Randomised clinical trial of patient satisfaction with traditional and simplified complete dentures.

To clinically evaluate the patient satisfaction and associated costs of dentures made using a simplified procedure that eliminates assembly on the articulator and dentures made with the conventional technique. Single-blind randomised clinical trial. Forty edentulous patients were randomly divided into 2 groups. One group received dentures made using the conventional method (CG), and the other using a simplified technique (SG) that omits the use of functional impressions (with modelling compound and ZOE impression paste) and an articulator to assemble the models. Overall patient satisfaction was assessed at 3 and 6 months by means of a Numerical Rating Scale (NRS). The comparisons were made using a repeated measures ANOVA (P = .05). No significant differences were found in terms of the satisfaction stated by the patients or the quality of the prosthesis evaluated by a professional among the dentures made using the traditional (n = 17) and simplified (n = 21) techniques. The rehabilitation of an edentulous patient with a simplified technique for the preparation of a total prosthesis is a feasible, more economical alternative and accepted by most patients.

Primary immunosuppression and outcome differences after heart transplantation: tacrolimus versus cyclosporine.

BACKGROUND: The superiority of tacrolimus (Tac) as primary immunosuppression for heart transplantation (HT) compared with cyclosporine (CsA) is still under debate. Outcomes of comparison studies are not consistent; the duration of these studies has been limited. The aim of this study was to evaluate long-term outcomes of patients undergoing HT based on primary immunosuppression regime. METHODS AND RESULTS: We analyzed a single-center registry of all HT patients between 1998 and 2009, comparing outcomes based on primary immunosuppressions (Tac or CsA). Patients who died before starting immunosuppression were excluded. A total of 197 patients entered the study; 103 received Tac and 94 CsA. There were no differences between groups in baseline characteristics, United Network for Organ Sharing status 1A or ventricular assist device use, except for ischemia time (195 ± 50 min in Tac group vs 182 ± 55 min in CsA; P = .08) and days on waiting list (164 ± 155 vs 100 ± 73; P < .001). After mean follow-ups of 4.5 ± 2.3 years in the Tac group and 6.3 ± 4.3 years in the CsA group, there were 19 and 36 deaths, respectively. Kaplan-Meier analysis showed increased survival for the Tac group (log rank P = .04). Tac also was significantly superior to CsA regarding mortality (relative risk 0.55; 95% confidence interval, 0.31-0.98; P = .04). CONCLUSIONS: In our series the use of tacrolimus resulted in improved long-term survival compared with cyclosporine. At 1-year follow-up, there were no differences in acute rejection episodes or the appearance of vasculopathy.

Outcome after steroid withdrawal in heart transplantation.

BACKGROUND: There is a lack of consensus and insufficient data to assess the impact of late steroid withdrawal after heart transplantation (HTx). The aim of the study was to investigate the security and feasibility of corticosteroid withdrawal at 1 year after transplantation. METHODS AND RESULTS: Steroid withdrawal was attempted after at least 12 months of treatment in 86 HTx patients who fulfilled the criteria. At 1 and 3 months after drug discontinuation, patients underwent 2 endomyocardial biopsies (EMB). After a mean follow-up of 25 +/- 13 months, 63% of the patients remained steroid free. In 30 patients (35%) corticosteroids were reinitiated, in 15 cases because of acute rejection (7%), 5 (6%) because of worsening renal function, 5 (6%) because of malignancy, 3 (4%) because of adverse effects of immunosuppressive drugs, and 2 because of severe allograft coronary artery disease. Four patients (5%) died after drug discontinuation. There was a significant decrease in total cholesterol (198 +/- 35 to 181 +/- 38 mg/dL; P < .001) and low-density lipoprotain (LDL) cholesterol levels (113 +/- 30 to 105 +/- 30 mg/dL; P < .001). There were no differences in mortality between patients with and without corticosteroids. CONCLUSION: Steroid withdrawal is feasible and safe in HTx patients. In our study, it was successfully maintained in 63% of the patients. EMB is helpful to identify patients with acute rejection at 1 and 3 months after withdrawal. Short- to mid-term metabolic benefits are significant reductions in serum total and LDL cholesterol.

Decreased expression of thrombospondin-1 in failing hearts may favor ventricular remodeling.

BACKGROUND: Thrombospondin-1 (TSP-1) is a potent inhibitor of angiogenesis and an activator of tissue transforming growth factor-beta1 (TGF-beta1). Analyses using genetically modified mice suggested that TSP-1 may play a protective role to prevent infiltration and tissue remodeling responses after myocardial infarction. The expression levels of TSP-1 and their putative role in ventricular remodeling have not been determined in patients with heart failure (HF). MATERIALS AND METHODS: We analyzed the expression of TSP-1 and TGF-beta1 mRNA in myocardial biopsies from 34 subjects with end-stage HF undergoing heart transplantation and 13 healthy controls from heart donors. Among total RNA extracted from the left ventricle, 1 microg was retrotranscribed and mRNA expression levels were quantified by real-time polymerase chain reaction (PCR). RESULTS: The mean age of subjects was 54 +/- 2 years; mean ejection fraction, 21 +/- 5%; end-diastolic diameter and end-systolic diameter, 73 +/- 10 and 61 +/- 11 mm, respectively. TSP-1 mRNA expression in ventricular tissue from HF patients was lower (159.04 +/- 14.55 ng-equivalents [ng-equiv]) than in controls (234 +/- 30.66 ng-equiv; P < .05). Tissue from HF subjects also showed lower levels of TGF-beta1 (68.42 +/- 4.36 vs 80.58 +/- 5.26 ng-equiv; P < .05). TSP-1 mRNA levels correlated positively with TGF-beta1 (P = .001; R(2) = .2), and lower TSP-1 mRNA levels were observed with increasing left ventricular diameters. CONCLUSIONS: Patients with end-stage HF show decreased TSP-1 mRNA levels, which agrees with published results showing lower circulating TSP-1. Ventricular dilatation observed in these patients may be related to lower expression of TSP-1. Surprisingly, TGF-beta1 mRNA levels were lower in failing hearts, which suggested that fibrogenesis takes place in earlier phases of HF.

