The Omni design: evolution of a valve.

The Lillehei-Kaster prosthesis has been the subject of an engineering evolution to close the gap between engineering expectations and clinical performance. Advanced engineering development in response to users has narrowed this gap with the Omni design (Omniscience titanium and omnicarbon Pyrolite cages). Our studies on mitral Omniscience valves demonstrated that because anatomic and surgical variations, the anterior orientation was more forgiving than the posterior orientation, resulting in lower thrombotic complications (0.5% versus 3.3% patient-year). A subsequent thicker cuff was used to reduce the probability of anatomic interference and incomplete opening after cardiac recovery. Such findings were also incorporated in the Omnicarbon design. Five European centers implanted 354 patients (198 atrial valve replacement, 115 mitral valve replacement, and 41 double valve replacement with Omniscience valves between August 1984 and January 1986. No restrictive patient selection criteria were used. As of June 1987, 96% of the patients at risk were accounted for. Average follow-up was 1.7 +/- 0.4 years (range, 0.3 to 2.8 years), with a total follow-up of 555 years. There were no cases of structural failure or clinically significant hemolysis. Ninety-one percent of the patients improved one or more functional classes. Actuarial analysis of survival probability at 3 years is 92.5% for atrial valve replacement, 97.9% for mitral valve replacement, and 93.6% overall. There were no late deaths from valve thrombosis or thromboembolism. The actuarial freedom from all thromboembolic events (valve thrombosis, thromboembolism, and transient ischemia) is 97.8% at 2 1/2 years. Through close rapport between user surgeons and designers, the evolution of a valve with improved performance becomes a reality.

Successful orthotopic transplantation of a fresh tricuspid valve homograft in a human.

We report a successful transplantation of a human tricuspid valve in a human. We used a fresh tricuspid homograft with its chordae tendineae and papillary muscles, harvested 5 days earlier under sterile conditions from a multiorgan donor a few minutes after cardiectomy (the heart was not suitable for cardiac transplantation) and immediately stored at 4 degrees C. We elected to implant the homograft in a young heroin addict. Our experience demonstrates that the implantation of an atrioventricular homograft in the orthotopic position is technically feasible and can achieve good results, at least in the short term.

Porcine cardiac bioprostheses: evaluation of long-term results in 990 patients.

Clinical results with porcine bioprostheses were reviewed for 990 patients who underwent heart valve replacement from January, 1974, to December, 1980. Eight hundred and seventy-four Hancock, 283 Carpentier-Edwards, and 10 Liotta bioprostheses were used. In 23 patients, 26 mechanical prostheses were implanted as well. Overall operative mortality was 60 out of 990 (6.06%): 30 out of 506 (5.9%) for mitral valve replacement (MVR), 13 out of 287 (4.5%) for aortic valve replacement (AVR), 1 out of 4 (25%) for tricuspid valve replacement, 0 out of 2 for pulmonary valve replacement, and 16 out of 191 (8.4%) for multiple valve replacement. Cumulative follow-up covered 1,793 patient-years. (Actuarial survival at 7 years was 76.6 +/- 3% for MVR. At 6 years, it was 83.2 +/- 2.8% for AVR and 55 +/- 13.5% for multiple valve replacement.) Prosthesis-related survival at 7 years was 91.7 +/- 1.9% for MVR, and at 6 years, it was 96.6 +/- 1.5% for AVR and 95.1 +/- 2.2% for multiple valve replacement. Bioprosthesis survival, considering deaths or complications that led to reoperation as final events, was 84.2 +/- 3.7% at 7 years for mitral valves and 87.7 +/- 3.8% at 6 years for aortic valves. Emboli per 100 patient-years numbered 3.2 for MVR, 0.5 for AVR, and 1.6 for multiple valve replacement. Twenty-seven patients underwent reoperation, 12 for perivalvular leak, 5 for endocarditis, 6 for valve thrombosis, and 4 for primary tissue failure (linearized rates of 0.7, 0.3, 0.3, and 0.2% per patient-year, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Major sternal wound infection after open-heart surgery: a multivariate analysis of risk factors in 2,579 consecutive operative procedures.

