Non-Intubated Anesthesia for Adult Heart Transplantation

Heart transplant recipients are at high risk of pulmonary complications and early graft dysfunction because of preexisting heart failure, cardiopulmonary bypass, ischemia-reperfusion injury, and perioperative hemodynamic changes. Conventional endotracheal intubation and mechanical ventilation provide reliable airway control but may contribute to airway injury, pulmonary complications, and delayed recovery. NISVA uses a supraglottic airway to maintain ventilation while preserving or restoring spontaneous breathing when clinically feasible, potentially reducing airway stimulation and mechanical ventilation exposure.

Eligible adults undergoing isolated orthotopic heart transplantation will be randomly assigned to NISVA or conventional endotracheal general anesthesia. Both groups will receive standard perioperative heart transplantation care. Participant safety will take priority, and endotracheal intubation or additional respiratory or circulatory support will be provided whenever clinically necessary. In addition to the 30-day cardiopulmonary composite endpoint, the study will assess pulmonary recovery, early graft function, mechanical ventilation and circulatory support, major complications, safety events, recovery milestones, length of stay, rejection, quality of life, rehospitalization, and survival for up to 1 year. Key outcomes will be evaluated according to predefined criteria, with independent assessment of the primary endpoint.

Inclusion criteria

Age 18 years or older, regardless of sex. Listed for heart transplantation and scheduled to undergo isolated orthotopic heart transplantation.

Able to breathe spontaneously without ongoing dependence on preoperative invasive mechanical ventilation.

Perioperative anesthesia, surgical, intensive care unit, and follow-up data can be collected as required by the study protocol.

Considered eligible for either NISVA or conventional endotracheal anesthesia following multidisciplinary assessment by the heart transplant surgery, anesthesia, cardiopulmonary bypass, and intensive care teams.

Relatively stable vital signs after appropriate treatment and able to complete perioperative assessments and postoperative follow-up.

Voluntary participation and written informed consent provided by the participant or the participant's legally authorized representative.

Exclusion criteria

Previous solid-organ transplantation that may substantially affect the assessment of perioperative outcomes for the current transplantation.

Planned combined organ transplantation, including combined heart-kidney, heart-liver, or heart-lung transplantation.

Complex anatomy associated with adult congenital heart disease that would substantially alter the surgical procedure or anesthetic management and is considered unsuitable for enrollment by the investigator.

Preoperative endotracheal intubation or ongoing dependence on invasive mechanical ventilation.

Severe pulmonary infection, severe respiratory failure, significant pulmonary edema, severe hypercapnia, or inability to tolerate a spontaneous ventilation anesthesia strategy, as determined by the study team.

Severe pulmonary hypertension, severe right heart failure, or severely impaired baseline right ventricular function considered to present an unacceptably high risk for NISVA.

Severe preoperative hemodynamic instability requiring high-dose vasoactive support, or use of mechanical circulatory support other than a durable left ventricular assist device or an intra-aortic balloon pump.

Known difficult airway, high risk of aspiration, full stomach, gastric retention, severe gastroesophageal reflux, or another contraindication to supraglottic airway use.

Estimated glomerular filtration rate below 40 mL/min/1.73 m², need for dialysis or ultrafiltration, or rapidly progressive renal dysfunction.

Known liver disease-related coagulopathy, severe hepatic failure, or heparin-induced thrombocytopenia.

A systemic disease that may substantially affect transplantation outcomes, including systemic lupus erythematosus, sarcoidosis, or amyloidosis.

Active sepsis or a positive blood culture before surgery. ABO-incompatible transplantation. Ongoing pretransplant desensitization therapy, including peri-transplant plasma exchange or another treatment that may substantially affect inflammatory, immunologic, or outcome assessments.

Concurrent participation in another interventional transplantation-related clinical trial that may affect the results of this study.

Pregnancy or breastfeeding. Inability to understand the study, inability to complete the informed consent process, or considered unsuitable for enrollment by the investigator.