Clinical implications of late mitral valve regurgitation appearance in the follow-up of heart transplantation.

BACKGROUND: Tricuspid regurgitation is frequently observed after orthotopic heart transplantation (OHT), in association with severe pulmonary hypertension. However, the incidence of left-sided valvular disease has not been addressed. AIM: We analyzed the incidence and prognostic implications of left-sided valve disease in 141 patients after OHT. METHODS: Echocardiography was performed with every endomyocardial biopsy during the first year after OHT and every 6 months thereafter. Mitral regurgitation (MR) grade II or III was considered significant. Graft vasculopathy was assessed using coronary angiography. RESULTS: Eight patients (6%) developed significant left-sided valvular disease, namely, MR in 6 (4%) and aortic regurgitation (AR) in 2 (1.4%). The 2 cases with AR were diagnosed the first week after OHT, whereas significant MR was diagnosed at mean follow- up of 34 +/- 6 months. Mean regurgitant orifice and volume were 34 +/- 14 mm2 and 41 +/- 15 mL/beat, respectively. Patients with significant MR had experienced a greater number of acute rejection episodes >or=3A, (1.8 +/- 1.7 vs 0.8 +/- 1.05; P = .02) and were associated with allograft vasculopathy in 83% vs 6% among unaffected patients (P = .0001). Four of 6 patients with significant MR died during follow-up (67%) and 1 of the living patients underwent reparative mitral valve surgery. The probability of survival using Kaplan-Meier curves was significantly lower when patients developed late significant MR (54% vs 76%; P = .0001). CONCLUSIONS: The incidence of significant left-sided valvular disease after OHT was low. MR was associated with a higher degree of previous acute rejection, of graft vasculopathy, and mortality. The presence of moderate or severe MR of late appearance identified a group of OHT patients with poor outcomes.

Value of NT-proBNP determinations in the follow-up of heart transplantation.

BACKGROUND: The N-terminal pro-brain natriuretic peptide (NT-proBNP) has been useful in the diagnosis and follow-up of heart failure. Whether it can be useful in the detection of acute rejection (AR) after heart transplantation (HT) has not been addressed. Our aim was to assess the prognostic value of NT-proBNP determinations after HT. METHODS: We analyzed 137 endomyocardial biopsies (EMB) performed in 51 patients as assessment of AR and correlated them with NT-proBNP determinations. The value of NT-proBNP in the early follow-up of the novo HT was also assessed. RESULTS: AR grade > or =3A was diagnosed in 10 of the 137 performed biopsies. There were no significant differences in NT-proBNP values between patients with or without AR (1047 +/- 629 versus 1886 +/- 3026 pg/mL, P = NS). There were 24 de novo HT, in these patients increased NT-proBNP levels showed an inverse significant correlation with time since HT (r = -0.40, P = .0001). During follow-up, 15 of the novo HT had a descending NT-proBNP curve over time, and in the remaining 9 (37%) a late increase of NT-proBNP values were observed. Those 9 patients had the following complications: AR > or =3A in 5 cases, 1 death, 2 required a permanent pacemaker, and in the last patient a significant EMB could not be obtained. CONCLUSIONS: NT-proBNP values follow a descending curve early after HT. During the first months, a late increase of NT-proBNP value was associated with HT complications, with AR being the most frequent. Isolated increased NT-proBNP levels were not useful for the detection of AR. More studies are needed to establish the prognostic value of NT-proBNP after HT.

Experience with single-dose daclizumab in the prevention of acute rejection in heart transplantation.

INTRODUCTION: Daclizumab is a monoclonal antibody that binds to the interleukin-2 receptor. It has been used as induction therapy in heart transplantation with two to five repeated administrations over several weeks. The objective of our study was to estimate the efficacy and safety of induction therapy with only one dose of daclizumab in a consecutive series of patients undergoing heart transplantation. METHODS: Thirty-two consecutive heart transplants performed since July 2002, who received single-dose daclizumab as induction therapy, were compared with the 30 patients transplanted previously, who received OKT3. In both groups, maintenance immunosuppression included cyclosporine or tacrolimus, mycophenolate mofetil, and corticosteroids. Follow-up time was 1 year. RESULTS: There were no baseline differences between the two groups regarding age, gender, or etiology. In the group treated with daclizumab there were more diabetics (43% versus 10%, P = .01) and the ischemia time was longer (192 versus 156 minutes, P = .03). During the first posttransplant year, 76% of patients treated with OKT3 and 55% of those treated with daclizumab presented acute rejection > or =3A; 20% and 25%, respectively, presented infections; and 5 (17%) patients in the OKT3 group and 2 (6%) in the group treated with daclizumab died. None of these differences was statistically significant. CONCLUSIONS: Our experience suggests that induction therapy with a single-dose regimen of daclizumab seems to have an efficacy and safety profile similar to OKT3, and it is easier to administer and has a lower cost than other induction regimens.