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Biomedical subjects

M G Crespo-Leiro

Publications and source records attributed to M G Crespo-Leiro.

At least 19 recordsLinked to original sources
PubMed2006

Superior prevention of acute rejection by tacrolimus vs. cyclosporine in heart transplant recipients--a large European trial.

We compared efficacy and safety of tacrolimus (Tac)-based vs. cyclosporine (CyA) microemulsion-based immunosuppression in combination with azathioprine (Aza) and corticosteroids in heart transplant recipients. During antibody induction, patients were randomized (1:1) to oral treatment with Tac or CyA. Episodes of acute rejection were assessed by protocol biopsies, which underwent local and blinded central evaluation. The full analysis set comprised 157 patients per group. Patient/graft survival was 92.9% for Tac and 89.8% for CyA at 18 months. The primary end point, incidence of first biopsy proven acute rejection (BPAR) of grade >/= 1B at month 6, was 54.0% for Tac vs. 66.4% for CyA (p = 0.029) according to central assessment. Also, incidence of first BPAR of grade >/= 3A at month 6 was significantly lower for Tac vs. CyA; 28.0% vs. 42.0%, respectively (p = 0.013). Significant differences (p < 0.05) emerged between groups for these clinically relevant adverse events: new-onset diabetes mellitus (20.3% vs. 10.5%); post-transplant arterial hypertension (65.6% vs. 77.7%); and dyslipidemia (28.7% vs. 40.1%) for Tac vs. CyA, respectively. Incidence and pattern of infections over 18 months were comparable between groups, as was renal function. Primary use of Tac during antibody induction resulted in superior prevention of acute rejection without an associated increase in infections.

Acute Disease↗
PubMed2005

Independent predictors of renal dysfunction after heart transplantation in patients with normal pretransplant renal function.

BACKGROUND: Renal dysfunction (RD) is a common complication after heart transplantation (HT), but predictors of post-HT RD have not been clearly identified. METHODS: We studied 262 HT patients (mean age 54 years, 221 men) with normal baseline renal function. Potential risk factors examined were age, sex, pre-HT ischemic cardiomyopathy, pre- and post-HT diabetes mellitus, pre- and post-HT arterial hypertension, initial immunosuppressive protocol (before 1998 [high cyclosporine, azathioprine, and prednisone] vs after 1998 [low cyclosporine, mycophenolate mofetil, and prednisone]), occurrence of rejection episodes > or =ISHLT Grade 3A, and creatinine level 1 month after HT. RD was considered mild if creatinine level was 1.5 to 2.5 mg/dl, moderate if creatinine level was >2.5 mg/dl, and severe if dialysis or kidney transplant was required. RESULTS: The cumulative incidence of RD (creatinine >1.5 mg/dl) was 35% at 12 months, 42% at 24 months, and 47% at 60 months (mean follow-up 59 +/- 31 months). Only 1% of patients had severe RD 60 months after HT. Independent predictors of RD 24 months after HT were older age (odds ratio [OR] 1.1 [95% confidence interval (95% CI) 1.0-1.1]; p = 0.001), male sex (OR 3.3 [95% CI 1.3-8.1]; p = 0.008), pre-1998 immunosuppressive protocol (OR 2.8 [95% CI 1.4-5.4]; p = 0.003), and creatinine level 1 month after HT (OR 3.2 [95% CI 1.0-5.4]; p < 0.0001). CONCLUSIONS: The cumulative incidence of RD in HT patients treated with calcineurin inhibitors increased with time after HT. Age, male sex, an immunosuppressive protocol with relatively high cyclosporine levels and creatinine level 1 month after HT were independent predictors of the presence of RD 24 months after HT.

Adult↗
PubMed2005

Calcineurin inhibitors in heart transplantation.

The calcineurin inhibitors (CNIs) cyclosporine and tacrolimus are routinely used for immunosuppression following heart transplantation in conjunction with an antiproliferative agent with or without maintenance steroids. In randomized multicenter trials both agents showed similar efficacies to prevent rejection and death within the first year after transplant. Neither cyclosporine nor tacrolimus have been shown to prevent coronary allograft vasculopathy. Their use is limited by many side effects like kidney damage, hypertension, new-onset diabetes, and hyperlipidemia, although they may have different cardiovascular side effect profiles. The choice of CNIs seems to be currently dictated by their adverse effect profiles, by the results obtained for the individual patient, and possibly by institutional preference.

