Lung Transplant Techniques for Lung Transplant

Recruiting at 9 trial locations

Overseen By Jackie Reiter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Single lung transplant, Multiorgan transplant, Re-transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative plus the first 24 hours in the ICU

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Do I need to stop my current medications for the trial?

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.

How does the treatment Off-pump lung transplantation with Venoarterial ECMO differ from other treatments for lung transplantation?

Off-pump lung transplantation with Venoarterial ECMO (VA ECMO) is unique because it avoids the use of cardiopulmonary bypass, which can reduce the risk of bleeding and primary graft dysfunction. This approach also allows for better chest wall function and less postoperative pain compared to traditional methods that use extracorporeal circulation. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Off-pump lung transplantation and Venoarterial ECMO for lung transplant?

Research suggests that using venoarterial extracorporeal membrane oxygenation (VA ECMO) during lung transplants may be more effective than off-pump support for patients without severe lung blood pressure issues. VA ECMO is increasingly used and may offer better outcomes compared to traditional methods. ^{1 3 5 6 7}

Who Is on the Research Team?

Mauricio Villavicencio, MD, MBA

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people who need both lungs replaced and can have surgery with or without a heart-lung machine (ECMO), as decided by their surgeon. They must have a certain level of blood pressure in the lungs to qualify. It's not for those needing only one lung, multiple organs, re-transplants, or who had major lung surgeries before.

Inclusion Criteria

Mean pulmonary artery pressure < or = 35 mmHg

I have received a transplant for both of my lungs.

My surgeon thinks I can have surgery without using a heart-lung machine.

Exclusion Criteria

My organ donor died of cardiac failure.

I plan to use a machine to help my heart and lungs after surgery.

I have had a single lung transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral lung transplantation using either off-pump or VA ECMO techniques

Intraoperative plus the first 24 hours in the ICU

Follow-up

Participants are monitored for safety and effectiveness, including incidence of PGD, mortality, and other complications

90 days

Long-term follow-up

Participants are monitored for long-term outcomes such as transplant rejection and overall survival

Up to 90 days or discharge from the index hospitalization

What Are the Treatments Tested in This Trial?

Interventions

• Off-pump lung transplantation
• Venoarterial ECMO lung transplantation

Trial Overview The study compares two ways to do lung transplants: 'off-pump' without using ECMO and using venoarterial ECMO during the procedure. The main focus is on which method leads to fewer complications with the new lungs starting to work ('primary graft dysfunction').

How Is the Trial Designed?

Group I: Off-Pump Bilateral Lung Transplantation Active Control 1 Intervention

Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care

Group II: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation Active Control 1 Intervention

Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Off-pump lung transplantation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Off-pump lung transplantation for:

• End-stage lung disease
• Cystic fibrosis
• Bronchiectasis
• Pulmonary hypertension
• Emphysema
• Pulmonary fibrosis

Approved in United States as Off-pump lung transplantation for:

• End-stage lung disease
• Cystic fibrosis
• Bronchiectasis
• Pulmonary hypertension
• Emphysema
• Pulmonary fibrosis

Approved in Canada as Off-pump lung transplantation for:

• End-stage lung disease
• Cystic fibrosis
• Bronchiectasis
• Pulmonary hypertension
• Emphysema
• Pulmonary fibrosis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The new 'bilateral single lung' transplantation technique allows for the successful transplantation of both lungs without the complications associated with traditional methods, such as tracheal issues and the need for cardiopulmonary bypass.

This technique is particularly beneficial for patients with severe pleural adhesions, as it combines the advantages of single lung transplantation while effectively addressing the challenges of bilateral lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique for double lung transplantation. "Bilateral single lung" transplantation. Bisson, A., Bonnette, P.[2004]

Intraoperative venoarterial extracorporeal membrane oxygenation (VA-ECMO) during lung transplantation resulted in fewer blood transfusions and shorter mechanical ventilation compared to cardiopulmonary bypass (CPB), based on a study of 795 patients from 2011 to 2020.

Despite differences in postoperative recovery, neither VA-ECMO nor CPB was linked to improved survival rates at 1 or 3 years, indicating that both methods are similarly safe in terms of long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Support for Primary Bilateral Lung Transplantation: A Propensity-Matched Analysis. Chan, EG., Hyzny, EJ., Furukawa, M., et al.[2023]

In a study of 237 patients undergoing bilateral orthotopic lung transplantation (BOLT), those who received planned venoarterial extracorporeal membrane oxygenation (VA ECMO) had significantly higher odds of achieving a 'textbook outcome' compared to those who had off-pump support, with an odds ratio of 3.89.

The study suggests that planned VA ECMO may be a superior support strategy for lung transplant recipients without pulmonary hypertension, indicating its potential benefits in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Textbook outcome in lung transplantation: Planned venoarterial extracorporeal membrane oxygenation versus off-pump support for patients without pulmonary hypertension. Halpern, SE., Wright, MC., Madsen, G., et al.[2023]

Recent trends in lung transplantation show a shift from using cardiopulmonary bypass (CPB) to intraoperative extracorporeal membrane oxygenation (ECMO), which has been associated with improved survival rates for patients during and after surgery.

A meta-analysis indicates that while ECMO provides favorable outcomes compared to CPB, there is currently no randomized controlled trial to definitively guide the choice of mechanical circulatory support strategy in lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulatory support during lung transplantation. Kiziltug, H., Falter, F.[2021]

Off-pump strategies during lung transplantation are associated with better outcomes compared to traditional cardiopulmonary bypass (CPB), suggesting they should be prioritized when possible.

Extracorporeal membrane oxygenation (ECMO) generally shows better outcomes than CPB, but the evidence is not strong enough to definitively recommend it over other methods, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mechanical cardiopulmonary support strategies during lung transplantation. Weingarten, N., Schraufnagel, D., Plitt, G., et al.[2022]

Extracorporeal life support (ECLS) techniques, particularly venovenous ECMO, are crucial in thoracic surgery and lung transplantation for providing mechanical support and facilitating gas exchange, with the choice of vascular access tailored to patient needs.

Venoarterial ECMO, especially in its central configuration, is preferred in lung transplantation to reduce hemorrhagic risks and primary graft dysfunction, highlighting the importance of selecting the appropriate ECLS method based on clinical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access for extracorporeal life support: tips and tricks. Reeb, J., Olland, A., Renaud, S., et al.[2022]

The novel off-pump technique for bilateral lung transplantation via median sternotomy may reduce postoperative pain and improve chest wall function compared to the standard clamshell incision approach.

This method also aims to lower the risks of primary graft dysfunction and bleeding complications, addressing some of the disadvantages associated with using cardiopulmonary bypass in traditional surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Pump Bilateral Lung Transplantation via Median Sternotomy: A Novel Approach With Potential Benefits. Senbaklavaci, O.[2019]

Citations

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

A new technique for double lung transplantation. "Bilateral single lung" transplantation. [2004]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative Support for Primary Bilateral Lung Transplantation: A Propensity-Matched Analysis. [2023]

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

Textbook outcome in lung transplantation: Planned venoarterial extracorporeal membrane oxygenation versus off-pump support for patients without pulmonary hypertension. [2023]

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

Circulatory support during lung transplantation. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of mechanical cardiopulmonary support strategies during lung transplantation. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Vascular access for extracorporeal life support: tips and tricks. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Off-Pump Bilateral Lung Transplantation via Median Sternotomy: A Novel Approach With Potential Benefits. [2019]