From January, 1979, to December, 1984, at the Cardiac Surgery Department of the University of Torino Medical School, major sternal wound infections developed in 48 (1.86%) of 2,579 consecutive patients. These patients underwent open-heart procedures through a midline sternotomy and survived long enough for infection to appear. Possible risk factors were evaluated by means of a multivariate analysis. For the group of patients, we considered age, sex, hospital environment (different locations of our surgical facilities over the years), interval between hospital admission and operation, antibiotic prophylaxis, type of surgical procedure, elective or emergency surgical procedure, reoperation, duration of surgical procedures, duration of cardiopulmonary bypass, amount of blood transfused, postoperative blood loss, chest reexploration, rewiring of a sterile sternal dehiscence, duration of mechanical ventilation, and days of treatment in the intensive care unit. Univariate analysis indicated that age, sex, type and mode of surgical procedure, antibiotic prophylaxis, and duration of mechanical ventilation were not significantly associated with wound infection. For all other predisposing factors, a p value of less than .05 was demonstrated. These variables were entered in a multiple stepwise logistic regression. Six emerged as significant: hospital environment (p = .0001), interval between admission and surgery (p = .041), reoperation (p less than .0001), blood transfusions (p = .031), early chest reexploration (p less than .0001), and sternal rewiring (p less than .0001). Contamination of patients may occur before, during, and after operation, and any kind of reintervention may predispose to wound infection.

Reoperations on heart valve prostheses: an analysis of operative risks and late results.

To evaluate risks and complications of reoperations on heart valve prostheses, we reviewed data on 183 patients who underwent reoperation because of prosthetic valve malfunction. The incremental effect of the redo procedure on hospital mortality and morbidity was studied by comparing primary and reoperative procedures and analyzing a series of possible predisposing factors. Late survival after first and second reoperations was computed, and possible determinants of late mortality were examined. Overall operative mortality was 8.7%; emergency operation (p = 0.0001), previous thromboembolism (p = 0.05), and advanced New York Heart Association functional class (p = 0.031) were the independent determinants. In a series of 1,355 patients having primary or secondary isolated valve replacement, the redo procedure was a significant risk factor in the univariate analysis (p = 0.025) but not in the multivariate analysis except for the subset of patients having mitral valve replacement (p = 0.052). The postoperative course was quite complicated, as evidenced by the long mean stay in the intensive care unit (mean stay, 3.8 days; longer than 2 days for 26% of the survivors). Nevertheless, postoperative complications were not significantly greater after a redo procedure than after a primary operation. Actuarial survival at 7 years was 57.3% +/- 8%. A comparison with a nonhomogeneous series from our institution did not demonstrate significant differences. In the subset of 16 patients having a second reoperation, late survival was 37.8% +/- 16% at 2 years. Advanced New York Heart Association class (p = 0.0001), double prosthetic valve dysfunction (p = 0.003), and any indication other than primary tissue failure (p = 0.06) were determinants of late mortality.(ABSTRACT TRUNCATED AT 250 WORDS)

Stentless porcine and pericardial valve in aortic position.

Fifty-seven patients underwent aortic valve replacement with a stentless glutaraldehyde-fixed bioprosthesis; 27 received a porcine aortic valve and 30 had a bovine pericardial valve. Two groups of 30 patients each who had aortic valve replacement with a tilting-disc mechanical valve or a stented porcine bioprosthesis served as controls. There were no differences in sex, body surface area, valve lesion, and valve size among the four groups. Results were assessed on a Doppler-based determination of maximum velocity across the valve, aortic valve area, and degree of valve regurgitation. Velocity across the valve was significantly less with stentless pericardial valves than with stentless porcine valves, stented bioprostheses, and mechanical valves. Stentless valves had a significantly larger aortic valve area when compared with stented valves. Mild central aortic insufficiency was detected more often with stentless pericardial than with stentless porcine bioprostheses (p = 0.04). Stentless valves showed a higher incidence of complete atrioventricular block when compared with stented valves (p = 0.04). Long-term studies are now warranted to assess the durability of both types of stentless valves.