Calcineurin Inhibitors↗
PubMed2005

Long-term results of heart transplant in recipients older and younger than 65 years: a comparative study of mortality, rejections, and neoplasia in a cohort of 445 patients.

BACKGROUND: Whether being older than 65 years should be considered an absolute counterindication to heart transplant (HT), as it is in some centers, is controversial. In our centre, patients older than 65 years are accepted for HT if they satisfy stringent conditions. The aim of this study was to examine whether heart recipients older than 65 years have a greater risk of rejection, neoplasia, or mortality than younger ones. METHODS: We studied 445 patients who underwent HT between April 1991 and December 2003, 42 of whom were older than 65 years and 403 who were 65 years or younger. The parameters evaluated were the cumulative incidences of neoplasias and rejections (ISHLT grade > or = 3A), and the survival rates 1 month, 1 year, and 5 years post-HT. RESULTS: The two groups had similar percentages of patients with at least one rejection episode (< or =65 years 56.9%, >65 years 51.3%; P > .05), and although there were proportionally almost twice as many tumors in the older group (14.2%) as in the younger (7.9%), this difference was not statistically significant either. Nor were there any significant differences in survival, the 1-month, 1-year, and 5-year rates being 87.8%, 82.1%, and 68.8%, respectively, in the younger group and 85.7%, 78.6%, and 73.4%, respectively, in the older. CONCLUSIONS: Among carefully selected patients aged more than 65 years, HT can be performed without incurring greater risk of rejection, malignancy, or death than is found among recipients younger than 65 years.

Age Factors↗
PubMed2005

Safety of statins when response is carefully monitored: a study of 336 heart recipients.

BACKGROUND: Statins are used as first-line drugs against hypercholesterolemia after heart transplantation. Randomized clinical trials have shown that they reduce cholesterol levels, and the incidence of rejection and coronary vasculopathy. Adverse effects have been related to the use of certain statins, high statin dosages, comorbidities, and coadministration with cyclosporine. However, estimation of the risk of adverse effects for a given patient is difficult. The aims of this study were to determine the incidence of various kinds of adverse effect of statins; to evaluate certain potential risk factors; and to assess the efficacy of early response to signs of adverse effects. METHODS: Between April 1991 and December 2003, we retrospectively evaluated 336 heart transplant patients (including 55 women) with regard to the occurrence of possible adverse effects of statins (rhabdomyolysis, myalgia, hepatotoxicity, high CK without muscle symptoms, and others). Resolution on reduction of dosage or discontinuance and/or change of statin were deemed to constitute confirmation of cause. Relations were sought between adverse effects and age, sex, immunosuppressive therapy, kidney failure, body mass index (BMI), arterial hypertension, and diabetes mellitus. RESULTS: Possible adverse events of statins were suffered by 60 patients, all of them men. The causal role of statins was confirmed in 41 (12.2% of all 336): hepatotoxicity was suffered by 13, high CK without muscle ache or weakness by 18, rhabdomyolysis by 5, myalgia by 3, and other effects by 2. The incidence of confirmed statin-related complications was higher among patients with BMI >29 kg/m(2) than among those with lower BMI (P = .055). None of the patients with confirmed statin-related complications needed dialysis, none died, and permanent suspension of statin treatment was only necessary in 13 cases (3.9% of the 336). CONCLUSIONS: Some 10% to 20% of HT patients appear to suffer adverse side effects of initial statin therapy. However, early detection of such effects through diligent clinical and analytical monitoring allows the therapy to be modified in time to minimize the appearance of severe complications. In only a minority of cases permanent suspension of statin therapy is necessary.

Adolescent↗
PubMed2003

Tacrolimus in heart transplantation.

