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Biomedical subjects

J Fraile

Publications and source records attributed to J Fraile.

At least 37 records · Page 2Linked to original sources

Comparative clinical results with Omniscience (STM1), Medtronic-Hall, and Björk-Shiley convexo-concave (70 degrees) prostheses in mitral valve replacement.

The intermediate clinical results of 289 patients undergoing isolated mitral valve replacement with three different low-profile mechanical prostheses have been retrospectively analyzed and compared. Between June, 1980, and September, 1983, 70 patients received the Omniscience prosthesis, 159 patients the Medtronic-Hall valve, and 60 patients the convexo-concave 70 degree Björk-Shiley prosthesis. Hospital mortality was 15% for the Björk-Shiley group, 4.4% for the Medtronic-Hall group, and 7.1% for the Omniscience group. Cumulative follow-up was 88 years (mean 1.7 years) for the Björk-Shiley, 229 years (mean 1.5 years) for the Medtronic-Hall, and 223 years (mean 3.3 years) for the Omniscience group. All patients were placed on a program of anticoagulant therapy (dicumarol) postoperatively. Actuarial survival rates (+/-SE) 2 years postoperatively were comparable for the three groups: Björk-Shiley, 90% +/- 4.7%; Medtronic-Hall, 93% +/- 2.2%; and Omniscience, 88% +/- 4.1% (p = NS). Late mortality, expressed at linearized rates (percent patient-year +/-SE), was 3.4% +/- 1.9% for the Björk-Shiley group, 1.7% +/- 0.8% for the Medtronic-Hall group, and 3.6% +/- 1.2% for the Omniscience group (p = NS). Actuarially determined rates of freedom from thromboembolic complications (systemic embolism and valvular thrombosis) 2 years postoperatively were 97% +/- 2.2% for the Björk-Shiley group, 94% +/- 2.1% for the Medtronic-Hall, and 84% +/- 4.7% for the Omniscience group (p = 0.05, Omniscience versus Medtronic-Hall; p = 0.02, Omniscience versus Björk-Shiley) The actuarial probability of being free from reoperation 2 years postoperatively was 92 +/- 3.5 for the Björk-Shiley group, 92 +/- 2.9 for the Medtronic-Hall group, and 82 +/- 3.9 for the Omniscience group (p = 0.04). The major cause for reoperation in the Omniscience group was valve thrombosis (seven patients), yielding a linearized incidence (+/-SE) of 3.1 +/- 1.1 (p = 0.01). No statistically significant differences were obtained regarding the incidence of prosthetic infective endocarditis or perivalvular leak. Overall rates of anticoagulant-related hemorrhage were comparable for the three groups.

Actuarial Analysis↗

Prophylaxis of infective endocarditis for dental procedures. Report of a working party of the European Society of Cardiology.

Bacterial endocarditis still remains a serious disease with significant morbidity and mortality. In patients with known valve disease, most cases are caused by oral viridans streptococci. These organisms are present in vast numbers on the gum margins and in gum pockets. They cause transient bacteraemia during eating and tooth brushing. More substantial, but short-lived bacteraemia can occur during dental treatment such as extraction and scaling. Bacteria may then become attached to abnormal endocardium leading to the development of infective endocarditis. Prophylaxis of endocarditis during dental procedures in patients with known valve disease should thus be aimed at reducing the number of bacteria entering the blood stream and eliminating those that get there. This can be sought first by good oro-dental hygiene and secondly by the use of prophylactic antibiotics. In this paper, we set out simple guidelines for practitioners in those countries that do not already have recommendations of their own. They are based on guidelines already in use in the United Kingdom, France, Switzerland and the United States.

Anti-Bacterial Agents↗

Long-term comparative analysis of the Björk-Shiley and Hancock valves implanted in 1975.

The long-term results in all patients undergoing isolated mitral, aortic, or double mitral-aortic heart valve replacement operated upon in 1975 has been retrospectively analyzed. A total of 153 patients received the standard Björk-Shiley (flat pyrolytic disc) mechanical prostheses and 150 patients received the noncomposite Hancock porcine xenograft. Overall operative mortality was not significantly different between groups. All patients receiving a Björk-Shiley prosthesis, but none in the Hancock group, received long-term anticoagulant therapy. Medium and long-term actuarial survival rates (5 and 10 years postoperatively) were comparable for the two groups (88% for Björk-Shiley and 84% for Hancock [NS] at 5 years; 86% for Björk-Shiley and 80% for Hancock at 10 years [NS]). The incidence of systemic embolism was similar in the two groups (1.6% +/- 0.4% per patient-year for the Björk-Shiley group and 1.3% +/- 0.3% per patient-year for the Hancock group [NS]). Also the incidence of endocarditis was similar (0.6% +/- 0.2% per patient-year for the Björk-Shiley group and 0.8% +/- 0.3% per patient-year for the Hancock group [NS]). In the Hancock group the overall incidence of reoperations was significantly higher than in the Björk-Shiley group (4.2% +/- 0.6% per patient-year versus 0.9% +/- 0.3% per patient-year (p = 0.001). The major cause for reoperation in the Hancock group was primary tissue failure (3% +/- 0.5% per patient-year). In the Björk-Shiley group the major cause of reoperation was valve thrombosis (0.5% +/- 0.2% per patient-year). Therefore, accepting the fact that other bioprostheses may behave differently from the Hancock noncomposite xenograft, we currently restrict our indications for valve replacement with bioprostheses.

