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How many endomyocardial biopsies are necessary in the first year after heart transplantation?
Insights
Reducing routine endomyocardial biopsies (EMBs) in heart transplant recipients on effective immunosuppression is safe. This approach, using cyclosporin, azathioprine, and prednisone, maintained excellent survival rates and low rejection incidence.
Area of Science:
- Cardiology
- Immunology
- Transplantation Medicine
Background:
- The standard immunosuppressive regimen for heart transplant (HTx) patients has historically included frequent endomyocardial biopsies (EMBs) to monitor for rejection.
- Optimizing immunosuppression and reducing invasive procedures are key goals in post-transplant care.
Purpose of the Study:
- To evaluate the safety and efficacy of reducing routine endomyocardial biopsies (EMBs) in heart transplant recipients receiving a specific immunosuppressive regimen.
- To assess the incidence of acute rejection and patient survival rates with a modified EMB protocol.
Main Methods:
- A retrospective analysis of 100 consecutive heart transplant patients treated with cyclosporin, azathioprine, and prednisone without prophylactic cytolytic agents.
- Gradual reduction in the frequency of routine endomyocardial biopsies (EMBs) over three patient subgroups.
- Monitoring for acute rejection episodes and requiring increased immunosuppression or treatment.
Main Results:
- The incidence of acute rejection requiring increased therapy was 24%, with only 7% needing intravenous steroids and 2% requiring ALG and/or OKT3.
- Actuarial survival rates were 98% at 30 days, 94% at 1 year, and 92% at 2 years.
- The mean number of EMBs per patient in the first year decreased significantly in later patient cohorts.
Conclusions:
- An effective immunosuppressive regimen (cyclosporin, azathioprine, prednisone) may allow for a reduction in routine endomyocardial biopsies (EMBs) without compromising patient outcomes.
- The number of routine EMBs performed at many centers may be excessive, and a less invasive approach is feasible.
- Excellent medium-term survival suggests that reduced EMB frequency did not lead to hemodynamically significant missed rejection episodes.
Abstract:
Since 1989, the immunosuppressive regimen used in all heart transplant (HTx) patients at our center has consisted of a combination of cyclosporin, azathioprine, and prednisone. No prophylactic cytolytic agents have been given. One hundred consecutive patients were followed for periods of 4-56 months (mean 27 months). The incidence of rejection was so low in the initial 18 patients that we felt confident about reducing the number of routine endomyocardial biopsies (EMBs) that were performed. The mean number of EMBs in this subgroup was 10 (median 11). In the next 20 patients, EMB was performed routinely on only three occasions during the 1st post-transplant year (at 2, 4, and 8 weeks). In the subsequent 62 patients, EMB was performed on post-transplant days 10, 20, 30, and 60. Further EMBs were performed after acute rejection episodes had been treated. No noninvasive methods of diagnosing rejection were employed. In 82 consecutive patients, therefore, the mean number of EMBs within the 1st year was five per patient (median four), with 58% undergoing fewer than five EMBs and 25% requiring more than five EMBs. In the entire group of 100 patients, the mean number of EMBs was 5.9. The incidence of acute rejection requiring increased therapy was 24%. Only 7% required i.v. steroids, two of whom (2%) also required ALG and/or OKT3, with 17% requiring increased oral immunosuppression alone. Actuarial survival was 98% at 30 days, 94% at 1 year, and 92% at 2 years. It is possible that we may have missed acute rejection episodes that resolved spontaneously. However, the excellent medium-term results would suggest that any such rejection episode did not progress to become hemodynamically significant. It may be, therefore, that when an effective immunosuppressive regimen is utilized, the number of EMBs performed at many centers is excessive.