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1.
J Clin Microbiol ; 48(5): 1978-82, 2010 May.
Article in English | MEDLINE | ID: mdl-20220160
2.
J Heart Lung Transplant ; 26(7): 693-9, 2007 Jul.
Article in English | MEDLINE | ID: mdl-17613399

ABSTRACT

BACKGROUND: Conventional antibody induction therapy is currently used in heart transplantation despite safety concerns. This 6-month, prospective, randomized, multicenter, open-label study examined whether basiliximab offers a tolerability benefit compared with anti-thymocyte globulin (ATG) while maintaining similar efficacy in de novo heart transplant recipients. METHODS: Adult heart transplant recipients were randomized to receive basiliximab (20 mg on Day 0 and Day 4) or ATG (2.5 mg/kg/day for 3 to 5 days) with cyclosporine, mycophenolate mofetil and steroids. The primary safety end-point was a composite of serum sickness, fever, cutaneous rash, anaphylaxis, infection, thrombocytopenia, leukopenia and post-transplant proliferative disease. Efficacy was assessed by a composite end-point of death, graft loss, acute rejection Grade > 1B, acute rejection associated with hemodynamic compromise or treated with antibody therapy, or loss to follow-up, whichever occurred first. RESULTS: Eighty patients were randomized and analyzed. By Month 6, the incidence of the composite safety end-point was significantly lower with basiliximab than with ATG (50.0% vs 78.6%, p = 0.01), and infectious death was less frequent in the basiliximab group (0 of 38 vs 6 of 42, p = 0.027). The composite efficacy end-point occurred in 24 patients (63.2%) in the basiliximab arm vs 28 patients (66.7%, p = not significant [NS]) receiving ATG. Acute rejection episodes of Grade > or = 1B were reported with similar frequency (50% with basiliximab vs 45.2% with ATG, p = NS); 7 patients (18.4%) in the basiliximab group and 3 (7.1%) in the ATG group had rejection Grade > or = 3A. CONCLUSIONS: These results suggest that basiliximab offers improved tolerability with similar efficacy compared with current polyclonal antibody induction therapy in de novo heart transplant patients.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antilymphocyte Serum/therapeutic use , Communicable Diseases/etiology , Heart Transplantation/adverse effects , Heart Transplantation/methods , Immunosuppressive Agents/therapeutic use , Recombinant Fusion Proteins/therapeutic use , Adolescent , Adult , Aged , Antibodies, Monoclonal/adverse effects , Antilymphocyte Serum/adverse effects , Basiliximab , Communicable Diseases/mortality , Cyclosporine/therapeutic use , Drug Therapy, Combination , Endpoint Determination , Female , Graft Rejection/immunology , Heart Transplantation/immunology , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Mycophenolic Acid/analogs & derivatives , Mycophenolic Acid/therapeutic use , Prospective Studies , Recombinant Fusion Proteins/adverse effects , Risk Factors , Steroids/therapeutic use , Transplantation Immunology , Treatment Outcome
3.
Ann Thorac Surg ; 75(6): 1878-85, 2003 Jun.
Article in English | MEDLINE | ID: mdl-12822631

ABSTRACT

BACKGROUND: We compared the morbidity and mortality rates of patients who had urgent heart transplantation or transplantation after bridging with a ventricular assist device, with the rates of patients whose clinical stability allowed them to wait at home. METHODS: From March 1985 to December 2000, 404 patients underwent heart transplantation in a single center. There were 273 patients with UNOS status 2 (US 2), 103 patients with UNOS Status 1A (US 1A), and 28 patients with UNOS Status 1B (US 1B). We compared the groups retrospectively with respect to pretransplantation status and operative results. RESULTS: Despite more severely impaired hemodynamics and a significantly higher preoperative infection rate in US 1A and 1B patients, there were no statistically significant differences in survival rates among the three groups. Donor sex and age, cytomegalovirus and toxoplasmosis, mismatch rate, ischemic time, method of myocardial protection, and operative technique did not differ statistically among the three groups. Length of intensive care unit stay, postoperative morbidity, first year postoperative rejection rate, and graft occlusive vascular disease rate were statistically similar among the three groups. Although pretransplantation cancer assessment was less complete in US 1A and 1B than in US 2 patients, the late-cancer rate was not statistically different among the three groups. CONCLUSIONS: These data suggest that urgently transplanted patients have both early and long term morbidity and mortality similar to those of patients waiting for transplantation at home or with a ventricular assist device.


Subject(s)
Heart Failure/surgery , Heart Transplantation/mortality , Heart-Assist Devices , Postoperative Complications/mortality , Adolescent , Adult , Aged , Cause of Death , Child , Emergencies , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Multivariate Analysis , Retrospective Studies , Risk Factors , Survival Analysis , Waiting Lists
4.
J Heart Lung Transplant ; 21(8): 914-7, 2002 Aug.
Article in English | MEDLINE | ID: mdl-12163094

ABSTRACT

The purpose of this study was to report a single center's experience of 5 new pregnancies following heart-lung transplantation. These 5 pregnancies gave rise to 4 live births. Vaginal delivery occurred at a mean of 38 +/- 1 weeks of amenorrhea (range, 37-39 weeks) and the mean birth weight was 3,143 +/- 757 grams (range, 2,270-3,990 grams). Mean maternal forced expiratory volume in 1 second (%) before, during (sixth month), and after (1 year) pregnancy was 87 +/- 18, 87 +/- 22, and 88 +/- 17, respectively (p = NS). In conclusion, pregnancy after heart-lung transplantation can be associated with a good prognosis for mother and child.


Subject(s)
Heart-Lung Transplantation , Pregnancy Outcome , Pregnancy, High-Risk , Adult , Female , Humans , Postoperative Period , Pregnancy
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