Actuarial Analysis↗

Results and complications with the Omniscience prosthesis.

A clinical trial with the Omniscience heart valve was conducted from June, 1980, until May, 1981. In this period 166 patients underwent heart valve replacement: mitral valve replacement (MVR) 70 patients, aortic valve replacement (AVR) 37, and combined mitral-aortic valve replacement (M/AVR) 59 patients. There were 20 hospital deaths, for a mortality of 12%. Total follow-up was 226 patient-years (range 6 to 28 months, mean 18 months). There were eight late deaths (MVR 4.6%, AVR 3.1%, and M/AVR 8.1%). All patients were taking oral anticoagulants. The incidence of valve-related complications (expressed as events per 100 patient-years) was as follows: Systemic embolism--MVR 2, AVR 4.7, and M/AVR 2.5; and anticoagulant complications--MVR 1.9, AVR 2.3, and M/AVR 0. The incidence of valvular dysfunction (expressed as events per 100 patient-years) was as follows: valvular thrombosis--MVR 4.8, AVR 0, and M/AVR 1.2; perivalvular leakage--MVR 1.9, AVR 2.3, and M/AVR 2.5; and infective endocarditis--MVR 0.96, AVR 0, and M/AVR 1.2. The actuarial probability of being free of valvular dysfunction 30 months postoperatively is 73% for the MVR group, 90% for the AVR group, and 71% for the M/AVR group. Despite a short follow-up, the incidence of valvular dysfunction has been significant. For this reason, we have discontinued using these prostheses for heart valve replacement.

Aortic Valve↗

Early surgical results of the Medtronic-Hall valve.

A clinical trial with the Medtronic-Hall (M-H) valve was started in November 1981. From then until December 1982, 157 patients underwent heart valve replacement: Mitral valve replacement (MVR) 63 patients, isolated aortic valve replacement (MVR) 41 patients, and 53 underwent combined mitral-aortic valve replacement (MVR + AVR). Hospital mortality was 2.5% overall (4/157). The total follow-up was 147 patient-years (range 1 to 12 months). Late mortality was 3.2% for MVR, 2.5% for AVR and 1.9% for double MVR + AVR. Oral anticoagulation therapy (Dicumarol) was administered to all patients included in this study. There were no anticoagulant complications and no prosthetic bacterial endocarditis registered in this series of patients up to date. The incidence of systemic embolism was 2.5 events per 100 patient-years in the AVR group. No embolic episodes have been registered in the other 2 groups. The incidence of valvular dysfunction (expressed as events per 100 patient-years) were: --Perivalvular leak (0 MVR, 0 AVR and 2 MVR + AVR) --Valve thrombosis (1.7 MVR, 0 AVR and 0 MVR + AVR) --Mechanical dysfunction (1.7 MVR, 0 AVR and 0 MVR + AVR) Despite a short follow-up, the results with the Medtronic-Hall valve are encouraging and compare favorably with other mechanical prostheses.

Adult↗

Early in vivo hemodynamic evaluation of the mitral Medtronic-Hall cardiac valve.

We studied the hemodynamics of 14 patients with a Medtronic-Hall prosthesis in mitral position 6 months after valve implantation. The usual hemodynamic parameters showed a striking improvement after surgery. The mean pulmonary arterial pressure decreased from (mean +/- SD) 37 +/- 10.7 mmHg to 20 +/- 6.5 mmHg (p less than 0.005). Mean pulmonary capillary pressure decreased from 24 +/- 7.1 mmHg to 10 +/- 3.0 mmHg (p less than 0.001). Cardiac output increased slightly from 3.7 +/- 0.8 L/min to 4.2 +/- 0.45 L/min, the difference not being significant. Valvular area at rest was 1.82 +/- 0.25 cm2 and increased significantly during exercise to 2.47 +/- 0.45 cm2 (p less than 0.001). The opening angle of the disk occluder reached a mean value of 64 +/- 4.6 degrees, that is 91% of the maximal theoretical opening angle. We fitted a hydraulic function gradient = Ax (Flow)n (mean r = 0.9176), to the paired data of gradient and flow obtained during progressive exercise. This procedure permitted us to establish the actual hemodynamic behavior of the prostheses which did not concur with the behavior predicted by the Gorlin formula. We conclude that the Medtronic-Hall mitral prosthesis is an acceptable alternative when mitral valve replacement is considered.