Endocarditis in patients with bioprostheses: pathology and clinical correlations.

We studied 13 porcine bioprostheses removed from patients with endocarditis at our institute during the last 4.5 years. All bioprostheses had been removed at reoperation and were analyzed using anatomical and histological techniques. Each bioprosthesis was found to have developed rather constant lesions which were not related to the type of bioprosthesis. The stage of infection was not related to the duration of implantation. The presence of perivalvular abscesses was an ominous finding, often being the seat of persistent endocarditis. Our good clinical results of reoperation lead us to suggest that this be performed early once valvular or prosthetic malfunction is detected. Bioprostheses are, in our experience, the best choice in the surgical treatment of prosthetic valve endocarditis.

Molecular characterization of the Lactobacillus community in traditional processing of Mozzarella cheese.

The natural Lactobacillus community involved in traditional Mozzarella cheese production has been investigated. The bacterial associations of whey, curd before stretching and Mozzarella were analyzed using randomly amplified polymorphic DNA (RAPD) to follow growth kinetics, and 16S rDNA sequencing to identify the taxonomical position of isolated strains. Analysis of RAPD fingerprints revealed that the Lactobacillus community was composed of 13 different biotypes and the sequence analysis of 16S rDNA demonstrated that the isolated strains belong to L. plantarum, L. fermentum, L. helveticus and L. casei subsp. casei. In addition, two strains of Weissella hellenica were isolated on selective media for lactobacilli. The four L. casei subsp. casei strains and W. hellenica contained sequences related to the prtP gene coding for proteinase, and the highest proteolytic activity in milk was found in one strain of L. casei subsp.casei.

Phenotypic and molecular identification and clustering of lactic acid bacteria and yeasts from wheat (species Triticum durum and Triticum aestivum) sourdoughs of Southern Italy.

The microflora of 25 wheat sourdoughs from the Apulia region, Southern Italy, was characterized. The sourdoughs were mainly produced from Triticum durum wheat. The number of lactic acid bacteria and yeasts ranged from ca. log 7.5 to log 9.3 colony forming units (cfu)/g and from log 5.5 to log 8.4 cfu/g, respectively. About 38% of the 317 isolates of lactic acid bacteria were identified by conventional physiological and biochemical tests. Phenotypic identification was confirmed by 16S rDNA and 16S/23S rRNA spacer region PCR. Overall, 30% of the isolates were identified as Lactobacillus sanfranciscensis, 20% as Lb. alimentarius, 14% as Lb. brevis, 12% as Leuconostoc citreum, 7% as Lb. plantarum, 6% as Lactococcus lactis subsp. lactis, 4% as Lb. fermentum and Lb. acidophilus, 2% as Weissella confusa and 1% as Lb. delbrueckii subsp. delbrueckii. Some of these species have not been previously isolated from sourdoughs. Since bakers yeast is widely used in sourdough production, Saccharomyces cerevisiae was largely found. The phenotypical relationships within the main lactic acid bacteria identified were established by using cluster analysis. A microbial map of the 25 sourdoughs was plotted showing characteristic associations among lactic acid bacteria and differences in the lactic acid bacteria species which were mainly due to the species of wheat flour, use of bakers yeast and type of bread.

