FDA panel votes against approval for bivalirudin.
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Biomedical subjects
Publications and source records attributed to I Piña.
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BACKGROUND: Use of a permanent left ventricular assist device (LVAD) has been proposed as an alternate treatment of patients with end-stage heart failure. The purpose of this study was to compare the functional capacity of patients following implantation of a LVAD vs heart transplant (HTx). METHODS: Eighteen patients from 6 centers who received an intracorporeal LVAD as a bridge to HTx underwent treadmill testing 1 to 3 months post-LVAD and again post-HTx. Baseline and peak measurements, including oxygen consumption, blood pressures, and respiratory rate were made during each treadmill test. RESULTS: Peak oxygen consumption was 14.5+/-3.9 ml/kg/minute post-LVAD and 17.5+/-5.0 ml/kg/minute post-HTx (p < .005). The percentage of the predicted peak oxygen consumption based on gender, weight, and age was 39.5%+/-5.5% post-LVAD and 47.7%+/-10.9% post-HTx (p < .005). Exercise duration was lower post-LVAD than post-HTx (10.3+/-4.2 minute vs 12.5+/-5.4 minute, p < .05). After LVAD implantation, peak total oxygen consumption correlated with peak LVAD rate and output. Eight patients reached an LVAD rate of 120 beats per minute (bpm) before the conclusion of exercise, the maximum rate for the outpatient electric device. The peak respiratory exchange ratio post-LVAD was 1.15+/-0.22 and post-HTx was 1.15+/-0.18, consistent with a good effort in both groups. CONCLUSIONS: Patients demonstrated a lower functional capacity post-LVAD than post-HTx. For some patients functional capacity post-LVAD may be improved by a higher maximum LVAD rate and output.
OBJECTIVE: To determine the risk factors for and the incidence, morbidity, mortality, and outcome of pancreaticobiliary disease in patients who have had orthotopic heart transplantation. DESIGN: Retrospective case-control analysis. SETTING: University hospital-based heart transplantation center. PATIENTS: 20 case-patients with pancreaticobiliary disease and 40 controls; all patients received heart transplants between 1985 and 1994. Controls were matched to case-patients by time of transplantation and length of survival. MEASUREMENTS: Charts were reviewed and data were extracted using a structured data abstraction protocol. Risk factors assessed before transplantation were cause of heart disease, history of diabetes, reproductive history, and sex. Risk factors assessed at presentation of pancreaticobiliary disease were weight change after transplantation, alcohol use, use of medications, recent total parenteral nutrition, age at symptom onset, recent rejection episode, cyclosporine level, complete blood count, time between transplantation and onset of symptoms, body mass index, calcium level, liver function test results before and at symptom onset, and lipid profile. RESULTS: Pancreaticobiliary disease occurred in 20 of 255 transplant recipients (7.8%). The incidence of disease in these patients within 1 year after transplantation was 3.9% compared with an expected rate of 0.2% per year (P < 0.01). A decreased serum calcium level was the only risk factor found to differ significantly between the two groups (mean +/- SD, 2.19 +/- 0.17 mmol/L in case-patients and 2.31 +/- 0.14 mmol/L in controls; P = 0.005). The duration of hospitalization for the treatment of pancreaticobiliary disease was longer for patients who received transplants than for patients who did not receive transplants and were treated at Temple University Hospital during a similar period (17.1 days compared with 7.2 days; P < 0.001). However, the outcome was excellent in most patients. CONCLUSIONS: Pancreaticobiliary disease occurs 17.4 times (95% CI, 9.2 to 32.7 times) more frequently in patients receiving transplants than in the general population. It is a seldom recognized but apparently common complication of orthotopic heart transplantation that results in substantial morbidity and health care resource use. Further study is needed to ascertain why this condition occurs and how the risk for developing it can be reduced.
A 29-year-old woman had an acute myocardial infarction 5 days after giving birth. Serial coronary angiography showed multiple progressive coronary artery dissections, which eventually involved both the right and left coronary trees. Persistent cardiogenic shock necessitated emergent orthotopic heart transplantation. Examination of the cardiectomy specimen confirmed the presence of multiple myocardial infarctions, coronary artery dissection, and fibromuscular dysplasia of the coronary arteries. Fibromuscular dysplasia combined with changes in the arterial ground substance and hormonal milieu attributable to pregnancy or parturition are proposed as possible causes of coronary artery dissection in this case.