Outcome in patients with an ICD incorporating cardiac resynchronisation therapy: differences between primary and secondary prophylaxis.

BACKGROUND: The incidence of ventricular tachyarrhythmias in ICD patients with cardiac resynchronisation therapy (CRT-D) is not well studied. AIM: To analyse event free survival in CRT-D patients with a primary or a secondary prophylactic ICD indication. METHODS: Prospective, single centre. Eighty-six patients, 44% with a primary prophylactic indication. Actuarial event-free rates for mortality and arrhythmias were calculated. RESULTS: Baseline clinical characteristics were not significantly different between primary and secondary prophylaxis. Primary prophylaxis patients were more likely to be in NYHA class III. Over 21 months, 724 ventricular events with therapy occurred in 36 patients (42%). The actuarial event-free rates, at 1 and 3 years, from appropriate ICD therapy were higher (P<0.001) for primary (79.0% and 67.8%) than for secondary prophylaxis (45.6% and 27.0%). Appropriate ICD therapy occurred more in NYHA class II compared to class III (P=0.016). Underlying disease (ischemic versus non-ischemic) and functional class did not play a role in multivariate analysis. CONCLUSION: Important arrhythmic events in patients with heart failure, and CRT-D occur at a very high rate when the indication is secondary prophylaxis. Patients with primary prophylaxis have an annual event rate of 10%, even though they tend to have a worse heart failure class.

Abdominal aortic aneurysms after heart transplantation.

BACKGROUND: In recent years abdominal aortic aneurysms were diagnosed in several heart transplant recipients at our center. Only case reports or small series have been reported previously and little is known about abdominal aortic aneurysms after heart transplantation. Therefore, the goals of this study were to estimate the incidence of this condition after heart transplantation, to identify risk factors for its development, and to assess its clinical consequences. METHODS: Our investigation was a retrospective, single-center cohort study of 368 consecutive patients transplanted between 1984 and 1999. RESULTS: During a mean follow-up of 75 +/- 49 months, 37 of the 368 (10%) transplant recipients and 36 of 202 (18%) of the sub-group with a history of ischemic heart disease were found to have an abdominal aortic aneurysm. All patients were male, and all except 1 had a history of ischemic heart disease. A history of ischemic heart disease prior to heart transplantation was the sole independent risk factor for developing an aneurysm by multivariate analysis. Aneurysm-related events occurred earlier and more frequently in the 7 transplant recipients who already had a dilated abdominal aorta prior to transplantation. The abdominal aortic aneurysm was the direct or indirect cause of death in at least 9 patients. CONCLUSIONS: Abdominal aortic aneurysms are relatively frequent after heart transplantation, occur at a younger age than in the general population, and have serious clinical consequences. Close ultrasonographic follow-up of patients with a history of ischemic heart disease or with an abnormal abdominal aorta prior to heart transplantation seems indicated.

Ten-year follow-up of recipients of a kidney or heart transplant who received induction therapy with a monoclonal antibody against the interleukin-2 receptor.

OBJECTIVES: Twelve years ago, we performed two randomized clinical trials to investigate safety and efficacy of induction therapy with BT563, a highly potent murine monoclonal antibody against the interleukin-2 receptor after kidney and heart transplantation. We analyzed the long-term safety and efficacy data from all 120 patients who participated in the two randomized trials after kidney and heart transplantation 10 years ago. MATERIALS AND METHODS: One of these two trials was a randomized, double-blind, placebo-controlled trial, with 60 primary and secondary kidney allograft recipients (cadaveric and living-related donors). The control group was treated with the standard regimen at that time, consisting of cyclosporin and prednisone. In the study group, BT563 was added for 10 days. The second trial was a randomized, double-blind trial, with 60 recipients of a primary heart transplant. In that study, we compared induction therapy with BT563 with the standard regimen at that time, consisting of cyclosporin, prednisone, and OKT3 (both induction agents were given for 7 days). RESULTS: Patient survival in the kidney trial was excellent: in the BT563 group, 24 patients were alive (80%), and in the placebo, group 21 (70%) 10 years after transplantation. Also, graft survival was good: in the BT563 group, 63.3% of the kidneys (19/30) were functioning, in the placebo group, 72.4% (21/29) were functioning (P = 0.455). Also, in the heart study, patient (and graft) survival was excellent: 18 patients were alive in the BT563 group (58%), and in the OKT3 group, 21 (72%) patients were alive (P = ns). No increase in the incidence of malignancies was observed between patients treated with BT563 compared with the control groups. Patients following heart transplantation more often suffered from a malignancy than did patients after kidney transplantation (20/60 vs 10/59). CONCLUSIONS: We report follow-up data on all patients participating in the two randomized trials, and our data reflect a total of 932 years of patient follow-up. Patient and graft survival appear to be excellent in both the BT563-treated patients and the control groups. BT563 treatment was not associated with an increased likelihood of developing infections or malignancies.