Molecular and physiological characterization of dominant bacterial populations in traditional mozzarella cheese processing

The development of the dominant bacterial populations during traditional Mozzarella cheese production was investigated using physiological analyses and molecular techniques for strain typing and taxonomic identification. Analysis of RAPD fingerprints revealed that the dominant bacterial community was composed of 25 different biotypes, and the sequence analysis of 16S rDNA demonstrated that the isolated strains belonged to Leuconostoc mesenteroides subsp. mesenteroides, Leuc. lactis, Streptococcus thermophilus, Strep. bovis, Strep. uberis, Lactococcus lactis subsp. lactis, L. garviae, Carnobacterium divergens, C. piscicola, Aerococcus viridans, Staphylococcus carnosus, Staph. epidermidis, Enterococcus faecalis, Ent. sulphureus and Enterococcus spp. The bacterial populations were characterized for their physiological properties. Two strains, belonging to Strep. thermophilus and L. lactis subsp. lactis, were the most acidifying; theL. lactis subsp. lactis strain was also proteolytic and eight strains were positive to citrate fermentation. Moreover, the molecular techniques allowed the identification of potential pathogens in a non-ripened cheese produced from raw milk.

Mitral annulus size in isolated mitral stenosis.

M-mode and two-dimensional echocardiographic images were obtained using the planimeter method in the short axis view and calculated by Doppler-derived pressure half-time in 24 patients with mitral stenosis before and after surgical commissurotomy and posterior annuloplasty. The diameter of the mitral valve annulus was measured in the standard long axis view and in the apical four-chamber view using two-dimensional echocardiography. Preoperatively, the mitral annulus was dilated in all patients as a consequence of left atrial dilation. This could be one of the factors causing residual regurgitation after surgical mitral commissurotomy. However, more data are needed to demonstrate that annuloplasty can prevent the development of mitral regurgitation after surgery.

Mitral valve replacement with the Biocor stentless mitral valve: early results.

Chordal preservation during mitral valve replacement is thought to greatly preserve left ventricular function. Recently a stentless mitral valve (Biocor) became available for clinical use. It is a porcine mitral valve with the entire chordal apparatus, the sewing ring being reinforced by a bovine pericardial ring and the chordae being sutured together onto two pericardial patches. During a six months period, seven patients undergoing mitral valve replacement for mitral insufficiency (four cases), mitral stenosis (two cases) or mixed lesions (one case) received a stentless mitral valve. Their mean age was 66.3 +/- 4.8. The valve was implanted by suturing the pericardial patches onto the papillary muscles and the sewing ring onto the mitral annulus. Echocardiography control immediately after surgery showed good valve function. Three valves failed after a period of seven days, seven and 12 months respectively. The valve lesions were similar and consistent with an excessive tension on the chordae and on the valvular tissue. There were tears along the posterior annulus and at the level of the commissures, often accompanied by chordal rupture. Histology and scanning electron microscopy showed good integration of the prosthesis with the patients own tissues. There were areas of overgrowing tissue without endothelial cells especially in the area of papillary muscle -pericardial patch interaction. The remaining four patients continue to do well after a mean follow up of two years. The apparent excessive tension on the valve tissues leading to the premature failure of the prosthesis could be due to the variability in the distance between mitral annulus and papillary muscles.(ABSTRACT TRUNCATED AT 250 WORDS)

New bileaflet bioprosthesis: early and mid term results.

A new bovine pericardial bioprosthesis (AMB bioprosthesis) with a bileaflet geometry was designed and developed, with the aim of achieving uniform stress distribution within the prosthesis. The ultimate goal was to limit tissue degeneration to a minimum by attaining optimum fluid dynamics, thereby obtaining an extended clinical durability. The two-leaflet, dome-shaped geometry with a central hinge allowed a very low profile, low ventricular projection in the mitral position, large effective orifice area and low gradients. The design of the thin Delrin stent and the centrally crossing bridge was developed using finite element analysis. Pre-clinical laboratory investigations showed very low trans-valvular gradients and no mechanical or tissue failure after 400 million cycle accelerated wear test. The final model of the prosthesis was manufactured by Baxter-Edwards CVS Division and tested in sheep with good results for up to five months. A limited clinical trial was started in January 1990 and stopped one year later encompassing 12 aortic and six mitral implants. The patients were followed clinically and by echocardiography three, six and 12 months, and four years after surgery. Mean gradients were 4 mmHg in the mitral and 10 mmHg in the aortic position with only minimum regurgitation and no tissue failure. We conclude that early and mid term results with this new pericardial bioprosthesis appear to be favorable and intend to closely monitor further outcome within the limited patient population.