Tacrolimus (Tac), which blocks T- and B-cell proliferation by inhibiting calcineurin, was first used for immunosuppression following heart transplant (HT) in 1989. Two multicenter randomized trials have compared Tac to the oil-based cyclosporine (CsA) formulation (both combined with azathioprine and steroids) in HT patients. The two drugs displayed similar patient survival rates and incidences of rejection, nephrotoxicity, diabetes, and infections. The Tac group however, showed a lower incidence of arterial hypertension (and, in one study, of dyslipidemia). A pilot study of Tac in combination with mycophenolate mofetil (MMF) and steroids suggested that maintenance of serum mycophenolic acid levels at 2.5 to 4.5 microg/mL yields lower rejection rates without greater toxicity than previous regimens. Currently, a European multicenter randomized trial is comparing Tac with Neoral CsA, both used in combination with MMF, steroids, and induction antibodies. For patients undergoing primary immunosuppression with CsA, Tac has proved effective for rescue from steroid-resistant acute rejection. It also has tentatively been used without other drugs in selected patients. It is a valid alternative to CsA in current immunosuppressive regimens, because it does not cause gingival hyperplasia or hirsutism and, thus, may improve the quality of life and treatment compliance of female and pediatric patients. It may be preferable to CsA for patients with arterial hypertension or intractable dyslipidemia. Current and future studies will clarify the efficacy and safety of regimens combining Tac with MMF or rapamycin.

Drug Therapy, Combination↗
PubMed2003

Neither acute rejection nor immunosuppressant drug therapy (cyclosporine or tacrolimus) correlates with expression of either CD40 or CD154 on peripheral blood cells among human cardiac transplant patients.

Acute allograft rejection (AAR) is an important cause of graft loss following heart transplantation (HT). Increasing evidence shows that CD40-CD154 interactions play a central role in the immune processes leading to AAR. In this study we investigated the expression of CD40 and CD154 on peripheral blood cells from HT patients so as to determine possible association with AAR. Using two-color flow cytometry, we determined the expression of CD40 and CD154 in 102 samples of peripheral blood taken from 53 adult HT patients and in 17 samples from healthy adult volunteers. Samples from patients were obtained at the same time as endomyocardial biopsy was performed. We analyzed the relationships between the expression of these molecules and the following parameters: immunosuppressive treatment (cyclosporine vs tacrolimus), gender, age, time post-HT, and AAR (indicated by an ISHLT rating > or =3A). The percentages of HT patients' blood samples showing above-normal CD40 or CD154 expression did not differ significantly from those of controls. The percentage of patients' samples showing above-normal CD40 expression decreased with time after HT. Expression of these molecules was not above normal during rejection episodes, and for neither was there any statistically significant correlation between expression level and the immunosuppressor drug.

Adult↗
PubMed2003

Renal dysfunction after orthotopic heart transplantation: incidence, natural history, and risk factors.

BACKGROUND: Renal dysfunction is a common complication after orthotopic heart transplantation (HT). The importance of factors other than exposure to immunosuppressive drugs is unclear. The purpose of this study was to determine the incidence and natural history of renal dysfunction following heart transplantation, and to evaluate a number of variables as risk factors for this condition. METHODS: We examined the creatinine levels at 1, 6, 12, 24, and 60 months in 262 consecutive heart transplant patients who survived at least 1 year. The potential risk factors included pre- and posttransplantation diabetes mellitus, arterial hypertension, and drugs used to control arterial hypertension. RESULTS: 17.2% of patients showed mild renal dysfunction (creatinine 1.5-2.5 mg/dL) and 1.9% moderate dysfunction (creatinine >2.5 mg/dL) at 1 month; 29.8% showed mild and 1.1% moderate dysfunction at 6 months; 33.2% showed mild and 1.9% moderate dysfunction at 1 year; 40% showed mild, 0.9% moderate and 0.4% severe dysfunction (requiring dialysis or renal transplantation) at 2 years; and 43.6% showed mild, 1.7% moderate and 0.9% severe dysfunction at 5 years. None of the conditions analyzed as possible risk factors showed a significant association with renal dysfunction except the use of diuretics. CONCLUSION: The incidence of renal dysfunction after orthotopic heart transplantation was 33.6% within the first year after transplant and 44% within the first five years, although more than 95% of cases were mild. The incidence increased with time after transplantation. Renal dysfunction seems likely to be multifactorial in origin, but no individual risk factors were identified.

