had concomitant procedures and those who did not (71% vs. 79%), suggesting that while these procedures may complicate the immediate recovery, they do not significantly impact long-term survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant cardiac surgery procedures during left ventricular assist device implantation: single-centre experience. Riebandt, J., Schaefer, A., Wiedemann, D., et al.[2022]

In a study of 101 patients undergoing LVAD implantation, those who received tricuspid valve repair (TVR) showed a significant improvement in survival rates compared to those who did not, with a hazard ratio of 0.1 (p = 0.049).

Despite the survival benefit, there was no significant difference in the incidence of right ventricular failure (RVF) between the TVR and non-TVR groups, suggesting that while TVR may enhance survival, it does not necessarily prevent RVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival. Brewer, RJ., Cabrera, R., El-Atrache, M., et al.[2022]

In a study of 156 patients who underwent tricuspid valve repair (TVr) during left ventricular assist device (LVAD) implantation, 37.8% experienced failure of the TVr, indicating a significant rate of recurrence of tricuspid regurgitation (TR).

The failure of TVr was found to be an independent predictor of late right heart failure (RHF), with a hazard ratio of 2.62, suggesting that patients with failed TVr are at a higher risk for developing late RHF after LVAD surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability and Efficacy of Tricuspid Valve Repair in Patients Undergoing Left Ventricular Assist Device Implantation. Barac, YD., Nicoara, A., Bishawi, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Device exchange from Heartmate II to HeartWare HVAD. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Concomitant tricuspid valve repair in left ventricular assist device implantation may increase the risk for temporary right ventricular support but does not impact overall outcomes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

HeartWare to HeartMate 3 left ventricular assist device exchange via a left lateral thoracotomy. [2022]

5. South Africa pubmed.ncbi.nlm.nih.gov

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

In-hospital stroke and mortality trends after left ventricular assist device implantation in the United States from 2017 to 2019. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

European results with a continuous-flow ventricular assist device for advanced heart-failure patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. [2019]

11. China pubmed.ncbi.nlm.nih.gov

Concomitant cardiac surgery procedures during left ventricular assist device implantation: single-centre experience. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Durability and Efficacy of Tricuspid Valve Repair in Patients Undergoing Left Ventricular Assist Device Implantation. [2021]