Twelve-year follow up with the Sorin Pericarbon bioprosthesis in the mitral position.

BACKGROUND AND AIMS OF THE STUDY: The aim of this study was to evaluate the long-term follow up of the Pericarbon pericardial bioprosthesis implanted in the mitral position. METHODS: Between January 1985 and January 1991, 78 patients (26 males, 52 females; mean age 56.9 +/- 7.8 years) underwent isolated mitral valve replacement with a Pericarbon valve. All bioprostheses were size 29 mm and implanted by the same surgeon. RESULTS: Total follow up was 663.2 pt-years and it was 97% complete. Early mortality was 1.3% (1/78); two minor cerebral embolisms were observed as early complications. At 12 years the overall survival rate was 85.0 +/- and valve-related survival 93.1 +/- 3.0%; freedom from embolic events was 83.0 +/- 4.5% and from endocarditis 98.7 +/- 1.3%. Freedom from primary tissue failure was 56.8 +/- 6.6%; it was 86.3 +/- 7.5% in patients aged > 60 years and 36.8 +/- 8.2% in younger patients. There were 27 reoperations, 26 for primary tissue failure, one for endocarditis. Comparison between basal and follow up echocardiographic studies showed a significant stenotic deterioration of the bioprosthesis and a negligible incidence of regurgitation. Morphological findings of explanted bioprostheses were characterized by stenotic and diffuse microcalcification, but no tissue tear was observed. CONCLUSIONS: These results confirm that the Pericarbon bioprosthesis is structurally safe and free from the fatigue problems which afflicted the first and second generation of pericardial valves. As with other tissue valves, the rate of calcification is age-dependent, suggesting preferential use of the Pericarbon prosthesis in elderly people.

Morphological comparison of primary tissue failure (PTF) in porcine mitral and aortic bioprostheses in the same patient.

Clinical and pathological studies have not clearly demonstrated whether primary tissue failure (PTF) in porcine bioprostheses occurs more often in the mitral than in the aortic position. We have studied morphological alterations in both positions in the same individual in 15 patients (14 mitroaortic and 1 mitroaortotricuspid) reoperated upon for PTF. Bioprostheses explanted were photographed, radiographed and observed in transmitted polarizing light. All lesions received a score on the basis of morphological criteria. The creep of the stent was measured. Calcification was slightly heavier and the degree of creep was significantly greater in the mitral position. Tears, infiltration and pannus growth did not differ between the two positions. According to our study, there is no conclusive demonstration that bioprostheses degenerate earlier and more extensively in the mitral than in the aortic position.

Protection of the heart by nifedipine cardioplegia during coronary artery surgery. A clinical-haemodynamic evaluation.

This study was undertaken to evaluate the myocardial preservation obtained by adding a Ca++ channel blocker, nifedipine, to cold potassium cardioplegia (4 mcg/Kg/L) in 24 patients undergoing coronary artery surgery. They were randomly divided into a treated (N) and a control (C) group. Significant differences between the two groups were noted in the cardiac arrest time (p less than 0.001), in the mechanical recovery mode (p less than 0.01) and in the inotropic support needed (p less than 0.01). Cardiac index increased significantly in group N but decreased in group C (p less than 0.01). Peripheral delta P/delta t and endocardial viability ratio (EVR) decreased in both groups. Coronary sinus and serum CK and CK-MB release were significantly lower in the treated group. ECG ischaemic changes occurred in 8 patients in group C but only in 1 case in group N (p less than 0.001). Arrhythmias occurred in 3 cases in group C (p less than 0.05). The incidence of perioperative myocardial infarction was not significant (2 cases in group C). These data suggest that nifedipine can protect the myocardial cell from ischaemic injury without depressing myocardial contractility or AV conduction.

Knot Formation Caused by Pseudomonas syringae subsp. savastanoi on Olive Plants Is hrp-Dependent.