Adult↗

Thrombotic obstruction of the Björk-Shiley aortic valve prosthesis. Report of four cases.

We present four cases of late thrombotic obstruction of the Björk-Shiley aortic valve prosthesis. The incidence of this complication reported in the literature to vary from 0.7% to 5%. In our experience of a total of 623 Björk-Shiley aortic valve replacements, we observed this complication in only 4 patients (0.6%). Two of them had poorly controlled anticoagulation therapy. The clinical presentation was subacute in all four patients. Surgical treatment, thrombectomy and debridement, was performed in all of them. The diagnosis was made upon abrupt and progressive onset of dyspnoea, physical examination data and echocardiographic and radioscopic findings. Angiocardiographic studies were needed in two patients.

Adult↗

Cytokine-driven inflammatory response is associated with the hypermetabolism of AIDS patients with opportunistic infections.

BACKGROUND: To assess a possible role of systemic inflammation in the resting metabolic response in AIDS patients with active secondary infections. METHODS: Fifty-two patients with AIDS-defined criteria and concomitant active infections and 19 healthy subjects were studied. Measurements were as follows: body composition assessed by bioelectrical impedance; resting energy expenditure (REE) by 30-minute indirect calorimetry; cytokine concentrations (IL-6, IFNalpha, TNFalpha, sTNF-R1) by ELISA; C-reactive protein (CRP), erythrocyte sedimentation rate, fibrinogen, and nutritional parameters by standard techniques. RESULTS: REE adjusted for fat-free mass (REEFFM) was significantly increased in AIDS patients despite 39% of them not being hypermetabolic. The patients were undernourished and were found to have increased levels of acute-phase proteins and increased concentrations of IL-6 and sTNF-R1 relative to controls. REE parameters were positively related to CRP, ESR, ferritin, IL-6, and sTNF-R1 and negatively related to albumin, prealbumin, and transferrin. CRP was an independent predictor of REEFFM in AIDS patients and explained 25% of its variability. Patients with severe inflammation (CRP > or = 37 mg/dL) were significantly hypermetabolic with respect to patients without inflammation (CRP < 6 mg/dL) and had higher levels of IL-6 and sTNF-R1 and lower levels of albumin and prealbumin. Although no significant differences were observed with respect to the infection type, patients with tuberculosis and Pneumocystis carinii infections had higher resting metabolic and inflammatory responses, whereas patients with recurrent bacterial pneumonia were normometabolic and had lower levels of inflammatory markers. CONCLUSIONS: Resting hypermetabolism observed in AIDS patients with concurrent active infections is related to the presence and severity of systemic cytokine-driven inflammatory response, which could reflect the type of secondary infection.

AIDS-Related Opportunistic Infections↗

The new De Vega technique in tricuspid annuloplasty (results in 150 patients).

A new technique of circular tricuspid annuloplasty in the treatment of tricuspid insufficiency is described. One hundred and fifty patients have been operated on by this technique between April 1973 and March 1975. The operative findings and the results of the operation from 6 to 30 months after operation are described. The addition of tricuspid circular annuloplasty to mitral and aortic valve replacements where indicated has resulted in a gratifying fall in operative mortality and better long term functional result.

Adolescent↗

[Decrease of the incidence of sepsis syndrome after early enteral nutrition of patients with severe burns].

The objective of this study was to evaluate the effect of early enteral nutrition on the incidence of the septic syndrome as well as its tolerance, in patients with severe burns. We retrospectively studied 64 patients older than 15 years of age, with a greater than 20% burned body surface area. They were divided into 2 groups as a function of the time elapsed between the beginning of Enteral Nutrition and the time of the burning: 23 patients were given Enteral Nutrition within 24 hours after the burn, and in 41 patients the enteral nutrition was started later than 24 hours after sustaining the thermal injury. Both groups were similar with respect to age, sex, percentage of 2nd and 3rd degree burns, incidence of inhalation, and deaths. All patients received the Enteral Nutrition through a nasogastric tube, with administration of a polymeric, hyperprotein and hypocaloric formula through a continuous infusion pump. In our study we saw a reduction of the incidence of the septic syndrome in the patients who received early enteral Nutrition (26%; 6 patients of a total of 23), with respect to those who did non receive early Enteral Nutrition (54%; 22 patients of a total of 41), with a statistical significance of p > 0.05. There were no differences between both groups with respect to the digestive tolerance to Enteral Nutrition. From our study we can deduce that early Enteral Nutrition reduces the incidence of septic complications, without this increasing the digestive intolerance to the same.

Adolescent↗