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?

This trial aims to determine which lung transplant technique better prevents primary graft dysfunction, a complication where the new lung doesn't function well immediately. It compares two methods: one performed "off-pump" (without a machine to support circulation) and another using venoarterial ECMO (a machine that assists in pumping and oxygenating blood). Individuals needing a double lung transplant with specific lung pressure may qualify to participate, provided they do not require certain pre-surgery support or have undergone specific previous lung surgeries. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance lung transplant outcomes.

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.

What prior data suggests that these lung transplant techniques are safe?

A previous study demonstrated that off-pump lung transplantation is a safe option. This method avoids cutting through the breastbone, reducing complications and pain after surgery while maintaining better chest function.

Research on venoarterial ECMO, a machine that supports heart and lung function during surgery, has shown it is also safe. It can result in fewer lung and kidney problems compared to other support methods. Both treatments have been studied for their safety and have shown promising results.

Overall, studies have found both methods to be well-tolerated. The choice between them often depends on the specific needs of the patient and the medical team’s expertise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lung transplantation techniques because they offer innovative approaches that could improve outcomes for patients needing lung transplants. Off-pump lung transplantation eliminates the need for cardiopulmonary bypass, potentially reducing complications associated with traditional methods. On the other hand, the Venoarterial ECMO technique provides circulatory support during the transplant, which can stabilize patients with severe heart-lung conditions. Both techniques aim to enhance the safety and effectiveness of lung transplants, which are crucial for patients with end-stage lung disease.

What evidence suggests that these lung transplant techniques are effective for reducing primary graft dysfunction?

Research has shown that off-pump lung transplantation, a technique under study in this trial, can be effective and safe. This method avoids large chest incisions, potentially reducing pain and post-surgery complications. Studies also suggest it could improve chest mobility.

Another technique in this trial is venoarterial ECMO, a machine used during lung transplants to support the heart and lungs. It maintains blood and oxygen flow, which might shorten hospital stays and improve survival rates. Both methods have shown promising results, but their effectiveness can depend on individual circumstances. ^{1 2 3 4 5}

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

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10636478/

Off-pump lung re-transplantation avoiding clamshell ... This study aims to describe our center's experience to illustrate the feasibility and safety of off-pump re-LTx avoiding clamshell incision.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31004582/

Off-Pump Bilateral Lung Transplantation via Median ... This approach has the potential to combine the advantages of median sternotomy with less postoperative pain, better chest wall function, and reduced risk of ...

3. researchgate.net researchgate.net/publication/332503873_Off-Pump_Bilateral_Lung_Transplantation_via_Median_Sternotomy_A_Novel_Approach_With_Potential_Benefits

Off-Pump Bilateral Lung Transplantation via Median Sternotomy The bilateral anterolateral thoracotomy without sternal splitting is a safe and effective approach for BSLT; it allows to avoid sternal complications and ...

4. jtcvstechniques.org jtcvstechniques.org/article/S2666-2507(25)00132-4/fulltext

Current intraoperative mechanical circulatory support ... The current evidence supporting use of the off-pump technique versus routine use of ECMO/CPB in “standard” cases is still evolving, and an ongoing randomized ...

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/BOLT

Veno-Arterial ECMO Versus Off-Pump Bilateral Orthotopic ... The purpose of this study is to compare the technique of performing bilateral lung transplantation off-pump versus venoarterial ECMO.