ABSTRACT The virulence of Pseudomonas syringae subsp. savastanoi, which causes hyperplastic symptoms (knots) on olive plants, is associated with secreted phytohormones. We identified a Tn5-induced mutant of P. syringae subsp. savastanoi that did not cause disease symptoms on olive plants although it was still able to produce phytohormones. In addition, the mutant failed to elicit a hypersensitive response in a nonhost plant. Molecular characterization of the mutant revealed that a single Tn5 insertion occurred within an open reading frame encoding a protein 92% identical to the HrcC protein of P. syringae pv. syringae. Moreover, sequence analysis revealed that the gene encoding the HrcC protein in P. syringae subsp. savastanoi was part of an operon that included five genes arranged as in other phytopathogenic bacteria. These results imply that hrp/hrc genes are functional in P. syringae subsp. savastanoi and that they play a key role in the pathogenicity of this plant pathogen.

Complicated removal of a hydatid cyst of the interventricular septum.

In a 27-year-old woman with a large hydatid cyst of the liver, an asymptomatic cardiac cyst located in the interventricular septum was discovered as well. The diagnosis was based upon echocardiography, computerized axial tomography and nuclear magnetic resonance. There was no evidence of damage to the atrioventricular conduction system or to the cardiac valves. At operation, however, the left posterior papillary muscle and chordae were firmly adherent to the cyst. Patch closure of the resulting ventricular septal defect, and mitral valve and chordae repair were necessary. The patient is alive and well 6 months after the operation, with mild residual mitral regurgitation. Precise anatomical delineation of the hydatid cyst localization within the heart, particularly in the interventricular septum, and its relations with the various cardiac structures is a difficult task, in spite of all the imaging techniques available. The surgical approach therefore has to be very careful and mindful of the potential complications.

Traumatic rupture of the thoracic aorta. (Report of two unusual cases).

Two unusual cases of traumatic aneurysm of the aorta are described. Both presented several days after thoracic trauma sustained in a car accident. The presenting features were progressing dysphagia and displacement of the oesophagus in the first case and a coarctation-like syndrome in the second. Diagnosis was confirmed in each case by aortography and emergency resection of the aneurysm with a dacron prosthesis was carried out. Aortic rupture should be considered in all cases of thoracic trauma, especially when severe, even several days after the trauma itself. Patients should be evaluated with serial chest roentgenograms and an aortography should be performed in any suspicious case. Treatment is surgical and the operative mortality and morbidity is acceptably low.

Mitral valve prolapse. Comparison between valvular repair and replacement in severe mitral regurgitation.

BACKGROUND: The aim of this study was to analyse long term results of mitral valve repair of degenerative mitral regurgitation compared to valve replacement. METHODS: A hundred-twenty-five consecutive patients with severe mitral valve insufficiency who underwent cardiac surgery from January 1987 to December 1995 were included in the study. Mean age was 55+/-16 years (77 males, 48 females). Mitral repair was performed in 62 patients and mitral valve was replaced in 63 patients. Mean follow-up was 5 years. The repair procedures were based on quadrangular resection of the posterior leaflet, chordal replacement and transposition. Annuloplasty was performed in 100% of cases. The technique of valve replacement was conventional with complete excision of the valve in the majority of cases. RESULTS: Operative mortality following valve repair was 1.6%, no death occurred in the prosthesic group. In the repair group overall survival and re-operation rate were respectively 95.2% and 6.5%, while in the replacement group were 93.7% and 7.9%. No endocarditis and thromboembolic accidents were observed following valvuloplasty, while in the prostheses 6.3% of patients had endocarditis and 1.6% had a thromboembolic event. Mild or moderate left ventricular dysfunction was present in 5 patients after valvuloplasty and in 9 patients with prostheses. CONCLUSIONS: Considering these results we conclude that, in patients with severe degenerative mitral insufficiency, mitral valve repair is warranted whenever it is possible. The advantages given by maintaining the native valve suggest that surgery should be considered in asymptomatic patients before the occurrence of the left ventricular dysfunction.