What is the criteria and procedure for a heart transplant in patients with end-stage heart failure?

From the Guidelines

Heart transplantation is considered for patients with end-stage heart failure who have exhausted all other medical and surgical options, with primary criteria including NYHA class III-IV symptoms, severely reduced left ventricular ejection fraction, and peak oxygen consumption <14 mL/kg/min. The evaluation process for heart transplant candidacy involves comprehensive cardiac assessment, pulmonary function tests, laboratory screening, infectious disease screening, psychosocial evaluation, and dental examination, as outlined in the guidelines by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 1. Key considerations for heart transplant candidacy include:

• Severe functional impairment or dependence on intravenous inotropic agents
• Refractory cardiogenic shock
• Documented dependence on IV inotropic support to maintain adequate organ perfusion
• Peak VO2 less than 10 mL per kg per minute with achievement of anaerobic metabolism
• Severe symptoms of ischemia that consistently limit routine activity and are not amenable to coronary artery bypass surgery or percutaneous coronary intervention
• Recurrent symptomatic ventricular arrhythmias refractory to all therapeutic modalities Patients must also be free of significant comorbidities that would limit survival, including severe irreversible pulmonary hypertension, active malignancy, severe liver or kidney dysfunction, recent stroke, active infection, substance abuse within the past 6 months, and significant psychiatric illness that would impair compliance, as noted in the guidelines 1. The use of mechanical circulatory assist devices, such as left ventricular assist devices (LVADs), may be considered for patients awaiting heart transplantation or as destination therapy for those who are not transplant candidates, with studies such as the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial demonstrating improved survival with device therapy 1. After transplantation, lifelong immunosuppression is required, typically including tacrolimus or cyclosporine, mycophenolate mofetil, and corticosteroids, along with regular follow-up and surveillance for rejection and complications, as recommended in the guidelines 1.

From the FDA Drug Label

A double-blind, randomized, comparative, parallel-group, multicenter study in primary de novo heart transplant recipients was performed at centers in the United States (20), in Canada (1), in Europe (5) and in Australia (2). The two primary efficacy endpoints were: (1) the proportion of patients who, after transplantation, had at least one endomyocardial biopsy-proven rejection with hemodynamic compromise, or were re-transplanted or died, within the first 6 months, and (2) the proportion of patients who died or were re-transplanted during the first 12 months following transplantation

The criteria for a heart transplant in patients with end-stage heart failure are not explicitly stated in the provided text. However, the procedure for a heart transplant is mentioned as part of a study where patients received mycophenolate mofetil 1.5 g twice daily or AZA 1.5 to 3 mg/kg/day, in combination with cyclosporine and corticosteroids as maintenance immunosuppressive therapy 2.

• The study had two primary efficacy endpoints:
  • The proportion of patients who had at least one endomyocardial biopsy-proven rejection with hemodynamic compromise, or were re-transplanted or died, within the first 6 months
  • The proportion of patients who died or were re-transplanted during the first 12 months following transplantation
• Hemodynamic compromise occurred if any of the following criteria were met:
  • Pulmonary capillary wedge pressure >20 mm or a 25% increase
  • Cardiac index < 2.0 L/min/m² or a 25% decrease
  • Ejection fraction <30%
  • Pulmonary artery oxygen saturation <60% or a 25% decrease
  • Presence of new S3 gallop
  • Fractional shortening was <20% or a 25% decrease
  • Inotropic support required to manage the clinical condition The provided text does not give explicit criteria for a heart transplant, but it does describe a study of immunosuppressive therapy in heart transplant patients.

From the Research

Heart Transplant Criteria

• The primary criteria for a heart transplant in patients with end-stage heart failure is that they remain symptomatic despite optimal medical therapy 3, 4.
• Risk stratification is essential to identify patients who are most likely to benefit from a heart transplant, as the number of suitable donors is insufficient to meet demand 3.
• The Heart Failure Survival Score (HFSS) and Seattle Heart Failure Model (SHFM) are used to evaluate the risk of patients with end-stage heart failure 3.

Heart Transplant Procedure

• Cardiac transplantation is the treatment of choice for many patients with end-stage heart failure who have exhausted all other treatment options 4, 5.
• The procedure involves orthotopic heart transplantation, where the diseased heart is replaced with a healthy donor heart 6.
• After heart transplantation, patients require immunosuppressive therapy to prevent rejection of the donor heart 6.

Contraindications and Outcomes

• Common contraindications for heart transplant include certain medical conditions that may increase the risk of complications or reduce the chances of a successful transplant 3.
• Outcomes after heart transplantation include improved survival and quality of life, but also common complications such as coronary allograft vasculopathy 3, 7.
• Exercise training in cardiac rehabilitation programs is recommended to improve peak oxygen uptake and reduce the severity of cardiac allograft vasculopathy 7.