Creatinine↗
PubMed2003

Hypotension, acidosis and vasodilation syndrome after heart transplant: incidence, risk factors, and prognosis.

BACKGROUND: HAV syndrome, the combination of hypotension, acidosis and vasodilation (HAV), is a serious postoperative complication after heart transplantation (HT). Its etiology and prognosis are poorly understood. AIM: To determine the incidence and prognosis of post-HT HAV syndrome and examine possible risk factors. METHODS: Retrospective examination of the records of 85 consecutive patients who underwent HT between December 1999 and June 2002 sought the HAV criteria: systolic BP <85 mm Hg plus HCO3 <19 mEq/l whole excluding cardiogenic, hypovolemic and septic shock. Donor variables included sex, age, weight, height, cause of death, time in ICU, and ischemic time; while recipient variables, sex, age, weight, height, etiology of cardiopathy, previous cardiopulmonary bypass surgery, preoperative amiodarone, beta-blockers, catecholamines, mechanical ventilation or intra aortic balloon pump (IABP), RVP, time on waiting list, pump time, reoperations, polytransfusion, preoperative creatinine, GOT, GPT and GGT, induction with OKT3 or anti-CD25, bypass-to-HAV time, duration of catecholamine treatment, and 1 month survival after HT. RESULTS: The 11 HAV cases (13%) appeared between 1 and 72 h after HT (75% in the first hour). Catecholamines were used for 1 to 6 days; control was achieved within 48 h in 58% of cases. Two HAV patients (18%) died within the first month versus six non-HAV patients (8.1%) (P=.275). Only polytransfusion showed more than a borderline value to predict HAV syndrome. CONCLUSIONS: HAV syndrome has an incidence of 13% and a mortality of 18% within 1 month post-HT. The only likely risk factor is polytransfusion.

Acidosis↗
PubMed2000

[Dermatologic complications after heart transplantation: incidence and prognosis].

BACKGROUND: This study was conducted to analyze the type, incidence, predisposing factors and prognosis of cutaneous complications (CC) occurring in heart transplant recipients (HTR). PATIENTS AND METHODS: A retrospective study was carried out among 192 HTR with a survival > 1 month. The following variables were recorded: age, sex, place of residence, post-transplant diabetes, glucocorticoid dose, prophylaxis with acyclovir/itraconazole and CC. RESULTS: One hundred sixty three CC were diagnosed in 93 patients. The major types were infectious complications (n = 115; 70.5%) and tumors (n = 20; 12.3%). The most common infections were viral (herpes zoster; n = 22) and fungal (pityriasis versicolor; n = 53). Out the 20 tumors, 3 were malignant: 2 squamous cell carcinomas (SCC) and 1 Kaposi sarcoma. None of the CC caused mortality or prolonged hospital stay. No relationship was found between CC and the variables studied. CONCLUSIONS: Skin infections were the most common CC in this cohort of HTR. The incidence of SCC was very low and its prognosis was good due to early diagnosis and surgical excision.

Aged↗
PubMed2000

Absence of enteroviral RNA in hearts explanted from patients with dilated cardiomyopathy.

BACKGROUND: The role of enterovirus infection in the pathogenesis of dilated cardiomyopathy (DCM) remains unclear. The objective of this study was to determine the prevalence of enterovirus in hearts explanted from patients with DCM and to compare it with enterovirus prevalence in hearts explanted from patients with other etiologies and in healthy donor hearts. METHODS: A total of 138 cardiac samples were analyzed, 70 from heart donors and 68 from transplant recipients (22 with DCM). A highly sensitive enterovirus-specific nested RT-PCR was used to test for enterovirus. RESULTS: All tests were negative except for one positive result that was attributed to carryover because sequencing of the amplification product showed it to be identical to the positive control. CONCLUSIONS: In this study the sample of explanted hearts nested RT-PCR showed no evidence of the presence of enteroviral RNA. This suggests that if enterovirus had a role in the genesis of DCM, it does not require or lead to the persistence of the virus in myocardial tissue.

Adolescent↗